The Roman Catholic Church continues to be rocked by the burgeoning reality of priests as sexual predators. Some Catholics, including the Pope, have stepped up and acknowledged the blame for the decades of abuse, but others have been less inclined to do so. The latter attitude was and still is crushing to some the victims.

“Being raised Catholic, I remember – you don’t speak out against your own church,” Jim VanSickle says in an interview with National Catholic Reporter. “Nobody’s going to listen to you.”

Many of the survivors, Mr. VanSickle included, belonged to very conservative parishes. Parishioners often showed no compassion. After being sexually assaulted at age 16, he suffered in silence for almost 4 decades before speaking out during the recent release of Grand Jury report on the church abuses by the Pennsylvania attorney general.

“I’ve known others [who] came forward. They were ridiculed and ostracized – even by their own family members,” Mr. VanSickle says.

“We lived in a neighborhood where most of the people in the subdivision were Catholic. Everything in our lives revolved around the church,” said another victim, Utah resident Judy Larson. To be in that kind of environment and try to say something horrible happened to you, by a person everybody thinks is a god on earth, you’re all alone.”

As reported by Zita Ballinger Fletcher of the Catholic News Service, “survivors also faced a stigma caused by sexual assault. The victims were molested at an age when they did not know about sex. Confused, they realized what happened when they grew up. Feeling disgust, anger, and shame, they feared hostile reactions from their traditional communities.”

The childhood horror has left many of the victims angry and disillusioned with the Catholic Church.

“People say, ‘You’re a bad person,’ ” Mr. VanSickle says. “It’s amazing that they attack their own people. They attack their own faithful.”

Click here to read about the challenges faced by these survivors.

The Roman Catholic Church continues to be rocked by the burgeoning reality of priests as sexual predators. Some Catholics, including the Pope, have stepped up and acknowledged the blame for the decades of abuse, but others have been less inclined to do so. The latter attitude was and still is crushing to some the victims.

“Being raised Catholic, I remember – you don’t speak out against your own church,” Jim VanSickle says in an interview with National Catholic Reporter. “Nobody’s going to listen to you.”

Many of the survivors, Mr. VanSickle included, belonged to very conservative parishes. Parishioners often showed no compassion. After being sexually assaulted at age 16, he suffered in silence for almost 4 decades before speaking out during the recent release of Grand Jury report on the church abuses by the Pennsylvania attorney general.

“I’ve known others [who] came forward. They were ridiculed and ostracized – even by their own family members,” Mr. VanSickle says.

“We lived in a neighborhood where most of the people in the subdivision were Catholic. Everything in our lives revolved around the church,” said another victim, Utah resident Judy Larson. To be in that kind of environment and try to say something horrible happened to you, by a person everybody thinks is a god on earth, you’re all alone.”

As reported by Zita Ballinger Fletcher of the Catholic News Service, “survivors also faced a stigma caused by sexual assault. The victims were molested at an age when they did not know about sex. Confused, they realized what happened when they grew up. Feeling disgust, anger, and shame, they feared hostile reactions from their traditional communities.”

The childhood horror has left many of the victims angry and disillusioned with the Catholic Church.

“People say, ‘You’re a bad person,’ ” Mr. VanSickle says. “It’s amazing that they attack their own people. They attack their own faithful.”

Click here to read about the challenges faced by these survivors.

The Roman Catholic Church continues to be rocked by the burgeoning reality of priests as sexual predators. Some Catholics, including the Pope, have stepped up and acknowledged the blame for the decades of abuse, but others have been less inclined to do so. The latter attitude was and still is crushing to some the victims.

“Being raised Catholic, I remember – you don’t speak out against your own church,” Jim VanSickle says in an interview with National Catholic Reporter. “Nobody’s going to listen to you.”

Many of the survivors, Mr. VanSickle included, belonged to very conservative parishes. Parishioners often showed no compassion. After being sexually assaulted at age 16, he suffered in silence for almost 4 decades before speaking out during the recent release of Grand Jury report on the church abuses by the Pennsylvania attorney general.

“I’ve known others [who] came forward. They were ridiculed and ostracized – even by their own family members,” Mr. VanSickle says.

“We lived in a neighborhood where most of the people in the subdivision were Catholic. Everything in our lives revolved around the church,” said another victim, Utah resident Judy Larson. To be in that kind of environment and try to say something horrible happened to you, by a person everybody thinks is a god on earth, you’re all alone.”

As reported by Zita Ballinger Fletcher of the Catholic News Service, “survivors also faced a stigma caused by sexual assault. The victims were molested at an age when they did not know about sex. Confused, they realized what happened when they grew up. Feeling disgust, anger, and shame, they feared hostile reactions from their traditional communities.”

The childhood horror has left many of the victims angry and disillusioned with the Catholic Church.

“People say, ‘You’re a bad person,’ ” Mr. VanSickle says. “It’s amazing that they attack their own people. They attack their own faithful.”

Click here to read about the challenges faced by these survivors.

MUNICH – The big news in the field of heart failure at the annual congress of the European Society of Cardiology concerned an obscure form of the disease traditionally considered rare: transthyretin amyloid cardiomyopathy (TAC).

Bruce Jancin/MDedge News

It turns out that TAC is far more common than previously recognized; it can now be diagnosed and staged noninvasively; and – most important of all – there is for the first time an effective disease-modifying treatment in the form of a novel oral drug called tafamidis, as demonstrated in the Transthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT) presented at the meeting.

“This is the first phase 3 trial that can offer a chance for people with a terrible, severe disease. And within the last year, while the trial was being conducted, it became clear that this disease is much more underdiagnosed than rare,” said Claudio Rapezzi, MD, ATTR-ACT principal investigator and director of the school of cardiovascular diseases at the University of Bologna, Italy.

ATTR-ACT participants randomized to tafamidis showed significant reductions in all-cause mortality and cardiovascular hospitalizations, compared with placebo-treated controls at 30 months follow-up. They also experienced significantly lesser declines in both quality of life as reflected in Kansas City Cardiomyopathy Questionnaire scores and in physical function as captured in 6-minute walk distance.

Bruce Jancin/MDedge News

Designated discussant Jacob George, MD, was over the moon regarding the results.

“This is a pioneering, game-changing trial that is likely to transform the way we diagnose and treat patients with cardiac amyloidosis,” said Dr. George of Kaplan Medical Center in Rehovot, Israel.

“We’re now in an era that, to my opinion, any patient with nonischemic unexplained heart failure should be screened for the presence of amyloidosis because, first, we now know how to prognosticate these patients, and second, we can offer them a real disease-modifying agent,” he added.
 

An underdiagnosed disease

Transthyretin amyloid cardiomyopathy occurs when transthyretin, a transport protein, becomes destabilized and misfolds, promoting deposition of amyloid fibrils in the myocardium. This results in progressive ventricular wall thickening and stiffness, manifest as restrictive cardiomyopathy and progressive heart failure. The cause of transthyretin destabilization can be either autosomal dominant inheritance of any of more than 100 pathogenic mutations in the transthyretin gene identified to date or a spontaneous wild type protein.

Think of TAC as a sort of dementia of the heart. As Dr. George noted, the cardiac disease bears “remarkable similarities” to Alzheimer’s disease, with both conditions entailing extracellular deposition of amyloid.

In the heritable form of TAC, patients typically present with heart failure symptoms at about age 50-55, while the wild type form becomes symptomatic much later at a mean age of about 75. Average survival from time of diagnosis is only about 3 years.

Recent studies from multiple centers have reported that the prevalence of TAC was 16% in patients undergoing transcatheter aortic valve replacement for severe aortic stenosis, 13% among patients with heart failure with preserved ejection fraction, and 5% in patients who had been presumed to have hypertrophic cardiomyopathy: So, not a rare condition.

“In our clinic, vast and surprising numbers of patients with unexplained nonischemic heart failure are scan positive [for TAC],” according to Dr. George.
 

Breakthroughs in diagnosis and staging

The echocardiographic red flag for TAC in a patient with heart failure symptoms is symmetric hypertrophy with a normal end-diastolic volume and thickened ventricles. The end-diastolic interventricular septal wall thickness is typically about 15 mm. The left ventricular ejection fraction is typically in the normal range, “but the clue is not the preservation of the ejection fraction, it’s the [normal] quality of the volume,” Dr. Rapezzi said.

A clinical clue suggestive of TAC upon physical examination, even in the absence of heart failure symptoms, is development of bilateral carpal tunnel syndrome in an older man. That’s because the same disease process that results in TAC can involve deposition of amyloid fibrils in peripheral nerves. Indeed, tafamidis is already approved in Europe and Japan under the trade name Vyndaqel as a treatment for familial amyloid polyneuropathy. For TAC, however, tafamidis remains investigational with fast-track status provided by both the Food and Drug Administration and the European Medicines Agency.

When TAC is suspected, it’s no longer necessary to subject patients to an onerous myocardial biopsy. Total body scintigraphy with bone tracers has been shown to be nearly as sensitive and specific as biopsy for the diagnosis.

Staging can now be done noninvasively as well. Investigators at the U.K. National Amyloidosis Centre recently reported that patients with TAC can be accurately staged using two biomarkers: N-terminal pro-B-type natriuretic peptide (NT-proBNP) and estimated glomerular filtration rate (eGFR). In their series of 869 patients with TAC, median survival for those with stage I disease as defined by their protocol was 69 months, compared with 47 months for stage II disease and 24 months for those with stage III disease. This simple U.K. staging system was then validated in a separate French cohort of TAC patients (Eur Heart J. 2018 Aug 7;39[30]:2799-806).
 

The ATTR-ACT trial

Dr. Rapezzi reported on 441 patients with TAC who were randomized to oral tafamidis at either 20 mg or 80 mg per day or placebo and followed prospectively for 30 months in the 13-country, double-blind, phase 3 trial. At 30 months, all-cause mortality was 29.5% in patients who received tafamidis, compared with 42.9% in controls, for a 30% relative risk reduction. The rate of cardiovascular hospitalizations was 0.48 per year with tafamidis, compared with 0.70 per year with placebo, for a 38% relative risk reduction. The mortality benefit didn’t achieve significance until 15-18 months into the trial, as to be expected given tafamidis’ mechanism of action, which involves binding to transthyretin, gradually stabilizing it, and curbing amyloid fibril deposition.

Of note, the benefit was similar regardless of the dose used and whether patients had hereditary or wild type TAC.

Tafamidis proved safe and well tolerated, with a side-effect profile similar to placebo. While diarrhea and urinary tract infections have been an issue in tafamidis-treated patients with familial amyloid polyneuropathy, these adverse events were actually less common in TAC patients who received tafamidis than with placebo, according to Dr. Rapezzi.

A key point, the cardiologist emphasized, is that the benefits of active treatment were greatest in patients with earlier-stage disease. Therefore it’s vital that the diagnosis of TAC be made early, with prompt initiation of treatment to follow, in order to catch the disease at a more reversible stage. That could mean there will be a whole lot more bone scintigraphy being done in patients with unexplained nonischemic heart failure.

Dr. Rapezzi reported receiving research grants, speaker honoraria, and consulting fees from Pfizer, which sponsored the ATTR-ACT trial. Simultaneous with his presentation in Munich, the study results were published online at NEJM.org (doi: 10.1056/NEJMoa1805689). Dr. George reported no financial conflicts.

bjancin@mdedge.com

MUNICH – The big news in the field of heart failure at the annual congress of the European Society of Cardiology concerned an obscure form of the disease traditionally considered rare: transthyretin amyloid cardiomyopathy (TAC).

