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Sugar Substitutes Satisfy Appetite, Blunt Insulin Response

Article Type
Changed
Wed, 04/17/2024 - 14:06

 

TOPLINE:

Biscuits reformulated with the sweeteners and sweetness enhancers (S&SEs) neotame and stevia rebaudioside M (StRebM) yield appetite responses similar to those of sucrose-sweetened ones but decrease post-meal insulin and glucose levels in adults with overweight or obesity.

METHODOLOGY:

  • In 2023, the World Health Organization issued a conditional recommendation that S&SE should not be used for weight control, apparently due to a lack of evidence for a clear benefit and weak evidence linking S&SE intake with excess weight and poorer health outcomes.
  • This randomized crossover trial, conducted in England and France between 2021 and 2022, evaluated the acute (1 day) and repeated (daily for 2 weeks) effects of S&SEs vs sucrose in solid food on appetite and endocrine responses in adults with overweight or obesity.
  • Overall, 53 adults (33 women, 20 men; aged 18-60 years) with overweight or obesity consumed biscuits with fruit filling containing either sucrose or reformulated with the S&SEs StRebM or neotame, daily for three 2-week intervention periods separated by a washout period of 14-21 days.
  • Participants were required to fast for 12 hours before attending a laboratory session at the beginning (day 1) and end (day 14) of each consumption period.
  • The primary endpoint was the composite appetite score, while secondary endpoints included food preferences, postprandial glucose and insulin response, and other satiety-related peptides, such as ghrelin, glucagon-like peptide 1, and pancreatic polypeptide.

TAKEAWAY:

  • The composite appetite scores were comparable between the sucrose, StRebM, and neotame groups, with lower appetite suppression observed on day 14 than on day 1 for all three formulations.
  • Neotame (P < .001) and StRebM (P < .001) lowered postprandial insulin levels compared with sucrose, while glucose levels saw a decline only with StRebM (and not with neotame) compared with sucrose (P < .05).
  • The S&SEs had no effect on satiety levels, as any acute or repeated exposures to StRebM or neotame vs sucrose did not affect the ghrelin and glucagon-like peptide-1 responses.
  • Gastrointestinal issues were more frequently reported in the neotame and StRebM groups than in the sucrose group.

IN PRACTICE:

“There is no detrimental impact of replacing sugar with S&SE in these endpoints,” the authors wrote. “Additionally, glucose and insulin responses were blunted after acute and repeated consumption of S&SE-reformulated biscuits, which may confer a benefit for blood glucose control, for example, in individuals at risk of developing type 2 diabetes.”

SOURCE:

This study was led by Catherine Gibbons, School of Psychology, Faculty of Medicine and Health, University of Leeds, England. It was published online in eBioMedicine.

LIMITATIONS:

The reformulated products required the addition of polyol bulking agents (8% maltitol and 8% sorbitol) to match the biscuits in sensory qualities as closely as possible. Gastrointestinal symptoms (initial bloating and flatulence) in the neotame and StRebM formulations may be due to the polyols, classed as low-digestible carbohydrates.

DISCLOSURES:

This study received funding from a European Union Horizon 2020 program, SWEET (Sweeteners and sweetness enhancers: Impact on health, obesity, safety, and sustainability). The authors reported receiving funding and honoraria from the food and beverage industry and trade groups from various entities.

A version of this article appeared on Medscape.com.

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TOPLINE:

Biscuits reformulated with the sweeteners and sweetness enhancers (S&SEs) neotame and stevia rebaudioside M (StRebM) yield appetite responses similar to those of sucrose-sweetened ones but decrease post-meal insulin and glucose levels in adults with overweight or obesity.

METHODOLOGY:

  • In 2023, the World Health Organization issued a conditional recommendation that S&SE should not be used for weight control, apparently due to a lack of evidence for a clear benefit and weak evidence linking S&SE intake with excess weight and poorer health outcomes.
  • This randomized crossover trial, conducted in England and France between 2021 and 2022, evaluated the acute (1 day) and repeated (daily for 2 weeks) effects of S&SEs vs sucrose in solid food on appetite and endocrine responses in adults with overweight or obesity.
  • Overall, 53 adults (33 women, 20 men; aged 18-60 years) with overweight or obesity consumed biscuits with fruit filling containing either sucrose or reformulated with the S&SEs StRebM or neotame, daily for three 2-week intervention periods separated by a washout period of 14-21 days.
  • Participants were required to fast for 12 hours before attending a laboratory session at the beginning (day 1) and end (day 14) of each consumption period.
  • The primary endpoint was the composite appetite score, while secondary endpoints included food preferences, postprandial glucose and insulin response, and other satiety-related peptides, such as ghrelin, glucagon-like peptide 1, and pancreatic polypeptide.

TAKEAWAY:

  • The composite appetite scores were comparable between the sucrose, StRebM, and neotame groups, with lower appetite suppression observed on day 14 than on day 1 for all three formulations.
  • Neotame (P < .001) and StRebM (P < .001) lowered postprandial insulin levels compared with sucrose, while glucose levels saw a decline only with StRebM (and not with neotame) compared with sucrose (P < .05).
  • The S&SEs had no effect on satiety levels, as any acute or repeated exposures to StRebM or neotame vs sucrose did not affect the ghrelin and glucagon-like peptide-1 responses.
  • Gastrointestinal issues were more frequently reported in the neotame and StRebM groups than in the sucrose group.

IN PRACTICE:

“There is no detrimental impact of replacing sugar with S&SE in these endpoints,” the authors wrote. “Additionally, glucose and insulin responses were blunted after acute and repeated consumption of S&SE-reformulated biscuits, which may confer a benefit for blood glucose control, for example, in individuals at risk of developing type 2 diabetes.”

SOURCE:

This study was led by Catherine Gibbons, School of Psychology, Faculty of Medicine and Health, University of Leeds, England. It was published online in eBioMedicine.

LIMITATIONS:

The reformulated products required the addition of polyol bulking agents (8% maltitol and 8% sorbitol) to match the biscuits in sensory qualities as closely as possible. Gastrointestinal symptoms (initial bloating and flatulence) in the neotame and StRebM formulations may be due to the polyols, classed as low-digestible carbohydrates.

DISCLOSURES:

This study received funding from a European Union Horizon 2020 program, SWEET (Sweeteners and sweetness enhancers: Impact on health, obesity, safety, and sustainability). The authors reported receiving funding and honoraria from the food and beverage industry and trade groups from various entities.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Biscuits reformulated with the sweeteners and sweetness enhancers (S&SEs) neotame and stevia rebaudioside M (StRebM) yield appetite responses similar to those of sucrose-sweetened ones but decrease post-meal insulin and glucose levels in adults with overweight or obesity.

METHODOLOGY:

  • In 2023, the World Health Organization issued a conditional recommendation that S&SE should not be used for weight control, apparently due to a lack of evidence for a clear benefit and weak evidence linking S&SE intake with excess weight and poorer health outcomes.
  • This randomized crossover trial, conducted in England and France between 2021 and 2022, evaluated the acute (1 day) and repeated (daily for 2 weeks) effects of S&SEs vs sucrose in solid food on appetite and endocrine responses in adults with overweight or obesity.
  • Overall, 53 adults (33 women, 20 men; aged 18-60 years) with overweight or obesity consumed biscuits with fruit filling containing either sucrose or reformulated with the S&SEs StRebM or neotame, daily for three 2-week intervention periods separated by a washout period of 14-21 days.
  • Participants were required to fast for 12 hours before attending a laboratory session at the beginning (day 1) and end (day 14) of each consumption period.
  • The primary endpoint was the composite appetite score, while secondary endpoints included food preferences, postprandial glucose and insulin response, and other satiety-related peptides, such as ghrelin, glucagon-like peptide 1, and pancreatic polypeptide.

TAKEAWAY:

  • The composite appetite scores were comparable between the sucrose, StRebM, and neotame groups, with lower appetite suppression observed on day 14 than on day 1 for all three formulations.
  • Neotame (P < .001) and StRebM (P < .001) lowered postprandial insulin levels compared with sucrose, while glucose levels saw a decline only with StRebM (and not with neotame) compared with sucrose (P < .05).
  • The S&SEs had no effect on satiety levels, as any acute or repeated exposures to StRebM or neotame vs sucrose did not affect the ghrelin and glucagon-like peptide-1 responses.
  • Gastrointestinal issues were more frequently reported in the neotame and StRebM groups than in the sucrose group.

IN PRACTICE:

“There is no detrimental impact of replacing sugar with S&SE in these endpoints,” the authors wrote. “Additionally, glucose and insulin responses were blunted after acute and repeated consumption of S&SE-reformulated biscuits, which may confer a benefit for blood glucose control, for example, in individuals at risk of developing type 2 diabetes.”

SOURCE:

This study was led by Catherine Gibbons, School of Psychology, Faculty of Medicine and Health, University of Leeds, England. It was published online in eBioMedicine.

LIMITATIONS:

The reformulated products required the addition of polyol bulking agents (8% maltitol and 8% sorbitol) to match the biscuits in sensory qualities as closely as possible. Gastrointestinal symptoms (initial bloating and flatulence) in the neotame and StRebM formulations may be due to the polyols, classed as low-digestible carbohydrates.

DISCLOSURES:

This study received funding from a European Union Horizon 2020 program, SWEET (Sweeteners and sweetness enhancers: Impact on health, obesity, safety, and sustainability). The authors reported receiving funding and honoraria from the food and beverage industry and trade groups from various entities.

A version of this article appeared on Medscape.com.

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Working From Home: Doctors’ Options Are Not Limited to Classic Telemedicine

Article Type
Changed
Tue, 04/16/2024 - 12:54

The appeal of working from home is undeniable. It comes with no daily commute, casual dress, and the ability to manage work-life balance more effectively.

Telemedicine is often the first thing that comes to mind when physicians think about remote medical practice. In its traditional sense, telemedicine entails live video consults, replicating the in-person experience as closely as possible, minus the hands-on component. However, this format is just one of many types of virtual care presenting opportunities to practice medicine from home.

The scope and volume of such opportunities are expanding due to technology, regulatory shifts at the state and federal levels favoring remote healthcare, and a wider move toward remote work. Virtual practice options for physicians range from full-time employment to flexible part-time positions that can be used to earn supplementary income.

Just a few of those virtual options are:

Remote Patient Monitoring

Remote patient monitoring uses technology for tracking patient health data, applicable in real-time or asynchronously, through devices ranging from specialized monitors to consumer wearables. Data are securely transmitted to healthcare providers, enabling them to guide or make treatment choices remotely. This method has proven particularly valuable in managing chronic diseases where continuous monitoring can significantly affect outcomes.

Like standard telemedicine, remote patient monitoring offers flexibility, autonomy, and the ability to work from home. It is picking up steam across the healthcare industry, especially in critical care, surgery, post-acute care, and primary care, so there are opportunities for physicians across a variety of specialties.

Online Medication Management and Text-Based Consults

Gathering necessary information for patient care decisions often doesn’t require a direct, face-to-face visit in person or by telemedicine. Clinical data can be efficiently collected through online forms, HIPAA-compliant messaging, medical record reviews, and information gathered by staff.

An approach that uses all these sources enables effective medication management for stable chronic conditions (such as hypertension), as well as straightforward but simple acute issues (such as urinary tract infections). It also is useful for quick follow-ups with patients after starting new treatments, to address questions between visits, and to give them educational material.

Some medical practices and virtual healthcare corporations have made online medication management and text-based consults the center of their business model. Part-time positions with platforms that offer this type of care let physicians fit consultations into their schedule as time permits, without committing to scheduled appointments.

eConsults

Electronic consultations, or eConsults, facilitate collaboration among healthcare professionals about complex cases without direct patient interaction.

These services operate via online platforms that support asynchronous communication and often bypass the need for a traditional referral. Typically, a primary care provider submits a query that is then assigned to a specialist. Next, the specialist reviews the information and offers recommendations for the patient’s care plan.

Major eConsult platforms such as AristaMD and RubiconMD contract with healthcare systems and medical practices. Physicians can easily join the specialist panels of these companies and complete assigned consultations from their homes or offices, paid on a per-consult basis. They should check their employment contracts to make sure such independent contract work is allowed.

 

 

Phone-Only On-Call Positions

On-call rotations for after-hour care bring with them challenges in staffing and scheduling vacations. These challenges have helped trigger as-needed or per diem on-call roles, in which a physician provides recommendations and orders over the phone without needing to visit an office or a hospital.

Examples of workplaces that employ phone-only on-call physicians include smaller jails, mental health facilities, dialysis centers, long-term care facilities, and sporting groups or events needing back-up for on-site nurses or emergency medical technicians.

While these positions can sometimes be challenging for a physician to find, they are out there. They can be a fantastic option to earn additional income through low-stress clinical work performed from home.

Supervision of Nurse Practitioners (NPs) and Physician Assistants (PAs)

In states that mandate such physician oversight, it often be conducted remotely — depending on that state’s rules, the practice type, and the scope of services being provided. This remote option introduces part-time opportunities for physicians to oversee NPs and PAs without being in the medical office. Essentially, the doctor needs to be available for phone or email consultations, complete chart reviews, and meet regularly with the provider.

Remote supervision roles are available across various types of healthcare organizations and medical practices. There also are opportunities with insurers, many of which have established NP-run, in-home member assessment programs that require remote supervision by a doctor.

Remote Medical Directorships

Medical directors are a key part of the clinician team in a wide variety of healthcare settings requiring clinical protocol oversight, regulatory compliance, and guidance for other clinicians making treatment decisions. Many directorships do not require direct patient contact and therefore are conducive to remote work, given technologies such as electronic health record and secure messaging systems.

Organizations such as emergency medical service agencies, hospice services, med spas, blood and plasma donation centers, home health agencies, and substance use disorder treatment programs increasingly rely on remote medical directorships to meet legal requirements and accreditation standards.

Although these positions are often viewed as “nonclinical,” they carry significant clinical responsibilities. Examples are developing and reviewing treatment protocols, ensuring adherence to healthcare regulations, and sometimes intervening in complex patient cases or when adverse outcomes occur.

Keeping a Role in Patient Welfare

Clearly, working from home as a physician doesn’t have to mean taking on a nonclinical job. Beyond the options already mentioned, there are numerous others — for example, working as a medical monitor for clinical trials, in utilization management for insurance companies, or in conducting independent medical exams for insurance claims. While these roles don’t involve direct patient treatment, they require similar skills and affect the quality of care.

If such remote opportunities aren’t currently available in your workplace, consider approaching your management about trying them. You can make an effective argument that remote practice alternatives bring value to the organization through expanded patient care capabilities and potential cost savings.

Physicians who are experiencing burnout, seeking a career change, or interested in earning extra income should consider exploring more of the unconventional ways that they can practice medicine.

A version of this article appeared on Medscape.com.

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The appeal of working from home is undeniable. It comes with no daily commute, casual dress, and the ability to manage work-life balance more effectively.

Telemedicine is often the first thing that comes to mind when physicians think about remote medical practice. In its traditional sense, telemedicine entails live video consults, replicating the in-person experience as closely as possible, minus the hands-on component. However, this format is just one of many types of virtual care presenting opportunities to practice medicine from home.

The scope and volume of such opportunities are expanding due to technology, regulatory shifts at the state and federal levels favoring remote healthcare, and a wider move toward remote work. Virtual practice options for physicians range from full-time employment to flexible part-time positions that can be used to earn supplementary income.

Just a few of those virtual options are:

Remote Patient Monitoring

Remote patient monitoring uses technology for tracking patient health data, applicable in real-time or asynchronously, through devices ranging from specialized monitors to consumer wearables. Data are securely transmitted to healthcare providers, enabling them to guide or make treatment choices remotely. This method has proven particularly valuable in managing chronic diseases where continuous monitoring can significantly affect outcomes.

Like standard telemedicine, remote patient monitoring offers flexibility, autonomy, and the ability to work from home. It is picking up steam across the healthcare industry, especially in critical care, surgery, post-acute care, and primary care, so there are opportunities for physicians across a variety of specialties.

Online Medication Management and Text-Based Consults

Gathering necessary information for patient care decisions often doesn’t require a direct, face-to-face visit in person or by telemedicine. Clinical data can be efficiently collected through online forms, HIPAA-compliant messaging, medical record reviews, and information gathered by staff.

An approach that uses all these sources enables effective medication management for stable chronic conditions (such as hypertension), as well as straightforward but simple acute issues (such as urinary tract infections). It also is useful for quick follow-ups with patients after starting new treatments, to address questions between visits, and to give them educational material.

Some medical practices and virtual healthcare corporations have made online medication management and text-based consults the center of their business model. Part-time positions with platforms that offer this type of care let physicians fit consultations into their schedule as time permits, without committing to scheduled appointments.

eConsults

Electronic consultations, or eConsults, facilitate collaboration among healthcare professionals about complex cases without direct patient interaction.

These services operate via online platforms that support asynchronous communication and often bypass the need for a traditional referral. Typically, a primary care provider submits a query that is then assigned to a specialist. Next, the specialist reviews the information and offers recommendations for the patient’s care plan.

Major eConsult platforms such as AristaMD and RubiconMD contract with healthcare systems and medical practices. Physicians can easily join the specialist panels of these companies and complete assigned consultations from their homes or offices, paid on a per-consult basis. They should check their employment contracts to make sure such independent contract work is allowed.

 

 

Phone-Only On-Call Positions

On-call rotations for after-hour care bring with them challenges in staffing and scheduling vacations. These challenges have helped trigger as-needed or per diem on-call roles, in which a physician provides recommendations and orders over the phone without needing to visit an office or a hospital.

Examples of workplaces that employ phone-only on-call physicians include smaller jails, mental health facilities, dialysis centers, long-term care facilities, and sporting groups or events needing back-up for on-site nurses or emergency medical technicians.

While these positions can sometimes be challenging for a physician to find, they are out there. They can be a fantastic option to earn additional income through low-stress clinical work performed from home.

Supervision of Nurse Practitioners (NPs) and Physician Assistants (PAs)

In states that mandate such physician oversight, it often be conducted remotely — depending on that state’s rules, the practice type, and the scope of services being provided. This remote option introduces part-time opportunities for physicians to oversee NPs and PAs without being in the medical office. Essentially, the doctor needs to be available for phone or email consultations, complete chart reviews, and meet regularly with the provider.

Remote supervision roles are available across various types of healthcare organizations and medical practices. There also are opportunities with insurers, many of which have established NP-run, in-home member assessment programs that require remote supervision by a doctor.

