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Truncal vagotomy might help delay Parkinson’s disease
Patients who were followed for more than 5 years after truncal vagotomy had about a 40% lower risk of being diagnosed with Parkinson’s disease, compared with matched population controls, according to the results of a cohort registry study.
Selective vagotomy did not decrease the risk of Parkinson’s disease (PD), however, reported Bojing Liu of Karolinska Institutet, Stockholm, and her associates. The findings, which reflect those from a prior Danish study, “provide preliminary and indirect support” for the idea that Lewy pathology in PD begins in peripheral nerves and spreads to the central nervous system through “prion-like mechanisms,” they added.
The findings reflect a prior registry study that found a 15% decrease in the risk of PD compared with the general population more than 5 years after truncal vagotomy (Ann Neurol. 2015 Oct. 78[4];522-9). “This Danish study, however, did not differentiate truncal from selective vagotomy and thus might have underestimated the association of truncal vagotomy with PD,” the researchers said.
Another study found that truncal vagotomy exhibited a nonsignificant protective effect overall and an insignificantly increased risk of PD more than 20 years after surgery (Neurology Today 2015 Dec 3;15[23]:27-30). Likewise, the current study yielded “stronger evidence for PD risk reduction more than 5 or 10 years after truncal vagotomy,” and the protective effect appeared to weaken with longer follow-up, the investigators noted. If PD started at multiple sites within the peripheral nervous system, “even truncal vagotomy may delay, rather than eliminate, the risk for PD,” they emphasized. “Indeed, abnormal alpha-synuclein accumulation has been found throughout the digestive tract of patients with PD with descending pattern of density, and even in the submandibular gland in patients with preclinical PD.”
The study was funded by the Swedish Research Council for Health, Working Life and Welfare, the Parkinson Research Foundation in Sweden, the Karolinska Institutet, the Swedish Society for Medical Research, the Stockholm County Council, and Karolinska Institutet–NIH Doctoral Partnership Program in Neuroscience. The investigators had no relevant disclosures.
The current study provides an independent dataset suggesting that truncal vagotomy may be protective in Parkinson’s disease. Therefore, the time has come to seriously consider the implications of these findings.
Could it be true that alpha-synuclein misfolding in PD may originate in the autonomic nerve terminals of the gastrointestinal tract? For the moment, more research is needed. One may consider studying the effects of vagotomy in patients with mutations in the leucine-rich repeat kinase-2 gene (LRRK2), which dramatically increases the risk of developing neurodegenerative parkinsonism. Some of these mutations have a penetrance of up to 80% in the very elderly. However, it is largely unknown whether alpha-synuclein aggregates are present in gastrointestinal nerve endings of these patients. At this stage, we have insufficient knowledge to propose vagotomy as a putative treatment for PD. Although vagotomy will likely never become a widespread treatment for PD, strategies to prevent alpha-synuclein misfolding in the gastrointestinal tract may be proposed, because nerve terminals are reachable by oral therapeutic interventions.
Per Borghammer, MD, PhD, is in the department of nuclear medicine and PET Centre, Aarhus University Hospital, Denmark. Clement Hamani, MD, PhD, is at the division of neurosurgery, Toronto Western Hospital, University of Toronto, and the department of neuroimaging, Centre for Addiction and Mental Health, Campbell Family Mental Health Research Institute, Toronto. They reported no conflicts of interest. These comments are excerpted from their editorial (Neurology. 2017 Apr 26. doi: 10.1212/WNL.0000000000003969).
The current study provides an independent dataset suggesting that truncal vagotomy may be protective in Parkinson’s disease. Therefore, the time has come to seriously consider the implications of these findings.
Could it be true that alpha-synuclein misfolding in PD may originate in the autonomic nerve terminals of the gastrointestinal tract? For the moment, more research is needed. One may consider studying the effects of vagotomy in patients with mutations in the leucine-rich repeat kinase-2 gene (LRRK2), which dramatically increases the risk of developing neurodegenerative parkinsonism. Some of these mutations have a penetrance of up to 80% in the very elderly. However, it is largely unknown whether alpha-synuclein aggregates are present in gastrointestinal nerve endings of these patients. At this stage, we have insufficient knowledge to propose vagotomy as a putative treatment for PD. Although vagotomy will likely never become a widespread treatment for PD, strategies to prevent alpha-synuclein misfolding in the gastrointestinal tract may be proposed, because nerve terminals are reachable by oral therapeutic interventions.
Per Borghammer, MD, PhD, is in the department of nuclear medicine and PET Centre, Aarhus University Hospital, Denmark. Clement Hamani, MD, PhD, is at the division of neurosurgery, Toronto Western Hospital, University of Toronto, and the department of neuroimaging, Centre for Addiction and Mental Health, Campbell Family Mental Health Research Institute, Toronto. They reported no conflicts of interest. These comments are excerpted from their editorial (Neurology. 2017 Apr 26. doi: 10.1212/WNL.0000000000003969).
The current study provides an independent dataset suggesting that truncal vagotomy may be protective in Parkinson’s disease. Therefore, the time has come to seriously consider the implications of these findings.
Could it be true that alpha-synuclein misfolding in PD may originate in the autonomic nerve terminals of the gastrointestinal tract? For the moment, more research is needed. One may consider studying the effects of vagotomy in patients with mutations in the leucine-rich repeat kinase-2 gene (LRRK2), which dramatically increases the risk of developing neurodegenerative parkinsonism. Some of these mutations have a penetrance of up to 80% in the very elderly. However, it is largely unknown whether alpha-synuclein aggregates are present in gastrointestinal nerve endings of these patients. At this stage, we have insufficient knowledge to propose vagotomy as a putative treatment for PD. Although vagotomy will likely never become a widespread treatment for PD, strategies to prevent alpha-synuclein misfolding in the gastrointestinal tract may be proposed, because nerve terminals are reachable by oral therapeutic interventions.
Per Borghammer, MD, PhD, is in the department of nuclear medicine and PET Centre, Aarhus University Hospital, Denmark. Clement Hamani, MD, PhD, is at the division of neurosurgery, Toronto Western Hospital, University of Toronto, and the department of neuroimaging, Centre for Addiction and Mental Health, Campbell Family Mental Health Research Institute, Toronto. They reported no conflicts of interest. These comments are excerpted from their editorial (Neurology. 2017 Apr 26. doi: 10.1212/WNL.0000000000003969).
Patients who were followed for more than 5 years after truncal vagotomy had about a 40% lower risk of being diagnosed with Parkinson’s disease, compared with matched population controls, according to the results of a cohort registry study.
Selective vagotomy did not decrease the risk of Parkinson’s disease (PD), however, reported Bojing Liu of Karolinska Institutet, Stockholm, and her associates. The findings, which reflect those from a prior Danish study, “provide preliminary and indirect support” for the idea that Lewy pathology in PD begins in peripheral nerves and spreads to the central nervous system through “prion-like mechanisms,” they added.
The findings reflect a prior registry study that found a 15% decrease in the risk of PD compared with the general population more than 5 years after truncal vagotomy (Ann Neurol. 2015 Oct. 78[4];522-9). “This Danish study, however, did not differentiate truncal from selective vagotomy and thus might have underestimated the association of truncal vagotomy with PD,” the researchers said.
Another study found that truncal vagotomy exhibited a nonsignificant protective effect overall and an insignificantly increased risk of PD more than 20 years after surgery (Neurology Today 2015 Dec 3;15[23]:27-30). Likewise, the current study yielded “stronger evidence for PD risk reduction more than 5 or 10 years after truncal vagotomy,” and the protective effect appeared to weaken with longer follow-up, the investigators noted. If PD started at multiple sites within the peripheral nervous system, “even truncal vagotomy may delay, rather than eliminate, the risk for PD,” they emphasized. “Indeed, abnormal alpha-synuclein accumulation has been found throughout the digestive tract of patients with PD with descending pattern of density, and even in the submandibular gland in patients with preclinical PD.”
The study was funded by the Swedish Research Council for Health, Working Life and Welfare, the Parkinson Research Foundation in Sweden, the Karolinska Institutet, the Swedish Society for Medical Research, the Stockholm County Council, and Karolinska Institutet–NIH Doctoral Partnership Program in Neuroscience. The investigators had no relevant disclosures.
Patients who were followed for more than 5 years after truncal vagotomy had about a 40% lower risk of being diagnosed with Parkinson’s disease, compared with matched population controls, according to the results of a cohort registry study.
Selective vagotomy did not decrease the risk of Parkinson’s disease (PD), however, reported Bojing Liu of Karolinska Institutet, Stockholm, and her associates. The findings, which reflect those from a prior Danish study, “provide preliminary and indirect support” for the idea that Lewy pathology in PD begins in peripheral nerves and spreads to the central nervous system through “prion-like mechanisms,” they added.
The findings reflect a prior registry study that found a 15% decrease in the risk of PD compared with the general population more than 5 years after truncal vagotomy (Ann Neurol. 2015 Oct. 78[4];522-9). “This Danish study, however, did not differentiate truncal from selective vagotomy and thus might have underestimated the association of truncal vagotomy with PD,” the researchers said.
Another study found that truncal vagotomy exhibited a nonsignificant protective effect overall and an insignificantly increased risk of PD more than 20 years after surgery (Neurology Today 2015 Dec 3;15[23]:27-30). Likewise, the current study yielded “stronger evidence for PD risk reduction more than 5 or 10 years after truncal vagotomy,” and the protective effect appeared to weaken with longer follow-up, the investigators noted. If PD started at multiple sites within the peripheral nervous system, “even truncal vagotomy may delay, rather than eliminate, the risk for PD,” they emphasized. “Indeed, abnormal alpha-synuclein accumulation has been found throughout the digestive tract of patients with PD with descending pattern of density, and even in the submandibular gland in patients with preclinical PD.”
The study was funded by the Swedish Research Council for Health, Working Life and Welfare, the Parkinson Research Foundation in Sweden, the Karolinska Institutet, the Swedish Society for Medical Research, the Stockholm County Council, and Karolinska Institutet–NIH Doctoral Partnership Program in Neuroscience. The investigators had no relevant disclosures.
Key clinical point:
Major finding: Compared with controls, patients who underwent truncal vagotomy were at decreased risk of Parkinson’s disease after more than 5 years (hazard ratio, 0.59, 95% confidence interval, 0.37-0.93). Selective vagotomy did not show this association.
Data source: A matched cohort study of 9,430 vagotomized patients (3,445 truncal, 5,978 selective, 7 unknown) between 1970 and 2010, and 377,200 population controls matched by age and sex.
Disclosures: The Swedish Research Council for Health, Working Life and Welfare, the Parkinson Research Foundation in Sweden, the Karolinska Institutet, the Swedish Society for Medical Research, the Stockholm County Council, and Karolinska Institutet–NIH Doctoral Partnership Program in Neuroscience funded the study. The investigators had no relevant disclosures.
RIV poster contest a meeting highlight
Look back at the history of SHM’s annual Research, Innovations and Clinical Vignettes poster competition – better known as the RIV – and it may seem inevitable that it’s grown into one of the main highlights of the conference. The RIV has become so popular that the number of submissions has nearly tripled from 634 in 2010 to 1,712 this year.
“Certainly, there is some natural evolution,” said Dr. Fang, a hospitalist, researcher, and anticoagulation clinic director at the University of California San Francisco. “But not all specialty societies embrace research or encourage its growth, so I would give a lot of credit to the Society of Hospital Medicine for being very deliberate in trying to strengthen its research program, highlight the research that hospitalists do, and make research a core pillar of what SHM stands for.”
The efforts have clearly worked, as RIV is a major driver for annual meeting attendance. The poster competition draws massive crowds that snake their way through the accepted posters.
For those interested in a deeper dive, SHM chooses a dozen or so top abstracts for oral presentations that are, in Dr. Fang’s words, “the creme de la creme of all the research and innovations for the given year.”
The growth of the abstracts competition comes, of course, as the specialty itself has seen its ranks skyrocket. Hospitalists now number an estimated 52,000 nationally, and in addition to providing direct clinical care, have taken ownership of key health care drivers like patient safety, quality improvement, and systems change.
“We do what we do for the good of health care and, ultimately, for the good of our patients,” Dr. Fang said. “Sometimes that’s rounding and taking care of patients in a clinical fashion, and sometimes it’s contributing to the medical literature. It could have been really easy for a specialty to say, ‘Not our problem,’ or ‘No, we’re just rounding.’ ”
HM17 course director Lenny Feldman, MD, FACP, FAAP, SFHM, believes that the commitment of SHM’s founding generation to do research for the past decade has created a group of mentors that push younger hospitalists to do more of the same.
“If we didn’t have the research engine part of hospital medicine, if we didn’t have the folks who are getting into administration and other important leadership areas, we wouldn’t see the maturation of this specialty and we would, in many ways, be stuck at the point at which we started,” Dr. Feldman said. “The only way for us to move forward is to do the research, to be in position to make sure that hospital medicine continues to grow in a direction that is good for our patients, for us, and for the entire system.”
