PA convicted of distributing more than 1.2 million opioid pills

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A federal sting operation led to the recent conviction of a Texas physician assistant on charges of illegally prescribing a total of $3 million in drugs to patients at two “pill mill” clinics in Houston and helping others do the same.

The May 20 conviction of Charles Thompson, 76, of Houston, was based on charges of distributing more than 1.2 million opioid pills to thousands of individuals posing as patients at two pain management clinics, according to the U.S. Department of Justice.

Thompson’s conviction was the latest legal action in a string of cases involving the operation, including a doctor convicted in March who worked with Thompson at the West Parker Medical Clinic. Internist James Pierre, MD, 52, faces charges of unlawfully prescribing more than $1 million worth of opioid hydrocodone, according to federal officials.

Thompson also worked at Priority Wellness Clinic. Six people have pled guilty in connection with their conduct at West Parker or Priority Wellness, the justice department reported.

From June 2015 through July 2016, while Thompson was at West Parker, he helped Dr. Pierre unlawfully prescribe hydrocodone and the muscle relaxant carisoprodol, a combination of controlled substances for pain management known as the “Las Vegas cocktail,” to people in the sting operations pretending to be patients, authorities stated.

Thompson also distributed unlawful prescriptions for carisoprodol. So-called “runners” brought numerous people to pose as patients at West Parker and paid the clinic about $220 to $500 in cash for each visit that resulted in prescriptions for dangerous drugs. Throughout the scheme, West Parker pocketed about $1.75 million from prescriptions; Thompson was paid more than $208,000.

According to authorities, Thompson also helped others illegally prescribe controlled substances, including hydrocodone and oxycodone, from May to July 2017 at Priority Wellness, which opened in December 2016 after West Parker closed.

Priority Wellness reportedly operated as a pill mill similar to West Parker’s. Runners brought people posing as patients to Priority Wellness and paid the clinic between $300 and $600. The cost depended on whether the purported patient received a prescription for hydrocodone or oxycodone, almost always prescribed in combination with carisoprodol, authorities said. Throughout the scheme, Priority Wellness made about $1.1 million, and Thompson made between $700 and $900 a day.

He was convicted of one count of conspiracy to unlawfully distribute and dispense controlled substances and seven counts of unlawfully distributing and dispensing controlled substances in connection with his conduct at West Parker. For his conduct at Priority Wellness, he was convicted of one count of conspiracy to unlawfully distribute and dispense controlled substances and one count of unlawfully distributing and dispensing controlled substances.

He faces up to 20 years in prison for each count of conviction with sentencing scheduled for Oct. 3.

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

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A federal sting operation led to the recent conviction of a Texas physician assistant on charges of illegally prescribing a total of $3 million in drugs to patients at two “pill mill” clinics in Houston and helping others do the same.

The May 20 conviction of Charles Thompson, 76, of Houston, was based on charges of distributing more than 1.2 million opioid pills to thousands of individuals posing as patients at two pain management clinics, according to the U.S. Department of Justice.

Thompson’s conviction was the latest legal action in a string of cases involving the operation, including a doctor convicted in March who worked with Thompson at the West Parker Medical Clinic. Internist James Pierre, MD, 52, faces charges of unlawfully prescribing more than $1 million worth of opioid hydrocodone, according to federal officials.

Thompson also worked at Priority Wellness Clinic. Six people have pled guilty in connection with their conduct at West Parker or Priority Wellness, the justice department reported.

From June 2015 through July 2016, while Thompson was at West Parker, he helped Dr. Pierre unlawfully prescribe hydrocodone and the muscle relaxant carisoprodol, a combination of controlled substances for pain management known as the “Las Vegas cocktail,” to people in the sting operations pretending to be patients, authorities stated.

Thompson also distributed unlawful prescriptions for carisoprodol. So-called “runners” brought numerous people to pose as patients at West Parker and paid the clinic about $220 to $500 in cash for each visit that resulted in prescriptions for dangerous drugs. Throughout the scheme, West Parker pocketed about $1.75 million from prescriptions; Thompson was paid more than $208,000.

According to authorities, Thompson also helped others illegally prescribe controlled substances, including hydrocodone and oxycodone, from May to July 2017 at Priority Wellness, which opened in December 2016 after West Parker closed.

Priority Wellness reportedly operated as a pill mill similar to West Parker’s. Runners brought people posing as patients to Priority Wellness and paid the clinic between $300 and $600. The cost depended on whether the purported patient received a prescription for hydrocodone or oxycodone, almost always prescribed in combination with carisoprodol, authorities said. Throughout the scheme, Priority Wellness made about $1.1 million, and Thompson made between $700 and $900 a day.

He was convicted of one count of conspiracy to unlawfully distribute and dispense controlled substances and seven counts of unlawfully distributing and dispensing controlled substances in connection with his conduct at West Parker. For his conduct at Priority Wellness, he was convicted of one count of conspiracy to unlawfully distribute and dispense controlled substances and one count of unlawfully distributing and dispensing controlled substances.

He faces up to 20 years in prison for each count of conviction with sentencing scheduled for Oct. 3.

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

A federal sting operation led to the recent conviction of a Texas physician assistant on charges of illegally prescribing a total of $3 million in drugs to patients at two “pill mill” clinics in Houston and helping others do the same.

The May 20 conviction of Charles Thompson, 76, of Houston, was based on charges of distributing more than 1.2 million opioid pills to thousands of individuals posing as patients at two pain management clinics, according to the U.S. Department of Justice.

Thompson’s conviction was the latest legal action in a string of cases involving the operation, including a doctor convicted in March who worked with Thompson at the West Parker Medical Clinic. Internist James Pierre, MD, 52, faces charges of unlawfully prescribing more than $1 million worth of opioid hydrocodone, according to federal officials.

Thompson also worked at Priority Wellness Clinic. Six people have pled guilty in connection with their conduct at West Parker or Priority Wellness, the justice department reported.

From June 2015 through July 2016, while Thompson was at West Parker, he helped Dr. Pierre unlawfully prescribe hydrocodone and the muscle relaxant carisoprodol, a combination of controlled substances for pain management known as the “Las Vegas cocktail,” to people in the sting operations pretending to be patients, authorities stated.

Thompson also distributed unlawful prescriptions for carisoprodol. So-called “runners” brought numerous people to pose as patients at West Parker and paid the clinic about $220 to $500 in cash for each visit that resulted in prescriptions for dangerous drugs. Throughout the scheme, West Parker pocketed about $1.75 million from prescriptions; Thompson was paid more than $208,000.

According to authorities, Thompson also helped others illegally prescribe controlled substances, including hydrocodone and oxycodone, from May to July 2017 at Priority Wellness, which opened in December 2016 after West Parker closed.

Priority Wellness reportedly operated as a pill mill similar to West Parker’s. Runners brought people posing as patients to Priority Wellness and paid the clinic between $300 and $600. The cost depended on whether the purported patient received a prescription for hydrocodone or oxycodone, almost always prescribed in combination with carisoprodol, authorities said. Throughout the scheme, Priority Wellness made about $1.1 million, and Thompson made between $700 and $900 a day.

He was convicted of one count of conspiracy to unlawfully distribute and dispense controlled substances and seven counts of unlawfully distributing and dispensing controlled substances in connection with his conduct at West Parker. For his conduct at Priority Wellness, he was convicted of one count of conspiracy to unlawfully distribute and dispense controlled substances and one count of unlawfully distributing and dispensing controlled substances.

He faces up to 20 years in prison for each count of conviction with sentencing scheduled for Oct. 3.

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

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Innovative med school curriculum could help curb the opioid epidemic

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Tue, 05/24/2022 - 12:19

An opioid-centered curriculum for medical students improves awareness of pain management and treatment of opioid use disorder (OUD) and may help mitigate the current opioid crisis in the United States, new research suggests.

“Our study showed that implementing training for medical students about opioid use disorder and its treatment improves knowledge and understanding of clinical principles and may better prepare students to treat patients with this disorder,” study investigator Kimberly Hu, MD, psychiatry resident, Ohio State University, Columbus, told this news organization.

The findings were presented at the annual meeting of the American Psychiatric Association.

The U.S. opioid epidemic claims thousands of lives every year, and there’s evidence it’s getting worse, said Dr. Hu. U.S. data from December 2020 to December 2021 show opioid-related deaths increased by almost 15%.

In 2019, about 70% of the nearly 71,000 drug overdose deaths in the United States involved opioids and now it exceeds 100,000 per year, said Dr. Hu. She noted 80% of heroin users report their addiction started with prescription opioids, data that she described as “pretty staggering.”

Although treatments such as buprenorphine are available for OUD, “insufficient access to medications for opioid use disorder remains a significant barrier for patients,” said Dr. Hu.

“Training the next generation of physicians across all specialties is one way that we can work to improve access to care and improve the health and well-being of our patients.”

The study, which is ongoing, included 405 3rd-year medical students at Ohio State. Researchers provided these students with in-person or virtual (during the pandemic) training in buprenorphine prescribing and in-person clinical experience.

Dr. Hu and her colleagues tested the students before and after the intervention and estimated improvement in knowledge (score 0-23) and approach to clinical management principles (1-5).

The investigators found a statistically significant increase in overall knowledge (from a mean total score of 18.34 to 19.32; P < .001). There was also a statistically significant increase in self-reported understanding of clinical management principles related to screening for and treating OUDs (from a mean of 3.12 to a mean of 4.02; P < .001).

An additional evaluation survey was completed by 162 students at the end of the program. About 83% of these students said they knew how to manage acute pain, 62% felt they knew how to manage chronic pain, and 77% agreed they knew how to screen a patient for OUD.

Dr. Hu noted 3rd-year medical students are a little over halfway through medical school, after which they will go into residency in various specialties. Providing them with this knowledge early on allows them to incorporate it as they continue their training, she said.

“If they are able to screen their patients in any specialty they eventually choose to go into, then they can help link these patients to resources early and make sure there aren’t patients who are slipping through the cracks.”
 

Worthwhile, important research

Howard Liu, MD, chair of the department of psychiatry at the University of Nebraska Medical Center, Omaha, and incoming chair of the APA’s Council on Communications, applauded the study.

The proposed curriculum, he said, instills confidence in students and teaches important lessons they can apply no matter what field they choose.

Dr. Howard Liu

Dr. Liu, who moderated a press briefing highlighting the study, noted every state is affected differently by the opioid epidemic, but the shortage of appropriate treatments for OUD is nationwide.

Commenting on the study, addiction specialist Elie G. Aoun, MD, of the division of law, medicine, and psychiatry at Columbia University, New York, said this research is “very worthwhile and important.”

He noted that attitudes about addiction need to change. When he taught medical students about substance use disorders, he was struck by some of their negative beliefs about addiction. For example, considering addicts as “junkies” who are “taking resources away” from what they perceive as more deserving patients.

Addiction has been ignored in medicine for too long, added Dr. Aoun. He noted the requirement for addiction training for psychiatry residents is 2 months while they spend 4 months learning internal medicine. “That makes no sense,” he said.

“And now with the opioid epidemic, we’re faced with the consequences of dismissing addiction for such a long time.”

A lack of understanding about addiction, and the “very limited number” of experienced people treating addictions, has contributed to the “huge problem” experts now face in treating addictions, said Dr. Aoun.

“So you want to approach this problem from as many different angles as you can.”

He praised the study for presenting “a framework to ‘medicalize’ the addiction model” for students. This, he said, will help them build empathy and see those with a substance use disorder as no different from other patients with medical conditions.

A curriculum such as the one presented by Dr. Hu and colleagues may spur more medical students into the addiction field, he said. “It may make them more willing to treat patients with addiction using evidence-based medicine rather than dismissing them.”

The study was supported by the Substance Abuse and Mental Health Services Administration.

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

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An opioid-centered curriculum for medical students improves awareness of pain management and treatment of opioid use disorder (OUD) and may help mitigate the current opioid crisis in the United States, new research suggests.

“Our study showed that implementing training for medical students about opioid use disorder and its treatment improves knowledge and understanding of clinical principles and may better prepare students to treat patients with this disorder,” study investigator Kimberly Hu, MD, psychiatry resident, Ohio State University, Columbus, told this news organization.

The findings were presented at the annual meeting of the American Psychiatric Association.

The U.S. opioid epidemic claims thousands of lives every year, and there’s evidence it’s getting worse, said Dr. Hu. U.S. data from December 2020 to December 2021 show opioid-related deaths increased by almost 15%.

In 2019, about 70% of the nearly 71,000 drug overdose deaths in the United States involved opioids and now it exceeds 100,000 per year, said Dr. Hu. She noted 80% of heroin users report their addiction started with prescription opioids, data that she described as “pretty staggering.”

Although treatments such as buprenorphine are available for OUD, “insufficient access to medications for opioid use disorder remains a significant barrier for patients,” said Dr. Hu.

“Training the next generation of physicians across all specialties is one way that we can work to improve access to care and improve the health and well-being of our patients.”

The study, which is ongoing, included 405 3rd-year medical students at Ohio State. Researchers provided these students with in-person or virtual (during the pandemic) training in buprenorphine prescribing and in-person clinical experience.

Dr. Hu and her colleagues tested the students before and after the intervention and estimated improvement in knowledge (score 0-23) and approach to clinical management principles (1-5).

The investigators found a statistically significant increase in overall knowledge (from a mean total score of 18.34 to 19.32; P < .001). There was also a statistically significant increase in self-reported understanding of clinical management principles related to screening for and treating OUDs (from a mean of 3.12 to a mean of 4.02; P < .001).

An additional evaluation survey was completed by 162 students at the end of the program. About 83% of these students said they knew how to manage acute pain, 62% felt they knew how to manage chronic pain, and 77% agreed they knew how to screen a patient for OUD.

Dr. Hu noted 3rd-year medical students are a little over halfway through medical school, after which they will go into residency in various specialties. Providing them with this knowledge early on allows them to incorporate it as they continue their training, she said.

“If they are able to screen their patients in any specialty they eventually choose to go into, then they can help link these patients to resources early and make sure there aren’t patients who are slipping through the cracks.”
 

Worthwhile, important research

Howard Liu, MD, chair of the department of psychiatry at the University of Nebraska Medical Center, Omaha, and incoming chair of the APA’s Council on Communications, applauded the study.

The proposed curriculum, he said, instills confidence in students and teaches important lessons they can apply no matter what field they choose.

Dr. Howard Liu

Dr. Liu, who moderated a press briefing highlighting the study, noted every state is affected differently by the opioid epidemic, but the shortage of appropriate treatments for OUD is nationwide.

Commenting on the study, addiction specialist Elie G. Aoun, MD, of the division of law, medicine, and psychiatry at Columbia University, New York, said this research is “very worthwhile and important.”

He noted that attitudes about addiction need to change. When he taught medical students about substance use disorders, he was struck by some of their negative beliefs about addiction. For example, considering addicts as “junkies” who are “taking resources away” from what they perceive as more deserving patients.

Addiction has been ignored in medicine for too long, added Dr. Aoun. He noted the requirement for addiction training for psychiatry residents is 2 months while they spend 4 months learning internal medicine. “That makes no sense,” he said.

“And now with the opioid epidemic, we’re faced with the consequences of dismissing addiction for such a long time.”

A lack of understanding about addiction, and the “very limited number” of experienced people treating addictions, has contributed to the “huge problem” experts now face in treating addictions, said Dr. Aoun.

“So you want to approach this problem from as many different angles as you can.”

He praised the study for presenting “a framework to ‘medicalize’ the addiction model” for students. This, he said, will help them build empathy and see those with a substance use disorder as no different from other patients with medical conditions.

A curriculum such as the one presented by Dr. Hu and colleagues may spur more medical students into the addiction field, he said. “It may make them more willing to treat patients with addiction using evidence-based medicine rather than dismissing them.”