Bruce Jancin/MDedge News

It turns out that TAC is far more common than previously recognized; it can now be diagnosed and staged noninvasively; and – most important of all – there is for the first time an effective disease-modifying treatment in the form of a novel oral drug called tafamidis, as demonstrated in the Transthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT) presented at the meeting.

“This is the first phase 3 trial that can offer a chance for people with a terrible, severe disease. And within the last year, while the trial was being conducted, it became clear that this disease is much more underdiagnosed than rare,” said Claudio Rapezzi, MD, ATTR-ACT principal investigator and director of the school of cardiovascular diseases at the University of Bologna, Italy.

ATTR-ACT participants randomized to tafamidis showed significant reductions in all-cause mortality and cardiovascular hospitalizations, compared with placebo-treated controls at 30 months follow-up. They also experienced significantly lesser declines in both quality of life as reflected in Kansas City Cardiomyopathy Questionnaire scores and in physical function as captured in 6-minute walk distance.

Bruce Jancin/MDedge News

Designated discussant Jacob George, MD, was over the moon regarding the results.

“This is a pioneering, game-changing trial that is likely to transform the way we diagnose and treat patients with cardiac amyloidosis,” said Dr. George of Kaplan Medical Center in Rehovot, Israel.

“We’re now in an era that, to my opinion, any patient with nonischemic unexplained heart failure should be screened for the presence of amyloidosis because, first, we now know how to prognosticate these patients, and second, we can offer them a real disease-modifying agent,” he added.
 

An underdiagnosed disease

Transthyretin amyloid cardiomyopathy occurs when transthyretin, a transport protein, becomes destabilized and misfolds, promoting deposition of amyloid fibrils in the myocardium. This results in progressive ventricular wall thickening and stiffness, manifest as restrictive cardiomyopathy and progressive heart failure. The cause of transthyretin destabilization can be either autosomal dominant inheritance of any of more than 100 pathogenic mutations in the transthyretin gene identified to date or a spontaneous wild type protein.

Think of TAC as a sort of dementia of the heart. As Dr. George noted, the cardiac disease bears “remarkable similarities” to Alzheimer’s disease, with both conditions entailing extracellular deposition of amyloid.

In the heritable form of TAC, patients typically present with heart failure symptoms at about age 50-55, while the wild type form becomes symptomatic much later at a mean age of about 75. Average survival from time of diagnosis is only about 3 years.

Recent studies from multiple centers have reported that the prevalence of TAC was 16% in patients undergoing transcatheter aortic valve replacement for severe aortic stenosis, 13% among patients with heart failure with preserved ejection fraction, and 5% in patients who had been presumed to have hypertrophic cardiomyopathy: So, not a rare condition.

“In our clinic, vast and surprising numbers of patients with unexplained nonischemic heart failure are scan positive [for TAC],” according to Dr. George.
 

Breakthroughs in diagnosis and staging

The echocardiographic red flag for TAC in a patient with heart failure symptoms is symmetric hypertrophy with a normal end-diastolic volume and thickened ventricles. The end-diastolic interventricular septal wall thickness is typically about 15 mm. The left ventricular ejection fraction is typically in the normal range, “but the clue is not the preservation of the ejection fraction, it’s the [normal] quality of the volume,” Dr. Rapezzi said.

A clinical clue suggestive of TAC upon physical examination, even in the absence of heart failure symptoms, is development of bilateral carpal tunnel syndrome in an older man. That’s because the same disease process that results in TAC can involve deposition of amyloid fibrils in peripheral nerves. Indeed, tafamidis is already approved in Europe and Japan under the trade name Vyndaqel as a treatment for familial amyloid polyneuropathy. For TAC, however, tafamidis remains investigational with fast-track status provided by both the Food and Drug Administration and the European Medicines Agency.

When TAC is suspected, it’s no longer necessary to subject patients to an onerous myocardial biopsy. Total body scintigraphy with bone tracers has been shown to be nearly as sensitive and specific as biopsy for the diagnosis.

Staging can now be done noninvasively as well. Investigators at the U.K. National Amyloidosis Centre recently reported that patients with TAC can be accurately staged using two biomarkers: N-terminal pro-B-type natriuretic peptide (NT-proBNP) and estimated glomerular filtration rate (eGFR). In their series of 869 patients with TAC, median survival for those with stage I disease as defined by their protocol was 69 months, compared with 47 months for stage II disease and 24 months for those with stage III disease. This simple U.K. staging system was then validated in a separate French cohort of TAC patients (Eur Heart J. 2018 Aug 7;39[30]:2799-806).
 

The ATTR-ACT trial

Dr. Rapezzi reported on 441 patients with TAC who were randomized to oral tafamidis at either 20 mg or 80 mg per day or placebo and followed prospectively for 30 months in the 13-country, double-blind, phase 3 trial. At 30 months, all-cause mortality was 29.5% in patients who received tafamidis, compared with 42.9% in controls, for a 30% relative risk reduction. The rate of cardiovascular hospitalizations was 0.48 per year with tafamidis, compared with 0.70 per year with placebo, for a 38% relative risk reduction. The mortality benefit didn’t achieve significance until 15-18 months into the trial, as to be expected given tafamidis’ mechanism of action, which involves binding to transthyretin, gradually stabilizing it, and curbing amyloid fibril deposition.

Of note, the benefit was similar regardless of the dose used and whether patients had hereditary or wild type TAC.

Tafamidis proved safe and well tolerated, with a side-effect profile similar to placebo. While diarrhea and urinary tract infections have been an issue in tafamidis-treated patients with familial amyloid polyneuropathy, these adverse events were actually less common in TAC patients who received tafamidis than with placebo, according to Dr. Rapezzi.

A key point, the cardiologist emphasized, is that the benefits of active treatment were greatest in patients with earlier-stage disease. Therefore it’s vital that the diagnosis of TAC be made early, with prompt initiation of treatment to follow, in order to catch the disease at a more reversible stage. That could mean there will be a whole lot more bone scintigraphy being done in patients with unexplained nonischemic heart failure.

Dr. Rapezzi reported receiving research grants, speaker honoraria, and consulting fees from Pfizer, which sponsored the ATTR-ACT trial. Simultaneous with his presentation in Munich, the study results were published online at NEJM.org (doi: 10.1056/NEJMoa1805689). Dr. George reported no financial conflicts.

bjancin@mdedge.com

MUNICH – The big news in the field of heart failure at the annual congress of the European Society of Cardiology concerned an obscure form of the disease traditionally considered rare: transthyretin amyloid cardiomyopathy (TAC).

Bruce Jancin/MDedge News

It turns out that TAC is far more common than previously recognized; it can now be diagnosed and staged noninvasively; and – most important of all – there is for the first time an effective disease-modifying treatment in the form of a novel oral drug called tafamidis, as demonstrated in the Transthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT) presented at the meeting.

“This is the first phase 3 trial that can offer a chance for people with a terrible, severe disease. And within the last year, while the trial was being conducted, it became clear that this disease is much more underdiagnosed than rare,” said Claudio Rapezzi, MD, ATTR-ACT principal investigator and director of the school of cardiovascular diseases at the University of Bologna, Italy.

ATTR-ACT participants randomized to tafamidis showed significant reductions in all-cause mortality and cardiovascular hospitalizations, compared with placebo-treated controls at 30 months follow-up. They also experienced significantly lesser declines in both quality of life as reflected in Kansas City Cardiomyopathy Questionnaire scores and in physical function as captured in 6-minute walk distance.

Bruce Jancin/MDedge News

Designated discussant Jacob George, MD, was over the moon regarding the results.

“This is a pioneering, game-changing trial that is likely to transform the way we diagnose and treat patients with cardiac amyloidosis,” said Dr. George of Kaplan Medical Center in Rehovot, Israel.

“We’re now in an era that, to my opinion, any patient with nonischemic unexplained heart failure should be screened for the presence of amyloidosis because, first, we now know how to prognosticate these patients, and second, we can offer them a real disease-modifying agent,” he added.
 

An underdiagnosed disease

Transthyretin amyloid cardiomyopathy occurs when transthyretin, a transport protein, becomes destabilized and misfolds, promoting deposition of amyloid fibrils in the myocardium. This results in progressive ventricular wall thickening and stiffness, manifest as restrictive cardiomyopathy and progressive heart failure. The cause of transthyretin destabilization can be either autosomal dominant inheritance of any of more than 100 pathogenic mutations in the transthyretin gene identified to date or a spontaneous wild type protein.

Think of TAC as a sort of dementia of the heart. As Dr. George noted, the cardiac disease bears “remarkable similarities” to Alzheimer’s disease, with both conditions entailing extracellular deposition of amyloid.

In the heritable form of TAC, patients typically present with heart failure symptoms at about age 50-55, while the wild type form becomes symptomatic much later at a mean age of about 75. Average survival from time of diagnosis is only about 3 years.

Recent studies from multiple centers have reported that the prevalence of TAC was 16% in patients undergoing transcatheter aortic valve replacement for severe aortic stenosis, 13% among patients with heart failure with preserved ejection fraction, and 5% in patients who had been presumed to have hypertrophic cardiomyopathy: So, not a rare condition.

“In our clinic, vast and surprising numbers of patients with unexplained nonischemic heart failure are scan positive [for TAC],” according to Dr. George.
 

Breakthroughs in diagnosis and staging

The echocardiographic red flag for TAC in a patient with heart failure symptoms is symmetric hypertrophy with a normal end-diastolic volume and thickened ventricles. The end-diastolic interventricular septal wall thickness is typically about 15 mm. The left ventricular ejection fraction is typically in the normal range, “but the clue is not the preservation of the ejection fraction, it’s the [normal] quality of the volume,” Dr. Rapezzi said.

A clinical clue suggestive of TAC upon physical examination, even in the absence of heart failure symptoms, is development of bilateral carpal tunnel syndrome in an older man. That’s because the same disease process that results in TAC can involve deposition of amyloid fibrils in peripheral nerves. Indeed, tafamidis is already approved in Europe and Japan under the trade name Vyndaqel as a treatment for familial amyloid polyneuropathy. For TAC, however, tafamidis remains investigational with fast-track status provided by both the Food and Drug Administration and the European Medicines Agency.

When TAC is suspected, it’s no longer necessary to subject patients to an onerous myocardial biopsy. Total body scintigraphy with bone tracers has been shown to be nearly as sensitive and specific as biopsy for the diagnosis.

Staging can now be done noninvasively as well. Investigators at the U.K. National Amyloidosis Centre recently reported that patients with TAC can be accurately staged using two biomarkers: N-terminal pro-B-type natriuretic peptide (NT-proBNP) and estimated glomerular filtration rate (eGFR). In their series of 869 patients with TAC, median survival for those with stage I disease as defined by their protocol was 69 months, compared with 47 months for stage II disease and 24 months for those with stage III disease. This simple U.K. staging system was then validated in a separate French cohort of TAC patients (Eur Heart J. 2018 Aug 7;39[30]:2799-806).
 

The ATTR-ACT trial

Dr. Rapezzi reported on 441 patients with TAC who were randomized to oral tafamidis at either 20 mg or 80 mg per day or placebo and followed prospectively for 30 months in the 13-country, double-blind, phase 3 trial. At 30 months, all-cause mortality was 29.5% in patients who received tafamidis, compared with 42.9% in controls, for a 30% relative risk reduction. The rate of cardiovascular hospitalizations was 0.48 per year with tafamidis, compared with 0.70 per year with placebo, for a 38% relative risk reduction. The mortality benefit didn’t achieve significance until 15-18 months into the trial, as to be expected given tafamidis’ mechanism of action, which involves binding to transthyretin, gradually stabilizing it, and curbing amyloid fibril deposition.

