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How much pain is in the mind? This doctor thinks the answer is, most
More than 3 decades ago, John E. Sarno, MD, published Healing Back Pain, a popular book that garnered something of a cult following. Looking at his own practice, Dr. Sarno, a rehabilitation medicine specialist in New York, saw that most of his patients with chronic pain did not have evidence of acute injury or degenerative disk disease. Their persistent pain appeared to be independent of any structural damage to the spine. Dr. Sarno attributed the pain to what he called tension myoneural syndrome (TMS), or the body’s reaction to suppressed stress and emotional turmoil. Resolving that psychological conflict, Dr. Sarno believed, would lead to an improvement in pain.
Dr. Sarno’s theory has met skepticism from the mainstream community, but glowing testimonies from patients who say they benefited from his strategies fill the Internet. Dr. Sarno wrote several books on his ideas before his death in 2017. But he published only one peer-reviewed study, a 2003 review in the Archives of Physical Medicine and Rehabilitation coauthored by Ira Rashbaum, MD.
The interview has been edited for length and clarity.
What is your theory of back pain?
Dr. Rashbaum: My null hypothesis is that back pain is not due to psychological issues, so as to not be a biased doctor, I try to accept the null hypothesis or reject the null hypothesis. In most cases chronic back pain is not due to structural etiology. My sense is it’s a mind-body issue – the avoidance of feeling strong emotions like anger, rage, sadness, fear, shame, and guilt. Patients can embrace psychoeducational programs and if they don’t get better, we work with a psychotherapist or a licensed mental health counselor to help work through the patient’s feelings. That’s my experience over a number of years.
How do you determine if a patient has back pain from a mind-body issue or another cause?
Dr. Rashbaum: I do a very careful medical history, including a physical examination and review of any diagnostic studies they’ve undergone. In most situations, there’s not really a medical cause of the back pain. For instance, a lot of asymptomatic individuals have all sorts of horrible findings on medical imaging like CTs and MRIs, and the reverse is also true – many people with negative findings on imaging tests experience significant pain. My job as a diagnostician is to see how much of this is really a mind-body problem or something that stems from structural pathology.
How well do your patients react to being told that their back pain is, in a way, “in their head?”
Dr. Rashbaum: I have a skewed population. I’m sort of like a guru in mind-body back pain, so the people who come to me are already thinking along those lines. I ask: “What’s going on in your life?” Maybe there are job issues, marital issues, health issues, and I’d say that it’s certainly possible that stress can be causing this back pain.
Sometimes when I see a patient referred from another physician, I’m a bit hesitant to ask about what’s going on in their life. Even earlier today, I’d seen a patient with back pain and I had a sense that they were not really going to be open to a mind-body approach. So I said, do physical therapy.
What do you recommend primary care clinicians do with patients with back pain?
Dr. Rashbaum: You have to do a proper neurologic examination and musculoskeletal examination. It’s a tough situation because doctors in primary care have limited time to take care of patients. It’s difficult to have a deeper dive just to kind of see what’s going on in their life. But you can recommend useful agents like acetaminophen and muscle relaxants, which are sometimes okay.
What sorts of things do you tell patients to say to themselves when they’re experiencing pain?
Dr. Rashbaum: If the pain is severe, I recommend they take medication – over-the-counter analgesics or a muscle relaxant, if they have them – and take a warm shower or bath. I prefer acetaminophen up to three times per day, if that’s okay with the patient’s primary care physician, over NSAIDs because most pain is noninflammatory in nature. Once the pain is more manageable, patients should journal about what’s going on in their lives and/or meditate, and try to feel any strong emotions, such as anger, sadness, or fear.
What do you say to clinicians who are dismissive of the notion that chronic pain may stem from emotional repression, and that addressing the latter can resolve the former – particularly those who point to a lack of peer-reviewed data for such a link?
Dr. Rashbaum: I would tell them they could be looking harder for that evidence. For example, in a patient page from JAMA from April 24, 2013, on low back pain, often the cause of back pain is unknown. There are data in spine surgical journals that patients with psychological issues do worse with spine surgery. And in 2016 JAMA published a study from Cherkin and colleagues, which found that, among adults with chronic low back pain, treatment with mindfulness-based stress reduction or cognitive behavioral therapy resulted in greater improvement in back pain and functional limitations at 26 weeks, compared with usual care.
My feeling is that these psychosocial interventions are easy to try, relatively inexpensive, noninvasive, and, in my experience, often can lead to marked improvements. I believe that, for the vast majority of people with chronic pain, it makes much more sense to start by addressing mind-body issues than turning to that approach as a last resort.
Dr. Rashbaum reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
More than 3 decades ago, John E. Sarno, MD, published Healing Back Pain, a popular book that garnered something of a cult following. Looking at his own practice, Dr. Sarno, a rehabilitation medicine specialist in New York, saw that most of his patients with chronic pain did not have evidence of acute injury or degenerative disk disease. Their persistent pain appeared to be independent of any structural damage to the spine. Dr. Sarno attributed the pain to what he called tension myoneural syndrome (TMS), or the body’s reaction to suppressed stress and emotional turmoil. Resolving that psychological conflict, Dr. Sarno believed, would lead to an improvement in pain.
Dr. Sarno’s theory has met skepticism from the mainstream community, but glowing testimonies from patients who say they benefited from his strategies fill the Internet. Dr. Sarno wrote several books on his ideas before his death in 2017. But he published only one peer-reviewed study, a 2003 review in the Archives of Physical Medicine and Rehabilitation coauthored by Ira Rashbaum, MD.
The interview has been edited for length and clarity.
What is your theory of back pain?
Dr. Rashbaum: My null hypothesis is that back pain is not due to psychological issues, so as to not be a biased doctor, I try to accept the null hypothesis or reject the null hypothesis. In most cases chronic back pain is not due to structural etiology. My sense is it’s a mind-body issue – the avoidance of feeling strong emotions like anger, rage, sadness, fear, shame, and guilt. Patients can embrace psychoeducational programs and if they don’t get better, we work with a psychotherapist or a licensed mental health counselor to help work through the patient’s feelings. That’s my experience over a number of years.
How do you determine if a patient has back pain from a mind-body issue or another cause?
Dr. Rashbaum: I do a very careful medical history, including a physical examination and review of any diagnostic studies they’ve undergone. In most situations, there’s not really a medical cause of the back pain. For instance, a lot of asymptomatic individuals have all sorts of horrible findings on medical imaging like CTs and MRIs, and the reverse is also true – many people with negative findings on imaging tests experience significant pain. My job as a diagnostician is to see how much of this is really a mind-body problem or something that stems from structural pathology.
How well do your patients react to being told that their back pain is, in a way, “in their head?”
Dr. Rashbaum: I have a skewed population. I’m sort of like a guru in mind-body back pain, so the people who come to me are already thinking along those lines. I ask: “What’s going on in your life?” Maybe there are job issues, marital issues, health issues, and I’d say that it’s certainly possible that stress can be causing this back pain.
Sometimes when I see a patient referred from another physician, I’m a bit hesitant to ask about what’s going on in their life. Even earlier today, I’d seen a patient with back pain and I had a sense that they were not really going to be open to a mind-body approach. So I said, do physical therapy.
What do you recommend primary care clinicians do with patients with back pain?
Dr. Rashbaum: You have to do a proper neurologic examination and musculoskeletal examination. It’s a tough situation because doctors in primary care have limited time to take care of patients. It’s difficult to have a deeper dive just to kind of see what’s going on in their life. But you can recommend useful agents like acetaminophen and muscle relaxants, which are sometimes okay.
What sorts of things do you tell patients to say to themselves when they’re experiencing pain?
Dr. Rashbaum: If the pain is severe, I recommend they take medication – over-the-counter analgesics or a muscle relaxant, if they have them – and take a warm shower or bath. I prefer acetaminophen up to three times per day, if that’s okay with the patient’s primary care physician, over NSAIDs because most pain is noninflammatory in nature. Once the pain is more manageable, patients should journal about what’s going on in their lives and/or meditate, and try to feel any strong emotions, such as anger, sadness, or fear.
What do you say to clinicians who are dismissive of the notion that chronic pain may stem from emotional repression, and that addressing the latter can resolve the former – particularly those who point to a lack of peer-reviewed data for such a link?
