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GI-Targeted Bitter Hop Extract Curbs Hunger, Food Cravings
TOPLINE:
METHODOLOGY:
- Researchers conducted a randomized, double-blind, crossover study with 30 normal-weight women ages 18-40 with BMIs of 18.5-25. The trial design was similar to that used previously to test the intervention among men.
- Participants engaged in a water-only fast for 24 hours (6 p.m. to 6 p.m.) on three occasions and were given an ad libitum meal to break each fast.
- Participants were randomly assigned to one of three treatments: placebo, a high-dose (500 mg) bitter hop–based appetite suppressant (Amarasate), or a low dose (250 mg) of the appetite suppressant.
- Treatment capsules of half the total dose were given twice daily (16 hours and 20 hours into the fast).
- Participants recorded their subjective feelings about appetite and food cravings using a visual analog scale at 30-minute intervals starting 16 hours into the fast.
TAKEAWAY:
- Both the high-dose and low-dose treatment groups experienced a significant reduction in appetite (ie, hunger, fullness, satisfaction, thoughts of food) and food cravings compared with the placebo group.
- Energy intake at the ad libitum meal was 14.3% lower in the high-dose group than the placebo group (P < .05). It was 8.1% lower in the low-dose group, but the difference was not statistically significant.
- In the high-dose group, two participants reported loose stools and one reported heartburn. In the low-dose group, one participant reported loose stools.
IN PRACTICE:
“These data suggest that appetite suppressant co-therapy may be useful in reducing hunger during fasting in women and show that gastrointestinal delivery of bitter compounds may also be an effective method of reducing cravings for food,” the authors wrote.
SOURCE:
The study, led by Edward Walker, PhD, of the New Zealand Institute for Plant and Food Research Limited, Auckland, New Zealand, was published online in Obesity Pillars.
LIMITATIONS:
The study has limitations that affect its application for weight management. First, the study included only normal-weight individuals, which limits extension of the results for weight loss treatments. Second, it involved acute fasting and does not assess any accommodation to the intervention that may occur over longer-term use. An additional limitation is the small number of participants.
DISCLOSURES:
The research was funded by Calocurb Limited. The article processing charge was funded by the New Zealand Institute for Plant and Food Research Limited, a New Zealand government–owned Crown Research Institute. The authors declare no competing financial interests. The New Zealand Institute for Plant and Food Research Limited has licensed a hop extract as a dietary supplement to Calocurb to commercialize and currently holds a minor shareholding in this company.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers conducted a randomized, double-blind, crossover study with 30 normal-weight women ages 18-40 with BMIs of 18.5-25. The trial design was similar to that used previously to test the intervention among men.
- Participants engaged in a water-only fast for 24 hours (6 p.m. to 6 p.m.) on three occasions and were given an ad libitum meal to break each fast.
- Participants were randomly assigned to one of three treatments: placebo, a high-dose (500 mg) bitter hop–based appetite suppressant (Amarasate), or a low dose (250 mg) of the appetite suppressant.
- Treatment capsules of half the total dose were given twice daily (16 hours and 20 hours into the fast).
- Participants recorded their subjective feelings about appetite and food cravings using a visual analog scale at 30-minute intervals starting 16 hours into the fast.
TAKEAWAY:
- Both the high-dose and low-dose treatment groups experienced a significant reduction in appetite (ie, hunger, fullness, satisfaction, thoughts of food) and food cravings compared with the placebo group.
- Energy intake at the ad libitum meal was 14.3% lower in the high-dose group than the placebo group (P < .05). It was 8.1% lower in the low-dose group, but the difference was not statistically significant.
- In the high-dose group, two participants reported loose stools and one reported heartburn. In the low-dose group, one participant reported loose stools.
IN PRACTICE:
“These data suggest that appetite suppressant co-therapy may be useful in reducing hunger during fasting in women and show that gastrointestinal delivery of bitter compounds may also be an effective method of reducing cravings for food,” the authors wrote.
SOURCE:
The study, led by Edward Walker, PhD, of the New Zealand Institute for Plant and Food Research Limited, Auckland, New Zealand, was published online in Obesity Pillars.
LIMITATIONS:
The study has limitations that affect its application for weight management. First, the study included only normal-weight individuals, which limits extension of the results for weight loss treatments. Second, it involved acute fasting and does not assess any accommodation to the intervention that may occur over longer-term use. An additional limitation is the small number of participants.
DISCLOSURES:
The research was funded by Calocurb Limited. The article processing charge was funded by the New Zealand Institute for Plant and Food Research Limited, a New Zealand government–owned Crown Research Institute. The authors declare no competing financial interests. The New Zealand Institute for Plant and Food Research Limited has licensed a hop extract as a dietary supplement to Calocurb to commercialize and currently holds a minor shareholding in this company.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers conducted a randomized, double-blind, crossover study with 30 normal-weight women ages 18-40 with BMIs of 18.5-25. The trial design was similar to that used previously to test the intervention among men.
- Participants engaged in a water-only fast for 24 hours (6 p.m. to 6 p.m.) on three occasions and were given an ad libitum meal to break each fast.
- Participants were randomly assigned to one of three treatments: placebo, a high-dose (500 mg) bitter hop–based appetite suppressant (Amarasate), or a low dose (250 mg) of the appetite suppressant.
- Treatment capsules of half the total dose were given twice daily (16 hours and 20 hours into the fast).
- Participants recorded their subjective feelings about appetite and food cravings using a visual analog scale at 30-minute intervals starting 16 hours into the fast.
TAKEAWAY:
- Both the high-dose and low-dose treatment groups experienced a significant reduction in appetite (ie, hunger, fullness, satisfaction, thoughts of food) and food cravings compared with the placebo group.
- Energy intake at the ad libitum meal was 14.3% lower in the high-dose group than the placebo group (P < .05). It was 8.1% lower in the low-dose group, but the difference was not statistically significant.
- In the high-dose group, two participants reported loose stools and one reported heartburn. In the low-dose group, one participant reported loose stools.
IN PRACTICE:
“These data suggest that appetite suppressant co-therapy may be useful in reducing hunger during fasting in women and show that gastrointestinal delivery of bitter compounds may also be an effective method of reducing cravings for food,” the authors wrote.
SOURCE:
The study, led by Edward Walker, PhD, of the New Zealand Institute for Plant and Food Research Limited, Auckland, New Zealand, was published online in Obesity Pillars.
LIMITATIONS:
The study has limitations that affect its application for weight management. First, the study included only normal-weight individuals, which limits extension of the results for weight loss treatments. Second, it involved acute fasting and does not assess any accommodation to the intervention that may occur over longer-term use. An additional limitation is the small number of participants.
DISCLOSURES:
The research was funded by Calocurb Limited. The article processing charge was funded by the New Zealand Institute for Plant and Food Research Limited, a New Zealand government–owned Crown Research Institute. The authors declare no competing financial interests. The New Zealand Institute for Plant and Food Research Limited has licensed a hop extract as a dietary supplement to Calocurb to commercialize and currently holds a minor shareholding in this company.
A version of this article first appeared on Medscape.com.
Night Owls May Be at Greater Risk for T2D, Beyond Lifestyle
MADRID — research presented at the annual meeting of the European Association for the Study of Diabetes suggested.
In the study, night owls were almost 50% more likely to develop T2D than those who went to sleep earlier.
“The magnitude of this risk was more than I expected, [although] residual confounding may have occurred,” said Jeroen van der Velde, PhD, Leiden University Medical Center in the Netherlands, who presented the study.
“Late chronotype has previously been associated with unhealthy lifestyle and overweight or obesity and, subsequently, cardiometabolic diseases,” he said in an interview. However, although the current study found that individuals with late chronotypes did indeed have larger waists and more visceral fat, “we (and others) believe that lifestyle cannot fully explain the relation between late chronotype and metabolic disorders.”
“In addition,” he noted, “previous studies that observed that late chronotype is associated with overweight or obesity mainly focused on body mass index [BMI]. However, BMI alone does not provide accurate information regarding fat distribution in the body. People with similar BMI may have different underlying fat distribution, and this may be more relevant than BMI for metabolic risk.”
The researchers examined associations between chronotype and BMI, waist circumference, visceral fat, liver fat, and the risk for T2D in a middle-aged population from the Netherlands Epidemiology of Obesity study. Among the 5026 participants, the mean age was 56 years, 54% were women, and mean BMI was 30.
Using data from the study, the study investigators calculated the midpoint of sleep (MPS) and divided participants into three chronotypes: Early MPS < 2:30 PM (20% of participants); intermediate MPS 2:30–4:00 PM (reference category; 60% of participants); and late MPS ≥ 4:00 PM (20% of participants). BMI and waist circumference were measured in all participants, and visceral fat and liver fat were measured in 1576 participants using MRI scans and MR spectroscopy, respectively.
During a median follow-up of 6.6 years, 225 participants were diagnosed with T2D. After adjustment for age, sex, education, physical activity, smoking, alcohol intake, diet quality, sleep quality and duration, and total body fat, participants with a late chronotype had a 46% increased risk for T2D.
Further, those with a late chronotype had 0.7 higher BMI, 1.9-cm larger waist circumference, 7 cm2 more visceral fat, and 14% more liver fat.
Body Clock Out of Sync?
“Late chronotype was associated with increased ectopic body fat and with an increased risk of T2D independent of lifestyle factors and is an emerging risk factor for metabolic diseases,” the researchers concluded.
“A likely explanation is that the circadian rhythm or body clock in late chronotypes is out of sync with the work and social schedules followed by society,” Dr. van der Velde suggested. “This can lead to circadian misalignment, which we know can lead to metabolic disturbances and ultimately type 2 diabetes.”
Might trying to adjust chronotype earlier in life have an effect on risk?
“Chronotype, as measured via midpoint of sleep, does change a lot in the first 30 years or so in life,” he said. “After that it seems to stabilize. I suppose that if you adapt an intermediate or early chronotype around the age of 30 years, this will help to maintain an earlier chronotype later in life, although we cannot answer this from our study.”
Nevertheless, with respect to T2D risk, “chronotype is likely only part of the puzzle,” he noted.
“People with late chronotypes typically eat late in the evening, and this has also been associated with adverse metabolic effects. At this stage, we do not know if a person changes his/her chronotype that this will also lead to metabolic improvements. More research is needed before we can make recommendations regarding chronotype and timing of other lifestyle behaviors.”
Commenting on the study, Gianluca Iacobellis, MD, PhD, director of the University of Miami Hospital Diabetes Service, Coral Gables, Florida, said: “Interesting data. Altering the physiological circadian rhythm can affect the complex hormonal system — including cortisol, ghrelin, leptin, and serotonin — that regulates insulin sensitivity, glucose, and blood pressure control. The night owl may become more insulin resistant and therefore at higher risk of developing diabetes.”
Like Dr. van der Velde, he noted that “late sleep may be associated with night binging that can cause weight gain and ultimately obesity, further increasing the risk of diabetes.”
Dr. Iacobellis’s group recently showed that vital exhaustion, which is characterized by fatigue and loss of vigor, is associated with a higher cardiovascular risk for and markers of visceral adiposity.
“Abnormal circadian rhythms can be easily associated with vital exhaustion,” he said. Therefore, night owls with more visceral than peripheral fat accumulation might also be at higher cardiometabolic risk through that mechanism.
“However environmental factors and family history can play an important role too,” he added.
Regardless of the mechanisms involved, “preventive actions should be taken to educate teenagers and individuals at higher risk to have healthy sleep habits,” Dr. Iacobellis concluded.
No information regarding funding was provided; Dr. van der Velde and Dr. Iacobellis reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
MADRID — research presented at the annual meeting of the European Association for the Study of Diabetes suggested.
In the study, night owls were almost 50% more likely to develop T2D than those who went to sleep earlier.
“The magnitude of this risk was more than I expected, [although] residual confounding may have occurred,” said Jeroen van der Velde, PhD, Leiden University Medical Center in the Netherlands, who presented the study.
“Late chronotype has previously been associated with unhealthy lifestyle and overweight or obesity and, subsequently, cardiometabolic diseases,” he said in an interview. However, although the current study found that individuals with late chronotypes did indeed have larger waists and more visceral fat, “we (and others) believe that lifestyle cannot fully explain the relation between late chronotype and metabolic disorders.”
“In addition,” he noted, “previous studies that observed that late chronotype is associated with overweight or obesity mainly focused on body mass index [BMI]. However, BMI alone does not provide accurate information regarding fat distribution in the body. People with similar BMI may have different underlying fat distribution, and this may be more relevant than BMI for metabolic risk.”
The researchers examined associations between chronotype and BMI, waist circumference, visceral fat, liver fat, and the risk for T2D in a middle-aged population from the Netherlands Epidemiology of Obesity study. Among the 5026 participants, the mean age was 56 years, 54% were women, and mean BMI was 30.
Using data from the study, the study investigators calculated the midpoint of sleep (MPS) and divided participants into three chronotypes: Early MPS < 2:30 PM (20% of participants); intermediate MPS 2:30–4:00 PM (reference category; 60% of participants); and late MPS ≥ 4:00 PM (20% of participants). BMI and waist circumference were measured in all participants, and visceral fat and liver fat were measured in 1576 participants using MRI scans and MR spectroscopy, respectively.
During a median follow-up of 6.6 years, 225 participants were diagnosed with T2D. After adjustment for age, sex, education, physical activity, smoking, alcohol intake, diet quality, sleep quality and duration, and total body fat, participants with a late chronotype had a 46% increased risk for T2D.
Further, those with a late chronotype had 0.7 higher BMI, 1.9-cm larger waist circumference, 7 cm2 more visceral fat, and 14% more liver fat.
Body Clock Out of Sync?
“Late chronotype was associated with increased ectopic body fat and with an increased risk of T2D independent of lifestyle factors and is an emerging risk factor for metabolic diseases,” the researchers concluded.
“A likely explanation is that the circadian rhythm or body clock in late chronotypes is out of sync with the work and social schedules followed by society,” Dr. van der Velde suggested. “This can lead to circadian misalignment, which we know can lead to metabolic disturbances and ultimately type 2 diabetes.”
Might trying to adjust chronotype earlier in life have an effect on risk?
“Chronotype, as measured via midpoint of sleep, does change a lot in the first 30 years or so in life,” he said. “After that it seems to stabilize. I suppose that if you adapt an intermediate or early chronotype around the age of 30 years, this will help to maintain an earlier chronotype later in life, although we cannot answer this from our study.”
Nevertheless, with respect to T2D risk, “chronotype is likely only part of the puzzle,” he noted.
“People with late chronotypes typically eat late in the evening, and this has also been associated with adverse metabolic effects. At this stage, we do not know if a person changes his/her chronotype that this will also lead to metabolic improvements. More research is needed before we can make recommendations regarding chronotype and timing of other lifestyle behaviors.”
Commenting on the study, Gianluca Iacobellis, MD, PhD, director of the University of Miami Hospital Diabetes Service, Coral Gables, Florida, said: “Interesting data. Altering the physiological circadian rhythm can affect the complex hormonal system — including cortisol, ghrelin, leptin, and serotonin — that regulates insulin sensitivity, glucose, and blood pressure control. The night owl may become more insulin resistant and therefore at higher risk of developing diabetes.”
Like Dr. van der Velde, he noted that “late sleep may be associated with night binging that can cause weight gain and ultimately obesity, further increasing the risk of diabetes.”
Dr. Iacobellis’s group recently showed that vital exhaustion, which is characterized by fatigue and loss of vigor, is associated with a higher cardiovascular risk for and markers of visceral adiposity.
“Abnormal circadian rhythms can be easily associated with vital exhaustion,” he said. Therefore, night owls with more visceral than peripheral fat accumulation might also be at higher cardiometabolic risk through that mechanism.
“However environmental factors and family history can play an important role too,” he added.
Regardless of the mechanisms involved, “preventive actions should be taken to educate teenagers and individuals at higher risk to have healthy sleep habits,” Dr. Iacobellis concluded.
No information regarding funding was provided; Dr. van der Velde and Dr. Iacobellis reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
MADRID — research presented at the annual meeting of the European Association for the Study of Diabetes suggested.
In the study, night owls were almost 50% more likely to develop T2D than those who went to sleep earlier.
“The magnitude of this risk was more than I expected, [although] residual confounding may have occurred,” said Jeroen van der Velde, PhD, Leiden University Medical Center in the Netherlands, who presented the study.
“Late chronotype has previously been associated with unhealthy lifestyle and overweight or obesity and, subsequently, cardiometabolic diseases,” he said in an interview. However, although the current study found that individuals with late chronotypes did indeed have larger waists and more visceral fat, “we (and others) believe that lifestyle cannot fully explain the relation between late chronotype and metabolic disorders.”
“In addition,” he noted, “previous studies that observed that late chronotype is associated with overweight or obesity mainly focused on body mass index [BMI]. However, BMI alone does not provide accurate information regarding fat distribution in the body. People with similar BMI may have different underlying fat distribution, and this may be more relevant than BMI for metabolic risk.”
The researchers examined associations between chronotype and BMI, waist circumference, visceral fat, liver fat, and the risk for T2D in a middle-aged population from the Netherlands Epidemiology of Obesity study. Among the 5026 participants, the mean age was 56 years, 54% were women, and mean BMI was 30.
Using data from the study, the study investigators calculated the midpoint of sleep (MPS) and divided participants into three chronotypes: Early MPS < 2:30 PM (20% of participants); intermediate MPS 2:30–4:00 PM (reference category; 60% of participants); and late MPS ≥ 4:00 PM (20% of participants). BMI and waist circumference were measured in all participants, and visceral fat and liver fat were measured in 1576 participants using MRI scans and MR spectroscopy, respectively.
