MDedge Internal Medicine

Scene 1: Exercise Medicine Clinic, Rio de Janeiro, Brazil I just finished one evaluation on physical fitness and health and looked at my schedule. My next patient would be a 65-year-old man. How fit will he be? Will he have evident age-related muscle loss? I gave myself a short break and my mind went to the late 1970s. 

Once upon a time, the practice of medicine was based primarily on the skill of your physical examination, previous experiences, and your ability to reason logically and make solid deductions. In 1979, the stethoscope was part of my dress code. After one elective semester as a research fellow at the Ambrose Cardiorespiratory Unit at McMaster University Medical Centre, in Hamilton, Canada, where I was honored to witness the dawn of evidence-based medicine, I graduated from Federal University of Rio de Janeiro. I still remember being introduced to some promising novelties in cardiology, such as M-mode echocardiograms and myocardial scintigraphy. Radiology was primarily centered on x-rays, and lab testing was basic and poorly automatized.

Over the following decades, medical practice changed dramatically with the incorporation of new technologies. Recent advances in diagnostic tools, genetics, artificial intelligence, and sophisticated statistical analyses, along with well-collected scientific data, have molded how clinicians should think and work.

At the same time, clinical profiles also changed. Internists and primary care physicians are regularly managing patients who are, on average, older and have or are on the way to having potentially life-threatening chronic diseases, accompanied by poor lifestyle habits, and, highly important, often some degree of disability, frailty, and loss of independence. Many of them exhibit age-related muscle loss. 

Scene 2: Exercise Medicine Clinic, Rio de Janeiro, Brazil 

Conscious of the benefits of interrupting my sitting time with activity, I left my office and walked to meet my patient in the waiting room. I called his name and introduced myself. I watched how he listened and reacted to my speech, and how easy or hard it was for him to rise from the chair — readiness, velocity, and number of supports required: none, one, or two hands. I offered my own hand to him, and when we shook, I gauged the strength of his grip. 

I invited him into my office and took note of his somatotype and body composition, and whether he had any central obesity. Of course, and I should by no means miss this chance, I carefully observed how he walked in — his gait, speed, balance, posture — how he pulled up the chair, and how he managed to lower himself into his seat. Before I even sat in my own chair, I asked him if he remembered what his body weight was 5 years ago and what it was today. Before we got started in earnest, I had already managed to collect several pieces of relevant information. 

Exercise Physiology: Changing Landscape

Muscle activity depends on muscle mass and function, and peaks somewhere between ages 25 and 35 before declining. The drop is slow in the early stages but accelerates rapidly after age 60 or 65.

Two of the most relevant variables in muscle function are strength and power. As a product of force and velocity, muscle power could be a more crucial factor than strength for many daily activities that demand movement against gravity or inertia, such as placing carry-on baggage in the overhead bin of an airplane or rising from the floor or chair.

The association between muscle mass and muscle strength or power is moderate, and physiologic data have indicated that the decline of muscle power with aging is faster and larger than that of muscle strength.

The term “sarcopenia” has become definitively incorporated into the medical glossary. From the Greek (“sark” and “penia”), sarcopenia was defined as reduced muscle mass, but more recently it has encompassed muscle strength in its definition. However, a recent consensus paper from the Global Leadership Initiative in Sarcopenia, using a Delphi approach, rejected the inclusion of muscle power in the concept of sarcopenia. On the other hand, a long time ago, some authors coined and advocated the use the term “dynapenia” to more precisely reflect the reduced levels of muscle strength and power that often accompany aging.

The best available intervention to counteract age-related deterioration of muscle activity is resistance exercise. The types of resistance exercises vary widely — by number of sets and repetitions, intervals between sets, speed of execution of movement, and percentage of maximal weight/load.

We recently proposed that, after an evaluation to identify the main muscle variable requiring attention, the resistance exercise program should be individually tailored and prescribed according to the objective to counteract sarcopenia or dynapenia.

What is more important for autonomy and better daily living conditions in old and very old individuals: muscle mass, muscle strength, or muscle power? More likely the response is muscle power — in practical terms, dynapenia rather than sarcopenia. This short video presents practical tips for obtaining optimal results in fighting dynapenia. The first choice should be power training or high velocity–based training, emphasizing two to three sets of six to eight repetitions performed as fast as possible (on the concentric or shortening phase of muscle contraction) with relatively high loads.

Internists and primary care physicians are most likely satisfied with the information they obtain by simple observation, and already can superficially grade the magnitude of a patient’s age-related muscle loss and its consequences to daily living.

However, those who want more objective information on nonaerobic physical fitness can add one to three simple tests to their consultation: the sitting-rising test (SRT); the 10-second one-legged test (10sOLS test); and the Flexitest. Poor performance on each of these — and particularly all three — is strongly associated with an increased risk for premature death in middle-aged and older individuals. These tests require no extra equipment and can be performed rapidly, and interpreting the results takes only a few moments using published reference values.

Age-related muscle loss profoundly affects our ability to sit and rise from the floor, so if time is limited, the SRT is the best assessment, as it measures all nonaerobic components of physical fitness. For a quick interpretation, consider that SRT scores vary from 0 to 10, do not substantially differ by sex, and that a composite score equal to or greater than 8 will reflect a minimum age-adjusted percentile of 61, most likely indicating relevant age-related muscle loss is not yet occurring. 
 

Dr. Araújo is Professor and Dean of Research and Education, Exercise Medicine Clinic (CLINIMEX), Rio de Janeiro, Brazil. He reported conflicts of interest with INBRAMED.


A version of this article first appeared on Medscape.com.

Scene 1: Exercise Medicine Clinic, Rio de Janeiro, Brazil I just finished one evaluation on physical fitness and health and looked at my schedule. My next patient would be a 65-year-old man. How fit will he be? Will he have evident age-related muscle loss? I gave myself a short break and my mind went to the late 1970s. 

Once upon a time, the practice of medicine was based primarily on the skill of your physical examination, previous experiences, and your ability to reason logically and make solid deductions. In 1979, the stethoscope was part of my dress code. After one elective semester as a research fellow at the Ambrose Cardiorespiratory Unit at McMaster University Medical Centre, in Hamilton, Canada, where I was honored to witness the dawn of evidence-based medicine, I graduated from Federal University of Rio de Janeiro. I still remember being introduced to some promising novelties in cardiology, such as M-mode echocardiograms and myocardial scintigraphy. Radiology was primarily centered on x-rays, and lab testing was basic and poorly automatized.

Over the following decades, medical practice changed dramatically with the incorporation of new technologies. Recent advances in diagnostic tools, genetics, artificial intelligence, and sophisticated statistical analyses, along with well-collected scientific data, have molded how clinicians should think and work.

At the same time, clinical profiles also changed. Internists and primary care physicians are regularly managing patients who are, on average, older and have or are on the way to having potentially life-threatening chronic diseases, accompanied by poor lifestyle habits, and, highly important, often some degree of disability, frailty, and loss of independence. Many of them exhibit age-related muscle loss. 

Scene 2: Exercise Medicine Clinic, Rio de Janeiro, Brazil 

Conscious of the benefits of interrupting my sitting time with activity, I left my office and walked to meet my patient in the waiting room. I called his name and introduced myself. I watched how he listened and reacted to my speech, and how easy or hard it was for him to rise from the chair — readiness, velocity, and number of supports required: none, one, or two hands. I offered my own hand to him, and when we shook, I gauged the strength of his grip. 

I invited him into my office and took note of his somatotype and body composition, and whether he had any central obesity. Of course, and I should by no means miss this chance, I carefully observed how he walked in — his gait, speed, balance, posture — how he pulled up the chair, and how he managed to lower himself into his seat. Before I even sat in my own chair, I asked him if he remembered what his body weight was 5 years ago and what it was today. Before we got started in earnest, I had already managed to collect several pieces of relevant information. 

Exercise Physiology: Changing Landscape

Muscle activity depends on muscle mass and function, and peaks somewhere between ages 25 and 35 before declining. The drop is slow in the early stages but accelerates rapidly after age 60 or 65.

Two of the most relevant variables in muscle function are strength and power. As a product of force and velocity, muscle power could be a more crucial factor than strength for many daily activities that demand movement against gravity or inertia, such as placing carry-on baggage in the overhead bin of an airplane or rising from the floor or chair.

The association between muscle mass and muscle strength or power is moderate, and physiologic data have indicated that the decline of muscle power with aging is faster and larger than that of muscle strength.

The term “sarcopenia” has become definitively incorporated into the medical glossary. From the Greek (“sark” and “penia”), sarcopenia was defined as reduced muscle mass, but more recently it has encompassed muscle strength in its definition. However, a recent consensus paper from the Global Leadership Initiative in Sarcopenia, using a Delphi approach, rejected the inclusion of muscle power in the concept of sarcopenia. On the other hand, a long time ago, some authors coined and advocated the use the term “dynapenia” to more precisely reflect the reduced levels of muscle strength and power that often accompany aging.