Remote Medical Directorships

Medical directors are a key part of the clinician team in a wide variety of healthcare settings requiring clinical protocol oversight, regulatory compliance, and guidance for other clinicians making treatment decisions. Many directorships do not require direct patient contact and therefore are conducive to remote work, given technologies such as electronic health record and secure messaging systems.

Organizations such as emergency medical service agencies, hospice services, med spas, blood and plasma donation centers, home health agencies, and substance use disorder treatment programs increasingly rely on remote medical directorships to meet legal requirements and accreditation standards.

Although these positions are often viewed as “nonclinical,” they carry significant clinical responsibilities. Examples are developing and reviewing treatment protocols, ensuring adherence to healthcare regulations, and sometimes intervening in complex patient cases or when adverse outcomes occur.

Keeping a Role in Patient Welfare

Clearly, working from home as a physician doesn’t have to mean taking on a nonclinical job. Beyond the options already mentioned, there are numerous others — for example, working as a medical monitor for clinical trials, in utilization management for insurance companies, or in conducting independent medical exams for insurance claims. While these roles don’t involve direct patient treatment, they require similar skills and affect the quality of care.

If such remote opportunities aren’t currently available in your workplace, consider approaching your management about trying them. You can make an effective argument that remote practice alternatives bring value to the organization through expanded patient care capabilities and potential cost savings.

Physicians who are experiencing burnout, seeking a career change, or interested in earning extra income should consider exploring more of the unconventional ways that they can practice medicine.

A version of this article appeared on Medscape.com.

The appeal of working from home is undeniable. It comes with no daily commute, casual dress, and the ability to manage work-life balance more effectively.

Telemedicine is often the first thing that comes to mind when physicians think about remote medical practice. In its traditional sense, telemedicine entails live video consults, replicating the in-person experience as closely as possible, minus the hands-on component. However, this format is just one of many types of virtual care presenting opportunities to practice medicine from home.

The scope and volume of such opportunities are expanding due to technology, regulatory shifts at the state and federal levels favoring remote healthcare, and a wider move toward remote work. Virtual practice options for physicians range from full-time employment to flexible part-time positions that can be used to earn supplementary income.

Just a few of those virtual options are:

Remote Patient Monitoring

Remote patient monitoring uses technology for tracking patient health data, applicable in real-time or asynchronously, through devices ranging from specialized monitors to consumer wearables. Data are securely transmitted to healthcare providers, enabling them to guide or make treatment choices remotely. This method has proven particularly valuable in managing chronic diseases where continuous monitoring can significantly affect outcomes.

Like standard telemedicine, remote patient monitoring offers flexibility, autonomy, and the ability to work from home. It is picking up steam across the healthcare industry, especially in critical care, surgery, post-acute care, and primary care, so there are opportunities for physicians across a variety of specialties.

Online Medication Management and Text-Based Consults

Gathering necessary information for patient care decisions often doesn’t require a direct, face-to-face visit in person or by telemedicine. Clinical data can be efficiently collected through online forms, HIPAA-compliant messaging, medical record reviews, and information gathered by staff.

An approach that uses all these sources enables effective medication management for stable chronic conditions (such as hypertension), as well as straightforward but simple acute issues (such as urinary tract infections). It also is useful for quick follow-ups with patients after starting new treatments, to address questions between visits, and to give them educational material.

Some medical practices and virtual healthcare corporations have made online medication management and text-based consults the center of their business model. Part-time positions with platforms that offer this type of care let physicians fit consultations into their schedule as time permits, without committing to scheduled appointments.

eConsults

Electronic consultations, or eConsults, facilitate collaboration among healthcare professionals about complex cases without direct patient interaction.

These services operate via online platforms that support asynchronous communication and often bypass the need for a traditional referral. Typically, a primary care provider submits a query that is then assigned to a specialist. Next, the specialist reviews the information and offers recommendations for the patient’s care plan.

Major eConsult platforms such as AristaMD and RubiconMD contract with healthcare systems and medical practices. Physicians can easily join the specialist panels of these companies and complete assigned consultations from their homes or offices, paid on a per-consult basis. They should check their employment contracts to make sure such independent contract work is allowed.

 

 

Phone-Only On-Call Positions

On-call rotations for after-hour care bring with them challenges in staffing and scheduling vacations. These challenges have helped trigger as-needed or per diem on-call roles, in which a physician provides recommendations and orders over the phone without needing to visit an office or a hospital.

Examples of workplaces that employ phone-only on-call physicians include smaller jails, mental health facilities, dialysis centers, long-term care facilities, and sporting groups or events needing back-up for on-site nurses or emergency medical technicians.

While these positions can sometimes be challenging for a physician to find, they are out there. They can be a fantastic option to earn additional income through low-stress clinical work performed from home.

Supervision of Nurse Practitioners (NPs) and Physician Assistants (PAs)

In states that mandate such physician oversight, it often be conducted remotely — depending on that state’s rules, the practice type, and the scope of services being provided. This remote option introduces part-time opportunities for physicians to oversee NPs and PAs without being in the medical office. Essentially, the doctor needs to be available for phone or email consultations, complete chart reviews, and meet regularly with the provider.

Remote supervision roles are available across various types of healthcare organizations and medical practices. There also are opportunities with insurers, many of which have established NP-run, in-home member assessment programs that require remote supervision by a doctor.

Remote Medical Directorships

Medical directors are a key part of the clinician team in a wide variety of healthcare settings requiring clinical protocol oversight, regulatory compliance, and guidance for other clinicians making treatment decisions. Many directorships do not require direct patient contact and therefore are conducive to remote work, given technologies such as electronic health record and secure messaging systems.

Organizations such as emergency medical service agencies, hospice services, med spas, blood and plasma donation centers, home health agencies, and substance use disorder treatment programs increasingly rely on remote medical directorships to meet legal requirements and accreditation standards.

Although these positions are often viewed as “nonclinical,” they carry significant clinical responsibilities. Examples are developing and reviewing treatment protocols, ensuring adherence to healthcare regulations, and sometimes intervening in complex patient cases or when adverse outcomes occur.

Keeping a Role in Patient Welfare

Clearly, working from home as a physician doesn’t have to mean taking on a nonclinical job. Beyond the options already mentioned, there are numerous others — for example, working as a medical monitor for clinical trials, in utilization management for insurance companies, or in conducting independent medical exams for insurance claims. While these roles don’t involve direct patient treatment, they require similar skills and affect the quality of care.

If such remote opportunities aren’t currently available in your workplace, consider approaching your management about trying them. You can make an effective argument that remote practice alternatives bring value to the organization through expanded patient care capabilities and potential cost savings.

Physicians who are experiencing burnout, seeking a career change, or interested in earning extra income should consider exploring more of the unconventional ways that they can practice medicine.

A version of this article appeared on Medscape.com.

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Low-Fat Vegan Diet May Improve Cardiometabolic Health in T1D

Article Type
Changed
Tue, 04/16/2024 - 11:42

 

TOPLINE:

A low-fat vegan diet — high in fiber and carbohydrates and moderate in protein — reduces insulin requirement, increases insulin sensitivity, and improves glycemic control in individuals with type 1 diabetes (T1D) compared with a conventional portion-controlled diet.

METHODOLOGY:

  • The effects of a low-fat vegan diet (without carbohydrate or portion restriction) were compared with those of a conventional portion-controlled, carbohydrate-controlled diet in 58 patients with T1D (age, ≥ 18 years) who had been receiving stable insulin treatment for the past 3 months.
  • Participants were randomly assigned to receive either the vegan diet (n = 29), comprising vegetables, grains, legumes, and fruits, or the portion-controlled diet (n = 29), which reduced daily energy intake by 500-1000 kcal/d in participants with overweight while maintaining a stable carbohydrate intake.
  • The primary clinical outcomes were insulin requirement (total daily dose of insulin), insulin sensitivity, and glycemic control (A1c).
  • Other assessments included the blood, lipid profile, blood urea nitrogen, blood urea nitrogen-to-creatinine ratio, and body weight.

TAKEAWAY:

  • The study was completed by 18 participants in the vegan-diet group and 17 in the portion-controlled group.
  • In the vegan group, the total daily dose of insulin decreased by 12.1 units/d (P = .007) and insulin sensitivity increased by 6.6 g of carbohydrate per unit of insulin on average (P = .002), with no significant changes in the portion-controlled diet group.
  • Participants on the vegan diet had lower levels of total and low-density lipoprotein cholesterol and blood urea nitrogen and a lower blood urea nitrogen-to-creatinine ratio (P for all < .001), whereas both vegan and portion-controlled groups had lower A1c levels.
  • Body weight decreased by 5.2 kg (P < .001) in the vegan group; there were no significant changes in the portion-controlled group.
  • For every 1-kg weight loss, there was a 2.16-unit decrease in the insulin total daily dose and a 0.9-unit increase in insulin sensitivity.

IN PRACTICE:

“This study provides substantial support for a low-fat vegan diet that is high in fiber and carbohydrates, low in fat, and moderate in protein” and suggests the potential therapeutic use of this diet in type 1 diabetes management, the authors wrote.

SOURCE:

The study led by Hana Kahleova, MD, PhD, Physicians Committee for Responsible Medicine, Washington, was published in Clinical Diabetes.

LIMITATIONS:

Dietary intake was recorded on the basis of self-reported data. A higher attrition rate was observed due to meal and blood glucose monitoring. The findings may have limited generalizability as the study participants comprised those seeking help for T1D.

DISCLOSURES:

The study was supported by the Physicians Committee for Responsible Medicine and a grant from the Institute for Technology in Healthcare. Some authors reported receiving compensation, being cofounders of a coaching program, writing books, providing nutrition coaching, giving lectures, or receiving royalties and honoraria from various sources.

A version of this article appeared on Medscape.com.

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TOPLINE:

A low-fat vegan diet — high in fiber and carbohydrates and moderate in protein — reduces insulin requirement, increases insulin sensitivity, and improves glycemic control in individuals with type 1 diabetes (T1D) compared with a conventional portion-controlled diet.

METHODOLOGY:

  • The effects of a low-fat vegan diet (without carbohydrate or portion restriction) were compared with those of a conventional portion-controlled, carbohydrate-controlled diet in 58 patients with T1D (age, ≥ 18 years) who had been receiving stable insulin treatment for the past 3 months.
  • Participants were randomly assigned to receive either the vegan diet (n = 29), comprising vegetables, grains, legumes, and fruits, or the portion-controlled diet (n = 29), which reduced daily energy intake by 500-1000 kcal/d in participants with overweight while maintaining a stable carbohydrate intake.
  • The primary clinical outcomes were insulin requirement (total daily dose of insulin), insulin sensitivity, and glycemic control (A1c).
  • Other assessments included the blood, lipid profile, blood urea nitrogen, blood urea nitrogen-to-creatinine ratio, and body weight.

TAKEAWAY:

  • The study was completed by 18 participants in the vegan-diet group and 17 in the portion-controlled group.
  • In the vegan group, the total daily dose of insulin decreased by 12.1 units/d (P = .007) and insulin sensitivity increased by 6.6 g of carbohydrate per unit of insulin on average (P = .002), with no significant changes in the portion-controlled diet group.
  • Participants on the vegan diet had lower levels of total and low-density lipoprotein cholesterol and blood urea nitrogen and a lower blood urea nitrogen-to-creatinine ratio (P for all < .001), whereas both vegan and portion-controlled groups had lower A1c levels.
  • Body weight decreased by 5.2 kg (P < .001) in the vegan group; there were no significant changes in the portion-controlled group.
  • For every 1-kg weight loss, there was a 2.16-unit decrease in the insulin total daily dose and a 0.9-unit increase in insulin sensitivity.

IN PRACTICE:

“This study provides substantial support for a low-fat vegan diet that is high in fiber and carbohydrates, low in fat, and moderate in protein” and suggests the potential therapeutic use of this diet in type 1 diabetes management, the authors wrote.

SOURCE:

The study led by Hana Kahleova, MD, PhD, Physicians Committee for Responsible Medicine, Washington, was published in Clinical Diabetes.

LIMITATIONS:

Dietary intake was recorded on the basis of self-reported data. A higher attrition rate was observed due to meal and blood glucose monitoring. The findings may have limited generalizability as the study participants comprised those seeking help for T1D.

DISCLOSURES:

The study was supported by the Physicians Committee for Responsible Medicine and a grant from the Institute for Technology in Healthcare. Some authors reported receiving compensation, being cofounders of a coaching program, writing books, providing nutrition coaching, giving lectures, or receiving royalties and honoraria from various sources.

A version of this article appeared on Medscape.com.

 

TOPLINE:

A low-fat vegan diet — high in fiber and carbohydrates and moderate in protein — reduces insulin requirement, increases insulin sensitivity, and improves glycemic control in individuals with type 1 diabetes (T1D) compared with a conventional portion-controlled diet.

METHODOLOGY:

  • The effects of a low-fat vegan diet (without carbohydrate or portion restriction) were compared with those of a conventional portion-controlled, carbohydrate-controlled diet in 58 patients with T1D (age, ≥ 18 years) who had been receiving stable insulin treatment for the past 3 months.
  • Participants were randomly assigned to receive either the vegan diet (n = 29), comprising vegetables, grains, legumes, and fruits, or the portion-controlled diet (n = 29), which reduced daily energy intake by 500-1000 kcal/d in participants with overweight while maintaining a stable carbohydrate intake.
  • The primary clinical outcomes were insulin requirement (total daily dose of insulin), insulin sensitivity, and glycemic control (A1c).
  • Other assessments included the blood, lipid profile, blood urea nitrogen, blood urea nitrogen-to-creatinine ratio, and body weight.

TAKEAWAY:

  • The study was completed by 18 participants in the vegan-diet group and 17 in the portion-controlled group.
  • In the vegan group, the total daily dose of insulin decreased by 12.1 units/d (P = .007) and insulin sensitivity increased by 6.6 g of carbohydrate per unit of insulin on average (P = .002), with no significant changes in the portion-controlled diet group.
  • Participants on the vegan diet had lower levels of total and low-density lipoprotein cholesterol and blood urea nitrogen and a lower blood urea nitrogen-to-creatinine ratio (P for all < .001), whereas both vegan and portion-controlled groups had lower A1c levels.
  • Body weight decreased by 5.2 kg (P < .001) in the vegan group; there were no significant changes in the portion-controlled group.
  • For every 1-kg weight loss, there was a 2.16-unit decrease in the insulin total daily dose and a 0.9-unit increase in insulin sensitivity.

IN PRACTICE:

“This study provides substantial support for a low-fat vegan diet that is high in fiber and carbohydrates, low in fat, and moderate in protein” and suggests the potential therapeutic use of this diet in type 1 diabetes management, the authors wrote.

SOURCE:

The study led by Hana Kahleova, MD, PhD, Physicians Committee for Responsible Medicine, Washington, was published in Clinical Diabetes.

LIMITATIONS:

Dietary intake was recorded on the basis of self-reported data. A higher attrition rate was observed due to meal and blood glucose monitoring. The findings may have limited generalizability as the study participants comprised those seeking help for T1D.

DISCLOSURES:

The study was supported by the Physicians Committee for Responsible Medicine and a grant from the Institute for Technology in Healthcare. Some authors reported receiving compensation, being cofounders of a coaching program, writing books, providing nutrition coaching, giving lectures, or receiving royalties and honoraria from various sources.

A version of this article appeared on Medscape.com.

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Are You Ready for AI to Be a Better Doctor Than You?

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Mon, 04/15/2024 - 17:28

 

In a 2023 study published in the Annals of Emergency Medicine, European researchers fed the AI system ChatGPT information on 30 ER patients. Details included physician notes on the patients’ symptoms, physical exams, and lab results. ChatGPT made the correct diagnosis in 97% of patients compared to 87% for human doctors.

AI 1, Physicians 0

JAMA Cardiology reported in 2021 that an AI trained on nearly a million ECGs performed comparably to or exceeded cardiologist clinical diagnoses and the MUSE (GE Healthcare) system›s automated ECG analysis for most diagnostic classes.

AI 2, Physicians 0

Google’s medically focused AI model (Med-PaLM2scored 85%+ when answering US Medical Licensing Examination–style questions. That›s an «expert» physician level and far beyond the accuracy threshold needed to pass the actual exam.

AI 3, Physicians 0

A new AI tool that uses an online finger-tapping test outperformed primary care physicians when assessing the severity of Parkinson’s disease.

AI 4, Physicians 0

JAMA Ophthalmology reported in 2024 that a chatbot outperformed glaucoma specialists and matched retina specialists in diagnostic and treatment accuracy.

AI 5, Physicians 0

Should we stop? Because we could go on. In the last few years, these AI vs Physician studies have proliferated, and guess who’s winning?

65% of Doctors are Concerned

Now, the standard answer with anything AI-and-Medicine goes something like this: AI is coming, and it will be a transformative tool for physicians and improve patient care.

But the underlying unanswered question is: Physicians spend many years and a lot of money to become really good at what they do. How, exactly, should a doctor feel about a machine that can suddenly do the job better and faster?

The Medscape 2023 Physician and AI Report surveyed 1043 US physicians about their views on AI. In total, 65% are concerned about AI making diagnosis and treatment decisions, but 56% are enthusiastic about having it as an adjunct.

Cardiologists, anesthesiologists, and radiologists are most enthusiastic about AI, whereas family physicians and pediatricians are the least enthusiastic.

To get a more personal view of how physicians and other healthcare professionals are feeling about this transformative tech, I spoke with a variety of practicing doctors, a psychotherapist, and a third-year Harvard Medical School student.

‘Abysmally Poor Understanding’

Alfredo A. Sadun, MD, PhD, has been a neuro-ophthalmologist for nearly 50 years. A graduate of MIT and vice-chair of ophthalmology at UCLA, he’s long been fascinated by AI’s march into medicine. He’s watched it accomplish things that no ophthalmologist can do, such as identify gender, age, and risk for heart attack and stroke from retinal scans. But he doesn›t see the same level of interest and comprehension among the medical community.

“There’s still an abysmally poor understanding of AI among physicians in general,” he said. “It’s striking because these are intelligent, well-educated people. But we tend to draw conclusions based on what we’re familiar with, and most doctors’ experience with computers involves EHRs [electronic health records] and administrative garbage. It’s the reason they’re burning out.”

Easing the Burden

Anthony Philippakis, MD, PhD, left his cardiology practice in 2015 to become the chief data officer at the Broad Institute of MIT and Harvard. While there, he helped develop an AI-based method for identifying patients at risk for atrial fibrillation. Now, he’s a general partner at Google Ventures with the goal of bridging the gap between data sciences and medicine. His perspective on AI is unique, given that he’s seen the issue from both sides.