Dr. Rashbaum: I would tell them they could be looking harder for that evidence. For example, in a patient page from JAMA from April 24, 2013, on low back pain, often the cause of back pain is unknown. There are data in spine surgical journals that patients with psychological issues do worse with spine surgery. And in 2016 JAMA published a study from Cherkin and colleagues, which found that, among adults with chronic low back pain, treatment with mindfulness-based stress reduction or cognitive behavioral therapy resulted in greater improvement in back pain and functional limitations at 26 weeks, compared with usual care.
My feeling is that these psychosocial interventions are easy to try, relatively inexpensive, noninvasive, and, in my experience, often can lead to marked improvements. I believe that, for the vast majority of people with chronic pain, it makes much more sense to start by addressing mind-body issues than turning to that approach as a last resort.
Dr. Rashbaum reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
More than 3 decades ago, John E. Sarno, MD, published Healing Back Pain, a popular book that garnered something of a cult following. Looking at his own practice, Dr. Sarno, a rehabilitation medicine specialist in New York, saw that most of his patients with chronic pain did not have evidence of acute injury or degenerative disk disease. Their persistent pain appeared to be independent of any structural damage to the spine. Dr. Sarno attributed the pain to what he called tension myoneural syndrome (TMS), or the body’s reaction to suppressed stress and emotional turmoil. Resolving that psychological conflict, Dr. Sarno believed, would lead to an improvement in pain.
Dr. Sarno’s theory has met skepticism from the mainstream community, but glowing testimonies from patients who say they benefited from his strategies fill the Internet. Dr. Sarno wrote several books on his ideas before his death in 2017. But he published only one peer-reviewed study, a 2003 review in the Archives of Physical Medicine and Rehabilitation coauthored by Ira Rashbaum, MD.
The interview has been edited for length and clarity.
What is your theory of back pain?
Dr. Rashbaum: My null hypothesis is that back pain is not due to psychological issues, so as to not be a biased doctor, I try to accept the null hypothesis or reject the null hypothesis. In most cases chronic back pain is not due to structural etiology. My sense is it’s a mind-body issue – the avoidance of feeling strong emotions like anger, rage, sadness, fear, shame, and guilt. Patients can embrace psychoeducational programs and if they don’t get better, we work with a psychotherapist or a licensed mental health counselor to help work through the patient’s feelings. That’s my experience over a number of years.
How do you determine if a patient has back pain from a mind-body issue or another cause?
Dr. Rashbaum: I do a very careful medical history, including a physical examination and review of any diagnostic studies they’ve undergone. In most situations, there’s not really a medical cause of the back pain. For instance, a lot of asymptomatic individuals have all sorts of horrible findings on medical imaging like CTs and MRIs, and the reverse is also true – many people with negative findings on imaging tests experience significant pain. My job as a diagnostician is to see how much of this is really a mind-body problem or something that stems from structural pathology.
How well do your patients react to being told that their back pain is, in a way, “in their head?”
Dr. Rashbaum: I have a skewed population. I’m sort of like a guru in mind-body back pain, so the people who come to me are already thinking along those lines. I ask: “What’s going on in your life?” Maybe there are job issues, marital issues, health issues, and I’d say that it’s certainly possible that stress can be causing this back pain.
Sometimes when I see a patient referred from another physician, I’m a bit hesitant to ask about what’s going on in their life. Even earlier today, I’d seen a patient with back pain and I had a sense that they were not really going to be open to a mind-body approach. So I said, do physical therapy.
What do you recommend primary care clinicians do with patients with back pain?
Dr. Rashbaum: You have to do a proper neurologic examination and musculoskeletal examination. It’s a tough situation because doctors in primary care have limited time to take care of patients. It’s difficult to have a deeper dive just to kind of see what’s going on in their life. But you can recommend useful agents like acetaminophen and muscle relaxants, which are sometimes okay.
What sorts of things do you tell patients to say to themselves when they’re experiencing pain?
Dr. Rashbaum: If the pain is severe, I recommend they take medication – over-the-counter analgesics or a muscle relaxant, if they have them – and take a warm shower or bath. I prefer acetaminophen up to three times per day, if that’s okay with the patient’s primary care physician, over NSAIDs because most pain is noninflammatory in nature. Once the pain is more manageable, patients should journal about what’s going on in their lives and/or meditate, and try to feel any strong emotions, such as anger, sadness, or fear.
What do you say to clinicians who are dismissive of the notion that chronic pain may stem from emotional repression, and that addressing the latter can resolve the former – particularly those who point to a lack of peer-reviewed data for such a link?
Dr. Rashbaum: I would tell them they could be looking harder for that evidence. For example, in a patient page from JAMA from April 24, 2013, on low back pain, often the cause of back pain is unknown. There are data in spine surgical journals that patients with psychological issues do worse with spine surgery. And in 2016 JAMA published a study from Cherkin and colleagues, which found that, among adults with chronic low back pain, treatment with mindfulness-based stress reduction or cognitive behavioral therapy resulted in greater improvement in back pain and functional limitations at 26 weeks, compared with usual care.
My feeling is that these psychosocial interventions are easy to try, relatively inexpensive, noninvasive, and, in my experience, often can lead to marked improvements. I believe that, for the vast majority of people with chronic pain, it makes much more sense to start by addressing mind-body issues than turning to that approach as a last resort.
Dr. Rashbaum reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The 2023 ‘Meddy’ awards
Without further ado (or comedy skits or musical numbers or extended tributes or commercials), the Meddys go to ...
Best depiction of emergency medicine’s rollercoaster
M*A*S*H (1970)
The original film, not the TV show, jumps from Frank Burns being hauled away in a straitjacket to a soldier’s spurting neck wound. Hawkeye Pierce calmly steps in and we see the entire sequence of him applying pressure, then stepping back to gown-and-glove (“it’s going to spurt a bit”), then jumping back in with arterial sutures, quipping, “Baby, we’re gonna see some stitchin’ like you never saw before.” After that, cocktail hour. Yes, medicine in Hollywood can be overdramatized and even inaccurate, but Robert Altman’s take on the novel by former U.S. Army surgeon Richard Hooker still stands tall for just how crazy emergency medicine can be.
Best ‘is there a doctor in the house?’ moment
Field of Dreams (1989)
When Ray Kinsella’s daughter gets knocked off the back of the bleachers, everything stops. No one knows what to do … except Doc “Moonlight” Graham, who gives up his life’s (and afterlife’s) dream to step off the field and save the girl from choking to death. Burt Lancaster, in his final movie role, embodies everything people wish a doctor to be: Calm, kind, and able to offer a quick, effective solution to a crisis. “Hey rookie! You were good.” Yes, he sure was.
Most unethical doctor
Elvis (2022)
No doctor wants to be remembered as the guy who killed Elvis. But that legacy clings to Dr. George Nichopoulos, Elvis’s personal physician in the 1970s. In Elvis, Dr. Nichopoulos, played by Tony Nixon, hovers in the background, enabling the King’s worsening addictions. Taking late-night calls for narcotics and injecting the unconscious star with stimulants, “unethical” is an understatement for the fictional “Dr. Nick.” The real Dr. Nichopoulos was acquitted of wrongdoing in Elvis’ death, although there is little doubt that the thousands of medication doses he prescribed played a role. When his license was finally revoked for overprescribing in the 1990s, the obliging doc reportedly claimed, “I cared too much.”
Best self-use of a defibrillator
Casino Royale (2006)
We expect backlash in the post-award press conference since James Bond technically only attempted to self-defibrillate in the passenger seat of his car. He never attached the device to the leads. Vesper Lynd had to pick up his slack and save the day. Also, supporters of fellow self-defibrillating nominee Jason Statham in Crank will no doubt raise a stink on Twitter. But we stand by our choice because it was such an, ahem, heart-stopper of a scene.
Best worst patient lying about an injury
Tár (2022)
Love it or hate it, few recent movies have been as polarizing as Tár. Cate Blanchett’s portrayal of a musical genius might be toweringly brilliant or outrageously offensive (or both) depending on whom you ask. But clearly the character has a loose relationship with facts. More than a few doctors might have raised an eyebrow had Lydia Tár appeared with injuries to her face, claiming to have been attacked in a mugging. In reality, Lydia tripped and fell while pursuing an attractive young cellist into a hazardous basement. Did she lie to protect her image, preserve her marriage, or – like many patients – avoid a lecture on unhealthy behavior? We pick D, all of the above.