During a median follow-up of 6.6 years, 225 participants were diagnosed with T2D. After adjustment for age, sex, education, physical activity, smoking, alcohol intake, diet quality, sleep quality and duration, and total body fat, participants with a late chronotype had a 46% increased risk for T2D.
Further, those with a late chronotype had 0.7 higher BMI, 1.9-cm larger waist circumference, 7 cm2 more visceral fat, and 14% more liver fat.
Body Clock Out of Sync?
“Late chronotype was associated with increased ectopic body fat and with an increased risk of T2D independent of lifestyle factors and is an emerging risk factor for metabolic diseases,” the researchers concluded.
“A likely explanation is that the circadian rhythm or body clock in late chronotypes is out of sync with the work and social schedules followed by society,” Dr. van der Velde suggested. “This can lead to circadian misalignment, which we know can lead to metabolic disturbances and ultimately type 2 diabetes.”
Might trying to adjust chronotype earlier in life have an effect on risk?
“Chronotype, as measured via midpoint of sleep, does change a lot in the first 30 years or so in life,” he said. “After that it seems to stabilize. I suppose that if you adapt an intermediate or early chronotype around the age of 30 years, this will help to maintain an earlier chronotype later in life, although we cannot answer this from our study.”
Nevertheless, with respect to T2D risk, “chronotype is likely only part of the puzzle,” he noted.
“People with late chronotypes typically eat late in the evening, and this has also been associated with adverse metabolic effects. At this stage, we do not know if a person changes his/her chronotype that this will also lead to metabolic improvements. More research is needed before we can make recommendations regarding chronotype and timing of other lifestyle behaviors.”
Commenting on the study, Gianluca Iacobellis, MD, PhD, director of the University of Miami Hospital Diabetes Service, Coral Gables, Florida, said: “Interesting data. Altering the physiological circadian rhythm can affect the complex hormonal system — including cortisol, ghrelin, leptin, and serotonin — that regulates insulin sensitivity, glucose, and blood pressure control. The night owl may become more insulin resistant and therefore at higher risk of developing diabetes.”
Like Dr. van der Velde, he noted that “late sleep may be associated with night binging that can cause weight gain and ultimately obesity, further increasing the risk of diabetes.”
Dr. Iacobellis’s group recently showed that vital exhaustion, which is characterized by fatigue and loss of vigor, is associated with a higher cardiovascular risk for and markers of visceral adiposity.
“Abnormal circadian rhythms can be easily associated with vital exhaustion,” he said. Therefore, night owls with more visceral than peripheral fat accumulation might also be at higher cardiometabolic risk through that mechanism.
“However environmental factors and family history can play an important role too,” he added.
Regardless of the mechanisms involved, “preventive actions should be taken to educate teenagers and individuals at higher risk to have healthy sleep habits,” Dr. Iacobellis concluded.
No information regarding funding was provided; Dr. van der Velde and Dr. Iacobellis reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM EASD 2024
Will Tirzepatide Vials Help Patients? Endos Weigh in
Tirzepatide (Zepbound) is not in shortage for now, but the weight loss drug has remained inaccessible to people without insurance coverage who can’t afford to pay out of pocket. Now, its manufacturer, Eli Lilly, has introduced a new formulation it says will “significantly expand” the supply. But not all endocrinologists are enthusiastic.
As of August 27, LillyDirect made 2.5-mg and 5-mg single-dose vials of tirzepatide available to self-pay patients with an on-label electronic prescription. Lilly’s announcement said the single-dose vials “are priced at a 50% or greater discount compared to the list price of all other incretin (glucagon-like peptide 1 receptor agonists or GLP-1) medicines for obesity.”
For a 4-week supply of the weekly injections, the discount at LillyDirect translates to $399 for a 2.5-mg single-dose vial ($99.75 per vial) and $549 for the 5-mg dose ($137.25 per vial), which the company noted was “in line with the Zepbound savings program for noncovered individuals.” (The new direct single-dose prescriptions cannot be filled at community or retail pharmacies.)
“In a clinical study, the 5-mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off,” according to the announcement.
The clinical study, which is not named or referenced in the announcement, is SURMOUNT-1, a Lilly spokesperson said in an interview. Yet, that study also found that patients achieved an average weight loss of 19.5% with 10-mg doses and 20.9% with 15-mg doses of tirzepatide. Furthermore, the percentage of participants achieving body weight reductions of ≥ 5% was 85% (5 mg), 89% (10 mg), and 91% (15 mg), showing the benefits of higher doses.
And there’s the rub.
‘Only Two Different Doses’
Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the University of Southern California, Los Angeles, said in an interview: “My concern is, they’re only providing two different doses, 2.5 mg and 5 mg. You get somebody on it, and then they still have to go back to the traditional pens. I’m very opposed to getting patients connected to a medication they can’t then continue to take.
“Now we have starter doses that are easy to come by,” she said. “But the problem isn’t starting. The problem for all of these patients is chronic continuation of the right dose of the drug, and out-of-pocket costs become exorbitantly higher when they have to self-purchase the pens for the higher doses.
“Yes, the 5-mg dose has benefits, but not the same as higher doses,” she continued. “I have nobody for whom 5 mg is the right dose. They have to take more, sometimes within a month or 2 of starting, in order to achieve the kind of weight loss they need.”
If their insurance doesn’t cover the drug, “what are they going to do to stay on 5 mg? Or pay a crapload of money to buy three of the 5-mg doses to reach a higher dose?”
Michael Weintraub, MD, clinical assistant professor in the Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism at New York University Grossman School of Medicine in New York City, said that, “for many, this lower monthly cost is attainable and is a significant advancement in increasing access. For others, however, an out-of-pocket monthly cost of $349-549 for a chronic medication is still unaffordable.”
And like Dr. Peters, he said, “some patients do not lose a clinically significant amount of weight with 2.5 mg or 5 mg and require higher doses. There is no way of prescribing a higher dose of Zepbound vials, so patients would have to resort to the higher-dose auto-injector pens that are still double the price.”
A Lilly spokesperson countered in a comment: “Offering Zepbound single-dose vials in higher dosage strengths could increase the potential for dose splitting, which is not contemplated by the FDA [Food and Drug Adminstration]–approved label and may pose patient safety risks.”
But Dr. Peters wondered: “Wouldn’t dose splitting of a known-to-be-pure compound be better than getting it at a compounding pharmacy that lacks purity/safety? The one message from all of this is that patients need to know what they’re getting into. They’re starting a drug that can help with weight loss, but they’re going to be on a sub-max dose. And a higher dose is going to be double the price.”
In addition, said Robert F. Kushner, MD, a professor at Northwestern University Feinberg School of Medicine in Chicago, Illinois, “for the lower-dose vials, instead of administering the drug with a self-auto-injection pen, patients will need to use a needle and syringe and draw up the dose from a vial. This will take a higher skill level and health literacy that may be challenging for some patients. Patients may need additional training on how to use this new formulation. That will take additional time and resources, such as a demonstration in the office or referral to video.”
The Lilly news release noted that “patients can also purchase ancillary supplies, like syringes and needles, and will have access to important patient-friendly instructional materials on correctly administering the medicine via needle and syringe.”
Protection From Compounders?
According to the Lilly spokesperson, the launch of Zepbound vials “furthers our commitment to helping patients avoid the risks associated with compounded products by providing patients another option for access to genuine Lilly medicine.”
Indeed, said Jaime Almandoz, MD, medical director of the Weight Wellness Program and associate professor of internal medicine at the University of Texas Southwestern Medical Center in Dallas, “The introduction of Zepbound/tirzepatide in single-dose vials should improve access to evidence-based obesity treatments, reducing potential risks associated with compounded additives and eliminating the need for patients to calculate correct medication doses,” which have led to accidental overdoses of compounded semaglutide.
Lilly’s spokesperson added: “We have taken multiple steps — including publishing an open letter and launching lilly.com/real-medicine — to warn the public about the risks posed by the proliferation of counterfeit, fake, unsafe, or untested knockoffs of Lilly’s genuine medicines.”
But whether these steps are strong enough to overcome the realities of cost and the need for affordable higher doses remains to be seen.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a statement that the new version of Zepbound “is great news for patients. It’s a much more rational and care-focused response to the remarkable demand for their drug than the lawsuits and cease-and-desist letters Lilly has been raining down on compounding pharmacies.”
“For 20 months now,” he continued,
Dr. Almandoz affirmed: “Everyone wants to see improved access to evidence-based obesity care. It’s crucial to ensure patients receive the most appropriate interventions, whether it is lifestyle changes, medications, or bariatric surgery,” he said. “There are resources available, [including his recent paper], for nutrition and lifestyle modifications specifically for patients taking obesity medications, which can help clinicians guide their patients toward better health.”
Dr. Almandoz is a member of advisory boards and consults for: Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. Dr. Kushner is an adviser to Eli Lilly and Novo Nordisk. Dr. Peters and Dr. Weintraub declared no competing interests.
A version of this article appeared on Medscape.com.
Tirzepatide (Zepbound) is not in shortage for now, but the weight loss drug has remained inaccessible to people without insurance coverage who can’t afford to pay out of pocket. Now, its manufacturer, Eli Lilly, has introduced a new formulation it says will “significantly expand” the supply. But not all endocrinologists are enthusiastic.
As of August 27, LillyDirect made 2.5-mg and 5-mg single-dose vials of tirzepatide available to self-pay patients with an on-label electronic prescription. Lilly’s announcement said the single-dose vials “are priced at a 50% or greater discount compared to the list price of all other incretin (glucagon-like peptide 1 receptor agonists or GLP-1) medicines for obesity.”
For a 4-week supply of the weekly injections, the discount at LillyDirect translates to $399 for a 2.5-mg single-dose vial ($99.75 per vial) and $549 for the 5-mg dose ($137.25 per vial), which the company noted was “in line with the Zepbound savings program for noncovered individuals.” (The new direct single-dose prescriptions cannot be filled at community or retail pharmacies.)
“In a clinical study, the 5-mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off,” according to the announcement.
The clinical study, which is not named or referenced in the announcement, is SURMOUNT-1, a Lilly spokesperson said in an interview. Yet, that study also found that patients achieved an average weight loss of 19.5% with 10-mg doses and 20.9% with 15-mg doses of tirzepatide. Furthermore, the percentage of participants achieving body weight reductions of ≥ 5% was 85% (5 mg), 89% (10 mg), and 91% (15 mg), showing the benefits of higher doses.
And there’s the rub.
‘Only Two Different Doses’
Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the University of Southern California, Los Angeles, said in an interview: “My concern is, they’re only providing two different doses, 2.5 mg and 5 mg. You get somebody on it, and then they still have to go back to the traditional pens. I’m very opposed to getting patients connected to a medication they can’t then continue to take.
“Now we have starter doses that are easy to come by,” she said. “But the problem isn’t starting. The problem for all of these patients is chronic continuation of the right dose of the drug, and out-of-pocket costs become exorbitantly higher when they have to self-purchase the pens for the higher doses.
“Yes, the 5-mg dose has benefits, but not the same as higher doses,” she continued. “I have nobody for whom 5 mg is the right dose. They have to take more, sometimes within a month or 2 of starting, in order to achieve the kind of weight loss they need.”
If their insurance doesn’t cover the drug, “what are they going to do to stay on 5 mg? Or pay a crapload of money to buy three of the 5-mg doses to reach a higher dose?”
Michael Weintraub, MD, clinical assistant professor in the Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism at New York University Grossman School of Medicine in New York City, said that, “for many, this lower monthly cost is attainable and is a significant advancement in increasing access. For others, however, an out-of-pocket monthly cost of $349-549 for a chronic medication is still unaffordable.”
And like Dr. Peters, he said, “some patients do not lose a clinically significant amount of weight with 2.5 mg or 5 mg and require higher doses. There is no way of prescribing a higher dose of Zepbound vials, so patients would have to resort to the higher-dose auto-injector pens that are still double the price.”
A Lilly spokesperson countered in a comment: “Offering Zepbound single-dose vials in higher dosage strengths could increase the potential for dose splitting, which is not contemplated by the FDA [Food and Drug Adminstration]–approved label and may pose patient safety risks.”
But Dr. Peters wondered: “Wouldn’t dose splitting of a known-to-be-pure compound be better than getting it at a compounding pharmacy that lacks purity/safety? The one message from all of this is that patients need to know what they’re getting into. They’re starting a drug that can help with weight loss, but they’re going to be on a sub-max dose. And a higher dose is going to be double the price.”
In addition, said Robert F. Kushner, MD, a professor at Northwestern University Feinberg School of Medicine in Chicago, Illinois, “for the lower-dose vials, instead of administering the drug with a self-auto-injection pen, patients will need to use a needle and syringe and draw up the dose from a vial. This will take a higher skill level and health literacy that may be challenging for some patients. Patients may need additional training on how to use this new formulation. That will take additional time and resources, such as a demonstration in the office or referral to video.”
The Lilly news release noted that “patients can also purchase ancillary supplies, like syringes and needles, and will have access to important patient-friendly instructional materials on correctly administering the medicine via needle and syringe.”
Protection From Compounders?
According to the Lilly spokesperson, the launch of Zepbound vials “furthers our commitment to helping patients avoid the risks associated with compounded products by providing patients another option for access to genuine Lilly medicine.”
Indeed, said Jaime Almandoz, MD, medical director of the Weight Wellness Program and associate professor of internal medicine at the University of Texas Southwestern Medical Center in Dallas, “The introduction of Zepbound/tirzepatide in single-dose vials should improve access to evidence-based obesity treatments, reducing potential risks associated with compounded additives and eliminating the need for patients to calculate correct medication doses,” which have led to accidental overdoses of compounded semaglutide.
Lilly’s spokesperson added: “We have taken multiple steps — including publishing an open letter and launching lilly.com/real-medicine — to warn the public about the risks posed by the proliferation of counterfeit, fake, unsafe, or untested knockoffs of Lilly’s genuine medicines.”
But whether these steps are strong enough to overcome the realities of cost and the need for affordable higher doses remains to be seen.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a statement that the new version of Zepbound “is great news for patients. It’s a much more rational and care-focused response to the remarkable demand for their drug than the lawsuits and cease-and-desist letters Lilly has been raining down on compounding pharmacies.”
“For 20 months now,” he continued,
Dr. Almandoz affirmed: “Everyone wants to see improved access to evidence-based obesity care. It’s crucial to ensure patients receive the most appropriate interventions, whether it is lifestyle changes, medications, or bariatric surgery,” he said. “There are resources available, [including his recent paper], for nutrition and lifestyle modifications specifically for patients taking obesity medications, which can help clinicians guide their patients toward better health.”
Dr. Almandoz is a member of advisory boards and consults for: Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. Dr. Kushner is an adviser to Eli Lilly and Novo Nordisk. Dr. Peters and Dr. Weintraub declared no competing interests.
A version of this article appeared on Medscape.com.
Tirzepatide (Zepbound) is not in shortage for now, but the weight loss drug has remained inaccessible to people without insurance coverage who can’t afford to pay out of pocket. Now, its manufacturer, Eli Lilly, has introduced a new formulation it says will “significantly expand” the supply. But not all endocrinologists are enthusiastic.
As of August 27, LillyDirect made 2.5-mg and 5-mg single-dose vials of tirzepatide available to self-pay patients with an on-label electronic prescription. Lilly’s announcement said the single-dose vials “are priced at a 50% or greater discount compared to the list price of all other incretin (glucagon-like peptide 1 receptor agonists or GLP-1) medicines for obesity.”
For a 4-week supply of the weekly injections, the discount at LillyDirect translates to $399 for a 2.5-mg single-dose vial ($99.75 per vial) and $549 for the 5-mg dose ($137.25 per vial), which the company noted was “in line with the Zepbound savings program for noncovered individuals.” (The new direct single-dose prescriptions cannot be filled at community or retail pharmacies.)
“In a clinical study, the 5-mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off,” according to the announcement.
The clinical study, which is not named or referenced in the announcement, is SURMOUNT-1, a Lilly spokesperson said in an interview. Yet, that study also found that patients achieved an average weight loss of 19.5% with 10-mg doses and 20.9% with 15-mg doses of tirzepatide. Furthermore, the percentage of participants achieving body weight reductions of ≥ 5% was 85% (5 mg), 89% (10 mg), and 91% (15 mg), showing the benefits of higher doses.
And there’s the rub.
‘Only Two Different Doses’
Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the University of Southern California, Los Angeles, said in an interview: “My concern is, they’re only providing two different doses, 2.5 mg and 5 mg. You get somebody on it, and then they still have to go back to the traditional pens. I’m very opposed to getting patients connected to a medication they can’t then continue to take.
“Now we have starter doses that are easy to come by,” she said. “But the problem isn’t starting. The problem for all of these patients is chronic continuation of the right dose of the drug, and out-of-pocket costs become exorbitantly higher when they have to self-purchase the pens for the higher doses.
“Yes, the 5-mg dose has benefits, but not the same as higher doses,” she continued. “I have nobody for whom 5 mg is the right dose. They have to take more, sometimes within a month or 2 of starting, in order to achieve the kind of weight loss they need.”
If their insurance doesn’t cover the drug, “what are they going to do to stay on 5 mg? Or pay a crapload of money to buy three of the 5-mg doses to reach a higher dose?”
Michael Weintraub, MD, clinical assistant professor in the Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism at New York University Grossman School of Medicine in New York City, said that, “for many, this lower monthly cost is attainable and is a significant advancement in increasing access. For others, however, an out-of-pocket monthly cost of $349-549 for a chronic medication is still unaffordable.”
