Clinical Trial: The Checklist to Prevent MRSA Surgical Site Infections

Article Type
Changed
Wed, 01/02/2019 - 10:03

 

The Checklist to Prevent MRSA Surgical Site Infections study is an interventional trial recruiting veteran patients who are undergoing or have undergone cardiac surgery or total joint arthroplasty.

The Department of Veteran Affairs has previously implemented the VA MRSA Prevention Initiative, which successfully reduced patient-to-patient MRSA transmission; however, this initiative does not prevent most MRSA surgical site infections, which are spread differently. The VA has developed a new checklist which will be tested in this study aimed at reducing MRSA surgical site infections (SSIs), and will be implemented at 10 VA medical centers.

Inclusion criteria include patients on VA databases who underwent cardiac surgery or total joint arthroplasty at VA centers within an 8-year stretch – 5 years prior to intervention and 3 years after intervention. Patients will be excluded if they have endocarditis, have an infection prior to surgery, undergo cardiac transplants or procedures performed using a percutaneous or thoracotomy approach, undergo hip or knee revisions, or have documented allergies to mupirocin.

The primary outcome measure is superficial and deep/organ space MRSA infections within 90 days of operation. Secondary outcome measures include superficial and deep/organ space MRSA infections within 1 year of operation, presurgical bundle and individual bundle components compliance for 30 days prior to operation, length of postoperative stay, all-cause mortality 1 year after surgery, readmission within 90 days of surgery, and mupirocin and chlorhexidine resistance 30 days presurgery to 90 days postsurgery.

The study will end in April 2019. More than 10,000 people are expected to be included in the final analysis.

Find more information on the study page at Clinicaltrials.gov.

Publications
Topics
Sections

 

The Checklist to Prevent MRSA Surgical Site Infections study is an interventional trial recruiting veteran patients who are undergoing or have undergone cardiac surgery or total joint arthroplasty.

The Department of Veteran Affairs has previously implemented the VA MRSA Prevention Initiative, which successfully reduced patient-to-patient MRSA transmission; however, this initiative does not prevent most MRSA surgical site infections, which are spread differently. The VA has developed a new checklist which will be tested in this study aimed at reducing MRSA surgical site infections (SSIs), and will be implemented at 10 VA medical centers.

Inclusion criteria include patients on VA databases who underwent cardiac surgery or total joint arthroplasty at VA centers within an 8-year stretch – 5 years prior to intervention and 3 years after intervention. Patients will be excluded if they have endocarditis, have an infection prior to surgery, undergo cardiac transplants or procedures performed using a percutaneous or thoracotomy approach, undergo hip or knee revisions, or have documented allergies to mupirocin.

The primary outcome measure is superficial and deep/organ space MRSA infections within 90 days of operation. Secondary outcome measures include superficial and deep/organ space MRSA infections within 1 year of operation, presurgical bundle and individual bundle components compliance for 30 days prior to operation, length of postoperative stay, all-cause mortality 1 year after surgery, readmission within 90 days of surgery, and mupirocin and chlorhexidine resistance 30 days presurgery to 90 days postsurgery.

The study will end in April 2019. More than 10,000 people are expected to be included in the final analysis.

Find more information on the study page at Clinicaltrials.gov.

 

The Checklist to Prevent MRSA Surgical Site Infections study is an interventional trial recruiting veteran patients who are undergoing or have undergone cardiac surgery or total joint arthroplasty.

The Department of Veteran Affairs has previously implemented the VA MRSA Prevention Initiative, which successfully reduced patient-to-patient MRSA transmission; however, this initiative does not prevent most MRSA surgical site infections, which are spread differently. The VA has developed a new checklist which will be tested in this study aimed at reducing MRSA surgical site infections (SSIs), and will be implemented at 10 VA medical centers.

Inclusion criteria include patients on VA databases who underwent cardiac surgery or total joint arthroplasty at VA centers within an 8-year stretch – 5 years prior to intervention and 3 years after intervention. Patients will be excluded if they have endocarditis, have an infection prior to surgery, undergo cardiac transplants or procedures performed using a percutaneous or thoracotomy approach, undergo hip or knee revisions, or have documented allergies to mupirocin.

The primary outcome measure is superficial and deep/organ space MRSA infections within 90 days of operation. Secondary outcome measures include superficial and deep/organ space MRSA infections within 1 year of operation, presurgical bundle and individual bundle components compliance for 30 days prior to operation, length of postoperative stay, all-cause mortality 1 year after surgery, readmission within 90 days of surgery, and mupirocin and chlorhexidine resistance 30 days presurgery to 90 days postsurgery.

The study will end in April 2019. More than 10,000 people are expected to be included in the final analysis.

Find more information on the study page at Clinicaltrials.gov.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM CLINICALTRIALS.GOV

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

Omalizumab for chronic urticaria quells suffocation fears

Article Type
Changed
Mon, 01/14/2019 - 10:14

 

Omalizumab for treatment of chronic spontaneous urticaria brings about a profound improvement in angioedema-related quality of life, a widely underappreciated dimension of the impairment caused by this disease, Karsten Weller, MD, said at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/Frontline Medical News
Dr. Karsten Weller
He presented key findings of the X-ACT study, a phase 3 double-blind, placebo-controlled, randomized trial of omalizumab (Xolair) for chronic spontaneous urticaria (CSU) that focused specifically on the monoclonal antibody’s effect on angioedema-related quality of life. Such a study, he added, is long overdue.

“Virtually all clinical studies of CSU in recent decades focus on the wheal and pruritus components and not on the angioedema component, even though angioedema is a frequent symptom in the disease. Roughly half of patients with CSU experience wheals and angioedema, and up to 13% experience angioedema only,” said Dr. Weller, a dermatologist at Charité University Hospital in Berlin.

“Angioedema is a major driver of quality-of-life impairment in CSU,” he continued. “We know that these are the patients who particularly suffer from the unpredictability of the disease, from disfigurement, from embarrassment. These are the patients who come to the emergency rooms, who lose working days, and these are the patients who often have the feeling of losing control over their lives.”

X-ACT was a multicenter German study which included 91 patients with moderate to severe CSU marked by at least four angioedema episodes during the 6 months prior to enrollment. Participants also had to be refractory to second-generation H1 antihistamines at two to four times the approved dose. The subjects were randomized to subcutaneous omalizumab at 300 mg every 4 weeks or placebo for 28 weeks; they were then further assessed for changes in quality of life during 8 weeks off omalizumab.

Because assessment of quality of life was such a major part of X-ACT, the investigators pulled out all the stops. Their multimodal evaluation included the Angioedema Quality of Life questionnaire – a patient-reported, 17-item instrument that is the first validated tool for evaluation of angioedema-specific quality of life – as well as the Dermatology Life Quality Index and the weekly Angioedema Activity Score.

Patients were also asked to rate on a 0-4 scale their degree of fearfulness of life-threatening swelling episodes and also their degree of fearfulness of angioedema-related suffocation. “To my knowledge, this is the first time this has been done in a randomized clinical trial,” Dr. Weller noted.

The patient reports were striking: At baseline, 49% indicated that they occasionally, often, or very often were afraid of suffocating caused by swelling episodes; only 4% of patients expressed that fear after 28 weeks on omalizumab, compared with 25% of placebo-treated controls. Similarly, at baseline two-thirds of patients reported occasionally, often, or very often being fearful of life-threatening swelling episodes, a rate that fell to 14% after 28 weeks on omalizumab, compared with 42% for controls.

Scores on the Angioedema Quality of Life Questionnaire improved continuously from a baseline of roughly 60 on a 0-100 scale – indicative of severe impairment – to less than 20 after 28 weeks on omalizumab; these scores steadily worsened again during the 8 weeks following treatment discontinuation. The Dermatology Life Quality Index scores dropped from a mean baseline of 15.6 down to 5 by week 4, remained in the 3-5 range for the remainder of the treatment period, then increased again when treatment was discontinued. The Angioedema Activity Score followed a similar pattern.

One audience member observed that the placebo response was quite strong in the study, with the percentage of patients reporting fear of suffocating caused by angioedema episodes falling from 49% at baseline to 25% after 28 weeks on placebo.

Dr. Weller replied that a potent placebo response is a consistent feature of all clinical trials of CSU therapies. The explanation, he added, is unknown.

He reported receiving research grants from and serving as a consultant to Novartis, which sponsored the X-ACT trial.
 

SOURCE: Weller K et al. EADV Congress 2017.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event
Related Articles

 

Omalizumab for treatment of chronic spontaneous urticaria brings about a profound improvement in angioedema-related quality of life, a widely underappreciated dimension of the impairment caused by this disease, Karsten Weller, MD, said at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/Frontline Medical News
Dr. Karsten Weller
He presented key findings of the X-ACT study, a phase 3 double-blind, placebo-controlled, randomized trial of omalizumab (Xolair) for chronic spontaneous urticaria (CSU) that focused specifically on the monoclonal antibody’s effect on angioedema-related quality of life. Such a study, he added, is long overdue.

“Virtually all clinical studies of CSU in recent decades focus on the wheal and pruritus components and not on the angioedema component, even though angioedema is a frequent symptom in the disease. Roughly half of patients with CSU experience wheals and angioedema, and up to 13% experience angioedema only,” said Dr. Weller, a dermatologist at Charité University Hospital in Berlin.

“Angioedema is a major driver of quality-of-life impairment in CSU,” he continued. “We know that these are the patients who particularly suffer from the unpredictability of the disease, from disfigurement, from embarrassment. These are the patients who come to the emergency rooms, who lose working days, and these are the patients who often have the feeling of losing control over their lives.”

X-ACT was a multicenter German study which included 91 patients with moderate to severe CSU marked by at least four angioedema episodes during the 6 months prior to enrollment. Participants also had to be refractory to second-generation H1 antihistamines at two to four times the approved dose. The subjects were randomized to subcutaneous omalizumab at 300 mg every 4 weeks or placebo for 28 weeks; they were then further assessed for changes in quality of life during 8 weeks off omalizumab.

Because assessment of quality of life was such a major part of X-ACT, the investigators pulled out all the stops. Their multimodal evaluation included the Angioedema Quality of Life questionnaire – a patient-reported, 17-item instrument that is the first validated tool for evaluation of angioedema-specific quality of life – as well as the Dermatology Life Quality Index and the weekly Angioedema Activity Score.

Patients were also asked to rate on a 0-4 scale their degree of fearfulness of life-threatening swelling episodes and also their degree of fearfulness of angioedema-related suffocation. “To my knowledge, this is the first time this has been done in a randomized clinical trial,” Dr. Weller noted.

The patient reports were striking: At baseline, 49% indicated that they occasionally, often, or very often were afraid of suffocating caused by swelling episodes; only 4% of patients expressed that fear after 28 weeks on omalizumab, compared with 25% of placebo-treated controls. Similarly, at baseline two-thirds of patients reported occasionally, often, or very often being fearful of life-threatening swelling episodes, a rate that fell to 14% after 28 weeks on omalizumab, compared with 42% for controls.

Scores on the Angioedema Quality of Life Questionnaire improved continuously from a baseline of roughly 60 on a 0-100 scale – indicative of severe impairment – to less than 20 after 28 weeks on omalizumab; these scores steadily worsened again during the 8 weeks following treatment discontinuation. The Dermatology Life Quality Index scores dropped from a mean baseline of 15.6 down to 5 by week 4, remained in the 3-5 range for the remainder of the treatment period, then increased again when treatment was discontinued. The Angioedema Activity Score followed a similar pattern.

One audience member observed that the placebo response was quite strong in the study, with the percentage of patients reporting fear of suffocating caused by angioedema episodes falling from 49% at baseline to 25% after 28 weeks on placebo.

Dr. Weller replied that a potent placebo response is a consistent feature of all clinical trials of CSU therapies. The explanation, he added, is unknown.

He reported receiving research grants from and serving as a consultant to Novartis, which sponsored the X-ACT trial.
 

SOURCE: Weller K et al. EADV Congress 2017.

 

Omalizumab for treatment of chronic spontaneous urticaria brings about a profound improvement in angioedema-related quality of life, a widely underappreciated dimension of the impairment caused by this disease, Karsten Weller, MD, said at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/Frontline Medical News
Dr. Karsten Weller
He presented key findings of the X-ACT study, a phase 3 double-blind, placebo-controlled, randomized trial of omalizumab (Xolair) for chronic spontaneous urticaria (CSU) that focused specifically on the monoclonal antibody’s effect on angioedema-related quality of life. Such a study, he added, is long overdue.

“Virtually all clinical studies of CSU in recent decades focus on the wheal and pruritus components and not on the angioedema component, even though angioedema is a frequent symptom in the disease. Roughly half of patients with CSU experience wheals and angioedema, and up to 13% experience angioedema only,” said Dr. Weller, a dermatologist at Charité University Hospital in Berlin.

“Angioedema is a major driver of quality-of-life impairment in CSU,” he continued. “We know that these are the patients who particularly suffer from the unpredictability of the disease, from disfigurement, from embarrassment. These are the patients who come to the emergency rooms, who lose working days, and these are the patients who often have the feeling of losing control over their lives.”

X-ACT was a multicenter German study which included 91 patients with moderate to severe CSU marked by at least four angioedema episodes during the 6 months prior to enrollment. Participants also had to be refractory to second-generation H1 antihistamines at two to four times the approved dose. The subjects were randomized to subcutaneous omalizumab at 300 mg every 4 weeks or placebo for 28 weeks; they were then further assessed for changes in quality of life during 8 weeks off omalizumab.

Because assessment of quality of life was such a major part of X-ACT, the investigators pulled out all the stops. Their multimodal evaluation included the Angioedema Quality of Life questionnaire – a patient-reported, 17-item instrument that is the first validated tool for evaluation of angioedema-specific quality of life – as well as the Dermatology Life Quality Index and the weekly Angioedema Activity Score.

Patients were also asked to rate on a 0-4 scale their degree of fearfulness of life-threatening swelling episodes and also their degree of fearfulness of angioedema-related suffocation. “To my knowledge, this is the first time this has been done in a randomized clinical trial,” Dr. Weller noted.

The patient reports were striking: At baseline, 49% indicated that they occasionally, often, or very often were afraid of suffocating caused by swelling episodes; only 4% of patients expressed that fear after 28 weeks on omalizumab, compared with 25% of placebo-treated controls. Similarly, at baseline two-thirds of patients reported occasionally, often, or very often being fearful of life-threatening swelling episodes, a rate that fell to 14% after 28 weeks on omalizumab, compared with 42% for controls.

Scores on the Angioedema Quality of Life Questionnaire improved continuously from a baseline of roughly 60 on a 0-100 scale – indicative of severe impairment – to less than 20 after 28 weeks on omalizumab; these scores steadily worsened again during the 8 weeks following treatment discontinuation. The Dermatology Life Quality Index scores dropped from a mean baseline of 15.6 down to 5 by week 4, remained in the 3-5 range for the remainder of the treatment period, then increased again when treatment was discontinued. The Angioedema Activity Score followed a similar pattern.

One audience member observed that the placebo response was quite strong in the study, with the percentage of patients reporting fear of suffocating caused by angioedema episodes falling from 49% at baseline to 25% after 28 weeks on placebo.

Dr. Weller replied that a potent placebo response is a consistent feature of all clinical trials of CSU therapies. The explanation, he added, is unknown.

He reported receiving research grants from and serving as a consultant to Novartis, which sponsored the X-ACT trial.
 

SOURCE: Weller K et al. EADV Congress 2017.

Publications
Publications
Topics
Article Type
Sections
Article Source

REPORTING FROM THE EADV CONGRESS

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: Omalizumab relieves the heavy quality-of-life burden associated with CSU.

Major finding: At baseline, 49% of CSU patients indicated they occasionally, often, or very often were afraid of suffocating due to swelling episodes; after 28 weeks on omalizumab, only 4% expressed that fear.

Study details: The X-ACT trial was a phase 3 double-blind, multicenter, placebo-controlled randomized trial including 91 patients with CSU.

Disclosures: The presenter reported receiving research grants from and serving as a consultant to Novartis, which sponsored the X-ACT trial.

Source: Weller K et al. EADV Congress 2017.

Disqus Comments
Default

The Right, and Now the Wrong of 2017

Article Type
Changed
Wed, 03/27/2019 - 11:46

In my December 2017 editorial, I presented a values-based roundup of the year. That column explained the criteria for the selections of the most right and most wrong in 2017 in terms of 3 ethical theories: utilitarianism, deontology, and virtue ethics. December featured the good in federal practice. This month, the editorial turns to the bad in federal practice.

Sadly, there were far more candidates for the ethical worst of 2017 in the DoD, VA, and PHS than those of us dedicated to federal service would wish to see. Unfortunately, this reflects both the current state of our society and the nature of the human condition.

On Sunday morning, November 5, 2017, near my hometown of San Antonio, Texas, a gunman in military gear and firearms murdered 26 people who were worshipping at a rural Baptist church. The context of this horrific offense simultaneously mocked the fidelity of our armed forces and a religious faith that in many forms has been a foundation of our nation. Leading forensic mental health experts advise against using the name of mass murderers to avoid perversely glorifying them, and I will adopt that wise convention here.1

Soon after the massacre, news organizations reported that the perpetrator had served in the Air Force, stationed in my adopted home of New Mexico. The shooter had been given a bad conduct discharge after a court-martial in 2012 found him guilty of brutally assaulting his then current wife and their child.2 More than 1 military law expert has opined that perhaps the discharge should have been dishonorable, given the brutality of the conduct, although whether that verdict would have made it more likely, the crime was reported is not certain.

The day following the mass shooting, the Air Force euphemistically acknowledged that it had made an “error,” “mistake,” in not reporting the attacker’s violent history to the federal database, which tracks such offenders to prevent them from lawfully purchasing a weapon. These words and others, such as blunder and failure, used in the media do an injustice to the worshippers’ lives lost that ill-fated morning.3

I must stop here and emphasize as strongly as possible that the selection of this attack is in no way meant to demonize the Air Force as an agency or any individual serving in it. In fact, further investigation suggested that all branches of the armed forces did not fulfill their reporting obligations under the law. Nor am I making the unprovable claim, as some politicians have hinted, that if the Air Force had followed its procedure and policy, the shooter would never have taken 26 innocent lives. Although I note that this is exactly the assumption driving a number of lawsuits brought by the victims’ families against the Air Force for its failure to follow its rules.

Rather, I chose this terrible incident because of its universality and generalizability as a paradigm of what philosopher Hannah Arendt called the banality of evil. As she wrote in her book Eichmann in Jerusalem, “There is a strange interdependence between thoughtlessness and evil.”4 Although the law must deem the attack a capital crime, ethics should see it as a the ripple effect of hundreds of small moral failures of dozens of individuals and the system that neither inspired nor held them accountable for taking routine tasks as morally serious. An Office of Special Investigations officer told CNN, “The system as it is now is personality dependent, which is obviously irresponsible and broken,” noting that accurate recording of case details depends on the discretion of individual case workers.5

Those federal workers are no better or worse than any of us. This bloody tragedy that might be dismissed as an administrative oversight powerfully demonstrates that even the smallest task matters greatly. It is the systemic, long-standing, repeated nature of the DoD’s improper reporting of servicemen and women that makes this action ethically problematic and warrants my selection as the worst event of 2018.

Major newspapers on November 7 carried a report from the Associated Press with a damning headline, “Pentagon has known of crime reporting lapses for 20 years.”6 National Public Radio reported that several Inspector General investigations had documented that over this period the DoD was not regularly reporting violent offenses to the National Criminal Information Center database as mandated. A Fordham law professor and gun regulation specialist quoted on the program zeroed in on an absence of accountability as the leadership flaw that permitted rank and file staff to ignore their protocols. “It’s a ‘who’s watching the watchers’ kind of issue,” he said. “There is no oversight over the Air Force or over the FBI that demands that these regulatory obligations are actually followed through with.”7

Finally, after the tragedy, it was discovered that the Air Force had not just 1 but 2 chances to prevent the gunman from future firearm purchases. The shooter had escaped from a psychiatric facility—his status in the psychiatric hospital was unclear—but it is known that he was admitted after he had smuggled weapons onto the base and threatened to kill his commanders. His hospitalization should have been reported to the national database, which would have raised a red flag when he tried to buy guns.8

Each of the hundreds of prosaic decisions that indirectly contributed to the Texas shooting was borne of a juggernaut of small compromises from procrustean bureaucratic leadership at the top to mindless conformity at the bottom: a breach all 3 ethical theories. Even if 1 unfiled report leads to no untoward outcome, it is clear that for utilitarianism, it is safer and sounder public policy to take lawful steps to prevent individuals with violent pasts and the potential to kill others from purchasing firearms. Deontologically, whether by omission or commission, not reporting such individuals violates the duty of veracity, as it withholds the truth from those who have a right to possess it. Finally, for this horror to be possible, many people had to not act with integrity, accountability, and trustworthiness.

Many may criticize my a choice to begin the new year so inauspiciously drawing attention to ethical failures and such a malicious crime. I would counter this criticism with the contention that a sober analysis of serious moral lapses in terms of the ethical theory introduced last month is a most salutatory welcome to 2018. So as we embark upon a new year in federal practice, let us strive not only for clinical expertise and administrative efficiency, but also for moral excellence.

References

1. Pies RW. After Las Vegas, the danger of copy-cat murders. Psychiatric Times. November 14, 2017. http://www.psychiatrictimes.com/blogs/couch-crisis/after-las-vegas-danger -copy-cat-killers. Accessed December 16, 2017.

2. Horton A. The Air Force says it failed to follow procedures, allowing Texas church shooter to obtain firearms. The Washington Post. November 7, 2017. https://www.washingtonpost .com/news/checkpoint/wp/2017/11/06/the-air-force-says-it -failed-to-follow-procedures-allowing-texas-church-shooter -to-obtain-firearms/. Accessed December 17, 2017.

3. Montgomery D, Mele C, Fernandez M. Gunman kills at least 26 in attack on rural Texas church. The New York Times. November 5, 2017. https://www.nytimes.com/2017/11/05/us/church-shooting-texas.html Accessed December 16, 2017.

4. Arendt H. Eichmann in Jerusalem: A Report on the Banality of Evil. London: Penguin;1977.

5. Cohen Z, Devine C. Failure to report Texas gunman’s record reflects systemic problem, sources say.” CNN Politics. November 10, 2017. http://www.cnn.com/2017/11/10/politics/us-military-crime-database-flaws-texas-church-shooting/index.html Accessed December 17, 2017.

6. Burns R. Pentagon has known of crime reporting lapses for 20 years. Chicago Tribune/Associated Press. November 7, 2017. http://www.chicagotribune.com/news/nationworld/ct -texas-church-shooter-air-force-mattis-20171107-story.html. Accessed December 17, 2017.

7. Domonoske C. Oversight groups have repeatedly identified flaws in military crime reporting. NPR. November 19, 2017. https://www.npr.org/sections/thetwo-way/2017/11/19/564792784/oversight-groups-have-repeatedly-identified-flaws-in-military-crime-reporting. Accessed December 16, 2017

8. Romero S, Blinder A, Pérez-Pena R. Texas gunman once escaped from mental health facility. The New York Times. November 7, 2017. https://www.nytimes.com/2017/11/07/us /texas-shooting-church.html. Accessed December 17, 2017.

Article PDF
Author and Disclosure Information

Cynthia M.A. Geppert, MD, Editor-in-Chief
Correspondence: Cynthia Geppert ([email protected])

Author Disclosure
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and does not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

Issue
Federal Practitioner - 35(1)a
Publications
Topics
Page Number
14-15
Sections
Author and Disclosure Information

Cynthia M.A. Geppert, MD, Editor-in-Chief
Correspondence: Cynthia Geppert ([email protected])

Author Disclosure
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and does not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

Author and Disclosure Information

Cynthia M.A. Geppert, MD, Editor-in-Chief
Correspondence: Cynthia Geppert ([email protected])

Author Disclosure
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and does not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

Article PDF
Article PDF

In my December 2017 editorial, I presented a values-based roundup of the year. That column explained the criteria for the selections of the most right and most wrong in 2017 in terms of 3 ethical theories: utilitarianism, deontology, and virtue ethics. December featured the good in federal practice. This month, the editorial turns to the bad in federal practice.

Sadly, there were far more candidates for the ethical worst of 2017 in the DoD, VA, and PHS than those of us dedicated to federal service would wish to see. Unfortunately, this reflects both the current state of our society and the nature of the human condition.

On Sunday morning, November 5, 2017, near my hometown of San Antonio, Texas, a gunman in military gear and firearms murdered 26 people who were worshipping at a rural Baptist church. The context of this horrific offense simultaneously mocked the fidelity of our armed forces and a religious faith that in many forms has been a foundation of our nation. Leading forensic mental health experts advise against using the name of mass murderers to avoid perversely glorifying them, and I will adopt that wise convention here.1

Soon after the massacre, news organizations reported that the perpetrator had served in the Air Force, stationed in my adopted home of New Mexico. The shooter had been given a bad conduct discharge after a court-martial in 2012 found him guilty of brutally assaulting his then current wife and their child.2 More than 1 military law expert has opined that perhaps the discharge should have been dishonorable, given the brutality of the conduct, although whether that verdict would have made it more likely, the crime was reported is not certain.

The day following the mass shooting, the Air Force euphemistically acknowledged that it had made an “error,” “mistake,” in not reporting the attacker’s violent history to the federal database, which tracks such offenders to prevent them from lawfully purchasing a weapon. These words and others, such as blunder and failure, used in the media do an injustice to the worshippers’ lives lost that ill-fated morning.3

I must stop here and emphasize as strongly as possible that the selection of this attack is in no way meant to demonize the Air Force as an agency or any individual serving in it. In fact, further investigation suggested that all branches of the armed forces did not fulfill their reporting obligations under the law. Nor am I making the unprovable claim, as some politicians have hinted, that if the Air Force had followed its procedure and policy, the shooter would never have taken 26 innocent lives. Although I note that this is exactly the assumption driving a number of lawsuits brought by the victims’ families against the Air Force for its failure to follow its rules.