Best therapy for a speech disorder
The King’s Speech (2010)
Public speaking might cause anxiety for many of us, but how about doing it in front of a global radio audience while wrestling with a speech disorder? Based on a true story, The King’s Speech revealed that terrifying experience for England’s King George VI. Enter Lionel Logue, played by Geoffrey Rush. Irreverent, unconventional, and untrained, the Australian pioneer in speech and language therapy uses a range of strategies – some of which are still used today – to help the royal find his voice. But when singing, shouting swear words, and provoking rage don’t do the trick, Mr. Logue turns to psychotherapy to unearth the childhood traumas at the root of the king’s disability. Experience, as Mr. Logue tells his patient, matters just as much as “letters after your name.”
A version of this article first appeared on Medscape.com.
Without further ado (or comedy skits or musical numbers or extended tributes or commercials), the Meddys go to ...
Best depiction of emergency medicine’s rollercoaster
M*A*S*H (1970)
The original film, not the TV show, jumps from Frank Burns being hauled away in a straitjacket to a soldier’s spurting neck wound. Hawkeye Pierce calmly steps in and we see the entire sequence of him applying pressure, then stepping back to gown-and-glove (“it’s going to spurt a bit”), then jumping back in with arterial sutures, quipping, “Baby, we’re gonna see some stitchin’ like you never saw before.” After that, cocktail hour. Yes, medicine in Hollywood can be overdramatized and even inaccurate, but Robert Altman’s take on the novel by former U.S. Army surgeon Richard Hooker still stands tall for just how crazy emergency medicine can be.
Best ‘is there a doctor in the house?’ moment
Field of Dreams (1989)
When Ray Kinsella’s daughter gets knocked off the back of the bleachers, everything stops. No one knows what to do … except Doc “Moonlight” Graham, who gives up his life’s (and afterlife’s) dream to step off the field and save the girl from choking to death. Burt Lancaster, in his final movie role, embodies everything people wish a doctor to be: Calm, kind, and able to offer a quick, effective solution to a crisis. “Hey rookie! You were good.” Yes, he sure was.
Most unethical doctor
Elvis (2022)
No doctor wants to be remembered as the guy who killed Elvis. But that legacy clings to Dr. George Nichopoulos, Elvis’s personal physician in the 1970s. In Elvis, Dr. Nichopoulos, played by Tony Nixon, hovers in the background, enabling the King’s worsening addictions. Taking late-night calls for narcotics and injecting the unconscious star with stimulants, “unethical” is an understatement for the fictional “Dr. Nick.” The real Dr. Nichopoulos was acquitted of wrongdoing in Elvis’ death, although there is little doubt that the thousands of medication doses he prescribed played a role. When his license was finally revoked for overprescribing in the 1990s, the obliging doc reportedly claimed, “I cared too much.”
Best self-use of a defibrillator
Casino Royale (2006)
We expect backlash in the post-award press conference since James Bond technically only attempted to self-defibrillate in the passenger seat of his car. He never attached the device to the leads. Vesper Lynd had to pick up his slack and save the day. Also, supporters of fellow self-defibrillating nominee Jason Statham in Crank will no doubt raise a stink on Twitter. But we stand by our choice because it was such an, ahem, heart-stopper of a scene.
Best worst patient lying about an injury
Tár (2022)
Love it or hate it, few recent movies have been as polarizing as Tár. Cate Blanchett’s portrayal of a musical genius might be toweringly brilliant or outrageously offensive (or both) depending on whom you ask. But clearly the character has a loose relationship with facts. More than a few doctors might have raised an eyebrow had Lydia Tár appeared with injuries to her face, claiming to have been attacked in a mugging. In reality, Lydia tripped and fell while pursuing an attractive young cellist into a hazardous basement. Did she lie to protect her image, preserve her marriage, or – like many patients – avoid a lecture on unhealthy behavior? We pick D, all of the above.
Best therapy for a speech disorder
The King’s Speech (2010)
Public speaking might cause anxiety for many of us, but how about doing it in front of a global radio audience while wrestling with a speech disorder? Based on a true story, The King’s Speech revealed that terrifying experience for England’s King George VI. Enter Lionel Logue, played by Geoffrey Rush. Irreverent, unconventional, and untrained, the Australian pioneer in speech and language therapy uses a range of strategies – some of which are still used today – to help the royal find his voice. But when singing, shouting swear words, and provoking rage don’t do the trick, Mr. Logue turns to psychotherapy to unearth the childhood traumas at the root of the king’s disability. Experience, as Mr. Logue tells his patient, matters just as much as “letters after your name.”
A version of this article first appeared on Medscape.com.
Without further ado (or comedy skits or musical numbers or extended tributes or commercials), the Meddys go to ...
Best depiction of emergency medicine’s rollercoaster
M*A*S*H (1970)
The original film, not the TV show, jumps from Frank Burns being hauled away in a straitjacket to a soldier’s spurting neck wound. Hawkeye Pierce calmly steps in and we see the entire sequence of him applying pressure, then stepping back to gown-and-glove (“it’s going to spurt a bit”), then jumping back in with arterial sutures, quipping, “Baby, we’re gonna see some stitchin’ like you never saw before.” After that, cocktail hour. Yes, medicine in Hollywood can be overdramatized and even inaccurate, but Robert Altman’s take on the novel by former U.S. Army surgeon Richard Hooker still stands tall for just how crazy emergency medicine can be.
Best ‘is there a doctor in the house?’ moment
Field of Dreams (1989)
When Ray Kinsella’s daughter gets knocked off the back of the bleachers, everything stops. No one knows what to do … except Doc “Moonlight” Graham, who gives up his life’s (and afterlife’s) dream to step off the field and save the girl from choking to death. Burt Lancaster, in his final movie role, embodies everything people wish a doctor to be: Calm, kind, and able to offer a quick, effective solution to a crisis. “Hey rookie! You were good.” Yes, he sure was.
Most unethical doctor
Elvis (2022)
No doctor wants to be remembered as the guy who killed Elvis. But that legacy clings to Dr. George Nichopoulos, Elvis’s personal physician in the 1970s. In Elvis, Dr. Nichopoulos, played by Tony Nixon, hovers in the background, enabling the King’s worsening addictions. Taking late-night calls for narcotics and injecting the unconscious star with stimulants, “unethical” is an understatement for the fictional “Dr. Nick.” The real Dr. Nichopoulos was acquitted of wrongdoing in Elvis’ death, although there is little doubt that the thousands of medication doses he prescribed played a role. When his license was finally revoked for overprescribing in the 1990s, the obliging doc reportedly claimed, “I cared too much.”
Best self-use of a defibrillator
Casino Royale (2006)
We expect backlash in the post-award press conference since James Bond technically only attempted to self-defibrillate in the passenger seat of his car. He never attached the device to the leads. Vesper Lynd had to pick up his slack and save the day. Also, supporters of fellow self-defibrillating nominee Jason Statham in Crank will no doubt raise a stink on Twitter. But we stand by our choice because it was such an, ahem, heart-stopper of a scene.
Best worst patient lying about an injury
Tár (2022)
Love it or hate it, few recent movies have been as polarizing as Tár. Cate Blanchett’s portrayal of a musical genius might be toweringly brilliant or outrageously offensive (or both) depending on whom you ask. But clearly the character has a loose relationship with facts. More than a few doctors might have raised an eyebrow had Lydia Tár appeared with injuries to her face, claiming to have been attacked in a mugging. In reality, Lydia tripped and fell while pursuing an attractive young cellist into a hazardous basement. Did she lie to protect her image, preserve her marriage, or – like many patients – avoid a lecture on unhealthy behavior? We pick D, all of the above.
Best therapy for a speech disorder
The King’s Speech (2010)
Public speaking might cause anxiety for many of us, but how about doing it in front of a global radio audience while wrestling with a speech disorder? Based on a true story, The King’s Speech revealed that terrifying experience for England’s King George VI. Enter Lionel Logue, played by Geoffrey Rush. Irreverent, unconventional, and untrained, the Australian pioneer in speech and language therapy uses a range of strategies – some of which are still used today – to help the royal find his voice. But when singing, shouting swear words, and provoking rage don’t do the trick, Mr. Logue turns to psychotherapy to unearth the childhood traumas at the root of the king’s disability. Experience, as Mr. Logue tells his patient, matters just as much as “letters after your name.”