The study was supported by the Substance Abuse and Mental Health Services Administration.

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

An opioid-centered curriculum for medical students improves awareness of pain management and treatment of opioid use disorder (OUD) and may help mitigate the current opioid crisis in the United States, new research suggests.

“Our study showed that implementing training for medical students about opioid use disorder and its treatment improves knowledge and understanding of clinical principles and may better prepare students to treat patients with this disorder,” study investigator Kimberly Hu, MD, psychiatry resident, Ohio State University, Columbus, told this news organization.

The findings were presented at the annual meeting of the American Psychiatric Association.

The U.S. opioid epidemic claims thousands of lives every year, and there’s evidence it’s getting worse, said Dr. Hu. U.S. data from December 2020 to December 2021 show opioid-related deaths increased by almost 15%.

In 2019, about 70% of the nearly 71,000 drug overdose deaths in the United States involved opioids and now it exceeds 100,000 per year, said Dr. Hu. She noted 80% of heroin users report their addiction started with prescription opioids, data that she described as “pretty staggering.”

Although treatments such as buprenorphine are available for OUD, “insufficient access to medications for opioid use disorder remains a significant barrier for patients,” said Dr. Hu.

“Training the next generation of physicians across all specialties is one way that we can work to improve access to care and improve the health and well-being of our patients.”

The study, which is ongoing, included 405 3rd-year medical students at Ohio State. Researchers provided these students with in-person or virtual (during the pandemic) training in buprenorphine prescribing and in-person clinical experience.

Dr. Hu and her colleagues tested the students before and after the intervention and estimated improvement in knowledge (score 0-23) and approach to clinical management principles (1-5).

The investigators found a statistically significant increase in overall knowledge (from a mean total score of 18.34 to 19.32; P < .001). There was also a statistically significant increase in self-reported understanding of clinical management principles related to screening for and treating OUDs (from a mean of 3.12 to a mean of 4.02; P < .001).

An additional evaluation survey was completed by 162 students at the end of the program. About 83% of these students said they knew how to manage acute pain, 62% felt they knew how to manage chronic pain, and 77% agreed they knew how to screen a patient for OUD.

Dr. Hu noted 3rd-year medical students are a little over halfway through medical school, after which they will go into residency in various specialties. Providing them with this knowledge early on allows them to incorporate it as they continue their training, she said.

“If they are able to screen their patients in any specialty they eventually choose to go into, then they can help link these patients to resources early and make sure there aren’t patients who are slipping through the cracks.”
 

Worthwhile, important research

Howard Liu, MD, chair of the department of psychiatry at the University of Nebraska Medical Center, Omaha, and incoming chair of the APA’s Council on Communications, applauded the study.

The proposed curriculum, he said, instills confidence in students and teaches important lessons they can apply no matter what field they choose.

Dr. Howard Liu

Dr. Liu, who moderated a press briefing highlighting the study, noted every state is affected differently by the opioid epidemic, but the shortage of appropriate treatments for OUD is nationwide.

Commenting on the study, addiction specialist Elie G. Aoun, MD, of the division of law, medicine, and psychiatry at Columbia University, New York, said this research is “very worthwhile and important.”

He noted that attitudes about addiction need to change. When he taught medical students about substance use disorders, he was struck by some of their negative beliefs about addiction. For example, considering addicts as “junkies” who are “taking resources away” from what they perceive as more deserving patients.

Addiction has been ignored in medicine for too long, added Dr. Aoun. He noted the requirement for addiction training for psychiatry residents is 2 months while they spend 4 months learning internal medicine. “That makes no sense,” he said.

“And now with the opioid epidemic, we’re faced with the consequences of dismissing addiction for such a long time.”

A lack of understanding about addiction, and the “very limited number” of experienced people treating addictions, has contributed to the “huge problem” experts now face in treating addictions, said Dr. Aoun.

“So you want to approach this problem from as many different angles as you can.”

He praised the study for presenting “a framework to ‘medicalize’ the addiction model” for students. This, he said, will help them build empathy and see those with a substance use disorder as no different from other patients with medical conditions.

A curriculum such as the one presented by Dr. Hu and colleagues may spur more medical students into the addiction field, he said. “It may make them more willing to treat patients with addiction using evidence-based medicine rather than dismissing them.”

The study was supported by the Substance Abuse and Mental Health Services Administration.

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

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Bupivacaine following Mohs surgery reduces opioid use, study finds

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Thu, 05/19/2022 - 15:34

An injection of bupivacaine following Mohs micrographic surgery procedures that have notable postsurgical pain significantly reduces pain scores and, importantly, use of postsurgical narcotics, a randomized trial shows.

“Single-dose, in-office bupivacaine administration immediately following reconstructions known to be high risk for pain reduces postoperative narcotic use and acute pain during the time period when our patients have the highest levels of pain,” said first author Vanessa B. Voss, MD, of the University of Missouri–Columbia, who presented the findings at the annual meeting of the American College of Mohs Surgery.

Dr. Vanessa Voss
Dr. Vanessa Voss

“It was well tolerated, there were no adverse effects, and we recommend the consideration of using this in Mohs micrographic surgery reconstructions that are at the highest risk for pain,” she said.

Recent research has shown that Mohs micrographic surgeons have the highest rates of opioid prescribing of all dermatologists, with about 11% of patients undergoing a Mohs procedure prescribed the drugs for postoperative use, Dr. Voss explained.

Yet, with the ongoing opioid epidemic and even short courses of postoperative opioids placing patients at risk for addiction, the pressure is on to find alternative, nonaddictive strategies for the treatment of acute postoperative pain.

Bupivacaine is commonly used intraoperatively with other types of surgeries to reduce postoperative pain, with a favorable duration of action lasting up to 7 hours, compared with just 2-3 hours with lidocaine. And while its use in Mohs surgery is typically also intraoperative, along with lidocaine, the unique postoperative treatment approach in Mohs surgery has not been well studied, Dr. Voss noted.

To investigate, Dr. Voss and colleagues conducted the prospective, multicenter randomized trial, enrolling 174 patients undergoing Mohs micrographic surgery for skin cancer.

Patients were receiving complex flap reconstructions that have been specifically designated in an American Academy of Dermatology position statement to be high risk for pain following Mohs surgeries, and hence, more likely to involve prescriptions for opioids. These include reconstruction flaps of the scalp, ear, nose or lip, a wedge repair of the ear or lip, or a Mustarde cheek rotation flap.

The mean age of the patients was about 69 years, and about 65% were male. The two groups had no significant differences in demographics, tumor types, or repairs. They were randomized to receive either local injections of bupivacaine 0.5% (with no epinephrine) or placebo with sterile saline injection immediately following the procedure, with the total amount of injection standardized and dependent upon the flap surface area, ranging from 2.5 to 5 cm3.



For postoperative pain, all patients were prescribed acetaminophen 1,000 mg alternating with ibuprofen 400 mg, and tramadol, with instructions to only use tramadol as needed for breakthrough pain.

The reported use of narcotic analgesics by participants was significantly higher among those receiving placebo versus bupivacaine in the first 24 hours following surgery (odds ratio, 2.18; P = .03), as well as in the second 24 hours (OR, 2.18; P = .08) and at 48 hours combined (OR, 2.58; P < .01).

Those in the bupivacaine group also reported lower average pain scores, on a scale of 0-10, during the first 8-hour interval (mean difference, 1.6; P < .001). Importantly, overall, reports of pain medication use and the percentage of patients reporting pain under control were similar between groups, despite lower opioid use in the bupivacaine group.

“The percentage of patients reporting their pain to be under control was similar at all time intervals in both groups, so this means the bupivacaine group had their pain well-controlled despite fewer narcotics, with significant reductions in opioid use,” Dr. Voss noted.

Bupivacaine, though generally regarded as safe, has a reputation for being the most cardiotoxic of the local anesthetic agents; however, there were no such side effects reported in the study. Dr. Voss said the likely explanation is the use of low doses.

“In our study, we had no cardiotoxic effects when using up to 5 cc of 0.5%, which equates to 25 mg per patient,” she explained. This is considered a “very low dose,” since the maximum in the Food and Drug Administration pamphlet for local infiltration is 175 mg per patient every 3 hours, “yet is sufficient for reducing pain/narcotic use.”

She added that “surgeons must be careful to avoid accidental intravascular injection, which could increase risks of systemic toxicity, but this is very rare in the reconstruction settings described.”

Overall, the study suggests a potentially beneficial and unique nonopioid approach that is currently lacking for Mohs procedures associated with a high level of pain. “These findings offer a very effective intervention to reduce postoperative opioid use in this subset of patients,” Dr. Voss told this news organization. “There is not any other intervention that I am aware of to address this, although further study into other long-acting anesthetics may demonstrate similar effects.”

Dr. Justin J. Leitenberger
Dr. Justin J. Leitenberger

Commenting on the study, Justin J. Leitenberger, MD, session moderator, said that these “data could be impactful for reducing pain as well as the need for opioid medication after dermatologic surgery, both of which would be significant for our patients and public health outcomes.”

Among the challenges in treating pain following Mohs surgeries is that “every patient has a different pain threshold and expectation after surgery,” said Dr. Leitenberger, assistant professor of medicine and dermatology and codirector of dermatologic surgery, Mohs micrographic surgery, and laser and cosmetic surgery at Oregon Health & Science University, Portland.

“Patients undergoing larger repairs in tense areas of skin can experience increased pain and require prescription pain medication,” he said. “Bupivacaine, in this study, shows promise to provide longer lasting pain control from the surgical appointment and easier bridging to nonopioid pain control.”

Regarding the potential cardiotoxicities associated with the drug, Dr. Leitenberger agreed that the risks are low, and added that many surgeons have, in fact, switched to full use of bupivacaine, as opposed to combination with lidocaine, apparently without problems. “This is a small dose locally to the area after a procedure and I agree that the risks are minuscule,” he said.

“Of note, during national lidocaine shortages over the past few years, many practices transitioned to exclusive use of bupivacaine for the entire Mohs procedure, and [anecdotally], this transition did not result in toxicities that were reported,” Dr. Leitenberger said.

GW Medical Faculty Associates
Dr. Vishal Patel

Commenting further, Vishal Patel, MD, assistant professor of dermatology and hematology/oncology at George Washington University and director of cutaneous oncology at the GW Cancer Center, both in Washington, also agreed that the benefits appear important. “The benefit from using bupivacaine is encouraging on multiple levels,” he said in an interview.

“Given all that we know about opioids and their negative side effect profile as well as their limited help in cutaneous surgery pain control, the use of long-acting anesthetics is an innovative and reasonable approach to provide pain control in the immediate postoperative window when patients tend to have the most pain,” said Dr. Patel, who is also director of dermatologic surgery at George Washington University.

“After this window, acetaminophen and ibuprofen, which have been shown when used in tandem in an alternating schedule to be superior to opioids, provides an effective pain regimen,” he said. “For larger and more pain-sensitive patients, this appears to be a promising combination.”

Dr. Voss, Dr. Leitenberger, and Dr. Patel have reported no relevant financial relationships.

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

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An injection of bupivacaine following Mohs micrographic surgery procedures that have notable postsurgical pain significantly reduces pain scores and, importantly, use of postsurgical narcotics, a randomized trial shows.

“Single-dose, in-office bupivacaine administration immediately following reconstructions known to be high risk for pain reduces postoperative narcotic use and acute pain during the time period when our patients have the highest levels of pain,” said first author Vanessa B. Voss, MD, of the University of Missouri–Columbia, who presented the findings at the annual meeting of the American College of Mohs Surgery.

Dr. Vanessa Voss
Dr. Vanessa Voss

“It was well tolerated, there were no adverse effects, and we recommend the consideration of using this in Mohs micrographic surgery reconstructions that are at the highest risk for pain,” she said.

Recent research has shown that Mohs micrographic surgeons have the highest rates of opioid prescribing of all dermatologists, with about 11% of patients undergoing a Mohs procedure prescribed the drugs for postoperative use, Dr. Voss explained.

Yet, with the ongoing opioid epidemic and even short courses of postoperative opioids placing patients at risk for addiction, the pressure is on to find alternative, nonaddictive strategies for the treatment of acute postoperative pain.

Bupivacaine is commonly used intraoperatively with other types of surgeries to reduce postoperative pain, with a favorable duration of action lasting up to 7 hours, compared with just 2-3 hours with lidocaine. And while its use in Mohs surgery is typically also intraoperative, along with lidocaine, the unique postoperative treatment approach in Mohs surgery has not been well studied, Dr. Voss noted.

To investigate, Dr. Voss and colleagues conducted the prospective, multicenter randomized trial, enrolling 174 patients undergoing Mohs micrographic surgery for skin cancer.

Patients were receiving complex flap reconstructions that have been specifically designated in an American Academy of Dermatology position statement to be high risk for pain following Mohs surgeries, and hence, more likely to involve prescriptions for opioids. These include reconstruction flaps of the scalp, ear, nose or lip, a wedge repair of the ear or lip, or a Mustarde cheek rotation flap.

The mean age of the patients was about 69 years, and about 65% were male. The two groups had no significant differences in demographics, tumor types, or repairs. They were randomized to receive either local injections of bupivacaine 0.5% (with no epinephrine) or placebo with sterile saline injection immediately following the procedure, with the total amount of injection standardized and dependent upon the flap surface area, ranging from 2.5 to 5 cm3.



For postoperative pain, all patients were prescribed acetaminophen 1,000 mg alternating with ibuprofen 400 mg, and tramadol, with instructions to only use tramadol as needed for breakthrough pain.

The reported use of narcotic analgesics by participants was significantly higher among those receiving placebo versus bupivacaine in the first 24 hours following surgery (odds ratio, 2.18; P = .03), as well as in the second 24 hours (OR, 2.18; P = .08) and at 48 hours combined (OR, 2.58; P < .01).

Those in the bupivacaine group also reported lower average pain scores, on a scale of 0-10, during the first 8-hour interval (mean difference, 1.6; P < .001). Importantly, overall, reports of pain medication use and the percentage of patients reporting pain under control were similar between groups, despite lower opioid use in the bupivacaine group.

“The percentage of patients reporting their pain to be under control was similar at all time intervals in both groups, so this means the bupivacaine group had their pain well-controlled despite fewer narcotics, with significant reductions in opioid use,” Dr. Voss noted.

Bupivacaine, though generally regarded as safe, has a reputation for being the most cardiotoxic of the local anesthetic agents; however, there were no such side effects reported in the study. Dr. Voss said the likely explanation is the use of low doses.

“In our study, we had no cardiotoxic effects when using up to 5 cc of 0.5%, which equates to 25 mg per patient,” she explained. This is considered a “very low dose,” since the maximum in the Food and Drug Administration pamphlet for local infiltration is 175 mg per patient every 3 hours, “yet is sufficient for reducing pain/narcotic use.”

She added that “surgeons must be careful to avoid accidental intravascular injection, which could increase risks of systemic toxicity, but this is very rare in the reconstruction settings described.”

Overall, the study suggests a potentially beneficial and unique nonopioid approach that is currently lacking for Mohs procedures associated with a high level of pain. “These findings offer a very effective intervention to reduce postoperative opioid use in this subset of patients,” Dr. Voss told this news organization. “There is not any other intervention that I am aware of to address this, although further study into other long-acting anesthetics may demonstrate similar effects.”

Dr. Justin J. Leitenberger
Dr. Justin J. Leitenberger

Commenting on the study, Justin J. Leitenberger, MD, session moderator, said that these “data could be impactful for reducing pain as well as the need for opioid medication after dermatologic surgery, both of which would be significant for our patients and public health outcomes.”

Among the challenges in treating pain following Mohs surgeries is that “every patient has a different pain threshold and expectation after surgery,” said Dr. Leitenberger, assistant professor of medicine and dermatology and codirector of dermatologic surgery, Mohs micrographic surgery, and laser and cosmetic surgery at Oregon Health & Science University, Portland.