Of note, the benefit was similar regardless of the dose used and whether patients had hereditary or wild type TAC.

Tafamidis proved safe and well tolerated, with a side-effect profile similar to placebo. While diarrhea and urinary tract infections have been an issue in tafamidis-treated patients with familial amyloid polyneuropathy, these adverse events were actually less common in TAC patients who received tafamidis than with placebo, according to Dr. Rapezzi.

A key point, the cardiologist emphasized, is that the benefits of active treatment were greatest in patients with earlier-stage disease. Therefore it’s vital that the diagnosis of TAC be made early, with prompt initiation of treatment to follow, in order to catch the disease at a more reversible stage. That could mean there will be a whole lot more bone scintigraphy being done in patients with unexplained nonischemic heart failure.

Dr. Rapezzi reported receiving research grants, speaker honoraria, and consulting fees from Pfizer, which sponsored the ATTR-ACT trial. Simultaneous with his presentation in Munich, the study results were published online at NEJM.org (doi: 10.1056/NEJMoa1805689). Dr. George reported no financial conflicts.

bjancin@mdedge.com

A suicide attempt can be devastating for family members. For a son or daughter, the fallout can include feelings of guilt at missing the warning signs and the knowledge that they may have contributed to the despair that might have driven their loved one to trying to end their own lives.

PhotoDisk

There also can be the feeling that the attempt to deliberately exit this life is an indication that those left behind are not valued.

As related in a StoryCorps episode, which described the attempted suicide of Linda Kwong and the toll on her daughter Emily, Linda’s longstanding suicidal depression was separate from her love for her family.

The news of the suicide attempt rocked Emily. “I described our family as a table, and you were the most important leg. So you disappearing just knocked the whole thing over,” she says.

Yet, the past had seen Emily distancing herself from Linda, with the reality of her mother’s ongoing darkness. “I thought if I spent too much time with you, I would become like you,” Emily says to Linda during their StoryCorps interview.

In the aftermath of Linda’s suicide attempt, the mother-daughter bond could have been shattered. Instead, in the intervening 5 years, it has been stripped down and rebuilt, with both individuals coming to a better understanding of one another and the pain in their lives.

“I mean, I know it’s not over yet, but seeing you come back from this, I couldn’t be more proud of you,” Emily says to Linda.

“I can’t believe that you can use the word ‘proud,’ but it makes me feel like that bond between us will always be there,” Linda says. “And that means the world to me.”

Click here to listen to their StoryCorps episode, broadcast on NPR.

A suicide attempt can be devastating for family members. For a son or daughter, the fallout can include feelings of guilt at missing the warning signs and the knowledge that they may have contributed to the despair that might have driven their loved one to trying to end their own lives.

PhotoDisk

There also can be the feeling that the attempt to deliberately exit this life is an indication that those left behind are not valued.

As related in a StoryCorps episode, which described the attempted suicide of Linda Kwong and the toll on her daughter Emily, Linda’s longstanding suicidal depression was separate from her love for her family.

The news of the suicide attempt rocked Emily. “I described our family as a table, and you were the most important leg. So you disappearing just knocked the whole thing over,” she says.

Yet, the past had seen Emily distancing herself from Linda, with the reality of her mother’s ongoing darkness. “I thought if I spent too much time with you, I would become like you,” Emily says to Linda during their StoryCorps interview.

In the aftermath of Linda’s suicide attempt, the mother-daughter bond could have been shattered. Instead, in the intervening 5 years, it has been stripped down and rebuilt, with both individuals coming to a better understanding of one another and the pain in their lives.

“I mean, I know it’s not over yet, but seeing you come back from this, I couldn’t be more proud of you,” Emily says to Linda.

“I can’t believe that you can use the word ‘proud,’ but it makes me feel like that bond between us will always be there,” Linda says. “And that means the world to me.”

Click here to listen to their StoryCorps episode, broadcast on NPR.

A suicide attempt can be devastating for family members. For a son or daughter, the fallout can include feelings of guilt at missing the warning signs and the knowledge that they may have contributed to the despair that might have driven their loved one to trying to end their own lives.

PhotoDisk

There also can be the feeling that the attempt to deliberately exit this life is an indication that those left behind are not valued.

As related in a StoryCorps episode, which described the attempted suicide of Linda Kwong and the toll on her daughter Emily, Linda’s longstanding suicidal depression was separate from her love for her family.

The news of the suicide attempt rocked Emily. “I described our family as a table, and you were the most important leg. So you disappearing just knocked the whole thing over,” she says.

Yet, the past had seen Emily distancing herself from Linda, with the reality of her mother’s ongoing darkness. “I thought if I spent too much time with you, I would become like you,” Emily says to Linda during their StoryCorps interview.

In the aftermath of Linda’s suicide attempt, the mother-daughter bond could have been shattered. Instead, in the intervening 5 years, it has been stripped down and rebuilt, with both individuals coming to a better understanding of one another and the pain in their lives.

“I mean, I know it’s not over yet, but seeing you come back from this, I couldn’t be more proud of you,” Emily says to Linda.

“I can’t believe that you can use the word ‘proud,’ but it makes me feel like that bond between us will always be there,” Linda says. “And that means the world to me.”

Click here to listen to their StoryCorps episode, broadcast on NPR.

SURGICAL SITE WOUND THERAPY

PICO NPWT is a negative-pressure wound therapy device to treat surgical site infection (SSI). According to Smith & Nephew, a new meta-analysis demonstrates that the prophylactic application of PICO with AIRLOCK™ Technology significantly reduces surgical site complications by 58%, the rate of dehiscence by 26%, and length of stay by one-half day when compared with standard care.

The PICO System is canister-free and disposable. Patients can be discharged safely with PICO in place. Seven days of therapy are provided in each kit, with 1 pump, 2 dressings, and fixation strips to allow for a dressing change.

PICO uses a 4-layer multifunction dressing design in which the layers work together to ensure that negative pressure is delivered to the wound bed and exudate is removed through absorption and evaporation. Approximately 20% of fluid still remains in the dressing. The top film layer has a high-moisture vapor transmission rate to transpire as much as 80% of the exudate, says Smith & Nephew.

FOR MORE INFORMATION, VISIT: http://www.smith-nephew.com/

SHIELDED LAPAROSCOPIC INSTRUMENTS PREVENT BURNS

Encision’s patented Active Electrode Monitoring (AEM®) Shielded Laparoscopic Instruments eliminate patient burns and the associated complications.

Every 90 minutes in the United States, a patient is severely injured from a stray energy burn during laparoscopic surgery, according to Encision. The AEM® Shielded Instruments are designed to eliminate burns caused by monopolar energy insulation failure and capacitive coupling, reducing complications and re-admissions.

In addition to helping health care professionals improve patient safety in line with a recent FDA safety communication, Active Electrode Monitoring is a recommended practice of AORN and AAGL.

Encision offers a complete line of premium laparoscopic monopolar surgical instruments with integrated AEM® technology as well as complimentary products to improve clinical effectiveness and patient safety, including bipolar and cold instrumentation.

FOR MORE INFORMATION, VISIT: https://www.encision.com/

iSORT: 7-DAY BLUETOOTH PILLBOX

TimerCap has a new Bluetooth-enabled 7-day pill box called the iSort that sends reminders to take medication to a patient’s phone using a free TimerCap App found at the AppStore and Android Market.

The iSort automatically records and stores the times when each door/slot is opened and closed. It knows which door has been used and seamlessly updates the TimerCap App. The app will notify the patient and, if designated, a caregiver, whenever a dose is due or missed using pictures to show what and how many meds are scheduled. More than one iSort box can be used with the app.

iSort provides reminders that help improve adherence to medication dosing instructions and eliminates annoying false alarms, double entries, and unnecessary reminders when pills already have been taken. The portable iSort uses 2 AA batteries that need to be changed about once per year.

FOR MORE INFORMATION, VISIT: https://www.timercap.com/isort

PLATFORM TO COORDINATE HEALTH AND TECHNOLOGY

The American Medical Association (AMA) recently has established a new initiative that introduces a solution to improve, organize, and share health care information. The Integrated Health Model Initiative (IHMI) is a platform that coordinates the health and technology sectors around a common data model. IHMI fills the national imperative to pioneer a shared framework for organizing health data, emphasizing patient-centric information, and refining data elements to those most predictive of better outcomes. The AMA says that evolving available health data to depict a complete picture of a patient’s journey from wellness to illness to treatment and beyond allows health care delivery to fully focus on patient outcomes, goals, and wellness. Participation in IHMI is open to all health care and technology stakeholders.

FOR MORE INFORMATION, VISIT: www.ama-assn.org/ihmi

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice. 

SURGICAL SITE WOUND THERAPY

PICO NPWT is a negative-pressure wound therapy device to treat surgical site infection (SSI). According to Smith & Nephew, a new meta-analysis demonstrates that the prophylactic application of PICO with AIRLOCK™ Technology significantly reduces surgical site complications by 58%, the rate of dehiscence by 26%, and length of stay by one-half day when compared with standard care.

The PICO System is canister-free and disposable. Patients can be discharged safely with PICO in place. Seven days of therapy are provided in each kit, with 1 pump, 2 dressings, and fixation strips to allow for a dressing change.

PICO uses a 4-layer multifunction dressing design in which the layers work together to ensure that negative pressure is delivered to the wound bed and exudate is removed through absorption and evaporation. Approximately 20% of fluid still remains in the dressing. The top film layer has a high-moisture vapor transmission rate to transpire as much as 80% of the exudate, says Smith & Nephew.

FOR MORE INFORMATION, VISIT: http://www.smith-nephew.com/

SHIELDED LAPAROSCOPIC INSTRUMENTS PREVENT BURNS

Encision’s patented Active Electrode Monitoring (AEM®) Shielded Laparoscopic Instruments eliminate patient burns and the associated complications.

Every 90 minutes in the United States, a patient is severely injured from a stray energy burn during laparoscopic surgery, according to Encision. The AEM® Shielded Instruments are designed to eliminate burns caused by monopolar energy insulation failure and capacitive coupling, reducing complications and re-admissions.

In addition to helping health care professionals improve patient safety in line with a recent FDA safety communication, Active Electrode Monitoring is a recommended practice of AORN and AAGL.

Encision offers a complete line of premium laparoscopic monopolar surgical instruments with integrated AEM® technology as well as complimentary products to improve clinical effectiveness and patient safety, including bipolar and cold instrumentation.

FOR MORE INFORMATION, VISIT: https://www.encision.com/

iSORT: 7-DAY BLUETOOTH PILLBOX

TimerCap has a new Bluetooth-enabled 7-day pill box called the iSort that sends reminders to take medication to a patient’s phone using a free TimerCap App found at the AppStore and Android Market.

The iSort automatically records and stores the times when each door/slot is opened and closed. It knows which door has been used and seamlessly updates the TimerCap App. The app will notify the patient and, if designated, a caregiver, whenever a dose is due or missed using pictures to show what and how many meds are scheduled. More than one iSort box can be used with the app.

iSort provides reminders that help improve adherence to medication dosing instructions and eliminates annoying false alarms, double entries, and unnecessary reminders when pills already have been taken. The portable iSort uses 2 AA batteries that need to be changed about once per year.