A version of this article first appeared on Medscape.com.
Two cups of coffee increase heart dangers with hypertension
according to researchers at Institute for Global Health Policy Research, Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo.
What to know
People with severely high blood pressure who drink two or more cups of caffeinated coffee each day could double their risk of dying from a heart attack, stroke, or any type of cardiovascular disease.
Too much coffee may raise blood pressure and lead to anxiety, heart palpitations, and difficulty sleeping.
An 8-ounce cup of coffee has 80-100 mg of caffeine, while an 8-ounce cup of green or black tea has 30-50 mg.
Drinking one cup of coffee a day or any amount of green tea was not associated with risk of death across any blood pressure categories, and drinking green tea was not associated with increased risk of death related to cardiovascular disease at any blood pressure level.
Frequent consumers of coffee were more likely to be younger, current smokers, current drinkers, to eat fewer vegetables, and to have higher total cholesterol levels and lower systolic blood pressure regardless of their blood pressure category.
This is a summary of the article “Coffee and Green Tea Consumption and Cardiovascular Disease Mortality Among People With and Without Hypertension,” published in the Journal of the American Heart Association.
A version of this article first appeared on Medscape.com.
according to researchers at Institute for Global Health Policy Research, Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo.
What to know
People with severely high blood pressure who drink two or more cups of caffeinated coffee each day could double their risk of dying from a heart attack, stroke, or any type of cardiovascular disease.
Too much coffee may raise blood pressure and lead to anxiety, heart palpitations, and difficulty sleeping.
An 8-ounce cup of coffee has 80-100 mg of caffeine, while an 8-ounce cup of green or black tea has 30-50 mg.
Drinking one cup of coffee a day or any amount of green tea was not associated with risk of death across any blood pressure categories, and drinking green tea was not associated with increased risk of death related to cardiovascular disease at any blood pressure level.
Frequent consumers of coffee were more likely to be younger, current smokers, current drinkers, to eat fewer vegetables, and to have higher total cholesterol levels and lower systolic blood pressure regardless of their blood pressure category.
This is a summary of the article “Coffee and Green Tea Consumption and Cardiovascular Disease Mortality Among People With and Without Hypertension,” published in the Journal of the American Heart Association.
A version of this article first appeared on Medscape.com.
according to researchers at Institute for Global Health Policy Research, Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo.
What to know
People with severely high blood pressure who drink two or more cups of caffeinated coffee each day could double their risk of dying from a heart attack, stroke, or any type of cardiovascular disease.
Too much coffee may raise blood pressure and lead to anxiety, heart palpitations, and difficulty sleeping.
An 8-ounce cup of coffee has 80-100 mg of caffeine, while an 8-ounce cup of green or black tea has 30-50 mg.
Drinking one cup of coffee a day or any amount of green tea was not associated with risk of death across any blood pressure categories, and drinking green tea was not associated with increased risk of death related to cardiovascular disease at any blood pressure level.
Frequent consumers of coffee were more likely to be younger, current smokers, current drinkers, to eat fewer vegetables, and to have higher total cholesterol levels and lower systolic blood pressure regardless of their blood pressure category.
This is a summary of the article “Coffee and Green Tea Consumption and Cardiovascular Disease Mortality Among People With and Without Hypertension,” published in the Journal of the American Heart Association.
A version of this article first appeared on Medscape.com.
FROM JOURNAL OF AMERICAN HEART ASSOCIATION
Doctors and their families tend to ignore medical guidelines
according to a study by economic professors from the Massachusetts Institute of Technology, Cambridge; Stanford (Calif.) University; and the George Gund Professor of Economics and Business Administration at Harvard University, Boston.
What to know
- Doctors’ medical knowledge may influence them and their families to often ignore medical advice while the rest of the population adheres to general medication guidelines.
- Of the 63 guidelines used in the study, doctors and their families followed the standards less than a third of the time.
- The difference in adherence to guidelines between experts and nonexperts is largest with respect to antibiotics, in which doctors and their families are 5.2 percentage points less in compliance than everyone else.
- Doctors could be more likely to prescribe broader-spectrum antibiotics for themselves and their families, whereas most patients receive more narrow-spectrum antibiotics.
- Many members of the general public don’t understand medical guidelines, finding them too complex to follow, and many people don’t trust their doctors.
This is a summary of the article, “A Taste of Their Own Medicine: Guideline Adherence and Access to Expertise,” published in the American Economic Review: Insights on December 13, 2022. The full article can be found on aeaweb.org.
A version of this article first appeared on Medscape.com.
according to a study by economic professors from the Massachusetts Institute of Technology, Cambridge; Stanford (Calif.) University; and the George Gund Professor of Economics and Business Administration at Harvard University, Boston.
What to know
- Doctors’ medical knowledge may influence them and their families to often ignore medical advice while the rest of the population adheres to general medication guidelines.
- Of the 63 guidelines used in the study, doctors and their families followed the standards less than a third of the time.
- The difference in adherence to guidelines between experts and nonexperts is largest with respect to antibiotics, in which doctors and their families are 5.2 percentage points less in compliance than everyone else.
- Doctors could be more likely to prescribe broader-spectrum antibiotics for themselves and their families, whereas most patients receive more narrow-spectrum antibiotics.
- Many members of the general public don’t understand medical guidelines, finding them too complex to follow, and many people don’t trust their doctors.
This is a summary of the article, “A Taste of Their Own Medicine: Guideline Adherence and Access to Expertise,” published in the American Economic Review: Insights on December 13, 2022. The full article can be found on aeaweb.org.
A version of this article first appeared on Medscape.com.
according to a study by economic professors from the Massachusetts Institute of Technology, Cambridge; Stanford (Calif.) University; and the George Gund Professor of Economics and Business Administration at Harvard University, Boston.
What to know
- Doctors’ medical knowledge may influence them and their families to often ignore medical advice while the rest of the population adheres to general medication guidelines.
- Of the 63 guidelines used in the study, doctors and their families followed the standards less than a third of the time.
- The difference in adherence to guidelines between experts and nonexperts is largest with respect to antibiotics, in which doctors and their families are 5.2 percentage points less in compliance than everyone else.
- Doctors could be more likely to prescribe broader-spectrum antibiotics for themselves and their families, whereas most patients receive more narrow-spectrum antibiotics.
- Many members of the general public don’t understand medical guidelines, finding them too complex to follow, and many people don’t trust their doctors.
This is a summary of the article, “A Taste of Their Own Medicine: Guideline Adherence and Access to Expertise,” published in the American Economic Review: Insights on December 13, 2022. The full article can be found on aeaweb.org.
A version of this article first appeared on Medscape.com.
Adult brains contain millions of ‘silent synapses’
according to neuroscientists from the Massachusetts Institute of Technology.
What to know:
- An estimated 30% of all synapses in the brain’s cortex are silent and become active to allow the adult brain to continually form new memories and leave existing conventional synapses unmodified.
- Silent synapses are looking for new connections, and when important new information is presented, connections between the relevant neurons are strengthened to allow the brain to remember new things.
- Using the silent synapses for the new memories does not overwrite the important memories stored in more mature synapses, which are harder to change.
- The brain’s neurons display a wide range of plasticity mechanisms that account for how brains can efficiently learn new things and retain them in long-term memory.
- Flexibility of synapses is critical for acquiring new information, and stability is required to retain important information, enabling one to more easily adjust and change behaviors and habits or incorporate new information.
This is a summary of the article, “Filopodia Are a Structural Substrate for Silent Synapses in Adult Neocortex,” published in Nature Nov. 30, 2022. The full article can be found at nature.com .
A version of this article first appeared on Medscape.com.
according to neuroscientists from the Massachusetts Institute of Technology.
What to know:
- An estimated 30% of all synapses in the brain’s cortex are silent and become active to allow the adult brain to continually form new memories and leave existing conventional synapses unmodified.
- Silent synapses are looking for new connections, and when important new information is presented, connections between the relevant neurons are strengthened to allow the brain to remember new things.
- Using the silent synapses for the new memories does not overwrite the important memories stored in more mature synapses, which are harder to change.
- The brain’s neurons display a wide range of plasticity mechanisms that account for how brains can efficiently learn new things and retain them in long-term memory.