 

 

“I am not a bitter physician, but to be honest, when I was practicing, way too much of my time was spent staring at screens and not enough laying hands on patients,” he said. “Can you imagine what it would be like to speak to the EHR naturally and say, ‘Please order the following labs for this patient and notify me when the results come in.’ Boy, would that improve healthcare and physician satisfaction. Every physician I know is excited and optimistic about that. Almost everyone I’ve talked to feels like AI could take a lot of the stuff they don’t like doing off their plates.”

Indeed, the dividing line between physician support for AI and physician suspicion or skepticism of AI is just that. In our survey, more than three quarters of physicians said they would consider using AI for office administrative tasks, scheduling, EHRs, researching medical conditions, and even summarizing a patient’s record before a visit. But far fewer are supportive of it delivering diagnoses and treatments. This, despite an estimated 800,000 Americans dying or becoming permanently disabled each year because of diagnostic error.

Could AI Have Diagnosed This?

John D. Nuschke, MD, has been a primary care physician in Allentown, Pennsylvania, for 40 years. He’s a jovial general physician who insists his patients call him Jack. He’s recently started using an AI medical scribe called Freed. With the patient’s permission, it listens in on the visit and generates notes, saving Dr. Nuschke time and helping him focus on the person. He likes that type of assistance, but when it comes to AI replacing him, he’s skeptical.

“I had this patient I diagnosed with prostate cancer,” he explained. “He got treated and was fine for 5 years. Then, he started losing weight and feeling awful — got weak as a kitten. He went back to his urologist and oncologist who thought he had metastatic prostate cancer. He went through PET scans and blood work, but there was no sign his cancer had returned. So the specialists sent him back to me, and the second he walked in, I saw he was floridly hyperthyroid. I could tell across the room just by looking at him. Would AI have been able to make that diagnosis? Does AI do physical exams?”

Dr. Nuschke said he’s also had several instances where patients received their cancer diagnosis from the lab through an automated patient-portal system rather than from him. “That’s an AI of sorts, and I found it distressing,” he said.

Empathy From a Robot

All the doctors I spoke to were hopeful that by freeing them from the burden of administrative work, they would be able to return to the reason they got into this business in the first place — to spend more time with patients in need and support them with grace and compassion.

But suppose AI could do that too?

In a 2023 study conducted at the University of California San Diego and published in JAMA Internal Medicine, three licensed healthcare professionals compared the responses of ChatGPT and physicians to real-world health questions. The panel rated the AI’s answers nearly four times higher in quality and almost 10 times more empathetic than physicians’ replies.

A similar 2024 study in Nature found that Google’s large-language model AI matched or surpassed physician diagnostic accuracy in all six of the medical specialties considered. Plus, it outperformed doctors in 24 of 26 criteria for conversation quality, including politeness, explanation, honesty, and expressing care and commitment.

Nathaniel Chin, MD, is a gerontologist at the University of Wisconsin and advisory board member for the Alzheimer’s Foundation of America. Although he admits that studies like these “sadden me,” he’s also a realist. “There was hesitation among physicians at the beginning of the pandemic to virtual care because we missed the human connection,” he explained, “but we worked our way around that. We need to remember that what makes a chatbot strong is that it’s nothuman. It doesn’t burn out, it doesn’t get tired, it can look at data very quickly, and it doesn’t have to go home to a family and try to balance work with other aspects of life. A human being is very complex, whereas a chatbot has one single purpose.”

“Even if you don’t have AI in your space now or don’t like the idea of it, that doesn’t matter,” he added. “It’s coming. But it needs to be done right. If AI is implemented by clinicians for clinicians, it has great potential. But if it’s implemented by businesspeople for business reasons, perhaps not.”

 

 

‘The Ones Who Use the Tools the Best Will Be the Best’

One branch of medicine that stands to be dramatically affected by AI is mental health. Because bots are natural data-crunchers, they are becoming adept at analyzing the many subtle clues (phrasing in social media posts and text messages, smartwatch biometrics, therapy session videos…) that could indicate depression or other psychological disorders. In fact, its availability via smartphone apps could help democratize and destigmatize the practice.

“There is a day ahead — probably within 5 years — when a patient won’t be able to tell the difference between a real therapist and an AI therapist,” said Ken Mallon, MS, LMFT, a clinical psychotherapist and data scientist in San Jose, California. “That doesn’t worry me, though. It’s hard on therapists’ egos, but new technologies get developed. Things change. People who embrace these tools will benefit from them. The ones who use the tools the best will be the best.”

Time to Restructure Med School

Aditya Jain is in his third year at Harvard Medical School. At age 24, he’s heading into this brave new medical world with excitement and anxiety. Excitement because he sees AI revolutionizing healthcare on every level. Although the current generations of physicians and patients may grumble about its onset, he believes younger ones will feel comfortable with “DocGPT.” He’s excited that his generation of physicians will be the “translators and managers of this transition” and redefine “what it means to be a doctor.”

His anxiety, however, stems from the fact that AI has come on so fast that “it has not yet crossed the threshold of medical education,” he said. “Medical schools still largely prepare students to work as solo clinical decision makers. Most of my first 2 years were spent on pattern recognition and rote memorization, skills that AI can and will master.”

Indeed, Mr. Jain said AI was not a part of his first- or second-year curriculum. “I talk to students who are a year older than me, graduating, heading to residency, and they tell me they wish they had gotten a better grasp of how to use these technologies in medicine and in their practice. They were surprised to hear that people in my year hadn’t started using ChatGPT. We need to expend a lot more effort within the field, within academia, within practicing physicians, to figure out what our role will be in a world where AI is matching or even exceeding human intelligence. And then we need to restructure the medical education to better accomplish these goals.”

So Are You Ready for AI to Be a Better Doctor Than You?

“Yes, I am,” said Dr. Philippakis without hesitation. “When I was going through my medical training, I was continually confronted with the reality that I personally was not smart enough to keep all the information in my head that could be used to make a good decision for a patient. We have now reached a point where the amount of information that is important and useful in the practice of medicine outstrips what a human being can know. The opportunity to enable physicians with AI to remedy that situation is a good thing for doctors and, most importantly, a good thing for patients. I believe the future of medicine belongs not so much to the AI practitioner but to the AI-enabled practitioner.”

“Quick story,” added Dr. Chin. “I asked ChatGPT two questions. The first was ‘Explain the difference between Alzheimer’s and dementia’ because that’s the most common misconception in my field. And it gave me a pretty darn good answer — one I would use in a presentation with some tweaking. Then I asked it, ‘Are you a better doctor than me?’ And it replied, ‘My purpose is not to replace you, my purpose is to be supportive of you and enhance your ability.’ ”

A version of this article appeared on Medscape.com.

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In a 2023 study published in the Annals of Emergency Medicine, European researchers fed the AI system ChatGPT information on 30 ER patients. Details included physician notes on the patients’ symptoms, physical exams, and lab results. ChatGPT made the correct diagnosis in 97% of patients compared to 87% for human doctors.

AI 1, Physicians 0

JAMA Cardiology reported in 2021 that an AI trained on nearly a million ECGs performed comparably to or exceeded cardiologist clinical diagnoses and the MUSE (GE Healthcare) system›s automated ECG analysis for most diagnostic classes.

AI 2, Physicians 0

Google’s medically focused AI model (Med-PaLM2scored 85%+ when answering US Medical Licensing Examination–style questions. That›s an «expert» physician level and far beyond the accuracy threshold needed to pass the actual exam.

AI 3, Physicians 0

A new AI tool that uses an online finger-tapping test outperformed primary care physicians when assessing the severity of Parkinson’s disease.

AI 4, Physicians 0

JAMA Ophthalmology reported in 2024 that a chatbot outperformed glaucoma specialists and matched retina specialists in diagnostic and treatment accuracy.

AI 5, Physicians 0

Should we stop? Because we could go on. In the last few years, these AI vs Physician studies have proliferated, and guess who’s winning?

65% of Doctors are Concerned

Now, the standard answer with anything AI-and-Medicine goes something like this: AI is coming, and it will be a transformative tool for physicians and improve patient care.

But the underlying unanswered question is: Physicians spend many years and a lot of money to become really good at what they do. How, exactly, should a doctor feel about a machine that can suddenly do the job better and faster?

The Medscape 2023 Physician and AI Report surveyed 1043 US physicians about their views on AI. In total, 65% are concerned about AI making diagnosis and treatment decisions, but 56% are enthusiastic about having it as an adjunct.

Cardiologists, anesthesiologists, and radiologists are most enthusiastic about AI, whereas family physicians and pediatricians are the least enthusiastic.

To get a more personal view of how physicians and other healthcare professionals are feeling about this transformative tech, I spoke with a variety of practicing doctors, a psychotherapist, and a third-year Harvard Medical School student.

‘Abysmally Poor Understanding’

Alfredo A. Sadun, MD, PhD, has been a neuro-ophthalmologist for nearly 50 years. A graduate of MIT and vice-chair of ophthalmology at UCLA, he’s long been fascinated by AI’s march into medicine. He’s watched it accomplish things that no ophthalmologist can do, such as identify gender, age, and risk for heart attack and stroke from retinal scans. But he doesn›t see the same level of interest and comprehension among the medical community.

“There’s still an abysmally poor understanding of AI among physicians in general,” he said. “It’s striking because these are intelligent, well-educated people. But we tend to draw conclusions based on what we’re familiar with, and most doctors’ experience with computers involves EHRs [electronic health records] and administrative garbage. It’s the reason they’re burning out.”

Easing the Burden

Anthony Philippakis, MD, PhD, left his cardiology practice in 2015 to become the chief data officer at the Broad Institute of MIT and Harvard. While there, he helped develop an AI-based method for identifying patients at risk for atrial fibrillation. Now, he’s a general partner at Google Ventures with the goal of bridging the gap between data sciences and medicine. His perspective on AI is unique, given that he’s seen the issue from both sides.

 

 

“I am not a bitter physician, but to be honest, when I was practicing, way too much of my time was spent staring at screens and not enough laying hands on patients,” he said. “Can you imagine what it would be like to speak to the EHR naturally and say, ‘Please order the following labs for this patient and notify me when the results come in.’ Boy, would that improve healthcare and physician satisfaction. Every physician I know is excited and optimistic about that. Almost everyone I’ve talked to feels like AI could take a lot of the stuff they don’t like doing off their plates.”

Indeed, the dividing line between physician support for AI and physician suspicion or skepticism of AI is just that. In our survey, more than three quarters of physicians said they would consider using AI for office administrative tasks, scheduling, EHRs, researching medical conditions, and even summarizing a patient’s record before a visit. But far fewer are supportive of it delivering diagnoses and treatments. This, despite an estimated 800,000 Americans dying or becoming permanently disabled each year because of diagnostic error.

Could AI Have Diagnosed This?

John D. Nuschke, MD, has been a primary care physician in Allentown, Pennsylvania, for 40 years. He’s a jovial general physician who insists his patients call him Jack. He’s recently started using an AI medical scribe called Freed. With the patient’s permission, it listens in on the visit and generates notes, saving Dr. Nuschke time and helping him focus on the person. He likes that type of assistance, but when it comes to AI replacing him, he’s skeptical.

“I had this patient I diagnosed with prostate cancer,” he explained. “He got treated and was fine for 5 years. Then, he started losing weight and feeling awful — got weak as a kitten. He went back to his urologist and oncologist who thought he had metastatic prostate cancer. He went through PET scans and blood work, but there was no sign his cancer had returned. So the specialists sent him back to me, and the second he walked in, I saw he was floridly hyperthyroid. I could tell across the room just by looking at him. Would AI have been able to make that diagnosis? Does AI do physical exams?”

Dr. Nuschke said he’s also had several instances where patients received their cancer diagnosis from the lab through an automated patient-portal system rather than from him. “That’s an AI of sorts, and I found it distressing,” he said.

Empathy From a Robot

All the doctors I spoke to were hopeful that by freeing them from the burden of administrative work, they would be able to return to the reason they got into this business in the first place — to spend more time with patients in need and support them with grace and compassion.

But suppose AI could do that too?

In a 2023 study conducted at the University of California San Diego and published in JAMA Internal Medicine, three licensed healthcare professionals compared the responses of ChatGPT and physicians to real-world health questions. The panel rated the AI’s answers nearly four times higher in quality and almost 10 times more empathetic than physicians’ replies.

A similar 2024 study in Nature found that Google’s large-language model AI matched or surpassed physician diagnostic accuracy in all six of the medical specialties considered. Plus, it outperformed doctors in 24 of 26 criteria for conversation quality, including politeness, explanation, honesty, and expressing care and commitment.

Nathaniel Chin, MD, is a gerontologist at the University of Wisconsin and advisory board member for the Alzheimer’s Foundation of America. Although he admits that studies like these “sadden me,” he’s also a realist. “There was hesitation among physicians at the beginning of the pandemic to virtual care because we missed the human connection,” he explained, “but we worked our way around that. We need to remember that what makes a chatbot strong is that it’s nothuman. It doesn’t burn out, it doesn’t get tired, it can look at data very quickly, and it doesn’t have to go home to a family and try to balance work with other aspects of life. A human being is very complex, whereas a chatbot has one single purpose.”

“Even if you don’t have AI in your space now or don’t like the idea of it, that doesn’t matter,” he added. “It’s coming. But it needs to be done right. If AI is implemented by clinicians for clinicians, it has great potential. But if it’s implemented by businesspeople for business reasons, perhaps not.”

 

 

‘The Ones Who Use the Tools the Best Will Be the Best’

One branch of medicine that stands to be dramatically affected by AI is mental health. Because bots are natural data-crunchers, they are becoming adept at analyzing the many subtle clues (phrasing in social media posts and text messages, smartwatch biometrics, therapy session videos…) that could indicate depression or other psychological disorders. In fact, its availability via smartphone apps could help democratize and destigmatize the practice.

“There is a day ahead — probably within 5 years — when a patient won’t be able to tell the difference between a real therapist and an AI therapist,” said Ken Mallon, MS, LMFT, a clinical psychotherapist and data scientist in San Jose, California. “That doesn’t worry me, though. It’s hard on therapists’ egos, but new technologies get developed. Things change. People who embrace these tools will benefit from them. The ones who use the tools the best will be the best.”

Time to Restructure Med School

Aditya Jain is in his third year at Harvard Medical School. At age 24, he’s heading into this brave new medical world with excitement and anxiety. Excitement because he sees AI revolutionizing healthcare on every level. Although the current generations of physicians and patients may grumble about its onset, he believes younger ones will feel comfortable with “DocGPT.” He’s excited that his generation of physicians will be the “translators and managers of this transition” and redefine “what it means to be a doctor.”

His anxiety, however, stems from the fact that AI has come on so fast that “it has not yet crossed the threshold of medical education,” he said. “Medical schools still largely prepare students to work as solo clinical decision makers. Most of my first 2 years were spent on pattern recognition and rote memorization, skills that AI can and will master.”

Indeed, Mr. Jain said AI was not a part of his first- or second-year curriculum. “I talk to students who are a year older than me, graduating, heading to residency, and they tell me they wish they had gotten a better grasp of how to use these technologies in medicine and in their practice. They were surprised to hear that people in my year hadn’t started using ChatGPT. We need to expend a lot more effort within the field, within academia, within practicing physicians, to figure out what our role will be in a world where AI is matching or even exceeding human intelligence. And then we need to restructure the medical education to better accomplish these goals.”

So Are You Ready for AI to Be a Better Doctor Than You?

“Yes, I am,” said Dr. Philippakis without hesitation. “When I was going through my medical training, I was continually confronted with the reality that I personally was not smart enough to keep all the information in my head that could be used to make a good decision for a patient. We have now reached a point where the amount of information that is important and useful in the practice of medicine outstrips what a human being can know. The opportunity to enable physicians with AI to remedy that situation is a good thing for doctors and, most importantly, a good thing for patients. I believe the future of medicine belongs not so much to the AI practitioner but to the AI-enabled practitioner.”

“Quick story,” added Dr. Chin. “I asked ChatGPT two questions. The first was ‘Explain the difference between Alzheimer’s and dementia’ because that’s the most common misconception in my field. And it gave me a pretty darn good answer — one I would use in a presentation with some tweaking. Then I asked it, ‘Are you a better doctor than me?’ And it replied, ‘My purpose is not to replace you, my purpose is to be supportive of you and enhance your ability.’ ”

A version of this article appeared on Medscape.com.

 

In a 2023 study published in the Annals of Emergency Medicine, European researchers fed the AI system ChatGPT information on 30 ER patients. Details included physician notes on the patients’ symptoms, physical exams, and lab results. ChatGPT made the correct diagnosis in 97% of patients compared to 87% for human doctors.

AI 1, Physicians 0

JAMA Cardiology reported in 2021 that an AI trained on nearly a million ECGs performed comparably to or exceeded cardiologist clinical diagnoses and the MUSE (GE Healthcare) system›s automated ECG analysis for most diagnostic classes.

AI 2, Physicians 0

Google’s medically focused AI model (Med-PaLM2scored 85%+ when answering US Medical Licensing Examination–style questions. That›s an «expert» physician level and far beyond the accuracy threshold needed to pass the actual exam.

AI 3, Physicians 0

A new AI tool that uses an online finger-tapping test outperformed primary care physicians when assessing the severity of Parkinson’s disease.

AI 4, Physicians 0

JAMA Ophthalmology reported in 2024 that a chatbot outperformed glaucoma specialists and matched retina specialists in diagnostic and treatment accuracy.

AI 5, Physicians 0

Should we stop? Because we could go on. In the last few years, these AI vs Physician studies have proliferated, and guess who’s winning?

65% of Doctors are Concerned

Now, the standard answer with anything AI-and-Medicine goes something like this: AI is coming, and it will be a transformative tool for physicians and improve patient care.

But the underlying unanswered question is: Physicians spend many years and a lot of money to become really good at what they do. How, exactly, should a doctor feel about a machine that can suddenly do the job better and faster?

The Medscape 2023 Physician and AI Report surveyed 1043 US physicians about their views on AI. In total, 65% are concerned about AI making diagnosis and treatment decisions, but 56% are enthusiastic about having it as an adjunct.

Cardiologists, anesthesiologists, and radiologists are most enthusiastic about AI, whereas family physicians and pediatricians are the least enthusiastic.

To get a more personal view of how physicians and other healthcare professionals are feeling about this transformative tech, I spoke with a variety of practicing doctors, a psychotherapist, and a third-year Harvard Medical School student.