Rather, I chose this terrible incident because of its universality and generalizability as a paradigm of what philosopher Hannah Arendt called the banality of evil. As she wrote in her book Eichmann in Jerusalem, “There is a strange interdependence between thoughtlessness and evil.”4 Although the law must deem the attack a capital crime, ethics should see it as a the ripple effect of hundreds of small moral failures of dozens of individuals and the system that neither inspired nor held them accountable for taking routine tasks as morally serious. An Office of Special Investigations officer told CNN, “The system as it is now is personality dependent, which is obviously irresponsible and broken,” noting that accurate recording of case details depends on the discretion of individual case workers.5

Those federal workers are no better or worse than any of us. This bloody tragedy that might be dismissed as an administrative oversight powerfully demonstrates that even the smallest task matters greatly. It is the systemic, long-standing, repeated nature of the DoD’s improper reporting of servicemen and women that makes this action ethically problematic and warrants my selection as the worst event of 2018.

Major newspapers on November 7 carried a report from the Associated Press with a damning headline, “Pentagon has known of crime reporting lapses for 20 years.”6 National Public Radio reported that several Inspector General investigations had documented that over this period the DoD was not regularly reporting violent offenses to the National Criminal Information Center database as mandated. A Fordham law professor and gun regulation specialist quoted on the program zeroed in on an absence of accountability as the leadership flaw that permitted rank and file staff to ignore their protocols. “It’s a ‘who’s watching the watchers’ kind of issue,” he said. “There is no oversight over the Air Force or over the FBI that demands that these regulatory obligations are actually followed through with.”7

Finally, after the tragedy, it was discovered that the Air Force had not just 1 but 2 chances to prevent the gunman from future firearm purchases. The shooter had escaped from a psychiatric facility—his status in the psychiatric hospital was unclear—but it is known that he was admitted after he had smuggled weapons onto the base and threatened to kill his commanders. His hospitalization should have been reported to the national database, which would have raised a red flag when he tried to buy guns.8

Each of the hundreds of prosaic decisions that indirectly contributed to the Texas shooting was borne of a juggernaut of small compromises from procrustean bureaucratic leadership at the top to mindless conformity at the bottom: a breach all 3 ethical theories. Even if 1 unfiled report leads to no untoward outcome, it is clear that for utilitarianism, it is safer and sounder public policy to take lawful steps to prevent individuals with violent pasts and the potential to kill others from purchasing firearms. Deontologically, whether by omission or commission, not reporting such individuals violates the duty of veracity, as it withholds the truth from those who have a right to possess it. Finally, for this horror to be possible, many people had to not act with integrity, accountability, and trustworthiness.

Many may criticize my a choice to begin the new year so inauspiciously drawing attention to ethical failures and such a malicious crime. I would counter this criticism with the contention that a sober analysis of serious moral lapses in terms of the ethical theory introduced last month is a most salutatory welcome to 2018. So as we embark upon a new year in federal practice, let us strive not only for clinical expertise and administrative efficiency, but also for moral excellence.

In my December 2017 editorial, I presented a values-based roundup of the year. That column explained the criteria for the selections of the most right and most wrong in 2017 in terms of 3 ethical theories: utilitarianism, deontology, and virtue ethics. December featured the good in federal practice. This month, the editorial turns to the bad in federal practice.

Sadly, there were far more candidates for the ethical worst of 2017 in the DoD, VA, and PHS than those of us dedicated to federal service would wish to see. Unfortunately, this reflects both the current state of our society and the nature of the human condition.

On Sunday morning, November 5, 2017, near my hometown of San Antonio, Texas, a gunman in military gear and firearms murdered 26 people who were worshipping at a rural Baptist church. The context of this horrific offense simultaneously mocked the fidelity of our armed forces and a religious faith that in many forms has been a foundation of our nation. Leading forensic mental health experts advise against using the name of mass murderers to avoid perversely glorifying them, and I will adopt that wise convention here.1

Soon after the massacre, news organizations reported that the perpetrator had served in the Air Force, stationed in my adopted home of New Mexico. The shooter had been given a bad conduct discharge after a court-martial in 2012 found him guilty of brutally assaulting his then current wife and their child.2 More than 1 military law expert has opined that perhaps the discharge should have been dishonorable, given the brutality of the conduct, although whether that verdict would have made it more likely, the crime was reported is not certain.

The day following the mass shooting, the Air Force euphemistically acknowledged that it had made an “error,” “mistake,” in not reporting the attacker’s violent history to the federal database, which tracks such offenders to prevent them from lawfully purchasing a weapon. These words and others, such as blunder and failure, used in the media do an injustice to the worshippers’ lives lost that ill-fated morning.3

I must stop here and emphasize as strongly as possible that the selection of this attack is in no way meant to demonize the Air Force as an agency or any individual serving in it. In fact, further investigation suggested that all branches of the armed forces did not fulfill their reporting obligations under the law. Nor am I making the unprovable claim, as some politicians have hinted, that if the Air Force had followed its procedure and policy, the shooter would never have taken 26 innocent lives. Although I note that this is exactly the assumption driving a number of lawsuits brought by the victims’ families against the Air Force for its failure to follow its rules.

Rather, I chose this terrible incident because of its universality and generalizability as a paradigm of what philosopher Hannah Arendt called the banality of evil. As she wrote in her book Eichmann in Jerusalem, “There is a strange interdependence between thoughtlessness and evil.”4 Although the law must deem the attack a capital crime, ethics should see it as a the ripple effect of hundreds of small moral failures of dozens of individuals and the system that neither inspired nor held them accountable for taking routine tasks as morally serious. An Office of Special Investigations officer told CNN, “The system as it is now is personality dependent, which is obviously irresponsible and broken,” noting that accurate recording of case details depends on the discretion of individual case workers.5

Those federal workers are no better or worse than any of us. This bloody tragedy that might be dismissed as an administrative oversight powerfully demonstrates that even the smallest task matters greatly. It is the systemic, long-standing, repeated nature of the DoD’s improper reporting of servicemen and women that makes this action ethically problematic and warrants my selection as the worst event of 2018.

Major newspapers on November 7 carried a report from the Associated Press with a damning headline, “Pentagon has known of crime reporting lapses for 20 years.”6 National Public Radio reported that several Inspector General investigations had documented that over this period the DoD was not regularly reporting violent offenses to the National Criminal Information Center database as mandated. A Fordham law professor and gun regulation specialist quoted on the program zeroed in on an absence of accountability as the leadership flaw that permitted rank and file staff to ignore their protocols. “It’s a ‘who’s watching the watchers’ kind of issue,” he said. “There is no oversight over the Air Force or over the FBI that demands that these regulatory obligations are actually followed through with.”7

Finally, after the tragedy, it was discovered that the Air Force had not just 1 but 2 chances to prevent the gunman from future firearm purchases. The shooter had escaped from a psychiatric facility—his status in the psychiatric hospital was unclear—but it is known that he was admitted after he had smuggled weapons onto the base and threatened to kill his commanders. His hospitalization should have been reported to the national database, which would have raised a red flag when he tried to buy guns.8

Each of the hundreds of prosaic decisions that indirectly contributed to the Texas shooting was borne of a juggernaut of small compromises from procrustean bureaucratic leadership at the top to mindless conformity at the bottom: a breach all 3 ethical theories. Even if 1 unfiled report leads to no untoward outcome, it is clear that for utilitarianism, it is safer and sounder public policy to take lawful steps to prevent individuals with violent pasts and the potential to kill others from purchasing firearms. Deontologically, whether by omission or commission, not reporting such individuals violates the duty of veracity, as it withholds the truth from those who have a right to possess it. Finally, for this horror to be possible, many people had to not act with integrity, accountability, and trustworthiness.

Many may criticize my a choice to begin the new year so inauspiciously drawing attention to ethical failures and such a malicious crime. I would counter this criticism with the contention that a sober analysis of serious moral lapses in terms of the ethical theory introduced last month is a most salutatory welcome to 2018. So as we embark upon a new year in federal practice, let us strive not only for clinical expertise and administrative efficiency, but also for moral excellence.

References

1. Pies RW. After Las Vegas, the danger of copy-cat murders. Psychiatric Times. November 14, 2017. http://www.psychiatrictimes.com/blogs/couch-crisis/after-las-vegas-danger -copy-cat-killers. Accessed December 16, 2017.

2. Horton A. The Air Force says it failed to follow procedures, allowing Texas church shooter to obtain firearms. The Washington Post. November 7, 2017. https://www.washingtonpost .com/news/checkpoint/wp/2017/11/06/the-air-force-says-it -failed-to-follow-procedures-allowing-texas-church-shooter -to-obtain-firearms/. Accessed December 17, 2017.

3. Montgomery D, Mele C, Fernandez M. Gunman kills at least 26 in attack on rural Texas church. The New York Times. November 5, 2017. https://www.nytimes.com/2017/11/05/us/church-shooting-texas.html Accessed December 16, 2017.

4. Arendt H. Eichmann in Jerusalem: A Report on the Banality of Evil. London: Penguin;1977.

5. Cohen Z, Devine C. Failure to report Texas gunman’s record reflects systemic problem, sources say.” CNN Politics. November 10, 2017. http://www.cnn.com/2017/11/10/politics/us-military-crime-database-flaws-texas-church-shooting/index.html Accessed December 17, 2017.

6. Burns R. Pentagon has known of crime reporting lapses for 20 years. Chicago Tribune/Associated Press. November 7, 2017. http://www.chicagotribune.com/news/nationworld/ct -texas-church-shooter-air-force-mattis-20171107-story.html. Accessed December 17, 2017.

7. Domonoske C. Oversight groups have repeatedly identified flaws in military crime reporting. NPR. November 19, 2017. https://www.npr.org/sections/thetwo-way/2017/11/19/564792784/oversight-groups-have-repeatedly-identified-flaws-in-military-crime-reporting. Accessed December 16, 2017

8. Romero S, Blinder A, Pérez-Pena R. Texas gunman once escaped from mental health facility. The New York Times. November 7, 2017. https://www.nytimes.com/2017/11/07/us /texas-shooting-church.html. Accessed December 17, 2017.

References

1. Pies RW. After Las Vegas, the danger of copy-cat murders. Psychiatric Times. November 14, 2017. http://www.psychiatrictimes.com/blogs/couch-crisis/after-las-vegas-danger -copy-cat-killers. Accessed December 16, 2017.

2. Horton A. The Air Force says it failed to follow procedures, allowing Texas church shooter to obtain firearms. The Washington Post. November 7, 2017. https://www.washingtonpost .com/news/checkpoint/wp/2017/11/06/the-air-force-says-it -failed-to-follow-procedures-allowing-texas-church-shooter -to-obtain-firearms/. Accessed December 17, 2017.

3. Montgomery D, Mele C, Fernandez M. Gunman kills at least 26 in attack on rural Texas church. The New York Times. November 5, 2017. https://www.nytimes.com/2017/11/05/us/church-shooting-texas.html Accessed December 16, 2017.

4. Arendt H. Eichmann in Jerusalem: A Report on the Banality of Evil. London: Penguin;1977.

5. Cohen Z, Devine C. Failure to report Texas gunman’s record reflects systemic problem, sources say.” CNN Politics. November 10, 2017. http://www.cnn.com/2017/11/10/politics/us-military-crime-database-flaws-texas-church-shooting/index.html Accessed December 17, 2017.

6. Burns R. Pentagon has known of crime reporting lapses for 20 years. Chicago Tribune/Associated Press. November 7, 2017. http://www.chicagotribune.com/news/nationworld/ct -texas-church-shooter-air-force-mattis-20171107-story.html. Accessed December 17, 2017.

7. Domonoske C. Oversight groups have repeatedly identified flaws in military crime reporting. NPR. November 19, 2017. https://www.npr.org/sections/thetwo-way/2017/11/19/564792784/oversight-groups-have-repeatedly-identified-flaws-in-military-crime-reporting. Accessed December 16, 2017

8. Romero S, Blinder A, Pérez-Pena R. Texas gunman once escaped from mental health facility. The New York Times. November 7, 2017. https://www.nytimes.com/2017/11/07/us /texas-shooting-church.html. Accessed December 17, 2017.

Issue
Federal Practitioner - 35(1)a
Issue
Federal Practitioner - 35(1)a
Page Number
14-15
Page Number
14-15
Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Article PDF Media

No Sulfates, No Parabens, and the “No-Poo” Method: A New Patient Perspective on Common Shampoo Ingredients

Article Type
Changed
Thu, 10/29/2020 - 14:53
Display Headline
No Sulfates, No Parabens, and the “No-Poo” Method: A New Patient Perspective on Common Shampoo Ingredients
In Collaboration with the Skin of Color Society

Shampoo is a staple in hair grooming that is ever-evolving along with cultural trends. The global shampoo market is expected to reach an estimated value of $25.73 billion by 2019. A major driver of this upward trend in market growth is the increasing demand for natural and organic hair shampoos.1 Society today has a growing fixation on healthy living practices, and as of late, the ingredients in shampoos and other cosmetic products have become one of the latest targets in the health-consciousness craze. In the age of the Internet where information—and misinformation—is widely accessible and dispersed, the general public often strives to self-educate on specialized matters that are out of their expertise. As a result, individuals have developed an aversion to using certain shampoos out of fear that the ingredients, often referred to as “chemicals” by patients due to their complex names, are unnatural and therefore unhealthy.1,2 Product developers are working to meet the demand by reformulating shampoos with labels that indicate sulfate free or paraben free, despite the lack of proof that these formulations are an improvement over traditional approaches to hair health. Additionally, alternative methods of cleansing the hair and scalp, also known as the no-shampoo or “no-poo” method, have begun to gain popularity.2,3


It is essential that dermatologists acknowledge the concerns that their patients have about common shampoo ingredients to dispel the myths that may misinform patient decision-making. This article reviews the controversy surrounding the use of sulfates and parabens in shampoos as well as commonly used shampoo alternatives. Due to the increased prevalence of dry hair shafts in the skin of color population, especially black women, this group is particularly interested in products that will minimize breakage and dryness of the hair. To that end, this population has great interest in the removal of chemical ingredients that may cause damage to the hair shafts, despite the lack of data to support sulfates and paraben damage to hair shafts or scalp skin. Blogs and uninformed hairstylists may propagate these beliefs in a group of consumers who are desperate for new approaches to hair fragility and breakage.

Surfactants and Sulfates

The cleansing ability of a shampoo depends on the surface activity of its detergents. Surface-active ingredients, or surfactants, reduce the surface tension between water and dirt, thus facilitating the removal of environmental dirt from the hair and scalp,4 which is achieved by a molecular structure containing both a hydrophilic and a lipophilic group. Sebum and dirt are bound by the lipophilic ends of the surfactant, becoming the center of a micelle structure with the hydrophilic molecule ends pointing outward. Dirt particles become water soluble and are removed from the scalp and hair shaft upon rinsing with water.4

Surfactants are classified according to the electric charge of the hydrophilic polar group as either anionic, cationic, amphoteric (zwitterionic), or nonionic.5 Each possesses different hair conditioning and cleansing qualities, and multiple surfactants are used in shampoos in differing ratios to accommodate different hair types. In most shampoos, the base consists of anionic and amphoteric surfactants. Depending on individual product requirements, nonionic and cationic surfactants are used to either modify the effects of the surfactants or as conditioning agents.4,5

One subcategory of surfactants that receives much attention is the group of anionic surfactants known as sulfates. Sulfates, particularly sodium lauryl sulfate (SLS), recently have developed a negative reputation as cosmetic ingredients, as reports from various unscientific sources have labeled them as hazardous to one’s health; SLS has been described as a skin and scalp irritant, has been linked to cataract formation, and has even been wrongly labeled as carcinogenic.6 The origins of some of these claims are not clear, though they likely arose from the misinterpretation of complex scientific studies that are easily accessible to laypeople. The link between SLS and ocular irritation or cataract formation is a good illustration of this unsubstantiated fear. A study by Green et al7 showed that corneal exposure to extremely high concentrations of SLS following physical or chemical damage to the eye can result in a slowed healing process. The results of this study have since been wrongly quoted to state that SLS-containing products lead to blindness or severe corneal damage.8 A different study tested for possible ocular irritation in vivo by submerging the lens of an eye into a 20% SLS solution, which accurately approximates the concentration of SLS in rinse-off consumer products.9 However, to achieve ocular irritation, the eyes of laboratory animals were exposed to SLS constantly for 14 days, which would not occur in practical use.9 Similarly, a third study achieved cataract formation in a laboratory only by immersing the lens of an eye into a highly concentrated solution of SLS.10 Such studies are not appropriate representations of how SLS-containing products are used by consumers and have unfortunately been vulnerable to misinterpretation by the general public.

There is no known study that has shown SLS to be carcinogenic. One possible origin of this idea may be from the wrongful interpretation of studies that used SLS as a vehicle substance to test agents that were deemed to be carcinogenic.11 Another possible source of the idea that SLS is carcinogenic comes from its association with 1,4-dioxane, a by-product of the synthesis of certain sulfates such as sodium laureth sulfate due to a process known as ethoxylation.6,12 Although SLS does not undergo this process in its formation and is not linked to 1,4-dioxane, there is potential for cross-contamination of SLS with 1,4-dioxane, which cannot be overlooked. 1,4-Dioxane is classified as “possibly carcinogenic to humans (Group 2B)” by the International Agency for Research on Cancer,13 but screening of SLS for this substance prior to its use in commercial products is standard.

Sulfates are inexpensive detergents that are responsible for lather formation in shampoos as well as in many household cleaning agents.5 Sulfates, similar to all anionic surfactants, are characterized by a negatively charged hydrophilic polar group. The best-known and most commonly used anionic surfactants are sulfated fatty alcohols, alkyl sulfates, and their polyethoxylated analogues alkyl ether sulfates.5,6 Sodium lauryl sulfate (also known as sodium laurilsulfate or sodium dodecyl sulfate) is the most common of them all, found in shampoo and conditioner formulations. Ammonium lauryl sulfate and sodium laureth sulfate are other sulfates commonly used in shampoos and household cleansing products. Sodium lauryl sulfate is a nonvolatile, water-soluble compound. Its partition coefficient (P0), a measure of a substance’s hydrophilic or lipophilic nature, is low at 1.6, making it a rather hydrophilic substance.6 Hydrophilic substances tend to have low bioaccumulation profiles in the body. Additionally, SLS is readily biodegradable. It can be derived from both synthetic and naturally occurring sources; for example, palm kernel oil, petrolatum, and coconut oil are all sources of lauric acid, the starting ingredient used to synthesize SLS. Sodium lauryl sulfate is created by reacting lauryl alcohol with sulfur trioxide gas, followed by neutralization with sodium carbonate (also a naturally occurring compound).6 Sodium lauryl sulfate and other sulfate-containing shampoos widely replaced the usage of traditional soaps formulated from animal or vegetable fats, as these latter formations created a film of insoluble calcium salts on the hair strands upon contact with water, resulting in tangled, dull-appearing hair.5 Additionally, sulfates were preferred to the alkaline pH of traditional soap, which can be harsh on hair strands and cause irritation of the skin and mucous membranes.14 Because they are highly water soluble, sulfates enable the formulation of clear shampoos. They exhibit remarkable cleaning properties and lather formation.5,14

Because sulfates are potent surfactants, they can remove dirt and debris as well as naturally produced healthy oils from the hair and scalp. As a result, sulfates can leave the hair feeling dry and stripped of moisture.4,5 Sulfates are used as the primary detergents in the formulation of deep-cleaning shampoos, which are designed for people who accumulate a heavy buildup of dirt, sebum, and debris from frequent use of styling products. Due to their potent detergency, these shampoos typically are not used on a daily basis but rather at longer intervals.15 A downside to sulfates is that they can have cosmetically unpleasant properties, which can be compensated for by including appropriate softening additives in shampoo formulations.4 A number of anionic surfactants such as olefin sulfonate, alkyl sulfosuccinate, acyl peptides, and alkyl ether carboxylates are well tolerated by the skin and are used together with other anionic and amphoteric surfactants to optimize shampoo properties. Alternatively, sulfate-free shampoos are cleansers compounded by the removal of the anionic group and switched for surfactants with less detergency.4,5

 

 

Preservatives and Parabens

Parabens refer to a group of esters of 4-hydroxybenzoic acid commonly used as preservatives in foods, pharmaceuticals, and cosmetics whose widespread use dates back to 1923.16 Concerns over the presence of parabens in shampoos and other cosmetics have been raised by patients for their reputed estrogenic and antiandrogenic effects and suspected involvement in carcinogenesis via endocrine modulation.16,17 In in vitro studies done on yeast assays, parabens have shown weak estrogenic activity that increases in proportion to both the length and increased branching of the alkyl side chains in the paraben’s molecular structure.18 They are 10,000-fold less potent than 17β-estradiol. In in vivo animal studies, parabens show weak estrogenic activity and are 100,000-fold less potent than 17β-estradiol.18 4-Hydroxybenzoic acid, a common metabolite, showed no estrogenic activity when tested both in vitro and in vivo.19 Some concerning research has implicated a link between parabens used in underarm cosmetics, such as deodorants and antiperspirants, and breast cancer16; however, the studies have been conflicting, and there is simply not enough data to assert that parabens cause breast cancer.

The Cosmetic Ingredient Review expert panel first reviewed parabens in 1984 and concluded that “methylparaben, ethylparaben, propylparaben, and butylparaben are safe as cosmetic ingredients in the present practices of use.”20 They extended this statement to include isopropylparaben and isobutylparaben in a later review.21 In 2005, the Scientific Committee on Consumer Products (now known as the Scientific Committee for Consumer Safety) in Europe stated that methylparaben and ethylparaben can be used at levels up to 0.4% in products.22 This decision was reached due to reports of decreased sperm counts and testosterone levels in male juvenile rats exposed to these parabens; however, these reults were not successfully replicated in larger studies.16,22 In 2010, the Scientific Committee for Consumer Safety revisited its stance on parabens, and they then revised their recommendations to say that concentrations of propylparaben and butylparaben should not exceed concentrations of 0.19%, based on “the conservative choice for the calculation of the [Margin-of-Safety] of butyl- and propylparaben.”23 However, in 2011 the use of propylparaben and butylparaben was banned in Denmark for cosmetic products used in children 3 years or younger,16 and the European Commission subsequently amended their directive in 2014, banning isopropylparaben, isobutylparaben, phenylparaben, benzylparaben, and pentylparaben due to lack of data available to evaluate the human risk of these products.24

Contrary to the trends in Europe, there currently are no regulations against the use of parabens in shampoos or other cosmetics in the United States. The American Cancer Society found that there is no evidence to suggest that the current levels of parabens in cosmetic products (eg, antiperspirants) increase one’s risk of breast cancer.25 Parabens are readily absorbed into the body both transdermally and through ingestion but also are believed to be rapidly transformed into harmless and nonspecific metabolites; they are readily metabolized by the liver and excreted in urine, and there is no measured accumulation in tissues.17

Parabens continue to be the most widely used preservatives in personal care products, usually in conjunction with other preservatives. Parabens are good biocides; short-chain esters (eg, methylparabens, ethylparabens) are effective against gram-positive bacteria and are weakly effective against gram-negative bacteria. Long-chain paraben esters (eg, propylparabens, butylparabens) are effective against mold and yeast. The addition of other preservatives creates a broad spectrum of antimicrobial defense in consumer products. Other preservatives include formaldehyde releasers or phenoxyethanol, as well as chelating agents such as EDTA, which improve the stability of these cosmetic products when exposed to air.16 Parabens are naturally occurring substances found in foods such as blueberries, barley, strawberries, yeast, olives, and grapes. As a colorless, odorless, and inexpensive substance, their use has been heavily favored in cosmetic and food products.16

 

 

Shampoo Alternatives and the No-Poo Method

Although research has not demonstrated any long-term danger to using shampoo, certain chemicals found in shampoos have the potential to irritate the scalp. Commonly cited allergens in shampoos include cocamidopropyl betaine, propylene glycol, vitamin E (tocopherol), parabens, and benzophenones.5 Additionally, the rising use of formaldehyde-releasing preservatives and isothiazolinones due to mounting pressures to move away from parabens has led to an increase in cases of allergic contact dermatitis (ACD).16 However, the irritability (rather than allergenicity) of these substances often is established during patch testing, a method of detecting delayed-type allergic reactions, which is important to note because patch testing requires a substance to be exposed to the skin for 24 to 48 hours, whereas exposure to shampoo ingredients may last a matter of minutes at most and occur in lesser concentrations because the ingredients are diluted by water in the rinsing process. Given these differences, it is unlikely that a patient would develop a true allergic response from regular shampoo use. Nevertheless, in patients who are already sensitized, exposure could conceivably trigger ACD, and patients must be cognizant of the composition of their shampoos.16

The no-poo method refers to the avoidance of commercial shampoo products when cleansing the hair and scalp and encompasses different methods of cleansing the hair, such as the use of household items (eg, baking soda, apple cider vinegar [ACV]), the use of conditioners to wash the hair (also known as conditioner-only washing or co-washing), treating the scalp with tea tree oil, or simply rinsing the hair with water. Proponents of the no-poo method believe that abstaining from shampoo use leads to healthier hair, retained natural oils, and less exposure to supposedly dangerous chemicals such as parabens or sulfates.2,3,26-28 However, there are no known studies in the literature that assess or support the hypotheses of the no-poo method.