- Flexibility of synapses is critical for acquiring new information, and stability is required to retain important information, enabling one to more easily adjust and change behaviors and habits or incorporate new information.
This is a summary of the article, “Filopodia Are a Structural Substrate for Silent Synapses in Adult Neocortex,” published in Nature Nov. 30, 2022. The full article can be found at nature.com .
A version of this article first appeared on Medscape.com.
according to neuroscientists from the Massachusetts Institute of Technology.
What to know:
- An estimated 30% of all synapses in the brain’s cortex are silent and become active to allow the adult brain to continually form new memories and leave existing conventional synapses unmodified.
- Silent synapses are looking for new connections, and when important new information is presented, connections between the relevant neurons are strengthened to allow the brain to remember new things.
- Using the silent synapses for the new memories does not overwrite the important memories stored in more mature synapses, which are harder to change.
- The brain’s neurons display a wide range of plasticity mechanisms that account for how brains can efficiently learn new things and retain them in long-term memory.
- Flexibility of synapses is critical for acquiring new information, and stability is required to retain important information, enabling one to more easily adjust and change behaviors and habits or incorporate new information.
This is a summary of the article, “Filopodia Are a Structural Substrate for Silent Synapses in Adult Neocortex,” published in Nature Nov. 30, 2022. The full article can be found at nature.com .
A version of this article first appeared on Medscape.com.
Using devices to calm children can backfire long term
according to developmental behavioral pediatricians at University of Michigan Health C. S. Mott Children’s Hospital, Ann Arbor.
What to know
- Using a mobile device to distract children from how they are feeling may displace opportunities for them to develop independent, alternative methods to self-regulate, especially in early childhood.
- Signs of increased dysregulation could include rapid shifts between sadness and excitement, a sudden change in mood or feelings, and heightened impulsivity.
- The association between device-calming and emotional consequences may be particularly high among young boys and children who are already experiencing hyperactivity, impulsiveness, and a strong temperament that makes them more likely to react intensely to feelings such as anger, frustration, and sadness.
- While occasional use of media to occupy children is expected and understandable, it is important that it not become a primary or regular soothing tool, and children should be given clear expectations of when and where devices can be used.
- The preschool-to-kindergarten period is a developmental stage in which children may be more likely to exhibit difficult behaviors, such as tantrums, defiance, and intense emotions, but parents should resist using devices as a parenting strategy.
This is a summary of the article, “Longitudinal Association Between Use of Mobile Devices for Calming and Emotional Reactivity and Executive Functioning in Children Aged 3 to 5 Years,” published in JAMA Pediatrics on Dec. 20, 2022. The full article can be found on jamanetwork.com. A version of this article originally appeared on Medscape.com.
according to developmental behavioral pediatricians at University of Michigan Health C. S. Mott Children’s Hospital, Ann Arbor.
What to know
- Using a mobile device to distract children from how they are feeling may displace opportunities for them to develop independent, alternative methods to self-regulate, especially in early childhood.
- Signs of increased dysregulation could include rapid shifts between sadness and excitement, a sudden change in mood or feelings, and heightened impulsivity.
- The association between device-calming and emotional consequences may be particularly high among young boys and children who are already experiencing hyperactivity, impulsiveness, and a strong temperament that makes them more likely to react intensely to feelings such as anger, frustration, and sadness.
- While occasional use of media to occupy children is expected and understandable, it is important that it not become a primary or regular soothing tool, and children should be given clear expectations of when and where devices can be used.
- The preschool-to-kindergarten period is a developmental stage in which children may be more likely to exhibit difficult behaviors, such as tantrums, defiance, and intense emotions, but parents should resist using devices as a parenting strategy.
This is a summary of the article, “Longitudinal Association Between Use of Mobile Devices for Calming and Emotional Reactivity and Executive Functioning in Children Aged 3 to 5 Years,” published in JAMA Pediatrics on Dec. 20, 2022. The full article can be found on jamanetwork.com. A version of this article originally appeared on Medscape.com.
according to developmental behavioral pediatricians at University of Michigan Health C. S. Mott Children’s Hospital, Ann Arbor.
What to know
- Using a mobile device to distract children from how they are feeling may displace opportunities for them to develop independent, alternative methods to self-regulate, especially in early childhood.
- Signs of increased dysregulation could include rapid shifts between sadness and excitement, a sudden change in mood or feelings, and heightened impulsivity.
- The association between device-calming and emotional consequences may be particularly high among young boys and children who are already experiencing hyperactivity, impulsiveness, and a strong temperament that makes them more likely to react intensely to feelings such as anger, frustration, and sadness.
- While occasional use of media to occupy children is expected and understandable, it is important that it not become a primary or regular soothing tool, and children should be given clear expectations of when and where devices can be used.
- The preschool-to-kindergarten period is a developmental stage in which children may be more likely to exhibit difficult behaviors, such as tantrums, defiance, and intense emotions, but parents should resist using devices as a parenting strategy.
This is a summary of the article, “Longitudinal Association Between Use of Mobile Devices for Calming and Emotional Reactivity and Executive Functioning in Children Aged 3 to 5 Years,” published in JAMA Pediatrics on Dec. 20, 2022. The full article can be found on jamanetwork.com. A version of this article originally appeared on Medscape.com.
Drinking tea can keep your heart healthy as you age
according to the Heart Foundation and researchers from Edith Cowan University, Perth, Australia.
What to know
- Elderly women who drank black tea on a regular basis or consumed a high level of flavonoids in their diet were found to be far less likely to develop extensive AAC.
- AAC is calcification of the large artery that supplies oxygenated blood from the heart to the abdominal organs and lower limbs. It is associated with cardiovascular disorders, such as heart attack and stroke, as well as late-life dementia.
- Flavonoids are naturally occurring substances that regulate cellular activity. They are found in many common foods and beverages, such as black tea, green tea, apples, nuts, citrus fruit, berries, red wine, dark chocolate, and others.
- Study participants who had a higher intake of total flavonoids, flavan-3-ols, and flavonols were almost 40% less likely to have extensive AAC, while those who drank two to six cups of black tea per day had up to 42% less chance of experiencing extensive AAC.
- People who do not drink tea can still benefit by including foods rich in flavonoids in their diet, which protects against extensive calcification of the arteries.
This is a summary of the article, “Higher Habitual Dietary Flavonoid Intake Associates With Less Extensive Abdominal Aortic Calcification in a Cohort of Older Women,” published in Arteriosclerosis, Thrombosis, and Vascular Biology on Nov. 2, 2022. The full article can be found on ahajournals.org. A version of this article originally appeared on Medscape.com.
according to the Heart Foundation and researchers from Edith Cowan University, Perth, Australia.
What to know
- Elderly women who drank black tea on a regular basis or consumed a high level of flavonoids in their diet were found to be far less likely to develop extensive AAC.
- AAC is calcification of the large artery that supplies oxygenated blood from the heart to the abdominal organs and lower limbs. It is associated with cardiovascular disorders, such as heart attack and stroke, as well as late-life dementia.
- Flavonoids are naturally occurring substances that regulate cellular activity. They are found in many common foods and beverages, such as black tea, green tea, apples, nuts, citrus fruit, berries, red wine, dark chocolate, and others.
- Study participants who had a higher intake of total flavonoids, flavan-3-ols, and flavonols were almost 40% less likely to have extensive AAC, while those who drank two to six cups of black tea per day had up to 42% less chance of experiencing extensive AAC.
- People who do not drink tea can still benefit by including foods rich in flavonoids in their diet, which protects against extensive calcification of the arteries.
This is a summary of the article, “Higher Habitual Dietary Flavonoid Intake Associates With Less Extensive Abdominal Aortic Calcification in a Cohort of Older Women,” published in Arteriosclerosis, Thrombosis, and Vascular Biology on Nov. 2, 2022. The full article can be found on ahajournals.org. A version of this article originally appeared on Medscape.com.
according to the Heart Foundation and researchers from Edith Cowan University, Perth, Australia.
What to know
- Elderly women who drank black tea on a regular basis or consumed a high level of flavonoids in their diet were found to be far less likely to develop extensive AAC.
- AAC is calcification of the large artery that supplies oxygenated blood from the heart to the abdominal organs and lower limbs. It is associated with cardiovascular disorders, such as heart attack and stroke, as well as late-life dementia.
