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Guidelines: Convalescent plasma not recommended for most hospitalized with COVID
In summarizing the practice statement, the authors write, “CCP is most effective when transfused with high neutralizing titers early after symptom onset.”
The five guidelines, were published in Annals of Internal Medicine. The guidelines and strength of recommendations are:
- Nonhospitalized patients at high risk for disease progression should have CCP transfusion in addition to usual standard of care. (weak)
- CCP transfusion should not be done for unselected hospitalized patients with moderate or severe disease. This does not apply to immunosuppressed patients or those who lack antibodies against SARS-CoV-2. (strong)
- CCP transfusion is suggested in addition to the usual standard of care for hospitalized patients with COVID-19 who do not have SARS-CoV-2 antibodies at admission. (weak)
- Prophylactic CCP transfusion is not recommended for uninfected people with close contact exposure to someone with COVID-19. (weak)
- The AABB suggests CCP transfusion along with standard of care for hospitalized patients with COVID-19 and preexisting immunosuppression. (weak)
Multiple guidelines for use of CCP are similar
In an accompanying editorial, Jason V. Baker, MD, MS, and H. Clifford Lane, MD, who are part of the National Institutes of Health Treatment Guidelines Panel, say guidelines from that organization around CCP generally align with those of the AABB and the Infectious Diseases Society of America.
They all note CCP’s potential for helping immunocompromised patients and they recommend against CCP in unselected, hospitalized patients.
The main difference is that the AABB also “suggests” using CCP in combination with other standard treatments for outpatients at high risk for disease progression, regardless of their immune status, write Dr. Baker, who is with Hennepin Healthcare and the department of medicine at the University of Minnesota in Minneapolis, and Dr. Lane, who is with the National Institutes of Health.
The precise circumstance for recommending CCP remains unclear, Dr. Baker and Dr. Lane write. That’s because most available evidence has come in the absence of vaccines and antiviral agents, including nirmatrelvir–ritonavir (Paxlovid), they explain.
“At this point in the pandemic, it seems that the patient most likely to benefit from passive antibody therapy is the immunocompromised host with COVID-19 who cannot mount their own antibody response to vaccine or prior infection,” they write.
“In that setting, and in the absence of other antiviral treatments or progression despite receipt of standard treatments, high-titer CCP from a recently recovered donor is a reasonable approach,” they conclude.
Eileen Barrett, MD, MPH, an assistant professor in the division of hospital medicine at the University of New Mexico in Albuquerque, said in an interview that “clinical guidelines like this really help practicing physicians as we navigate the explosion of research findings since the start of the pandemic.”
One strong recommendation
Dr. Barrett pointed out that four of the five recommendations are rated “weak.”
“The weak recommendations for convalescent plasma in most situations is very humbling,” she said, “particularly as we recall the earliest days of the pandemic when many hospitalized patients received this treatment when little was known about what could help.”
She highlighted the paper’s only strong recommendation, which was against convalescent plasma use for the vast majority of hospitalized patients with COVID.
“That clinical bottom line is what most clinicians will look for,” she said.
“Similarly,” she said, “the accompanying editorial is so helpful in reminding the reader that, despite some possible benefit to convalescent plasma in a smaller subgroup of patients, variant-appropriate monoclonal antibodies and antivirals are better options.”
The disclosures for lead author of the guidelines, Lise J. Estcourt, MB BChir, DPhil, with the National Health Service Blood and Transplant Department and Radcliffe department of medicine at the University of Oxford (England) and her colleagues are available at https://rmed.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-1079. The editorialists and Dr. Barrett declare no relevant financial relationships.
In summarizing the practice statement, the authors write, “CCP is most effective when transfused with high neutralizing titers early after symptom onset.”
The five guidelines, were published in Annals of Internal Medicine. The guidelines and strength of recommendations are:
- Nonhospitalized patients at high risk for disease progression should have CCP transfusion in addition to usual standard of care. (weak)
- CCP transfusion should not be done for unselected hospitalized patients with moderate or severe disease. This does not apply to immunosuppressed patients or those who lack antibodies against SARS-CoV-2. (strong)
- CCP transfusion is suggested in addition to the usual standard of care for hospitalized patients with COVID-19 who do not have SARS-CoV-2 antibodies at admission. (weak)
- Prophylactic CCP transfusion is not recommended for uninfected people with close contact exposure to someone with COVID-19. (weak)
- The AABB suggests CCP transfusion along with standard of care for hospitalized patients with COVID-19 and preexisting immunosuppression. (weak)
Multiple guidelines for use of CCP are similar
In an accompanying editorial, Jason V. Baker, MD, MS, and H. Clifford Lane, MD, who are part of the National Institutes of Health Treatment Guidelines Panel, say guidelines from that organization around CCP generally align with those of the AABB and the Infectious Diseases Society of America.
They all note CCP’s potential for helping immunocompromised patients and they recommend against CCP in unselected, hospitalized patients.
The main difference is that the AABB also “suggests” using CCP in combination with other standard treatments for outpatients at high risk for disease progression, regardless of their immune status, write Dr. Baker, who is with Hennepin Healthcare and the department of medicine at the University of Minnesota in Minneapolis, and Dr. Lane, who is with the National Institutes of Health.
The precise circumstance for recommending CCP remains unclear, Dr. Baker and Dr. Lane write. That’s because most available evidence has come in the absence of vaccines and antiviral agents, including nirmatrelvir–ritonavir (Paxlovid), they explain.
“At this point in the pandemic, it seems that the patient most likely to benefit from passive antibody therapy is the immunocompromised host with COVID-19 who cannot mount their own antibody response to vaccine or prior infection,” they write.
“In that setting, and in the absence of other antiviral treatments or progression despite receipt of standard treatments, high-titer CCP from a recently recovered donor is a reasonable approach,” they conclude.
Eileen Barrett, MD, MPH, an assistant professor in the division of hospital medicine at the University of New Mexico in Albuquerque, said in an interview that “clinical guidelines like this really help practicing physicians as we navigate the explosion of research findings since the start of the pandemic.”
One strong recommendation
Dr. Barrett pointed out that four of the five recommendations are rated “weak.”
“The weak recommendations for convalescent plasma in most situations is very humbling,” she said, “particularly as we recall the earliest days of the pandemic when many hospitalized patients received this treatment when little was known about what could help.”
She highlighted the paper’s only strong recommendation, which was against convalescent plasma use for the vast majority of hospitalized patients with COVID.
“That clinical bottom line is what most clinicians will look for,” she said.
“Similarly,” she said, “the accompanying editorial is so helpful in reminding the reader that, despite some possible benefit to convalescent plasma in a smaller subgroup of patients, variant-appropriate monoclonal antibodies and antivirals are better options.”
The disclosures for lead author of the guidelines, Lise J. Estcourt, MB BChir, DPhil, with the National Health Service Blood and Transplant Department and Radcliffe department of medicine at the University of Oxford (England) and her colleagues are available at https://rmed.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-1079. The editorialists and Dr. Barrett declare no relevant financial relationships.
In summarizing the practice statement, the authors write, “CCP is most effective when transfused with high neutralizing titers early after symptom onset.”
The five guidelines, were published in Annals of Internal Medicine. The guidelines and strength of recommendations are:
- Nonhospitalized patients at high risk for disease progression should have CCP transfusion in addition to usual standard of care. (weak)
- CCP transfusion should not be done for unselected hospitalized patients with moderate or severe disease. This does not apply to immunosuppressed patients or those who lack antibodies against SARS-CoV-2. (strong)
- CCP transfusion is suggested in addition to the usual standard of care for hospitalized patients with COVID-19 who do not have SARS-CoV-2 antibodies at admission. (weak)
- Prophylactic CCP transfusion is not recommended for uninfected people with close contact exposure to someone with COVID-19. (weak)
- The AABB suggests CCP transfusion along with standard of care for hospitalized patients with COVID-19 and preexisting immunosuppression. (weak)
Multiple guidelines for use of CCP are similar
In an accompanying editorial, Jason V. Baker, MD, MS, and H. Clifford Lane, MD, who are part of the National Institutes of Health Treatment Guidelines Panel, say guidelines from that organization around CCP generally align with those of the AABB and the Infectious Diseases Society of America.
They all note CCP’s potential for helping immunocompromised patients and they recommend against CCP in unselected, hospitalized patients.
The main difference is that the AABB also “suggests” using CCP in combination with other standard treatments for outpatients at high risk for disease progression, regardless of their immune status, write Dr. Baker, who is with Hennepin Healthcare and the department of medicine at the University of Minnesota in Minneapolis, and Dr. Lane, who is with the National Institutes of Health.
The precise circumstance for recommending CCP remains unclear, Dr. Baker and Dr. Lane write. That’s because most available evidence has come in the absence of vaccines and antiviral agents, including nirmatrelvir–ritonavir (Paxlovid), they explain.
“At this point in the pandemic, it seems that the patient most likely to benefit from passive antibody therapy is the immunocompromised host with COVID-19 who cannot mount their own antibody response to vaccine or prior infection,” they write.
“In that setting, and in the absence of other antiviral treatments or progression despite receipt of standard treatments, high-titer CCP from a recently recovered donor is a reasonable approach,” they conclude.
Eileen Barrett, MD, MPH, an assistant professor in the division of hospital medicine at the University of New Mexico in Albuquerque, said in an interview that “clinical guidelines like this really help practicing physicians as we navigate the explosion of research findings since the start of the pandemic.”
One strong recommendation
Dr. Barrett pointed out that four of the five recommendations are rated “weak.”
“The weak recommendations for convalescent plasma in most situations is very humbling,” she said, “particularly as we recall the earliest days of the pandemic when many hospitalized patients received this treatment when little was known about what could help.”
She highlighted the paper’s only strong recommendation, which was against convalescent plasma use for the vast majority of hospitalized patients with COVID.
“That clinical bottom line is what most clinicians will look for,” she said.
“Similarly,” she said, “the accompanying editorial is so helpful in reminding the reader that, despite some possible benefit to convalescent plasma in a smaller subgroup of patients, variant-appropriate monoclonal antibodies and antivirals are better options.”
The disclosures for lead author of the guidelines, Lise J. Estcourt, MB BChir, DPhil, with the National Health Service Blood and Transplant Department and Radcliffe department of medicine at the University of Oxford (England) and her colleagues are available at https://rmed.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-1079. The editorialists and Dr. Barrett declare no relevant financial relationships.
FROM ANNALS OF INTERNAL MEDICINE
Polio virus found in NYC sewer system
Polio virus has been discovered in New York City’s sewers, suggesting that the virus is circulating in the city, New York’s health authorities said Aug. 12.
“For every one case of paralytic polio identified, hundreds more may be undetected,” Dr. Bassett said. “The best way to keep adults and children polio-free is through safe and effective immunization.”
Polio can cause permanent paralysis of limbs and even death in some cases. Before this outbreak, the last case of polio in the United States was in 2013.
The announcement came after a man in Rockland County, New York, north of the city, was stricken with polio at the end of July and paralyzed.
Now, health officials fear that the detection of polio in NYC wastewater could bring other cases of paralytic polio.
“It is not surprising, since this is something already seen with Rockland County,” Amesh Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security in Baltimore, told this news organization. “This is solely the result of under-vaccination in the area. I think it’s likely that we will see a few paralytic cases but not a high number.”
Vaccinations declined in pandemic
Among the worries is that vaccination rates across New York City dipped during the pandemic because pediatrician visits were postponed.
In New York City, the overall rate of polio vaccination among children aged 5 years or younger is 86%. Still, in some city ZIP codes, fewer than two-thirds of children in that age group have received the full dosage, which worries health officials.
However, most adults were vaccinated against polio as children.
Across New York state, nearly 80% of people have been vaccinated, according to data from the state public health department. Those who are unvaccinated are at risk, but the polio vaccine is nearly 100% effective in people who are fully immunized.
New York health authorities are calling on those who are unvaccinated to get their shots immediately.
“The risk to New Yorkers is real, but the defense is so simple – get vaccinated against polio,” New York City Health Commissioner Ashwin Vasan, MD, PhD, said in a statement. “Polio is entirely preventable, and its reappearance should be a call for all of us.”
Though many of those who are infected have no symptoms, about 4% will get viral meningitis “and about 1 in 200 will become paralyzed,” according to a news release.
Symptoms can be flu-like
Symptoms can include those similar to the flu, such as sore throat, fever, fatigue, nausea, and stomach ache. There is no cure for the disease.
The city’s health department has given no details about where exactly polio had been found in NYC’s wastewater nor did they give dates the virus was detected.
Health authorities urged parents of children who are not yet fully vaccinated to bring them to their pediatricians.
In 1916, polio killed 6,000 people in the United States and left at least another 21,000 – most of them children – permanently disabled.
An outbreak in 1952 caused paralysis in more than 20,000 people and left many children on iron lungs. The first effective vaccine emerged just a few years later and the virus began to wane.
A version of this article first appeared on Medscape.com.
Polio virus has been discovered in New York City’s sewers, suggesting that the virus is circulating in the city, New York’s health authorities said Aug. 12.
“For every one case of paralytic polio identified, hundreds more may be undetected,” Dr. Bassett said. “The best way to keep adults and children polio-free is through safe and effective immunization.”
Polio can cause permanent paralysis of limbs and even death in some cases. Before this outbreak, the last case of polio in the United States was in 2013.
The announcement came after a man in Rockland County, New York, north of the city, was stricken with polio at the end of July and paralyzed.
Now, health officials fear that the detection of polio in NYC wastewater could bring other cases of paralytic polio.
“It is not surprising, since this is something already seen with Rockland County,” Amesh Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security in Baltimore, told this news organization. “This is solely the result of under-vaccination in the area. I think it’s likely that we will see a few paralytic cases but not a high number.”
Vaccinations declined in pandemic
Among the worries is that vaccination rates across New York City dipped during the pandemic because pediatrician visits were postponed.
In New York City, the overall rate of polio vaccination among children aged 5 years or younger is 86%. Still, in some city ZIP codes, fewer than two-thirds of children in that age group have received the full dosage, which worries health officials.
However, most adults were vaccinated against polio as children.
Across New York state, nearly 80% of people have been vaccinated, according to data from the state public health department. Those who are unvaccinated are at risk, but the polio vaccine is nearly 100% effective in people who are fully immunized.
New York health authorities are calling on those who are unvaccinated to get their shots immediately.
“The risk to New Yorkers is real, but the defense is so simple – get vaccinated against polio,” New York City Health Commissioner Ashwin Vasan, MD, PhD, said in a statement. “Polio is entirely preventable, and its reappearance should be a call for all of us.”
Though many of those who are infected have no symptoms, about 4% will get viral meningitis “and about 1 in 200 will become paralyzed,” according to a news release.
Symptoms can be flu-like
Symptoms can include those similar to the flu, such as sore throat, fever, fatigue, nausea, and stomach ache. There is no cure for the disease.
The city’s health department has given no details about where exactly polio had been found in NYC’s wastewater nor did they give dates the virus was detected.
Health authorities urged parents of children who are not yet fully vaccinated to bring them to their pediatricians.
In 1916, polio killed 6,000 people in the United States and left at least another 21,000 – most of them children – permanently disabled.
An outbreak in 1952 caused paralysis in more than 20,000 people and left many children on iron lungs. The first effective vaccine emerged just a few years later and the virus began to wane.
A version of this article first appeared on Medscape.com.
Polio virus has been discovered in New York City’s sewers, suggesting that the virus is circulating in the city, New York’s health authorities said Aug. 12.
“For every one case of paralytic polio identified, hundreds more may be undetected,” Dr. Bassett said. “The best way to keep adults and children polio-free is through safe and effective immunization.”