Baking Soda and ACV
Baking soda (sodium bicarbonate) is a substance commonly found in the average household. It has been used in toothpaste formulas and cosmetic products and is known for its acid-neutralizing properties. Baking soda has been shown to have some antifungal and viricidal properties through an unknown mechanism of action.28 It has gained popularity for its use as a means of reducing the appearance of excessive greasiness of the hair shafts. Users also have reported that when washing their hair with baking soda, they are able to achieve a clean scalp and hair that feels soft to the touch.2,3,26,27,29 Despite these reports, users must beware of using baking soda without adequately diluting it with water. Baking soda is a known alkaline irritant.26,30 With a pH of 9, baking soda causes the cuticle layer of the hair fiber to open, increasing the capacity for water absorption. Water penetrates the scales that open, breaking the hydrogen bonds of the keratin molecule.31 Keratin is a spiral helical molecule that keeps its shape due to hydrogen, disulfide, and ionic bonds, as well as Van der Waals force.30 Hydrolysis of these bonds due to exposure to baking soda lowers the elasticity of the hair and increases the negative electrical net charge of the hair fiber surface, which leads to increased friction between fibers, cuticle damage, hair fragility, and fiber breakage.32,33

Apple cider vinegar is an apple-derived acetic acid solution with a pH ranging from 3.1 to 5.28 The pH range of ACV is considered to be ideal for hair by no-poo proponents, as it is similar to the natural pH of the scalp. Its acidic properties are responsible for its antimicrobial abilities, particularly its effectiveness against gram-negative bacteria.30 The acetic acid of ACV can partially interrupt oil interfaces, which contributes to its mild ability to remove product residue and scalp buildup from the hair shaft; the acetic acid also tightens the cuticles on hair fibers.33 Apple cider vinegar is used as a means of cleansing the hair and scalp by no-poo proponents2,3,26; other uses for ACV include using it as a rinse following washing and/or conditioning of the hair or as a means of preserving color in color-treated hair. There also is evidence that ACV may have antifungal properties.28 However, consumers must be aware that if it is not diluted in water, ACV may be too caustic for direct application to the hair and may lead to damage; it can be irritating to eyes, mucus membranes, and acutely inflamed skin. Also, vinegar rinses used on processed or chemically damaged hair may lead to increased hair fragility.2,3

Hair fibers have a pH of 3.67, while the scalp has a pH between 4.5 and 6.2. This slightly acidic film acts as a barrier to viruses, bacteria, and other potential contaminants.33 Studies have shown that the pH of skin increases in proportion to the pH of the cleanser used.34 Therefore, due to the naturally acidic pH of the scalp, acid-balanced shampoos generally are recommended. Shampoos should not have a pH higher than 5.5, as hair shafts can swell due to alkalinization, which can be prevented by pH balancing the shampoo through the addition of an acidic substance (eg, glycolic acid, citric acid) to lower the pH down to approximately 5.5. Apple cider vinegar often is used for this purpose. However, one study revealed that 82% of shampoos already have an acidic pH.34

Conditioner-Only Washing (Co-washing)
Conditioner-only washing, or co-washing, is a widely practiced method of hair grooming. It is popular among individuals who find that commercial shampoos strip too much of the natural hair oils away, leaving the hair rough or unmanageable. Co-washing is not harmful to the hair; however, the molecular structure and function of a conditioner and that of a shampoo are very different.5,35,36 Conditioners are not formulated to remove dirt and buildup in the hair but rather to add substances to the hair, and thus cannot provide extensive cleansing of the hair and scalp; therefore, it is inappropriate to use co-washing as a replacement for shampooing. Quaternary conditioning agents are an exception because they contain amphoteric detergents comprised of both anionic and cationic groups, which allow them both the ability to remove dirt and sebum with its anionic group, typically found in shampoos, as well as the ability to coat and condition the hair due to the high affinity of the cationic group for the negatively charged hair fibers.36,37 Amphoteric detergents are commonly found in 2-in-1 conditioning cleansers, among other ingredients, such as hydrolyzed animal proteins that temporarily plug surface defects on the hair fiber, and dimethicone, a synthetic oil that creates a thin film over the hair shaft, increasing shine and manageability. Of note, these conditioning shampoos are ideal for individuals with minimal product buildup on the hair and scalp and are not adequate scalp cleansers for individuals who either wash their hair infrequently or who regularly use hairstyling products.36,37

Tea Tree Oil
Tea tree oil is an essential oil extracted from the Melaleuca alternifolia plant of the Myrtaceae family. It is native to the coast of northeastern Australia. A holy grail of natural cosmetics, tea tree oil is widely known for its antiviral, antifungal, and antiseptic properties.38 Although not used as a stand-alone cleanser, it is often added to a number of cosmetic products, including shampoos and co-washes. Although deemed safe for topical use, it has been shown to be quite toxic when ingested. Symptoms of ingestion include nausea, vomiting, hallucinations, and coma. The common concern with tea tree oil is its ability to cause ACD. In particular, it is believed that the oxidation products of tea tree oil are allergenic rather than the tea tree oil itself. The evaluation of tea tree oil as a potential contact allergen has been quite difficult; it consists of more than 100 distinct compounds and is often mislabeled, or does not meet the guidelines of the International Organization for Standardization. Nonetheless, the prevalence of ACD due to tea tree oil is low (approximately 1.4%). Despite its low prevalence, tea tree oil should remain in the differential as an ACD-inducing agent. Patch testing with the patient’s supply of tea tree oil is advised when possible.38

Conclusion

It is customary that the ingredients used in shampoos undergo periodic testing and monitoring to assure the safety of their use. Although it is encouraging that patients are proactive in their efforts to stay abreast of the literature, it is still important that cosmetic scientists, dermatologists, and other experts remain at the forefront of educating the public about these substances. Not doing so can result in the propagation of misinformation and unnecessary fears, which can lead to the adaptation of unhygienic or even unsafe hair care practices. As dermatologists, we must ensure that patients are educated about the benefits and hazards of off-label use of household ingredients to the extent that evidence-based medicine permits. Patients must be informed that not all synthetic substances are harmful, and likewise not all naturally occurring substances are safe.

References
  1. The global shampoo market 2014-2019 trends, forecast, and opportunity analysis [press release]. New York, NY: Reportlinker; May 21, 2015.
  2. Is the ‘no shampoo’ trend healthy or harmful? Mercola website. Published January 16, 2016. Accessed December 8, 2017.
  3. Feltman R. The science (or lack thereof) behind the ‘no-poo’ hair trend. Washington Post. March 10, 2016. https://www.washingtonpost.com/news/speaking-of-science/wp/2016/03/10/the-science-or-lack-thereof-behind-the-no-poo-hair-trend/?utm_term=.9a61edf3fd5a. Accessed December 11, 2017.
  4. Bouillon C. Shampoos. Clin Dermatol. 1996;14:113-121.
  5. Trueb RM. Shampoos: ingredients, efficacy, and adverse effects. J Dtsch Dermatol Ges. 2007;5:356-365.
  6. Bondi CA, Marks JL, Wroblewski LB, et al. Human and environmental toxicity of sodium lauryl sulfate (SLS): evidence for safe use in household cleaning products. Environ Health Insights. 2015;9:27-32.
  7. Green K, Johnson RE, Chapman JM, et al. Preservative effects on the healing rate of rabbit corneal epithelium. Lens Eye Toxic Res. 1989;6:37-41.
  8. Sodium lauryl sulphate. Healthy Choices website. http://www.healthychoices.co.uk/sls.html. Accessed December 8, 2017.
  9. Tekbas¸ ÖF, Uysal Y, Og˘ur R, et al. Non-irritant baby shampoos may cause cataract development. TSK Koruyucu Hekimlik Bülteni. 2008;1:1-6.
  10. Cater KC, Harbell JW. Prediction of eye irritation potential of surfactant-based rinse-off personal care formulations by the bovine corneal opacity and permeability (BCOP) assay. Cutan Ocul Toxicol. 2006;25:217-233.
  11. Birt DF, Lawson TA, Julius AD, et al. Inhibition by dietary selenium of colon cancer induced in the rat by bis(2-oxopropyl) nitrosamine. Cancer Res. 1982;42:4455-4459.
  12. Rastogi SC. Headspace analysis of 1,4-dioxane in products containing polyethoxylated surfactants by GC-MS. Chromatographia. 1990;29:441-445.
  13. 1,4-Dioxane. IARC Monogr Eval Carcinog Risks Hum. 1999;71, pt 2:589-602.
  14. Trueb RM. Dermocosmetic aspects of hair and scalp. J Investig Dermatol Symp Proc. 2005;10:289-292.
  15. D’Souza P, Rathi SK. Shampoo and conditioners: what a dermatologist should know? Indian J Dermatol. 2015;60:248-254.
  16. Sasseville D, Alfalah M, Lacroix JP. “Parabenoia” debunked, or “who’s afraid of parabens?” Dermatitis. 2015;26:254-259.
  17. Krowka JF, Loretz L, Geis PA, et al. Preserving the facts on parabens: an overview of these important tools of the trade. Cosmetics & Toiletries. http://www.cosmeticsandtoiletries.com/research/chemistry/Preserving-the-Facts-on-Parabens-An-Overview-of-These-Important-Tools-of-the Trade-425784294.html. Published June 1, 2017. Accessed December 20, 2017.
  18. Routledge EJ, Parker J, Odum J, et al. Some alkyl hydroxy benzoate preservatives (parabens) are estrogenic. Toxicol Appl Pharmacol. 1998;153:12Y19.
  19. Hossaini A, Larsen JJ, Larsen JC. Lack of oestrogenic effects of food preservatives (parabens) in uterotrophic assays. Food Chem Toxicol. 2000;38:319-323.
  20. Cosmetic Ingredient Review. Final report on the safety assessment of methylparaben, ethylparaben, propylparaben and butylparaben. J Am Coll Toxicol. 1984;3:147-209.
  21. Cosmetic Ingredient Review. Final report on the safety assessment of isobutylparaben and isopropylparaben. J Am Coll Toxicol. 1995;14:364-372.
  22. Scientific Committee on Consumer Products. Extended Opinion on the Safety Evaluation of Parabens. European Commission website. https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_019.pdf. Published January 28, 2005. Accessed December 20, 2017.
  23. Scientific Committee on Consumer Products. Opinion on Parabens. European Commission website. http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_041.pdf. Revised March 22, 2011. Accessed December 20, 2017.
  24. European Commission. Commission Regulation (EU) No 258/2014 of 9 April 2014 amending Annexes II and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. EUR-Lex website. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.107.01.0005.01.ENG. Accessed December 20, 2017.
  25. American Cancer Society. Antiperspirants and breast cancer risk. https://www.cancer.org/cancer/cancer-causes/antiperspirants-and-breast-cancer-risk.html#references. Revised October 14, 2014. Accessed January 2, 2018.
  26. MacMillan A. Cutting back on shampoo? 15 things you should know. Health. February 25, 2014. http://www.health.com/health/gallery/0,,20788089,00.html#should-you-go-no-poo--1. Accessed December 10, 2017.
  27. The ‘no poo’ method. https://www.nopoomethod.com/. Accessed December 10, 2017.
  28. Fong, D, Gaulin C, Le M, et al. Effectiveness of alternative antimicrobial agents for disinfection of hard surfaces. National Collaborating Centre for Environmental Health website. http://www.ncceh.ca/sites/default/files/Alternative_Antimicrobial_Agents_Aug_2014.pdf. Published August 2014. Accessed December 10, 2017.
  29. Is baking soda too harsh for natural hair? Black Girl With Long Hair website. http://blackgirllonghair.com/2012/02/is-baking-soda-too-harsh-for-hair/2/. Published February 5, 2012. Accessed December 12, 2017.
  30. O’Lenick T. Anionic/cationic complexes in hair care. J Cosmet Sci. 2011;62:209-228.
  31. Gavazzoni Dias MF, de Almeida AM, Cecato PM, et al. The shampoo pH can affect the hair: myth or reality? Int J Trichology. 2014;6:95-99.
  32. Goodman H. The acid mantle of the skin surface. Ind Med Surg. 1958;27:105-108.
  33. Korting HC, Kober M, Mueller M, et al. Influence of repeated washings with soap and synthetic detergents on pH and resident flora of the skin of forehead and forearm. results of a cross-over trial in health probationers. Acta Derm Venereol. 1987;67:41-47.
  34. Tarun J, Susan J, Suria J, et al. Evaluation of pH of bathing soaps and shampoos for skin and hair care. Indian J Dermatol. 2014;59:442-444.
  35. Corbett JF. The chemistry of hair-care products. J Soc Dyers Colour. 1976;92:285-303.
  36. McMichael AJ, Hordinsky M. Hair Diseases: Medical, Surgical, and Cosmetic Treatments. New York, NY: Taylor & Francis; 2008:59-72.
  37. Allardice A, Gummo G. Hair conditioning: quaternary ammonium compounds on various hair types. Cosmet Toiletries. 1993;108:107-109.
  38. Larson D, Jacob SE. Tea tree oil. Dermatitis. 2012;23:48-49.
Article PDF
Author and Disclosure Information

 

Dr. Cline is from Augusta University Medical Center, Georgia. Drs. Uwakwe and McMichael are from the Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina.

Drs. Cline and Uwakwe report no conflict of interest. Dr. McMichael is a consultant for Johnson & Johnson and Procter & Gamble. She also is an investigator for and has received research grants from Procter & Gamble.

Correspondence: Amy J. McMichael, MD, Department of Dermatology, Wake Forest Baptist Medical Center, 4618 Country Club Rd, Winston-Salem, NC 27104 ([email protected]).

Issue
Cutis - 101(1)
Publications
Topics
Page Number
22-26
Sections
Author and Disclosure Information

 

Dr. Cline is from Augusta University Medical Center, Georgia. Drs. Uwakwe and McMichael are from the Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina.

Drs. Cline and Uwakwe report no conflict of interest. Dr. McMichael is a consultant for Johnson & Johnson and Procter & Gamble. She also is an investigator for and has received research grants from Procter & Gamble.

Correspondence: Amy J. McMichael, MD, Department of Dermatology, Wake Forest Baptist Medical Center, 4618 Country Club Rd, Winston-Salem, NC 27104 ([email protected]).

Author and Disclosure Information

 

Dr. Cline is from Augusta University Medical Center, Georgia. Drs. Uwakwe and McMichael are from the Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina.

Drs. Cline and Uwakwe report no conflict of interest. Dr. McMichael is a consultant for Johnson & Johnson and Procter & Gamble. She also is an investigator for and has received research grants from Procter & Gamble.

Correspondence: Amy J. McMichael, MD, Department of Dermatology, Wake Forest Baptist Medical Center, 4618 Country Club Rd, Winston-Salem, NC 27104 ([email protected]).

Article PDF
Article PDF
Related Articles
In Collaboration with the Skin of Color Society
In Collaboration with the Skin of Color Society

Shampoo is a staple in hair grooming that is ever-evolving along with cultural trends. The global shampoo market is expected to reach an estimated value of $25.73 billion by 2019. A major driver of this upward trend in market growth is the increasing demand for natural and organic hair shampoos.1 Society today has a growing fixation on healthy living practices, and as of late, the ingredients in shampoos and other cosmetic products have become one of the latest targets in the health-consciousness craze. In the age of the Internet where information—and misinformation—is widely accessible and dispersed, the general public often strives to self-educate on specialized matters that are out of their expertise. As a result, individuals have developed an aversion to using certain shampoos out of fear that the ingredients, often referred to as “chemicals” by patients due to their complex names, are unnatural and therefore unhealthy.1,2 Product developers are working to meet the demand by reformulating shampoos with labels that indicate sulfate free or paraben free, despite the lack of proof that these formulations are an improvement over traditional approaches to hair health. Additionally, alternative methods of cleansing the hair and scalp, also known as the no-shampoo or “no-poo” method, have begun to gain popularity.2,3


It is essential that dermatologists acknowledge the concerns that their patients have about common shampoo ingredients to dispel the myths that may misinform patient decision-making. This article reviews the controversy surrounding the use of sulfates and parabens in shampoos as well as commonly used shampoo alternatives. Due to the increased prevalence of dry hair shafts in the skin of color population, especially black women, this group is particularly interested in products that will minimize breakage and dryness of the hair. To that end, this population has great interest in the removal of chemical ingredients that may cause damage to the hair shafts, despite the lack of data to support sulfates and paraben damage to hair shafts or scalp skin. Blogs and uninformed hairstylists may propagate these beliefs in a group of consumers who are desperate for new approaches to hair fragility and breakage.

Surfactants and Sulfates

The cleansing ability of a shampoo depends on the surface activity of its detergents. Surface-active ingredients, or surfactants, reduce the surface tension between water and dirt, thus facilitating the removal of environmental dirt from the hair and scalp,4 which is achieved by a molecular structure containing both a hydrophilic and a lipophilic group. Sebum and dirt are bound by the lipophilic ends of the surfactant, becoming the center of a micelle structure with the hydrophilic molecule ends pointing outward. Dirt particles become water soluble and are removed from the scalp and hair shaft upon rinsing with water.4

Surfactants are classified according to the electric charge of the hydrophilic polar group as either anionic, cationic, amphoteric (zwitterionic), or nonionic.5 Each possesses different hair conditioning and cleansing qualities, and multiple surfactants are used in shampoos in differing ratios to accommodate different hair types. In most shampoos, the base consists of anionic and amphoteric surfactants. Depending on individual product requirements, nonionic and cationic surfactants are used to either modify the effects of the surfactants or as conditioning agents.4,5

One subcategory of surfactants that receives much attention is the group of anionic surfactants known as sulfates. Sulfates, particularly sodium lauryl sulfate (SLS), recently have developed a negative reputation as cosmetic ingredients, as reports from various unscientific sources have labeled them as hazardous to one’s health; SLS has been described as a skin and scalp irritant, has been linked to cataract formation, and has even been wrongly labeled as carcinogenic.6 The origins of some of these claims are not clear, though they likely arose from the misinterpretation of complex scientific studies that are easily accessible to laypeople. The link between SLS and ocular irritation or cataract formation is a good illustration of this unsubstantiated fear. A study by Green et al7 showed that corneal exposure to extremely high concentrations of SLS following physical or chemical damage to the eye can result in a slowed healing process. The results of this study have since been wrongly quoted to state that SLS-containing products lead to blindness or severe corneal damage.8 A different study tested for possible ocular irritation in vivo by submerging the lens of an eye into a 20% SLS solution, which accurately approximates the concentration of SLS in rinse-off consumer products.9 However, to achieve ocular irritation, the eyes of laboratory animals were exposed to SLS constantly for 14 days, which would not occur in practical use.9 Similarly, a third study achieved cataract formation in a laboratory only by immersing the lens of an eye into a highly concentrated solution of SLS.10 Such studies are not appropriate representations of how SLS-containing products are used by consumers and have unfortunately been vulnerable to misinterpretation by the general public.

There is no known study that has shown SLS to be carcinogenic. One possible origin of this idea may be from the wrongful interpretation of studies that used SLS as a vehicle substance to test agents that were deemed to be carcinogenic.11 Another possible source of the idea that SLS is carcinogenic comes from its association with 1,4-dioxane, a by-product of the synthesis of certain sulfates such as sodium laureth sulfate due to a process known as ethoxylation.6,12 Although SLS does not undergo this process in its formation and is not linked to 1,4-dioxane, there is potential for cross-contamination of SLS with 1,4-dioxane, which cannot be overlooked. 1,4-Dioxane is classified as “possibly carcinogenic to humans (Group 2B)” by the International Agency for Research on Cancer,13 but screening of SLS for this substance prior to its use in commercial products is standard.

Sulfates are inexpensive detergents that are responsible for lather formation in shampoos as well as in many household cleaning agents.5 Sulfates, similar to all anionic surfactants, are characterized by a negatively charged hydrophilic polar group. The best-known and most commonly used anionic surfactants are sulfated fatty alcohols, alkyl sulfates, and their polyethoxylated analogues alkyl ether sulfates.5,6 Sodium lauryl sulfate (also known as sodium laurilsulfate or sodium dodecyl sulfate) is the most common of them all, found in shampoo and conditioner formulations. Ammonium lauryl sulfate and sodium laureth sulfate are other sulfates commonly used in shampoos and household cleansing products. Sodium lauryl sulfate is a nonvolatile, water-soluble compound. Its partition coefficient (P0), a measure of a substance’s hydrophilic or lipophilic nature, is low at 1.6, making it a rather hydrophilic substance.6 Hydrophilic substances tend to have low bioaccumulation profiles in the body. Additionally, SLS is readily biodegradable. It can be derived from both synthetic and naturally occurring sources; for example, palm kernel oil, petrolatum, and coconut oil are all sources of lauric acid, the starting ingredient used to synthesize SLS. Sodium lauryl sulfate is created by reacting lauryl alcohol with sulfur trioxide gas, followed by neutralization with sodium carbonate (also a naturally occurring compound).6 Sodium lauryl sulfate and other sulfate-containing shampoos widely replaced the usage of traditional soaps formulated from animal or vegetable fats, as these latter formations created a film of insoluble calcium salts on the hair strands upon contact with water, resulting in tangled, dull-appearing hair.5 Additionally, sulfates were preferred to the alkaline pH of traditional soap, which can be harsh on hair strands and cause irritation of the skin and mucous membranes.14 Because they are highly water soluble, sulfates enable the formulation of clear shampoos. They exhibit remarkable cleaning properties and lather formation.5,14

Because sulfates are potent surfactants, they can remove dirt and debris as well as naturally produced healthy oils from the hair and scalp. As a result, sulfates can leave the hair feeling dry and stripped of moisture.4,5 Sulfates are used as the primary detergents in the formulation of deep-cleaning shampoos, which are designed for people who accumulate a heavy buildup of dirt, sebum, and debris from frequent use of styling products. Due to their potent detergency, these shampoos typically are not used on a daily basis but rather at longer intervals.15 A downside to sulfates is that they can have cosmetically unpleasant properties, which can be compensated for by including appropriate softening additives in shampoo formulations.4 A number of anionic surfactants such as olefin sulfonate, alkyl sulfosuccinate, acyl peptides, and alkyl ether carboxylates are well tolerated by the skin and are used together with other anionic and amphoteric surfactants to optimize shampoo properties. Alternatively, sulfate-free shampoos are cleansers compounded by the removal of the anionic group and switched for surfactants with less detergency.4,5

 

 

Preservatives and Parabens

Parabens refer to a group of esters of 4-hydroxybenzoic acid commonly used as preservatives in foods, pharmaceuticals, and cosmetics whose widespread use dates back to 1923.16 Concerns over the presence of parabens in shampoos and other cosmetics have been raised by patients for their reputed estrogenic and antiandrogenic effects and suspected involvement in carcinogenesis via endocrine modulation.16,17 In in vitro studies done on yeast assays, parabens have shown weak estrogenic activity that increases in proportion to both the length and increased branching of the alkyl side chains in the paraben’s molecular structure.18 They are 10,000-fold less potent than 17β-estradiol. In in vivo animal studies, parabens show weak estrogenic activity and are 100,000-fold less potent than 17β-estradiol.18 4-Hydroxybenzoic acid, a common metabolite, showed no estrogenic activity when tested both in vitro and in vivo.19 Some concerning research has implicated a link between parabens used in underarm cosmetics, such as deodorants and antiperspirants, and breast cancer16; however, the studies have been conflicting, and there is simply not enough data to assert that parabens cause breast cancer.

The Cosmetic Ingredient Review expert panel first reviewed parabens in 1984 and concluded that “methylparaben, ethylparaben, propylparaben, and butylparaben are safe as cosmetic ingredients in the present practices of use.”20 They extended this statement to include isopropylparaben and isobutylparaben in a later review.21 In 2005, the Scientific Committee on Consumer Products (now known as the Scientific Committee for Consumer Safety) in Europe stated that methylparaben and ethylparaben can be used at levels up to 0.4% in products.22 This decision was reached due to reports of decreased sperm counts and testosterone levels in male juvenile rats exposed to these parabens; however, these reults were not successfully replicated in larger studies.16,22 In 2010, the Scientific Committee for Consumer Safety revisited its stance on parabens, and they then revised their recommendations to say that concentrations of propylparaben and butylparaben should not exceed concentrations of 0.19%, based on “the conservative choice for the calculation of the [Margin-of-Safety] of butyl- and propylparaben.”23 However, in 2011 the use of propylparaben and butylparaben was banned in Denmark for cosmetic products used in children 3 years or younger,16 and the European Commission subsequently amended their directive in 2014, banning isopropylparaben, isobutylparaben, phenylparaben, benzylparaben, and pentylparaben due to lack of data available to evaluate the human risk of these products.24

Contrary to the trends in Europe, there currently are no regulations against the use of parabens in shampoos or other cosmetics in the United States. The American Cancer Society found that there is no evidence to suggest that the current levels of parabens in cosmetic products (eg, antiperspirants) increase one’s risk of breast cancer.25 Parabens are readily absorbed into the body both transdermally and through ingestion but also are believed to be rapidly transformed into harmless and nonspecific metabolites; they are readily metabolized by the liver and excreted in urine, and there is no measured accumulation in tissues.17

Parabens continue to be the most widely used preservatives in personal care products, usually in conjunction with other preservatives. Parabens are good biocides; short-chain esters (eg, methylparabens, ethylparabens) are effective against gram-positive bacteria and are weakly effective against gram-negative bacteria. Long-chain paraben esters (eg, propylparabens, butylparabens) are effective against mold and yeast. The addition of other preservatives creates a broad spectrum of antimicrobial defense in consumer products. Other preservatives include formaldehyde releasers or phenoxyethanol, as well as chelating agents such as EDTA, which improve the stability of these cosmetic products when exposed to air.16 Parabens are naturally occurring substances found in foods such as blueberries, barley, strawberries, yeast, olives, and grapes. As a colorless, odorless, and inexpensive substance, their use has been heavily favored in cosmetic and food products.16

 

 

Shampoo Alternatives and the No-Poo Method

Although research has not demonstrated any long-term danger to using shampoo, certain chemicals found in shampoos have the potential to irritate the scalp. Commonly cited allergens in shampoos include cocamidopropyl betaine, propylene glycol, vitamin E (tocopherol), parabens, and benzophenones.5 Additionally, the rising use of formaldehyde-releasing preservatives and isothiazolinones due to mounting pressures to move away from parabens has led to an increase in cases of allergic contact dermatitis (ACD).16 However, the irritability (rather than allergenicity) of these substances often is established during patch testing, a method of detecting delayed-type allergic reactions, which is important to note because patch testing requires a substance to be exposed to the skin for 24 to 48 hours, whereas exposure to shampoo ingredients may last a matter of minutes at most and occur in lesser concentrations because the ingredients are diluted by water in the rinsing process. Given these differences, it is unlikely that a patient would develop a true allergic response from regular shampoo use. Nevertheless, in patients who are already sensitized, exposure could conceivably trigger ACD, and patients must be cognizant of the composition of their shampoos.16

The no-poo method refers to the avoidance of commercial shampoo products when cleansing the hair and scalp and encompasses different methods of cleansing the hair, such as the use of household items (eg, baking soda, apple cider vinegar [ACV]), the use of conditioners to wash the hair (also known as conditioner-only washing or co-washing), treating the scalp with tea tree oil, or simply rinsing the hair with water. Proponents of the no-poo method believe that abstaining from shampoo use leads to healthier hair, retained natural oils, and less exposure to supposedly dangerous chemicals such as parabens or sulfates.2,3,26-28 However, there are no known studies in the literature that assess or support the hypotheses of the no-poo method.