‘Abysmally Poor Understanding’

Alfredo A. Sadun, MD, PhD, has been a neuro-ophthalmologist for nearly 50 years. A graduate of MIT and vice-chair of ophthalmology at UCLA, he’s long been fascinated by AI’s march into medicine. He’s watched it accomplish things that no ophthalmologist can do, such as identify gender, age, and risk for heart attack and stroke from retinal scans. But he doesn›t see the same level of interest and comprehension among the medical community.

“There’s still an abysmally poor understanding of AI among physicians in general,” he said. “It’s striking because these are intelligent, well-educated people. But we tend to draw conclusions based on what we’re familiar with, and most doctors’ experience with computers involves EHRs [electronic health records] and administrative garbage. It’s the reason they’re burning out.”

Easing the Burden

Anthony Philippakis, MD, PhD, left his cardiology practice in 2015 to become the chief data officer at the Broad Institute of MIT and Harvard. While there, he helped develop an AI-based method for identifying patients at risk for atrial fibrillation. Now, he’s a general partner at Google Ventures with the goal of bridging the gap between data sciences and medicine. His perspective on AI is unique, given that he’s seen the issue from both sides.

 

 

“I am not a bitter physician, but to be honest, when I was practicing, way too much of my time was spent staring at screens and not enough laying hands on patients,” he said. “Can you imagine what it would be like to speak to the EHR naturally and say, ‘Please order the following labs for this patient and notify me when the results come in.’ Boy, would that improve healthcare and physician satisfaction. Every physician I know is excited and optimistic about that. Almost everyone I’ve talked to feels like AI could take a lot of the stuff they don’t like doing off their plates.”

Indeed, the dividing line between physician support for AI and physician suspicion or skepticism of AI is just that. In our survey, more than three quarters of physicians said they would consider using AI for office administrative tasks, scheduling, EHRs, researching medical conditions, and even summarizing a patient’s record before a visit. But far fewer are supportive of it delivering diagnoses and treatments. This, despite an estimated 800,000 Americans dying or becoming permanently disabled each year because of diagnostic error.

Could AI Have Diagnosed This?

John D. Nuschke, MD, has been a primary care physician in Allentown, Pennsylvania, for 40 years. He’s a jovial general physician who insists his patients call him Jack. He’s recently started using an AI medical scribe called Freed. With the patient’s permission, it listens in on the visit and generates notes, saving Dr. Nuschke time and helping him focus on the person. He likes that type of assistance, but when it comes to AI replacing him, he’s skeptical.

“I had this patient I diagnosed with prostate cancer,” he explained. “He got treated and was fine for 5 years. Then, he started losing weight and feeling awful — got weak as a kitten. He went back to his urologist and oncologist who thought he had metastatic prostate cancer. He went through PET scans and blood work, but there was no sign his cancer had returned. So the specialists sent him back to me, and the second he walked in, I saw he was floridly hyperthyroid. I could tell across the room just by looking at him. Would AI have been able to make that diagnosis? Does AI do physical exams?”

Dr. Nuschke said he’s also had several instances where patients received their cancer diagnosis from the lab through an automated patient-portal system rather than from him. “That’s an AI of sorts, and I found it distressing,” he said.

Empathy From a Robot

All the doctors I spoke to were hopeful that by freeing them from the burden of administrative work, they would be able to return to the reason they got into this business in the first place — to spend more time with patients in need and support them with grace and compassion.

But suppose AI could do that too?

In a 2023 study conducted at the University of California San Diego and published in JAMA Internal Medicine, three licensed healthcare professionals compared the responses of ChatGPT and physicians to real-world health questions. The panel rated the AI’s answers nearly four times higher in quality and almost 10 times more empathetic than physicians’ replies.

A similar 2024 study in Nature found that Google’s large-language model AI matched or surpassed physician diagnostic accuracy in all six of the medical specialties considered. Plus, it outperformed doctors in 24 of 26 criteria for conversation quality, including politeness, explanation, honesty, and expressing care and commitment.

Nathaniel Chin, MD, is a gerontologist at the University of Wisconsin and advisory board member for the Alzheimer’s Foundation of America. Although he admits that studies like these “sadden me,” he’s also a realist. “There was hesitation among physicians at the beginning of the pandemic to virtual care because we missed the human connection,” he explained, “but we worked our way around that. We need to remember that what makes a chatbot strong is that it’s nothuman. It doesn’t burn out, it doesn’t get tired, it can look at data very quickly, and it doesn’t have to go home to a family and try to balance work with other aspects of life. A human being is very complex, whereas a chatbot has one single purpose.”

“Even if you don’t have AI in your space now or don’t like the idea of it, that doesn’t matter,” he added. “It’s coming. But it needs to be done right. If AI is implemented by clinicians for clinicians, it has great potential. But if it’s implemented by businesspeople for business reasons, perhaps not.”

 

 

‘The Ones Who Use the Tools the Best Will Be the Best’

One branch of medicine that stands to be dramatically affected by AI is mental health. Because bots are natural data-crunchers, they are becoming adept at analyzing the many subtle clues (phrasing in social media posts and text messages, smartwatch biometrics, therapy session videos…) that could indicate depression or other psychological disorders. In fact, its availability via smartphone apps could help democratize and destigmatize the practice.

“There is a day ahead — probably within 5 years — when a patient won’t be able to tell the difference between a real therapist and an AI therapist,” said Ken Mallon, MS, LMFT, a clinical psychotherapist and data scientist in San Jose, California. “That doesn’t worry me, though. It’s hard on therapists’ egos, but new technologies get developed. Things change. People who embrace these tools will benefit from them. The ones who use the tools the best will be the best.”

Time to Restructure Med School

Aditya Jain is in his third year at Harvard Medical School. At age 24, he’s heading into this brave new medical world with excitement and anxiety. Excitement because he sees AI revolutionizing healthcare on every level. Although the current generations of physicians and patients may grumble about its onset, he believes younger ones will feel comfortable with “DocGPT.” He’s excited that his generation of physicians will be the “translators and managers of this transition” and redefine “what it means to be a doctor.”

His anxiety, however, stems from the fact that AI has come on so fast that “it has not yet crossed the threshold of medical education,” he said. “Medical schools still largely prepare students to work as solo clinical decision makers. Most of my first 2 years were spent on pattern recognition and rote memorization, skills that AI can and will master.”

Indeed, Mr. Jain said AI was not a part of his first- or second-year curriculum. “I talk to students who are a year older than me, graduating, heading to residency, and they tell me they wish they had gotten a better grasp of how to use these technologies in medicine and in their practice. They were surprised to hear that people in my year hadn’t started using ChatGPT. We need to expend a lot more effort within the field, within academia, within practicing physicians, to figure out what our role will be in a world where AI is matching or even exceeding human intelligence. And then we need to restructure the medical education to better accomplish these goals.”

So Are You Ready for AI to Be a Better Doctor Than You?

“Yes, I am,” said Dr. Philippakis without hesitation. “When I was going through my medical training, I was continually confronted with the reality that I personally was not smart enough to keep all the information in my head that could be used to make a good decision for a patient. We have now reached a point where the amount of information that is important and useful in the practice of medicine outstrips what a human being can know. The opportunity to enable physicians with AI to remedy that situation is a good thing for doctors and, most importantly, a good thing for patients. I believe the future of medicine belongs not so much to the AI practitioner but to the AI-enabled practitioner.”

“Quick story,” added Dr. Chin. “I asked ChatGPT two questions. The first was ‘Explain the difference between Alzheimer’s and dementia’ because that’s the most common misconception in my field. And it gave me a pretty darn good answer — one I would use in a presentation with some tweaking. Then I asked it, ‘Are you a better doctor than me?’ And it replied, ‘My purpose is not to replace you, my purpose is to be supportive of you and enhance your ability.’ ”

A version of this article appeared on Medscape.com.

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Endoscopic Sleeve Gastroplasty More Cost-Effective Long Term Than Semaglutide for Treating Obesity

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Changed
Tue, 04/16/2024 - 11:53

 

TOPLINE:

Endoscopic sleeve gastroplasty (ESG) is more cost-effective, and achieves and sustains greater weight loss, than semaglutide over a 5-year period in patients with class II obesity.

METHODOLOGY:

  • Researchers used a Markov cohort model to assess the cost-effectiveness of semaglutide vs ESG over 5 years in people with class II obesity (body mass index [BMI], 35-39.9), with the model costs based on the US healthcare system.
  • A 45-year-old patient with a BMI of 37 was included as the base case in this study.
  • The model simulated hypothetical patients with class II obesity who received ESG, semaglutide, or no treatment (reference group with zero treatment costs).
  • The model derived clinical data for the first year from two randomized clinical trials, STEP 1 (semaglutide) and MERIT (ESG); for the following years, data were derived from published studies and publicly available data sources.
  • Study outcomes were total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).

TAKEAWAY:

  • ESG led to better weight loss outcomes (BMI, 31.7 vs 33.0) and added 0.06 more QALYs relative to semaglutide in the modelled patients over the 5-year time horizon; about 20% of the patients receiving semaglutide dropped out owing to medication intolerance or other reasons.
  • The semaglutide treatment was $33,583 more expensive than the ESG treatment over the 5-year period.
  • ESG became more cost-effective than semaglutide at 2 years and remained so over a 5-year time horizon, with an ICER of — $595,532 per QALY for the base case.
  • The annual price of semaglutide would need to be reduced from $13,618 to $3591 to achieve nondominance compared with ESG.

IN PRACTICE:

“The strategic choice of cost saving yet effective treatment such as ESG compared with semaglutide for specific patient groups could help alleviate the potential budget strain expected from the use of semaglutide,” the authors wrote.

SOURCE:

Muhammad Haseeb, MD, MSc, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, led this study, which was published online on April 12, 2024, in JAMA Network Open.

LIMITATIONS:

The study did not look at benefits associated with improvements in comorbidities from either treatment strategy, and the model used did not account for any microlevel follow-up costs such as routine clinic visits. The authors acknowledged that semaglutide’s prices may fall in the future when more anti-obesity drugs get approved.

DISCLOSURES:

This study was supported in part by the National Institutes of Health. Some authors declared receiving personal fees, royalty payments, and/or grants and having other ties with several sources.

A version of this article appeared on Medscape.com.

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TOPLINE:

Endoscopic sleeve gastroplasty (ESG) is more cost-effective, and achieves and sustains greater weight loss, than semaglutide over a 5-year period in patients with class II obesity.

METHODOLOGY:

  • Researchers used a Markov cohort model to assess the cost-effectiveness of semaglutide vs ESG over 5 years in people with class II obesity (body mass index [BMI], 35-39.9), with the model costs based on the US healthcare system.
  • A 45-year-old patient with a BMI of 37 was included as the base case in this study.
  • The model simulated hypothetical patients with class II obesity who received ESG, semaglutide, or no treatment (reference group with zero treatment costs).
  • The model derived clinical data for the first year from two randomized clinical trials, STEP 1 (semaglutide) and MERIT (ESG); for the following years, data were derived from published studies and publicly available data sources.
  • Study outcomes were total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).

TAKEAWAY:

  • ESG led to better weight loss outcomes (BMI, 31.7 vs 33.0) and added 0.06 more QALYs relative to semaglutide in the modelled patients over the 5-year time horizon; about 20% of the patients receiving semaglutide dropped out owing to medication intolerance or other reasons.
  • The semaglutide treatment was $33,583 more expensive than the ESG treatment over the 5-year period.
  • ESG became more cost-effective than semaglutide at 2 years and remained so over a 5-year time horizon, with an ICER of — $595,532 per QALY for the base case.
  • The annual price of semaglutide would need to be reduced from $13,618 to $3591 to achieve nondominance compared with ESG.

IN PRACTICE:

“The strategic choice of cost saving yet effective treatment such as ESG compared with semaglutide for specific patient groups could help alleviate the potential budget strain expected from the use of semaglutide,” the authors wrote.

SOURCE:

Muhammad Haseeb, MD, MSc, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, led this study, which was published online on April 12, 2024, in JAMA Network Open.

LIMITATIONS:

The study did not look at benefits associated with improvements in comorbidities from either treatment strategy, and the model used did not account for any microlevel follow-up costs such as routine clinic visits. The authors acknowledged that semaglutide’s prices may fall in the future when more anti-obesity drugs get approved.

DISCLOSURES:

This study was supported in part by the National Institutes of Health. Some authors declared receiving personal fees, royalty payments, and/or grants and having other ties with several sources.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Endoscopic sleeve gastroplasty (ESG) is more cost-effective, and achieves and sustains greater weight loss, than semaglutide over a 5-year period in patients with class II obesity.

METHODOLOGY:

  • Researchers used a Markov cohort model to assess the cost-effectiveness of semaglutide vs ESG over 5 years in people with class II obesity (body mass index [BMI], 35-39.9), with the model costs based on the US healthcare system.
  • A 45-year-old patient with a BMI of 37 was included as the base case in this study.
  • The model simulated hypothetical patients with class II obesity who received ESG, semaglutide, or no treatment (reference group with zero treatment costs).
  • The model derived clinical data for the first year from two randomized clinical trials, STEP 1 (semaglutide) and MERIT (ESG); for the following years, data were derived from published studies and publicly available data sources.
  • Study outcomes were total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).

TAKEAWAY:

  • ESG led to better weight loss outcomes (BMI, 31.7 vs 33.0) and added 0.06 more QALYs relative to semaglutide in the modelled patients over the 5-year time horizon; about 20% of the patients receiving semaglutide dropped out owing to medication intolerance or other reasons.
  • The semaglutide treatment was $33,583 more expensive than the ESG treatment over the 5-year period.
  • ESG became more cost-effective than semaglutide at 2 years and remained so over a 5-year time horizon, with an ICER of — $595,532 per QALY for the base case.
  • The annual price of semaglutide would need to be reduced from $13,618 to $3591 to achieve nondominance compared with ESG.

IN PRACTICE:

“The strategic choice of cost saving yet effective treatment such as ESG compared with semaglutide for specific patient groups could help alleviate the potential budget strain expected from the use of semaglutide,” the authors wrote.

SOURCE:

Muhammad Haseeb, MD, MSc, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, led this study, which was published online on April 12, 2024, in JAMA Network Open.

LIMITATIONS:

The study did not look at benefits associated with improvements in comorbidities from either treatment strategy, and the model used did not account for any microlevel follow-up costs such as routine clinic visits. The authors acknowledged that semaglutide’s prices may fall in the future when more anti-obesity drugs get approved.

DISCLOSURES:

This study was supported in part by the National Institutes of Health. Some authors declared receiving personal fees, royalty payments, and/or grants and having other ties with several sources.

A version of this article appeared on Medscape.com.

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GLP-1 Receptor Agonists Don’t Raise Thyroid Cancer Risk

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Changed
Mon, 04/15/2024 - 09:24

 

TOPLINE:

No significant association was found between the use of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) and thyroid cancer over nearly 4 years.

METHODOLOGY:

  • A cohort study using data from nationwide registers in Denmark, Norway, and Sweden between 2007 and 2021 included 145,410 patients who initiated GLP-1 RAs and 291,667 propensity score-matched patients initiating dipeptidyl peptidase 4 (DPP4) inhibitors as active comparators.
  • Additional analysis included 111,744 who initiated GLP-1 RAs and 148,179 patients initiating sodium-glucose cotransporter 2 (SGLT2) inhibitors.
  • Overall, mean follow-up time was 3.9 years, with 25% followed for more than 6 years.

TAKEAWAY:

  • The most common individual GLP-1 RAs were liraglutide (57.3%) and semaglutide (32.9%).
  • During follow-up, there were 76 incident thyroid cancer cases among GLP-1 RA users and 184 cases in DPP4 inhibitor users, giving incidence rates per 10,000 of 1.33 and 1.46, respectively, a nonsignificant difference (hazard ratio [HR], 0.93; 95% CI, 0.66-1.31).
  • Papillary thyroid cancer was the most common thyroid cancer subtype, followed by follicular and medullary, with no significant increases in risk with GLP-1 RAs by cancer type, although the numbers were small.
  • In the SGLT2 inhibitor comparison, there was also no significantly increased thyroid cancer risk for GLP-1 RAs (HR, 1.16; 95% CI, 0.65-2.05).

IN PRACTICE:

“Given the upper limit of the confidence interval, the findings are incompatible with more than a 31% increased relative risk of thyroid cancer. In absolute terms, this translates to no more than 0.36 excess cases per 10 000 person-years, a figure that should be interpreted against the background incidence of 1.46 per 10,000 person-years among the comparator group in the study populations.”

SOURCE:

This study was conducted by Björn Pasternak, MD, PhD, of the Karolinska Institutet, Stockholm, and colleagues. It was published online on April 10, 2024, in The BMJ.

LIMITATIONS:

Relatively short follow-up for cancer risk. Risk by individual GLP-1 RA not analyzed. Small event numbers. Observational, with potential for residual confounding and time-release bias.

DISCLOSURES:

The study was supported by grants from the Swedish Cancer Society and the Swedish Research Council. Dr. Pasternak was supported by a consolidator investigator grant from Karolinska Institutet. Some of the coauthors had industry disclosures.

A version of this article appeared on Medscape.com.

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TOPLINE:

No significant association was found between the use of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) and thyroid cancer over nearly 4 years.

METHODOLOGY:

  • A cohort study using data from nationwide registers in Denmark, Norway, and Sweden between 2007 and 2021 included 145,410 patients who initiated GLP-1 RAs and 291,667 propensity score-matched patients initiating dipeptidyl peptidase 4 (DPP4) inhibitors as active comparators.
  • Additional analysis included 111,744 who initiated GLP-1 RAs and 148,179 patients initiating sodium-glucose cotransporter 2 (SGLT2) inhibitors.
  • Overall, mean follow-up time was 3.9 years, with 25% followed for more than 6 years.

TAKEAWAY:

  • The most common individual GLP-1 RAs were liraglutide (57.3%) and semaglutide (32.9%).
  • During follow-up, there were 76 incident thyroid cancer cases among GLP-1 RA users and 184 cases in DPP4 inhibitor users, giving incidence rates per 10,000 of 1.33 and 1.46, respectively, a nonsignificant difference (hazard ratio [HR], 0.93; 95% CI, 0.66-1.31).
  • Papillary thyroid cancer was the most common thyroid cancer subtype, followed by follicular and medullary, with no significant increases in risk with GLP-1 RAs by cancer type, although the numbers were small.
  • In the SGLT2 inhibitor comparison, there was also no significantly increased thyroid cancer risk for GLP-1 RAs (HR, 1.16; 95% CI, 0.65-2.05).

IN PRACTICE:

“Given the upper limit of the confidence interval, the findings are incompatible with more than a 31% increased relative risk of thyroid cancer. In absolute terms, this translates to no more than 0.36 excess cases per 10 000 person-years, a figure that should be interpreted against the background incidence of 1.46 per 10,000 person-years among the comparator group in the study populations.”

