Journal of Clinical Outcomes Management

Despite Spain’s lack of a national project or standard protocol for biomarker testing, more than half of patients diagnosed with stage 4 non–small cell lung cancer (NSCLC) are tested for biomarkers, according to a Spanish national registry study reported at the 2022 European Lung Cancer Congress.

“In recent years we’ve developed drugs that target biomarkers, so it’s important to identify those biomarkers to guide treatment and have an impact on the survival of our patients,” said lead author Virginia Calvo, MD, a medical oncologist with the Puerta de Hierro Majadahonda University Hospital, Madrid.

“If we don’t know our patients’ biomarkers, we can’t treat them with targeted therapies,” she added, noting that the overall survival of lung cancer patients has increased by 15% in the last 10 years, largely because of better therapies such as targeted drugs for advanced stage disease and immunotherapies.

To assess the status of biomarker testing in Spain, Dr. Calvo and colleagues analyzed data from the country’s Thoracic Tumor Registry on 9,239 patients diagnosed with metastatic NSCLC from 2016 to the present, 7,467 (81%) with nonsquamous tumors and 1,772 (19%) with squamous tumors.

They found that 85% of patients with nonsquamous NSCLC and about 53% of those with squamous cancers had undergone biomarker testing. They discovered that 4,115 (44%) of patients tested positive for EGFR, ALK, KRAS, BRAF, ROS1, or PD-L1.

Dr. Calvo attributes the widespread use of biomarker testing and its significant increase in the last 5 years to the growing knowledge and understanding of the disease.

“We are learning more about NSCLC, and I think in the next few years the number of biomarkers are going to grow,” she said.

The study’s findings also highlight the importance of establishing and maintaining cancer registries, Dr. Calvo said, noting that 182 hospitals across Spain and more than 550 experts participate in the Thoracic Tumors Registry, which includes data on patients from every Spanish territory.

“It’s important to collect information on real-life cancer care so that we know what our real situation is and take steps to improve it,” she said.

She anticipates that treatment for NSCLC patients will become increasingly complex in the future with the growing number of different biomarkers and the proportion of patients who test positive for them. “We may need to establish national strategies to implement next generation sequencing so that we can identify different biomarkers and improve the survival of our patients.”

In a press release, Rolf Stahel, MD, president of the European Thoracic Oncology Platform, said that it would be helpful to look at how frequently molecular testing led to patients receiving appropriate targeted treatment.

In the United States, the National Comprehensive Cancer Network recommends biomarker testing for eligible patients with newly diagnosed stage 4 NSCLC, and it can be considered for patients with squamous histology because 5%-10% of these tumors have targetable mutations. “This is because numerous lines of evidence show that patients with stage 4 NSCLC and a targetable mutation, typically have improved overall survival when treated with a targeted therapy,” wrote the authors of the NCCN recommendations.

“For newly diagnosed stage 4 NSCLC, there is always a tension between the need to start therapy versus waiting for molecular results. This is because if a recommended targeted option is identified, it is the optimal first-line therapy. Targeted therapy cannot be given to everyone. Different biomarkers predict response to different agents. This has been well illustrated and it makes testing critically important for patients with NSCLC,” Dara Aisner, MD, PhD, associate professor of pathology with the University of Colorado at Denver, Aurora, wrote in the NCCN guideline.

The study presented at ELCC was funded by a grant from the European Union’s Horizon 2020 Research and Innovation Program. Dr. Calvo has received fees from Roche, Bristol-Myers Squibb, MSD and AstraZeneca.

Despite Spain’s lack of a national project or standard protocol for biomarker testing, more than half of patients diagnosed with stage 4 non–small cell lung cancer (NSCLC) are tested for biomarkers, according to a Spanish national registry study reported at the 2022 European Lung Cancer Congress.

“In recent years we’ve developed drugs that target biomarkers, so it’s important to identify those biomarkers to guide treatment and have an impact on the survival of our patients,” said lead author Virginia Calvo, MD, a medical oncologist with the Puerta de Hierro Majadahonda University Hospital, Madrid.

“If we don’t know our patients’ biomarkers, we can’t treat them with targeted therapies,” she added, noting that the overall survival of lung cancer patients has increased by 15% in the last 10 years, largely because of better therapies such as targeted drugs for advanced stage disease and immunotherapies.

To assess the status of biomarker testing in Spain, Dr. Calvo and colleagues analyzed data from the country’s Thoracic Tumor Registry on 9,239 patients diagnosed with metastatic NSCLC from 2016 to the present, 7,467 (81%) with nonsquamous tumors and 1,772 (19%) with squamous tumors.

They found that 85% of patients with nonsquamous NSCLC and about 53% of those with squamous cancers had undergone biomarker testing. They discovered that 4,115 (44%) of patients tested positive for EGFR, ALK, KRAS, BRAF, ROS1, or PD-L1.

Dr. Calvo attributes the widespread use of biomarker testing and its significant increase in the last 5 years to the growing knowledge and understanding of the disease.

“We are learning more about NSCLC, and I think in the next few years the number of biomarkers are going to grow,” she said.

The study’s findings also highlight the importance of establishing and maintaining cancer registries, Dr. Calvo said, noting that 182 hospitals across Spain and more than 550 experts participate in the Thoracic Tumors Registry, which includes data on patients from every Spanish territory.

“It’s important to collect information on real-life cancer care so that we know what our real situation is and take steps to improve it,” she said.

She anticipates that treatment for NSCLC patients will become increasingly complex in the future with the growing number of different biomarkers and the proportion of patients who test positive for them. “We may need to establish national strategies to implement next generation sequencing so that we can identify different biomarkers and improve the survival of our patients.”

In a press release, Rolf Stahel, MD, president of the European Thoracic Oncology Platform, said that it would be helpful to look at how frequently molecular testing led to patients receiving appropriate targeted treatment.

In the United States, the National Comprehensive Cancer Network recommends biomarker testing for eligible patients with newly diagnosed stage 4 NSCLC, and it can be considered for patients with squamous histology because 5%-10% of these tumors have targetable mutations. “This is because numerous lines of evidence show that patients with stage 4 NSCLC and a targetable mutation, typically have improved overall survival when treated with a targeted therapy,” wrote the authors of the NCCN recommendations.

“For newly diagnosed stage 4 NSCLC, there is always a tension between the need to start therapy versus waiting for molecular results. This is because if a recommended targeted option is identified, it is the optimal first-line therapy. Targeted therapy cannot be given to everyone. Different biomarkers predict response to different agents. This has been well illustrated and it makes testing critically important for patients with NSCLC,” Dara Aisner, MD, PhD, associate professor of pathology with the University of Colorado at Denver, Aurora, wrote in the NCCN guideline.

The study presented at ELCC was funded by a grant from the European Union’s Horizon 2020 Research and Innovation Program. Dr. Calvo has received fees from Roche, Bristol-Myers Squibb, MSD and AstraZeneca.

Despite Spain’s lack of a national project or standard protocol for biomarker testing, more than half of patients diagnosed with stage 4 non–small cell lung cancer (NSCLC) are tested for biomarkers, according to a Spanish national registry study reported at the 2022 European Lung Cancer Congress.

“In recent years we’ve developed drugs that target biomarkers, so it’s important to identify those biomarkers to guide treatment and have an impact on the survival of our patients,” said lead author Virginia Calvo, MD, a medical oncologist with the Puerta de Hierro Majadahonda University Hospital, Madrid.

“If we don’t know our patients’ biomarkers, we can’t treat them with targeted therapies,” she added, noting that the overall survival of lung cancer patients has increased by 15% in the last 10 years, largely because of better therapies such as targeted drugs for advanced stage disease and immunotherapies.

To assess the status of biomarker testing in Spain, Dr. Calvo and colleagues analyzed data from the country’s Thoracic Tumor Registry on 9,239 patients diagnosed with metastatic NSCLC from 2016 to the present, 7,467 (81%) with nonsquamous tumors and 1,772 (19%) with squamous tumors.

They found that 85% of patients with nonsquamous NSCLC and about 53% of those with squamous cancers had undergone biomarker testing. They discovered that 4,115 (44%) of patients tested positive for EGFR, ALK, KRAS, BRAF, ROS1, or PD-L1.

Dr. Calvo attributes the widespread use of biomarker testing and its significant increase in the last 5 years to the growing knowledge and understanding of the disease.

“We are learning more about NSCLC, and I think in the next few years the number of biomarkers are going to grow,” she said.

The study’s findings also highlight the importance of establishing and maintaining cancer registries, Dr. Calvo said, noting that 182 hospitals across Spain and more than 550 experts participate in the Thoracic Tumors Registry, which includes data on patients from every Spanish territory.

“It’s important to collect information on real-life cancer care so that we know what our real situation is and take steps to improve it,” she said.

She anticipates that treatment for NSCLC patients will become increasingly complex in the future with the growing number of different biomarkers and the proportion of patients who test positive for them. “We may need to establish national strategies to implement next generation sequencing so that we can identify different biomarkers and improve the survival of our patients.”

In a press release, Rolf Stahel, MD, president of the European Thoracic Oncology Platform, said that it would be helpful to look at how frequently molecular testing led to patients receiving appropriate targeted treatment.

In the United States, the National Comprehensive Cancer Network recommends biomarker testing for eligible patients with newly diagnosed stage 4 NSCLC, and it can be considered for patients with squamous histology because 5%-10% of these tumors have targetable mutations. “This is because numerous lines of evidence show that patients with stage 4 NSCLC and a targetable mutation, typically have improved overall survival when treated with a targeted therapy,” wrote the authors of the NCCN recommendations.

“For newly diagnosed stage 4 NSCLC, there is always a tension between the need to start therapy versus waiting for molecular results. This is because if a recommended targeted option is identified, it is the optimal first-line therapy. Targeted therapy cannot be given to everyone. Different biomarkers predict response to different agents. This has been well illustrated and it makes testing critically important for patients with NSCLC,” Dara Aisner, MD, PhD, associate professor of pathology with the University of Colorado at Denver, Aurora, wrote in the NCCN guideline.

The study presented at ELCC was funded by a grant from the European Union’s Horizon 2020 Research and Innovation Program. Dr. Calvo has received fees from Roche, Bristol-Myers Squibb, MSD and AstraZeneca.

About 30% of COVID-19 patients developed the condition known as long COVID, University of California, Los Angeles, researchers said in a study published in the Journal of General Internal Medicine.

The UCLA researchers studied 1,038 people enrolled in the UCLA COVID Ambulatory Program between April 2020 and February 2021 and found that 309 developed long COVID.

A long-COVID diagnosis came if a patient answering a questionnaire reported persistent symptoms 60-90 days after they were infected or hospitalized. The most persistent symptoms were fatigue (31%) and shortness of breath (15%) in hospitalized participants. Among outpatients, 16% reported losing sense of smell.

The study’s findings differ from earlier research. The University of California, Davis, for example, estimated that 10% of COVID-19 patients develop long-haul symptoms. A 2021 study from Penn State University found that more than half of worldwide COVID-19 patients would develop long COVID.

Part of the discrepancy can blamed on the fact there is no official, widely accepted definition of long COVID. The Centers for Disease Control and Prevention has said it means patients who experience “new, returning, or ongoing health problems 4 or more weeks after an initial infection” the coronavirus. The UCLA study, meanwhile, included patients still having symptoms 60-90 days after infection.

Still, the UCLA research team looked at demographics and clinical characteristics in an attempt to develop effective treatments.

People with a history of hospitalization, diabetes, and higher body mass index were most likely to develop long COVID, the researchers said. The kind of insurance the patients had also seemed to be a factor, though the researchers didn’t offer a reason why.

“Surprisingly, patients with commercial insurance had double the likelihood of developing [long COVID] compared to patients with Medicaid,” they wrote. “This association will be important to explore further to understand if insurance status in this group is representing unmeasured demographic factors or exposures.”

Older age and socioeconomic status were not associated with long COVID in the study – a surprise because those characteristics are often linked with severe illness and higher risk of death from COVID-19.

Weaknesses in the study included the subjective nature of how patients rated their symptoms and the limited number of symptoms evaluated.

“This study illustrates the need to follow diverse patient populations ... to understand the long COVID disease trajectory and evaluate how individual factors such as preexisting comorbidities, sociodemographic factors, vaccination status and virus variant type affect type and persistence of long COVID symptoms,” said Sun Yoo, MD, health sciences assistant clinical professor at UCLA.

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

About 30% of COVID-19 patients developed the condition known as long COVID, University of California, Los Angeles, researchers said in a study published in the Journal of General Internal Medicine.

The UCLA researchers studied 1,038 people enrolled in the UCLA COVID Ambulatory Program between April 2020 and February 2021 and found that 309 developed long COVID.

A long-COVID diagnosis came if a patient answering a questionnaire reported persistent symptoms 60-90 days after they were infected or hospitalized. The most persistent symptoms were fatigue (31%) and shortness of breath (15%) in hospitalized participants. Among outpatients, 16% reported losing sense of smell.

The study’s findings differ from earlier research. The University of California, Davis, for example, estimated that 10% of COVID-19 patients develop long-haul symptoms. A 2021 study from Penn State University found that more than half of worldwide COVID-19 patients would develop long COVID.

Part of the discrepancy can blamed on the fact there is no official, widely accepted definition of long COVID. The Centers for Disease Control and Prevention has said it means patients who experience “new, returning, or ongoing health problems 4 or more weeks after an initial infection” the coronavirus. The UCLA study, meanwhile, included patients still having symptoms 60-90 days after infection.

Still, the UCLA research team looked at demographics and clinical characteristics in an attempt to develop effective treatments.

People with a history of hospitalization, diabetes, and higher body mass index were most likely to develop long COVID, the researchers said. The kind of insurance the patients had also seemed to be a factor, though the researchers didn’t offer a reason why.

“Surprisingly, patients with commercial insurance had double the likelihood of developing [long COVID] compared to patients with Medicaid,” they wrote. “This association will be important to explore further to understand if insurance status in this group is representing unmeasured demographic factors or exposures.”

Older age and socioeconomic status were not associated with long COVID in the study – a surprise because those characteristics are often linked with severe illness and higher risk of death from COVID-19.

Weaknesses in the study included the subjective nature of how patients rated their symptoms and the limited number of symptoms evaluated.

“This study illustrates the need to follow diverse patient populations ... to understand the long COVID disease trajectory and evaluate how individual factors such as preexisting comorbidities, sociodemographic factors, vaccination status and virus variant type affect type and persistence of long COVID symptoms,” said Sun Yoo, MD, health sciences assistant clinical professor at UCLA.