And like Dr. Peters, he said, “some patients do not lose a clinically significant amount of weight with 2.5 mg or 5 mg and require higher doses. There is no way of prescribing a higher dose of Zepbound vials, so patients would have to resort to the higher-dose auto-injector pens that are still double the price.”
A Lilly spokesperson countered in a comment: “Offering Zepbound single-dose vials in higher dosage strengths could increase the potential for dose splitting, which is not contemplated by the FDA [Food and Drug Adminstration]–approved label and may pose patient safety risks.”
But Dr. Peters wondered: “Wouldn’t dose splitting of a known-to-be-pure compound be better than getting it at a compounding pharmacy that lacks purity/safety? The one message from all of this is that patients need to know what they’re getting into. They’re starting a drug that can help with weight loss, but they’re going to be on a sub-max dose. And a higher dose is going to be double the price.”
In addition, said Robert F. Kushner, MD, a professor at Northwestern University Feinberg School of Medicine in Chicago, Illinois, “for the lower-dose vials, instead of administering the drug with a self-auto-injection pen, patients will need to use a needle and syringe and draw up the dose from a vial. This will take a higher skill level and health literacy that may be challenging for some patients. Patients may need additional training on how to use this new formulation. That will take additional time and resources, such as a demonstration in the office or referral to video.”
The Lilly news release noted that “patients can also purchase ancillary supplies, like syringes and needles, and will have access to important patient-friendly instructional materials on correctly administering the medicine via needle and syringe.”
Protection From Compounders?
According to the Lilly spokesperson, the launch of Zepbound vials “furthers our commitment to helping patients avoid the risks associated with compounded products by providing patients another option for access to genuine Lilly medicine.”
Indeed, said Jaime Almandoz, MD, medical director of the Weight Wellness Program and associate professor of internal medicine at the University of Texas Southwestern Medical Center in Dallas, “The introduction of Zepbound/tirzepatide in single-dose vials should improve access to evidence-based obesity treatments, reducing potential risks associated with compounded additives and eliminating the need for patients to calculate correct medication doses,” which have led to accidental overdoses of compounded semaglutide.
Lilly’s spokesperson added: “We have taken multiple steps — including publishing an open letter and launching lilly.com/real-medicine — to warn the public about the risks posed by the proliferation of counterfeit, fake, unsafe, or untested knockoffs of Lilly’s genuine medicines.”
But whether these steps are strong enough to overcome the realities of cost and the need for affordable higher doses remains to be seen.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a statement that the new version of Zepbound “is great news for patients. It’s a much more rational and care-focused response to the remarkable demand for their drug than the lawsuits and cease-and-desist letters Lilly has been raining down on compounding pharmacies.”
“For 20 months now,” he continued,
Dr. Almandoz affirmed: “Everyone wants to see improved access to evidence-based obesity care. It’s crucial to ensure patients receive the most appropriate interventions, whether it is lifestyle changes, medications, or bariatric surgery,” he said. “There are resources available, [including his recent paper], for nutrition and lifestyle modifications specifically for patients taking obesity medications, which can help clinicians guide their patients toward better health.”
Dr. Almandoz is a member of advisory boards and consults for: Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. Dr. Kushner is an adviser to Eli Lilly and Novo Nordisk. Dr. Peters and Dr. Weintraub declared no competing interests.
A version of this article appeared on Medscape.com.
Cell Phone Use Linked to Higher Heart Disease Risk
“We found that a poor sleep pattern, psychological distress, and neuroticism significantly mediated the positive association between weekly mobile phone usage time and the risk for incident CVD, with a mediating proportion of 5.11%, 11.50%, and 2.25%, respectively,” said principal investigator Xianhui Qin, MD, professor of nephrology at Southern Medical University, Guangzhou, China.
Poor sleep patterns and poor mental health could disrupt circadian rhythms and endocrine and metabolic functions, as well as increase inflammation, he explained.
In addition, chronic exposure to radiofrequency electromagnetic fields (RF-EMF) emitted from cell phones could lead to oxidative stress and an inflammatory response. Combined with smoking and diabetes, this exposure “may have a synergistic effect in increasing CVD risk,” Dr. Qin suggested.
The study was published online in the Canadian Journal of Cardiology.
Risk Underestimated?
The researchers aimed to examine the association of regular cell phone use with incident CVD and explore the mediating effects of sleep and mental health using linked hospital and mortality records.
Their analysis included 444,027 participants (mean age, 56 years; 44% men) without a history of CVD from the UK Biobank. A total of 378,161 participants were regular cell phone users.
Regular cell phone use was defined as at least one call per week. Weekly use was self-reported as the average time of calls per week during the previous 3 months.
The primary outcome was incident CVD. Secondary outcomes were each component of CVD (ie, coronary heart disease, stroke, atrial fibrillation, and heart failure) and increased carotid intima media thickness (CIMT).
Compared with nonregular cell phone users, regular users were younger, had higher proportions of current smokers and urban residents, and had lower proportions of history of hypertension and diabetes. They also had higher income, Townsend deprivation index, and body mass index, and lower education levels.
During a median follow-up of 12.3 years, 56,181 participants developed incident CVD. Compared with nonregular cell phone users, regular users had a significantly higher risk for incident CVD (hazard ratio, 1.04) and increased CIMT (odds ratio, 1.11).
Among regular cell phone users, the duration of cell phone use and hands-free device/speakerphone use during calls was not significantly associated with incident CVD. Yet a significant and positive dose-response relationship was seen between weekly cell phone usage time and the risk for CVD. The positive association was stronger in current vs noncurrent smokers and people with vs without diabetes.
To different extents, sleep patterns (5.11%), psychologic distress (11.5%), and neuroticism (2.25%) mediated the relationship between weekly cell phone usage time and the risk for incident CVD.
“Our study suggests that despite the advantages of mobile phone use, we should also pay attention to the potential harm of mobile phone use to cardiovascular health,” Dr. Qin said. “Future studies to assess the risk-benefit balance will help promote mobile phone use patterns that are conducive to cardiovascular health.”
Meanwhile, he added, “We encourage measures to reduce time spent on mobile phones to promote the primary prevention of CVD. On the other hand, improving sleep and mental health status may help reduce the higher risk of CVD associated with mobile phone use.”
There are several limitations to the study in addition to its observational nature, which cannot show cause and effect. The questionnaires on cell phone use were restricted to phone calls; other use patterns of cell phones (eg, messaging, watching videos, and browsing the web) were not considered. Although the researchers adjusted for many potential confounders, unmeasured confounding bias (eg, the type of cell phone used and other sources of RF-EMF) cannot be eliminated.
Weak Link?
In a comment, Nicholas Grubic, MSc, a PhD student in epidemiology at the University of Toronto, Ontario, Canada, and coauthor of a related editorial, said, “I found it interesting that there was a connection observed between mobile phone use and CVD. However, it is crucial to understand that this link appeared to be much weaker compared with other well-known cardiovascular risk factors, such as smoking, diabetes, and high blood pressure. For now, mobile phone use should not be a major concern for most people.”
Nevertheless, clinicians should encourage patients to practice healthy habits around their screen time, he advised. “This could include limiting mobile phone use before bedtime and taking regular breaks to engage in activities that promote heart health, such as exercising or spending time outdoors.
“For the time being, we probably won’t see mobile phone use included in standard assessments for cardiovascular risk or as a focal point of cardiovascular health promotion initiatives,” he added. Instead, clinicians should “focus on established risk factors that have a stronger impact on patients’ cardiovascular health.”
Nieca Goldberg, MD, a clinical associate professor of medicine at NYU Grossman School of Medicine in New York City and American Heart Association volunteer expert, had a similar message. “You don’t have to go back to using a landline,” she said. “Instead, patients should be more mindful of how much phone use is taking away from their physical activity, keeping them from sleeping, and causing them stress.” Clinicians should also remember to counsel smokers on smoking cessation.
“It would be important for future studies to look at time spent on the phone and the type of activities patients are doing on their phones, such as social media, calls, texts, movies, or streaming TV shows,” she said. “It would be important to see how phone use is leading to a sedentary lifestyle” and what that means for a larger, more diverse population.
The study was supported by the National Key R&D Program, the National Natural Science Foundation of China, and the Outstanding Youth Development Scheme of Nanfang Hospital, Southern Medical University. Dr. Qin, Dr. Grubic, and Dr. Goldberg reported having no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“We found that a poor sleep pattern, psychological distress, and neuroticism significantly mediated the positive association between weekly mobile phone usage time and the risk for incident CVD, with a mediating proportion of 5.11%, 11.50%, and 2.25%, respectively,” said principal investigator Xianhui Qin, MD, professor of nephrology at Southern Medical University, Guangzhou, China.
Poor sleep patterns and poor mental health could disrupt circadian rhythms and endocrine and metabolic functions, as well as increase inflammation, he explained.
In addition, chronic exposure to radiofrequency electromagnetic fields (RF-EMF) emitted from cell phones could lead to oxidative stress and an inflammatory response. Combined with smoking and diabetes, this exposure “may have a synergistic effect in increasing CVD risk,” Dr. Qin suggested.
The study was published online in the Canadian Journal of Cardiology.
Risk Underestimated?
The researchers aimed to examine the association of regular cell phone use with incident CVD and explore the mediating effects of sleep and mental health using linked hospital and mortality records.
Their analysis included 444,027 participants (mean age, 56 years; 44% men) without a history of CVD from the UK Biobank. A total of 378,161 participants were regular cell phone users.
Regular cell phone use was defined as at least one call per week. Weekly use was self-reported as the average time of calls per week during the previous 3 months.
The primary outcome was incident CVD. Secondary outcomes were each component of CVD (ie, coronary heart disease, stroke, atrial fibrillation, and heart failure) and increased carotid intima media thickness (CIMT).
Compared with nonregular cell phone users, regular users were younger, had higher proportions of current smokers and urban residents, and had lower proportions of history of hypertension and diabetes. They also had higher income, Townsend deprivation index, and body mass index, and lower education levels.
During a median follow-up of 12.3 years, 56,181 participants developed incident CVD. Compared with nonregular cell phone users, regular users had a significantly higher risk for incident CVD (hazard ratio, 1.04) and increased CIMT (odds ratio, 1.11).
Among regular cell phone users, the duration of cell phone use and hands-free device/speakerphone use during calls was not significantly associated with incident CVD. Yet a significant and positive dose-response relationship was seen between weekly cell phone usage time and the risk for CVD. The positive association was stronger in current vs noncurrent smokers and people with vs without diabetes.
To different extents, sleep patterns (5.11%), psychologic distress (11.5%), and neuroticism (2.25%) mediated the relationship between weekly cell phone usage time and the risk for incident CVD.
“Our study suggests that despite the advantages of mobile phone use, we should also pay attention to the potential harm of mobile phone use to cardiovascular health,” Dr. Qin said. “Future studies to assess the risk-benefit balance will help promote mobile phone use patterns that are conducive to cardiovascular health.”
Meanwhile, he added, “We encourage measures to reduce time spent on mobile phones to promote the primary prevention of CVD. On the other hand, improving sleep and mental health status may help reduce the higher risk of CVD associated with mobile phone use.”
There are several limitations to the study in addition to its observational nature, which cannot show cause and effect. The questionnaires on cell phone use were restricted to phone calls; other use patterns of cell phones (eg, messaging, watching videos, and browsing the web) were not considered. Although the researchers adjusted for many potential confounders, unmeasured confounding bias (eg, the type of cell phone used and other sources of RF-EMF) cannot be eliminated.
Weak Link?
In a comment, Nicholas Grubic, MSc, a PhD student in epidemiology at the University of Toronto, Ontario, Canada, and coauthor of a related editorial, said, “I found it interesting that there was a connection observed between mobile phone use and CVD. However, it is crucial to understand that this link appeared to be much weaker compared with other well-known cardiovascular risk factors, such as smoking, diabetes, and high blood pressure. For now, mobile phone use should not be a major concern for most people.”
Nevertheless, clinicians should encourage patients to practice healthy habits around their screen time, he advised. “This could include limiting mobile phone use before bedtime and taking regular breaks to engage in activities that promote heart health, such as exercising or spending time outdoors.
“For the time being, we probably won’t see mobile phone use included in standard assessments for cardiovascular risk or as a focal point of cardiovascular health promotion initiatives,” he added. Instead, clinicians should “focus on established risk factors that have a stronger impact on patients’ cardiovascular health.”
Nieca Goldberg, MD, a clinical associate professor of medicine at NYU Grossman School of Medicine in New York City and American Heart Association volunteer expert, had a similar message. “You don’t have to go back to using a landline,” she said. “Instead, patients should be more mindful of how much phone use is taking away from their physical activity, keeping them from sleeping, and causing them stress.” Clinicians should also remember to counsel smokers on smoking cessation.
“It would be important for future studies to look at time spent on the phone and the type of activities patients are doing on their phones, such as social media, calls, texts, movies, or streaming TV shows,” she said. “It would be important to see how phone use is leading to a sedentary lifestyle” and what that means for a larger, more diverse population.
The study was supported by the National Key R&D Program, the National Natural Science Foundation of China, and the Outstanding Youth Development Scheme of Nanfang Hospital, Southern Medical University. Dr. Qin, Dr. Grubic, and Dr. Goldberg reported having no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“We found that a poor sleep pattern, psychological distress, and neuroticism significantly mediated the positive association between weekly mobile phone usage time and the risk for incident CVD, with a mediating proportion of 5.11%, 11.50%, and 2.25%, respectively,” said principal investigator Xianhui Qin, MD, professor of nephrology at Southern Medical University, Guangzhou, China.
Poor sleep patterns and poor mental health could disrupt circadian rhythms and endocrine and metabolic functions, as well as increase inflammation, he explained.
In addition, chronic exposure to radiofrequency electromagnetic fields (RF-EMF) emitted from cell phones could lead to oxidative stress and an inflammatory response. Combined with smoking and diabetes, this exposure “may have a synergistic effect in increasing CVD risk,” Dr. Qin suggested.
The study was published online in the Canadian Journal of Cardiology.
Risk Underestimated?
The researchers aimed to examine the association of regular cell phone use with incident CVD and explore the mediating effects of sleep and mental health using linked hospital and mortality records.
Their analysis included 444,027 participants (mean age, 56 years; 44% men) without a history of CVD from the UK Biobank. A total of 378,161 participants were regular cell phone users.
Regular cell phone use was defined as at least one call per week. Weekly use was self-reported as the average time of calls per week during the previous 3 months.
The primary outcome was incident CVD. Secondary outcomes were each component of CVD (ie, coronary heart disease, stroke, atrial fibrillation, and heart failure) and increased carotid intima media thickness (CIMT).
Compared with nonregular cell phone users, regular users were younger, had higher proportions of current smokers and urban residents, and had lower proportions of history of hypertension and diabetes. They also had higher income, Townsend deprivation index, and body mass index, and lower education levels.
During a median follow-up of 12.3 years, 56,181 participants developed incident CVD. Compared with nonregular cell phone users, regular users had a significantly higher risk for incident CVD (hazard ratio, 1.04) and increased CIMT (odds ratio, 1.11).
Among regular cell phone users, the duration of cell phone use and hands-free device/speakerphone use during calls was not significantly associated with incident CVD. Yet a significant and positive dose-response relationship was seen between weekly cell phone usage time and the risk for CVD. The positive association was stronger in current vs noncurrent smokers and people with vs without diabetes.
To different extents, sleep patterns (5.11%), psychologic distress (11.5%), and neuroticism (2.25%) mediated the relationship between weekly cell phone usage time and the risk for incident CVD.
“Our study suggests that despite the advantages of mobile phone use, we should also pay attention to the potential harm of mobile phone use to cardiovascular health,” Dr. Qin said. “Future studies to assess the risk-benefit balance will help promote mobile phone use patterns that are conducive to cardiovascular health.”
Meanwhile, he added, “We encourage measures to reduce time spent on mobile phones to promote the primary prevention of CVD. On the other hand, improving sleep and mental health status may help reduce the higher risk of CVD associated with mobile phone use.”
There are several limitations to the study in addition to its observational nature, which cannot show cause and effect. The questionnaires on cell phone use were restricted to phone calls; other use patterns of cell phones (eg, messaging, watching videos, and browsing the web) were not considered. Although the researchers adjusted for many potential confounders, unmeasured confounding bias (eg, the type of cell phone used and other sources of RF-EMF) cannot be eliminated.
Weak Link?
In a comment, Nicholas Grubic, MSc, a PhD student in epidemiology at the University of Toronto, Ontario, Canada, and coauthor of a related editorial, said, “I found it interesting that there was a connection observed between mobile phone use and CVD. However, it is crucial to understand that this link appeared to be much weaker compared with other well-known cardiovascular risk factors, such as smoking, diabetes, and high blood pressure. For now, mobile phone use should not be a major concern for most people.”
Nevertheless, clinicians should encourage patients to practice healthy habits around their screen time, he advised. “This could include limiting mobile phone use before bedtime and taking regular breaks to engage in activities that promote heart health, such as exercising or spending time outdoors.
“For the time being, we probably won’t see mobile phone use included in standard assessments for cardiovascular risk or as a focal point of cardiovascular health promotion initiatives,” he added. Instead, clinicians should “focus on established risk factors that have a stronger impact on patients’ cardiovascular health.”
Nieca Goldberg, MD, a clinical associate professor of medicine at NYU Grossman School of Medicine in New York City and American Heart Association volunteer expert, had a similar message. “You don’t have to go back to using a landline,” she said. “Instead, patients should be more mindful of how much phone use is taking away from their physical activity, keeping them from sleeping, and causing them stress.” Clinicians should also remember to counsel smokers on smoking cessation.