SOURCE:

This study was conducted by Björn Pasternak, MD, PhD, of the Karolinska Institutet, Stockholm, and colleagues. It was published online on April 10, 2024, in The BMJ.

LIMITATIONS:

Relatively short follow-up for cancer risk. Risk by individual GLP-1 RA not analyzed. Small event numbers. Observational, with potential for residual confounding and time-release bias.

DISCLOSURES:

The study was supported by grants from the Swedish Cancer Society and the Swedish Research Council. Dr. Pasternak was supported by a consolidator investigator grant from Karolinska Institutet. Some of the coauthors had industry disclosures.

A version of this article appeared on Medscape.com.

 

TOPLINE:

No significant association was found between the use of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) and thyroid cancer over nearly 4 years.

METHODOLOGY:

  • A cohort study using data from nationwide registers in Denmark, Norway, and Sweden between 2007 and 2021 included 145,410 patients who initiated GLP-1 RAs and 291,667 propensity score-matched patients initiating dipeptidyl peptidase 4 (DPP4) inhibitors as active comparators.
  • Additional analysis included 111,744 who initiated GLP-1 RAs and 148,179 patients initiating sodium-glucose cotransporter 2 (SGLT2) inhibitors.
  • Overall, mean follow-up time was 3.9 years, with 25% followed for more than 6 years.

TAKEAWAY:

  • The most common individual GLP-1 RAs were liraglutide (57.3%) and semaglutide (32.9%).
  • During follow-up, there were 76 incident thyroid cancer cases among GLP-1 RA users and 184 cases in DPP4 inhibitor users, giving incidence rates per 10,000 of 1.33 and 1.46, respectively, a nonsignificant difference (hazard ratio [HR], 0.93; 95% CI, 0.66-1.31).
  • Papillary thyroid cancer was the most common thyroid cancer subtype, followed by follicular and medullary, with no significant increases in risk with GLP-1 RAs by cancer type, although the numbers were small.
  • In the SGLT2 inhibitor comparison, there was also no significantly increased thyroid cancer risk for GLP-1 RAs (HR, 1.16; 95% CI, 0.65-2.05).

IN PRACTICE:

“Given the upper limit of the confidence interval, the findings are incompatible with more than a 31% increased relative risk of thyroid cancer. In absolute terms, this translates to no more than 0.36 excess cases per 10 000 person-years, a figure that should be interpreted against the background incidence of 1.46 per 10,000 person-years among the comparator group in the study populations.”

SOURCE:

This study was conducted by Björn Pasternak, MD, PhD, of the Karolinska Institutet, Stockholm, and colleagues. It was published online on April 10, 2024, in The BMJ.

LIMITATIONS:

Relatively short follow-up for cancer risk. Risk by individual GLP-1 RA not analyzed. Small event numbers. Observational, with potential for residual confounding and time-release bias.

DISCLOSURES:

The study was supported by grants from the Swedish Cancer Society and the Swedish Research Council. Dr. Pasternak was supported by a consolidator investigator grant from Karolinska Institutet. Some of the coauthors had industry disclosures.

A version of this article appeared on Medscape.com.

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Speedy Eating and Late-Night Meals May Take a Toll on Health

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Changed
Fri, 04/19/2024 - 11:19

You are what you eat, as the adage goes. But a growing body of evidence indicates that it’s not just what and how much you eat that influence your health. How fast and when you eat also play a role.

Research now indicates that these two factors may affect the risk for gastrointestinal problems, obesity, and type 2 diabetes (T2D). Because meal timing and speed of consumption are modifiable, they present new opportunities to change patient behavior to help prevent and perhaps address these conditions.

Not So Fast

Most people are well acquainted with the short-term gastrointestinal effects of eating too quickly, which include indigestion, gas, bloating, and nausea. But regularly eating too fast can cause long-term consequences.

Obtaining a sense of fullness is key to staving off overeating and excess caloric intake. However, it takes approximately 20 minutes for the stomach to alert the brain to feelings of fullness. Eat too quickly and the fullness signaling might not set in until you’ve consumed more calories than intended. Research links this habit to excess body weight.

The practice also can lead to gastrointestinal diseases over the long term because overeating causes food to remain in the stomach longer, thus prolonging the time that the gastric mucosa is exposed to gastric acids.

A study of 10,893 adults in Korea reported that those with the fastest eating speed (< 5 min/meal) had a 1.7 times greater likelihood of endoscopic erosive gastritis than those with the slowest times (≥ 15 min/meal). Faster eating also was linked to increased risk for functional dyspepsia in a study involving 89 young-adult female military cadets in Korea with relatively controlled eating patterns.

On the extreme end of the spectrum, researchers who performed an assessment of a competitive speed eater speculated that the observed physiological accommodation required for the role (expanding the stomach to form a large flaccid sac) makes speed eaters vulnerable to morbid obesity, gastroparesis, intractable nausea and vomiting, and the need for gastrectomy.

The risk for metabolic changes and eventual development of T2D also appear to be linked to how quickly food is consumed.

Two clinical studies conducted in Japan — a cohort study of 2050 male factory workers and a nationwide study with 197,825 participants — identified a significant association between faster eating and T2D and insulin resistance. A case-control study involving 234 patients with new onset T2D and 468 controls from Lithuania linked faster eating to a greater than twofold risk for T2D. And a Chinese cross-sectional study of 7972 adults indicated that faster eating significantly increased the risk for metabolic syndrome, elevated blood pressure, and central obesity in adults.

Various hypotheses have been proposed to explain why fast eating may upset metabolic processes, including a delayed sense of fullness contributing to spiking postprandial glucose levels, lack of time for mastication causing higher glucose concentrations, and the triggering of specific cytokines (eg, interleukin-1 beta and interleukin-6) that lead to insulin resistance. It is also possible that the association is the result of people who eat quickly having relatively higher body weights, which translates to a higher risk for T2D.

However, there’s an opportunity in the association of rapid meal consumption with gastrointestinal and metabolic diseases, as people can slow the speed at which they eat so they feel full before they overeat.

A 2019 study in which 21 participants were instructed to eat a 600-kcal meal at a “normal” or “slow” pace (6 minutes or 24 minutes) found that the latter group reported feeling fuller while consuming fewer calories.

This approach may not work for all patients, however. There’s evidence to suggest that tactics to slow down eating may not limit the energy intake of those who are already overweight or obese.

Patients with obesity may physiologically differ in their processing of food, according to Michael Camilleri, MD, consultant in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester, Minnesota.

“We have demonstrated that about 20%-25% of people with obesity actually have rapid gastric emptying,” he told this news organization. “As a result, they don’t feel full after they eat a meal and that might impact the total volume of food that they eat before they really feel full.”

 

 

The Ideal Time to Eat

It’s not only the speed at which individuals eat that may influence outcomes but when they take their meals. Research indicates that eating earlier in the day to align meals with the body’s circadian rhythms in metabolism offers health benefits.

“The focus would be to eat a meal that syncs during those daytime hours,” Collin Popp, PhD, MS, RD, a research scientist at the NYU Grossman School of Medicine in New York, told this news organization. “I typically suggest patients have their largest meal in the morning, whether that’s a large or medium-sized breakfast, or a big lunch.”

recent cross-sectional study of 2050 participants found that having the largest meal at lunch protected against obesity (odds ratio [OR], 0.71), whereas having it at dinner increased the risk for obesity (OR, 1.67) and led to higher body mass index.

Consuming the majority of calories in meals earlier in the day may have metabolic health benefits, as well.

2015 randomized controlled trial involving 18 adults with obesity and T2D found that eating a high-energy breakfast and a low-energy dinner leads to reduced hyperglycemia throughout the day compared with eating a low-energy breakfast and a high-energy dinner.

Time-restricted eating (TRE), a form of intermittent fasting, also can improve metabolic health depending on the time of day.

2023 meta-analysis found that TRE was more effective at reducing fasting glucose levels in participants who were overweight and obese if done earlier rather than later in the day. Similarly, a 2022 study involving 82 healthy patients without diabetes or obesity found that early TRE was more effective than mid-day TRE at improving insulin sensitivity and that it improved fasting glucose and reduced total body mass and adiposity, while mid-day TRE did not.

study that analyzed the effects of TRE in eight adult men with overweight and prediabetes found “better insulin resistance when the window of food consumption was earlier in the day,» noted endocrinologist Beverly Tchang, MD, an assistant professor of clinical medicine at Weill Cornell Medicine with a focus on obesity medication.

Patients May Benefit From Behavioral Interventions

Patients potentially negatively affected by eating too quickly or at late hours may benefit from adopting behavioral interventions to address these tendencies. To determine if a patient is a candidate for such interventions, Dr. Popp recommends starting with a simple conversation.

“When I first meet patients, I always ask them to describe to me a typical day for how they eat — when they’re eating, what they’re eating, the food quality, who are they with — to see if there’s social aspects to it. Then try and make the recommendations based on that,” said Dr. Popp, whose work focuses on biobehavioral interventions for the treatment and prevention of obesity, T2D, and other cardiometabolic outcomes.

Dr. Tchang said she encourages her patients to be mindful of hunger and fullness cues.

“Eat if you’re hungry; don’t force yourself to eat if you’re not hungry,” she said. “If you’re not sure whether you’re hungry or not, speak to a doctor because this points to an abnormality in your appetite-regulation system, which can be helped with GLP-1 [glucagon-like peptide 1] receptor agonists.”

Adjusting what patients eat can help them improve their meal timing.

“For example, we know that a high-fiber diet or a diet that has a large amount of fat in it tends to empty from the stomach slower,” Dr. Camilleri said. “That might give a sensation of fullness that lasts longer and that might prevent, for instance, the ingestion of the next meal.”

Those trying to eat more slowly are advised to seek out foods that are hard in texture and minimally processed.

study involving 50 patients with healthy weights found that hard foods are consumed more slowly than soft foods and that energy intake is lowest with hard, minimally processed foods. Combining hard-textured foods with explicit instructions to reduce eating speed has also been shown to be an effective strategy. For those inclined to seek out technology-based solution, evidence suggests that a self-monitoring wearable device can slow the eating rate.

Although the evidence is mounting that the timing and duration of meals have an impact on certain chronic diseases, clinicians should remember that these two factors are far from the most important contributors, Dr. Popp said.

“We also have to consider total caloric intake, food quality, sleep, alcohol use, smoking, and physical activity,” he said. “Meal timing should be considered as under the umbrella of health that is important for a lot of folks.”

A version of this article appeared on Medscape.com.

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You are what you eat, as the adage goes. But a growing body of evidence indicates that it’s not just what and how much you eat that influence your health. How fast and when you eat also play a role.

Research now indicates that these two factors may affect the risk for gastrointestinal problems, obesity, and type 2 diabetes (T2D). Because meal timing and speed of consumption are modifiable, they present new opportunities to change patient behavior to help prevent and perhaps address these conditions.

Not So Fast

Most people are well acquainted with the short-term gastrointestinal effects of eating too quickly, which include indigestion, gas, bloating, and nausea. But regularly eating too fast can cause long-term consequences.

Obtaining a sense of fullness is key to staving off overeating and excess caloric intake. However, it takes approximately 20 minutes for the stomach to alert the brain to feelings of fullness. Eat too quickly and the fullness signaling might not set in until you’ve consumed more calories than intended. Research links this habit to excess body weight.

The practice also can lead to gastrointestinal diseases over the long term because overeating causes food to remain in the stomach longer, thus prolonging the time that the gastric mucosa is exposed to gastric acids.

A study of 10,893 adults in Korea reported that those with the fastest eating speed (< 5 min/meal) had a 1.7 times greater likelihood of endoscopic erosive gastritis than those with the slowest times (≥ 15 min/meal). Faster eating also was linked to increased risk for functional dyspepsia in a study involving 89 young-adult female military cadets in Korea with relatively controlled eating patterns.

On the extreme end of the spectrum, researchers who performed an assessment of a competitive speed eater speculated that the observed physiological accommodation required for the role (expanding the stomach to form a large flaccid sac) makes speed eaters vulnerable to morbid obesity, gastroparesis, intractable nausea and vomiting, and the need for gastrectomy.

The risk for metabolic changes and eventual development of T2D also appear to be linked to how quickly food is consumed.

Two clinical studies conducted in Japan — a cohort study of 2050 male factory workers and a nationwide study with 197,825 participants — identified a significant association between faster eating and T2D and insulin resistance. A case-control study involving 234 patients with new onset T2D and 468 controls from Lithuania linked faster eating to a greater than twofold risk for T2D. And a Chinese cross-sectional study of 7972 adults indicated that faster eating significantly increased the risk for metabolic syndrome, elevated blood pressure, and central obesity in adults.

Various hypotheses have been proposed to explain why fast eating may upset metabolic processes, including a delayed sense of fullness contributing to spiking postprandial glucose levels, lack of time for mastication causing higher glucose concentrations, and the triggering of specific cytokines (eg, interleukin-1 beta and interleukin-6) that lead to insulin resistance. It is also possible that the association is the result of people who eat quickly having relatively higher body weights, which translates to a higher risk for T2D.

However, there’s an opportunity in the association of rapid meal consumption with gastrointestinal and metabolic diseases, as people can slow the speed at which they eat so they feel full before they overeat.

A 2019 study in which 21 participants were instructed to eat a 600-kcal meal at a “normal” or “slow” pace (6 minutes or 24 minutes) found that the latter group reported feeling fuller while consuming fewer calories.

This approach may not work for all patients, however. There’s evidence to suggest that tactics to slow down eating may not limit the energy intake of those who are already overweight or obese.

Patients with obesity may physiologically differ in their processing of food, according to Michael Camilleri, MD, consultant in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester, Minnesota.

“We have demonstrated that about 20%-25% of people with obesity actually have rapid gastric emptying,” he told this news organization. “As a result, they don’t feel full after they eat a meal and that might impact the total volume of food that they eat before they really feel full.”

 

 

The Ideal Time to Eat

It’s not only the speed at which individuals eat that may influence outcomes but when they take their meals. Research indicates that eating earlier in the day to align meals with the body’s circadian rhythms in metabolism offers health benefits.

“The focus would be to eat a meal that syncs during those daytime hours,” Collin Popp, PhD, MS, RD, a research scientist at the NYU Grossman School of Medicine in New York, told this news organization. “I typically suggest patients have their largest meal in the morning, whether that’s a large or medium-sized breakfast, or a big lunch.”

recent cross-sectional study of 2050 participants found that having the largest meal at lunch protected against obesity (odds ratio [OR], 0.71), whereas having it at dinner increased the risk for obesity (OR, 1.67) and led to higher body mass index.

Consuming the majority of calories in meals earlier in the day may have metabolic health benefits, as well.

2015 randomized controlled trial involving 18 adults with obesity and T2D found that eating a high-energy breakfast and a low-energy dinner leads to reduced hyperglycemia throughout the day compared with eating a low-energy breakfast and a high-energy dinner.

Time-restricted eating (TRE), a form of intermittent fasting, also can improve metabolic health depending on the time of day.

2023 meta-analysis found that TRE was more effective at reducing fasting glucose levels in participants who were overweight and obese if done earlier rather than later in the day. Similarly, a 2022 study involving 82 healthy patients without diabetes or obesity found that early TRE was more effective than mid-day TRE at improving insulin sensitivity and that it improved fasting glucose and reduced total body mass and adiposity, while mid-day TRE did not.

study that analyzed the effects of TRE in eight adult men with overweight and prediabetes found “better insulin resistance when the window of food consumption was earlier in the day,» noted endocrinologist Beverly Tchang, MD, an assistant professor of clinical medicine at Weill Cornell Medicine with a focus on obesity medication.

Patients May Benefit From Behavioral Interventions

Patients potentially negatively affected by eating too quickly or at late hours may benefit from adopting behavioral interventions to address these tendencies. To determine if a patient is a candidate for such interventions, Dr. Popp recommends starting with a simple conversation.

“When I first meet patients, I always ask them to describe to me a typical day for how they eat — when they’re eating, what they’re eating, the food quality, who are they with — to see if there’s social aspects to it. Then try and make the recommendations based on that,” said Dr. Popp, whose work focuses on biobehavioral interventions for the treatment and prevention of obesity, T2D, and other cardiometabolic outcomes.

Dr. Tchang said she encourages her patients to be mindful of hunger and fullness cues.

“Eat if you’re hungry; don’t force yourself to eat if you’re not hungry,” she said. “If you’re not sure whether you’re hungry or not, speak to a doctor because this points to an abnormality in your appetite-regulation system, which can be helped with GLP-1 [glucagon-like peptide 1] receptor agonists.”

Adjusting what patients eat can help them improve their meal timing.

“For example, we know that a high-fiber diet or a diet that has a large amount of fat in it tends to empty from the stomach slower,” Dr. Camilleri said. “That might give a sensation of fullness that lasts longer and that might prevent, for instance, the ingestion of the next meal.”

Those trying to eat more slowly are advised to seek out foods that are hard in texture and minimally processed.

study involving 50 patients with healthy weights found that hard foods are consumed more slowly than soft foods and that energy intake is lowest with hard, minimally processed foods. Combining hard-textured foods with explicit instructions to reduce eating speed has also been shown to be an effective strategy. For those inclined to seek out technology-based solution, evidence suggests that a self-monitoring wearable device can slow the eating rate.

Although the evidence is mounting that the timing and duration of meals have an impact on certain chronic diseases, clinicians should remember that these two factors are far from the most important contributors, Dr. Popp said.

“We also have to consider total caloric intake, food quality, sleep, alcohol use, smoking, and physical activity,” he said. “Meal timing should be considered as under the umbrella of health that is important for a lot of folks.”

A version of this article appeared on Medscape.com.

You are what you eat, as the adage goes. But a growing body of evidence indicates that it’s not just what and how much you eat that influence your health. How fast and when you eat also play a role.

Research now indicates that these two factors may affect the risk for gastrointestinal problems, obesity, and type 2 diabetes (T2D). Because meal timing and speed of consumption are modifiable, they present new opportunities to change patient behavior to help prevent and perhaps address these conditions.

Not So Fast

Most people are well acquainted with the short-term gastrointestinal effects of eating too quickly, which include indigestion, gas, bloating, and nausea. But regularly eating too fast can cause long-term consequences.

Obtaining a sense of fullness is key to staving off overeating and excess caloric intake. However, it takes approximately 20 minutes for the stomach to alert the brain to feelings of fullness. Eat too quickly and the fullness signaling might not set in until you’ve consumed more calories than intended. Research links this habit to excess body weight.