FOR MORE INFORMATION, VISIT: https://www.timercap.com/isort

PLATFORM TO COORDINATE HEALTH AND TECHNOLOGY

The American Medical Association (AMA) recently has established a new initiative that introduces a solution to improve, organize, and share health care information. The Integrated Health Model Initiative (IHMI) is a platform that coordinates the health and technology sectors around a common data model. IHMI fills the national imperative to pioneer a shared framework for organizing health data, emphasizing patient-centric information, and refining data elements to those most predictive of better outcomes. The AMA says that evolving available health data to depict a complete picture of a patient’s journey from wellness to illness to treatment and beyond allows health care delivery to fully focus on patient outcomes, goals, and wellness. Participation in IHMI is open to all health care and technology stakeholders.

FOR MORE INFORMATION, VISIT: www.ama-assn.org/ihmi

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice. 

SURGICAL SITE WOUND THERAPY

PICO NPWT is a negative-pressure wound therapy device to treat surgical site infection (SSI). According to Smith & Nephew, a new meta-analysis demonstrates that the prophylactic application of PICO with AIRLOCK™ Technology significantly reduces surgical site complications by 58%, the rate of dehiscence by 26%, and length of stay by one-half day when compared with standard care.

The PICO System is canister-free and disposable. Patients can be discharged safely with PICO in place. Seven days of therapy are provided in each kit, with 1 pump, 2 dressings, and fixation strips to allow for a dressing change.

PICO uses a 4-layer multifunction dressing design in which the layers work together to ensure that negative pressure is delivered to the wound bed and exudate is removed through absorption and evaporation. Approximately 20% of fluid still remains in the dressing. The top film layer has a high-moisture vapor transmission rate to transpire as much as 80% of the exudate, says Smith & Nephew.

FOR MORE INFORMATION, VISIT: http://www.smith-nephew.com/

SHIELDED LAPAROSCOPIC INSTRUMENTS PREVENT BURNS

Encision’s patented Active Electrode Monitoring (AEM®) Shielded Laparoscopic Instruments eliminate patient burns and the associated complications.

Every 90 minutes in the United States, a patient is severely injured from a stray energy burn during laparoscopic surgery, according to Encision. The AEM® Shielded Instruments are designed to eliminate burns caused by monopolar energy insulation failure and capacitive coupling, reducing complications and re-admissions.

In addition to helping health care professionals improve patient safety in line with a recent FDA safety communication, Active Electrode Monitoring is a recommended practice of AORN and AAGL.

Encision offers a complete line of premium laparoscopic monopolar surgical instruments with integrated AEM® technology as well as complimentary products to improve clinical effectiveness and patient safety, including bipolar and cold instrumentation.

FOR MORE INFORMATION, VISIT: https://www.encision.com/

iSORT: 7-DAY BLUETOOTH PILLBOX

TimerCap has a new Bluetooth-enabled 7-day pill box called the iSort that sends reminders to take medication to a patient’s phone using a free TimerCap App found at the AppStore and Android Market.

The iSort automatically records and stores the times when each door/slot is opened and closed. It knows which door has been used and seamlessly updates the TimerCap App. The app will notify the patient and, if designated, a caregiver, whenever a dose is due or missed using pictures to show what and how many meds are scheduled. More than one iSort box can be used with the app.

iSort provides reminders that help improve adherence to medication dosing instructions and eliminates annoying false alarms, double entries, and unnecessary reminders when pills already have been taken. The portable iSort uses 2 AA batteries that need to be changed about once per year.

FOR MORE INFORMATION, VISIT: https://www.timercap.com/isort

PLATFORM TO COORDINATE HEALTH AND TECHNOLOGY

The American Medical Association (AMA) recently has established a new initiative that introduces a solution to improve, organize, and share health care information. The Integrated Health Model Initiative (IHMI) is a platform that coordinates the health and technology sectors around a common data model. IHMI fills the national imperative to pioneer a shared framework for organizing health data, emphasizing patient-centric information, and refining data elements to those most predictive of better outcomes. The AMA says that evolving available health data to depict a complete picture of a patient’s journey from wellness to illness to treatment and beyond allows health care delivery to fully focus on patient outcomes, goals, and wellness. Participation in IHMI is open to all health care and technology stakeholders.

FOR MORE INFORMATION, VISIT: www.ama-assn.org/ihmi

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice. 

The number of children diagnosed with ADHD has reached more than 10%, a significant increase during the past 20 years, according to a recent study in JAMA.

The rise was most pronounced in minority groups, suggesting that better access to health insurance and mental health treatment through the Affordable Care Act might have played some role in the increase. The rate of diagnosis during that time period doubled in girls, although it was still much lower than in boys.

But the researchers say they found no evidence confirming frequent complaints that the condition is overdiagnosed or misdiagnosed.

The United States has significantly more instances of ADHD than do other developed countries, which researchers said has led some to think Americans are overdiagnosing children. Wei Bao, MD, PhD, lead author of the study, said in an interview that a review of studies around the world does not support that.

”I don’t think overdiagnosis is the main issue,” he said.

Nonetheless, those doubts persist. Stephen Hinshaw, MD, who coauthored a 2014 book called “The ADHD Explosion: Myths, Medication, Money, and Today’s Push for Performance,” compared ADHD with depression. He said in an interview that neither condition has unequivocal biological markers, which makes it hard to determine if a patient truly has the condition without lengthy psychological evaluations. Symptoms of ADHD can include inattention, fidgety behavior, and impulsivity.

“It’s probably not a true epidemic of ADHD,” said Dr. Hinshaw, a professor of psychology at the University of California, Berkeley, and a professor of psychiatry at University of California, San Francisco. “It might be an epidemic of diagnosing it.”

In interpreting their results, however, the study’s authors tied the higher numbers to better understanding of the condition by doctors and the public, new standards for diagnosis and an increase in access to health insurance through the ACA.

Because of the ACA, “some low-income families have improved access to services and referrals,” said Dr. Bao, an epidemiologist at the University of Iowa College of Public Health in Iowa City.

The study, published in JAMA Network Open, used data from the National Health Interview Survey, an annual federal survey of about 35,000 households. It found a steady increase in diagnoses in children from about 6% during 1997-1998 to more than 10% during 2015-2016.

Advances in medical technology also may have contributed to the increase, according to the research. Twenty years ago, preterm or low-birth-weight babies had a harder time surviving. Those factors increase the risk of being diagnosed with ADHD.

The study also suggests that fewer stigmas about mental health care in minority communities also may lead to more people receiving an ADHD diagnosis.

In the late 1990s, 7.2% of non-Hispanic white children, 4.7% of non-Hispanic black children, and 3.6% of Hispanic children were diagnosed with ADHD, according to the study. By 2016, it was 12% of white kids, 12.8% of blacks, and 6.1% of Hispanics.

Over the past several decades, Dr. Hinshaw said, there’s been an expanded view of who can develop ADHD. It’s no longer viewed as a disease that affects only white middle-class boys, as eating disorders are no longer seen as afflicting only white middle-class girls.

Still, he cautioned against overdiagnosing ADHD in communities in which behavioral issues could be the result of social or environmental factors such as overcrowded classrooms.

The study found rates of ADHD among girls rose from 3% to more than 6% over the study period. It said that was partly a result of a change in how the condition is classified. For years, ADHD pertained to children who were hyperactive. But in recent years, the American Psychiatric Association added to its guide of mental health conditions that diagnosis should also include some children who are inattentive, Dr. Bao said. That raised the number of girls, he explained, because it seems they are more likely to be in that second subtype.

“If we compare these two, you can easily imagine people will easily recognize hyperactivity,” he said.

That rang true for Ruth Hay, a 25-year-old student and cook from New York who now lives in Jerusalem. She was diagnosed with what was then called ADD the summer between second and third grade.

Ms. Hay said her hyperactive tendencies aren’t as “loud” as some people’s. She’s less likely to bounce around a room than she is to bounce in her chair, she said.

Yet, despite her early diagnosis, Ms. Hay said, no one ever told her about other symptoms. For example, she said, she suffers from executive dysfunction, which leaves her feeling unable to accomplish tasks, no matter how much she wanted to or tried.

“I grew up being called lazy in periods of time when I wasn’t,” Ms. Hay said. “If you look at a list of all the various ADHD symptoms, I have all of them to one degree or another, but the only ones ever discussed with me was you might be less focused and more fidgety.”

“I don’t know how my brain would be if I didn’t have it,” she added. “I don’t know if I’d still be me, but all it has been for me is a disability.”

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The number of children diagnosed with ADHD has reached more than 10%, a significant increase during the past 20 years, according to a recent study in JAMA.

The rise was most pronounced in minority groups, suggesting that better access to health insurance and mental health treatment through the Affordable Care Act might have played some role in the increase. The rate of diagnosis during that time period doubled in girls, although it was still much lower than in boys.

But the researchers say they found no evidence confirming frequent complaints that the condition is overdiagnosed or misdiagnosed.

The United States has significantly more instances of ADHD than do other developed countries, which researchers said has led some to think Americans are overdiagnosing children. Wei Bao, MD, PhD, lead author of the study, said in an interview that a review of studies around the world does not support that.

”I don’t think overdiagnosis is the main issue,” he said.

Nonetheless, those doubts persist. Stephen Hinshaw, MD, who coauthored a 2014 book called “The ADHD Explosion: Myths, Medication, Money, and Today’s Push for Performance,” compared ADHD with depression. He said in an interview that neither condition has unequivocal biological markers, which makes it hard to determine if a patient truly has the condition without lengthy psychological evaluations. Symptoms of ADHD can include inattention, fidgety behavior, and impulsivity.

“It’s probably not a true epidemic of ADHD,” said Dr. Hinshaw, a professor of psychology at the University of California, Berkeley, and a professor of psychiatry at University of California, San Francisco. “It might be an epidemic of diagnosing it.”

In interpreting their results, however, the study’s authors tied the higher numbers to better understanding of the condition by doctors and the public, new standards for diagnosis and an increase in access to health insurance through the ACA.

Because of the ACA, “some low-income families have improved access to services and referrals,” said Dr. Bao, an epidemiologist at the University of Iowa College of Public Health in Iowa City.

The study, published in JAMA Network Open, used data from the National Health Interview Survey, an annual federal survey of about 35,000 households. It found a steady increase in diagnoses in children from about 6% during 1997-1998 to more than 10% during 2015-2016.

Advances in medical technology also may have contributed to the increase, according to the research. Twenty years ago, preterm or low-birth-weight babies had a harder time surviving. Those factors increase the risk of being diagnosed with ADHD.

The study also suggests that fewer stigmas about mental health care in minority communities also may lead to more people receiving an ADHD diagnosis.

In the late 1990s, 7.2% of non-Hispanic white children, 4.7% of non-Hispanic black children, and 3.6% of Hispanic children were diagnosed with ADHD, according to the study. By 2016, it was 12% of white kids, 12.8% of blacks, and 6.1% of Hispanics.

Over the past several decades, Dr. Hinshaw said, there’s been an expanded view of who can develop ADHD. It’s no longer viewed as a disease that affects only white middle-class boys, as eating disorders are no longer seen as afflicting only white middle-class girls.

Still, he cautioned against overdiagnosing ADHD in communities in which behavioral issues could be the result of social or environmental factors such as overcrowded classrooms.

The study found rates of ADHD among girls rose from 3% to more than 6% over the study period. It said that was partly a result of a change in how the condition is classified. For years, ADHD pertained to children who were hyperactive. But in recent years, the American Psychiatric Association added to its guide of mental health conditions that diagnosis should also include some children who are inattentive, Dr. Bao said. That raised the number of girls, he explained, because it seems they are more likely to be in that second subtype.

“If we compare these two, you can easily imagine people will easily recognize hyperactivity,” he said.

That rang true for Ruth Hay, a 25-year-old student and cook from New York who now lives in Jerusalem. She was diagnosed with what was then called ADD the summer between second and third grade.

