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Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.
“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.
“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.
“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.
The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.
Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.
“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.
The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.
Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.
“This did not occur in patients in the ER who did not visit with a therapy dog.
“This gives us confidence in the intervention,” Dr. Dell says.
Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.
The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.
“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.
Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.
“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.
A version of this article first appeared on WebMD.com.
Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.
“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.
“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.
“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.
The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.
Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.
“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.
The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.
Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.
“This did not occur in patients in the ER who did not visit with a therapy dog.
“This gives us confidence in the intervention,” Dr. Dell says.
Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.
The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.
“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.
Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.
“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.
A version of this article first appeared on WebMD.com.
Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.
“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.
“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.
“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.
The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.
Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.
“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.
The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.
Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.
“This did not occur in patients in the ER who did not visit with a therapy dog.
“This gives us confidence in the intervention,” Dr. Dell says.
Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.
The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.
“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.
Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.
“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.
A version of this article first appeared on WebMD.com.
FROM PLOS ONE
Twelve physicians sentenced in illegal opioid, billing fraud scheme
according to the U.S. Department of Justice (DOJ). The defendants’s activities also resulted in more than $250 million in false billings.
“It is unconscionable that doctors and health care professionals would violate their oath to do no harm and exploit vulnerable patients struggling with addiction,” said Assistant Attorney General Kenneth Polite Jr., of the Justice Department’s Criminal Division, in the announcement. “These are not just crimes of greed, these are crimes that make this country’s opioid crisis even worse – and that is why the department will continue to relentlessly pursue these cases.”
Francisco Patino, MD, 66, a Wayne County, Michigan-based emergency medicine physician and part owner of one of the clinics involved, purchased cars, jewelry, and vacations as a result of the fraudulent activity, according to federal officials. He will face sentencing at a later date on a variety of counts related to defrauding the United States, health care fraud, money laundering, and wire fraud after his conviction in a 2021 trial.
Prosecutors also allege that he laundered money through a diet program and spent funds on sponsoring mixed martial arts fighters, the Detroit News reported.
Mashiyat Rashid, Dr. Patino’s business partner and part owner of the Tri-County Wellness Group, was sentenced to 15 years in prison and ordered to pay more than $51 million in restitution in connection with his guilty plea to one count of conspiracy to commit health care fraud and wire fraud, in addition to one count of money laundering. As a result of the scheme, Mr. Rashid bought courtside tickets to the NBA Finals, expensive real estate, and private jet flights, according to the DOJ.
Gold bars, indoor basketball courts, luxury cars, and swimming pools were purchases secured by other defendants who were involved in the fraudulent scheme.
Court documents and evidence show that the physicians required that patients receive unnecessary and costly back injections in return for opioids, per the agency charged with enforcing federal law. The scheme, which took place from 2007 to 2018, involved a network of pain clinics across multiple states. Referred to as “pill mills” by the DOJ, the pain clinics dispensed the high-dosage prescriptions, such as oxycodone, to drug dealers and patients with opioid use disorder.
The procedures, billed to insurance, were for facet joint injections. According to the DOJ, the injections were chosen because they generated high reimbursements rather than being medically necessary.
The Detroit News reported in September that some of the medically unnecessary drugs prescribed by Dr. Patino, which included fentanyl, oxycodone, and oxymorphone, per an indictment, were resold “on the street.” Dr. Patino wrote prescriptions for more than 2.2 million pills between 2016 and 2017.
Dr. Patino and Mr. Rashid join physicians and others in the health care field, who are charged or sentenced for their involvement in the scheme. In total, five physicians were convicted in two separate trials and 18 defendants pleaded guilty, per the DOJ. Meanwhile, seven defendants await sentencing.
Included in this group were:
- Spilios Pappas, MD, 63, an emergency medicine specialist in Lucas County, Ohio, sentenced to nine years in prison and ordered to pay $32.2 million in restitution
- Joseph Betro, DO, 60, an emergency medicine physician from Oakland County, Mich., sentenced to nine years in prison and ordered to pay $27.4 million in restitution
- Tariq Omar, MD, 63, a pulmonologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $24.2 million in restitution
- Mohammed Zahoor, MD, 53, a neurologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $36.6 million in restitution
The four physicians worked at various clinics under the Tri-County Wellness Group, operated by Mr. Rashid, according to federal officials. During their employment with the clinics, they defrauded Medicare of more than $150 million through the scheme that involved opioids for medically unnecessary services, the DOJ noted.
Shortly after being indicted, Dr. Pappas posted a fundraising page for his legal services, claiming he and the other doctors had no idea what was going on and that he was “sickened and nauseous” when learning of the details of the case.
More than $16 million was forfeited by the defendants to the United States, according to the DOJ.
A version of this article first appeared on Medscape.com.
according to the U.S. Department of Justice (DOJ). The defendants’s activities also resulted in more than $250 million in false billings.
“It is unconscionable that doctors and health care professionals would violate their oath to do no harm and exploit vulnerable patients struggling with addiction,” said Assistant Attorney General Kenneth Polite Jr., of the Justice Department’s Criminal Division, in the announcement. “These are not just crimes of greed, these are crimes that make this country’s opioid crisis even worse – and that is why the department will continue to relentlessly pursue these cases.”
Francisco Patino, MD, 66, a Wayne County, Michigan-based emergency medicine physician and part owner of one of the clinics involved, purchased cars, jewelry, and vacations as a result of the fraudulent activity, according to federal officials. He will face sentencing at a later date on a variety of counts related to defrauding the United States, health care fraud, money laundering, and wire fraud after his conviction in a 2021 trial.
Prosecutors also allege that he laundered money through a diet program and spent funds on sponsoring mixed martial arts fighters, the Detroit News reported.
Mashiyat Rashid, Dr. Patino’s business partner and part owner of the Tri-County Wellness Group, was sentenced to 15 years in prison and ordered to pay more than $51 million in restitution in connection with his guilty plea to one count of conspiracy to commit health care fraud and wire fraud, in addition to one count of money laundering. As a result of the scheme, Mr. Rashid bought courtside tickets to the NBA Finals, expensive real estate, and private jet flights, according to the DOJ.
Gold bars, indoor basketball courts, luxury cars, and swimming pools were purchases secured by other defendants who were involved in the fraudulent scheme.
Court documents and evidence show that the physicians required that patients receive unnecessary and costly back injections in return for opioids, per the agency charged with enforcing federal law. The scheme, which took place from 2007 to 2018, involved a network of pain clinics across multiple states. Referred to as “pill mills” by the DOJ, the pain clinics dispensed the high-dosage prescriptions, such as oxycodone, to drug dealers and patients with opioid use disorder.
The procedures, billed to insurance, were for facet joint injections. According to the DOJ, the injections were chosen because they generated high reimbursements rather than being medically necessary.
The Detroit News reported in September that some of the medically unnecessary drugs prescribed by Dr. Patino, which included fentanyl, oxycodone, and oxymorphone, per an indictment, were resold “on the street.” Dr. Patino wrote prescriptions for more than 2.2 million pills between 2016 and 2017.
Dr. Patino and Mr. Rashid join physicians and others in the health care field, who are charged or sentenced for their involvement in the scheme. In total, five physicians were convicted in two separate trials and 18 defendants pleaded guilty, per the DOJ. Meanwhile, seven defendants await sentencing.
Included in this group were:
- Spilios Pappas, MD, 63, an emergency medicine specialist in Lucas County, Ohio, sentenced to nine years in prison and ordered to pay $32.2 million in restitution
- Joseph Betro, DO, 60, an emergency medicine physician from Oakland County, Mich., sentenced to nine years in prison and ordered to pay $27.4 million in restitution
- Tariq Omar, MD, 63, a pulmonologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $24.2 million in restitution
- Mohammed Zahoor, MD, 53, a neurologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $36.6 million in restitution
The four physicians worked at various clinics under the Tri-County Wellness Group, operated by Mr. Rashid, according to federal officials. During their employment with the clinics, they defrauded Medicare of more than $150 million through the scheme that involved opioids for medically unnecessary services, the DOJ noted.
Shortly after being indicted, Dr. Pappas posted a fundraising page for his legal services, claiming he and the other doctors had no idea what was going on and that he was “sickened and nauseous” when learning of the details of the case.
More than $16 million was forfeited by the defendants to the United States, according to the DOJ.
A version of this article first appeared on Medscape.com.
according to the U.S. Department of Justice (DOJ). The defendants’s activities also resulted in more than $250 million in false billings.
“It is unconscionable that doctors and health care professionals would violate their oath to do no harm and exploit vulnerable patients struggling with addiction,” said Assistant Attorney General Kenneth Polite Jr., of the Justice Department’s Criminal Division, in the announcement. “These are not just crimes of greed, these are crimes that make this country’s opioid crisis even worse – and that is why the department will continue to relentlessly pursue these cases.”
Francisco Patino, MD, 66, a Wayne County, Michigan-based emergency medicine physician and part owner of one of the clinics involved, purchased cars, jewelry, and vacations as a result of the fraudulent activity, according to federal officials. He will face sentencing at a later date on a variety of counts related to defrauding the United States, health care fraud, money laundering, and wire fraud after his conviction in a 2021 trial.
Prosecutors also allege that he laundered money through a diet program and spent funds on sponsoring mixed martial arts fighters, the Detroit News reported.
Mashiyat Rashid, Dr. Patino’s business partner and part owner of the Tri-County Wellness Group, was sentenced to 15 years in prison and ordered to pay more than $51 million in restitution in connection with his guilty plea to one count of conspiracy to commit health care fraud and wire fraud, in addition to one count of money laundering. As a result of the scheme, Mr. Rashid bought courtside tickets to the NBA Finals, expensive real estate, and private jet flights, according to the DOJ.
Gold bars, indoor basketball courts, luxury cars, and swimming pools were purchases secured by other defendants who were involved in the fraudulent scheme.
Court documents and evidence show that the physicians required that patients receive unnecessary and costly back injections in return for opioids, per the agency charged with enforcing federal law. The scheme, which took place from 2007 to 2018, involved a network of pain clinics across multiple states. Referred to as “pill mills” by the DOJ, the pain clinics dispensed the high-dosage prescriptions, such as oxycodone, to drug dealers and patients with opioid use disorder.
The procedures, billed to insurance, were for facet joint injections. According to the DOJ, the injections were chosen because they generated high reimbursements rather than being medically necessary.
The Detroit News reported in September that some of the medically unnecessary drugs prescribed by Dr. Patino, which included fentanyl, oxycodone, and oxymorphone, per an indictment, were resold “on the street.” Dr. Patino wrote prescriptions for more than 2.2 million pills between 2016 and 2017.
Dr. Patino and Mr. Rashid join physicians and others in the health care field, who are charged or sentenced for their involvement in the scheme. In total, five physicians were convicted in two separate trials and 18 defendants pleaded guilty, per the DOJ. Meanwhile, seven defendants await sentencing.
Included in this group were:
- Spilios Pappas, MD, 63, an emergency medicine specialist in Lucas County, Ohio, sentenced to nine years in prison and ordered to pay $32.2 million in restitution
- Joseph Betro, DO, 60, an emergency medicine physician from Oakland County, Mich., sentenced to nine years in prison and ordered to pay $27.4 million in restitution
- Tariq Omar, MD, 63, a pulmonologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $24.2 million in restitution
- Mohammed Zahoor, MD, 53, a neurologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $36.6 million in restitution
The four physicians worked at various clinics under the Tri-County Wellness Group, operated by Mr. Rashid, according to federal officials. During their employment with the clinics, they defrauded Medicare of more than $150 million through the scheme that involved opioids for medically unnecessary services, the DOJ noted.
Shortly after being indicted, Dr. Pappas posted a fundraising page for his legal services, claiming he and the other doctors had no idea what was going on and that he was “sickened and nauseous” when learning of the details of the case.
More than $16 million was forfeited by the defendants to the United States, according to the DOJ.
A version of this article first appeared on Medscape.com.
Addiction expert says CBD may help people cut cannabis use
PARIS – Following the suspension of the decree that banned the sale of cannabidiol (CBD) flowers, raw cannabis is again available in France for over-the-counter sales. The “feel-good” plant is praised for its relaxing properties.
The suspension of the ban, which lasted for 3 weeks, is a mixed blessing for businesses that sell CBD-based products in France. Professional organizations in this booming sector filed a petition with France’s highest administrative court, the Council of State. At the end of January, the court suspended the government decree that banned the sale of cannabis-derived CBD flowers and leaves; however, it has yet to hand down a final decision as to the legality of the decree.
In just a few years, numerous shops have opened across France. They no longer have to settle for selling processed CBD products such as chocolate, oils, cookies – even wine. They can resume the sale of CBD hemp, which mainly comes in clusters of flower buds and can be smoked or used as an infusion.
Cannabis-derived CBD must have less than 0.2% tetrahydrocannabinol (THC) to be considered “feel-good hemp,” which is used in various consumer goods (such as food, cosmetics, and e-cigarette liquids) and is praised for its calming effects. But not all hemp is the same. Medical hemp, which is currently in clinical trials, combines varying doses of CBD and THC. And then there is THC-rich psychotropic hemp, which is illegal to sell.
The government’s decree cites health concerns as a justification for the ban. While uncertainties remain, “research studies have shown that CBD acts on dopamine and serotonin receptors in the brain. ... Therefore, using CBD can produce psychoactive, sedative, and sleep-inducing effects.” In addition to a preventive approach, the authorities cite the difficulties in distinguishing cannabis-derived CBD from THC-rich illegal cannabis – difficulties that complicate efforts in the war on drugs.
The government’s position sows confusion among consumers, who are attracted by the arguments in favor of CBD and intrigued by the promise of the substance’s calming effects. This confusion is heightened by the fact that there are not enough scientific data either to declare that CBD poses a real risk or, alternatively, to confirm that it has beneficial effects. While some studies have suggested that CBD has a potential benefit for treating anxiety, pain, and sleep problems, others suggest that it may instead be a placebo effect.
What actual benefit can be expected from CBD-derived products, in particular from using the plant’s raw extracts? We asked Dan Velea, MD, an addiction psychiatrist in Paris, to give us his thoughts.
What do you think of the government’s position of banning the sale of cannabis-derived CBD flowers and leaves?
Dr. Velea: I don’t understand the reasoning behind this ban. Unlike THC, CBD is not an addictive substance. We’ve suspected that CBD had beneficial effects ever since noting that, just like THC, it could bind to the two types of cannabinoid receptors found in our bodies, CB1 and CB2, but without inducing a psychotropic effect or giving rise to dependence.
The CBD-derived products that are available on the market have infinitesimal amounts of THC – the threshold is 0.2% – which pose no risk. These products seem to be a particularly good alternative for certain at-risk users who are looking for a way that will help them cut down on their use of “traditional” cannabis, which has THC. However, due to a lack of research, the benefits of CBD cannot be confirmed.
Now that the decree’s been suspended, we can leave behind the ideological debate that has been built around cannabis in France. It’s time to focus only on discussions based on science. On that note, we also have to encourage people to do more research into cannabis’s therapeutic value.
You believe that CBD can help people cut down on their cannabis use. Is that based on what you see in your practice as an addiction specialist?
Dr. Velea: Of course, they don’t get the same dazzling effect that’s produced by THC, very high concentrations of which are often found in cannabis. But for them, the sensation they get from CBD is still pleasant. They describe it as having a soothing and fun effect; they quite like it. Given that the vast majority of people use cannabis recreationally, we can consider that this effect is no small benefit.
Even those who are highly dependent prefer to alternate, using CBD during the day and having just one THC joint in the evening. This makes them feel a lot better. In addition, it clearly reduces the health risks. In my opinion, CBD can be viewed as an alternative for people whose cannabis use is problematic. If a patient asks me about it, I give them an unequivocal answer: There are fewer risks associated with CBD than with regular cannabis.
Isn’t there still a risk for abuse? A dose of cannabidiol that shouldn’t be exceeded?
Dr. Velea: Honestly, apart from the harmful effects of smoking CBD, I don’t see any health risks associated with its use. I’ve never had a patient present with complaints after using these products. No one has ever told me that they became addicted or experienced psychotropic effects. There are no changes in behavior, even at high doses. It should be mentioned that World Health Organization experts hold that there’s no abuse or dependence potential associated with the use of pure CBD. Furthermore, they say that the product is generally well tolerated.
What other actual benefits does CBD have? People mention its relaxing, even anxiolytic, effects.
Dr. Velea: CBD-derived products are praised for their relaxing properties, which particularly help improve one’s sleep. It’s a question of knowing whether these are actual benefits or whether a placebo effect is involved here – something that would be enhanced in a person who firmly believes that these products bring about a sense of well-being. Even when CBD is used for pain relief, we can’t rule out the placebo effect as playing an important role in the outcome.
Some patients with serious diseases have been able to find comfort by using CBD. However, because there haven’t been any well-designed randomized studies, we’ve never been able to show clearly that the beneficial effect comes from the product itself. It’s also possible that the soothing, muscle-relaxing effect induced by CBD’s stimulation of cannabinoid receptors is actually what’s helping to relieve the pain. But this has yet to be proved.
So, what position can a doctor take toward patients who express their desire to use CBD-derived products?
Dr. Velea: Without reliable studies to back them up, it’s difficult to say. Also, at the moment, there are legal gray areas that don’t allow doctors to take a position. As a result, users are put at a disadvantage and not given the opportunity to make the choice to use CBD-derived products in an informed manner. Even so, I think that as long as we don’t have scientific data, the use of these products must be limited to recreational use with the aim of bringing about relaxation. In the case of a sleep disorder, for example, doctors can’t replace standard therapeutic management aimed at improving the patient’s sleep cycles. For now, the only genuinely interesting aspect of CBD that I can see is that it makes it possible to cut down on the use of THC-containing cannabis.
A version of this article first appeared on Medscape.com.
PARIS – Following the suspension of the decree that banned the sale of cannabidiol (CBD) flowers, raw cannabis is again available in France for over-the-counter sales. The “feel-good” plant is praised for its relaxing properties.
The suspension of the ban, which lasted for 3 weeks, is a mixed blessing for businesses that sell CBD-based products in France. Professional organizations in this booming sector filed a petition with France’s highest administrative court, the Council of State. At the end of January, the court suspended the government decree that banned the sale of cannabis-derived CBD flowers and leaves; however, it has yet to hand down a final decision as to the legality of the decree.
In just a few years, numerous shops have opened across France. They no longer have to settle for selling processed CBD products such as chocolate, oils, cookies – even wine. They can resume the sale of CBD hemp, which mainly comes in clusters of flower buds and can be smoked or used as an infusion.
Cannabis-derived CBD must have less than 0.2% tetrahydrocannabinol (THC) to be considered “feel-good hemp,” which is used in various consumer goods (such as food, cosmetics, and e-cigarette liquids) and is praised for its calming effects. But not all hemp is the same. Medical hemp, which is currently in clinical trials, combines varying doses of CBD and THC. And then there is THC-rich psychotropic hemp, which is illegal to sell.
The government’s decree cites health concerns as a justification for the ban. While uncertainties remain, “research studies have shown that CBD acts on dopamine and serotonin receptors in the brain. ... Therefore, using CBD can produce psychoactive, sedative, and sleep-inducing effects.” In addition to a preventive approach, the authorities cite the difficulties in distinguishing cannabis-derived CBD from THC-rich illegal cannabis – difficulties that complicate efforts in the war on drugs.
The government’s position sows confusion among consumers, who are attracted by the arguments in favor of CBD and intrigued by the promise of the substance’s calming effects. This confusion is heightened by the fact that there are not enough scientific data either to declare that CBD poses a real risk or, alternatively, to confirm that it has beneficial effects. While some studies have suggested that CBD has a potential benefit for treating anxiety, pain, and sleep problems, others suggest that it may instead be a placebo effect.
What actual benefit can be expected from CBD-derived products, in particular from using the plant’s raw extracts? We asked Dan Velea, MD, an addiction psychiatrist in Paris, to give us his thoughts.
What do you think of the government’s position of banning the sale of cannabis-derived CBD flowers and leaves?
Dr. Velea: I don’t understand the reasoning behind this ban. Unlike THC, CBD is not an addictive substance. We’ve suspected that CBD had beneficial effects ever since noting that, just like THC, it could bind to the two types of cannabinoid receptors found in our bodies, CB1 and CB2, but without inducing a psychotropic effect or giving rise to dependence.
The CBD-derived products that are available on the market have infinitesimal amounts of THC – the threshold is 0.2% – which pose no risk. These products seem to be a particularly good alternative for certain at-risk users who are looking for a way that will help them cut down on their use of “traditional” cannabis, which has THC. However, due to a lack of research, the benefits of CBD cannot be confirmed.
Now that the decree’s been suspended, we can leave behind the ideological debate that has been built around cannabis in France. It’s time to focus only on discussions based on science. On that note, we also have to encourage people to do more research into cannabis’s therapeutic value.
You believe that CBD can help people cut down on their cannabis use. Is that based on what you see in your practice as an addiction specialist?
Dr. Velea: Of course, they don’t get the same dazzling effect that’s produced by THC, very high concentrations of which are often found in cannabis. But for them, the sensation they get from CBD is still pleasant. They describe it as having a soothing and fun effect; they quite like it. Given that the vast majority of people use cannabis recreationally, we can consider that this effect is no small benefit.
Even those who are highly dependent prefer to alternate, using CBD during the day and having just one THC joint in the evening. This makes them feel a lot better. In addition, it clearly reduces the health risks. In my opinion, CBD can be viewed as an alternative for people whose cannabis use is problematic. If a patient asks me about it, I give them an unequivocal answer: There are fewer risks associated with CBD than with regular cannabis.
Isn’t there still a risk for abuse? A dose of cannabidiol that shouldn’t be exceeded?