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

About 30% of COVID-19 patients developed the condition known as long COVID, University of California, Los Angeles, researchers said in a study published in the Journal of General Internal Medicine.

The UCLA researchers studied 1,038 people enrolled in the UCLA COVID Ambulatory Program between April 2020 and February 2021 and found that 309 developed long COVID.

A long-COVID diagnosis came if a patient answering a questionnaire reported persistent symptoms 60-90 days after they were infected or hospitalized. The most persistent symptoms were fatigue (31%) and shortness of breath (15%) in hospitalized participants. Among outpatients, 16% reported losing sense of smell.

The study’s findings differ from earlier research. The University of California, Davis, for example, estimated that 10% of COVID-19 patients develop long-haul symptoms. A 2021 study from Penn State University found that more than half of worldwide COVID-19 patients would develop long COVID.

Part of the discrepancy can blamed on the fact there is no official, widely accepted definition of long COVID. The Centers for Disease Control and Prevention has said it means patients who experience “new, returning, or ongoing health problems 4 or more weeks after an initial infection” the coronavirus. The UCLA study, meanwhile, included patients still having symptoms 60-90 days after infection.

Still, the UCLA research team looked at demographics and clinical characteristics in an attempt to develop effective treatments.

People with a history of hospitalization, diabetes, and higher body mass index were most likely to develop long COVID, the researchers said. The kind of insurance the patients had also seemed to be a factor, though the researchers didn’t offer a reason why.

“Surprisingly, patients with commercial insurance had double the likelihood of developing [long COVID] compared to patients with Medicaid,” they wrote. “This association will be important to explore further to understand if insurance status in this group is representing unmeasured demographic factors or exposures.”

Older age and socioeconomic status were not associated with long COVID in the study – a surprise because those characteristics are often linked with severe illness and higher risk of death from COVID-19.

Weaknesses in the study included the subjective nature of how patients rated their symptoms and the limited number of symptoms evaluated.

“This study illustrates the need to follow diverse patient populations ... to understand the long COVID disease trajectory and evaluate how individual factors such as preexisting comorbidities, sociodemographic factors, vaccination status and virus variant type affect type and persistence of long COVID symptoms,” said Sun Yoo, MD, health sciences assistant clinical professor at UCLA.

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

Not so fast! Daily fasting with calorie restriction may not lead to shedding more pounds than just cutting back on calories, according to the authors of a new study.

Over the course of a year, study participants who ate only from 8:00 a.m. to 4:00 p.m. did not lose significantly more weight than individuals who ate whenever they wanted, nor did they achieve significantly greater improvements in other obesity-related health measures like body mass index (BMI) or metabolic risk, reported lead author Deying Liu, MD, of Nanfang Hospital, Southern Medical University, Guangzhou, China, and colleagues.

“[Daily fasting] has gained popularity because it is a weight-loss strategy that is simple to follow, which may enhance adherence,” Dr. Liu and colleagues wrote in the New England Journal of Medicine. However, “the long-term efficacy and safety of time-restricted eating as a weight-loss strategy are still uncertain, and the long-term effects on weight loss of time-restricted eating as compared with daily calorie restriction alone have not been fully explored.”

To learn more, Dr. Liu and colleagues recruited 139 adult patients with BMIs between 28 and 45. Individuals with serious medical conditions, such as malignant tumors, diabetes, chronic kidney disease, and others were excluded. Other exclusion criteria included smoking, ongoing participation in a weight-loss program, GI surgery within the prior year, use of medications that impact energy balance and weight, and planned or current pregnancy.

All participants were advised to eat calorie-restricted diets, with ranges of 1,500-1,800 kcal per day for men and 1,200-1,500 kcal per day for women. To determine the added impact of fasting, participants were randomized in a 1:1 ratio into time-restricted (fasting) or non–time-restricted (nonfasting) groups, in which fasting participants ate only during an 8-hour window from 8:00 a.m. to 4:00 p.m., whereas nonfasting participants ate whenever they wanted.

At 6 months and 12 months, participants were re-evaluated for changes in weight, body fat, BMI, blood pressure, lean body mass, and metabolic risk factors, including glucose level, triglycerides, blood pressure, and others.
 

Caloric intake restriction seems to explain most of beneficial effects

At one-year follow-up, 118 participants (84.9%) remained in the study. Although members of the fasting group lost slightly more weight on average than those in the non-fasting group (mean, 8.0 kg vs. 6.3 kg), the difference between groups was not statistically significant (95% confidence interval, −4.0 to 0.4; P = .11).

Most of the other obesity-related health measures also trended toward favoring the fasting group, but again, none of these improvements was statistically significant. Weight circumference at 1 year, for example, decreased by a mean of 9.4 cm in the fasting group versus 8.8 cm in the nonfasting group, a net difference of 1.8 cm (95% CI, –4.0 to 0.5).

“We found that the two weight-loss regimens that we evaluated had similar success in patients with obesity, regardless of whether they reduced their calorie consumption through time-restricted eating or through calorie restriction alone,” Dr. Liu and colleagues concluded.

Principal investigator Huijie Zhang MD, PhD, professor, chief physician, and deputy director of the department of endocrinology and metabolism at Nafang Hospital, noted that their findings are “consistent with the findings in previous studies.”

“Our data suggest that caloric intake restriction explained most of the beneficial effects of a time-restricted eating regimen,” Dr. Zhang said.

Still, Dr. Zhang called time-restricted eating “a viable and sustainable approach for a person who wants to lose weight.”

More work is needed, Dr. Zhang said, to uncover the impact of fasting in “diverse groups,” including patients with chronic disease like diabetes and cardiovascular disease. Investigators should also conduct studies to compare outcomes between men and women, and evaluate the effects of other fasting durations.
 

Can trial be applied to a wider population?

According to Blandine Laferrère, MD, PhD, and Satchidananda Panda, PhD, of Columbia University Irving Medical Center, New York, and the Salk Institute for Biological Studies, La Jolla, Calif., respectively, “the results of the trial suggest that calorie restriction combined with time restriction, when delivered with intensive coaching and monitoring, is an approach that is as safe, sustainable, and effective for weight loss as calorie restriction alone.”

Yet Dr. Laferrère and Dr. Panda also expressed skepticism about broader implementation of a similar regime.

“The applicability of this trial to wider populations is debatable,” they wrote in an accompanying editorial. “The short time period for eating at baseline may be specific to the population studied, since investigators outside China have reported longer time windows. The rigorous coaching and monitoring by trial staff also leaves open the question of whether time-restricted eating is easier to adhere to than intentional calorie restriction. Such cost-benefit analyses are important for the assessment of the scalability of a lifestyle intervention.”
 

Duration is trial’s greatest strength

Kristina Varady, PhD, professor of nutrition in the department of kinesiology and nutrition at the University of Illinois at Chicago, said the “key strength” of the trial was its duration, at 12 months, making it the longest time-restricted eating trial to date”; however, she was critical of the design.

“Quite frankly, I’m surprised this study got into such a high-caliber medical journal,” Dr. Varady said in a written comment. “It doesn’t even have a control group! It goes to show how popular these diets are and how much people want to know about them.”

She also noted that “the study was flawed in that it didn’t really look at the effects of true time-restricted eating.” According to Dr. Varady, combining calorie restriction with time-restricted eating “kind of defeats the purpose” of a time-restricted diet.

“The main benefit of time-restricted eating is that you don’t need to count calories in order to lose weight,” Dr. Varady said, citing two of her own studies from 2018 and 2020. “Just by limiting the eating window to 8 hours per day, people naturally cut out 300-500 calories per day. That’s why people like [time-restricted eating] so much.”

Dr. Varady was also “very surprised” at the adherence data. At 1 year, approximately 85% of the patients were still following the protocol, a notably higher rate than most dietary intervention studies, which typically report adherence rates of 50-60%, she said. The high adherence rate was particularly unexpected because of the 8:00 a.m.–4:00 p.m. eating window, Dr. Varady added, since that meant skipping “the family/social meal every evening over 1 whole year!”

The study was funded by the National Key Research and Development Project and others. The study investigators reported no conflicts of interest. Dr. Varady disclosed author fees from the Hachette Book group for her book “The Every Other Day Diet.”

Not so fast! Daily fasting with calorie restriction may not lead to shedding more pounds than just cutting back on calories, according to the authors of a new study.

Over the course of a year, study participants who ate only from 8:00 a.m. to 4:00 p.m. did not lose significantly more weight than individuals who ate whenever they wanted, nor did they achieve significantly greater improvements in other obesity-related health measures like body mass index (BMI) or metabolic risk, reported lead author Deying Liu, MD, of Nanfang Hospital, Southern Medical University, Guangzhou, China, and colleagues.

“[Daily fasting] has gained popularity because it is a weight-loss strategy that is simple to follow, which may enhance adherence,” Dr. Liu and colleagues wrote in the New England Journal of Medicine. However, “the long-term efficacy and safety of time-restricted eating as a weight-loss strategy are still uncertain, and the long-term effects on weight loss of time-restricted eating as compared with daily calorie restriction alone have not been fully explored.”

To learn more, Dr. Liu and colleagues recruited 139 adult patients with BMIs between 28 and 45. Individuals with serious medical conditions, such as malignant tumors, diabetes, chronic kidney disease, and others were excluded. Other exclusion criteria included smoking, ongoing participation in a weight-loss program, GI surgery within the prior year, use of medications that impact energy balance and weight, and planned or current pregnancy.

All participants were advised to eat calorie-restricted diets, with ranges of 1,500-1,800 kcal per day for men and 1,200-1,500 kcal per day for women. To determine the added impact of fasting, participants were randomized in a 1:1 ratio into time-restricted (fasting) or non–time-restricted (nonfasting) groups, in which fasting participants ate only during an 8-hour window from 8:00 a.m. to 4:00 p.m., whereas nonfasting participants ate whenever they wanted.

At 6 months and 12 months, participants were re-evaluated for changes in weight, body fat, BMI, blood pressure, lean body mass, and metabolic risk factors, including glucose level, triglycerides, blood pressure, and others.
 

Caloric intake restriction seems to explain most of beneficial effects

At one-year follow-up, 118 participants (84.9%) remained in the study. Although members of the fasting group lost slightly more weight on average than those in the non-fasting group (mean, 8.0 kg vs. 6.3 kg), the difference between groups was not statistically significant (95% confidence interval, −4.0 to 0.4; P = .11).

Most of the other obesity-related health measures also trended toward favoring the fasting group, but again, none of these improvements was statistically significant. Weight circumference at 1 year, for example, decreased by a mean of 9.4 cm in the fasting group versus 8.8 cm in the nonfasting group, a net difference of 1.8 cm (95% CI, –4.0 to 0.5).

“We found that the two weight-loss regimens that we evaluated had similar success in patients with obesity, regardless of whether they reduced their calorie consumption through time-restricted eating or through calorie restriction alone,” Dr. Liu and colleagues concluded.

Principal investigator Huijie Zhang MD, PhD, professor, chief physician, and deputy director of the department of endocrinology and metabolism at Nafang Hospital, noted that their findings are “consistent with the findings in previous studies.”

“Our data suggest that caloric intake restriction explained most of the beneficial effects of a time-restricted eating regimen,” Dr. Zhang said.

Still, Dr. Zhang called time-restricted eating “a viable and sustainable approach for a person who wants to lose weight.”

More work is needed, Dr. Zhang said, to uncover the impact of fasting in “diverse groups,” including patients with chronic disease like diabetes and cardiovascular disease. Investigators should also conduct studies to compare outcomes between men and women, and evaluate the effects of other fasting durations.
 

Can trial be applied to a wider population?

According to Blandine Laferrère, MD, PhD, and Satchidananda Panda, PhD, of Columbia University Irving Medical Center, New York, and the Salk Institute for Biological Studies, La Jolla, Calif., respectively, “the results of the trial suggest that calorie restriction combined with time restriction, when delivered with intensive coaching and monitoring, is an approach that is as safe, sustainable, and effective for weight loss as calorie restriction alone.”

Yet Dr. Laferrère and Dr. Panda also expressed skepticism about broader implementation of a similar regime.

“The applicability of this trial to wider populations is debatable,” they wrote in an accompanying editorial. “The short time period for eating at baseline may be specific to the population studied, since investigators outside China have reported longer time windows. The rigorous coaching and monitoring by trial staff also leaves open the question of whether time-restricted eating is easier to adhere to than intentional calorie restriction. Such cost-benefit analyses are important for the assessment of the scalability of a lifestyle intervention.”
 

Duration is trial’s greatest strength

Kristina Varady, PhD, professor of nutrition in the department of kinesiology and nutrition at the University of Illinois at Chicago, said the “key strength” of the trial was its duration, at 12 months, making it the longest time-restricted eating trial to date”; however, she was critical of the design.

“Quite frankly, I’m surprised this study got into such a high-caliber medical journal,” Dr. Varady said in a written comment. “It doesn’t even have a control group! It goes to show how popular these diets are and how much people want to know about them.”

She also noted that “the study was flawed in that it didn’t really look at the effects of true time-restricted eating.” According to Dr. Varady, combining calorie restriction with time-restricted eating “kind of defeats the purpose” of a time-restricted diet.

“The main benefit of time-restricted eating is that you don’t need to count calories in order to lose weight,” Dr. Varady said, citing two of her own studies from 2018 and 2020. “Just by limiting the eating window to 8 hours per day, people naturally cut out 300-500 calories per day. That’s why people like [time-restricted eating] so much.”

Dr. Varady was also “very surprised” at the adherence data. At 1 year, approximately 85% of the patients were still following the protocol, a notably higher rate than most dietary intervention studies, which typically report adherence rates of 50-60%, she said. The high adherence rate was particularly unexpected because of the 8:00 a.m.–4:00 p.m. eating window, Dr. Varady added, since that meant skipping “the family/social meal every evening over 1 whole year!”

The study was funded by the National Key Research and Development Project and others. The study investigators reported no conflicts of interest. Dr. Varady disclosed author fees from the Hachette Book group for her book “The Every Other Day Diet.”

Not so fast! Daily fasting with calorie restriction may not lead to shedding more pounds than just cutting back on calories, according to the authors of a new study.

Over the course of a year, study participants who ate only from 8:00 a.m. to 4:00 p.m. did not lose significantly more weight than individuals who ate whenever they wanted, nor did they achieve significantly greater improvements in other obesity-related health measures like body mass index (BMI) or metabolic risk, reported lead author Deying Liu, MD, of Nanfang Hospital, Southern Medical University, Guangzhou, China, and colleagues.