Ms. Hay said her hyperactive tendencies aren’t as “loud” as some people’s. She’s less likely to bounce around a room than she is to bounce in her chair, she said.

Yet, despite her early diagnosis, Ms. Hay said, no one ever told her about other symptoms. For example, she said, she suffers from executive dysfunction, which leaves her feeling unable to accomplish tasks, no matter how much she wanted to or tried.

“I grew up being called lazy in periods of time when I wasn’t,” Ms. Hay said. “If you look at a list of all the various ADHD symptoms, I have all of them to one degree or another, but the only ones ever discussed with me was you might be less focused and more fidgety.”

“I don’t know how my brain would be if I didn’t have it,” she added. “I don’t know if I’d still be me, but all it has been for me is a disability.”

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The number of children diagnosed with ADHD has reached more than 10%, a significant increase during the past 20 years, according to a recent study in JAMA.

The rise was most pronounced in minority groups, suggesting that better access to health insurance and mental health treatment through the Affordable Care Act might have played some role in the increase. The rate of diagnosis during that time period doubled in girls, although it was still much lower than in boys.

But the researchers say they found no evidence confirming frequent complaints that the condition is overdiagnosed or misdiagnosed.

The United States has significantly more instances of ADHD than do other developed countries, which researchers said has led some to think Americans are overdiagnosing children. Wei Bao, MD, PhD, lead author of the study, said in an interview that a review of studies around the world does not support that.

”I don’t think overdiagnosis is the main issue,” he said.

Nonetheless, those doubts persist. Stephen Hinshaw, MD, who coauthored a 2014 book called “The ADHD Explosion: Myths, Medication, Money, and Today’s Push for Performance,” compared ADHD with depression. He said in an interview that neither condition has unequivocal biological markers, which makes it hard to determine if a patient truly has the condition without lengthy psychological evaluations. Symptoms of ADHD can include inattention, fidgety behavior, and impulsivity.

“It’s probably not a true epidemic of ADHD,” said Dr. Hinshaw, a professor of psychology at the University of California, Berkeley, and a professor of psychiatry at University of California, San Francisco. “It might be an epidemic of diagnosing it.”

In interpreting their results, however, the study’s authors tied the higher numbers to better understanding of the condition by doctors and the public, new standards for diagnosis and an increase in access to health insurance through the ACA.

Because of the ACA, “some low-income families have improved access to services and referrals,” said Dr. Bao, an epidemiologist at the University of Iowa College of Public Health in Iowa City.

The study, published in JAMA Network Open, used data from the National Health Interview Survey, an annual federal survey of about 35,000 households. It found a steady increase in diagnoses in children from about 6% during 1997-1998 to more than 10% during 2015-2016.

Advances in medical technology also may have contributed to the increase, according to the research. Twenty years ago, preterm or low-birth-weight babies had a harder time surviving. Those factors increase the risk of being diagnosed with ADHD.

The study also suggests that fewer stigmas about mental health care in minority communities also may lead to more people receiving an ADHD diagnosis.

In the late 1990s, 7.2% of non-Hispanic white children, 4.7% of non-Hispanic black children, and 3.6% of Hispanic children were diagnosed with ADHD, according to the study. By 2016, it was 12% of white kids, 12.8% of blacks, and 6.1% of Hispanics.

Over the past several decades, Dr. Hinshaw said, there’s been an expanded view of who can develop ADHD. It’s no longer viewed as a disease that affects only white middle-class boys, as eating disorders are no longer seen as afflicting only white middle-class girls.

Still, he cautioned against overdiagnosing ADHD in communities in which behavioral issues could be the result of social or environmental factors such as overcrowded classrooms.

The study found rates of ADHD among girls rose from 3% to more than 6% over the study period. It said that was partly a result of a change in how the condition is classified. For years, ADHD pertained to children who were hyperactive. But in recent years, the American Psychiatric Association added to its guide of mental health conditions that diagnosis should also include some children who are inattentive, Dr. Bao said. That raised the number of girls, he explained, because it seems they are more likely to be in that second subtype.

“If we compare these two, you can easily imagine people will easily recognize hyperactivity,” he said.

That rang true for Ruth Hay, a 25-year-old student and cook from New York who now lives in Jerusalem. She was diagnosed with what was then called ADD the summer between second and third grade.

Ms. Hay said her hyperactive tendencies aren’t as “loud” as some people’s. She’s less likely to bounce around a room than she is to bounce in her chair, she said.

Yet, despite her early diagnosis, Ms. Hay said, no one ever told her about other symptoms. For example, she said, she suffers from executive dysfunction, which leaves her feeling unable to accomplish tasks, no matter how much she wanted to or tried.

“I grew up being called lazy in periods of time when I wasn’t,” Ms. Hay said. “If you look at a list of all the various ADHD symptoms, I have all of them to one degree or another, but the only ones ever discussed with me was you might be less focused and more fidgety.”

“I don’t know how my brain would be if I didn’t have it,” she added. “I don’t know if I’d still be me, but all it has been for me is a disability.”

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Almost 11 million adults use e-cigarettes in the United States, and the majority are under the age of 35 years, according to the American Heart Association.

As of 2016, an estimated 4.5% of adults – more than 10.8 million individuals – used e-cigarettes every day or some days, which defined current use for the 466,842 people who responded to the Behavioral Risk Factor Surveillance System survey and were included in the study conducted by the AHA’s Tobacco Regulation and Addiction Center and published in the Annals of Internal Medicine.

Based on that survey data, an estimated 51% of current users were under the age of 35 years in 2016. Daily use was highest among those aged 18-24 years, and of those respondents, 44% said that they had never been regular cigarette users. “It’s particularly disturbing to see these younger people who have never been regular cigarette smokers taking up the use of e-cigarettes, perhaps with the assumption that this alternative nicotine delivery system has been proven to be safe,” said Rose Marie Robertson, MD, who is the AHA’s chief science and medical officer.

The analysis also showed that about 60% of e-cigarette users were men and that use was higher among LGBT people. The first-ever estimates of current use by state put the prevalence highest in Oklahoma at 7.0% and lowest in South Dakota (3.1%) and the District of Columbia (2.3%), the AHA said.

The study was funded through a grant from the National Institutes of Health and the Food and Drug Administration’s Center for Tobacco Products.

rfranki@mdedge.com

SOURCE: Mirbolouk M et al. Ann Intern Med. 2018 Aug 28. doi: 10.7326/M17-3440.

Almost 11 million adults use e-cigarettes in the United States, and the majority are under the age of 35 years, according to the American Heart Association.

As of 2016, an estimated 4.5% of adults – more than 10.8 million individuals – used e-cigarettes every day or some days, which defined current use for the 466,842 people who responded to the Behavioral Risk Factor Surveillance System survey and were included in the study conducted by the AHA’s Tobacco Regulation and Addiction Center and published in the Annals of Internal Medicine.

Based on that survey data, an estimated 51% of current users were under the age of 35 years in 2016. Daily use was highest among those aged 18-24 years, and of those respondents, 44% said that they had never been regular cigarette users. “It’s particularly disturbing to see these younger people who have never been regular cigarette smokers taking up the use of e-cigarettes, perhaps with the assumption that this alternative nicotine delivery system has been proven to be safe,” said Rose Marie Robertson, MD, who is the AHA’s chief science and medical officer.

The analysis also showed that about 60% of e-cigarette users were men and that use was higher among LGBT people. The first-ever estimates of current use by state put the prevalence highest in Oklahoma at 7.0% and lowest in South Dakota (3.1%) and the District of Columbia (2.3%), the AHA said.

The study was funded through a grant from the National Institutes of Health and the Food and Drug Administration’s Center for Tobacco Products.

rfranki@mdedge.com

SOURCE: Mirbolouk M et al. Ann Intern Med. 2018 Aug 28. doi: 10.7326/M17-3440.

Almost 11 million adults use e-cigarettes in the United States, and the majority are under the age of 35 years, according to the American Heart Association.

As of 2016, an estimated 4.5% of adults – more than 10.8 million individuals – used e-cigarettes every day or some days, which defined current use for the 466,842 people who responded to the Behavioral Risk Factor Surveillance System survey and were included in the study conducted by the AHA’s Tobacco Regulation and Addiction Center and published in the Annals of Internal Medicine.

Based on that survey data, an estimated 51% of current users were under the age of 35 years in 2016. Daily use was highest among those aged 18-24 years, and of those respondents, 44% said that they had never been regular cigarette users. “It’s particularly disturbing to see these younger people who have never been regular cigarette smokers taking up the use of e-cigarettes, perhaps with the assumption that this alternative nicotine delivery system has been proven to be safe,” said Rose Marie Robertson, MD, who is the AHA’s chief science and medical officer.

The analysis also showed that about 60% of e-cigarette users were men and that use was higher among LGBT people. The first-ever estimates of current use by state put the prevalence highest in Oklahoma at 7.0% and lowest in South Dakota (3.1%) and the District of Columbia (2.3%), the AHA said.

The study was funded through a grant from the National Institutes of Health and the Food and Drug Administration’s Center for Tobacco Products.

rfranki@mdedge.com

SOURCE: Mirbolouk M et al. Ann Intern Med. 2018 Aug 28. doi: 10.7326/M17-3440.

New research suggests that better access to quality care may reduce disparities in survival between cancer patients living in rural areas of the United States and those living in urban areas.

The study showed that urban and rural cancer patients had similar survival outcomes when they were enrolled in clinical trials.

These results, published in JAMA Network Open, cast new light on decades of research showing that cancer patients living in rural areas don’t live as long as do urban cancer patients.

“These findings were a surprise, since we thought we might find the same disparities others had found,” study author Joseph Unger, PhD, of Fred Hutchinson Cancer Research Center, Seattle, said in a statement.

“But clinical trials are a key difference here. In trials, patients are uniformly assessed, treated, and followed under a strict, guideline-driven protocol. This suggests that giving people with cancer access to uniform treatment strategies could help resolve the disparities in outcomes that we see between rural and urban patients.”

Dr. Unger and his colleagues studied data on 36,995 patients who were enrolled in 44 phase 3 or phase 2/3 SWOG trials from 1986 through 2012. All 50 states were represented.

Patients had 17 different cancer types, including acute myeloid leukemia (AML), non-Hodgkin lymphoma (NHL), and multiple myeloma (MM).

A minority of patients (19.4%, n = 7,184) were from rural locations. They were significantly more likely than were urban patients to be 65 years or older (P less than .001) and significantly less likely to be black (vs. all other races; P less than .001).

However, there was no significant between-group differences in sex, and all major U.S. geographic regions (West, Midwest, South, and Northeast) were represented.

The researchers limited their analysis of survival to the first 5 years after trial enrollment to emphasize outcomes related to cancer and its treatment. They looked at overall survival (OS) as well as cancer-specific survival.

The team found no meaningful difference in OS or cancer-specific survival between rural and urban patients for 16 of the 17 cancer types.

The exception was estrogen receptor-–negative, progesterone receptor–negative breast cancer. Rural patients with this cancer didn’t live as long as did their urban counterparts. The hazard ratio (HR) was 1.27 (95% confidence interval, 1.06-1.51; P = .008) for OS and 1.26 (95% CI, 1.04-1.52; P = .02) for cancer-specific survival.

The researchers said this finding could be attributed to a few factors, including timely access to follow-up chemotherapy after patients’ first round of cancer treatment.

Although there were no significant survival differences for patients with hematologic malignancies, rural patients had slightly better OS if they had advanced indolent NHL or AML, but slightly worse OS if they had MM or advanced aggressive NHL.