Dr. Velea: Honestly, apart from the harmful effects of smoking CBD, I don’t see any health risks associated with its use. I’ve never had a patient present with complaints after using these products. No one has ever told me that they became addicted or experienced psychotropic effects. There are no changes in behavior, even at high doses. It should be mentioned that World Health Organization experts hold that there’s no abuse or dependence potential associated with the use of pure CBD. Furthermore, they say that the product is generally well tolerated.
What other actual benefits does CBD have? People mention its relaxing, even anxiolytic, effects.
Dr. Velea: CBD-derived products are praised for their relaxing properties, which particularly help improve one’s sleep. It’s a question of knowing whether these are actual benefits or whether a placebo effect is involved here – something that would be enhanced in a person who firmly believes that these products bring about a sense of well-being. Even when CBD is used for pain relief, we can’t rule out the placebo effect as playing an important role in the outcome.
Some patients with serious diseases have been able to find comfort by using CBD. However, because there haven’t been any well-designed randomized studies, we’ve never been able to show clearly that the beneficial effect comes from the product itself. It’s also possible that the soothing, muscle-relaxing effect induced by CBD’s stimulation of cannabinoid receptors is actually what’s helping to relieve the pain. But this has yet to be proved.
So, what position can a doctor take toward patients who express their desire to use CBD-derived products?
Dr. Velea: Without reliable studies to back them up, it’s difficult to say. Also, at the moment, there are legal gray areas that don’t allow doctors to take a position. As a result, users are put at a disadvantage and not given the opportunity to make the choice to use CBD-derived products in an informed manner. Even so, I think that as long as we don’t have scientific data, the use of these products must be limited to recreational use with the aim of bringing about relaxation. In the case of a sleep disorder, for example, doctors can’t replace standard therapeutic management aimed at improving the patient’s sleep cycles. For now, the only genuinely interesting aspect of CBD that I can see is that it makes it possible to cut down on the use of THC-containing cannabis.
A version of this article first appeared on Medscape.com.
PARIS – Following the suspension of the decree that banned the sale of cannabidiol (CBD) flowers, raw cannabis is again available in France for over-the-counter sales. The “feel-good” plant is praised for its relaxing properties.
The suspension of the ban, which lasted for 3 weeks, is a mixed blessing for businesses that sell CBD-based products in France. Professional organizations in this booming sector filed a petition with France’s highest administrative court, the Council of State. At the end of January, the court suspended the government decree that banned the sale of cannabis-derived CBD flowers and leaves; however, it has yet to hand down a final decision as to the legality of the decree.
In just a few years, numerous shops have opened across France. They no longer have to settle for selling processed CBD products such as chocolate, oils, cookies – even wine. They can resume the sale of CBD hemp, which mainly comes in clusters of flower buds and can be smoked or used as an infusion.
Cannabis-derived CBD must have less than 0.2% tetrahydrocannabinol (THC) to be considered “feel-good hemp,” which is used in various consumer goods (such as food, cosmetics, and e-cigarette liquids) and is praised for its calming effects. But not all hemp is the same. Medical hemp, which is currently in clinical trials, combines varying doses of CBD and THC. And then there is THC-rich psychotropic hemp, which is illegal to sell.
The government’s decree cites health concerns as a justification for the ban. While uncertainties remain, “research studies have shown that CBD acts on dopamine and serotonin receptors in the brain. ... Therefore, using CBD can produce psychoactive, sedative, and sleep-inducing effects.” In addition to a preventive approach, the authorities cite the difficulties in distinguishing cannabis-derived CBD from THC-rich illegal cannabis – difficulties that complicate efforts in the war on drugs.
The government’s position sows confusion among consumers, who are attracted by the arguments in favor of CBD and intrigued by the promise of the substance’s calming effects. This confusion is heightened by the fact that there are not enough scientific data either to declare that CBD poses a real risk or, alternatively, to confirm that it has beneficial effects. While some studies have suggested that CBD has a potential benefit for treating anxiety, pain, and sleep problems, others suggest that it may instead be a placebo effect.
What actual benefit can be expected from CBD-derived products, in particular from using the plant’s raw extracts? We asked Dan Velea, MD, an addiction psychiatrist in Paris, to give us his thoughts.
What do you think of the government’s position of banning the sale of cannabis-derived CBD flowers and leaves?
Dr. Velea: I don’t understand the reasoning behind this ban. Unlike THC, CBD is not an addictive substance. We’ve suspected that CBD had beneficial effects ever since noting that, just like THC, it could bind to the two types of cannabinoid receptors found in our bodies, CB1 and CB2, but without inducing a psychotropic effect or giving rise to dependence.
The CBD-derived products that are available on the market have infinitesimal amounts of THC – the threshold is 0.2% – which pose no risk. These products seem to be a particularly good alternative for certain at-risk users who are looking for a way that will help them cut down on their use of “traditional” cannabis, which has THC. However, due to a lack of research, the benefits of CBD cannot be confirmed.
Now that the decree’s been suspended, we can leave behind the ideological debate that has been built around cannabis in France. It’s time to focus only on discussions based on science. On that note, we also have to encourage people to do more research into cannabis’s therapeutic value.
You believe that CBD can help people cut down on their cannabis use. Is that based on what you see in your practice as an addiction specialist?
Dr. Velea: Of course, they don’t get the same dazzling effect that’s produced by THC, very high concentrations of which are often found in cannabis. But for them, the sensation they get from CBD is still pleasant. They describe it as having a soothing and fun effect; they quite like it. Given that the vast majority of people use cannabis recreationally, we can consider that this effect is no small benefit.
Even those who are highly dependent prefer to alternate, using CBD during the day and having just one THC joint in the evening. This makes them feel a lot better. In addition, it clearly reduces the health risks. In my opinion, CBD can be viewed as an alternative for people whose cannabis use is problematic. If a patient asks me about it, I give them an unequivocal answer: There are fewer risks associated with CBD than with regular cannabis.
Isn’t there still a risk for abuse? A dose of cannabidiol that shouldn’t be exceeded?
Dr. Velea: Honestly, apart from the harmful effects of smoking CBD, I don’t see any health risks associated with its use. I’ve never had a patient present with complaints after using these products. No one has ever told me that they became addicted or experienced psychotropic effects. There are no changes in behavior, even at high doses. It should be mentioned that World Health Organization experts hold that there’s no abuse or dependence potential associated with the use of pure CBD. Furthermore, they say that the product is generally well tolerated.
What other actual benefits does CBD have? People mention its relaxing, even anxiolytic, effects.
Dr. Velea: CBD-derived products are praised for their relaxing properties, which particularly help improve one’s sleep. It’s a question of knowing whether these are actual benefits or whether a placebo effect is involved here – something that would be enhanced in a person who firmly believes that these products bring about a sense of well-being. Even when CBD is used for pain relief, we can’t rule out the placebo effect as playing an important role in the outcome.
Some patients with serious diseases have been able to find comfort by using CBD. However, because there haven’t been any well-designed randomized studies, we’ve never been able to show clearly that the beneficial effect comes from the product itself. It’s also possible that the soothing, muscle-relaxing effect induced by CBD’s stimulation of cannabinoid receptors is actually what’s helping to relieve the pain. But this has yet to be proved.
So, what position can a doctor take toward patients who express their desire to use CBD-derived products?
Dr. Velea: Without reliable studies to back them up, it’s difficult to say. Also, at the moment, there are legal gray areas that don’t allow doctors to take a position. As a result, users are put at a disadvantage and not given the opportunity to make the choice to use CBD-derived products in an informed manner. Even so, I think that as long as we don’t have scientific data, the use of these products must be limited to recreational use with the aim of bringing about relaxation. In the case of a sleep disorder, for example, doctors can’t replace standard therapeutic management aimed at improving the patient’s sleep cycles. For now, the only genuinely interesting aspect of CBD that I can see is that it makes it possible to cut down on the use of THC-containing cannabis.
A version of this article first appeared on Medscape.com.
FDA, DEA pushed to make gabapentin a controlled substance to stop ‘widespread misuse’
In a bid to stop abuse and diversion of the anticonvulsant gabapentin, a watchdog group is petitioning federal regulators to make the drug a controlled substance.
Gabapentin is a generic drug, best known under the brand name Neurontin. The petition also covers the related drug gabapentin enacarbil (Horizant).
Public Citizen requested that gabapentin come under the DEA’s Schedule V category, which already includes the similar drug pregabalin (Lyrica). Schedule V is the lowest rung on the DEA’s drug schedule, meaning it has lower potential for abuse then Schedule I through IV drugs. This tier also includes cough preparations with less than 200 milligrams of codeine.
Classifying gabapentin as a Schedule V drug would facilitate better tracking of the drug’s use and misuse and put in place educational and limitation requirements to mitigate the risk of addiction, overdose, and death, Michael Abrams, MPH, PhD, senior health researcher with Public Citizen’s Health Research Group, and colleagues write in the petition.
‘Widespread misuse’
There is “substantial evidence of widespread misuse” of gabapentin, plausibly helped by “extraordinary levels of off-label prescribing,” Public Citizen said in the petition.
Some estimates have pegged off-label use at more than 90%, with gabapentin prescribed for indications such as chronic cough, hiccups, postoperative pain, and postmenopausal hot flashes, the group said.
“Moreover, there are numerous reports indicating that gabapentin is widely used and diverted on the street to induce ‘highs’ or otherwise self-medicate,” Public Citizen said. “Both gabapentin and pregabalin have been empirically linked to the opioid overdose epidemic as drugs that potentiate the activity of these oftentimes deadly analgesics.”
This news organization tried several times to reach Azurity for comment but did not receive a response. Pfizer included gabapentin in the portfolio of drugs used to create the Viatris spin-off, which took place in 2020. Pfizer referred this news organization to Viatris for comment, but it also did not respond.
It is unclear how the FDA and DEA will respond to the petition. Public Citizen has received a reply from the FDA, in which the agency acknowledged receipt of the petition. However, the “acceptance of the petition for filing is a procedural matter and in no way reflects the agency’s decision on the substantive merits of the petition,” the FDA said in a letter.
As is common practice, the agency assigned a docket number for the petition, FDA-2022-P-0149. The docket’s website allows interested parties to track the issue.
‘Unnoticed’ abuse
There have been rising concerns about risks and abuse of gabapentin in recent years. In its petition, Public Citizen noted that the United Kingdom and several U.S. states have already sought tighter control of gabapentin prescriptions.
In 2019, the United Kingdom announced it would reclassify both pregabalin and gabapentin as class C controlled substances because of the rising numbers of deaths linked to the drugs.
As of November 2020, seven states – Alabama, Kentucky, Michigan, North Dakota, Tennessee, Virginia, and West Virginia – had classified gabapentin as a schedule V drug, while another 12 states required prescription monitoring of the drug, Public Citizen noted.
In 2018, researchers at the University of Louisville, Kentucky, a state that has been hit particularly hard by the opioid crisis, tried to draw more attention to the risks of gabapentin.
“Amid the opioid epidemic, abuse of a different prescription painkiller has widely gone unnoticed,” the University said in a press release at the time.
The release highlighted a study led by Rachel Vickers Smith, PhD, assistant professor in the University of Louisville School of Nursing that was published in Psychology of Addictive Behaviors.
It included 33 individuals who reported recent recreational use of gabapentin. Use of the drug was combined with buprenorphine, other opioids, cocaine, and caffeine to produce effects such as muscle relaxation, pain reduction, sleep induction, feeling drunk, and feeling “high.”
In the press release, Dr. Vickers Smith said individuals who abuse gabapentin often mix it with opioids, marijuana, cocaine, and opioid treatment medication, compounding side effects to the central nervous system that include euphoria and sedation.
In addition, some individuals who primarily abused opioid pain medication have turned to gabapentin after law-enforcement actions made it more difficult to obtain prescription opioids, she noted.
“People are looking for other drugs to substitute for opioids, and gabapentin has filled that place for some,” Dr. Vickers Smith said. “Some have said it gives them a high similar to opioids.”
FDA 2019 warning
In 2019, the FDA issued a warning about serious breathing difficulties associated with gabapentin and pregabalin in patients with respiratory risk factors.
These factors include opioid use and other drugs that depress the central nervous system, as well as conditions such as chronic obstructive pulmonary disease that reduce lung function. Older patients are also at higher risk, the FDA said.
The agency noted that gabapentinoids are often co-prescribed with opioids for for medical conditions and abused in combination with opioids. Data collected in 2016 from an office-based physician survey showed 14% of patient encounters involving gabapentin also involved opioids, the FDA said.
“Our evaluation shows that the use of these medicines, often referred to as gabapentinoids, has been growing for prescribed medical use, as well as misuse and abuse,” the agency said in its 2019 alert.
A version of this article first appeared on Medscape.com.
In a bid to stop abuse and diversion of the anticonvulsant gabapentin, a watchdog group is petitioning federal regulators to make the drug a controlled substance.
Gabapentin is a generic drug, best known under the brand name Neurontin. The petition also covers the related drug gabapentin enacarbil (Horizant).
Public Citizen requested that gabapentin come under the DEA’s Schedule V category, which already includes the similar drug pregabalin (Lyrica). Schedule V is the lowest rung on the DEA’s drug schedule, meaning it has lower potential for abuse then Schedule I through IV drugs. This tier also includes cough preparations with less than 200 milligrams of codeine.
Classifying gabapentin as a Schedule V drug would facilitate better tracking of the drug’s use and misuse and put in place educational and limitation requirements to mitigate the risk of addiction, overdose, and death, Michael Abrams, MPH, PhD, senior health researcher with Public Citizen’s Health Research Group, and colleagues write in the petition.
‘Widespread misuse’
There is “substantial evidence of widespread misuse” of gabapentin, plausibly helped by “extraordinary levels of off-label prescribing,” Public Citizen said in the petition.
Some estimates have pegged off-label use at more than 90%, with gabapentin prescribed for indications such as chronic cough, hiccups, postoperative pain, and postmenopausal hot flashes, the group said.
“Moreover, there are numerous reports indicating that gabapentin is widely used and diverted on the street to induce ‘highs’ or otherwise self-medicate,” Public Citizen said. “Both gabapentin and pregabalin have been empirically linked to the opioid overdose epidemic as drugs that potentiate the activity of these oftentimes deadly analgesics.”
This news organization tried several times to reach Azurity for comment but did not receive a response. Pfizer included gabapentin in the portfolio of drugs used to create the Viatris spin-off, which took place in 2020. Pfizer referred this news organization to Viatris for comment, but it also did not respond.
It is unclear how the FDA and DEA will respond to the petition. Public Citizen has received a reply from the FDA, in which the agency acknowledged receipt of the petition. However, the “acceptance of the petition for filing is a procedural matter and in no way reflects the agency’s decision on the substantive merits of the petition,” the FDA said in a letter.
As is common practice, the agency assigned a docket number for the petition, FDA-2022-P-0149. The docket’s website allows interested parties to track the issue.
‘Unnoticed’ abuse
There have been rising concerns about risks and abuse of gabapentin in recent years. In its petition, Public Citizen noted that the United Kingdom and several U.S. states have already sought tighter control of gabapentin prescriptions.
In 2019, the United Kingdom announced it would reclassify both pregabalin and gabapentin as class C controlled substances because of the rising numbers of deaths linked to the drugs.
As of November 2020, seven states – Alabama, Kentucky, Michigan, North Dakota, Tennessee, Virginia, and West Virginia – had classified gabapentin as a schedule V drug, while another 12 states required prescription monitoring of the drug, Public Citizen noted.
In 2018, researchers at the University of Louisville, Kentucky, a state that has been hit particularly hard by the opioid crisis, tried to draw more attention to the risks of gabapentin.
“Amid the opioid epidemic, abuse of a different prescription painkiller has widely gone unnoticed,” the University said in a press release at the time.
The release highlighted a study led by Rachel Vickers Smith, PhD, assistant professor in the University of Louisville School of Nursing that was published in Psychology of Addictive Behaviors.
It included 33 individuals who reported recent recreational use of gabapentin. Use of the drug was combined with buprenorphine, other opioids, cocaine, and caffeine to produce effects such as muscle relaxation, pain reduction, sleep induction, feeling drunk, and feeling “high.”
In the press release, Dr. Vickers Smith said individuals who abuse gabapentin often mix it with opioids, marijuana, cocaine, and opioid treatment medication, compounding side effects to the central nervous system that include euphoria and sedation.
In addition, some individuals who primarily abused opioid pain medication have turned to gabapentin after law-enforcement actions made it more difficult to obtain prescription opioids, she noted.
“People are looking for other drugs to substitute for opioids, and gabapentin has filled that place for some,” Dr. Vickers Smith said. “Some have said it gives them a high similar to opioids.”
FDA 2019 warning
In 2019, the FDA issued a warning about serious breathing difficulties associated with gabapentin and pregabalin in patients with respiratory risk factors.
These factors include opioid use and other drugs that depress the central nervous system, as well as conditions such as chronic obstructive pulmonary disease that reduce lung function. Older patients are also at higher risk, the FDA said.
The agency noted that gabapentinoids are often co-prescribed with opioids for for medical conditions and abused in combination with opioids. Data collected in 2016 from an office-based physician survey showed 14% of patient encounters involving gabapentin also involved opioids, the FDA said.
“Our evaluation shows that the use of these medicines, often referred to as gabapentinoids, has been growing for prescribed medical use, as well as misuse and abuse,” the agency said in its 2019 alert.
A version of this article first appeared on Medscape.com.
In a bid to stop abuse and diversion of the anticonvulsant gabapentin, a watchdog group is petitioning federal regulators to make the drug a controlled substance.
Gabapentin is a generic drug, best known under the brand name Neurontin. The petition also covers the related drug gabapentin enacarbil (Horizant).
Public Citizen requested that gabapentin come under the DEA’s Schedule V category, which already includes the similar drug pregabalin (Lyrica). Schedule V is the lowest rung on the DEA’s drug schedule, meaning it has lower potential for abuse then Schedule I through IV drugs. This tier also includes cough preparations with less than 200 milligrams of codeine.
Classifying gabapentin as a Schedule V drug would facilitate better tracking of the drug’s use and misuse and put in place educational and limitation requirements to mitigate the risk of addiction, overdose, and death, Michael Abrams, MPH, PhD, senior health researcher with Public Citizen’s Health Research Group, and colleagues write in the petition.
‘Widespread misuse’
There is “substantial evidence of widespread misuse” of gabapentin, plausibly helped by “extraordinary levels of off-label prescribing,” Public Citizen said in the petition.
Some estimates have pegged off-label use at more than 90%, with gabapentin prescribed for indications such as chronic cough, hiccups, postoperative pain, and postmenopausal hot flashes, the group said.
“Moreover, there are numerous reports indicating that gabapentin is widely used and diverted on the street to induce ‘highs’ or otherwise self-medicate,” Public Citizen said. “Both gabapentin and pregabalin have been empirically linked to the opioid overdose epidemic as drugs that potentiate the activity of these oftentimes deadly analgesics.”
This news organization tried several times to reach Azurity for comment but did not receive a response. Pfizer included gabapentin in the portfolio of drugs used to create the Viatris spin-off, which took place in 2020. Pfizer referred this news organization to Viatris for comment, but it also did not respond.
It is unclear how the FDA and DEA will respond to the petition. Public Citizen has received a reply from the FDA, in which the agency acknowledged receipt of the petition. However, the “acceptance of the petition for filing is a procedural matter and in no way reflects the agency’s decision on the substantive merits of the petition,” the FDA said in a letter.
As is common practice, the agency assigned a docket number for the petition, FDA-2022-P-0149. The docket’s website allows interested parties to track the issue.
‘Unnoticed’ abuse
There have been rising concerns about risks and abuse of gabapentin in recent years. In its petition, Public Citizen noted that the United Kingdom and several U.S. states have already sought tighter control of gabapentin prescriptions.
In 2019, the United Kingdom announced it would reclassify both pregabalin and gabapentin as class C controlled substances because of the rising numbers of deaths linked to the drugs.
As of November 2020, seven states – Alabama, Kentucky, Michigan, North Dakota, Tennessee, Virginia, and West Virginia – had classified gabapentin as a schedule V drug, while another 12 states required prescription monitoring of the drug, Public Citizen noted.
In 2018, researchers at the University of Louisville, Kentucky, a state that has been hit particularly hard by the opioid crisis, tried to draw more attention to the risks of gabapentin.
“Amid the opioid epidemic, abuse of a different prescription painkiller has widely gone unnoticed,” the University said in a press release at the time.
The release highlighted a study led by Rachel Vickers Smith, PhD, assistant professor in the University of Louisville School of Nursing that was published in Psychology of Addictive Behaviors.
It included 33 individuals who reported recent recreational use of gabapentin. Use of the drug was combined with buprenorphine, other opioids, cocaine, and caffeine to produce effects such as muscle relaxation, pain reduction, sleep induction, feeling drunk, and feeling “high.”
In the press release, Dr. Vickers Smith said individuals who abuse gabapentin often mix it with opioids, marijuana, cocaine, and opioid treatment medication, compounding side effects to the central nervous system that include euphoria and sedation.
In addition, some individuals who primarily abused opioid pain medication have turned to gabapentin after law-enforcement actions made it more difficult to obtain prescription opioids, she noted.
“People are looking for other drugs to substitute for opioids, and gabapentin has filled that place for some,” Dr. Vickers Smith said. “Some have said it gives them a high similar to opioids.”
FDA 2019 warning
In 2019, the FDA issued a warning about serious breathing difficulties associated with gabapentin and pregabalin in patients with respiratory risk factors.
These factors include opioid use and other drugs that depress the central nervous system, as well as conditions such as chronic obstructive pulmonary disease that reduce lung function. Older patients are also at higher risk, the FDA said.
The agency noted that gabapentinoids are often co-prescribed with opioids for for medical conditions and abused in combination with opioids. Data collected in 2016 from an office-based physician survey showed 14% of patient encounters involving gabapentin also involved opioids, the FDA said.