- Flavonoids are naturally occurring substances that regulate cellular activity. They are found in many common foods and beverages, such as black tea, green tea, apples, nuts, citrus fruit, berries, red wine, dark chocolate, and others.
- Study participants who had a higher intake of total flavonoids, flavan-3-ols, and flavonols were almost 40% less likely to have extensive AAC, while those who drank two to six cups of black tea per day had up to 42% less chance of experiencing extensive AAC.
- People who do not drink tea can still benefit by including foods rich in flavonoids in their diet, which protects against extensive calcification of the arteries.
This is a summary of the article, “Higher Habitual Dietary Flavonoid Intake Associates With Less Extensive Abdominal Aortic Calcification in a Cohort of Older Women,” published in Arteriosclerosis, Thrombosis, and Vascular Biology on Nov. 2, 2022. The full article can be found on ahajournals.org. A version of this article originally appeared on Medscape.com.
Almonds may be a good diet option
according to researchers at the University of South Australia’s Alliance for Research in Exercise, Nutrition and Activity.
What to know
People who consume as few as 30-50 g of almonds, as opposed to an energy-equivalent carbohydrate snack, can lower their energy intake significantly at the subsequent meal.
People who eat almonds can experience changes in their appetite-regulating hormones that may contribute to less food intake.
Almond consumption can lower C-peptide responses, which can improve insulin sensitivity and reduce the risk of developing diabetes and cardiovascular disease.
Eating almonds can raise levels of glucose-dependent insulinotropic polypeptide glucagon, which can send satiety signals to the brain, and pancreatic polypeptide, which slows digestion, which may reduce food intake, supporting weight loss.
Almonds are high in protein, fiber, and unsaturated fatty acids, which may contribute to their satiating properties and help explain why fewer calories are consumed.
A version of this article originally appeared on Medscape.com.
This is a summary of the article “Acute Feeding With Almonds Compared to a Carbohydrate-Based Snack Improves Appetite-Regulating Hormones With No Effect on Self-reported Appetite Sensations: A Randomised Controlled Trial,” published in the European Journal of Nutrition on Oct. 11, 2022. The full article can be found on link.springer.com.
according to researchers at the University of South Australia’s Alliance for Research in Exercise, Nutrition and Activity.
What to know
People who consume as few as 30-50 g of almonds, as opposed to an energy-equivalent carbohydrate snack, can lower their energy intake significantly at the subsequent meal.
People who eat almonds can experience changes in their appetite-regulating hormones that may contribute to less food intake.
Almond consumption can lower C-peptide responses, which can improve insulin sensitivity and reduce the risk of developing diabetes and cardiovascular disease.
Eating almonds can raise levels of glucose-dependent insulinotropic polypeptide glucagon, which can send satiety signals to the brain, and pancreatic polypeptide, which slows digestion, which may reduce food intake, supporting weight loss.
Almonds are high in protein, fiber, and unsaturated fatty acids, which may contribute to their satiating properties and help explain why fewer calories are consumed.
A version of this article originally appeared on Medscape.com.
This is a summary of the article “Acute Feeding With Almonds Compared to a Carbohydrate-Based Snack Improves Appetite-Regulating Hormones With No Effect on Self-reported Appetite Sensations: A Randomised Controlled Trial,” published in the European Journal of Nutrition on Oct. 11, 2022. The full article can be found on link.springer.com.
according to researchers at the University of South Australia’s Alliance for Research in Exercise, Nutrition and Activity.
What to know
People who consume as few as 30-50 g of almonds, as opposed to an energy-equivalent carbohydrate snack, can lower their energy intake significantly at the subsequent meal.
People who eat almonds can experience changes in their appetite-regulating hormones that may contribute to less food intake.
Almond consumption can lower C-peptide responses, which can improve insulin sensitivity and reduce the risk of developing diabetes and cardiovascular disease.
Eating almonds can raise levels of glucose-dependent insulinotropic polypeptide glucagon, which can send satiety signals to the brain, and pancreatic polypeptide, which slows digestion, which may reduce food intake, supporting weight loss.
Almonds are high in protein, fiber, and unsaturated fatty acids, which may contribute to their satiating properties and help explain why fewer calories are consumed.
A version of this article originally appeared on Medscape.com.
This is a summary of the article “Acute Feeding With Almonds Compared to a Carbohydrate-Based Snack Improves Appetite-Regulating Hormones With No Effect on Self-reported Appetite Sensations: A Randomised Controlled Trial,” published in the European Journal of Nutrition on Oct. 11, 2022. The full article can be found on link.springer.com.
FROM THE EUROPEAN JOURNAL OF NUTRITION
FDA OKs first fecal microbiota therapy for recurrent C. difficile
Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrence of CDI.
“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing approval.
As the first FDA-approved fecal microbiota product, this approval “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” Dr. Marks added.
A panel of FDA advisors recommended approval of Rebyota in September.
The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
A vicious cycle
Treatment options for recurrent CDI are limited. It’s been estimated that up to one-third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.
Following the first recurrence, up to two-thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI.
“This is a major milestone in the translation of gut microbiome science to clinical solutions for patients,” Phillip I. Tarr, MD, chair of the American Gastroenterological Association’s Center for Gut Microbiome Research and Education Scientific Advisory Board, said in a written statement issued by the AGA. “This accomplishment is based on decades of work on the gut microbiome by gastroenterologists and collaborators. AGA applauds FDA for recognizing the demonstrated and conceptual merit of microbiota-based therapies.”
Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.
The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1,000 participants, the company notes in a press release.
In one trial, following a standard course of antibiotics, a one-time treatment with Rebyota was successful for three-quarters of participants at 8 weeks.
The treatment also prevented additional bouts; 84% of these initial responders remaining free of CDI at 6 months.
Two-thirds of participants reported treatment-emergent adverse events. Most events were mild to moderate in severity. Diarrhea and abdominal pain were the most common.
The data, from the ongoing PUNCH CD3-OLS study, were presented in October at the annual meeting of the American College of Gastroenterology and were published simultaneously in the journal Drugs.
“This is a positive adjunct to our current therapies for C. difficile in terms of trying to knock it out once a standard course of antibiotics has been administered,” Lisa Malter, MD, a gastroenterologist and professor of medicine at New York University Langone Health, said in an interview.
Dr. Malter acknowledged that, because it’s delivered rectally, there could be “some hesitation” on the patient’s part to undergo the therapy.
However, C. difficile can be “excruciating” for patients, and they “may be more than willing to take [this agent] because it gets them feeling better,” said Dr. Malter said, who reported no relevant financial relationships.
The AGA will continue to follow the long-term effectiveness and safety of patients receiving Rebyota, fecal microbiota transplant, and other microbiota-based therapies through its FMT National Registry, according to the AGA statement.
Full prescribing information for Rebyota is available online.
For more information about CDI and FMT, visit patient.gastro.org.
Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrence of CDI.
“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing approval.
As the first FDA-approved fecal microbiota product, this approval “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” Dr. Marks added.
A panel of FDA advisors recommended approval of Rebyota in September.
The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
A vicious cycle
Treatment options for recurrent CDI are limited. It’s been estimated that up to one-third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.
Following the first recurrence, up to two-thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI.
“This is a major milestone in the translation of gut microbiome science to clinical solutions for patients,” Phillip I. Tarr, MD, chair of the American Gastroenterological Association’s Center for Gut Microbiome Research and Education Scientific Advisory Board, said in a written statement issued by the AGA. “This accomplishment is based on decades of work on the gut microbiome by gastroenterologists and collaborators. AGA applauds FDA for recognizing the demonstrated and conceptual merit of microbiota-based therapies.”
Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.
The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1,000 participants, the company notes in a press release.
In one trial, following a standard course of antibiotics, a one-time treatment with Rebyota was successful for three-quarters of participants at 8 weeks.
The treatment also prevented additional bouts; 84% of these initial responders remaining free of CDI at 6 months.
Two-thirds of participants reported treatment-emergent adverse events. Most events were mild to moderate in severity. Diarrhea and abdominal pain were the most common.
The data, from the ongoing PUNCH CD3-OLS study, were presented in October at the annual meeting of the American College of Gastroenterology and were published simultaneously in the journal Drugs.