Polio can cause permanent paralysis of limbs and even death in some cases. Before this outbreak, the last case of polio in the United States was in 2013.
The announcement came after a man in Rockland County, New York, north of the city, was stricken with polio at the end of July and paralyzed.
Now, health officials fear that the detection of polio in NYC wastewater could bring other cases of paralytic polio.
“It is not surprising, since this is something already seen with Rockland County,” Amesh Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security in Baltimore, told this news organization. “This is solely the result of under-vaccination in the area. I think it’s likely that we will see a few paralytic cases but not a high number.”
Vaccinations declined in pandemic
Among the worries is that vaccination rates across New York City dipped during the pandemic because pediatrician visits were postponed.
In New York City, the overall rate of polio vaccination among children aged 5 years or younger is 86%. Still, in some city ZIP codes, fewer than two-thirds of children in that age group have received the full dosage, which worries health officials.
However, most adults were vaccinated against polio as children.
Across New York state, nearly 80% of people have been vaccinated, according to data from the state public health department. Those who are unvaccinated are at risk, but the polio vaccine is nearly 100% effective in people who are fully immunized.
New York health authorities are calling on those who are unvaccinated to get their shots immediately.
“The risk to New Yorkers is real, but the defense is so simple – get vaccinated against polio,” New York City Health Commissioner Ashwin Vasan, MD, PhD, said in a statement. “Polio is entirely preventable, and its reappearance should be a call for all of us.”
Though many of those who are infected have no symptoms, about 4% will get viral meningitis “and about 1 in 200 will become paralyzed,” according to a news release.
Symptoms can be flu-like
Symptoms can include those similar to the flu, such as sore throat, fever, fatigue, nausea, and stomach ache. There is no cure for the disease.
The city’s health department has given no details about where exactly polio had been found in NYC’s wastewater nor did they give dates the virus was detected.
Health authorities urged parents of children who are not yet fully vaccinated to bring them to their pediatricians.
In 1916, polio killed 6,000 people in the United States and left at least another 21,000 – most of them children – permanently disabled.
An outbreak in 1952 caused paralysis in more than 20,000 people and left many children on iron lungs. The first effective vaccine emerged just a few years later and the virus began to wane.
A version of this article first appeared on Medscape.com.
Sexual dysfunction, hair loss linked with long COVID
according to findings of a large study.
Anuradhaa Subramanian, PhD, with the Institute of Applied Health Research at the University of Birmingham (England), led the research published online in Nature Medicine.
The team analyzed 486,149 electronic health records from adult patients with confirmed COVID in the United Kingdom, compared with 1.9 million people with no history of COVID, from January 2020 to April 2021. Researchers matched both groups closely in terms of demographic, social, and clinical traits.
New symptoms
The team identified 62 symptoms, including the well-known indicators of long COVID, such as fatigue, loss of sense of smell, shortness of breath, and brain fog, but also hair loss, sexual dysfunction, chest pain, fever, loss of control of bowel movements, and limb swelling.
“These differences in symptoms reported between the infected and uninfected groups remained even after we accounted for age, sex, ethnic group, socioeconomic status, body mass index, smoking status, the presence of more than 80 health conditions, and past reporting of the same symptom,” Dr. Subramanian and coresearcher Shamil Haroon, PhD, wrote in a summary of their research in The Conversation.
They pointed out that only 20 of the symptoms they found are included in the World Health Organization’s clinical case definition for long COVID.
They also found that people more likely to have persistent symptoms 3 months after COVID infection were also more likely to be young, female, smokers, to belong to certain minority ethnic groups, and to have lower socioeconomic status. They were also more likely to be obese and have a wide range of health conditions.
Dr. Haroon, an associate clinical professor at the University of Birmingham, said that one reason it appeared that younger people were more likely to get symptoms of long COVID may be that older adults with COVID were more likely to be hospitalized and weren’t included in this study.
“Since we only considered nonhospitalized adults, the older adults we included in our study may have been relatively healthier and thus had a lower symptom burden,” he said.
Dr. Subramania noted that older patients were more likely to report lasting COVID-related symptoms in the study, but when researchers accounted for a wide range of other conditions that patients had before infection (which generally more commonly happen in older adults), they found younger age as a risk factor for long-term COVID-related symptoms.
In the study period, most patients were unvaccinated, and results came before the widespread Delta and Omicron variants.
More than half (56.6%) of the patients infected with the virus that causes COVID had been diagnosed in 2020, and 43.4% in 2021. Less than 5% (4.5%) of the patients infected with the virus and 4.7% of the patients with no recorded evidence of a COVID infection had received at least a single dose of a COVID vaccine before the study started.
Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, said more studies need to be done to see whether results would be different with vaccination status and evolving variants.
But he noted that this study has several strengths: “The hair loss, libido loss, and ejaculation difficulty are all new symptoms,” and the study – large and carefully controlled – shows these issues were among those more likely to occur.
A loss of sense of smell – which is not a new observation – was still the most likely risk shown in the study, followed by hair loss, sneezing, ejaculation difficulty, and reduced sex drive; followed by shortness of breath, fatigue, chest pain associated with breathing difficulties, hoarseness, and fever.
Three main clusters of symptoms
Given the wide range of symptoms, long COVID likely represents a group of conditions, the authors wrote.
They found three main clusters. The largest, with roughly 80% of people with long COVID in the study, faced a broad spectrum of symptoms, ranging from fatigue to headache and pain. The second-largest group, (15%) mostly had symptoms having to do with mental health and thinking skills, including depression, anxiety, brain fog, and insomnia. The smallest group (5%) had mainly respiratory symptoms such as shortness of breath, coughing, and wheezing.
Putting symptoms in clusters will be important to start understanding what leads to long COVID, said Farha Ikramuddin, MD, a rehabilitation specialist at the University of Minnesota, Minneapolis.
She added that, while the symptoms listed in this paper are new in published research, she has certainly been seeing them over time in her long COVID clinic. (The researchers also used only coded health care data, so they were limited in what symptoms they could discover, she notes.)
Dr. Ikramuddin said a strength of the paper is its large size, but she also cautioned that it’s difficult to determine whether members of the comparison group truly had no COVID infection when the information is taken from their medical records. Often, people test at home or assume they have COVID and don’t test; therefore the information wouldn’t be recorded.
Evaluating nonhospitalized patients is also important, she said, as much of the research on long COVID has come from hospitalized patients, so little has been known about the symptoms of those with milder infections.
“Patients who have been hospitalized and have long COVID look very different from the patients who were not hospitalized,” Dr. Ikramuddin said.
One clear message from the paper, she said, is that listening and asking extensive questions about symptoms are important with patients who have had COVID.
“Counseling has also become very important for our patients in the pandemic,” she said.
It will also be important to do studies on returning to work for patients with long COVID to see how many are able to return and at what capacity, Dr. Ikramuddin said.
A version of this article first appeared on WebMD.com.
according to findings of a large study.
Anuradhaa Subramanian, PhD, with the Institute of Applied Health Research at the University of Birmingham (England), led the research published online in Nature Medicine.
The team analyzed 486,149 electronic health records from adult patients with confirmed COVID in the United Kingdom, compared with 1.9 million people with no history of COVID, from January 2020 to April 2021. Researchers matched both groups closely in terms of demographic, social, and clinical traits.
New symptoms
The team identified 62 symptoms, including the well-known indicators of long COVID, such as fatigue, loss of sense of smell, shortness of breath, and brain fog, but also hair loss, sexual dysfunction, chest pain, fever, loss of control of bowel movements, and limb swelling.
“These differences in symptoms reported between the infected and uninfected groups remained even after we accounted for age, sex, ethnic group, socioeconomic status, body mass index, smoking status, the presence of more than 80 health conditions, and past reporting of the same symptom,” Dr. Subramanian and coresearcher Shamil Haroon, PhD, wrote in a summary of their research in The Conversation.
They pointed out that only 20 of the symptoms they found are included in the World Health Organization’s clinical case definition for long COVID.
They also found that people more likely to have persistent symptoms 3 months after COVID infection were also more likely to be young, female, smokers, to belong to certain minority ethnic groups, and to have lower socioeconomic status. They were also more likely to be obese and have a wide range of health conditions.
Dr. Haroon, an associate clinical professor at the University of Birmingham, said that one reason it appeared that younger people were more likely to get symptoms of long COVID may be that older adults with COVID were more likely to be hospitalized and weren’t included in this study.
“Since we only considered nonhospitalized adults, the older adults we included in our study may have been relatively healthier and thus had a lower symptom burden,” he said.
Dr. Subramania noted that older patients were more likely to report lasting COVID-related symptoms in the study, but when researchers accounted for a wide range of other conditions that patients had before infection (which generally more commonly happen in older adults), they found younger age as a risk factor for long-term COVID-related symptoms.
In the study period, most patients were unvaccinated, and results came before the widespread Delta and Omicron variants.
More than half (56.6%) of the patients infected with the virus that causes COVID had been diagnosed in 2020, and 43.4% in 2021. Less than 5% (4.5%) of the patients infected with the virus and 4.7% of the patients with no recorded evidence of a COVID infection had received at least a single dose of a COVID vaccine before the study started.
Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, said more studies need to be done to see whether results would be different with vaccination status and evolving variants.
But he noted that this study has several strengths: “The hair loss, libido loss, and ejaculation difficulty are all new symptoms,” and the study – large and carefully controlled – shows these issues were among those more likely to occur.
A loss of sense of smell – which is not a new observation – was still the most likely risk shown in the study, followed by hair loss, sneezing, ejaculation difficulty, and reduced sex drive; followed by shortness of breath, fatigue, chest pain associated with breathing difficulties, hoarseness, and fever.
Three main clusters of symptoms
Given the wide range of symptoms, long COVID likely represents a group of conditions, the authors wrote.
They found three main clusters. The largest, with roughly 80% of people with long COVID in the study, faced a broad spectrum of symptoms, ranging from fatigue to headache and pain. The second-largest group, (15%) mostly had symptoms having to do with mental health and thinking skills, including depression, anxiety, brain fog, and insomnia. The smallest group (5%) had mainly respiratory symptoms such as shortness of breath, coughing, and wheezing.
Putting symptoms in clusters will be important to start understanding what leads to long COVID, said Farha Ikramuddin, MD, a rehabilitation specialist at the University of Minnesota, Minneapolis.
She added that, while the symptoms listed in this paper are new in published research, she has certainly been seeing them over time in her long COVID clinic. (The researchers also used only coded health care data, so they were limited in what symptoms they could discover, she notes.)
Dr. Ikramuddin said a strength of the paper is its large size, but she also cautioned that it’s difficult to determine whether members of the comparison group truly had no COVID infection when the information is taken from their medical records. Often, people test at home or assume they have COVID and don’t test; therefore the information wouldn’t be recorded.
Evaluating nonhospitalized patients is also important, she said, as much of the research on long COVID has come from hospitalized patients, so little has been known about the symptoms of those with milder infections.
“Patients who have been hospitalized and have long COVID look very different from the patients who were not hospitalized,” Dr. Ikramuddin said.
One clear message from the paper, she said, is that listening and asking extensive questions about symptoms are important with patients who have had COVID.
“Counseling has also become very important for our patients in the pandemic,” she said.
It will also be important to do studies on returning to work for patients with long COVID to see how many are able to return and at what capacity, Dr. Ikramuddin said.
A version of this article first appeared on WebMD.com.
according to findings of a large study.
Anuradhaa Subramanian, PhD, with the Institute of Applied Health Research at the University of Birmingham (England), led the research published online in Nature Medicine.
The team analyzed 486,149 electronic health records from adult patients with confirmed COVID in the United Kingdom, compared with 1.9 million people with no history of COVID, from January 2020 to April 2021. Researchers matched both groups closely in terms of demographic, social, and clinical traits.
New symptoms
The team identified 62 symptoms, including the well-known indicators of long COVID, such as fatigue, loss of sense of smell, shortness of breath, and brain fog, but also hair loss, sexual dysfunction, chest pain, fever, loss of control of bowel movements, and limb swelling.
“These differences in symptoms reported between the infected and uninfected groups remained even after we accounted for age, sex, ethnic group, socioeconomic status, body mass index, smoking status, the presence of more than 80 health conditions, and past reporting of the same symptom,” Dr. Subramanian and coresearcher Shamil Haroon, PhD, wrote in a summary of their research in The Conversation.
They pointed out that only 20 of the symptoms they found are included in the World Health Organization’s clinical case definition for long COVID.
They also found that people more likely to have persistent symptoms 3 months after COVID infection were also more likely to be young, female, smokers, to belong to certain minority ethnic groups, and to have lower socioeconomic status. They were also more likely to be obese and have a wide range of health conditions.
Dr. Haroon, an associate clinical professor at the University of Birmingham, said that one reason it appeared that younger people were more likely to get symptoms of long COVID may be that older adults with COVID were more likely to be hospitalized and weren’t included in this study.
“Since we only considered nonhospitalized adults, the older adults we included in our study may have been relatively healthier and thus had a lower symptom burden,” he said.
Dr. Subramania noted that older patients were more likely to report lasting COVID-related symptoms in the study, but when researchers accounted for a wide range of other conditions that patients had before infection (which generally more commonly happen in older adults), they found younger age as a risk factor for long-term COVID-related symptoms.
In the study period, most patients were unvaccinated, and results came before the widespread Delta and Omicron variants.
More than half (56.6%) of the patients infected with the virus that causes COVID had been diagnosed in 2020, and 43.4% in 2021. Less than 5% (4.5%) of the patients infected with the virus and 4.7% of the patients with no recorded evidence of a COVID infection had received at least a single dose of a COVID vaccine before the study started.
Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, said more studies need to be done to see whether results would be different with vaccination status and evolving variants.
But he noted that this study has several strengths: “The hair loss, libido loss, and ejaculation difficulty are all new symptoms,” and the study – large and carefully controlled – shows these issues were among those more likely to occur.
A loss of sense of smell – which is not a new observation – was still the most likely risk shown in the study, followed by hair loss, sneezing, ejaculation difficulty, and reduced sex drive; followed by shortness of breath, fatigue, chest pain associated with breathing difficulties, hoarseness, and fever.
Three main clusters of symptoms
Given the wide range of symptoms, long COVID likely represents a group of conditions, the authors wrote.
They found three main clusters. The largest, with roughly 80% of people with long COVID in the study, faced a broad spectrum of symptoms, ranging from fatigue to headache and pain. The second-largest group, (15%) mostly had symptoms having to do with mental health and thinking skills, including depression, anxiety, brain fog, and insomnia. The smallest group (5%) had mainly respiratory symptoms such as shortness of breath, coughing, and wheezing.
Putting symptoms in clusters will be important to start understanding what leads to long COVID, said Farha Ikramuddin, MD, a rehabilitation specialist at the University of Minnesota, Minneapolis.
She added that, while the symptoms listed in this paper are new in published research, she has certainly been seeing them over time in her long COVID clinic. (The researchers also used only coded health care data, so they were limited in what symptoms they could discover, she notes.)
Dr. Ikramuddin said a strength of the paper is its large size, but she also cautioned that it’s difficult to determine whether members of the comparison group truly had no COVID infection when the information is taken from their medical records. Often, people test at home or assume they have COVID and don’t test; therefore the information wouldn’t be recorded.
Evaluating nonhospitalized patients is also important, she said, as much of the research on long COVID has come from hospitalized patients, so little has been known about the symptoms of those with milder infections.
“Patients who have been hospitalized and have long COVID look very different from the patients who were not hospitalized,” Dr. Ikramuddin said.
One clear message from the paper, she said, is that listening and asking extensive questions about symptoms are important with patients who have had COVID.