“Our evaluation shows that the use of these medicines, often referred to as gabapentinoids, has been growing for prescribed medical use, as well as misuse and abuse,” the agency said in its 2019 alert.
A version of this article first appeared on Medscape.com.
Dyspareunia: Keys to biopsychosocial evaluation and treatment planning
Dyspareunia is persistent or recurrent pain before, during, or after sexual contact and is not limited to cisgender individuals or vaginal intercourse.1-3 With a prevalence as high as 45% in the United States,2-5 it is one of the most common complaints in gynecologic practices.5,6
Causes and contributing factors
There are many possible causes of dyspareunia.2,4,6 While some patients have a single cause, most cases are complex, with multiple overlapping causes and maintaining factors.4,6 Identifying each contributing factor can help you appropriately address all components.
Physical conditions. The range of physical contributors to dyspareunia includes inflammatory processes, structural abnormalities, musculoskeletal dysfunctions, pelvic organ disorders, injuries, iatrogenic effects, infections, allergic reactions, sensitization, hormonal changes, medication effects, adhesions, autoimmune disorders, and other pain syndromes (TABLE 12-4,6-11).
Inadequate arousal. One of the primary causes of pain during vaginal penetration is inadequate arousal and lubrication.1,2,9-11 Arousal is the phase of the sexual response cycle that leads to genital tumescence and prepares the genitals for sexual contact through penile/clitoral erection, vaginal engorgement, and lubrication, which prevents pain and enhances pleasurable sensation.9-11
While some physical conditions can lead to an inability to lubricate, the most common causes of inadequate lubrication are psychosocial-behavioral, wherein patients have the same physical ability to lubricate as patients without genital pain but do not progress through the arousal phase.9-11 Behavioral factors such as inadequate or ineffective foreplay can fail to produce engorgement and lubrication, while psychosocial factors such as low attraction to partner, relationship stressors, anxiety, or low self-esteem can have an inhibitory effect on sexual arousal.1,2,9-11 Psychosocial and behavioral factors may also be maintaining factors or consequences of dyspareunia, and need to be assessed and treated.1,2,9-11
Psychological trauma. Exposure to psychological traumas and the development of posttraumatic stress disorder (PTSD) have been linked with the development of pain disorders in general and dyspareunia specifically. Most patients seeking treatment for chronic pain disorders have a history of physical or sexual abuse.12 Changes in physiologic processes (eg, neurochemical, endocrine) that occur with PTSD interfere with the sexual response cycle, and sexual traumas specifically have been linked with pelvic floor dysfunction.13,14 Additionally, when PTSD is caused by a sexual trauma, even consensual sexual encounters can trigger flashbacks, intrusive memories, hyperarousal, and muscle tension that interfere with the sexual response cycle and contribute to genital pain.13
Vaginismus is both a physiologic and psychological contributor to dyspareunia.1,2,4 Patients experiencing pain can develop anxiety about repeated pain and involuntarily contract their pelvic muscles, thereby creating more pain, increasing anxiety, decreasing lubrication, and causing pelvic floor dysfunction.1-4,6 Consequently, all patients with dyspareunia should be assessed and continually monitored for symptoms of vaginismus.
Continue to: Anxiety
Anxiety. As with other pain disorders, anxiety develops around pain triggers.10,15 When expecting sexual activity, patients can experience extreme worry and panic attacks.10,15,16 The distress of sexual encounters can interfere with physiologic arousal and sexual desire, impacting all phases of the sexual response cycle.1,2
Relationship issues. Difficulty engaging in or avoidance of sexual activity can interfere with romantic relationships.2,10,16 Severe pain or vaginismus contractions can prevent penetration, leading to unconsummated marriages and an inability to conceive through intercourse.10 The distress surrounding sexual encounters can precipitate erectile dysfunction in male partners, or partners may continue to demand sexual encounters despite the patient’s pain, further impacting the relationship and heightening sexual distress.10 These stressors have led to relationships ending, patients reluctantly agreeing to nonmonogamy to appease their partners, and patients avoiding relationships altogether.10,16
Devalued self-image. Difficulties with sexuality and relationships impact the self-image of patients with dyspareunia. Diminished self-image may include feeling “inadequate” as a woman and as a sexual partner, or feeling like a “failure.”16 Women with dyspareunia often have more distress related to their body image, physical appearance, and genital self-image than do women without genital pain.17 Feeling resentment toward their body, or feeling “ugly,” embarrassed, shamed, “broken,” and “useless” also contribute to increased depressive symptoms found in patients with dyspareunia.16,18
Making the diagnosis
Most patients do not report symptoms unless directly asked2,7; therefore, it is recommended that all patients be screened as a part of an initial intake and before any genital exam (TABLE 22-4,6,7,9,11,19,20).4,7,21 If this screen is positive, a separate appointment may be needed for a thorough evaluation and before any attempt is made at a genital exam.4,7
Items to include in the clinical interview
Given the range of possible causes of dyspareunia and its contributing factors and symptoms, a thorough clinical interview is essential. Begin with a review of the patient’s complete medical and surgical history to identify possible known contributors to genital pain.4 Pregnancy history is of particular importance as the prevalence of postpartum dyspareunia is 35%, with risk being greater for patients who experienced dyspareunia symptoms before pregnancy.22
Knowing the location and quality of pain is important for differentiating between possible diagnoses, as is specifying dyspareunia as lifelong or acquired, superficial or deep, and primary or secondary.1-4,6 Confirm the specific location(s) of pain—eg, at the introitus, in the vestibule, on the labia, in the perineum, or near the clitoris.2,4,6 A diagram or model may be needed to help patients to localize pain.4
To help narrow the differential, include the following elements in your assessment: pain quality, timing (eg, initial onset, episode onset, episode duration, situational triggers), alleviating factors, symptoms in surrounding structures (eg, bladder, bowel, muscles, bones), sexual history, other areas of sexual functioning, history of psychological trauma, relationship effects, and mental health (TABLE 22-4,6,7,9,11,19,20 and Table 323-28). Screening for a history of sexual trauma is particularly important, as a recent systematic review and meta-analysis found that women with a history of sexual assault had a 42% higher risk of gynecologic problems overall, a 74% higher risk of dyspareunia, and a 71% higher risk of vaginismus than women without a history of sexual assault.29 Using measures such as the Female Sexual Function Index or the McGill Pain Questionnaire can help patients more thoroughly describe their symptoms (TABLE 323-28).3
Continue to: Guidelines for the physical exam
Guidelines for the physical exam
Before the exam, ensure the patient has not used any topical genital treatment in the past 2 weeks that may interfere with sensitivity to the exam.4 To decrease patients’ anxiety about the exam, remind them that they can stop the exam at any time.7 Also consider offering the use of a mirror to better pinpoint the location of pain, and to possibly help the patient learn more about her anatomy.2,7
Begin the exam by palpating surrounding areas that may be involved in pain, including the abdomen and musculoskeletal features.3,6,19 Next visually inspect the external genitalia for lesions, abrasions, discoloration, erythema, or other abnormal findings.2,3,6 Ask the patient for permission before contacting the genitals. Because the labia may be a site of pain, apply gentle pressure in retracting it to fully examine the vestibule.6,7 Contraction of the pelvic floor muscles during approach or initial palpation could signal possible vaginismus.4
After visual inspection of external genitalia, use a cotton swab to map the vulva and vestibule in a clockwise fashion to precisely identify any painful locations.2-4,6 If the patient’s history of pain has been intermittent, it’s possible that the cotton swab will not elicit pain on the day of the initial exam, but it may on other days.4
Begin the internal exam by inserting a single finger into the first inch of the vagina and have the patient squeeze and release to assess tenderness, muscle tightness, and control.2,6 Advance the finger further into the vagina and palpate clockwise, examining the levator muscles, obturator muscles, rectum, urethra, and bladder for abnormal tightness or reproduction of pain.2,4,6 Complete a bimanual exam to evaluate the pelvic organs and adnexa.2,4 If indicated, a more thorough evaluation of pelvic floor musculature can be performed by a physical therapist or gynecologist who specializes in pelvic pain.2-4
If the patient consents to further evaluation, consider using a small speculum, advanced slowly, for further internal examination, noting any lesions, abrasions, discharge, ectropion, or tenderness.2-4,7 A rectal exam may also be needed in cases of deep dyspareunia.6 Initial work-up may include a potassium hydroxide wet prep, sexually transmitted infection testing, and pelvic ultrasound.2,4 In some cases, laparoscopy or biopsy may be needed.2,4
Treatments for common causes
Treatment often begins with education about anatomy, to help patients communicate about symptoms and engage more fully in their care.3 Additional education may be needed on genital functioning and the necessity of adequate stimulation and lubrication prior to penetration.1,2,9-11 A discussion of treatments for the wide range of possible causes of dyspareunia is outside the scope of this article. However, some basic behavioral changes may help patients address some of the more common contributing factors.
For example, if vaginal infection is suspected, advise patients to discontinue the use of harsh soaps, known vaginal irritants (eg, perfumed products, bath additives), and douches.3 Recommend using only preservative- and alcohol-free lubricants for sexual contact, and avoiding lubricants with added functions (eg, warming).3 It’s worth noting that avoidance of tight clothing and thong underwear due to possible risk for infections may not be necessary. A recent study found that women who frequently wore thong underwear (more than half of the time) were no more likely to develop urinary tract infections, yeast vaginitis, or bacterial vaginosis than those who avoid such items.30 However, noncotton underwear fabric, rather than tightness, was associated with yeast vaginitis30; therefore, patients may want to consider using only breathable underwear.3
Continue to: Medication
Medication. Medication may be used to treat the underlying contributing conditions or the symptom of pain directly. Some common options are particularly important for patients whose dyspareunia does not have an identifiable cause. These medications include anti-inflammatory agents, topical anesthetics, tricyclic antidepressants, and hormonal treatments.2-4 Since effectiveness varies based on subtypes of pain, select a medication according to the location, timing, and hypothesized mechanism of pain.3,31,32
Medication for deep pain. A meta-analysis and systematic review found that patients with some types of chronic pelvic pain with pain deep in the vagina or pelvis experienced greater than 50% reduction in pain using medroxyprogesterone acetate compared with placebo.33 Other treatments for deep pain depend on physical exam findings.
Medication for superficial pain. Many remedies have been tried, with at least 26 different treatments for vulvodynia pain alone.16 Only some of these treatments have supporting evidence. For patients with vulvar pain, an intent-to-treat RCT found that patients using a topical steroid experienced a 23% reduction in pain from pre-treatment to 6-month follow-up.32
Surgery is also effective for vulvar pain.34,35 For provoked vestibulodynia (in which pain is localized to the vestibule and triggered by contact with the vulva), or vulvar vestibulitis, RCTs have found that vestibulectomy has stronger effects on pain than other treatments,31,35 with a 53% reduction in pain during intercourse and a 70% reduction in vestibular pain overall.35 However, while vestibulectomy is effective for provoked vestibulodynia, it is not recommended for generalized vulvodynia, in which pain is diffuse across the vulva and occurs without vulvar contact.34
Unsupported treatments. A number of other treatments have not yet been found effective. Although lidocaine for vulvar pain is often used, RCTs have not found any significant reduction in symptoms, and a double-blind RCT found that lidocaine ointment actually performed worse than placebo.31,34 Similarly, oral tricyclics have not been found to decrease vulvar pain more than placebo in double-blind studies.31,34 Furthermore, a meta-analysis of RCTs comparing treatments with placebo for vestibular pain found no significant decrease in dyspareunia for topical conjugated estrogen, topical lidocaine, oral desipramine, oral desipramine with topical lidocaine, laser therapy, or transcranial direct current.32
Tx risks to consider. Risks and benefits of dyspareunia treatment options should be thoroughly weighed and discussed with the patient.2-4 Vestibulectomy, despite reducing pain for many patients, has led to increased pain for 9% of patients who underwent the procedure.35 Topical treatments may lead to allergic reactions, inflammation, and worsening of symptoms,4 and hormonal treatments have been found to increase the risk of weight gain and bloating and are not appropriate for patients trying to conceive.33
Coordinate care with other providers
While medications and surgery can reduce pain, they have not been shown to improve other aspects of sexual functioning such as sexual satisfaction, frequency of sexual intercourse, or overall sense of sexual functioning.35 Additionally, pain reduction does not address muscle tension, anxiety, self-esteem, and relationship problems. As a result, a multidisciplinary approach is generally needed.3,4,32,33
Continue to: Physical therapists
Physical therapists. Pelvic floor physical therapists are often members of the dyspareunia treatment team and can provide a thorough evaluation and treatment of pelvic floor disorders.2-4 An RCT with intent-to-treat analysis found that pain was reduced by 71% following pelvic floor physical therapy.36 Another RCT found that 90% of patients reported a clinically meaningful decrease in pain with pelvic floor physical therapy.37 In addition to addressing pain, pelvic floor physical therapy has also been found to improve sexual functioning, sexual satisfaction, distress, and patient perception of improvement.34,36,37
Behavioral health specialists. Psychotherapists, especially those trained in sex therapy, couples therapy, or cognitive behavioral therapy (CBT), are also typically on the treatment team. Multiple RCTs have found evidence of CBT’s effectiveness in the direct treatment of dyspareunia pain. Bergeron et al35 found a 37.5% reduction in vulvar vestibulitis pain intensity during intercourse after patients completed group CBT. Another intent-to-treat RCT found that patients receiving CBT experienced more pain reduction (~ 30%) than patients who were treated with a topical steroid.38
In addition to having a direct impact on pain, CBT has also been found to have a clinically and statistically significant positive impact on other aspects of sexual experience, such as overall sexuality, self-efficacy, overall sexual functioning, frequency of intercourse, and catastrophizing.34,38 A recent meta-analysis of RCTs found that about 80% of vaginismus patients were able to achieve penetrative intercourse after treatment with behavioral sex therapy or CBT.39 This success rate was not exceeded by physical or surgical treatments.39
When PTSD is thought to be a contributing factor, trauma therapy will likely be needed in addition to treatments for dyspareunia. First-line treatments for PTSD include cognitive processing therapy, prolonged exposure, trauma-focused CBT, and cognitive therapy.40
Psychotherapists can also help patients reduce anxiety, reintroduce sexual contact without triggering pain or anxiety, address emotional and self-esteem effects of dyspareunia, address relationship issues, and refocus sexual encounters on pleasure rather than pain avoidance.2-4 Despite patient reports of high treatment satisfaction following therapy,38 many patients may initially lack confidence in psychotherapy as a treatment for pain35 and may need to be educated on its effectiveness and multidimensional benefits.
Gynecologists. Often a gynecologist with specialization in pelvic pain is an essential member of the team for diagnostic clarification, recommendation of treatment options, and performance of more advanced treatments.2,3 If pain has become chronic, the patient may also benefit from a pain management team and support groups.2,3
Follow-up steps
Patients who screen negative for dyspareunia should be re-screened periodically. Continue to assess patients diagnosed with dyspareunia for vaginismus symptoms (if they are not initially present) to ensure that the treatment plan is appropriately adjusted. Once treatment has begun, ask about adverse effects and confidence in the treatment plan to minimize negative impacts on treatment adherence and to anticipate a need for a change in the treatment approach.31,35 In addition to tracking treatment effects on pain, continue to assess for patient-centered outcomes such as emotional functioning, self-esteem, and sexual and relationship satisfaction.34 The Female Sexual Function Index can be a useful tool to track symptoms.27,34
Finally, patients who do not experience sufficient improvement in symptoms and functioning with initial treatment may need continued support and encouragement. Given the broad range of contributing factors and the high number of potential treatments, patients may find hope in learning that multiple other treatment options may be available.
CORRESPONDENCE
Adrienne A. Williams, PhD, Department of Family and Community Medicine, University of Illinois at Chicago College of Medicine, 1919 W Taylor Street, MC 663, Chicago, IL 60612; [email protected]
1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th Ed. American Psychiatric Publishing; 2013.
2. Seehusen DA, Baird DC, Bode DV. Dyspareunia in women. Am Fam Phys. 2014;90:465-470.
3. Sorensen J, Bautista KE, Lamvu G, et al. Evaluation and treatment of female sexual pain: a clinical review. Cureus. 2018;10:e2379.
4. MacNeill C. Dyspareunia. Obstet Gynecol Clin North Am. 2006;33:565-77.
5. Latthe P, Latthe M, Say L, et al. WHO systematic review of prevalence of chronic pelvic pain: a neglected reproductive health morbidity. BMC Public Health. 2006;6:177.
6. Steege JF, Zolnoun DA. Evaluation and treatment of dyspareunia. Obstet Gynecol. 2009;113:1124-1136.
7. Williams AA, Williams M. A guide to performing pelvic speculum exams: a patient-centered approach to reducing iatrogenic effects. Teach Learn Med. 2013;25:383-391.
8. Ünlü Z, Yentur A, Çakil N. Pudendal nerve neuropathy: An unknown-rare cause of pelvic pain. Arch Rheumatol. 2016;31:102-103.
9. Dewitte M, Borg C, Lowenstein L. A psychosocial approach to female genital pain. Nat Rev Urol. 2018;15:25-41.
10. Masters WH, Johnson VE. Human Sexual Inadequacy. 1st ed. Little, Brown; 1970.
11. Rathus SA, Nevid JS, Fichner-Rathus L. Human Sexuality in a World of Diversity. 5th ed. Allyn and Bacon; 2002.
12. Bailey BE, Freedenfeld RN, Kiser RS, et al. Lifetime physical and sexual abuse in chronic pain patients: psychosocial correlates and treatment outcomes. Disabil Rehabil. 2003;25:331-342.
13. Yehuda R, Lehrner A, Rosenbaum TY. PTSD and sexual dysfunction in men and women. J Sex Med. 2015;12:1107-1119.
14. Postma R, Bicanic I, van der Vaart H, et al. Pelvic floor muscle problems mediate sexual problems in young adult rape victims. J Sex Med. 2013;10:1978-1987.
15. Binik YM, Bergeron S, Khalifé S. Dyspareunia and vaginismus: so-called sexual pain. In: Leiblum SR, ed. 4th ed. Principles and Practice of Sex Therapy. The Guilford Press; 2007:124-156.
16. Ayling K, Ussher JM. “If sex hurts, am I still a woman?” The subjective experience of vulvodynia in hetero-sexual women. Arch Sex Behav. 2008;37:294-304.
17. Pazmany E, Bergeron S, Van Oudenhove L, et al. Body image and genital self-image in pre-menopausal women with dyspareunia. Arch Sex Behav. 2013;42:999-1010.
18. Maillé DL, Bergeron S, Lambert B. Body image in women with primary and secondary provoked vestibulodynia: a controlled study. J Sex Med. 2015;12:505-515.
19. Ryan L, Hawton K. Female dyspareunia. BMJ. 2004;328:1357.
20. Waldura JF, Arora I, Randall AM, et al. Fifty shades of stigma: exploring the health care experiences of kink-oriented patients. J Sex Med. 2016;13:1918-1929.
21. Hinchliff S, Gott M. Seeking medical help for sexual concerns in mid- and later life: a review of the literature. J Sex Res. 2011;48:106-117.
22. Banaei M, Kariman N, Ozgoli G, et al. Prevalence of postpartum dyspareunia: a systematic review and meta-analysis. Int J Gynaecol Obstet. 2021;153:14-24.
23. Kroenke K, Spitzer RL. The PHQ-9: A new depression diagnostic and severity measure. Psychiatr Ann. 2002;32:509-515.
24. Spitzer RL, Kroenke K, Williams JB, et al. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166:1092-1097.
25. U.S. Department of Veterans Affairs. PTSD: National Center for PTSD. Life events checklist for DSM-5 (LEC-5). Accessed February 3, 2022. www.ptsd.va.gov/professional/assessment/te-measures/life_events_checklist.asp
26. Weathers FW, Litz BT, Keane TM, et al. The PTSD checklist for DSM-5 (PCL-5). 2013. Accessed February 3, 2022. www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp
27. Rosen R, Brown C, Heiman J, et al. The female sexual function index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26:191-208.
28. Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987;30:191-197.
29. Hassam T, Kelso E, Chowdary P, et al. Sexual assault as a risk factor for gynaecological morbidity: an exploratory systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2020;255:222-230.
30. Hamlin AA, Sheeder J, Muffly TM. Brief versus thong hygiene in obstetrics and gynecology (B-THONG): a survey study. J Obstet Gynaecol Res. 2019;45:1190-1196.
31. Foster DC, Kotok MB, Huang LS, et al. Oral desipramine and topical lidocaine for vulvodynia: a randomized controlled trial. Obstet Gynecol. 2010;116:583-593.
32. Pérez-López FR, Bueno-Notivol J, Hernandez AV, et al. Systematic review and meta-analysis of the effects of treatment modalities for vestibulodynia in women. Eur J Contracept Reprod Health Care. 2019;24:337-346.
33. Cheong YC, Smotra G, Williams AC. Non-surgical interventions for the management of chronic pelvic pain. Cochrane Database Syst Rev. 2014;(3):CD008797.
34. Goldstein AT, Pukall CF, Brown C, et al. Vulvodynia: assessment and treatment. J Sex Med. 2016;13:572-590.
35. Bergeron S, Binik YM, Khalifé S, et al. A randomized comparison of group cognitive-behavioral therapy, surface electromyographic biofeedback, and vestibulectomy in the treatment of dyspareunia resulting from vulvar vestibulitis. Pain. 2001;91:297-306.
36. Schvartzman R, Schvartzman L, Ferreira CF, et al. Physical therapy intervention for women with dyspareunia: a randomized clinical trial. J Sex Marital Ther. 2019;45:378-394.