“It would be important for future studies to look at time spent on the phone and the type of activities patients are doing on their phones, such as social media, calls, texts, movies, or streaming TV shows,” she said. “It would be important to see how phone use is leading to a sedentary lifestyle” and what that means for a larger, more diverse population.
The study was supported by the National Key R&D Program, the National Natural Science Foundation of China, and the Outstanding Youth Development Scheme of Nanfang Hospital, Southern Medical University. Dr. Qin, Dr. Grubic, and Dr. Goldberg reported having no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE CANADIAN JOURNAL OF CARDIOLOGY
Listeriosis During Pregnancy Can Be Fatal for the Fetus
Listeriosis during pregnancy, when invasive, can be fatal for the fetus, with a rate of fetal loss or neonatal death of 29%, investigators reported in an article alerting clinicians to this condition.
The article was prompted when the Reproductive Infectious Diseases team at The University of British Columbia in Vancouver, British Columbia, Canada, “received many phone calls from concerned doctors and patients after the plant-based milk recall in early July,” Jeffrey Man Hay Wong, MD, told this news organization. “With such concerns, we updated our British Columbia guidelines for our patients but quickly realized that our recommendations would be useful across the country.”
The article was published online in the Canadian Medical Association Journal.
Five Key Points
Dr. Wong and colleagues provided the following five points and recommendations:
First, invasive listeriosis (bacteremia or meningitis) in pregnancy can have major fetal consequences, including fetal loss or neonatal death in 29% of cases. Affected patients can be asymptomatic or experience gastrointestinal symptoms, myalgias, fevers, acute respiratory distress syndrome, or sepsis.
Second, pregnant people should avoid foods at a high risk for Listeria monocytogenes contamination, including unpasteurized dairy products, luncheon meats, refrigerated meat spreads, and prepared salads. They also should stay aware of Health Canada recalls.
Third, it is not necessary to investigate or treat patients who may have ingested contaminated food but are asymptomatic. Listeriosis can present at 2-3 months after exposure because the incubation period can be as long as 70 days.
Fourth, for patients with mild gastroenteritis or flu-like symptoms who may have ingested contaminated food, obtaining blood cultures or starting a 2-week course of oral amoxicillin (500 mg, three times daily) could be considered.
Fifth, for patients with fever and possible exposure to L monocytogenes, blood cultures should be drawn immediately, and high-dose ampicillin should be initiated, along with electronic fetal heart rate monitoring.
“While choosing safer foods in pregnancy is recommended, it is most important to be aware of Health Canada food recalls and pay attention to symptoms if you’ve ingested these foods,” said Dr. Wong. “Working with the BC Centre for Disease Control, our teams are actively monitoring for cases of listeriosis in pregnancy here in British Columbia.
“Thankfully,” he said, “there haven’t been any confirmed cases in British Columbia related to the plant-based milk recall, though the bacteria’s incubation period can be up to 70 days in pregnancy.”
No Increase Suspected
Commenting on the article, Khady Diouf, MD, director of global obstetrics and gynecology at Brigham and Women’s Hospital in Boston, said, “It summarizes the main management, which is based mostly on expert opinion.”
US clinicians also should be reminded about listeriosis in pregnancy, she noted, pointing to “helpful guidance” from the American College of Obstetrics and Gynecology.
Although the United States similarly experienced a recent listeriosis outbreak resulting from contaminated deli meats, both Dr. Wong and Dr. Diouf said that these outbreaks do not seem to signal an increase in listeriosis cases overall.
“Food-borne listeriosis seems to come in waves,” said Dr. Wong. “At a public health level, we certainly have better surveillance programs for Listeria infections. In 2023, Health Canada updated its Policy on L monocytogenes in ready-to-eat foods, which emphasizes the good manufacturing practices recommended for food processing environments to identify outbreaks earlier.”
“I think we get these recalls yearly, and this has been the case for as long as I can remember,” Dr. Diouf agreed.
No funding was declared, and the authors declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Listeriosis during pregnancy, when invasive, can be fatal for the fetus, with a rate of fetal loss or neonatal death of 29%, investigators reported in an article alerting clinicians to this condition.
The article was prompted when the Reproductive Infectious Diseases team at The University of British Columbia in Vancouver, British Columbia, Canada, “received many phone calls from concerned doctors and patients after the plant-based milk recall in early July,” Jeffrey Man Hay Wong, MD, told this news organization. “With such concerns, we updated our British Columbia guidelines for our patients but quickly realized that our recommendations would be useful across the country.”
The article was published online in the Canadian Medical Association Journal.
Five Key Points
Dr. Wong and colleagues provided the following five points and recommendations:
First, invasive listeriosis (bacteremia or meningitis) in pregnancy can have major fetal consequences, including fetal loss or neonatal death in 29% of cases. Affected patients can be asymptomatic or experience gastrointestinal symptoms, myalgias, fevers, acute respiratory distress syndrome, or sepsis.
Second, pregnant people should avoid foods at a high risk for Listeria monocytogenes contamination, including unpasteurized dairy products, luncheon meats, refrigerated meat spreads, and prepared salads. They also should stay aware of Health Canada recalls.
Third, it is not necessary to investigate or treat patients who may have ingested contaminated food but are asymptomatic. Listeriosis can present at 2-3 months after exposure because the incubation period can be as long as 70 days.
Fourth, for patients with mild gastroenteritis or flu-like symptoms who may have ingested contaminated food, obtaining blood cultures or starting a 2-week course of oral amoxicillin (500 mg, three times daily) could be considered.
Fifth, for patients with fever and possible exposure to L monocytogenes, blood cultures should be drawn immediately, and high-dose ampicillin should be initiated, along with electronic fetal heart rate monitoring.
“While choosing safer foods in pregnancy is recommended, it is most important to be aware of Health Canada food recalls and pay attention to symptoms if you’ve ingested these foods,” said Dr. Wong. “Working with the BC Centre for Disease Control, our teams are actively monitoring for cases of listeriosis in pregnancy here in British Columbia.
“Thankfully,” he said, “there haven’t been any confirmed cases in British Columbia related to the plant-based milk recall, though the bacteria’s incubation period can be up to 70 days in pregnancy.”
No Increase Suspected
Commenting on the article, Khady Diouf, MD, director of global obstetrics and gynecology at Brigham and Women’s Hospital in Boston, said, “It summarizes the main management, which is based mostly on expert opinion.”
US clinicians also should be reminded about listeriosis in pregnancy, she noted, pointing to “helpful guidance” from the American College of Obstetrics and Gynecology.
Although the United States similarly experienced a recent listeriosis outbreak resulting from contaminated deli meats, both Dr. Wong and Dr. Diouf said that these outbreaks do not seem to signal an increase in listeriosis cases overall.
“Food-borne listeriosis seems to come in waves,” said Dr. Wong. “At a public health level, we certainly have better surveillance programs for Listeria infections. In 2023, Health Canada updated its Policy on L monocytogenes in ready-to-eat foods, which emphasizes the good manufacturing practices recommended for food processing environments to identify outbreaks earlier.”
“I think we get these recalls yearly, and this has been the case for as long as I can remember,” Dr. Diouf agreed.
No funding was declared, and the authors declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Listeriosis during pregnancy, when invasive, can be fatal for the fetus, with a rate of fetal loss or neonatal death of 29%, investigators reported in an article alerting clinicians to this condition.
The article was prompted when the Reproductive Infectious Diseases team at The University of British Columbia in Vancouver, British Columbia, Canada, “received many phone calls from concerned doctors and patients after the plant-based milk recall in early July,” Jeffrey Man Hay Wong, MD, told this news organization. “With such concerns, we updated our British Columbia guidelines for our patients but quickly realized that our recommendations would be useful across the country.”
The article was published online in the Canadian Medical Association Journal.
Five Key Points
Dr. Wong and colleagues provided the following five points and recommendations:
First, invasive listeriosis (bacteremia or meningitis) in pregnancy can have major fetal consequences, including fetal loss or neonatal death in 29% of cases. Affected patients can be asymptomatic or experience gastrointestinal symptoms, myalgias, fevers, acute respiratory distress syndrome, or sepsis.
Second, pregnant people should avoid foods at a high risk for Listeria monocytogenes contamination, including unpasteurized dairy products, luncheon meats, refrigerated meat spreads, and prepared salads. They also should stay aware of Health Canada recalls.
Third, it is not necessary to investigate or treat patients who may have ingested contaminated food but are asymptomatic. Listeriosis can present at 2-3 months after exposure because the incubation period can be as long as 70 days.
Fourth, for patients with mild gastroenteritis or flu-like symptoms who may have ingested contaminated food, obtaining blood cultures or starting a 2-week course of oral amoxicillin (500 mg, three times daily) could be considered.
Fifth, for patients with fever and possible exposure to L monocytogenes, blood cultures should be drawn immediately, and high-dose ampicillin should be initiated, along with electronic fetal heart rate monitoring.
“While choosing safer foods in pregnancy is recommended, it is most important to be aware of Health Canada food recalls and pay attention to symptoms if you’ve ingested these foods,” said Dr. Wong. “Working with the BC Centre for Disease Control, our teams are actively monitoring for cases of listeriosis in pregnancy here in British Columbia.
“Thankfully,” he said, “there haven’t been any confirmed cases in British Columbia related to the plant-based milk recall, though the bacteria’s incubation period can be up to 70 days in pregnancy.”
No Increase Suspected
Commenting on the article, Khady Diouf, MD, director of global obstetrics and gynecology at Brigham and Women’s Hospital in Boston, said, “It summarizes the main management, which is based mostly on expert opinion.”
US clinicians also should be reminded about listeriosis in pregnancy, she noted, pointing to “helpful guidance” from the American College of Obstetrics and Gynecology.
Although the United States similarly experienced a recent listeriosis outbreak resulting from contaminated deli meats, both Dr. Wong and Dr. Diouf said that these outbreaks do not seem to signal an increase in listeriosis cases overall.
“Food-borne listeriosis seems to come in waves,” said Dr. Wong. “At a public health level, we certainly have better surveillance programs for Listeria infections. In 2023, Health Canada updated its Policy on L monocytogenes in ready-to-eat foods, which emphasizes the good manufacturing practices recommended for food processing environments to identify outbreaks earlier.”
“I think we get these recalls yearly, and this has been the case for as long as I can remember,” Dr. Diouf agreed.
No funding was declared, and the authors declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE CANADIAN MEDICAL ASSOCIATION JOURNAL
HIIT May Best Moderate Exercise for Poststroke Fitness
, according to a multicenter randomized controlled trial.
“We hoped that we would see improvements in cardiovascular fitness after HIIT and anticipated that these improvements would be greater than in the moderate-intensity group, but we were pleasantly surprised by the degree of improvement we observed,” said Ada Tang, PT, PhD, associate professor of health sciences at McMaster University in Hamilton, Ontario, Canada. “The improvements seen in the HIIT group were twofold higher than in the other group.”
The results were published in Stroke.
Clinically Meaningful
Researchers compared the effects of 12 weeks of short-interval HIIT with those of moderate-intensity continuous training (MICT) on peak oxygen uptake (VO2peak), cardiovascular risk factors, and mobility outcomes after stroke.
They randomly assigned participants to receive 3 days per week of HIIT or traditional moderate exercise sessions for 12 weeks. Participants’ mean age was 65 years, and 39% were women. They enrolled at a mean age of 1.8 years after sustaining a mild stroke.
A total of 42 participants were randomized to HIIT and 40 to MICT. There were no significant differences between the groups at baseline, and both groups exercised on adaptive recumbent steppers, which are suitable for stroke survivors with varying abilities.
The short-interval HIIT protocol involved 10 1-minute intervals of high-intensity exercise, interspersed with nine 1-minute low-intensity intervals, for a total of 19 minutes. HIIT intervals targeted 80% heart rate reserve (HRR) and progressed by 10% every 4 weeks up to 100% HRR. The low-intensity intervals targeted 30% HRR.
The traditional MICT protocol for stroke rehabilitation targeted 40% HRR for 20 minutes and progressed by 10% HRR and 5 minutes every 4 weeks, up to 60% HRR for 30 minutes.
The HIIT group’s cardiorespiratory fitness levels (VO2peak) improved twice as much as those of the MICT group: 3.5 mL of oxygen consumed in 1 minute per kg of body weight (mL/kg/min) compared with 1.8 mL/kg/min.
Of note, changes in VO2peak from baseline remained above the clinically important threshold of 1.0 mL/kg/min at 8-week follow-up in the HIIT group (1.71 mL/kg/min) but not in the MICT group (0.67 mL/kg/min).
Both groups increased their 6-minute walk test distances by 8.8 m at 12 weeks and by 18.5 m at 20 weeks. No between-group differences were found for cardiovascular risk or mobility outcomes, and no adverse events occurred in either group.
On average, the HIIT group spent 36% of total training time exercising at intensities above 80% HRR throughout the intervention, while the MICT group spent 42% of time at intensities of 40%-59% HRR.
The study was limited by a small sample size of high-functioning individuals who sustained a mild stroke. Enrollment was halted for 2 years due to the COVID-19 lockdowns, limiting the study’s statistical power.
Nevertheless, the authors concluded, “Given that a lack of time is a significant barrier to the implementation of aerobic exercise in stroke clinical practice, our findings suggest that short-interval HIIT may be an effective alternative to traditional MICT for improving VO2peak after stroke, with potential clinically meaningful benefits sustained in the short-term.”
“Our findings show that a short HIIT protocol is possible in people with stroke, which is exciting to see,” said Tang. “But there are different factors that clinicians should consider before recommending this training for their patients, such as their health status and their physical status. Stroke rehabilitation specialists, including stroke physical therapists, can advise on how to proceed to ensure the safety and effectiveness of HIIT.”
Selected Patients May Benefit
“Broad implementation of this intervention may be premature without further research,” said Ryan Glatt, CPT, senior brain health coach and director of the FitBrain Program at Pacific Neuroscience Institute in Santa Monica, California. “The study focused on relatively high-functioning stroke survivors, which raises questions about the applicability of the results to those with more severe impairments.” Mr. Glatt did not participate in the research.
“Additional studies are needed to confirm whether these findings are applicable to more diverse and severely affected populations and to assess the long-term sustainability of the benefits observed,” he said. “Also, the lack of significant improvements in other critical outcomes, such as mobility, suggests limitations in the broader application of HIIT for stroke rehabilitation.”
“While HIIT shows potential, it should be approached with caution,” Mr. Glatt continued. “It may benefit select patients, but replacing traditional exercise protocols with HIIT should not be done in all cases. More robust evidence and careful consideration of individual patient needs are essential.”
This study was funded by an operating grant from the Canadian Institutes of Health Research. Dr. Tang reported grants from the Canadian Institutes of Health Research, the Physiotherapy Foundation of Canada, and the Heart and Stroke Foundation of Canada. Mr. Glatt declared no relevant financial relationships.
A version of this article appeared on Medscape.com.
, according to a multicenter randomized controlled trial.
“We hoped that we would see improvements in cardiovascular fitness after HIIT and anticipated that these improvements would be greater than in the moderate-intensity group, but we were pleasantly surprised by the degree of improvement we observed,” said Ada Tang, PT, PhD, associate professor of health sciences at McMaster University in Hamilton, Ontario, Canada. “The improvements seen in the HIIT group were twofold higher than in the other group.”
The results were published in Stroke.
Clinically Meaningful
Researchers compared the effects of 12 weeks of short-interval HIIT with those of moderate-intensity continuous training (MICT) on peak oxygen uptake (VO2peak), cardiovascular risk factors, and mobility outcomes after stroke.
They randomly assigned participants to receive 3 days per week of HIIT or traditional moderate exercise sessions for 12 weeks. Participants’ mean age was 65 years, and 39% were women. They enrolled at a mean age of 1.8 years after sustaining a mild stroke.
A total of 42 participants were randomized to HIIT and 40 to MICT. There were no significant differences between the groups at baseline, and both groups exercised on adaptive recumbent steppers, which are suitable for stroke survivors with varying abilities.
The short-interval HIIT protocol involved 10 1-minute intervals of high-intensity exercise, interspersed with nine 1-minute low-intensity intervals, for a total of 19 minutes. HIIT intervals targeted 80% heart rate reserve (HRR) and progressed by 10% every 4 weeks up to 100% HRR. The low-intensity intervals targeted 30% HRR.
The traditional MICT protocol for stroke rehabilitation targeted 40% HRR for 20 minutes and progressed by 10% HRR and 5 minutes every 4 weeks, up to 60% HRR for 30 minutes.
The HIIT group’s cardiorespiratory fitness levels (VO2peak) improved twice as much as those of the MICT group: 3.5 mL of oxygen consumed in 1 minute per kg of body weight (mL/kg/min) compared with 1.8 mL/kg/min.
Of note, changes in VO2peak from baseline remained above the clinically important threshold of 1.0 mL/kg/min at 8-week follow-up in the HIIT group (1.71 mL/kg/min) but not in the MICT group (0.67 mL/kg/min).
Both groups increased their 6-minute walk test distances by 8.8 m at 12 weeks and by 18.5 m at 20 weeks. No between-group differences were found for cardiovascular risk or mobility outcomes, and no adverse events occurred in either group.
On average, the HIIT group spent 36% of total training time exercising at intensities above 80% HRR throughout the intervention, while the MICT group spent 42% of time at intensities of 40%-59% HRR.
The study was limited by a small sample size of high-functioning individuals who sustained a mild stroke. Enrollment was halted for 2 years due to the COVID-19 lockdowns, limiting the study’s statistical power.