“[Daily fasting] has gained popularity because it is a weight-loss strategy that is simple to follow, which may enhance adherence,” Dr. Liu and colleagues wrote in the New England Journal of Medicine. However, “the long-term efficacy and safety of time-restricted eating as a weight-loss strategy are still uncertain, and the long-term effects on weight loss of time-restricted eating as compared with daily calorie restriction alone have not been fully explored.”

To learn more, Dr. Liu and colleagues recruited 139 adult patients with BMIs between 28 and 45. Individuals with serious medical conditions, such as malignant tumors, diabetes, chronic kidney disease, and others were excluded. Other exclusion criteria included smoking, ongoing participation in a weight-loss program, GI surgery within the prior year, use of medications that impact energy balance and weight, and planned or current pregnancy.

All participants were advised to eat calorie-restricted diets, with ranges of 1,500-1,800 kcal per day for men and 1,200-1,500 kcal per day for women. To determine the added impact of fasting, participants were randomized in a 1:1 ratio into time-restricted (fasting) or non–time-restricted (nonfasting) groups, in which fasting participants ate only during an 8-hour window from 8:00 a.m. to 4:00 p.m., whereas nonfasting participants ate whenever they wanted.

At 6 months and 12 months, participants were re-evaluated for changes in weight, body fat, BMI, blood pressure, lean body mass, and metabolic risk factors, including glucose level, triglycerides, blood pressure, and others.
 

Caloric intake restriction seems to explain most of beneficial effects

At one-year follow-up, 118 participants (84.9%) remained in the study. Although members of the fasting group lost slightly more weight on average than those in the non-fasting group (mean, 8.0 kg vs. 6.3 kg), the difference between groups was not statistically significant (95% confidence interval, −4.0 to 0.4; P = .11).

Most of the other obesity-related health measures also trended toward favoring the fasting group, but again, none of these improvements was statistically significant. Weight circumference at 1 year, for example, decreased by a mean of 9.4 cm in the fasting group versus 8.8 cm in the nonfasting group, a net difference of 1.8 cm (95% CI, –4.0 to 0.5).

“We found that the two weight-loss regimens that we evaluated had similar success in patients with obesity, regardless of whether they reduced their calorie consumption through time-restricted eating or through calorie restriction alone,” Dr. Liu and colleagues concluded.

Principal investigator Huijie Zhang MD, PhD, professor, chief physician, and deputy director of the department of endocrinology and metabolism at Nafang Hospital, noted that their findings are “consistent with the findings in previous studies.”

“Our data suggest that caloric intake restriction explained most of the beneficial effects of a time-restricted eating regimen,” Dr. Zhang said.

Still, Dr. Zhang called time-restricted eating “a viable and sustainable approach for a person who wants to lose weight.”

More work is needed, Dr. Zhang said, to uncover the impact of fasting in “diverse groups,” including patients with chronic disease like diabetes and cardiovascular disease. Investigators should also conduct studies to compare outcomes between men and women, and evaluate the effects of other fasting durations.
 

Can trial be applied to a wider population?

According to Blandine Laferrère, MD, PhD, and Satchidananda Panda, PhD, of Columbia University Irving Medical Center, New York, and the Salk Institute for Biological Studies, La Jolla, Calif., respectively, “the results of the trial suggest that calorie restriction combined with time restriction, when delivered with intensive coaching and monitoring, is an approach that is as safe, sustainable, and effective for weight loss as calorie restriction alone.”

Yet Dr. Laferrère and Dr. Panda also expressed skepticism about broader implementation of a similar regime.

“The applicability of this trial to wider populations is debatable,” they wrote in an accompanying editorial. “The short time period for eating at baseline may be specific to the population studied, since investigators outside China have reported longer time windows. The rigorous coaching and monitoring by trial staff also leaves open the question of whether time-restricted eating is easier to adhere to than intentional calorie restriction. Such cost-benefit analyses are important for the assessment of the scalability of a lifestyle intervention.”
 

Duration is trial’s greatest strength

Kristina Varady, PhD, professor of nutrition in the department of kinesiology and nutrition at the University of Illinois at Chicago, said the “key strength” of the trial was its duration, at 12 months, making it the longest time-restricted eating trial to date”; however, she was critical of the design.

“Quite frankly, I’m surprised this study got into such a high-caliber medical journal,” Dr. Varady said in a written comment. “It doesn’t even have a control group! It goes to show how popular these diets are and how much people want to know about them.”

She also noted that “the study was flawed in that it didn’t really look at the effects of true time-restricted eating.” According to Dr. Varady, combining calorie restriction with time-restricted eating “kind of defeats the purpose” of a time-restricted diet.

“The main benefit of time-restricted eating is that you don’t need to count calories in order to lose weight,” Dr. Varady said, citing two of her own studies from 2018 and 2020. “Just by limiting the eating window to 8 hours per day, people naturally cut out 300-500 calories per day. That’s why people like [time-restricted eating] so much.”

Dr. Varady was also “very surprised” at the adherence data. At 1 year, approximately 85% of the patients were still following the protocol, a notably higher rate than most dietary intervention studies, which typically report adherence rates of 50-60%, she said. The high adherence rate was particularly unexpected because of the 8:00 a.m.–4:00 p.m. eating window, Dr. Varady added, since that meant skipping “the family/social meal every evening over 1 whole year!”

The study was funded by the National Key Research and Development Project and others. The study investigators reported no conflicts of interest. Dr. Varady disclosed author fees from the Hachette Book group for her book “The Every Other Day Diet.”

Peripheral muscle fatigue was the most common cause of exercise limitation in patients recovered from COVID-19 regardless of disease severity, in a study of nearly 300 individuals.

The source and magnitude of exercise intolerance in post–COVID-19 patients has not been well studied, said Mauricio Milani, MD, of Fitcordis Exercise Medicine Clinic, Brasilia, Brazil, in a presentation at the annual congress of the European Association of Preventive Cardiology.

Midas Anim/Shutterstock

To assess exercise intolerance, the researchers performed cardiopulmonary exercise testing (CPET) on 144 adults who had recovered from COVID-19 and 144 matched controls who had not had COVID-19. The average age of the participants was 43 years, and 57% were male. COVID-19 was defined as mild, moderate, or severe in 60%, 21%, and 19% of the cases, respectively.

Residual symptoms were present in 41% of cases. CPET was performed at roughly 14 weeks after disease onset.

Among the COVID-19 patients, most of the CPET limitations (92%) were caused by muscle fatigue; cardiovascular limitations were noted in 2%, and pulmonary limitations were noted in 6%.

Data from the post-COVID CPET showed differences in peak oxygen consumption, as well as the first and second ventilatory thresholds (VT1 and VT2) between COVID-19 patients and controls, and with lower values related to higher illness severities, Dr. Milani said. Heart rate also varied according to illness severity, with lower values significantly related to higher illness severities and significant differences between COVID patients and controls.

A total of 42 individuals with COVID-19 had previous CPET data for comparison (27 with mild disease and 15 with moderate or severe disease), Dr. Milani said. In the subgroup with mild disease, the only significant difference in CPET results before and after COVID-19 was peak speed. In the moderate/severe group, the researchers observed higher reductions in peak speed and also reductions in oxygen consumption at peak and thresholds.

However, peak oxygen flows were not different before and after COVID-19 in either the mild or moderate/severe subgroups, Dr. Milani said.

The study findings were limited in part by the relatively small study population; however, the results indicate that peripheral muscle fatigue is the primary etiology in exercise limitation in post–COVID-19 patients.

“Our data suggest that treatment should emphasize comprehensive rehabilitation programs, including aerobic and muscle strengthening components,” Dr. Milani concluded.

COVID challenges remain unclear

“After COVID, patients often display a postviral syndrome with a wide range of symptoms,” Matthew Martinez, MD, a sports cardiologist at the Atlantic Health System in Morristown, N.J., in an interview said. “These conditions frequently lead to a sense of tiredness and weakness, pain, difficulty concentrating, and headaches that linger after the viral infection has cleared,” and these symptoms may continue for weeks.

However, this scenario is not unique to COVID-19: “This study confirms the importance of muscle fatigue in recovery,” said Dr. Martinez. “Recovery from viral illness requires hydration, sleep and slow progression return to exercise.” Consequently, Dr. Martinez said he was not surprised by the current study findings.

The take-home message for clinicians is to be aware that COVID-19 can have postviral syndrome, as is common after other infections, Dr. Martinez noted. The findings provide a starting point for discussing concerns with patients and explaining that a slow return to normal with usual care is expected. “Time to recovery will vary by individual,” he said. “Additional research is needed to identify which specific therapies are most important to help reduce time to recovery, and what new therapies could be developed to help facilitate muscle fatigue recovery and reduce time needed to recover.”

The study was supported by CAPES and CNPq. Dr. Milani had no financial conflicts to disclose. Dr. Martinez had no financial conflicts to disclose.

Peripheral muscle fatigue was the most common cause of exercise limitation in patients recovered from COVID-19 regardless of disease severity, in a study of nearly 300 individuals.

The source and magnitude of exercise intolerance in post–COVID-19 patients has not been well studied, said Mauricio Milani, MD, of Fitcordis Exercise Medicine Clinic, Brasilia, Brazil, in a presentation at the annual congress of the European Association of Preventive Cardiology.

Midas Anim/Shutterstock

To assess exercise intolerance, the researchers performed cardiopulmonary exercise testing (CPET) on 144 adults who had recovered from COVID-19 and 144 matched controls who had not had COVID-19. The average age of the participants was 43 years, and 57% were male. COVID-19 was defined as mild, moderate, or severe in 60%, 21%, and 19% of the cases, respectively.

Residual symptoms were present in 41% of cases. CPET was performed at roughly 14 weeks after disease onset.

Among the COVID-19 patients, most of the CPET limitations (92%) were caused by muscle fatigue; cardiovascular limitations were noted in 2%, and pulmonary limitations were noted in 6%.

Data from the post-COVID CPET showed differences in peak oxygen consumption, as well as the first and second ventilatory thresholds (VT1 and VT2) between COVID-19 patients and controls, and with lower values related to higher illness severities, Dr. Milani said. Heart rate also varied according to illness severity, with lower values significantly related to higher illness severities and significant differences between COVID patients and controls.

A total of 42 individuals with COVID-19 had previous CPET data for comparison (27 with mild disease and 15 with moderate or severe disease), Dr. Milani said. In the subgroup with mild disease, the only significant difference in CPET results before and after COVID-19 was peak speed. In the moderate/severe group, the researchers observed higher reductions in peak speed and also reductions in oxygen consumption at peak and thresholds.

However, peak oxygen flows were not different before and after COVID-19 in either the mild or moderate/severe subgroups, Dr. Milani said.

The study findings were limited in part by the relatively small study population; however, the results indicate that peripheral muscle fatigue is the primary etiology in exercise limitation in post–COVID-19 patients.

“Our data suggest that treatment should emphasize comprehensive rehabilitation programs, including aerobic and muscle strengthening components,” Dr. Milani concluded.

COVID challenges remain unclear

“After COVID, patients often display a postviral syndrome with a wide range of symptoms,” Matthew Martinez, MD, a sports cardiologist at the Atlantic Health System in Morristown, N.J., in an interview said. “These conditions frequently lead to a sense of tiredness and weakness, pain, difficulty concentrating, and headaches that linger after the viral infection has cleared,” and these symptoms may continue for weeks.

However, this scenario is not unique to COVID-19: “This study confirms the importance of muscle fatigue in recovery,” said Dr. Martinez. “Recovery from viral illness requires hydration, sleep and slow progression return to exercise.” Consequently, Dr. Martinez said he was not surprised by the current study findings.

The take-home message for clinicians is to be aware that COVID-19 can have postviral syndrome, as is common after other infections, Dr. Martinez noted. The findings provide a starting point for discussing concerns with patients and explaining that a slow return to normal with usual care is expected. “Time to recovery will vary by individual,” he said. “Additional research is needed to identify which specific therapies are most important to help reduce time to recovery, and what new therapies could be developed to help facilitate muscle fatigue recovery and reduce time needed to recover.”

The study was supported by CAPES and CNPq. Dr. Milani had no financial conflicts to disclose. Dr. Martinez had no financial conflicts to disclose.

Peripheral muscle fatigue was the most common cause of exercise limitation in patients recovered from COVID-19 regardless of disease severity, in a study of nearly 300 individuals.

The source and magnitude of exercise intolerance in post–COVID-19 patients has not been well studied, said Mauricio Milani, MD, of Fitcordis Exercise Medicine Clinic, Brasilia, Brazil, in a presentation at the annual congress of the European Association of Preventive Cardiology.

Midas Anim/Shutterstock

To assess exercise intolerance, the researchers performed cardiopulmonary exercise testing (CPET) on 144 adults who had recovered from COVID-19 and 144 matched controls who had not had COVID-19. The average age of the participants was 43 years, and 57% were male. COVID-19 was defined as mild, moderate, or severe in 60%, 21%, and 19% of the cases, respectively.

Residual symptoms were present in 41% of cases. CPET was performed at roughly 14 weeks after disease onset.

Among the COVID-19 patients, most of the CPET limitations (92%) were caused by muscle fatigue; cardiovascular limitations were noted in 2%, and pulmonary limitations were noted in 6%.

Data from the post-COVID CPET showed differences in peak oxygen consumption, as well as the first and second ventilatory thresholds (VT1 and VT2) between COVID-19 patients and controls, and with lower values related to higher illness severities, Dr. Milani said. Heart rate also varied according to illness severity, with lower values significantly related to higher illness severities and significant differences between COVID patients and controls.

A total of 42 individuals with COVID-19 had previous CPET data for comparison (27 with mild disease and 15 with moderate or severe disease), Dr. Milani said. In the subgroup with mild disease, the only significant difference in CPET results before and after COVID-19 was peak speed. In the moderate/severe group, the researchers observed higher reductions in peak speed and also reductions in oxygen consumption at peak and thresholds.

However, peak oxygen flows were not different before and after COVID-19 in either the mild or moderate/severe subgroups, Dr. Milani said.

The study findings were limited in part by the relatively small study population; however, the results indicate that peripheral muscle fatigue is the primary etiology in exercise limitation in post–COVID-19 patients.

“Our data suggest that treatment should emphasize comprehensive rehabilitation programs, including aerobic and muscle strengthening components,” Dr. Milani concluded.