37. Morin M, Dumoulin C, Bergeron S, et al. Multimodal physical therapy versus topical lidocaine for provoked vestibulodynia: a multicenter, randomized trial. Am J Obstet Gynecol. 2021;224:189.e1-189.e12.
38. Bergeron S, Khalifé S, Dupuis M-J, et al. A randomized clinical trial comparing group cognitive-behavioral therapy and a topical steroid for women with dyspareunia. J Consult Clin Psychol. 2016;84:259-268.
39. Maseroli E, Scavello I, Rastrelli G, et al. Outcome of medical and psychosexual interventions for vaginismus: a systematic review and meta-analysis. J Sex Med. 2018;15:1752-1764.
40. American Psychological Association. Clinical practice guideline for the treatment of posttraumatic stress disorder (PTSD) in adults. 2017. Accessed February 3, 2022. www.apa.org/ptsd-guideline/ptsd.pdf
Dyspareunia is persistent or recurrent pain before, during, or after sexual contact and is not limited to cisgender individuals or vaginal intercourse.1-3 With a prevalence as high as 45% in the United States,2-5 it is one of the most common complaints in gynecologic practices.5,6
Causes and contributing factors
There are many possible causes of dyspareunia.2,4,6 While some patients have a single cause, most cases are complex, with multiple overlapping causes and maintaining factors.4,6 Identifying each contributing factor can help you appropriately address all components.
Physical conditions. The range of physical contributors to dyspareunia includes inflammatory processes, structural abnormalities, musculoskeletal dysfunctions, pelvic organ disorders, injuries, iatrogenic effects, infections, allergic reactions, sensitization, hormonal changes, medication effects, adhesions, autoimmune disorders, and other pain syndromes (TABLE 12-4,6-11).
Inadequate arousal. One of the primary causes of pain during vaginal penetration is inadequate arousal and lubrication.1,2,9-11 Arousal is the phase of the sexual response cycle that leads to genital tumescence and prepares the genitals for sexual contact through penile/clitoral erection, vaginal engorgement, and lubrication, which prevents pain and enhances pleasurable sensation.9-11
While some physical conditions can lead to an inability to lubricate, the most common causes of inadequate lubrication are psychosocial-behavioral, wherein patients have the same physical ability to lubricate as patients without genital pain but do not progress through the arousal phase.9-11 Behavioral factors such as inadequate or ineffective foreplay can fail to produce engorgement and lubrication, while psychosocial factors such as low attraction to partner, relationship stressors, anxiety, or low self-esteem can have an inhibitory effect on sexual arousal.1,2,9-11 Psychosocial and behavioral factors may also be maintaining factors or consequences of dyspareunia, and need to be assessed and treated.1,2,9-11
Psychological trauma. Exposure to psychological traumas and the development of posttraumatic stress disorder (PTSD) have been linked with the development of pain disorders in general and dyspareunia specifically. Most patients seeking treatment for chronic pain disorders have a history of physical or sexual abuse.12 Changes in physiologic processes (eg, neurochemical, endocrine) that occur with PTSD interfere with the sexual response cycle, and sexual traumas specifically have been linked with pelvic floor dysfunction.13,14 Additionally, when PTSD is caused by a sexual trauma, even consensual sexual encounters can trigger flashbacks, intrusive memories, hyperarousal, and muscle tension that interfere with the sexual response cycle and contribute to genital pain.13
Vaginismus is both a physiologic and psychological contributor to dyspareunia.1,2,4 Patients experiencing pain can develop anxiety about repeated pain and involuntarily contract their pelvic muscles, thereby creating more pain, increasing anxiety, decreasing lubrication, and causing pelvic floor dysfunction.1-4,6 Consequently, all patients with dyspareunia should be assessed and continually monitored for symptoms of vaginismus.
Continue to: Anxiety
Anxiety. As with other pain disorders, anxiety develops around pain triggers.10,15 When expecting sexual activity, patients can experience extreme worry and panic attacks.10,15,16 The distress of sexual encounters can interfere with physiologic arousal and sexual desire, impacting all phases of the sexual response cycle.1,2
Relationship issues. Difficulty engaging in or avoidance of sexual activity can interfere with romantic relationships.2,10,16 Severe pain or vaginismus contractions can prevent penetration, leading to unconsummated marriages and an inability to conceive through intercourse.10 The distress surrounding sexual encounters can precipitate erectile dysfunction in male partners, or partners may continue to demand sexual encounters despite the patient’s pain, further impacting the relationship and heightening sexual distress.10 These stressors have led to relationships ending, patients reluctantly agreeing to nonmonogamy to appease their partners, and patients avoiding relationships altogether.10,16
Devalued self-image. Difficulties with sexuality and relationships impact the self-image of patients with dyspareunia. Diminished self-image may include feeling “inadequate” as a woman and as a sexual partner, or feeling like a “failure.”16 Women with dyspareunia often have more distress related to their body image, physical appearance, and genital self-image than do women without genital pain.17 Feeling resentment toward their body, or feeling “ugly,” embarrassed, shamed, “broken,” and “useless” also contribute to increased depressive symptoms found in patients with dyspareunia.16,18
Making the diagnosis
Most patients do not report symptoms unless directly asked2,7; therefore, it is recommended that all patients be screened as a part of an initial intake and before any genital exam (TABLE 22-4,6,7,9,11,19,20).4,7,21 If this screen is positive, a separate appointment may be needed for a thorough evaluation and before any attempt is made at a genital exam.4,7
Items to include in the clinical interview
Given the range of possible causes of dyspareunia and its contributing factors and symptoms, a thorough clinical interview is essential. Begin with a review of the patient’s complete medical and surgical history to identify possible known contributors to genital pain.4 Pregnancy history is of particular importance as the prevalence of postpartum dyspareunia is 35%, with risk being greater for patients who experienced dyspareunia symptoms before pregnancy.22
Knowing the location and quality of pain is important for differentiating between possible diagnoses, as is specifying dyspareunia as lifelong or acquired, superficial or deep, and primary or secondary.1-4,6 Confirm the specific location(s) of pain—eg, at the introitus, in the vestibule, on the labia, in the perineum, or near the clitoris.2,4,6 A diagram or model may be needed to help patients to localize pain.4
To help narrow the differential, include the following elements in your assessment: pain quality, timing (eg, initial onset, episode onset, episode duration, situational triggers), alleviating factors, symptoms in surrounding structures (eg, bladder, bowel, muscles, bones), sexual history, other areas of sexual functioning, history of psychological trauma, relationship effects, and mental health (TABLE 22-4,6,7,9,11,19,20 and Table 323-28). Screening for a history of sexual trauma is particularly important, as a recent systematic review and meta-analysis found that women with a history of sexual assault had a 42% higher risk of gynecologic problems overall, a 74% higher risk of dyspareunia, and a 71% higher risk of vaginismus than women without a history of sexual assault.29 Using measures such as the Female Sexual Function Index or the McGill Pain Questionnaire can help patients more thoroughly describe their symptoms (TABLE 323-28).3
Continue to: Guidelines for the physical exam
Guidelines for the physical exam
Before the exam, ensure the patient has not used any topical genital treatment in the past 2 weeks that may interfere with sensitivity to the exam.4 To decrease patients’ anxiety about the exam, remind them that they can stop the exam at any time.7 Also consider offering the use of a mirror to better pinpoint the location of pain, and to possibly help the patient learn more about her anatomy.2,7
Begin the exam by palpating surrounding areas that may be involved in pain, including the abdomen and musculoskeletal features.3,6,19 Next visually inspect the external genitalia for lesions, abrasions, discoloration, erythema, or other abnormal findings.2,3,6 Ask the patient for permission before contacting the genitals. Because the labia may be a site of pain, apply gentle pressure in retracting it to fully examine the vestibule.6,7 Contraction of the pelvic floor muscles during approach or initial palpation could signal possible vaginismus.4
After visual inspection of external genitalia, use a cotton swab to map the vulva and vestibule in a clockwise fashion to precisely identify any painful locations.2-4,6 If the patient’s history of pain has been intermittent, it’s possible that the cotton swab will not elicit pain on the day of the initial exam, but it may on other days.4
Begin the internal exam by inserting a single finger into the first inch of the vagina and have the patient squeeze and release to assess tenderness, muscle tightness, and control.2,6 Advance the finger further into the vagina and palpate clockwise, examining the levator muscles, obturator muscles, rectum, urethra, and bladder for abnormal tightness or reproduction of pain.2,4,6 Complete a bimanual exam to evaluate the pelvic organs and adnexa.2,4 If indicated, a more thorough evaluation of pelvic floor musculature can be performed by a physical therapist or gynecologist who specializes in pelvic pain.2-4
If the patient consents to further evaluation, consider using a small speculum, advanced slowly, for further internal examination, noting any lesions, abrasions, discharge, ectropion, or tenderness.2-4,7 A rectal exam may also be needed in cases of deep dyspareunia.6 Initial work-up may include a potassium hydroxide wet prep, sexually transmitted infection testing, and pelvic ultrasound.2,4 In some cases, laparoscopy or biopsy may be needed.2,4
Treatments for common causes
Treatment often begins with education about anatomy, to help patients communicate about symptoms and engage more fully in their care.3 Additional education may be needed on genital functioning and the necessity of adequate stimulation and lubrication prior to penetration.1,2,9-11 A discussion of treatments for the wide range of possible causes of dyspareunia is outside the scope of this article. However, some basic behavioral changes may help patients address some of the more common contributing factors.
For example, if vaginal infection is suspected, advise patients to discontinue the use of harsh soaps, known vaginal irritants (eg, perfumed products, bath additives), and douches.3 Recommend using only preservative- and alcohol-free lubricants for sexual contact, and avoiding lubricants with added functions (eg, warming).3 It’s worth noting that avoidance of tight clothing and thong underwear due to possible risk for infections may not be necessary. A recent study found that women who frequently wore thong underwear (more than half of the time) were no more likely to develop urinary tract infections, yeast vaginitis, or bacterial vaginosis than those who avoid such items.30 However, noncotton underwear fabric, rather than tightness, was associated with yeast vaginitis30; therefore, patients may want to consider using only breathable underwear.3
Continue to: Medication
Medication. Medication may be used to treat the underlying contributing conditions or the symptom of pain directly. Some common options are particularly important for patients whose dyspareunia does not have an identifiable cause. These medications include anti-inflammatory agents, topical anesthetics, tricyclic antidepressants, and hormonal treatments.2-4 Since effectiveness varies based on subtypes of pain, select a medication according to the location, timing, and hypothesized mechanism of pain.3,31,32
Medication for deep pain. A meta-analysis and systematic review found that patients with some types of chronic pelvic pain with pain deep in the vagina or pelvis experienced greater than 50% reduction in pain using medroxyprogesterone acetate compared with placebo.33 Other treatments for deep pain depend on physical exam findings.
Medication for superficial pain. Many remedies have been tried, with at least 26 different treatments for vulvodynia pain alone.16 Only some of these treatments have supporting evidence. For patients with vulvar pain, an intent-to-treat RCT found that patients using a topical steroid experienced a 23% reduction in pain from pre-treatment to 6-month follow-up.32
Surgery is also effective for vulvar pain.34,35 For provoked vestibulodynia (in which pain is localized to the vestibule and triggered by contact with the vulva), or vulvar vestibulitis, RCTs have found that vestibulectomy has stronger effects on pain than other treatments,31,35 with a 53% reduction in pain during intercourse and a 70% reduction in vestibular pain overall.35 However, while vestibulectomy is effective for provoked vestibulodynia, it is not recommended for generalized vulvodynia, in which pain is diffuse across the vulva and occurs without vulvar contact.34
Unsupported treatments. A number of other treatments have not yet been found effective. Although lidocaine for vulvar pain is often used, RCTs have not found any significant reduction in symptoms, and a double-blind RCT found that lidocaine ointment actually performed worse than placebo.31,34 Similarly, oral tricyclics have not been found to decrease vulvar pain more than placebo in double-blind studies.31,34 Furthermore, a meta-analysis of RCTs comparing treatments with placebo for vestibular pain found no significant decrease in dyspareunia for topical conjugated estrogen, topical lidocaine, oral desipramine, oral desipramine with topical lidocaine, laser therapy, or transcranial direct current.32
Tx risks to consider. Risks and benefits of dyspareunia treatment options should be thoroughly weighed and discussed with the patient.2-4 Vestibulectomy, despite reducing pain for many patients, has led to increased pain for 9% of patients who underwent the procedure.35 Topical treatments may lead to allergic reactions, inflammation, and worsening of symptoms,4 and hormonal treatments have been found to increase the risk of weight gain and bloating and are not appropriate for patients trying to conceive.33
Coordinate care with other providers
While medications and surgery can reduce pain, they have not been shown to improve other aspects of sexual functioning such as sexual satisfaction, frequency of sexual intercourse, or overall sense of sexual functioning.35 Additionally, pain reduction does not address muscle tension, anxiety, self-esteem, and relationship problems. As a result, a multidisciplinary approach is generally needed.3,4,32,33
Continue to: Physical therapists
Physical therapists. Pelvic floor physical therapists are often members of the dyspareunia treatment team and can provide a thorough evaluation and treatment of pelvic floor disorders.2-4 An RCT with intent-to-treat analysis found that pain was reduced by 71% following pelvic floor physical therapy.36 Another RCT found that 90% of patients reported a clinically meaningful decrease in pain with pelvic floor physical therapy.37 In addition to addressing pain, pelvic floor physical therapy has also been found to improve sexual functioning, sexual satisfaction, distress, and patient perception of improvement.34,36,37
Behavioral health specialists. Psychotherapists, especially those trained in sex therapy, couples therapy, or cognitive behavioral therapy (CBT), are also typically on the treatment team. Multiple RCTs have found evidence of CBT’s effectiveness in the direct treatment of dyspareunia pain. Bergeron et al35 found a 37.5% reduction in vulvar vestibulitis pain intensity during intercourse after patients completed group CBT. Another intent-to-treat RCT found that patients receiving CBT experienced more pain reduction (~ 30%) than patients who were treated with a topical steroid.38
In addition to having a direct impact on pain, CBT has also been found to have a clinically and statistically significant positive impact on other aspects of sexual experience, such as overall sexuality, self-efficacy, overall sexual functioning, frequency of intercourse, and catastrophizing.34,38 A recent meta-analysis of RCTs found that about 80% of vaginismus patients were able to achieve penetrative intercourse after treatment with behavioral sex therapy or CBT.39 This success rate was not exceeded by physical or surgical treatments.39
When PTSD is thought to be a contributing factor, trauma therapy will likely be needed in addition to treatments for dyspareunia. First-line treatments for PTSD include cognitive processing therapy, prolonged exposure, trauma-focused CBT, and cognitive therapy.40
Psychotherapists can also help patients reduce anxiety, reintroduce sexual contact without triggering pain or anxiety, address emotional and self-esteem effects of dyspareunia, address relationship issues, and refocus sexual encounters on pleasure rather than pain avoidance.2-4 Despite patient reports of high treatment satisfaction following therapy,38 many patients may initially lack confidence in psychotherapy as a treatment for pain35 and may need to be educated on its effectiveness and multidimensional benefits.
Gynecologists. Often a gynecologist with specialization in pelvic pain is an essential member of the team for diagnostic clarification, recommendation of treatment options, and performance of more advanced treatments.2,3 If pain has become chronic, the patient may also benefit from a pain management team and support groups.2,3
Follow-up steps
Patients who screen negative for dyspareunia should be re-screened periodically. Continue to assess patients diagnosed with dyspareunia for vaginismus symptoms (if they are not initially present) to ensure that the treatment plan is appropriately adjusted. Once treatment has begun, ask about adverse effects and confidence in the treatment plan to minimize negative impacts on treatment adherence and to anticipate a need for a change in the treatment approach.31,35 In addition to tracking treatment effects on pain, continue to assess for patient-centered outcomes such as emotional functioning, self-esteem, and sexual and relationship satisfaction.34 The Female Sexual Function Index can be a useful tool to track symptoms.27,34
Finally, patients who do not experience sufficient improvement in symptoms and functioning with initial treatment may need continued support and encouragement. Given the broad range of contributing factors and the high number of potential treatments, patients may find hope in learning that multiple other treatment options may be available.
CORRESPONDENCE
Adrienne A. Williams, PhD, Department of Family and Community Medicine, University of Illinois at Chicago College of Medicine, 1919 W Taylor Street, MC 663, Chicago, IL 60612; [email protected]
Dyspareunia is persistent or recurrent pain before, during, or after sexual contact and is not limited to cisgender individuals or vaginal intercourse.1-3 With a prevalence as high as 45% in the United States,2-5 it is one of the most common complaints in gynecologic practices.5,6
Causes and contributing factors
There are many possible causes of dyspareunia.2,4,6 While some patients have a single cause, most cases are complex, with multiple overlapping causes and maintaining factors.4,6 Identifying each contributing factor can help you appropriately address all components.
Physical conditions. The range of physical contributors to dyspareunia includes inflammatory processes, structural abnormalities, musculoskeletal dysfunctions, pelvic organ disorders, injuries, iatrogenic effects, infections, allergic reactions, sensitization, hormonal changes, medication effects, adhesions, autoimmune disorders, and other pain syndromes (TABLE 12-4,6-11).
Inadequate arousal. One of the primary causes of pain during vaginal penetration is inadequate arousal and lubrication.1,2,9-11 Arousal is the phase of the sexual response cycle that leads to genital tumescence and prepares the genitals for sexual contact through penile/clitoral erection, vaginal engorgement, and lubrication, which prevents pain and enhances pleasurable sensation.9-11
While some physical conditions can lead to an inability to lubricate, the most common causes of inadequate lubrication are psychosocial-behavioral, wherein patients have the same physical ability to lubricate as patients without genital pain but do not progress through the arousal phase.9-11 Behavioral factors such as inadequate or ineffective foreplay can fail to produce engorgement and lubrication, while psychosocial factors such as low attraction to partner, relationship stressors, anxiety, or low self-esteem can have an inhibitory effect on sexual arousal.1,2,9-11 Psychosocial and behavioral factors may also be maintaining factors or consequences of dyspareunia, and need to be assessed and treated.1,2,9-11
Psychological trauma. Exposure to psychological traumas and the development of posttraumatic stress disorder (PTSD) have been linked with the development of pain disorders in general and dyspareunia specifically. Most patients seeking treatment for chronic pain disorders have a history of physical or sexual abuse.12 Changes in physiologic processes (eg, neurochemical, endocrine) that occur with PTSD interfere with the sexual response cycle, and sexual traumas specifically have been linked with pelvic floor dysfunction.13,14 Additionally, when PTSD is caused by a sexual trauma, even consensual sexual encounters can trigger flashbacks, intrusive memories, hyperarousal, and muscle tension that interfere with the sexual response cycle and contribute to genital pain.13
Vaginismus is both a physiologic and psychological contributor to dyspareunia.1,2,4 Patients experiencing pain can develop anxiety about repeated pain and involuntarily contract their pelvic muscles, thereby creating more pain, increasing anxiety, decreasing lubrication, and causing pelvic floor dysfunction.1-4,6 Consequently, all patients with dyspareunia should be assessed and continually monitored for symptoms of vaginismus.