Rural patients had slightly better cancer-specific survival if they had advanced indolent NHL but slightly worse cancer-specific survival if they had AML, MM, or advanced aggressive NHL.

The researchers said these findings suggest it is access to care, and not other characteristics, that drives the survival disparities typically observed between urban and rural cancer patients.

“If people diagnosed with cancer, regardless of where they live, receive similar care and have similar outcomes, then a reasonable inference is that the best way to improve outcomes for rural patients is to improve their access to quality care,” Dr. Unger said.

The National Cancer Institute and the HOPE Foundation supported the study. The researchers reported financial relationships with various pharmaceutical companies.

jensmith@mdedge.com

SOURCE: Unger JM et al. JAMA Network Open. 2018;1(4):e181235. doi: 10.1001/jamanetworkopen.2018.1235.

New research suggests that better access to quality care may reduce disparities in survival between cancer patients living in rural areas of the United States and those living in urban areas.

The study showed that urban and rural cancer patients had similar survival outcomes when they were enrolled in clinical trials.

These results, published in JAMA Network Open, cast new light on decades of research showing that cancer patients living in rural areas don’t live as long as do urban cancer patients.

“These findings were a surprise, since we thought we might find the same disparities others had found,” study author Joseph Unger, PhD, of Fred Hutchinson Cancer Research Center, Seattle, said in a statement.

“But clinical trials are a key difference here. In trials, patients are uniformly assessed, treated, and followed under a strict, guideline-driven protocol. This suggests that giving people with cancer access to uniform treatment strategies could help resolve the disparities in outcomes that we see between rural and urban patients.”

Dr. Unger and his colleagues studied data on 36,995 patients who were enrolled in 44 phase 3 or phase 2/3 SWOG trials from 1986 through 2012. All 50 states were represented.

Patients had 17 different cancer types, including acute myeloid leukemia (AML), non-Hodgkin lymphoma (NHL), and multiple myeloma (MM).

A minority of patients (19.4%, n = 7,184) were from rural locations. They were significantly more likely than were urban patients to be 65 years or older (P less than .001) and significantly less likely to be black (vs. all other races; P less than .001).

However, there was no significant between-group differences in sex, and all major U.S. geographic regions (West, Midwest, South, and Northeast) were represented.

The researchers limited their analysis of survival to the first 5 years after trial enrollment to emphasize outcomes related to cancer and its treatment. They looked at overall survival (OS) as well as cancer-specific survival.

The team found no meaningful difference in OS or cancer-specific survival between rural and urban patients for 16 of the 17 cancer types.

The exception was estrogen receptor-–negative, progesterone receptor–negative breast cancer. Rural patients with this cancer didn’t live as long as did their urban counterparts. The hazard ratio (HR) was 1.27 (95% confidence interval, 1.06-1.51; P = .008) for OS and 1.26 (95% CI, 1.04-1.52; P = .02) for cancer-specific survival.

The researchers said this finding could be attributed to a few factors, including timely access to follow-up chemotherapy after patients’ first round of cancer treatment.

Although there were no significant survival differences for patients with hematologic malignancies, rural patients had slightly better OS if they had advanced indolent NHL or AML, but slightly worse OS if they had MM or advanced aggressive NHL.

Rural patients had slightly better cancer-specific survival if they had advanced indolent NHL but slightly worse cancer-specific survival if they had AML, MM, or advanced aggressive NHL.

The researchers said these findings suggest it is access to care, and not other characteristics, that drives the survival disparities typically observed between urban and rural cancer patients.

“If people diagnosed with cancer, regardless of where they live, receive similar care and have similar outcomes, then a reasonable inference is that the best way to improve outcomes for rural patients is to improve their access to quality care,” Dr. Unger said.

The National Cancer Institute and the HOPE Foundation supported the study. The researchers reported financial relationships with various pharmaceutical companies.

jensmith@mdedge.com

SOURCE: Unger JM et al. JAMA Network Open. 2018;1(4):e181235. doi: 10.1001/jamanetworkopen.2018.1235.

New research suggests that better access to quality care may reduce disparities in survival between cancer patients living in rural areas of the United States and those living in urban areas.

The study showed that urban and rural cancer patients had similar survival outcomes when they were enrolled in clinical trials.

These results, published in JAMA Network Open, cast new light on decades of research showing that cancer patients living in rural areas don’t live as long as do urban cancer patients.

“These findings were a surprise, since we thought we might find the same disparities others had found,” study author Joseph Unger, PhD, of Fred Hutchinson Cancer Research Center, Seattle, said in a statement.

“But clinical trials are a key difference here. In trials, patients are uniformly assessed, treated, and followed under a strict, guideline-driven protocol. This suggests that giving people with cancer access to uniform treatment strategies could help resolve the disparities in outcomes that we see between rural and urban patients.”

Dr. Unger and his colleagues studied data on 36,995 patients who were enrolled in 44 phase 3 or phase 2/3 SWOG trials from 1986 through 2012. All 50 states were represented.

Patients had 17 different cancer types, including acute myeloid leukemia (AML), non-Hodgkin lymphoma (NHL), and multiple myeloma (MM).

A minority of patients (19.4%, n = 7,184) were from rural locations. They were significantly more likely than were urban patients to be 65 years or older (P less than .001) and significantly less likely to be black (vs. all other races; P less than .001).

However, there was no significant between-group differences in sex, and all major U.S. geographic regions (West, Midwest, South, and Northeast) were represented.

The researchers limited their analysis of survival to the first 5 years after trial enrollment to emphasize outcomes related to cancer and its treatment. They looked at overall survival (OS) as well as cancer-specific survival.

The team found no meaningful difference in OS or cancer-specific survival between rural and urban patients for 16 of the 17 cancer types.

The exception was estrogen receptor-–negative, progesterone receptor–negative breast cancer. Rural patients with this cancer didn’t live as long as did their urban counterparts. The hazard ratio (HR) was 1.27 (95% confidence interval, 1.06-1.51; P = .008) for OS and 1.26 (95% CI, 1.04-1.52; P = .02) for cancer-specific survival.

The researchers said this finding could be attributed to a few factors, including timely access to follow-up chemotherapy after patients’ first round of cancer treatment.

Although there were no significant survival differences for patients with hematologic malignancies, rural patients had slightly better OS if they had advanced indolent NHL or AML, but slightly worse OS if they had MM or advanced aggressive NHL.

Rural patients had slightly better cancer-specific survival if they had advanced indolent NHL but slightly worse cancer-specific survival if they had AML, MM, or advanced aggressive NHL.

The researchers said these findings suggest it is access to care, and not other characteristics, that drives the survival disparities typically observed between urban and rural cancer patients.

“If people diagnosed with cancer, regardless of where they live, receive similar care and have similar outcomes, then a reasonable inference is that the best way to improve outcomes for rural patients is to improve their access to quality care,” Dr. Unger said.

The National Cancer Institute and the HOPE Foundation supported the study. The researchers reported financial relationships with various pharmaceutical companies.

jensmith@mdedge.com

SOURCE: Unger JM et al. JAMA Network Open. 2018;1(4):e181235. doi: 10.1001/jamanetworkopen.2018.1235.

ATLANTA – In just 7 months, the University of North Carolina Children’s Hospital, Chapel Hill, dropped the length of stay for neonatal abstinence syndrome from about 11 days to 5 days by moving from scheduled to PRN morphine dosing and abandoning the Finnegan score, according to a report at the Pediatric Hospital Medicine meeting.

The use of morphine fell from 93% of infants transferred to the hospital’s inpatient floors for neonatal abstinence syndrome (NAS) to just 12%, with no downsides for infants or moms.

“Our results have been incredibly encouraging,” said lead investigator and pediatrics resident Thomas Blount, MD. The take-home message is to treat the infant, rather than relying on the Finnegan score.

UNC Children’s, which treats about 50 infants a year for NAS on its inpatient floors, had been using the traditional approach: babies were automatically scheduled for morphine and Finnegan scoring – a withdrawal symptom checklist – every 4 hours, regardless of need. Sometimes infants weren’t even assessed to see if they actually needed morphine before the next dose was given.

“Waking babies up every 4 hours just seemed crazy; of course, they were going to have heightened neurologic signs and symptoms.” Meanwhile, families and providers were frustrated that infants who were otherwise doing well were held for an extra week or more to wean them off morphine, Dr. Blount said at the meeting.

In Nov. 2017, the hospital switched to the eat/sleep/console (ESC) model for NAS on its inpatient floors. The model emphasizes what’s been shown to work in recent years: keeping the infant with the mother; encouraging breast feeding, skin-on-skin contact, and other comfort measures; and supplementing feeds to help with weight gain. Morphine is reserved for when those measures fail and given only with a needs assessment (Hosp Pediatr. 2018 Jan;8(1):1-6).

The hospital ditched Finnegan scoring on its inpatient floors. Nurses were asked instead to check if infants were feeding adequately, sleeping at least an hour between feedings, and able to be consoled within 10 minutes when upset. If the infants met all three of those ESC criteria, providers moved on. They left the baby swaddled, relied on ambient white noise of ocean waves, and checked back on them later. “They didn’t mess with them,” Dr. Blount said at the meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Finnegan scoring “was causing so much anxiety. Staff and families became hypervigilant,” set off by every little twitch and yawn the baby made. It was a good thing when it was abandoned; everyone relaxed, he said.

The changes made a huge difference. The average number of morphine doses dropped from 39 per infant to just 7 total doses among 23 infants in the first 7 months of the ESC initiative. Currently, morphine is used in only about 1 of 10 cases. “We estimate that we’ve given over 900 fewer doses” since ESC was put in place, Dr. Blount said.

Courtesy UNC Children's Hospital

“We had a lot of pushback initially, mostly from nursing staff and residents wondering how this was going to work. It quickly went away,” Dr. Blount said.

His team is now considering rolling ESC out to the newborn nursery and NICU.

There was no industry funding for the work, and Dr. Blount didn’t have any disclosures.

aotto@frontlinemedcom.com

ATLANTA – In just 7 months, the University of North Carolina Children’s Hospital, Chapel Hill, dropped the length of stay for neonatal abstinence syndrome from about 11 days to 5 days by moving from scheduled to PRN morphine dosing and abandoning the Finnegan score, according to a report at the Pediatric Hospital Medicine meeting.

The use of morphine fell from 93% of infants transferred to the hospital’s inpatient floors for neonatal abstinence syndrome (NAS) to just 12%, with no downsides for infants or moms.

“Our results have been incredibly encouraging,” said lead investigator and pediatrics resident Thomas Blount, MD. The take-home message is to treat the infant, rather than relying on the Finnegan score.

UNC Children’s, which treats about 50 infants a year for NAS on its inpatient floors, had been using the traditional approach: babies were automatically scheduled for morphine and Finnegan scoring – a withdrawal symptom checklist – every 4 hours, regardless of need. Sometimes infants weren’t even assessed to see if they actually needed morphine before the next dose was given.

“Waking babies up every 4 hours just seemed crazy; of course, they were going to have heightened neurologic signs and symptoms.” Meanwhile, families and providers were frustrated that infants who were otherwise doing well were held for an extra week or more to wean them off morphine, Dr. Blount said at the meeting.

In Nov. 2017, the hospital switched to the eat/sleep/console (ESC) model for NAS on its inpatient floors. The model emphasizes what’s been shown to work in recent years: keeping the infant with the mother; encouraging breast feeding, skin-on-skin contact, and other comfort measures; and supplementing feeds to help with weight gain. Morphine is reserved for when those measures fail and given only with a needs assessment (Hosp Pediatr. 2018 Jan;8(1):1-6).