Nevertheless, the authors concluded, “Given that a lack of time is a significant barrier to the implementation of aerobic exercise in stroke clinical practice, our findings suggest that short-interval HIIT may be an effective alternative to traditional MICT for improving VO2peak after stroke, with potential clinically meaningful benefits sustained in the short-term.”
“Our findings show that a short HIIT protocol is possible in people with stroke, which is exciting to see,” said Tang. “But there are different factors that clinicians should consider before recommending this training for their patients, such as their health status and their physical status. Stroke rehabilitation specialists, including stroke physical therapists, can advise on how to proceed to ensure the safety and effectiveness of HIIT.”
Selected Patients May Benefit
“Broad implementation of this intervention may be premature without further research,” said Ryan Glatt, CPT, senior brain health coach and director of the FitBrain Program at Pacific Neuroscience Institute in Santa Monica, California. “The study focused on relatively high-functioning stroke survivors, which raises questions about the applicability of the results to those with more severe impairments.” Mr. Glatt did not participate in the research.
“Additional studies are needed to confirm whether these findings are applicable to more diverse and severely affected populations and to assess the long-term sustainability of the benefits observed,” he said. “Also, the lack of significant improvements in other critical outcomes, such as mobility, suggests limitations in the broader application of HIIT for stroke rehabilitation.”
“While HIIT shows potential, it should be approached with caution,” Mr. Glatt continued. “It may benefit select patients, but replacing traditional exercise protocols with HIIT should not be done in all cases. More robust evidence and careful consideration of individual patient needs are essential.”
This study was funded by an operating grant from the Canadian Institutes of Health Research. Dr. Tang reported grants from the Canadian Institutes of Health Research, the Physiotherapy Foundation of Canada, and the Heart and Stroke Foundation of Canada. Mr. Glatt declared no relevant financial relationships.
A version of this article appeared on Medscape.com.
, according to a multicenter randomized controlled trial.
“We hoped that we would see improvements in cardiovascular fitness after HIIT and anticipated that these improvements would be greater than in the moderate-intensity group, but we were pleasantly surprised by the degree of improvement we observed,” said Ada Tang, PT, PhD, associate professor of health sciences at McMaster University in Hamilton, Ontario, Canada. “The improvements seen in the HIIT group were twofold higher than in the other group.”
The results were published in Stroke.
Clinically Meaningful
Researchers compared the effects of 12 weeks of short-interval HIIT with those of moderate-intensity continuous training (MICT) on peak oxygen uptake (VO2peak), cardiovascular risk factors, and mobility outcomes after stroke.
They randomly assigned participants to receive 3 days per week of HIIT or traditional moderate exercise sessions for 12 weeks. Participants’ mean age was 65 years, and 39% were women. They enrolled at a mean age of 1.8 years after sustaining a mild stroke.
A total of 42 participants were randomized to HIIT and 40 to MICT. There were no significant differences between the groups at baseline, and both groups exercised on adaptive recumbent steppers, which are suitable for stroke survivors with varying abilities.
The short-interval HIIT protocol involved 10 1-minute intervals of high-intensity exercise, interspersed with nine 1-minute low-intensity intervals, for a total of 19 minutes. HIIT intervals targeted 80% heart rate reserve (HRR) and progressed by 10% every 4 weeks up to 100% HRR. The low-intensity intervals targeted 30% HRR.
The traditional MICT protocol for stroke rehabilitation targeted 40% HRR for 20 minutes and progressed by 10% HRR and 5 minutes every 4 weeks, up to 60% HRR for 30 minutes.
The HIIT group’s cardiorespiratory fitness levels (VO2peak) improved twice as much as those of the MICT group: 3.5 mL of oxygen consumed in 1 minute per kg of body weight (mL/kg/min) compared with 1.8 mL/kg/min.
Of note, changes in VO2peak from baseline remained above the clinically important threshold of 1.0 mL/kg/min at 8-week follow-up in the HIIT group (1.71 mL/kg/min) but not in the MICT group (0.67 mL/kg/min).
Both groups increased their 6-minute walk test distances by 8.8 m at 12 weeks and by 18.5 m at 20 weeks. No between-group differences were found for cardiovascular risk or mobility outcomes, and no adverse events occurred in either group.
On average, the HIIT group spent 36% of total training time exercising at intensities above 80% HRR throughout the intervention, while the MICT group spent 42% of time at intensities of 40%-59% HRR.
The study was limited by a small sample size of high-functioning individuals who sustained a mild stroke. Enrollment was halted for 2 years due to the COVID-19 lockdowns, limiting the study’s statistical power.
Nevertheless, the authors concluded, “Given that a lack of time is a significant barrier to the implementation of aerobic exercise in stroke clinical practice, our findings suggest that short-interval HIIT may be an effective alternative to traditional MICT for improving VO2peak after stroke, with potential clinically meaningful benefits sustained in the short-term.”
“Our findings show that a short HIIT protocol is possible in people with stroke, which is exciting to see,” said Tang. “But there are different factors that clinicians should consider before recommending this training for their patients, such as their health status and their physical status. Stroke rehabilitation specialists, including stroke physical therapists, can advise on how to proceed to ensure the safety and effectiveness of HIIT.”
Selected Patients May Benefit
“Broad implementation of this intervention may be premature without further research,” said Ryan Glatt, CPT, senior brain health coach and director of the FitBrain Program at Pacific Neuroscience Institute in Santa Monica, California. “The study focused on relatively high-functioning stroke survivors, which raises questions about the applicability of the results to those with more severe impairments.” Mr. Glatt did not participate in the research.
“Additional studies are needed to confirm whether these findings are applicable to more diverse and severely affected populations and to assess the long-term sustainability of the benefits observed,” he said. “Also, the lack of significant improvements in other critical outcomes, such as mobility, suggests limitations in the broader application of HIIT for stroke rehabilitation.”
“While HIIT shows potential, it should be approached with caution,” Mr. Glatt continued. “It may benefit select patients, but replacing traditional exercise protocols with HIIT should not be done in all cases. More robust evidence and careful consideration of individual patient needs are essential.”
This study was funded by an operating grant from the Canadian Institutes of Health Research. Dr. Tang reported grants from the Canadian Institutes of Health Research, the Physiotherapy Foundation of Canada, and the Heart and Stroke Foundation of Canada. Mr. Glatt declared no relevant financial relationships.
A version of this article appeared on Medscape.com.
Will Compounding ‘Best Practices’ Guide Reassure Clinicians?
A new “best practices” guide released by the Alliance for Pharmacy Compounding (APC) aims to educate compounding pharmacists and reassure prescribers about the ethical, legal, and practical considerations that must be addressed to ensure quality standards and protect patients’ health.
Endocrinologists have expressed skepticism about the quality of compounded drugs, particularly the popular glucagon-like peptide 1 (GLP-1) semaglutide. The Food and Drug Administration (FDA) recently issued an alert linking hospitalizations to overdoses of compounded semaglutide.
“This document goes beyond today’s media-grabbing shortages,” APC Board Chair-Elect Gina Besteman, RPh, of Belmar Pharma Solutions told this news organization. “We developed these best practices to apply to all shortage drug compounding, and especially in this moment when so many are compounding GLP-1s. These serve as a reminder about what compliance and care look like.”
Prescribers determine whether a patient needs a compounded medication, not pharmacists, Ms. Besteman noted. “A patient-specific prescription order must be authorized for a compounded medication to be dispensed. Prescribers should ensure pharmacies they work with regularly check the FDA Drug Shortage List, as compounding of ‘essential copies’ of FDA-approved drugs is only allowed when a drug is listed as ‘currently in shortage.’ ”
Framework for Compounding
“With fake and illegal online stores popping up, it’s critical for legitimate, state-licensed compounding pharmacies to maintain the profession’s high standards,” the APC said in a media communication.
Highlights of its best practices, which are directed toward 503A state-licensed compounding pharmacies, include the following, among others:
- Pharmacies should check the FDA drug shortage list prior to preparing a copy of an FDA-approved drug and maintain documentation to demonstrate to regulators that the drug was in shortage at the time it was compounded.
- Pharmacies may only source active pharmaceutical ingredients (APIs) from state-licensed wholesalers who purchase from FDA-registered manufacturers or order directly from FDA-registered manufacturers.
- Verify from the wholesaler that the manufacturer is registered with the FDA and the API meets all the requirements of section 503A, and that both hold the appropriate permits or licenses in their home state and the shipped to state.
- Adhere to USP Chapter <797> testing requirements for sterility, endotoxin, stability, particulate, antimicrobial effectiveness, and container closure integrity studies.
- Counseling must be offered to the patient or the patient’s agent/caregiver. Providing written information that assists in the understanding of how to properly use the compounded medication is advised.
- Instructions should be written in a way that a layperson can understand (especially directions including dosage titrations and conversions between milligrams and milliliters or units).
- Like all medications, compounded drugs can only be prescribed in the presence of a valid patient-practitioner relationship and can only be dispensed by a pharmacy after receipt of a valid patient-specific prescription order.
- When marketing, never make claims of safety or efficacy of the compounded product.
- Advertising that patients will/may save money using compounded medications, compared with manufactured products is not allowed.
“Compounding FDA-approved drugs during shortages is nothing new — pharmacies have been doing it well before GLP-1s came on the scene, and they’ll continue long after this current shortage ends,” Ms. Besteman said. “Prescribers should be aware of APC’s guidelines because they provide a framework for ethically and legally compounding medications during drug shortages.
“To paraphrase The Police,” she concluded, “every move you make, every step you take, they’ll be watching you. Make sure they see those best practices in action.”
‘Reduces the Risks’
Commenting on the best practices guidance, Ivania Rizo, MD, director of Obesity Medicine and Diabetes and clinical colead at Boston Medical Center’s Health Equity Accelerator in Massachusetts, said: “These best practices will hopefully make a difference in the quality of compounded drugs.”
“The emphasis on rigorous testing of APIs and adherence to USP standards is particularly important for maintaining drug quality,” she noted. “This structured approach reduces the risk of variability and ensures that compounded drugs meet high-quality standards, thus enhancing their reliability.”
“Knowing that compounding pharmacies are adhering to rigorous standards for sourcing, testing, and compounding can at least reassure clinicians that specific steps are being taken for the safety and efficacy of these medications,” she said. “The transparency in documenting compliance with FDA guidelines and maintaining high-quality control measures can enhance trust among healthcare providers.”
Although clinicians are likely to have more confidence in compounded drugs when these best practices are followed, she said, “overall, we all hope that the shortages of medications such as tirzepatide are resolved promptly, allowing patients to access FDA-approved drugs without the need for compounding.”
“While the implementation of best practices for compounding during shortages is a positive and necessary step, our ultimate goal remains to address and resolve these shortages in the near future,” she concluded.
Dr. Rizo declared no competing interests.
A version of this article first appeared on Medscape.com.
A new “best practices” guide released by the Alliance for Pharmacy Compounding (APC) aims to educate compounding pharmacists and reassure prescribers about the ethical, legal, and practical considerations that must be addressed to ensure quality standards and protect patients’ health.
Endocrinologists have expressed skepticism about the quality of compounded drugs, particularly the popular glucagon-like peptide 1 (GLP-1) semaglutide. The Food and Drug Administration (FDA) recently issued an alert linking hospitalizations to overdoses of compounded semaglutide.
“This document goes beyond today’s media-grabbing shortages,” APC Board Chair-Elect Gina Besteman, RPh, of Belmar Pharma Solutions told this news organization. “We developed these best practices to apply to all shortage drug compounding, and especially in this moment when so many are compounding GLP-1s. These serve as a reminder about what compliance and care look like.”
Prescribers determine whether a patient needs a compounded medication, not pharmacists, Ms. Besteman noted. “A patient-specific prescription order must be authorized for a compounded medication to be dispensed. Prescribers should ensure pharmacies they work with regularly check the FDA Drug Shortage List, as compounding of ‘essential copies’ of FDA-approved drugs is only allowed when a drug is listed as ‘currently in shortage.’ ”
Framework for Compounding
“With fake and illegal online stores popping up, it’s critical for legitimate, state-licensed compounding pharmacies to maintain the profession’s high standards,” the APC said in a media communication.
Highlights of its best practices, which are directed toward 503A state-licensed compounding pharmacies, include the following, among others:
- Pharmacies should check the FDA drug shortage list prior to preparing a copy of an FDA-approved drug and maintain documentation to demonstrate to regulators that the drug was in shortage at the time it was compounded.
- Pharmacies may only source active pharmaceutical ingredients (APIs) from state-licensed wholesalers who purchase from FDA-registered manufacturers or order directly from FDA-registered manufacturers.
- Verify from the wholesaler that the manufacturer is registered with the FDA and the API meets all the requirements of section 503A, and that both hold the appropriate permits or licenses in their home state and the shipped to state.
- Adhere to USP Chapter <797> testing requirements for sterility, endotoxin, stability, particulate, antimicrobial effectiveness, and container closure integrity studies.
- Counseling must be offered to the patient or the patient’s agent/caregiver. Providing written information that assists in the understanding of how to properly use the compounded medication is advised.
- Instructions should be written in a way that a layperson can understand (especially directions including dosage titrations and conversions between milligrams and milliliters or units).
- Like all medications, compounded drugs can only be prescribed in the presence of a valid patient-practitioner relationship and can only be dispensed by a pharmacy after receipt of a valid patient-specific prescription order.
- When marketing, never make claims of safety or efficacy of the compounded product.
- Advertising that patients will/may save money using compounded medications, compared with manufactured products is not allowed.
“Compounding FDA-approved drugs during shortages is nothing new — pharmacies have been doing it well before GLP-1s came on the scene, and they’ll continue long after this current shortage ends,” Ms. Besteman said. “Prescribers should be aware of APC’s guidelines because they provide a framework for ethically and legally compounding medications during drug shortages.
“To paraphrase The Police,” she concluded, “every move you make, every step you take, they’ll be watching you. Make sure they see those best practices in action.”
‘Reduces the Risks’
Commenting on the best practices guidance, Ivania Rizo, MD, director of Obesity Medicine and Diabetes and clinical colead at Boston Medical Center’s Health Equity Accelerator in Massachusetts, said: “These best practices will hopefully make a difference in the quality of compounded drugs.”
“The emphasis on rigorous testing of APIs and adherence to USP standards is particularly important for maintaining drug quality,” she noted. “This structured approach reduces the risk of variability and ensures that compounded drugs meet high-quality standards, thus enhancing their reliability.”
“Knowing that compounding pharmacies are adhering to rigorous standards for sourcing, testing, and compounding can at least reassure clinicians that specific steps are being taken for the safety and efficacy of these medications,” she said. “The transparency in documenting compliance with FDA guidelines and maintaining high-quality control measures can enhance trust among healthcare providers.”
Although clinicians are likely to have more confidence in compounded drugs when these best practices are followed, she said, “overall, we all hope that the shortages of medications such as tirzepatide are resolved promptly, allowing patients to access FDA-approved drugs without the need for compounding.”
“While the implementation of best practices for compounding during shortages is a positive and necessary step, our ultimate goal remains to address and resolve these shortages in the near future,” she concluded.
Dr. Rizo declared no competing interests.
A version of this article first appeared on Medscape.com.
A new “best practices” guide released by the Alliance for Pharmacy Compounding (APC) aims to educate compounding pharmacists and reassure prescribers about the ethical, legal, and practical considerations that must be addressed to ensure quality standards and protect patients’ health.
Endocrinologists have expressed skepticism about the quality of compounded drugs, particularly the popular glucagon-like peptide 1 (GLP-1) semaglutide. The Food and Drug Administration (FDA) recently issued an alert linking hospitalizations to overdoses of compounded semaglutide.
“This document goes beyond today’s media-grabbing shortages,” APC Board Chair-Elect Gina Besteman, RPh, of Belmar Pharma Solutions told this news organization. “We developed these best practices to apply to all shortage drug compounding, and especially in this moment when so many are compounding GLP-1s. These serve as a reminder about what compliance and care look like.”
Prescribers determine whether a patient needs a compounded medication, not pharmacists, Ms. Besteman noted. “A patient-specific prescription order must be authorized for a compounded medication to be dispensed. Prescribers should ensure pharmacies they work with regularly check the FDA Drug Shortage List, as compounding of ‘essential copies’ of FDA-approved drugs is only allowed when a drug is listed as ‘currently in shortage.’ ”
Framework for Compounding
“With fake and illegal online stores popping up, it’s critical for legitimate, state-licensed compounding pharmacies to maintain the profession’s high standards,” the APC said in a media communication.
Highlights of its best practices, which are directed toward 503A state-licensed compounding pharmacies, include the following, among others:
- Pharmacies should check the FDA drug shortage list prior to preparing a copy of an FDA-approved drug and maintain documentation to demonstrate to regulators that the drug was in shortage at the time it was compounded.
- Pharmacies may only source active pharmaceutical ingredients (APIs) from state-licensed wholesalers who purchase from FDA-registered manufacturers or order directly from FDA-registered manufacturers.
- Verify from the wholesaler that the manufacturer is registered with the FDA and the API meets all the requirements of section 503A, and that both hold the appropriate permits or licenses in their home state and the shipped to state.
- Adhere to USP Chapter <797> testing requirements for sterility, endotoxin, stability, particulate, antimicrobial effectiveness, and container closure integrity studies.
- Counseling must be offered to the patient or the patient’s agent/caregiver. Providing written information that assists in the understanding of how to properly use the compounded medication is advised.
- Instructions should be written in a way that a layperson can understand (especially directions including dosage titrations and conversions between milligrams and milliliters or units).
- Like all medications, compounded drugs can only be prescribed in the presence of a valid patient-practitioner relationship and can only be dispensed by a pharmacy after receipt of a valid patient-specific prescription order.