“This is a positive adjunct to our current therapies for C. difficile in terms of trying to knock it out once a standard course of antibiotics has been administered,” Lisa Malter, MD, a gastroenterologist and professor of medicine at New York University Langone Health, said in an interview.
Dr. Malter acknowledged that, because it’s delivered rectally, there could be “some hesitation” on the patient’s part to undergo the therapy.
However, C. difficile can be “excruciating” for patients, and they “may be more than willing to take [this agent] because it gets them feeling better,” said Dr. Malter said, who reported no relevant financial relationships.
The AGA will continue to follow the long-term effectiveness and safety of patients receiving Rebyota, fecal microbiota transplant, and other microbiota-based therapies through its FMT National Registry, according to the AGA statement.
Full prescribing information for Rebyota is available online.
For more information about CDI and FMT, visit patient.gastro.org.
Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrence of CDI.
“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing approval.
As the first FDA-approved fecal microbiota product, this approval “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” Dr. Marks added.
A panel of FDA advisors recommended approval of Rebyota in September.
The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
A vicious cycle
Treatment options for recurrent CDI are limited. It’s been estimated that up to one-third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.
Following the first recurrence, up to two-thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI.
“This is a major milestone in the translation of gut microbiome science to clinical solutions for patients,” Phillip I. Tarr, MD, chair of the American Gastroenterological Association’s Center for Gut Microbiome Research and Education Scientific Advisory Board, said in a written statement issued by the AGA. “This accomplishment is based on decades of work on the gut microbiome by gastroenterologists and collaborators. AGA applauds FDA for recognizing the demonstrated and conceptual merit of microbiota-based therapies.”
Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.
The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1,000 participants, the company notes in a press release.
In one trial, following a standard course of antibiotics, a one-time treatment with Rebyota was successful for three-quarters of participants at 8 weeks.
The treatment also prevented additional bouts; 84% of these initial responders remaining free of CDI at 6 months.
Two-thirds of participants reported treatment-emergent adverse events. Most events were mild to moderate in severity. Diarrhea and abdominal pain were the most common.
The data, from the ongoing PUNCH CD3-OLS study, were presented in October at the annual meeting of the American College of Gastroenterology and were published simultaneously in the journal Drugs.
“This is a positive adjunct to our current therapies for C. difficile in terms of trying to knock it out once a standard course of antibiotics has been administered,” Lisa Malter, MD, a gastroenterologist and professor of medicine at New York University Langone Health, said in an interview.
Dr. Malter acknowledged that, because it’s delivered rectally, there could be “some hesitation” on the patient’s part to undergo the therapy.
However, C. difficile can be “excruciating” for patients, and they “may be more than willing to take [this agent] because it gets them feeling better,” said Dr. Malter said, who reported no relevant financial relationships.
The AGA will continue to follow the long-term effectiveness and safety of patients receiving Rebyota, fecal microbiota transplant, and other microbiota-based therapies through its FMT National Registry, according to the AGA statement.
Full prescribing information for Rebyota is available online.
For more information about CDI and FMT, visit patient.gastro.org.
Good news, bad news for GI in 2023 CMS physician fee schedule
Medicare expanded coverage of colorectal cancer (CRC) testing through the 2023 physician payment rule while also finalizing certain mandated budget cuts.
The 2023 Medicare Physician Fee Schedule (MPFS) lowers the minimum age for CRC screening to 45 from 50 years, in keeping with the recommendation from the U.S. Preventive Services Task Force. The physician payment rule, which was unveiled on November 1, also ends the copay for colonoscopies that follow a positive stool-based colon cancer test. However, it is important to note that colonoscopies that involve polyp removal are still subject to Medicare coinsurance requirements, although the financial responsibility eventually diminishes to zero by 2030: From 2023 to 2026, patient responsibility is 15% of the cost; from 2027 to 2029 it falls to 10%; and by 2030 it will be covered 100% by Medicare.
These changes come after a year of intense advocacy led by AGA, including multiple meetings with senior officials at the Centers for Medicare and Medicaid Services and legislative pressure by members across the country. In the 2023 MPFS proposed rule, CMS attributed its decision to expand Medicare benefits to colonoscopy following a positive stool test to involvement from AGA, saying, “We consulted with and reviewed recommendations from a number of professional societies in developing this proposal, including supportive letters and communications with representatives from American Gastroenterological Association, American Cancer Society, and Fight Colorectal Cancer.”
“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives. Importantly, the changes will lessen colorectal cancer disparities, eliminating a financial burden for many patients,” says AGA President John Carethers, MD, AGAF, who met with CMS earlier this year to advocate for the coverage of colonoscopy following a positive noninvasive colorectal cancer screening test.
David Lieberman, MD, AGAF, who met with CMS officials multiple times, offered, “Cost-sharing is a well-recognized barrier to screening and has resulted in disparities. Patients can now engage in a CRC screening program and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test.”
‘Déjà vu all over again’
CMS uses its annual updates of the Physician Fee Schedule to make myriad policy decisions, with the 2023 version of the rule running close to 3,000 pages. AGA’s summary of the 2023 MPFS final rule highlights changes that impact gastroenterologists.
But the most controversial provisions in the rule involve federal mandates meant to control spending that CMS has no control over. These include a reduction in one of the variables used in determining payment, known as the conversion factor. This will fall by $1.55 from the current level of $34.61 to $33.06 in 2023.
There’s widespread agreement that Congress needs to reconsider its approach to setting Medicare payment for clinicians.
Between 2003 and April 2014, Congress passed 17 laws overriding the cuts to physician pay that were required under the old sustainable growth rate (SGR) formula.
The Medicare Access and CHIP Reauthorization Act of 2015 was supposed to end the annual battles over reimbursement cuts resulting from the SGR formula by changing the way physician payment is updated each year.
However, physicians face a 4.42% Medicare payment cut under the new payment system, as reflected in 2023 payment rule.
Two physicians serving in Congress, Rep. Ami Bera, MD (D-CA), and Rep. Larry Bucshon, MD (R-IN), have introduced legislation that would block next year’s cuts.
The current fight to stave off 2023 cuts seems like “déjà vu all over again,” said Kathleen Teixeira, AGA’s vice president of government affairs, in an interview with this news organization. Congress needs to shift away from the “Band-Aid approach” and concentrate on longer-term issues with physician payment, she said.
Rep. Bera and Rep. Buchson in September issued a letter seeking feedback on ways to “stabilize the Medicare payment system” without dramatically increasing the cost to taxpayers.
Louis Wilson, MD, chair of the American College of Gastroenterology’s legislative and public policy council, told this news organization that Congress needs to revisit Medicare’s physician payment system, especially in terms of addressing inflation.
Lawmakers’ attempts to restrain growth in Medicare physician payments have had the unintended consequence of fueling the acquisition of practices by hospitals, said Dr. Wilson, the managing partner of a physician-owned single-specialty private practice in Wichita Falls, Tex. Once doctors are employed by hospitals, Medicare often pays higher rates for their services than it would pay to physicians for providing the same care in a private practice.
Indeed, the Federal Trade Commission has said the U.S. physician workplace is “undergoing a dramatic restructuring,” with traditional solo practices and small single-specialty group practices rapidly being replaced by large multispecialty physician group practices, or practices that are owned or employed by hospital systems. The FTC is in the midst of a major series of studies on the effects of this consolidation.
“There’s been so much market distortion, so much limitation in innovation by failing to adequately pay in the Physician Fee Schedule, that the consequence is the widespread consolidation,” said Dr. Wilson. “That’s recognized on both sides of the aisle as being essentially expensive and inefficient and not in patients’ best interest.”
Medicare expanded coverage of colorectal cancer (CRC) testing through the 2023 physician payment rule while also finalizing certain mandated budget cuts.
The 2023 Medicare Physician Fee Schedule (MPFS) lowers the minimum age for CRC screening to 45 from 50 years, in keeping with the recommendation from the U.S. Preventive Services Task Force. The physician payment rule, which was unveiled on November 1, also ends the copay for colonoscopies that follow a positive stool-based colon cancer test. However, it is important to note that colonoscopies that involve polyp removal are still subject to Medicare coinsurance requirements, although the financial responsibility eventually diminishes to zero by 2030: From 2023 to 2026, patient responsibility is 15% of the cost; from 2027 to 2029 it falls to 10%; and by 2030 it will be covered 100% by Medicare.