“Patients undergoing larger repairs in tense areas of skin can experience increased pain and require prescription pain medication,” he said. “Bupivacaine, in this study, shows promise to provide longer lasting pain control from the surgical appointment and easier bridging to nonopioid pain control.”

Regarding the potential cardiotoxicities associated with the drug, Dr. Leitenberger agreed that the risks are low, and added that many surgeons have, in fact, switched to full use of bupivacaine, as opposed to combination with lidocaine, apparently without problems. “This is a small dose locally to the area after a procedure and I agree that the risks are minuscule,” he said.

“Of note, during national lidocaine shortages over the past few years, many practices transitioned to exclusive use of bupivacaine for the entire Mohs procedure, and [anecdotally], this transition did not result in toxicities that were reported,” Dr. Leitenberger said.

GW Medical Faculty Associates
Dr. Vishal Patel

Commenting further, Vishal Patel, MD, assistant professor of dermatology and hematology/oncology at George Washington University and director of cutaneous oncology at the GW Cancer Center, both in Washington, also agreed that the benefits appear important. “The benefit from using bupivacaine is encouraging on multiple levels,” he said in an interview.

“Given all that we know about opioids and their negative side effect profile as well as their limited help in cutaneous surgery pain control, the use of long-acting anesthetics is an innovative and reasonable approach to provide pain control in the immediate postoperative window when patients tend to have the most pain,” said Dr. Patel, who is also director of dermatologic surgery at George Washington University.

“After this window, acetaminophen and ibuprofen, which have been shown when used in tandem in an alternating schedule to be superior to opioids, provides an effective pain regimen,” he said. “For larger and more pain-sensitive patients, this appears to be a promising combination.”

Dr. Voss, Dr. Leitenberger, and Dr. Patel have reported no relevant financial relationships.

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

An injection of bupivacaine following Mohs micrographic surgery procedures that have notable postsurgical pain significantly reduces pain scores and, importantly, use of postsurgical narcotics, a randomized trial shows.

“Single-dose, in-office bupivacaine administration immediately following reconstructions known to be high risk for pain reduces postoperative narcotic use and acute pain during the time period when our patients have the highest levels of pain,” said first author Vanessa B. Voss, MD, of the University of Missouri–Columbia, who presented the findings at the annual meeting of the American College of Mohs Surgery.

Dr. Vanessa Voss
Dr. Vanessa Voss

“It was well tolerated, there were no adverse effects, and we recommend the consideration of using this in Mohs micrographic surgery reconstructions that are at the highest risk for pain,” she said.

Recent research has shown that Mohs micrographic surgeons have the highest rates of opioid prescribing of all dermatologists, with about 11% of patients undergoing a Mohs procedure prescribed the drugs for postoperative use, Dr. Voss explained.

Yet, with the ongoing opioid epidemic and even short courses of postoperative opioids placing patients at risk for addiction, the pressure is on to find alternative, nonaddictive strategies for the treatment of acute postoperative pain.

Bupivacaine is commonly used intraoperatively with other types of surgeries to reduce postoperative pain, with a favorable duration of action lasting up to 7 hours, compared with just 2-3 hours with lidocaine. And while its use in Mohs surgery is typically also intraoperative, along with lidocaine, the unique postoperative treatment approach in Mohs surgery has not been well studied, Dr. Voss noted.

To investigate, Dr. Voss and colleagues conducted the prospective, multicenter randomized trial, enrolling 174 patients undergoing Mohs micrographic surgery for skin cancer.

Patients were receiving complex flap reconstructions that have been specifically designated in an American Academy of Dermatology position statement to be high risk for pain following Mohs surgeries, and hence, more likely to involve prescriptions for opioids. These include reconstruction flaps of the scalp, ear, nose or lip, a wedge repair of the ear or lip, or a Mustarde cheek rotation flap.

The mean age of the patients was about 69 years, and about 65% were male. The two groups had no significant differences in demographics, tumor types, or repairs. They were randomized to receive either local injections of bupivacaine 0.5% (with no epinephrine) or placebo with sterile saline injection immediately following the procedure, with the total amount of injection standardized and dependent upon the flap surface area, ranging from 2.5 to 5 cm3.



For postoperative pain, all patients were prescribed acetaminophen 1,000 mg alternating with ibuprofen 400 mg, and tramadol, with instructions to only use tramadol as needed for breakthrough pain.

The reported use of narcotic analgesics by participants was significantly higher among those receiving placebo versus bupivacaine in the first 24 hours following surgery (odds ratio, 2.18; P = .03), as well as in the second 24 hours (OR, 2.18; P = .08) and at 48 hours combined (OR, 2.58; P < .01).

Those in the bupivacaine group also reported lower average pain scores, on a scale of 0-10, during the first 8-hour interval (mean difference, 1.6; P < .001). Importantly, overall, reports of pain medication use and the percentage of patients reporting pain under control were similar between groups, despite lower opioid use in the bupivacaine group.

“The percentage of patients reporting their pain to be under control was similar at all time intervals in both groups, so this means the bupivacaine group had their pain well-controlled despite fewer narcotics, with significant reductions in opioid use,” Dr. Voss noted.

Bupivacaine, though generally regarded as safe, has a reputation for being the most cardiotoxic of the local anesthetic agents; however, there were no such side effects reported in the study. Dr. Voss said the likely explanation is the use of low doses.

“In our study, we had no cardiotoxic effects when using up to 5 cc of 0.5%, which equates to 25 mg per patient,” she explained. This is considered a “very low dose,” since the maximum in the Food and Drug Administration pamphlet for local infiltration is 175 mg per patient every 3 hours, “yet is sufficient for reducing pain/narcotic use.”

She added that “surgeons must be careful to avoid accidental intravascular injection, which could increase risks of systemic toxicity, but this is very rare in the reconstruction settings described.”

Overall, the study suggests a potentially beneficial and unique nonopioid approach that is currently lacking for Mohs procedures associated with a high level of pain. “These findings offer a very effective intervention to reduce postoperative opioid use in this subset of patients,” Dr. Voss told this news organization. “There is not any other intervention that I am aware of to address this, although further study into other long-acting anesthetics may demonstrate similar effects.”

Dr. Justin J. Leitenberger
Dr. Justin J. Leitenberger

Commenting on the study, Justin J. Leitenberger, MD, session moderator, said that these “data could be impactful for reducing pain as well as the need for opioid medication after dermatologic surgery, both of which would be significant for our patients and public health outcomes.”

Among the challenges in treating pain following Mohs surgeries is that “every patient has a different pain threshold and expectation after surgery,” said Dr. Leitenberger, assistant professor of medicine and dermatology and codirector of dermatologic surgery, Mohs micrographic surgery, and laser and cosmetic surgery at Oregon Health & Science University, Portland.

“Patients undergoing larger repairs in tense areas of skin can experience increased pain and require prescription pain medication,” he said. “Bupivacaine, in this study, shows promise to provide longer lasting pain control from the surgical appointment and easier bridging to nonopioid pain control.”

Regarding the potential cardiotoxicities associated with the drug, Dr. Leitenberger agreed that the risks are low, and added that many surgeons have, in fact, switched to full use of bupivacaine, as opposed to combination with lidocaine, apparently without problems. “This is a small dose locally to the area after a procedure and I agree that the risks are minuscule,” he said.

“Of note, during national lidocaine shortages over the past few years, many practices transitioned to exclusive use of bupivacaine for the entire Mohs procedure, and [anecdotally], this transition did not result in toxicities that were reported,” Dr. Leitenberger said.

GW Medical Faculty Associates
Dr. Vishal Patel

Commenting further, Vishal Patel, MD, assistant professor of dermatology and hematology/oncology at George Washington University and director of cutaneous oncology at the GW Cancer Center, both in Washington, also agreed that the benefits appear important. “The benefit from using bupivacaine is encouraging on multiple levels,” he said in an interview.

“Given all that we know about opioids and their negative side effect profile as well as their limited help in cutaneous surgery pain control, the use of long-acting anesthetics is an innovative and reasonable approach to provide pain control in the immediate postoperative window when patients tend to have the most pain,” said Dr. Patel, who is also director of dermatologic surgery at George Washington University.

“After this window, acetaminophen and ibuprofen, which have been shown when used in tandem in an alternating schedule to be superior to opioids, provides an effective pain regimen,” he said. “For larger and more pain-sensitive patients, this appears to be a promising combination.”

Dr. Voss, Dr. Leitenberger, and Dr. Patel have reported no relevant financial relationships.

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

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Using anti-inflammatory drugs may prolong back pain

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Thu, 12/15/2022 - 15:38

A new study questions the conventional wisdom of using steroids and anti-inflammatory drugs like ibuprofen to treat low back pain if exercise and other nondrug therapies don’t work right away.

Those medications offer relief from acute pain but may actually increase a person’s chances of developing chronic pain, said the investigators for a study published in Science Translational Medicine. The study results indicate that inflammation is a normal part of recovering from a painful injury and that inhibiting inflammation may result in more-difficult-to-treat chronic pain.

“For many decades it’s been standard medical practice to treat pain with anti-inflammatory drugs,” Jeffrey Mogil, PhD, a psychology professor at McGill University, Montreal, said in a school news release. “But we found that this short-term fix could lead to longer-term problems.”

Researchers looked at low back pain because it’s so common, with 25% of U.S. adults saying they had low back pain in the previous 3 months, according to the Centers for Disease Control and Prevention. Acute back pain is defined as lasting less than 4 weeks while chronic back pain lasts more than 12 weeks.

By examining blood samples, researchers discovered that people whose low back pain was resolved had high inflammation driven by neutrophils, a type of white blood cell that helps the body fight infection, the study said.

“Neutrophils dominate the early stages of inflammation and set the stage for repair of tissue damage. Inflammation occurs for a reason, and it looks like it’s dangerous to interfere with it,” Dr. Mogil said in the news release.

The research team found that blocking neutrophils in mice prolonged pain in the animals up to 10-fold. Pain also was prolonged when the mice were given anti-inflammatory drugs and steroids, the news release says.

McGill University said other studies support the findings. The school cited an analysis of 500,000 people in the United Kingdom. The analysis found that those taking anti-inflammatory drugs for pain were more likely to have pain 2 to 10 years later.

While saying the study suggests it’s time to reconsider how pain is treated, the researchers called for clinical trials on humans, not just observations of people with low back pain.

Experts warned about accepting the results without further investigation.

“It’s intriguing but requires further study,” Steven J. Atlas, MD, director of the Primary Care Research & Quality Improvement Network at Massachusetts General Hospital, Boston, told The New York Times.

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

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A new study questions the conventional wisdom of using steroids and anti-inflammatory drugs like ibuprofen to treat low back pain if exercise and other nondrug therapies don’t work right away.

Those medications offer relief from acute pain but may actually increase a person’s chances of developing chronic pain, said the investigators for a study published in Science Translational Medicine. The study results indicate that inflammation is a normal part of recovering from a painful injury and that inhibiting inflammation may result in more-difficult-to-treat chronic pain.

“For many decades it’s been standard medical practice to treat pain with anti-inflammatory drugs,” Jeffrey Mogil, PhD, a psychology professor at McGill University, Montreal, said in a school news release. “But we found that this short-term fix could lead to longer-term problems.”

Researchers looked at low back pain because it’s so common, with 25% of U.S. adults saying they had low back pain in the previous 3 months, according to the Centers for Disease Control and Prevention. Acute back pain is defined as lasting less than 4 weeks while chronic back pain lasts more than 12 weeks.

By examining blood samples, researchers discovered that people whose low back pain was resolved had high inflammation driven by neutrophils, a type of white blood cell that helps the body fight infection, the study said.

“Neutrophils dominate the early stages of inflammation and set the stage for repair of tissue damage. Inflammation occurs for a reason, and it looks like it’s dangerous to interfere with it,” Dr. Mogil said in the news release.

The research team found that blocking neutrophils in mice prolonged pain in the animals up to 10-fold. Pain also was prolonged when the mice were given anti-inflammatory drugs and steroids, the news release says.

McGill University said other studies support the findings. The school cited an analysis of 500,000 people in the United Kingdom. The analysis found that those taking anti-inflammatory drugs for pain were more likely to have pain 2 to 10 years later.

While saying the study suggests it’s time to reconsider how pain is treated, the researchers called for clinical trials on humans, not just observations of people with low back pain.

Experts warned about accepting the results without further investigation.

“It’s intriguing but requires further study,” Steven J. Atlas, MD, director of the Primary Care Research & Quality Improvement Network at Massachusetts General Hospital, Boston, told The New York Times.

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

A new study questions the conventional wisdom of using steroids and anti-inflammatory drugs like ibuprofen to treat low back pain if exercise and other nondrug therapies don’t work right away.

Those medications offer relief from acute pain but may actually increase a person’s chances of developing chronic pain, said the investigators for a study published in Science Translational Medicine. The study results indicate that inflammation is a normal part of recovering from a painful injury and that inhibiting inflammation may result in more-difficult-to-treat chronic pain.

“For many decades it’s been standard medical practice to treat pain with anti-inflammatory drugs,” Jeffrey Mogil, PhD, a psychology professor at McGill University, Montreal, said in a school news release. “But we found that this short-term fix could lead to longer-term problems.”

Researchers looked at low back pain because it’s so common, with 25% of U.S. adults saying they had low back pain in the previous 3 months, according to the Centers for Disease Control and Prevention. Acute back pain is defined as lasting less than 4 weeks while chronic back pain lasts more than 12 weeks.

By examining blood samples, researchers discovered that people whose low back pain was resolved had high inflammation driven by neutrophils, a type of white blood cell that helps the body fight infection, the study said.

“Neutrophils dominate the early stages of inflammation and set the stage for repair of tissue damage. Inflammation occurs for a reason, and it looks like it’s dangerous to interfere with it,” Dr. Mogil said in the news release.

The research team found that blocking neutrophils in mice prolonged pain in the animals up to 10-fold. Pain also was prolonged when the mice were given anti-inflammatory drugs and steroids, the news release says.

McGill University said other studies support the findings. The school cited an analysis of 500,000 people in the United Kingdom. The analysis found that those taking anti-inflammatory drugs for pain were more likely to have pain 2 to 10 years later.

While saying the study suggests it’s time to reconsider how pain is treated, the researchers called for clinical trials on humans, not just observations of people with low back pain.

Experts warned about accepting the results without further investigation.

“It’s intriguing but requires further study,” Steven J. Atlas, MD, director of the Primary Care Research & Quality Improvement Network at Massachusetts General Hospital, Boston, told The New York Times.

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

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Most COVID-19 survivors return to work within 2 years

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Tue, 05/24/2022 - 15:41

Regardless of the severity of their initial illness, 89% of people who were hospitalized with COVID-19 had returned to their original work 2 years later, a new study shows.

The burden of persistent COVID-19 symptoms appeared to improve over time, but a higher percentage of former patients reported poor health, compared with the general population. This suggests that some patients need more time to completely recover from COVID-19, wrote the authors of the new study, which was published in The Lancet Respiratory Medicine. Previous research has shown that the health effects of COVID-19 last for up to a year, but data from longer-term studies are limited, said Lixue Huang, MD, of Capital Medical University, Beijing, one of the study authors, and colleagues.

Methods and results

In the new study, the researchers reviewed data from 1,192 adult patients who were discharged from the hospital after surviving COVID-19 between Jan. 7, 2020, and May 29, 2020. The researchers measured the participants’ health outcomes at 6 months, 12 months, and 2 years after their onset of symptoms. A community-based dataset of 3,383 adults with no history of COVID-19 served as controls to measure the recovery of the COVID-19 patients. The median age of the patients at the time of hospital discharge was 57 years, and 46% were women. The median follow-up time after the onset of symptoms was 185 days, 349 days, and 685 days for the 6-month, 12-month, and 2-year visits, respectively. The researchers measured health outcomes using a 6-min walking distance (6MWD) test, laboratory tests, and questionnaires about symptoms, mental health, health-related quality of life, returning to work, and health care use since leaving the hospital.