Baking Soda and ACV
Baking soda (sodium bicarbonate) is a substance commonly found in the average household. It has been used in toothpaste formulas and cosmetic products and is known for its acid-neutralizing properties. Baking soda has been shown to have some antifungal and viricidal properties through an unknown mechanism of action.28 It has gained popularity for its use as a means of reducing the appearance of excessive greasiness of the hair shafts. Users also have reported that when washing their hair with baking soda, they are able to achieve a clean scalp and hair that feels soft to the touch.2,3,26,27,29 Despite these reports, users must beware of using baking soda without adequately diluting it with water. Baking soda is a known alkaline irritant.26,30 With a pH of 9, baking soda causes the cuticle layer of the hair fiber to open, increasing the capacity for water absorption. Water penetrates the scales that open, breaking the hydrogen bonds of the keratin molecule.31 Keratin is a spiral helical molecule that keeps its shape due to hydrogen, disulfide, and ionic bonds, as well as Van der Waals force.30 Hydrolysis of these bonds due to exposure to baking soda lowers the elasticity of the hair and increases the negative electrical net charge of the hair fiber surface, which leads to increased friction between fibers, cuticle damage, hair fragility, and fiber breakage.32,33

Apple cider vinegar is an apple-derived acetic acid solution with a pH ranging from 3.1 to 5.28 The pH range of ACV is considered to be ideal for hair by no-poo proponents, as it is similar to the natural pH of the scalp. Its acidic properties are responsible for its antimicrobial abilities, particularly its effectiveness against gram-negative bacteria.30 The acetic acid of ACV can partially interrupt oil interfaces, which contributes to its mild ability to remove product residue and scalp buildup from the hair shaft; the acetic acid also tightens the cuticles on hair fibers.33 Apple cider vinegar is used as a means of cleansing the hair and scalp by no-poo proponents2,3,26; other uses for ACV include using it as a rinse following washing and/or conditioning of the hair or as a means of preserving color in color-treated hair. There also is evidence that ACV may have antifungal properties.28 However, consumers must be aware that if it is not diluted in water, ACV may be too caustic for direct application to the hair and may lead to damage; it can be irritating to eyes, mucus membranes, and acutely inflamed skin. Also, vinegar rinses used on processed or chemically damaged hair may lead to increased hair fragility.2,3

Hair fibers have a pH of 3.67, while the scalp has a pH between 4.5 and 6.2. This slightly acidic film acts as a barrier to viruses, bacteria, and other potential contaminants.33 Studies have shown that the pH of skin increases in proportion to the pH of the cleanser used.34 Therefore, due to the naturally acidic pH of the scalp, acid-balanced shampoos generally are recommended. Shampoos should not have a pH higher than 5.5, as hair shafts can swell due to alkalinization, which can be prevented by pH balancing the shampoo through the addition of an acidic substance (eg, glycolic acid, citric acid) to lower the pH down to approximately 5.5. Apple cider vinegar often is used for this purpose. However, one study revealed that 82% of shampoos already have an acidic pH.34

Conditioner-Only Washing (Co-washing)
Conditioner-only washing, or co-washing, is a widely practiced method of hair grooming. It is popular among individuals who find that commercial shampoos strip too much of the natural hair oils away, leaving the hair rough or unmanageable. Co-washing is not harmful to the hair; however, the molecular structure and function of a conditioner and that of a shampoo are very different.5,35,36 Conditioners are not formulated to remove dirt and buildup in the hair but rather to add substances to the hair, and thus cannot provide extensive cleansing of the hair and scalp; therefore, it is inappropriate to use co-washing as a replacement for shampooing. Quaternary conditioning agents are an exception because they contain amphoteric detergents comprised of both anionic and cationic groups, which allow them both the ability to remove dirt and sebum with its anionic group, typically found in shampoos, as well as the ability to coat and condition the hair due to the high affinity of the cationic group for the negatively charged hair fibers.36,37 Amphoteric detergents are commonly found in 2-in-1 conditioning cleansers, among other ingredients, such as hydrolyzed animal proteins that temporarily plug surface defects on the hair fiber, and dimethicone, a synthetic oil that creates a thin film over the hair shaft, increasing shine and manageability. Of note, these conditioning shampoos are ideal for individuals with minimal product buildup on the hair and scalp and are not adequate scalp cleansers for individuals who either wash their hair infrequently or who regularly use hairstyling products.36,37

Tea Tree Oil
Tea tree oil is an essential oil extracted from the Melaleuca alternifolia plant of the Myrtaceae family. It is native to the coast of northeastern Australia. A holy grail of natural cosmetics, tea tree oil is widely known for its antiviral, antifungal, and antiseptic properties.38 Although not used as a stand-alone cleanser, it is often added to a number of cosmetic products, including shampoos and co-washes. Although deemed safe for topical use, it has been shown to be quite toxic when ingested. Symptoms of ingestion include nausea, vomiting, hallucinations, and coma. The common concern with tea tree oil is its ability to cause ACD. In particular, it is believed that the oxidation products of tea tree oil are allergenic rather than the tea tree oil itself. The evaluation of tea tree oil as a potential contact allergen has been quite difficult; it consists of more than 100 distinct compounds and is often mislabeled, or does not meet the guidelines of the International Organization for Standardization. Nonetheless, the prevalence of ACD due to tea tree oil is low (approximately 1.4%). Despite its low prevalence, tea tree oil should remain in the differential as an ACD-inducing agent. Patch testing with the patient’s supply of tea tree oil is advised when possible.38

Conclusion

It is customary that the ingredients used in shampoos undergo periodic testing and monitoring to assure the safety of their use. Although it is encouraging that patients are proactive in their efforts to stay abreast of the literature, it is still important that cosmetic scientists, dermatologists, and other experts remain at the forefront of educating the public about these substances. Not doing so can result in the propagation of misinformation and unnecessary fears, which can lead to the adaptation of unhygienic or even unsafe hair care practices. As dermatologists, we must ensure that patients are educated about the benefits and hazards of off-label use of household ingredients to the extent that evidence-based medicine permits. Patients must be informed that not all synthetic substances are harmful, and likewise not all naturally occurring substances are safe.

Shampoo is a staple in hair grooming that is ever-evolving along with cultural trends. The global shampoo market is expected to reach an estimated value of $25.73 billion by 2019. A major driver of this upward trend in market growth is the increasing demand for natural and organic hair shampoos.1 Society today has a growing fixation on healthy living practices, and as of late, the ingredients in shampoos and other cosmetic products have become one of the latest targets in the health-consciousness craze. In the age of the Internet where information—and misinformation—is widely accessible and dispersed, the general public often strives to self-educate on specialized matters that are out of their expertise. As a result, individuals have developed an aversion to using certain shampoos out of fear that the ingredients, often referred to as “chemicals” by patients due to their complex names, are unnatural and therefore unhealthy.1,2 Product developers are working to meet the demand by reformulating shampoos with labels that indicate sulfate free or paraben free, despite the lack of proof that these formulations are an improvement over traditional approaches to hair health. Additionally, alternative methods of cleansing the hair and scalp, also known as the no-shampoo or “no-poo” method, have begun to gain popularity.2,3


It is essential that dermatologists acknowledge the concerns that their patients have about common shampoo ingredients to dispel the myths that may misinform patient decision-making. This article reviews the controversy surrounding the use of sulfates and parabens in shampoos as well as commonly used shampoo alternatives. Due to the increased prevalence of dry hair shafts in the skin of color population, especially black women, this group is particularly interested in products that will minimize breakage and dryness of the hair. To that end, this population has great interest in the removal of chemical ingredients that may cause damage to the hair shafts, despite the lack of data to support sulfates and paraben damage to hair shafts or scalp skin. Blogs and uninformed hairstylists may propagate these beliefs in a group of consumers who are desperate for new approaches to hair fragility and breakage.

Surfactants and Sulfates

The cleansing ability of a shampoo depends on the surface activity of its detergents. Surface-active ingredients, or surfactants, reduce the surface tension between water and dirt, thus facilitating the removal of environmental dirt from the hair and scalp,4 which is achieved by a molecular structure containing both a hydrophilic and a lipophilic group. Sebum and dirt are bound by the lipophilic ends of the surfactant, becoming the center of a micelle structure with the hydrophilic molecule ends pointing outward. Dirt particles become water soluble and are removed from the scalp and hair shaft upon rinsing with water.4

Surfactants are classified according to the electric charge of the hydrophilic polar group as either anionic, cationic, amphoteric (zwitterionic), or nonionic.5 Each possesses different hair conditioning and cleansing qualities, and multiple surfactants are used in shampoos in differing ratios to accommodate different hair types. In most shampoos, the base consists of anionic and amphoteric surfactants. Depending on individual product requirements, nonionic and cationic surfactants are used to either modify the effects of the surfactants or as conditioning agents.4,5

One subcategory of surfactants that receives much attention is the group of anionic surfactants known as sulfates. Sulfates, particularly sodium lauryl sulfate (SLS), recently have developed a negative reputation as cosmetic ingredients, as reports from various unscientific sources have labeled them as hazardous to one’s health; SLS has been described as a skin and scalp irritant, has been linked to cataract formation, and has even been wrongly labeled as carcinogenic.6 The origins of some of these claims are not clear, though they likely arose from the misinterpretation of complex scientific studies that are easily accessible to laypeople. The link between SLS and ocular irritation or cataract formation is a good illustration of this unsubstantiated fear. A study by Green et al7 showed that corneal exposure to extremely high concentrations of SLS following physical or chemical damage to the eye can result in a slowed healing process. The results of this study have since been wrongly quoted to state that SLS-containing products lead to blindness or severe corneal damage.8 A different study tested for possible ocular irritation in vivo by submerging the lens of an eye into a 20% SLS solution, which accurately approximates the concentration of SLS in rinse-off consumer products.9 However, to achieve ocular irritation, the eyes of laboratory animals were exposed to SLS constantly for 14 days, which would not occur in practical use.9 Similarly, a third study achieved cataract formation in a laboratory only by immersing the lens of an eye into a highly concentrated solution of SLS.10 Such studies are not appropriate representations of how SLS-containing products are used by consumers and have unfortunately been vulnerable to misinterpretation by the general public.

There is no known study that has shown SLS to be carcinogenic. One possible origin of this idea may be from the wrongful interpretation of studies that used SLS as a vehicle substance to test agents that were deemed to be carcinogenic.11 Another possible source of the idea that SLS is carcinogenic comes from its association with 1,4-dioxane, a by-product of the synthesis of certain sulfates such as sodium laureth sulfate due to a process known as ethoxylation.6,12 Although SLS does not undergo this process in its formation and is not linked to 1,4-dioxane, there is potential for cross-contamination of SLS with 1,4-dioxane, which cannot be overlooked. 1,4-Dioxane is classified as “possibly carcinogenic to humans (Group 2B)” by the International Agency for Research on Cancer,13 but screening of SLS for this substance prior to its use in commercial products is standard.

Sulfates are inexpensive detergents that are responsible for lather formation in shampoos as well as in many household cleaning agents.5 Sulfates, similar to all anionic surfactants, are characterized by a negatively charged hydrophilic polar group. The best-known and most commonly used anionic surfactants are sulfated fatty alcohols, alkyl sulfates, and their polyethoxylated analogues alkyl ether sulfates.5,6 Sodium lauryl sulfate (also known as sodium laurilsulfate or sodium dodecyl sulfate) is the most common of them all, found in shampoo and conditioner formulations. Ammonium lauryl sulfate and sodium laureth sulfate are other sulfates commonly used in shampoos and household cleansing products. Sodium lauryl sulfate is a nonvolatile, water-soluble compound. Its partition coefficient (P0), a measure of a substance’s hydrophilic or lipophilic nature, is low at 1.6, making it a rather hydrophilic substance.6 Hydrophilic substances tend to have low bioaccumulation profiles in the body. Additionally, SLS is readily biodegradable. It can be derived from both synthetic and naturally occurring sources; for example, palm kernel oil, petrolatum, and coconut oil are all sources of lauric acid, the starting ingredient used to synthesize SLS. Sodium lauryl sulfate is created by reacting lauryl alcohol with sulfur trioxide gas, followed by neutralization with sodium carbonate (also a naturally occurring compound).6 Sodium lauryl sulfate and other sulfate-containing shampoos widely replaced the usage of traditional soaps formulated from animal or vegetable fats, as these latter formations created a film of insoluble calcium salts on the hair strands upon contact with water, resulting in tangled, dull-appearing hair.5 Additionally, sulfates were preferred to the alkaline pH of traditional soap, which can be harsh on hair strands and cause irritation of the skin and mucous membranes.14 Because they are highly water soluble, sulfates enable the formulation of clear shampoos. They exhibit remarkable cleaning properties and lather formation.5,14

Because sulfates are potent surfactants, they can remove dirt and debris as well as naturally produced healthy oils from the hair and scalp. As a result, sulfates can leave the hair feeling dry and stripped of moisture.4,5 Sulfates are used as the primary detergents in the formulation of deep-cleaning shampoos, which are designed for people who accumulate a heavy buildup of dirt, sebum, and debris from frequent use of styling products. Due to their potent detergency, these shampoos typically are not used on a daily basis but rather at longer intervals.15 A downside to sulfates is that they can have cosmetically unpleasant properties, which can be compensated for by including appropriate softening additives in shampoo formulations.4 A number of anionic surfactants such as olefin sulfonate, alkyl sulfosuccinate, acyl peptides, and alkyl ether carboxylates are well tolerated by the skin and are used together with other anionic and amphoteric surfactants to optimize shampoo properties. Alternatively, sulfate-free shampoos are cleansers compounded by the removal of the anionic group and switched for surfactants with less detergency.4,5

 

 

Preservatives and Parabens

Parabens refer to a group of esters of 4-hydroxybenzoic acid commonly used as preservatives in foods, pharmaceuticals, and cosmetics whose widespread use dates back to 1923.16 Concerns over the presence of parabens in shampoos and other cosmetics have been raised by patients for their reputed estrogenic and antiandrogenic effects and suspected involvement in carcinogenesis via endocrine modulation.16,17 In in vitro studies done on yeast assays, parabens have shown weak estrogenic activity that increases in proportion to both the length and increased branching of the alkyl side chains in the paraben’s molecular structure.18 They are 10,000-fold less potent than 17β-estradiol. In in vivo animal studies, parabens show weak estrogenic activity and are 100,000-fold less potent than 17β-estradiol.18 4-Hydroxybenzoic acid, a common metabolite, showed no estrogenic activity when tested both in vitro and in vivo.19 Some concerning research has implicated a link between parabens used in underarm cosmetics, such as deodorants and antiperspirants, and breast cancer16; however, the studies have been conflicting, and there is simply not enough data to assert that parabens cause breast cancer.

The Cosmetic Ingredient Review expert panel first reviewed parabens in 1984 and concluded that “methylparaben, ethylparaben, propylparaben, and butylparaben are safe as cosmetic ingredients in the present practices of use.”20 They extended this statement to include isopropylparaben and isobutylparaben in a later review.21 In 2005, the Scientific Committee on Consumer Products (now known as the Scientific Committee for Consumer Safety) in Europe stated that methylparaben and ethylparaben can be used at levels up to 0.4% in products.22 This decision was reached due to reports of decreased sperm counts and testosterone levels in male juvenile rats exposed to these parabens; however, these reults were not successfully replicated in larger studies.16,22 In 2010, the Scientific Committee for Consumer Safety revisited its stance on parabens, and they then revised their recommendations to say that concentrations of propylparaben and butylparaben should not exceed concentrations of 0.19%, based on “the conservative choice for the calculation of the [Margin-of-Safety] of butyl- and propylparaben.”23 However, in 2011 the use of propylparaben and butylparaben was banned in Denmark for cosmetic products used in children 3 years or younger,16 and the European Commission subsequently amended their directive in 2014, banning isopropylparaben, isobutylparaben, phenylparaben, benzylparaben, and pentylparaben due to lack of data available to evaluate the human risk of these products.24

Contrary to the trends in Europe, there currently are no regulations against the use of parabens in shampoos or other cosmetics in the United States. The American Cancer Society found that there is no evidence to suggest that the current levels of parabens in cosmetic products (eg, antiperspirants) increase one’s risk of breast cancer.25 Parabens are readily absorbed into the body both transdermally and through ingestion but also are believed to be rapidly transformed into harmless and nonspecific metabolites; they are readily metabolized by the liver and excreted in urine, and there is no measured accumulation in tissues.17

Parabens continue to be the most widely used preservatives in personal care products, usually in conjunction with other preservatives. Parabens are good biocides; short-chain esters (eg, methylparabens, ethylparabens) are effective against gram-positive bacteria and are weakly effective against gram-negative bacteria. Long-chain paraben esters (eg, propylparabens, butylparabens) are effective against mold and yeast. The addition of other preservatives creates a broad spectrum of antimicrobial defense in consumer products. Other preservatives include formaldehyde releasers or phenoxyethanol, as well as chelating agents such as EDTA, which improve the stability of these cosmetic products when exposed to air.16 Parabens are naturally occurring substances found in foods such as blueberries, barley, strawberries, yeast, olives, and grapes. As a colorless, odorless, and inexpensive substance, their use has been heavily favored in cosmetic and food products.16

 

 

Shampoo Alternatives and the No-Poo Method

Although research has not demonstrated any long-term danger to using shampoo, certain chemicals found in shampoos have the potential to irritate the scalp. Commonly cited allergens in shampoos include cocamidopropyl betaine, propylene glycol, vitamin E (tocopherol), parabens, and benzophenones.5 Additionally, the rising use of formaldehyde-releasing preservatives and isothiazolinones due to mounting pressures to move away from parabens has led to an increase in cases of allergic contact dermatitis (ACD).16 However, the irritability (rather than allergenicity) of these substances often is established during patch testing, a method of detecting delayed-type allergic reactions, which is important to note because patch testing requires a substance to be exposed to the skin for 24 to 48 hours, whereas exposure to shampoo ingredients may last a matter of minutes at most and occur in lesser concentrations because the ingredients are diluted by water in the rinsing process. Given these differences, it is unlikely that a patient would develop a true allergic response from regular shampoo use. Nevertheless, in patients who are already sensitized, exposure could conceivably trigger ACD, and patients must be cognizant of the composition of their shampoos.16

The no-poo method refers to the avoidance of commercial shampoo products when cleansing the hair and scalp and encompasses different methods of cleansing the hair, such as the use of household items (eg, baking soda, apple cider vinegar [ACV]), the use of conditioners to wash the hair (also known as conditioner-only washing or co-washing), treating the scalp with tea tree oil, or simply rinsing the hair with water. Proponents of the no-poo method believe that abstaining from shampoo use leads to healthier hair, retained natural oils, and less exposure to supposedly dangerous chemicals such as parabens or sulfates.2,3,26-28 However, there are no known studies in the literature that assess or support the hypotheses of the no-poo method.

Baking Soda and ACV
Baking soda (sodium bicarbonate) is a substance commonly found in the average household. It has been used in toothpaste formulas and cosmetic products and is known for its acid-neutralizing properties. Baking soda has been shown to have some antifungal and viricidal properties through an unknown mechanism of action.28 It has gained popularity for its use as a means of reducing the appearance of excessive greasiness of the hair shafts. Users also have reported that when washing their hair with baking soda, they are able to achieve a clean scalp and hair that feels soft to the touch.2,3,26,27,29 Despite these reports, users must beware of using baking soda without adequately diluting it with water. Baking soda is a known alkaline irritant.26,30 With a pH of 9, baking soda causes the cuticle layer of the hair fiber to open, increasing the capacity for water absorption. Water penetrates the scales that open, breaking the hydrogen bonds of the keratin molecule.31 Keratin is a spiral helical molecule that keeps its shape due to hydrogen, disulfide, and ionic bonds, as well as Van der Waals force.30 Hydrolysis of these bonds due to exposure to baking soda lowers the elasticity of the hair and increases the negative electrical net charge of the hair fiber surface, which leads to increased friction between fibers, cuticle damage, hair fragility, and fiber breakage.32,33

Apple cider vinegar is an apple-derived acetic acid solution with a pH ranging from 3.1 to 5.28 The pH range of ACV is considered to be ideal for hair by no-poo proponents, as it is similar to the natural pH of the scalp. Its acidic properties are responsible for its antimicrobial abilities, particularly its effectiveness against gram-negative bacteria.30 The acetic acid of ACV can partially interrupt oil interfaces, which contributes to its mild ability to remove product residue and scalp buildup from the hair shaft; the acetic acid also tightens the cuticles on hair fibers.33 Apple cider vinegar is used as a means of cleansing the hair and scalp by no-poo proponents2,3,26; other uses for ACV include using it as a rinse following washing and/or conditioning of the hair or as a means of preserving color in color-treated hair. There also is evidence that ACV may have antifungal properties.28 However, consumers must be aware that if it is not diluted in water, ACV may be too caustic for direct application to the hair and may lead to damage; it can be irritating to eyes, mucus membranes, and acutely inflamed skin. Also, vinegar rinses used on processed or chemically damaged hair may lead to increased hair fragility.2,3

Hair fibers have a pH of 3.67, while the scalp has a pH between 4.5 and 6.2. This slightly acidic film acts as a barrier to viruses, bacteria, and other potential contaminants.33 Studies have shown that the pH of skin increases in proportion to the pH of the cleanser used.34 Therefore, due to the naturally acidic pH of the scalp, acid-balanced shampoos generally are recommended. Shampoos should not have a pH higher than 5.5, as hair shafts can swell due to alkalinization, which can be prevented by pH balancing the shampoo through the addition of an acidic substance (eg, glycolic acid, citric acid) to lower the pH down to approximately 5.5. Apple cider vinegar often is used for this purpose. However, one study revealed that 82% of shampoos already have an acidic pH.34

Conditioner-Only Washing (Co-washing)
Conditioner-only washing, or co-washing, is a widely practiced method of hair grooming. It is popular among individuals who find that commercial shampoos strip too much of the natural hair oils away, leaving the hair rough or unmanageable. Co-washing is not harmful to the hair; however, the molecular structure and function of a conditioner and that of a shampoo are very different.5,35,36 Conditioners are not formulated to remove dirt and buildup in the hair but rather to add substances to the hair, and thus cannot provide extensive cleansing of the hair and scalp; therefore, it is inappropriate to use co-washing as a replacement for shampooing. Quaternary conditioning agents are an exception because they contain amphoteric detergents comprised of both anionic and cationic groups, which allow them both the ability to remove dirt and sebum with its anionic group, typically found in shampoos, as well as the ability to coat and condition the hair due to the high affinity of the cationic group for the negatively charged hair fibers.36,37 Amphoteric detergents are commonly found in 2-in-1 conditioning cleansers, among other ingredients, such as hydrolyzed animal proteins that temporarily plug surface defects on the hair fiber, and dimethicone, a synthetic oil that creates a thin film over the hair shaft, increasing shine and manageability. Of note, these conditioning shampoos are ideal for individuals with minimal product buildup on the hair and scalp and are not adequate scalp cleansers for individuals who either wash their hair infrequently or who regularly use hairstyling products.36,37

Tea Tree Oil
Tea tree oil is an essential oil extracted from the Melaleuca alternifolia plant of the Myrtaceae family. It is native to the coast of northeastern Australia. A holy grail of natural cosmetics, tea tree oil is widely known for its antiviral, antifungal, and antiseptic properties.38 Although not used as a stand-alone cleanser, it is often added to a number of cosmetic products, including shampoos and co-washes. Although deemed safe for topical use, it has been shown to be quite toxic when ingested. Symptoms of ingestion include nausea, vomiting, hallucinations, and coma. The common concern with tea tree oil is its ability to cause ACD. In particular, it is believed that the oxidation products of tea tree oil are allergenic rather than the tea tree oil itself. The evaluation of tea tree oil as a potential contact allergen has been quite difficult; it consists of more than 100 distinct compounds and is often mislabeled, or does not meet the guidelines of the International Organization for Standardization. Nonetheless, the prevalence of ACD due to tea tree oil is low (approximately 1.4%). Despite its low prevalence, tea tree oil should remain in the differential as an ACD-inducing agent. Patch testing with the patient’s supply of tea tree oil is advised when possible.38

Conclusion

It is customary that the ingredients used in shampoos undergo periodic testing and monitoring to assure the safety of their use. Although it is encouraging that patients are proactive in their efforts to stay abreast of the literature, it is still important that cosmetic scientists, dermatologists, and other experts remain at the forefront of educating the public about these substances. Not doing so can result in the propagation of misinformation and unnecessary fears, which can lead to the adaptation of unhygienic or even unsafe hair care practices. As dermatologists, we must ensure that patients are educated about the benefits and hazards of off-label use of household ingredients to the extent that evidence-based medicine permits. Patients must be informed that not all synthetic substances are harmful, and likewise not all naturally occurring substances are safe.