The best available intervention to counteract age-related deterioration of muscle activity is resistance exercise. The types of resistance exercises vary widely — by number of sets and repetitions, intervals between sets, speed of execution of movement, and percentage of maximal weight/load.

We recently proposed that, after an evaluation to identify the main muscle variable requiring attention, the resistance exercise program should be individually tailored and prescribed according to the objective to counteract sarcopenia or dynapenia.

What is more important for autonomy and better daily living conditions in old and very old individuals: muscle mass, muscle strength, or muscle power? More likely the response is muscle power — in practical terms, dynapenia rather than sarcopenia. This short video presents practical tips for obtaining optimal results in fighting dynapenia. The first choice should be power training or high velocity–based training, emphasizing two to three sets of six to eight repetitions performed as fast as possible (on the concentric or shortening phase of muscle contraction) with relatively high loads.

Internists and primary care physicians are most likely satisfied with the information they obtain by simple observation, and already can superficially grade the magnitude of a patient’s age-related muscle loss and its consequences to daily living.

However, those who want more objective information on nonaerobic physical fitness can add one to three simple tests to their consultation: the sitting-rising test (SRT); the 10-second one-legged test (10sOLS test); and the Flexitest. Poor performance on each of these — and particularly all three — is strongly associated with an increased risk for premature death in middle-aged and older individuals. These tests require no extra equipment and can be performed rapidly, and interpreting the results takes only a few moments using published reference values.

Age-related muscle loss profoundly affects our ability to sit and rise from the floor, so if time is limited, the SRT is the best assessment, as it measures all nonaerobic components of physical fitness. For a quick interpretation, consider that SRT scores vary from 0 to 10, do not substantially differ by sex, and that a composite score equal to or greater than 8 will reflect a minimum age-adjusted percentile of 61, most likely indicating relevant age-related muscle loss is not yet occurring. 
 

Dr. Araújo is Professor and Dean of Research and Education, Exercise Medicine Clinic (CLINIMEX), Rio de Janeiro, Brazil. He reported conflicts of interest with INBRAMED.


A version of this article first appeared on Medscape.com.

Scene 1: Exercise Medicine Clinic, Rio de Janeiro, Brazil I just finished one evaluation on physical fitness and health and looked at my schedule. My next patient would be a 65-year-old man. How fit will he be? Will he have evident age-related muscle loss? I gave myself a short break and my mind went to the late 1970s. 

Once upon a time, the practice of medicine was based primarily on the skill of your physical examination, previous experiences, and your ability to reason logically and make solid deductions. In 1979, the stethoscope was part of my dress code. After one elective semester as a research fellow at the Ambrose Cardiorespiratory Unit at McMaster University Medical Centre, in Hamilton, Canada, where I was honored to witness the dawn of evidence-based medicine, I graduated from Federal University of Rio de Janeiro. I still remember being introduced to some promising novelties in cardiology, such as M-mode echocardiograms and myocardial scintigraphy. Radiology was primarily centered on x-rays, and lab testing was basic and poorly automatized.

Over the following decades, medical practice changed dramatically with the incorporation of new technologies. Recent advances in diagnostic tools, genetics, artificial intelligence, and sophisticated statistical analyses, along with well-collected scientific data, have molded how clinicians should think and work.

At the same time, clinical profiles also changed. Internists and primary care physicians are regularly managing patients who are, on average, older and have or are on the way to having potentially life-threatening chronic diseases, accompanied by poor lifestyle habits, and, highly important, often some degree of disability, frailty, and loss of independence. Many of them exhibit age-related muscle loss. 

Scene 2: Exercise Medicine Clinic, Rio de Janeiro, Brazil 

Conscious of the benefits of interrupting my sitting time with activity, I left my office and walked to meet my patient in the waiting room. I called his name and introduced myself. I watched how he listened and reacted to my speech, and how easy or hard it was for him to rise from the chair — readiness, velocity, and number of supports required: none, one, or two hands. I offered my own hand to him, and when we shook, I gauged the strength of his grip. 

I invited him into my office and took note of his somatotype and body composition, and whether he had any central obesity. Of course, and I should by no means miss this chance, I carefully observed how he walked in — his gait, speed, balance, posture — how he pulled up the chair, and how he managed to lower himself into his seat. Before I even sat in my own chair, I asked him if he remembered what his body weight was 5 years ago and what it was today. Before we got started in earnest, I had already managed to collect several pieces of relevant information. 

Exercise Physiology: Changing Landscape

Muscle activity depends on muscle mass and function, and peaks somewhere between ages 25 and 35 before declining. The drop is slow in the early stages but accelerates rapidly after age 60 or 65.

Two of the most relevant variables in muscle function are strength and power. As a product of force and velocity, muscle power could be a more crucial factor than strength for many daily activities that demand movement against gravity or inertia, such as placing carry-on baggage in the overhead bin of an airplane or rising from the floor or chair.

The association between muscle mass and muscle strength or power is moderate, and physiologic data have indicated that the decline of muscle power with aging is faster and larger than that of muscle strength.

The term “sarcopenia” has become definitively incorporated into the medical glossary. From the Greek (“sark” and “penia”), sarcopenia was defined as reduced muscle mass, but more recently it has encompassed muscle strength in its definition. However, a recent consensus paper from the Global Leadership Initiative in Sarcopenia, using a Delphi approach, rejected the inclusion of muscle power in the concept of sarcopenia. On the other hand, a long time ago, some authors coined and advocated the use the term “dynapenia” to more precisely reflect the reduced levels of muscle strength and power that often accompany aging.

The best available intervention to counteract age-related deterioration of muscle activity is resistance exercise. The types of resistance exercises vary widely — by number of sets and repetitions, intervals between sets, speed of execution of movement, and percentage of maximal weight/load.

We recently proposed that, after an evaluation to identify the main muscle variable requiring attention, the resistance exercise program should be individually tailored and prescribed according to the objective to counteract sarcopenia or dynapenia.

What is more important for autonomy and better daily living conditions in old and very old individuals: muscle mass, muscle strength, or muscle power? More likely the response is muscle power — in practical terms, dynapenia rather than sarcopenia. This short video presents practical tips for obtaining optimal results in fighting dynapenia. The first choice should be power training or high velocity–based training, emphasizing two to three sets of six to eight repetitions performed as fast as possible (on the concentric or shortening phase of muscle contraction) with relatively high loads.

Internists and primary care physicians are most likely satisfied with the information they obtain by simple observation, and already can superficially grade the magnitude of a patient’s age-related muscle loss and its consequences to daily living.

However, those who want more objective information on nonaerobic physical fitness can add one to three simple tests to their consultation: the sitting-rising test (SRT); the 10-second one-legged test (10sOLS test); and the Flexitest. Poor performance on each of these — and particularly all three — is strongly associated with an increased risk for premature death in middle-aged and older individuals. These tests require no extra equipment and can be performed rapidly, and interpreting the results takes only a few moments using published reference values.

Age-related muscle loss profoundly affects our ability to sit and rise from the floor, so if time is limited, the SRT is the best assessment, as it measures all nonaerobic components of physical fitness. For a quick interpretation, consider that SRT scores vary from 0 to 10, do not substantially differ by sex, and that a composite score equal to or greater than 8 will reflect a minimum age-adjusted percentile of 61, most likely indicating relevant age-related muscle loss is not yet occurring. 
 

Dr. Araújo is Professor and Dean of Research and Education, Exercise Medicine Clinic (CLINIMEX), Rio de Janeiro, Brazil. He reported conflicts of interest with INBRAMED.


A version of this article first appeared on Medscape.com.

Methadone has been shown to be highly effective for opioid use disorder. So why is it still so difficult to prescribe in the United States and is that about to change?

A recent study from Canada adds to the growing body of evidence supporting methadone’s effectiveness in treating opioid use disorder and bolsters efforts to expand access in the United States by removing restrictive barriers.

This paper included more than 30,000 patients with opioid use disorder and showed those on methadone were almost 60% significantly less likely to stop treatment at 24 months than their peers assigned to buprenorphine/naloxone (adjusted hazard ratio [aHR], 1.58), with no difference in mortality risk (aHR, 0.57).

“In Canada, unlike the US, methadone and buprenorphine/naloxone are both available in office-based settings. Methadone really outperforms buprenorphine/naloxone in being able to retain people in treatment, which is our main goal and comes with a host of benefits,” Bohdan Nosyk, PhD, with Simon Fraser University in Burnaby, British Columbia, Canada, who worked on the study, said in an interview.

In addition, a recent systematic review and meta-analysis of relevant research involving more than 1 million patients with opioid use disorder also showed better treatment retention with methadone than with buprenorphine.

During the COVID-19 pandemic, relaxed methadone regulations, that included take-home medications, did not lead to an increase in overdoses. Instead, these changes improved treatment retention and patient experiences, highlighting the potential benefits of further deregulation.
 