Overall, the proportion of COVID-19 survivors with at least one symptom decreased from 68% at 6 months to 55% at 2 years (P < .0001). The most frequent symptoms were fatigue and muscle weakness, reported by approximately one-third of the patients (31%); sleep problems also were reported by 31% of the patients.

The proportion of individuals with poor results on the 6MWD decreased continuously over time, not only in COVID-19 survivors overall, but also in three subgroups of varying initial disease severity. Of the 494 survivors who reported working before becoming ill, 438 (89%) had returned to their original jobs 2 years later. The most common reasons for not returning to work were decreased physical function, unwillingness to return, and unemployment, the researchers noted.

However, at 2 years, COVID-19 survivors reported more pain and discomfort, as well as more anxiety and depression, compared with the controls (23% vs. 5% and 12% vs. 5%, respectively).

In addition, significantly more survivors who needed high levels of respiratory support while hospitalized had lung diffusion impairment (65%), reduced residual volume (62%), and total lung capacity (39%), compared with matched controls (36%, 20%, and 6%, respectively) at 2 years.

Long-COVID concerns

Approximately half of the survivors had symptoms of long COVID at 2 years. These individuals were more likely to report pain or discomfort or anxiety or depression, as well as mobility problems, compared to survivors without long COVID. Participants with long-COVID symptoms were more than twice as likely to have an outpatient clinic visit (odds ratio, 2.82), and not quite twice as likely to be rehospitalized (OR, 1.64).

 

 

“We found that [health-related quality of life], exercise capacity, and mental health continued to improve throughout the 2 years regardless of initial disease severity, but about half still had symptomatic sequelae at 2 years,” the researchers wrote in their paper.

Findings can inform doctor-patient discussions

“We are increasingly recognizing that the health effects of COVID-19 may persist beyond acute illness, therefore this is a timely study to assess the long-term impact of COVID-19 with a long follow-up period,” said Suman Pal, MD, an internal medicine physician at the University of New Mexico, Albuquerque, in an interview.

The findings are consistent with the existing literature, said Dr. Pal, who was not involved in the study.  The data from the study “can help clinicians have discussions regarding expected recovery and long-term prognosis for patients with COVID-19,” he noted.

What patients should know is that “studies such as this can help COVID-19 survivors understand and monitor persistent symptoms they may experience, and bring them to the attention of their clinicians,” said Dr. Pal.

However, “As a single-center study with high attrition of subjects during the study period, the findings may not be generalizable,” Dr. Pal emphasized. “Larger-scale studies and patient registries distributed over different geographical areas and time periods will help obtain a better understanding of the nature and prevalence of long COVID,” he said.

The study findings were limited by several factors, including the lack of formerly hospitalized controls with respiratory infections other than COVID-19 to determine which outcomes are COVID-19 specific, the researchers noted. Other limitations included the use of data from only patients at a single center, and from the early stages of the pandemic, as well as the use of self-reports for comorbidities and health outcomes, they said.

However, the results represent the longest-known published longitudinal follow-up of patients who recovered from acute COVID-19, the researchers emphasized. Study strengths included the large sample size, longitudinal design, and long-term follow-up with non-COVID controls to determine outcomes. The researchers noted their plans to conduct annual follow-ups in the current study population. They added that more research is needed to explore rehabilitation programs to promote recovery for COVID-19 survivors and to reduce the effects of long COVID.

The study was supported by the Chinese Academy of Medical Sciences, National Natural Science Foundation of China, National Key Research and Development Program of China, National Administration of Traditional Chinese Medicine, Major Projects of National Science and Technology on New Drug Creation and Development of Pulmonary Tuberculosis, China Evergrande Group, Jack Ma Foundation, Sino Biopharmaceutical, Ping An Insurance (Group), and New Sunshine Charity Foundation. The researchers and Dr. Pal had no financial conflicts to disclose.

This article was updated on 5/16/2022.

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Regardless of the severity of their initial illness, 89% of people who were hospitalized with COVID-19 had returned to their original work 2 years later, a new study shows.

The burden of persistent COVID-19 symptoms appeared to improve over time, but a higher percentage of former patients reported poor health, compared with the general population. This suggests that some patients need more time to completely recover from COVID-19, wrote the authors of the new study, which was published in The Lancet Respiratory Medicine. Previous research has shown that the health effects of COVID-19 last for up to a year, but data from longer-term studies are limited, said Lixue Huang, MD, of Capital Medical University, Beijing, one of the study authors, and colleagues.

Methods and results

In the new study, the researchers reviewed data from 1,192 adult patients who were discharged from the hospital after surviving COVID-19 between Jan. 7, 2020, and May 29, 2020. The researchers measured the participants’ health outcomes at 6 months, 12 months, and 2 years after their onset of symptoms. A community-based dataset of 3,383 adults with no history of COVID-19 served as controls to measure the recovery of the COVID-19 patients. The median age of the patients at the time of hospital discharge was 57 years, and 46% were women. The median follow-up time after the onset of symptoms was 185 days, 349 days, and 685 days for the 6-month, 12-month, and 2-year visits, respectively. The researchers measured health outcomes using a 6-min walking distance (6MWD) test, laboratory tests, and questionnaires about symptoms, mental health, health-related quality of life, returning to work, and health care use since leaving the hospital.

Overall, the proportion of COVID-19 survivors with at least one symptom decreased from 68% at 6 months to 55% at 2 years (P < .0001). The most frequent symptoms were fatigue and muscle weakness, reported by approximately one-third of the patients (31%); sleep problems also were reported by 31% of the patients.

The proportion of individuals with poor results on the 6MWD decreased continuously over time, not only in COVID-19 survivors overall, but also in three subgroups of varying initial disease severity. Of the 494 survivors who reported working before becoming ill, 438 (89%) had returned to their original jobs 2 years later. The most common reasons for not returning to work were decreased physical function, unwillingness to return, and unemployment, the researchers noted.

However, at 2 years, COVID-19 survivors reported more pain and discomfort, as well as more anxiety and depression, compared with the controls (23% vs. 5% and 12% vs. 5%, respectively).

In addition, significantly more survivors who needed high levels of respiratory support while hospitalized had lung diffusion impairment (65%), reduced residual volume (62%), and total lung capacity (39%), compared with matched controls (36%, 20%, and 6%, respectively) at 2 years.

Long-COVID concerns

Approximately half of the survivors had symptoms of long COVID at 2 years. These individuals were more likely to report pain or discomfort or anxiety or depression, as well as mobility problems, compared to survivors without long COVID. Participants with long-COVID symptoms were more than twice as likely to have an outpatient clinic visit (odds ratio, 2.82), and not quite twice as likely to be rehospitalized (OR, 1.64).

 

 

“We found that [health-related quality of life], exercise capacity, and mental health continued to improve throughout the 2 years regardless of initial disease severity, but about half still had symptomatic sequelae at 2 years,” the researchers wrote in their paper.

Findings can inform doctor-patient discussions

“We are increasingly recognizing that the health effects of COVID-19 may persist beyond acute illness, therefore this is a timely study to assess the long-term impact of COVID-19 with a long follow-up period,” said Suman Pal, MD, an internal medicine physician at the University of New Mexico, Albuquerque, in an interview.

The findings are consistent with the existing literature, said Dr. Pal, who was not involved in the study.  The data from the study “can help clinicians have discussions regarding expected recovery and long-term prognosis for patients with COVID-19,” he noted.

What patients should know is that “studies such as this can help COVID-19 survivors understand and monitor persistent symptoms they may experience, and bring them to the attention of their clinicians,” said Dr. Pal.

However, “As a single-center study with high attrition of subjects during the study period, the findings may not be generalizable,” Dr. Pal emphasized. “Larger-scale studies and patient registries distributed over different geographical areas and time periods will help obtain a better understanding of the nature and prevalence of long COVID,” he said.

The study findings were limited by several factors, including the lack of formerly hospitalized controls with respiratory infections other than COVID-19 to determine which outcomes are COVID-19 specific, the researchers noted. Other limitations included the use of data from only patients at a single center, and from the early stages of the pandemic, as well as the use of self-reports for comorbidities and health outcomes, they said.

However, the results represent the longest-known published longitudinal follow-up of patients who recovered from acute COVID-19, the researchers emphasized. Study strengths included the large sample size, longitudinal design, and long-term follow-up with non-COVID controls to determine outcomes. The researchers noted their plans to conduct annual follow-ups in the current study population. They added that more research is needed to explore rehabilitation programs to promote recovery for COVID-19 survivors and to reduce the effects of long COVID.

The study was supported by the Chinese Academy of Medical Sciences, National Natural Science Foundation of China, National Key Research and Development Program of China, National Administration of Traditional Chinese Medicine, Major Projects of National Science and Technology on New Drug Creation and Development of Pulmonary Tuberculosis, China Evergrande Group, Jack Ma Foundation, Sino Biopharmaceutical, Ping An Insurance (Group), and New Sunshine Charity Foundation. The researchers and Dr. Pal had no financial conflicts to disclose.

This article was updated on 5/16/2022.

Regardless of the severity of their initial illness, 89% of people who were hospitalized with COVID-19 had returned to their original work 2 years later, a new study shows.

The burden of persistent COVID-19 symptoms appeared to improve over time, but a higher percentage of former patients reported poor health, compared with the general population. This suggests that some patients need more time to completely recover from COVID-19, wrote the authors of the new study, which was published in The Lancet Respiratory Medicine. Previous research has shown that the health effects of COVID-19 last for up to a year, but data from longer-term studies are limited, said Lixue Huang, MD, of Capital Medical University, Beijing, one of the study authors, and colleagues.

Methods and results

In the new study, the researchers reviewed data from 1,192 adult patients who were discharged from the hospital after surviving COVID-19 between Jan. 7, 2020, and May 29, 2020. The researchers measured the participants’ health outcomes at 6 months, 12 months, and 2 years after their onset of symptoms. A community-based dataset of 3,383 adults with no history of COVID-19 served as controls to measure the recovery of the COVID-19 patients. The median age of the patients at the time of hospital discharge was 57 years, and 46% were women. The median follow-up time after the onset of symptoms was 185 days, 349 days, and 685 days for the 6-month, 12-month, and 2-year visits, respectively. The researchers measured health outcomes using a 6-min walking distance (6MWD) test, laboratory tests, and questionnaires about symptoms, mental health, health-related quality of life, returning to work, and health care use since leaving the hospital.

Overall, the proportion of COVID-19 survivors with at least one symptom decreased from 68% at 6 months to 55% at 2 years (P < .0001). The most frequent symptoms were fatigue and muscle weakness, reported by approximately one-third of the patients (31%); sleep problems also were reported by 31% of the patients.

The proportion of individuals with poor results on the 6MWD decreased continuously over time, not only in COVID-19 survivors overall, but also in three subgroups of varying initial disease severity. Of the 494 survivors who reported working before becoming ill, 438 (89%) had returned to their original jobs 2 years later. The most common reasons for not returning to work were decreased physical function, unwillingness to return, and unemployment, the researchers noted.

However, at 2 years, COVID-19 survivors reported more pain and discomfort, as well as more anxiety and depression, compared with the controls (23% vs. 5% and 12% vs. 5%, respectively).

In addition, significantly more survivors who needed high levels of respiratory support while hospitalized had lung diffusion impairment (65%), reduced residual volume (62%), and total lung capacity (39%), compared with matched controls (36%, 20%, and 6%, respectively) at 2 years.

Long-COVID concerns

Approximately half of the survivors had symptoms of long COVID at 2 years. These individuals were more likely to report pain or discomfort or anxiety or depression, as well as mobility problems, compared to survivors without long COVID. Participants with long-COVID symptoms were more than twice as likely to have an outpatient clinic visit (odds ratio, 2.82), and not quite twice as likely to be rehospitalized (OR, 1.64).

 

 

“We found that [health-related quality of life], exercise capacity, and mental health continued to improve throughout the 2 years regardless of initial disease severity, but about half still had symptomatic sequelae at 2 years,” the researchers wrote in their paper.

Findings can inform doctor-patient discussions

“We are increasingly recognizing that the health effects of COVID-19 may persist beyond acute illness, therefore this is a timely study to assess the long-term impact of COVID-19 with a long follow-up period,” said Suman Pal, MD, an internal medicine physician at the University of New Mexico, Albuquerque, in an interview.

The findings are consistent with the existing literature, said Dr. Pal, who was not involved in the study.  The data from the study “can help clinicians have discussions regarding expected recovery and long-term prognosis for patients with COVID-19,” he noted.

What patients should know is that “studies such as this can help COVID-19 survivors understand and monitor persistent symptoms they may experience, and bring them to the attention of their clinicians,” said Dr. Pal.

However, “As a single-center study with high attrition of subjects during the study period, the findings may not be generalizable,” Dr. Pal emphasized. “Larger-scale studies and patient registries distributed over different geographical areas and time periods will help obtain a better understanding of the nature and prevalence of long COVID,” he said.

The study findings were limited by several factors, including the lack of formerly hospitalized controls with respiratory infections other than COVID-19 to determine which outcomes are COVID-19 specific, the researchers noted. Other limitations included the use of data from only patients at a single center, and from the early stages of the pandemic, as well as the use of self-reports for comorbidities and health outcomes, they said.

However, the results represent the longest-known published longitudinal follow-up of patients who recovered from acute COVID-19, the researchers emphasized. Study strengths included the large sample size, longitudinal design, and long-term follow-up with non-COVID controls to determine outcomes. The researchers noted their plans to conduct annual follow-ups in the current study population. They added that more research is needed to explore rehabilitation programs to promote recovery for COVID-19 survivors and to reduce the effects of long COVID.

The study was supported by the Chinese Academy of Medical Sciences, National Natural Science Foundation of China, National Key Research and Development Program of China, National Administration of Traditional Chinese Medicine, Major Projects of National Science and Technology on New Drug Creation and Development of Pulmonary Tuberculosis, China Evergrande Group, Jack Ma Foundation, Sino Biopharmaceutical, Ping An Insurance (Group), and New Sunshine Charity Foundation. The researchers and Dr. Pal had no financial conflicts to disclose.

This article was updated on 5/16/2022.

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‘Goodie bag’ pill mill doctor sentenced to 2 decades in prison

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A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

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

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A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

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

 

A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

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

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Headache in pregnancy: New ACOG guidelines offer insight

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– If a medical professional is trying to figure out the best medical treatment for a pregnant woman with headache, it may be helpful to review data from randomized clinical trials (RCTs). Well, make that data from the RCT. There’s just been one, Northwestern Medicine obstetrician-gynecologist Catherine Stika, MD, told colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Only a single efficacy RCT has examined headache in pregnancy, said Dr. Stika. “Overall, we have very limited data in pregnancy to tell us exactly what to do,” she added.

But ob.gyns. aren’t entirely in the dark, according to medical specialists who spoke at the session. Expert opinion and fetal safety data offer insight into the best treatments, as does a new ACOG clinical practice guideline on headaches during pregnancy and post partum that was coauthored by the speakers.

And there’s some good news: Pregnancy itself is often a good treatment for headaches.

Pregnant women often find relief from one kind of headache – migraine – as their estradiol levels rise, said Laura Mercer, MD, an ob.gyn. at the University of Arizona, Phoenix. “About half of patients will report that migraines are getting better as early as the first trimester, and upwards of 83% will say that their migraines are better by the time they’re in their third trimester,” she said. “What this means for us as obstetricians is that oftentimes we can actually discontinue preventative therapies for patients during pregnancy.”