That perspective is what motivates hospitalists to make the RIV bigger each year, said Dr. Fang.
“Having your abstract accepted as a poster or an oral presentation showcases all the work that you’ve put into it,” Dr. Fang said. “There’s a huge amount of pride in showing what you’ve been able to achieve. The driving force is the desire to see what other people are doing, and network to share ideas. That’s the really wonderful part of the RIV competition.”
Look back at the history of SHM’s annual Research, Innovations and Clinical Vignettes poster competition – better known as the RIV – and it may seem inevitable that it’s grown into one of the main highlights of the conference. The RIV has become so popular that the number of submissions has nearly tripled from 634 in 2010 to 1,712 this year.
“Certainly, there is some natural evolution,” said Dr. Fang, a hospitalist, researcher, and anticoagulation clinic director at the University of California San Francisco. “But not all specialty societies embrace research or encourage its growth, so I would give a lot of credit to the Society of Hospital Medicine for being very deliberate in trying to strengthen its research program, highlight the research that hospitalists do, and make research a core pillar of what SHM stands for.”
The efforts have clearly worked, as RIV is a major driver for annual meeting attendance. The poster competition draws massive crowds that snake their way through the accepted posters.
For those interested in a deeper dive, SHM chooses a dozen or so top abstracts for oral presentations that are, in Dr. Fang’s words, “the creme de la creme of all the research and innovations for the given year.”
The growth of the abstracts competition comes, of course, as the specialty itself has seen its ranks skyrocket. Hospitalists now number an estimated 52,000 nationally, and in addition to providing direct clinical care, have taken ownership of key health care drivers like patient safety, quality improvement, and systems change.
“We do what we do for the good of health care and, ultimately, for the good of our patients,” Dr. Fang said. “Sometimes that’s rounding and taking care of patients in a clinical fashion, and sometimes it’s contributing to the medical literature. It could have been really easy for a specialty to say, ‘Not our problem,’ or ‘No, we’re just rounding.’ ”
HM17 course director Lenny Feldman, MD, FACP, FAAP, SFHM, believes that the commitment of SHM’s founding generation to do research for the past decade has created a group of mentors that push younger hospitalists to do more of the same.
“If we didn’t have the research engine part of hospital medicine, if we didn’t have the folks who are getting into administration and other important leadership areas, we wouldn’t see the maturation of this specialty and we would, in many ways, be stuck at the point at which we started,” Dr. Feldman said. “The only way for us to move forward is to do the research, to be in position to make sure that hospital medicine continues to grow in a direction that is good for our patients, for us, and for the entire system.”
That perspective is what motivates hospitalists to make the RIV bigger each year, said Dr. Fang.
“Having your abstract accepted as a poster or an oral presentation showcases all the work that you’ve put into it,” Dr. Fang said. “There’s a huge amount of pride in showing what you’ve been able to achieve. The driving force is the desire to see what other people are doing, and network to share ideas. That’s the really wonderful part of the RIV competition.”
Look back at the history of SHM’s annual Research, Innovations and Clinical Vignettes poster competition – better known as the RIV – and it may seem inevitable that it’s grown into one of the main highlights of the conference. The RIV has become so popular that the number of submissions has nearly tripled from 634 in 2010 to 1,712 this year.
“Certainly, there is some natural evolution,” said Dr. Fang, a hospitalist, researcher, and anticoagulation clinic director at the University of California San Francisco. “But not all specialty societies embrace research or encourage its growth, so I would give a lot of credit to the Society of Hospital Medicine for being very deliberate in trying to strengthen its research program, highlight the research that hospitalists do, and make research a core pillar of what SHM stands for.”
The efforts have clearly worked, as RIV is a major driver for annual meeting attendance. The poster competition draws massive crowds that snake their way through the accepted posters.
For those interested in a deeper dive, SHM chooses a dozen or so top abstracts for oral presentations that are, in Dr. Fang’s words, “the creme de la creme of all the research and innovations for the given year.”
The growth of the abstracts competition comes, of course, as the specialty itself has seen its ranks skyrocket. Hospitalists now number an estimated 52,000 nationally, and in addition to providing direct clinical care, have taken ownership of key health care drivers like patient safety, quality improvement, and systems change.
“We do what we do for the good of health care and, ultimately, for the good of our patients,” Dr. Fang said. “Sometimes that’s rounding and taking care of patients in a clinical fashion, and sometimes it’s contributing to the medical literature. It could have been really easy for a specialty to say, ‘Not our problem,’ or ‘No, we’re just rounding.’ ”
HM17 course director Lenny Feldman, MD, FACP, FAAP, SFHM, believes that the commitment of SHM’s founding generation to do research for the past decade has created a group of mentors that push younger hospitalists to do more of the same.
“If we didn’t have the research engine part of hospital medicine, if we didn’t have the folks who are getting into administration and other important leadership areas, we wouldn’t see the maturation of this specialty and we would, in many ways, be stuck at the point at which we started,” Dr. Feldman said. “The only way for us to move forward is to do the research, to be in position to make sure that hospital medicine continues to grow in a direction that is good for our patients, for us, and for the entire system.”
That perspective is what motivates hospitalists to make the RIV bigger each year, said Dr. Fang.
“Having your abstract accepted as a poster or an oral presentation showcases all the work that you’ve put into it,” Dr. Fang said. “There’s a huge amount of pride in showing what you’ve been able to achieve. The driving force is the desire to see what other people are doing, and network to share ideas. That’s the really wonderful part of the RIV competition.”
Postmenopausal hot flashes cut by 93% with novel nonhormonal treatment
AT ENDO 2017
ORLANDO –
After 12 weeks of treatment with the oral small molecule, women had a 93% reduction in moderate to severe hot flashes, compared with a 23% reduction for those taking placebo (P less than .0001). The effects of fezolinetant were seen earlier as well, with an 88% reduction in hot flashes at 4 weeks into the trial, compared with a 12% reduction for the placebo group (P less than .001).
The eight-site study enrolled 87 patients in a double-blind, randomized, placebo-controlled trial that assessed hot flash frequency and severity at study weeks 4 and 12. Postmenopausal women had to have frequent, moderate to severe hot flashes to qualify for enrollment, and they had to be otherwise healthy.
To capture data for a secondary endpoint, participants also completed a quality of life questionnaire. Dr. Fraser and his coinvestigators tracked safety and pharmacokinetic data by measuring levels of luteinizing hormone, follicle-stimulating hormone, estradiol, and sex hormone–binding globulin at baseline and 12 weeks, as well.
Evenly divided between study arms, 80 patients completed the trial. Two patients withdrew because of adverse events, one patient violated inclusion criteria, and the others withdrew for a variety of reasons. Mean age was similar between the two groups, at 53.7 years for those on placebo and 53.3 years for the fezolinetant group. Other anthropometric characteristics were similar, as well.
At baseline, patients taking placebo experienced a mean 10.3 moderate to severe hot flashes daily, compared with the fezolinetant group at a mean of 11.5. By study week 4, 14 of the 40 patients in the active arm had zero hot flashes, compared with 2 of 40 in the in the placebo arm, when the intention-to-treat population was examined. Hot flash severity dropped by 70% (P less than .0001).
Quality of life was assessed with the Hot Flash Related Daily Interference Scale (HFRDIS). When the two groups were compared, a significant (P less than .001) reduction in HFRDIS score was seen by week 4 and continued through to week 12 in the group on active treatment. Lower HFRDIS scores mean improved hot flash–related quality of life.
Using the Leeds Sleep Evaluation Questionnaire allowed Dr. Fraser and his colleagues to ask about how long it took patients to get to sleep while they were participating in the study, compared with their normal sleep latency. Patients taking fezolinetant reported getting to sleep significantly more quickly (P less than .01) than the placebo group. They also reported better quality of sleep (P less than .001) and a better awakening experience (P less than .05). However, they did not report feeling better after awakening (P = .08).
Women taking fezolinetant also showed significant improvement, compared with the placebo group, on other quality of life questionnaires, the Greene Climacteric Scale and the Sheehan Disability Scale. By week 8, a significant (P less than .001) improvement was seen on both scales and specifically at week 4 on the Sheehan Disability Scale.
Among the hormone biomarkers that were followed in the study, only plasma luteinizing-hormone levels dropped, compared with patients’ baseline levels. These were reduced 20% 12 hours after one of the two daily 60-mg oral doses, and 50% at 3 hours post dose, a point at which maximum serum fezolinetant concentration would be seen. These were all statistically significant reductions and expected effects of the drug’s mechanism of action.
Further pharmacokinetic analysis, said Dr. Fraser, “supports testing of once-daily dosing for vasomotor symptoms,” given that, when the drug was tested in premenopausal women in phase I clinical trials, there was no difference in peak and trough drug concentration.
The safety profile was good overall, said Dr. Fraser. No patients in the fezolinetant group reported serious treatment-emergent adverse events. “More patients reported treatment-emergent adverse events in the placebo group than in the fezolinetant group,” he said.
The NK3R antagonist is also under investigation for use in the treatment of polycystic ovary syndrome and uterine fibroids.
The study was funded by Ogeda, which employs Dr. Fraser. Another author reported serving as a clinical adviser for Ogeda.
[email protected]
On Twitter @karioakes
AT ENDO 2017
ORLANDO –
After 12 weeks of treatment with the oral small molecule, women had a 93% reduction in moderate to severe hot flashes, compared with a 23% reduction for those taking placebo (P less than .0001). The effects of fezolinetant were seen earlier as well, with an 88% reduction in hot flashes at 4 weeks into the trial, compared with a 12% reduction for the placebo group (P less than .001).
The eight-site study enrolled 87 patients in a double-blind, randomized, placebo-controlled trial that assessed hot flash frequency and severity at study weeks 4 and 12. Postmenopausal women had to have frequent, moderate to severe hot flashes to qualify for enrollment, and they had to be otherwise healthy.
To capture data for a secondary endpoint, participants also completed a quality of life questionnaire. Dr. Fraser and his coinvestigators tracked safety and pharmacokinetic data by measuring levels of luteinizing hormone, follicle-stimulating hormone, estradiol, and sex hormone–binding globulin at baseline and 12 weeks, as well.
Evenly divided between study arms, 80 patients completed the trial. Two patients withdrew because of adverse events, one patient violated inclusion criteria, and the others withdrew for a variety of reasons. Mean age was similar between the two groups, at 53.7 years for those on placebo and 53.3 years for the fezolinetant group. Other anthropometric characteristics were similar, as well.
At baseline, patients taking placebo experienced a mean 10.3 moderate to severe hot flashes daily, compared with the fezolinetant group at a mean of 11.5. By study week 4, 14 of the 40 patients in the active arm had zero hot flashes, compared with 2 of 40 in the in the placebo arm, when the intention-to-treat population was examined. Hot flash severity dropped by 70% (P less than .0001).
Quality of life was assessed with the Hot Flash Related Daily Interference Scale (HFRDIS). When the two groups were compared, a significant (P less than .001) reduction in HFRDIS score was seen by week 4 and continued through to week 12 in the group on active treatment. Lower HFRDIS scores mean improved hot flash–related quality of life.
Using the Leeds Sleep Evaluation Questionnaire allowed Dr. Fraser and his colleagues to ask about how long it took patients to get to sleep while they were participating in the study, compared with their normal sleep latency. Patients taking fezolinetant reported getting to sleep significantly more quickly (P less than .01) than the placebo group. They also reported better quality of sleep (P less than .001) and a better awakening experience (P less than .05). However, they did not report feeling better after awakening (P = .08).
Women taking fezolinetant also showed significant improvement, compared with the placebo group, on other quality of life questionnaires, the Greene Climacteric Scale and the Sheehan Disability Scale. By week 8, a significant (P less than .001) improvement was seen on both scales and specifically at week 4 on the Sheehan Disability Scale.
Among the hormone biomarkers that were followed in the study, only plasma luteinizing-hormone levels dropped, compared with patients’ baseline levels. These were reduced 20% 12 hours after one of the two daily 60-mg oral doses, and 50% at 3 hours post dose, a point at which maximum serum fezolinetant concentration would be seen. These were all statistically significant reductions and expected effects of the drug’s mechanism of action.
Further pharmacokinetic analysis, said Dr. Fraser, “supports testing of once-daily dosing for vasomotor symptoms,” given that, when the drug was tested in premenopausal women in phase I clinical trials, there was no difference in peak and trough drug concentration.
The safety profile was good overall, said Dr. Fraser. No patients in the fezolinetant group reported serious treatment-emergent adverse events. “More patients reported treatment-emergent adverse events in the placebo group than in the fezolinetant group,” he said.
The NK3R antagonist is also under investigation for use in the treatment of polycystic ovary syndrome and uterine fibroids.