“Counseling has also become very important for our patients in the pandemic,” she said.
It will also be important to do studies on returning to work for patients with long COVID to see how many are able to return and at what capacity, Dr. Ikramuddin said.
A version of this article first appeared on WebMD.com.
FROM NATURE MEDICINE
Dermatologists share vitiligo breakthrough news with patients
For the first time, patients with vitiligo who have long lived with patches of skin that are without pigment can now have even skin tones on their faces and other bodily regions with a Food and Drug Administration–approved, easy-to-use topical treatment.
In July, , the most common form of the disease.
Topical ruxolitinib was first approved in September 2021 for atopic dermatitis, and dermatologists are already writing prescriptions for its new vitiligo indication.
“The FDA approval of ruxolitinib for repigmentation of vitiligo is historic and groundbreaking,” Seemal R. Desai, MD, a dermatologist at the University of Texas Southwestern Medical Center, Dallas, told this news organization.
The news brings hope to patients 12 years and older who suffer from the psychosocial effects of the disease, which is estimated to affect 1.9 million to 2.8 million adults in the United States.
The announcement followed FDA approval a month earlier of another dermatologic milestone – an oral JAK inhibitor, baricitinib, which became the first treatment for patients with alopecia areata.
For Dr. Desai, the ruxolitinib news is personal. His brother, also a physician, has lived a lifetime with vitiligo. His family experience, Dr. Desai said, showed him “what a disease like this can do to a person psychologically.”
Dr. Desai said his early exposure helped lead to his own decision to dedicate his career to pigmentary diseases.
His brother won’t personally benefit from the cream because his skin has been completely depigmented and repigmentation is not of interest to him, Dr. Desai said. But both brothers are excited as physicians. “It’s really quite an emotional moment,” he said.
Getting the news to patients
As dermatologists introduce the topical treatment to patients, common questions center on why this cream is different and whether it is safe.
David Rosmarin, MD, vice chair of research and education, department of dermatology, Tufts Medical Center, Boston, led the Topical Ruxolitinib Evaluation in Vitiligo Study 1 and 2 (TruE-V1, TruE-V2), conducted in North America and Europe.
He summarized some key findings.
“If patients have involvement on the face, trunk, or extremities, the data show that about half the patients at 52 weeks will get half or more of their pigment back,” he said in an interview. Results for the face alone are even better. “Half the patients will get 75% or more pigment back in the face,” Dr. Rosmarin said.
In addition, analysis of subgroups shows benefit for all patients. “Patients seem to respond similarly well across all subgroups – across gender, sex, age, ethnicity, and race,” Dr. Rosmarin said.
However, anatomic region matters, he pointed out. Skin of the head and neck responds the best, followed by skin of the trunk and extremities. The hands and feet are the most difficult to repigment because there are few hair follicles, which help enable repigmentation.
He added that it’s important to understand patients’ goals, and dermatologists shouldn’t assume that all who have vitiligo will want to undergo repigmentation. They may be interested in the new treatment but may not want it for themselves, he explained.
Explaining risks
Patients may ask about the boxed warning on the label that lists risk of heart attack, stroke, cancer, infections, blood clots, and death. Dermatologists can explain that the warning pertains to the whole JAK class and was based on patients with rheumatoid arthritis, Dr. Rosmarin said.
He added, “We didn’t see a signal for heart attack and stroke for patients using the topical. But it’s still important to discuss the label as the FDA states it.”
There are two main side effects, Dr. Rosmarin said: acne (about 6% of treated patients get it, and it’s usually mild) and application-site reactions. “Luckily, the medication has a tendency not to sting or burn, which is not the case with some of our other treatments. It’s very well tolerated,” he said.
Patients should also know that repigmentation can take time, because initially, the immune system is directed to calm down with treatment, and then pigment must travel back to the affected sites.
Some patients may have a response in as early as 2-3 months, and others need more time, Dr. Rosmarin said.
Treatment responses among adolescents have been particularly good. Responses regarding the skin of the face have been similar to those of adults. “However, on the body, they respond even better,” Dr. Rosmarin said. “About 60% achieve 50% or more repigmentation on the whole body.”
It’s important that ruxolitinib has been approved for persons aged 12 years and older, he said, because “about half the patients will develop vitiligo by the age of 20.”
Approval and insurance coverage
FDA approval will help with reimbursement for the expensive treatment.
The label indicates that patients should not use more than one 60-g tube a week. Currently, the out-of-pocket cost for one tube can be close to $2,000, according to GoodRx.
Raj Chovatiya, MD, PhD, assistant professor of dermatology and director of the Center for Eczema and Itch at Northwestern University, Chicago, said that in recent years, vitiligo patients, aware that their condition could be treated by JAK inhibitors, have been paying out of pocket at compounding pharmacies, which take oral versions of the medication and compound them into topical formulations.
Unlike baricitinib, which is used to treat severe alopecia areata, and other oral JAK inhibitors, testing for TB and hepatitis is not required for initiating treatment with ruxolitinib, so no delay is necessary, Dr. Chovatiya said.
He noted, however, that patients with vitiligo may have given up on effective care after experiencing little or no improvement with topical corticosteroids, phototherapy, or topical calcineurin inhibitors.
“They end up losing steam, are less motivated on therapy, and are lost to care,” he said.
Dermatologists, he said, may need to proactively find these patients and tell them the good news. “Now that we have really good targeted therapeutic options, it’s really up to us to figure out how to bring these people back to the clinic and educate them,” Dr. Chovatiya said.
Unanswered questions to address
Some questions are still unanswered, lead study author Dr. Rosmarin said.
Two big questions are how long people will need to continue using ruxolitinib cream and whether depigmentation will recur if people stop using it.
Another aspect of therapy being studied is whether the cream will be even more effective in combination with other treatments.
“The main combination we think about is ruxolitinib with phototherapy – a light treatment – because light could stimulate those pigment cells,” Dr. Rosmarin said,
He noted that light therapy was included in phase 2 testing and that patients did respond. “What we need and what’s planned is a larger study looking at the combination to see whether it is synergistic or not. The longer patients use the cream, the more benefit we see,” Dr. Rosmarin said.
Dr. Desai has served as an investigator and/or consultant to several companies, including Incyte. Dr. Rosmarin has received honoraria as a consultant and has received research support from Incyte, and has served as a paid speaker for Incyte, as well as other companies.. Dr. Chovatiya has served as an advisory board member, consultant, and/or investigator for companies that include Incyte.
For the first time, patients with vitiligo who have long lived with patches of skin that are without pigment can now have even skin tones on their faces and other bodily regions with a Food and Drug Administration–approved, easy-to-use topical treatment.
In July, , the most common form of the disease.
Topical ruxolitinib was first approved in September 2021 for atopic dermatitis, and dermatologists are already writing prescriptions for its new vitiligo indication.
“The FDA approval of ruxolitinib for repigmentation of vitiligo is historic and groundbreaking,” Seemal R. Desai, MD, a dermatologist at the University of Texas Southwestern Medical Center, Dallas, told this news organization.
The news brings hope to patients 12 years and older who suffer from the psychosocial effects of the disease, which is estimated to affect 1.9 million to 2.8 million adults in the United States.
The announcement followed FDA approval a month earlier of another dermatologic milestone – an oral JAK inhibitor, baricitinib, which became the first treatment for patients with alopecia areata.
For Dr. Desai, the ruxolitinib news is personal. His brother, also a physician, has lived a lifetime with vitiligo. His family experience, Dr. Desai said, showed him “what a disease like this can do to a person psychologically.”
Dr. Desai said his early exposure helped lead to his own decision to dedicate his career to pigmentary diseases.
His brother won’t personally benefit from the cream because his skin has been completely depigmented and repigmentation is not of interest to him, Dr. Desai said. But both brothers are excited as physicians. “It’s really quite an emotional moment,” he said.
Getting the news to patients
As dermatologists introduce the topical treatment to patients, common questions center on why this cream is different and whether it is safe.
David Rosmarin, MD, vice chair of research and education, department of dermatology, Tufts Medical Center, Boston, led the Topical Ruxolitinib Evaluation in Vitiligo Study 1 and 2 (TruE-V1, TruE-V2), conducted in North America and Europe.
He summarized some key findings.
“If patients have involvement on the face, trunk, or extremities, the data show that about half the patients at 52 weeks will get half or more of their pigment back,” he said in an interview. Results for the face alone are even better. “Half the patients will get 75% or more pigment back in the face,” Dr. Rosmarin said.
In addition, analysis of subgroups shows benefit for all patients. “Patients seem to respond similarly well across all subgroups – across gender, sex, age, ethnicity, and race,” Dr. Rosmarin said.
However, anatomic region matters, he pointed out. Skin of the head and neck responds the best, followed by skin of the trunk and extremities. The hands and feet are the most difficult to repigment because there are few hair follicles, which help enable repigmentation.
He added that it’s important to understand patients’ goals, and dermatologists shouldn’t assume that all who have vitiligo will want to undergo repigmentation. They may be interested in the new treatment but may not want it for themselves, he explained.
Explaining risks
Patients may ask about the boxed warning on the label that lists risk of heart attack, stroke, cancer, infections, blood clots, and death. Dermatologists can explain that the warning pertains to the whole JAK class and was based on patients with rheumatoid arthritis, Dr. Rosmarin said.
He added, “We didn’t see a signal for heart attack and stroke for patients using the topical. But it’s still important to discuss the label as the FDA states it.”
There are two main side effects, Dr. Rosmarin said: acne (about 6% of treated patients get it, and it’s usually mild) and application-site reactions. “Luckily, the medication has a tendency not to sting or burn, which is not the case with some of our other treatments. It’s very well tolerated,” he said.
Patients should also know that repigmentation can take time, because initially, the immune system is directed to calm down with treatment, and then pigment must travel back to the affected sites.
Some patients may have a response in as early as 2-3 months, and others need more time, Dr. Rosmarin said.
Treatment responses among adolescents have been particularly good. Responses regarding the skin of the face have been similar to those of adults. “However, on the body, they respond even better,” Dr. Rosmarin said. “About 60% achieve 50% or more repigmentation on the whole body.”
It’s important that ruxolitinib has been approved for persons aged 12 years and older, he said, because “about half the patients will develop vitiligo by the age of 20.”
Approval and insurance coverage
FDA approval will help with reimbursement for the expensive treatment.
The label indicates that patients should not use more than one 60-g tube a week. Currently, the out-of-pocket cost for one tube can be close to $2,000, according to GoodRx.
Raj Chovatiya, MD, PhD, assistant professor of dermatology and director of the Center for Eczema and Itch at Northwestern University, Chicago, said that in recent years, vitiligo patients, aware that their condition could be treated by JAK inhibitors, have been paying out of pocket at compounding pharmacies, which take oral versions of the medication and compound them into topical formulations.
Unlike baricitinib, which is used to treat severe alopecia areata, and other oral JAK inhibitors, testing for TB and hepatitis is not required for initiating treatment with ruxolitinib, so no delay is necessary, Dr. Chovatiya said.
He noted, however, that patients with vitiligo may have given up on effective care after experiencing little or no improvement with topical corticosteroids, phototherapy, or topical calcineurin inhibitors.
“They end up losing steam, are less motivated on therapy, and are lost to care,” he said.
Dermatologists, he said, may need to proactively find these patients and tell them the good news. “Now that we have really good targeted therapeutic options, it’s really up to us to figure out how to bring these people back to the clinic and educate them,” Dr. Chovatiya said.
Unanswered questions to address
Some questions are still unanswered, lead study author Dr. Rosmarin said.
Two big questions are how long people will need to continue using ruxolitinib cream and whether depigmentation will recur if people stop using it.
Another aspect of therapy being studied is whether the cream will be even more effective in combination with other treatments.
“The main combination we think about is ruxolitinib with phototherapy – a light treatment – because light could stimulate those pigment cells,” Dr. Rosmarin said,
He noted that light therapy was included in phase 2 testing and that patients did respond. “What we need and what’s planned is a larger study looking at the combination to see whether it is synergistic or not. The longer patients use the cream, the more benefit we see,” Dr. Rosmarin said.
Dr. Desai has served as an investigator and/or consultant to several companies, including Incyte. Dr. Rosmarin has received honoraria as a consultant and has received research support from Incyte, and has served as a paid speaker for Incyte, as well as other companies.. Dr. Chovatiya has served as an advisory board member, consultant, and/or investigator for companies that include Incyte.
For the first time, patients with vitiligo who have long lived with patches of skin that are without pigment can now have even skin tones on their faces and other bodily regions with a Food and Drug Administration–approved, easy-to-use topical treatment.
In July, , the most common form of the disease.
Topical ruxolitinib was first approved in September 2021 for atopic dermatitis, and dermatologists are already writing prescriptions for its new vitiligo indication.
“The FDA approval of ruxolitinib for repigmentation of vitiligo is historic and groundbreaking,” Seemal R. Desai, MD, a dermatologist at the University of Texas Southwestern Medical Center, Dallas, told this news organization.
The news brings hope to patients 12 years and older who suffer from the psychosocial effects of the disease, which is estimated to affect 1.9 million to 2.8 million adults in the United States.
The announcement followed FDA approval a month earlier of another dermatologic milestone – an oral JAK inhibitor, baricitinib, which became the first treatment for patients with alopecia areata.
For Dr. Desai, the ruxolitinib news is personal. His brother, also a physician, has lived a lifetime with vitiligo. His family experience, Dr. Desai said, showed him “what a disease like this can do to a person psychologically.”
Dr. Desai said his early exposure helped lead to his own decision to dedicate his career to pigmentary diseases.
His brother won’t personally benefit from the cream because his skin has been completely depigmented and repigmentation is not of interest to him, Dr. Desai said. But both brothers are excited as physicians. “It’s really quite an emotional moment,” he said.
Getting the news to patients
As dermatologists introduce the topical treatment to patients, common questions center on why this cream is different and whether it is safe.
David Rosmarin, MD, vice chair of research and education, department of dermatology, Tufts Medical Center, Boston, led the Topical Ruxolitinib Evaluation in Vitiligo Study 1 and 2 (TruE-V1, TruE-V2), conducted in North America and Europe.
He summarized some key findings.
“If patients have involvement on the face, trunk, or extremities, the data show that about half the patients at 52 weeks will get half or more of their pigment back,” he said in an interview. Results for the face alone are even better. “Half the patients will get 75% or more pigment back in the face,” Dr. Rosmarin said.
In addition, analysis of subgroups shows benefit for all patients. “Patients seem to respond similarly well across all subgroups – across gender, sex, age, ethnicity, and race,” Dr. Rosmarin said.
However, anatomic region matters, he pointed out. Skin of the head and neck responds the best, followed by skin of the trunk and extremities. The hands and feet are the most difficult to repigment because there are few hair follicles, which help enable repigmentation.
He added that it’s important to understand patients’ goals, and dermatologists shouldn’t assume that all who have vitiligo will want to undergo repigmentation. They may be interested in the new treatment but may not want it for themselves, he explained.
Explaining risks
Patients may ask about the boxed warning on the label that lists risk of heart attack, stroke, cancer, infections, blood clots, and death. Dermatologists can explain that the warning pertains to the whole JAK class and was based on patients with rheumatoid arthritis, Dr. Rosmarin said.
He added, “We didn’t see a signal for heart attack and stroke for patients using the topical. But it’s still important to discuss the label as the FDA states it.”
There are two main side effects, Dr. Rosmarin said: acne (about 6% of treated patients get it, and it’s usually mild) and application-site reactions. “Luckily, the medication has a tendency not to sting or burn, which is not the case with some of our other treatments. It’s very well tolerated,” he said.