But simply discontinuing every headache treatment during pregnancy may not be the right approach, Dr. Mercer said. Instead, she said, consider the benefits and risks.

Divalproex sodium (Depakote) and topiramate (Topamax) must be avoided because of fetal risk, she said. “In fact, we will prefer that people stop these medications before they discontinue their contraception if they’re planning on getting pregnant,” she said.

Other medications, such as ACE inhibitors and the herbal remedy feverfew, should not be used at any time during pregnancy, she said.

On the other hand, calcium channel blockers and antihistamines are alright to use in pregnancy, she said. “These two should be considered first-line because there’s no known risks for them.”

Beta-blockers also may be used “with some consideration to the known risks that we’re familiar with when we use them for other indications,” she said.

There are questions about the safety of oral magnesium in pregnancy, although it’s generally considered safe, she added, and “nerve blocks and nerve stimulators seem very promising and have little known risks.”

Dr. Mercer recommended gradually tapering most medications prior to conception. But it’s crucial to stop higher-risk drugs immediately once pregnancy is confirmed, she said.

In regard to acute headache, Dr. Stika urged caution if a patient reports taking a headache medication more than twice a week. “All the medications we use for the treatment of migraine, both in and outside of pregnancy, carry the risk of what’s called medication overuse” that can lead to rebound headaches, she said.

Excedrin Tension Headache may be used for headaches in pregnancy, she said, but not Excedrin Migraine since it includes aspirin. Triptans are not recommended as first-line therapy, she added, and they “should absolutely not be used in any pregnant patient with a history of known cardiac disease or hypertension.”

Dr. Stika added that ACOG advises against the use of drugs that contain butalbital, a barbiturate that’s combined with other agents to treat headache. “Butalbital is the drug that’s most closely associated with getting people into this medication overuse headache,” she said. “It’s even worse than opioids.”

Unlike multiple other countries and the entire European Union, the United States has not banned compounds that contain butalbital, she said.

In some cases, she said, patients may present to triage with vomiting, an inability to keep food down, and persistent headache despite treatment. “This is a really classic presentation.”

The ACOG clinical practice guideline offers a flow chart about what to do, she said. Hydration is key, she said, and various treatment options can help. A referral to neurology may be needed in extreme cases, she said. But “most of the time, you’re able to get rid of her headache.”

Dr. Mercer and Dr. Stika report no disclosures.

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– If a medical professional is trying to figure out the best medical treatment for a pregnant woman with headache, it may be helpful to review data from randomized clinical trials (RCTs). Well, make that data from the RCT. There’s just been one, Northwestern Medicine obstetrician-gynecologist Catherine Stika, MD, told colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Only a single efficacy RCT has examined headache in pregnancy, said Dr. Stika. “Overall, we have very limited data in pregnancy to tell us exactly what to do,” she added.

But ob.gyns. aren’t entirely in the dark, according to medical specialists who spoke at the session. Expert opinion and fetal safety data offer insight into the best treatments, as does a new ACOG clinical practice guideline on headaches during pregnancy and post partum that was coauthored by the speakers.

And there’s some good news: Pregnancy itself is often a good treatment for headaches.

Pregnant women often find relief from one kind of headache – migraine – as their estradiol levels rise, said Laura Mercer, MD, an ob.gyn. at the University of Arizona, Phoenix. “About half of patients will report that migraines are getting better as early as the first trimester, and upwards of 83% will say that their migraines are better by the time they’re in their third trimester,” she said. “What this means for us as obstetricians is that oftentimes we can actually discontinue preventative therapies for patients during pregnancy.”

But simply discontinuing every headache treatment during pregnancy may not be the right approach, Dr. Mercer said. Instead, she said, consider the benefits and risks.

Divalproex sodium (Depakote) and topiramate (Topamax) must be avoided because of fetal risk, she said. “In fact, we will prefer that people stop these medications before they discontinue their contraception if they’re planning on getting pregnant,” she said.

Other medications, such as ACE inhibitors and the herbal remedy feverfew, should not be used at any time during pregnancy, she said.

On the other hand, calcium channel blockers and antihistamines are alright to use in pregnancy, she said. “These two should be considered first-line because there’s no known risks for them.”

Beta-blockers also may be used “with some consideration to the known risks that we’re familiar with when we use them for other indications,” she said.

There are questions about the safety of oral magnesium in pregnancy, although it’s generally considered safe, she added, and “nerve blocks and nerve stimulators seem very promising and have little known risks.”

Dr. Mercer recommended gradually tapering most medications prior to conception. But it’s crucial to stop higher-risk drugs immediately once pregnancy is confirmed, she said.

In regard to acute headache, Dr. Stika urged caution if a patient reports taking a headache medication more than twice a week. “All the medications we use for the treatment of migraine, both in and outside of pregnancy, carry the risk of what’s called medication overuse” that can lead to rebound headaches, she said.

Excedrin Tension Headache may be used for headaches in pregnancy, she said, but not Excedrin Migraine since it includes aspirin. Triptans are not recommended as first-line therapy, she added, and they “should absolutely not be used in any pregnant patient with a history of known cardiac disease or hypertension.”

Dr. Stika added that ACOG advises against the use of drugs that contain butalbital, a barbiturate that’s combined with other agents to treat headache. “Butalbital is the drug that’s most closely associated with getting people into this medication overuse headache,” she said. “It’s even worse than opioids.”

Unlike multiple other countries and the entire European Union, the United States has not banned compounds that contain butalbital, she said.

In some cases, she said, patients may present to triage with vomiting, an inability to keep food down, and persistent headache despite treatment. “This is a really classic presentation.”

The ACOG clinical practice guideline offers a flow chart about what to do, she said. Hydration is key, she said, and various treatment options can help. A referral to neurology may be needed in extreme cases, she said. But “most of the time, you’re able to get rid of her headache.”

Dr. Mercer and Dr. Stika report no disclosures.

– If a medical professional is trying to figure out the best medical treatment for a pregnant woman with headache, it may be helpful to review data from randomized clinical trials (RCTs). Well, make that data from the RCT. There’s just been one, Northwestern Medicine obstetrician-gynecologist Catherine Stika, MD, told colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Only a single efficacy RCT has examined headache in pregnancy, said Dr. Stika. “Overall, we have very limited data in pregnancy to tell us exactly what to do,” she added.

But ob.gyns. aren’t entirely in the dark, according to medical specialists who spoke at the session. Expert opinion and fetal safety data offer insight into the best treatments, as does a new ACOG clinical practice guideline on headaches during pregnancy and post partum that was coauthored by the speakers.

And there’s some good news: Pregnancy itself is often a good treatment for headaches.

Pregnant women often find relief from one kind of headache – migraine – as their estradiol levels rise, said Laura Mercer, MD, an ob.gyn. at the University of Arizona, Phoenix. “About half of patients will report that migraines are getting better as early as the first trimester, and upwards of 83% will say that their migraines are better by the time they’re in their third trimester,” she said. “What this means for us as obstetricians is that oftentimes we can actually discontinue preventative therapies for patients during pregnancy.”

But simply discontinuing every headache treatment during pregnancy may not be the right approach, Dr. Mercer said. Instead, she said, consider the benefits and risks.

Divalproex sodium (Depakote) and topiramate (Topamax) must be avoided because of fetal risk, she said. “In fact, we will prefer that people stop these medications before they discontinue their contraception if they’re planning on getting pregnant,” she said.

Other medications, such as ACE inhibitors and the herbal remedy feverfew, should not be used at any time during pregnancy, she said.

On the other hand, calcium channel blockers and antihistamines are alright to use in pregnancy, she said. “These two should be considered first-line because there’s no known risks for them.”

Beta-blockers also may be used “with some consideration to the known risks that we’re familiar with when we use them for other indications,” she said.

There are questions about the safety of oral magnesium in pregnancy, although it’s generally considered safe, she added, and “nerve blocks and nerve stimulators seem very promising and have little known risks.”

Dr. Mercer recommended gradually tapering most medications prior to conception. But it’s crucial to stop higher-risk drugs immediately once pregnancy is confirmed, she said.

In regard to acute headache, Dr. Stika urged caution if a patient reports taking a headache medication more than twice a week. “All the medications we use for the treatment of migraine, both in and outside of pregnancy, carry the risk of what’s called medication overuse” that can lead to rebound headaches, she said.

Excedrin Tension Headache may be used for headaches in pregnancy, she said, but not Excedrin Migraine since it includes aspirin. Triptans are not recommended as first-line therapy, she added, and they “should absolutely not be used in any pregnant patient with a history of known cardiac disease or hypertension.”

Dr. Stika added that ACOG advises against the use of drugs that contain butalbital, a barbiturate that’s combined with other agents to treat headache. “Butalbital is the drug that’s most closely associated with getting people into this medication overuse headache,” she said. “It’s even worse than opioids.”

Unlike multiple other countries and the entire European Union, the United States has not banned compounds that contain butalbital, she said.

In some cases, she said, patients may present to triage with vomiting, an inability to keep food down, and persistent headache despite treatment. “This is a really classic presentation.”

The ACOG clinical practice guideline offers a flow chart about what to do, she said. Hydration is key, she said, and various treatment options can help. A referral to neurology may be needed in extreme cases, she said. But “most of the time, you’re able to get rid of her headache.”

Dr. Mercer and Dr. Stika report no disclosures.

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Does platelet-rich plasma improve patellar tendinopathy symptoms?

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Evidence summary

Symptoms improve with PRP—but not significantly

A 2014 double-blind RCT (n = 23) explored recovery outcomes in patients with patellar tendinopathy who received either 1 injection of leukocyte-rich PRP or ultrasound-­guided dry needling.1 Both groups also completed standardized eccentric exercises. Participants were predominantly men, ages ≥ 18 years. Symptomatic improvement was assessed using the Victorian Institute of Sport ­Assessment–Patella (VISA-P), an 8-item subjective questionnaire of functionality with a range of 0 to 100, with 100 as the maximum score for an asymptomatic individual.

At 12 weeks posttreatment, VISA-P scores improved in both groups. However, the improvement in the dry needling group was not statistically significant (5.2 points; 95% CI, –2.2 to 12.6; P = .20), while in the PRP group it was statistically significant (25.4 points; 95% CI, 10.3 to 40.6; P = .01). At ≥ 26 weeks, statistically significant improvement was observed in both treatment groups: scores improved by 33.2 points (95% CI, 24.1 to 42.4; P = .001) in the dry needling group and by 28.9 points (95% CI, 11.4 to 46.3; P = .01) in the PRP group. However, the difference between the groups’ VISA-P scores at ≥ 26 weeks was not significant (P = .66).1

No significant differences observed for PRP vs placebo or physical therapy

A 2019 single-blind RCT (n = 57) involved patients who were treated with 1 injection of either leukocyte-rich PRP, leukocyte-poor PRP, or saline, all in combination with 6 weeks of physical therapy.2 Participants were predominantly men, ages 18 to 50 years, and engaged in recreational sporting activities. There was no statistically significant difference in mean change in VISA-P score at any timepoint of the 2-year study period. P values were not reported.2

A 2010 RCT (n = 31) compared PRP (unspecified whether leukocyte-rich or -poor) in combination with physical therapy to physical therapy alone.3 Groups were matched for sex, age, and sports activity level; patients in the PRP group were required to have failed previous treatment, while control subjects must not have received any treatment for at least 2 months. Subjects were evaluated pretreatment, immediately posttreatment, and 6 months posttreatment. Clinical evaluation was aided by use of the Tegner activity score, a 1-item score that grades activity level on a scale of 0 to 10; the EuroQol-visual analog scale (EQ-VAS), which evaluates subjective rating of overall health; and pain level scores.

At 6 months posttreatment, no statistically significant differences were observed between groups in EQ-VAS and pain level scores. However, Tegner activity scores among PRP recipients showed significant percent improvement over controls at 6 months posttreatment (39% vs 20%; P = .048).3

Recommendations from others

Currently, national orthopedic and professional athletic medical associations have recommended that further research be conducted in order to make a strong statement in favor of or against PRP.4,5

Editor’s takeaway

Existing data regarding PRP fails, again, to show consistent benefits. These small sample sizes, inconsistent comparators, and heterogeneous results limit our certainty. This lack of quality evidence does not prove a lack of effect, but it raises serious doubts.

References

1. Dragoo JL, Wasterlain AS, Braun HJ, et al. Platelet-rich plasma as a treatment for patellar tendinopathy: a double-blind, randomized controlled trial. Am J Sports Med. 2014;42:610-618. doi: 10.1177/0363546513518416

2. Scott A, LaPrade R, Harmon K, et al. Platelet-rich plasma for patellar tendinopathy: a randomized controlled trial of leukocyte-rich PRP or leukocyte-poor PRP versus saline. Am J Sports Med. 2019;47:1654-1661. doi: 10.1177/0363546519837954

3. Filardo G, Kon E, Villa S Della, et al. Use of platelet-rich plasma for the treatment of refractory jumper’s knee. Int Orthop. 2010;34:909. doi: 10.1007/s00264-009-0845-7

4. LaPrade R, Dragoo J, Koh J, et al. AAOS Research Symposium updates and consensus: biologic treatment of orthopaedic injuries. J Am Acad Orthop Surg. 2016;24:e62-e78. doi: 10.5435/JAAOS-D-16-00086

5. Rodeo SA, Bedi A. 2019-2020 NFL and NFL Physician Society orthobiologics consensus statement. Sports Health. 2020;12:58-60. doi: 10.1177/1941738119889013

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Emily Wolfenden, MD, MPH
Brian Vukelic, MD
Matthew DeMarco, MD
Jordan Knox, MD

University of Utah, Salt Lake City

Dominik Ose, DrPH, MPH
University of Utah, Salt Lake City

DEPUTY EDITOR
Rick Guthmann, MD, MPH

Advocate Health Care Illinois Masonic Medical Center Program, Chicago

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Emily Wolfenden, MD, MPH
Brian Vukelic, MD
Matthew DeMarco, MD
Jordan Knox, MD

University of Utah, Salt Lake City

Dominik Ose, DrPH, MPH
University of Utah, Salt Lake City

DEPUTY EDITOR
Rick Guthmann, MD, MPH

Advocate Health Care Illinois Masonic Medical Center Program, Chicago

Author and Disclosure Information

Emily Wolfenden, MD, MPH
Brian Vukelic, MD
Matthew DeMarco, MD
Jordan Knox, MD

University of Utah, Salt Lake City

Dominik Ose, DrPH, MPH
University of Utah, Salt Lake City

DEPUTY EDITOR
Rick Guthmann, MD, MPH

Advocate Health Care Illinois Masonic Medical Center Program, Chicago

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Evidence summary

Symptoms improve with PRP—but not significantly

A 2014 double-blind RCT (n = 23) explored recovery outcomes in patients with patellar tendinopathy who received either 1 injection of leukocyte-rich PRP or ultrasound-­guided dry needling.1 Both groups also completed standardized eccentric exercises. Participants were predominantly men, ages ≥ 18 years. Symptomatic improvement was assessed using the Victorian Institute of Sport ­Assessment–Patella (VISA-P), an 8-item subjective questionnaire of functionality with a range of 0 to 100, with 100 as the maximum score for an asymptomatic individual.