Continue to: Anxiety
Anxiety. As with other pain disorders, anxiety develops around pain triggers.10,15 When expecting sexual activity, patients can experience extreme worry and panic attacks.10,15,16 The distress of sexual encounters can interfere with physiologic arousal and sexual desire, impacting all phases of the sexual response cycle.1,2
Relationship issues. Difficulty engaging in or avoidance of sexual activity can interfere with romantic relationships.2,10,16 Severe pain or vaginismus contractions can prevent penetration, leading to unconsummated marriages and an inability to conceive through intercourse.10 The distress surrounding sexual encounters can precipitate erectile dysfunction in male partners, or partners may continue to demand sexual encounters despite the patient’s pain, further impacting the relationship and heightening sexual distress.10 These stressors have led to relationships ending, patients reluctantly agreeing to nonmonogamy to appease their partners, and patients avoiding relationships altogether.10,16
Devalued self-image. Difficulties with sexuality and relationships impact the self-image of patients with dyspareunia. Diminished self-image may include feeling “inadequate” as a woman and as a sexual partner, or feeling like a “failure.”16 Women with dyspareunia often have more distress related to their body image, physical appearance, and genital self-image than do women without genital pain.17 Feeling resentment toward their body, or feeling “ugly,” embarrassed, shamed, “broken,” and “useless” also contribute to increased depressive symptoms found in patients with dyspareunia.16,18
Making the diagnosis
Most patients do not report symptoms unless directly asked2,7; therefore, it is recommended that all patients be screened as a part of an initial intake and before any genital exam (TABLE 22-4,6,7,9,11,19,20).4,7,21 If this screen is positive, a separate appointment may be needed for a thorough evaluation and before any attempt is made at a genital exam.4,7
Items to include in the clinical interview
Given the range of possible causes of dyspareunia and its contributing factors and symptoms, a thorough clinical interview is essential. Begin with a review of the patient’s complete medical and surgical history to identify possible known contributors to genital pain.4 Pregnancy history is of particular importance as the prevalence of postpartum dyspareunia is 35%, with risk being greater for patients who experienced dyspareunia symptoms before pregnancy.22
Knowing the location and quality of pain is important for differentiating between possible diagnoses, as is specifying dyspareunia as lifelong or acquired, superficial or deep, and primary or secondary.1-4,6 Confirm the specific location(s) of pain—eg, at the introitus, in the vestibule, on the labia, in the perineum, or near the clitoris.2,4,6 A diagram or model may be needed to help patients to localize pain.4
To help narrow the differential, include the following elements in your assessment: pain quality, timing (eg, initial onset, episode onset, episode duration, situational triggers), alleviating factors, symptoms in surrounding structures (eg, bladder, bowel, muscles, bones), sexual history, other areas of sexual functioning, history of psychological trauma, relationship effects, and mental health (TABLE 22-4,6,7,9,11,19,20 and Table 323-28). Screening for a history of sexual trauma is particularly important, as a recent systematic review and meta-analysis found that women with a history of sexual assault had a 42% higher risk of gynecologic problems overall, a 74% higher risk of dyspareunia, and a 71% higher risk of vaginismus than women without a history of sexual assault.29 Using measures such as the Female Sexual Function Index or the McGill Pain Questionnaire can help patients more thoroughly describe their symptoms (TABLE 323-28).3
Continue to: Guidelines for the physical exam
Guidelines for the physical exam
Before the exam, ensure the patient has not used any topical genital treatment in the past 2 weeks that may interfere with sensitivity to the exam.4 To decrease patients’ anxiety about the exam, remind them that they can stop the exam at any time.7 Also consider offering the use of a mirror to better pinpoint the location of pain, and to possibly help the patient learn more about her anatomy.2,7
Begin the exam by palpating surrounding areas that may be involved in pain, including the abdomen and musculoskeletal features.3,6,19 Next visually inspect the external genitalia for lesions, abrasions, discoloration, erythema, or other abnormal findings.2,3,6 Ask the patient for permission before contacting the genitals. Because the labia may be a site of pain, apply gentle pressure in retracting it to fully examine the vestibule.6,7 Contraction of the pelvic floor muscles during approach or initial palpation could signal possible vaginismus.4
After visual inspection of external genitalia, use a cotton swab to map the vulva and vestibule in a clockwise fashion to precisely identify any painful locations.2-4,6 If the patient’s history of pain has been intermittent, it’s possible that the cotton swab will not elicit pain on the day of the initial exam, but it may on other days.4
Begin the internal exam by inserting a single finger into the first inch of the vagina and have the patient squeeze and release to assess tenderness, muscle tightness, and control.2,6 Advance the finger further into the vagina and palpate clockwise, examining the levator muscles, obturator muscles, rectum, urethra, and bladder for abnormal tightness or reproduction of pain.2,4,6 Complete a bimanual exam to evaluate the pelvic organs and adnexa.2,4 If indicated, a more thorough evaluation of pelvic floor musculature can be performed by a physical therapist or gynecologist who specializes in pelvic pain.2-4
If the patient consents to further evaluation, consider using a small speculum, advanced slowly, for further internal examination, noting any lesions, abrasions, discharge, ectropion, or tenderness.2-4,7 A rectal exam may also be needed in cases of deep dyspareunia.6 Initial work-up may include a potassium hydroxide wet prep, sexually transmitted infection testing, and pelvic ultrasound.2,4 In some cases, laparoscopy or biopsy may be needed.2,4
Treatments for common causes
Treatment often begins with education about anatomy, to help patients communicate about symptoms and engage more fully in their care.3 Additional education may be needed on genital functioning and the necessity of adequate stimulation and lubrication prior to penetration.1,2,9-11 A discussion of treatments for the wide range of possible causes of dyspareunia is outside the scope of this article. However, some basic behavioral changes may help patients address some of the more common contributing factors.
For example, if vaginal infection is suspected, advise patients to discontinue the use of harsh soaps, known vaginal irritants (eg, perfumed products, bath additives), and douches.3 Recommend using only preservative- and alcohol-free lubricants for sexual contact, and avoiding lubricants with added functions (eg, warming).3 It’s worth noting that avoidance of tight clothing and thong underwear due to possible risk for infections may not be necessary. A recent study found that women who frequently wore thong underwear (more than half of the time) were no more likely to develop urinary tract infections, yeast vaginitis, or bacterial vaginosis than those who avoid such items.30 However, noncotton underwear fabric, rather than tightness, was associated with yeast vaginitis30; therefore, patients may want to consider using only breathable underwear.3
Continue to: Medication
Medication. Medication may be used to treat the underlying contributing conditions or the symptom of pain directly. Some common options are particularly important for patients whose dyspareunia does not have an identifiable cause. These medications include anti-inflammatory agents, topical anesthetics, tricyclic antidepressants, and hormonal treatments.2-4 Since effectiveness varies based on subtypes of pain, select a medication according to the location, timing, and hypothesized mechanism of pain.3,31,32
Medication for deep pain. A meta-analysis and systematic review found that patients with some types of chronic pelvic pain with pain deep in the vagina or pelvis experienced greater than 50% reduction in pain using medroxyprogesterone acetate compared with placebo.33 Other treatments for deep pain depend on physical exam findings.
Medication for superficial pain. Many remedies have been tried, with at least 26 different treatments for vulvodynia pain alone.16 Only some of these treatments have supporting evidence. For patients with vulvar pain, an intent-to-treat RCT found that patients using a topical steroid experienced a 23% reduction in pain from pre-treatment to 6-month follow-up.32
Surgery is also effective for vulvar pain.34,35 For provoked vestibulodynia (in which pain is localized to the vestibule and triggered by contact with the vulva), or vulvar vestibulitis, RCTs have found that vestibulectomy has stronger effects on pain than other treatments,31,35 with a 53% reduction in pain during intercourse and a 70% reduction in vestibular pain overall.35 However, while vestibulectomy is effective for provoked vestibulodynia, it is not recommended for generalized vulvodynia, in which pain is diffuse across the vulva and occurs without vulvar contact.34
Unsupported treatments. A number of other treatments have not yet been found effective. Although lidocaine for vulvar pain is often used, RCTs have not found any significant reduction in symptoms, and a double-blind RCT found that lidocaine ointment actually performed worse than placebo.31,34 Similarly, oral tricyclics have not been found to decrease vulvar pain more than placebo in double-blind studies.31,34 Furthermore, a meta-analysis of RCTs comparing treatments with placebo for vestibular pain found no significant decrease in dyspareunia for topical conjugated estrogen, topical lidocaine, oral desipramine, oral desipramine with topical lidocaine, laser therapy, or transcranial direct current.32
Tx risks to consider. Risks and benefits of dyspareunia treatment options should be thoroughly weighed and discussed with the patient.2-4 Vestibulectomy, despite reducing pain for many patients, has led to increased pain for 9% of patients who underwent the procedure.35 Topical treatments may lead to allergic reactions, inflammation, and worsening of symptoms,4 and hormonal treatments have been found to increase the risk of weight gain and bloating and are not appropriate for patients trying to conceive.33
Coordinate care with other providers
While medications and surgery can reduce pain, they have not been shown to improve other aspects of sexual functioning such as sexual satisfaction, frequency of sexual intercourse, or overall sense of sexual functioning.35 Additionally, pain reduction does not address muscle tension, anxiety, self-esteem, and relationship problems. As a result, a multidisciplinary approach is generally needed.3,4,32,33
Continue to: Physical therapists
Physical therapists. Pelvic floor physical therapists are often members of the dyspareunia treatment team and can provide a thorough evaluation and treatment of pelvic floor disorders.2-4 An RCT with intent-to-treat analysis found that pain was reduced by 71% following pelvic floor physical therapy.36 Another RCT found that 90% of patients reported a clinically meaningful decrease in pain with pelvic floor physical therapy.37 In addition to addressing pain, pelvic floor physical therapy has also been found to improve sexual functioning, sexual satisfaction, distress, and patient perception of improvement.34,36,37
Behavioral health specialists. Psychotherapists, especially those trained in sex therapy, couples therapy, or cognitive behavioral therapy (CBT), are also typically on the treatment team. Multiple RCTs have found evidence of CBT’s effectiveness in the direct treatment of dyspareunia pain. Bergeron et al35 found a 37.5% reduction in vulvar vestibulitis pain intensity during intercourse after patients completed group CBT. Another intent-to-treat RCT found that patients receiving CBT experienced more pain reduction (~ 30%) than patients who were treated with a topical steroid.38
In addition to having a direct impact on pain, CBT has also been found to have a clinically and statistically significant positive impact on other aspects of sexual experience, such as overall sexuality, self-efficacy, overall sexual functioning, frequency of intercourse, and catastrophizing.34,38 A recent meta-analysis of RCTs found that about 80% of vaginismus patients were able to achieve penetrative intercourse after treatment with behavioral sex therapy or CBT.39 This success rate was not exceeded by physical or surgical treatments.39
When PTSD is thought to be a contributing factor, trauma therapy will likely be needed in addition to treatments for dyspareunia. First-line treatments for PTSD include cognitive processing therapy, prolonged exposure, trauma-focused CBT, and cognitive therapy.40
Psychotherapists can also help patients reduce anxiety, reintroduce sexual contact without triggering pain or anxiety, address emotional and self-esteem effects of dyspareunia, address relationship issues, and refocus sexual encounters on pleasure rather than pain avoidance.2-4 Despite patient reports of high treatment satisfaction following therapy,38 many patients may initially lack confidence in psychotherapy as a treatment for pain35 and may need to be educated on its effectiveness and multidimensional benefits.
Gynecologists. Often a gynecologist with specialization in pelvic pain is an essential member of the team for diagnostic clarification, recommendation of treatment options, and performance of more advanced treatments.2,3 If pain has become chronic, the patient may also benefit from a pain management team and support groups.2,3
Follow-up steps
Patients who screen negative for dyspareunia should be re-screened periodically. Continue to assess patients diagnosed with dyspareunia for vaginismus symptoms (if they are not initially present) to ensure that the treatment plan is appropriately adjusted. Once treatment has begun, ask about adverse effects and confidence in the treatment plan to minimize negative impacts on treatment adherence and to anticipate a need for a change in the treatment approach.31,35 In addition to tracking treatment effects on pain, continue to assess for patient-centered outcomes such as emotional functioning, self-esteem, and sexual and relationship satisfaction.34 The Female Sexual Function Index can be a useful tool to track symptoms.27,34
Finally, patients who do not experience sufficient improvement in symptoms and functioning with initial treatment may need continued support and encouragement. Given the broad range of contributing factors and the high number of potential treatments, patients may find hope in learning that multiple other treatment options may be available.
CORRESPONDENCE
Adrienne A. Williams, PhD, Department of Family and Community Medicine, University of Illinois at Chicago College of Medicine, 1919 W Taylor Street, MC 663, Chicago, IL 60612; [email protected]
1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th Ed. American Psychiatric Publishing; 2013.
2. Seehusen DA, Baird DC, Bode DV. Dyspareunia in women. Am Fam Phys. 2014;90:465-470.
3. Sorensen J, Bautista KE, Lamvu G, et al. Evaluation and treatment of female sexual pain: a clinical review. Cureus. 2018;10:e2379.
4. MacNeill C. Dyspareunia. Obstet Gynecol Clin North Am. 2006;33:565-77.
5. Latthe P, Latthe M, Say L, et al. WHO systematic review of prevalence of chronic pelvic pain: a neglected reproductive health morbidity. BMC Public Health. 2006;6:177.
6. Steege JF, Zolnoun DA. Evaluation and treatment of dyspareunia. Obstet Gynecol. 2009;113:1124-1136.
7. Williams AA, Williams M. A guide to performing pelvic speculum exams: a patient-centered approach to reducing iatrogenic effects. Teach Learn Med. 2013;25:383-391.
8. Ünlü Z, Yentur A, Çakil N. Pudendal nerve neuropathy: An unknown-rare cause of pelvic pain. Arch Rheumatol. 2016;31:102-103.
9. Dewitte M, Borg C, Lowenstein L. A psychosocial approach to female genital pain. Nat Rev Urol. 2018;15:25-41.
10. Masters WH, Johnson VE. Human Sexual Inadequacy. 1st ed. Little, Brown; 1970.
11. Rathus SA, Nevid JS, Fichner-Rathus L. Human Sexuality in a World of Diversity. 5th ed. Allyn and Bacon; 2002.
12. Bailey BE, Freedenfeld RN, Kiser RS, et al. Lifetime physical and sexual abuse in chronic pain patients: psychosocial correlates and treatment outcomes. Disabil Rehabil. 2003;25:331-342.
13. Yehuda R, Lehrner A, Rosenbaum TY. PTSD and sexual dysfunction in men and women. J Sex Med. 2015;12:1107-1119.
14. Postma R, Bicanic I, van der Vaart H, et al. Pelvic floor muscle problems mediate sexual problems in young adult rape victims. J Sex Med. 2013;10:1978-1987.
15. Binik YM, Bergeron S, Khalifé S. Dyspareunia and vaginismus: so-called sexual pain. In: Leiblum SR, ed. 4th ed. Principles and Practice of Sex Therapy. The Guilford Press; 2007:124-156.
16. Ayling K, Ussher JM. “If sex hurts, am I still a woman?” The subjective experience of vulvodynia in hetero-sexual women. Arch Sex Behav. 2008;37:294-304.
17. Pazmany E, Bergeron S, Van Oudenhove L, et al. Body image and genital self-image in pre-menopausal women with dyspareunia. Arch Sex Behav. 2013;42:999-1010.
18. Maillé DL, Bergeron S, Lambert B. Body image in women with primary and secondary provoked vestibulodynia: a controlled study. J Sex Med. 2015;12:505-515.
19. Ryan L, Hawton K. Female dyspareunia. BMJ. 2004;328:1357.
20. Waldura JF, Arora I, Randall AM, et al. Fifty shades of stigma: exploring the health care experiences of kink-oriented patients. J Sex Med. 2016;13:1918-1929.
21. Hinchliff S, Gott M. Seeking medical help for sexual concerns in mid- and later life: a review of the literature. J Sex Res. 2011;48:106-117.
22. Banaei M, Kariman N, Ozgoli G, et al. Prevalence of postpartum dyspareunia: a systematic review and meta-analysis. Int J Gynaecol Obstet. 2021;153:14-24.
23. Kroenke K, Spitzer RL. The PHQ-9: A new depression diagnostic and severity measure. Psychiatr Ann. 2002;32:509-515.
24. Spitzer RL, Kroenke K, Williams JB, et al. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166:1092-1097.
25. U.S. Department of Veterans Affairs. PTSD: National Center for PTSD. Life events checklist for DSM-5 (LEC-5). Accessed February 3, 2022. www.ptsd.va.gov/professional/assessment/te-measures/life_events_checklist.asp
26. Weathers FW, Litz BT, Keane TM, et al. The PTSD checklist for DSM-5 (PCL-5). 2013. Accessed February 3, 2022. www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp
27. Rosen R, Brown C, Heiman J, et al. The female sexual function index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26:191-208.
28. Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987;30:191-197.
29. Hassam T, Kelso E, Chowdary P, et al. Sexual assault as a risk factor for gynaecological morbidity: an exploratory systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2020;255:222-230.
30. Hamlin AA, Sheeder J, Muffly TM. Brief versus thong hygiene in obstetrics and gynecology (B-THONG): a survey study. J Obstet Gynaecol Res. 2019;45:1190-1196.
31. Foster DC, Kotok MB, Huang LS, et al. Oral desipramine and topical lidocaine for vulvodynia: a randomized controlled trial. Obstet Gynecol. 2010;116:583-593.
32. Pérez-López FR, Bueno-Notivol J, Hernandez AV, et al. Systematic review and meta-analysis of the effects of treatment modalities for vestibulodynia in women. Eur J Contracept Reprod Health Care. 2019;24:337-346.
33. Cheong YC, Smotra G, Williams AC. Non-surgical interventions for the management of chronic pelvic pain. Cochrane Database Syst Rev. 2014;(3):CD008797.
34. Goldstein AT, Pukall CF, Brown C, et al. Vulvodynia: assessment and treatment. J Sex Med. 2016;13:572-590.
35. Bergeron S, Binik YM, Khalifé S, et al. A randomized comparison of group cognitive-behavioral therapy, surface electromyographic biofeedback, and vestibulectomy in the treatment of dyspareunia resulting from vulvar vestibulitis. Pain. 2001;91:297-306.
36. Schvartzman R, Schvartzman L, Ferreira CF, et al. Physical therapy intervention for women with dyspareunia: a randomized clinical trial. J Sex Marital Ther. 2019;45:378-394.
37. Morin M, Dumoulin C, Bergeron S, et al. Multimodal physical therapy versus topical lidocaine for provoked vestibulodynia: a multicenter, randomized trial. Am J Obstet Gynecol. 2021;224:189.e1-189.e12.
38. Bergeron S, Khalifé S, Dupuis M-J, et al. A randomized clinical trial comparing group cognitive-behavioral therapy and a topical steroid for women with dyspareunia. J Consult Clin Psychol. 2016;84:259-268.
39. Maseroli E, Scavello I, Rastrelli G, et al. Outcome of medical and psychosexual interventions for vaginismus: a systematic review and meta-analysis. J Sex Med. 2018;15:1752-1764.
40. American Psychological Association. Clinical practice guideline for the treatment of posttraumatic stress disorder (PTSD) in adults. 2017. Accessed February 3, 2022. www.apa.org/ptsd-guideline/ptsd.pdf
1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th Ed. American Psychiatric Publishing; 2013.
2. Seehusen DA, Baird DC, Bode DV. Dyspareunia in women. Am Fam Phys. 2014;90:465-470.
3. Sorensen J, Bautista KE, Lamvu G, et al. Evaluation and treatment of female sexual pain: a clinical review. Cureus. 2018;10:e2379.
4. MacNeill C. Dyspareunia. Obstet Gynecol Clin North Am. 2006;33:565-77.
5. Latthe P, Latthe M, Say L, et al. WHO systematic review of prevalence of chronic pelvic pain: a neglected reproductive health morbidity. BMC Public Health. 2006;6:177.
6. Steege JF, Zolnoun DA. Evaluation and treatment of dyspareunia. Obstet Gynecol. 2009;113:1124-1136.
7. Williams AA, Williams M. A guide to performing pelvic speculum exams: a patient-centered approach to reducing iatrogenic effects. Teach Learn Med. 2013;25:383-391.
8. Ünlü Z, Yentur A, Çakil N. Pudendal nerve neuropathy: An unknown-rare cause of pelvic pain. Arch Rheumatol. 2016;31:102-103.
9. Dewitte M, Borg C, Lowenstein L. A psychosocial approach to female genital pain. Nat Rev Urol. 2018;15:25-41.
10. Masters WH, Johnson VE. Human Sexual Inadequacy. 1st ed. Little, Brown; 1970.
11. Rathus SA, Nevid JS, Fichner-Rathus L. Human Sexuality in a World of Diversity. 5th ed. Allyn and Bacon; 2002.
12. Bailey BE, Freedenfeld RN, Kiser RS, et al. Lifetime physical and sexual abuse in chronic pain patients: psychosocial correlates and treatment outcomes. Disabil Rehabil. 2003;25:331-342.
13. Yehuda R, Lehrner A, Rosenbaum TY. PTSD and sexual dysfunction in men and women. J Sex Med. 2015;12:1107-1119.
14. Postma R, Bicanic I, van der Vaart H, et al. Pelvic floor muscle problems mediate sexual problems in young adult rape victims. J Sex Med. 2013;10:1978-1987.
15. Binik YM, Bergeron S, Khalifé S. Dyspareunia and vaginismus: so-called sexual pain. In: Leiblum SR, ed. 4th ed. Principles and Practice of Sex Therapy. The Guilford Press; 2007:124-156.
16. Ayling K, Ussher JM. “If sex hurts, am I still a woman?” The subjective experience of vulvodynia in hetero-sexual women. Arch Sex Behav. 2008;37:294-304.
17. Pazmany E, Bergeron S, Van Oudenhove L, et al. Body image and genital self-image in pre-menopausal women with dyspareunia. Arch Sex Behav. 2013;42:999-1010.
18. Maillé DL, Bergeron S, Lambert B. Body image in women with primary and secondary provoked vestibulodynia: a controlled study. J Sex Med. 2015;12:505-515.
19. Ryan L, Hawton K. Female dyspareunia. BMJ. 2004;328:1357.
20. Waldura JF, Arora I, Randall AM, et al. Fifty shades of stigma: exploring the health care experiences of kink-oriented patients. J Sex Med. 2016;13:1918-1929.
21. Hinchliff S, Gott M. Seeking medical help for sexual concerns in mid- and later life: a review of the literature. J Sex Res. 2011;48:106-117.
22. Banaei M, Kariman N, Ozgoli G, et al. Prevalence of postpartum dyspareunia: a systematic review and meta-analysis. Int J Gynaecol Obstet. 2021;153:14-24.
23. Kroenke K, Spitzer RL. The PHQ-9: A new depression diagnostic and severity measure. Psychiatr Ann. 2002;32:509-515.
24. Spitzer RL, Kroenke K, Williams JB, et al. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166:1092-1097.
25. U.S. Department of Veterans Affairs. PTSD: National Center for PTSD. Life events checklist for DSM-5 (LEC-5). Accessed February 3, 2022. www.ptsd.va.gov/professional/assessment/te-measures/life_events_checklist.asp
26. Weathers FW, Litz BT, Keane TM, et al. The PTSD checklist for DSM-5 (PCL-5). 2013. Accessed February 3, 2022. www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp
27. Rosen R, Brown C, Heiman J, et al. The female sexual function index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26:191-208.
28. Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987;30:191-197.
29. Hassam T, Kelso E, Chowdary P, et al. Sexual assault as a risk factor for gynaecological morbidity: an exploratory systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2020;255:222-230.
30. Hamlin AA, Sheeder J, Muffly TM. Brief versus thong hygiene in obstetrics and gynecology (B-THONG): a survey study. J Obstet Gynaecol Res. 2019;45:1190-1196.
31. Foster DC, Kotok MB, Huang LS, et al. Oral desipramine and topical lidocaine for vulvodynia: a randomized controlled trial. Obstet Gynecol. 2010;116:583-593.
32. Pérez-López FR, Bueno-Notivol J, Hernandez AV, et al. Systematic review and meta-analysis of the effects of treatment modalities for vestibulodynia in women. Eur J Contracept Reprod Health Care. 2019;24:337-346.