References
  1. The global shampoo market 2014-2019 trends, forecast, and opportunity analysis [press release]. New York, NY: Reportlinker; May 21, 2015.
  2. Is the ‘no shampoo’ trend healthy or harmful? Mercola website. Published January 16, 2016. Accessed December 8, 2017.
  3. Feltman R. The science (or lack thereof) behind the ‘no-poo’ hair trend. Washington Post. March 10, 2016. https://www.washingtonpost.com/news/speaking-of-science/wp/2016/03/10/the-science-or-lack-thereof-behind-the-no-poo-hair-trend/?utm_term=.9a61edf3fd5a. Accessed December 11, 2017.
  4. Bouillon C. Shampoos. Clin Dermatol. 1996;14:113-121.
  5. Trueb RM. Shampoos: ingredients, efficacy, and adverse effects. J Dtsch Dermatol Ges. 2007;5:356-365.
  6. Bondi CA, Marks JL, Wroblewski LB, et al. Human and environmental toxicity of sodium lauryl sulfate (SLS): evidence for safe use in household cleaning products. Environ Health Insights. 2015;9:27-32.
  7. Green K, Johnson RE, Chapman JM, et al. Preservative effects on the healing rate of rabbit corneal epithelium. Lens Eye Toxic Res. 1989;6:37-41.
  8. Sodium lauryl sulphate. Healthy Choices website. http://www.healthychoices.co.uk/sls.html. Accessed December 8, 2017.
  9. Tekbas¸ ÖF, Uysal Y, Og˘ur R, et al. Non-irritant baby shampoos may cause cataract development. TSK Koruyucu Hekimlik Bülteni. 2008;1:1-6.
  10. Cater KC, Harbell JW. Prediction of eye irritation potential of surfactant-based rinse-off personal care formulations by the bovine corneal opacity and permeability (BCOP) assay. Cutan Ocul Toxicol. 2006;25:217-233.
  11. Birt DF, Lawson TA, Julius AD, et al. Inhibition by dietary selenium of colon cancer induced in the rat by bis(2-oxopropyl) nitrosamine. Cancer Res. 1982;42:4455-4459.
  12. Rastogi SC. Headspace analysis of 1,4-dioxane in products containing polyethoxylated surfactants by GC-MS. Chromatographia. 1990;29:441-445.
  13. 1,4-Dioxane. IARC Monogr Eval Carcinog Risks Hum. 1999;71, pt 2:589-602.
  14. Trueb RM. Dermocosmetic aspects of hair and scalp. J Investig Dermatol Symp Proc. 2005;10:289-292.
  15. D’Souza P, Rathi SK. Shampoo and conditioners: what a dermatologist should know? Indian J Dermatol. 2015;60:248-254.
  16. Sasseville D, Alfalah M, Lacroix JP. “Parabenoia” debunked, or “who’s afraid of parabens?” Dermatitis. 2015;26:254-259.
  17. Krowka JF, Loretz L, Geis PA, et al. Preserving the facts on parabens: an overview of these important tools of the trade. Cosmetics & Toiletries. http://www.cosmeticsandtoiletries.com/research/chemistry/Preserving-the-Facts-on-Parabens-An-Overview-of-These-Important-Tools-of-the Trade-425784294.html. Published June 1, 2017. Accessed December 20, 2017.
  18. Routledge EJ, Parker J, Odum J, et al. Some alkyl hydroxy benzoate preservatives (parabens) are estrogenic. Toxicol Appl Pharmacol. 1998;153:12Y19.
  19. Hossaini A, Larsen JJ, Larsen JC. Lack of oestrogenic effects of food preservatives (parabens) in uterotrophic assays. Food Chem Toxicol. 2000;38:319-323.
  20. Cosmetic Ingredient Review. Final report on the safety assessment of methylparaben, ethylparaben, propylparaben and butylparaben. J Am Coll Toxicol. 1984;3:147-209.
  21. Cosmetic Ingredient Review. Final report on the safety assessment of isobutylparaben and isopropylparaben. J Am Coll Toxicol. 1995;14:364-372.
  22. Scientific Committee on Consumer Products. Extended Opinion on the Safety Evaluation of Parabens. European Commission website. https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_019.pdf. Published January 28, 2005. Accessed December 20, 2017.
  23. Scientific Committee on Consumer Products. Opinion on Parabens. European Commission website. http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_041.pdf. Revised March 22, 2011. Accessed December 20, 2017.
  24. European Commission. Commission Regulation (EU) No 258/2014 of 9 April 2014 amending Annexes II and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. EUR-Lex website. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.107.01.0005.01.ENG. Accessed December 20, 2017.
  25. American Cancer Society. Antiperspirants and breast cancer risk. https://www.cancer.org/cancer/cancer-causes/antiperspirants-and-breast-cancer-risk.html#references. Revised October 14, 2014. Accessed January 2, 2018.
  26. MacMillan A. Cutting back on shampoo? 15 things you should know. Health. February 25, 2014. http://www.health.com/health/gallery/0,,20788089,00.html#should-you-go-no-poo--1. Accessed December 10, 2017.
  27. The ‘no poo’ method. https://www.nopoomethod.com/. Accessed December 10, 2017.
  28. Fong, D, Gaulin C, Le M, et al. Effectiveness of alternative antimicrobial agents for disinfection of hard surfaces. National Collaborating Centre for Environmental Health website. http://www.ncceh.ca/sites/default/files/Alternative_Antimicrobial_Agents_Aug_2014.pdf. Published August 2014. Accessed December 10, 2017.
  29. Is baking soda too harsh for natural hair? Black Girl With Long Hair website. http://blackgirllonghair.com/2012/02/is-baking-soda-too-harsh-for-hair/2/. Published February 5, 2012. Accessed December 12, 2017.
  30. O’Lenick T. Anionic/cationic complexes in hair care. J Cosmet Sci. 2011;62:209-228.
  31. Gavazzoni Dias MF, de Almeida AM, Cecato PM, et al. The shampoo pH can affect the hair: myth or reality? Int J Trichology. 2014;6:95-99.
  32. Goodman H. The acid mantle of the skin surface. Ind Med Surg. 1958;27:105-108.
  33. Korting HC, Kober M, Mueller M, et al. Influence of repeated washings with soap and synthetic detergents on pH and resident flora of the skin of forehead and forearm. results of a cross-over trial in health probationers. Acta Derm Venereol. 1987;67:41-47.
  34. Tarun J, Susan J, Suria J, et al. Evaluation of pH of bathing soaps and shampoos for skin and hair care. Indian J Dermatol. 2014;59:442-444.
  35. Corbett JF. The chemistry of hair-care products. J Soc Dyers Colour. 1976;92:285-303.
  36. McMichael AJ, Hordinsky M. Hair Diseases: Medical, Surgical, and Cosmetic Treatments. New York, NY: Taylor & Francis; 2008:59-72.
  37. Allardice A, Gummo G. Hair conditioning: quaternary ammonium compounds on various hair types. Cosmet Toiletries. 1993;108:107-109.
  38. Larson D, Jacob SE. Tea tree oil. Dermatitis. 2012;23:48-49.
References
  1. The global shampoo market 2014-2019 trends, forecast, and opportunity analysis [press release]. New York, NY: Reportlinker; May 21, 2015.
  2. Is the ‘no shampoo’ trend healthy or harmful? Mercola website. Published January 16, 2016. Accessed December 8, 2017.
  3. Feltman R. The science (or lack thereof) behind the ‘no-poo’ hair trend. Washington Post. March 10, 2016. https://www.washingtonpost.com/news/speaking-of-science/wp/2016/03/10/the-science-or-lack-thereof-behind-the-no-poo-hair-trend/?utm_term=.9a61edf3fd5a. Accessed December 11, 2017.
  4. Bouillon C. Shampoos. Clin Dermatol. 1996;14:113-121.
  5. Trueb RM. Shampoos: ingredients, efficacy, and adverse effects. J Dtsch Dermatol Ges. 2007;5:356-365.
  6. Bondi CA, Marks JL, Wroblewski LB, et al. Human and environmental toxicity of sodium lauryl sulfate (SLS): evidence for safe use in household cleaning products. Environ Health Insights. 2015;9:27-32.
  7. Green K, Johnson RE, Chapman JM, et al. Preservative effects on the healing rate of rabbit corneal epithelium. Lens Eye Toxic Res. 1989;6:37-41.
  8. Sodium lauryl sulphate. Healthy Choices website. http://www.healthychoices.co.uk/sls.html. Accessed December 8, 2017.
  9. Tekbas¸ ÖF, Uysal Y, Og˘ur R, et al. Non-irritant baby shampoos may cause cataract development. TSK Koruyucu Hekimlik Bülteni. 2008;1:1-6.
  10. Cater KC, Harbell JW. Prediction of eye irritation potential of surfactant-based rinse-off personal care formulations by the bovine corneal opacity and permeability (BCOP) assay. Cutan Ocul Toxicol. 2006;25:217-233.
  11. Birt DF, Lawson TA, Julius AD, et al. Inhibition by dietary selenium of colon cancer induced in the rat by bis(2-oxopropyl) nitrosamine. Cancer Res. 1982;42:4455-4459.
  12. Rastogi SC. Headspace analysis of 1,4-dioxane in products containing polyethoxylated surfactants by GC-MS. Chromatographia. 1990;29:441-445.
  13. 1,4-Dioxane. IARC Monogr Eval Carcinog Risks Hum. 1999;71, pt 2:589-602.
  14. Trueb RM. Dermocosmetic aspects of hair and scalp. J Investig Dermatol Symp Proc. 2005;10:289-292.
  15. D’Souza P, Rathi SK. Shampoo and conditioners: what a dermatologist should know? Indian J Dermatol. 2015;60:248-254.
  16. Sasseville D, Alfalah M, Lacroix JP. “Parabenoia” debunked, or “who’s afraid of parabens?” Dermatitis. 2015;26:254-259.
  17. Krowka JF, Loretz L, Geis PA, et al. Preserving the facts on parabens: an overview of these important tools of the trade. Cosmetics & Toiletries. http://www.cosmeticsandtoiletries.com/research/chemistry/Preserving-the-Facts-on-Parabens-An-Overview-of-These-Important-Tools-of-the Trade-425784294.html. Published June 1, 2017. Accessed December 20, 2017.
  18. Routledge EJ, Parker J, Odum J, et al. Some alkyl hydroxy benzoate preservatives (parabens) are estrogenic. Toxicol Appl Pharmacol. 1998;153:12Y19.
  19. Hossaini A, Larsen JJ, Larsen JC. Lack of oestrogenic effects of food preservatives (parabens) in uterotrophic assays. Food Chem Toxicol. 2000;38:319-323.
  20. Cosmetic Ingredient Review. Final report on the safety assessment of methylparaben, ethylparaben, propylparaben and butylparaben. J Am Coll Toxicol. 1984;3:147-209.
  21. Cosmetic Ingredient Review. Final report on the safety assessment of isobutylparaben and isopropylparaben. J Am Coll Toxicol. 1995;14:364-372.
  22. Scientific Committee on Consumer Products. Extended Opinion on the Safety Evaluation of Parabens. European Commission website. https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_019.pdf. Published January 28, 2005. Accessed December 20, 2017.
  23. Scientific Committee on Consumer Products. Opinion on Parabens. European Commission website. http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_041.pdf. Revised March 22, 2011. Accessed December 20, 2017.
  24. European Commission. Commission Regulation (EU) No 258/2014 of 9 April 2014 amending Annexes II and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. EUR-Lex website. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.107.01.0005.01.ENG. Accessed December 20, 2017.
  25. American Cancer Society. Antiperspirants and breast cancer risk. https://www.cancer.org/cancer/cancer-causes/antiperspirants-and-breast-cancer-risk.html#references. Revised October 14, 2014. Accessed January 2, 2018.
  26. MacMillan A. Cutting back on shampoo? 15 things you should know. Health. February 25, 2014. http://www.health.com/health/gallery/0,,20788089,00.html#should-you-go-no-poo--1. Accessed December 10, 2017.
  27. The ‘no poo’ method. https://www.nopoomethod.com/. Accessed December 10, 2017.
  28. Fong, D, Gaulin C, Le M, et al. Effectiveness of alternative antimicrobial agents for disinfection of hard surfaces. National Collaborating Centre for Environmental Health website. http://www.ncceh.ca/sites/default/files/Alternative_Antimicrobial_Agents_Aug_2014.pdf. Published August 2014. Accessed December 10, 2017.
  29. Is baking soda too harsh for natural hair? Black Girl With Long Hair website. http://blackgirllonghair.com/2012/02/is-baking-soda-too-harsh-for-hair/2/. Published February 5, 2012. Accessed December 12, 2017.
  30. O’Lenick T. Anionic/cationic complexes in hair care. J Cosmet Sci. 2011;62:209-228.
  31. Gavazzoni Dias MF, de Almeida AM, Cecato PM, et al. The shampoo pH can affect the hair: myth or reality? Int J Trichology. 2014;6:95-99.
  32. Goodman H. The acid mantle of the skin surface. Ind Med Surg. 1958;27:105-108.
  33. Korting HC, Kober M, Mueller M, et al. Influence of repeated washings with soap and synthetic detergents on pH and resident flora of the skin of forehead and forearm. results of a cross-over trial in health probationers. Acta Derm Venereol. 1987;67:41-47.
  34. Tarun J, Susan J, Suria J, et al. Evaluation of pH of bathing soaps and shampoos for skin and hair care. Indian J Dermatol. 2014;59:442-444.
  35. Corbett JF. The chemistry of hair-care products. J Soc Dyers Colour. 1976;92:285-303.
  36. McMichael AJ, Hordinsky M. Hair Diseases: Medical, Surgical, and Cosmetic Treatments. New York, NY: Taylor & Francis; 2008:59-72.
  37. Allardice A, Gummo G. Hair conditioning: quaternary ammonium compounds on various hair types. Cosmet Toiletries. 1993;108:107-109.
  38. Larson D, Jacob SE. Tea tree oil. Dermatitis. 2012;23:48-49.
Issue
Cutis - 101(1)
Issue
Cutis - 101(1)
Page Number
22-26
Page Number
22-26
Publications
Publications
Topics
Article Type
Display Headline
No Sulfates, No Parabens, and the “No-Poo” Method: A New Patient Perspective on Common Shampoo Ingredients
Display Headline
No Sulfates, No Parabens, and the “No-Poo” Method: A New Patient Perspective on Common Shampoo Ingredients
Sections
Inside the Article

Practice Points

  • The ingredients in shampoos and other cosmetic products have become scrutinized by the general public and the Internet has contributed to misinformation about certain shampoos.
  • Dermatologists must be prepared to acknowledge the concerns that their patients have about common shampoo ingredients to dispel the myths that may misinform patient decision-making.
  • This article reviews the controversy surrounding the use of sulfates and parabens in shampoos, as well as commonly used shampoo alternatives, often called the “no-poo” method.
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Article PDF Media

MSQC quality recommendations improve SSI in colectomy patients

Article Type
Changed
Wed, 01/02/2019 - 10:03

 

The rate of surgical site infections in colectomy patients decreased as hospitals implemented three specific care measures promoted by the Michigan Surgical Quality Collaborative, according to a study funded by the Blue Cross Blue Shield of Michigan.

With surgical site infections (SSIs) after colectomy associated with high morbidity as the second leading hospital acquired infection, and costing the health care system approximately $315 million annually, investment in this quality improvement program could ease a tremendous burden, according to Joceline V. Vu, MD, general surgery resident at the University of Michigan, Ann Arbor, and fellow investigators. The study was published in the Journal of the American College of Surgeons (2018 Jan;226[1]:91-99).

The study cohort included 5,742 colectomy patients at 1 of 52 hospitals associated with the Michigan Surgical Quality Collaborative (MSQC) between 2012 and 2016. Investigators assessed the use of the MSQC-recommended care bundle – cefazolin/metronidazole, oral antibiotics with mechanical bowel preparation, and postoperative day-1 glucose less than or equal to 140 mg/dL – and the impact of the bundle components on surgical site infection (SSI).

Patients were also split into groups based on the use of perioperative treatments previously found to be associated with SSI improvement, which included the three treatments in the care bundle as well as postoperative normothermia, minimally invasive surgery, and operative duration defined as either less than or greater than 100 minutes.

Those who had received these perioperative measures were given one point for each measure received.

Of the total, 8.1% of patients received 0-1 point, 22.2% received 2 points, 31.7% received 3 points, 27.2% received 4 points, and 10.7% received 5-6 points.

Patients were split relatively evenly between male and female, and the majority of patients were white across all six SSI perioperative groups.

Patients with 0-1 point were more likely to be older than 65 years (56.4%), while those who received 5-6 points were more likely to be between 45 and 64 years old (45.6% [P less than .001]).

Hospitals increased the use of three of the promoted processes (cefazolin/metronidazole, oral antibiotics with mechanical bowel preparation, and normoglycemia) during 2012-2016, and average use scores for patients went from 1.1 to 1.5 (P less than .001), according to investigators. As the rate of cefazolin/metronidazole and oral antibiotics with mechanical bowel preparation use rose from 18.6% and 42.9%, respectively, to 32.3% and 62.0% (P less than .001), SSI rates fell from 6.7% to 3.9% (P = .012) during the same period. The change in the normoglycemia rate (48.9% to 57.7%) was not significant (P = .112).

Hospitals that used all six recommended items saw a slightly decreased rate of SSI (r = –.39) between 2012 and 2016, according to Dr. Vu and her colleagues. Patients who received more measures had lower rates of complications, with SSI rates at 5.7% for those with 0-1 point, compared with 1.1% in those with 5-6 (P less than .001).

Rates of sepsis, pneumonia, emergency department visits, readmission, reoperation, and morbidity were also significantly lower.

“The MSQC and other collaborative quality improvement organizations represent a step toward this vision [of a learning health care system],” according to Dr. Vu and her colleagues. “Collaborating organizations can identify problems in care, adopt practice changes, and analyze the effect of those changes in a timely fashion.”

The findings of this study may be limited by a selection bias of how many bundle procedures a patient received based on comorbidities such as chronic obstructive pulmonary disease, hypertension, and obesity, which were all higher among those with fewer points. Investigators were also unable to discern causality of certain results because of the observational nature of the study. Hospitals included in the cohort volunteered to use the MSQC infrastructure, which may have limited the generalizability of the study,

Investigators reported no relevant financial disclosures. The study was funded by the Blue Cross Blue Shield of Michigan.

SOURCE: Vu, J V et al. J Am Coll Surg. 2018 Jan;226(1):91-9.

Publications
Topics
Sections

 

The rate of surgical site infections in colectomy patients decreased as hospitals implemented three specific care measures promoted by the Michigan Surgical Quality Collaborative, according to a study funded by the Blue Cross Blue Shield of Michigan.

With surgical site infections (SSIs) after colectomy associated with high morbidity as the second leading hospital acquired infection, and costing the health care system approximately $315 million annually, investment in this quality improvement program could ease a tremendous burden, according to Joceline V. Vu, MD, general surgery resident at the University of Michigan, Ann Arbor, and fellow investigators. The study was published in the Journal of the American College of Surgeons (2018 Jan;226[1]:91-99).

The study cohort included 5,742 colectomy patients at 1 of 52 hospitals associated with the Michigan Surgical Quality Collaborative (MSQC) between 2012 and 2016. Investigators assessed the use of the MSQC-recommended care bundle – cefazolin/metronidazole, oral antibiotics with mechanical bowel preparation, and postoperative day-1 glucose less than or equal to 140 mg/dL – and the impact of the bundle components on surgical site infection (SSI).

Patients were also split into groups based on the use of perioperative treatments previously found to be associated with SSI improvement, which included the three treatments in the care bundle as well as postoperative normothermia, minimally invasive surgery, and operative duration defined as either less than or greater than 100 minutes.

Those who had received these perioperative measures were given one point for each measure received.

Of the total, 8.1% of patients received 0-1 point, 22.2% received 2 points, 31.7% received 3 points, 27.2% received 4 points, and 10.7% received 5-6 points.

Patients were split relatively evenly between male and female, and the majority of patients were white across all six SSI perioperative groups.

Patients with 0-1 point were more likely to be older than 65 years (56.4%), while those who received 5-6 points were more likely to be between 45 and 64 years old (45.6% [P less than .001]).

Hospitals increased the use of three of the promoted processes (cefazolin/metronidazole, oral antibiotics with mechanical bowel preparation, and normoglycemia) during 2012-2016, and average use scores for patients went from 1.1 to 1.5 (P less than .001), according to investigators. As the rate of cefazolin/metronidazole and oral antibiotics with mechanical bowel preparation use rose from 18.6% and 42.9%, respectively, to 32.3% and 62.0% (P less than .001), SSI rates fell from 6.7% to 3.9% (P = .012) during the same period. The change in the normoglycemia rate (48.9% to 57.7%) was not significant (P = .112).

Hospitals that used all six recommended items saw a slightly decreased rate of SSI (r = –.39) between 2012 and 2016, according to Dr. Vu and her colleagues. Patients who received more measures had lower rates of complications, with SSI rates at 5.7% for those with 0-1 point, compared with 1.1% in those with 5-6 (P less than .001).

Rates of sepsis, pneumonia, emergency department visits, readmission, reoperation, and morbidity were also significantly lower.

“The MSQC and other collaborative quality improvement organizations represent a step toward this vision [of a learning health care system],” according to Dr. Vu and her colleagues. “Collaborating organizations can identify problems in care, adopt practice changes, and analyze the effect of those changes in a timely fashion.”

The findings of this study may be limited by a selection bias of how many bundle procedures a patient received based on comorbidities such as chronic obstructive pulmonary disease, hypertension, and obesity, which were all higher among those with fewer points. Investigators were also unable to discern causality of certain results because of the observational nature of the study. Hospitals included in the cohort volunteered to use the MSQC infrastructure, which may have limited the generalizability of the study,

Investigators reported no relevant financial disclosures. The study was funded by the Blue Cross Blue Shield of Michigan.

SOURCE: Vu, J V et al. J Am Coll Surg. 2018 Jan;226(1):91-9.

 

The rate of surgical site infections in colectomy patients decreased as hospitals implemented three specific care measures promoted by the Michigan Surgical Quality Collaborative, according to a study funded by the Blue Cross Blue Shield of Michigan.

With surgical site infections (SSIs) after colectomy associated with high morbidity as the second leading hospital acquired infection, and costing the health care system approximately $315 million annually, investment in this quality improvement program could ease a tremendous burden, according to Joceline V. Vu, MD, general surgery resident at the University of Michigan, Ann Arbor, and fellow investigators. The study was published in the Journal of the American College of Surgeons (2018 Jan;226[1]:91-99).

The study cohort included 5,742 colectomy patients at 1 of 52 hospitals associated with the Michigan Surgical Quality Collaborative (MSQC) between 2012 and 2016. Investigators assessed the use of the MSQC-recommended care bundle – cefazolin/metronidazole, oral antibiotics with mechanical bowel preparation, and postoperative day-1 glucose less than or equal to 140 mg/dL – and the impact of the bundle components on surgical site infection (SSI).

Patients were also split into groups based on the use of perioperative treatments previously found to be associated with SSI improvement, which included the three treatments in the care bundle as well as postoperative normothermia, minimally invasive surgery, and operative duration defined as either less than or greater than 100 minutes.

Those who had received these perioperative measures were given one point for each measure received.

Of the total, 8.1% of patients received 0-1 point, 22.2% received 2 points, 31.7% received 3 points, 27.2% received 4 points, and 10.7% received 5-6 points.

Patients were split relatively evenly between male and female, and the majority of patients were white across all six SSI perioperative groups.

Patients with 0-1 point were more likely to be older than 65 years (56.4%), while those who received 5-6 points were more likely to be between 45 and 64 years old (45.6% [P less than .001]).

Hospitals increased the use of three of the promoted processes (cefazolin/metronidazole, oral antibiotics with mechanical bowel preparation, and normoglycemia) during 2012-2016, and average use scores for patients went from 1.1 to 1.5 (P less than .001), according to investigators. As the rate of cefazolin/metronidazole and oral antibiotics with mechanical bowel preparation use rose from 18.6% and 42.9%, respectively, to 32.3% and 62.0% (P less than .001), SSI rates fell from 6.7% to 3.9% (P = .012) during the same period. The change in the normoglycemia rate (48.9% to 57.7%) was not significant (P = .112).

Hospitals that used all six recommended items saw a slightly decreased rate of SSI (r = –.39) between 2012 and 2016, according to Dr. Vu and her colleagues. Patients who received more measures had lower rates of complications, with SSI rates at 5.7% for those with 0-1 point, compared with 1.1% in those with 5-6 (P less than .001).

Rates of sepsis, pneumonia, emergency department visits, readmission, reoperation, and morbidity were also significantly lower.