At 12 weeks posttreatment, VISA-P scores improved in both groups. However, the improvement in the dry needling group was not statistically significant (5.2 points; 95% CI, –2.2 to 12.6; P = .20), while in the PRP group it was statistically significant (25.4 points; 95% CI, 10.3 to 40.6; P = .01). At ≥ 26 weeks, statistically significant improvement was observed in both treatment groups: scores improved by 33.2 points (95% CI, 24.1 to 42.4; P = .001) in the dry needling group and by 28.9 points (95% CI, 11.4 to 46.3; P = .01) in the PRP group. However, the difference between the groups’ VISA-P scores at ≥ 26 weeks was not significant (P = .66).1

No significant differences observed for PRP vs placebo or physical therapy

A 2019 single-blind RCT (n = 57) involved patients who were treated with 1 injection of either leukocyte-rich PRP, leukocyte-poor PRP, or saline, all in combination with 6 weeks of physical therapy.2 Participants were predominantly men, ages 18 to 50 years, and engaged in recreational sporting activities. There was no statistically significant difference in mean change in VISA-P score at any timepoint of the 2-year study period. P values were not reported.2

A 2010 RCT (n = 31) compared PRP (unspecified whether leukocyte-rich or -poor) in combination with physical therapy to physical therapy alone.3 Groups were matched for sex, age, and sports activity level; patients in the PRP group were required to have failed previous treatment, while control subjects must not have received any treatment for at least 2 months. Subjects were evaluated pretreatment, immediately posttreatment, and 6 months posttreatment. Clinical evaluation was aided by use of the Tegner activity score, a 1-item score that grades activity level on a scale of 0 to 10; the EuroQol-visual analog scale (EQ-VAS), which evaluates subjective rating of overall health; and pain level scores.

At 6 months posttreatment, no statistically significant differences were observed between groups in EQ-VAS and pain level scores. However, Tegner activity scores among PRP recipients showed significant percent improvement over controls at 6 months posttreatment (39% vs 20%; P = .048).3

Recommendations from others

Currently, national orthopedic and professional athletic medical associations have recommended that further research be conducted in order to make a strong statement in favor of or against PRP.4,5

Editor’s takeaway

Existing data regarding PRP fails, again, to show consistent benefits. These small sample sizes, inconsistent comparators, and heterogeneous results limit our certainty. This lack of quality evidence does not prove a lack of effect, but it raises serious doubts.

Evidence summary

Symptoms improve with PRP—but not significantly

A 2014 double-blind RCT (n = 23) explored recovery outcomes in patients with patellar tendinopathy who received either 1 injection of leukocyte-rich PRP or ultrasound-­guided dry needling.1 Both groups also completed standardized eccentric exercises. Participants were predominantly men, ages ≥ 18 years. Symptomatic improvement was assessed using the Victorian Institute of Sport ­Assessment–Patella (VISA-P), an 8-item subjective questionnaire of functionality with a range of 0 to 100, with 100 as the maximum score for an asymptomatic individual.

At 12 weeks posttreatment, VISA-P scores improved in both groups. However, the improvement in the dry needling group was not statistically significant (5.2 points; 95% CI, –2.2 to 12.6; P = .20), while in the PRP group it was statistically significant (25.4 points; 95% CI, 10.3 to 40.6; P = .01). At ≥ 26 weeks, statistically significant improvement was observed in both treatment groups: scores improved by 33.2 points (95% CI, 24.1 to 42.4; P = .001) in the dry needling group and by 28.9 points (95% CI, 11.4 to 46.3; P = .01) in the PRP group. However, the difference between the groups’ VISA-P scores at ≥ 26 weeks was not significant (P = .66).1

No significant differences observed for PRP vs placebo or physical therapy

A 2019 single-blind RCT (n = 57) involved patients who were treated with 1 injection of either leukocyte-rich PRP, leukocyte-poor PRP, or saline, all in combination with 6 weeks of physical therapy.2 Participants were predominantly men, ages 18 to 50 years, and engaged in recreational sporting activities. There was no statistically significant difference in mean change in VISA-P score at any timepoint of the 2-year study period. P values were not reported.2

A 2010 RCT (n = 31) compared PRP (unspecified whether leukocyte-rich or -poor) in combination with physical therapy to physical therapy alone.3 Groups were matched for sex, age, and sports activity level; patients in the PRP group were required to have failed previous treatment, while control subjects must not have received any treatment for at least 2 months. Subjects were evaluated pretreatment, immediately posttreatment, and 6 months posttreatment. Clinical evaluation was aided by use of the Tegner activity score, a 1-item score that grades activity level on a scale of 0 to 10; the EuroQol-visual analog scale (EQ-VAS), which evaluates subjective rating of overall health; and pain level scores.

At 6 months posttreatment, no statistically significant differences were observed between groups in EQ-VAS and pain level scores. However, Tegner activity scores among PRP recipients showed significant percent improvement over controls at 6 months posttreatment (39% vs 20%; P = .048).3

Recommendations from others

Currently, national orthopedic and professional athletic medical associations have recommended that further research be conducted in order to make a strong statement in favor of or against PRP.4,5

Editor’s takeaway

Existing data regarding PRP fails, again, to show consistent benefits. These small sample sizes, inconsistent comparators, and heterogeneous results limit our certainty. This lack of quality evidence does not prove a lack of effect, but it raises serious doubts.

References

1. Dragoo JL, Wasterlain AS, Braun HJ, et al. Platelet-rich plasma as a treatment for patellar tendinopathy: a double-blind, randomized controlled trial. Am J Sports Med. 2014;42:610-618. doi: 10.1177/0363546513518416

2. Scott A, LaPrade R, Harmon K, et al. Platelet-rich plasma for patellar tendinopathy: a randomized controlled trial of leukocyte-rich PRP or leukocyte-poor PRP versus saline. Am J Sports Med. 2019;47:1654-1661. doi: 10.1177/0363546519837954

3. Filardo G, Kon E, Villa S Della, et al. Use of platelet-rich plasma for the treatment of refractory jumper’s knee. Int Orthop. 2010;34:909. doi: 10.1007/s00264-009-0845-7

4. LaPrade R, Dragoo J, Koh J, et al. AAOS Research Symposium updates and consensus: biologic treatment of orthopaedic injuries. J Am Acad Orthop Surg. 2016;24:e62-e78. doi: 10.5435/JAAOS-D-16-00086

5. Rodeo SA, Bedi A. 2019-2020 NFL and NFL Physician Society orthobiologics consensus statement. Sports Health. 2020;12:58-60. doi: 10.1177/1941738119889013

References

1. Dragoo JL, Wasterlain AS, Braun HJ, et al. Platelet-rich plasma as a treatment for patellar tendinopathy: a double-blind, randomized controlled trial. Am J Sports Med. 2014;42:610-618. doi: 10.1177/0363546513518416

2. Scott A, LaPrade R, Harmon K, et al. Platelet-rich plasma for patellar tendinopathy: a randomized controlled trial of leukocyte-rich PRP or leukocyte-poor PRP versus saline. Am J Sports Med. 2019;47:1654-1661. doi: 10.1177/0363546519837954

3. Filardo G, Kon E, Villa S Della, et al. Use of platelet-rich plasma for the treatment of refractory jumper’s knee. Int Orthop. 2010;34:909. doi: 10.1007/s00264-009-0845-7

4. LaPrade R, Dragoo J, Koh J, et al. AAOS Research Symposium updates and consensus: biologic treatment of orthopaedic injuries. J Am Acad Orthop Surg. 2016;24:e62-e78. doi: 10.5435/JAAOS-D-16-00086

5. Rodeo SA, Bedi A. 2019-2020 NFL and NFL Physician Society orthobiologics consensus statement. Sports Health. 2020;12:58-60. doi: 10.1177/1941738119889013

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EVIDENCE-BASED ANSWER:

IT’S UNCLEAR. High-quality data have not consistently established the effectiveness of platelet-rich plasma (PRP) injections to improve symptomatic recovery in patellar tendinopathy, compared to placebo (strength of recommendation [SOR]: A, based on 3 small randomized controlled trials [RCTs]). The 3 small RCTs included only 111 patients, total. One found no evidence of significant improvement with PRP compared to controls. The other 2 studies showed mixed results, with different outcome measures favoring different treatment groups and heterogeneous results depending on follow-up duration.

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Relugolix combo eases a long-neglected fibroid symptom: Pain

Article Type
Changed
Wed, 05/11/2022 - 11:36

Combination therapy with relugolix (Orgovyx, Relumina), a gonadotropin-releasing hormone antagonist, significantly reduced the pain of uterine fibroids, an undertreated aspect of this disease.

In pooled results from the multicenter randomized placebo-controlled LIBERTY 1 and 2 trials, relugolix combination therapy (CT) with the progestin norethindrone (Aygestin, Camila) markedly decreased both menstrual and nonmenstrual fibroid pain, as well as heavy bleeding and other symptoms of leiomyomas. This hormone-dependent condition occurs in 70%-80% of premenopausal women.

Dr. Elizabeth A. Stewart

“Historically, studies of uterine fibroids have not asked about pain, so one of strengths of these studies is that they asked women to rate their pain and found a substantial proportion listed pain as a symptom,” lead author Elizabeth A. Stewart, MD, director of reproductive endocrinology at the Mayo Clinic in Rochester, Minn., said in an interview.

The combination was effective against all categories of leiomyoma symptoms, she said, and adverse events were few.

Bleeding has been the main focus of studies of leiomyoma therapies, while chronic pain has been largely neglected, said James H. Segars Jr., MD, director of the division of reproductive science and women’s health research at Johns Hopkins Medicine in Baltimore, who was not involved in the studies. Across both of the LIBERTY trials, involving 509 women randomized during the period April 2017 to December 2018, more than half overall (54.4%) met their pain reduction goals in a subpopulation analysis. Pain reduction was a secondary outcome of the trials, with bleeding reduction the primary endpoint. Other fibroid symptoms are abdominal bloating and pressure.

“The consistent and significant reduction in measures of pain with relugolix-CT observed in the LIBERTY program is clinically meaningful, patient-relevant, and together with an improvement of heavy menstrual bleeding and other uterine leiomyoma–associated symptoms, is likely to have a substantial effect on the life of women with symptomatic uterine leiomyomas,” Dr. Stewart and colleagues wrote. Their report was published online in Obstetrics & Gynecology.

Dr. Segars concurred. “This study is important because sometimes the only fibroid symptom women have is pain. If we ignore that, we miss a lot of women who have pain but no bleeding.”
 

The study

The premenopausal participants had a mean age of just over 42 years (range, 18-50) and were enrolled from North and South America, Europe, and Africa. All reported leiomyoma-associated heavy menstrual bleeding of 80 mL or greater per cycle for two cycles, or 160 mL or greater during one cycle.

In both arms, the mean body mass index was 32 kg/m2, while menstrual blood loss volume was 245.4 (± 186.4) mL in the relugolix-CT and 207.4 (± 114.3) mL in the placebo group.

Pain was a frequent symptom, with approximately 70% in the intervention group and 74% in the placebo group reporting fibroid pain at baseline.

Women were randomized 1:1:1 to receive:

  • Relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg)
  • Delayed relugolix-CT (relugolix 40 mg monotherapy followed by relugolix-CT, each for 12 weeks)
  • Placebo, taken orally once daily for 24 weeks

The therapy was well tolerated and adverse events were low.

The subpopulation analysis found that over the study period, the proportion of women achieving minimal to no pain (level 0 to 1) during the last 35 days of treatment was notably higher in the relugolix-CT arm than in the placebo arm: 45.2% (95% confidence interval [CI], 36.4%-54.3%) versus 13.9% (95% CI, 8.8%-20.5%) in the placebo group (nominal P = .001).

Moreover, the proportions of women with minimal to no pain during both menstrual days and nonmenstrual days were significantly higher with relugolix-CT: 65.0% (95% CI, 55.6%-73.5%) and 44.6% (95% CI, 32.3%-7.5%), respectively, compared with placebo: 19.3% (95% CI 13.2%–26.7%, nominal P = 001), and 21.6% (95% CI, 12.9%-32.7%, nominal P = 004), respectively.

Studies of relugolix monotherapy in Japanese women with uterine leiomyomas have demonstrated reductions in pain.

“Significantly, this combination therapy allows women to be treated over 2 years and to take the oral tablet themselves, unlike Lupron [leuprolide], which is injected and can only be taken for a couple of months because of bone loss,” Dr. Segars said. And the add-back component of combination therapy prevents the adverse symptoms of a hypoestrogenic state.

Dr. James H. Segars Jr.

“The pain of fibroids is chronic, and the longer treatment allows time for the pain fibers to revert to a normal state,” he explained. “The pain pathways get etched into the nerves and it takes time to revert.”

He noted that the LIBERTY trials showed a slight downward trend in pain continuing after 24 weeks of treatment. Other studies of similar hormonal treatments have shown a reduction in the size of fibroids, which can be as large as a tennis ball.

As in endometriosis, leiomyomas are associated with elevated circulating cytokines and a systemic proinflammatory state. In endometriosis, this milieu is linked to the risk of inflammatory arthritis, fibromyalgia, lupus, and cardiovascular disease, Dr. Segars said. “If we did a deeper dive, we might find the same associations for fibroids.” Apart from chronic depression and fatigue, fibroids are linked to downstream pregnancy complications and poor outcomes such as miscarriage and preterm birth, he said.

“There remains a high unmet need for effective treatments, especially nonsurgical interventions, for women with uterine leiomyomas,” the authors wrote. Dr. Stewart added that “it would be helpful to learn more about how relugolix and other drugs in its class work in fibroids. No category of symptoms has been unresponsive to these medications – they are powerful drugs to help women with uterine fibroids.” She noted that relugolix-CT has already been approved outside the United States for symptoms beyond heavy menstrual bleeding.

Future research should focus on developing a therapy that does not interfere with fertility, Dr. Segars said. “We need a treatment that will allow women to get pregnant on it.”

Myovant Sciences GmbH sponsored LIBERTY 1 and 2 and oversaw all aspects of the studies. Dr. Stewart has provided consulting services to Myovant, Bayer, AbbVie, and ObsEva. She has received royalties from UpToDate and fees from Med Learning Group, Med-IQ, Medscape, Peer View, and PER, as well as honoraria from the American College of Obstetricians and Gynecologists and Massachusetts Medical Society. She holds a patent for methods and compounds for treatment of abnormal uterine bleeding. Dr. Segars has consulted for Bayer and Organon. Several coauthors reported similar financial relationships with private-sector entities and two coauthors are employees of Myovant.

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Combination therapy with relugolix (Orgovyx, Relumina), a gonadotropin-releasing hormone antagonist, significantly reduced the pain of uterine fibroids, an undertreated aspect of this disease.

In pooled results from the multicenter randomized placebo-controlled LIBERTY 1 and 2 trials, relugolix combination therapy (CT) with the progestin norethindrone (Aygestin, Camila) markedly decreased both menstrual and nonmenstrual fibroid pain, as well as heavy bleeding and other symptoms of leiomyomas. This hormone-dependent condition occurs in 70%-80% of premenopausal women.

Dr. Elizabeth A. Stewart

“Historically, studies of uterine fibroids have not asked about pain, so one of strengths of these studies is that they asked women to rate their pain and found a substantial proportion listed pain as a symptom,” lead author Elizabeth A. Stewart, MD, director of reproductive endocrinology at the Mayo Clinic in Rochester, Minn., said in an interview.

The combination was effective against all categories of leiomyoma symptoms, she said, and adverse events were few.

Bleeding has been the main focus of studies of leiomyoma therapies, while chronic pain has been largely neglected, said James H. Segars Jr., MD, director of the division of reproductive science and women’s health research at Johns Hopkins Medicine in Baltimore, who was not involved in the studies. Across both of the LIBERTY trials, involving 509 women randomized during the period April 2017 to December 2018, more than half overall (54.4%) met their pain reduction goals in a subpopulation analysis. Pain reduction was a secondary outcome of the trials, with bleeding reduction the primary endpoint. Other fibroid symptoms are abdominal bloating and pressure.

“The consistent and significant reduction in measures of pain with relugolix-CT observed in the LIBERTY program is clinically meaningful, patient-relevant, and together with an improvement of heavy menstrual bleeding and other uterine leiomyoma–associated symptoms, is likely to have a substantial effect on the life of women with symptomatic uterine leiomyomas,” Dr. Stewart and colleagues wrote. Their report was published online in Obstetrics & Gynecology.