The hospital ditched Finnegan scoring on its inpatient floors. Nurses were asked instead to check if infants were feeding adequately, sleeping at least an hour between feedings, and able to be consoled within 10 minutes when upset. If the infants met all three of those ESC criteria, providers moved on. They left the baby swaddled, relied on ambient white noise of ocean waves, and checked back on them later. “They didn’t mess with them,” Dr. Blount said at the meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Finnegan scoring “was causing so much anxiety. Staff and families became hypervigilant,” set off by every little twitch and yawn the baby made. It was a good thing when it was abandoned; everyone relaxed, he said.

The changes made a huge difference. The average number of morphine doses dropped from 39 per infant to just 7 total doses among 23 infants in the first 7 months of the ESC initiative. Currently, morphine is used in only about 1 of 10 cases. “We estimate that we’ve given over 900 fewer doses” since ESC was put in place, Dr. Blount said.

Courtesy UNC Children's Hospital

“We had a lot of pushback initially, mostly from nursing staff and residents wondering how this was going to work. It quickly went away,” Dr. Blount said.

His team is now considering rolling ESC out to the newborn nursery and NICU.

There was no industry funding for the work, and Dr. Blount didn’t have any disclosures.

aotto@frontlinemedcom.com

ATLANTA – In just 7 months, the University of North Carolina Children’s Hospital, Chapel Hill, dropped the length of stay for neonatal abstinence syndrome from about 11 days to 5 days by moving from scheduled to PRN morphine dosing and abandoning the Finnegan score, according to a report at the Pediatric Hospital Medicine meeting.

The use of morphine fell from 93% of infants transferred to the hospital’s inpatient floors for neonatal abstinence syndrome (NAS) to just 12%, with no downsides for infants or moms.

“Our results have been incredibly encouraging,” said lead investigator and pediatrics resident Thomas Blount, MD. The take-home message is to treat the infant, rather than relying on the Finnegan score.

UNC Children’s, which treats about 50 infants a year for NAS on its inpatient floors, had been using the traditional approach: babies were automatically scheduled for morphine and Finnegan scoring – a withdrawal symptom checklist – every 4 hours, regardless of need. Sometimes infants weren’t even assessed to see if they actually needed morphine before the next dose was given.

“Waking babies up every 4 hours just seemed crazy; of course, they were going to have heightened neurologic signs and symptoms.” Meanwhile, families and providers were frustrated that infants who were otherwise doing well were held for an extra week or more to wean them off morphine, Dr. Blount said at the meeting.

In Nov. 2017, the hospital switched to the eat/sleep/console (ESC) model for NAS on its inpatient floors. The model emphasizes what’s been shown to work in recent years: keeping the infant with the mother; encouraging breast feeding, skin-on-skin contact, and other comfort measures; and supplementing feeds to help with weight gain. Morphine is reserved for when those measures fail and given only with a needs assessment (Hosp Pediatr. 2018 Jan;8(1):1-6).

The hospital ditched Finnegan scoring on its inpatient floors. Nurses were asked instead to check if infants were feeding adequately, sleeping at least an hour between feedings, and able to be consoled within 10 minutes when upset. If the infants met all three of those ESC criteria, providers moved on. They left the baby swaddled, relied on ambient white noise of ocean waves, and checked back on them later. “They didn’t mess with them,” Dr. Blount said at the meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Finnegan scoring “was causing so much anxiety. Staff and families became hypervigilant,” set off by every little twitch and yawn the baby made. It was a good thing when it was abandoned; everyone relaxed, he said.

The changes made a huge difference. The average number of morphine doses dropped from 39 per infant to just 7 total doses among 23 infants in the first 7 months of the ESC initiative. Currently, morphine is used in only about 1 of 10 cases. “We estimate that we’ve given over 900 fewer doses” since ESC was put in place, Dr. Blount said.

Courtesy UNC Children's Hospital

“We had a lot of pushback initially, mostly from nursing staff and residents wondering how this was going to work. It quickly went away,” Dr. Blount said.

His team is now considering rolling ESC out to the newborn nursery and NICU.

There was no industry funding for the work, and Dr. Blount didn’t have any disclosures.

aotto@frontlinemedcom.com

The European Commission has expanded the approved indication for blinatumomab (Blincyto), a bispecific, CD19-directed, CD3 T-cell engager immunotherapy.

Blinatumomab is now approved as monotherapy for children aged 1 year or older who have relapsed/refractory, Philadelphia chromosome–negative, CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). The patients must have received at least two prior therapies, or they must have relapsed after allogeneic hematopoietic stem cell transplant.

The European Commission’s (EC) new approval of blinatumomab extends to all countries in the European Union, as well as Norway, Iceland, and Liechtenstein.

In 2015, the EC approved blinatumomab to treat adults with Philadelphia chromosome–negative, relapsed/refractory B-cell precursor ALL.The EC’s approval of blinatumomab in pediatric patients is based on results from a phase 1/2 study published in the Journal of Clinical Oncology in 2016. The study included 93 pediatric patients with relapsed/refractory B-cell precursor ALL. Patients received blinatumomab as a continuous intravenous infusion – 49 patients in the phase 1 portion of the trial and 44 in phase 2. The patients were followed for 2 years.

There were four dose-limiting toxicities during the phase 1 portion of the trial, two of which were fatal. Three patients had grade 4 cytokine release syndrome (CRS), one had grade 5 cardiac failure (as well as grade 4 CRS), and one had grade 5 respiratory failure. Based on the dose-limiting toxicities, the maximum tolerated dose of blinatumomab was 15 mcg/m2 per day, but a stepwise dosage was recommended to reduce the risk of CRS.

The recommended dose was 5 mcg/m² per day on days 1-7 and 15 mcg/m² per day on days 8-28 for cycle 1, and 15 mcg/m² per day on days 1-28 for subsequent cycles, according to the study results.Among the 70 patients who received the recommended dose of blinatumomab, 27 (39%) achieved a complete response within the first two cycles. A total of 14 of these patients (52%) achieved minimal residual disease negativity.

jensmith@mdedge.com

The European Commission has expanded the approved indication for blinatumomab (Blincyto), a bispecific, CD19-directed, CD3 T-cell engager immunotherapy.

Blinatumomab is now approved as monotherapy for children aged 1 year or older who have relapsed/refractory, Philadelphia chromosome–negative, CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). The patients must have received at least two prior therapies, or they must have relapsed after allogeneic hematopoietic stem cell transplant.

The European Commission’s (EC) new approval of blinatumomab extends to all countries in the European Union, as well as Norway, Iceland, and Liechtenstein.

In 2015, the EC approved blinatumomab to treat adults with Philadelphia chromosome–negative, relapsed/refractory B-cell precursor ALL.The EC’s approval of blinatumomab in pediatric patients is based on results from a phase 1/2 study published in the Journal of Clinical Oncology in 2016. The study included 93 pediatric patients with relapsed/refractory B-cell precursor ALL. Patients received blinatumomab as a continuous intravenous infusion – 49 patients in the phase 1 portion of the trial and 44 in phase 2. The patients were followed for 2 years.

There were four dose-limiting toxicities during the phase 1 portion of the trial, two of which were fatal. Three patients had grade 4 cytokine release syndrome (CRS), one had grade 5 cardiac failure (as well as grade 4 CRS), and one had grade 5 respiratory failure. Based on the dose-limiting toxicities, the maximum tolerated dose of blinatumomab was 15 mcg/m2 per day, but a stepwise dosage was recommended to reduce the risk of CRS.

The recommended dose was 5 mcg/m² per day on days 1-7 and 15 mcg/m² per day on days 8-28 for cycle 1, and 15 mcg/m² per day on days 1-28 for subsequent cycles, according to the study results.Among the 70 patients who received the recommended dose of blinatumomab, 27 (39%) achieved a complete response within the first two cycles. A total of 14 of these patients (52%) achieved minimal residual disease negativity.

jensmith@mdedge.com

The European Commission has expanded the approved indication for blinatumomab (Blincyto), a bispecific, CD19-directed, CD3 T-cell engager immunotherapy.

Blinatumomab is now approved as monotherapy for children aged 1 year or older who have relapsed/refractory, Philadelphia chromosome–negative, CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). The patients must have received at least two prior therapies, or they must have relapsed after allogeneic hematopoietic stem cell transplant.

The European Commission’s (EC) new approval of blinatumomab extends to all countries in the European Union, as well as Norway, Iceland, and Liechtenstein.

In 2015, the EC approved blinatumomab to treat adults with Philadelphia chromosome–negative, relapsed/refractory B-cell precursor ALL.The EC’s approval of blinatumomab in pediatric patients is based on results from a phase 1/2 study published in the Journal of Clinical Oncology in 2016. The study included 93 pediatric patients with relapsed/refractory B-cell precursor ALL. Patients received blinatumomab as a continuous intravenous infusion – 49 patients in the phase 1 portion of the trial and 44 in phase 2. The patients were followed for 2 years.

There were four dose-limiting toxicities during the phase 1 portion of the trial, two of which were fatal. Three patients had grade 4 cytokine release syndrome (CRS), one had grade 5 cardiac failure (as well as grade 4 CRS), and one had grade 5 respiratory failure. Based on the dose-limiting toxicities, the maximum tolerated dose of blinatumomab was 15 mcg/m2 per day, but a stepwise dosage was recommended to reduce the risk of CRS.

The recommended dose was 5 mcg/m² per day on days 1-7 and 15 mcg/m² per day on days 8-28 for cycle 1, and 15 mcg/m² per day on days 1-28 for subsequent cycles, according to the study results.Among the 70 patients who received the recommended dose of blinatumomab, 27 (39%) achieved a complete response within the first two cycles. A total of 14 of these patients (52%) achieved minimal residual disease negativity.

jensmith@mdedge.com

In recent years, an increasing number of laser and radiofrequency device outpatient treatments have been heralded as safe and effective interventions for various gynecologic conditions. Laser devices and radiofrequency technology rapidly have been incorporated into certain clinical settings, including medical practices specializing in dermatology, plastic surgery, and gynecology. While this developing technology has excellent promise, many clinical and research questions remain unanswered.

Illustration: Kimberly Martens for OBG Management

Concerns about energy-based vaginal treatments

Although marketing material often suggests otherwise, most laser and radiofrequency devices are cleared by the US Food and Drug Administration (FDA) only for nonspecific gynecologic and hematologic interventions. However, both laser and radiofrequency device treatments, performed as outpatient procedures, have been touted as appropriate interventions for many conditions, including female sexual dysfunction, arousal and orgasmic concerns, vaginal laxity, vaginismus, lichen sclerosus, urinary incontinence, and vulvar vestibulitis.

Well-designed studies are needed. Prospective, randomized sham-controlled trials of energy-based devices are rare, and most data in the public domain are derived from case series. Many studies are of short duration with limited follow-up. Randomized controlled trials therefore are warranted and should have stringent inclusion and exclusion criteria. Body dysmorphic syndrome, for example, should be a trial exclusion. Study design for research should include the use of standardized, validated scales and long-term follow-up of participants.

Which specialists have the expertise to offer treatment? Important ethical and medical concerns regarding the technology need to be addressed. A prime concern is determining which health care professional specialist is best qualified to assess and treat underlying gynecologic conditions. It is not uncommon to see internists, emergency medicine providers, family physicians, plastic surgeons, psychiatrists, and dermatologists self-proclaiming their gynecologic “vaginal rejuvenation” expertise.