“The MSQC and other collaborative quality improvement organizations represent a step toward this vision [of a learning health care system],” according to Dr. Vu and her colleagues. “Collaborating organizations can identify problems in care, adopt practice changes, and analyze the effect of those changes in a timely fashion.”

The findings of this study may be limited by a selection bias of how many bundle procedures a patient received based on comorbidities such as chronic obstructive pulmonary disease, hypertension, and obesity, which were all higher among those with fewer points. Investigators were also unable to discern causality of certain results because of the observational nature of the study. Hospitals included in the cohort volunteered to use the MSQC infrastructure, which may have limited the generalizability of the study,

Investigators reported no relevant financial disclosures. The study was funded by the Blue Cross Blue Shield of Michigan.

SOURCE: Vu, J V et al. J Am Coll Surg. 2018 Jan;226(1):91-9.

Publications
Publications
Topics
Article Type
Click for Credit Status
Ready
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: Promotion of quality improvement bundled process measures by regional programs is associated with lower SSI in colectomy patients.

Major finding: As use of bundled care processes increased, surgical site infections (SSI) decreased from 6.7% to 3.9% (P = .012) across 52 hospitals.

Study details: Observational study of 5,742 colectomy patients at 1 of 52 hospitals in the Michigan Surgical Quality Collaborative system between 2012 and 2016.

Disclosures: Investigators reported no relevant financial disclosures. The study was funded by the Blue Cross Blue Shield of Michigan.

Source: Vu, J V et al. J Am Coll Surg. 2018 Jan;226(1):91-99.

Disqus Comments
Default

Running on empty: CHIP funding could run out Jan. 19 for some states

Article Type
Changed
Thu, 03/28/2019 - 14:43

 

Some states are facing a mid-January loss of funding for their Children’s Health Insurance Program (CHIP) despite spending approved by Congress in late December that was expected to keep the program running for 3 months, federal health officials said Jan. 5.

The $2.85 billion was supposed to fund states’ CHIP programs through March 31. But some states will start running out of money after Jan. 19, according to the Centers for Medicare & Medicaid Services. The CMS did not say which states are likely to be affected first.

The latest estimates for when federal funding runs out could cause states to soon freeze enrollment and alert parents that the program could soon shut down.

The CHIP program provides health coverage to 9 million children from lower-income households that make too much money to qualify for Medicaid. Its federal authorization ended Oct. 1, and states were then forced to use unspent funds to carry them over while the House and Senate try to agree on a way to continue funding.

Congress extended funding on Dec. 21 and touted that states would have money to last while Congress worked on a long-term funding solution. But the CMS said on Jan. 5 it could only guarantee that the appropriation will be enough to fund all states through Jan. 19.

The CMS said the agency is in discussions with states to help deal with the funding shortfall.

“The funding … should carry all the states through January 19th based upon best estimates of state expenditures to date,” said CMS spokesman Johnathan Monroe. “However, due to a number of variables relating to state expenditure rates and reporting, we are unable to say with certainty whether there is enough funding for every state to continue its CHIP program through March 31, 2018.”

“States need to know whether they will need to find additional funding for children covered under the Medicaid CHIP program at a much lower federal matching rate, send letters to families, and re-program their eligibility systems,” said Lisa Dubay, a senior fellow at the Urban Institute. “Of course, the implications for families with CHIP-eligible children cannot be understated: Parents are worried that their children will lose coverage. And they should be.”

Although the program enjoys bipartisan support on Capitol Hill, the Republican-controlled House and Senate have for months been unable to agree on how to continue funding CHIP, which began in 1997.

The House plan includes a controversial funding provision – opposed by Democrats -– that takes millions of dollars from the Affordable Care Act’s Prevention and Public Health Fund and increases Medicare premiums for some higher-earning beneficiaries.

The Senate Finance Committee reached an agreement to extend the program for 5 years but did not unite around a plan on funding.

Before the CHIP funding extension on Dec. 21, Alabama said it would freeze enrollment Jan. 1 and shut down the program Jan. 31. Colorado, Connecticut, and Virginia sent letters to CHIP families warning that the program could soon end.

After the funding extension, Alabama put a hold on shutting down CHIP.

“Some states will begin exhausting all available funding earlier than others,” a CMS official said Jan. 5. “But the exact timing of when states will exhaust their funding is a moving target.”

Bruce Lesley, president of First Focus, a child advocacy group, said Congress should have known its short-term funding plan was not enough.

“The math never worked on the patch, as it only bought a few weeks,” he said. “Congress must get this finalized before Jan. 19.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.

Publications
Topics
Sections

 

Some states are facing a mid-January loss of funding for their Children’s Health Insurance Program (CHIP) despite spending approved by Congress in late December that was expected to keep the program running for 3 months, federal health officials said Jan. 5.

The $2.85 billion was supposed to fund states’ CHIP programs through March 31. But some states will start running out of money after Jan. 19, according to the Centers for Medicare & Medicaid Services. The CMS did not say which states are likely to be affected first.

The latest estimates for when federal funding runs out could cause states to soon freeze enrollment and alert parents that the program could soon shut down.

The CHIP program provides health coverage to 9 million children from lower-income households that make too much money to qualify for Medicaid. Its federal authorization ended Oct. 1, and states were then forced to use unspent funds to carry them over while the House and Senate try to agree on a way to continue funding.

Congress extended funding on Dec. 21 and touted that states would have money to last while Congress worked on a long-term funding solution. But the CMS said on Jan. 5 it could only guarantee that the appropriation will be enough to fund all states through Jan. 19.

The CMS said the agency is in discussions with states to help deal with the funding shortfall.

“The funding … should carry all the states through January 19th based upon best estimates of state expenditures to date,” said CMS spokesman Johnathan Monroe. “However, due to a number of variables relating to state expenditure rates and reporting, we are unable to say with certainty whether there is enough funding for every state to continue its CHIP program through March 31, 2018.”

“States need to know whether they will need to find additional funding for children covered under the Medicaid CHIP program at a much lower federal matching rate, send letters to families, and re-program their eligibility systems,” said Lisa Dubay, a senior fellow at the Urban Institute. “Of course, the implications for families with CHIP-eligible children cannot be understated: Parents are worried that their children will lose coverage. And they should be.”

Although the program enjoys bipartisan support on Capitol Hill, the Republican-controlled House and Senate have for months been unable to agree on how to continue funding CHIP, which began in 1997.

The House plan includes a controversial funding provision – opposed by Democrats -– that takes millions of dollars from the Affordable Care Act’s Prevention and Public Health Fund and increases Medicare premiums for some higher-earning beneficiaries.

The Senate Finance Committee reached an agreement to extend the program for 5 years but did not unite around a plan on funding.

Before the CHIP funding extension on Dec. 21, Alabama said it would freeze enrollment Jan. 1 and shut down the program Jan. 31. Colorado, Connecticut, and Virginia sent letters to CHIP families warning that the program could soon end.

After the funding extension, Alabama put a hold on shutting down CHIP.

“Some states will begin exhausting all available funding earlier than others,” a CMS official said Jan. 5. “But the exact timing of when states will exhaust their funding is a moving target.”

Bruce Lesley, president of First Focus, a child advocacy group, said Congress should have known its short-term funding plan was not enough.

“The math never worked on the patch, as it only bought a few weeks,” he said. “Congress must get this finalized before Jan. 19.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.

 

Some states are facing a mid-January loss of funding for their Children’s Health Insurance Program (CHIP) despite spending approved by Congress in late December that was expected to keep the program running for 3 months, federal health officials said Jan. 5.

The $2.85 billion was supposed to fund states’ CHIP programs through March 31. But some states will start running out of money after Jan. 19, according to the Centers for Medicare & Medicaid Services. The CMS did not say which states are likely to be affected first.

The latest estimates for when federal funding runs out could cause states to soon freeze enrollment and alert parents that the program could soon shut down.

The CHIP program provides health coverage to 9 million children from lower-income households that make too much money to qualify for Medicaid. Its federal authorization ended Oct. 1, and states were then forced to use unspent funds to carry them over while the House and Senate try to agree on a way to continue funding.

Congress extended funding on Dec. 21 and touted that states would have money to last while Congress worked on a long-term funding solution. But the CMS said on Jan. 5 it could only guarantee that the appropriation will be enough to fund all states through Jan. 19.

The CMS said the agency is in discussions with states to help deal with the funding shortfall.

“The funding … should carry all the states through January 19th based upon best estimates of state expenditures to date,” said CMS spokesman Johnathan Monroe. “However, due to a number of variables relating to state expenditure rates and reporting, we are unable to say with certainty whether there is enough funding for every state to continue its CHIP program through March 31, 2018.”

“States need to know whether they will need to find additional funding for children covered under the Medicaid CHIP program at a much lower federal matching rate, send letters to families, and re-program their eligibility systems,” said Lisa Dubay, a senior fellow at the Urban Institute. “Of course, the implications for families with CHIP-eligible children cannot be understated: Parents are worried that their children will lose coverage. And they should be.”

Although the program enjoys bipartisan support on Capitol Hill, the Republican-controlled House and Senate have for months been unable to agree on how to continue funding CHIP, which began in 1997.

The House plan includes a controversial funding provision – opposed by Democrats -– that takes millions of dollars from the Affordable Care Act’s Prevention and Public Health Fund and increases Medicare premiums for some higher-earning beneficiaries.

The Senate Finance Committee reached an agreement to extend the program for 5 years but did not unite around a plan on funding.

Before the CHIP funding extension on Dec. 21, Alabama said it would freeze enrollment Jan. 1 and shut down the program Jan. 31. Colorado, Connecticut, and Virginia sent letters to CHIP families warning that the program could soon end.

After the funding extension, Alabama put a hold on shutting down CHIP.

“Some states will begin exhausting all available funding earlier than others,” a CMS official said Jan. 5. “But the exact timing of when states will exhaust their funding is a moving target.”

Bruce Lesley, president of First Focus, a child advocacy group, said Congress should have known its short-term funding plan was not enough.

“The math never worked on the patch, as it only bought a few weeks,” he said. “Congress must get this finalized before Jan. 19.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

Purpuric Macule of the Right Axilla

Article Type
Changed
Thu, 01/10/2019 - 13:48
Display Headline
Purpuric Macule of the Right Axilla

The Diagnosis: Atypical Vascular Lesion

Atypical vascular lesion (AVL)(quiz image), named by Fineberg and Rosen,1 is a vascular lesion that arises on mammary skin with a history of radiation exposure. Clinically, AVL can present as a papule or erythematous patch that manifests 3 to 7 years after radiation therapy.2,3 There are 2 histologic subtypes of AVL: lymphatic and vascular.2,4 Lymphatic-type AVL is comprised of a symmetric distribution of thin, dilated, and anastomosing vessels usually found in the superficial and mid dermis. The vessels are lined by flat or hobnail protuberant endothelial cells that lack nuclear irregularity or pleomorphism; however, hyperchromatism of endothelial cell nuclei is a common finding. Vascular-type AVL is morphologically similar to a capillary hemangioma, and histologic features include irregular growth of capillary-sized vessels that extend to the dermis and subcutis.2,4 Atypical vascular lesions are benign lesions but may be a precursor to angiosarcoma. Along with vascular markers, D2-40 typically is positive. Surgical excision with clear margins is recommended when the lesion is small.4,5 Observation is more appropriate for extensive lesions.

Angiosarcoma can arise spontaneously or in association with radiation or chronic lymphedema. Given the shared risk factors and presentation with AVL, it is essential to differentiate angiosarcoma from AVL. Primary cutaneous angiosarcoma usually presents on the head of elderly patients as an ecchymotic patch or plaque with ulceration.4 Secondary angiosarcoma may arise following radiation or chronic lymphedema (Stewart-Treves syndrome); however, some authors now prefer to consider lymphangiosarcoma arising in chronic lymphedematous limbs a distinct entity.6 Surgical excision with wide margins is the mainstay of therapy, but angiosarcoma has high recurrence rates, and the 5-year survival rate has been reported to be as low as 35%.7 Histologic overlap with AVL includes dissecting anastomosing vessels lined by hyperchromatic nuclei; however, angiosarcoma is distinguished by endothelial cell layering, nuclear pleomorphism, and prominent nucleoli (Figure 1).4,8 Increased positivity for Ki-67 immunostain, which indicates cell proliferation, may be used to distinguish angiosarcoma from an AVL (Figure 1 [inset]).9 Further, in contrast to AVL, radiation-induced angiosarcoma is characterized by amplification of C-MYC, a regulator gene, and FLT4 (FMS-related tyrosine kinase 4), a gene encoding vascular endothelial growth factor receptor 3. Gene amplification may be detected through immunohistochemistry or fluorescence in situ hybridization.10 Ki-67 labeling showed less than 10% staining in endothelial cells in our case (quiz image [inset]), and fluorescence in situ hybridization was negative for C-MYC amplification, supporting the diagnosis of AVL.

Figure 1. Hyperchromatic, enlarged, and irregular nuclei of endothelial vessels are characteristic features of angiosarcoma (H&E, original magnification ×400). Increased proliferation was noted by increased staining for Ki-67 (original magnification ×100 [inset]).

Lymphangioma circumscriptum, the most common superficial lymphangioma, is a hamartomatous malformation that usually occurs at the axillary folds, neck, and trunk. It clinically presents as small agminated vesicles with a characteristic frog spawn appearance.11 Dermoscopic features include yellow lacunae that may alternate with a dark red color secondary to extravasation of erythrocytes.12 These clinical features often lead to a differential diagnosis of verrucae, angiokeratoma, and angiosarcoma. Lymphangioma circumscriptum histologically is characterized by an overgrowth of dilated lymphatic vessels that fill the papillary dermis. The vessels are composed of flat endothelial cells typically filled with acellular proteinaceous debris and occasional erythrocytes (Figure 2). As the lesion traverses deeper into the dermis, the caliber of the lymphatic channel becomes narrower. The presence of deep lymphatic cisterns with surrounding smooth muscle is helpful to differentiate lymphangioma circumscriptum from other lymphatic malformations such as acquired lymphangiectasia. Treatment options include surgical excision, sclerosing agents, and destructive modalities such as cryotherapy.

Figure 2. Lymphangioma circumscriptum histopathology showed the presence of dilated lymphatic vessels within the papillary dermis that can form superficial vesicles. Vascular caliber diminishes as the vessels go deeper into the dermis (H&E, original magnification ×20). Higher-power view (inset) shows the endothelial cells with no atypia (H&E, original magnification ×200).

Hobnail hemangioma, originally termed targetoid hemosiderotic hemangioma by Santa Cruz and Aronberg,13 presents as a violaceous papule or nodule surrounded by a characteristic brown halo on the leg. Trauma has been proposed as the inciting factor for the clinical appearance of hobnail hemangioma.14 Microscopically, the lesion shows vessels in a wedge shape. The superficial component has telangiectatic vessels with focal areas of papillary projections lined by endothelial cells. Although the endothelial nuclei typically project into the lumen, the nuclei are small, bland, and without mitotic activity.15 Deeper components show slit-shaped vasculature with dermal collagen dissection. Hemosiderin, extravasated red blood cells, and inflammation are found adjacent to the vessels (Figure 3). Given the benign nature, hobnail hemangiomas may be monitored.

Figure 3. Hobnail hemangioma with hemosiderin (H&E, original magnification ×200; inset, original magnification ×200).

Kaposi sarcoma (KS) is a low-grade vascular neoplasm associated with human herpesvirus 8 that arises in multiple clinical settings, especially in immunosuppression secondary to human immunodeficiency virus. There are 3 distinct clinical stages: patch, plaque, and tumor. The patch stage appears as red macules that blend into larger plaques; the tumor stage is defined as larger nodules developing from plaques. Histologic features differ by stage. Similar to angiosarcoma, KS is comprised of anastomosing vessels that dissect collagen bundles; endothelial cell atypia is minimal. A useful feature of KS is its propensity to involve adnexa and display the promontory sign, which involves the tumor growing into normal vasculature (Figure 4).16 Positive immunohistochemistry for human herpesvirus 8 aids in confirmation of the diagnosis. Treatment options for KS are numerous but include destructive modalities, chemotherapeutic agents such as doxorubicin, or highly active antiretroviral therapy for AIDS-related KS.17

Figure 4. Kaposi sarcoma with promontory sign, which involves the tumor growing into normal vasculature (H&E, original magnification ×40; inset, original magnification ×200).

References
  1. Fineberg S, Rosen PP. Cutaneous angiosarcoma and atypical vascular lesions of the skin and breast after radiation therapy for breast carcinoma. Am J Clin Pathol. 1994;102:757-763.
  2. Patton KT, Deyrup AT, Weiss SW. Atypical vascular lesions after surgery and radiation of the breast: a clinicopathologic study of 32 cases analyzing histologic heterogeneity and association with angiosarcoma. Am J Surg Pathol. 2008;32:943-950.
  3. Billings SD, McKenney JK, Folpe AL, et al. Cutaneous angiosarcoma following breast-conserving surgery and radiation: an analysis of 27 cases. Am J Surg Pathol. 2004;28:781-788.
  4. Lucas DR. Angiosarcoma, radiation-associated angiosarcoma, and atypical vascular lesion. Arch Pathol Lab Med. 2009;133:1804-1809.
  5. Udager AM, Ishikawa MK, Lucas DR, et al. MYC immunohistochemistry in angiosarcoma and atypical vascular lesions: practical considerations based on a single institutional experience. Pathology. 2016;48:697-704.
  6. Patterson JW, Hosler GA. Weedon's Skin Pathology. 4th ed. Philadelphia, PA: Elsevier; 2016:1069-1115.  
  7. Shin JY, Roh SG, Lee NH, et al. Predisposing factors for poor prognosis of angiosarcoma of the scalp and face: systematic review and meta-analysis. Head Neck. 2017;39:380-386.
  8. Fraga-Guedes C, Gobbi H, Mastropasqua MG, et al. Clinicopathological and immunohistochemical study of 30 cases of post-radiation atypical vascular lesion of the breast. Breast Cancer Res Treat. 2014;146:347-354.
  9. Shin SJ, Lesser M, Rosen PP. Hemangiomas and angiosarcomas of the breast: diagnostic utility of cell cycle markers with emphasis on Ki-67. Arch Pathol Lab Med. 2007;131:538-544.
  10. Cornejo KM, Deng A, Wu H, et al. The utility of MYC and FLT4 in the diagnosis and treatment of postradiation atypical vascular lesion and angiosarcoma of the breast. Hum Pathol. 2015;46:868-875.
  11. Patel GA, Schwartz RA. Cutaneous lymphangioma circumscriptum: frog spawn on the skin. Int J Dermatol. 2009;48:1290-1295.
  12. Massa AF, Menezes N, Baptista A, et al. Cutaneous lymphangioma circumscriptum--dermoscopic features. An Bras Dermatol. 2015;90:262-264.
  13. Santa Cruz DJ, Aronberg J. Targetoid hemosiderotic hemangioma. J Am Acad Dermatol. 1988;19:550-558.
  14. Christenson LJ, Stone MS. Trauma-induced simulator of targetoid hemosiderotic hemangioma. Am J Dermatopathol. 2001;23:221-223.
  15. Trindade F, Kutzner H, Tellechea O, et al. Hobnail hemangioma reclassified as superficial lymphatic malformation: a study of 52 cases. J Am Acad Dermatol. 2012;66:112-115.
  16. Radu O, Pantanowitz L. Kaposi sarcoma. Arch Pathol Lab Med. 2013;137:289-294.
  17. Di Lorenzo G, Di Trolio R, Montesarchio V, et al. Pegylated liposomal doxorubicin as second-line therapy in the treatment of patients with advanced classic Kaposi sarcoma: a retrospective study. Cancer. 2008;112:1147-1152.
Article PDF
Author and Disclosure Information

Dr. Dunn is from the Department of Pathology and Laboratory Services, University of Arkansas for Medical Sciences, Little Rock. Drs. Keeling, Bandino, Elston, and Metcalf are from the Medical University of South Carolina, Charleston. Drs. Keeling, Bandino, and Metcalf are from the Department of Pathology and Laboratory Medicine, and Dr. Elston is from the Department of Dermatology and Dermatologic Surgery.

The authors report no conflict of interest.

Correspondence: Andrew L.J. Dunn, MD, Department of Pathology and Laboratory Services, University of Arkansas for Medical Sciences, 4301 W Markham St, Slot #517, Little Rock, AR 72205 ([email protected]).

Issue
Cutis - 101(1)
Publications
Topics
Page Number
16, 29-30
Sections
Author and Disclosure Information

Dr. Dunn is from the Department of Pathology and Laboratory Services, University of Arkansas for Medical Sciences, Little Rock. Drs. Keeling, Bandino, Elston, and Metcalf are from the Medical University of South Carolina, Charleston. Drs. Keeling, Bandino, and Metcalf are from the Department of Pathology and Laboratory Medicine, and Dr. Elston is from the Department of Dermatology and Dermatologic Surgery.

The authors report no conflict of interest.

Correspondence: Andrew L.J. Dunn, MD, Department of Pathology and Laboratory Services, University of Arkansas for Medical Sciences, 4301 W Markham St, Slot #517, Little Rock, AR 72205 ([email protected]).

Author and Disclosure Information

Dr. Dunn is from the Department of Pathology and Laboratory Services, University of Arkansas for Medical Sciences, Little Rock. Drs. Keeling, Bandino, Elston, and Metcalf are from the Medical University of South Carolina, Charleston. Drs. Keeling, Bandino, and Metcalf are from the Department of Pathology and Laboratory Medicine, and Dr. Elston is from the Department of Dermatology and Dermatologic Surgery.

The authors report no conflict of interest.

Correspondence: Andrew L.J. Dunn, MD, Department of Pathology and Laboratory Services, University of Arkansas for Medical Sciences, 4301 W Markham St, Slot #517, Little Rock, AR 72205 ([email protected]).

Article PDF
Article PDF
Related Articles

The Diagnosis: Atypical Vascular Lesion

Atypical vascular lesion (AVL)(quiz image), named by Fineberg and Rosen,1 is a vascular lesion that arises on mammary skin with a history of radiation exposure. Clinically, AVL can present as a papule or erythematous patch that manifests 3 to 7 years after radiation therapy.2,3 There are 2 histologic subtypes of AVL: lymphatic and vascular.2,4 Lymphatic-type AVL is comprised of a symmetric distribution of thin, dilated, and anastomosing vessels usually found in the superficial and mid dermis. The vessels are lined by flat or hobnail protuberant endothelial cells that lack nuclear irregularity or pleomorphism; however, hyperchromatism of endothelial cell nuclei is a common finding. Vascular-type AVL is morphologically similar to a capillary hemangioma, and histologic features include irregular growth of capillary-sized vessels that extend to the dermis and subcutis.2,4 Atypical vascular lesions are benign lesions but may be a precursor to angiosarcoma. Along with vascular markers, D2-40 typically is positive. Surgical excision with clear margins is recommended when the lesion is small.4,5 Observation is more appropriate for extensive lesions.

Angiosarcoma can arise spontaneously or in association with radiation or chronic lymphedema. Given the shared risk factors and presentation with AVL, it is essential to differentiate angiosarcoma from AVL. Primary cutaneous angiosarcoma usually presents on the head of elderly patients as an ecchymotic patch or plaque with ulceration.4 Secondary angiosarcoma may arise following radiation or chronic lymphedema (Stewart-Treves syndrome); however, some authors now prefer to consider lymphangiosarcoma arising in chronic lymphedematous limbs a distinct entity.6 Surgical excision with wide margins is the mainstay of therapy, but angiosarcoma has high recurrence rates, and the 5-year survival rate has been reported to be as low as 35%.7 Histologic overlap with AVL includes dissecting anastomosing vessels lined by hyperchromatic nuclei; however, angiosarcoma is distinguished by endothelial cell layering, nuclear pleomorphism, and prominent nucleoli (Figure 1).4,8 Increased positivity for Ki-67 immunostain, which indicates cell proliferation, may be used to distinguish angiosarcoma from an AVL (Figure 1 [inset]).9 Further, in contrast to AVL, radiation-induced angiosarcoma is characterized by amplification of C-MYC, a regulator gene, and FLT4 (FMS-related tyrosine kinase 4), a gene encoding vascular endothelial growth factor receptor 3. Gene amplification may be detected through immunohistochemistry or fluorescence in situ hybridization.10 Ki-67 labeling showed less than 10% staining in endothelial cells in our case (quiz image [inset]), and fluorescence in situ hybridization was negative for C-MYC amplification, supporting the diagnosis of AVL.

Figure 1. Hyperchromatic, enlarged, and irregular nuclei of endothelial vessels are characteristic features of angiosarcoma (H&E, original magnification ×400). Increased proliferation was noted by increased staining for Ki-67 (original magnification ×100 [inset]).

Lymphangioma circumscriptum, the most common superficial lymphangioma, is a hamartomatous malformation that usually occurs at the axillary folds, neck, and trunk. It clinically presents as small agminated vesicles with a characteristic frog spawn appearance.11 Dermoscopic features include yellow lacunae that may alternate with a dark red color secondary to extravasation of erythrocytes.12 These clinical features often lead to a differential diagnosis of verrucae, angiokeratoma, and angiosarcoma. Lymphangioma circumscriptum histologically is characterized by an overgrowth of dilated lymphatic vessels that fill the papillary dermis. The vessels are composed of flat endothelial cells typically filled with acellular proteinaceous debris and occasional erythrocytes (Figure 2). As the lesion traverses deeper into the dermis, the caliber of the lymphatic channel becomes narrower. The presence of deep lymphatic cisterns with surrounding smooth muscle is helpful to differentiate lymphangioma circumscriptum from other lymphatic malformations such as acquired lymphangiectasia. Treatment options include surgical excision, sclerosing agents, and destructive modalities such as cryotherapy.