Dr. Segars concurred. “This study is important because sometimes the only fibroid symptom women have is pain. If we ignore that, we miss a lot of women who have pain but no bleeding.”
 

The study

The premenopausal participants had a mean age of just over 42 years (range, 18-50) and were enrolled from North and South America, Europe, and Africa. All reported leiomyoma-associated heavy menstrual bleeding of 80 mL or greater per cycle for two cycles, or 160 mL or greater during one cycle.

In both arms, the mean body mass index was 32 kg/m2, while menstrual blood loss volume was 245.4 (± 186.4) mL in the relugolix-CT and 207.4 (± 114.3) mL in the placebo group.

Pain was a frequent symptom, with approximately 70% in the intervention group and 74% in the placebo group reporting fibroid pain at baseline.

Women were randomized 1:1:1 to receive:

  • Relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg)
  • Delayed relugolix-CT (relugolix 40 mg monotherapy followed by relugolix-CT, each for 12 weeks)
  • Placebo, taken orally once daily for 24 weeks

The therapy was well tolerated and adverse events were low.

The subpopulation analysis found that over the study period, the proportion of women achieving minimal to no pain (level 0 to 1) during the last 35 days of treatment was notably higher in the relugolix-CT arm than in the placebo arm: 45.2% (95% confidence interval [CI], 36.4%-54.3%) versus 13.9% (95% CI, 8.8%-20.5%) in the placebo group (nominal P = .001).

Moreover, the proportions of women with minimal to no pain during both menstrual days and nonmenstrual days were significantly higher with relugolix-CT: 65.0% (95% CI, 55.6%-73.5%) and 44.6% (95% CI, 32.3%-7.5%), respectively, compared with placebo: 19.3% (95% CI 13.2%–26.7%, nominal P = 001), and 21.6% (95% CI, 12.9%-32.7%, nominal P = 004), respectively.

Studies of relugolix monotherapy in Japanese women with uterine leiomyomas have demonstrated reductions in pain.

“Significantly, this combination therapy allows women to be treated over 2 years and to take the oral tablet themselves, unlike Lupron [leuprolide], which is injected and can only be taken for a couple of months because of bone loss,” Dr. Segars said. And the add-back component of combination therapy prevents the adverse symptoms of a hypoestrogenic state.

Dr. James H. Segars Jr.

“The pain of fibroids is chronic, and the longer treatment allows time for the pain fibers to revert to a normal state,” he explained. “The pain pathways get etched into the nerves and it takes time to revert.”

He noted that the LIBERTY trials showed a slight downward trend in pain continuing after 24 weeks of treatment. Other studies of similar hormonal treatments have shown a reduction in the size of fibroids, which can be as large as a tennis ball.

As in endometriosis, leiomyomas are associated with elevated circulating cytokines and a systemic proinflammatory state. In endometriosis, this milieu is linked to the risk of inflammatory arthritis, fibromyalgia, lupus, and cardiovascular disease, Dr. Segars said. “If we did a deeper dive, we might find the same associations for fibroids.” Apart from chronic depression and fatigue, fibroids are linked to downstream pregnancy complications and poor outcomes such as miscarriage and preterm birth, he said.

“There remains a high unmet need for effective treatments, especially nonsurgical interventions, for women with uterine leiomyomas,” the authors wrote. Dr. Stewart added that “it would be helpful to learn more about how relugolix and other drugs in its class work in fibroids. No category of symptoms has been unresponsive to these medications – they are powerful drugs to help women with uterine fibroids.” She noted that relugolix-CT has already been approved outside the United States for symptoms beyond heavy menstrual bleeding.

Future research should focus on developing a therapy that does not interfere with fertility, Dr. Segars said. “We need a treatment that will allow women to get pregnant on it.”

Myovant Sciences GmbH sponsored LIBERTY 1 and 2 and oversaw all aspects of the studies. Dr. Stewart has provided consulting services to Myovant, Bayer, AbbVie, and ObsEva. She has received royalties from UpToDate and fees from Med Learning Group, Med-IQ, Medscape, Peer View, and PER, as well as honoraria from the American College of Obstetricians and Gynecologists and Massachusetts Medical Society. She holds a patent for methods and compounds for treatment of abnormal uterine bleeding. Dr. Segars has consulted for Bayer and Organon. Several coauthors reported similar financial relationships with private-sector entities and two coauthors are employees of Myovant.

Combination therapy with relugolix (Orgovyx, Relumina), a gonadotropin-releasing hormone antagonist, significantly reduced the pain of uterine fibroids, an undertreated aspect of this disease.

In pooled results from the multicenter randomized placebo-controlled LIBERTY 1 and 2 trials, relugolix combination therapy (CT) with the progestin norethindrone (Aygestin, Camila) markedly decreased both menstrual and nonmenstrual fibroid pain, as well as heavy bleeding and other symptoms of leiomyomas. This hormone-dependent condition occurs in 70%-80% of premenopausal women.

Dr. Elizabeth A. Stewart

“Historically, studies of uterine fibroids have not asked about pain, so one of strengths of these studies is that they asked women to rate their pain and found a substantial proportion listed pain as a symptom,” lead author Elizabeth A. Stewart, MD, director of reproductive endocrinology at the Mayo Clinic in Rochester, Minn., said in an interview.

The combination was effective against all categories of leiomyoma symptoms, she said, and adverse events were few.

Bleeding has been the main focus of studies of leiomyoma therapies, while chronic pain has been largely neglected, said James H. Segars Jr., MD, director of the division of reproductive science and women’s health research at Johns Hopkins Medicine in Baltimore, who was not involved in the studies. Across both of the LIBERTY trials, involving 509 women randomized during the period April 2017 to December 2018, more than half overall (54.4%) met their pain reduction goals in a subpopulation analysis. Pain reduction was a secondary outcome of the trials, with bleeding reduction the primary endpoint. Other fibroid symptoms are abdominal bloating and pressure.

“The consistent and significant reduction in measures of pain with relugolix-CT observed in the LIBERTY program is clinically meaningful, patient-relevant, and together with an improvement of heavy menstrual bleeding and other uterine leiomyoma–associated symptoms, is likely to have a substantial effect on the life of women with symptomatic uterine leiomyomas,” Dr. Stewart and colleagues wrote. Their report was published online in Obstetrics & Gynecology.

Dr. Segars concurred. “This study is important because sometimes the only fibroid symptom women have is pain. If we ignore that, we miss a lot of women who have pain but no bleeding.”
 

The study

The premenopausal participants had a mean age of just over 42 years (range, 18-50) and were enrolled from North and South America, Europe, and Africa. All reported leiomyoma-associated heavy menstrual bleeding of 80 mL or greater per cycle for two cycles, or 160 mL or greater during one cycle.

In both arms, the mean body mass index was 32 kg/m2, while menstrual blood loss volume was 245.4 (± 186.4) mL in the relugolix-CT and 207.4 (± 114.3) mL in the placebo group.

Pain was a frequent symptom, with approximately 70% in the intervention group and 74% in the placebo group reporting fibroid pain at baseline.

Women were randomized 1:1:1 to receive:

  • Relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg)
  • Delayed relugolix-CT (relugolix 40 mg monotherapy followed by relugolix-CT, each for 12 weeks)
  • Placebo, taken orally once daily for 24 weeks

The therapy was well tolerated and adverse events were low.

The subpopulation analysis found that over the study period, the proportion of women achieving minimal to no pain (level 0 to 1) during the last 35 days of treatment was notably higher in the relugolix-CT arm than in the placebo arm: 45.2% (95% confidence interval [CI], 36.4%-54.3%) versus 13.9% (95% CI, 8.8%-20.5%) in the placebo group (nominal P = .001).

Moreover, the proportions of women with minimal to no pain during both menstrual days and nonmenstrual days were significantly higher with relugolix-CT: 65.0% (95% CI, 55.6%-73.5%) and 44.6% (95% CI, 32.3%-7.5%), respectively, compared with placebo: 19.3% (95% CI 13.2%–26.7%, nominal P = 001), and 21.6% (95% CI, 12.9%-32.7%, nominal P = 004), respectively.

Studies of relugolix monotherapy in Japanese women with uterine leiomyomas have demonstrated reductions in pain.

“Significantly, this combination therapy allows women to be treated over 2 years and to take the oral tablet themselves, unlike Lupron [leuprolide], which is injected and can only be taken for a couple of months because of bone loss,” Dr. Segars said. And the add-back component of combination therapy prevents the adverse symptoms of a hypoestrogenic state.

Dr. James H. Segars Jr.

“The pain of fibroids is chronic, and the longer treatment allows time for the pain fibers to revert to a normal state,” he explained. “The pain pathways get etched into the nerves and it takes time to revert.”

He noted that the LIBERTY trials showed a slight downward trend in pain continuing after 24 weeks of treatment. Other studies of similar hormonal treatments have shown a reduction in the size of fibroids, which can be as large as a tennis ball.

As in endometriosis, leiomyomas are associated with elevated circulating cytokines and a systemic proinflammatory state. In endometriosis, this milieu is linked to the risk of inflammatory arthritis, fibromyalgia, lupus, and cardiovascular disease, Dr. Segars said. “If we did a deeper dive, we might find the same associations for fibroids.” Apart from chronic depression and fatigue, fibroids are linked to downstream pregnancy complications and poor outcomes such as miscarriage and preterm birth, he said.

“There remains a high unmet need for effective treatments, especially nonsurgical interventions, for women with uterine leiomyomas,” the authors wrote. Dr. Stewart added that “it would be helpful to learn more about how relugolix and other drugs in its class work in fibroids. No category of symptoms has been unresponsive to these medications – they are powerful drugs to help women with uterine fibroids.” She noted that relugolix-CT has already been approved outside the United States for symptoms beyond heavy menstrual bleeding.

Future research should focus on developing a therapy that does not interfere with fertility, Dr. Segars said. “We need a treatment that will allow women to get pregnant on it.”

Myovant Sciences GmbH sponsored LIBERTY 1 and 2 and oversaw all aspects of the studies. Dr. Stewart has provided consulting services to Myovant, Bayer, AbbVie, and ObsEva. She has received royalties from UpToDate and fees from Med Learning Group, Med-IQ, Medscape, Peer View, and PER, as well as honoraria from the American College of Obstetricians and Gynecologists and Massachusetts Medical Society. She holds a patent for methods and compounds for treatment of abnormal uterine bleeding. Dr. Segars has consulted for Bayer and Organon. Several coauthors reported similar financial relationships with private-sector entities and two coauthors are employees of Myovant.

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Time to consider topical capsaicin for acute trauma pain?

ILLUSTRATIVE CASE

A 23-year-old man with no significant past medical history presents to an urgent care center after a fall on his right arm while playing football. He reports a pain level of 6 using the visual analog scale (VAS). Physical exam reveals minor erythema and edema of his forearm with pain to palpation. Range of motion, strength, and sensation are intact. No lacerations are present. His vital signs are normal. No fracture is found on imaging. The physician decides that treatment with a topical analgesic is reasonable for this uncomplicated contusion of the right forearm. Is there a role for topical capsaicin in the treatment of this patient’s pain?

Topical nonsteroidal anti-­inflammatory drugs (NSAIDs) are effective for the treatment of acute non–low back pain musculoskeletal injuries.2 They are generally well tolerated and just as effective as oral NSAIDS or acetaminophen for localized injuries. Their ubiquitous availability, affordability, and low adverse effect profile make them an attractive first-line treatment option for acute musculoskeletal pain.

Capsaicin, a topical agent derived from a genus of red peppers, has been used for the treatment of neuropathic and chronic pain via its interactions with substance P, transient receptor potential vanilloid subtype 1 (TRPV1), and nociceptive nerve fibers.3,4 It has demonstrated effectiveness in the management of diabetic neuropathy, knee osteoarthritis, and postherpetic neuralgia, as well as various causes of pruritus.5,6

Although many studies have compared oral and topical NSAIDs, opiates, and acetaminophen, few studies have directly compared topical NSAIDs and capsaicin. This study compared the topical NSAID piroxicam with topical capsaicin.

STUDY SUMMARY

Topical capsaicin demonstrated superior pain reduction

This prospective, double-blind RCT compared the efficacy of topical capsaicin vs topical piroxicam for the treatment of acute pain following upper extremity blunt trauma. Patients (ages ≥ 18 years) who presented to a Turkish emergency department within 2 hours of upper extremity injury were randomized to receive either 0.05% capsaicin gel (n = 69) or 0.5% piroxicam gel (n = 67). Patients reported level 5 or higher pain on the VAS. Those with fractures, dislocations, skin disruption, or other trauma were excluded. Age, gender, pain duration, and mechanism of injury did not differ significantly between study groups.1

Blinding was ensured by placing the gels in opaque containers containing 30 mg of either capsaicin or piroxicam and dyeing the medicine with red and yellow food coloring. A thin layer of medication was applied to an area no larger than 5 × 5 cm on the upper extremity and rubbed for 1 minute. Patients were observed in the emergency department for 2 hours and discharged with instructions to apply the medication 3 times daily for 72 hours.

Topical capsaicin is an effective alternative to a topical NSAID in reducing pain associated with acute upper extremity injuries.

The investigators measured pain using VAS scores at 1 hour, 2 hours, 24 hours, and 72 hours after treatment. Topical capsaicin was superior to topical piroxicam at achieving both primary outcomes: a VAS score of ≤ 4 (85.5% vs 50.7%; number needed to treat [NNT] = 2.9; P < .001) and a > 50% reduction in VAS score (87% vs 62.7%; NNT = 4.1; P < .01) at the end of treatment.1 (These outcomes were based on earlier determinations of the minimal clinically important difference.7,8)

Additionally, capsaicin was more effective than piroxicam at each time interval. This difference was most pronounced at 72 hours, with a mean difference of delta VAS scores of 1.53 (95% CI, 0.85-2.221) and a mean percentage of the reduction in VAS scores of 19.7% (95% CI, 12.4%-27.2%) (P < .001).1

 

 

Reported adverse effects, such as burning, itching, and rash, were mild and infrequent and showed no significant difference between the treatment groups.

WHAT’S NEW

First study comparing topical capsaicin and a topical NSAID in acute trauma

Although both capsaicin and topical piroxicam have proven efficacy for the treatment of pain, this RCT is the first study to directly compare these agents in the setting of acute upper extremity blunt trauma. Capsaicin is currently more commonly prescribed as a treatment for chronic neuropathic pain.4,9 In this study, capsaicin demonstrated superior results in pain reduction at each assessed time interval and at the primary end point of 72 hours.

CAVEATS

Limited generalizability to lower extremity and truncal trauma

This RCT included a relatively small sample size (136 patients). Researchers evaluated only blunt upper extremity injuries; as such, the generalizability of the effectiveness of topical capsaicin in blunt lower extremity and truncal trauma is limited, especially over larger surface areas.

 

CHALLENGES TO IMPLEMENTATION

No major challenges found

There are no major challenges to implementing this inexpensive treatment.