The study was funded by Ogeda, which employs Dr. Fraser. Another author reported serving as a clinical adviser for Ogeda.
[email protected]
On Twitter @karioakes
AT ENDO 2017
ORLANDO –
After 12 weeks of treatment with the oral small molecule, women had a 93% reduction in moderate to severe hot flashes, compared with a 23% reduction for those taking placebo (P less than .0001). The effects of fezolinetant were seen earlier as well, with an 88% reduction in hot flashes at 4 weeks into the trial, compared with a 12% reduction for the placebo group (P less than .001).
The eight-site study enrolled 87 patients in a double-blind, randomized, placebo-controlled trial that assessed hot flash frequency and severity at study weeks 4 and 12. Postmenopausal women had to have frequent, moderate to severe hot flashes to qualify for enrollment, and they had to be otherwise healthy.
To capture data for a secondary endpoint, participants also completed a quality of life questionnaire. Dr. Fraser and his coinvestigators tracked safety and pharmacokinetic data by measuring levels of luteinizing hormone, follicle-stimulating hormone, estradiol, and sex hormone–binding globulin at baseline and 12 weeks, as well.
Evenly divided between study arms, 80 patients completed the trial. Two patients withdrew because of adverse events, one patient violated inclusion criteria, and the others withdrew for a variety of reasons. Mean age was similar between the two groups, at 53.7 years for those on placebo and 53.3 years for the fezolinetant group. Other anthropometric characteristics were similar, as well.
At baseline, patients taking placebo experienced a mean 10.3 moderate to severe hot flashes daily, compared with the fezolinetant group at a mean of 11.5. By study week 4, 14 of the 40 patients in the active arm had zero hot flashes, compared with 2 of 40 in the in the placebo arm, when the intention-to-treat population was examined. Hot flash severity dropped by 70% (P less than .0001).
Quality of life was assessed with the Hot Flash Related Daily Interference Scale (HFRDIS). When the two groups were compared, a significant (P less than .001) reduction in HFRDIS score was seen by week 4 and continued through to week 12 in the group on active treatment. Lower HFRDIS scores mean improved hot flash–related quality of life.
Using the Leeds Sleep Evaluation Questionnaire allowed Dr. Fraser and his colleagues to ask about how long it took patients to get to sleep while they were participating in the study, compared with their normal sleep latency. Patients taking fezolinetant reported getting to sleep significantly more quickly (P less than .01) than the placebo group. They also reported better quality of sleep (P less than .001) and a better awakening experience (P less than .05). However, they did not report feeling better after awakening (P = .08).
Women taking fezolinetant also showed significant improvement, compared with the placebo group, on other quality of life questionnaires, the Greene Climacteric Scale and the Sheehan Disability Scale. By week 8, a significant (P less than .001) improvement was seen on both scales and specifically at week 4 on the Sheehan Disability Scale.
Among the hormone biomarkers that were followed in the study, only plasma luteinizing-hormone levels dropped, compared with patients’ baseline levels. These were reduced 20% 12 hours after one of the two daily 60-mg oral doses, and 50% at 3 hours post dose, a point at which maximum serum fezolinetant concentration would be seen. These were all statistically significant reductions and expected effects of the drug’s mechanism of action.
Further pharmacokinetic analysis, said Dr. Fraser, “supports testing of once-daily dosing for vasomotor symptoms,” given that, when the drug was tested in premenopausal women in phase I clinical trials, there was no difference in peak and trough drug concentration.
The safety profile was good overall, said Dr. Fraser. No patients in the fezolinetant group reported serious treatment-emergent adverse events. “More patients reported treatment-emergent adverse events in the placebo group than in the fezolinetant group,” he said.
The NK3R antagonist is also under investigation for use in the treatment of polycystic ovary syndrome and uterine fibroids.
The study was funded by Ogeda, which employs Dr. Fraser. Another author reported serving as a clinical adviser for Ogeda.
[email protected]
On Twitter @karioakes
Key clinical point:
Major finding: Women on fezolinetant had a 93% drop in hot flash frequency, compared with a 23% reduction for those on placebo (P less than .0001).
Data source: A phase II randomized, double-blind, placebo-controlled clinical trial of 87 postmenopausal women with moderate to severe hot flashes.
Disclosures: The study was funded by Ogeda, which employs Dr. Fraser. Another author reported serving as a clinical adviser for Ogeda.
Multiple miscarriages in a 29-year-old woman
A) Didelphys uterus INCORRECT
A didelphys uterus occurs as a result of complete nonfusion of the Müllerian duct, resulting in duplicated uterine horns, duplicated cervices, and occasionally the proximal vagina, which is often associated with a transverse or longitudinal vaginal septum.1,2 Fusion anomalies (didelphys and bicornuate) can be differentiated from resorption anomalies (septate and arcuate) on ultrasonography (US) by a deep fundal cleft (>1 cm).1 3D US is highly accurate in identifying Müllerian duct anomalies (MDAs), it correlates well with magnetic resonance imaging (MRI), and it is more cost effective and accessible.3 For the didelphys uterus, 3D US obtained coronal to the uterine fundus often demonstrates widely divergent uterine horns separated by a deep serosal fundal cleft (>1 cm) and noncommunicating endometrial cavities with 2 cervices.1 Identifying a duplicated vaginal canal can help differentiate a didelphys uterus from a bicornuate bicollis uterus.1
B) Unicornuate uterus INCORRECT
A unicornuate uterus results from arrested development of one Müllerian duct and normal development of the other. There are 4 different subtypes: no rudimentary horn, rudimentary horn without endometrial cavity, rudimentary horn with communicating endometrial cavity, and rudimentary horn with noncommunicating uterine cavity.1 Renal anomalies, especially renal agenesis when present, are usually ipsilateral to the rudimentary horn.1 On US, unicornuate uterus appears as a lobular oblong (banana-shaped) structure away from the midline. The rudimentary horn is often difficult to identify and, when seen, the presence or absence of endometrium is an important finding.1
C) Partial septate uterus CORRECT
A septate uterus is a result of a resorption anomaly. The septum may be partial (subseptate) or complete secondary to failure of resorption of the uterovaginal septum. A complete septum extends to the external cervical os and occasionally to the vagina.1 US demonstrates interruption of the myometrium by a hypoechoic fibrous septum and/or a muscular septum which is isoechoic to the myometrium and arises midline from the fundus.1 3D US often clearly delineates the septum and improves visualization of the external fundal contour.2 The external fundal contour in septate uterus is convex (little or no serosal fundal cleft) and the apex is greater than 5 mm above the interostial line compared with a bicornuate or didelphys uterus, where the apex is less than 5 mm from the interostial line.1,2 Additionally, the intercornual distance is less than 4 cm.4 A septate uterus with duplicated cervix can appear similar to a bicornuate bicollis uterus and can be correctly diagnosed by evaluating the external fundal contour.1
D) Arcuate uterus INCORRECT
The arcuate uterus also represents a resorption anomaly as a sequela of near-complete resorption of the uterovaginal septum.1 On 3D US, the fundal indentation in an arcuate uterus is well delineated and appears broad based with an obtuse angle at the most central point, which can help differentiate it from a septate uterus that has an acute angle.2,3 Both an arcuate and a septate uterus have a normal external (serosal) fundal contour.2,3 With an arcuate uterus, the length of the vertical measurement from the tubal ostia line, which is drawn horizontally between the tubal ostia to the fundal midline component of the endometrial cavity, is 1 cm or less. With a septate uterus, this vertical distance is greater than 1 cm.
- CambriaBehr SC, Courtier JL, Qayyum A. Imaging of MMS PGothicüCambriallerian duct anomalies. RadioGraphics. 2012;32(6):e23.
- Bermejo C, Martinez Ten P, Diaz D, et al. Three-dimensional ultrasound in the diagnosis of MMS PGothicüCambriallerian duct anomaly and concordance with MRI. Ultrasound Obstet Gynecol.Cambria 2010;35(5):593–601.
- Deutch TD, Abuhamed AZ. The role of 3-dimensional ultrasonography and magnetic resonance imaging in the diagnosis of MMS PGothicüCambriallerian duct anomalies. J Ultrasound Med. 2008;27(3):413–423.
- CambriaChandler TM, Machan LS, Cooperberg PL, Harris AC, Chang SD. MMS PGothicüCambriallerian duct anomalies: from diagnosis to intervention.Cambria Br J Radiol. 2009;82(984):1034–1042.
A) Didelphys uterus INCORRECT
A didelphys uterus occurs as a result of complete nonfusion of the Müllerian duct, resulting in duplicated uterine horns, duplicated cervices, and occasionally the proximal vagina, which is often associated with a transverse or longitudinal vaginal septum.1,2 Fusion anomalies (didelphys and bicornuate) can be differentiated from resorption anomalies (septate and arcuate) on ultrasonography (US) by a deep fundal cleft (>1 cm).1 3D US is highly accurate in identifying Müllerian duct anomalies (MDAs), it correlates well with magnetic resonance imaging (MRI), and it is more cost effective and accessible.3 For the didelphys uterus, 3D US obtained coronal to the uterine fundus often demonstrates widely divergent uterine horns separated by a deep serosal fundal cleft (>1 cm) and noncommunicating endometrial cavities with 2 cervices.1 Identifying a duplicated vaginal canal can help differentiate a didelphys uterus from a bicornuate bicollis uterus.1
B) Unicornuate uterus INCORRECT
A unicornuate uterus results from arrested development of one Müllerian duct and normal development of the other. There are 4 different subtypes: no rudimentary horn, rudimentary horn without endometrial cavity, rudimentary horn with communicating endometrial cavity, and rudimentary horn with noncommunicating uterine cavity.1 Renal anomalies, especially renal agenesis when present, are usually ipsilateral to the rudimentary horn.1 On US, unicornuate uterus appears as a lobular oblong (banana-shaped) structure away from the midline. The rudimentary horn is often difficult to identify and, when seen, the presence or absence of endometrium is an important finding.1
C) Partial septate uterus CORRECT
A septate uterus is a result of a resorption anomaly. The septum may be partial (subseptate) or complete secondary to failure of resorption of the uterovaginal septum. A complete septum extends to the external cervical os and occasionally to the vagina.1 US demonstrates interruption of the myometrium by a hypoechoic fibrous septum and/or a muscular septum which is isoechoic to the myometrium and arises midline from the fundus.1 3D US often clearly delineates the septum and improves visualization of the external fundal contour.2 The external fundal contour in septate uterus is convex (little or no serosal fundal cleft) and the apex is greater than 5 mm above the interostial line compared with a bicornuate or didelphys uterus, where the apex is less than 5 mm from the interostial line.1,2 Additionally, the intercornual distance is less than 4 cm.4 A septate uterus with duplicated cervix can appear similar to a bicornuate bicollis uterus and can be correctly diagnosed by evaluating the external fundal contour.1
D) Arcuate uterus INCORRECT
The arcuate uterus also represents a resorption anomaly as a sequela of near-complete resorption of the uterovaginal septum.1 On 3D US, the fundal indentation in an arcuate uterus is well delineated and appears broad based with an obtuse angle at the most central point, which can help differentiate it from a septate uterus that has an acute angle.2,3 Both an arcuate and a septate uterus have a normal external (serosal) fundal contour.2,3 With an arcuate uterus, the length of the vertical measurement from the tubal ostia line, which is drawn horizontally between the tubal ostia to the fundal midline component of the endometrial cavity, is 1 cm or less. With a septate uterus, this vertical distance is greater than 1 cm.