‘Atrocious’ Outdated Policies

However, despite methadone’s proven efficacy and safety for opioid use disorder, it remains vastly underutilized because of outdated US policies restricting its use to opioid treatment programs (OTPs).

“It’s absolutely atrocious that methadone policies have not kept up with the evidence. If you look at other countries that have expanded their access to methadone, their overdose rates have fallen dramatically,” said Leslie Suen, MD, with the University of California, San Francisco, and coauthor of a recent JAMA Viewpoint on this topic.

“Methadone is a very good medication that’s been shown over and over to be very effective and safe,” Alan Leshner, PhD, past director of the National Institute on Drug Abuse, said in an interview.

“There is no reason why it couldn’t be administered through pharmacies or through physicians’ offices as long as it’s done in a controlled and careful way,” said Leshner.

Leshner chaired the committee that produced the 2019 report Medications for Opioid Use Disorder Save Lives.

“We learned during COVID that increasing the amount of take-home methadone and increasing access does not lead to an increase in deaths or an increase in overdose, so it’s hard to find a reason not to do it,” he said.
 

Change Finally on the Horizon?

Several recent and proposed policy changes could revolutionize methadone delivery in the United States.

In March 2022, in response to the pandemic, the Drug Enforcement Administration (DEA) allowed hospitals to dispense up to a 3-day supply of methadone (known as the 72-hour rule) to bridge care transitions without needing OTPs.

In April 2024, the Substance Abuse and Mental Health Services Administration and DEA codified many methadone and buprenorphine delivery flexibilities granted temporarily during the pandemic, including increased use of telehealth assessments and earlier access to take-home methadone doses.

Another contemporary policy change is expansion of the Americans with Disabilities Act mandating that patients taking medications for opioid use disorder, such as methadone, be able to continue treatment when transitioning to settings such as hospitals, jails, and skilled nursing facilities.

At the state level, California Governor Gavin Newsom recently signed a bill, effective immediately, that expands access to methadone treatment in his state.

On the horizon at the federal level is the Modernizing Opioid Treatment Access Act (MOTAA) — the bipartisan and bicameral bill introduced by Sen. Ed Markey (D-MA) and Sen. Rand Paul (R-KY), along with Rep. Donald Norcross (D-NJ) and Rep. Don Bacon, (R-NE) — that would allow methadone to be prescribed by addiction specialists and dispensed in community pharmacies.
 

An Ethical Imperative

“With only about 2000 OTP clinics clustered in urban areas, less than 25% of people who are diagnosed with opioid use disorder are actually able to access methadone,” Caty Simon, with the National Survivors Union, Greensboro, North Carolina, and coauthor of the JAMA Viewpoint, said in an interview.

While MOTAA represents a major step forward, limiting methadone prescribing to addiction specialists may not fully address the treatment gap, particularly in rural and underserved areas, Simon said.

To optimize methadone’s potential, she’d like to see further expansion of prescribing privileges to general healthcare providers.

“As someone with lived and living experience of opioid use and treatment, and somebody who works nationally and locally in organizations of people impacted by drug use, I know people in my area right now — marginalized people of color — who would have much better chances of survival if they were able to access methadone. If MOTAA passed tomorrow, we could save so many lives. There is an ethical imperative to pass it,” Simon said.

Leshner said he is “always very concerned about access, particularly for underserved populations, poor people, people living in rural areas. If you can access the medications you need, you’re in big trouble.”

Is this methadone’s moment? “I’m a little optimistic, but I haven’t seen the progress I would like to see,” Leshner said.

A version of this article first appeared on Medscape.com.

Methadone has been shown to be highly effective for opioid use disorder. So why is it still so difficult to prescribe in the United States and is that about to change?

A recent study from Canada adds to the growing body of evidence supporting methadone’s effectiveness in treating opioid use disorder and bolsters efforts to expand access in the United States by removing restrictive barriers.

This paper included more than 30,000 patients with opioid use disorder and showed those on methadone were almost 60% significantly less likely to stop treatment at 24 months than their peers assigned to buprenorphine/naloxone (adjusted hazard ratio [aHR], 1.58), with no difference in mortality risk (aHR, 0.57).

“In Canada, unlike the US, methadone and buprenorphine/naloxone are both available in office-based settings. Methadone really outperforms buprenorphine/naloxone in being able to retain people in treatment, which is our main goal and comes with a host of benefits,” Bohdan Nosyk, PhD, with Simon Fraser University in Burnaby, British Columbia, Canada, who worked on the study, said in an interview.

In addition, a recent systematic review and meta-analysis of relevant research involving more than 1 million patients with opioid use disorder also showed better treatment retention with methadone than with buprenorphine.

During the COVID-19 pandemic, relaxed methadone regulations, that included take-home medications, did not lead to an increase in overdoses. Instead, these changes improved treatment retention and patient experiences, highlighting the potential benefits of further deregulation.
 

‘Atrocious’ Outdated Policies

However, despite methadone’s proven efficacy and safety for opioid use disorder, it remains vastly underutilized because of outdated US policies restricting its use to opioid treatment programs (OTPs).

“It’s absolutely atrocious that methadone policies have not kept up with the evidence. If you look at other countries that have expanded their access to methadone, their overdose rates have fallen dramatically,” said Leslie Suen, MD, with the University of California, San Francisco, and coauthor of a recent JAMA Viewpoint on this topic.

“Methadone is a very good medication that’s been shown over and over to be very effective and safe,” Alan Leshner, PhD, past director of the National Institute on Drug Abuse, said in an interview.

“There is no reason why it couldn’t be administered through pharmacies or through physicians’ offices as long as it’s done in a controlled and careful way,” said Leshner.

Leshner chaired the committee that produced the 2019 report Medications for Opioid Use Disorder Save Lives.

“We learned during COVID that increasing the amount of take-home methadone and increasing access does not lead to an increase in deaths or an increase in overdose, so it’s hard to find a reason not to do it,” he said.
 

Change Finally on the Horizon?

Several recent and proposed policy changes could revolutionize methadone delivery in the United States.

In March 2022, in response to the pandemic, the Drug Enforcement Administration (DEA) allowed hospitals to dispense up to a 3-day supply of methadone (known as the 72-hour rule) to bridge care transitions without needing OTPs.

In April 2024, the Substance Abuse and Mental Health Services Administration and DEA codified many methadone and buprenorphine delivery flexibilities granted temporarily during the pandemic, including increased use of telehealth assessments and earlier access to take-home methadone doses.

Another contemporary policy change is expansion of the Americans with Disabilities Act mandating that patients taking medications for opioid use disorder, such as methadone, be able to continue treatment when transitioning to settings such as hospitals, jails, and skilled nursing facilities.

At the state level, California Governor Gavin Newsom recently signed a bill, effective immediately, that expands access to methadone treatment in his state.

On the horizon at the federal level is the Modernizing Opioid Treatment Access Act (MOTAA) — the bipartisan and bicameral bill introduced by Sen. Ed Markey (D-MA) and Sen. Rand Paul (R-KY), along with Rep. Donald Norcross (D-NJ) and Rep. Don Bacon, (R-NE) — that would allow methadone to be prescribed by addiction specialists and dispensed in community pharmacies.
 

An Ethical Imperative

“With only about 2000 OTP clinics clustered in urban areas, less than 25% of people who are diagnosed with opioid use disorder are actually able to access methadone,” Caty Simon, with the National Survivors Union, Greensboro, North Carolina, and coauthor of the JAMA Viewpoint, said in an interview.

While MOTAA represents a major step forward, limiting methadone prescribing to addiction specialists may not fully address the treatment gap, particularly in rural and underserved areas, Simon said.

To optimize methadone’s potential, she’d like to see further expansion of prescribing privileges to general healthcare providers.

“As someone with lived and living experience of opioid use and treatment, and somebody who works nationally and locally in organizations of people impacted by drug use, I know people in my area right now — marginalized people of color — who would have much better chances of survival if they were able to access methadone. If MOTAA passed tomorrow, we could save so many lives. There is an ethical imperative to pass it,” Simon said.

Leshner said he is “always very concerned about access, particularly for underserved populations, poor people, people living in rural areas. If you can access the medications you need, you’re in big trouble.”

Is this methadone’s moment? “I’m a little optimistic, but I haven’t seen the progress I would like to see,” Leshner said.

A version of this article first appeared on Medscape.com.

Methadone has been shown to be highly effective for opioid use disorder. So why is it still so difficult to prescribe in the United States and is that about to change?

A recent study from Canada adds to the growing body of evidence supporting methadone’s effectiveness in treating opioid use disorder and bolsters efforts to expand access in the United States by removing restrictive barriers.

This paper included more than 30,000 patients with opioid use disorder and showed those on methadone were almost 60% significantly less likely to stop treatment at 24 months than their peers assigned to buprenorphine/naloxone (adjusted hazard ratio [aHR], 1.58), with no difference in mortality risk (aHR, 0.57).