COVID challenges remain unclear

“After COVID, patients often display a postviral syndrome with a wide range of symptoms,” Matthew Martinez, MD, a sports cardiologist at the Atlantic Health System in Morristown, N.J., in an interview said. “These conditions frequently lead to a sense of tiredness and weakness, pain, difficulty concentrating, and headaches that linger after the viral infection has cleared,” and these symptoms may continue for weeks.

However, this scenario is not unique to COVID-19: “This study confirms the importance of muscle fatigue in recovery,” said Dr. Martinez. “Recovery from viral illness requires hydration, sleep and slow progression return to exercise.” Consequently, Dr. Martinez said he was not surprised by the current study findings.

The take-home message for clinicians is to be aware that COVID-19 can have postviral syndrome, as is common after other infections, Dr. Martinez noted. The findings provide a starting point for discussing concerns with patients and explaining that a slow return to normal with usual care is expected. “Time to recovery will vary by individual,” he said. “Additional research is needed to identify which specific therapies are most important to help reduce time to recovery, and what new therapies could be developed to help facilitate muscle fatigue recovery and reduce time needed to recover.”

The study was supported by CAPES and CNPq. Dr. Milani had no financial conflicts to disclose. Dr. Martinez had no financial conflicts to disclose.

Can’t sleep? When slumber doesn’t come naturally, some are turning to melatonin, an over-the-counter sleep aid that often is mistaken for a supplement. This powerful hormone plays an important role in human biology, and specialists are questioning whether increasing levels could be doing more harm than good.

A new investigation launched by the American Academy of Sleep Medicine is looking into the safety of melatonin. And while the health advisory checking the evidence is underway, the academy is recommending that melatonin not be used for insomnia in adults or children.

But what is insomnia, and how is it different from a few bad nights of sleep? Insomnia disturbs sleep at least three times a week for more than 3 months, often causing people to feel tired during the day as well.

Production of melatonin (dubbed the “vampire hormone”) begins at night, when it starts getting dark outside. Melatonin release is scheduled by the small but mighty pineal gland at the back of the head. Melatonin signals to the body that it’s time to sleep. And as the sun rises and light shines, melatonin levels decline again to help the body wake.

Sometimes packaged in gummy bear fruit flavors, melatonin can have an alluring appeal to sleep-deprived parents looking for relief for themselves and their children.

Muhammad Adeel Rishi, MD, vice chair of the public safety committee for the American Academy of Sleep Medicine, said he has a doctor colleague who started taking melatonin to help him during the pandemic when he was having trouble falling asleep at night. His doctor friend started giving the hormone to his own children, who were also having sleep issues.

But Dr. Rishi said there are important reasons to not use melatonin for insomnia until more information is available.

Melatonin affects sleep, but this hormone also influences other functions in the body. “It has an impact on body temperature, blood sugar, and even the tone of blood vessels,” Dr. Rishi said.

And because melatonin is available over the counter in the United States, it hasn’t been approved as a medicine under the Food and Drug Administration. A previous study of melatonin products, for instance, flagged problems with inconsistent doses, which make it hard for people to know exactly how much they are getting and prompted calls for more FDA oversight.
 

Imprecise doses

While melatonin doses typically range from 1 to 5 milligrams, bottles examined have been off target with much more or less hormone in the product than listed on the label.

Researchers from the University of Guelph (Ont.), tested 30 commercially available formulas and found the melatonin content varied from the ingredients labeled on the bottles by more than 10%. In addition to melatonin, the researchers found other substances in the bottles too: In about a quarter of the products, they also identified serotonin.
 

Impurities

While melatonin plays a role in setting the body’s biological clock and the sleep and wake cycle, serotonin is also at work. Occurring naturally in our bodies, serotonin is involved in mood and helps with deep REM sleep. But adding serotonin in unknown amounts could be unhealthy.

Dr. Rishi said it can be dangerous to use a product as a medication when doses can be so off and there are unknown byproducts in it.

Serotonin can influence the heart, blood vessels, and brain, so it’s not something Dr. Rishi wants to see people taking without paying attention. People taking medication for mood disorders could be especially affected by the serotonin in their sleep aid, he warns.

For anyone taking melatonin, Dr. Rishi recommended they check the bottle to see whether they are using a product with a USP-verified check mark, which indicates that the product meets the standards of the U.S. Pharmacopeia Convention.

The risk of impurities is a good reason for kids to not be given the hormone, but another worry is whether melatonin interferes with puberty in children – which is also a question researchers at the Children’s Hospital of Eastern Ontario in Ottawa are asking.
 

Disrupting puberty

While short-term melatonin use is considered safe, the researchers reported, concerns that long-term use might delay children’s sexual maturation require more study. One theory is that nightly melatonin use might interrupt the decline of natural hormone levels and interfere with the start of puberty.

Researchers from the Children’s Hospital of Michigan in Detroit also reported an uptick in accidental ingestion of melatonin in children. Kids got their hands on melatonin and swallowed too many capsules more often than other pill-related mishaps during the pandemic.

Dr. Rishi said more research is needed to assess the safe use of melatonin in children. He points out that the hormone can treat circadian rhythm disorders in adults.

While specialists weigh the benefits and risks of melatonin use and where it is safest to try, Dr. Rishi said the hormone does have a role in medicine.

Melatonin will probably need to be regulated by the FDA as a medication – especially for children – Dr. Rishi pointed out. And what place, if any, it will have for managing chronic insomnia is “a big question mark.”

Results of the investigation by the American Academy of Sleep Medicine will be published on its sleepeducation.org website in a few months.

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

Can’t sleep? When slumber doesn’t come naturally, some are turning to melatonin, an over-the-counter sleep aid that often is mistaken for a supplement. This powerful hormone plays an important role in human biology, and specialists are questioning whether increasing levels could be doing more harm than good.

A new investigation launched by the American Academy of Sleep Medicine is looking into the safety of melatonin. And while the health advisory checking the evidence is underway, the academy is recommending that melatonin not be used for insomnia in adults or children.

But what is insomnia, and how is it different from a few bad nights of sleep? Insomnia disturbs sleep at least three times a week for more than 3 months, often causing people to feel tired during the day as well.

Production of melatonin (dubbed the “vampire hormone”) begins at night, when it starts getting dark outside. Melatonin release is scheduled by the small but mighty pineal gland at the back of the head. Melatonin signals to the body that it’s time to sleep. And as the sun rises and light shines, melatonin levels decline again to help the body wake.

Sometimes packaged in gummy bear fruit flavors, melatonin can have an alluring appeal to sleep-deprived parents looking for relief for themselves and their children.

Muhammad Adeel Rishi, MD, vice chair of the public safety committee for the American Academy of Sleep Medicine, said he has a doctor colleague who started taking melatonin to help him during the pandemic when he was having trouble falling asleep at night. His doctor friend started giving the hormone to his own children, who were also having sleep issues.

But Dr. Rishi said there are important reasons to not use melatonin for insomnia until more information is available.

Melatonin affects sleep, but this hormone also influences other functions in the body. “It has an impact on body temperature, blood sugar, and even the tone of blood vessels,” Dr. Rishi said.

And because melatonin is available over the counter in the United States, it hasn’t been approved as a medicine under the Food and Drug Administration. A previous study of melatonin products, for instance, flagged problems with inconsistent doses, which make it hard for people to know exactly how much they are getting and prompted calls for more FDA oversight.
 

Imprecise doses

While melatonin doses typically range from 1 to 5 milligrams, bottles examined have been off target with much more or less hormone in the product than listed on the label.

Researchers from the University of Guelph (Ont.), tested 30 commercially available formulas and found the melatonin content varied from the ingredients labeled on the bottles by more than 10%. In addition to melatonin, the researchers found other substances in the bottles too: In about a quarter of the products, they also identified serotonin.
 

Impurities

While melatonin plays a role in setting the body’s biological clock and the sleep and wake cycle, serotonin is also at work. Occurring naturally in our bodies, serotonin is involved in mood and helps with deep REM sleep. But adding serotonin in unknown amounts could be unhealthy.

Dr. Rishi said it can be dangerous to use a product as a medication when doses can be so off and there are unknown byproducts in it.

Serotonin can influence the heart, blood vessels, and brain, so it’s not something Dr. Rishi wants to see people taking without paying attention. People taking medication for mood disorders could be especially affected by the serotonin in their sleep aid, he warns.

For anyone taking melatonin, Dr. Rishi recommended they check the bottle to see whether they are using a product with a USP-verified check mark, which indicates that the product meets the standards of the U.S. Pharmacopeia Convention.

The risk of impurities is a good reason for kids to not be given the hormone, but another worry is whether melatonin interferes with puberty in children – which is also a question researchers at the Children’s Hospital of Eastern Ontario in Ottawa are asking.
 

Disrupting puberty

While short-term melatonin use is considered safe, the researchers reported, concerns that long-term use might delay children’s sexual maturation require more study. One theory is that nightly melatonin use might interrupt the decline of natural hormone levels and interfere with the start of puberty.

Researchers from the Children’s Hospital of Michigan in Detroit also reported an uptick in accidental ingestion of melatonin in children. Kids got their hands on melatonin and swallowed too many capsules more often than other pill-related mishaps during the pandemic.

Dr. Rishi said more research is needed to assess the safe use of melatonin in children. He points out that the hormone can treat circadian rhythm disorders in adults.

While specialists weigh the benefits and risks of melatonin use and where it is safest to try, Dr. Rishi said the hormone does have a role in medicine.

Melatonin will probably need to be regulated by the FDA as a medication – especially for children – Dr. Rishi pointed out. And what place, if any, it will have for managing chronic insomnia is “a big question mark.”

Results of the investigation by the American Academy of Sleep Medicine will be published on its sleepeducation.org website in a few months.

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

Can’t sleep? When slumber doesn’t come naturally, some are turning to melatonin, an over-the-counter sleep aid that often is mistaken for a supplement. This powerful hormone plays an important role in human biology, and specialists are questioning whether increasing levels could be doing more harm than good.

A new investigation launched by the American Academy of Sleep Medicine is looking into the safety of melatonin. And while the health advisory checking the evidence is underway, the academy is recommending that melatonin not be used for insomnia in adults or children.

But what is insomnia, and how is it different from a few bad nights of sleep? Insomnia disturbs sleep at least three times a week for more than 3 months, often causing people to feel tired during the day as well.

Production of melatonin (dubbed the “vampire hormone”) begins at night, when it starts getting dark outside. Melatonin release is scheduled by the small but mighty pineal gland at the back of the head. Melatonin signals to the body that it’s time to sleep. And as the sun rises and light shines, melatonin levels decline again to help the body wake.

Sometimes packaged in gummy bear fruit flavors, melatonin can have an alluring appeal to sleep-deprived parents looking for relief for themselves and their children.

Muhammad Adeel Rishi, MD, vice chair of the public safety committee for the American Academy of Sleep Medicine, said he has a doctor colleague who started taking melatonin to help him during the pandemic when he was having trouble falling asleep at night. His doctor friend started giving the hormone to his own children, who were also having sleep issues.

But Dr. Rishi said there are important reasons to not use melatonin for insomnia until more information is available.

Melatonin affects sleep, but this hormone also influences other functions in the body. “It has an impact on body temperature, blood sugar, and even the tone of blood vessels,” Dr. Rishi said.

And because melatonin is available over the counter in the United States, it hasn’t been approved as a medicine under the Food and Drug Administration. A previous study of melatonin products, for instance, flagged problems with inconsistent doses, which make it hard for people to know exactly how much they are getting and prompted calls for more FDA oversight.
 

Imprecise doses

While melatonin doses typically range from 1 to 5 milligrams, bottles examined have been off target with much more or less hormone in the product than listed on the label.

Researchers from the University of Guelph (Ont.), tested 30 commercially available formulas and found the melatonin content varied from the ingredients labeled on the bottles by more than 10%. In addition to melatonin, the researchers found other substances in the bottles too: In about a quarter of the products, they also identified serotonin.
 

Impurities

While melatonin plays a role in setting the body’s biological clock and the sleep and wake cycle, serotonin is also at work. Occurring naturally in our bodies, serotonin is involved in mood and helps with deep REM sleep. But adding serotonin in unknown amounts could be unhealthy.

Dr. Rishi said it can be dangerous to use a product as a medication when doses can be so off and there are unknown byproducts in it.

Serotonin can influence the heart, blood vessels, and brain, so it’s not something Dr. Rishi wants to see people taking without paying attention. People taking medication for mood disorders could be especially affected by the serotonin in their sleep aid, he warns.

For anyone taking melatonin, Dr. Rishi recommended they check the bottle to see whether they are using a product with a USP-verified check mark, which indicates that the product meets the standards of the U.S. Pharmacopeia Convention.

The risk of impurities is a good reason for kids to not be given the hormone, but another worry is whether melatonin interferes with puberty in children – which is also a question researchers at the Children’s Hospital of Eastern Ontario in Ottawa are asking.
 

Disrupting puberty

While short-term melatonin use is considered safe, the researchers reported, concerns that long-term use might delay children’s sexual maturation require more study. One theory is that nightly melatonin use might interrupt the decline of natural hormone levels and interfere with the start of puberty.

Researchers from the Children’s Hospital of Michigan in Detroit also reported an uptick in accidental ingestion of melatonin in children. Kids got their hands on melatonin and swallowed too many capsules more often than other pill-related mishaps during the pandemic.

Dr. Rishi said more research is needed to assess the safe use of melatonin in children. He points out that the hormone can treat circadian rhythm disorders in adults.

While specialists weigh the benefits and risks of melatonin use and where it is safest to try, Dr. Rishi said the hormone does have a role in medicine.

Melatonin will probably need to be regulated by the FDA as a medication – especially for children – Dr. Rishi pointed out. And what place, if any, it will have for managing chronic insomnia is “a big question mark.”

Results of the investigation by the American Academy of Sleep Medicine will be published on its sleepeducation.org website in a few months.

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

Poverty is known to be associated with poor health outcomes throughout life. Now, new research has shown that, from as early as the second trimester of pregnancy, fetuses are already feeling the effects of poverty.

“There is a well-recognized health inequality where quality and duration of life are lower among the most poor. This divide is present both within and between countries,” said Steve Turner, who led the study.

Given the association of poverty and low birth weight, the authors of the new multi-national study, published in the Journal of Epidemiology and Community Health, hypothesized that “individuals from highest household income compared to those with lowest household income will have increased fetal size in the second and third trimester and birth.”