A) Didelphys uterus INCORRECT
A didelphys uterus occurs as a result of complete nonfusion of the Müllerian duct, resulting in duplicated uterine horns, duplicated cervices, and occasionally the proximal vagina, which is often associated with a transverse or longitudinal vaginal septum.1,2 Fusion anomalies (didelphys and bicornuate) can be differentiated from resorption anomalies (septate and arcuate) on ultrasonography (US) by a deep fundal cleft (>1 cm).1 3D US is highly accurate in identifying Müllerian duct anomalies (MDAs), it correlates well with magnetic resonance imaging (MRI), and it is more cost effective and accessible.3 For the didelphys uterus, 3D US obtained coronal to the uterine fundus often demonstrates widely divergent uterine horns separated by a deep serosal fundal cleft (>1 cm) and noncommunicating endometrial cavities with 2 cervices.1 Identifying a duplicated vaginal canal can help differentiate a didelphys uterus from a bicornuate bicollis uterus.1
B) Unicornuate uterus INCORRECT
A unicornuate uterus results from arrested development of one Müllerian duct and normal development of the other. There are 4 different subtypes: no rudimentary horn, rudimentary horn without endometrial cavity, rudimentary horn with communicating endometrial cavity, and rudimentary horn with noncommunicating uterine cavity.1 Renal anomalies, especially renal agenesis when present, are usually ipsilateral to the rudimentary horn.1 On US, unicornuate uterus appears as a lobular oblong (banana-shaped) structure away from the midline. The rudimentary horn is often difficult to identify and, when seen, the presence or absence of endometrium is an important finding.1
C) Partial septate uterus CORRECT
A septate uterus is a result of a resorption anomaly. The septum may be partial (subseptate) or complete secondary to failure of resorption of the uterovaginal septum. A complete septum extends to the external cervical os and occasionally to the vagina.1 US demonstrates interruption of the myometrium by a hypoechoic fibrous septum and/or a muscular septum which is isoechoic to the myometrium and arises midline from the fundus.1 3D US often clearly delineates the septum and improves visualization of the external fundal contour.2 The external fundal contour in septate uterus is convex (little or no serosal fundal cleft) and the apex is greater than 5 mm above the interostial line compared with a bicornuate or didelphys uterus, where the apex is less than 5 mm from the interostial line.1,2 Additionally, the intercornual distance is less than 4 cm.4 A septate uterus with duplicated cervix can appear similar to a bicornuate bicollis uterus and can be correctly diagnosed by evaluating the external fundal contour.1
D) Arcuate uterus INCORRECT
The arcuate uterus also represents a resorption anomaly as a sequela of near-complete resorption of the uterovaginal septum.1 On 3D US, the fundal indentation in an arcuate uterus is well delineated and appears broad based with an obtuse angle at the most central point, which can help differentiate it from a septate uterus that has an acute angle.2,3 Both an arcuate and a septate uterus have a normal external (serosal) fundal contour.2,3 With an arcuate uterus, the length of the vertical measurement from the tubal ostia line, which is drawn horizontally between the tubal ostia to the fundal midline component of the endometrial cavity, is 1 cm or less. With a septate uterus, this vertical distance is greater than 1 cm.
- CambriaBehr SC, Courtier JL, Qayyum A. Imaging of MMS PGothicüCambriallerian duct anomalies. RadioGraphics. 2012;32(6):e23.
- Bermejo C, Martinez Ten P, Diaz D, et al. Three-dimensional ultrasound in the diagnosis of MMS PGothicüCambriallerian duct anomaly and concordance with MRI. Ultrasound Obstet Gynecol.Cambria 2010;35(5):593–601.
- Deutch TD, Abuhamed AZ. The role of 3-dimensional ultrasonography and magnetic resonance imaging in the diagnosis of MMS PGothicüCambriallerian duct anomalies. J Ultrasound Med. 2008;27(3):413–423.
- CambriaChandler TM, Machan LS, Cooperberg PL, Harris AC, Chang SD. MMS PGothicüCambriallerian duct anomalies: from diagnosis to intervention.Cambria Br J Radiol. 2009;82(984):1034–1042.
- CambriaBehr SC, Courtier JL, Qayyum A. Imaging of MMS PGothicüCambriallerian duct anomalies. RadioGraphics. 2012;32(6):e23.
- Bermejo C, Martinez Ten P, Diaz D, et al. Three-dimensional ultrasound in the diagnosis of MMS PGothicüCambriallerian duct anomaly and concordance with MRI. Ultrasound Obstet Gynecol.Cambria 2010;35(5):593–601.
- Deutch TD, Abuhamed AZ. The role of 3-dimensional ultrasonography and magnetic resonance imaging in the diagnosis of MMS PGothicüCambriallerian duct anomalies. J Ultrasound Med. 2008;27(3):413–423.
- CambriaChandler TM, Machan LS, Cooperberg PL, Harris AC, Chang SD. MMS PGothicüCambriallerian duct anomalies: from diagnosis to intervention.Cambria Br J Radiol. 2009;82(984):1034–1042.
A 29-year-old woman presents to her ObGyn’s office with a history of multiple miscarriages. Transverse pelvic 2D ultrasonography of the uterus (A) and coronal 3D imaging (B) are performed.
GOP health reform: Essential health benefits, community rating under fire
Republicans are targeting two key consumer protections in their latest attempt to gain enough votes to pass the American Health Care Act, phase 1 of their Affordable Care Act repeal and replace plan.
On the chopping block are the essential health care benefits package and so-called community rating provisions – which prevent insurers from charging significantly more for older patients and those with preexisting conditions.
“Obamacare is already in a race to the bottom in terms of quality coverage for the sick and that’s because of the law’s community rating provisions, which penalize high-quality coverage for the sick,” Michael F. Cannon, director of health policy studies at the Cato Institute, said in an interview. “The [AHCA] would arguably accelerate that race to the bottom. The waiver provision in this amendment definitely would and it would because the bill would allow states to waive the community rating provisions, but only for people who were not previously insured.”
The waiver provisions would “increase premiums for the previously uninsured and discourage them from enrolling,” Mr. Cannon predicted.
David Anderson, research associate at the Margolis Center for Health Policy at Duke University, Durham, N.C., said that, if a state elects to take a waiver, so-called high-cost patients “such as individuals with cancer, individuals with cystic fibrosis, individuals with coagulation disorders, [would be] shrugged to the side into a high-cost risk pool or some kind of risk sharing ... with their own premium pool.” This could lower premium costs for healthy patients, he added.
This could be enhanced by narrowing the essential health benefits. For example, Mr. Anderson said that a state could keep the drug benefit, but apply for a waiver to narrow its coverage for all generics plus a limited list of brand names.
“Someone with cystic fibrosis with a $300,000-a-year medication will not have that covered and will be put in the high-cost risk pool,” Mr. Anderson said. “What it does is that it makes insurance cheaper for individuals who are highly unlikely to be high cost, and it makes it much more expensive for any individuals with known high-cost conditions.”
The draft amendment also would make it easier a whole lot easier to get such waivers approved: If enacted, the legislation would give default approval of such waivers and allow just 60 days for the Department of Health & Human Services to deny waiver request.
States would be able to apply for a waiver from the essential health benefits requirements for the 2020 plan year and a waiver to charge higher premiums to certain individuals for the 2019 plan year.
Waivers to change the essential health benefits package would need to meet one or more of the following conditions:
- Reduce average premiums.
- Increase enrollment.
- Stabilize the health insurance market.
- Stabilize premiums for individuals with preexisting conditions.
- Increase consumer choice.
For a state to change community rating provisions, its waiver also would need to create a mechanism, such as high-risk pools, to help those patients. Funding for these pools is provided for in the AHCA, but has been criticized as being inadequate on a national level.
Mr. Cannon of the Cato Institute predicted that such waivers ultimately would lead to more adverse selections for people needing comprehensive coverage and could force more people to lose coverage than to gain access to affordable, high-quality plans.
“If you waive essential health benefits in a community-rated market, you get even more adverse selection against comprehensive plans that sick people want, so those plans disappear,” Mr. Cannon said. “They either disappear because the insurers stop offering them or they disappear because insurers try to make the coverage worse, because Obamacare penalizes them if they don’t make coverage worse.”
He said these waivers provide little incentive for health insurers to stay in the individual markets and they could, as they are already, flee the individual markets.
The AHCA is phase 1 of the GOP repeal and replace plan. Congressional Republicans want to use the budget reconciliation process for the AHCA, so that they need only a simple majority to change revenue-generating provisions of the ACA. Phase 2 is a comprehensive review of all federal health care regulations and phase 3 is slated to be new legislation to replace the ACA with a new health care reform plan, which will require a two-thirds majority in the Senate to pass.
Republicans are targeting two key consumer protections in their latest attempt to gain enough votes to pass the American Health Care Act, phase 1 of their Affordable Care Act repeal and replace plan.
On the chopping block are the essential health care benefits package and so-called community rating provisions – which prevent insurers from charging significantly more for older patients and those with preexisting conditions.
“Obamacare is already in a race to the bottom in terms of quality coverage for the sick and that’s because of the law’s community rating provisions, which penalize high-quality coverage for the sick,” Michael F. Cannon, director of health policy studies at the Cato Institute, said in an interview. “The [AHCA] would arguably accelerate that race to the bottom. The waiver provision in this amendment definitely would and it would because the bill would allow states to waive the community rating provisions, but only for people who were not previously insured.”
The waiver provisions would “increase premiums for the previously uninsured and discourage them from enrolling,” Mr. Cannon predicted.
David Anderson, research associate at the Margolis Center for Health Policy at Duke University, Durham, N.C., said that, if a state elects to take a waiver, so-called high-cost patients “such as individuals with cancer, individuals with cystic fibrosis, individuals with coagulation disorders, [would be] shrugged to the side into a high-cost risk pool or some kind of risk sharing ... with their own premium pool.” This could lower premium costs for healthy patients, he added.
This could be enhanced by narrowing the essential health benefits. For example, Mr. Anderson said that a state could keep the drug benefit, but apply for a waiver to narrow its coverage for all generics plus a limited list of brand names.
“Someone with cystic fibrosis with a $300,000-a-year medication will not have that covered and will be put in the high-cost risk pool,” Mr. Anderson said. “What it does is that it makes insurance cheaper for individuals who are highly unlikely to be high cost, and it makes it much more expensive for any individuals with known high-cost conditions.”
The draft amendment also would make it easier a whole lot easier to get such waivers approved: If enacted, the legislation would give default approval of such waivers and allow just 60 days for the Department of Health & Human Services to deny waiver request.
States would be able to apply for a waiver from the essential health benefits requirements for the 2020 plan year and a waiver to charge higher premiums to certain individuals for the 2019 plan year.
Waivers to change the essential health benefits package would need to meet one or more of the following conditions:
- Reduce average premiums.
- Increase enrollment.
- Stabilize the health insurance market.
- Stabilize premiums for individuals with preexisting conditions.
- Increase consumer choice.
For a state to change community rating provisions, its waiver also would need to create a mechanism, such as high-risk pools, to help those patients. Funding for these pools is provided for in the AHCA, but has been criticized as being inadequate on a national level.
Mr. Cannon of the Cato Institute predicted that such waivers ultimately would lead to more adverse selections for people needing comprehensive coverage and could force more people to lose coverage than to gain access to affordable, high-quality plans.
“If you waive essential health benefits in a community-rated market, you get even more adverse selection against comprehensive plans that sick people want, so those plans disappear,” Mr. Cannon said. “They either disappear because the insurers stop offering them or they disappear because insurers try to make the coverage worse, because Obamacare penalizes them if they don’t make coverage worse.”
He said these waivers provide little incentive for health insurers to stay in the individual markets and they could, as they are already, flee the individual markets.
The AHCA is phase 1 of the GOP repeal and replace plan. Congressional Republicans want to use the budget reconciliation process for the AHCA, so that they need only a simple majority to change revenue-generating provisions of the ACA. Phase 2 is a comprehensive review of all federal health care regulations and phase 3 is slated to be new legislation to replace the ACA with a new health care reform plan, which will require a two-thirds majority in the Senate to pass.
Republicans are targeting two key consumer protections in their latest attempt to gain enough votes to pass the American Health Care Act, phase 1 of their Affordable Care Act repeal and replace plan.
On the chopping block are the essential health care benefits package and so-called community rating provisions – which prevent insurers from charging significantly more for older patients and those with preexisting conditions.
“Obamacare is already in a race to the bottom in terms of quality coverage for the sick and that’s because of the law’s community rating provisions, which penalize high-quality coverage for the sick,” Michael F. Cannon, director of health policy studies at the Cato Institute, said in an interview. “The [AHCA] would arguably accelerate that race to the bottom. The waiver provision in this amendment definitely would and it would because the bill would allow states to waive the community rating provisions, but only for people who were not previously insured.”
The waiver provisions would “increase premiums for the previously uninsured and discourage them from enrolling,” Mr. Cannon predicted.
David Anderson, research associate at the Margolis Center for Health Policy at Duke University, Durham, N.C., said that, if a state elects to take a waiver, so-called high-cost patients “such as individuals with cancer, individuals with cystic fibrosis, individuals with coagulation disorders, [would be] shrugged to the side into a high-cost risk pool or some kind of risk sharing ... with their own premium pool.” This could lower premium costs for healthy patients, he added.
This could be enhanced by narrowing the essential health benefits. For example, Mr. Anderson said that a state could keep the drug benefit, but apply for a waiver to narrow its coverage for all generics plus a limited list of brand names.
“Someone with cystic fibrosis with a $300,000-a-year medication will not have that covered and will be put in the high-cost risk pool,” Mr. Anderson said. “What it does is that it makes insurance cheaper for individuals who are highly unlikely to be high cost, and it makes it much more expensive for any individuals with known high-cost conditions.”
The draft amendment also would make it easier a whole lot easier to get such waivers approved: If enacted, the legislation would give default approval of such waivers and allow just 60 days for the Department of Health & Human Services to deny waiver request.
States would be able to apply for a waiver from the essential health benefits requirements for the 2020 plan year and a waiver to charge higher premiums to certain individuals for the 2019 plan year.
Waivers to change the essential health benefits package would need to meet one or more of the following conditions:
- Reduce average premiums.
- Increase enrollment.
- Stabilize the health insurance market.