Patients should also know that repigmentation can take time, because initially, the immune system is directed to calm down with treatment, and then pigment must travel back to the affected sites.
Some patients may have a response in as early as 2-3 months, and others need more time, Dr. Rosmarin said.
Treatment responses among adolescents have been particularly good. Responses regarding the skin of the face have been similar to those of adults. “However, on the body, they respond even better,” Dr. Rosmarin said. “About 60% achieve 50% or more repigmentation on the whole body.”
It’s important that ruxolitinib has been approved for persons aged 12 years and older, he said, because “about half the patients will develop vitiligo by the age of 20.”
Approval and insurance coverage
FDA approval will help with reimbursement for the expensive treatment.
The label indicates that patients should not use more than one 60-g tube a week. Currently, the out-of-pocket cost for one tube can be close to $2,000, according to GoodRx.
Raj Chovatiya, MD, PhD, assistant professor of dermatology and director of the Center for Eczema and Itch at Northwestern University, Chicago, said that in recent years, vitiligo patients, aware that their condition could be treated by JAK inhibitors, have been paying out of pocket at compounding pharmacies, which take oral versions of the medication and compound them into topical formulations.
Unlike baricitinib, which is used to treat severe alopecia areata, and other oral JAK inhibitors, testing for TB and hepatitis is not required for initiating treatment with ruxolitinib, so no delay is necessary, Dr. Chovatiya said.
He noted, however, that patients with vitiligo may have given up on effective care after experiencing little or no improvement with topical corticosteroids, phototherapy, or topical calcineurin inhibitors.
“They end up losing steam, are less motivated on therapy, and are lost to care,” he said.
Dermatologists, he said, may need to proactively find these patients and tell them the good news. “Now that we have really good targeted therapeutic options, it’s really up to us to figure out how to bring these people back to the clinic and educate them,” Dr. Chovatiya said.
Unanswered questions to address
Some questions are still unanswered, lead study author Dr. Rosmarin said.
Two big questions are how long people will need to continue using ruxolitinib cream and whether depigmentation will recur if people stop using it.
Another aspect of therapy being studied is whether the cream will be even more effective in combination with other treatments.
“The main combination we think about is ruxolitinib with phototherapy – a light treatment – because light could stimulate those pigment cells,” Dr. Rosmarin said,
He noted that light therapy was included in phase 2 testing and that patients did respond. “What we need and what’s planned is a larger study looking at the combination to see whether it is synergistic or not. The longer patients use the cream, the more benefit we see,” Dr. Rosmarin said.
Dr. Desai has served as an investigator and/or consultant to several companies, including Incyte. Dr. Rosmarin has received honoraria as a consultant and has received research support from Incyte, and has served as a paid speaker for Incyte, as well as other companies.. Dr. Chovatiya has served as an advisory board member, consultant, and/or investigator for companies that include Incyte.
One in eight COVID patients likely to develop long COVID: Large study
a large study published in The Lancet indicates.
The researchers determined that percentage by comparing long-term symptoms in people infected by SARS-CoV-2 with similar symptoms in uninfected people over the same time period.
Among the group of infected study participants in the Netherlands, 21.4% had at least one new or severely increased symptom 3-5 months after infection compared with before infection. When that group of 21.4% was compared with 8.7% of uninfected people in the same study, the researchers were able to calculate a prevalence 12.7% with long COVID.
“This finding shows that post–COVID-19 condition is an urgent problem with a mounting human toll,” the study authors wrote.
The research design was novel, two editorialists said in an accompanying commentary.
Christopher Brightling, PhD, and Rachael Evans, MBChB, PhD, of the Institute for Lung Health, University of Leicester (England), noted: “This is a major advance on prior long COVID prevalence estimates as it includes a matched uninfected group and accounts for symptoms before COVID-19 infection.”
Symptoms that persist
The Lancet study found that 3-5 months after COVID (compared with before COVID) and compared with the non-COVID comparison group, the symptoms that persist were chest pain, breathing difficulties, pain when breathing, muscle pain, loss of taste and/or smell, tingling extremities, lump in throat, feeling hot and cold alternately, heavy limbs, and tiredness.
The authors noted that symptoms such as brain fog were found to be relevant to long COVID after the data collection period for this paper and were not included in this research.
Researcher Aranka V. Ballering, MSc, PhD candidate, said in an interview that the researchers found fever is a symptom that is clearly present during the acute phase of the disease and it peaks the day of the COVID-19 diagnosis, but also wears off.
Loss of taste and smell, however, rapidly increases in severity when COVID-19 is diagnosed, but also persists and is still present 3-5 months after COVID.
Ms. Ballering, with the department of psychiatry at the University of Groningen (the Netherlands), said she was surprised by the sex difference made evident in their research: “Women showed more severe persistent symptoms than men.”
Closer to a clearer definition
The authors said their findings also pinpoint symptoms that bring us closer to a better definition of long COVID, which has many different definitions globally.
“These symptoms have the highest discriminative ability to distinguish between post–COVID-19 condition and non–COVID-19–related symptoms,” they wrote.
Researchers collected data by asking participants in the northern Netherlands, who were part of the population-based Lifelines COVID-19 study, to regularly complete digital questionnaires on 23 symptoms commonly associated with long COVID. The questionnaire was sent out 24 times to the same people between March 2020 and August 2021. At that time, people had the Alpha or earlier variants.
Participants were considered COVID-19 positive if they had either a positive test or a doctor’s diagnosis of COVID-19.
Of 76,422 study participants, the 5.5% (4,231) who had COVID were matched to 8,462 controls. Researchers accounted for sex, age, and time of completing questionnaires.
Effect of hospitalization, vaccination unclear
Ms. Ballering said it’s unclear from this data whether vaccination or whether a person was hospitalized would change the prevalence of persistent symptoms.
Because of the period when the data were collected, “the vast majority of our study population was not fully vaccinated,” she said.
However, she pointed to recent research that shows that immunization against COVID is only partially effective against persistent somatic symptoms after COVID.
Also, only 5% of men and 2.5% of women in the study were hospitalized as a result of COVID-19, so the findings can’t easily be generalized to hospitalized patients.
The Lifelines study was an add-on study to the multidisciplinary, prospective, population-based, observational Dutch Lifelines cohort study examining 167,729 people in the Netherlands. Almost all were White, a limitation of the study, and 58% were female. Average age was 54.
The editorialists also noted additional limitations of the study were that this research “did not fully consider the impact on mental health” and was conducted in one region in the Netherlands.
Janko Nikolich-Žugich, MD, PhD, director of the Aegis Consortium for Pandemic-Free Future and head of the immunobiology department at University of Arizona, Tucson, said in an interview that he agreed with the editorialists that a primary benefit of this study is that it corrected for symptoms people had before COVID, something other studies have not been able to do.
However, he cautioned about generalizing the results for the United States and other countries because of the lack of diversity in the study population with regard to education level, socioeconomic factors, and race. He pointed out that access issues are also different in the Netherlands, which has universal health care.
He said brain fog as a symptom of long COVID is of high interest and will be important to include in future studies that are able to extend the study period.
The work was funded by ZonMw; the Dutch Ministry of Health, Welfare, and Sport; Dutch Ministry of Economic Affairs; University Medical Center Groningen, University of Groningen; and the provinces of Drenthe, Friesland, and Groningen. The study authors and Dr. Nikolich-Žugich have reported no relevant financial relationships. Dr. Brightling has received consultancy and or grants paid to his institution from GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Novartis, Chiesi, Genentech, Roche, Sanofi, Regeneron, Mologic, and 4DPharma for asthma and chronic obstructive pulmonary disease research. Dr. Evans has received consultancy fees from AstraZeneca on the topic of long COVID and from GlaxoSmithKline on digital health, and speaker’s fees from Boehringer Ingelheim on long COVID.
A version of this article first appeared on Medscape.com.
a large study published in The Lancet indicates.
The researchers determined that percentage by comparing long-term symptoms in people infected by SARS-CoV-2 with similar symptoms in uninfected people over the same time period.
Among the group of infected study participants in the Netherlands, 21.4% had at least one new or severely increased symptom 3-5 months after infection compared with before infection. When that group of 21.4% was compared with 8.7% of uninfected people in the same study, the researchers were able to calculate a prevalence 12.7% with long COVID.
“This finding shows that post–COVID-19 condition is an urgent problem with a mounting human toll,” the study authors wrote.
The research design was novel, two editorialists said in an accompanying commentary.
Christopher Brightling, PhD, and Rachael Evans, MBChB, PhD, of the Institute for Lung Health, University of Leicester (England), noted: “This is a major advance on prior long COVID prevalence estimates as it includes a matched uninfected group and accounts for symptoms before COVID-19 infection.”
Symptoms that persist
The Lancet study found that 3-5 months after COVID (compared with before COVID) and compared with the non-COVID comparison group, the symptoms that persist were chest pain, breathing difficulties, pain when breathing, muscle pain, loss of taste and/or smell, tingling extremities, lump in throat, feeling hot and cold alternately, heavy limbs, and tiredness.
The authors noted that symptoms such as brain fog were found to be relevant to long COVID after the data collection period for this paper and were not included in this research.
Researcher Aranka V. Ballering, MSc, PhD candidate, said in an interview that the researchers found fever is a symptom that is clearly present during the acute phase of the disease and it peaks the day of the COVID-19 diagnosis, but also wears off.
Loss of taste and smell, however, rapidly increases in severity when COVID-19 is diagnosed, but also persists and is still present 3-5 months after COVID.
Ms. Ballering, with the department of psychiatry at the University of Groningen (the Netherlands), said she was surprised by the sex difference made evident in their research: “Women showed more severe persistent symptoms than men.”
Closer to a clearer definition
The authors said their findings also pinpoint symptoms that bring us closer to a better definition of long COVID, which has many different definitions globally.
“These symptoms have the highest discriminative ability to distinguish between post–COVID-19 condition and non–COVID-19–related symptoms,” they wrote.
Researchers collected data by asking participants in the northern Netherlands, who were part of the population-based Lifelines COVID-19 study, to regularly complete digital questionnaires on 23 symptoms commonly associated with long COVID. The questionnaire was sent out 24 times to the same people between March 2020 and August 2021. At that time, people had the Alpha or earlier variants.
Participants were considered COVID-19 positive if they had either a positive test or a doctor’s diagnosis of COVID-19.
Of 76,422 study participants, the 5.5% (4,231) who had COVID were matched to 8,462 controls. Researchers accounted for sex, age, and time of completing questionnaires.
Effect of hospitalization, vaccination unclear
Ms. Ballering said it’s unclear from this data whether vaccination or whether a person was hospitalized would change the prevalence of persistent symptoms.
Because of the period when the data were collected, “the vast majority of our study population was not fully vaccinated,” she said.
However, she pointed to recent research that shows that immunization against COVID is only partially effective against persistent somatic symptoms after COVID.
Also, only 5% of men and 2.5% of women in the study were hospitalized as a result of COVID-19, so the findings can’t easily be generalized to hospitalized patients.
The Lifelines study was an add-on study to the multidisciplinary, prospective, population-based, observational Dutch Lifelines cohort study examining 167,729 people in the Netherlands. Almost all were White, a limitation of the study, and 58% were female. Average age was 54.
The editorialists also noted additional limitations of the study were that this research “did not fully consider the impact on mental health” and was conducted in one region in the Netherlands.
Janko Nikolich-Žugich, MD, PhD, director of the Aegis Consortium for Pandemic-Free Future and head of the immunobiology department at University of Arizona, Tucson, said in an interview that he agreed with the editorialists that a primary benefit of this study is that it corrected for symptoms people had before COVID, something other studies have not been able to do.
However, he cautioned about generalizing the results for the United States and other countries because of the lack of diversity in the study population with regard to education level, socioeconomic factors, and race. He pointed out that access issues are also different in the Netherlands, which has universal health care.
He said brain fog as a symptom of long COVID is of high interest and will be important to include in future studies that are able to extend the study period.
The work was funded by ZonMw; the Dutch Ministry of Health, Welfare, and Sport; Dutch Ministry of Economic Affairs; University Medical Center Groningen, University of Groningen; and the provinces of Drenthe, Friesland, and Groningen. The study authors and Dr. Nikolich-Žugich have reported no relevant financial relationships. Dr. Brightling has received consultancy and or grants paid to his institution from GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Novartis, Chiesi, Genentech, Roche, Sanofi, Regeneron, Mologic, and 4DPharma for asthma and chronic obstructive pulmonary disease research. Dr. Evans has received consultancy fees from AstraZeneca on the topic of long COVID and from GlaxoSmithKline on digital health, and speaker’s fees from Boehringer Ingelheim on long COVID.
A version of this article first appeared on Medscape.com.
a large study published in The Lancet indicates.
The researchers determined that percentage by comparing long-term symptoms in people infected by SARS-CoV-2 with similar symptoms in uninfected people over the same time period.
Among the group of infected study participants in the Netherlands, 21.4% had at least one new or severely increased symptom 3-5 months after infection compared with before infection. When that group of 21.4% was compared with 8.7% of uninfected people in the same study, the researchers were able to calculate a prevalence 12.7% with long COVID.
“This finding shows that post–COVID-19 condition is an urgent problem with a mounting human toll,” the study authors wrote.
The research design was novel, two editorialists said in an accompanying commentary.
Christopher Brightling, PhD, and Rachael Evans, MBChB, PhD, of the Institute for Lung Health, University of Leicester (England), noted: “This is a major advance on prior long COVID prevalence estimates as it includes a matched uninfected group and accounts for symptoms before COVID-19 infection.”
Symptoms that persist
The Lancet study found that 3-5 months after COVID (compared with before COVID) and compared with the non-COVID comparison group, the symptoms that persist were chest pain, breathing difficulties, pain when breathing, muscle pain, loss of taste and/or smell, tingling extremities, lump in throat, feeling hot and cold alternately, heavy limbs, and tiredness.
The authors noted that symptoms such as brain fog were found to be relevant to long COVID after the data collection period for this paper and were not included in this research.
Researcher Aranka V. Ballering, MSc, PhD candidate, said in an interview that the researchers found fever is a symptom that is clearly present during the acute phase of the disease and it peaks the day of the COVID-19 diagnosis, but also wears off.
Loss of taste and smell, however, rapidly increases in severity when COVID-19 is diagnosed, but also persists and is still present 3-5 months after COVID.
Ms. Ballering, with the department of psychiatry at the University of Groningen (the Netherlands), said she was surprised by the sex difference made evident in their research: “Women showed more severe persistent symptoms than men.”
Closer to a clearer definition
The authors said their findings also pinpoint symptoms that bring us closer to a better definition of long COVID, which has many different definitions globally.
“These symptoms have the highest discriminative ability to distinguish between post–COVID-19 condition and non–COVID-19–related symptoms,” they wrote.
Researchers collected data by asking participants in the northern Netherlands, who were part of the population-based Lifelines COVID-19 study, to regularly complete digital questionnaires on 23 symptoms commonly associated with long COVID. The questionnaire was sent out 24 times to the same people between March 2020 and August 2021. At that time, people had the Alpha or earlier variants.
Participants were considered COVID-19 positive if they had either a positive test or a doctor’s diagnosis of COVID-19.
Of 76,422 study participants, the 5.5% (4,231) who had COVID were matched to 8,462 controls. Researchers accounted for sex, age, and time of completing questionnaires.
Effect of hospitalization, vaccination unclear
Ms. Ballering said it’s unclear from this data whether vaccination or whether a person was hospitalized would change the prevalence of persistent symptoms.
Because of the period when the data were collected, “the vast majority of our study population was not fully vaccinated,” she said.
However, she pointed to recent research that shows that immunization against COVID is only partially effective against persistent somatic symptoms after COVID.