Figure 2. Lymphangioma circumscriptum histopathology showed the presence of dilated lymphatic vessels within the papillary dermis that can form superficial vesicles. Vascular caliber diminishes as the vessels go deeper into the dermis (H&E, original magnification ×20). Higher-power view (inset) shows the endothelial cells with no atypia (H&E, original magnification ×200).

Hobnail hemangioma, originally termed targetoid hemosiderotic hemangioma by Santa Cruz and Aronberg,13 presents as a violaceous papule or nodule surrounded by a characteristic brown halo on the leg. Trauma has been proposed as the inciting factor for the clinical appearance of hobnail hemangioma.14 Microscopically, the lesion shows vessels in a wedge shape. The superficial component has telangiectatic vessels with focal areas of papillary projections lined by endothelial cells. Although the endothelial nuclei typically project into the lumen, the nuclei are small, bland, and without mitotic activity.15 Deeper components show slit-shaped vasculature with dermal collagen dissection. Hemosiderin, extravasated red blood cells, and inflammation are found adjacent to the vessels (Figure 3). Given the benign nature, hobnail hemangiomas may be monitored.

Figure 3. Hobnail hemangioma with hemosiderin (H&E, original magnification ×200; inset, original magnification ×200).

Kaposi sarcoma (KS) is a low-grade vascular neoplasm associated with human herpesvirus 8 that arises in multiple clinical settings, especially in immunosuppression secondary to human immunodeficiency virus. There are 3 distinct clinical stages: patch, plaque, and tumor. The patch stage appears as red macules that blend into larger plaques; the tumor stage is defined as larger nodules developing from plaques. Histologic features differ by stage. Similar to angiosarcoma, KS is comprised of anastomosing vessels that dissect collagen bundles; endothelial cell atypia is minimal. A useful feature of KS is its propensity to involve adnexa and display the promontory sign, which involves the tumor growing into normal vasculature (Figure 4).16 Positive immunohistochemistry for human herpesvirus 8 aids in confirmation of the diagnosis. Treatment options for KS are numerous but include destructive modalities, chemotherapeutic agents such as doxorubicin, or highly active antiretroviral therapy for AIDS-related KS.17

Figure 4. Kaposi sarcoma with promontory sign, which involves the tumor growing into normal vasculature (H&E, original magnification ×40; inset, original magnification ×200).

The Diagnosis: Atypical Vascular Lesion

Atypical vascular lesion (AVL)(quiz image), named by Fineberg and Rosen,1 is a vascular lesion that arises on mammary skin with a history of radiation exposure. Clinically, AVL can present as a papule or erythematous patch that manifests 3 to 7 years after radiation therapy.2,3 There are 2 histologic subtypes of AVL: lymphatic and vascular.2,4 Lymphatic-type AVL is comprised of a symmetric distribution of thin, dilated, and anastomosing vessels usually found in the superficial and mid dermis. The vessels are lined by flat or hobnail protuberant endothelial cells that lack nuclear irregularity or pleomorphism; however, hyperchromatism of endothelial cell nuclei is a common finding. Vascular-type AVL is morphologically similar to a capillary hemangioma, and histologic features include irregular growth of capillary-sized vessels that extend to the dermis and subcutis.2,4 Atypical vascular lesions are benign lesions but may be a precursor to angiosarcoma. Along with vascular markers, D2-40 typically is positive. Surgical excision with clear margins is recommended when the lesion is small.4,5 Observation is more appropriate for extensive lesions.

Angiosarcoma can arise spontaneously or in association with radiation or chronic lymphedema. Given the shared risk factors and presentation with AVL, it is essential to differentiate angiosarcoma from AVL. Primary cutaneous angiosarcoma usually presents on the head of elderly patients as an ecchymotic patch or plaque with ulceration.4 Secondary angiosarcoma may arise following radiation or chronic lymphedema (Stewart-Treves syndrome); however, some authors now prefer to consider lymphangiosarcoma arising in chronic lymphedematous limbs a distinct entity.6 Surgical excision with wide margins is the mainstay of therapy, but angiosarcoma has high recurrence rates, and the 5-year survival rate has been reported to be as low as 35%.7 Histologic overlap with AVL includes dissecting anastomosing vessels lined by hyperchromatic nuclei; however, angiosarcoma is distinguished by endothelial cell layering, nuclear pleomorphism, and prominent nucleoli (Figure 1).4,8 Increased positivity for Ki-67 immunostain, which indicates cell proliferation, may be used to distinguish angiosarcoma from an AVL (Figure 1 [inset]).9 Further, in contrast to AVL, radiation-induced angiosarcoma is characterized by amplification of C-MYC, a regulator gene, and FLT4 (FMS-related tyrosine kinase 4), a gene encoding vascular endothelial growth factor receptor 3. Gene amplification may be detected through immunohistochemistry or fluorescence in situ hybridization.10 Ki-67 labeling showed less than 10% staining in endothelial cells in our case (quiz image [inset]), and fluorescence in situ hybridization was negative for C-MYC amplification, supporting the diagnosis of AVL.

Figure 1. Hyperchromatic, enlarged, and irregular nuclei of endothelial vessels are characteristic features of angiosarcoma (H&E, original magnification ×400). Increased proliferation was noted by increased staining for Ki-67 (original magnification ×100 [inset]).

Lymphangioma circumscriptum, the most common superficial lymphangioma, is a hamartomatous malformation that usually occurs at the axillary folds, neck, and trunk. It clinically presents as small agminated vesicles with a characteristic frog spawn appearance.11 Dermoscopic features include yellow lacunae that may alternate with a dark red color secondary to extravasation of erythrocytes.12 These clinical features often lead to a differential diagnosis of verrucae, angiokeratoma, and angiosarcoma. Lymphangioma circumscriptum histologically is characterized by an overgrowth of dilated lymphatic vessels that fill the papillary dermis. The vessels are composed of flat endothelial cells typically filled with acellular proteinaceous debris and occasional erythrocytes (Figure 2). As the lesion traverses deeper into the dermis, the caliber of the lymphatic channel becomes narrower. The presence of deep lymphatic cisterns with surrounding smooth muscle is helpful to differentiate lymphangioma circumscriptum from other lymphatic malformations such as acquired lymphangiectasia. Treatment options include surgical excision, sclerosing agents, and destructive modalities such as cryotherapy.

Figure 2. Lymphangioma circumscriptum histopathology showed the presence of dilated lymphatic vessels within the papillary dermis that can form superficial vesicles. Vascular caliber diminishes as the vessels go deeper into the dermis (H&E, original magnification ×20). Higher-power view (inset) shows the endothelial cells with no atypia (H&E, original magnification ×200).

Hobnail hemangioma, originally termed targetoid hemosiderotic hemangioma by Santa Cruz and Aronberg,13 presents as a violaceous papule or nodule surrounded by a characteristic brown halo on the leg. Trauma has been proposed as the inciting factor for the clinical appearance of hobnail hemangioma.14 Microscopically, the lesion shows vessels in a wedge shape. The superficial component has telangiectatic vessels with focal areas of papillary projections lined by endothelial cells. Although the endothelial nuclei typically project into the lumen, the nuclei are small, bland, and without mitotic activity.15 Deeper components show slit-shaped vasculature with dermal collagen dissection. Hemosiderin, extravasated red blood cells, and inflammation are found adjacent to the vessels (Figure 3). Given the benign nature, hobnail hemangiomas may be monitored.

Figure 3. Hobnail hemangioma with hemosiderin (H&E, original magnification ×200; inset, original magnification ×200).

Kaposi sarcoma (KS) is a low-grade vascular neoplasm associated with human herpesvirus 8 that arises in multiple clinical settings, especially in immunosuppression secondary to human immunodeficiency virus. There are 3 distinct clinical stages: patch, plaque, and tumor. The patch stage appears as red macules that blend into larger plaques; the tumor stage is defined as larger nodules developing from plaques. Histologic features differ by stage. Similar to angiosarcoma, KS is comprised of anastomosing vessels that dissect collagen bundles; endothelial cell atypia is minimal. A useful feature of KS is its propensity to involve adnexa and display the promontory sign, which involves the tumor growing into normal vasculature (Figure 4).16 Positive immunohistochemistry for human herpesvirus 8 aids in confirmation of the diagnosis. Treatment options for KS are numerous but include destructive modalities, chemotherapeutic agents such as doxorubicin, or highly active antiretroviral therapy for AIDS-related KS.17

Figure 4. Kaposi sarcoma with promontory sign, which involves the tumor growing into normal vasculature (H&E, original magnification ×40; inset, original magnification ×200).

References
  1. Fineberg S, Rosen PP. Cutaneous angiosarcoma and atypical vascular lesions of the skin and breast after radiation therapy for breast carcinoma. Am J Clin Pathol. 1994;102:757-763.
  2. Patton KT, Deyrup AT, Weiss SW. Atypical vascular lesions after surgery and radiation of the breast: a clinicopathologic study of 32 cases analyzing histologic heterogeneity and association with angiosarcoma. Am J Surg Pathol. 2008;32:943-950.
  3. Billings SD, McKenney JK, Folpe AL, et al. Cutaneous angiosarcoma following breast-conserving surgery and radiation: an analysis of 27 cases. Am J Surg Pathol. 2004;28:781-788.
  4. Lucas DR. Angiosarcoma, radiation-associated angiosarcoma, and atypical vascular lesion. Arch Pathol Lab Med. 2009;133:1804-1809.
  5. Udager AM, Ishikawa MK, Lucas DR, et al. MYC immunohistochemistry in angiosarcoma and atypical vascular lesions: practical considerations based on a single institutional experience. Pathology. 2016;48:697-704.
  6. Patterson JW, Hosler GA. Weedon's Skin Pathology. 4th ed. Philadelphia, PA: Elsevier; 2016:1069-1115.  
  7. Shin JY, Roh SG, Lee NH, et al. Predisposing factors for poor prognosis of angiosarcoma of the scalp and face: systematic review and meta-analysis. Head Neck. 2017;39:380-386.
  8. Fraga-Guedes C, Gobbi H, Mastropasqua MG, et al. Clinicopathological and immunohistochemical study of 30 cases of post-radiation atypical vascular lesion of the breast. Breast Cancer Res Treat. 2014;146:347-354.
  9. Shin SJ, Lesser M, Rosen PP. Hemangiomas and angiosarcomas of the breast: diagnostic utility of cell cycle markers with emphasis on Ki-67. Arch Pathol Lab Med. 2007;131:538-544.
  10. Cornejo KM, Deng A, Wu H, et al. The utility of MYC and FLT4 in the diagnosis and treatment of postradiation atypical vascular lesion and angiosarcoma of the breast. Hum Pathol. 2015;46:868-875.
  11. Patel GA, Schwartz RA. Cutaneous lymphangioma circumscriptum: frog spawn on the skin. Int J Dermatol. 2009;48:1290-1295.
  12. Massa AF, Menezes N, Baptista A, et al. Cutaneous lymphangioma circumscriptum--dermoscopic features. An Bras Dermatol. 2015;90:262-264.
  13. Santa Cruz DJ, Aronberg J. Targetoid hemosiderotic hemangioma. J Am Acad Dermatol. 1988;19:550-558.
  14. Christenson LJ, Stone MS. Trauma-induced simulator of targetoid hemosiderotic hemangioma. Am J Dermatopathol. 2001;23:221-223.
  15. Trindade F, Kutzner H, Tellechea O, et al. Hobnail hemangioma reclassified as superficial lymphatic malformation: a study of 52 cases. J Am Acad Dermatol. 2012;66:112-115.
  16. Radu O, Pantanowitz L. Kaposi sarcoma. Arch Pathol Lab Med. 2013;137:289-294.
  17. Di Lorenzo G, Di Trolio R, Montesarchio V, et al. Pegylated liposomal doxorubicin as second-line therapy in the treatment of patients with advanced classic Kaposi sarcoma: a retrospective study. Cancer. 2008;112:1147-1152.
References
  1. Fineberg S, Rosen PP. Cutaneous angiosarcoma and atypical vascular lesions of the skin and breast after radiation therapy for breast carcinoma. Am J Clin Pathol. 1994;102:757-763.
  2. Patton KT, Deyrup AT, Weiss SW. Atypical vascular lesions after surgery and radiation of the breast: a clinicopathologic study of 32 cases analyzing histologic heterogeneity and association with angiosarcoma. Am J Surg Pathol. 2008;32:943-950.
  3. Billings SD, McKenney JK, Folpe AL, et al. Cutaneous angiosarcoma following breast-conserving surgery and radiation: an analysis of 27 cases. Am J Surg Pathol. 2004;28:781-788.
  4. Lucas DR. Angiosarcoma, radiation-associated angiosarcoma, and atypical vascular lesion. Arch Pathol Lab Med. 2009;133:1804-1809.
  5. Udager AM, Ishikawa MK, Lucas DR, et al. MYC immunohistochemistry in angiosarcoma and atypical vascular lesions: practical considerations based on a single institutional experience. Pathology. 2016;48:697-704.
  6. Patterson JW, Hosler GA. Weedon's Skin Pathology. 4th ed. Philadelphia, PA: Elsevier; 2016:1069-1115.  
  7. Shin JY, Roh SG, Lee NH, et al. Predisposing factors for poor prognosis of angiosarcoma of the scalp and face: systematic review and meta-analysis. Head Neck. 2017;39:380-386.
  8. Fraga-Guedes C, Gobbi H, Mastropasqua MG, et al. Clinicopathological and immunohistochemical study of 30 cases of post-radiation atypical vascular lesion of the breast. Breast Cancer Res Treat. 2014;146:347-354.
  9. Shin SJ, Lesser M, Rosen PP. Hemangiomas and angiosarcomas of the breast: diagnostic utility of cell cycle markers with emphasis on Ki-67. Arch Pathol Lab Med. 2007;131:538-544.
  10. Cornejo KM, Deng A, Wu H, et al. The utility of MYC and FLT4 in the diagnosis and treatment of postradiation atypical vascular lesion and angiosarcoma of the breast. Hum Pathol. 2015;46:868-875.
  11. Patel GA, Schwartz RA. Cutaneous lymphangioma circumscriptum: frog spawn on the skin. Int J Dermatol. 2009;48:1290-1295.
  12. Massa AF, Menezes N, Baptista A, et al. Cutaneous lymphangioma circumscriptum--dermoscopic features. An Bras Dermatol. 2015;90:262-264.
  13. Santa Cruz DJ, Aronberg J. Targetoid hemosiderotic hemangioma. J Am Acad Dermatol. 1988;19:550-558.
  14. Christenson LJ, Stone MS. Trauma-induced simulator of targetoid hemosiderotic hemangioma. Am J Dermatopathol. 2001;23:221-223.
  15. Trindade F, Kutzner H, Tellechea O, et al. Hobnail hemangioma reclassified as superficial lymphatic malformation: a study of 52 cases. J Am Acad Dermatol. 2012;66:112-115.
  16. Radu O, Pantanowitz L. Kaposi sarcoma. Arch Pathol Lab Med. 2013;137:289-294.
  17. Di Lorenzo G, Di Trolio R, Montesarchio V, et al. Pegylated liposomal doxorubicin as second-line therapy in the treatment of patients with advanced classic Kaposi sarcoma: a retrospective study. Cancer. 2008;112:1147-1152.
Issue
Cutis - 101(1)
Issue
Cutis - 101(1)
Page Number
16, 29-30
Page Number
16, 29-30
Publications
Publications
Topics
Article Type
Display Headline
Purpuric Macule of the Right Axilla
Display Headline
Purpuric Macule of the Right Axilla
Sections
Questionnaire Body

H&E, original magnification ×100 (Ki-67 immunostain, original magnification ×100 [inset]).

A 67-year-old woman presented with a lesion on the medial aspect of the right axilla of 2 weeks' duration. The patient had a history of cancer of the right breast treated with a mastectomy and adjuvant radiation. She denied pain, bleeding, pruritus, or rapid growth, as well as any changes in medication or recent trauma. Physical examination revealed a 5-mm purpuric macule of the right axilla. A punch biopsy was performed. Amplification for the C-MYC gene was negative by fluorescence in situ hybridization.

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Article PDF Media

A love of teaching: James Kim, MD

Article Type
Changed
Fri, 09/14/2018 - 11:55
Dr. Kim joins The Hospitalist editorial advisory board

 

While James Kim, MD, did not originally begin medical school with a plan to become a hospitalist, he has embraced his current role wholeheartedly.

Since becoming board certified in both internal medicine and infectious diseases, Dr. Kim has welcomed the opportunity to be part of hospital medicine, which gives him the opportunity to pursue his other passion: teaching and mentoring.

Dr. James Kim
As an assistant professor of medicine at Emory University in Atlanta, Dr. Kim has tried to emulate his own mentors by not simply distributing factual information to students but also by teaching ways of thinking.

“It’s not just what you know but how you convey what you know to other people,” said Dr. Kim. “While you might get useful information from a didactic teaching style, it’s important to ask questions to encourage the learner to think about not only what the right answer is but also what’s the thought process required to get the answer.”

As one of the newest additions to the editorial advisory board of The Hospitalist, Dr. Kim took time to tell us more about himself in a recent interview.
 

QUESTION: How did you find your career path in medicine?

ANSWER: I originally went into medical school thinking I was going to do pediatrics, but then I realized that I really enjoy talking to people and that I like the process of thinking through diagnoses, managing patients, and learning about what makes their circumstances unique.

Q: How did you get into hospital medicine?

A: When I finished my internal medicine residency, I thought I was going to do medical missions. However, I realized along the way that the care you need to provide in order to really make a difference in other countries requires a constant presence there – not just a week or two. So after my fellowship, I was searching for jobs and found a hospitalist position at the University of California, Los Angeles. When I saw it, I thought ‘Wow, I really miss doing inpatient medicine.’

Q: Since you started, what have been some of your favorite parts of hospital medicine?

A: When people come to you in the hospital setting, they are usually pretty sick. It is very satisfying when, through the course of a person’s hospital stay, we are able to come up with a plan that can get them acutely better.

Q: What do you think is the hardest part of hospital medicine?

A: I think one of the things that is most frustrating is when we are placed into a situation in which we are not necessarily doing medical work for a patient but are doing something more like social work. For instance, there are cases in which patients can not be on their own in the community, and there’s no family to take them in, so the hospital, on behalf of the state, has to take them in.

Q: What else do you do outside of hospitalist work?

A: Since I’ve finished medical school, I’ve always been in some kind of academia, which is not something I would have expected. But as time has gone by, I have really come to appreciate being in academia. I really enjoy teaching, and I also think that an academic institution kind of keeps me on my toes. I’m involved with interprofessional education at Emory, with teaching medical students, interns, and residents when I’m on teaching service, and obviously now I’m on The Hospitalist editorial board. I’m looking forward to keeping abreast of what’s hot in the world of hospital medicine.

Q: What are you excited about bringing to The Hospitalist editorial board?

A: I want to try to contribute ideas. I feel that even in my short time at Emory, I’ve gotten to know a few people who might be good resources for reporters to interview or even who might write articles themselves. I also think that seeing what is trending in the world of hospital medicine is a nice way of understanding the future direction of hospital medicine.

Q: What have you seen as being the biggest change in hospital medicine since you started?

A: I feel as though I’ve kept my head down and plowed forward through the first part of my career, but I think that, more than anything else, what I’ve noticed is bigger shifts within health care itself. I know that there’s a lot of consolidation going on. I think that there are many questions that are going to come up about how do we manage a health care system as complicated as America’s and how do we deliver optimal care to people especially when sometimes we end up in situations in which we don’t have all the resources that we would want to have because of circumstances.

 

 

Q: Do you see anything in particular on the horizon for hospital medicine?

A: I’ve noticed that there’s been more “hospitalist-ization” – if that’s even a term – of other medical services. At our institution, we already have an acute care service that is basically hospital medicine for general surgery. I think another thing that’s been kind of a hot topic recently is a point-of-care testing, including ultrasounds for line placements.

Q: Where do you see yourself in 10 years?

A: I really enjoy my work at Emory. I want to find more opportunities to teach. For example, I’ve already gotten involved in teaching physician assistant students about how to perform interviews and deliver presentations for attendings. A lot of serendipitous things have happened to me over time, so I think I will continue to teach, but I’m open to those opportunities that present themselves in the future.

Q: What’s the best book you’ve read recently and why?

A: “The Hero with a Thousand Faces,” by Joseph Campbell. This is a very well-known book – I think George Lucas made reference to it when he was writing Star Wars – but I think it was a great literary way to examine the hero’s journey. Once you read the book, and you then watch any kind of movie or read any other kind of adventure narrative, you can’t miss the pattern.

Publications
Sections
Dr. Kim joins The Hospitalist editorial advisory board
Dr. Kim joins The Hospitalist editorial advisory board

 

While James Kim, MD, did not originally begin medical school with a plan to become a hospitalist, he has embraced his current role wholeheartedly.

Since becoming board certified in both internal medicine and infectious diseases, Dr. Kim has welcomed the opportunity to be part of hospital medicine, which gives him the opportunity to pursue his other passion: teaching and mentoring.

Dr. James Kim
As an assistant professor of medicine at Emory University in Atlanta, Dr. Kim has tried to emulate his own mentors by not simply distributing factual information to students but also by teaching ways of thinking.

“It’s not just what you know but how you convey what you know to other people,” said Dr. Kim. “While you might get useful information from a didactic teaching style, it’s important to ask questions to encourage the learner to think about not only what the right answer is but also what’s the thought process required to get the answer.”

As one of the newest additions to the editorial advisory board of The Hospitalist, Dr. Kim took time to tell us more about himself in a recent interview.
 

QUESTION: How did you find your career path in medicine?

ANSWER: I originally went into medical school thinking I was going to do pediatrics, but then I realized that I really enjoy talking to people and that I like the process of thinking through diagnoses, managing patients, and learning about what makes their circumstances unique.

Q: How did you get into hospital medicine?

A: When I finished my internal medicine residency, I thought I was going to do medical missions. However, I realized along the way that the care you need to provide in order to really make a difference in other countries requires a constant presence there – not just a week or two. So after my fellowship, I was searching for jobs and found a hospitalist position at the University of California, Los Angeles. When I saw it, I thought ‘Wow, I really miss doing inpatient medicine.’

Q: Since you started, what have been some of your favorite parts of hospital medicine?

A: When people come to you in the hospital setting, they are usually pretty sick. It is very satisfying when, through the course of a person’s hospital stay, we are able to come up with a plan that can get them acutely better.

Q: What do you think is the hardest part of hospital medicine?

A: I think one of the things that is most frustrating is when we are placed into a situation in which we are not necessarily doing medical work for a patient but are doing something more like social work. For instance, there are cases in which patients can not be on their own in the community, and there’s no family to take them in, so the hospital, on behalf of the state, has to take them in.

Q: What else do you do outside of hospitalist work?

A: Since I’ve finished medical school, I’ve always been in some kind of academia, which is not something I would have expected. But as time has gone by, I have really come to appreciate being in academia. I really enjoy teaching, and I also think that an academic institution kind of keeps me on my toes. I’m involved with interprofessional education at Emory, with teaching medical students, interns, and residents when I’m on teaching service, and obviously now I’m on The Hospitalist editorial board. I’m looking forward to keeping abreast of what’s hot in the world of hospital medicine.

Q: What are you excited about bringing to The Hospitalist editorial board?

A: I want to try to contribute ideas. I feel that even in my short time at Emory, I’ve gotten to know a few people who might be good resources for reporters to interview or even who might write articles themselves. I also think that seeing what is trending in the world of hospital medicine is a nice way of understanding the future direction of hospital medicine.

Q: What have you seen as being the biggest change in hospital medicine since you started?

A: I feel as though I’ve kept my head down and plowed forward through the first part of my career, but I think that, more than anything else, what I’ve noticed is bigger shifts within health care itself. I know that there’s a lot of consolidation going on. I think that there are many questions that are going to come up about how do we manage a health care system as complicated as America’s and how do we deliver optimal care to people especially when sometimes we end up in situations in which we don’t have all the resources that we would want to have because of circumstances.

 

 

Q: Do you see anything in particular on the horizon for hospital medicine?

A: I’ve noticed that there’s been more “hospitalist-ization” – if that’s even a term – of other medical services. At our institution, we already have an acute care service that is basically hospital medicine for general surgery. I think another thing that’s been kind of a hot topic recently is a point-of-care testing, including ultrasounds for line placements.

Q: Where do you see yourself in 10 years?

A: I really enjoy my work at Emory. I want to find more opportunities to teach. For example, I’ve already gotten involved in teaching physician assistant students about how to perform interviews and deliver presentations for attendings. A lot of serendipitous things have happened to me over time, so I think I will continue to teach, but I’m open to those opportunities that present themselves in the future.

Q: What’s the best book you’ve read recently and why?

A: “The Hero with a Thousand Faces,” by Joseph Campbell. This is a very well-known book – I think George Lucas made reference to it when he was writing Star Wars – but I think it was a great literary way to examine the hero’s journey. Once you read the book, and you then watch any kind of movie or read any other kind of adventure narrative, you can’t miss the pattern.

 

While James Kim, MD, did not originally begin medical school with a plan to become a hospitalist, he has embraced his current role wholeheartedly.

Since becoming board certified in both internal medicine and infectious diseases, Dr. Kim has welcomed the opportunity to be part of hospital medicine, which gives him the opportunity to pursue his other passion: teaching and mentoring.

Dr. James Kim
As an assistant professor of medicine at Emory University in Atlanta, Dr. Kim has tried to emulate his own mentors by not simply distributing factual information to students but also by teaching ways of thinking.

“It’s not just what you know but how you convey what you know to other people,” said Dr. Kim. “While you might get useful information from a didactic teaching style, it’s important to ask questions to encourage the learner to think about not only what the right answer is but also what’s the thought process required to get the answer.”