- Stabilize premiums for individuals with preexisting conditions.
- Increase consumer choice.
For a state to change community rating provisions, its waiver also would need to create a mechanism, such as high-risk pools, to help those patients. Funding for these pools is provided for in the AHCA, but has been criticized as being inadequate on a national level.
Mr. Cannon of the Cato Institute predicted that such waivers ultimately would lead to more adverse selections for people needing comprehensive coverage and could force more people to lose coverage than to gain access to affordable, high-quality plans.
“If you waive essential health benefits in a community-rated market, you get even more adverse selection against comprehensive plans that sick people want, so those plans disappear,” Mr. Cannon said. “They either disappear because the insurers stop offering them or they disappear because insurers try to make the coverage worse, because Obamacare penalizes them if they don’t make coverage worse.”
He said these waivers provide little incentive for health insurers to stay in the individual markets and they could, as they are already, flee the individual markets.
The AHCA is phase 1 of the GOP repeal and replace plan. Congressional Republicans want to use the budget reconciliation process for the AHCA, so that they need only a simple majority to change revenue-generating provisions of the ACA. Phase 2 is a comprehensive review of all federal health care regulations and phase 3 is slated to be new legislation to replace the ACA with a new health care reform plan, which will require a two-thirds majority in the Senate to pass.
VIDEO: Cannabidiol reduces convulsive seizures in Dravet syndrome
BOSTON – Adjunctive treatment with cannabidiol significantly reduced convulsive seizure frequency in Dravet syndrome patients in a randomized, double-blind, placebo-controlled trial.
Over a 14-week treatment period, including 2 weeks of titration and 12 weeks of maintenance, convulsive seizure frequency in 61 treated children and adolescents decreased from a median of 12.4 to 5.9 per month (median reduction of 39%), compared with a decrease from a median of 14.9 to 14.1 per month (median reduction of 13%) in 59 patients who received placebo, J. Helen Cross, MD, reported at the annual meeting of the American Academy of Neurology.
The proportion of patients with at least a 50% reduction in convulsive seizures was 42.6% with cannabidiol vs. 27.1% with placebo (odds ratio, 2.0), but this difference did not reach statistical significance, said Dr. Cross of the University College London Great Ormond Street Institute of Child Health and the Great Ormond Street Hospital for Children NHS Trust, London.
In a video interview, Dr. Cross discussed the findings and the importance of improving seizure control in patients with Dravet syndrome, a rare infantile-onset developmental and epileptic encephalopathy with very poor prognosis for long-term seizure control and neurodevelopmental outcomes.
Participants in the study (GWPCARE1) had a mean age of 10 years, but nearly a third were younger than 6 years. All had Dravet syndrome and drug-resistant seizures; the median number of antiepilepsy drugs previously tried was four, and the median number being used was three. Those randomized to the treatment group received cannabidiol oral solution up to 20 mg/kg per day.
Adverse events were common, occurring in 93.4% and 74.6% of treatment group and placebo group patients, respectively. But adverse events reported in the treatment group were mild or moderate in 84% of patients, and treatment was generally well tolerated.
“These are very complex patients with a high seizure burden... and therefore, to have another medication that looks as if it can be of benefit is really very exciting for this population,” Dr. Cross said, noting that cannabidiol was also shown in other studies presented at the AAN meeting (GWPCARE3 and GWPCARE4) to reduce seizure frequency in patients with Lennox-Gastaut syndrome.
GW Research sponsored the study. Dr. Cross is a member of the advisory boards for Eisai, GW Pharmaceuticals, Shire, and Zogenix.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
BOSTON – Adjunctive treatment with cannabidiol significantly reduced convulsive seizure frequency in Dravet syndrome patients in a randomized, double-blind, placebo-controlled trial.
Over a 14-week treatment period, including 2 weeks of titration and 12 weeks of maintenance, convulsive seizure frequency in 61 treated children and adolescents decreased from a median of 12.4 to 5.9 per month (median reduction of 39%), compared with a decrease from a median of 14.9 to 14.1 per month (median reduction of 13%) in 59 patients who received placebo, J. Helen Cross, MD, reported at the annual meeting of the American Academy of Neurology.
The proportion of patients with at least a 50% reduction in convulsive seizures was 42.6% with cannabidiol vs. 27.1% with placebo (odds ratio, 2.0), but this difference did not reach statistical significance, said Dr. Cross of the University College London Great Ormond Street Institute of Child Health and the Great Ormond Street Hospital for Children NHS Trust, London.
In a video interview, Dr. Cross discussed the findings and the importance of improving seizure control in patients with Dravet syndrome, a rare infantile-onset developmental and epileptic encephalopathy with very poor prognosis for long-term seizure control and neurodevelopmental outcomes.
Participants in the study (GWPCARE1) had a mean age of 10 years, but nearly a third were younger than 6 years. All had Dravet syndrome and drug-resistant seizures; the median number of antiepilepsy drugs previously tried was four, and the median number being used was three. Those randomized to the treatment group received cannabidiol oral solution up to 20 mg/kg per day.
Adverse events were common, occurring in 93.4% and 74.6% of treatment group and placebo group patients, respectively. But adverse events reported in the treatment group were mild or moderate in 84% of patients, and treatment was generally well tolerated.
“These are very complex patients with a high seizure burden... and therefore, to have another medication that looks as if it can be of benefit is really very exciting for this population,” Dr. Cross said, noting that cannabidiol was also shown in other studies presented at the AAN meeting (GWPCARE3 and GWPCARE4) to reduce seizure frequency in patients with Lennox-Gastaut syndrome.
GW Research sponsored the study. Dr. Cross is a member of the advisory boards for Eisai, GW Pharmaceuticals, Shire, and Zogenix.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
BOSTON – Adjunctive treatment with cannabidiol significantly reduced convulsive seizure frequency in Dravet syndrome patients in a randomized, double-blind, placebo-controlled trial.
Over a 14-week treatment period, including 2 weeks of titration and 12 weeks of maintenance, convulsive seizure frequency in 61 treated children and adolescents decreased from a median of 12.4 to 5.9 per month (median reduction of 39%), compared with a decrease from a median of 14.9 to 14.1 per month (median reduction of 13%) in 59 patients who received placebo, J. Helen Cross, MD, reported at the annual meeting of the American Academy of Neurology.
The proportion of patients with at least a 50% reduction in convulsive seizures was 42.6% with cannabidiol vs. 27.1% with placebo (odds ratio, 2.0), but this difference did not reach statistical significance, said Dr. Cross of the University College London Great Ormond Street Institute of Child Health and the Great Ormond Street Hospital for Children NHS Trust, London.
In a video interview, Dr. Cross discussed the findings and the importance of improving seizure control in patients with Dravet syndrome, a rare infantile-onset developmental and epileptic encephalopathy with very poor prognosis for long-term seizure control and neurodevelopmental outcomes.
Participants in the study (GWPCARE1) had a mean age of 10 years, but nearly a third were younger than 6 years. All had Dravet syndrome and drug-resistant seizures; the median number of antiepilepsy drugs previously tried was four, and the median number being used was three. Those randomized to the treatment group received cannabidiol oral solution up to 20 mg/kg per day.
Adverse events were common, occurring in 93.4% and 74.6% of treatment group and placebo group patients, respectively. But adverse events reported in the treatment group were mild or moderate in 84% of patients, and treatment was generally well tolerated.
“These are very complex patients with a high seizure burden... and therefore, to have another medication that looks as if it can be of benefit is really very exciting for this population,” Dr. Cross said, noting that cannabidiol was also shown in other studies presented at the AAN meeting (GWPCARE3 and GWPCARE4) to reduce seizure frequency in patients with Lennox-Gastaut syndrome.
GW Research sponsored the study. Dr. Cross is a member of the advisory boards for Eisai, GW Pharmaceuticals, Shire, and Zogenix.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
At ANN 2017
Key clinical point:
Major finding: Children and adolescents treated with cannabidiol had a decline in convulsive seizure frequency, from a median of 12.4 to 5.9 per month (median reduction of 39%), compared with a decrease from a median of 14.9 to 14.1 per month with placebo (median reduction of 13%).
Data source: A randomized, double-blind, placebo-controlled trial of adjunctive treatment with cannabidiol in 120 children and adolescents with Dravet syndrome.
Disclosures: GW Research sponsored the study. Dr. Cross is a member of the advisory boards for Eisai, GW Pharmaceuticals, Shire, and Zogenix.
Kids with MS face higher risk of mental disorders
BOSTON – Children with multiple sclerosis (MS) and related conditions are as much as 10 times more likely than the general population to need to be hospitalized for various psychiatric conditions, a study showed.
“The true prevalence of morbidity is almost certainly higher than suggested by our data,” said study lead author Julia Pakpoor, BM BCh, who presented data from her research at the annual meeting of the American Academy of Neurology.
While several studies have examined links between MS and mental illness in adults, there’s been little research into the topic in children. The number of children with the disease is far from tiny, however. According to the National MS Society, an estimated 8,000-10,000 children have the condition in the United States.
The researchers tracked future psychiatric visits by these patients and compared them with a reference cohort of more than 1.1 million children.
The risks of mental conditions in children with MS, compared with the reference cohort, were as follows: psychotic disorders (relative risk [RR] = 10.76; 95% confidence interval [CI], 2.93-27.63; P less than .001), mood disorders (RR = 2.57; 95% CI, 1.03-5.31; P = .022), and intellectual disability (RR = 6.08; 95% CI, 1.25-17.80; P = .004).
The children with other CNS demyelinating diseases also had higher risk levels, compared with the reference cohort: psychotic disorders (RR = 5.77; 95% CI, 2.48-11.41; P less than .001), anxiety, stress-related, and somatoform disorders that cause symptoms like pain (RR = 2.38; 95% CI, 1.39-3.81; P less than .001); intellectual disability (RR = 6.56; 95% CI, 3.66-10.84; P less than .001), and other behavioral disorders (RR = 8.99; 95% CI, 5.13-14.62; P less than .001).
The researchers also reported evidence of a reverse trend. Children with several mental conditions had greater risk than did the reference cohort to go on to develop CNS demyelinating diseases, specifically anxiety, stress-related, and somatoform disorders (RR = 3.15; 95% CI, 1.70-5.39; P less than .001), ADHD (RR = 3.88; 95% CI, 1.75-7.48; P less than .001), autism (RR = 3.80; 95% CI, 2.05-6.50; P less than .001), intellectual disability (RR = 6.33; 95% CI, 2.86-12.21; P less than .001), and other behavioral disorders (RR = 8.30; 95% CI, 5.17-12.75; P less than .001).
“We detected strong associations, and further associations likely exist,” Dr. Pakpoor said.
She acknowledged that the research is limited because it includes information only about patients admitted to a hospital. “There may be many more with psychiatric conditions that are mild,” she said. “We’re probably detecting cases that are more severe.”
In an interview, Flavia M. Nelson, MD, interim chief of the multiple sclerosis division at the University of Texas Health Science Center at Houston, said she often sees psychiatric conditions in her pediatric patients.
Conditions such as depression and anxiety disorders are common, she said, and the pediatric patients often suffer from isolation. “There’s a lot of fear about what this will do to their lives,” she said. Some patients have even refused to go to college because they fear that “they’ll have a disabling attack and everyone will know.”
As for the link between psychiatric illness and MS, Dr. Nelson said the disorders may develop because stress, fear, and anxiety push young people to their limits. “I had one patient who developed tics and rage,” she said. “That was his way of coping with the disease.”
Dr. Nelson suggested doing cognitive testing on young patients and referring them to counseling, especially in light of the fact that teens often put up walls when they don’t know how to express their feelings. Simply asking questions may not be enough to draw them out, she said, so professional counseling can be helpful.
No specific funding was reported. Dr. Pakpoor reported no relevant disclosures. Dr. Nelson has received personal compensation for activities with Bayer, Sanofi-Genzyme, Genentech, Novartis, Teva, and the Consortium of Multiple Sclerosis Centers. She has received research support from the National Institutes of Health, the National MS Society, and Novartis.
BOSTON – Children with multiple sclerosis (MS) and related conditions are as much as 10 times more likely than the general population to need to be hospitalized for various psychiatric conditions, a study showed.
“The true prevalence of morbidity is almost certainly higher than suggested by our data,” said study lead author Julia Pakpoor, BM BCh, who presented data from her research at the annual meeting of the American Academy of Neurology.
While several studies have examined links between MS and mental illness in adults, there’s been little research into the topic in children. The number of children with the disease is far from tiny, however. According to the National MS Society, an estimated 8,000-10,000 children have the condition in the United States.
The researchers tracked future psychiatric visits by these patients and compared them with a reference cohort of more than 1.1 million children.
The risks of mental conditions in children with MS, compared with the reference cohort, were as follows: psychotic disorders (relative risk [RR] = 10.76; 95% confidence interval [CI], 2.93-27.63; P less than .001), mood disorders (RR = 2.57; 95% CI, 1.03-5.31; P = .022), and intellectual disability (RR = 6.08; 95% CI, 1.25-17.80; P = .004).