For their study, researchers from the University of Aberdeen gathered details of ante-natal and birth size – second and third trimester fetal ultrasound measurements of estimated fetal weight, biparietal diameter, and femur length, as well as birth measurements of weight, occipitofrontal circumference, and crown heel length – from eight cohorts that included 21,714 individuals from nations including Scotland, England, Saudi Arabia, the U.S., Netherlands, Spain, Norway, Sweden, and France.

They then related these to household income, taking into account other factors, including mother’s age, height, number of other children, and smoking, analyzing the data using cross-sectional two-stage individual patient data analyses and a longitudinal one-stage individual patient data analysis.
 

Household income closely related to birth size

The authors found that higher household income was associated with larger fetal head size and weight but not length, from the second half of pregnancy, compared with lowest household income. They said that their results argue for “a relationship where household income is closely related to birth size.”

The results showed that, across the countries studied, babies were smaller at birth if they came from a lower income household, and this discrepancy in size was already apparent at 20 weeks gestation.

“This is the first time that size differences have been found at such an early stage of development,” the authors said, “and also the first time it has been compared across continents.”

Professor Turner pointed out that “what this study shows is that the inequality, as seen by reduced size in fetal life, is present long before birth, and this poverty gap widens between twenty weeks gestation and birth.”

He added: “Basically, regardless of whether you live in Saudi, the U.S., or Europe, and accounting for things that might affect fetal growth, if your parents are poor, you will be smaller before birth and at birth compared to if your parents were not poor.”
 

Increase engagement with pregnant mothers living in poverty

He emphasized how this was problematic, as small size before and after birth puts an individual at “increased risk for many serious illnesses in later life.”

The authors hope that this study will encourage health care providers to recognize the health risks associated with lower income for mothers and their unborn children and to provide more support and guidance to mitigate the risks.

They said, “interventions aimed at softening the impact of poverty on pregnant mothers could reduce incidence of small for gestational age and the associated burden of excessive morbidity and mortality throughout the life course.”

Professor Turner described how the mechanisms that drive this inequity may be explained by pregnant mothers from poor households having difficulty in accessing or engaging with antenatal care. 

“We would like to see health care providers around the world strive to increase engagement with pregnant mothers living in poverty,” he said. “This engagement will reward all of society by putting unborn children on a trajectory to longer and healthier lives.”

A version of this article first appeared on Medscape UK.

Poverty is known to be associated with poor health outcomes throughout life. Now, new research has shown that, from as early as the second trimester of pregnancy, fetuses are already feeling the effects of poverty.

“There is a well-recognized health inequality where quality and duration of life are lower among the most poor. This divide is present both within and between countries,” said Steve Turner, who led the study.

Given the association of poverty and low birth weight, the authors of the new multi-national study, published in the Journal of Epidemiology and Community Health, hypothesized that “individuals from highest household income compared to those with lowest household income will have increased fetal size in the second and third trimester and birth.”

For their study, researchers from the University of Aberdeen gathered details of ante-natal and birth size – second and third trimester fetal ultrasound measurements of estimated fetal weight, biparietal diameter, and femur length, as well as birth measurements of weight, occipitofrontal circumference, and crown heel length – from eight cohorts that included 21,714 individuals from nations including Scotland, England, Saudi Arabia, the U.S., Netherlands, Spain, Norway, Sweden, and France.

They then related these to household income, taking into account other factors, including mother’s age, height, number of other children, and smoking, analyzing the data using cross-sectional two-stage individual patient data analyses and a longitudinal one-stage individual patient data analysis.
 

Household income closely related to birth size

The authors found that higher household income was associated with larger fetal head size and weight but not length, from the second half of pregnancy, compared with lowest household income. They said that their results argue for “a relationship where household income is closely related to birth size.”

The results showed that, across the countries studied, babies were smaller at birth if they came from a lower income household, and this discrepancy in size was already apparent at 20 weeks gestation.

“This is the first time that size differences have been found at such an early stage of development,” the authors said, “and also the first time it has been compared across continents.”

Professor Turner pointed out that “what this study shows is that the inequality, as seen by reduced size in fetal life, is present long before birth, and this poverty gap widens between twenty weeks gestation and birth.”

He added: “Basically, regardless of whether you live in Saudi, the U.S., or Europe, and accounting for things that might affect fetal growth, if your parents are poor, you will be smaller before birth and at birth compared to if your parents were not poor.”
 

Increase engagement with pregnant mothers living in poverty

He emphasized how this was problematic, as small size before and after birth puts an individual at “increased risk for many serious illnesses in later life.”

The authors hope that this study will encourage health care providers to recognize the health risks associated with lower income for mothers and their unborn children and to provide more support and guidance to mitigate the risks.

They said, “interventions aimed at softening the impact of poverty on pregnant mothers could reduce incidence of small for gestational age and the associated burden of excessive morbidity and mortality throughout the life course.”

Professor Turner described how the mechanisms that drive this inequity may be explained by pregnant mothers from poor households having difficulty in accessing or engaging with antenatal care. 

“We would like to see health care providers around the world strive to increase engagement with pregnant mothers living in poverty,” he said. “This engagement will reward all of society by putting unborn children on a trajectory to longer and healthier lives.”

A version of this article first appeared on Medscape UK.

Poverty is known to be associated with poor health outcomes throughout life. Now, new research has shown that, from as early as the second trimester of pregnancy, fetuses are already feeling the effects of poverty.

“There is a well-recognized health inequality where quality and duration of life are lower among the most poor. This divide is present both within and between countries,” said Steve Turner, who led the study.

Given the association of poverty and low birth weight, the authors of the new multi-national study, published in the Journal of Epidemiology and Community Health, hypothesized that “individuals from highest household income compared to those with lowest household income will have increased fetal size in the second and third trimester and birth.”

For their study, researchers from the University of Aberdeen gathered details of ante-natal and birth size – second and third trimester fetal ultrasound measurements of estimated fetal weight, biparietal diameter, and femur length, as well as birth measurements of weight, occipitofrontal circumference, and crown heel length – from eight cohorts that included 21,714 individuals from nations including Scotland, England, Saudi Arabia, the U.S., Netherlands, Spain, Norway, Sweden, and France.

They then related these to household income, taking into account other factors, including mother’s age, height, number of other children, and smoking, analyzing the data using cross-sectional two-stage individual patient data analyses and a longitudinal one-stage individual patient data analysis.
 

Household income closely related to birth size

The authors found that higher household income was associated with larger fetal head size and weight but not length, from the second half of pregnancy, compared with lowest household income. They said that their results argue for “a relationship where household income is closely related to birth size.”

The results showed that, across the countries studied, babies were smaller at birth if they came from a lower income household, and this discrepancy in size was already apparent at 20 weeks gestation.

“This is the first time that size differences have been found at such an early stage of development,” the authors said, “and also the first time it has been compared across continents.”

Professor Turner pointed out that “what this study shows is that the inequality, as seen by reduced size in fetal life, is present long before birth, and this poverty gap widens between twenty weeks gestation and birth.”

He added: “Basically, regardless of whether you live in Saudi, the U.S., or Europe, and accounting for things that might affect fetal growth, if your parents are poor, you will be smaller before birth and at birth compared to if your parents were not poor.”
 

Increase engagement with pregnant mothers living in poverty

He emphasized how this was problematic, as small size before and after birth puts an individual at “increased risk for many serious illnesses in later life.”

The authors hope that this study will encourage health care providers to recognize the health risks associated with lower income for mothers and their unborn children and to provide more support and guidance to mitigate the risks.

They said, “interventions aimed at softening the impact of poverty on pregnant mothers could reduce incidence of small for gestational age and the associated burden of excessive morbidity and mortality throughout the life course.”

Professor Turner described how the mechanisms that drive this inequity may be explained by pregnant mothers from poor households having difficulty in accessing or engaging with antenatal care. 

“We would like to see health care providers around the world strive to increase engagement with pregnant mothers living in poverty,” he said. “This engagement will reward all of society by putting unborn children on a trajectory to longer and healthier lives.”

A version of this article first appeared on Medscape UK.

Sips of pickle juice may be all it takes to lessen the severity of muscle cramps in adults with cirrhosis, according to results of the PICCLES randomized controlled trial.

In the trial, patients with cirrhotic cramps who sipped pickle brine at the onset of a muscle cramp saw a significant decrease in cramp severity relative to peers who sipped tap water when the cramp hit.

“The acid (vinegar) in the brine triggers a nerve reflex to stop the cramp when it hits the throat. This is why only a sip is needed,” lead investigator Elliot Tapper, MD, division of gastroenterology and hepatology, University of Michigan, Ann Arbor, told this news organization. The study was published online April 13 in American Journal of Gastroenterology.
 

Common and bothersome

Cramps are common in adults with cirrhosis, irrespective of disease severity. They can sometimes last for hours, and treatment options are limited.

In a prior study, 1 tablespoon of pickle juice rapidly stopped experimentally induced cramps.

“This is something that athletes use, and kidney doctors often recommend to their patients, so it is nothing unique to cirrhosis,” Dr. Tapper said.

The PICCLES trial involved 74 adults (mean age, 56.6 years) with at least 4 muscle cramps in the prior month. In the cohort, 54% were men, and 41% had ascites.

The median cramp frequency was 11-12 per month, with an average cramp severity of more than 4 out of 10 on the Visual Analog Scale (VAS) for cramps. 

Some patients were receiving medications for their cramps at baseline, such as magnesium, potassium, baclofen, vitamin E, taurine, and gabapentin/pregabalin.

Thirty-eight patients were randomly allocated to sip pickle juice and 36 to sip tap water at the onset of a muscle cramp.

The proportion of cramps treated was similar in the pickle juice and tap water groups (77% and 72%). More patients in the pickle juice group said their cramps were aborted by the intervention (69% vs. 40%).

The primary outcome was the change in cramp severity at 28-days VAS for cramps. Cramps were assessed 10 times over 28 days using interactive text messages.

Pickle juice was associated with a larger average reduction in cramp severity than tap water (–2.25 points vs. –0.36 on the VAS-cramps), a difference that was statistically significant (P = .03).

There were no significant changes in the proportion of days with cramp severity of more than 5 on the VAS, or on sleep quality or health-related quality of life. 

Because pickle juice contains sodium, the researchers also assessed weight change as a safety outcome. They found no significant differences in weight change between the two groups overall or in the subset with ascites.

Pickle juice is a “safe option that can stop painful cramps,” Dr. Tapper said in an interview, but was “disheartened” that it did not improve quality of life.

Dr. Tapper encourages patients with cramps to ask their doctor about pickle juice and doctors to ask their patients about muscle cramps.

“Awareness of a patient’s cramps is often lacking. Asking about cramps is not routine but could be the most important advance relating to this study,” he said.

While sips of pickle juice are “unlikely to cause harm,” Dr. Tapper said, he is “a little nervous about advising patients to address their complex needs alone. [Doctors] are there to think through the root causes and help make adjustments that could prevent the cramps in the first place,” he said.
 

Outside experts weigh in

This news organization reached out to several outside experts for their perspective on the study.

Nancy Reau, MD, professor of internal medicine, associate director of solid organ transplantation, and section chief of hepatology. Rush University Medical Center, Chicago, noted that interventions to manage and prevent muscle cramps are “important, as cramping is common in cirrhosis and strongly affects quality of life.”

Dr. Reau cautioned that while pickle juice “sounds benign, it does have a lot of salt. Despite the salt content, this study didn’t show any difference between patients with and without ascites.

“However, cramping is more common in our patients with sarcopenia and those on diuretics for fluid management and it would be easy to see how this might impact fluid management,” Dr. Reau noted.

“Given that it is the acid (not the salt) in the pickle juice, there might be low salt alternatives,” Dr. Reau said.

Echoing Dr. Reau, Ankur Shah, MD, division of kidney disease and hypertension, Brown University, Providence, R.I., noted that “overuse of pickle juice could place patients at risk of developing high blood pressure and fluid overload, and pickle juice should be included in the sodium restriction guidance given to patients with high blood pressure and heart failure.”

In this study, however, the individual dose consumed was low, Dr. Shah noted.

He said the study “elegantly provides evidence to support the practice of sipping pickle juice for cramping.”

The authors should be “applauded for studying a simple solution with the most rigorous of methodologies, a randomized controlled trial,” Dr. Shah added.  

“This simple treatment may be helpful to patients far beyond those with just cirrhosis, and expect future studies to explore this treatment in other populations,” Dr. Shah said in an interview.

Paul Martin, MD, chief of the division of digestive health and liver diseases and Mandel Chair in Gastroenterology, University of Miami, noted that, while muscle cramps can have a major impact on quality of life, “in terms of some of the other complications of cirrhosis that health care providers are dealing with, they may seem relatively innocuous, but obviously patients have a slightly different interpretation because of the effect cramps can have on sleep and so on.

“There have been a variety of home remedies to treat muscle cramps, but this study is intriguing as it suggests that pickle juice, which is freely available, helps mitigate the severity of the cramps. However, it’s unclear whether it prevents cramps,” Dr. Martin said in an interview.

Given that the study is getting traction on Twitter, Dr. Martin encouraged health care providers to be aware of the study and prepared to answer questions from patients.

The study had no specific funding. Dr. Tapper has served as a consultant to Novartis, Axcella, and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has received unrestricted research grants from Gilead and Valeant. Dr. Reau, Dr. Shah, and Dr. Martin have disclosed no relevant financial relationships.

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

Sips of pickle juice may be all it takes to lessen the severity of muscle cramps in adults with cirrhosis, according to results of the PICCLES randomized controlled trial.

In the trial, patients with cirrhotic cramps who sipped pickle brine at the onset of a muscle cramp saw a significant decrease in cramp severity relative to peers who sipped tap water when the cramp hit.

“The acid (vinegar) in the brine triggers a nerve reflex to stop the cramp when it hits the throat. This is why only a sip is needed,” lead investigator Elliot Tapper, MD, division of gastroenterology and hepatology, University of Michigan, Ann Arbor, told this news organization. The study was published online April 13 in American Journal of Gastroenterology.
 

Common and bothersome

Cramps are common in adults with cirrhosis, irrespective of disease severity. They can sometimes last for hours, and treatment options are limited.

In a prior study, 1 tablespoon of pickle juice rapidly stopped experimentally induced cramps.

“This is something that athletes use, and kidney doctors often recommend to their patients, so it is nothing unique to cirrhosis,” Dr. Tapper said.

The PICCLES trial involved 74 adults (mean age, 56.6 years) with at least 4 muscle cramps in the prior month. In the cohort, 54% were men, and 41% had ascites.