33. Cheong YC, Smotra G, Williams AC. Non-surgical interventions for the management of chronic pelvic pain. Cochrane Database Syst Rev. 2014;(3):CD008797.
34. Goldstein AT, Pukall CF, Brown C, et al. Vulvodynia: assessment and treatment. J Sex Med. 2016;13:572-590.
35. Bergeron S, Binik YM, Khalifé S, et al. A randomized comparison of group cognitive-behavioral therapy, surface electromyographic biofeedback, and vestibulectomy in the treatment of dyspareunia resulting from vulvar vestibulitis. Pain. 2001;91:297-306.
36. Schvartzman R, Schvartzman L, Ferreira CF, et al. Physical therapy intervention for women with dyspareunia: a randomized clinical trial. J Sex Marital Ther. 2019;45:378-394.
37. Morin M, Dumoulin C, Bergeron S, et al. Multimodal physical therapy versus topical lidocaine for provoked vestibulodynia: a multicenter, randomized trial. Am J Obstet Gynecol. 2021;224:189.e1-189.e12.
38. Bergeron S, Khalifé S, Dupuis M-J, et al. A randomized clinical trial comparing group cognitive-behavioral therapy and a topical steroid for women with dyspareunia. J Consult Clin Psychol. 2016;84:259-268.
39. Maseroli E, Scavello I, Rastrelli G, et al. Outcome of medical and psychosexual interventions for vaginismus: a systematic review and meta-analysis. J Sex Med. 2018;15:1752-1764.
40. American Psychological Association. Clinical practice guideline for the treatment of posttraumatic stress disorder (PTSD) in adults. 2017. Accessed February 3, 2022. www.apa.org/ptsd-guideline/ptsd.pdf
PRACTICE RECOMMENDATIONS
› Screen all patients for sexual dysfunctions, as patients often do not report symptoms on their own. B
› Refer patients with dyspareunia for psychotherapy to address both pain and psychosocial causes and sequela of dyspareunia. A
› Refer patients with dyspareunia for pelvic floor physical therapy to address pain and sexual functioning. A
Strength of recommendation (SOR)
A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series
Former physician sentenced to 20 years in pill mill case
A former pain medicine physician received a sentence of 20 years in prison for selling opioids and writing prescriptions for patients who were abusing or diverting the medications.
Patrick Titus, 58, operated Lighthouse Internal Medicine in Milford, Delaware, from 2005-2014.
Federal prosecutors said Mr. Titus unlawfully distributed or dispensed opioids including fentanyl, morphine, methadone, OxyContin, and oxycodone outside the scope of practice and often prescribed them in combination with each other or in other dangerous combinations. Mr. Titus distributed over 1 million pills, said the government.
In a 2018 indictment, the government said that Mr. Titus would, “at the first and nearly every follow-up visit” prescribe opioids in high dosages, often without conducting an exam or reviewing any urine test results. He would also write prescriptions for opioids without getting patients’s prior medical records or reviewing test results and rarely referred patients to alternative pain treatments such as physical therapy, psychotherapy, or massage.
According to the indictment, he ignored “red flags,” including that patients would come from long distances, sometimes from out of state, and would pay cash, despite having Medicaid coverage.
“Today’s sentencing makes clear that medical professionals who recklessly prescribe opioids and endanger the safety and health of patients will be held accountable,” said Anne Milgram, a Drug Enforcement Administration administrator.
“This sentence is a reminder that the Department of Justice will hold accountable those doctors who are illegitimately prescribing opioids and fueling the country’s opioid crisis,” said Assistant Attorney General Kenneth A. Polite Jr., of the Justice Department’s Criminal Division, in the same statement. “Doctors who commit these unlawful acts exploit their roles as stewards of their patients’s care for their own profit,” he added.
The sentence follows Mr. Titus’s 2-week jury trial in 2021, when he was convicted of 13 counts of unlawful distribution and dispensing of controlled substances and one count of maintaining his practice primarily as a location to sell drugs. Mr. Titus faced a maximum of 20 years per count.
At the time of his conviction, Mr. Titus’s attorney said he planned to appeal, according to Delaware Online.
Delaware suspended Mr. Titus’s registration to prescribe controlled substances for 1 year in 2011. At the time, the state said it had determined that his continued prescribing “poses [an] imminent danger to the public health or safety.”
The state found that from January to November 2011, Mr. Titus issued 3,941 prescriptions for almost 750,000 pills for 17 different controlled substances, all sent to a single pharmacy.
The state also alleged that he wrote prescriptions for controlled substances to patients with felony convictions for drug trafficking and to at least one patient who his staff told him was selling the opioid that Mr. Titus had prescribed. It later determined that Mr. Titus continued prescribing even after it had suspended his DEA registration.
According to a 2014 consent agreement, the state subsequently ordered another 1-year suspension of his DEA registration, to be followed by a 3-year probation period.
Meanwhile, the same year, the state Board of Medical Licensure put Mr. Titus’s medical license on probation for 2 years and ordered him to complete 15 continuing medical education credits in medical recordkeeping, ethics, how to detect diversion and abuse, and in some other areas, and to pay a $7,500 fine.
In 2016, the medical board revoked Mr. Titus’s license, after finding that he continued to prescribe pain medications to patients he did not screen or monitor and for a multitude of other infractions.
A version of this article first appeared on Medscape.com.
A former pain medicine physician received a sentence of 20 years in prison for selling opioids and writing prescriptions for patients who were abusing or diverting the medications.
Patrick Titus, 58, operated Lighthouse Internal Medicine in Milford, Delaware, from 2005-2014.
Federal prosecutors said Mr. Titus unlawfully distributed or dispensed opioids including fentanyl, morphine, methadone, OxyContin, and oxycodone outside the scope of practice and often prescribed them in combination with each other or in other dangerous combinations. Mr. Titus distributed over 1 million pills, said the government.
In a 2018 indictment, the government said that Mr. Titus would, “at the first and nearly every follow-up visit” prescribe opioids in high dosages, often without conducting an exam or reviewing any urine test results. He would also write prescriptions for opioids without getting patients’s prior medical records or reviewing test results and rarely referred patients to alternative pain treatments such as physical therapy, psychotherapy, or massage.
According to the indictment, he ignored “red flags,” including that patients would come from long distances, sometimes from out of state, and would pay cash, despite having Medicaid coverage.
“Today’s sentencing makes clear that medical professionals who recklessly prescribe opioids and endanger the safety and health of patients will be held accountable,” said Anne Milgram, a Drug Enforcement Administration administrator.
“This sentence is a reminder that the Department of Justice will hold accountable those doctors who are illegitimately prescribing opioids and fueling the country’s opioid crisis,” said Assistant Attorney General Kenneth A. Polite Jr., of the Justice Department’s Criminal Division, in the same statement. “Doctors who commit these unlawful acts exploit their roles as stewards of their patients’s care for their own profit,” he added.
The sentence follows Mr. Titus’s 2-week jury trial in 2021, when he was convicted of 13 counts of unlawful distribution and dispensing of controlled substances and one count of maintaining his practice primarily as a location to sell drugs. Mr. Titus faced a maximum of 20 years per count.
At the time of his conviction, Mr. Titus’s attorney said he planned to appeal, according to Delaware Online.
Delaware suspended Mr. Titus’s registration to prescribe controlled substances for 1 year in 2011. At the time, the state said it had determined that his continued prescribing “poses [an] imminent danger to the public health or safety.”
The state found that from January to November 2011, Mr. Titus issued 3,941 prescriptions for almost 750,000 pills for 17 different controlled substances, all sent to a single pharmacy.
The state also alleged that he wrote prescriptions for controlled substances to patients with felony convictions for drug trafficking and to at least one patient who his staff told him was selling the opioid that Mr. Titus had prescribed. It later determined that Mr. Titus continued prescribing even after it had suspended his DEA registration.
According to a 2014 consent agreement, the state subsequently ordered another 1-year suspension of his DEA registration, to be followed by a 3-year probation period.
Meanwhile, the same year, the state Board of Medical Licensure put Mr. Titus’s medical license on probation for 2 years and ordered him to complete 15 continuing medical education credits in medical recordkeeping, ethics, how to detect diversion and abuse, and in some other areas, and to pay a $7,500 fine.
In 2016, the medical board revoked Mr. Titus’s license, after finding that he continued to prescribe pain medications to patients he did not screen or monitor and for a multitude of other infractions.
A version of this article first appeared on Medscape.com.
A former pain medicine physician received a sentence of 20 years in prison for selling opioids and writing prescriptions for patients who were abusing or diverting the medications.
Patrick Titus, 58, operated Lighthouse Internal Medicine in Milford, Delaware, from 2005-2014.
Federal prosecutors said Mr. Titus unlawfully distributed or dispensed opioids including fentanyl, morphine, methadone, OxyContin, and oxycodone outside the scope of practice and often prescribed them in combination with each other or in other dangerous combinations. Mr. Titus distributed over 1 million pills, said the government.
In a 2018 indictment, the government said that Mr. Titus would, “at the first and nearly every follow-up visit” prescribe opioids in high dosages, often without conducting an exam or reviewing any urine test results. He would also write prescriptions for opioids without getting patients’s prior medical records or reviewing test results and rarely referred patients to alternative pain treatments such as physical therapy, psychotherapy, or massage.
According to the indictment, he ignored “red flags,” including that patients would come from long distances, sometimes from out of state, and would pay cash, despite having Medicaid coverage.
“Today’s sentencing makes clear that medical professionals who recklessly prescribe opioids and endanger the safety and health of patients will be held accountable,” said Anne Milgram, a Drug Enforcement Administration administrator.
“This sentence is a reminder that the Department of Justice will hold accountable those doctors who are illegitimately prescribing opioids and fueling the country’s opioid crisis,” said Assistant Attorney General Kenneth A. Polite Jr., of the Justice Department’s Criminal Division, in the same statement. “Doctors who commit these unlawful acts exploit their roles as stewards of their patients’s care for their own profit,” he added.
The sentence follows Mr. Titus’s 2-week jury trial in 2021, when he was convicted of 13 counts of unlawful distribution and dispensing of controlled substances and one count of maintaining his practice primarily as a location to sell drugs. Mr. Titus faced a maximum of 20 years per count.
At the time of his conviction, Mr. Titus’s attorney said he planned to appeal, according to Delaware Online.
Delaware suspended Mr. Titus’s registration to prescribe controlled substances for 1 year in 2011. At the time, the state said it had determined that his continued prescribing “poses [an] imminent danger to the public health or safety.”
The state found that from January to November 2011, Mr. Titus issued 3,941 prescriptions for almost 750,000 pills for 17 different controlled substances, all sent to a single pharmacy.
The state also alleged that he wrote prescriptions for controlled substances to patients with felony convictions for drug trafficking and to at least one patient who his staff told him was selling the opioid that Mr. Titus had prescribed. It later determined that Mr. Titus continued prescribing even after it had suspended his DEA registration.
According to a 2014 consent agreement, the state subsequently ordered another 1-year suspension of his DEA registration, to be followed by a 3-year probation period.
Meanwhile, the same year, the state Board of Medical Licensure put Mr. Titus’s medical license on probation for 2 years and ordered him to complete 15 continuing medical education credits in medical recordkeeping, ethics, how to detect diversion and abuse, and in some other areas, and to pay a $7,500 fine.
In 2016, the medical board revoked Mr. Titus’s license, after finding that he continued to prescribe pain medications to patients he did not screen or monitor and for a multitude of other infractions.
A version of this article first appeared on Medscape.com.
Mindfulness intervention curbs opioid misuse, chronic pain
In a randomized clinical trial, 250 adults with both opioid misuse and chronic pain received either the intervention, called mindfulness-oriented recovery enhancement (MORE), or supportive psychotherapy.
Results showed the first group was twice as likely to reduce opioid misuse after 9 months than the latter group.
The intervention was developed by Eric Garland, PhD, director of the Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), University of Utah, Salt Lake City. “As the largest and longest-term clinical trial of MORE ever conducted, this study definitively establishes the efficacy of MORE as a treatment for chronic pain and opioid misuse,” he told this news organization.
The findings were published online Feb. 28 in JAMA Internal Medicine.
Self-regulation
Study participants included 250 adults (64% women; mean age, 51.8 years) with co-occurring opioid misuse and chronic pain who were randomly allocated to receive MORE or supportive psychotherapy, which served as a control group.
Both interventions were delivered by trained clinical social workers in six primary care clinics in Utah to groups of 6-12 participants across 8 weekly 2-hour sessions.
The MORE intervention, detailed on Dr. Garland’s website, provides sequenced training in mindfulness, reappraisal, and savoring skills.
Mindfulness consisted of meditation on breathing and body sensations to strengthen self-regulation of compulsive opioid use and to mitigate pain and opioid craving by reinterpreting these experiences as innocuous sensory information.
Reappraisal consisted of reframing maladaptive thoughts to decrease negative emotions and engender meaning in life.
Savoring consisted of training in focusing awareness on pleasurable events and sensations to amplify positive emotions and reward.
Fewer depressive symptoms
Through 9 months of follow-up, the MORE group had about a twofold greater likelihood than the supportive psychotherapy group for reduction in opioid misuse (odds ratio [OR], 2.06; 95% confidence interval, 1.17-3.61; P = .01)
“MORE reduced opioid misuse by 45% 9 months after the end of treatment, more than doubling the effect of standard supportive psychotherapy and exceeding the effect size of other therapies for opioid misuse among people with chronic pain,” Dr. Garland said.
Members of the MORE group experienced greater reduction in pain severity and pain-related functional interference compared with members of the control group.
“MORE’s effect size on chronic pain symptoms was greater than that observed for CBT, the current gold standard psychological treatment for chronic pain,” Dr. Garland noted.
Compared with supportive psychotherapy, MORE decreased emotional distress, depressive symptoms, and real-time reports of opioid craving in daily life.
“Although nearly 70% of participants met criteria for depression at the beginning of the trial, on average, patients in MORE no longer exhibited symptoms consistent with major depressive disorder by the end of the study,” Dr. Garland said.
The current study builds on prior studies of MORE showing similar results, as reported previously by this news organization.
MORE can be successfully delivered in routine primary care, Dr. Garland noted. “In this trial, we delivered MORE in conference rooms, break rooms, and lunch rooms at community primary care clinics,” he added.
‘Powerful program’
To date, Dr. Garland has trained more than 450 physicians, nurses, social workers, and psychologists in health care systems across the country to implement MORE as an insurance-reimbursable group visit for patients in need.
One of them is Nancy Sudak, MD, chief well-being officer and director of integrative health, Essentia Health, Duluth, Minn.
“MORE is a very powerful program that teaches patients how to turn down the volume of their pain. I’ve been quite impressed by the power of MORE,” Dr. Sudak told this news organization
She noted that “buy-in” from patients is key – and the more a clinician knows a patient, the easier the buy-in.
“I recruited most of the patients in my groups from my own practice, so I already knew the patients quite well and there wasn’t really a need to sell it,” Dr. Sudak said.
“We have tried to operationalize it through our system and find that, as long as our recruitment techniques are robust enough, it’s not that hard to find patients to fill the groups, especially because chronic pain is just so common,” she added.
Dr. Sudak has found that patients who participate in MORE “bond and learn with each other and support each other. Patients love it, providers love it, and it’s a way to address isolation and loneliness” that can come with certain conditions.
“There are really only upsides to the group visit model and I think we’ll be seeing quite a bit more of it in the future,” she added.
Evidence-based data
Anna Parisi, PhD, is also delivering MORE to patients. She told this news organization, she was “really drawn” to the MORE program because oftentimes patients who require the most sophisticated therapies receive the ones with the least evidence.
This is often “what folks in the community are getting when they’re struggling with substance use,” added Dr. Parisi, a postdoctoral research associate working with Dr. Garland at the University of Utah. Dr. Parisi was not a coauthor on the current study.
“With MORE, all of the strategies and techniques are tied to mechanistic studies of their efficacy, so you know that what you’re delivering has a rationale behind it,” she said.
Like Dr. Sudak, Dr. Parisi said her patients, for the most part, have been receptive to the program. Although at first some were skeptical about mindfulness – with one patient using the term “tree-hugging” – they found immediate benefit even after the first session.
“That really helps them stay motivated to finish the program,” Dr. Parisi said.
This work was supported by a grant from the National Institute on Drug Abuse. Dr. Garland serves as director of the Center on Mindfulness and Integrative Health Intervention Development, which provides MORE, mindfulness-based therapy, and CBT in the context of research trials for no cost to research participants. He receives honoraria and payment for delivering seminars, lectures, and teaching engagements related to training clinicians in MORE and mindfulness and receives royalties from BehaVR and from the sales of books related to MORE outside the submitted work. Dr. Sudak and Dr. Parisi have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a randomized clinical trial, 250 adults with both opioid misuse and chronic pain received either the intervention, called mindfulness-oriented recovery enhancement (MORE), or supportive psychotherapy.
Results showed the first group was twice as likely to reduce opioid misuse after 9 months than the latter group.
The intervention was developed by Eric Garland, PhD, director of the Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), University of Utah, Salt Lake City. “As the largest and longest-term clinical trial of MORE ever conducted, this study definitively establishes the efficacy of MORE as a treatment for chronic pain and opioid misuse,” he told this news organization.
The findings were published online Feb. 28 in JAMA Internal Medicine.
Self-regulation
Study participants included 250 adults (64% women; mean age, 51.8 years) with co-occurring opioid misuse and chronic pain who were randomly allocated to receive MORE or supportive psychotherapy, which served as a control group.
Both interventions were delivered by trained clinical social workers in six primary care clinics in Utah to groups of 6-12 participants across 8 weekly 2-hour sessions.
The MORE intervention, detailed on Dr. Garland’s website, provides sequenced training in mindfulness, reappraisal, and savoring skills.
Mindfulness consisted of meditation on breathing and body sensations to strengthen self-regulation of compulsive opioid use and to mitigate pain and opioid craving by reinterpreting these experiences as innocuous sensory information.
Reappraisal consisted of reframing maladaptive thoughts to decrease negative emotions and engender meaning in life.
Savoring consisted of training in focusing awareness on pleasurable events and sensations to amplify positive emotions and reward.
Fewer depressive symptoms
Through 9 months of follow-up, the MORE group had about a twofold greater likelihood than the supportive psychotherapy group for reduction in opioid misuse (odds ratio [OR], 2.06; 95% confidence interval, 1.17-3.61; P = .01)
“MORE reduced opioid misuse by 45% 9 months after the end of treatment, more than doubling the effect of standard supportive psychotherapy and exceeding the effect size of other therapies for opioid misuse among people with chronic pain,” Dr. Garland said.
Members of the MORE group experienced greater reduction in pain severity and pain-related functional interference compared with members of the control group.
“MORE’s effect size on chronic pain symptoms was greater than that observed for CBT, the current gold standard psychological treatment for chronic pain,” Dr. Garland noted.
Compared with supportive psychotherapy, MORE decreased emotional distress, depressive symptoms, and real-time reports of opioid craving in daily life.
“Although nearly 70% of participants met criteria for depression at the beginning of the trial, on average, patients in MORE no longer exhibited symptoms consistent with major depressive disorder by the end of the study,” Dr. Garland said.
The current study builds on prior studies of MORE showing similar results, as reported previously by this news organization.
MORE can be successfully delivered in routine primary care, Dr. Garland noted. “In this trial, we delivered MORE in conference rooms, break rooms, and lunch rooms at community primary care clinics,” he added.
‘Powerful program’
To date, Dr. Garland has trained more than 450 physicians, nurses, social workers, and psychologists in health care systems across the country to implement MORE as an insurance-reimbursable group visit for patients in need.
One of them is Nancy Sudak, MD, chief well-being officer and director of integrative health, Essentia Health, Duluth, Minn.
“MORE is a very powerful program that teaches patients how to turn down the volume of their pain. I’ve been quite impressed by the power of MORE,” Dr. Sudak told this news organization
She noted that “buy-in” from patients is key – and the more a clinician knows a patient, the easier the buy-in.
“I recruited most of the patients in my groups from my own practice, so I already knew the patients quite well and there wasn’t really a need to sell it,” Dr. Sudak said.
“We have tried to operationalize it through our system and find that, as long as our recruitment techniques are robust enough, it’s not that hard to find patients to fill the groups, especially because chronic pain is just so common,” she added.
Dr. Sudak has found that patients who participate in MORE “bond and learn with each other and support each other. Patients love it, providers love it, and it’s a way to address isolation and loneliness” that can come with certain conditions.
“There are really only upsides to the group visit model and I think we’ll be seeing quite a bit more of it in the future,” she added.
Evidence-based data
Anna Parisi, PhD, is also delivering MORE to patients. She told this news organization, she was “really drawn” to the MORE program because oftentimes patients who require the most sophisticated therapies receive the ones with the least evidence.
This is often “what folks in the community are getting when they’re struggling with substance use,” added Dr. Parisi, a postdoctoral research associate working with Dr. Garland at the University of Utah. Dr. Parisi was not a coauthor on the current study.
“With MORE, all of the strategies and techniques are tied to mechanistic studies of their efficacy, so you know that what you’re delivering has a rationale behind it,” she said.
Like Dr. Sudak, Dr. Parisi said her patients, for the most part, have been receptive to the program. Although at first some were skeptical about mindfulness – with one patient using the term “tree-hugging” – they found immediate benefit even after the first session.
“That really helps them stay motivated to finish the program,” Dr. Parisi said.
This work was supported by a grant from the National Institute on Drug Abuse. Dr. Garland serves as director of the Center on Mindfulness and Integrative Health Intervention Development, which provides MORE, mindfulness-based therapy, and CBT in the context of research trials for no cost to research participants. He receives honoraria and payment for delivering seminars, lectures, and teaching engagements related to training clinicians in MORE and mindfulness and receives royalties from BehaVR and from the sales of books related to MORE outside the submitted work. Dr. Sudak and Dr. Parisi have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a randomized clinical trial, 250 adults with both opioid misuse and chronic pain received either the intervention, called mindfulness-oriented recovery enhancement (MORE), or supportive psychotherapy.