“In Canada, unlike the US, methadone and buprenorphine/naloxone are both available in office-based settings. Methadone really outperforms buprenorphine/naloxone in being able to retain people in treatment, which is our main goal and comes with a host of benefits,” Bohdan Nosyk, PhD, with Simon Fraser University in Burnaby, British Columbia, Canada, who worked on the study, said in an interview.

In addition, a recent systematic review and meta-analysis of relevant research involving more than 1 million patients with opioid use disorder also showed better treatment retention with methadone than with buprenorphine.

During the COVID-19 pandemic, relaxed methadone regulations, that included take-home medications, did not lead to an increase in overdoses. Instead, these changes improved treatment retention and patient experiences, highlighting the potential benefits of further deregulation.
 

‘Atrocious’ Outdated Policies

However, despite methadone’s proven efficacy and safety for opioid use disorder, it remains vastly underutilized because of outdated US policies restricting its use to opioid treatment programs (OTPs).

“It’s absolutely atrocious that methadone policies have not kept up with the evidence. If you look at other countries that have expanded their access to methadone, their overdose rates have fallen dramatically,” said Leslie Suen, MD, with the University of California, San Francisco, and coauthor of a recent JAMA Viewpoint on this topic.

“Methadone is a very good medication that’s been shown over and over to be very effective and safe,” Alan Leshner, PhD, past director of the National Institute on Drug Abuse, said in an interview.

“There is no reason why it couldn’t be administered through pharmacies or through physicians’ offices as long as it’s done in a controlled and careful way,” said Leshner.

Leshner chaired the committee that produced the 2019 report Medications for Opioid Use Disorder Save Lives.

“We learned during COVID that increasing the amount of take-home methadone and increasing access does not lead to an increase in deaths or an increase in overdose, so it’s hard to find a reason not to do it,” he said.
 

Change Finally on the Horizon?

Several recent and proposed policy changes could revolutionize methadone delivery in the United States.

In March 2022, in response to the pandemic, the Drug Enforcement Administration (DEA) allowed hospitals to dispense up to a 3-day supply of methadone (known as the 72-hour rule) to bridge care transitions without needing OTPs.

In April 2024, the Substance Abuse and Mental Health Services Administration and DEA codified many methadone and buprenorphine delivery flexibilities granted temporarily during the pandemic, including increased use of telehealth assessments and earlier access to take-home methadone doses.

Another contemporary policy change is expansion of the Americans with Disabilities Act mandating that patients taking medications for opioid use disorder, such as methadone, be able to continue treatment when transitioning to settings such as hospitals, jails, and skilled nursing facilities.

At the state level, California Governor Gavin Newsom recently signed a bill, effective immediately, that expands access to methadone treatment in his state.

On the horizon at the federal level is the Modernizing Opioid Treatment Access Act (MOTAA) — the bipartisan and bicameral bill introduced by Sen. Ed Markey (D-MA) and Sen. Rand Paul (R-KY), along with Rep. Donald Norcross (D-NJ) and Rep. Don Bacon, (R-NE) — that would allow methadone to be prescribed by addiction specialists and dispensed in community pharmacies.
 

An Ethical Imperative

“With only about 2000 OTP clinics clustered in urban areas, less than 25% of people who are diagnosed with opioid use disorder are actually able to access methadone,” Caty Simon, with the National Survivors Union, Greensboro, North Carolina, and coauthor of the JAMA Viewpoint, said in an interview.

While MOTAA represents a major step forward, limiting methadone prescribing to addiction specialists may not fully address the treatment gap, particularly in rural and underserved areas, Simon said.

To optimize methadone’s potential, she’d like to see further expansion of prescribing privileges to general healthcare providers.

“As someone with lived and living experience of opioid use and treatment, and somebody who works nationally and locally in organizations of people impacted by drug use, I know people in my area right now — marginalized people of color — who would have much better chances of survival if they were able to access methadone. If MOTAA passed tomorrow, we could save so many lives. There is an ethical imperative to pass it,” Simon said.

Leshner said he is “always very concerned about access, particularly for underserved populations, poor people, people living in rural areas. If you can access the medications you need, you’re in big trouble.”

Is this methadone’s moment? “I’m a little optimistic, but I haven’t seen the progress I would like to see,” Leshner said.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved a 10-mg dose of Roxybond (Protega Pharmaceuticals), an opioid analgesic indicated for the management of severe pain in cases where other treatments are not well-tolerated or prove ineffective.

Roxybond, an immediate-release (IR) formulation of oxycodone hydrochloride, is made with Protega’s SentryBond technology, which makes it harder for people to crush, inject, or snort, according to the company.

In a statement from Protega, Paul Howe, the company’s chief commercial officer, said the drug meets an “unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated.”

To determine the tablet’s ability to withstand manipulation, more than 2000 in vitro tests were conducted, according to the release. The findings indicate Roxybond reduces — but does not entirely negate — the potential for intranasal and intravenous abuse.

Roxybond was previously approved in 5-, 15-, and 30-mg doses. The 10 mg option provides clinicians with the ability to better modify side effects, manage titration, and provide precision care for patients on opioid therapy, according to Protega.

“For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions,” the company stated.

Roxybond is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, or hypersensitivity to oxycodone. The drug is not intended for long-term use unless otherwise determined by a clinician. Roxybond also is subject to the FDA’s Risk Evaluation and Mitigation Strategies for opioids.

“The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protega, in a release. “Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved a 10-mg dose of Roxybond (Protega Pharmaceuticals), an opioid analgesic indicated for the management of severe pain in cases where other treatments are not well-tolerated or prove ineffective.

Roxybond, an immediate-release (IR) formulation of oxycodone hydrochloride, is made with Protega’s SentryBond technology, which makes it harder for people to crush, inject, or snort, according to the company.

In a statement from Protega, Paul Howe, the company’s chief commercial officer, said the drug meets an “unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated.”

To determine the tablet’s ability to withstand manipulation, more than 2000 in vitro tests were conducted, according to the release. The findings indicate Roxybond reduces — but does not entirely negate — the potential for intranasal and intravenous abuse.

Roxybond was previously approved in 5-, 15-, and 30-mg doses. The 10 mg option provides clinicians with the ability to better modify side effects, manage titration, and provide precision care for patients on opioid therapy, according to Protega.

“For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions,” the company stated.

Roxybond is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, or hypersensitivity to oxycodone. The drug is not intended for long-term use unless otherwise determined by a clinician. Roxybond also is subject to the FDA’s Risk Evaluation and Mitigation Strategies for opioids.

“The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protega, in a release. “Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved a 10-mg dose of Roxybond (Protega Pharmaceuticals), an opioid analgesic indicated for the management of severe pain in cases where other treatments are not well-tolerated or prove ineffective.

Roxybond, an immediate-release (IR) formulation of oxycodone hydrochloride, is made with Protega’s SentryBond technology, which makes it harder for people to crush, inject, or snort, according to the company.

In a statement from Protega, Paul Howe, the company’s chief commercial officer, said the drug meets an “unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated.”

To determine the tablet’s ability to withstand manipulation, more than 2000 in vitro tests were conducted, according to the release. The findings indicate Roxybond reduces — but does not entirely negate — the potential for intranasal and intravenous abuse.

Roxybond was previously approved in 5-, 15-, and 30-mg doses. The 10 mg option provides clinicians with the ability to better modify side effects, manage titration, and provide precision care for patients on opioid therapy, according to Protega.

“For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions,” the company stated.

Roxybond is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, or hypersensitivity to oxycodone. The drug is not intended for long-term use unless otherwise determined by a clinician. Roxybond also is subject to the FDA’s Risk Evaluation and Mitigation Strategies for opioids.

“The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protega, in a release. “Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse.”

A version of this article first appeared on Medscape.com.

For people with severe symptomatic hip osteoarthritis, total hip replacement (THR) alleviates hip pain and improves function much more effectively than a resistance training program supervised by a physiotherapist, according to the results of a randomized controlled clinical trial. 

In the PROHIP study, the mean increases in Oxford Hip Scores from baseline to 6 months were 15.9 points for THR and 4.5 points for resistance training. The 11.4-point difference in scores was both statistically and clinically significant, the study’s investigators reported in The New England Journal of Medicine. 

“Our results are clear: Surgery is superior to exercise in patients who have hip osteoarthritis and indication for surgery, and now we have finally proven that with the highest level of evidence,” corresponding author Thomas Frydendal, PT, PhD, MSc, told this news organization.

Frydendal, who was involved in the study while working on his PhD at University Hospital of Southern Denmark – Lillebaelt Hospital, Vejle, Denmark, the primary center for the trial, is now a postdoctoral researcher at the Department of Clinical Medicine, Aarhus University, and Department of Orthopedic Surgery, Aarhus University Hospital.

“We believe that our findings are pretty robust,” Frydendal added. “I think if someone in the world conducts a trial similar to ours, they will find fairly close or consistent findings, no matter what type of exercise they choose.”