Also, only 5% of men and 2.5% of women in the study were hospitalized as a result of COVID-19, so the findings can’t easily be generalized to hospitalized patients.
The Lifelines study was an add-on study to the multidisciplinary, prospective, population-based, observational Dutch Lifelines cohort study examining 167,729 people in the Netherlands. Almost all were White, a limitation of the study, and 58% were female. Average age was 54.
The editorialists also noted additional limitations of the study were that this research “did not fully consider the impact on mental health” and was conducted in one region in the Netherlands.
Janko Nikolich-Žugich, MD, PhD, director of the Aegis Consortium for Pandemic-Free Future and head of the immunobiology department at University of Arizona, Tucson, said in an interview that he agreed with the editorialists that a primary benefit of this study is that it corrected for symptoms people had before COVID, something other studies have not been able to do.
However, he cautioned about generalizing the results for the United States and other countries because of the lack of diversity in the study population with regard to education level, socioeconomic factors, and race. He pointed out that access issues are also different in the Netherlands, which has universal health care.
He said brain fog as a symptom of long COVID is of high interest and will be important to include in future studies that are able to extend the study period.
The work was funded by ZonMw; the Dutch Ministry of Health, Welfare, and Sport; Dutch Ministry of Economic Affairs; University Medical Center Groningen, University of Groningen; and the provinces of Drenthe, Friesland, and Groningen. The study authors and Dr. Nikolich-Žugich have reported no relevant financial relationships. Dr. Brightling has received consultancy and or grants paid to his institution from GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Novartis, Chiesi, Genentech, Roche, Sanofi, Regeneron, Mologic, and 4DPharma for asthma and chronic obstructive pulmonary disease research. Dr. Evans has received consultancy fees from AstraZeneca on the topic of long COVID and from GlaxoSmithKline on digital health, and speaker’s fees from Boehringer Ingelheim on long COVID.
A version of this article first appeared on Medscape.com.
FROM THE LANCET
Sugary drinks, rather than artificially sweetened beverages or juices, show link to IBD
Drinks sweetened with sugar – but not natural juices or drinks sweetened artificially – were linked to a higher risk of inflammatory bowel disease (IBD) in people who drank more than one a day in a study of more than 120,000 people.
IBD has previously been linked with high consumption of sugar, but population-based evidence has been inconclusive, and natural juices have not been studied, write lead author Tian Fu, with the department of gastroenterology, the Third Xiangya Hospital of Central South University in Changsha, China, and colleagues.
Their study compared the associations of sugar-sweetened drinks, artificially sweetened beverages, and natural juices (including pure fruit or vegetable juices) with IBD risk.
“As one of the major sources of free sugar, beverages have been related to inflammation-related health outcomes but received less attention in the field of IBD,” the authors wrote.
, especially Crohn’s disease (CD), but further studies are needed to confirm these findings and explore the underlying mechanism,” they write.
The study was published online in Alimentary Pharmacology and Therapeutics.
Link significant for Crohn’s disease but not ulcerative colitis
The researchers used data from 121,490 participants in the UK Biobank who did not have IBD at trial recruitment in 2006-2010. The average age of the participants was 56 years, and almost all (96.9%) were White. The researchers studied their intake of beverages with 24-hour diet recalls from 2009 to 2012.
Participants were sorted into three groups according to the consumption of each beverage: 0 unit (glasses, cans, or 250 mL/cartons) per day (reference group), 0-1 unit per day, and more than 1 unit per day.
While most (66.3%) did not drink any sugar-sweetened beverages, participants who reported drinking more than 1 unit per day were more likely to have a higher body mass index and consume higher amounts of total energy and sugar.
During an average follow-up of about 10 years, the investigators documented 510 incident IBD cases: 143 cases of CD and 367 cases of ulcerative colitis (UC).
Compared to people who did not drink sugar-sweetened beverages, those who drank at least 1 unit per day had a significantly higher IBD risk (hazard ratio, 1.51; 95% confidence interval, 1.11-2.05), but the trend was statistically nonsignificant.
The association was significant for CD (HR, 2.05; 95% CI, 1.22,3.46) but not for UC (HR, 1.31; 95% CI, 0.89-1.92). The positive association between sugar-sweetened drinks and risk of CD, but not UC, was in line with previous studies showing that dietary patterns were more associated with CD risk, the authors noted.
They also highlighted that there was no positive link between artificially sweetened beverages, natural juices, or total sugar intake and IBD risk. They noted that the inflammatory role of artificial sweeteners is still being debated.
Additionally, the effect of natural sugar in juices may be counteracted by fiber and bioactive compounds in the juices, the authors wrote.
A limitation of the study is that at baseline, all participants in the UK Biobank were older than 40 years, so the researchers could not examine any links with younger-onset IBD.
Additionally, the self-reported questionnaires are subject to recall bias, though the survey has been validated.
Study adds to previous evidence
Hasan Zaki, PhD, an assistant professor with the department of pathology at University of Texas Southwestern Medical Center, Dallas, said in an interview that the size of this population-based study adds evidence that simple sugar can increase the risk for IBD. Dr. Zaki studies the relationship of inflammatory disorders and diet and was not involved in the study.
“This study is very strong evidence of the association between high sugar and IBD,” he said. He noted that more studies are needed because there are few studies in this area and results have varied.
His lab conducted work on the subject previously in mice. In a 2020 study, they found that a high-sugar diet helped promote IBD development and gut microbiota dysfunction.
Dr. Zaki pointed out that, among people in the United Kingdom and those in the United States, diets, demographics, and IBD incidence are similar, a fact that may make the findings more generalizable.
However, studies comparing the categories of sweetened drinks should be conducted in a U.S. population to assess the results in a diverse group to see whether ethnicity plays a role, because almost all of the people in the UK group were White, he said.
Also important, Dr. Zaki said, will be follow-up studies of the link between sweet drinks and IBD in U.S. children, among whom consumption is particularly high and the IBD incidence is rising. One study showed the prevalence increased 133% from 2007 to 2016.
The results of this study should help gastroenterologists counsel patients on an ideal diet to avoid IBD or reduce IBD severity, he said.
The study was supported by the National Natural Science Foundation of China and Key Project of Research and Development Plan of Hunan Province. The study authors and Dr. Zaki report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Drinks sweetened with sugar – but not natural juices or drinks sweetened artificially – were linked to a higher risk of inflammatory bowel disease (IBD) in people who drank more than one a day in a study of more than 120,000 people.
IBD has previously been linked with high consumption of sugar, but population-based evidence has been inconclusive, and natural juices have not been studied, write lead author Tian Fu, with the department of gastroenterology, the Third Xiangya Hospital of Central South University in Changsha, China, and colleagues.
Their study compared the associations of sugar-sweetened drinks, artificially sweetened beverages, and natural juices (including pure fruit or vegetable juices) with IBD risk.
“As one of the major sources of free sugar, beverages have been related to inflammation-related health outcomes but received less attention in the field of IBD,” the authors wrote.
, especially Crohn’s disease (CD), but further studies are needed to confirm these findings and explore the underlying mechanism,” they write.
The study was published online in Alimentary Pharmacology and Therapeutics.
Link significant for Crohn’s disease but not ulcerative colitis
The researchers used data from 121,490 participants in the UK Biobank who did not have IBD at trial recruitment in 2006-2010. The average age of the participants was 56 years, and almost all (96.9%) were White. The researchers studied their intake of beverages with 24-hour diet recalls from 2009 to 2012.
Participants were sorted into three groups according to the consumption of each beverage: 0 unit (glasses, cans, or 250 mL/cartons) per day (reference group), 0-1 unit per day, and more than 1 unit per day.
While most (66.3%) did not drink any sugar-sweetened beverages, participants who reported drinking more than 1 unit per day were more likely to have a higher body mass index and consume higher amounts of total energy and sugar.
During an average follow-up of about 10 years, the investigators documented 510 incident IBD cases: 143 cases of CD and 367 cases of ulcerative colitis (UC).
Compared to people who did not drink sugar-sweetened beverages, those who drank at least 1 unit per day had a significantly higher IBD risk (hazard ratio, 1.51; 95% confidence interval, 1.11-2.05), but the trend was statistically nonsignificant.
The association was significant for CD (HR, 2.05; 95% CI, 1.22,3.46) but not for UC (HR, 1.31; 95% CI, 0.89-1.92). The positive association between sugar-sweetened drinks and risk of CD, but not UC, was in line with previous studies showing that dietary patterns were more associated with CD risk, the authors noted.
They also highlighted that there was no positive link between artificially sweetened beverages, natural juices, or total sugar intake and IBD risk. They noted that the inflammatory role of artificial sweeteners is still being debated.
Additionally, the effect of natural sugar in juices may be counteracted by fiber and bioactive compounds in the juices, the authors wrote.
A limitation of the study is that at baseline, all participants in the UK Biobank were older than 40 years, so the researchers could not examine any links with younger-onset IBD.
Additionally, the self-reported questionnaires are subject to recall bias, though the survey has been validated.
Study adds to previous evidence
Hasan Zaki, PhD, an assistant professor with the department of pathology at University of Texas Southwestern Medical Center, Dallas, said in an interview that the size of this population-based study adds evidence that simple sugar can increase the risk for IBD. Dr. Zaki studies the relationship of inflammatory disorders and diet and was not involved in the study.
“This study is very strong evidence of the association between high sugar and IBD,” he said. He noted that more studies are needed because there are few studies in this area and results have varied.
His lab conducted work on the subject previously in mice. In a 2020 study, they found that a high-sugar diet helped promote IBD development and gut microbiota dysfunction.
Dr. Zaki pointed out that, among people in the United Kingdom and those in the United States, diets, demographics, and IBD incidence are similar, a fact that may make the findings more generalizable.
However, studies comparing the categories of sweetened drinks should be conducted in a U.S. population to assess the results in a diverse group to see whether ethnicity plays a role, because almost all of the people in the UK group were White, he said.
Also important, Dr. Zaki said, will be follow-up studies of the link between sweet drinks and IBD in U.S. children, among whom consumption is particularly high and the IBD incidence is rising. One study showed the prevalence increased 133% from 2007 to 2016.
The results of this study should help gastroenterologists counsel patients on an ideal diet to avoid IBD or reduce IBD severity, he said.
The study was supported by the National Natural Science Foundation of China and Key Project of Research and Development Plan of Hunan Province. The study authors and Dr. Zaki report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Drinks sweetened with sugar – but not natural juices or drinks sweetened artificially – were linked to a higher risk of inflammatory bowel disease (IBD) in people who drank more than one a day in a study of more than 120,000 people.
IBD has previously been linked with high consumption of sugar, but population-based evidence has been inconclusive, and natural juices have not been studied, write lead author Tian Fu, with the department of gastroenterology, the Third Xiangya Hospital of Central South University in Changsha, China, and colleagues.
Their study compared the associations of sugar-sweetened drinks, artificially sweetened beverages, and natural juices (including pure fruit or vegetable juices) with IBD risk.
“As one of the major sources of free sugar, beverages have been related to inflammation-related health outcomes but received less attention in the field of IBD,” the authors wrote.
, especially Crohn’s disease (CD), but further studies are needed to confirm these findings and explore the underlying mechanism,” they write.
The study was published online in Alimentary Pharmacology and Therapeutics.
Link significant for Crohn’s disease but not ulcerative colitis
The researchers used data from 121,490 participants in the UK Biobank who did not have IBD at trial recruitment in 2006-2010. The average age of the participants was 56 years, and almost all (96.9%) were White. The researchers studied their intake of beverages with 24-hour diet recalls from 2009 to 2012.
Participants were sorted into three groups according to the consumption of each beverage: 0 unit (glasses, cans, or 250 mL/cartons) per day (reference group), 0-1 unit per day, and more than 1 unit per day.
While most (66.3%) did not drink any sugar-sweetened beverages, participants who reported drinking more than 1 unit per day were more likely to have a higher body mass index and consume higher amounts of total energy and sugar.
During an average follow-up of about 10 years, the investigators documented 510 incident IBD cases: 143 cases of CD and 367 cases of ulcerative colitis (UC).
Compared to people who did not drink sugar-sweetened beverages, those who drank at least 1 unit per day had a significantly higher IBD risk (hazard ratio, 1.51; 95% confidence interval, 1.11-2.05), but the trend was statistically nonsignificant.
The association was significant for CD (HR, 2.05; 95% CI, 1.22,3.46) but not for UC (HR, 1.31; 95% CI, 0.89-1.92). The positive association between sugar-sweetened drinks and risk of CD, but not UC, was in line with previous studies showing that dietary patterns were more associated with CD risk, the authors noted.
They also highlighted that there was no positive link between artificially sweetened beverages, natural juices, or total sugar intake and IBD risk. They noted that the inflammatory role of artificial sweeteners is still being debated.
Additionally, the effect of natural sugar in juices may be counteracted by fiber and bioactive compounds in the juices, the authors wrote.
A limitation of the study is that at baseline, all participants in the UK Biobank were older than 40 years, so the researchers could not examine any links with younger-onset IBD.
Additionally, the self-reported questionnaires are subject to recall bias, though the survey has been validated.
Study adds to previous evidence
Hasan Zaki, PhD, an assistant professor with the department of pathology at University of Texas Southwestern Medical Center, Dallas, said in an interview that the size of this population-based study adds evidence that simple sugar can increase the risk for IBD. Dr. Zaki studies the relationship of inflammatory disorders and diet and was not involved in the study.
“This study is very strong evidence of the association between high sugar and IBD,” he said. He noted that more studies are needed because there are few studies in this area and results have varied.
His lab conducted work on the subject previously in mice. In a 2020 study, they found that a high-sugar diet helped promote IBD development and gut microbiota dysfunction.
Dr. Zaki pointed out that, among people in the United Kingdom and those in the United States, diets, demographics, and IBD incidence are similar, a fact that may make the findings more generalizable.
However, studies comparing the categories of sweetened drinks should be conducted in a U.S. population to assess the results in a diverse group to see whether ethnicity plays a role, because almost all of the people in the UK group were White, he said.
Also important, Dr. Zaki said, will be follow-up studies of the link between sweet drinks and IBD in U.S. children, among whom consumption is particularly high and the IBD incidence is rising. One study showed the prevalence increased 133% from 2007 to 2016.
The results of this study should help gastroenterologists counsel patients on an ideal diet to avoid IBD or reduce IBD severity, he said.
The study was supported by the National Natural Science Foundation of China and Key Project of Research and Development Plan of Hunan Province. The study authors and Dr. Zaki report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ALIMENTARY PHARMACOLOGY AND THERAPEUTICS
Biologics for IBD may come with added risks in Hispanic patients
Biologic agents may not be as safe or effective in Hispanic patients with inflammatory bowel disease (IBD) as they are in non-Hispanic patients, suggest new data published online in Clinical Gastroenterology and Hepatology.
To compare risk for hospitalization, surgery, and serious infections, Nghia H. Nguyen, MD, and his team at the Inflammatory Bowel Disease Center at the University of California, San Diego, included a multicenter, electronic health record–based cohort of biologic-treated Hispanic and non-Hispanic patients with IBD and used 1:4 propensity score matching.
They compared 240 Hispanic patients (53% male; 45% with ulcerative colitis; 73% treated with tumor necrosis factor alpha [TNF-alpha] antagonist; 20% with prior biologic exposure) with 960 non-Hispanic patients (51% male; 44% with ulcerative colitis; 67% treated with TNF-alpha antagonist; 27% with prior biologic exposure). Patients were new users of biologics (TNF-alpha antagonist, ustekinumab, or vedolizumab).