The median cramp frequency was 11-12 per month, with an average cramp severity of more than 4 out of 10 on the Visual Analog Scale (VAS) for cramps. 

Some patients were receiving medications for their cramps at baseline, such as magnesium, potassium, baclofen, vitamin E, taurine, and gabapentin/pregabalin.

Thirty-eight patients were randomly allocated to sip pickle juice and 36 to sip tap water at the onset of a muscle cramp.

The proportion of cramps treated was similar in the pickle juice and tap water groups (77% and 72%). More patients in the pickle juice group said their cramps were aborted by the intervention (69% vs. 40%).

The primary outcome was the change in cramp severity at 28-days VAS for cramps. Cramps were assessed 10 times over 28 days using interactive text messages.

Pickle juice was associated with a larger average reduction in cramp severity than tap water (–2.25 points vs. –0.36 on the VAS-cramps), a difference that was statistically significant (P = .03).

There were no significant changes in the proportion of days with cramp severity of more than 5 on the VAS, or on sleep quality or health-related quality of life. 

Because pickle juice contains sodium, the researchers also assessed weight change as a safety outcome. They found no significant differences in weight change between the two groups overall or in the subset with ascites.

Pickle juice is a “safe option that can stop painful cramps,” Dr. Tapper said in an interview, but was “disheartened” that it did not improve quality of life.

Dr. Tapper encourages patients with cramps to ask their doctor about pickle juice and doctors to ask their patients about muscle cramps.

“Awareness of a patient’s cramps is often lacking. Asking about cramps is not routine but could be the most important advance relating to this study,” he said.

While sips of pickle juice are “unlikely to cause harm,” Dr. Tapper said, he is “a little nervous about advising patients to address their complex needs alone. [Doctors] are there to think through the root causes and help make adjustments that could prevent the cramps in the first place,” he said.
 

Outside experts weigh in

This news organization reached out to several outside experts for their perspective on the study.

Nancy Reau, MD, professor of internal medicine, associate director of solid organ transplantation, and section chief of hepatology. Rush University Medical Center, Chicago, noted that interventions to manage and prevent muscle cramps are “important, as cramping is common in cirrhosis and strongly affects quality of life.”

Dr. Reau cautioned that while pickle juice “sounds benign, it does have a lot of salt. Despite the salt content, this study didn’t show any difference between patients with and without ascites.

“However, cramping is more common in our patients with sarcopenia and those on diuretics for fluid management and it would be easy to see how this might impact fluid management,” Dr. Reau noted.

“Given that it is the acid (not the salt) in the pickle juice, there might be low salt alternatives,” Dr. Reau said.

Echoing Dr. Reau, Ankur Shah, MD, division of kidney disease and hypertension, Brown University, Providence, R.I., noted that “overuse of pickle juice could place patients at risk of developing high blood pressure and fluid overload, and pickle juice should be included in the sodium restriction guidance given to patients with high blood pressure and heart failure.”

In this study, however, the individual dose consumed was low, Dr. Shah noted.

He said the study “elegantly provides evidence to support the practice of sipping pickle juice for cramping.”

The authors should be “applauded for studying a simple solution with the most rigorous of methodologies, a randomized controlled trial,” Dr. Shah added.  

“This simple treatment may be helpful to patients far beyond those with just cirrhosis, and expect future studies to explore this treatment in other populations,” Dr. Shah said in an interview.

Paul Martin, MD, chief of the division of digestive health and liver diseases and Mandel Chair in Gastroenterology, University of Miami, noted that, while muscle cramps can have a major impact on quality of life, “in terms of some of the other complications of cirrhosis that health care providers are dealing with, they may seem relatively innocuous, but obviously patients have a slightly different interpretation because of the effect cramps can have on sleep and so on.

“There have been a variety of home remedies to treat muscle cramps, but this study is intriguing as it suggests that pickle juice, which is freely available, helps mitigate the severity of the cramps. However, it’s unclear whether it prevents cramps,” Dr. Martin said in an interview.

Given that the study is getting traction on Twitter, Dr. Martin encouraged health care providers to be aware of the study and prepared to answer questions from patients.

The study had no specific funding. Dr. Tapper has served as a consultant to Novartis, Axcella, and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has received unrestricted research grants from Gilead and Valeant. Dr. Reau, Dr. Shah, and Dr. Martin have disclosed no relevant financial relationships.

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

Sips of pickle juice may be all it takes to lessen the severity of muscle cramps in adults with cirrhosis, according to results of the PICCLES randomized controlled trial.

In the trial, patients with cirrhotic cramps who sipped pickle brine at the onset of a muscle cramp saw a significant decrease in cramp severity relative to peers who sipped tap water when the cramp hit.

“The acid (vinegar) in the brine triggers a nerve reflex to stop the cramp when it hits the throat. This is why only a sip is needed,” lead investigator Elliot Tapper, MD, division of gastroenterology and hepatology, University of Michigan, Ann Arbor, told this news organization. The study was published online April 13 in American Journal of Gastroenterology.
 

Common and bothersome

Cramps are common in adults with cirrhosis, irrespective of disease severity. They can sometimes last for hours, and treatment options are limited.

In a prior study, 1 tablespoon of pickle juice rapidly stopped experimentally induced cramps.

“This is something that athletes use, and kidney doctors often recommend to their patients, so it is nothing unique to cirrhosis,” Dr. Tapper said.

The PICCLES trial involved 74 adults (mean age, 56.6 years) with at least 4 muscle cramps in the prior month. In the cohort, 54% were men, and 41% had ascites.

The median cramp frequency was 11-12 per month, with an average cramp severity of more than 4 out of 10 on the Visual Analog Scale (VAS) for cramps. 

Some patients were receiving medications for their cramps at baseline, such as magnesium, potassium, baclofen, vitamin E, taurine, and gabapentin/pregabalin.

Thirty-eight patients were randomly allocated to sip pickle juice and 36 to sip tap water at the onset of a muscle cramp.

The proportion of cramps treated was similar in the pickle juice and tap water groups (77% and 72%). More patients in the pickle juice group said their cramps were aborted by the intervention (69% vs. 40%).

The primary outcome was the change in cramp severity at 28-days VAS for cramps. Cramps were assessed 10 times over 28 days using interactive text messages.

Pickle juice was associated with a larger average reduction in cramp severity than tap water (–2.25 points vs. –0.36 on the VAS-cramps), a difference that was statistically significant (P = .03).

There were no significant changes in the proportion of days with cramp severity of more than 5 on the VAS, or on sleep quality or health-related quality of life. 

Because pickle juice contains sodium, the researchers also assessed weight change as a safety outcome. They found no significant differences in weight change between the two groups overall or in the subset with ascites.

Pickle juice is a “safe option that can stop painful cramps,” Dr. Tapper said in an interview, but was “disheartened” that it did not improve quality of life.

Dr. Tapper encourages patients with cramps to ask their doctor about pickle juice and doctors to ask their patients about muscle cramps.

“Awareness of a patient’s cramps is often lacking. Asking about cramps is not routine but could be the most important advance relating to this study,” he said.

While sips of pickle juice are “unlikely to cause harm,” Dr. Tapper said, he is “a little nervous about advising patients to address their complex needs alone. [Doctors] are there to think through the root causes and help make adjustments that could prevent the cramps in the first place,” he said.
 

Outside experts weigh in

This news organization reached out to several outside experts for their perspective on the study.

Nancy Reau, MD, professor of internal medicine, associate director of solid organ transplantation, and section chief of hepatology. Rush University Medical Center, Chicago, noted that interventions to manage and prevent muscle cramps are “important, as cramping is common in cirrhosis and strongly affects quality of life.”

Dr. Reau cautioned that while pickle juice “sounds benign, it does have a lot of salt. Despite the salt content, this study didn’t show any difference between patients with and without ascites.

“However, cramping is more common in our patients with sarcopenia and those on diuretics for fluid management and it would be easy to see how this might impact fluid management,” Dr. Reau noted.

“Given that it is the acid (not the salt) in the pickle juice, there might be low salt alternatives,” Dr. Reau said.

Echoing Dr. Reau, Ankur Shah, MD, division of kidney disease and hypertension, Brown University, Providence, R.I., noted that “overuse of pickle juice could place patients at risk of developing high blood pressure and fluid overload, and pickle juice should be included in the sodium restriction guidance given to patients with high blood pressure and heart failure.”

In this study, however, the individual dose consumed was low, Dr. Shah noted.

He said the study “elegantly provides evidence to support the practice of sipping pickle juice for cramping.”

The authors should be “applauded for studying a simple solution with the most rigorous of methodologies, a randomized controlled trial,” Dr. Shah added.  

“This simple treatment may be helpful to patients far beyond those with just cirrhosis, and expect future studies to explore this treatment in other populations,” Dr. Shah said in an interview.

Paul Martin, MD, chief of the division of digestive health and liver diseases and Mandel Chair in Gastroenterology, University of Miami, noted that, while muscle cramps can have a major impact on quality of life, “in terms of some of the other complications of cirrhosis that health care providers are dealing with, they may seem relatively innocuous, but obviously patients have a slightly different interpretation because of the effect cramps can have on sleep and so on.

“There have been a variety of home remedies to treat muscle cramps, but this study is intriguing as it suggests that pickle juice, which is freely available, helps mitigate the severity of the cramps. However, it’s unclear whether it prevents cramps,” Dr. Martin said in an interview.

Given that the study is getting traction on Twitter, Dr. Martin encouraged health care providers to be aware of the study and prepared to answer questions from patients.

The study had no specific funding. Dr. Tapper has served as a consultant to Novartis, Axcella, and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has received unrestricted research grants from Gilead and Valeant. Dr. Reau, Dr. Shah, and Dr. Martin have disclosed no relevant financial relationships.

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

During the first year of the pandemic, at least four people in Michigan were infected with a coronavirus variant that has been found in mink.

The cluster, which previously included three cases, marks the first known instance of likely animal-to-human “spillover” of the virus in the United States, according to the New York Times. All four people fully recovered.

Two of the infected people were employees of a mink farm in Michigan that had an outbreak in October 2020. The other two people didn’t have known links to the farm, which may mean that the coronavirus variant among mink may have been circulating more widely among residents in that area during that time.

Virus samples from all four people contained two mutations that may show signs of an adaptation to mink. The mutations have also been documented in farmed mink in Europe and people with connections to those farms.

“This, in addition to the mink farmworkers testing positive for COVID-19 after the mink herd had begun experiencing illness and increased mortality, suggests that the most likely hypothesis is that the workers were infected after contact with mink on the farm,” Casey Barton Behravesh, DVM, who directs the Centers for Disease Control and Prevention’s One Health Office, told the newspaper.

But researchers are unable to prove the cause, she noted.

“Because there are few genetic sequences available from the communities around the farm, it is impossible to know for sure whether the mutations came from mink on the farm or were already circulating in the community,” she said.

In August 2020, the U.S. Department of Agriculture announced the first confirmed COVID-19 case in mink at farms in Utah, followed by a case in Wisconsin. Worldwide, the coronavirus has been detected in mink on farms in the Netherlands, Denmark, Poland, and Spain.

In early October 2020, Michigan officials announced that the coronavirus had been detected in mink on a local farm. Several of the animals had died. The CDC helped to investigate the outbreak by collecting samples from animals, farmworkers, and residents in the community.

By March 2021, the CDC had updated its website to note that a “small number of people” had contracted a coronavirus variant that “contained unique mink-related mutations.”

In April 2021, the Detroit Free Press and the Documenting COVID-19 project first reported on the first three cases – two farmworkers and a taxidermist who didn’t have a connection to the mink farm. This week, the news outlets reported an update that the fourth case was the taxidermist’s wife.

Earlier this month, National Geographic first reported on the fourth human case based on government documents about the mink farm outbreak.

Overall, animal-to-human transmission is rare, but the CDC is continuing to monitor potential coronavirus cases in wildlife, livestock, and zoo animals for new variants and virus reservoirs, the Times reported.

“These results highlight the importance of routinely studying the genetic material of SARS-CoV-2 in susceptible animal populations like mink, as well as in people,” the CDC wrote.

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

During the first year of the pandemic, at least four people in Michigan were infected with a coronavirus variant that has been found in mink.

The cluster, which previously included three cases, marks the first known instance of likely animal-to-human “spillover” of the virus in the United States, according to the New York Times. All four people fully recovered.

Two of the infected people were employees of a mink farm in Michigan that had an outbreak in October 2020. The other two people didn’t have known links to the farm, which may mean that the coronavirus variant among mink may have been circulating more widely among residents in that area during that time.

Virus samples from all four people contained two mutations that may show signs of an adaptation to mink. The mutations have also been documented in farmed mink in Europe and people with connections to those farms.

“This, in addition to the mink farmworkers testing positive for COVID-19 after the mink herd had begun experiencing illness and increased mortality, suggests that the most likely hypothesis is that the workers were infected after contact with mink on the farm,” Casey Barton Behravesh, DVM, who directs the Centers for Disease Control and Prevention’s One Health Office, told the newspaper.

But researchers are unable to prove the cause, she noted.

“Because there are few genetic sequences available from the communities around the farm, it is impossible to know for sure whether the mutations came from mink on the farm or were already circulating in the community,” she said.

In August 2020, the U.S. Department of Agriculture announced the first confirmed COVID-19 case in mink at farms in Utah, followed by a case in Wisconsin. Worldwide, the coronavirus has been detected in mink on farms in the Netherlands, Denmark, Poland, and Spain.

In early October 2020, Michigan officials announced that the coronavirus had been detected in mink on a local farm. Several of the animals had died. The CDC helped to investigate the outbreak by collecting samples from animals, farmworkers, and residents in the community.

By March 2021, the CDC had updated its website to note that a “small number of people” had contracted a coronavirus variant that “contained unique mink-related mutations.”

In April 2021, the Detroit Free Press and the Documenting COVID-19 project first reported on the first three cases – two farmworkers and a taxidermist who didn’t have a connection to the mink farm. This week, the news outlets reported an update that the fourth case was the taxidermist’s wife.

Earlier this month, National Geographic first reported on the fourth human case based on government documents about the mink farm outbreak.

Overall, animal-to-human transmission is rare, but the CDC is continuing to monitor potential coronavirus cases in wildlife, livestock, and zoo animals for new variants and virus reservoirs, the Times reported.

“These results highlight the importance of routinely studying the genetic material of SARS-CoV-2 in susceptible animal populations like mink, as well as in people,” the CDC wrote.

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

During the first year of the pandemic, at least four people in Michigan were infected with a coronavirus variant that has been found in mink.