Charlotte Dahl, Lillebaelt Hospital–University Hospital of Southern Denmark, Vejle Hospital

The PROHIP Study

THR is routinely recommended for the management of severe hip osteoarthritis, but since there are no clinical trial data on the effectiveness of this procedure as compared with first-line treatment such as resistance training, the PROHIP study was conceived. 

The trial was conducted at four Danish orthopedic centers and designed as a superiority study, the hypothesis being that THR would be better at alleviating self-reported hip pain and improving hip function than resistance training. 

Of a possible 1474 individuals with a clinical suspicion of hip osteoarthritis, 791 were deemed eligible for inclusion in the trial. Inclusion criteria were being aged 50 years or older and having an indication for THR based on the presence of hip pain and clinical and radiographic findings.

However, the majority (86%) declined to enter the study, with almost half (43%) deciding to have a THR and enroll in a parallel observational cohort. This meant that only 110 (14%) individuals agreed to participate and underwent randomization, which does limit the study’s generalizability, the PROHIP investigators acknowledged. 
 

Design and Study Population

The change in Oxford Hip Score from baseline to 6 months was selected as the primary outcome measure based on the findings of a prior qualitative study. This 12-item, patient-reported outcome measure gives a score ranging from 0 to 48, with higher scores indicating less hip pain and better hip function. The estimated minimal clinically important difference is a change of 5 points. 

After a baseline assessment, 53 of 109 individuals were randomly assigned to undergo THR and 56 to participate in the resistance training program. Overall, the mean age of participants was 67.6 years, and half were women. The average duration of hip pain was a median of 1.7 years. 

The median time to receipt of the allocated treatment was 2.8 months in the THR group and 0.5 months in the resistance training group. 

Those allocated to the THR group also underwent a “fast track” program that involved patient education, pain management, and early mobilization. 

The resistance training group received 12 weeks of exercise supervised by a physiotherapist and then offered 12 weeks of additional exercise conducted on their own. The physiotherapist-supervised exercise sessions were held twice weekly and lasted for 1 hour. These started with a 10-minute warm-up on a stationary bike, followed by a standard set of resistance-based exercises that included a leg press, hip extension, hip flexion, and hip abduction. 
 

‘Reassuring’ Results

In a comment, consultant orthopedic surgeon Antony Palmer, MA, BMBCh, DPhil, said: “It’s reassuring that patients with advanced symptomatic osteoarthritis do well with hip replacements.”

THR does of course come with the potential risk for complications, but “the rate of these is what you’d expect for that procedure,” Palmer said, who works for the Nuffield Orthopaedic Centre, Oxford University Hospital NHS Foundation Trust, and is a senior clinical research fellow at Oxford University in England.

Dr. Palmer

Resistance Training Role 

A notable finding was that, at 6 months, five (9%) people assigned to the THR arm had not undergone surgery, and 12 (21%) people in the resistance training group had undergone a THR.

This could suggest two things, Palmer suggested in the interview. The first is that there could be a small proportion of people assigned to THR who may not need the operation and do well with exercise therapy. And, conversely, there may be those who would do well having the surgery without first going through the intermediate stage of physical therapy. 

It’s a suggestion that “maybe we’ve got to refine that a bit better and identify the patients that really do benefit from physiotherapy and who might not need hip replacement as a result,” Palmer said.

Or in other words, “should all patients undergo a program of physiotherapy before considering surgery?” he added.
 

Authors’ View

The PROHIP investigators conclude: “These results support current recommendations for the management of hip osteoarthritis and may be used to inform and guide shared decision making in clinical practice.”

Moreover, the results “do not oppose the use of resistance training as initial treatment,” says the authors. 

Frydendal highlighted in his interview that nearly three out of four of the patients reported not to have undertaken any type of supervised exercise before entry into the study, which is a first-line, guideline-recommended option.

“If a patient tells me, ‘I haven’t done any exercise previously,’ I’d recommend starting with completing a 6- to 12-week exercise program that is tailored to your individual needs and evaluate your symptoms afterward,” he said. 

“But we should refer the patient if our first-line treatment does not offer any improvements in the patient’s symptoms, as surgery with total hip replacement is clearly a really good treatment option,” Frydendal said.

The study was funded by the Danish Rheumatism Association, among other independent bodies. Frydendal and Palmer reported no relevant financial relationships. 
 

A version of this article first appeared on Medscape.com.

For people with severe symptomatic hip osteoarthritis, total hip replacement (THR) alleviates hip pain and improves function much more effectively than a resistance training program supervised by a physiotherapist, according to the results of a randomized controlled clinical trial. 

In the PROHIP study, the mean increases in Oxford Hip Scores from baseline to 6 months were 15.9 points for THR and 4.5 points for resistance training. The 11.4-point difference in scores was both statistically and clinically significant, the study’s investigators reported in The New England Journal of Medicine. 

“Our results are clear: Surgery is superior to exercise in patients who have hip osteoarthritis and indication for surgery, and now we have finally proven that with the highest level of evidence,” corresponding author Thomas Frydendal, PT, PhD, MSc, told this news organization.

Frydendal, who was involved in the study while working on his PhD at University Hospital of Southern Denmark – Lillebaelt Hospital, Vejle, Denmark, the primary center for the trial, is now a postdoctoral researcher at the Department of Clinical Medicine, Aarhus University, and Department of Orthopedic Surgery, Aarhus University Hospital.

“We believe that our findings are pretty robust,” Frydendal added. “I think if someone in the world conducts a trial similar to ours, they will find fairly close or consistent findings, no matter what type of exercise they choose.”

Charlotte Dahl, Lillebaelt Hospital–University Hospital of Southern Denmark, Vejle Hospital

The PROHIP Study

THR is routinely recommended for the management of severe hip osteoarthritis, but since there are no clinical trial data on the effectiveness of this procedure as compared with first-line treatment such as resistance training, the PROHIP study was conceived. 

The trial was conducted at four Danish orthopedic centers and designed as a superiority study, the hypothesis being that THR would be better at alleviating self-reported hip pain and improving hip function than resistance training. 

Of a possible 1474 individuals with a clinical suspicion of hip osteoarthritis, 791 were deemed eligible for inclusion in the trial. Inclusion criteria were being aged 50 years or older and having an indication for THR based on the presence of hip pain and clinical and radiographic findings.

However, the majority (86%) declined to enter the study, with almost half (43%) deciding to have a THR and enroll in a parallel observational cohort. This meant that only 110 (14%) individuals agreed to participate and underwent randomization, which does limit the study’s generalizability, the PROHIP investigators acknowledged. 
 

Design and Study Population

The change in Oxford Hip Score from baseline to 6 months was selected as the primary outcome measure based on the findings of a prior qualitative study. This 12-item, patient-reported outcome measure gives a score ranging from 0 to 48, with higher scores indicating less hip pain and better hip function. The estimated minimal clinically important difference is a change of 5 points. 

After a baseline assessment, 53 of 109 individuals were randomly assigned to undergo THR and 56 to participate in the resistance training program. Overall, the mean age of participants was 67.6 years, and half were women. The average duration of hip pain was a median of 1.7 years. 

The median time to receipt of the allocated treatment was 2.8 months in the THR group and 0.5 months in the resistance training group. 

Those allocated to the THR group also underwent a “fast track” program that involved patient education, pain management, and early mobilization. 

The resistance training group received 12 weeks of exercise supervised by a physiotherapist and then offered 12 weeks of additional exercise conducted on their own. The physiotherapist-supervised exercise sessions were held twice weekly and lasted for 1 hour. These started with a 10-minute warm-up on a stationary bike, followed by a standard set of resistance-based exercises that included a leg press, hip extension, hip flexion, and hip abduction. 
 

‘Reassuring’ Results

In a comment, consultant orthopedic surgeon Antony Palmer, MA, BMBCh, DPhil, said: “It’s reassuring that patients with advanced symptomatic osteoarthritis do well with hip replacements.”

THR does of course come with the potential risk for complications, but “the rate of these is what you’d expect for that procedure,” Palmer said, who works for the Nuffield Orthopaedic Centre, Oxford University Hospital NHS Foundation Trust, and is a senior clinical research fellow at Oxford University in England.

Dr. Palmer

Resistance Training Role 

A notable finding was that, at 6 months, five (9%) people assigned to the THR arm had not undergone surgery, and 12 (21%) people in the resistance training group had undergone a THR.

This could suggest two things, Palmer suggested in the interview. The first is that there could be a small proportion of people assigned to THR who may not need the operation and do well with exercise therapy. And, conversely, there may be those who would do well having the surgery without first going through the intermediate stage of physical therapy. 

It’s a suggestion that “maybe we’ve got to refine that a bit better and identify the patients that really do benefit from physiotherapy and who might not need hip replacement as a result,” Palmer said.

Or in other words, “should all patients undergo a program of physiotherapy before considering surgery?” he added.
 