- When marketing, never make claims of safety or efficacy of the compounded product.
- Advertising that patients will/may save money using compounded medications, compared with manufactured products is not allowed.
“Compounding FDA-approved drugs during shortages is nothing new — pharmacies have been doing it well before GLP-1s came on the scene, and they’ll continue long after this current shortage ends,” Ms. Besteman said. “Prescribers should be aware of APC’s guidelines because they provide a framework for ethically and legally compounding medications during drug shortages.
“To paraphrase The Police,” she concluded, “every move you make, every step you take, they’ll be watching you. Make sure they see those best practices in action.”
‘Reduces the Risks’
Commenting on the best practices guidance, Ivania Rizo, MD, director of Obesity Medicine and Diabetes and clinical colead at Boston Medical Center’s Health Equity Accelerator in Massachusetts, said: “These best practices will hopefully make a difference in the quality of compounded drugs.”
“The emphasis on rigorous testing of APIs and adherence to USP standards is particularly important for maintaining drug quality,” she noted. “This structured approach reduces the risk of variability and ensures that compounded drugs meet high-quality standards, thus enhancing their reliability.”
“Knowing that compounding pharmacies are adhering to rigorous standards for sourcing, testing, and compounding can at least reassure clinicians that specific steps are being taken for the safety and efficacy of these medications,” she said. “The transparency in documenting compliance with FDA guidelines and maintaining high-quality control measures can enhance trust among healthcare providers.”
Although clinicians are likely to have more confidence in compounded drugs when these best practices are followed, she said, “overall, we all hope that the shortages of medications such as tirzepatide are resolved promptly, allowing patients to access FDA-approved drugs without the need for compounding.”
“While the implementation of best practices for compounding during shortages is a positive and necessary step, our ultimate goal remains to address and resolve these shortages in the near future,” she concluded.
Dr. Rizo declared no competing interests.
A version of this article first appeared on Medscape.com.
Could Dry Fasting Aid in Metabolic Disorders, Diabetes?
Dry fasting, the practice of going without food and water, has enthusiastic advocates on TikTok, X, YouTube, and other social media platforms. Devotees claim a wide range of health effects, but medical professionals advise caution to ensure that the practice does more good than harm, especially for individuals with diabetes.
Purported benefits and risks vary, depending on who is following the regimen and how long they abstain from food and water. Advocates on social media assert that dry fasting makes “intuition skyrocket” and puts autophagy on “overdrive.” Although such statements may rev up followers, there is little evidence to support these and many other dry-fasting claims. In fact, several physicians warned about unintended consequences.
“I had one patient who followed this fasting method often, and over time she developed kidney stones that led to a severe infection,” said Deena Adimoolam, MD, an endocrinologist in private practice in New York City and New Jersey. “Lack of both water and food can fuel hunger and increase the likelihood of overeating or binge eating once the fast is completed, which does not lead to weight loss. Untreated dehydration can lead to loss of consciousness.”
“For individuals with type 2 diabetes, dehydration can exacerbate hyperglycemia and increase the risk of complications such as diabetic ketoacidosis (DKA),” said Abeer Bader, lead clinical nutrition specialist at the Massachusetts General Hospital Weight Center in Boston. “Research also consistently shows that adequate hydration is crucial for maintaining physical and cognitive performance.”
, Ms. Bader noted. “Prolonged dry fasting can result in nutrient deficiencies. For individuals with diabetes, maintaining adequate nutrition is crucial to manage blood sugar levels and overall health. The lack of both food and water can exacerbate deficiencies.”
Joanne Bruno, MD, an endocrinologist at NYU Langone Health, added, “Certain medications used for the management of type 2 diabetes, such as SGLT2 inhibitors, can cause dehydration. It is critical that patients stay well hydrated while on these medications to avoid serious side effects such as euglycemic DKA.”
What Exactly Is Dry Fasting?
Defining dry fasting, like any kind of fasting, has remained a challenge, according to authors of the first international consensus on fasting terminology, published on July 25 in Cell Metabolism. The clinical terminology “has remained heterogeneous and often confusing, with similar terms being used to define different fasting regimens ... reflecting the manifold contexts in which fasting is practiced.”
Indeed, dry fasting was among the most discussed terms by the consensus panel and went through several rounds before the panelists came to agreement. A few experts were critical of the practice, whereas those familiar with religious fasting traditions, such as during Ramadan, were clear about the importance of including this term in the consensus process.
“The dissent was resolved by the clarification that this form of fasting has historical and geographical extensions and that the present consensus process did not aim at evaluating therapeutic effectiveness or safety for any term defined,” the authors wrote.
The panel concluded that dry fasting is not the same as total or complete fasting because the latter can include water (such as water-only fasting). Their final definition of dry fasting is ‘’a fasting regimen during which a voluntary abstinence from all foods and beverages, including water, is practiced for a certain period of time.’’
Different types of fasting regimens, such as intermittent fasting, may include dry fasting, in which case it is referred to as “intermittent dry fasting.” This is defined in the consensus as intermittent fasting regimens that involve abstaining from food and fluid intake during the fasting interval, which typically lasts 9-20 hours.
Most dry fasts, including religious ones, are maintained for a specific interval and are followed by a refeeding period. These fasts are not starvation, defined as no food or water intake for days.
What the Evidence Says
All that said, dry fasting by any other name remains dry fasting. “Abundant” evidence from animal studies suggests the potential of various types of fasting for disease prevention and treatment in humans, noted the authors of the consensus report, Along with the risks described above, small studies have explored short-term effects in people, all of which have yet to be established by larger and longer-term studies.
In a recent small study, researchers at Baylor College of Medicine, Houston, Texas, reported that dawn-to-dusk dry fasting for 30 days reduced levels of inflammatory cytokines in the 13 participants with a high body mass index. Earlier work by the group showed that dawn-to-dusk dry fasting for 30 days induced “anti-atherosclerotic, anti-inflammatory, and anti-tumorigenic proteome” in peripheral blood mononuclear cells of 14 individuals with metabolic syndrome (The researchers declined to comment for this article.)
Importantly, the health effects can vary among individuals for unknown reasons, found a recent cross-sectional study of fasting blood glucose (FBG) changes in 181 patients with type 2 diabetes during Ramadan intermittent fasting (RIF), which involves dry fasting during daylight hours for 1 month. The researchers classified participants into three groups: reduced average FBG levels (44%), no change in FBG levels (24%), and increased FBG levels (32%). The authors wrote that further studies are needed to identify factors associated with the differences and to identify “those who are great candidates for RIF.”
In contrast to some of the concerns expressed by clinicians, an exploratory study of daytime dry fasting among 34 healthy Baha’i volunteers in Germany concluded that the 19-day regimen “is safe, has no negative effects on hydration, can improve fat metabolism and can cause transient phase shifts of circadian rhythms.” The authors acknowledge that a larger number and more diverse participants are needed to validate the findings and assess the impact on long-term health.
What to Advise Patients
For patients who want to fast as part of their weight loss regimen or to help manage diabetes, clinicians can consider suggesting “alternate ways of eating that might achieve similar goals,” Ms. Bader said. One is intermittent fasting without dry fasting: the 16:8 method (16 hours of fasting, 8 hours of eating) or the 5:2 method (normal eating for 5 days, reduced calorie intake for 2 days), which can support improved insulin sensitivity and metabolic health.
Caloric restriction can also work if the patient maintains a balanced diet that includes all essential nutrients, she said. A low-carbohydrate diet that focuses on limiting carbohydrate intake while increasing consumption of lean proteins and healthy fats has been shown to lower blood sugar levels and improve insulin sensitivity.
Other healthy strategies for patients include the Mediterranean diet, which emphasizes whole grains, fruits, vegetables, nuts, seeds, olive oil, and lean proteins such as fish, or a similar plant-based diet with less animal protein. Ms. Bader advises cultivating mindful eating, which involves paying attention to hunger and fullness cues, making thoughtful food choices, and focusing on being present during meals.
“Each of these dietary strategies offers potential benefits for managing type 2 diabetes and improving overall health,” Ms. Bader said. “I have not had any patients who have tried dry fasting specifically. However, I have encountered scenarios where individuals abstained from food and beverages due to religious practices. In those cases, we focused on ensuring that they maintained proper hydration and balanced nutrition during their eating periods to manage their diabetes effectively and prevent complications.”
Overall, Dr. Adimoolam suggests that clinicians help patients find a weight-loss plan that works best for them based on understanding the calories in the foods they like and don’t like. For fasting regimens, patients can be encouraged to choose one with fluids when possible, as well as intervals of time to fast and eat that work best for their lifestyle.
Ms. Bader, Dr. Bruno, and Dr. Adimoolam report no relevant conflicts.
A version of this article appeared on Medscape.com.
Dry fasting, the practice of going without food and water, has enthusiastic advocates on TikTok, X, YouTube, and other social media platforms. Devotees claim a wide range of health effects, but medical professionals advise caution to ensure that the practice does more good than harm, especially for individuals with diabetes.
Purported benefits and risks vary, depending on who is following the regimen and how long they abstain from food and water. Advocates on social media assert that dry fasting makes “intuition skyrocket” and puts autophagy on “overdrive.” Although such statements may rev up followers, there is little evidence to support these and many other dry-fasting claims. In fact, several physicians warned about unintended consequences.
“I had one patient who followed this fasting method often, and over time she developed kidney stones that led to a severe infection,” said Deena Adimoolam, MD, an endocrinologist in private practice in New York City and New Jersey. “Lack of both water and food can fuel hunger and increase the likelihood of overeating or binge eating once the fast is completed, which does not lead to weight loss. Untreated dehydration can lead to loss of consciousness.”
“For individuals with type 2 diabetes, dehydration can exacerbate hyperglycemia and increase the risk of complications such as diabetic ketoacidosis (DKA),” said Abeer Bader, lead clinical nutrition specialist at the Massachusetts General Hospital Weight Center in Boston. “Research also consistently shows that adequate hydration is crucial for maintaining physical and cognitive performance.”
, Ms. Bader noted. “Prolonged dry fasting can result in nutrient deficiencies. For individuals with diabetes, maintaining adequate nutrition is crucial to manage blood sugar levels and overall health. The lack of both food and water can exacerbate deficiencies.”
Joanne Bruno, MD, an endocrinologist at NYU Langone Health, added, “Certain medications used for the management of type 2 diabetes, such as SGLT2 inhibitors, can cause dehydration. It is critical that patients stay well hydrated while on these medications to avoid serious side effects such as euglycemic DKA.”
What Exactly Is Dry Fasting?
Defining dry fasting, like any kind of fasting, has remained a challenge, according to authors of the first international consensus on fasting terminology, published on July 25 in Cell Metabolism. The clinical terminology “has remained heterogeneous and often confusing, with similar terms being used to define different fasting regimens ... reflecting the manifold contexts in which fasting is practiced.”
Indeed, dry fasting was among the most discussed terms by the consensus panel and went through several rounds before the panelists came to agreement. A few experts were critical of the practice, whereas those familiar with religious fasting traditions, such as during Ramadan, were clear about the importance of including this term in the consensus process.
“The dissent was resolved by the clarification that this form of fasting has historical and geographical extensions and that the present consensus process did not aim at evaluating therapeutic effectiveness or safety for any term defined,” the authors wrote.
The panel concluded that dry fasting is not the same as total or complete fasting because the latter can include water (such as water-only fasting). Their final definition of dry fasting is ‘’a fasting regimen during which a voluntary abstinence from all foods and beverages, including water, is practiced for a certain period of time.’’
Different types of fasting regimens, such as intermittent fasting, may include dry fasting, in which case it is referred to as “intermittent dry fasting.” This is defined in the consensus as intermittent fasting regimens that involve abstaining from food and fluid intake during the fasting interval, which typically lasts 9-20 hours.
Most dry fasts, including religious ones, are maintained for a specific interval and are followed by a refeeding period. These fasts are not starvation, defined as no food or water intake for days.
What the Evidence Says
All that said, dry fasting by any other name remains dry fasting. “Abundant” evidence from animal studies suggests the potential of various types of fasting for disease prevention and treatment in humans, noted the authors of the consensus report, Along with the risks described above, small studies have explored short-term effects in people, all of which have yet to be established by larger and longer-term studies.
In a recent small study, researchers at Baylor College of Medicine, Houston, Texas, reported that dawn-to-dusk dry fasting for 30 days reduced levels of inflammatory cytokines in the 13 participants with a high body mass index. Earlier work by the group showed that dawn-to-dusk dry fasting for 30 days induced “anti-atherosclerotic, anti-inflammatory, and anti-tumorigenic proteome” in peripheral blood mononuclear cells of 14 individuals with metabolic syndrome (The researchers declined to comment for this article.)
Importantly, the health effects can vary among individuals for unknown reasons, found a recent cross-sectional study of fasting blood glucose (FBG) changes in 181 patients with type 2 diabetes during Ramadan intermittent fasting (RIF), which involves dry fasting during daylight hours for 1 month. The researchers classified participants into three groups: reduced average FBG levels (44%), no change in FBG levels (24%), and increased FBG levels (32%). The authors wrote that further studies are needed to identify factors associated with the differences and to identify “those who are great candidates for RIF.”
In contrast to some of the concerns expressed by clinicians, an exploratory study of daytime dry fasting among 34 healthy Baha’i volunteers in Germany concluded that the 19-day regimen “is safe, has no negative effects on hydration, can improve fat metabolism and can cause transient phase shifts of circadian rhythms.” The authors acknowledge that a larger number and more diverse participants are needed to validate the findings and assess the impact on long-term health.
What to Advise Patients
For patients who want to fast as part of their weight loss regimen or to help manage diabetes, clinicians can consider suggesting “alternate ways of eating that might achieve similar goals,” Ms. Bader said. One is intermittent fasting without dry fasting: the 16:8 method (16 hours of fasting, 8 hours of eating) or the 5:2 method (normal eating for 5 days, reduced calorie intake for 2 days), which can support improved insulin sensitivity and metabolic health.
Caloric restriction can also work if the patient maintains a balanced diet that includes all essential nutrients, she said. A low-carbohydrate diet that focuses on limiting carbohydrate intake while increasing consumption of lean proteins and healthy fats has been shown to lower blood sugar levels and improve insulin sensitivity.
Other healthy strategies for patients include the Mediterranean diet, which emphasizes whole grains, fruits, vegetables, nuts, seeds, olive oil, and lean proteins such as fish, or a similar plant-based diet with less animal protein. Ms. Bader advises cultivating mindful eating, which involves paying attention to hunger and fullness cues, making thoughtful food choices, and focusing on being present during meals.
“Each of these dietary strategies offers potential benefits for managing type 2 diabetes and improving overall health,” Ms. Bader said. “I have not had any patients who have tried dry fasting specifically. However, I have encountered scenarios where individuals abstained from food and beverages due to religious practices. In those cases, we focused on ensuring that they maintained proper hydration and balanced nutrition during their eating periods to manage their diabetes effectively and prevent complications.”
Overall, Dr. Adimoolam suggests that clinicians help patients find a weight-loss plan that works best for them based on understanding the calories in the foods they like and don’t like. For fasting regimens, patients can be encouraged to choose one with fluids when possible, as well as intervals of time to fast and eat that work best for their lifestyle.
Ms. Bader, Dr. Bruno, and Dr. Adimoolam report no relevant conflicts.
A version of this article appeared on Medscape.com.
Dry fasting, the practice of going without food and water, has enthusiastic advocates on TikTok, X, YouTube, and other social media platforms. Devotees claim a wide range of health effects, but medical professionals advise caution to ensure that the practice does more good than harm, especially for individuals with diabetes.
Purported benefits and risks vary, depending on who is following the regimen and how long they abstain from food and water. Advocates on social media assert that dry fasting makes “intuition skyrocket” and puts autophagy on “overdrive.” Although such statements may rev up followers, there is little evidence to support these and many other dry-fasting claims. In fact, several physicians warned about unintended consequences.
“I had one patient who followed this fasting method often, and over time she developed kidney stones that led to a severe infection,” said Deena Adimoolam, MD, an endocrinologist in private practice in New York City and New Jersey. “Lack of both water and food can fuel hunger and increase the likelihood of overeating or binge eating once the fast is completed, which does not lead to weight loss. Untreated dehydration can lead to loss of consciousness.”
“For individuals with type 2 diabetes, dehydration can exacerbate hyperglycemia and increase the risk of complications such as diabetic ketoacidosis (DKA),” said Abeer Bader, lead clinical nutrition specialist at the Massachusetts General Hospital Weight Center in Boston. “Research also consistently shows that adequate hydration is crucial for maintaining physical and cognitive performance.”
, Ms. Bader noted. “Prolonged dry fasting can result in nutrient deficiencies. For individuals with diabetes, maintaining adequate nutrition is crucial to manage blood sugar levels and overall health. The lack of both food and water can exacerbate deficiencies.”
Joanne Bruno, MD, an endocrinologist at NYU Langone Health, added, “Certain medications used for the management of type 2 diabetes, such as SGLT2 inhibitors, can cause dehydration. It is critical that patients stay well hydrated while on these medications to avoid serious side effects such as euglycemic DKA.”
What Exactly Is Dry Fasting?
Defining dry fasting, like any kind of fasting, has remained a challenge, according to authors of the first international consensus on fasting terminology, published on July 25 in Cell Metabolism. The clinical terminology “has remained heterogeneous and often confusing, with similar terms being used to define different fasting regimens ... reflecting the manifold contexts in which fasting is practiced.”