The cluster, which previously included three cases, marks the first known instance of likely animal-to-human “spillover” of the virus in the United States, according to the New York Times. All four people fully recovered.

Two of the infected people were employees of a mink farm in Michigan that had an outbreak in October 2020. The other two people didn’t have known links to the farm, which may mean that the coronavirus variant among mink may have been circulating more widely among residents in that area during that time.

Virus samples from all four people contained two mutations that may show signs of an adaptation to mink. The mutations have also been documented in farmed mink in Europe and people with connections to those farms.

“This, in addition to the mink farmworkers testing positive for COVID-19 after the mink herd had begun experiencing illness and increased mortality, suggests that the most likely hypothesis is that the workers were infected after contact with mink on the farm,” Casey Barton Behravesh, DVM, who directs the Centers for Disease Control and Prevention’s One Health Office, told the newspaper.

But researchers are unable to prove the cause, she noted.

“Because there are few genetic sequences available from the communities around the farm, it is impossible to know for sure whether the mutations came from mink on the farm or were already circulating in the community,” she said.

In August 2020, the U.S. Department of Agriculture announced the first confirmed COVID-19 case in mink at farms in Utah, followed by a case in Wisconsin. Worldwide, the coronavirus has been detected in mink on farms in the Netherlands, Denmark, Poland, and Spain.

In early October 2020, Michigan officials announced that the coronavirus had been detected in mink on a local farm. Several of the animals had died. The CDC helped to investigate the outbreak by collecting samples from animals, farmworkers, and residents in the community.

By March 2021, the CDC had updated its website to note that a “small number of people” had contracted a coronavirus variant that “contained unique mink-related mutations.”

In April 2021, the Detroit Free Press and the Documenting COVID-19 project first reported on the first three cases – two farmworkers and a taxidermist who didn’t have a connection to the mink farm. This week, the news outlets reported an update that the fourth case was the taxidermist’s wife.

Earlier this month, National Geographic first reported on the fourth human case based on government documents about the mink farm outbreak.

Overall, animal-to-human transmission is rare, but the CDC is continuing to monitor potential coronavirus cases in wildlife, livestock, and zoo animals for new variants and virus reservoirs, the Times reported.

“These results highlight the importance of routinely studying the genetic material of SARS-CoV-2 in susceptible animal populations like mink, as well as in people,” the CDC wrote.

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

Inadequate pain relief was recorded in 68.8% of a sample of people with hip or knee OA who participated in the population-based EpiReumaPt study, researchers reported at the OARSI 2022 World Congress.

“This can be explained by a lack of effectiveness of current management strategies, low uptake of recommended interventions by health care professionals, and also by low adherence by patients to medication and lifestyle interventions,” said Daniela Sofia Albino Costa, MSc, a PhD student at NOVA University Lisbon.

BackyardProduction/Thinkstock

In addition to looking at the prevalence of inadequate pain relief ­– defined as a score of 5 or higher on the Numeric Pain Rating Scale (NPRS) – the study she presented at the congress, which was sponsored by the Osteoarthritis Research Society International, looked at the predictors for inadequate pain control.

It was found that being female, obesity, and having multimorbidity doubled the risk of inadequate versus adequate pain control, with respective odds ratios of 2.32 (P < .001), 2.26 (P = .006), and 2.07 (P = .001). Overweight was also associated with an increased odds ratio for poor pain control (OR, 1.84; P = .0035).

“We found that patients with inadequate pain relief also have a low performance on activities of daily living and a low quality of life,” Ms. Costa said.

Nearly one-third (29%) of patients in the inadequate pain relief group (n = 765) took medication, versus 15% of patients in the adequate pain relief group (n = 270). This was mostly NSAIDs, but also included analgesics and antipyretics, and in a few cases (4.8% vs. 1.3%), simple opioids.

“We know that current care is not concordant with recommendations,” said Ms. Costa, noting that medication being used as first-line treatment and core nonpharmacologic interventions are being offered to less than half of patients who are eligible.

In addition, the rate for total joint replacement has increased globally, and pain is an important predictor for this.

“So, we need to evaluate pain control and current management offered to people with hip or knee arthritis to identify to identify areas for improvement,” Ms. Costa said.

High rates of prescription opioid use before TKA

In a separate study also presented at the congress, Daniel Rhon, DPT, DSc, director of musculoskeletal research in primary care at Brooke Army Medical Center in San Antonio, gave a worrying glimpse of high rates of opioid use in the 4 years before total knee arthroplasty (TKA).

Using data from the U.S. Military Health System, the records of all individuals who had a knee replacement procedure between January 2017 and December 2018 were studied, to identify and characterize the use of prescription opioids.

Of the 46,362 individuals, 52.9% had prior opioid use, despite the fact that “opioids are not recommended for the management of knee OA,” said Dr. Rhon.

He also reported that as many as 40% of those who had at least one prescription for opioids had received a high-potency drug, such as fentanyl or oxycodone. The mean age of participants overall was 65 years, with a higher mean for those receiving opioids than those who did not (68 vs. 61.5 years). Data on sex and ethnicity were not available in time for presentation at the congress.

“Most of these individuals are getting these opioid prescriptions probably within 6 months, which maybe aligns with escalation of pain and maybe the decision to have that knee replacement,” Dr. Rhon said. Individuals that used opioids filled their most recent prescription a median of 146 days before TKA to surgery, with a mean of 317 days.

“You can’t always link the reason for the opioid prescription, that’s not really clear in the database,” he admitted; however, an analysis was performed to check if other surgeries had been performed that may have warranted the opioid treatment. The results revealed that very few of the opioid users (4%-7%) had undergone another type of surgical procedure.

“So, we feel a little bit better, that these findings weren’t for other surgical procedures,” said Dr. Rhon. He added that future qualitative research was needed to understand why health care professionals were prescribing opioids, and why patients felt like they needed them.

“That’s bad,” Haxby Abbott, PhD, DPT, a research professor at the University of Otago, Dunedin, New Zealand, commented on Twitter.

Dr. Abbott, who was not involved in the study, added: “We’ve done a similar study of the whole NZ population [currently under review] – similar to Australia and not nearly as bad as you found. That needs urgent attention.”
 

Sharp rise in opioid use 2 years before TKA

Lower rates of opioid use before TKA were seen in two European cohorts, at 43% in England and 33% in Sweden, as reported by Clara Hellberg, PhD, MD, of Lund (Sweden) University. However, rates had increased over a 10-year study period from a respective 23% and 16%, with a sharp increase in use in the 2 years before knee replacement.

The analysis was based on 49,043 patients from the English national database Clinical Practice Research Datalink, and 5,955 patients from the Swedish Skåne Healthcare register who had undergone total knee replacement between 2015 and 2019 and were matched by age, sex and general practice to individuals not undergoing knee replacement.

The prevalence ratio for using opioids over a 10-year period increased from 1.6 to 2.7 in England, and from 1.6 to 2.6 in Sweden.

“While the overall prevalence of opioid use was higher in England, the majority of both cases and controls were using weak opioids,” Dr. Hellberg said.

“Codeine was classified as a weak opioid, whereas morphine was classified as a strong opioid,” she added.

In contrast, the proportion of people using strong opioids in Sweden was greater than in England, she said.

The high opioid use found in the study highlights “the need for better opioid stewardship, and the availability of acceptable, effective alternatives,” Dr. Hellberg and associates concluded in their abstract.

The study presented by Ms. Costa was funded by the Portuguese national funding agency for science, research and technology and by an independent research grant from Pfizer. Dr. Rhon acknowledged grant funding from the National Institutes of Health and the U.S. Department of Defense. Dr. Hellberg had no conflicts of interest to disclose.

Inadequate pain relief was recorded in 68.8% of a sample of people with hip or knee OA who participated in the population-based EpiReumaPt study, researchers reported at the OARSI 2022 World Congress.

“This can be explained by a lack of effectiveness of current management strategies, low uptake of recommended interventions by health care professionals, and also by low adherence by patients to medication and lifestyle interventions,” said Daniela Sofia Albino Costa, MSc, a PhD student at NOVA University Lisbon.

BackyardProduction/Thinkstock

In addition to looking at the prevalence of inadequate pain relief ­– defined as a score of 5 or higher on the Numeric Pain Rating Scale (NPRS) – the study she presented at the congress, which was sponsored by the Osteoarthritis Research Society International, looked at the predictors for inadequate pain control.

It was found that being female, obesity, and having multimorbidity doubled the risk of inadequate versus adequate pain control, with respective odds ratios of 2.32 (P < .001), 2.26 (P = .006), and 2.07 (P = .001). Overweight was also associated with an increased odds ratio for poor pain control (OR, 1.84; P = .0035).

“We found that patients with inadequate pain relief also have a low performance on activities of daily living and a low quality of life,” Ms. Costa said.

Nearly one-third (29%) of patients in the inadequate pain relief group (n = 765) took medication, versus 15% of patients in the adequate pain relief group (n = 270). This was mostly NSAIDs, but also included analgesics and antipyretics, and in a few cases (4.8% vs. 1.3%), simple opioids.

“We know that current care is not concordant with recommendations,” said Ms. Costa, noting that medication being used as first-line treatment and core nonpharmacologic interventions are being offered to less than half of patients who are eligible.

In addition, the rate for total joint replacement has increased globally, and pain is an important predictor for this.

“So, we need to evaluate pain control and current management offered to people with hip or knee arthritis to identify to identify areas for improvement,” Ms. Costa said.

High rates of prescription opioid use before TKA

In a separate study also presented at the congress, Daniel Rhon, DPT, DSc, director of musculoskeletal research in primary care at Brooke Army Medical Center in San Antonio, gave a worrying glimpse of high rates of opioid use in the 4 years before total knee arthroplasty (TKA).

Using data from the U.S. Military Health System, the records of all individuals who had a knee replacement procedure between January 2017 and December 2018 were studied, to identify and characterize the use of prescription opioids.

Of the 46,362 individuals, 52.9% had prior opioid use, despite the fact that “opioids are not recommended for the management of knee OA,” said Dr. Rhon.

He also reported that as many as 40% of those who had at least one prescription for opioids had received a high-potency drug, such as fentanyl or oxycodone. The mean age of participants overall was 65 years, with a higher mean for those receiving opioids than those who did not (68 vs. 61.5 years). Data on sex and ethnicity were not available in time for presentation at the congress.

“Most of these individuals are getting these opioid prescriptions probably within 6 months, which maybe aligns with escalation of pain and maybe the decision to have that knee replacement,” Dr. Rhon said. Individuals that used opioids filled their most recent prescription a median of 146 days before TKA to surgery, with a mean of 317 days.

“You can’t always link the reason for the opioid prescription, that’s not really clear in the database,” he admitted; however, an analysis was performed to check if other surgeries had been performed that may have warranted the opioid treatment. The results revealed that very few of the opioid users (4%-7%) had undergone another type of surgical procedure.

“So, we feel a little bit better, that these findings weren’t for other surgical procedures,” said Dr. Rhon. He added that future qualitative research was needed to understand why health care professionals were prescribing opioids, and why patients felt like they needed them.

“That’s bad,” Haxby Abbott, PhD, DPT, a research professor at the University of Otago, Dunedin, New Zealand, commented on Twitter.

Dr. Abbott, who was not involved in the study, added: “We’ve done a similar study of the whole NZ population [currently under review] – similar to Australia and not nearly as bad as you found. That needs urgent attention.”
 

Sharp rise in opioid use 2 years before TKA

Lower rates of opioid use before TKA were seen in two European cohorts, at 43% in England and 33% in Sweden, as reported by Clara Hellberg, PhD, MD, of Lund (Sweden) University. However, rates had increased over a 10-year study period from a respective 23% and 16%, with a sharp increase in use in the 2 years before knee replacement.

The analysis was based on 49,043 patients from the English national database Clinical Practice Research Datalink, and 5,955 patients from the Swedish Skåne Healthcare register who had undergone total knee replacement between 2015 and 2019 and were matched by age, sex and general practice to individuals not undergoing knee replacement.

The prevalence ratio for using opioids over a 10-year period increased from 1.6 to 2.7 in England, and from 1.6 to 2.6 in Sweden.

“While the overall prevalence of opioid use was higher in England, the majority of both cases and controls were using weak opioids,” Dr. Hellberg said.

“Codeine was classified as a weak opioid, whereas morphine was classified as a strong opioid,” she added.

In contrast, the proportion of people using strong opioids in Sweden was greater than in England, she said.

The high opioid use found in the study highlights “the need for better opioid stewardship, and the availability of acceptable, effective alternatives,” Dr. Hellberg and associates concluded in their abstract.

The study presented by Ms. Costa was funded by the Portuguese national funding agency for science, research and technology and by an independent research grant from Pfizer. Dr. Rhon acknowledged grant funding from the National Institutes of Health and the U.S. Department of Defense. Dr. Hellberg had no conflicts of interest to disclose.

Inadequate pain relief was recorded in 68.8% of a sample of people with hip or knee OA who participated in the population-based EpiReumaPt study, researchers reported at the OARSI 2022 World Congress.

“This can be explained by a lack of effectiveness of current management strategies, low uptake of recommended interventions by health care professionals, and also by low adherence by patients to medication and lifestyle interventions,” said Daniela Sofia Albino Costa, MSc, a PhD student at NOVA University Lisbon.

BackyardProduction/Thinkstock

In addition to looking at the prevalence of inadequate pain relief ­– defined as a score of 5 or higher on the Numeric Pain Rating Scale (NPRS) – the study she presented at the congress, which was sponsored by the Osteoarthritis Research Society International, looked at the predictors for inadequate pain control.

It was found that being female, obesity, and having multimorbidity doubled the risk of inadequate versus adequate pain control, with respective odds ratios of 2.32 (P < .001), 2.26 (P = .006), and 2.07 (P = .001). Overweight was also associated with an increased odds ratio for poor pain control (OR, 1.84; P = .0035).

“We found that patients with inadequate pain relief also have a low performance on activities of daily living and a low quality of life,” Ms. Costa said.

Nearly one-third (29%) of patients in the inadequate pain relief group (n = 765) took medication, versus 15% of patients in the adequate pain relief group (n = 270). This was mostly NSAIDs, but also included analgesics and antipyretics, and in a few cases (4.8% vs. 1.3%), simple opioids.

“We know that current care is not concordant with recommendations,” said Ms. Costa, noting that medication being used as first-line treatment and core nonpharmacologic interventions are being offered to less than half of patients who are eligible.