Results showed the first group was twice as likely to reduce opioid misuse after 9 months than the latter group.
The intervention was developed by Eric Garland, PhD, director of the Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), University of Utah, Salt Lake City. “As the largest and longest-term clinical trial of MORE ever conducted, this study definitively establishes the efficacy of MORE as a treatment for chronic pain and opioid misuse,” he told this news organization.
The findings were published online Feb. 28 in JAMA Internal Medicine.
Self-regulation
Study participants included 250 adults (64% women; mean age, 51.8 years) with co-occurring opioid misuse and chronic pain who were randomly allocated to receive MORE or supportive psychotherapy, which served as a control group.
Both interventions were delivered by trained clinical social workers in six primary care clinics in Utah to groups of 6-12 participants across 8 weekly 2-hour sessions.
The MORE intervention, detailed on Dr. Garland’s website, provides sequenced training in mindfulness, reappraisal, and savoring skills.
Mindfulness consisted of meditation on breathing and body sensations to strengthen self-regulation of compulsive opioid use and to mitigate pain and opioid craving by reinterpreting these experiences as innocuous sensory information.
Reappraisal consisted of reframing maladaptive thoughts to decrease negative emotions and engender meaning in life.
Savoring consisted of training in focusing awareness on pleasurable events and sensations to amplify positive emotions and reward.
Fewer depressive symptoms
Through 9 months of follow-up, the MORE group had about a twofold greater likelihood than the supportive psychotherapy group for reduction in opioid misuse (odds ratio [OR], 2.06; 95% confidence interval, 1.17-3.61; P = .01)
“MORE reduced opioid misuse by 45% 9 months after the end of treatment, more than doubling the effect of standard supportive psychotherapy and exceeding the effect size of other therapies for opioid misuse among people with chronic pain,” Dr. Garland said.
Members of the MORE group experienced greater reduction in pain severity and pain-related functional interference compared with members of the control group.
“MORE’s effect size on chronic pain symptoms was greater than that observed for CBT, the current gold standard psychological treatment for chronic pain,” Dr. Garland noted.
Compared with supportive psychotherapy, MORE decreased emotional distress, depressive symptoms, and real-time reports of opioid craving in daily life.
“Although nearly 70% of participants met criteria for depression at the beginning of the trial, on average, patients in MORE no longer exhibited symptoms consistent with major depressive disorder by the end of the study,” Dr. Garland said.
The current study builds on prior studies of MORE showing similar results, as reported previously by this news organization.
MORE can be successfully delivered in routine primary care, Dr. Garland noted. “In this trial, we delivered MORE in conference rooms, break rooms, and lunch rooms at community primary care clinics,” he added.
‘Powerful program’
To date, Dr. Garland has trained more than 450 physicians, nurses, social workers, and psychologists in health care systems across the country to implement MORE as an insurance-reimbursable group visit for patients in need.
One of them is Nancy Sudak, MD, chief well-being officer and director of integrative health, Essentia Health, Duluth, Minn.
“MORE is a very powerful program that teaches patients how to turn down the volume of their pain. I’ve been quite impressed by the power of MORE,” Dr. Sudak told this news organization
She noted that “buy-in” from patients is key – and the more a clinician knows a patient, the easier the buy-in.
“I recruited most of the patients in my groups from my own practice, so I already knew the patients quite well and there wasn’t really a need to sell it,” Dr. Sudak said.
“We have tried to operationalize it through our system and find that, as long as our recruitment techniques are robust enough, it’s not that hard to find patients to fill the groups, especially because chronic pain is just so common,” she added.
Dr. Sudak has found that patients who participate in MORE “bond and learn with each other and support each other. Patients love it, providers love it, and it’s a way to address isolation and loneliness” that can come with certain conditions.
“There are really only upsides to the group visit model and I think we’ll be seeing quite a bit more of it in the future,” she added.
Evidence-based data
Anna Parisi, PhD, is also delivering MORE to patients. She told this news organization, she was “really drawn” to the MORE program because oftentimes patients who require the most sophisticated therapies receive the ones with the least evidence.
This is often “what folks in the community are getting when they’re struggling with substance use,” added Dr. Parisi, a postdoctoral research associate working with Dr. Garland at the University of Utah. Dr. Parisi was not a coauthor on the current study.
“With MORE, all of the strategies and techniques are tied to mechanistic studies of their efficacy, so you know that what you’re delivering has a rationale behind it,” she said.
Like Dr. Sudak, Dr. Parisi said her patients, for the most part, have been receptive to the program. Although at first some were skeptical about mindfulness – with one patient using the term “tree-hugging” – they found immediate benefit even after the first session.
“That really helps them stay motivated to finish the program,” Dr. Parisi said.
This work was supported by a grant from the National Institute on Drug Abuse. Dr. Garland serves as director of the Center on Mindfulness and Integrative Health Intervention Development, which provides MORE, mindfulness-based therapy, and CBT in the context of research trials for no cost to research participants. He receives honoraria and payment for delivering seminars, lectures, and teaching engagements related to training clinicians in MORE and mindfulness and receives royalties from BehaVR and from the sales of books related to MORE outside the submitted work. Dr. Sudak and Dr. Parisi have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Practice guidelines highlights from past year
Based on the most recent Infectious Diseases Society of America (IDSA) guidelines, what would be the preferred therapy?
A) Metronidazole
B) Fidaxomicin + bezlotoxumab
C) Vancomycin
D) Fecal microbiota transplant
The recommendations from the 2021 guidelines would be to treat with fidaxomicin and add bezlotoxumab.1 The guidelines highlight the following changes:
- In patients with an initial Clostridioides difficile infections (CDI) fidaxomicin is preferred over vancomycin.
- In patients with a recurrent CDI episode, fidaxomicin is favored over vancomycin. For patients with multiple recurrences, vancomycin in a tapered and pulsed regimen, vancomycin followed by rifaximin, and fecal microbiota transplantation are options in addition to fidaxomicin.
- Addition of bezlotoxumab to standard of care antibiotics is recommended for recurrence of CDI within the first 6 months over standard of care antibiotics alone
The feasibility of these recommendations is up for debate. The cost of a course of fidaxomicin is $2,800, and the cost of bezlotoxumab is about $4,500. Cost effectiveness studies that helped drive the recommendations show a savings by reducing future hospitalizations for C. diff.2 Unfortunately, this enthusiasm is not shared by many insurance companies for outpatient treatment.
Knee osteoarthritis
I will save you the excitement of the new acromegaly guidelines and focus on something we see all the time: knee osteoarthritis. The American Academy of Orthopedic Surgeons has released guidelines for this condition.3 The useful points I found were as follows:
- Topical application of nonsteroidal anti-inflammatory drugs (e.g., diclofenac) should be used to improve function and quality of life in patients with knee osteoarthritis.
- Exercise routines (i.e, supervised, unsupervised, and/or aquatic) are recommended versus no exercise for improving pain and function in patients with knee osteoarthritis.
- Not recommended is the use of oral narcotics (including tramadol), as they are not effective at improving pain or function, and their use results in a significant increased risk of adverse events.
- Not recommended for routine use in symptomatic knee osteoarthritis is intra-articular injection of hyaluronic acid.
I was happy to see topical NSAIDS recommended, as they are a much safer option in older patients than oral NSAIDS (which were also recommended). The recommendation against narcotics, including tramadol, is a shift from the recommendation of tramadol in the 2013 guidelines.4 Acetaminophen was enthusiastically recommended, and is still worth a try.
Sexually transmitted infections
- The dosing for the treatment of gonorrhea has increased to 500 mg of ceftriaxone (was 250 mg in 2015 guidelines), with a dose of 1 gram for patients who weigh more than 150 kg.
- Chlamydia infections should be treated with a 7-day course of doxycycline as the preferred antibiotic, except in pregnant women (where azithromycin is recommended).
- Herpes simplex virus 2 recurrences can be treated with twice-daily dosing of 800 mg of acyclovir for 5 days, or acyclovir 800 mg three times a day for 2 days. The shortest course for recurrence is famciclovir 1 gram twice a day for 1 day.
- The Centers for Disease Control and Prevention has removed the recommendation for avoidance of alcohol when taking metronidazole.
I hope these highlights of guidelines for common issues we see are helpful!
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
References
1. Johnson S et al. Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused update guidelines on management of Clostridioides difficile Infection in adults. Clin Infect Dis. 2021 Sep 7;73(5):e1029-e1044.
2. Pabhu VS et al. Cost-effectiveness of bezlotoxumab compared with placebo for the prevention of recurrent Clostridium difficile infection. Clin Infect Dis. 2018 Feb 1;66(3):355-62.
3. American Academy of Orthopaedic Surgeons: Management of osteoarthritis of the knee (non-arthroplasty) – Evidence-based clinical practice guideline (2021 Aug 31. https://www.aaos.org/oak3cpg).
4. Jevsevar DS. Treatment of osteoarthritis of the knee: Evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013: Sep;21(9):571-6.
5. Sexually transmitted infections treatment guidelines, 2021 recommendations and reports. MMWR 2021 Jul 23;70(4):1-187.
Based on the most recent Infectious Diseases Society of America (IDSA) guidelines, what would be the preferred therapy?
A) Metronidazole
B) Fidaxomicin + bezlotoxumab
C) Vancomycin
D) Fecal microbiota transplant
The recommendations from the 2021 guidelines would be to treat with fidaxomicin and add bezlotoxumab.1 The guidelines highlight the following changes:
- In patients with an initial Clostridioides difficile infections (CDI) fidaxomicin is preferred over vancomycin.
- In patients with a recurrent CDI episode, fidaxomicin is favored over vancomycin. For patients with multiple recurrences, vancomycin in a tapered and pulsed regimen, vancomycin followed by rifaximin, and fecal microbiota transplantation are options in addition to fidaxomicin.
- Addition of bezlotoxumab to standard of care antibiotics is recommended for recurrence of CDI within the first 6 months over standard of care antibiotics alone
The feasibility of these recommendations is up for debate. The cost of a course of fidaxomicin is $2,800, and the cost of bezlotoxumab is about $4,500. Cost effectiveness studies that helped drive the recommendations show a savings by reducing future hospitalizations for C. diff.2 Unfortunately, this enthusiasm is not shared by many insurance companies for outpatient treatment.
Knee osteoarthritis
I will save you the excitement of the new acromegaly guidelines and focus on something we see all the time: knee osteoarthritis. The American Academy of Orthopedic Surgeons has released guidelines for this condition.3 The useful points I found were as follows:
- Topical application of nonsteroidal anti-inflammatory drugs (e.g., diclofenac) should be used to improve function and quality of life in patients with knee osteoarthritis.
- Exercise routines (i.e, supervised, unsupervised, and/or aquatic) are recommended versus no exercise for improving pain and function in patients with knee osteoarthritis.
- Not recommended is the use of oral narcotics (including tramadol), as they are not effective at improving pain or function, and their use results in a significant increased risk of adverse events.
- Not recommended for routine use in symptomatic knee osteoarthritis is intra-articular injection of hyaluronic acid.
I was happy to see topical NSAIDS recommended, as they are a much safer option in older patients than oral NSAIDS (which were also recommended). The recommendation against narcotics, including tramadol, is a shift from the recommendation of tramadol in the 2013 guidelines.4 Acetaminophen was enthusiastically recommended, and is still worth a try.
Sexually transmitted infections
- The dosing for the treatment of gonorrhea has increased to 500 mg of ceftriaxone (was 250 mg in 2015 guidelines), with a dose of 1 gram for patients who weigh more than 150 kg.
- Chlamydia infections should be treated with a 7-day course of doxycycline as the preferred antibiotic, except in pregnant women (where azithromycin is recommended).
- Herpes simplex virus 2 recurrences can be treated with twice-daily dosing of 800 mg of acyclovir for 5 days, or acyclovir 800 mg three times a day for 2 days. The shortest course for recurrence is famciclovir 1 gram twice a day for 1 day.
- The Centers for Disease Control and Prevention has removed the recommendation for avoidance of alcohol when taking metronidazole.
I hope these highlights of guidelines for common issues we see are helpful!
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
References
1. Johnson S et al. Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused update guidelines on management of Clostridioides difficile Infection in adults. Clin Infect Dis. 2021 Sep 7;73(5):e1029-e1044.
2. Pabhu VS et al. Cost-effectiveness of bezlotoxumab compared with placebo for the prevention of recurrent Clostridium difficile infection. Clin Infect Dis. 2018 Feb 1;66(3):355-62.
3. American Academy of Orthopaedic Surgeons: Management of osteoarthritis of the knee (non-arthroplasty) – Evidence-based clinical practice guideline (2021 Aug 31. https://www.aaos.org/oak3cpg).
4. Jevsevar DS. Treatment of osteoarthritis of the knee: Evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013: Sep;21(9):571-6.
5. Sexually transmitted infections treatment guidelines, 2021 recommendations and reports. MMWR 2021 Jul 23;70(4):1-187.
Based on the most recent Infectious Diseases Society of America (IDSA) guidelines, what would be the preferred therapy?
A) Metronidazole
B) Fidaxomicin + bezlotoxumab
C) Vancomycin
D) Fecal microbiota transplant
The recommendations from the 2021 guidelines would be to treat with fidaxomicin and add bezlotoxumab.1 The guidelines highlight the following changes:
- In patients with an initial Clostridioides difficile infections (CDI) fidaxomicin is preferred over vancomycin.
- In patients with a recurrent CDI episode, fidaxomicin is favored over vancomycin. For patients with multiple recurrences, vancomycin in a tapered and pulsed regimen, vancomycin followed by rifaximin, and fecal microbiota transplantation are options in addition to fidaxomicin.
- Addition of bezlotoxumab to standard of care antibiotics is recommended for recurrence of CDI within the first 6 months over standard of care antibiotics alone
The feasibility of these recommendations is up for debate. The cost of a course of fidaxomicin is $2,800, and the cost of bezlotoxumab is about $4,500. Cost effectiveness studies that helped drive the recommendations show a savings by reducing future hospitalizations for C. diff.2 Unfortunately, this enthusiasm is not shared by many insurance companies for outpatient treatment.
Knee osteoarthritis
I will save you the excitement of the new acromegaly guidelines and focus on something we see all the time: knee osteoarthritis. The American Academy of Orthopedic Surgeons has released guidelines for this condition.3 The useful points I found were as follows:
- Topical application of nonsteroidal anti-inflammatory drugs (e.g., diclofenac) should be used to improve function and quality of life in patients with knee osteoarthritis.
- Exercise routines (i.e, supervised, unsupervised, and/or aquatic) are recommended versus no exercise for improving pain and function in patients with knee osteoarthritis.
- Not recommended is the use of oral narcotics (including tramadol), as they are not effective at improving pain or function, and their use results in a significant increased risk of adverse events.
- Not recommended for routine use in symptomatic knee osteoarthritis is intra-articular injection of hyaluronic acid.
I was happy to see topical NSAIDS recommended, as they are a much safer option in older patients than oral NSAIDS (which were also recommended). The recommendation against narcotics, including tramadol, is a shift from the recommendation of tramadol in the 2013 guidelines.4 Acetaminophen was enthusiastically recommended, and is still worth a try.
Sexually transmitted infections
- The dosing for the treatment of gonorrhea has increased to 500 mg of ceftriaxone (was 250 mg in 2015 guidelines), with a dose of 1 gram for patients who weigh more than 150 kg.
- Chlamydia infections should be treated with a 7-day course of doxycycline as the preferred antibiotic, except in pregnant women (where azithromycin is recommended).
- Herpes simplex virus 2 recurrences can be treated with twice-daily dosing of 800 mg of acyclovir for 5 days, or acyclovir 800 mg three times a day for 2 days. The shortest course for recurrence is famciclovir 1 gram twice a day for 1 day.
- The Centers for Disease Control and Prevention has removed the recommendation for avoidance of alcohol when taking metronidazole.
I hope these highlights of guidelines for common issues we see are helpful!
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
References
1. Johnson S et al. Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused update guidelines on management of Clostridioides difficile Infection in adults. Clin Infect Dis. 2021 Sep 7;73(5):e1029-e1044.
2. Pabhu VS et al. Cost-effectiveness of bezlotoxumab compared with placebo for the prevention of recurrent Clostridium difficile infection. Clin Infect Dis. 2018 Feb 1;66(3):355-62.
3. American Academy of Orthopaedic Surgeons: Management of osteoarthritis of the knee (non-arthroplasty) – Evidence-based clinical practice guideline (2021 Aug 31. https://www.aaos.org/oak3cpg).
4. Jevsevar DS. Treatment of osteoarthritis of the knee: Evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013: Sep;21(9):571-6.
5. Sexually transmitted infections treatment guidelines, 2021 recommendations and reports. MMWR 2021 Jul 23;70(4):1-187.
Epidural may lower odds of severe maternal birth complications
Use of neuraxial analgesia for vaginal delivery is associated with a 14% decreased risk for severe maternal morbidity, in part from a reduction in postpartum hemorrhage, new research shows.
The findings indicate that increasing the use of epidural or combined spinal-epidural analgesia may improve maternal health outcomes, especially for Hispanic, Black, and uninsured women who are less likely than White women to receive these interventions, according to the researchers, who published their findings online in JAMA Network Open.
About 80% of non-Hispanic White women receive neuraxial analgesia during labor in the United States, compared with 70% of non-Hispanic Black women and 65% of Hispanic women, according to birth certificate data. Among women without health insurance, half receive epidurals.
Programs that inform pregnant women about epidural use, expand Medicaid, and provide in-house obstetric anesthesia teams “may improve patient participation in clinical decision making and access to care,” study author Guohua Li, MD, DrPH, of Columbia University, New York, said in a statement about the research.
Earlier data from France showed that neuraxial analgesia is associated with reduced risk for severe postpartum hemorrhage. To examine the association between labor neuraxial analgesia and severe maternal morbidity in the United States, Dr. Li and colleagues analyzed more than 575,000 vaginal deliveries in New York hospitals between 2010 and 2017; about half (47.4%) of the women received epidurals during labor.
The researchers focused on severe maternal morbidity, including 16 complications, such as heart failure and sepsis, and five procedures, including hysterectomy and ventilation.
They also considered patient characteristics and comorbidities and hospital-related factors to identify patients who were at higher risk for injury or death.
Severe maternal morbidity occurred in 1.3% of the women. Of the 7,712 women with severe morbidity, more than one in three (35.6%) experienced postpartum hemorrhage.
The overall incidence of severe maternal morbidity was 1.3% among women who received an epidural injection and 1.4% among those who did not. In a weighted analysis, the adjusted odds ratio of severe maternal morbidity associated with epidurals was 0.86 (95% confidence interval, 0.82-0.90).
The study is limited by its observational design and does not prove causation, the authors acknowledged.
“Labor neuraxial analgesia may facilitate early evaluation and management of the third stage of labor to avoid escalation of postpartum hemorrhaging into grave complications and death,” study author Jean Guglielminotti, MD, PhD, an anesthesiologist at Columbia University, said in a statement.
Concerning trends
The Department of Health & Human Services has labeled severe maternal morbidity a public health priority. Recent data from the Centers for Disease Control and Prevention show an increase in maternal mortality rates and worsening disparities by race and ethnicity.
According to the CDC, 861 women died of maternal causes in 2020, up from 754 in 2019. The rate of maternal mortality increased from 20.1 to 23.8 deaths per 100,000 live births.
For Black women, however, the maternal mortality rate was far higher: 55.3 deaths per 100,000 live births – nearly triple the figure of 19.1 per 100,000 for White women. Between 2019 and 2020, the mortality rate increased significantly for Black and Hispanic women, but not White mothers.
Researchers affiliated with University of Toronto and the Hospital for Sick Children agreed in an accompanying editorial that more access to neuraxial labor analgesia for vaginal delivery might improve maternal health outcomes and “may be a strategy well worth pursuing in public health policy.”
The intervention is relatively safe and can “alleviate discomfort and distress,” they wrote.
Neuraxial anesthesia in surgical procedures has been shown to decrease the risk for complications like deep vein thrombosis, pulmonary embolus, transfusion requirements, and kidney failure, said editorialists Evelina Pankiv, MD; Alan Yang, MSc; and Kazuyoshi Aoyama, MD, PhD.
Benefits potentially could stem from improving blood flow, mitigating hypercoagulation, or reducing surgical stress response. But there are rare risks to consider as well, including hemorrhage, infection, and neurologic injury, they added.
Guglielminotti disclosed grants from the National Institute on Minority Health and Health Disparities. Dr. Aoyama reported receiving grants from the Perioperative Services Facilitator Grant Program and Hospital for Sick Children. The other authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Use of neuraxial analgesia for vaginal delivery is associated with a 14% decreased risk for severe maternal morbidity, in part from a reduction in postpartum hemorrhage, new research shows.
The findings indicate that increasing the use of epidural or combined spinal-epidural analgesia may improve maternal health outcomes, especially for Hispanic, Black, and uninsured women who are less likely than White women to receive these interventions, according to the researchers, who published their findings online in JAMA Network Open.
About 80% of non-Hispanic White women receive neuraxial analgesia during labor in the United States, compared with 70% of non-Hispanic Black women and 65% of Hispanic women, according to birth certificate data. Among women without health insurance, half receive epidurals.
Programs that inform pregnant women about epidural use, expand Medicaid, and provide in-house obstetric anesthesia teams “may improve patient participation in clinical decision making and access to care,” study author Guohua Li, MD, DrPH, of Columbia University, New York, said in a statement about the research.