The practice also can lead to gastrointestinal diseases over the long term because overeating causes food to remain in the stomach longer, thus prolonging the time that the gastric mucosa is exposed to gastric acids.

A study of 10,893 adults in Korea reported that those with the fastest eating speed (< 5 min/meal) had a 1.7 times greater likelihood of endoscopic erosive gastritis than those with the slowest times (≥ 15 min/meal). Faster eating also was linked to increased risk for functional dyspepsia in a study involving 89 young-adult female military cadets in Korea with relatively controlled eating patterns.

On the extreme end of the spectrum, researchers who performed an assessment of a competitive speed eater speculated that the observed physiological accommodation required for the role (expanding the stomach to form a large flaccid sac) makes speed eaters vulnerable to morbid obesity, gastroparesis, intractable nausea and vomiting, and the need for gastrectomy.

The risk for metabolic changes and eventual development of T2D also appear to be linked to how quickly food is consumed.

Two clinical studies conducted in Japan — a cohort study of 2050 male factory workers and a nationwide study with 197,825 participants — identified a significant association between faster eating and T2D and insulin resistance. A case-control study involving 234 patients with new onset T2D and 468 controls from Lithuania linked faster eating to a greater than twofold risk for T2D. And a Chinese cross-sectional study of 7972 adults indicated that faster eating significantly increased the risk for metabolic syndrome, elevated blood pressure, and central obesity in adults.

Various hypotheses have been proposed to explain why fast eating may upset metabolic processes, including a delayed sense of fullness contributing to spiking postprandial glucose levels, lack of time for mastication causing higher glucose concentrations, and the triggering of specific cytokines (eg, interleukin-1 beta and interleukin-6) that lead to insulin resistance. It is also possible that the association is the result of people who eat quickly having relatively higher body weights, which translates to a higher risk for T2D.

However, there’s an opportunity in the association of rapid meal consumption with gastrointestinal and metabolic diseases, as people can slow the speed at which they eat so they feel full before they overeat.

A 2019 study in which 21 participants were instructed to eat a 600-kcal meal at a “normal” or “slow” pace (6 minutes or 24 minutes) found that the latter group reported feeling fuller while consuming fewer calories.

This approach may not work for all patients, however. There’s evidence to suggest that tactics to slow down eating may not limit the energy intake of those who are already overweight or obese.

Patients with obesity may physiologically differ in their processing of food, according to Michael Camilleri, MD, consultant in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester, Minnesota.

“We have demonstrated that about 20%-25% of people with obesity actually have rapid gastric emptying,” he told this news organization. “As a result, they don’t feel full after they eat a meal and that might impact the total volume of food that they eat before they really feel full.”

 

 

The Ideal Time to Eat

It’s not only the speed at which individuals eat that may influence outcomes but when they take their meals. Research indicates that eating earlier in the day to align meals with the body’s circadian rhythms in metabolism offers health benefits.

“The focus would be to eat a meal that syncs during those daytime hours,” Collin Popp, PhD, MS, RD, a research scientist at the NYU Grossman School of Medicine in New York, told this news organization. “I typically suggest patients have their largest meal in the morning, whether that’s a large or medium-sized breakfast, or a big lunch.”

recent cross-sectional study of 2050 participants found that having the largest meal at lunch protected against obesity (odds ratio [OR], 0.71), whereas having it at dinner increased the risk for obesity (OR, 1.67) and led to higher body mass index.

Consuming the majority of calories in meals earlier in the day may have metabolic health benefits, as well.

2015 randomized controlled trial involving 18 adults with obesity and T2D found that eating a high-energy breakfast and a low-energy dinner leads to reduced hyperglycemia throughout the day compared with eating a low-energy breakfast and a high-energy dinner.

Time-restricted eating (TRE), a form of intermittent fasting, also can improve metabolic health depending on the time of day.

2023 meta-analysis found that TRE was more effective at reducing fasting glucose levels in participants who were overweight and obese if done earlier rather than later in the day. Similarly, a 2022 study involving 82 healthy patients without diabetes or obesity found that early TRE was more effective than mid-day TRE at improving insulin sensitivity and that it improved fasting glucose and reduced total body mass and adiposity, while mid-day TRE did not.

study that analyzed the effects of TRE in eight adult men with overweight and prediabetes found “better insulin resistance when the window of food consumption was earlier in the day,» noted endocrinologist Beverly Tchang, MD, an assistant professor of clinical medicine at Weill Cornell Medicine with a focus on obesity medication.

Patients May Benefit From Behavioral Interventions

Patients potentially negatively affected by eating too quickly or at late hours may benefit from adopting behavioral interventions to address these tendencies. To determine if a patient is a candidate for such interventions, Dr. Popp recommends starting with a simple conversation.

“When I first meet patients, I always ask them to describe to me a typical day for how they eat — when they’re eating, what they’re eating, the food quality, who are they with — to see if there’s social aspects to it. Then try and make the recommendations based on that,” said Dr. Popp, whose work focuses on biobehavioral interventions for the treatment and prevention of obesity, T2D, and other cardiometabolic outcomes.

Dr. Tchang said she encourages her patients to be mindful of hunger and fullness cues.

“Eat if you’re hungry; don’t force yourself to eat if you’re not hungry,” she said. “If you’re not sure whether you’re hungry or not, speak to a doctor because this points to an abnormality in your appetite-regulation system, which can be helped with GLP-1 [glucagon-like peptide 1] receptor agonists.”

Adjusting what patients eat can help them improve their meal timing.

“For example, we know that a high-fiber diet or a diet that has a large amount of fat in it tends to empty from the stomach slower,” Dr. Camilleri said. “That might give a sensation of fullness that lasts longer and that might prevent, for instance, the ingestion of the next meal.”

Those trying to eat more slowly are advised to seek out foods that are hard in texture and minimally processed.

study involving 50 patients with healthy weights found that hard foods are consumed more slowly than soft foods and that energy intake is lowest with hard, minimally processed foods. Combining hard-textured foods with explicit instructions to reduce eating speed has also been shown to be an effective strategy. For those inclined to seek out technology-based solution, evidence suggests that a self-monitoring wearable device can slow the eating rate.

Although the evidence is mounting that the timing and duration of meals have an impact on certain chronic diseases, clinicians should remember that these two factors are far from the most important contributors, Dr. Popp said.

“We also have to consider total caloric intake, food quality, sleep, alcohol use, smoking, and physical activity,” he said. “Meal timing should be considered as under the umbrella of health that is important for a lot of folks.”

A version of this article appeared on Medscape.com.

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EHR Copy and Paste Can Get Physicians Into Trouble

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Mon, 04/15/2024 - 17:22

Physicians who misuse the “copy-and-paste” feature in patients’ electronic health records (EHRs) can face serious consequences, including lost hospital privileges, fines, and malpractice lawsuits.

In California, a locum tenens physician lost her hospital privileges after repeatedly violating the copy-and-paste policy developed at Santa Rosa Memorial Hospital, Santa Rosa, California.

“Her use of copy and paste impaired continuity of care,” said Alvin Gore, MD, who was involved in the case as the hospital’s director of utilization management.

Dr. Gore said the hospital warned the doctor, but she did not change her behavior. He did not identify the physician, citing confidentiality. The case occurred more than 5 years ago. Since then, several physicians have been called onto the carpet for violations of the policy, but no one else has lost privileges, Dr. Gore said.

Copy-paste practices can save doctors’ time when dealing with cumbersome EHR systems, but they also can lead to redundant, outdated, or inconsistent information that can compromise patient care, experts said.

“EHRs are imperfect, time consuming, and somewhat rigid,” said Robert A. Dowling, MD, a practice management consultant for large medical groups. “If physicians can’t easily figure out a complex system, they’re likely to use a workaround like copy and paste.”

Copy-and-paste abuse has also led to fines. A six-member cardiology group in Somerville, New Jersey, paid a $422,000 fine to the federal government to settle copy-and-paste charges, following an investigation by the Office of the Inspector General of the Department of Health and Human Services, according to the Report on Medicare Compliance.

This big settlement, announced in 2016, is a rare case in which physicians were charged with copy-and-paste fraud — intentionally using it to enhance reimbursement.

More commonly, Medicare contractors identify physicians who unintentionally received overpayments through sloppy copy-and-paste practices, according to a coding and documentation auditor who worked for 10 years at a Medicare contractor in Pennsylvania.

Such cases are frequent and are handled confidentially, said the auditor, who asked not to be identified. Practices must return the overpayment, and the physicians involved are “contacted and educated,” she said.

Copy and paste can also show up in malpractice lawsuits. In a 2012 survey, 53% of professional liability carriers said they had handled an EHR-related malpractice claim, and 71% of those claims included copy-and-paste use.

One such case, described by CRICO, a malpractice carrier based in Massachusetts, took place in 2012-2013. “A patient developed amiodarone toxicity because the patient›s history and medications were copied from a previous note that did not document that the patient was already on the medication,» CRICO stated.

“If you do face a malpractice claim, copying and pasting the same note repeatedly makes you look clinically inattentive, even if the copy/pasted material is unrelated to the adverse event,” CRICO officials noted in a report.
 

The Push to Use Copy and Paste

Copy and paste is a great time-saver. One study linked its use to lower burnout rates. However, it can easily introduce errors into the medical record. “This can be a huge problem,” Dr. Dowling said. “If, for example, you copy forward a previous note that said the patient had blood in their urine ‘6 days ago,’ it is immediately inaccurate.”

Practices can control use of copy and paste through coding clerks who read the medical records and then educate doctors when problems crop up.

The Pennsylvania auditor, who now works for a large group practice, said the group has very few copy-and-paste problems because of her role. “Not charting responsibly rarely happens because I work very closely with the doctors,” she said.

Dr. Dowling, however, reports that many physicians continue to overuse copy and paste. He points to a 2022 study which found that, on average, half the clinical note at one health system had been copied and pasted.

One solution might be to sanction physicians for overusing copy and paste, just as they’re sometimes penalized for not completing their notes on time with a reduction in income or possible termination.

Practices could periodically audit medical records for excessive copy-paste use. EHR systems like Epic’s can indicate how much of a doctor’s note has been copied. But Dr. Dowling doesn’t know of any practices that do this.

“There is little appetite to introduce a new enforcement activity for physicians,” he said. “Physicians would see it just as a way to make their lives more difficult than they already are.”
 

Monitoring in Hospitals and Health Systems

Some hospitals and health systems have gone as far as disabling copy-and-paste function in their EHR systems. However, enterprising physicians have found ways around these blocks.

Some institutions have also introduced formal policies, directing doctors on how they can copy and paste, including Banner Health in Arizona, Northwell Health in New York, UConn Health in Connecticut, University of Maryland Medical System, and University of Toledo in Ohio.

Definitions of what is not acceptable vary, but most of these policies oppose copying someone else’s notes and direct physicians to indicate the origin of pasted material.

Santa Rosa Memorial’s policy is quite specific. It still allows some copy and paste but stipulates that it cannot be used for the chief complaint, the review of systems, the physical examination, and the assessment and plan in the medical record, except when the information can’t be obtained directly from the patient. Also, physicians must summarize test results and provide references to other providers’ notes.

Dr. Gore said he and a physician educator who works with physicians on clinical documentation proposed the policy about a decade ago. When physicians on staff were asked to comment, some said they would be opposed to a complete ban, but they generally agreed that copy and paste was a serious problem that needed to be addressed, he said.

The hospital could have simply adopted guidelines, as opposed to rules with consequences, but “we wanted our policy to have teeth,” Dr. Gore said.

When violators are identified, Dr. Gore says he meets with them confidentially and educates them on proper use of copy and paste. Sometimes, the department head is brought in. Some physicians go on to violate the policy again and have to attend another meeting, he said, but aside from the one case, no one else has been disciplined.

It’s unclear how many physicians have faced consequences for misusing copy-paste features — such data aren’t tracked, and sanctions are likely to be handled confidentially, as a personnel matter.

Geisinger Health in Pennsylvania regularly monitors copy-and-paste usage and makes it part of physicians’ professional evaluations, according to a 2022 presentation by a Geisinger official.

Meanwhile, even when systems don’t have specific policies, they may still discipline physicians when copy and paste leads to errors. Scott MacDonald, MD, chief medical information officer at UC Davis Health in Sacramento, California, told this news organization that copy-and-paste abuse has come up a few times over the years in investigations of clinical errors.
 

 

 

Holding Physicians Accountable

Physicians can be held accountable for copy and paste by Medicare contractors and in malpractice lawsuits, but the most obvious way is at their place of work: A practice, hospital, or health system.

One physician has lost staff privileges, but more typically, coding clerks or colleagues talk to offending physicians and try to educate them on proper use of copy and paste.

Educational outreach, however, is often ineffective, said Robert Hirschtick, MD, a retired teaching physician at Northwestern University Feinberg School of Medicine, Chicago, Illinois. “The physician may be directed to take an online course,” he said. “When they take the course, the goal is to get it done with, rather than to learn something new.”

Dr. Hirschtick’s articles on copy and paste, including one titled, “Sloppy and Paste,” have put him at the front lines of the debate. “This is an ethical issue,” he said in an interview. He agrees that some forms of copy and paste are permissible, but in many cases, “it is intellectually dishonest and potentially even plagiarism,” he said.

Dr. Hirschtick argues that copy-and-paste policies need more teeth. “Tying violations to compensation would be quite effective,” he said. “Even if physicians were rarely penalized, just knowing that it could happen to you might be enough. But I haven’t heard of anyone doing this.”

A version of this article appeared on Medscape.com.

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Physicians who misuse the “copy-and-paste” feature in patients’ electronic health records (EHRs) can face serious consequences, including lost hospital privileges, fines, and malpractice lawsuits.

In California, a locum tenens physician lost her hospital privileges after repeatedly violating the copy-and-paste policy developed at Santa Rosa Memorial Hospital, Santa Rosa, California.

“Her use of copy and paste impaired continuity of care,” said Alvin Gore, MD, who was involved in the case as the hospital’s director of utilization management.

Dr. Gore said the hospital warned the doctor, but she did not change her behavior. He did not identify the physician, citing confidentiality. The case occurred more than 5 years ago. Since then, several physicians have been called onto the carpet for violations of the policy, but no one else has lost privileges, Dr. Gore said.

Copy-paste practices can save doctors’ time when dealing with cumbersome EHR systems, but they also can lead to redundant, outdated, or inconsistent information that can compromise patient care, experts said.

“EHRs are imperfect, time consuming, and somewhat rigid,” said Robert A. Dowling, MD, a practice management consultant for large medical groups. “If physicians can’t easily figure out a complex system, they’re likely to use a workaround like copy and paste.”

Copy-and-paste abuse has also led to fines. A six-member cardiology group in Somerville, New Jersey, paid a $422,000 fine to the federal government to settle copy-and-paste charges, following an investigation by the Office of the Inspector General of the Department of Health and Human Services, according to the Report on Medicare Compliance.

This big settlement, announced in 2016, is a rare case in which physicians were charged with copy-and-paste fraud — intentionally using it to enhance reimbursement.

More commonly, Medicare contractors identify physicians who unintentionally received overpayments through sloppy copy-and-paste practices, according to a coding and documentation auditor who worked for 10 years at a Medicare contractor in Pennsylvania.

Such cases are frequent and are handled confidentially, said the auditor, who asked not to be identified. Practices must return the overpayment, and the physicians involved are “contacted and educated,” she said.

Copy and paste can also show up in malpractice lawsuits. In a 2012 survey, 53% of professional liability carriers said they had handled an EHR-related malpractice claim, and 71% of those claims included copy-and-paste use.

One such case, described by CRICO, a malpractice carrier based in Massachusetts, took place in 2012-2013. “A patient developed amiodarone toxicity because the patient›s history and medications were copied from a previous note that did not document that the patient was already on the medication,» CRICO stated.

“If you do face a malpractice claim, copying and pasting the same note repeatedly makes you look clinically inattentive, even if the copy/pasted material is unrelated to the adverse event,” CRICO officials noted in a report.
 

The Push to Use Copy and Paste

Copy and paste is a great time-saver. One study linked its use to lower burnout rates. However, it can easily introduce errors into the medical record. “This can be a huge problem,” Dr. Dowling said. “If, for example, you copy forward a previous note that said the patient had blood in their urine ‘6 days ago,’ it is immediately inaccurate.”

Practices can control use of copy and paste through coding clerks who read the medical records and then educate doctors when problems crop up.

The Pennsylvania auditor, who now works for a large group practice, said the group has very few copy-and-paste problems because of her role. “Not charting responsibly rarely happens because I work very closely with the doctors,” she said.

Dr. Dowling, however, reports that many physicians continue to overuse copy and paste. He points to a 2022 study which found that, on average, half the clinical note at one health system had been copied and pasted.

One solution might be to sanction physicians for overusing copy and paste, just as they’re sometimes penalized for not completing their notes on time with a reduction in income or possible termination.

Practices could periodically audit medical records for excessive copy-paste use. EHR systems like Epic’s can indicate how much of a doctor’s note has been copied. But Dr. Dowling doesn’t know of any practices that do this.

“There is little appetite to introduce a new enforcement activity for physicians,” he said. “Physicians would see it just as a way to make their lives more difficult than they already are.”
 

Monitoring in Hospitals and Health Systems

Some hospitals and health systems have gone as far as disabling copy-and-paste function in their EHR systems. However, enterprising physicians have found ways around these blocks.

Some institutions have also introduced formal policies, directing doctors on how they can copy and paste, including Banner Health in Arizona, Northwell Health in New York, UConn Health in Connecticut, University of Maryland Medical System, and University of Toledo in Ohio.

Definitions of what is not acceptable vary, but most of these policies oppose copying someone else’s notes and direct physicians to indicate the origin of pasted material.

Santa Rosa Memorial’s policy is quite specific. It still allows some copy and paste but stipulates that it cannot be used for the chief complaint, the review of systems, the physical examination, and the assessment and plan in the medical record, except when the information can’t be obtained directly from the patient. Also, physicians must summarize test results and provide references to other providers’ notes.

Dr. Gore said he and a physician educator who works with physicians on clinical documentation proposed the policy about a decade ago. When physicians on staff were asked to comment, some said they would be opposed to a complete ban, but they generally agreed that copy and paste was a serious problem that needed to be addressed, he said.

The hospital could have simply adopted guidelines, as opposed to rules with consequences, but “we wanted our policy to have teeth,” Dr. Gore said.

When violators are identified, Dr. Gore says he meets with them confidentially and educates them on proper use of copy and paste. Sometimes, the department head is brought in. Some physicians go on to violate the policy again and have to attend another meeting, he said, but aside from the one case, no one else has been disciplined.