In addition, the rate for total joint replacement has increased globally, and pain is an important predictor for this.

“So, we need to evaluate pain control and current management offered to people with hip or knee arthritis to identify to identify areas for improvement,” Ms. Costa said.

High rates of prescription opioid use before TKA

In a separate study also presented at the congress, Daniel Rhon, DPT, DSc, director of musculoskeletal research in primary care at Brooke Army Medical Center in San Antonio, gave a worrying glimpse of high rates of opioid use in the 4 years before total knee arthroplasty (TKA).

Using data from the U.S. Military Health System, the records of all individuals who had a knee replacement procedure between January 2017 and December 2018 were studied, to identify and characterize the use of prescription opioids.

Of the 46,362 individuals, 52.9% had prior opioid use, despite the fact that “opioids are not recommended for the management of knee OA,” said Dr. Rhon.

He also reported that as many as 40% of those who had at least one prescription for opioids had received a high-potency drug, such as fentanyl or oxycodone. The mean age of participants overall was 65 years, with a higher mean for those receiving opioids than those who did not (68 vs. 61.5 years). Data on sex and ethnicity were not available in time for presentation at the congress.

“Most of these individuals are getting these opioid prescriptions probably within 6 months, which maybe aligns with escalation of pain and maybe the decision to have that knee replacement,” Dr. Rhon said. Individuals that used opioids filled their most recent prescription a median of 146 days before TKA to surgery, with a mean of 317 days.

“You can’t always link the reason for the opioid prescription, that’s not really clear in the database,” he admitted; however, an analysis was performed to check if other surgeries had been performed that may have warranted the opioid treatment. The results revealed that very few of the opioid users (4%-7%) had undergone another type of surgical procedure.

“So, we feel a little bit better, that these findings weren’t for other surgical procedures,” said Dr. Rhon. He added that future qualitative research was needed to understand why health care professionals were prescribing opioids, and why patients felt like they needed them.

“That’s bad,” Haxby Abbott, PhD, DPT, a research professor at the University of Otago, Dunedin, New Zealand, commented on Twitter.

Dr. Abbott, who was not involved in the study, added: “We’ve done a similar study of the whole NZ population [currently under review] – similar to Australia and not nearly as bad as you found. That needs urgent attention.”
 

Sharp rise in opioid use 2 years before TKA

Lower rates of opioid use before TKA were seen in two European cohorts, at 43% in England and 33% in Sweden, as reported by Clara Hellberg, PhD, MD, of Lund (Sweden) University. However, rates had increased over a 10-year study period from a respective 23% and 16%, with a sharp increase in use in the 2 years before knee replacement.

The analysis was based on 49,043 patients from the English national database Clinical Practice Research Datalink, and 5,955 patients from the Swedish Skåne Healthcare register who had undergone total knee replacement between 2015 and 2019 and were matched by age, sex and general practice to individuals not undergoing knee replacement.

The prevalence ratio for using opioids over a 10-year period increased from 1.6 to 2.7 in England, and from 1.6 to 2.6 in Sweden.

“While the overall prevalence of opioid use was higher in England, the majority of both cases and controls were using weak opioids,” Dr. Hellberg said.

“Codeine was classified as a weak opioid, whereas morphine was classified as a strong opioid,” she added.

In contrast, the proportion of people using strong opioids in Sweden was greater than in England, she said.

The high opioid use found in the study highlights “the need for better opioid stewardship, and the availability of acceptable, effective alternatives,” Dr. Hellberg and associates concluded in their abstract.

The study presented by Ms. Costa was funded by the Portuguese national funding agency for science, research and technology and by an independent research grant from Pfizer. Dr. Rhon acknowledged grant funding from the National Institutes of Health and the U.S. Department of Defense. Dr. Hellberg had no conflicts of interest to disclose.

Although it disputed the allegations, Saint James School of Medicine has settled a complaint with the Federal Trade Commission that the school used deceptive marketing tactics to lure students. The complaint referenced the school’s medical license exam test pass rate and residency matches along with violations of rules that protect consumers, including those dealing with credit contracts.

The school, based in the Caribbean with operations in Illinois, agreed to pay $1.2 million toward refunds and debt cancellation for students harmed by the marketing in the past 5 years.

“While we strongly disagree with the FTC’s approach to this matter, we did not want a lengthy legal process to distract from our mission of providing a quality medical education at an affordable cost,” Kaushik Guha, executive vice president of the parent of the school, Human Resources Development Services, said in a YouTube statement posted on the school’s website.

“Saint James lured students by lying about their chances of success,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a press release. The settlement agreement was with HRDS, which bills itself as providing students from “non-traditional backgrounds the opportunity to pursue a medical degree and practice in the U.S. or Canada,” according to the school’s statement.

The complaint alleges that, since at least April 2018, the school, HRDS, and its operator Mr. Guha has lured students using “phony claims about the standardized test pass rate and students’ residency or job prospects. They lured consumers with false guarantees of student success at passing a critical medical school standardized test, the United States Medical Licensing Examination Step 1 Exam.”

For example, a brochure distributed at open houses claimed a first-time Step 1 pass rate of about 96.8%. The brochure further claimed: “Saint James is the first and only medical school to offer a USMLE Step 1 Pass Guarantee,” according to the FTC complaint.

The FTC said the USMLE rate is lower than touted and lower than reported by other U.S. and Canadian medical schools. “Since 2017, only 35% of Saint James students who have completed the necessary coursework to take the USMLE Step 1 exam passed the test.”

The school also misrepresented the residency match rate as “the same” as American medical schools, according to the complaint. For example, the school instructed telemarketers to tell consumers that the match rate for the school’s students was 85%-90%. The school stated on its website that the residency match rate for Saint James students was 83%. “In fact, the match rate for SJSM students is lower than touted and lower than that reported by U.S. medical schools. Since 2018, defendants’ average match rate has been 63%.”

The FTC also claims the school used illegal credit contracts when marketing financing for tuition and living expenses for students. “The financing contracts contained language attempting to waive consumers’ rights under federal law and omit legally mandated disclosures.”

Saint James’ tuition ranges from about $6,650 to $9,859 per trimester, depending on campus and course study, the complaint states. Between 2016 and 2020, about 1,300 students were enrolled each year in Saint James’ schools. Students who attended the schools between 2016 and 2022 are eligible for a refund under the settlement.

Saint James is required to notify consumers whose debts are being canceled through Delta Financial Solutions, Saint James’ financing partner. The debt will also be deleted from consumers’ credit reports.

“We have chosen to settle with the FTC over its allegations that disclosures on our website and in Delta’s loan agreements were insufficient,” Mr. Guha stated on the school website. “However, we have added additional language and clarifications any time the USMLE pass rate and placement rates are mentioned.”

He said he hopes the school will be “an industry leader for transparency and accountability” and that the school’s “efforts will lead to lasting change throughout the for-profit educational industry.”

Mr. Guha added that more than 600 of the school’s alumni are serving as doctors, including many “working to bridge the health equity gap in underserved areas in North America.”

The FTC has been cracking down on deceptive practices by for-profit institutions. In October, the FTC put 70 for-profit colleges on notice that it would investigate false promises the schools make about their graduates’ job prospects, expected earnings, and other educational outcomes and would levy significant financial penalties against violators. Saint James was not on that list, which included several of the largest for-profit universities in the nation, including Capella University, DeVry University, Strayer University, and Walden University.

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

Although it disputed the allegations, Saint James School of Medicine has settled a complaint with the Federal Trade Commission that the school used deceptive marketing tactics to lure students. The complaint referenced the school’s medical license exam test pass rate and residency matches along with violations of rules that protect consumers, including those dealing with credit contracts.

The school, based in the Caribbean with operations in Illinois, agreed to pay $1.2 million toward refunds and debt cancellation for students harmed by the marketing in the past 5 years.

“While we strongly disagree with the FTC’s approach to this matter, we did not want a lengthy legal process to distract from our mission of providing a quality medical education at an affordable cost,” Kaushik Guha, executive vice president of the parent of the school, Human Resources Development Services, said in a YouTube statement posted on the school’s website.

“Saint James lured students by lying about their chances of success,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a press release. The settlement agreement was with HRDS, which bills itself as providing students from “non-traditional backgrounds the opportunity to pursue a medical degree and practice in the U.S. or Canada,” according to the school’s statement.

The complaint alleges that, since at least April 2018, the school, HRDS, and its operator Mr. Guha has lured students using “phony claims about the standardized test pass rate and students’ residency or job prospects. They lured consumers with false guarantees of student success at passing a critical medical school standardized test, the United States Medical Licensing Examination Step 1 Exam.”

For example, a brochure distributed at open houses claimed a first-time Step 1 pass rate of about 96.8%. The brochure further claimed: “Saint James is the first and only medical school to offer a USMLE Step 1 Pass Guarantee,” according to the FTC complaint.

The FTC said the USMLE rate is lower than touted and lower than reported by other U.S. and Canadian medical schools. “Since 2017, only 35% of Saint James students who have completed the necessary coursework to take the USMLE Step 1 exam passed the test.”

The school also misrepresented the residency match rate as “the same” as American medical schools, according to the complaint. For example, the school instructed telemarketers to tell consumers that the match rate for the school’s students was 85%-90%. The school stated on its website that the residency match rate for Saint James students was 83%. “In fact, the match rate for SJSM students is lower than touted and lower than that reported by U.S. medical schools. Since 2018, defendants’ average match rate has been 63%.”

The FTC also claims the school used illegal credit contracts when marketing financing for tuition and living expenses for students. “The financing contracts contained language attempting to waive consumers’ rights under federal law and omit legally mandated disclosures.”

Saint James’ tuition ranges from about $6,650 to $9,859 per trimester, depending on campus and course study, the complaint states. Between 2016 and 2020, about 1,300 students were enrolled each year in Saint James’ schools. Students who attended the schools between 2016 and 2022 are eligible for a refund under the settlement.

Saint James is required to notify consumers whose debts are being canceled through Delta Financial Solutions, Saint James’ financing partner. The debt will also be deleted from consumers’ credit reports.

“We have chosen to settle with the FTC over its allegations that disclosures on our website and in Delta’s loan agreements were insufficient,” Mr. Guha stated on the school website. “However, we have added additional language and clarifications any time the USMLE pass rate and placement rates are mentioned.”

He said he hopes the school will be “an industry leader for transparency and accountability” and that the school’s “efforts will lead to lasting change throughout the for-profit educational industry.”

Mr. Guha added that more than 600 of the school’s alumni are serving as doctors, including many “working to bridge the health equity gap in underserved areas in North America.”

The FTC has been cracking down on deceptive practices by for-profit institutions. In October, the FTC put 70 for-profit colleges on notice that it would investigate false promises the schools make about their graduates’ job prospects, expected earnings, and other educational outcomes and would levy significant financial penalties against violators. Saint James was not on that list, which included several of the largest for-profit universities in the nation, including Capella University, DeVry University, Strayer University, and Walden University.

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

Although it disputed the allegations, Saint James School of Medicine has settled a complaint with the Federal Trade Commission that the school used deceptive marketing tactics to lure students. The complaint referenced the school’s medical license exam test pass rate and residency matches along with violations of rules that protect consumers, including those dealing with credit contracts.

The school, based in the Caribbean with operations in Illinois, agreed to pay $1.2 million toward refunds and debt cancellation for students harmed by the marketing in the past 5 years.

“While we strongly disagree with the FTC’s approach to this matter, we did not want a lengthy legal process to distract from our mission of providing a quality medical education at an affordable cost,” Kaushik Guha, executive vice president of the parent of the school, Human Resources Development Services, said in a YouTube statement posted on the school’s website.

“Saint James lured students by lying about their chances of success,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a press release. The settlement agreement was with HRDS, which bills itself as providing students from “non-traditional backgrounds the opportunity to pursue a medical degree and practice in the U.S. or Canada,” according to the school’s statement.

The complaint alleges that, since at least April 2018, the school, HRDS, and its operator Mr. Guha has lured students using “phony claims about the standardized test pass rate and students’ residency or job prospects. They lured consumers with false guarantees of student success at passing a critical medical school standardized test, the United States Medical Licensing Examination Step 1 Exam.”

For example, a brochure distributed at open houses claimed a first-time Step 1 pass rate of about 96.8%. The brochure further claimed: “Saint James is the first and only medical school to offer a USMLE Step 1 Pass Guarantee,” according to the FTC complaint.

The FTC said the USMLE rate is lower than touted and lower than reported by other U.S. and Canadian medical schools. “Since 2017, only 35% of Saint James students who have completed the necessary coursework to take the USMLE Step 1 exam passed the test.”

The school also misrepresented the residency match rate as “the same” as American medical schools, according to the complaint. For example, the school instructed telemarketers to tell consumers that the match rate for the school’s students was 85%-90%. The school stated on its website that the residency match rate for Saint James students was 83%. “In fact, the match rate for SJSM students is lower than touted and lower than that reported by U.S. medical schools. Since 2018, defendants’ average match rate has been 63%.”

The FTC also claims the school used illegal credit contracts when marketing financing for tuition and living expenses for students. “The financing contracts contained language attempting to waive consumers’ rights under federal law and omit legally mandated disclosures.”

Saint James’ tuition ranges from about $6,650 to $9,859 per trimester, depending on campus and course study, the complaint states. Between 2016 and 2020, about 1,300 students were enrolled each year in Saint James’ schools. Students who attended the schools between 2016 and 2022 are eligible for a refund under the settlement.

Saint James is required to notify consumers whose debts are being canceled through Delta Financial Solutions, Saint James’ financing partner. The debt will also be deleted from consumers’ credit reports.

“We have chosen to settle with the FTC over its allegations that disclosures on our website and in Delta’s loan agreements were insufficient,” Mr. Guha stated on the school website. “However, we have added additional language and clarifications any time the USMLE pass rate and placement rates are mentioned.”

He said he hopes the school will be “an industry leader for transparency and accountability” and that the school’s “efforts will lead to lasting change throughout the for-profit educational industry.”

Mr. Guha added that more than 600 of the school’s alumni are serving as doctors, including many “working to bridge the health equity gap in underserved areas in North America.”

The FTC has been cracking down on deceptive practices by for-profit institutions. In October, the FTC put 70 for-profit colleges on notice that it would investigate false promises the schools make about their graduates’ job prospects, expected earnings, and other educational outcomes and would levy significant financial penalties against violators. Saint James was not on that list, which included several of the largest for-profit universities in the nation, including Capella University, DeVry University, Strayer University, and Walden University.

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