Compared with non-Hispanic patients, Hispanic patients had a higher risk for all-cause hospitalization (31% vs. 23%) within 1 year of starting a biologic agent.
Hispanic patients also had almost twice the risk for IBD-related surgeries (7% vs. 4.6%, respectively) and trended toward a higher risk for serious infection (8.8% vs. 4.9%, respectively).
The findings are particularly important because incidence and prevalence of IBD in Hispanic adults are increasing rapidly, according to the authors.
“Currently, 1.2% of Hispanic adults in the United States report having IBD, and this number is expected to increase progressively over the next few years with global immigration patterns and changing demographics of the United States,” the authors write.
Potential drivers of disparities
Hispanic patients have been underrepresented in clinical trials of biologic agents in IBD, making up fewer than 5% of participants, the authors note. This has resulted in limited data and created challenges in discerning reasons for the disparity.
The authors note the potential role of genetics in the effectiveness of some biologic agents, although that has not been well studied in Hispanic patients.
Additionally, according to this study, Hispanic patients with IBD lived with more negative social determinants of health, particularly related to food insecurity (27%) and lack of adequate social support (83%), compared with non-Hispanic patients (unpublished data).
“In other studies on health care utilization, Hispanic patients were found to have limited access to appropriate specialist care and lack of insurance coverage,” the authors point out.
The authors acknowledge that limitations of their study include the inability to pinpoint the primary reason for hospitalization because data on primary versus secondary discharge diagnoses were not available. Also, they relied on prescription information in electronic health records and could not confirm that medications were dispensed or that patients took them.
They also acknowledged selection bias as a limitation, because the focus was only on patients treated with biologics and not on outcomes for those who may have warranted a biologic treatment but were unable to receive it.
“Future studies are needed to investigate the biological, social, and environmental drivers of these differences,” the authors write.
The authors’ complete financial disclosures are available with the full text of the paper.
A version of this article first appeared on Medscape.com.
Biologic agents may not be as safe or effective in Hispanic patients with inflammatory bowel disease (IBD) as they are in non-Hispanic patients, suggest new data published online in Clinical Gastroenterology and Hepatology.
To compare risk for hospitalization, surgery, and serious infections, Nghia H. Nguyen, MD, and his team at the Inflammatory Bowel Disease Center at the University of California, San Diego, included a multicenter, electronic health record–based cohort of biologic-treated Hispanic and non-Hispanic patients with IBD and used 1:4 propensity score matching.
They compared 240 Hispanic patients (53% male; 45% with ulcerative colitis; 73% treated with tumor necrosis factor alpha [TNF-alpha] antagonist; 20% with prior biologic exposure) with 960 non-Hispanic patients (51% male; 44% with ulcerative colitis; 67% treated with TNF-alpha antagonist; 27% with prior biologic exposure). Patients were new users of biologics (TNF-alpha antagonist, ustekinumab, or vedolizumab).
Compared with non-Hispanic patients, Hispanic patients had a higher risk for all-cause hospitalization (31% vs. 23%) within 1 year of starting a biologic agent.
Hispanic patients also had almost twice the risk for IBD-related surgeries (7% vs. 4.6%, respectively) and trended toward a higher risk for serious infection (8.8% vs. 4.9%, respectively).
The findings are particularly important because incidence and prevalence of IBD in Hispanic adults are increasing rapidly, according to the authors.
“Currently, 1.2% of Hispanic adults in the United States report having IBD, and this number is expected to increase progressively over the next few years with global immigration patterns and changing demographics of the United States,” the authors write.
Potential drivers of disparities
Hispanic patients have been underrepresented in clinical trials of biologic agents in IBD, making up fewer than 5% of participants, the authors note. This has resulted in limited data and created challenges in discerning reasons for the disparity.
The authors note the potential role of genetics in the effectiveness of some biologic agents, although that has not been well studied in Hispanic patients.
Additionally, according to this study, Hispanic patients with IBD lived with more negative social determinants of health, particularly related to food insecurity (27%) and lack of adequate social support (83%), compared with non-Hispanic patients (unpublished data).
“In other studies on health care utilization, Hispanic patients were found to have limited access to appropriate specialist care and lack of insurance coverage,” the authors point out.
The authors acknowledge that limitations of their study include the inability to pinpoint the primary reason for hospitalization because data on primary versus secondary discharge diagnoses were not available. Also, they relied on prescription information in electronic health records and could not confirm that medications were dispensed or that patients took them.
They also acknowledged selection bias as a limitation, because the focus was only on patients treated with biologics and not on outcomes for those who may have warranted a biologic treatment but were unable to receive it.
“Future studies are needed to investigate the biological, social, and environmental drivers of these differences,” the authors write.
The authors’ complete financial disclosures are available with the full text of the paper.
A version of this article first appeared on Medscape.com.
Biologic agents may not be as safe or effective in Hispanic patients with inflammatory bowel disease (IBD) as they are in non-Hispanic patients, suggest new data published online in Clinical Gastroenterology and Hepatology.
To compare risk for hospitalization, surgery, and serious infections, Nghia H. Nguyen, MD, and his team at the Inflammatory Bowel Disease Center at the University of California, San Diego, included a multicenter, electronic health record–based cohort of biologic-treated Hispanic and non-Hispanic patients with IBD and used 1:4 propensity score matching.
They compared 240 Hispanic patients (53% male; 45% with ulcerative colitis; 73% treated with tumor necrosis factor alpha [TNF-alpha] antagonist; 20% with prior biologic exposure) with 960 non-Hispanic patients (51% male; 44% with ulcerative colitis; 67% treated with TNF-alpha antagonist; 27% with prior biologic exposure). Patients were new users of biologics (TNF-alpha antagonist, ustekinumab, or vedolizumab).
Compared with non-Hispanic patients, Hispanic patients had a higher risk for all-cause hospitalization (31% vs. 23%) within 1 year of starting a biologic agent.
Hispanic patients also had almost twice the risk for IBD-related surgeries (7% vs. 4.6%, respectively) and trended toward a higher risk for serious infection (8.8% vs. 4.9%, respectively).
The findings are particularly important because incidence and prevalence of IBD in Hispanic adults are increasing rapidly, according to the authors.
“Currently, 1.2% of Hispanic adults in the United States report having IBD, and this number is expected to increase progressively over the next few years with global immigration patterns and changing demographics of the United States,” the authors write.
Potential drivers of disparities
Hispanic patients have been underrepresented in clinical trials of biologic agents in IBD, making up fewer than 5% of participants, the authors note. This has resulted in limited data and created challenges in discerning reasons for the disparity.
The authors note the potential role of genetics in the effectiveness of some biologic agents, although that has not been well studied in Hispanic patients.
Additionally, according to this study, Hispanic patients with IBD lived with more negative social determinants of health, particularly related to food insecurity (27%) and lack of adequate social support (83%), compared with non-Hispanic patients (unpublished data).
“In other studies on health care utilization, Hispanic patients were found to have limited access to appropriate specialist care and lack of insurance coverage,” the authors point out.
The authors acknowledge that limitations of their study include the inability to pinpoint the primary reason for hospitalization because data on primary versus secondary discharge diagnoses were not available. Also, they relied on prescription information in electronic health records and could not confirm that medications were dispensed or that patients took them.
They also acknowledged selection bias as a limitation, because the focus was only on patients treated with biologics and not on outcomes for those who may have warranted a biologic treatment but were unable to receive it.
“Future studies are needed to investigate the biological, social, and environmental drivers of these differences,” the authors write.
The authors’ complete financial disclosures are available with the full text of the paper.
A version of this article first appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Study pinpoints best predictor of when reflux symptoms don’t require PPI
Four days is an optimal time for wireless reflux monitoring to determine which patients can stop taking proton pump inhibitors (PPIs) and which ones need long-term antireflux therapy, researchers report.
“This first-of-its kind double-blinded clinical trial demonstrates the comparable, and in some cases better, performance of a simple assessment of daily acid exposure from multiple days of recording compared to other composite or complex assessments,” write Rena Yadlapati, MD, with the Division of Gastroenterology at the University of California, San Diego, and her coauthors.
Their findings were published online in the American Journal of Gastroenterology.
A substantial percentage of patients who have esophageal reflux symptoms do not have gastroesophageal reflux disease (GERD) and can stop taking PPIs.
Wireless reflux monitoring performed while patients are not taking PPIs is the gold standard for determining whether a patient has abnormal acid from GERD, but the optimal daily acid exposure time (AET) and the optimal duration of monitoring have not been well studied.
Aiming to fill this knowledge gap, Dr. Yadlapati and her colleagues conducted a single-arm, double-blinded clinical trial over 4 years at two tertiary care centers. They enrolled adult patients who had demonstrated an inadequate response to more than 8 weeks’ treatment with PPIs.
Study participants were asked to stop taking their PPI for 3 weeks in order for the investigators to determine the rate of relapse after PPI use and establish the study reference standard to discontinue therapy. During the 3-week period, after having stopped taking PPIs for at least a week, patients underwent 96-hour wireless reflux monitoring. They were then told to continue not taking PPIs for an additional 2 weeks. They could use over-the-counter antacids for symptom relief.
The primary outcome was whether PPIs could be successfully discontinued or restarted within 3 weeks. Of the 132 patients, 30% were able to stop taking PPIs.
AET less than 4.0% best discontinuation predictor
The team came to two key conclusions.
They found that acid exposure time of less than 4.0% was the best predictor of when stopping PPIs will be effective without worsening symptoms (odds ratio, 2.9; 95% confidence interval, 1.4-6.4). Comparatively, 45% (22 of 49 patients) with total AET of 4.0% or less discontinued taking PPIs, versus 22% (18 of 83 patients) with total AET of more than 4.0%.
Additionally, the investigators concluded that 96 hours of monitoring was better than 48 hours or fewer in predicting whether patients could stop taking PPIs (area under curve [AUC] for 96 hours, 0.63, versus AUC for 48 hours, 0.57).
Dr. Yadlapati told this news organization that the findings should be practice-changing.
“You really need to test for 4 days,” she said. She noted that the battery life of the monitor is 96 hours, and clinicians commonly only test for 2 days.
With only 1-2 days of monitoring, there is too much variability in how much acid is in the esophagus from one day to another. Monitoring over a 4-day period gives a clearer picture of acid exposure burden, she said.
Her advice: “If you have a patient with heartburn or chest pain and you think it might be from reflux, and they’re not responding to a trial of PPI, get the reflux monitoring. Don’t wait.”
After 4 days of monitoring, if exposure to acid is low, “they should really be taken off their PPI therapy,” she said.
They likely have a condition that requires a different therapy, she added.
“It is very consistent with what we have thought to be the case and what some lower-quality studies have shown,” she said. “It just hadn’t been done in a clinical trial with a large patient population and with a full outcome.”
PPI often used inappropriately
Interest is high both in discontinuing PPI in light of widespread and often inappropriate use and in not starting treatment with PPIs for patients who need a different therapy.
As this news organization has reported, some studies have linked long-term PPI use with intestinal infections, pneumonia, stomach cancer, osteoporosis-related bone fractures, chronic kidney disease, vitamin deficiencies, heart attacks, strokes, dementia, and early death.
Avin Aggarwal, MD, a gastroenterologist and medical director of Banner Health’s South Campus endoscopy services and clinical assistant professor at the University of Arizona, Tucson, said in an interview that this study provides the evidence needed to push for practice change.
He said his center has been using 48-hour reflux monitoring. He said that anecdotally, they had gotten better data with 4-day monitoring, but evidence was not directly tied to a measurable outcome such as this study provides.
With 4-day monitoring, “we get way more symptoms on the recorder to actually correlate them with reflux or not,” he said.
He said he will now push for the 96-hour monitoring in his clinic.
He added that part of the problem is in assuming patients have GERD and initiating PPIs in the first place without a specific diagnosis of acid reflux.
Patients, he said, are often aware of the long-term side effects of PPIs and are approaching their physicians to see whether they can discontinue them.
The data from this study, he said, will help guide physicians on when it is appropriate to discontinue treatment.
Dr. Yadlapati is a consultant for Medtronic, Phathom Pharmaceuticals, and StatLinkMD and receives research support from Ironwood Pharmaceuticals. She is on the advisory board with stock options for RJS Mediagnostix. Other study coauthors report ties to Medtronic, Diversatek, Ironwood, Iso-Thrive, Quintiles, Johnson & Johnson, Reckitt, Phathom Pharmaceuticals, Daewood, Takeda, and Crospon. Study coauthor Michael F. Vaezi, MD, PHD, holds a patent on mucosal integrity by Vanderbilt. Dr. Aggarwal reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Four days is an optimal time for wireless reflux monitoring to determine which patients can stop taking proton pump inhibitors (PPIs) and which ones need long-term antireflux therapy, researchers report.
“This first-of-its kind double-blinded clinical trial demonstrates the comparable, and in some cases better, performance of a simple assessment of daily acid exposure from multiple days of recording compared to other composite or complex assessments,” write Rena Yadlapati, MD, with the Division of Gastroenterology at the University of California, San Diego, and her coauthors.
Their findings were published online in the American Journal of Gastroenterology.
A substantial percentage of patients who have esophageal reflux symptoms do not have gastroesophageal reflux disease (GERD) and can stop taking PPIs.
Wireless reflux monitoring performed while patients are not taking PPIs is the gold standard for determining whether a patient has abnormal acid from GERD, but the optimal daily acid exposure time (AET) and the optimal duration of monitoring have not been well studied.
Aiming to fill this knowledge gap, Dr. Yadlapati and her colleagues conducted a single-arm, double-blinded clinical trial over 4 years at two tertiary care centers. They enrolled adult patients who had demonstrated an inadequate response to more than 8 weeks’ treatment with PPIs.
Study participants were asked to stop taking their PPI for 3 weeks in order for the investigators to determine the rate of relapse after PPI use and establish the study reference standard to discontinue therapy. During the 3-week period, after having stopped taking PPIs for at least a week, patients underwent 96-hour wireless reflux monitoring. They were then told to continue not taking PPIs for an additional 2 weeks. They could use over-the-counter antacids for symptom relief.
The primary outcome was whether PPIs could be successfully discontinued or restarted within 3 weeks. Of the 132 patients, 30% were able to stop taking PPIs.
AET less than 4.0% best discontinuation predictor
The team came to two key conclusions.
They found that acid exposure time of less than 4.0% was the best predictor of when stopping PPIs will be effective without worsening symptoms (odds ratio, 2.9; 95% confidence interval, 1.4-6.4). Comparatively, 45% (22 of 49 patients) with total AET of 4.0% or less discontinued taking PPIs, versus 22% (18 of 83 patients) with total AET of more than 4.0%.
Additionally, the investigators concluded that 96 hours of monitoring was better than 48 hours or fewer in predicting whether patients could stop taking PPIs (area under curve [AUC] for 96 hours, 0.63, versus AUC for 48 hours, 0.57).
Dr. Yadlapati told this news organization that the findings should be practice-changing.
“You really need to test for 4 days,” she said. She noted that the battery life of the monitor is 96 hours, and clinicians commonly only test for 2 days.
With only 1-2 days of monitoring, there is too much variability in how much acid is in the esophagus from one day to another. Monitoring over a 4-day period gives a clearer picture of acid exposure burden, she said.
Her advice: “If you have a patient with heartburn or chest pain and you think it might be from reflux, and they’re not responding to a trial of PPI, get the reflux monitoring. Don’t wait.”
After 4 days of monitoring, if exposure to acid is low, “they should really be taken off their PPI therapy,” she said.
They likely have a condition that requires a different therapy, she added.
“It is very consistent with what we have thought to be the case and what some lower-quality studies have shown,” she said. “It just hadn’t been done in a clinical trial with a large patient population and with a full outcome.”