It’s unclear how many physicians have faced consequences for misusing copy-paste features — such data aren’t tracked, and sanctions are likely to be handled confidentially, as a personnel matter.

Geisinger Health in Pennsylvania regularly monitors copy-and-paste usage and makes it part of physicians’ professional evaluations, according to a 2022 presentation by a Geisinger official.

Meanwhile, even when systems don’t have specific policies, they may still discipline physicians when copy and paste leads to errors. Scott MacDonald, MD, chief medical information officer at UC Davis Health in Sacramento, California, told this news organization that copy-and-paste abuse has come up a few times over the years in investigations of clinical errors.
 

 

 

Holding Physicians Accountable

Physicians can be held accountable for copy and paste by Medicare contractors and in malpractice lawsuits, but the most obvious way is at their place of work: A practice, hospital, or health system.

One physician has lost staff privileges, but more typically, coding clerks or colleagues talk to offending physicians and try to educate them on proper use of copy and paste.

Educational outreach, however, is often ineffective, said Robert Hirschtick, MD, a retired teaching physician at Northwestern University Feinberg School of Medicine, Chicago, Illinois. “The physician may be directed to take an online course,” he said. “When they take the course, the goal is to get it done with, rather than to learn something new.”

Dr. Hirschtick’s articles on copy and paste, including one titled, “Sloppy and Paste,” have put him at the front lines of the debate. “This is an ethical issue,” he said in an interview. He agrees that some forms of copy and paste are permissible, but in many cases, “it is intellectually dishonest and potentially even plagiarism,” he said.

Dr. Hirschtick argues that copy-and-paste policies need more teeth. “Tying violations to compensation would be quite effective,” he said. “Even if physicians were rarely penalized, just knowing that it could happen to you might be enough. But I haven’t heard of anyone doing this.”

A version of this article appeared on Medscape.com.

Physicians who misuse the “copy-and-paste” feature in patients’ electronic health records (EHRs) can face serious consequences, including lost hospital privileges, fines, and malpractice lawsuits.

In California, a locum tenens physician lost her hospital privileges after repeatedly violating the copy-and-paste policy developed at Santa Rosa Memorial Hospital, Santa Rosa, California.

“Her use of copy and paste impaired continuity of care,” said Alvin Gore, MD, who was involved in the case as the hospital’s director of utilization management.

Dr. Gore said the hospital warned the doctor, but she did not change her behavior. He did not identify the physician, citing confidentiality. The case occurred more than 5 years ago. Since then, several physicians have been called onto the carpet for violations of the policy, but no one else has lost privileges, Dr. Gore said.

Copy-paste practices can save doctors’ time when dealing with cumbersome EHR systems, but they also can lead to redundant, outdated, or inconsistent information that can compromise patient care, experts said.

“EHRs are imperfect, time consuming, and somewhat rigid,” said Robert A. Dowling, MD, a practice management consultant for large medical groups. “If physicians can’t easily figure out a complex system, they’re likely to use a workaround like copy and paste.”

Copy-and-paste abuse has also led to fines. A six-member cardiology group in Somerville, New Jersey, paid a $422,000 fine to the federal government to settle copy-and-paste charges, following an investigation by the Office of the Inspector General of the Department of Health and Human Services, according to the Report on Medicare Compliance.

This big settlement, announced in 2016, is a rare case in which physicians were charged with copy-and-paste fraud — intentionally using it to enhance reimbursement.

More commonly, Medicare contractors identify physicians who unintentionally received overpayments through sloppy copy-and-paste practices, according to a coding and documentation auditor who worked for 10 years at a Medicare contractor in Pennsylvania.

Such cases are frequent and are handled confidentially, said the auditor, who asked not to be identified. Practices must return the overpayment, and the physicians involved are “contacted and educated,” she said.

Copy and paste can also show up in malpractice lawsuits. In a 2012 survey, 53% of professional liability carriers said they had handled an EHR-related malpractice claim, and 71% of those claims included copy-and-paste use.

One such case, described by CRICO, a malpractice carrier based in Massachusetts, took place in 2012-2013. “A patient developed amiodarone toxicity because the patient›s history and medications were copied from a previous note that did not document that the patient was already on the medication,» CRICO stated.

“If you do face a malpractice claim, copying and pasting the same note repeatedly makes you look clinically inattentive, even if the copy/pasted material is unrelated to the adverse event,” CRICO officials noted in a report.
 

The Push to Use Copy and Paste

Copy and paste is a great time-saver. One study linked its use to lower burnout rates. However, it can easily introduce errors into the medical record. “This can be a huge problem,” Dr. Dowling said. “If, for example, you copy forward a previous note that said the patient had blood in their urine ‘6 days ago,’ it is immediately inaccurate.”

Practices can control use of copy and paste through coding clerks who read the medical records and then educate doctors when problems crop up.

The Pennsylvania auditor, who now works for a large group practice, said the group has very few copy-and-paste problems because of her role. “Not charting responsibly rarely happens because I work very closely with the doctors,” she said.

Dr. Dowling, however, reports that many physicians continue to overuse copy and paste. He points to a 2022 study which found that, on average, half the clinical note at one health system had been copied and pasted.

One solution might be to sanction physicians for overusing copy and paste, just as they’re sometimes penalized for not completing their notes on time with a reduction in income or possible termination.

Practices could periodically audit medical records for excessive copy-paste use. EHR systems like Epic’s can indicate how much of a doctor’s note has been copied. But Dr. Dowling doesn’t know of any practices that do this.

“There is little appetite to introduce a new enforcement activity for physicians,” he said. “Physicians would see it just as a way to make their lives more difficult than they already are.”
 

Monitoring in Hospitals and Health Systems

Some hospitals and health systems have gone as far as disabling copy-and-paste function in their EHR systems. However, enterprising physicians have found ways around these blocks.

Some institutions have also introduced formal policies, directing doctors on how they can copy and paste, including Banner Health in Arizona, Northwell Health in New York, UConn Health in Connecticut, University of Maryland Medical System, and University of Toledo in Ohio.

Definitions of what is not acceptable vary, but most of these policies oppose copying someone else’s notes and direct physicians to indicate the origin of pasted material.

Santa Rosa Memorial’s policy is quite specific. It still allows some copy and paste but stipulates that it cannot be used for the chief complaint, the review of systems, the physical examination, and the assessment and plan in the medical record, except when the information can’t be obtained directly from the patient. Also, physicians must summarize test results and provide references to other providers’ notes.

Dr. Gore said he and a physician educator who works with physicians on clinical documentation proposed the policy about a decade ago. When physicians on staff were asked to comment, some said they would be opposed to a complete ban, but they generally agreed that copy and paste was a serious problem that needed to be addressed, he said.

The hospital could have simply adopted guidelines, as opposed to rules with consequences, but “we wanted our policy to have teeth,” Dr. Gore said.

When violators are identified, Dr. Gore says he meets with them confidentially and educates them on proper use of copy and paste. Sometimes, the department head is brought in. Some physicians go on to violate the policy again and have to attend another meeting, he said, but aside from the one case, no one else has been disciplined.

It’s unclear how many physicians have faced consequences for misusing copy-paste features — such data aren’t tracked, and sanctions are likely to be handled confidentially, as a personnel matter.

Geisinger Health in Pennsylvania regularly monitors copy-and-paste usage and makes it part of physicians’ professional evaluations, according to a 2022 presentation by a Geisinger official.

Meanwhile, even when systems don’t have specific policies, they may still discipline physicians when copy and paste leads to errors. Scott MacDonald, MD, chief medical information officer at UC Davis Health in Sacramento, California, told this news organization that copy-and-paste abuse has come up a few times over the years in investigations of clinical errors.
 

 

 

Holding Physicians Accountable

Physicians can be held accountable for copy and paste by Medicare contractors and in malpractice lawsuits, but the most obvious way is at their place of work: A practice, hospital, or health system.

One physician has lost staff privileges, but more typically, coding clerks or colleagues talk to offending physicians and try to educate them on proper use of copy and paste.

Educational outreach, however, is often ineffective, said Robert Hirschtick, MD, a retired teaching physician at Northwestern University Feinberg School of Medicine, Chicago, Illinois. “The physician may be directed to take an online course,” he said. “When they take the course, the goal is to get it done with, rather than to learn something new.”

Dr. Hirschtick’s articles on copy and paste, including one titled, “Sloppy and Paste,” have put him at the front lines of the debate. “This is an ethical issue,” he said in an interview. He agrees that some forms of copy and paste are permissible, but in many cases, “it is intellectually dishonest and potentially even plagiarism,” he said.

Dr. Hirschtick argues that copy-and-paste policies need more teeth. “Tying violations to compensation would be quite effective,” he said. “Even if physicians were rarely penalized, just knowing that it could happen to you might be enough. But I haven’t heard of anyone doing this.”

A version of this article appeared on Medscape.com.

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Hormone Therapy After 65 a Good Option for Most Women

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Fri, 04/12/2024 - 12:35

Hormone Therapy (HT) is a good option for most women over age 65, despite entrenched fears about HT safety, according to findings from a new study published in Menopause.

The study, led by Seo H. Baik, PhD, of Lister Hill National Center for Biomedical Communications, National Library of Medicine, in Bethesda, Maryland, and colleagues is based on the health records of 10 million senior women on Medicare from 2007 to 2020. It concludes there are important health benefits with HT beyond age 65 and the effects of using HT after age 65 vary by type of therapy, route of administration, and dose.
 

Controversial Since Women’s Health Initiative

Use of HT after age 65 has been controversial in light of the findings of the Women’s Health Initiative (WHI) study in 2002. Since that study, many women have decided against HT, especially after age 65, because of fears of increased risks for cancers and heart disease.

Baik et al. concluded that, compared with never using or stopping use of HT before the age of 65 years, the use of estrogen alone beyond age 65 years was associated with the following significant risk reductions: mortality (19%); breast cancer (16%); lung cancer (13%); colorectal cancer (12%); congestive heart failure (5%); venous thromboembolism (5%); atrial fibrillation (4%); acute myocardial infarction (11%); and dementia (2%).

The authors further found that estrogen plus progestin was associated with significant risk reductions in endometrial cancer (45%); ovarian cancer (21%); ischemic heart disease (5%); congestive heart failure (5%); and venous thromboembolism (5%).

Estrogen plus progesterone, however, was linked with risk reduction only in congestive heart failure (4%).

Reassuring Results

“These results should provide additional reassurance to women about hormone therapy,” said Lisa C, Larkin, MD, president of The Menopause Society. “This data is largely consistent with the WHI data as we understand it today — that for the majority of women with symptoms transitioning through menopause, hormone therapy is the most effective treatment and has benefits that outweigh risks.”

There may be some exceptions, she noted, particularly in older women with high risk for cardiovascular disease and stroke. Among those women, she explained, the risks of HT may outweigh the benefits and it may be appropriate to stop hormone therapy.

“In these older women with specific risk factors, the discussion of continuing or stopping HT is nuanced and complex and must involve shared decision-making,” she said.

 

Elevated Breast Cancer Risk Can be Mitigated

With a therapy combining estrogen and progestogen, both estrogen plus progestin and estrogen plus progesterone were associated with a 10%-19% increased risk of breast cancer, but the authors say that risk can be mitigated using low doses of transdermal or vaginal estrogen plus progestin.

“In general, risk reductions appear to be greater with low rather than medium or high doses, vaginal or transdermal rather than oral preparations, and with E2 (estradiol) rather than conjugated estrogen,” the authors write.

The authors report that over 14 years of follow-up (from 2007 to 2020), the proportion of senior women taking any HT-containing estrogen dropped by half, from 11.4% to 5.5%. E2 has largely replaced conjugated estrogen (CEE); and vaginal administration largely replaced oral.

 

 

Controversy Remains

Even with these results, hormone use will remain controversial, Dr. Larkin said, without enormous efforts to educate. Menopausal HT therapy in young 50-year-old women having symptoms is still controversial — despite the large body of evidence supporting safety and benefit in the majority of women, she said.

“For the last 25 years we have completely neglected education of clinicians about menopause and the data on hormone therapy,” she said. “As a result, most of the clinicians practicing do not understand the data and remain very negative about hormones even in younger women. The decades of lack of education of clinicians about menopause is one of the major reasons far too many young, healthy, 50-year-old women with symptoms are not getting the care they need [hormone therapy] at menopause.” Instead, she says, women are told to take supplements because some providers think hormone therapy is too dangerous.

Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University’s Feinberg School of Medicine, and founding director of the Northwestern Medical Center for Sexual Medicine and Menopause, both in Chicago, says, “In the WHI, 70% of the women were over the age of 65 when they initiated therapy, which partially accounts for the negative outcomes. In addition, in WHI, everyone was taking oral [HT]. This (current) data is very reassuring — and validating — for women who would like to continue taking HT.”

Dr. Streicher says women who would like to start HT after 65 should be counseled on individual risks and after cardiac health is evaluated. But, she notes, this study did not address that.

‘Best Time to Stop HT is When You Die’

She says in her practice she will counsel women who are on HT and would like to continue after age 65 the way she always has: “If someone is taking HT and has no specific reason to stop, there is no reason to stop at some arbitrary age or time and that if they do, they will lose many of the benefits,” particularly bone, cognitive, cardiovascular, and vulvovaginal benefits, she explained. “The best time to stop HT is when you die,” Dr. Streicher said, “And, given the reduction in mortality in women who take HT, that will be at a much older age than women who don’t take HT.”

So will these new data be convincing?

“It will convince the already convinced — menopause experts who follow the data. It is the rare menopause expert that tells women to stop HT,” Dr. Streicher said.

However, she said, “The overwhelming majority of clinicians in the US currently do not prescribe HT. Sadly, I don’t think this will change much.”

The authors report no relevant financial relationships. Dr. Larkin consults for several women’s health companies including Mayne Pharma, Astellas, Johnson & Johnson, Grail, Pfizer, and Solv Wellness. Dr. Streicher reports no relevant financial relationships.

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Hormone Therapy (HT) is a good option for most women over age 65, despite entrenched fears about HT safety, according to findings from a new study published in Menopause.

The study, led by Seo H. Baik, PhD, of Lister Hill National Center for Biomedical Communications, National Library of Medicine, in Bethesda, Maryland, and colleagues is based on the health records of 10 million senior women on Medicare from 2007 to 2020. It concludes there are important health benefits with HT beyond age 65 and the effects of using HT after age 65 vary by type of therapy, route of administration, and dose.
 

Controversial Since Women’s Health Initiative

Use of HT after age 65 has been controversial in light of the findings of the Women’s Health Initiative (WHI) study in 2002. Since that study, many women have decided against HT, especially after age 65, because of fears of increased risks for cancers and heart disease.

Baik et al. concluded that, compared with never using or stopping use of HT before the age of 65 years, the use of estrogen alone beyond age 65 years was associated with the following significant risk reductions: mortality (19%); breast cancer (16%); lung cancer (13%); colorectal cancer (12%); congestive heart failure (5%); venous thromboembolism (5%); atrial fibrillation (4%); acute myocardial infarction (11%); and dementia (2%).

The authors further found that estrogen plus progestin was associated with significant risk reductions in endometrial cancer (45%); ovarian cancer (21%); ischemic heart disease (5%); congestive heart failure (5%); and venous thromboembolism (5%).

Estrogen plus progesterone, however, was linked with risk reduction only in congestive heart failure (4%).

Reassuring Results

“These results should provide additional reassurance to women about hormone therapy,” said Lisa C, Larkin, MD, president of The Menopause Society. “This data is largely consistent with the WHI data as we understand it today — that for the majority of women with symptoms transitioning through menopause, hormone therapy is the most effective treatment and has benefits that outweigh risks.”

There may be some exceptions, she noted, particularly in older women with high risk for cardiovascular disease and stroke. Among those women, she explained, the risks of HT may outweigh the benefits and it may be appropriate to stop hormone therapy.

“In these older women with specific risk factors, the discussion of continuing or stopping HT is nuanced and complex and must involve shared decision-making,” she said.

 

Elevated Breast Cancer Risk Can be Mitigated

With a therapy combining estrogen and progestogen, both estrogen plus progestin and estrogen plus progesterone were associated with a 10%-19% increased risk of breast cancer, but the authors say that risk can be mitigated using low doses of transdermal or vaginal estrogen plus progestin.

“In general, risk reductions appear to be greater with low rather than medium or high doses, vaginal or transdermal rather than oral preparations, and with E2 (estradiol) rather than conjugated estrogen,” the authors write.

The authors report that over 14 years of follow-up (from 2007 to 2020), the proportion of senior women taking any HT-containing estrogen dropped by half, from 11.4% to 5.5%. E2 has largely replaced conjugated estrogen (CEE); and vaginal administration largely replaced oral.

 

 

Controversy Remains

Even with these results, hormone use will remain controversial, Dr. Larkin said, without enormous efforts to educate. Menopausal HT therapy in young 50-year-old women having symptoms is still controversial — despite the large body of evidence supporting safety and benefit in the majority of women, she said.

“For the last 25 years we have completely neglected education of clinicians about menopause and the data on hormone therapy,” she said. “As a result, most of the clinicians practicing do not understand the data and remain very negative about hormones even in younger women. The decades of lack of education of clinicians about menopause is one of the major reasons far too many young, healthy, 50-year-old women with symptoms are not getting the care they need [hormone therapy] at menopause.” Instead, she says, women are told to take supplements because some providers think hormone therapy is too dangerous.

Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University’s Feinberg School of Medicine, and founding director of the Northwestern Medical Center for Sexual Medicine and Menopause, both in Chicago, says, “In the WHI, 70% of the women were over the age of 65 when they initiated therapy, which partially accounts for the negative outcomes. In addition, in WHI, everyone was taking oral [HT]. This (current) data is very reassuring — and validating — for women who would like to continue taking HT.”

Dr. Streicher says women who would like to start HT after 65 should be counseled on individual risks and after cardiac health is evaluated. But, she notes, this study did not address that.

‘Best Time to Stop HT is When You Die’

She says in her practice she will counsel women who are on HT and would like to continue after age 65 the way she always has: “If someone is taking HT and has no specific reason to stop, there is no reason to stop at some arbitrary age or time and that if they do, they will lose many of the benefits,” particularly bone, cognitive, cardiovascular, and vulvovaginal benefits, she explained. “The best time to stop HT is when you die,” Dr. Streicher said, “And, given the reduction in mortality in women who take HT, that will be at a much older age than women who don’t take HT.”

So will these new data be convincing?

“It will convince the already convinced — menopause experts who follow the data. It is the rare menopause expert that tells women to stop HT,” Dr. Streicher said.