These changes come after a year of intense advocacy led by AGA, including multiple meetings with senior officials at the Centers for Medicare and Medicaid Services and legislative pressure by members across the country. In the 2023 MPFS proposed rule, CMS attributed its decision to expand Medicare benefits to colonoscopy following a positive stool test to involvement from AGA, saying, “We consulted with and reviewed recommendations from a number of professional societies in developing this proposal, including supportive letters and communications with representatives from American Gastroenterological Association, American Cancer Society, and Fight Colorectal Cancer.”
“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives. Importantly, the changes will lessen colorectal cancer disparities, eliminating a financial burden for many patients,” says AGA President John Carethers, MD, AGAF, who met with CMS earlier this year to advocate for the coverage of colonoscopy following a positive noninvasive colorectal cancer screening test.
David Lieberman, MD, AGAF, who met with CMS officials multiple times, offered, “Cost-sharing is a well-recognized barrier to screening and has resulted in disparities. Patients can now engage in a CRC screening program and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test.”
‘Déjà vu all over again’
CMS uses its annual updates of the Physician Fee Schedule to make myriad policy decisions, with the 2023 version of the rule running close to 3,000 pages. AGA’s summary of the 2023 MPFS final rule highlights changes that impact gastroenterologists.
But the most controversial provisions in the rule involve federal mandates meant to control spending that CMS has no control over. These include a reduction in one of the variables used in determining payment, known as the conversion factor. This will fall by $1.55 from the current level of $34.61 to $33.06 in 2023.
There’s widespread agreement that Congress needs to reconsider its approach to setting Medicare payment for clinicians.
Between 2003 and April 2014, Congress passed 17 laws overriding the cuts to physician pay that were required under the old sustainable growth rate (SGR) formula.
The Medicare Access and CHIP Reauthorization Act of 2015 was supposed to end the annual battles over reimbursement cuts resulting from the SGR formula by changing the way physician payment is updated each year.
However, physicians face a 4.42% Medicare payment cut under the new payment system, as reflected in 2023 payment rule.
Two physicians serving in Congress, Rep. Ami Bera, MD (D-CA), and Rep. Larry Bucshon, MD (R-IN), have introduced legislation that would block next year’s cuts.
The current fight to stave off 2023 cuts seems like “déjà vu all over again,” said Kathleen Teixeira, AGA’s vice president of government affairs, in an interview with this news organization. Congress needs to shift away from the “Band-Aid approach” and concentrate on longer-term issues with physician payment, she said.
Rep. Bera and Rep. Buchson in September issued a letter seeking feedback on ways to “stabilize the Medicare payment system” without dramatically increasing the cost to taxpayers.
Louis Wilson, MD, chair of the American College of Gastroenterology’s legislative and public policy council, told this news organization that Congress needs to revisit Medicare’s physician payment system, especially in terms of addressing inflation.
Lawmakers’ attempts to restrain growth in Medicare physician payments have had the unintended consequence of fueling the acquisition of practices by hospitals, said Dr. Wilson, the managing partner of a physician-owned single-specialty private practice in Wichita Falls, Tex. Once doctors are employed by hospitals, Medicare often pays higher rates for their services than it would pay to physicians for providing the same care in a private practice.
Indeed, the Federal Trade Commission has said the U.S. physician workplace is “undergoing a dramatic restructuring,” with traditional solo practices and small single-specialty group practices rapidly being replaced by large multispecialty physician group practices, or practices that are owned or employed by hospital systems. The FTC is in the midst of a major series of studies on the effects of this consolidation.
“There’s been so much market distortion, so much limitation in innovation by failing to adequately pay in the Physician Fee Schedule, that the consequence is the widespread consolidation,” said Dr. Wilson. “That’s recognized on both sides of the aisle as being essentially expensive and inefficient and not in patients’ best interest.”
Medicare expanded coverage of colorectal cancer (CRC) testing through the 2023 physician payment rule while also finalizing certain mandated budget cuts.
The 2023 Medicare Physician Fee Schedule (MPFS) lowers the minimum age for CRC screening to 45 from 50 years, in keeping with the recommendation from the U.S. Preventive Services Task Force. The physician payment rule, which was unveiled on November 1, also ends the copay for colonoscopies that follow a positive stool-based colon cancer test. However, it is important to note that colonoscopies that involve polyp removal are still subject to Medicare coinsurance requirements, although the financial responsibility eventually diminishes to zero by 2030: From 2023 to 2026, patient responsibility is 15% of the cost; from 2027 to 2029 it falls to 10%; and by 2030 it will be covered 100% by Medicare.
These changes come after a year of intense advocacy led by AGA, including multiple meetings with senior officials at the Centers for Medicare and Medicaid Services and legislative pressure by members across the country. In the 2023 MPFS proposed rule, CMS attributed its decision to expand Medicare benefits to colonoscopy following a positive stool test to involvement from AGA, saying, “We consulted with and reviewed recommendations from a number of professional societies in developing this proposal, including supportive letters and communications with representatives from American Gastroenterological Association, American Cancer Society, and Fight Colorectal Cancer.”
“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives. Importantly, the changes will lessen colorectal cancer disparities, eliminating a financial burden for many patients,” says AGA President John Carethers, MD, AGAF, who met with CMS earlier this year to advocate for the coverage of colonoscopy following a positive noninvasive colorectal cancer screening test.
David Lieberman, MD, AGAF, who met with CMS officials multiple times, offered, “Cost-sharing is a well-recognized barrier to screening and has resulted in disparities. Patients can now engage in a CRC screening program and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test.”
‘Déjà vu all over again’
CMS uses its annual updates of the Physician Fee Schedule to make myriad policy decisions, with the 2023 version of the rule running close to 3,000 pages. AGA’s summary of the 2023 MPFS final rule highlights changes that impact gastroenterologists.
But the most controversial provisions in the rule involve federal mandates meant to control spending that CMS has no control over. These include a reduction in one of the variables used in determining payment, known as the conversion factor. This will fall by $1.55 from the current level of $34.61 to $33.06 in 2023.
There’s widespread agreement that Congress needs to reconsider its approach to setting Medicare payment for clinicians.
Between 2003 and April 2014, Congress passed 17 laws overriding the cuts to physician pay that were required under the old sustainable growth rate (SGR) formula.
The Medicare Access and CHIP Reauthorization Act of 2015 was supposed to end the annual battles over reimbursement cuts resulting from the SGR formula by changing the way physician payment is updated each year.
However, physicians face a 4.42% Medicare payment cut under the new payment system, as reflected in 2023 payment rule.
Two physicians serving in Congress, Rep. Ami Bera, MD (D-CA), and Rep. Larry Bucshon, MD (R-IN), have introduced legislation that would block next year’s cuts.
The current fight to stave off 2023 cuts seems like “déjà vu all over again,” said Kathleen Teixeira, AGA’s vice president of government affairs, in an interview with this news organization. Congress needs to shift away from the “Band-Aid approach” and concentrate on longer-term issues with physician payment, she said.
Rep. Bera and Rep. Buchson in September issued a letter seeking feedback on ways to “stabilize the Medicare payment system” without dramatically increasing the cost to taxpayers.
Louis Wilson, MD, chair of the American College of Gastroenterology’s legislative and public policy council, told this news organization that Congress needs to revisit Medicare’s physician payment system, especially in terms of addressing inflation.
Lawmakers’ attempts to restrain growth in Medicare physician payments have had the unintended consequence of fueling the acquisition of practices by hospitals, said Dr. Wilson, the managing partner of a physician-owned single-specialty private practice in Wichita Falls, Tex. Once doctors are employed by hospitals, Medicare often pays higher rates for their services than it would pay to physicians for providing the same care in a private practice.
Indeed, the Federal Trade Commission has said the U.S. physician workplace is “undergoing a dramatic restructuring,” with traditional solo practices and small single-specialty group practices rapidly being replaced by large multispecialty physician group practices, or practices that are owned or employed by hospital systems. The FTC is in the midst of a major series of studies on the effects of this consolidation.
“There’s been so much market distortion, so much limitation in innovation by failing to adequately pay in the Physician Fee Schedule, that the consequence is the widespread consolidation,” said Dr. Wilson. “That’s recognized on both sides of the aisle as being essentially expensive and inefficient and not in patients’ best interest.”