Earlier data from France showed that neuraxial analgesia is associated with reduced risk for severe postpartum hemorrhage. To examine the association between labor neuraxial analgesia and severe maternal morbidity in the United States, Dr. Li and colleagues analyzed more than 575,000 vaginal deliveries in New York hospitals between 2010 and 2017; about half (47.4%) of the women received epidurals during labor.
The researchers focused on severe maternal morbidity, including 16 complications, such as heart failure and sepsis, and five procedures, including hysterectomy and ventilation.
They also considered patient characteristics and comorbidities and hospital-related factors to identify patients who were at higher risk for injury or death.
Severe maternal morbidity occurred in 1.3% of the women. Of the 7,712 women with severe morbidity, more than one in three (35.6%) experienced postpartum hemorrhage.
The overall incidence of severe maternal morbidity was 1.3% among women who received an epidural injection and 1.4% among those who did not. In a weighted analysis, the adjusted odds ratio of severe maternal morbidity associated with epidurals was 0.86 (95% confidence interval, 0.82-0.90).
The study is limited by its observational design and does not prove causation, the authors acknowledged.
“Labor neuraxial analgesia may facilitate early evaluation and management of the third stage of labor to avoid escalation of postpartum hemorrhaging into grave complications and death,” study author Jean Guglielminotti, MD, PhD, an anesthesiologist at Columbia University, said in a statement.
Concerning trends
The Department of Health & Human Services has labeled severe maternal morbidity a public health priority. Recent data from the Centers for Disease Control and Prevention show an increase in maternal mortality rates and worsening disparities by race and ethnicity.
According to the CDC, 861 women died of maternal causes in 2020, up from 754 in 2019. The rate of maternal mortality increased from 20.1 to 23.8 deaths per 100,000 live births.
For Black women, however, the maternal mortality rate was far higher: 55.3 deaths per 100,000 live births – nearly triple the figure of 19.1 per 100,000 for White women. Between 2019 and 2020, the mortality rate increased significantly for Black and Hispanic women, but not White mothers.
Researchers affiliated with University of Toronto and the Hospital for Sick Children agreed in an accompanying editorial that more access to neuraxial labor analgesia for vaginal delivery might improve maternal health outcomes and “may be a strategy well worth pursuing in public health policy.”
The intervention is relatively safe and can “alleviate discomfort and distress,” they wrote.
Neuraxial anesthesia in surgical procedures has been shown to decrease the risk for complications like deep vein thrombosis, pulmonary embolus, transfusion requirements, and kidney failure, said editorialists Evelina Pankiv, MD; Alan Yang, MSc; and Kazuyoshi Aoyama, MD, PhD.
Benefits potentially could stem from improving blood flow, mitigating hypercoagulation, or reducing surgical stress response. But there are rare risks to consider as well, including hemorrhage, infection, and neurologic injury, they added.
Guglielminotti disclosed grants from the National Institute on Minority Health and Health Disparities. Dr. Aoyama reported receiving grants from the Perioperative Services Facilitator Grant Program and Hospital for Sick Children. The other authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Use of neuraxial analgesia for vaginal delivery is associated with a 14% decreased risk for severe maternal morbidity, in part from a reduction in postpartum hemorrhage, new research shows.
The findings indicate that increasing the use of epidural or combined spinal-epidural analgesia may improve maternal health outcomes, especially for Hispanic, Black, and uninsured women who are less likely than White women to receive these interventions, according to the researchers, who published their findings online in JAMA Network Open.
About 80% of non-Hispanic White women receive neuraxial analgesia during labor in the United States, compared with 70% of non-Hispanic Black women and 65% of Hispanic women, according to birth certificate data. Among women without health insurance, half receive epidurals.
Programs that inform pregnant women about epidural use, expand Medicaid, and provide in-house obstetric anesthesia teams “may improve patient participation in clinical decision making and access to care,” study author Guohua Li, MD, DrPH, of Columbia University, New York, said in a statement about the research.
Earlier data from France showed that neuraxial analgesia is associated with reduced risk for severe postpartum hemorrhage. To examine the association between labor neuraxial analgesia and severe maternal morbidity in the United States, Dr. Li and colleagues analyzed more than 575,000 vaginal deliveries in New York hospitals between 2010 and 2017; about half (47.4%) of the women received epidurals during labor.
The researchers focused on severe maternal morbidity, including 16 complications, such as heart failure and sepsis, and five procedures, including hysterectomy and ventilation.
They also considered patient characteristics and comorbidities and hospital-related factors to identify patients who were at higher risk for injury or death.
Severe maternal morbidity occurred in 1.3% of the women. Of the 7,712 women with severe morbidity, more than one in three (35.6%) experienced postpartum hemorrhage.
The overall incidence of severe maternal morbidity was 1.3% among women who received an epidural injection and 1.4% among those who did not. In a weighted analysis, the adjusted odds ratio of severe maternal morbidity associated with epidurals was 0.86 (95% confidence interval, 0.82-0.90).
The study is limited by its observational design and does not prove causation, the authors acknowledged.
“Labor neuraxial analgesia may facilitate early evaluation and management of the third stage of labor to avoid escalation of postpartum hemorrhaging into grave complications and death,” study author Jean Guglielminotti, MD, PhD, an anesthesiologist at Columbia University, said in a statement.
Concerning trends
The Department of Health & Human Services has labeled severe maternal morbidity a public health priority. Recent data from the Centers for Disease Control and Prevention show an increase in maternal mortality rates and worsening disparities by race and ethnicity.
According to the CDC, 861 women died of maternal causes in 2020, up from 754 in 2019. The rate of maternal mortality increased from 20.1 to 23.8 deaths per 100,000 live births.
For Black women, however, the maternal mortality rate was far higher: 55.3 deaths per 100,000 live births – nearly triple the figure of 19.1 per 100,000 for White women. Between 2019 and 2020, the mortality rate increased significantly for Black and Hispanic women, but not White mothers.
Researchers affiliated with University of Toronto and the Hospital for Sick Children agreed in an accompanying editorial that more access to neuraxial labor analgesia for vaginal delivery might improve maternal health outcomes and “may be a strategy well worth pursuing in public health policy.”
The intervention is relatively safe and can “alleviate discomfort and distress,” they wrote.
Neuraxial anesthesia in surgical procedures has been shown to decrease the risk for complications like deep vein thrombosis, pulmonary embolus, transfusion requirements, and kidney failure, said editorialists Evelina Pankiv, MD; Alan Yang, MSc; and Kazuyoshi Aoyama, MD, PhD.
Benefits potentially could stem from improving blood flow, mitigating hypercoagulation, or reducing surgical stress response. But there are rare risks to consider as well, including hemorrhage, infection, and neurologic injury, they added.
Guglielminotti disclosed grants from the National Institute on Minority Health and Health Disparities. Dr. Aoyama reported receiving grants from the Perioperative Services Facilitator Grant Program and Hospital for Sick Children. The other authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Rheumatology patients seek guidance on CBD, cannabis products
Although there is a lack of evidence for use of cannabidiol (CBD) products and cannabis in rheumatology, many patients are using them anyway and want to discuss the use of these products with their rheumatologists, according to a speaker at the 2022 Rheumatology Winter Clinical Symposium.
While cannabis is still regulated as a Schedule I drug in the United States, CBD products are “all over the place,” Orrin Troum, MD, a rheumatologist at the University of Southern California, Los Angeles, said in his presentation. “You can get it at the pharmacy; you can get it at the dispensaries.”
Patients in rheumatology are also increasingly using cannabis across the United States, Dr. Troum said. In an abstract from the 2019 American College of Rheumatology annual meeting, researchers examined data from FORWARD, the National Databank for Rheumatic Diseases, and found 17.6% of 11,006 respondents reported using cannabis in 2017, an increase from 6.3% of respondents in 2014.
“Putting your personal biases aside, you have to be able to discuss this, and I try to do that openly with my patients,” he said.
According to a 2018 report from the World Health Organization, CBD is “generally well tolerated with a good safety profile.” While CBD itself is safe, CBD products offered over the counter as pills, lotions, foods, drinks, shampoos, cosmetics, oils, and other products carry the risk of being manufactured with “unverified contents” because they are not subject to regulatory oversight.
“There may be heavy metals, pesticides, microbes, [and] mycotoxins that are in these substances that you’re recommending to patients,” Dr. Troum said. There may also be tetrahydrocannabinol (THC) in certain CBD products, he added. Other concerns about CBD products include potential drug-drug interactions with medications used in rheumatology, and potential inhibition of drug metabolism through the CYP450 pathway.
Rheumatologists should be careful when recommending CBD products for this reason, Dr. Troum cautioned. In the absence of products approved by the Food and Drug Administration, “try to get at least products that have a good manufacturing practices certification.”
Dr. Troum highlighted the additional problem of dispensaries recommending specific products, and emphasized that treatment shouldn’t be managed by dispensary personnel without a medical background. “Our patients are being promoted this, either from the dispensaries or even in some clinicians’ offices, without the real true knowledge as to what we’re dealing with,” he said.
Evidence of health effects of CBD, cannabis
When it comes to actual evidence of clinical benefit, “I can tell you there’s lacking data for the majority of what we’re being asked every day in our practices,” Dr. Troum said.
The greatest evidence for the health benefits of cannabinoids appears to be for chronic pain, according to a 2017 report from the National Academies of Sciences, Engineering, and Medicine. Within rheumatology, a position statement released by the Canadian Rheumatology Association in 2019 found insufficient evidence to recommend cannabinoids for use in fibromyalgia, osteoarthritis, RA, or back pain, but acknowledged medical cannabis may relieve symptoms based on evidence from other conditions.
There is some preliminary evidence that cannabis can be used as a substitute for opioids when treating chronic pain, to improve symptoms of fibromyalgia and inflammatory bowel disease, and although a trial of patients with Crohn’s disease failed its primary outcome of disease remission, 10 of 11 patients who smoked cigarettes with THC saw significant improvements in clinical outcomes (P = .028).
In RA, “clinical research focusing on the cannabinoids’ disease-modifying qualities is still lacking,” Dr. Troum said, although an active randomized, controlled trial led by researchers at the University of California, Los Angeles, is testing patients for clinical response to CBD. A separate randomized, double-blind, placebo-controlled trial in Denmark is evaluating whether CBD, followed by open-label add-on of THC, improves chronic pain for patients with RA or ankylosing spondylitis.
The lack of data in this area largely has to do with how cannabis is regulated at the federal level and the differing regulations between U.S. states. “There’s a lot of hurdles you have to go through, and therefore, I think, really has decreased the availability of good studies,” he said.
Overarching principles for medical cannabis in rheumatology
For the rheumatologist counseling a patient who either is self-medicating or wants to start using medical cannabis, the Canadian Rheumatology Association created overarching principles as part of their position statement to guide decision-making for clinicians.
First, clinicians should know that cannabis shouldn’t be used as an alternative treatment for standard of care in rheumatology, and the CRA noted that patients aged under 25 years should not use cannabis. CRA also recommended that clinicians try currently available treatment strategies for common reasons patients seek to use medical cannabis, such as pain relief or a sleep aid, before attempting to use medical cannabis. The CRA noted long-term effects of medical cannabis are not known for patients with rheumatic diseases.
In an interview, Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, and director of RWCS, said that CBD and cannabis “come up quite frequently” at his clinic. “Many patients have already tried CBD, especially the topical formulation, prior to discussing it with me. In general, I do not dissuade patients from trying CBD, especially topical.”
Typically, he said his practice situation gives him access to a counselor from the anesthesia department with “significant expertise” in dosing and formulations. “It would be great if there were proper controlled trials of specific formulations to allow us to have real scientific data that may help the patients make optimal choices.”
One issue that is brought up by patients is cost. “These preparations can be relatively expensive,” Dr. Kavanaugh said, but noted that this is also a consideration when patients decide to use any therapy.
Dr. Troum reported having financial relationships with eight pharmaceutical companies.
Although there is a lack of evidence for use of cannabidiol (CBD) products and cannabis in rheumatology, many patients are using them anyway and want to discuss the use of these products with their rheumatologists, according to a speaker at the 2022 Rheumatology Winter Clinical Symposium.
While cannabis is still regulated as a Schedule I drug in the United States, CBD products are “all over the place,” Orrin Troum, MD, a rheumatologist at the University of Southern California, Los Angeles, said in his presentation. “You can get it at the pharmacy; you can get it at the dispensaries.”
Patients in rheumatology are also increasingly using cannabis across the United States, Dr. Troum said. In an abstract from the 2019 American College of Rheumatology annual meeting, researchers examined data from FORWARD, the National Databank for Rheumatic Diseases, and found 17.6% of 11,006 respondents reported using cannabis in 2017, an increase from 6.3% of respondents in 2014.
“Putting your personal biases aside, you have to be able to discuss this, and I try to do that openly with my patients,” he said.
According to a 2018 report from the World Health Organization, CBD is “generally well tolerated with a good safety profile.” While CBD itself is safe, CBD products offered over the counter as pills, lotions, foods, drinks, shampoos, cosmetics, oils, and other products carry the risk of being manufactured with “unverified contents” because they are not subject to regulatory oversight.
“There may be heavy metals, pesticides, microbes, [and] mycotoxins that are in these substances that you’re recommending to patients,” Dr. Troum said. There may also be tetrahydrocannabinol (THC) in certain CBD products, he added. Other concerns about CBD products include potential drug-drug interactions with medications used in rheumatology, and potential inhibition of drug metabolism through the CYP450 pathway.
Rheumatologists should be careful when recommending CBD products for this reason, Dr. Troum cautioned. In the absence of products approved by the Food and Drug Administration, “try to get at least products that have a good manufacturing practices certification.”
Dr. Troum highlighted the additional problem of dispensaries recommending specific products, and emphasized that treatment shouldn’t be managed by dispensary personnel without a medical background. “Our patients are being promoted this, either from the dispensaries or even in some clinicians’ offices, without the real true knowledge as to what we’re dealing with,” he said.
Evidence of health effects of CBD, cannabis
When it comes to actual evidence of clinical benefit, “I can tell you there’s lacking data for the majority of what we’re being asked every day in our practices,” Dr. Troum said.
The greatest evidence for the health benefits of cannabinoids appears to be for chronic pain, according to a 2017 report from the National Academies of Sciences, Engineering, and Medicine. Within rheumatology, a position statement released by the Canadian Rheumatology Association in 2019 found insufficient evidence to recommend cannabinoids for use in fibromyalgia, osteoarthritis, RA, or back pain, but acknowledged medical cannabis may relieve symptoms based on evidence from other conditions.
There is some preliminary evidence that cannabis can be used as a substitute for opioids when treating chronic pain, to improve symptoms of fibromyalgia and inflammatory bowel disease, and although a trial of patients with Crohn’s disease failed its primary outcome of disease remission, 10 of 11 patients who smoked cigarettes with THC saw significant improvements in clinical outcomes (P = .028).
In RA, “clinical research focusing on the cannabinoids’ disease-modifying qualities is still lacking,” Dr. Troum said, although an active randomized, controlled trial led by researchers at the University of California, Los Angeles, is testing patients for clinical response to CBD. A separate randomized, double-blind, placebo-controlled trial in Denmark is evaluating whether CBD, followed by open-label add-on of THC, improves chronic pain for patients with RA or ankylosing spondylitis.
The lack of data in this area largely has to do with how cannabis is regulated at the federal level and the differing regulations between U.S. states. “There’s a lot of hurdles you have to go through, and therefore, I think, really has decreased the availability of good studies,” he said.
Overarching principles for medical cannabis in rheumatology
For the rheumatologist counseling a patient who either is self-medicating or wants to start using medical cannabis, the Canadian Rheumatology Association created overarching principles as part of their position statement to guide decision-making for clinicians.
First, clinicians should know that cannabis shouldn’t be used as an alternative treatment for standard of care in rheumatology, and the CRA noted that patients aged under 25 years should not use cannabis. CRA also recommended that clinicians try currently available treatment strategies for common reasons patients seek to use medical cannabis, such as pain relief or a sleep aid, before attempting to use medical cannabis. The CRA noted long-term effects of medical cannabis are not known for patients with rheumatic diseases.
In an interview, Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, and director of RWCS, said that CBD and cannabis “come up quite frequently” at his clinic. “Many patients have already tried CBD, especially the topical formulation, prior to discussing it with me. In general, I do not dissuade patients from trying CBD, especially topical.”
Typically, he said his practice situation gives him access to a counselor from the anesthesia department with “significant expertise” in dosing and formulations. “It would be great if there were proper controlled trials of specific formulations to allow us to have real scientific data that may help the patients make optimal choices.”
One issue that is brought up by patients is cost. “These preparations can be relatively expensive,” Dr. Kavanaugh said, but noted that this is also a consideration when patients decide to use any therapy.
Dr. Troum reported having financial relationships with eight pharmaceutical companies.
Although there is a lack of evidence for use of cannabidiol (CBD) products and cannabis in rheumatology, many patients are using them anyway and want to discuss the use of these products with their rheumatologists, according to a speaker at the 2022 Rheumatology Winter Clinical Symposium.
While cannabis is still regulated as a Schedule I drug in the United States, CBD products are “all over the place,” Orrin Troum, MD, a rheumatologist at the University of Southern California, Los Angeles, said in his presentation. “You can get it at the pharmacy; you can get it at the dispensaries.”
Patients in rheumatology are also increasingly using cannabis across the United States, Dr. Troum said. In an abstract from the 2019 American College of Rheumatology annual meeting, researchers examined data from FORWARD, the National Databank for Rheumatic Diseases, and found 17.6% of 11,006 respondents reported using cannabis in 2017, an increase from 6.3% of respondents in 2014.
“Putting your personal biases aside, you have to be able to discuss this, and I try to do that openly with my patients,” he said.
According to a 2018 report from the World Health Organization, CBD is “generally well tolerated with a good safety profile.” While CBD itself is safe, CBD products offered over the counter as pills, lotions, foods, drinks, shampoos, cosmetics, oils, and other products carry the risk of being manufactured with “unverified contents” because they are not subject to regulatory oversight.
“There may be heavy metals, pesticides, microbes, [and] mycotoxins that are in these substances that you’re recommending to patients,” Dr. Troum said. There may also be tetrahydrocannabinol (THC) in certain CBD products, he added. Other concerns about CBD products include potential drug-drug interactions with medications used in rheumatology, and potential inhibition of drug metabolism through the CYP450 pathway.
Rheumatologists should be careful when recommending CBD products for this reason, Dr. Troum cautioned. In the absence of products approved by the Food and Drug Administration, “try to get at least products that have a good manufacturing practices certification.”
Dr. Troum highlighted the additional problem of dispensaries recommending specific products, and emphasized that treatment shouldn’t be managed by dispensary personnel without a medical background. “Our patients are being promoted this, either from the dispensaries or even in some clinicians’ offices, without the real true knowledge as to what we’re dealing with,” he said.
Evidence of health effects of CBD, cannabis
When it comes to actual evidence of clinical benefit, “I can tell you there’s lacking data for the majority of what we’re being asked every day in our practices,” Dr. Troum said.
The greatest evidence for the health benefits of cannabinoids appears to be for chronic pain, according to a 2017 report from the National Academies of Sciences, Engineering, and Medicine. Within rheumatology, a position statement released by the Canadian Rheumatology Association in 2019 found insufficient evidence to recommend cannabinoids for use in fibromyalgia, osteoarthritis, RA, or back pain, but acknowledged medical cannabis may relieve symptoms based on evidence from other conditions.
There is some preliminary evidence that cannabis can be used as a substitute for opioids when treating chronic pain, to improve symptoms of fibromyalgia and inflammatory bowel disease, and although a trial of patients with Crohn’s disease failed its primary outcome of disease remission, 10 of 11 patients who smoked cigarettes with THC saw significant improvements in clinical outcomes (P = .028).
In RA, “clinical research focusing on the cannabinoids’ disease-modifying qualities is still lacking,” Dr. Troum said, although an active randomized, controlled trial led by researchers at the University of California, Los Angeles, is testing patients for clinical response to CBD. A separate randomized, double-blind, placebo-controlled trial in Denmark is evaluating whether CBD, followed by open-label add-on of THC, improves chronic pain for patients with RA or ankylosing spondylitis.
The lack of data in this area largely has to do with how cannabis is regulated at the federal level and the differing regulations between U.S. states. “There’s a lot of hurdles you have to go through, and therefore, I think, really has decreased the availability of good studies,” he said.
Overarching principles for medical cannabis in rheumatology
For the rheumatologist counseling a patient who either is self-medicating or wants to start using medical cannabis, the Canadian Rheumatology Association created overarching principles as part of their position statement to guide decision-making for clinicians.
First, clinicians should know that cannabis shouldn’t be used as an alternative treatment for standard of care in rheumatology, and the CRA noted that patients aged under 25 years should not use cannabis. CRA also recommended that clinicians try currently available treatment strategies for common reasons patients seek to use medical cannabis, such as pain relief or a sleep aid, before attempting to use medical cannabis. The CRA noted long-term effects of medical cannabis are not known for patients with rheumatic diseases.
In an interview, Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, and director of RWCS, said that CBD and cannabis “come up quite frequently” at his clinic. “Many patients have already tried CBD, especially the topical formulation, prior to discussing it with me. In general, I do not dissuade patients from trying CBD, especially topical.”
Typically, he said his practice situation gives him access to a counselor from the anesthesia department with “significant expertise” in dosing and formulations. “It would be great if there were proper controlled trials of specific formulations to allow us to have real scientific data that may help the patients make optimal choices.”
One issue that is brought up by patients is cost. “These preparations can be relatively expensive,” Dr. Kavanaugh said, but noted that this is also a consideration when patients decide to use any therapy.
Dr. Troum reported having financial relationships with eight pharmaceutical companies.
FROM RWCS 2022