Authors’ View

The PROHIP investigators conclude: “These results support current recommendations for the management of hip osteoarthritis and may be used to inform and guide shared decision making in clinical practice.”

Moreover, the results “do not oppose the use of resistance training as initial treatment,” says the authors. 

Frydendal highlighted in his interview that nearly three out of four of the patients reported not to have undertaken any type of supervised exercise before entry into the study, which is a first-line, guideline-recommended option.

“If a patient tells me, ‘I haven’t done any exercise previously,’ I’d recommend starting with completing a 6- to 12-week exercise program that is tailored to your individual needs and evaluate your symptoms afterward,” he said. 

“But we should refer the patient if our first-line treatment does not offer any improvements in the patient’s symptoms, as surgery with total hip replacement is clearly a really good treatment option,” Frydendal said.

The study was funded by the Danish Rheumatism Association, among other independent bodies. Frydendal and Palmer reported no relevant financial relationships. 
 

A version of this article first appeared on Medscape.com.

For people with severe symptomatic hip osteoarthritis, total hip replacement (THR) alleviates hip pain and improves function much more effectively than a resistance training program supervised by a physiotherapist, according to the results of a randomized controlled clinical trial. 

In the PROHIP study, the mean increases in Oxford Hip Scores from baseline to 6 months were 15.9 points for THR and 4.5 points for resistance training. The 11.4-point difference in scores was both statistically and clinically significant, the study’s investigators reported in The New England Journal of Medicine. 

“Our results are clear: Surgery is superior to exercise in patients who have hip osteoarthritis and indication for surgery, and now we have finally proven that with the highest level of evidence,” corresponding author Thomas Frydendal, PT, PhD, MSc, told this news organization.

Frydendal, who was involved in the study while working on his PhD at University Hospital of Southern Denmark – Lillebaelt Hospital, Vejle, Denmark, the primary center for the trial, is now a postdoctoral researcher at the Department of Clinical Medicine, Aarhus University, and Department of Orthopedic Surgery, Aarhus University Hospital.

“We believe that our findings are pretty robust,” Frydendal added. “I think if someone in the world conducts a trial similar to ours, they will find fairly close or consistent findings, no matter what type of exercise they choose.”

Charlotte Dahl, Lillebaelt Hospital–University Hospital of Southern Denmark, Vejle Hospital

The PROHIP Study

THR is routinely recommended for the management of severe hip osteoarthritis, but since there are no clinical trial data on the effectiveness of this procedure as compared with first-line treatment such as resistance training, the PROHIP study was conceived. 

The trial was conducted at four Danish orthopedic centers and designed as a superiority study, the hypothesis being that THR would be better at alleviating self-reported hip pain and improving hip function than resistance training. 

Of a possible 1474 individuals with a clinical suspicion of hip osteoarthritis, 791 were deemed eligible for inclusion in the trial. Inclusion criteria were being aged 50 years or older and having an indication for THR based on the presence of hip pain and clinical and radiographic findings.

However, the majority (86%) declined to enter the study, with almost half (43%) deciding to have a THR and enroll in a parallel observational cohort. This meant that only 110 (14%) individuals agreed to participate and underwent randomization, which does limit the study’s generalizability, the PROHIP investigators acknowledged. 
 

Design and Study Population

The change in Oxford Hip Score from baseline to 6 months was selected as the primary outcome measure based on the findings of a prior qualitative study. This 12-item, patient-reported outcome measure gives a score ranging from 0 to 48, with higher scores indicating less hip pain and better hip function. The estimated minimal clinically important difference is a change of 5 points. 

After a baseline assessment, 53 of 109 individuals were randomly assigned to undergo THR and 56 to participate in the resistance training program. Overall, the mean age of participants was 67.6 years, and half were women. The average duration of hip pain was a median of 1.7 years. 

The median time to receipt of the allocated treatment was 2.8 months in the THR group and 0.5 months in the resistance training group. 

Those allocated to the THR group also underwent a “fast track” program that involved patient education, pain management, and early mobilization. 

The resistance training group received 12 weeks of exercise supervised by a physiotherapist and then offered 12 weeks of additional exercise conducted on their own. The physiotherapist-supervised exercise sessions were held twice weekly and lasted for 1 hour. These started with a 10-minute warm-up on a stationary bike, followed by a standard set of resistance-based exercises that included a leg press, hip extension, hip flexion, and hip abduction. 
 

‘Reassuring’ Results

In a comment, consultant orthopedic surgeon Antony Palmer, MA, BMBCh, DPhil, said: “It’s reassuring that patients with advanced symptomatic osteoarthritis do well with hip replacements.”

THR does of course come with the potential risk for complications, but “the rate of these is what you’d expect for that procedure,” Palmer said, who works for the Nuffield Orthopaedic Centre, Oxford University Hospital NHS Foundation Trust, and is a senior clinical research fellow at Oxford University in England.

Dr. Palmer

Resistance Training Role 

A notable finding was that, at 6 months, five (9%) people assigned to the THR arm had not undergone surgery, and 12 (21%) people in the resistance training group had undergone a THR.

This could suggest two things, Palmer suggested in the interview. The first is that there could be a small proportion of people assigned to THR who may not need the operation and do well with exercise therapy. And, conversely, there may be those who would do well having the surgery without first going through the intermediate stage of physical therapy. 

It’s a suggestion that “maybe we’ve got to refine that a bit better and identify the patients that really do benefit from physiotherapy and who might not need hip replacement as a result,” Palmer said.

Or in other words, “should all patients undergo a program of physiotherapy before considering surgery?” he added.
 

Authors’ View

The PROHIP investigators conclude: “These results support current recommendations for the management of hip osteoarthritis and may be used to inform and guide shared decision making in clinical practice.”

Moreover, the results “do not oppose the use of resistance training as initial treatment,” says the authors. 

Frydendal highlighted in his interview that nearly three out of four of the patients reported not to have undertaken any type of supervised exercise before entry into the study, which is a first-line, guideline-recommended option.

“If a patient tells me, ‘I haven’t done any exercise previously,’ I’d recommend starting with completing a 6- to 12-week exercise program that is tailored to your individual needs and evaluate your symptoms afterward,” he said. 

“But we should refer the patient if our first-line treatment does not offer any improvements in the patient’s symptoms, as surgery with total hip replacement is clearly a really good treatment option,” Frydendal said.

The study was funded by the Danish Rheumatism Association, among other independent bodies. Frydendal and Palmer reported no relevant financial relationships. 
 

A version of this article first appeared on Medscape.com.

PHILADELPHIA — Low-volume bowel preparation is noninferior in adequacy to standard-volume prep in hospitalized patients undergoing colonoscopy, according to a study presented at the annual meeting of the American College of Gastroenterology (ACG).

Patients who received MoviPrep (2L of polyethylene glycol and ascorbic acid) reported higher tolerability and willingness to repeat colonoscopy preparation in the future than those taking GoLYTELY (4L of polyethylene glycol and electrolytes). In addition, the rates of electrolyte abnormalities and acute kidney injury were low and similar between the two groups.

Yale School of Medicine

“Bowel preparation remains a challenge in the inpatient setting, where 20%-50% of all colonoscopies can have inadequate bowel preparation,” said lead author Karen Xiao, MD, assistant professor in the section of digestive diseases at Yale School of Medicine, New Haven, Connecticut.

Previous studies have indicated that low-volume (2L), split-dose preparations are noninferior to high-volume (4L), split-dose regimens, and patients generally prefer low-volume options, she said. However, the current standard of care for inpatients continues to include high-volume polyethylene glycol electrocyte lavage, which may be less tolerable.

“Similar to prior studies, our study supports that MoviPrep may be a suitable alternative to traditional high-volume bowel preparation in hospitalized patients undergoing colonoscopy,” she said.

In a single-blind, multi-site, randomized controlled trial, Xiao and colleagues in the Yale–New Haven Health System randomly assigned inpatients undergoing colonoscopy to MoviPrep or GoLYTELY between January 2022 and July 2024. They excluded patients with prior small or large bowel resection, foreign body removal, or medical contraindications, such as obstruction, pregnancy, phenylketonuria, or glucose-6-phosphate dehydrogenase deficiency.

After bowel prep but before colonoscopy, patients took the Mayo Clinic Bowel Preparation survey. Colonoscopies were then recorded, and videos were scored by a single-blinded central reviewer. The primary outcome included the adequacy of bowel prep as defined by a Boston Bowel Preparation Scale score of 6 or higher, with each segment scoring 2 or higher.

In the final analysis, 202 patients received MoviPrep and 210 received GoLYTELY. In both groups, the average age was 62; about 60% were men; and 66% were White, about 22% Black, and 13%-15% Hispanic. About 65% of patients in both arms had an American Society of Anesthesiologists (ASA) score of 3, with another 20% in each group having an ASA score of 4, “reflective of a sicker inpatient population,” Xiao said.