PPI often used inappropriately
Interest is high both in discontinuing PPI in light of widespread and often inappropriate use and in not starting treatment with PPIs for patients who need a different therapy.
As this news organization has reported, some studies have linked long-term PPI use with intestinal infections, pneumonia, stomach cancer, osteoporosis-related bone fractures, chronic kidney disease, vitamin deficiencies, heart attacks, strokes, dementia, and early death.
Avin Aggarwal, MD, a gastroenterologist and medical director of Banner Health’s South Campus endoscopy services and clinical assistant professor at the University of Arizona, Tucson, said in an interview that this study provides the evidence needed to push for practice change.
He said his center has been using 48-hour reflux monitoring. He said that anecdotally, they had gotten better data with 4-day monitoring, but evidence was not directly tied to a measurable outcome such as this study provides.
With 4-day monitoring, “we get way more symptoms on the recorder to actually correlate them with reflux or not,” he said.
He said he will now push for the 96-hour monitoring in his clinic.
He added that part of the problem is in assuming patients have GERD and initiating PPIs in the first place without a specific diagnosis of acid reflux.
Patients, he said, are often aware of the long-term side effects of PPIs and are approaching their physicians to see whether they can discontinue them.
The data from this study, he said, will help guide physicians on when it is appropriate to discontinue treatment.
Dr. Yadlapati is a consultant for Medtronic, Phathom Pharmaceuticals, and StatLinkMD and receives research support from Ironwood Pharmaceuticals. She is on the advisory board with stock options for RJS Mediagnostix. Other study coauthors report ties to Medtronic, Diversatek, Ironwood, Iso-Thrive, Quintiles, Johnson & Johnson, Reckitt, Phathom Pharmaceuticals, Daewood, Takeda, and Crospon. Study coauthor Michael F. Vaezi, MD, PHD, holds a patent on mucosal integrity by Vanderbilt. Dr. Aggarwal reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Four days is an optimal time for wireless reflux monitoring to determine which patients can stop taking proton pump inhibitors (PPIs) and which ones need long-term antireflux therapy, researchers report.
“This first-of-its kind double-blinded clinical trial demonstrates the comparable, and in some cases better, performance of a simple assessment of daily acid exposure from multiple days of recording compared to other composite or complex assessments,” write Rena Yadlapati, MD, with the Division of Gastroenterology at the University of California, San Diego, and her coauthors.
Their findings were published online in the American Journal of Gastroenterology.
A substantial percentage of patients who have esophageal reflux symptoms do not have gastroesophageal reflux disease (GERD) and can stop taking PPIs.
Wireless reflux monitoring performed while patients are not taking PPIs is the gold standard for determining whether a patient has abnormal acid from GERD, but the optimal daily acid exposure time (AET) and the optimal duration of monitoring have not been well studied.
Aiming to fill this knowledge gap, Dr. Yadlapati and her colleagues conducted a single-arm, double-blinded clinical trial over 4 years at two tertiary care centers. They enrolled adult patients who had demonstrated an inadequate response to more than 8 weeks’ treatment with PPIs.
Study participants were asked to stop taking their PPI for 3 weeks in order for the investigators to determine the rate of relapse after PPI use and establish the study reference standard to discontinue therapy. During the 3-week period, after having stopped taking PPIs for at least a week, patients underwent 96-hour wireless reflux monitoring. They were then told to continue not taking PPIs for an additional 2 weeks. They could use over-the-counter antacids for symptom relief.
The primary outcome was whether PPIs could be successfully discontinued or restarted within 3 weeks. Of the 132 patients, 30% were able to stop taking PPIs.
AET less than 4.0% best discontinuation predictor
The team came to two key conclusions.
They found that acid exposure time of less than 4.0% was the best predictor of when stopping PPIs will be effective without worsening symptoms (odds ratio, 2.9; 95% confidence interval, 1.4-6.4). Comparatively, 45% (22 of 49 patients) with total AET of 4.0% or less discontinued taking PPIs, versus 22% (18 of 83 patients) with total AET of more than 4.0%.
Additionally, the investigators concluded that 96 hours of monitoring was better than 48 hours or fewer in predicting whether patients could stop taking PPIs (area under curve [AUC] for 96 hours, 0.63, versus AUC for 48 hours, 0.57).
Dr. Yadlapati told this news organization that the findings should be practice-changing.
“You really need to test for 4 days,” she said. She noted that the battery life of the monitor is 96 hours, and clinicians commonly only test for 2 days.
With only 1-2 days of monitoring, there is too much variability in how much acid is in the esophagus from one day to another. Monitoring over a 4-day period gives a clearer picture of acid exposure burden, she said.
Her advice: “If you have a patient with heartburn or chest pain and you think it might be from reflux, and they’re not responding to a trial of PPI, get the reflux monitoring. Don’t wait.”
After 4 days of monitoring, if exposure to acid is low, “they should really be taken off their PPI therapy,” she said.
They likely have a condition that requires a different therapy, she added.
“It is very consistent with what we have thought to be the case and what some lower-quality studies have shown,” she said. “It just hadn’t been done in a clinical trial with a large patient population and with a full outcome.”
PPI often used inappropriately
Interest is high both in discontinuing PPI in light of widespread and often inappropriate use and in not starting treatment with PPIs for patients who need a different therapy.
As this news organization has reported, some studies have linked long-term PPI use with intestinal infections, pneumonia, stomach cancer, osteoporosis-related bone fractures, chronic kidney disease, vitamin deficiencies, heart attacks, strokes, dementia, and early death.
Avin Aggarwal, MD, a gastroenterologist and medical director of Banner Health’s South Campus endoscopy services and clinical assistant professor at the University of Arizona, Tucson, said in an interview that this study provides the evidence needed to push for practice change.
He said his center has been using 48-hour reflux monitoring. He said that anecdotally, they had gotten better data with 4-day monitoring, but evidence was not directly tied to a measurable outcome such as this study provides.
With 4-day monitoring, “we get way more symptoms on the recorder to actually correlate them with reflux or not,” he said.
He said he will now push for the 96-hour monitoring in his clinic.
He added that part of the problem is in assuming patients have GERD and initiating PPIs in the first place without a specific diagnosis of acid reflux.
Patients, he said, are often aware of the long-term side effects of PPIs and are approaching their physicians to see whether they can discontinue them.
The data from this study, he said, will help guide physicians on when it is appropriate to discontinue treatment.
Dr. Yadlapati is a consultant for Medtronic, Phathom Pharmaceuticals, and StatLinkMD and receives research support from Ironwood Pharmaceuticals. She is on the advisory board with stock options for RJS Mediagnostix. Other study coauthors report ties to Medtronic, Diversatek, Ironwood, Iso-Thrive, Quintiles, Johnson & Johnson, Reckitt, Phathom Pharmaceuticals, Daewood, Takeda, and Crospon. Study coauthor Michael F. Vaezi, MD, PHD, holds a patent on mucosal integrity by Vanderbilt. Dr. Aggarwal reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Colonic Crohn’s: Segmental vs. total colectomy
Segmental rather than total colectomy may be a safe and effective choice for some patients with colonic Crohn’s disease (cCD), showing significantly lower rates of repeat surgery and reduced need for stoma, according to long-term data.
Gianluca Pellino, MD, with the department of advanced medical and surgical sciences, Università degli Studi della Campania “Luigi Vanvitelli” in Naples, Italy, led the study, which was published in the Journal of Crohn’s and Colitis.
CD of the colon has gotten less attention than the more prevalent small bowel disease, according to the authors, but it can be debilitating and permanently reduce quality of life. Isolated cCD incidence ranges between 14% and 32% of all CD cases from the start of disease. Historically, extensive resection has been linked with longer disease-free intervals, and reduced repeat surgeries compared with segmental resections. However, most of the data have included low-quality evidence and reports typically have not adequately considered the role of biologics or advances in perioperative management of patients with cCD, the authors wrote.
The Segmental Colectomy for Crohn’s disease (SCOTCH) international study included a retrospective analysis of data from six European Inflammatory Bowel Disease referral centers on patients operated on between 2000 and 2019 who had either segmental or total colectomy for cCD.
Among 687 patients (301 male; 386 female), segmental colectomy was performed in 285 (41.5%) of cases and total colectomy in 402 (58.5%). The 15-year surgical recurrence rate was 44% among patients who had TC and 27% for patients with segmental colectomy (P = .006).
The SCOTCH study found that segmental colectomy may be performed safely and effectively and reduce the need for stoma in cCD patients without increasing risk of repeat surgeries compared with total colectomy, which was the primary measure investigators studied.
The findings of this study also suggest that biologics, when used early and correctly, may allow more conservative options for cCD, with a fivefold reduction in surgical recurrence risk in patients who have one to three large bowel locations.
Morbidity and mortality were similar in the SC and TC groups.
Among the limitations of the study are that the total colectomy patients in the study had indications for total colectomy that were also higher risk factors for recurrence – for instance, perianal disease.
The authors wrote, “The differences between patients who underwent SC vs TC might have accounted for the choice of one treatment over the other. It is however difficult to obtain a homogenous population of cCD patients.” They also cite the difficulties in gathering enough patients for randomized trials.
“These findings need to be discussed with the patients, and the choice of operation should be individualised,” they concluded. “Multidisciplinary management of patients with cCD is of critical importance to achieve optimal long-term results of bowel-sparing approaches.”
Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at the Cleveland Clinic, who was not part of the study, told this publication the findings should be considered confirmatory rather than suggestive of practice change.
“If a patient has a limited segment of Crohn’s, for example ileocecal Crohn’s – a common phenotype – then the standard of care is a segmental resection and primary anastomosis,” he said. “If the patient has more extensive CD – perianal fistula, colonic-only CD – they’re more likely to undergo a total colectomy. This study confirms that.“
The authors and Dr. Regueiro declared no relevant financial relationships.
Segmental rather than total colectomy may be a safe and effective choice for some patients with colonic Crohn’s disease (cCD), showing significantly lower rates of repeat surgery and reduced need for stoma, according to long-term data.
Gianluca Pellino, MD, with the department of advanced medical and surgical sciences, Università degli Studi della Campania “Luigi Vanvitelli” in Naples, Italy, led the study, which was published in the Journal of Crohn’s and Colitis.
CD of the colon has gotten less attention than the more prevalent small bowel disease, according to the authors, but it can be debilitating and permanently reduce quality of life. Isolated cCD incidence ranges between 14% and 32% of all CD cases from the start of disease. Historically, extensive resection has been linked with longer disease-free intervals, and reduced repeat surgeries compared with segmental resections. However, most of the data have included low-quality evidence and reports typically have not adequately considered the role of biologics or advances in perioperative management of patients with cCD, the authors wrote.
The Segmental Colectomy for Crohn’s disease (SCOTCH) international study included a retrospective analysis of data from six European Inflammatory Bowel Disease referral centers on patients operated on between 2000 and 2019 who had either segmental or total colectomy for cCD.
Among 687 patients (301 male; 386 female), segmental colectomy was performed in 285 (41.5%) of cases and total colectomy in 402 (58.5%). The 15-year surgical recurrence rate was 44% among patients who had TC and 27% for patients with segmental colectomy (P = .006).
The SCOTCH study found that segmental colectomy may be performed safely and effectively and reduce the need for stoma in cCD patients without increasing risk of repeat surgeries compared with total colectomy, which was the primary measure investigators studied.
The findings of this study also suggest that biologics, when used early and correctly, may allow more conservative options for cCD, with a fivefold reduction in surgical recurrence risk in patients who have one to three large bowel locations.
Morbidity and mortality were similar in the SC and TC groups.
Among the limitations of the study are that the total colectomy patients in the study had indications for total colectomy that were also higher risk factors for recurrence – for instance, perianal disease.
The authors wrote, “The differences between patients who underwent SC vs TC might have accounted for the choice of one treatment over the other. It is however difficult to obtain a homogenous population of cCD patients.” They also cite the difficulties in gathering enough patients for randomized trials.
“These findings need to be discussed with the patients, and the choice of operation should be individualised,” they concluded. “Multidisciplinary management of patients with cCD is of critical importance to achieve optimal long-term results of bowel-sparing approaches.”
Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at the Cleveland Clinic, who was not part of the study, told this publication the findings should be considered confirmatory rather than suggestive of practice change.
“If a patient has a limited segment of Crohn’s, for example ileocecal Crohn’s – a common phenotype – then the standard of care is a segmental resection and primary anastomosis,” he said. “If the patient has more extensive CD – perianal fistula, colonic-only CD – they’re more likely to undergo a total colectomy. This study confirms that.“
The authors and Dr. Regueiro declared no relevant financial relationships.
Segmental rather than total colectomy may be a safe and effective choice for some patients with colonic Crohn’s disease (cCD), showing significantly lower rates of repeat surgery and reduced need for stoma, according to long-term data.
Gianluca Pellino, MD, with the department of advanced medical and surgical sciences, Università degli Studi della Campania “Luigi Vanvitelli” in Naples, Italy, led the study, which was published in the Journal of Crohn’s and Colitis.
CD of the colon has gotten less attention than the more prevalent small bowel disease, according to the authors, but it can be debilitating and permanently reduce quality of life. Isolated cCD incidence ranges between 14% and 32% of all CD cases from the start of disease. Historically, extensive resection has been linked with longer disease-free intervals, and reduced repeat surgeries compared with segmental resections. However, most of the data have included low-quality evidence and reports typically have not adequately considered the role of biologics or advances in perioperative management of patients with cCD, the authors wrote.
The Segmental Colectomy for Crohn’s disease (SCOTCH) international study included a retrospective analysis of data from six European Inflammatory Bowel Disease referral centers on patients operated on between 2000 and 2019 who had either segmental or total colectomy for cCD.
Among 687 patients (301 male; 386 female), segmental colectomy was performed in 285 (41.5%) of cases and total colectomy in 402 (58.5%). The 15-year surgical recurrence rate was 44% among patients who had TC and 27% for patients with segmental colectomy (P = .006).
The SCOTCH study found that segmental colectomy may be performed safely and effectively and reduce the need for stoma in cCD patients without increasing risk of repeat surgeries compared with total colectomy, which was the primary measure investigators studied.
The findings of this study also suggest that biologics, when used early and correctly, may allow more conservative options for cCD, with a fivefold reduction in surgical recurrence risk in patients who have one to three large bowel locations.
Morbidity and mortality were similar in the SC and TC groups.
Among the limitations of the study are that the total colectomy patients in the study had indications for total colectomy that were also higher risk factors for recurrence – for instance, perianal disease.
The authors wrote, “The differences between patients who underwent SC vs TC might have accounted for the choice of one treatment over the other. It is however difficult to obtain a homogenous population of cCD patients.” They also cite the difficulties in gathering enough patients for randomized trials.
“These findings need to be discussed with the patients, and the choice of operation should be individualised,” they concluded. “Multidisciplinary management of patients with cCD is of critical importance to achieve optimal long-term results of bowel-sparing approaches.”
Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at the Cleveland Clinic, who was not part of the study, told this publication the findings should be considered confirmatory rather than suggestive of practice change.
“If a patient has a limited segment of Crohn’s, for example ileocecal Crohn’s – a common phenotype – then the standard of care is a segmental resection and primary anastomosis,” he said. “If the patient has more extensive CD – perianal fistula, colonic-only CD – they’re more likely to undergo a total colectomy. This study confirms that.“
The authors and Dr. Regueiro declared no relevant financial relationships.
FROM JOURNAL OF CROHN’S AND COLITIS
Some have heavier periods after COVID vaccine
Many women who got a COVID-19 vaccine have reported heavier bleeding during their periods since they had the shots.