Files
References

1. Kocak AO, Dogruyol S, Akbas I, et al. Comparison of topical capsaicin and topical piroxicam in the treatment of acute trauma-induced pain: a randomized double-blind trial. Am J Emerg Med. 2020;38:1767-1771. doi: 10.1016/j.ajem.2020.05.104

2. Busse JW, Sadeghirad B, Oparin Y, et al. Management of acute pain from non–low back, musculoskeletal injuries: a systematic review and network meta-analysis of randomized trials. Ann Intern Med. 2020;173:730-738. doi: 10.7326/M19-3601

3. Chrubasik S, Weiser T, Beime B. Effectiveness and safety of topical capsaicin cream in the treatment of chronic soft tissue pain. Phytother Res. 2010;24:1877-1885. doi: 10.1002/ptr.3335

4. Derry S, Moore RA. Topical capsaicin (low concentration) for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2012(9):CD010111. doi: 10.1002/14651858.CD010111

5. Simpson DM, Robinson-Papp J, Van J, et al. Capsaicin 8% patch in painful diabetic peripheral neuropathy: a randomized, double-blind, placebo-controlled study. J Pain. 2017;18:42-53. doi: 10.1016/j.jpain.2016.09.008

6. Papoiu ADP, Yosipovitch G. Topical capsaicin. The fire of a ‘hot’ medicine is reignited. Expert Opin Pharmacother. 2010;11:1359-1371. doi: 10.1517/14656566.2010.481670

7. Kulkantrakorn K, Lorsuwansiri C, Meesawatsom P. 0.025% capsaicin gel for the treatment of painful diabetic neuropathy: a randomized, double-blind, crossover, placebo-controlled trial. Pain Pract. 2013;13:497-503. doi: 10.1111/papr.12013

8. Kocak AO, Ahiskalioglu A, Sengun E, et al. Comparison of intravenous NSAIDs and trigger point injection for low back pain in ED: a prospective randomized study. Am J Emerg Med. 2019;37:1927-1931. doi: 10.1016/j.ajem.2019.01.015

9. Derry S, Rice ASC, Cole P, et al. Topical capsaicin (high concentration) for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2017;1(1):CD007393. doi: 10.1002/14651858.CD007393.pub4

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Nellis Family Medicine Residency, Nellis Air Force Base, NV

DEPUTY EDITOR
Shailendra Prasad, MBBS, MPH

University of Minnesota North Memorial Family Medicine Residency Program, Minneapolis

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Nellis Family Medicine Residency, Nellis Air Force Base, NV

DEPUTY EDITOR
Shailendra Prasad, MBBS, MPH

University of Minnesota North Memorial Family Medicine Residency Program, Minneapolis

Author and Disclosure Information

Nellis Family Medicine Residency, Nellis Air Force Base, NV

DEPUTY EDITOR
Shailendra Prasad, MBBS, MPH

University of Minnesota North Memorial Family Medicine Residency Program, Minneapolis

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ILLUSTRATIVE CASE

A 23-year-old man with no significant past medical history presents to an urgent care center after a fall on his right arm while playing football. He reports a pain level of 6 using the visual analog scale (VAS). Physical exam reveals minor erythema and edema of his forearm with pain to palpation. Range of motion, strength, and sensation are intact. No lacerations are present. His vital signs are normal. No fracture is found on imaging. The physician decides that treatment with a topical analgesic is reasonable for this uncomplicated contusion of the right forearm. Is there a role for topical capsaicin in the treatment of this patient’s pain?

Topical nonsteroidal anti-­inflammatory drugs (NSAIDs) are effective for the treatment of acute non–low back pain musculoskeletal injuries.2 They are generally well tolerated and just as effective as oral NSAIDS or acetaminophen for localized injuries. Their ubiquitous availability, affordability, and low adverse effect profile make them an attractive first-line treatment option for acute musculoskeletal pain.

Capsaicin, a topical agent derived from a genus of red peppers, has been used for the treatment of neuropathic and chronic pain via its interactions with substance P, transient receptor potential vanilloid subtype 1 (TRPV1), and nociceptive nerve fibers.3,4 It has demonstrated effectiveness in the management of diabetic neuropathy, knee osteoarthritis, and postherpetic neuralgia, as well as various causes of pruritus.5,6

Although many studies have compared oral and topical NSAIDs, opiates, and acetaminophen, few studies have directly compared topical NSAIDs and capsaicin. This study compared the topical NSAID piroxicam with topical capsaicin.

STUDY SUMMARY

Topical capsaicin demonstrated superior pain reduction

This prospective, double-blind RCT compared the efficacy of topical capsaicin vs topical piroxicam for the treatment of acute pain following upper extremity blunt trauma. Patients (ages ≥ 18 years) who presented to a Turkish emergency department within 2 hours of upper extremity injury were randomized to receive either 0.05% capsaicin gel (n = 69) or 0.5% piroxicam gel (n = 67). Patients reported level 5 or higher pain on the VAS. Those with fractures, dislocations, skin disruption, or other trauma were excluded. Age, gender, pain duration, and mechanism of injury did not differ significantly between study groups.1

Blinding was ensured by placing the gels in opaque containers containing 30 mg of either capsaicin or piroxicam and dyeing the medicine with red and yellow food coloring. A thin layer of medication was applied to an area no larger than 5 × 5 cm on the upper extremity and rubbed for 1 minute. Patients were observed in the emergency department for 2 hours and discharged with instructions to apply the medication 3 times daily for 72 hours.

Topical capsaicin is an effective alternative to a topical NSAID in reducing pain associated with acute upper extremity injuries.

The investigators measured pain using VAS scores at 1 hour, 2 hours, 24 hours, and 72 hours after treatment. Topical capsaicin was superior to topical piroxicam at achieving both primary outcomes: a VAS score of ≤ 4 (85.5% vs 50.7%; number needed to treat [NNT] = 2.9; P < .001) and a > 50% reduction in VAS score (87% vs 62.7%; NNT = 4.1; P < .01) at the end of treatment.1 (These outcomes were based on earlier determinations of the minimal clinically important difference.7,8)

Additionally, capsaicin was more effective than piroxicam at each time interval. This difference was most pronounced at 72 hours, with a mean difference of delta VAS scores of 1.53 (95% CI, 0.85-2.221) and a mean percentage of the reduction in VAS scores of 19.7% (95% CI, 12.4%-27.2%) (P < .001).1

 

 

Reported adverse effects, such as burning, itching, and rash, were mild and infrequent and showed no significant difference between the treatment groups.

WHAT’S NEW

First study comparing topical capsaicin and a topical NSAID in acute trauma

Although both capsaicin and topical piroxicam have proven efficacy for the treatment of pain, this RCT is the first study to directly compare these agents in the setting of acute upper extremity blunt trauma. Capsaicin is currently more commonly prescribed as a treatment for chronic neuropathic pain.4,9 In this study, capsaicin demonstrated superior results in pain reduction at each assessed time interval and at the primary end point of 72 hours.

CAVEATS

Limited generalizability to lower extremity and truncal trauma

This RCT included a relatively small sample size (136 patients). Researchers evaluated only blunt upper extremity injuries; as such, the generalizability of the effectiveness of topical capsaicin in blunt lower extremity and truncal trauma is limited, especially over larger surface areas.

 

CHALLENGES TO IMPLEMENTATION

No major challenges found

There are no major challenges to implementing this inexpensive treatment.

ILLUSTRATIVE CASE

A 23-year-old man with no significant past medical history presents to an urgent care center after a fall on his right arm while playing football. He reports a pain level of 6 using the visual analog scale (VAS). Physical exam reveals minor erythema and edema of his forearm with pain to palpation. Range of motion, strength, and sensation are intact. No lacerations are present. His vital signs are normal. No fracture is found on imaging. The physician decides that treatment with a topical analgesic is reasonable for this uncomplicated contusion of the right forearm. Is there a role for topical capsaicin in the treatment of this patient’s pain?

Topical nonsteroidal anti-­inflammatory drugs (NSAIDs) are effective for the treatment of acute non–low back pain musculoskeletal injuries.2 They are generally well tolerated and just as effective as oral NSAIDS or acetaminophen for localized injuries. Their ubiquitous availability, affordability, and low adverse effect profile make them an attractive first-line treatment option for acute musculoskeletal pain.

Capsaicin, a topical agent derived from a genus of red peppers, has been used for the treatment of neuropathic and chronic pain via its interactions with substance P, transient receptor potential vanilloid subtype 1 (TRPV1), and nociceptive nerve fibers.3,4 It has demonstrated effectiveness in the management of diabetic neuropathy, knee osteoarthritis, and postherpetic neuralgia, as well as various causes of pruritus.5,6

Although many studies have compared oral and topical NSAIDs, opiates, and acetaminophen, few studies have directly compared topical NSAIDs and capsaicin. This study compared the topical NSAID piroxicam with topical capsaicin.

STUDY SUMMARY

Topical capsaicin demonstrated superior pain reduction

This prospective, double-blind RCT compared the efficacy of topical capsaicin vs topical piroxicam for the treatment of acute pain following upper extremity blunt trauma. Patients (ages ≥ 18 years) who presented to a Turkish emergency department within 2 hours of upper extremity injury were randomized to receive either 0.05% capsaicin gel (n = 69) or 0.5% piroxicam gel (n = 67). Patients reported level 5 or higher pain on the VAS. Those with fractures, dislocations, skin disruption, or other trauma were excluded. Age, gender, pain duration, and mechanism of injury did not differ significantly between study groups.1

Blinding was ensured by placing the gels in opaque containers containing 30 mg of either capsaicin or piroxicam and dyeing the medicine with red and yellow food coloring. A thin layer of medication was applied to an area no larger than 5 × 5 cm on the upper extremity and rubbed for 1 minute. Patients were observed in the emergency department for 2 hours and discharged with instructions to apply the medication 3 times daily for 72 hours.

Topical capsaicin is an effective alternative to a topical NSAID in reducing pain associated with acute upper extremity injuries.

The investigators measured pain using VAS scores at 1 hour, 2 hours, 24 hours, and 72 hours after treatment. Topical capsaicin was superior to topical piroxicam at achieving both primary outcomes: a VAS score of ≤ 4 (85.5% vs 50.7%; number needed to treat [NNT] = 2.9; P < .001) and a > 50% reduction in VAS score (87% vs 62.7%; NNT = 4.1; P < .01) at the end of treatment.1 (These outcomes were based on earlier determinations of the minimal clinically important difference.7,8)

Additionally, capsaicin was more effective than piroxicam at each time interval. This difference was most pronounced at 72 hours, with a mean difference of delta VAS scores of 1.53 (95% CI, 0.85-2.221) and a mean percentage of the reduction in VAS scores of 19.7% (95% CI, 12.4%-27.2%) (P < .001).1

 

 

Reported adverse effects, such as burning, itching, and rash, were mild and infrequent and showed no significant difference between the treatment groups.

WHAT’S NEW

First study comparing topical capsaicin and a topical NSAID in acute trauma

Although both capsaicin and topical piroxicam have proven efficacy for the treatment of pain, this RCT is the first study to directly compare these agents in the setting of acute upper extremity blunt trauma. Capsaicin is currently more commonly prescribed as a treatment for chronic neuropathic pain.4,9 In this study, capsaicin demonstrated superior results in pain reduction at each assessed time interval and at the primary end point of 72 hours.

CAVEATS

Limited generalizability to lower extremity and truncal trauma

This RCT included a relatively small sample size (136 patients). Researchers evaluated only blunt upper extremity injuries; as such, the generalizability of the effectiveness of topical capsaicin in blunt lower extremity and truncal trauma is limited, especially over larger surface areas.

 

CHALLENGES TO IMPLEMENTATION

No major challenges found

There are no major challenges to implementing this inexpensive treatment.

References

1. Kocak AO, Dogruyol S, Akbas I, et al. Comparison of topical capsaicin and topical piroxicam in the treatment of acute trauma-induced pain: a randomized double-blind trial. Am J Emerg Med. 2020;38:1767-1771. doi: 10.1016/j.ajem.2020.05.104

2. Busse JW, Sadeghirad B, Oparin Y, et al. Management of acute pain from non–low back, musculoskeletal injuries: a systematic review and network meta-analysis of randomized trials. Ann Intern Med. 2020;173:730-738. doi: 10.7326/M19-3601

3. Chrubasik S, Weiser T, Beime B. Effectiveness and safety of topical capsaicin cream in the treatment of chronic soft tissue pain. Phytother Res. 2010;24:1877-1885. doi: 10.1002/ptr.3335

4. Derry S, Moore RA. Topical capsaicin (low concentration) for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2012(9):CD010111. doi: 10.1002/14651858.CD010111

5. Simpson DM, Robinson-Papp J, Van J, et al. Capsaicin 8% patch in painful diabetic peripheral neuropathy: a randomized, double-blind, placebo-controlled study. J Pain. 2017;18:42-53. doi: 10.1016/j.jpain.2016.09.008

6. Papoiu ADP, Yosipovitch G. Topical capsaicin. The fire of a ‘hot’ medicine is reignited. Expert Opin Pharmacother. 2010;11:1359-1371. doi: 10.1517/14656566.2010.481670

7. Kulkantrakorn K, Lorsuwansiri C, Meesawatsom P. 0.025% capsaicin gel for the treatment of painful diabetic neuropathy: a randomized, double-blind, crossover, placebo-controlled trial. Pain Pract. 2013;13:497-503. doi: 10.1111/papr.12013

8. Kocak AO, Ahiskalioglu A, Sengun E, et al. Comparison of intravenous NSAIDs and trigger point injection for low back pain in ED: a prospective randomized study. Am J Emerg Med. 2019;37:1927-1931. doi: 10.1016/j.ajem.2019.01.015

9. Derry S, Rice ASC, Cole P, et al. Topical capsaicin (high concentration) for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2017;1(1):CD007393. doi: 10.1002/14651858.CD007393.pub4

References

1. Kocak AO, Dogruyol S, Akbas I, et al. Comparison of topical capsaicin and topical piroxicam in the treatment of acute trauma-induced pain: a randomized double-blind trial. Am J Emerg Med. 2020;38:1767-1771. doi: 10.1016/j.ajem.2020.05.104

2. Busse JW, Sadeghirad B, Oparin Y, et al. Management of acute pain from non–low back, musculoskeletal injuries: a systematic review and network meta-analysis of randomized trials. Ann Intern Med. 2020;173:730-738. doi: 10.7326/M19-3601

3. Chrubasik S, Weiser T, Beime B. Effectiveness and safety of topical capsaicin cream in the treatment of chronic soft tissue pain. Phytother Res. 2010;24:1877-1885. doi: 10.1002/ptr.3335

4. Derry S, Moore RA. Topical capsaicin (low concentration) for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2012(9):CD010111. doi: 10.1002/14651858.CD010111

5. Simpson DM, Robinson-Papp J, Van J, et al. Capsaicin 8% patch in painful diabetic peripheral neuropathy: a randomized, double-blind, placebo-controlled study. J Pain. 2017;18:42-53. doi: 10.1016/j.jpain.2016.09.008

6. Papoiu ADP, Yosipovitch G. Topical capsaicin. The fire of a ‘hot’ medicine is reignited. Expert Opin Pharmacother. 2010;11:1359-1371. doi: 10.1517/14656566.2010.481670

7. Kulkantrakorn K, Lorsuwansiri C, Meesawatsom P. 0.025% capsaicin gel for the treatment of painful diabetic neuropathy: a randomized, double-blind, crossover, placebo-controlled trial. Pain Pract. 2013;13:497-503. doi: 10.1111/papr.12013

8. Kocak AO, Ahiskalioglu A, Sengun E, et al. Comparison of intravenous NSAIDs and trigger point injection for low back pain in ED: a prospective randomized study. Am J Emerg Med. 2019;37:1927-1931. doi: 10.1016/j.ajem.2019.01.015

9. Derry S, Rice ASC, Cole P, et al. Topical capsaicin (high concentration) for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2017;1(1):CD007393. doi: 10.1002/14651858.CD007393.pub4

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The Journal of Family Practice - 71(4)
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176-177
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Time to consider topical capsaicin for acute trauma pain?
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PRACTICE CHANGER

Use topical capsaicin gel 0.05% for pain reduction in patients with isolated blunt injuries of the upper extremity without fracture.

STRENGTH OF RECOMMENDATION

B: Based on a single randomized controlled trial (RCT)1

Kocak AO, Dogruyol S, Akbas I, et al. Comparison of topical capsaicin and topical piroxicam in the treatment of acute trauma-induced pain: a randomized double-blind trial. Am J Emerg Med. 2020;38:1767-1771.

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