Indeed, dry fasting was among the most discussed terms by the consensus panel and went through several rounds before the panelists came to agreement. A few experts were critical of the practice, whereas those familiar with religious fasting traditions, such as during Ramadan, were clear about the importance of including this term in the consensus process.
“The dissent was resolved by the clarification that this form of fasting has historical and geographical extensions and that the present consensus process did not aim at evaluating therapeutic effectiveness or safety for any term defined,” the authors wrote.
The panel concluded that dry fasting is not the same as total or complete fasting because the latter can include water (such as water-only fasting). Their final definition of dry fasting is ‘’a fasting regimen during which a voluntary abstinence from all foods and beverages, including water, is practiced for a certain period of time.’’
Different types of fasting regimens, such as intermittent fasting, may include dry fasting, in which case it is referred to as “intermittent dry fasting.” This is defined in the consensus as intermittent fasting regimens that involve abstaining from food and fluid intake during the fasting interval, which typically lasts 9-20 hours.
Most dry fasts, including religious ones, are maintained for a specific interval and are followed by a refeeding period. These fasts are not starvation, defined as no food or water intake for days.
What the Evidence Says
All that said, dry fasting by any other name remains dry fasting. “Abundant” evidence from animal studies suggests the potential of various types of fasting for disease prevention and treatment in humans, noted the authors of the consensus report, Along with the risks described above, small studies have explored short-term effects in people, all of which have yet to be established by larger and longer-term studies.
In a recent small study, researchers at Baylor College of Medicine, Houston, Texas, reported that dawn-to-dusk dry fasting for 30 days reduced levels of inflammatory cytokines in the 13 participants with a high body mass index. Earlier work by the group showed that dawn-to-dusk dry fasting for 30 days induced “anti-atherosclerotic, anti-inflammatory, and anti-tumorigenic proteome” in peripheral blood mononuclear cells of 14 individuals with metabolic syndrome (The researchers declined to comment for this article.)
Importantly, the health effects can vary among individuals for unknown reasons, found a recent cross-sectional study of fasting blood glucose (FBG) changes in 181 patients with type 2 diabetes during Ramadan intermittent fasting (RIF), which involves dry fasting during daylight hours for 1 month. The researchers classified participants into three groups: reduced average FBG levels (44%), no change in FBG levels (24%), and increased FBG levels (32%). The authors wrote that further studies are needed to identify factors associated with the differences and to identify “those who are great candidates for RIF.”
In contrast to some of the concerns expressed by clinicians, an exploratory study of daytime dry fasting among 34 healthy Baha’i volunteers in Germany concluded that the 19-day regimen “is safe, has no negative effects on hydration, can improve fat metabolism and can cause transient phase shifts of circadian rhythms.” The authors acknowledge that a larger number and more diverse participants are needed to validate the findings and assess the impact on long-term health.
What to Advise Patients
For patients who want to fast as part of their weight loss regimen or to help manage diabetes, clinicians can consider suggesting “alternate ways of eating that might achieve similar goals,” Ms. Bader said. One is intermittent fasting without dry fasting: the 16:8 method (16 hours of fasting, 8 hours of eating) or the 5:2 method (normal eating for 5 days, reduced calorie intake for 2 days), which can support improved insulin sensitivity and metabolic health.
Caloric restriction can also work if the patient maintains a balanced diet that includes all essential nutrients, she said. A low-carbohydrate diet that focuses on limiting carbohydrate intake while increasing consumption of lean proteins and healthy fats has been shown to lower blood sugar levels and improve insulin sensitivity.
Other healthy strategies for patients include the Mediterranean diet, which emphasizes whole grains, fruits, vegetables, nuts, seeds, olive oil, and lean proteins such as fish, or a similar plant-based diet with less animal protein. Ms. Bader advises cultivating mindful eating, which involves paying attention to hunger and fullness cues, making thoughtful food choices, and focusing on being present during meals.
“Each of these dietary strategies offers potential benefits for managing type 2 diabetes and improving overall health,” Ms. Bader said. “I have not had any patients who have tried dry fasting specifically. However, I have encountered scenarios where individuals abstained from food and beverages due to religious practices. In those cases, we focused on ensuring that they maintained proper hydration and balanced nutrition during their eating periods to manage their diabetes effectively and prevent complications.”
Overall, Dr. Adimoolam suggests that clinicians help patients find a weight-loss plan that works best for them based on understanding the calories in the foods they like and don’t like. For fasting regimens, patients can be encouraged to choose one with fluids when possible, as well as intervals of time to fast and eat that work best for their lifestyle.
Ms. Bader, Dr. Bruno, and Dr. Adimoolam report no relevant conflicts.
A version of this article appeared on Medscape.com.
PPI Prophylaxis Prevents GI Bleed in Ventilated Patients
according to a randomized trial and a systematic review led by researchers at McMaster University, Hamilton, Ontario, Canada.
Patients in the intensive care unit (ICU) who need mechanical ventilation typically are given a PPI, such as pantoprazole, to prevent upper GI bleeding caused by stress-induced stomach ulcers, but some evidence suggested that their use might increase the risk for pneumonia and death in the most severely ill patients.
As a result, recent guidelines have issued only weak recommendations for stress ulcer prophylaxis, especially with PPIs, in critically ill patients at a high risk for bleeding, Deborah Cook, MD, professor of medicine at McMaster University, and colleagues noted.
To address clinical questions, they investigated the efficacy and safety of PPIs to prevent upper GI bleeding in critically ill patients.
Both the randomized trial in The New England Journal of Medicine and the systematic review in NEJM Evidence were published online in June.
Significantly Lower Bleeding Risk
The REVISE trial, conducted in eight countries, compared pantoprazole 40 mg daily with placebo in critically ill adults on mechanical ventilation.
The primary efficacy outcome was clinically important upper GI bleeding in the ICU at 90 days, and the primary safety outcome was death from any cause at 90 days.
A total of 4821 patients in 68 ICUs were randomly assigned to the pantoprazole group or placebo group.
Clinically important upper GI bleeding occurred in 25 patients (1%) receiving pantoprazole and in 84 patients (3.5%) receiving placebo. At 90 days, 696 patients (29.1%) in the pantoprazole group died, as did 734 (30.9%) in the placebo group.
No significant differences were found on key secondary outcomes, including ventilator-associated pneumonia and Clostridioides difficile infection in the hospital.
The authors concluded that pantoprazole resulted in a significantly lower risk for clinically important upper GI bleeding than placebo, and it had no significant effect on mortality.
Disease Severity as a Possible Factor
The systematic review included 12 randomized controlled trials comparing PPIs with placebo or no prophylaxis for stress ulcers in a total of 9533 critically ill adults. The researchers performed meta-analyses and assessed the certainty of the evidence. They also conducted a subgroup analysis combining within-trial subgroup data from the two largest trials.
They found that PPIs were associated with a reduced incidence of clinically important upper GI bleeding (relative risk [RR], 0.51, with high certainty evidence) and may have little or no effect on mortality (RR, 0.99, with low-certainty evidence).
However, the within-trial subgroup analysis with intermediate credibility suggested that the effect of PPIs on mortality may differ based on disease severity. The results also raised the possibility that PPI use may decrease 90-day mortality in less severely ill patients (RR, 0.89) and increase mortality in more severely ill patients (RR, 1.08). The mechanisms behind this possible signal are likely multifactorial, the authors noted.
In addition, the review found that PPIs may have no effect on pneumonia, duration of ICU stay, or duration of hospital stay, and little or no effect on C difficile infection or duration of mechanical ventilation (low-certainty evidence).
“Physicians, nurses, and pharmacists working in the ICU setting will use this information in practice right away, and the trial results and the updated meta-analysis will be incorporated into international practice guidelines,” Dr. Cook said.
Both studies had limitations. The REVISE trial did not include patient-reported disability outcomes, and the results may not be generalizable to patients with unassisted breathing. The systematic review included studies with diverse definitions of bleeding and pneumonia, and with mortality reported at different milestones, without considering competing risk analyses. Patient-important GI bleeding was available in only one trial. Other potential side effects of PPIs, such as infection with multidrug-resistant organisms, were not reported.
In an editorial accompanying both studies, Samuel M. Brown, MD, a pulmonologist and vice president of research at Intermountain Health, Salt Lake City, Utah, said that the REVISE trial was “well designed and executed, with generalizable eligibility criteria and excellent experimental separation.” He said the researchers had shown that PPIs “slightly but significantly” decrease the risk of important GI bleeding and have a “decent chance” of slightly decreasing mortality in less severely ill patients during mechanical ventilation. At the same time, he noted, PPIs “do not decrease — and may slightly increase — mortality” in severely ill patients.
Dr. Brown wrote that, in his own practice, he intends to prescribe prophylactic PPIs to patients during mechanical ventilation “if they have an APACHE II score of less than 25” or a reasonable equivalent. The APACHE II scoring system is a point-based system that estimates a patient’s risk of death while in an ICU.
“For sicker patients, I would probably reserve the use of proton-pump inhibitors for those who are being treated with antiplatelet agents, especially in the presence of therapeutic anticoagulants,” he added.
REVISE was supported by numerous grants from organizations in several countries. No funding was specified for the systematic review. Author disclosures and other supplementary materials are available with the full text of the article.
A version of this article first appeared on Medscape.com.
according to a randomized trial and a systematic review led by researchers at McMaster University, Hamilton, Ontario, Canada.
Patients in the intensive care unit (ICU) who need mechanical ventilation typically are given a PPI, such as pantoprazole, to prevent upper GI bleeding caused by stress-induced stomach ulcers, but some evidence suggested that their use might increase the risk for pneumonia and death in the most severely ill patients.
As a result, recent guidelines have issued only weak recommendations for stress ulcer prophylaxis, especially with PPIs, in critically ill patients at a high risk for bleeding, Deborah Cook, MD, professor of medicine at McMaster University, and colleagues noted.
To address clinical questions, they investigated the efficacy and safety of PPIs to prevent upper GI bleeding in critically ill patients.
Both the randomized trial in The New England Journal of Medicine and the systematic review in NEJM Evidence were published online in June.
Significantly Lower Bleeding Risk
The REVISE trial, conducted in eight countries, compared pantoprazole 40 mg daily with placebo in critically ill adults on mechanical ventilation.
The primary efficacy outcome was clinically important upper GI bleeding in the ICU at 90 days, and the primary safety outcome was death from any cause at 90 days.
A total of 4821 patients in 68 ICUs were randomly assigned to the pantoprazole group or placebo group.
Clinically important upper GI bleeding occurred in 25 patients (1%) receiving pantoprazole and in 84 patients (3.5%) receiving placebo. At 90 days, 696 patients (29.1%) in the pantoprazole group died, as did 734 (30.9%) in the placebo group.
No significant differences were found on key secondary outcomes, including ventilator-associated pneumonia and Clostridioides difficile infection in the hospital.
The authors concluded that pantoprazole resulted in a significantly lower risk for clinically important upper GI bleeding than placebo, and it had no significant effect on mortality.
Disease Severity as a Possible Factor
The systematic review included 12 randomized controlled trials comparing PPIs with placebo or no prophylaxis for stress ulcers in a total of 9533 critically ill adults. The researchers performed meta-analyses and assessed the certainty of the evidence. They also conducted a subgroup analysis combining within-trial subgroup data from the two largest trials.
They found that PPIs were associated with a reduced incidence of clinically important upper GI bleeding (relative risk [RR], 0.51, with high certainty evidence) and may have little or no effect on mortality (RR, 0.99, with low-certainty evidence).
However, the within-trial subgroup analysis with intermediate credibility suggested that the effect of PPIs on mortality may differ based on disease severity. The results also raised the possibility that PPI use may decrease 90-day mortality in less severely ill patients (RR, 0.89) and increase mortality in more severely ill patients (RR, 1.08). The mechanisms behind this possible signal are likely multifactorial, the authors noted.
In addition, the review found that PPIs may have no effect on pneumonia, duration of ICU stay, or duration of hospital stay, and little or no effect on C difficile infection or duration of mechanical ventilation (low-certainty evidence).
“Physicians, nurses, and pharmacists working in the ICU setting will use this information in practice right away, and the trial results and the updated meta-analysis will be incorporated into international practice guidelines,” Dr. Cook said.
Both studies had limitations. The REVISE trial did not include patient-reported disability outcomes, and the results may not be generalizable to patients with unassisted breathing. The systematic review included studies with diverse definitions of bleeding and pneumonia, and with mortality reported at different milestones, without considering competing risk analyses. Patient-important GI bleeding was available in only one trial. Other potential side effects of PPIs, such as infection with multidrug-resistant organisms, were not reported.
In an editorial accompanying both studies, Samuel M. Brown, MD, a pulmonologist and vice president of research at Intermountain Health, Salt Lake City, Utah, said that the REVISE trial was “well designed and executed, with generalizable eligibility criteria and excellent experimental separation.” He said the researchers had shown that PPIs “slightly but significantly” decrease the risk of important GI bleeding and have a “decent chance” of slightly decreasing mortality in less severely ill patients during mechanical ventilation. At the same time, he noted, PPIs “do not decrease — and may slightly increase — mortality” in severely ill patients.
Dr. Brown wrote that, in his own practice, he intends to prescribe prophylactic PPIs to patients during mechanical ventilation “if they have an APACHE II score of less than 25” or a reasonable equivalent. The APACHE II scoring system is a point-based system that estimates a patient’s risk of death while in an ICU.
“For sicker patients, I would probably reserve the use of proton-pump inhibitors for those who are being treated with antiplatelet agents, especially in the presence of therapeutic anticoagulants,” he added.
REVISE was supported by numerous grants from organizations in several countries. No funding was specified for the systematic review. Author disclosures and other supplementary materials are available with the full text of the article.
A version of this article first appeared on Medscape.com.
according to a randomized trial and a systematic review led by researchers at McMaster University, Hamilton, Ontario, Canada.
Patients in the intensive care unit (ICU) who need mechanical ventilation typically are given a PPI, such as pantoprazole, to prevent upper GI bleeding caused by stress-induced stomach ulcers, but some evidence suggested that their use might increase the risk for pneumonia and death in the most severely ill patients.
As a result, recent guidelines have issued only weak recommendations for stress ulcer prophylaxis, especially with PPIs, in critically ill patients at a high risk for bleeding, Deborah Cook, MD, professor of medicine at McMaster University, and colleagues noted.
To address clinical questions, they investigated the efficacy and safety of PPIs to prevent upper GI bleeding in critically ill patients.
Both the randomized trial in The New England Journal of Medicine and the systematic review in NEJM Evidence were published online in June.
Significantly Lower Bleeding Risk
The REVISE trial, conducted in eight countries, compared pantoprazole 40 mg daily with placebo in critically ill adults on mechanical ventilation.
The primary efficacy outcome was clinically important upper GI bleeding in the ICU at 90 days, and the primary safety outcome was death from any cause at 90 days.
A total of 4821 patients in 68 ICUs were randomly assigned to the pantoprazole group or placebo group.
Clinically important upper GI bleeding occurred in 25 patients (1%) receiving pantoprazole and in 84 patients (3.5%) receiving placebo. At 90 days, 696 patients (29.1%) in the pantoprazole group died, as did 734 (30.9%) in the placebo group.
No significant differences were found on key secondary outcomes, including ventilator-associated pneumonia and Clostridioides difficile infection in the hospital.
The authors concluded that pantoprazole resulted in a significantly lower risk for clinically important upper GI bleeding than placebo, and it had no significant effect on mortality.
Disease Severity as a Possible Factor
The systematic review included 12 randomized controlled trials comparing PPIs with placebo or no prophylaxis for stress ulcers in a total of 9533 critically ill adults. The researchers performed meta-analyses and assessed the certainty of the evidence. They also conducted a subgroup analysis combining within-trial subgroup data from the two largest trials.
They found that PPIs were associated with a reduced incidence of clinically important upper GI bleeding (relative risk [RR], 0.51, with high certainty evidence) and may have little or no effect on mortality (RR, 0.99, with low-certainty evidence).
However, the within-trial subgroup analysis with intermediate credibility suggested that the effect of PPIs on mortality may differ based on disease severity. The results also raised the possibility that PPI use may decrease 90-day mortality in less severely ill patients (RR, 0.89) and increase mortality in more severely ill patients (RR, 1.08). The mechanisms behind this possible signal are likely multifactorial, the authors noted.
In addition, the review found that PPIs may have no effect on pneumonia, duration of ICU stay, or duration of hospital stay, and little or no effect on C difficile infection or duration of mechanical ventilation (low-certainty evidence).
“Physicians, nurses, and pharmacists working in the ICU setting will use this information in practice right away, and the trial results and the updated meta-analysis will be incorporated into international practice guidelines,” Dr. Cook said.
Both studies had limitations. The REVISE trial did not include patient-reported disability outcomes, and the results may not be generalizable to patients with unassisted breathing. The systematic review included studies with diverse definitions of bleeding and pneumonia, and with mortality reported at different milestones, without considering competing risk analyses. Patient-important GI bleeding was available in only one trial. Other potential side effects of PPIs, such as infection with multidrug-resistant organisms, were not reported.
In an editorial accompanying both studies, Samuel M. Brown, MD, a pulmonologist and vice president of research at Intermountain Health, Salt Lake City, Utah, said that the REVISE trial was “well designed and executed, with generalizable eligibility criteria and excellent experimental separation.” He said the researchers had shown that PPIs “slightly but significantly” decrease the risk of important GI bleeding and have a “decent chance” of slightly decreasing mortality in less severely ill patients during mechanical ventilation. At the same time, he noted, PPIs “do not decrease — and may slightly increase — mortality” in severely ill patients.