The children with other CNS demyelinating diseases also had higher risk levels, compared with the reference cohort: psychotic disorders (RR = 5.77; 95% CI, 2.48-11.41; P less than .001), anxiety, stress-related, and somatoform disorders that cause symptoms like pain (RR = 2.38; 95% CI, 1.39-3.81; P less than .001); intellectual disability (RR = 6.56; 95% CI, 3.66-10.84; P less than .001), and other behavioral disorders (RR = 8.99; 95% CI, 5.13-14.62; P less than .001).
The researchers also reported evidence of a reverse trend. Children with several mental conditions had greater risk than did the reference cohort to go on to develop CNS demyelinating diseases, specifically anxiety, stress-related, and somatoform disorders (RR = 3.15; 95% CI, 1.70-5.39; P less than .001), ADHD (RR = 3.88; 95% CI, 1.75-7.48; P less than .001), autism (RR = 3.80; 95% CI, 2.05-6.50; P less than .001), intellectual disability (RR = 6.33; 95% CI, 2.86-12.21; P less than .001), and other behavioral disorders (RR = 8.30; 95% CI, 5.17-12.75; P less than .001).
“We detected strong associations, and further associations likely exist,” Dr. Pakpoor said.
She acknowledged that the research is limited because it includes information only about patients admitted to a hospital. “There may be many more with psychiatric conditions that are mild,” she said. “We’re probably detecting cases that are more severe.”
In an interview, Flavia M. Nelson, MD, interim chief of the multiple sclerosis division at the University of Texas Health Science Center at Houston, said she often sees psychiatric conditions in her pediatric patients.
Conditions such as depression and anxiety disorders are common, she said, and the pediatric patients often suffer from isolation. “There’s a lot of fear about what this will do to their lives,” she said. Some patients have even refused to go to college because they fear that “they’ll have a disabling attack and everyone will know.”
As for the link between psychiatric illness and MS, Dr. Nelson said the disorders may develop because stress, fear, and anxiety push young people to their limits. “I had one patient who developed tics and rage,” she said. “That was his way of coping with the disease.”
Dr. Nelson suggested doing cognitive testing on young patients and referring them to counseling, especially in light of the fact that teens often put up walls when they don’t know how to express their feelings. Simply asking questions may not be enough to draw them out, she said, so professional counseling can be helpful.
No specific funding was reported. Dr. Pakpoor reported no relevant disclosures. Dr. Nelson has received personal compensation for activities with Bayer, Sanofi-Genzyme, Genentech, Novartis, Teva, and the Consortium of Multiple Sclerosis Centers. She has received research support from the National Institutes of Health, the National MS Society, and Novartis.
BOSTON – Children with multiple sclerosis (MS) and related conditions are as much as 10 times more likely than the general population to need to be hospitalized for various psychiatric conditions, a study showed.
“The true prevalence of morbidity is almost certainly higher than suggested by our data,” said study lead author Julia Pakpoor, BM BCh, who presented data from her research at the annual meeting of the American Academy of Neurology.
While several studies have examined links between MS and mental illness in adults, there’s been little research into the topic in children. The number of children with the disease is far from tiny, however. According to the National MS Society, an estimated 8,000-10,000 children have the condition in the United States.
The researchers tracked future psychiatric visits by these patients and compared them with a reference cohort of more than 1.1 million children.
The risks of mental conditions in children with MS, compared with the reference cohort, were as follows: psychotic disorders (relative risk [RR] = 10.76; 95% confidence interval [CI], 2.93-27.63; P less than .001), mood disorders (RR = 2.57; 95% CI, 1.03-5.31; P = .022), and intellectual disability (RR = 6.08; 95% CI, 1.25-17.80; P = .004).
The children with other CNS demyelinating diseases also had higher risk levels, compared with the reference cohort: psychotic disorders (RR = 5.77; 95% CI, 2.48-11.41; P less than .001), anxiety, stress-related, and somatoform disorders that cause symptoms like pain (RR = 2.38; 95% CI, 1.39-3.81; P less than .001); intellectual disability (RR = 6.56; 95% CI, 3.66-10.84; P less than .001), and other behavioral disorders (RR = 8.99; 95% CI, 5.13-14.62; P less than .001).
The researchers also reported evidence of a reverse trend. Children with several mental conditions had greater risk than did the reference cohort to go on to develop CNS demyelinating diseases, specifically anxiety, stress-related, and somatoform disorders (RR = 3.15; 95% CI, 1.70-5.39; P less than .001), ADHD (RR = 3.88; 95% CI, 1.75-7.48; P less than .001), autism (RR = 3.80; 95% CI, 2.05-6.50; P less than .001), intellectual disability (RR = 6.33; 95% CI, 2.86-12.21; P less than .001), and other behavioral disorders (RR = 8.30; 95% CI, 5.17-12.75; P less than .001).
“We detected strong associations, and further associations likely exist,” Dr. Pakpoor said.
She acknowledged that the research is limited because it includes information only about patients admitted to a hospital. “There may be many more with psychiatric conditions that are mild,” she said. “We’re probably detecting cases that are more severe.”
In an interview, Flavia M. Nelson, MD, interim chief of the multiple sclerosis division at the University of Texas Health Science Center at Houston, said she often sees psychiatric conditions in her pediatric patients.
Conditions such as depression and anxiety disorders are common, she said, and the pediatric patients often suffer from isolation. “There’s a lot of fear about what this will do to their lives,” she said. Some patients have even refused to go to college because they fear that “they’ll have a disabling attack and everyone will know.”
As for the link between psychiatric illness and MS, Dr. Nelson said the disorders may develop because stress, fear, and anxiety push young people to their limits. “I had one patient who developed tics and rage,” she said. “That was his way of coping with the disease.”
Dr. Nelson suggested doing cognitive testing on young patients and referring them to counseling, especially in light of the fact that teens often put up walls when they don’t know how to express their feelings. Simply asking questions may not be enough to draw them out, she said, so professional counseling can be helpful.
No specific funding was reported. Dr. Pakpoor reported no relevant disclosures. Dr. Nelson has received personal compensation for activities with Bayer, Sanofi-Genzyme, Genentech, Novartis, Teva, and the Consortium of Multiple Sclerosis Centers. She has received research support from the National Institutes of Health, the National MS Society, and Novartis.
Key clinical point: Children with MS and similar conditions are at higher risk of a long list of psychiatric disorders.
Major finding:
Data source: An analysis of children admitted to hospitals in England from 1999 to 2011 with MS (n = 201) and other CNS demyelinating diseases (n = 1,097) plus a reference cohort of more than 1.1 million.
Disclosures: No specific funding or disclosures were reported.
Study reveals crazy quilt of laser laws across the United States
SAN DIEGO – Laser hair removal isn’t typically in an office cleaner’s job description. So it’s no wonder that Virginia legislators were spooked when they heard from a constituent who was treated by a spa worker who turned out to be a janitor.
Earlier this year, legislators in the Old Dominion passed a bill limiting laser hair removal procedures to a “properly trained” medical doctor, physician assistant, or nurse practitioner – or a “properly trained” person who is supervised by one of these professionals. Therefore, it’s still possible for a “properly trained” person without a degree of any kind to operate a laser in Virginia.
To the north in New Jersey, the rules are much stricter: Only physicians can perform laser procedures. But in New York, it appears that anyone can fire up a laser and go to work on unwanted hair. And in Florida, nonphysicians can perform laser procedures only if they’re physician assistants or nurse practitioners. But they’re only allowed to remove hair with lasers at a clinic that just performs laser hair removal.
Such is the chaotic state of laser law in the United States, a new study finds. The rules, which vary widely from state to state, are often vague and confusing. And, as Virginia’s new law shows, they’re still evolving. (The study is current as of March 2016.)
She and study coauthor Mathew M. Avram, MD, JD, director of the Laser and Cosmetic Center at Massachusetts General, analyzed regulations in the 50 states regarding the operation of lasers. They reported their findings at the annual meeting of the American Society for Laser Medicine and Surgery.
Dr. DiGiorgio said that laser operator laws address three issues:
1. Who can operate a laser?
At other clinics across the country, nonphysician employees — such as nurse practitioners and registered nurses – often operate lasers. Whether they can legally actually do so isn’t always obvious.
New Jersey is the only state that requires laser operators to be physicians. At the other extreme, 11 states, including Massachusetts, Colorado, Florida, Missouri, New York, and Pennsylvania, have “no” limits on who can perform laser procedures. (At Massachusetts General Hospital, physicians perform all laser procedures.)
So does that mean anyone can perform a laser procedure? It’s not clear. “The laws are a lot more vague than they should be,” Dr. DiGiorgio said in an interview.
Eighteen states allow people to perform laser procedures as part of the “practice of medicine,” although legislation can be vague on what that means. Those states include Illinois, Michigan, Minnesota, North Carolina, and Texas.
Another 19 states, including California, Ohio, Washington, Wisconsin, and now Virginia, have specific limits on who can perform laser procedures. In California, for example, physician assistants and registered nurses – but not licensed vocational nurses – are allowed to use lasers to remove hair, spider veins, and tattoos. Unlicensed medical assistants, cosmetologists, electrologists, and estheticians are not allowed to perform the procedures
2. Can someone delegate laser procedures to someone else?
In nine states, including Iowa and New Hampshire, there’s no oversight of delegation or nonphysicians can delegate procedures to someone else.
In another nine states, certain procedures can be delegated with no physician oversight, such as laser hair removal in Alaska and ablative procedures (to advanced practice registered nurses only) in Utah.
3. Is supervision required of nonphysicians?
Physicians don’t need to supervise certain laser procedures in 11 states, including Hawaii, Oregon, and Vermont, where they can be performed by a nonphysician with no supervision or under supervision by a non-physician.
In 17 states, supervision isn’t always required or it’s under the discretion of the supervising physician. These states include California, Michigan, Pennsylvania, and Wisconsin.
In 11 states, including Illinois and Massachusetts, only certain procedures require on-site supervision. Six states, including Connecticut and Maryland, require on-site physician supervision for all laser procedures, but Dr. DiGiorgio said the requirements can be vague about what “on site” actually means.
Idaho requires the physician to be on site or immediately available, and South Carolina allows registered nurses to perform laser hair and leg vein removal if a physician is on site and can respond within 5 minutes.
“We don’t know what the ideal regulation is,” Dr. DiGiorgio said. But she believes laser regulations are crucial to safety, especially as fields such as plastic surgery, ophthalmology, and gynecology embrace cosmetic laser procedures.
Information about state-by-state laser operator laws is available on the American Med Spa Association website.
Dr. DiGiorgio reported no relevant disclosures.
SAN DIEGO – Laser hair removal isn’t typically in an office cleaner’s job description. So it’s no wonder that Virginia legislators were spooked when they heard from a constituent who was treated by a spa worker who turned out to be a janitor.
Earlier this year, legislators in the Old Dominion passed a bill limiting laser hair removal procedures to a “properly trained” medical doctor, physician assistant, or nurse practitioner – or a “properly trained” person who is supervised by one of these professionals. Therefore, it’s still possible for a “properly trained” person without a degree of any kind to operate a laser in Virginia.
To the north in New Jersey, the rules are much stricter: Only physicians can perform laser procedures. But in New York, it appears that anyone can fire up a laser and go to work on unwanted hair. And in Florida, nonphysicians can perform laser procedures only if they’re physician assistants or nurse practitioners. But they’re only allowed to remove hair with lasers at a clinic that just performs laser hair removal.
Such is the chaotic state of laser law in the United States, a new study finds. The rules, which vary widely from state to state, are often vague and confusing. And, as Virginia’s new law shows, they’re still evolving. (The study is current as of March 2016.)
She and study coauthor Mathew M. Avram, MD, JD, director of the Laser and Cosmetic Center at Massachusetts General, analyzed regulations in the 50 states regarding the operation of lasers. They reported their findings at the annual meeting of the American Society for Laser Medicine and Surgery.
Dr. DiGiorgio said that laser operator laws address three issues:
1. Who can operate a laser?
At other clinics across the country, nonphysician employees — such as nurse practitioners and registered nurses – often operate lasers. Whether they can legally actually do so isn’t always obvious.
New Jersey is the only state that requires laser operators to be physicians. At the other extreme, 11 states, including Massachusetts, Colorado, Florida, Missouri, New York, and Pennsylvania, have “no” limits on who can perform laser procedures. (At Massachusetts General Hospital, physicians perform all laser procedures.)
So does that mean anyone can perform a laser procedure? It’s not clear. “The laws are a lot more vague than they should be,” Dr. DiGiorgio said in an interview.
Eighteen states allow people to perform laser procedures as part of the “practice of medicine,” although legislation can be vague on what that means. Those states include Illinois, Michigan, Minnesota, North Carolina, and Texas.