Inpatient colonoscopy was indicated for gastrointestinal bleeding (55%), diarrhea (15%-20%), abnormal imaging (10%-13%), inflammatory bowel disease (4%), or other (35%-41%). Patients could have more than one indication for colonoscopy.

Overall, bowel preparation was scored as adequate in 111 patients with MoviPrep (55%) and 111 patients with GoLYTELY (52.9%), and was inadequate in 91 patients with MoviPrep (45%) and 99 patients with GoLYTELY (47.1%). With a rate difference of 2.1% and a P value of .007, MoviPrep was considered noninferior to GoLYTELY for adequate bowel preparation.

In terms of secondary outcomes, there wasn’t a significant difference in the length of hospital stay, with a median stay of 6 days. Similarly, there were no differences in the rates of adverse events, including acute kidney injury and electrolyte abnormalities, with rates ranging from 1% to 9%. MoviPrep patients were slightly more likely to need additional bowel prep but also had a slightly shorter time to colonoscopy.
 

Ease of Use Is a Plus

On the basis of the Mayo Clinic Bowel Preparation survey, there wasn’t a difference between the groups in how much bowel prep solution was left in the bottle. However, more than twice as many patients who took MoviPrep said the prep was “easy,” and more MoviPrep patients called it “acceptable,” whereas more GoLYTELY patients said prep was “somewhat difficult” or “very difficult.”

In addition, significantly more MoviPrep patients (49.7% vs 33.7%) said they were “mostly willing” to drink the same prep again if they needed another colonoscopy in the future, while more GoLYTELY patients said they were “somewhat willing” (44.7% vs 34.6%) or “not willing at all” (21.6% vs 15.7%).

“Bowel prep, particularly in hospitals, is important because we do it so often. When you think about what our patients in the hospital are going through, they’re very sick and often have multiple comorbidities, so how can we give them a bowel prep that is safe for them, easiest for them, easy for our nursing staff who are experiencing shortages, and as good as the traditional bowel prep,” said the session’s moderator, Amy Oxentenko, MD, AGAF, professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota.

Mayo Clinic

“Here we’ve seen great data that we can provide half the volume of the prep, still get amazing results in terms of adequacy of preparation, and the patients had a better experience,” said Oxentenko, the incoming ACG president. “That’s important because they likely may need another colonoscopy in the future, and we would hate for the bowel prep in the hospital to potentially dissuade them from a future colonoscopy.”

Future studies could stratify patients on the basis of colonoscopy indication or patient history, including conditions such as chronic constipation or neurogenic bowel, where some patients may still need a high-volume prep, Oxentenko said.

“Also, in the hospital setting, we don’t always know when a patient is going to the endoscopy suite due to other patient cases that may get prolonged or pushed in,” she said. “So how do you time the second dose of the split dose in anticipation of when that patient will go to the endoscopy suite to maintain that great preparation with a smaller volume prep?”

The study was awarded the ACG Governors Award for Excellence in Clinical Research (Trainee). Xiao and Oxentenko reported no relevant disclosures.

A version of this article appeared on Medscape.com.

PHILADELPHIA — Low-volume bowel preparation is noninferior in adequacy to standard-volume prep in hospitalized patients undergoing colonoscopy, according to a study presented at the annual meeting of the American College of Gastroenterology (ACG).

Patients who received MoviPrep (2L of polyethylene glycol and ascorbic acid) reported higher tolerability and willingness to repeat colonoscopy preparation in the future than those taking GoLYTELY (4L of polyethylene glycol and electrolytes). In addition, the rates of electrolyte abnormalities and acute kidney injury were low and similar between the two groups.

Yale School of Medicine

“Bowel preparation remains a challenge in the inpatient setting, where 20%-50% of all colonoscopies can have inadequate bowel preparation,” said lead author Karen Xiao, MD, assistant professor in the section of digestive diseases at Yale School of Medicine, New Haven, Connecticut.

Previous studies have indicated that low-volume (2L), split-dose preparations are noninferior to high-volume (4L), split-dose regimens, and patients generally prefer low-volume options, she said. However, the current standard of care for inpatients continues to include high-volume polyethylene glycol electrocyte lavage, which may be less tolerable.

“Similar to prior studies, our study supports that MoviPrep may be a suitable alternative to traditional high-volume bowel preparation in hospitalized patients undergoing colonoscopy,” she said.

In a single-blind, multi-site, randomized controlled trial, Xiao and colleagues in the Yale–New Haven Health System randomly assigned inpatients undergoing colonoscopy to MoviPrep or GoLYTELY between January 2022 and July 2024. They excluded patients with prior small or large bowel resection, foreign body removal, or medical contraindications, such as obstruction, pregnancy, phenylketonuria, or glucose-6-phosphate dehydrogenase deficiency.

After bowel prep but before colonoscopy, patients took the Mayo Clinic Bowel Preparation survey. Colonoscopies were then recorded, and videos were scored by a single-blinded central reviewer. The primary outcome included the adequacy of bowel prep as defined by a Boston Bowel Preparation Scale score of 6 or higher, with each segment scoring 2 or higher.

In the final analysis, 202 patients received MoviPrep and 210 received GoLYTELY. In both groups, the average age was 62; about 60% were men; and 66% were White, about 22% Black, and 13%-15% Hispanic. About 65% of patients in both arms had an American Society of Anesthesiologists (ASA) score of 3, with another 20% in each group having an ASA score of 4, “reflective of a sicker inpatient population,” Xiao said.

Inpatient colonoscopy was indicated for gastrointestinal bleeding (55%), diarrhea (15%-20%), abnormal imaging (10%-13%), inflammatory bowel disease (4%), or other (35%-41%). Patients could have more than one indication for colonoscopy.

Overall, bowel preparation was scored as adequate in 111 patients with MoviPrep (55%) and 111 patients with GoLYTELY (52.9%), and was inadequate in 91 patients with MoviPrep (45%) and 99 patients with GoLYTELY (47.1%). With a rate difference of 2.1% and a P value of .007, MoviPrep was considered noninferior to GoLYTELY for adequate bowel preparation.

In terms of secondary outcomes, there wasn’t a significant difference in the length of hospital stay, with a median stay of 6 days. Similarly, there were no differences in the rates of adverse events, including acute kidney injury and electrolyte abnormalities, with rates ranging from 1% to 9%. MoviPrep patients were slightly more likely to need additional bowel prep but also had a slightly shorter time to colonoscopy.
 

Ease of Use Is a Plus

On the basis of the Mayo Clinic Bowel Preparation survey, there wasn’t a difference between the groups in how much bowel prep solution was left in the bottle. However, more than twice as many patients who took MoviPrep said the prep was “easy,” and more MoviPrep patients called it “acceptable,” whereas more GoLYTELY patients said prep was “somewhat difficult” or “very difficult.”

In addition, significantly more MoviPrep patients (49.7% vs 33.7%) said they were “mostly willing” to drink the same prep again if they needed another colonoscopy in the future, while more GoLYTELY patients said they were “somewhat willing” (44.7% vs 34.6%) or “not willing at all” (21.6% vs 15.7%).

“Bowel prep, particularly in hospitals, is important because we do it so often. When you think about what our patients in the hospital are going through, they’re very sick and often have multiple comorbidities, so how can we give them a bowel prep that is safe for them, easiest for them, easy for our nursing staff who are experiencing shortages, and as good as the traditional bowel prep,” said the session’s moderator, Amy Oxentenko, MD, AGAF, professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota.

Mayo Clinic

“Here we’ve seen great data that we can provide half the volume of the prep, still get amazing results in terms of adequacy of preparation, and the patients had a better experience,” said Oxentenko, the incoming ACG president. “That’s important because they likely may need another colonoscopy in the future, and we would hate for the bowel prep in the hospital to potentially dissuade them from a future colonoscopy.”

Future studies could stratify patients on the basis of colonoscopy indication or patient history, including conditions such as chronic constipation or neurogenic bowel, where some patients may still need a high-volume prep, Oxentenko said.

“Also, in the hospital setting, we don’t always know when a patient is going to the endoscopy suite due to other patient cases that may get prolonged or pushed in,” she said. “So how do you time the second dose of the split dose in anticipation of when that patient will go to the endoscopy suite to maintain that great preparation with a smaller volume prep?”

The study was awarded the ACG Governors Award for Excellence in Clinical Research (Trainee). Xiao and Oxentenko reported no relevant disclosures.

A version of this article appeared on Medscape.com.

PHILADELPHIA — Low-volume bowel preparation is noninferior in adequacy to standard-volume prep in hospitalized patients undergoing colonoscopy, according to a study presented at the annual meeting of the American College of Gastroenterology (ACG).

Patients who received MoviPrep (2L of polyethylene glycol and ascorbic acid) reported higher tolerability and willingness to repeat colonoscopy preparation in the future than those taking GoLYTELY (4L of polyethylene glycol and electrolytes). In addition, the rates of electrolyte abnormalities and acute kidney injury were low and similar between the two groups.