Dr. Brown wrote that, in his own practice, he intends to prescribe prophylactic PPIs to patients during mechanical ventilation “if they have an APACHE II score of less than 25” or a reasonable equivalent. The APACHE II scoring system is a point-based system that estimates a patient’s risk of death while in an ICU.
“For sicker patients, I would probably reserve the use of proton-pump inhibitors for those who are being treated with antiplatelet agents, especially in the presence of therapeutic anticoagulants,” he added.
REVISE was supported by numerous grants from organizations in several countries. No funding was specified for the systematic review. Author disclosures and other supplementary materials are available with the full text of the article.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
How Does ‘Eat Less, Move More’ Promote Obesity Bias?
Experts are debating whether and how to define obesity, but clinicians’ attitudes and behavior toward patients with obesity don’t seem to be undergoing similar scrutiny.
“Despite scientific evidence to the contrary, the prevailing view in society is that obesity is a choice that can be reversed by voluntary decisions to eat less and exercise more,” a multidisciplinary group of 36 international experts wrote in a joint consensus statement for ending the stigma of obesity, published a few years ago in Nature Medicine. “These assumptions mislead public health policies, confuse messages in popular media, undermine access to evidence-based treatments, and compromise advances in research.”
These assumptions also affect how clinicians view and treat their patients.
A systematic review and meta-analysis from Australia using 27 different outcomes to assess weight bias found that “medical doctors, nurses, dietitians, psychologists, physiotherapists, occupational therapists, speech pathologists, podiatrists, and exercise physiologists hold implicit and/or explicit weight-biased attitudes toward people with obesity.”
Another recent systematic review, this one from Brazil, found that obesity bias affected both clinical decision-making and quality of care. Patients with obesity had fewer screening exams for cancer, less-frequent treatment intensification in the management of obesity, and fewer pelvic exams. The authors concluded that their findings “reveal the urgent necessity for reflection and development of strategies to mitigate the adverse impacts” of obesity bias.
“Weight is one of those things that gets judged because it can be seen,” Obesity Society Spokesperson Peminda Cabandugama, MD, of Cleveland Clinic, told this news organization. “People just look at someone with overweight and say, ‘That person needs to eat less and exercise more.’ ”
How Obesity Bias Manifests
The Obesity Action Coalition (OAC), a partner organization to the consensus statement, defines weight bias as “negative attitudes, beliefs, judgments, stereotypes, and discriminatory acts aimed at individuals simply because of their weight. It can be overt or subtle and occur in any setting, including employment, healthcare, education, mass media, and relationships with family and friends.”
The organization notes that weight bias takes many forms, including verbal, written, media, and online.
The consensus statement authors offer these definitions, which encompass the manifestations of obesity bias: Weight stigma refers to “social devaluation and denigration of individuals because of their excess body weight and can lead to negative attitudes, stereotypes, prejudice, and discrimination.”
Weight discrimination refers to “overt forms of weight-based prejudice and unfair treatment (biased behaviors) toward individuals with overweight or obesity.” The authors noted that some public health efforts “openly embrace stigmatization of individuals with obesity based on the assumption that shame will motivate them to change behavior and achieve weight loss through a self-directed diet and increased physical exercise.”
The result: “Individuals with obesity face not only increased risk of serious medical complications but also a pervasive, resilient form of social stigma. Often perceived (without evidence) as lazy, gluttonous, lacking will power and self-discipline, individuals with overweight or obesity are vulnerable to stigma and discrimination in the workplace, education, healthcare settings, and society in general.”
“Obesity bias is so pervasive that the most common thing I hear when I ask a patient why they’re referred to me is ‘my doctor wants me to lose weight,’” Dr. Cabandugama said. “And the first thing I ask them is ‘what do you want to do?’ They come in because they’ve already been judged, and more often than not, in ways that come across as derogatory or punitive — like it’s their fault.”
Why It Persists
Experts say a big part of the problem is the lack of obesity education in medical school. A recent survey study found that medical schools are not prioritizing obesity in their curricula. Among 40 medical schools responding to the survey, only 10% said they believed their students were “very prepared” to manage patients with obesity, and one third had no obesity education program in place with no plans to develop one.
“Most healthcare providers do not get much meaningful education on obesity during medical school or postgraduate training, and many of their opinions may be influenced by the pervasive weight bias that exists in society,” affirmed Jaime Almandoz, MD, medical director of Weight Wellness Program and associate professor of internal medicine at UT Southwestern Medical Center in Dallas. “We need to prioritize updating education and certification curricula to reflect the current science.”
Small wonder that a recent comparison of explicit weight bias among US resident physicians from 49 medical schools across 16 clinical specialties found “problematic levels” of weight bias — eg, anti-fat blame, anti-fat dislike, and other negative attitudes toward patients — in all specialties.
What to Do
To counteract the stigma, when working with patients who have overweight, “We need to be respectful of them, their bodies, and their health wishes,” Dr. Almandoz told this news organization. “Clinicians should always ask for permission to discuss their weight and frame weight or BMI in the context of health, not just an arbitrary number or goal.”
“Many people with obesity have had traumatic and stigmatizing experiences with well-intentioned healthcare providers,” he noted. “This can lead to the avoidance of routine healthcare and screenings and potential exacerbations and maladaptive health behaviors.”
“Be mindful of the environment that you and your office create for people with obesity,” he advised. “Consider getting additional education and information about weight bias.”
The OAC has resources on obesity bias, including steps clinicians can take to reduce the impact. These include, among others: Encouraging patients to share their experiences of stigma to help them feel less isolated in these experiences; helping them identify ways to effectively cope with stigma, such as using positive “self-talk” and obtaining social support from others; and encouraging participation in activities that they may have restricted due to feelings of shame about their weight.
Clinicians can also improve the physical and social environment of their practice by having bathrooms that are easily negotiated by heavier individuals, sturdy armless chairs in waiting rooms, offices with large exam tables, gowns and blood pressure cuffs in appropriate sizes, and “weight-friendly” reading materials rather than fashion magazines with thin supermodels.
Importantly, clinicians need to address the issue of weight bias within themselves, their medical staff, and colleagues, according to the OAC. To be effective and empathic with individuals affected by obesity “requires honest self-examination of one’s own attitudes and weight bias.”
Dr. Almandoz reported being a consultant/advisory board member for Novo Nordisk, Boehringer Ingelheim, and Eli Lilly and Company. Dr. Cabandugama reported no competing interests.
A version of this article first appeared on Medscape.com.
Experts are debating whether and how to define obesity, but clinicians’ attitudes and behavior toward patients with obesity don’t seem to be undergoing similar scrutiny.
“Despite scientific evidence to the contrary, the prevailing view in society is that obesity is a choice that can be reversed by voluntary decisions to eat less and exercise more,” a multidisciplinary group of 36 international experts wrote in a joint consensus statement for ending the stigma of obesity, published a few years ago in Nature Medicine. “These assumptions mislead public health policies, confuse messages in popular media, undermine access to evidence-based treatments, and compromise advances in research.”
These assumptions also affect how clinicians view and treat their patients.
A systematic review and meta-analysis from Australia using 27 different outcomes to assess weight bias found that “medical doctors, nurses, dietitians, psychologists, physiotherapists, occupational therapists, speech pathologists, podiatrists, and exercise physiologists hold implicit and/or explicit weight-biased attitudes toward people with obesity.”
Another recent systematic review, this one from Brazil, found that obesity bias affected both clinical decision-making and quality of care. Patients with obesity had fewer screening exams for cancer, less-frequent treatment intensification in the management of obesity, and fewer pelvic exams. The authors concluded that their findings “reveal the urgent necessity for reflection and development of strategies to mitigate the adverse impacts” of obesity bias.
“Weight is one of those things that gets judged because it can be seen,” Obesity Society Spokesperson Peminda Cabandugama, MD, of Cleveland Clinic, told this news organization. “People just look at someone with overweight and say, ‘That person needs to eat less and exercise more.’ ”
How Obesity Bias Manifests
The Obesity Action Coalition (OAC), a partner organization to the consensus statement, defines weight bias as “negative attitudes, beliefs, judgments, stereotypes, and discriminatory acts aimed at individuals simply because of their weight. It can be overt or subtle and occur in any setting, including employment, healthcare, education, mass media, and relationships with family and friends.”
The organization notes that weight bias takes many forms, including verbal, written, media, and online.
The consensus statement authors offer these definitions, which encompass the manifestations of obesity bias: Weight stigma refers to “social devaluation and denigration of individuals because of their excess body weight and can lead to negative attitudes, stereotypes, prejudice, and discrimination.”
Weight discrimination refers to “overt forms of weight-based prejudice and unfair treatment (biased behaviors) toward individuals with overweight or obesity.” The authors noted that some public health efforts “openly embrace stigmatization of individuals with obesity based on the assumption that shame will motivate them to change behavior and achieve weight loss through a self-directed diet and increased physical exercise.”
The result: “Individuals with obesity face not only increased risk of serious medical complications but also a pervasive, resilient form of social stigma. Often perceived (without evidence) as lazy, gluttonous, lacking will power and self-discipline, individuals with overweight or obesity are vulnerable to stigma and discrimination in the workplace, education, healthcare settings, and society in general.”
“Obesity bias is so pervasive that the most common thing I hear when I ask a patient why they’re referred to me is ‘my doctor wants me to lose weight,’” Dr. Cabandugama said. “And the first thing I ask them is ‘what do you want to do?’ They come in because they’ve already been judged, and more often than not, in ways that come across as derogatory or punitive — like it’s their fault.”
Why It Persists
Experts say a big part of the problem is the lack of obesity education in medical school. A recent survey study found that medical schools are not prioritizing obesity in their curricula. Among 40 medical schools responding to the survey, only 10% said they believed their students were “very prepared” to manage patients with obesity, and one third had no obesity education program in place with no plans to develop one.
“Most healthcare providers do not get much meaningful education on obesity during medical school or postgraduate training, and many of their opinions may be influenced by the pervasive weight bias that exists in society,” affirmed Jaime Almandoz, MD, medical director of Weight Wellness Program and associate professor of internal medicine at UT Southwestern Medical Center in Dallas. “We need to prioritize updating education and certification curricula to reflect the current science.”
Small wonder that a recent comparison of explicit weight bias among US resident physicians from 49 medical schools across 16 clinical specialties found “problematic levels” of weight bias — eg, anti-fat blame, anti-fat dislike, and other negative attitudes toward patients — in all specialties.
What to Do
To counteract the stigma, when working with patients who have overweight, “We need to be respectful of them, their bodies, and their health wishes,” Dr. Almandoz told this news organization. “Clinicians should always ask for permission to discuss their weight and frame weight or BMI in the context of health, not just an arbitrary number or goal.”
“Many people with obesity have had traumatic and stigmatizing experiences with well-intentioned healthcare providers,” he noted. “This can lead to the avoidance of routine healthcare and screenings and potential exacerbations and maladaptive health behaviors.”
“Be mindful of the environment that you and your office create for people with obesity,” he advised. “Consider getting additional education and information about weight bias.”
The OAC has resources on obesity bias, including steps clinicians can take to reduce the impact. These include, among others: Encouraging patients to share their experiences of stigma to help them feel less isolated in these experiences; helping them identify ways to effectively cope with stigma, such as using positive “self-talk” and obtaining social support from others; and encouraging participation in activities that they may have restricted due to feelings of shame about their weight.
Clinicians can also improve the physical and social environment of their practice by having bathrooms that are easily negotiated by heavier individuals, sturdy armless chairs in waiting rooms, offices with large exam tables, gowns and blood pressure cuffs in appropriate sizes, and “weight-friendly” reading materials rather than fashion magazines with thin supermodels.
Importantly, clinicians need to address the issue of weight bias within themselves, their medical staff, and colleagues, according to the OAC. To be effective and empathic with individuals affected by obesity “requires honest self-examination of one’s own attitudes and weight bias.”
Dr. Almandoz reported being a consultant/advisory board member for Novo Nordisk, Boehringer Ingelheim, and Eli Lilly and Company. Dr. Cabandugama reported no competing interests.
A version of this article first appeared on Medscape.com.
Experts are debating whether and how to define obesity, but clinicians’ attitudes and behavior toward patients with obesity don’t seem to be undergoing similar scrutiny.
“Despite scientific evidence to the contrary, the prevailing view in society is that obesity is a choice that can be reversed by voluntary decisions to eat less and exercise more,” a multidisciplinary group of 36 international experts wrote in a joint consensus statement for ending the stigma of obesity, published a few years ago in Nature Medicine. “These assumptions mislead public health policies, confuse messages in popular media, undermine access to evidence-based treatments, and compromise advances in research.”
These assumptions also affect how clinicians view and treat their patients.
A systematic review and meta-analysis from Australia using 27 different outcomes to assess weight bias found that “medical doctors, nurses, dietitians, psychologists, physiotherapists, occupational therapists, speech pathologists, podiatrists, and exercise physiologists hold implicit and/or explicit weight-biased attitudes toward people with obesity.”
Another recent systematic review, this one from Brazil, found that obesity bias affected both clinical decision-making and quality of care. Patients with obesity had fewer screening exams for cancer, less-frequent treatment intensification in the management of obesity, and fewer pelvic exams. The authors concluded that their findings “reveal the urgent necessity for reflection and development of strategies to mitigate the adverse impacts” of obesity bias.
“Weight is one of those things that gets judged because it can be seen,” Obesity Society Spokesperson Peminda Cabandugama, MD, of Cleveland Clinic, told this news organization. “People just look at someone with overweight and say, ‘That person needs to eat less and exercise more.’ ”
How Obesity Bias Manifests
The Obesity Action Coalition (OAC), a partner organization to the consensus statement, defines weight bias as “negative attitudes, beliefs, judgments, stereotypes, and discriminatory acts aimed at individuals simply because of their weight. It can be overt or subtle and occur in any setting, including employment, healthcare, education, mass media, and relationships with family and friends.”
The organization notes that weight bias takes many forms, including verbal, written, media, and online.
The consensus statement authors offer these definitions, which encompass the manifestations of obesity bias: Weight stigma refers to “social devaluation and denigration of individuals because of their excess body weight and can lead to negative attitudes, stereotypes, prejudice, and discrimination.”
Weight discrimination refers to “overt forms of weight-based prejudice and unfair treatment (biased behaviors) toward individuals with overweight or obesity.” The authors noted that some public health efforts “openly embrace stigmatization of individuals with obesity based on the assumption that shame will motivate them to change behavior and achieve weight loss through a self-directed diet and increased physical exercise.”
The result: “Individuals with obesity face not only increased risk of serious medical complications but also a pervasive, resilient form of social stigma. Often perceived (without evidence) as lazy, gluttonous, lacking will power and self-discipline, individuals with overweight or obesity are vulnerable to stigma and discrimination in the workplace, education, healthcare settings, and society in general.”
“Obesity bias is so pervasive that the most common thing I hear when I ask a patient why they’re referred to me is ‘my doctor wants me to lose weight,’” Dr. Cabandugama said. “And the first thing I ask them is ‘what do you want to do?’ They come in because they’ve already been judged, and more often than not, in ways that come across as derogatory or punitive — like it’s their fault.”
Why It Persists
Experts say a big part of the problem is the lack of obesity education in medical school. A recent survey study found that medical schools are not prioritizing obesity in their curricula. Among 40 medical schools responding to the survey, only 10% said they believed their students were “very prepared” to manage patients with obesity, and one third had no obesity education program in place with no plans to develop one.
“Most healthcare providers do not get much meaningful education on obesity during medical school or postgraduate training, and many of their opinions may be influenced by the pervasive weight bias that exists in society,” affirmed Jaime Almandoz, MD, medical director of Weight Wellness Program and associate professor of internal medicine at UT Southwestern Medical Center in Dallas. “We need to prioritize updating education and certification curricula to reflect the current science.”
Small wonder that a recent comparison of explicit weight bias among US resident physicians from 49 medical schools across 16 clinical specialties found “problematic levels” of weight bias — eg, anti-fat blame, anti-fat dislike, and other negative attitudes toward patients — in all specialties.
What to Do
To counteract the stigma, when working with patients who have overweight, “We need to be respectful of them, their bodies, and their health wishes,” Dr. Almandoz told this news organization. “Clinicians should always ask for permission to discuss their weight and frame weight or BMI in the context of health, not just an arbitrary number or goal.”
“Many people with obesity have had traumatic and stigmatizing experiences with well-intentioned healthcare providers,” he noted. “This can lead to the avoidance of routine healthcare and screenings and potential exacerbations and maladaptive health behaviors.”
“Be mindful of the environment that you and your office create for people with obesity,” he advised. “Consider getting additional education and information about weight bias.”
The OAC has resources on obesity bias, including steps clinicians can take to reduce the impact. These include, among others: Encouraging patients to share their experiences of stigma to help them feel less isolated in these experiences; helping them identify ways to effectively cope with stigma, such as using positive “self-talk” and obtaining social support from others; and encouraging participation in activities that they may have restricted due to feelings of shame about their weight.
Clinicians can also improve the physical and social environment of their practice by having bathrooms that are easily negotiated by heavier individuals, sturdy armless chairs in waiting rooms, offices with large exam tables, gowns and blood pressure cuffs in appropriate sizes, and “weight-friendly” reading materials rather than fashion magazines with thin supermodels.
Importantly, clinicians need to address the issue of weight bias within themselves, their medical staff, and colleagues, according to the OAC. To be effective and empathic with individuals affected by obesity “requires honest self-examination of one’s own attitudes and weight bias.”
Dr. Almandoz reported being a consultant/advisory board member for Novo Nordisk, Boehringer Ingelheim, and Eli Lilly and Company. Dr. Cabandugama reported no competing interests.
A version of this article first appeared on Medscape.com.