Another 19 states, including California, Ohio, Washington, Wisconsin, and now Virginia, have specific limits on who can perform laser procedures. In California, for example, physician assistants and registered nurses – but not licensed vocational nurses – are allowed to use lasers to remove hair, spider veins, and tattoos. Unlicensed medical assistants, cosmetologists, electrologists, and estheticians are not allowed to perform the procedures
2. Can someone delegate laser procedures to someone else?
In nine states, including Iowa and New Hampshire, there’s no oversight of delegation or nonphysicians can delegate procedures to someone else.
In another nine states, certain procedures can be delegated with no physician oversight, such as laser hair removal in Alaska and ablative procedures (to advanced practice registered nurses only) in Utah.
3. Is supervision required of nonphysicians?
Physicians don’t need to supervise certain laser procedures in 11 states, including Hawaii, Oregon, and Vermont, where they can be performed by a nonphysician with no supervision or under supervision by a non-physician.
In 17 states, supervision isn’t always required or it’s under the discretion of the supervising physician. These states include California, Michigan, Pennsylvania, and Wisconsin.
In 11 states, including Illinois and Massachusetts, only certain procedures require on-site supervision. Six states, including Connecticut and Maryland, require on-site physician supervision for all laser procedures, but Dr. DiGiorgio said the requirements can be vague about what “on site” actually means.
Idaho requires the physician to be on site or immediately available, and South Carolina allows registered nurses to perform laser hair and leg vein removal if a physician is on site and can respond within 5 minutes.
“We don’t know what the ideal regulation is,” Dr. DiGiorgio said. But she believes laser regulations are crucial to safety, especially as fields such as plastic surgery, ophthalmology, and gynecology embrace cosmetic laser procedures.
Information about state-by-state laser operator laws is available on the American Med Spa Association website.
Dr. DiGiorgio reported no relevant disclosures.
SAN DIEGO – Laser hair removal isn’t typically in an office cleaner’s job description. So it’s no wonder that Virginia legislators were spooked when they heard from a constituent who was treated by a spa worker who turned out to be a janitor.
Earlier this year, legislators in the Old Dominion passed a bill limiting laser hair removal procedures to a “properly trained” medical doctor, physician assistant, or nurse practitioner – or a “properly trained” person who is supervised by one of these professionals. Therefore, it’s still possible for a “properly trained” person without a degree of any kind to operate a laser in Virginia.
To the north in New Jersey, the rules are much stricter: Only physicians can perform laser procedures. But in New York, it appears that anyone can fire up a laser and go to work on unwanted hair. And in Florida, nonphysicians can perform laser procedures only if they’re physician assistants or nurse practitioners. But they’re only allowed to remove hair with lasers at a clinic that just performs laser hair removal.
Such is the chaotic state of laser law in the United States, a new study finds. The rules, which vary widely from state to state, are often vague and confusing. And, as Virginia’s new law shows, they’re still evolving. (The study is current as of March 2016.)
She and study coauthor Mathew M. Avram, MD, JD, director of the Laser and Cosmetic Center at Massachusetts General, analyzed regulations in the 50 states regarding the operation of lasers. They reported their findings at the annual meeting of the American Society for Laser Medicine and Surgery.
Dr. DiGiorgio said that laser operator laws address three issues:
1. Who can operate a laser?
At other clinics across the country, nonphysician employees — such as nurse practitioners and registered nurses – often operate lasers. Whether they can legally actually do so isn’t always obvious.
New Jersey is the only state that requires laser operators to be physicians. At the other extreme, 11 states, including Massachusetts, Colorado, Florida, Missouri, New York, and Pennsylvania, have “no” limits on who can perform laser procedures. (At Massachusetts General Hospital, physicians perform all laser procedures.)
So does that mean anyone can perform a laser procedure? It’s not clear. “The laws are a lot more vague than they should be,” Dr. DiGiorgio said in an interview.
Eighteen states allow people to perform laser procedures as part of the “practice of medicine,” although legislation can be vague on what that means. Those states include Illinois, Michigan, Minnesota, North Carolina, and Texas.
Another 19 states, including California, Ohio, Washington, Wisconsin, and now Virginia, have specific limits on who can perform laser procedures. In California, for example, physician assistants and registered nurses – but not licensed vocational nurses – are allowed to use lasers to remove hair, spider veins, and tattoos. Unlicensed medical assistants, cosmetologists, electrologists, and estheticians are not allowed to perform the procedures
2. Can someone delegate laser procedures to someone else?
In nine states, including Iowa and New Hampshire, there’s no oversight of delegation or nonphysicians can delegate procedures to someone else.
In another nine states, certain procedures can be delegated with no physician oversight, such as laser hair removal in Alaska and ablative procedures (to advanced practice registered nurses only) in Utah.
3. Is supervision required of nonphysicians?
Physicians don’t need to supervise certain laser procedures in 11 states, including Hawaii, Oregon, and Vermont, where they can be performed by a nonphysician with no supervision or under supervision by a non-physician.
In 17 states, supervision isn’t always required or it’s under the discretion of the supervising physician. These states include California, Michigan, Pennsylvania, and Wisconsin.
In 11 states, including Illinois and Massachusetts, only certain procedures require on-site supervision. Six states, including Connecticut and Maryland, require on-site physician supervision for all laser procedures, but Dr. DiGiorgio said the requirements can be vague about what “on site” actually means.
Idaho requires the physician to be on site or immediately available, and South Carolina allows registered nurses to perform laser hair and leg vein removal if a physician is on site and can respond within 5 minutes.
“We don’t know what the ideal regulation is,” Dr. DiGiorgio said. But she believes laser regulations are crucial to safety, especially as fields such as plastic surgery, ophthalmology, and gynecology embrace cosmetic laser procedures.
Information about state-by-state laser operator laws is available on the American Med Spa Association website.
Dr. DiGiorgio reported no relevant disclosures.
AT LASER 2017
Key clinical point:
Major finding: The study found wide variations in who can operate lasers, and in regulations regarding the delegation and supervision of laser treatments in the different states.
Data source: Analysis of regulations in the 50 states regarding the operation of lasers.
Disclosures: Dr. DiGiorgio reported no relevant disclosures
What, you never filled the prescription?!
How many times do you come out of the exam room after seeing a patient in follow-up and heave a sigh because the parents did not give their child the medicine as you prescribed it?
Without adherence to the medication plan, a lot of suboptimal outcomes can and do occur. A urinary tract infection may come back partially treated, requiring a more extensive work-up. A strep infection may spread to family members. Inflammatory bowel disease may require bowel resection. Asthma may simmer with long-term inflammation and pulmonary compromise as well as concurrent activity limitations. Often children with asthma are given less than 50% of prescribed controller medicines. In one pediatric study, medication adherence was not even asked about in 66% of cases. In adults, 20%-30% of prescriptions are never filled.
As physicians, we are carefully schooled in making complex diagnoses, sorting out and prioritizing the laboratory work-up, and memorizing the latest and most effective treatment regimens. What is rarely taught, however, is how to conduct the conversation needed to optimize subsequent adherence to the medication plan.
Problem-solving counseling is an evidence-based method to improve medication adherence. This is a semistructured form of cognitive-behavioral intervention designed to engage the responsible person (parent or child) in shared decision making about whether and how to take medication, and which one to take. After all, for good or for bad, it is really their choice!
1. Problem definition. This step involves developing a clear and specific definition of the problem. Educating families about a medical condition has to start with asking what they already know. This often includes sagas of bad outcomes in relatives. Ask: Who do you know with asthma? How was it for them? The family needs to know symptoms, simple pathophysiology (such as inflammation you can’t see or feel), course, and prognosis. They also need to know where their child’s condition falls on the continuum. And they need to understand the essential prevention aspect of controllers in what appears to be an asymptomatic child. Failure to communicate this is a common reason for nonadherence in asthma.
2. Generation of alternatives. This involves brainstorming to identify multiple and creative solutions. This step will reveal past experiences as well as things the family learned on the Internet that may be true and relevant, or true but irrelevant, or false. Ask: What have you heard about treatments for asthma? What do you think would be best for your child? Generic handouts with a sampling of medicines, advantages and disadvantages, side effects, and costs of the main choices have been shown to be helpful guides that enhance adherence through empowering the family in their choice and reassuring family members that you have been thorough. It can be a balancing act to describe possible side effects without scaring the family into shutting down and being unable to make any choice at all. However, failure to discuss common effects they may notice – such as a racing heart from rescue medications – but that you think of as trivial, may also lead to nonadherence. A way to communicate about perceived side effects and manage them has to be part of an effective plan. Planning a phone or email check-in can make a big difference.
3. Decision making. This step involves evaluating all the solutions to identify the most effective and feasible option. Once the family understands the problem and the alternatives, it is crucial for you, as the physician, to not only ask their preference but be ready to suggest what you think would be best. While not wanting to be patronized, families want your opinion. I like to have family members close their eyes and visualize carrying out the selected routine. This is a good hypnotic technique for future remembering, but you also may discover important facts by this simple exercise, such as that the child gets up alone for school, making morning dosing unreliable. Shared decision making is not a way to abdicate your expert opinion, just to incorporate family preferences and factors.
4. Solution implementation. This step involves carrying out the plan. There is no substitute for a real life trial! There may be surprising issues: Autistic children may be afraid of a nebulizer machine. Sensitive children may refuse the flavor of some inhalers.
5. Solution verification. Evaluate the effectiveness of the solution and modify the plan as necessary. Follow-up contact is crucial, especially at the start of a new chronic medication plan. When families know that the plan can be changed if things do not go well or they change their minds, they will be less fearful of giving it a try and more honest about barriers they perceive or encounter rather than simply showing up at the next visit with the child’s condition out of control.
Although using problem-solving counseling may sound complicated, it is intended to be focused and brief, and has been shown to be feasibly done in the clinic by primary care providers, without lengthening the visit. CHADIS even has teleprompter text specific to parent-reported barriers to help you.
Even when family members understand and agrees to a medication plan during the visit, there are a variety of reasons they may not adhere to it. They may forget to give the medicine, be unable to afford it once prescribed, experience unpleasant side effects, encounter resistance from the child, or get unanticipated push back from family members. All of these issues can be addressed if you know that they happen. You just have to ask! Recommending smartphone reminders or reminder apps (such as Medisafe), using GoodRx to find cheaper sources, suggesting candy as a chaser, recommending behavior strategies for feisty kids, and providing written materials (or a phone call) for reluctant relatives are strategies you can prepare in advance to have in your quiver and are well worth your time.
If it weren’t enough to address adherence to optimize outcomes, asthma management and control will likely be a Clinical Quality Measure, determining how we will be paid starting this year. Now you have a tool to do it!
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to Frontline Medical News.
How many times do you come out of the exam room after seeing a patient in follow-up and heave a sigh because the parents did not give their child the medicine as you prescribed it?
Without adherence to the medication plan, a lot of suboptimal outcomes can and do occur. A urinary tract infection may come back partially treated, requiring a more extensive work-up. A strep infection may spread to family members. Inflammatory bowel disease may require bowel resection. Asthma may simmer with long-term inflammation and pulmonary compromise as well as concurrent activity limitations. Often children with asthma are given less than 50% of prescribed controller medicines. In one pediatric study, medication adherence was not even asked about in 66% of cases. In adults, 20%-30% of prescriptions are never filled.
As physicians, we are carefully schooled in making complex diagnoses, sorting out and prioritizing the laboratory work-up, and memorizing the latest and most effective treatment regimens. What is rarely taught, however, is how to conduct the conversation needed to optimize subsequent adherence to the medication plan.
Problem-solving counseling is an evidence-based method to improve medication adherence. This is a semistructured form of cognitive-behavioral intervention designed to engage the responsible person (parent or child) in shared decision making about whether and how to take medication, and which one to take. After all, for good or for bad, it is really their choice!
1. Problem definition. This step involves developing a clear and specific definition of the problem. Educating families about a medical condition has to start with asking what they already know. This often includes sagas of bad outcomes in relatives. Ask: Who do you know with asthma? How was it for them? The family needs to know symptoms, simple pathophysiology (such as inflammation you can’t see or feel), course, and prognosis. They also need to know where their child’s condition falls on the continuum. And they need to understand the essential prevention aspect of controllers in what appears to be an asymptomatic child. Failure to communicate this is a common reason for nonadherence in asthma.
2. Generation of alternatives. This involves brainstorming to identify multiple and creative solutions. This step will reveal past experiences as well as things the family learned on the Internet that may be true and relevant, or true but irrelevant, or false. Ask: What have you heard about treatments for asthma? What do you think would be best for your child? Generic handouts with a sampling of medicines, advantages and disadvantages, side effects, and costs of the main choices have been shown to be helpful guides that enhance adherence through empowering the family in their choice and reassuring family members that you have been thorough. It can be a balancing act to describe possible side effects without scaring the family into shutting down and being unable to make any choice at all. However, failure to discuss common effects they may notice – such as a racing heart from rescue medications – but that you think of as trivial, may also lead to nonadherence. A way to communicate about perceived side effects and manage them has to be part of an effective plan. Planning a phone or email check-in can make a big difference.