A team of researchers investigated the trend and set out to find out who among the vaccinated were more likely to experience the menstruation changes.
The researchers were led by Katharine M.N. Lee, PhD, MS, of the division of public health sciences at Washington University in St. Louis. Their findings were published ahead of print in Science Advances.
The investigators analyzed more than 139,000 responses from an online survey from both currently and formerly menstruating women.
They found that, among people who have regular periods, about the same percentage had heavier bleeding after they got a COVID vaccine as had no change in bleeding after the vaccine (44% vs. 42%, respectively).
“A much smaller portion had lighter periods,” they write.
The phenomenon has been difficult to study because questions about changes in menstruation are not a standard part of vaccine trials.
Date of last period is often tracked in clinical trials to make sure a participant is not pregnant, but the questions about periods often stop there.
Additionally, periods are different for everyone and can be influenced by all sorts of environmental factors, so making associations regarding exposures is problematic.
No changes found to fertility
The authors emphasized that, generally, changes to menstrual bleeding are not uncommon nor dangerous. They also emphasized that the changes in bleeding don’t mean changes to fertility.
The uterine reproductive system is flexible when the body is under stress, they note.
“We know that running a marathon may influence hormone concentrations in the short term while not rendering that person infertile,” the authors write.
However, they acknowledge that investigating these reports is critical in building trust in medicine.
This report includes information that hasn’t been available through the clinical trial follow-up process.
For instance, the authors write, “To the best of our knowledge, our work is the first to examine breakthrough bleeding after vaccination in either pre- or postmenopausal people.”
Reports of changes to periods after vaccination started emerging in 2021. But without data, reports were largely dismissed, fueling criticism from those waging campaigns against COVID vaccines.
Dr. Lee and colleagues gathered data from those who responded to the online survey and detailed some trends.
People who were bleeding more heavily after vaccination were more likely to be older, Hispanic, had vaccine side effects of fever and fatigue, had been pregnant at some point, or had given birth.
People with regular periods who had endometriosis, prolonged bleeding during their periods, polycystic ovarian syndrome (PCOS) or fibroids were also more likely to have increased bleeding after a COVID vaccine.
Breakthrough bleeding
For people who don’t menstruate, but have not reached menopause, breakthrough bleeding happened more often in women who had been pregnant and/or had given birth.
Among respondents who were postmenopausal, breakthrough bleeding happened more often in younger people and/or those who are Hispanic.
More than a third of the respondents (39%) who use gender-affirming hormones that eliminate menstruation reported breakthrough bleeding after vaccination.
The majority of premenopausal people on long-acting, reversible contraception (71%) and the majority of postmenopausal respondents (66%) had breakthrough bleeding as well.
The authors note that you can’t compare the percentages who report these experiences in the survey with the incidence of those who would experience changes in menstrual bleeding in the general population.
The nature of the online survey means it may be naturally biased because the people who responded may be more often those who noted some change in their own menstrual experiences, particularly if that involved discomfort, pain, or fear.
Researchers also acknowledge that Black, Indigenous, Latinx, and other respondents of color are underrepresented in this research and that represents a limitation in the work.
Alison Edelman, MD, MPH, with the department of obstetrics and gynecology at Oregon Health & Science University in Portland, was not involved with Dr. Lee and associates’ study but has also studied the relationship between COVID vaccines and menstruation.
Her team’s study found that COVID vaccination is associated with a small change in time between periods but not length of periods.
She said about the work by Dr. Lee and colleagues, “This work really elevates the voices of the public and what they’re experiencing.”
The association makes sense, Dr. Edelman says, in that the reproductive system and the immune system talk to each other and inflammation in the immune system is going to be noticed by the system governing periods.
Lack of data on the relationship between exposures and menstruation didn’t start with COVID. “There has been a signal in the population before with other vaccines that’s been dismissed,” she said.
Tracking menstruation information in clinical trials can help physicians counsel women on what may be coming with any vaccine and alleviate fears and vaccine hesitancy, Dr. Edelman explained. It can also help vaccine developers know what to include in information about their product.
“When you are counseled about what to expect, it’s not as scary. That provides trust in the system,” she said. She likened it to original lack of data on whether COVID-19 vaccines would affect pregnancy.
“We have great science now that COVID vaccine does not affect fertility and [vaccine] does not impact pregnancy.”
Another important aspect of this paper is that it included subgroups not studied before regarding menstruation and breakthrough bleeding, such as those taking gender-affirming hormones, she added.
Menstruation has been often overlooked as important in clinical trial exposures but Dr. Edelman hopes this recent attention and question will escalate and prompt more research.
“I’m hoping with the immense outpouring from the public about how important this is, that future studies will look at this a little bit better,” she says.
She said when the National Institutes of Health opened up funding for trials on COVID-19 vaccines and menstruation, researchers got flooded with requests from women to share their stories.
“As a researcher – I’ve been doing research for over 20 years – that’s not something that usually happens. I would love to have that happen for every research project.”
The authors and Dr. Edelman declare that they have no competing interests. This research was supported in part by the University of Illinois Beckman Institute for Advanced Science and Technology, the University of Illinois Interdisciplinary Health Sciences Institute, the National Institutes of Health, the Foundation for Barnes-Jewish Hospital, and the Siteman Cancer Center.
Many women who got a COVID-19 vaccine have reported heavier bleeding during their periods since they had the shots.
A team of researchers investigated the trend and set out to find out who among the vaccinated were more likely to experience the menstruation changes.
The researchers were led by Katharine M.N. Lee, PhD, MS, of the division of public health sciences at Washington University in St. Louis. Their findings were published ahead of print in Science Advances.
The investigators analyzed more than 139,000 responses from an online survey from both currently and formerly menstruating women.
They found that, among people who have regular periods, about the same percentage had heavier bleeding after they got a COVID vaccine as had no change in bleeding after the vaccine (44% vs. 42%, respectively).
“A much smaller portion had lighter periods,” they write.
The phenomenon has been difficult to study because questions about changes in menstruation are not a standard part of vaccine trials.
Date of last period is often tracked in clinical trials to make sure a participant is not pregnant, but the questions about periods often stop there.
Additionally, periods are different for everyone and can be influenced by all sorts of environmental factors, so making associations regarding exposures is problematic.
No changes found to fertility
The authors emphasized that, generally, changes to menstrual bleeding are not uncommon nor dangerous. They also emphasized that the changes in bleeding don’t mean changes to fertility.
The uterine reproductive system is flexible when the body is under stress, they note.
“We know that running a marathon may influence hormone concentrations in the short term while not rendering that person infertile,” the authors write.
However, they acknowledge that investigating these reports is critical in building trust in medicine.
This report includes information that hasn’t been available through the clinical trial follow-up process.
For instance, the authors write, “To the best of our knowledge, our work is the first to examine breakthrough bleeding after vaccination in either pre- or postmenopausal people.”
Reports of changes to periods after vaccination started emerging in 2021. But without data, reports were largely dismissed, fueling criticism from those waging campaigns against COVID vaccines.
Dr. Lee and colleagues gathered data from those who responded to the online survey and detailed some trends.
People who were bleeding more heavily after vaccination were more likely to be older, Hispanic, had vaccine side effects of fever and fatigue, had been pregnant at some point, or had given birth.
People with regular periods who had endometriosis, prolonged bleeding during their periods, polycystic ovarian syndrome (PCOS) or fibroids were also more likely to have increased bleeding after a COVID vaccine.
Breakthrough bleeding
For people who don’t menstruate, but have not reached menopause, breakthrough bleeding happened more often in women who had been pregnant and/or had given birth.
Among respondents who were postmenopausal, breakthrough bleeding happened more often in younger people and/or those who are Hispanic.
More than a third of the respondents (39%) who use gender-affirming hormones that eliminate menstruation reported breakthrough bleeding after vaccination.
The majority of premenopausal people on long-acting, reversible contraception (71%) and the majority of postmenopausal respondents (66%) had breakthrough bleeding as well.
The authors note that you can’t compare the percentages who report these experiences in the survey with the incidence of those who would experience changes in menstrual bleeding in the general population.
The nature of the online survey means it may be naturally biased because the people who responded may be more often those who noted some change in their own menstrual experiences, particularly if that involved discomfort, pain, or fear.
Researchers also acknowledge that Black, Indigenous, Latinx, and other respondents of color are underrepresented in this research and that represents a limitation in the work.
Alison Edelman, MD, MPH, with the department of obstetrics and gynecology at Oregon Health & Science University in Portland, was not involved with Dr. Lee and associates’ study but has also studied the relationship between COVID vaccines and menstruation.
Her team’s study found that COVID vaccination is associated with a small change in time between periods but not length of periods.
She said about the work by Dr. Lee and colleagues, “This work really elevates the voices of the public and what they’re experiencing.”
The association makes sense, Dr. Edelman says, in that the reproductive system and the immune system talk to each other and inflammation in the immune system is going to be noticed by the system governing periods.
Lack of data on the relationship between exposures and menstruation didn’t start with COVID. “There has been a signal in the population before with other vaccines that’s been dismissed,” she said.
Tracking menstruation information in clinical trials can help physicians counsel women on what may be coming with any vaccine and alleviate fears and vaccine hesitancy, Dr. Edelman explained. It can also help vaccine developers know what to include in information about their product.
“When you are counseled about what to expect, it’s not as scary. That provides trust in the system,” she said. She likened it to original lack of data on whether COVID-19 vaccines would affect pregnancy.
“We have great science now that COVID vaccine does not affect fertility and [vaccine] does not impact pregnancy.”
Another important aspect of this paper is that it included subgroups not studied before regarding menstruation and breakthrough bleeding, such as those taking gender-affirming hormones, she added.
Menstruation has been often overlooked as important in clinical trial exposures but Dr. Edelman hopes this recent attention and question will escalate and prompt more research.
“I’m hoping with the immense outpouring from the public about how important this is, that future studies will look at this a little bit better,” she says.
She said when the National Institutes of Health opened up funding for trials on COVID-19 vaccines and menstruation, researchers got flooded with requests from women to share their stories.
“As a researcher – I’ve been doing research for over 20 years – that’s not something that usually happens. I would love to have that happen for every research project.”
The authors and Dr. Edelman declare that they have no competing interests. This research was supported in part by the University of Illinois Beckman Institute for Advanced Science and Technology, the University of Illinois Interdisciplinary Health Sciences Institute, the National Institutes of Health, the Foundation for Barnes-Jewish Hospital, and the Siteman Cancer Center.
Many women who got a COVID-19 vaccine have reported heavier bleeding during their periods since they had the shots.
A team of researchers investigated the trend and set out to find out who among the vaccinated were more likely to experience the menstruation changes.
The researchers were led by Katharine M.N. Lee, PhD, MS, of the division of public health sciences at Washington University in St. Louis. Their findings were published ahead of print in Science Advances.
The investigators analyzed more than 139,000 responses from an online survey from both currently and formerly menstruating women.
They found that, among people who have regular periods, about the same percentage had heavier bleeding after they got a COVID vaccine as had no change in bleeding after the vaccine (44% vs. 42%, respectively).
“A much smaller portion had lighter periods,” they write.
The phenomenon has been difficult to study because questions about changes in menstruation are not a standard part of vaccine trials.
Date of last period is often tracked in clinical trials to make sure a participant is not pregnant, but the questions about periods often stop there.
Additionally, periods are different for everyone and can be influenced by all sorts of environmental factors, so making associations regarding exposures is problematic.
No changes found to fertility
The authors emphasized that, generally, changes to menstrual bleeding are not uncommon nor dangerous. They also emphasized that the changes in bleeding don’t mean changes to fertility.
The uterine reproductive system is flexible when the body is under stress, they note.
“We know that running a marathon may influence hormone concentrations in the short term while not rendering that person infertile,” the authors write.
However, they acknowledge that investigating these reports is critical in building trust in medicine.
This report includes information that hasn’t been available through the clinical trial follow-up process.
For instance, the authors write, “To the best of our knowledge, our work is the first to examine breakthrough bleeding after vaccination in either pre- or postmenopausal people.”
Reports of changes to periods after vaccination started emerging in 2021. But without data, reports were largely dismissed, fueling criticism from those waging campaigns against COVID vaccines.
Dr. Lee and colleagues gathered data from those who responded to the online survey and detailed some trends.
People who were bleeding more heavily after vaccination were more likely to be older, Hispanic, had vaccine side effects of fever and fatigue, had been pregnant at some point, or had given birth.
People with regular periods who had endometriosis, prolonged bleeding during their periods, polycystic ovarian syndrome (PCOS) or fibroids were also more likely to have increased bleeding after a COVID vaccine.
Breakthrough bleeding
For people who don’t menstruate, but have not reached menopause, breakthrough bleeding happened more often in women who had been pregnant and/or had given birth.
Among respondents who were postmenopausal, breakthrough bleeding happened more often in younger people and/or those who are Hispanic.
More than a third of the respondents (39%) who use gender-affirming hormones that eliminate menstruation reported breakthrough bleeding after vaccination.
The majority of premenopausal people on long-acting, reversible contraception (71%) and the majority of postmenopausal respondents (66%) had breakthrough bleeding as well.
The authors note that you can’t compare the percentages who report these experiences in the survey with the incidence of those who would experience changes in menstrual bleeding in the general population.
The nature of the online survey means it may be naturally biased because the people who responded may be more often those who noted some change in their own menstrual experiences, particularly if that involved discomfort, pain, or fear.
Researchers also acknowledge that Black, Indigenous, Latinx, and other respondents of color are underrepresented in this research and that represents a limitation in the work.
Alison Edelman, MD, MPH, with the department of obstetrics and gynecology at Oregon Health & Science University in Portland, was not involved with Dr. Lee and associates’ study but has also studied the relationship between COVID vaccines and menstruation.
Her team’s study found that COVID vaccination is associated with a small change in time between periods but not length of periods.
She said about the work by Dr. Lee and colleagues, “This work really elevates the voices of the public and what they’re experiencing.”
The association makes sense, Dr. Edelman says, in that the reproductive system and the immune system talk to each other and inflammation in the immune system is going to be noticed by the system governing periods.
Lack of data on the relationship between exposures and menstruation didn’t start with COVID. “There has been a signal in the population before with other vaccines that’s been dismissed,” she said.
Tracking menstruation information in clinical trials can help physicians counsel women on what may be coming with any vaccine and alleviate fears and vaccine hesitancy, Dr. Edelman explained. It can also help vaccine developers know what to include in information about their product.
“When you are counseled about what to expect, it’s not as scary. That provides trust in the system,” she said. She likened it to original lack of data on whether COVID-19 vaccines would affect pregnancy.
“We have great science now that COVID vaccine does not affect fertility and [vaccine] does not impact pregnancy.”
Another important aspect of this paper is that it included subgroups not studied before regarding menstruation and breakthrough bleeding, such as those taking gender-affirming hormones, she added.
Menstruation has been often overlooked as important in clinical trial exposures but Dr. Edelman hopes this recent attention and question will escalate and prompt more research.
“I’m hoping with the immense outpouring from the public about how important this is, that future studies will look at this a little bit better,” she says.
She said when the National Institutes of Health opened up funding for trials on COVID-19 vaccines and menstruation, researchers got flooded with requests from women to share their stories.
“As a researcher – I’ve been doing research for over 20 years – that’s not something that usually happens. I would love to have that happen for every research project.”
The authors and Dr. Edelman declare that they have no competing interests. This research was supported in part by the University of Illinois Beckman Institute for Advanced Science and Technology, the University of Illinois Interdisciplinary Health Sciences Institute, the National Institutes of Health, the Foundation for Barnes-Jewish Hospital, and the Siteman Cancer Center.
FROM SCIENCE ADVANCES