However, she said, “The overwhelming majority of clinicians in the US currently do not prescribe HT. Sadly, I don’t think this will change much.”

The authors report no relevant financial relationships. Dr. Larkin consults for several women’s health companies including Mayne Pharma, Astellas, Johnson & Johnson, Grail, Pfizer, and Solv Wellness. Dr. Streicher reports no relevant financial relationships.

Hormone Therapy (HT) is a good option for most women over age 65, despite entrenched fears about HT safety, according to findings from a new study published in Menopause.

The study, led by Seo H. Baik, PhD, of Lister Hill National Center for Biomedical Communications, National Library of Medicine, in Bethesda, Maryland, and colleagues is based on the health records of 10 million senior women on Medicare from 2007 to 2020. It concludes there are important health benefits with HT beyond age 65 and the effects of using HT after age 65 vary by type of therapy, route of administration, and dose.
 

Controversial Since Women’s Health Initiative

Use of HT after age 65 has been controversial in light of the findings of the Women’s Health Initiative (WHI) study in 2002. Since that study, many women have decided against HT, especially after age 65, because of fears of increased risks for cancers and heart disease.

Baik et al. concluded that, compared with never using or stopping use of HT before the age of 65 years, the use of estrogen alone beyond age 65 years was associated with the following significant risk reductions: mortality (19%); breast cancer (16%); lung cancer (13%); colorectal cancer (12%); congestive heart failure (5%); venous thromboembolism (5%); atrial fibrillation (4%); acute myocardial infarction (11%); and dementia (2%).

The authors further found that estrogen plus progestin was associated with significant risk reductions in endometrial cancer (45%); ovarian cancer (21%); ischemic heart disease (5%); congestive heart failure (5%); and venous thromboembolism (5%).

Estrogen plus progesterone, however, was linked with risk reduction only in congestive heart failure (4%).

Reassuring Results

“These results should provide additional reassurance to women about hormone therapy,” said Lisa C, Larkin, MD, president of The Menopause Society. “This data is largely consistent with the WHI data as we understand it today — that for the majority of women with symptoms transitioning through menopause, hormone therapy is the most effective treatment and has benefits that outweigh risks.”

There may be some exceptions, she noted, particularly in older women with high risk for cardiovascular disease and stroke. Among those women, she explained, the risks of HT may outweigh the benefits and it may be appropriate to stop hormone therapy.

“In these older women with specific risk factors, the discussion of continuing or stopping HT is nuanced and complex and must involve shared decision-making,” she said.

 

Elevated Breast Cancer Risk Can be Mitigated

With a therapy combining estrogen and progestogen, both estrogen plus progestin and estrogen plus progesterone were associated with a 10%-19% increased risk of breast cancer, but the authors say that risk can be mitigated using low doses of transdermal or vaginal estrogen plus progestin.

“In general, risk reductions appear to be greater with low rather than medium or high doses, vaginal or transdermal rather than oral preparations, and with E2 (estradiol) rather than conjugated estrogen,” the authors write.

The authors report that over 14 years of follow-up (from 2007 to 2020), the proportion of senior women taking any HT-containing estrogen dropped by half, from 11.4% to 5.5%. E2 has largely replaced conjugated estrogen (CEE); and vaginal administration largely replaced oral.

 

 

Controversy Remains

Even with these results, hormone use will remain controversial, Dr. Larkin said, without enormous efforts to educate. Menopausal HT therapy in young 50-year-old women having symptoms is still controversial — despite the large body of evidence supporting safety and benefit in the majority of women, she said.

“For the last 25 years we have completely neglected education of clinicians about menopause and the data on hormone therapy,” she said. “As a result, most of the clinicians practicing do not understand the data and remain very negative about hormones even in younger women. The decades of lack of education of clinicians about menopause is one of the major reasons far too many young, healthy, 50-year-old women with symptoms are not getting the care they need [hormone therapy] at menopause.” Instead, she says, women are told to take supplements because some providers think hormone therapy is too dangerous.

Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University’s Feinberg School of Medicine, and founding director of the Northwestern Medical Center for Sexual Medicine and Menopause, both in Chicago, says, “In the WHI, 70% of the women were over the age of 65 when they initiated therapy, which partially accounts for the negative outcomes. In addition, in WHI, everyone was taking oral [HT]. This (current) data is very reassuring — and validating — for women who would like to continue taking HT.”

Dr. Streicher says women who would like to start HT after 65 should be counseled on individual risks and after cardiac health is evaluated. But, she notes, this study did not address that.

‘Best Time to Stop HT is When You Die’

She says in her practice she will counsel women who are on HT and would like to continue after age 65 the way she always has: “If someone is taking HT and has no specific reason to stop, there is no reason to stop at some arbitrary age or time and that if they do, they will lose many of the benefits,” particularly bone, cognitive, cardiovascular, and vulvovaginal benefits, she explained. “The best time to stop HT is when you die,” Dr. Streicher said, “And, given the reduction in mortality in women who take HT, that will be at a much older age than women who don’t take HT.”

So will these new data be convincing?

“It will convince the already convinced — menopause experts who follow the data. It is the rare menopause expert that tells women to stop HT,” Dr. Streicher said.

However, she said, “The overwhelming majority of clinicians in the US currently do not prescribe HT. Sadly, I don’t think this will change much.”

The authors report no relevant financial relationships. Dr. Larkin consults for several women’s health companies including Mayne Pharma, Astellas, Johnson & Johnson, Grail, Pfizer, and Solv Wellness. Dr. Streicher reports no relevant financial relationships.

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Androgenetic Alopecia: Study Finds Efficacy of Topical and Oral Minoxidil Similar

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Fri, 04/12/2024 - 07:25

A rigorously conducted trial in men with androgenetic alopecia found that low-dose oral minoxidil was as effective in promoting hair growth as was topical minoxidil.

Oral minoxidil, 5 mg once a day, “did not demonstrate superiority” over topical minoxidil, 5%, applied twice a day, after 24 weeks, reported Mariana Alvares Penha, MD, of the department of dermatology at São Paulo State University, in Botucatu, Brazil, and coauthors. Their randomized, controlled, double-blind study was published online in JAMA Dermatology.

Topical minoxidil is approved by the US Food and Drug Administration (FDA) for androgenetic alopecia (AGA), but there has been increasing interest worldwide in the use of low-dose oral minoxidil, a vasodilator approved as an antihypertensive, as an alternative treatment.

The trial “is important information that’s never been elucidated before,” Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said in an interview. The data, he added, can be used to reassure patients who do not want to take the oral form of the drug that a topical is just as effective.

“This study does let us counsel patients better and really give them the evidence,” said Shari Lipner, MD, PhD, associate professor of clinical dermatology at Weill Cornell Medicine, New York, who was also asked to comment on the results.

Both Dr. Lipner and Dr. Friedman said the study was well-designed.



The investigators enrolled 90 men aged 18-55; 68 completed the trial. Most had mild to moderate AGA. Men were excluded if they had received treatment for alopecia in the previous 6 months, a history of hair transplant, cardiopathy, nephropathy, dermatoses involving the scalp, any clinical conditions causing hair loss, or hypersensitivity to minoxidil.

They were randomized to receive either 5 mg of oral minoxidil a day, plus a placebo solution to apply to the scalp, or topical minoxidil solution (5%) applied twice a day plus placebo capsules. They were told to take a capsule at bedtime and to apply 1 mL of the solution to dry hair in the morning and at night.

The final analysis included 35 men in the topical group and 33 in the oral group (mean age, 36.6 years). Seven people in the topical group and 11 in the oral group were not able to attend the final appointment at 24 weeks. Three additional patients in the topical group dropped out for insomnia, hair shedding, and scalp eczema, while one dropped out of the oral group because of headache.

At 24 weeks, the percentage increase in terminal hair density in the oral minoxidil group was 27% higher (P = .005) in the vertex and 13% higher (P = .15) in the frontal scalp, compared with the topical-treated group.

Total hair density increased by 2% in the oral group compared with topical treatment in the vertex and decreased by 0.2% in the frontal area compared with topical treatment. None of these differences were statistically significant.

Three dermatologists blinded to the treatments, who analyzed photographs, determined that 60% of the men in the oral group and 48% in the topical group had clinical improvement in the frontal area, which was not statistically significant. More orally-treated patients had improvement in the vertex area: 70% compared with 46% of those on topical treatment (P = .04).

 

 

Hypertrichosis, Headache

Of the original 90 patients in the trial, more men taking oral minoxidil had hypertrichosis: 49% compared with 25% in the topical formulation group. Headache was also more common among those on oral minoxidil: six cases (14%) vs. one case (2%) among those on topical minoxidil. There was no difference in mean arterial blood pressure or resting heart rate between the two groups. Transient hair loss was more common with topical treatment, but it was not significant.

Dr. Friedman said that the study results would not change how he practices, but that it would give him data to use to inform patients who do not want to take oral minoxidil. He generally prescribes the oral form, unless patients do not want to take it or there is a medical contraindication, which he said is rare.

“I personally think oral is superior to topical,” mainly “because the patient’s actually using it,” said Dr. Friedman. “They’re more likely to take a pill a day versus apply something topically twice a day,” he added.

Both Dr. Lipner and Dr. Friedman said that they doubted that individuals could — or would want to — follow the twice-daily topical regimen used in the trial.

“In real life, not in the clinical trial scenario, it may be very hard for patients to comply with putting on the topical minoxidil twice a day or even once a day,” Dr. Lipner said.

However, she continues to prescribe more topical minoxidil than oral, because she believes “there’s less potential for side effects.” For patients who can adhere to the topical regimen, the study shows that they will get results, said Dr. Lipner.

Dr. Friedman, however, said that for patients who are looking at a lifetime of medication, “an oral will always win out on a topical to the scalp from an adherence perspective.”

The study was supported by the Brazilian Dermatology Society Support Fund. Dr. Penha reported receiving grants from the fund; no other disclosures were reported. Dr. Friedman and Dr. Lipner reported no conflicts related to minoxidil.

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A rigorously conducted trial in men with androgenetic alopecia found that low-dose oral minoxidil was as effective in promoting hair growth as was topical minoxidil.

Oral minoxidil, 5 mg once a day, “did not demonstrate superiority” over topical minoxidil, 5%, applied twice a day, after 24 weeks, reported Mariana Alvares Penha, MD, of the department of dermatology at São Paulo State University, in Botucatu, Brazil, and coauthors. Their randomized, controlled, double-blind study was published online in JAMA Dermatology.

Topical minoxidil is approved by the US Food and Drug Administration (FDA) for androgenetic alopecia (AGA), but there has been increasing interest worldwide in the use of low-dose oral minoxidil, a vasodilator approved as an antihypertensive, as an alternative treatment.

The trial “is important information that’s never been elucidated before,” Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said in an interview. The data, he added, can be used to reassure patients who do not want to take the oral form of the drug that a topical is just as effective.

“This study does let us counsel patients better and really give them the evidence,” said Shari Lipner, MD, PhD, associate professor of clinical dermatology at Weill Cornell Medicine, New York, who was also asked to comment on the results.

Both Dr. Lipner and Dr. Friedman said the study was well-designed.



The investigators enrolled 90 men aged 18-55; 68 completed the trial. Most had mild to moderate AGA. Men were excluded if they had received treatment for alopecia in the previous 6 months, a history of hair transplant, cardiopathy, nephropathy, dermatoses involving the scalp, any clinical conditions causing hair loss, or hypersensitivity to minoxidil.

They were randomized to receive either 5 mg of oral minoxidil a day, plus a placebo solution to apply to the scalp, or topical minoxidil solution (5%) applied twice a day plus placebo capsules. They were told to take a capsule at bedtime and to apply 1 mL of the solution to dry hair in the morning and at night.

The final analysis included 35 men in the topical group and 33 in the oral group (mean age, 36.6 years). Seven people in the topical group and 11 in the oral group were not able to attend the final appointment at 24 weeks. Three additional patients in the topical group dropped out for insomnia, hair shedding, and scalp eczema, while one dropped out of the oral group because of headache.

At 24 weeks, the percentage increase in terminal hair density in the oral minoxidil group was 27% higher (P = .005) in the vertex and 13% higher (P = .15) in the frontal scalp, compared with the topical-treated group.

Total hair density increased by 2% in the oral group compared with topical treatment in the vertex and decreased by 0.2% in the frontal area compared with topical treatment. None of these differences were statistically significant.

Three dermatologists blinded to the treatments, who analyzed photographs, determined that 60% of the men in the oral group and 48% in the topical group had clinical improvement in the frontal area, which was not statistically significant. More orally-treated patients had improvement in the vertex area: 70% compared with 46% of those on topical treatment (P = .04).

 

 

Hypertrichosis, Headache

Of the original 90 patients in the trial, more men taking oral minoxidil had hypertrichosis: 49% compared with 25% in the topical formulation group. Headache was also more common among those on oral minoxidil: six cases (14%) vs. one case (2%) among those on topical minoxidil. There was no difference in mean arterial blood pressure or resting heart rate between the two groups. Transient hair loss was more common with topical treatment, but it was not significant.

Dr. Friedman said that the study results would not change how he practices, but that it would give him data to use to inform patients who do not want to take oral minoxidil. He generally prescribes the oral form, unless patients do not want to take it or there is a medical contraindication, which he said is rare.

“I personally think oral is superior to topical,” mainly “because the patient’s actually using it,” said Dr. Friedman. “They’re more likely to take a pill a day versus apply something topically twice a day,” he added.

Both Dr. Lipner and Dr. Friedman said that they doubted that individuals could — or would want to — follow the twice-daily topical regimen used in the trial.

“In real life, not in the clinical trial scenario, it may be very hard for patients to comply with putting on the topical minoxidil twice a day or even once a day,” Dr. Lipner said.

However, she continues to prescribe more topical minoxidil than oral, because she believes “there’s less potential for side effects.” For patients who can adhere to the topical regimen, the study shows that they will get results, said Dr. Lipner.

Dr. Friedman, however, said that for patients who are looking at a lifetime of medication, “an oral will always win out on a topical to the scalp from an adherence perspective.”

The study was supported by the Brazilian Dermatology Society Support Fund. Dr. Penha reported receiving grants from the fund; no other disclosures were reported. Dr. Friedman and Dr. Lipner reported no conflicts related to minoxidil.

A rigorously conducted trial in men with androgenetic alopecia found that low-dose oral minoxidil was as effective in promoting hair growth as was topical minoxidil.

Oral minoxidil, 5 mg once a day, “did not demonstrate superiority” over topical minoxidil, 5%, applied twice a day, after 24 weeks, reported Mariana Alvares Penha, MD, of the department of dermatology at São Paulo State University, in Botucatu, Brazil, and coauthors. Their randomized, controlled, double-blind study was published online in JAMA Dermatology.

Topical minoxidil is approved by the US Food and Drug Administration (FDA) for androgenetic alopecia (AGA), but there has been increasing interest worldwide in the use of low-dose oral minoxidil, a vasodilator approved as an antihypertensive, as an alternative treatment.

The trial “is important information that’s never been elucidated before,” Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said in an interview. The data, he added, can be used to reassure patients who do not want to take the oral form of the drug that a topical is just as effective.

“This study does let us counsel patients better and really give them the evidence,” said Shari Lipner, MD, PhD, associate professor of clinical dermatology at Weill Cornell Medicine, New York, who was also asked to comment on the results.

Both Dr. Lipner and Dr. Friedman said the study was well-designed.



The investigators enrolled 90 men aged 18-55; 68 completed the trial. Most had mild to moderate AGA. Men were excluded if they had received treatment for alopecia in the previous 6 months, a history of hair transplant, cardiopathy, nephropathy, dermatoses involving the scalp, any clinical conditions causing hair loss, or hypersensitivity to minoxidil.

They were randomized to receive either 5 mg of oral minoxidil a day, plus a placebo solution to apply to the scalp, or topical minoxidil solution (5%) applied twice a day plus placebo capsules. They were told to take a capsule at bedtime and to apply 1 mL of the solution to dry hair in the morning and at night.

The final analysis included 35 men in the topical group and 33 in the oral group (mean age, 36.6 years). Seven people in the topical group and 11 in the oral group were not able to attend the final appointment at 24 weeks. Three additional patients in the topical group dropped out for insomnia, hair shedding, and scalp eczema, while one dropped out of the oral group because of headache.

At 24 weeks, the percentage increase in terminal hair density in the oral minoxidil group was 27% higher (P = .005) in the vertex and 13% higher (P = .15) in the frontal scalp, compared with the topical-treated group.

Total hair density increased by 2% in the oral group compared with topical treatment in the vertex and decreased by 0.2% in the frontal area compared with topical treatment. None of these differences were statistically significant.

Three dermatologists blinded to the treatments, who analyzed photographs, determined that 60% of the men in the oral group and 48% in the topical group had clinical improvement in the frontal area, which was not statistically significant. More orally-treated patients had improvement in the vertex area: 70% compared with 46% of those on topical treatment (P = .04).

 

 

Hypertrichosis, Headache

Of the original 90 patients in the trial, more men taking oral minoxidil had hypertrichosis: 49% compared with 25% in the topical formulation group. Headache was also more common among those on oral minoxidil: six cases (14%) vs. one case (2%) among those on topical minoxidil. There was no difference in mean arterial blood pressure or resting heart rate between the two groups. Transient hair loss was more common with topical treatment, but it was not significant.

Dr. Friedman said that the study results would not change how he practices, but that it would give him data to use to inform patients who do not want to take oral minoxidil. He generally prescribes the oral form, unless patients do not want to take it or there is a medical contraindication, which he said is rare.

“I personally think oral is superior to topical,” mainly “because the patient’s actually using it,” said Dr. Friedman. “They’re more likely to take a pill a day versus apply something topically twice a day,” he added.

Both Dr. Lipner and Dr. Friedman said that they doubted that individuals could — or would want to — follow the twice-daily topical regimen used in the trial.

“In real life, not in the clinical trial scenario, it may be very hard for patients to comply with putting on the topical minoxidil twice a day or even once a day,” Dr. Lipner said.

However, she continues to prescribe more topical minoxidil than oral, because she believes “there’s less potential for side effects.” For patients who can adhere to the topical regimen, the study shows that they will get results, said Dr. Lipner.

Dr. Friedman, however, said that for patients who are looking at a lifetime of medication, “an oral will always win out on a topical to the scalp from an adherence perspective.”

The study was supported by the Brazilian Dermatology Society Support Fund. Dr. Penha reported receiving grants from the fund; no other disclosures were reported. Dr. Friedman and Dr. Lipner reported no conflicts related to minoxidil.

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