3. Decision making. This step involves evaluating all the solutions to identify the most effective and feasible option. Once the family understands the problem and the alternatives, it is crucial for you, as the physician, to not only ask their preference but be ready to suggest what you think would be best. While not wanting to be patronized, families want your opinion. I like to have family members close their eyes and visualize carrying out the selected routine. This is a good hypnotic technique for future remembering, but you also may discover important facts by this simple exercise, such as that the child gets up alone for school, making morning dosing unreliable. Shared decision making is not a way to abdicate your expert opinion, just to incorporate family preferences and factors.
4. Solution implementation. This step involves carrying out the plan. There is no substitute for a real life trial! There may be surprising issues: Autistic children may be afraid of a nebulizer machine. Sensitive children may refuse the flavor of some inhalers.
5. Solution verification. Evaluate the effectiveness of the solution and modify the plan as necessary. Follow-up contact is crucial, especially at the start of a new chronic medication plan. When families know that the plan can be changed if things do not go well or they change their minds, they will be less fearful of giving it a try and more honest about barriers they perceive or encounter rather than simply showing up at the next visit with the child’s condition out of control.
Although using problem-solving counseling may sound complicated, it is intended to be focused and brief, and has been shown to be feasibly done in the clinic by primary care providers, without lengthening the visit. CHADIS even has teleprompter text specific to parent-reported barriers to help you.
Even when family members understand and agrees to a medication plan during the visit, there are a variety of reasons they may not adhere to it. They may forget to give the medicine, be unable to afford it once prescribed, experience unpleasant side effects, encounter resistance from the child, or get unanticipated push back from family members. All of these issues can be addressed if you know that they happen. You just have to ask! Recommending smartphone reminders or reminder apps (such as Medisafe), using GoodRx to find cheaper sources, suggesting candy as a chaser, recommending behavior strategies for feisty kids, and providing written materials (or a phone call) for reluctant relatives are strategies you can prepare in advance to have in your quiver and are well worth your time.
If it weren’t enough to address adherence to optimize outcomes, asthma management and control will likely be a Clinical Quality Measure, determining how we will be paid starting this year. Now you have a tool to do it!
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to Frontline Medical News.
How many times do you come out of the exam room after seeing a patient in follow-up and heave a sigh because the parents did not give their child the medicine as you prescribed it?
Without adherence to the medication plan, a lot of suboptimal outcomes can and do occur. A urinary tract infection may come back partially treated, requiring a more extensive work-up. A strep infection may spread to family members. Inflammatory bowel disease may require bowel resection. Asthma may simmer with long-term inflammation and pulmonary compromise as well as concurrent activity limitations. Often children with asthma are given less than 50% of prescribed controller medicines. In one pediatric study, medication adherence was not even asked about in 66% of cases. In adults, 20%-30% of prescriptions are never filled.
As physicians, we are carefully schooled in making complex diagnoses, sorting out and prioritizing the laboratory work-up, and memorizing the latest and most effective treatment regimens. What is rarely taught, however, is how to conduct the conversation needed to optimize subsequent adherence to the medication plan.
Problem-solving counseling is an evidence-based method to improve medication adherence. This is a semistructured form of cognitive-behavioral intervention designed to engage the responsible person (parent or child) in shared decision making about whether and how to take medication, and which one to take. After all, for good or for bad, it is really their choice!
1. Problem definition. This step involves developing a clear and specific definition of the problem. Educating families about a medical condition has to start with asking what they already know. This often includes sagas of bad outcomes in relatives. Ask: Who do you know with asthma? How was it for them? The family needs to know symptoms, simple pathophysiology (such as inflammation you can’t see or feel), course, and prognosis. They also need to know where their child’s condition falls on the continuum. And they need to understand the essential prevention aspect of controllers in what appears to be an asymptomatic child. Failure to communicate this is a common reason for nonadherence in asthma.
2. Generation of alternatives. This involves brainstorming to identify multiple and creative solutions. This step will reveal past experiences as well as things the family learned on the Internet that may be true and relevant, or true but irrelevant, or false. Ask: What have you heard about treatments for asthma? What do you think would be best for your child? Generic handouts with a sampling of medicines, advantages and disadvantages, side effects, and costs of the main choices have been shown to be helpful guides that enhance adherence through empowering the family in their choice and reassuring family members that you have been thorough. It can be a balancing act to describe possible side effects without scaring the family into shutting down and being unable to make any choice at all. However, failure to discuss common effects they may notice – such as a racing heart from rescue medications – but that you think of as trivial, may also lead to nonadherence. A way to communicate about perceived side effects and manage them has to be part of an effective plan. Planning a phone or email check-in can make a big difference.
3. Decision making. This step involves evaluating all the solutions to identify the most effective and feasible option. Once the family understands the problem and the alternatives, it is crucial for you, as the physician, to not only ask their preference but be ready to suggest what you think would be best. While not wanting to be patronized, families want your opinion. I like to have family members close their eyes and visualize carrying out the selected routine. This is a good hypnotic technique for future remembering, but you also may discover important facts by this simple exercise, such as that the child gets up alone for school, making morning dosing unreliable. Shared decision making is not a way to abdicate your expert opinion, just to incorporate family preferences and factors.
4. Solution implementation. This step involves carrying out the plan. There is no substitute for a real life trial! There may be surprising issues: Autistic children may be afraid of a nebulizer machine. Sensitive children may refuse the flavor of some inhalers.
5. Solution verification. Evaluate the effectiveness of the solution and modify the plan as necessary. Follow-up contact is crucial, especially at the start of a new chronic medication plan. When families know that the plan can be changed if things do not go well or they change their minds, they will be less fearful of giving it a try and more honest about barriers they perceive or encounter rather than simply showing up at the next visit with the child’s condition out of control.
Although using problem-solving counseling may sound complicated, it is intended to be focused and brief, and has been shown to be feasibly done in the clinic by primary care providers, without lengthening the visit. CHADIS even has teleprompter text specific to parent-reported barriers to help you.
Even when family members understand and agrees to a medication plan during the visit, there are a variety of reasons they may not adhere to it. They may forget to give the medicine, be unable to afford it once prescribed, experience unpleasant side effects, encounter resistance from the child, or get unanticipated push back from family members. All of these issues can be addressed if you know that they happen. You just have to ask! Recommending smartphone reminders or reminder apps (such as Medisafe), using GoodRx to find cheaper sources, suggesting candy as a chaser, recommending behavior strategies for feisty kids, and providing written materials (or a phone call) for reluctant relatives are strategies you can prepare in advance to have in your quiver and are well worth your time.
If it weren’t enough to address adherence to optimize outcomes, asthma management and control will likely be a Clinical Quality Measure, determining how we will be paid starting this year. Now you have a tool to do it!
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to Frontline Medical News.
Medicine’s revenge against traveler’s diarrhea
Traveler’s diarrhea (TD) is the most common illness in people traveling from resource-advantaged countries to resource-limited regions of the globe. Approximately 50% of these types of travelers will contract diarrhea.
I knew of a group of infectious disease experts traveling to India together – presumably well-versed in how to avoid such things – and one-half of the group developed it.
I have many patients sending me electronic messages asking me for their standard 3-day ciprofloxacin prescriptions, “just in case.” I am guilty of having provided this, along with warnings that we could make matters worse by giving them Clostridium difficile colitis. Antibiotics may also increase the risk for post-TD irritable bowel syndrome, which can occur in up to 15% of patients.
Mild TD is defined as passage of one or two unformed stools in 24 hours without nausea, vomiting, abdominal pain, fever, or blood in stools. What is the evidence for the effectiveness of antibiotics, compared with other interventions such as loperamide, for mild TD?
Tinja Lääveri, MD, of the University of Helsinki, and colleagues conducted a systematic review on the efficacy and safety of loperamide for TD (Travel Med Infect Dis. 2016 Jul-Aug;14[4]:299-312). Fifteen articles were retrieved.
Loperamide was observed to be noninferior to antibiotics for the treatment of TD. In one study, loperamide was observed to be superior to bismuth, which is commonly recommended to prevent TD. Adverse events with loperamide occurred predominantly among patients with bloody diarrhea.
The authors remind us that loperamide is different from antimotility agents such as diphenoxylate with atropine, as loperamide has an antisecretory effect at lower doses and decreases motility only at higher doses.
If you subscribe to the idea that diarrhea helps rid the body of toxins, be reminded that secretory diarrhea is exploited by the organism to spread the infestation to as many humans as possible.
The recommended regimen for loperamide is a 4-mg loading dose, followed by 2 mg after every episode of diarrhea. Tell your patients not to use loperamide if they are having fever or bloody diarrhea, or if you suspect they could have C. difficile colitis (that is, recent antibiotics or other risk factors).
Happy travels.
Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.
Traveler’s diarrhea (TD) is the most common illness in people traveling from resource-advantaged countries to resource-limited regions of the globe. Approximately 50% of these types of travelers will contract diarrhea.
I knew of a group of infectious disease experts traveling to India together – presumably well-versed in how to avoid such things – and one-half of the group developed it.
I have many patients sending me electronic messages asking me for their standard 3-day ciprofloxacin prescriptions, “just in case.” I am guilty of having provided this, along with warnings that we could make matters worse by giving them Clostridium difficile colitis. Antibiotics may also increase the risk for post-TD irritable bowel syndrome, which can occur in up to 15% of patients.
Mild TD is defined as passage of one or two unformed stools in 24 hours without nausea, vomiting, abdominal pain, fever, or blood in stools. What is the evidence for the effectiveness of antibiotics, compared with other interventions such as loperamide, for mild TD?
Tinja Lääveri, MD, of the University of Helsinki, and colleagues conducted a systematic review on the efficacy and safety of loperamide for TD (Travel Med Infect Dis. 2016 Jul-Aug;14[4]:299-312). Fifteen articles were retrieved.
Loperamide was observed to be noninferior to antibiotics for the treatment of TD. In one study, loperamide was observed to be superior to bismuth, which is commonly recommended to prevent TD. Adverse events with loperamide occurred predominantly among patients with bloody diarrhea.
The authors remind us that loperamide is different from antimotility agents such as diphenoxylate with atropine, as loperamide has an antisecretory effect at lower doses and decreases motility only at higher doses.
If you subscribe to the idea that diarrhea helps rid the body of toxins, be reminded that secretory diarrhea is exploited by the organism to spread the infestation to as many humans as possible.
The recommended regimen for loperamide is a 4-mg loading dose, followed by 2 mg after every episode of diarrhea. Tell your patients not to use loperamide if they are having fever or bloody diarrhea, or if you suspect they could have C. difficile colitis (that is, recent antibiotics or other risk factors).
Happy travels.
Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.
Traveler’s diarrhea (TD) is the most common illness in people traveling from resource-advantaged countries to resource-limited regions of the globe. Approximately 50% of these types of travelers will contract diarrhea.
I knew of a group of infectious disease experts traveling to India together – presumably well-versed in how to avoid such things – and one-half of the group developed it.
I have many patients sending me electronic messages asking me for their standard 3-day ciprofloxacin prescriptions, “just in case.” I am guilty of having provided this, along with warnings that we could make matters worse by giving them Clostridium difficile colitis. Antibiotics may also increase the risk for post-TD irritable bowel syndrome, which can occur in up to 15% of patients.
Mild TD is defined as passage of one or two unformed stools in 24 hours without nausea, vomiting, abdominal pain, fever, or blood in stools. What is the evidence for the effectiveness of antibiotics, compared with other interventions such as loperamide, for mild TD?
Tinja Lääveri, MD, of the University of Helsinki, and colleagues conducted a systematic review on the efficacy and safety of loperamide for TD (Travel Med Infect Dis. 2016 Jul-Aug;14[4]:299-312). Fifteen articles were retrieved.
Loperamide was observed to be noninferior to antibiotics for the treatment of TD. In one study, loperamide was observed to be superior to bismuth, which is commonly recommended to prevent TD. Adverse events with loperamide occurred predominantly among patients with bloody diarrhea.
The authors remind us that loperamide is different from antimotility agents such as diphenoxylate with atropine, as loperamide has an antisecretory effect at lower doses and decreases motility only at higher doses.
If you subscribe to the idea that diarrhea helps rid the body of toxins, be reminded that secretory diarrhea is exploited by the organism to spread the infestation to as many humans as possible.
The recommended regimen for loperamide is a 4-mg loading dose, followed by 2 mg after every episode of diarrhea. Tell your patients not to use loperamide if they are having fever or bloody diarrhea, or if you suspect they could have C. difficile colitis (that is, recent antibiotics or other risk factors).
Happy travels.
Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.