As one of the newest additions to the editorial advisory board of The Hospitalist, Dr. Kim took time to tell us more about himself in a recent interview.
 

QUESTION: How did you find your career path in medicine?

ANSWER: I originally went into medical school thinking I was going to do pediatrics, but then I realized that I really enjoy talking to people and that I like the process of thinking through diagnoses, managing patients, and learning about what makes their circumstances unique.

Q: How did you get into hospital medicine?

A: When I finished my internal medicine residency, I thought I was going to do medical missions. However, I realized along the way that the care you need to provide in order to really make a difference in other countries requires a constant presence there – not just a week or two. So after my fellowship, I was searching for jobs and found a hospitalist position at the University of California, Los Angeles. When I saw it, I thought ‘Wow, I really miss doing inpatient medicine.’

Q: Since you started, what have been some of your favorite parts of hospital medicine?

A: When people come to you in the hospital setting, they are usually pretty sick. It is very satisfying when, through the course of a person’s hospital stay, we are able to come up with a plan that can get them acutely better.

Q: What do you think is the hardest part of hospital medicine?

A: I think one of the things that is most frustrating is when we are placed into a situation in which we are not necessarily doing medical work for a patient but are doing something more like social work. For instance, there are cases in which patients can not be on their own in the community, and there’s no family to take them in, so the hospital, on behalf of the state, has to take them in.

Q: What else do you do outside of hospitalist work?

A: Since I’ve finished medical school, I’ve always been in some kind of academia, which is not something I would have expected. But as time has gone by, I have really come to appreciate being in academia. I really enjoy teaching, and I also think that an academic institution kind of keeps me on my toes. I’m involved with interprofessional education at Emory, with teaching medical students, interns, and residents when I’m on teaching service, and obviously now I’m on The Hospitalist editorial board. I’m looking forward to keeping abreast of what’s hot in the world of hospital medicine.

Q: What are you excited about bringing to The Hospitalist editorial board?

A: I want to try to contribute ideas. I feel that even in my short time at Emory, I’ve gotten to know a few people who might be good resources for reporters to interview or even who might write articles themselves. I also think that seeing what is trending in the world of hospital medicine is a nice way of understanding the future direction of hospital medicine.

Q: What have you seen as being the biggest change in hospital medicine since you started?

A: I feel as though I’ve kept my head down and plowed forward through the first part of my career, but I think that, more than anything else, what I’ve noticed is bigger shifts within health care itself. I know that there’s a lot of consolidation going on. I think that there are many questions that are going to come up about how do we manage a health care system as complicated as America’s and how do we deliver optimal care to people especially when sometimes we end up in situations in which we don’t have all the resources that we would want to have because of circumstances.

 

 

Q: Do you see anything in particular on the horizon for hospital medicine?

A: I’ve noticed that there’s been more “hospitalist-ization” – if that’s even a term – of other medical services. At our institution, we already have an acute care service that is basically hospital medicine for general surgery. I think another thing that’s been kind of a hot topic recently is a point-of-care testing, including ultrasounds for line placements.

Q: Where do you see yourself in 10 years?

A: I really enjoy my work at Emory. I want to find more opportunities to teach. For example, I’ve already gotten involved in teaching physician assistant students about how to perform interviews and deliver presentations for attendings. A lot of serendipitous things have happened to me over time, so I think I will continue to teach, but I’m open to those opportunities that present themselves in the future.

Q: What’s the best book you’ve read recently and why?

A: “The Hero with a Thousand Faces,” by Joseph Campbell. This is a very well-known book – I think George Lucas made reference to it when he was writing Star Wars – but I think it was a great literary way to examine the hero’s journey. Once you read the book, and you then watch any kind of movie or read any other kind of adventure narrative, you can’t miss the pattern.

Publications
Publications
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

Prior biologic exposure doesn’t diminish ixekizumab’s efficacy

Article Type
Changed
Tue, 02/07/2023 - 16:55

 

REPORTING FROM THE EADV CONGRESS

– Psoriasis patients switched to ixekizumab after previous exposure to another interleukin-17 inhibitor respond as well as those who are IL-17 antagonist naive, Kim A. Papp, MD, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.

This finding is of importance in real-world clinical practice because it’s not at all uncommon for psoriasis patients on one biologic to have to switch to another because of insufficient efficacy, side effects, or a change in insurance coverage. Physicians would like to know what sort of responses can be expected to whatever agent they prescribe next.

“We’ve seen many cases in which previous use of biologics may detrimentally impact the efficacy of subsequent biologic treatments. It’s a general rule of thumb that patients tend not to respond as well,” noted Dr. Papp, president of Probity Medical Research in Waterloo, Ont.

However, that was not a problem in this secondary analysis of a large clinical trial whose primary purpose was to evaluate the relative safety and efficacy of ixekizumab (Taltz) when dosed every 2 weeks versus every 4 weeks.

“I think what we have seen here is a very compelling story: Previous exposure to biologics – and specifically to IL-17 antagonists – does not impact efficacy when you treat with ixekizumab, nor for that matter does it appear to impact safety,” the dermatologist said.

He reported on 1,227 patients with moderate to severe plaque psoriasis who were randomized to ixekizumab at 80 mg every 2 or 4 weeks following an initial 160 mg loading dose. Among those who started out on ixekizumab every 4 weeks, 306 patients got a per-protocol dose adjustment to biweekly therapy because of an insufficient response to monthly dosing as defined by a Physician’s Global Assessment score of 2 or more on two consecutive office visits during study weeks 12-40.

A total of 939 patients were IL-17 inhibitor naive. The other 288 had previously been on the IL-17 antagonists brodalumab (Siliq) or secukinumab (Cosentyx). The two groups had similar baseline demographics with the exception that the experienced cohort had on average a 22.2-year duration of psoriasis, 3.7 years more than IL-17 antagonist-naive patients.

In an intent-to-treat analysis, Psoriasis Area and Severity Index (PASI) 75, 90, and 100 responses at week 52 didn’t differ significantly between the IL-17 inhibitor-naive and -experienced groups. In fact, patients with prior exposure to other IL-17 antagonists showed a consistent trend for slightly higher response rates (see graphic).

It was clear from this analysis that dosing ixekizumab every 2 weeks provides significantly better efficacy than was dosing every 4 weeks, Dr. Papp noted. Yet the approved dosing is 160 mg at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.

No new safety issues arose in this study. The only difference between the naive and experienced groups was a lower rate of allergic reactions/hypersensitivity in the experienced group. For example, in patients on ixekizumab every 2 weeks for the entire 52-week study period the incidence of such reactions was 11.5% in the IL-17 antagonist-naive group, compared with 4.1% in the experienced cohort. This isn’t really surprising, according to Dr. Papp.

“Most injection site reactions occur in the newbies,” he said.

The study was sponsored by Eli Lilly. Dr. Papp serves as a consultant and/or adviser to Lilly and numerous other pharmaceutical companies involved in the development of dermatologic therapies.
 

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

REPORTING FROM THE EADV CONGRESS

– Psoriasis patients switched to ixekizumab after previous exposure to another interleukin-17 inhibitor respond as well as those who are IL-17 antagonist naive, Kim A. Papp, MD, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.

This finding is of importance in real-world clinical practice because it’s not at all uncommon for psoriasis patients on one biologic to have to switch to another because of insufficient efficacy, side effects, or a change in insurance coverage. Physicians would like to know what sort of responses can be expected to whatever agent they prescribe next.

“We’ve seen many cases in which previous use of biologics may detrimentally impact the efficacy of subsequent biologic treatments. It’s a general rule of thumb that patients tend not to respond as well,” noted Dr. Papp, president of Probity Medical Research in Waterloo, Ont.

However, that was not a problem in this secondary analysis of a large clinical trial whose primary purpose was to evaluate the relative safety and efficacy of ixekizumab (Taltz) when dosed every 2 weeks versus every 4 weeks.

“I think what we have seen here is a very compelling story: Previous exposure to biologics – and specifically to IL-17 antagonists – does not impact efficacy when you treat with ixekizumab, nor for that matter does it appear to impact safety,” the dermatologist said.

He reported on 1,227 patients with moderate to severe plaque psoriasis who were randomized to ixekizumab at 80 mg every 2 or 4 weeks following an initial 160 mg loading dose. Among those who started out on ixekizumab every 4 weeks, 306 patients got a per-protocol dose adjustment to biweekly therapy because of an insufficient response to monthly dosing as defined by a Physician’s Global Assessment score of 2 or more on two consecutive office visits during study weeks 12-40.

A total of 939 patients were IL-17 inhibitor naive. The other 288 had previously been on the IL-17 antagonists brodalumab (Siliq) or secukinumab (Cosentyx). The two groups had similar baseline demographics with the exception that the experienced cohort had on average a 22.2-year duration of psoriasis, 3.7 years more than IL-17 antagonist-naive patients.

In an intent-to-treat analysis, Psoriasis Area and Severity Index (PASI) 75, 90, and 100 responses at week 52 didn’t differ significantly between the IL-17 inhibitor-naive and -experienced groups. In fact, patients with prior exposure to other IL-17 antagonists showed a consistent trend for slightly higher response rates (see graphic).

It was clear from this analysis that dosing ixekizumab every 2 weeks provides significantly better efficacy than was dosing every 4 weeks, Dr. Papp noted. Yet the approved dosing is 160 mg at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.

No new safety issues arose in this study. The only difference between the naive and experienced groups was a lower rate of allergic reactions/hypersensitivity in the experienced group. For example, in patients on ixekizumab every 2 weeks for the entire 52-week study period the incidence of such reactions was 11.5% in the IL-17 antagonist-naive group, compared with 4.1% in the experienced cohort. This isn’t really surprising, according to Dr. Papp.

“Most injection site reactions occur in the newbies,” he said.

The study was sponsored by Eli Lilly. Dr. Papp serves as a consultant and/or adviser to Lilly and numerous other pharmaceutical companies involved in the development of dermatologic therapies.
 

 

REPORTING FROM THE EADV CONGRESS

– Psoriasis patients switched to ixekizumab after previous exposure to another interleukin-17 inhibitor respond as well as those who are IL-17 antagonist naive, Kim A. Papp, MD, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.

This finding is of importance in real-world clinical practice because it’s not at all uncommon for psoriasis patients on one biologic to have to switch to another because of insufficient efficacy, side effects, or a change in insurance coverage. Physicians would like to know what sort of responses can be expected to whatever agent they prescribe next.

“We’ve seen many cases in which previous use of biologics may detrimentally impact the efficacy of subsequent biologic treatments. It’s a general rule of thumb that patients tend not to respond as well,” noted Dr. Papp, president of Probity Medical Research in Waterloo, Ont.

However, that was not a problem in this secondary analysis of a large clinical trial whose primary purpose was to evaluate the relative safety and efficacy of ixekizumab (Taltz) when dosed every 2 weeks versus every 4 weeks.

“I think what we have seen here is a very compelling story: Previous exposure to biologics – and specifically to IL-17 antagonists – does not impact efficacy when you treat with ixekizumab, nor for that matter does it appear to impact safety,” the dermatologist said.

He reported on 1,227 patients with moderate to severe plaque psoriasis who were randomized to ixekizumab at 80 mg every 2 or 4 weeks following an initial 160 mg loading dose. Among those who started out on ixekizumab every 4 weeks, 306 patients got a per-protocol dose adjustment to biweekly therapy because of an insufficient response to monthly dosing as defined by a Physician’s Global Assessment score of 2 or more on two consecutive office visits during study weeks 12-40.

A total of 939 patients were IL-17 inhibitor naive. The other 288 had previously been on the IL-17 antagonists brodalumab (Siliq) or secukinumab (Cosentyx). The two groups had similar baseline demographics with the exception that the experienced cohort had on average a 22.2-year duration of psoriasis, 3.7 years more than IL-17 antagonist-naive patients.

In an intent-to-treat analysis, Psoriasis Area and Severity Index (PASI) 75, 90, and 100 responses at week 52 didn’t differ significantly between the IL-17 inhibitor-naive and -experienced groups. In fact, patients with prior exposure to other IL-17 antagonists showed a consistent trend for slightly higher response rates (see graphic).

It was clear from this analysis that dosing ixekizumab every 2 weeks provides significantly better efficacy than was dosing every 4 weeks, Dr. Papp noted. Yet the approved dosing is 160 mg at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.

No new safety issues arose in this study. The only difference between the naive and experienced groups was a lower rate of allergic reactions/hypersensitivity in the experienced group. For example, in patients on ixekizumab every 2 weeks for the entire 52-week study period the incidence of such reactions was 11.5% in the IL-17 antagonist-naive group, compared with 4.1% in the experienced cohort. This isn’t really surprising, according to Dr. Papp.

“Most injection site reactions occur in the newbies,” he said.

The study was sponsored by Eli Lilly. Dr. Papp serves as a consultant and/or adviser to Lilly and numerous other pharmaceutical companies involved in the development of dermatologic therapies.
 

Publications
Publications
Topics
Article Type
Click for Credit Status
Ready
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

Updosing omalizumab for chronic urticaria pays off

Article Type
Changed
Fri, 01/18/2019 - 17:18

 

– In real-world clinical practice, roughly two-thirds of patients with chronic spontaneous urticaria treated with the approved dose of omalizumab will achieve good disease control – and for those who don’t, three-quarters will respond upon updosing to 450 or 600 mg every 4 weeks.

That’s the key message of an open-label study of 286 patients with chronic spontaneous urticaria (CSU) conducted at 15 hospitals by the Catalan and Balearic Chronic Urticaria Network (XUrCB), Jorge Spertino, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/Frontline Medical News
Dr. Jorge Spertino
He and his Spanish coinvestigators performed this study to fill an information gap regarding the merits of updosing omalizumab (Xolair), a humanized monoclonal antibody that specifically binds to free immunoglobulin E in the blood and on the surface of selected B lymphocytes, but not on the surface of mast cells, antigen-presenting dendritic cells, or basophils. In the United States, omalizumab is approved at 150 mg or 300 mg subcutaneously administered every 4 weeks for the treatment of CSU not responsive to high-dose antihistamines.

In three published, pivotal, phase 3 randomized trials, the clinical response rate to omalizumab at 300 mg every 4 weeks, as defined by a weekly 7-day Urticaria Activity Score (UAS7) of 6 or less at 12 weeks, was 52% in ASTERIA I, 66% in ASTERIA II, and 52% in GLACIAL. But patients enrolled in formal randomized trials are often quite different from the broader group encountered in daily practice, and the Spanish dermatologists wanted to know if updosing in suboptimal responders was safe and effective. It turns out that it certainly is, according to Dr. Spertino of Teknon Medical Center in Barcelona.

The treatment algorithm followed by the XUrCB investigators was that, if after six doses at the approved dose of 300 mg every 4 weeks a patient didn’t have good control of disease activity, the dose was increased to 450 mg every 4 weeks. If after three doses at that level, there still wasn’t good control of the CSU, the dose was further increased to 600 mg every 4 weeks.

As in the pivotal phase 3 clinical trials, the XUrCB group defined good control of disease activity as a UAS7 score of 6 or less in accord with a study that demonstrated such a score on the 0- to 42-point UAS7 correlates well with minimal or no patient symptoms (Br J Dermatol. 2017 Oct;177[4]:1093-1101).

At baseline, the mean age of the 286 CSU patients was 44.6 years and the mean UAS7 score was 26.5; 74% were women. Forty-seven percent of patients experienced angioedema and 33% had inducible urticaria, most commonly brought forth by pressure or dermographism. One-third of patients had previously been on cyclosporine and half of the patients had a high d-dimer level.

Sixty-five percent of patients achieved good disease control on omalizumab at 300 mg every 4 weeks. Of the 99 patients (35%) who didn’t, 20 patients stopped treatment at their dermatologist’s request because their symptoms remained uncontrolled on the approved dose. But 59 of the 79 who updosed obtained good disease control: 43 on a dose of 450 mg and 16 on a dose of 600 mg.

In multivariate analysis, two predictors of treatment success with updosing were identified: previous treatment with cyclosporine and obesity. Among patients previously on cyclosporine – a marker for more severe disease – only 21% achieved a UAS7 score of 6 or less on the approved dose, while 41% did so upon updosing. And obesity was associated with a 3.7-fold increased likelihood of a favorable response to updosing after lack of treatment success at the approved dose.

Neither a high d-dimer or serum IgE level, baseline UAS7 score, gender, associated angioedema, nor inducible urticaria was significantly associated with an increased treatment success rate upon updosing.

Updosing proved to be safe. All adverse events were mild and infrequent, consisting of headache, local injection site reactions, and arthromyalgia s, each occurring in 1%-2% of patients. Frequencies were similar in updosed patients and those on the approved dosing schedule.

Session cochair Jorgen Serup, MD, DMsc, congratulated Dr. Spertino for supplying physicians with “very-much-needed data.”

“This is very convincing data and highly clinically relevant for those of us who have these patients in our practices,” said Dr. Serup, professor of dermatology at Copenhagen University.

Dr. Spertino reported having no financial conflicts of interest regarding his presentation.
 

SOURCE: Spertino J et al. EADV Congress

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event
Related Articles

 

– In real-world clinical practice, roughly two-thirds of patients with chronic spontaneous urticaria treated with the approved dose of omalizumab will achieve good disease control – and for those who don’t, three-quarters will respond upon updosing to 450 or 600 mg every 4 weeks.

That’s the key message of an open-label study of 286 patients with chronic spontaneous urticaria (CSU) conducted at 15 hospitals by the Catalan and Balearic Chronic Urticaria Network (XUrCB), Jorge Spertino, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/Frontline Medical News
Dr. Jorge Spertino
He and his Spanish coinvestigators performed this study to fill an information gap regarding the merits of updosing omalizumab (Xolair), a humanized monoclonal antibody that specifically binds to free immunoglobulin E in the blood and on the surface of selected B lymphocytes, but not on the surface of mast cells, antigen-presenting dendritic cells, or basophils. In the United States, omalizumab is approved at 150 mg or 300 mg subcutaneously administered every 4 weeks for the treatment of CSU not responsive to high-dose antihistamines.

In three published, pivotal, phase 3 randomized trials, the clinical response rate to omalizumab at 300 mg every 4 weeks, as defined by a weekly 7-day Urticaria Activity Score (UAS7) of 6 or less at 12 weeks, was 52% in ASTERIA I, 66% in ASTERIA II, and 52% in GLACIAL. But patients enrolled in formal randomized trials are often quite different from the broader group encountered in daily practice, and the Spanish dermatologists wanted to know if updosing in suboptimal responders was safe and effective. It turns out that it certainly is, according to Dr. Spertino of Teknon Medical Center in Barcelona.

The treatment algorithm followed by the XUrCB investigators was that, if after six doses at the approved dose of 300 mg every 4 weeks a patient didn’t have good control of disease activity, the dose was increased to 450 mg every 4 weeks. If after three doses at that level, there still wasn’t good control of the CSU, the dose was further increased to 600 mg every 4 weeks.

As in the pivotal phase 3 clinical trials, the XUrCB group defined good control of disease activity as a UAS7 score of 6 or less in accord with a study that demonstrated such a score on the 0- to 42-point UAS7 correlates well with minimal or no patient symptoms (Br J Dermatol. 2017 Oct;177[4]:1093-1101).

At baseline, the mean age of the 286 CSU patients was 44.6 years and the mean UAS7 score was 26.5; 74% were women. Forty-seven percent of patients experienced angioedema and 33% had inducible urticaria, most commonly brought forth by pressure or dermographism. One-third of patients had previously been on cyclosporine and half of the patients had a high d-dimer level.

Sixty-five percent of patients achieved good disease control on omalizumab at 300 mg every 4 weeks. Of the 99 patients (35%) who didn’t, 20 patients stopped treatment at their dermatologist’s request because their symptoms remained uncontrolled on the approved dose. But 59 of the 79 who updosed obtained good disease control: 43 on a dose of 450 mg and 16 on a dose of 600 mg.

In multivariate analysis, two predictors of treatment success with updosing were identified: previous treatment with cyclosporine and obesity. Among patients previously on cyclosporine – a marker for more severe disease – only 21% achieved a UAS7 score of 6 or less on the approved dose, while 41% did so upon updosing. And obesity was associated with a 3.7-fold increased likelihood of a favorable response to updosing after lack of treatment success at the approved dose.

Neither a high d-dimer or serum IgE level, baseline UAS7 score, gender, associated angioedema, nor inducible urticaria was significantly associated with an increased treatment success rate upon updosing.

Updosing proved to be safe. All adverse events were mild and infrequent, consisting of headache, local injection site reactions, and arthromyalgia s, each occurring in 1%-2% of patients. Frequencies were similar in updosed patients and those on the approved dosing schedule.

Session cochair Jorgen Serup, MD, DMsc, congratulated Dr. Spertino for supplying physicians with “very-much-needed data.”

“This is very convincing data and highly clinically relevant for those of us who have these patients in our practices,” said Dr. Serup, professor of dermatology at Copenhagen University.

Dr. Spertino reported having no financial conflicts of interest regarding his presentation.
 

SOURCE: Spertino J et al. EADV Congress

 

– In real-world clinical practice, roughly two-thirds of patients with chronic spontaneous urticaria treated with the approved dose of omalizumab will achieve good disease control – and for those who don’t, three-quarters will respond upon updosing to 450 or 600 mg every 4 weeks.

That’s the key message of an open-label study of 286 patients with chronic spontaneous urticaria (CSU) conducted at 15 hospitals by the Catalan and Balearic Chronic Urticaria Network (XUrCB), Jorge Spertino, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/Frontline Medical News
Dr. Jorge Spertino
He and his Spanish coinvestigators performed this study to fill an information gap regarding the merits of updosing omalizumab (Xolair), a humanized monoclonal antibody that specifically binds to free immunoglobulin E in the blood and on the surface of selected B lymphocytes, but not on the surface of mast cells, antigen-presenting dendritic cells, or basophils. In the United States, omalizumab is approved at 150 mg or 300 mg subcutaneously administered every 4 weeks for the treatment of CSU not responsive to high-dose antihistamines.

In three published, pivotal, phase 3 randomized trials, the clinical response rate to omalizumab at 300 mg every 4 weeks, as defined by a weekly 7-day Urticaria Activity Score (UAS7) of 6 or less at 12 weeks, was 52% in ASTERIA I, 66% in ASTERIA II, and 52% in GLACIAL. But patients enrolled in formal randomized trials are often quite different from the broader group encountered in daily practice, and the Spanish dermatologists wanted to know if updosing in suboptimal responders was safe and effective. It turns out that it certainly is, according to Dr. Spertino of Teknon Medical Center in Barcelona.

The treatment algorithm followed by the XUrCB investigators was that, if after six doses at the approved dose of 300 mg every 4 weeks a patient didn’t have good control of disease activity, the dose was increased to 450 mg every 4 weeks. If after three doses at that level, there still wasn’t good control of the CSU, the dose was further increased to 600 mg every 4 weeks.

As in the pivotal phase 3 clinical trials, the XUrCB group defined good control of disease activity as a UAS7 score of 6 or less in accord with a study that demonstrated such a score on the 0- to 42-point UAS7 correlates well with minimal or no patient symptoms (Br J Dermatol. 2017 Oct;177[4]:1093-1101).

At baseline, the mean age of the 286 CSU patients was 44.6 years and the mean UAS7 score was 26.5; 74% were women. Forty-seven percent of patients experienced angioedema and 33% had inducible urticaria, most commonly brought forth by pressure or dermographism. One-third of patients had previously been on cyclosporine and half of the patients had a high d-dimer level.

Sixty-five percent of patients achieved good disease control on omalizumab at 300 mg every 4 weeks. Of the 99 patients (35%) who didn’t, 20 patients stopped treatment at their dermatologist’s request because their symptoms remained uncontrolled on the approved dose. But 59 of the 79 who updosed obtained good disease control: 43 on a dose of 450 mg and 16 on a dose of 600 mg.

In multivariate analysis, two predictors of treatment success with updosing were identified: previous treatment with cyclosporine and obesity. Among patients previously on cyclosporine – a marker for more severe disease – only 21% achieved a UAS7 score of 6 or less on the approved dose, while 41% did so upon updosing. And obesity was associated with a 3.7-fold increased likelihood of a favorable response to updosing after lack of treatment success at the approved dose.

Neither a high d-dimer or serum IgE level, baseline UAS7 score, gender, associated angioedema, nor inducible urticaria was significantly associated with an increased treatment success rate upon updosing.

Updosing proved to be safe. All adverse events were mild and infrequent, consisting of headache, local injection site reactions, and arthromyalgia s, each occurring in 1%-2% of patients. Frequencies were similar in updosed patients and those on the approved dosing schedule.

Session cochair Jorgen Serup, MD, DMsc, congratulated Dr. Spertino for supplying physicians with “very-much-needed data.”

“This is very convincing data and highly clinically relevant for those of us who have these patients in our practices,” said Dr. Serup, professor of dermatology at Copenhagen University.

Dr. Spertino reported having no financial conflicts of interest regarding his presentation.
 

SOURCE: Spertino J et al. EADV Congress

Publications
Publications
Topics
Article Type
Sections
Article Source

REPORTING FROM THE EADV CONGRESS

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: Updosing of omalizumab to a maximum of twice the approved dose is safe and effective in chronic spontaneous urticaria patients unresponsive to the licensed dose.

Major finding: Upon updosing, 75% of nonresponders to the approved dose achieved good disease control with no increase in adverse events.

Study details: This multicenter study of an omalizumab updosing algorithm included 286 patients with chronic spontaneous urticaria.

Disclosures: The study presenter reported having no financial conflicts.

Disqus Comments
Default