Yale School of Medicine

“Bowel preparation remains a challenge in the inpatient setting, where 20%-50% of all colonoscopies can have inadequate bowel preparation,” said lead author Karen Xiao, MD, assistant professor in the section of digestive diseases at Yale School of Medicine, New Haven, Connecticut.

Previous studies have indicated that low-volume (2L), split-dose preparations are noninferior to high-volume (4L), split-dose regimens, and patients generally prefer low-volume options, she said. However, the current standard of care for inpatients continues to include high-volume polyethylene glycol electrocyte lavage, which may be less tolerable.

“Similar to prior studies, our study supports that MoviPrep may be a suitable alternative to traditional high-volume bowel preparation in hospitalized patients undergoing colonoscopy,” she said.

In a single-blind, multi-site, randomized controlled trial, Xiao and colleagues in the Yale–New Haven Health System randomly assigned inpatients undergoing colonoscopy to MoviPrep or GoLYTELY between January 2022 and July 2024. They excluded patients with prior small or large bowel resection, foreign body removal, or medical contraindications, such as obstruction, pregnancy, phenylketonuria, or glucose-6-phosphate dehydrogenase deficiency.

After bowel prep but before colonoscopy, patients took the Mayo Clinic Bowel Preparation survey. Colonoscopies were then recorded, and videos were scored by a single-blinded central reviewer. The primary outcome included the adequacy of bowel prep as defined by a Boston Bowel Preparation Scale score of 6 or higher, with each segment scoring 2 or higher.

In the final analysis, 202 patients received MoviPrep and 210 received GoLYTELY. In both groups, the average age was 62; about 60% were men; and 66% were White, about 22% Black, and 13%-15% Hispanic. About 65% of patients in both arms had an American Society of Anesthesiologists (ASA) score of 3, with another 20% in each group having an ASA score of 4, “reflective of a sicker inpatient population,” Xiao said.

Inpatient colonoscopy was indicated for gastrointestinal bleeding (55%), diarrhea (15%-20%), abnormal imaging (10%-13%), inflammatory bowel disease (4%), or other (35%-41%). Patients could have more than one indication for colonoscopy.

Overall, bowel preparation was scored as adequate in 111 patients with MoviPrep (55%) and 111 patients with GoLYTELY (52.9%), and was inadequate in 91 patients with MoviPrep (45%) and 99 patients with GoLYTELY (47.1%). With a rate difference of 2.1% and a P value of .007, MoviPrep was considered noninferior to GoLYTELY for adequate bowel preparation.

In terms of secondary outcomes, there wasn’t a significant difference in the length of hospital stay, with a median stay of 6 days. Similarly, there were no differences in the rates of adverse events, including acute kidney injury and electrolyte abnormalities, with rates ranging from 1% to 9%. MoviPrep patients were slightly more likely to need additional bowel prep but also had a slightly shorter time to colonoscopy.
 

Ease of Use Is a Plus

On the basis of the Mayo Clinic Bowel Preparation survey, there wasn’t a difference between the groups in how much bowel prep solution was left in the bottle. However, more than twice as many patients who took MoviPrep said the prep was “easy,” and more MoviPrep patients called it “acceptable,” whereas more GoLYTELY patients said prep was “somewhat difficult” or “very difficult.”

In addition, significantly more MoviPrep patients (49.7% vs 33.7%) said they were “mostly willing” to drink the same prep again if they needed another colonoscopy in the future, while more GoLYTELY patients said they were “somewhat willing” (44.7% vs 34.6%) or “not willing at all” (21.6% vs 15.7%).

“Bowel prep, particularly in hospitals, is important because we do it so often. When you think about what our patients in the hospital are going through, they’re very sick and often have multiple comorbidities, so how can we give them a bowel prep that is safe for them, easiest for them, easy for our nursing staff who are experiencing shortages, and as good as the traditional bowel prep,” said the session’s moderator, Amy Oxentenko, MD, AGAF, professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota.

Mayo Clinic

“Here we’ve seen great data that we can provide half the volume of the prep, still get amazing results in terms of adequacy of preparation, and the patients had a better experience,” said Oxentenko, the incoming ACG president. “That’s important because they likely may need another colonoscopy in the future, and we would hate for the bowel prep in the hospital to potentially dissuade them from a future colonoscopy.”

Future studies could stratify patients on the basis of colonoscopy indication or patient history, including conditions such as chronic constipation or neurogenic bowel, where some patients may still need a high-volume prep, Oxentenko said.

“Also, in the hospital setting, we don’t always know when a patient is going to the endoscopy suite due to other patient cases that may get prolonged or pushed in,” she said. “So how do you time the second dose of the split dose in anticipation of when that patient will go to the endoscopy suite to maintain that great preparation with a smaller volume prep?”

The study was awarded the ACG Governors Award for Excellence in Clinical Research (Trainee). Xiao and Oxentenko reported no relevant disclosures.

A version of this article appeared on Medscape.com.

PHILADELPHIA — Non-fasting breath gas patterns may help identify patients with irritable bowel syndrome (IBS) who are most likely to respond to a low fermentable oligo-, di-, monosaccharides and polyols (FODMAP) diet, according to a new study.

The low FODMAP diet is the most evidence-based dietary therapy for patients with IBS, but we know that “only about 50% of our patients respond to it,” said principal investigator Prashant Singh, MD, assistant professor at the University of Michigan in Ann Arbor, Michigan. “Exhaled breath gases represent bacterial fermentation of dietary carbohydrates. These measurements could provide a simple biomarker for response to low FODMAP diets.”

Even before starting the low FODMAP diet, “you could see notable differences in breath test patterns between responders and nonresponders,” he said. “We saw that low FODMAP responders had higher hydrogen (H2) and lower methane (CH4) at baseline than nonresponders and had a greater drop in hydrogen following FODMAP restriction vs nonresponders.”

He added that these results imply that responders to this diet may exhibit differences in baseline microbiota composition regarding saccharolytic capacity and/or methanogens. 

Singh presented the findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 
 

Breaths That Can Predict Response

To determine if pre-intervention non-fasting breath patterns are associated with a clinical response to low FODMAP diets, Singh and colleagues enrolled 284 self-selected participants (mean age, 45.2 years) with mild to moderate gastrointestinal (GI) symptoms. Participants used an app-connected breath analyzer to record hourly, non-fasting H2 and CH4 levels during waking hours, in addition to logging meal content and symptom severity (bloating, abdominal pain, and flatulence) on a 0-10 scale. 

Patients were directed to consume their habitual diet for 1 week, before following an app-directed low FODMAP diet for 1 week. Responders were defined as those with a ≥ 30% reduction in at least one mean symptom score. The researchers then compared average hourly H2 and CH4 levels and symptom scores at baseline between low FODMAP diet responders and nonresponders.

Of the participants, 111 were classified as responders and 173 as nonresponders. There were no significant differences between the groups in gender, age, body mass index, or FODMAP per calorie.

Following FODMAP restriction, responders had consistently lower abdominal pain throughout the day and lower bloating and flatulence predominantly in the latter part of the day. Nonresponders experienced no significant changes in key abdominal symptoms after adopting the low FODMAP diet. 

The researchers found that breath tests taken at baseline revealed predictive trends between the groups, even though average FODMAP consumption did not significantly differ between them. Baseline H2 levels were higher among responders than among nonresponders, especially in the morning and evening. However, responders had lower baseline CH4 levels throughout the day. 

Following FODMAP restrictions, responders had a significant drop in non-fasting H2 but not CH4, whereas nonresponders did not have a significant drop in either.

The study was limited by the fact that participants were not clinically diagnosed with IBS, their GI symptoms were mild overall, and no data were available on stool consistency/frequency or fecal microbiome composition for correlation with exhaled breath gas levels.
 

A Potential New Biomarker

Session co-moderator Kyle Staller, MD, MPH, director of the Gastrointestinal Motility Laboratory at Mass General and associate professor of medicine at Harvard Medical School in Boston, Massachusetts, said in an interview that if validated, these findings provide hope for better directing low FODMAP diets to those patients who may benefit. 

Massachusetts General Hospital

There are some patients who may or may not respond to a FODMAP diet, for reasons we don’t yet know, possibly related to fermentation of gas, and it’s helpful to know before starting treatment, he said. It may help us with more of “a precision medicine approach before we really torture people with diets that can be very difficult to adhere to.” 

Staller, who was not involved in the study, added that, “People tend to really focus on small intestinal bacteria overgrowth when it comes to hydrogen and methane production, but in reality, this is really a very agile day-to-day, meal-to-meal responsiveness. 

“It’s a different paradigm,” he continued. “I’d also like to see more data as to why we see the diurnal rhythm” and whether potential factors such as intestinal transit times are playing a role. 

Singh reported receiving royalties from UpToDate. Staller reported receiving research support from Ardelyx and Restasis and serving as a consultant to Anji, Ardelyx, GI Supply, Mahana, Restasis, and Sanofi. Funding associated with the study was not available at the time of publication.