In my experience, some ObGyns have voiced concern about the diverse medical specialties involved in performing these procedures. Currently, no standard level of training is required to perform them. In addition, those providers lack the training needed to adequately and accurately assess the potential for confounding, underlying gynecologic pathology, and they are inadequately trained to offer patients the full gamut of therapeutic interventions. Many may be unfamiliar with female pelvic anatomy and sexual function and a multidisciplinary treatment paradigm.

We need established standards. A common vernacular, nosology, classification, and decision-tree assessment paradigm for genitopelvic laxity (related to the condition of the pelvic floor and not simply a loose feeling in the vagina) is lacking, which may make research and peer-to-peer discussions difficult.

Which patients are appropriate candidates? Proper patient selection criteria for energy-based vaginal treatment have not been standardized, yet this remains a paramount need. A comprehensive patient evaluation should be performed and include a discussion on the difference between an aesthetic complaint and a functional medical problem. Assessment should include the patient’s level of concern or distress and the impact of her symptoms on her overall quality of life. Patients should be evaluated for body dysmorphic syndrome and relationship discord. A complete physical examination, including a detailed pelvic assessment, often is indicated. A treatment algorithm that incorporates conservative therapies coupled with medical, technologic, and psychologic interventions also should be developed.

Various energy-based devices are available for outpatient procedures

Although the number of procedures performed (such as vaginal rejuvenation, labiaplasty, vulvar liposculpturing, hymenoplasty, G-spot amplification, and O-Shot treatment) for both cosmetic and functional problems has increased, the published scientific data on the procedures’ short- and long-term efficacy and safety are limited. The American College of Obstetricians and Gynecologists (ACOG) published a committee opinion stating that many of these procedures, including “vaginal rejuvenation,” may not be considered medically indicated and may lack scientific merit or ample supportive data to confirm their efficacy and safety.¹ ObGyns should proceed with caution before incorporating these technologic treatments into their medical practice.

Much diversity exists within the device-technology space. The underpinnings of each device vary regarding their proposed mechanism of action and theoretical therapeutic and tissue effect. In device marketing materials, many devices have been claimed to have effects on multiple tissue types (for example, both vaginal mucosa and vulvar tissue), whereas others are said to have more focal and localized effects (that is, targeted behind the hymenal ring). Some are marketed as a one-time treatment, while others require multiple repeated treatments over an extended period. When it comes to published data, adverse effect reporting remains limited and follow-up data often are short term.

Radiofrequency and laser devices are separate and very distinct technologies with similar and differing proposed utilizations. Combining radiofrequency and laser treatments in tandem or sequentially may have clinical utility, but long-term safety may be a concern for lasers.

Radiofrequency-based devices

Typically, radiofrequency device treatments:

• are used for outpatient procedures
• do not require topical anesthesia
• are constructed to emit focused electromagnetic waves
• are applied to vaginal, vulvar, or vaginal introital or vestibular tissue
• deliver energy to the deeper connective tissue of the vaginal wall architecture.

Radiofrequency device energy can be monopolar, unipolar, bipolar, or multipolar depending on design. Design also dictates current and the number of electrodes that pass from the device to the grounding pad. Monopolar is the only type of radiofrequency that has a grounding pad; bipolar and multipolar energy returns to the treatment tip.

Radiofrequency devices typically are FDA 510(k)-cleared devices for nonspecific electrocoagulation and hemostasis for surgical procedures. None are currently FDA cleared in the United States for the treatment of vaginal or vulvar laxity or genitourinary syndrome of menopause (GSM). These energy-based devices aim to induce collagen contraction, neocollagenesis, vascularization, and growth factor infiltration to restore the elasticity and moisture of the underlying vaginal mucosa. Heat shock protein activation and inflammation activation are thought to be the underlying mechanisms of action.^2–5

Treatment outcomes with 2 radiofrequency devices

Multiple prospective small case series studies have reported outcomes of women treated with the ThermiVa (ThermiAesthetics LLC) radiofrequency system.^3,4 Typically, 3 treatments (with a between-treatment interval of 4 to 6 weeks) were applied. The clinical end point temperature had a range of 40°C to 45°C, which was maintained for 3 to 5 minutes per treated zone during 30 minutes’ total treatment time.

Some participants self-reported improvement in vaginal laxity symptoms with the 3 treatments. In addition, women reported subjective improvements in both vaginal atrophy symptoms and sexual function, including positive effect in multiple domains. No serious adverse events were reported in these case series. However, there was no placebo-controlled arm, and validated questionnaires were not used in much of this research.^3,4

In another trial, the ThermiVa system was studied in a cohort of 25 sexually active women with self-reported anorgasmia or increased latency to orgasmic response.⁶ Participants received 3 treatments 4 weeks apart. Approximately three-quarters of the participants reported improved orgasmic responsivity, vaginal lubrication, and clitoral sensitivity. Notably, this research did not use validated questionnaires or a placebo or sham-controlled design. The authors suggested sustained treatment benefits at 9 to 12 months. While repeat treatment was advocated, data were lacking to support the optimal time for repeat treatment efficacy.⁶

A cryogen-cooled monopolar radiofrequency device, the Viveve system (Viveve Medical, Inc) differs from other radiofrequency procedures because it systematically cryogen cools and protects the surface of the vaginal mucosal tissue while heating the underlying structures.

The Viveve system was evaluated in 2 small pilot studies (24 and 30 participants) and in a large, randomized, sham-controlled, prospective trial that included 108 participants (VIVEVE I trial).^5,7,8 Results from both preliminary small studies indicated that participants experienced significant improvement in overall sexual function at 6 months. In one of the small studies (in Japanese women), sustained efficacy at 12 months posttreatment was reported.⁷ Neither small study included a placebo-control arm, but they did include the use of validated questionnaires.

In the VIVEVE I trial (a multicenter international study), treatment in the active group consisted of a single, 30-minute outpatient procedure that delivered 90 J/cm² of radiofrequency energy at the level just behind the hymenal ring behind the vaginal introitus. The sham-treated group received ≤1 J/cm² of energy with a similar machine tip.⁸

Statistically significant improvements were reported in the arousal and orgasm domains of the validated Female Sexual Function Index (FSFI) for the active-treatment group compared with the sham-treated group. In addition, there were statistically significant differences in the FSFI and the Female Sexual Distress Scale–Revised total scores in favor of active treatment. Participants in the active-treatment arm reported statistically significant improvement in overall sexual satisfaction coupled with lowered overall sexual distress.⁸

These data are provocative, since the Viveve treatment demonstrated superior efficacy compared with the sham treatment, and prior evidence demonstrated that medical device trials employing a sham arm often demonstrate particularly large placebo/sham effects.⁹ A confirmatory randomized, sham-controlled multicenter US-based trial is currently underway. At present, the VIVEVE I trial remains the only published, large-scale, randomized, sham-controlled, blinded study of a radiofrequency-based treatment.

New emerging data support the efficacy and safety of this specific radiofrequency treatment in patients with mild to moderate urinary stress incontinence; further studies confirming these outcomes are anticipated. The Viveve system is approved in many countries for various conditions, including urinary incontinence (1 country), sexual function (17 countries), vaginal laxity (41 countries), and electrocoagulation and hemostasis (4 countries, including the United States).

Laser technology devices

Laser (Light Amplification by Stimulated Emission of Radiation) therapy, which uses a carbon dioxide (CO2), argon, YAG, or erbium energy source, also is currently marketed as a method to improve various gynecologic conditions, including genital pelvic relaxation syndrome, vaginal laxity, GSM, lichen sclerosus, and sexual problems such as dyspareunia and arousal or orgasmic disorders.

The CO2 laser therapy device, such as the MonaLisa Touch (DEKA Laser), appears to be very popular and widely available. It delivers fractional CO2 laser energy to the vaginal wall, creating sequential micro traumas that subsequently undergo a healing reaction; the newly healed area has an improved underlying tissue architecture (but at a superficial level). The laser’s proposed mechanism of action is that it ablates only a minute fraction of the superficial lamina propria; it acts primarily to stimulate rapid healing of the tissue, creating new collagen and elastic fibers. There is no evidence of scarring.¹⁰

Treatment outcomes with laser device therapy

Authors of a 2017 study series of CO2 laser treatments in women with moderate to severe GSM found that 84% of participants experienced significant improvement in sexual function, dyspareunia, and otherwise unspecified sexual issues from pretreatment to 12 to 24 months posttreatment.¹¹ These findings are consistent with several other case series and provide supportive evidence for the efficacy and safety of CO2 laser therapy. This technology may be appropriate for the treatment of GSM.

Laser technology shows excellent promise for the treatment of GSM symptoms by virtue of its superficial mechanism of action. In addition, several trials have demonstrated efficacy and safety in breast cancer patient populations.¹² This is particularly interesting since breast cancer treatments, such as aromatase inhibitors (considered a mainstay of cancer treatment), can cause severe atrophic vaginitis. Breast cancer survivors often avoid minimally absorbed local vaginal hormonal products, and over-the-counter products (moisturizers and lubricants) are not widely accepted. Hence, a nonhormonal treatment for distressing GSM symptoms is welcomed in this population.

Pagano and colleagues recently studied 82 breast cancer survivors in whom treatment with vaginal moisturizers and lubricants failed.¹² Participants underwent 3 laser treatment cycles approximately 30 to 40 days apart; they demonstrated improvements in vaginal dryness, vaginal itchiness, stinging, dyspareunia, and reduced sensitivity.

Microablative fractional CO2 laser may help reestablish a normative vaginal microbiome by altering the prevalence of lactobacillus species and reestablishing a normative postmenopausal vaginal flora.¹³

The tracking and reporting of adverse events associated with laser procedures has been less than optimal. In my personal clinical experience, consequences from both short- and long-term laser treatments have included vaginal canal agglutination, worsening dyspareunia, and constricture causing vaginal hemorrhage.

Cruz and colleagues recently conducted a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy of fractional CO2 laser compared with topical estriol and laser plus estriol for the treatment of vaginal atrophy in 45 postmenopausal women.¹⁴ They found statistically significant differences in dyspareunia, dryness, and burning compared with baseline levels in all 3 treatment groups. Results with the fractional CO2 laser treatment were deemed to be similar to those of the topical estriol and the combined therapy.¹⁴

By contrast, an erbium (Er):YAG laser, such as the IntimaLase (Fotona, LLC) laser, functions by heating the pelvic tissue and collagen within the introitus and vaginal canal.^15,16 When the underlying collagen is heated, the fibers are thought to thicken and shorten, which may result in immediate contracture of the treated tissue. Additionally, this process stimulates the existing collagen to undergo remodeling and it also may cause neocollagen deposition.¹⁵ In a general review of gynecologic procedures, after 1 to 4 treatment sessions (depending on the study), most patients reported improved sexual satisfaction or vaginal tightness.¹⁵

Although trials have included small numbers of patients, early evidence suggests some lasers with reportedly deeper penetration may be useful for treatment of vaginal laxity, but further studies are needed. In smaller studies, the Er:YAG laser has shown efficacy and safety in the treatment of stress urinary incontinence and improved lower urinary tract symptoms, quality of life, and sexual function.^16,17

Insurance does not cover energy-based treatment costs

Currently, both laser and radiofrequency device treatments are considered fee-for-service interventions. Radiofrequency and laser treatments for gynecologic conditions are not covered by health insurance, and treatment costs can be prohibitive for many patients. In addition, the long-term safety of these treatments remains to be studied further, and the optimal time for a repeat procedure has yet to be elucidated.

The FDA cautions against energy-based procedures

In July 2018, the FDA released a statement of concern reiterating the need for research and randomized clinical trials before energy-based device treatments can be widely accepted, and that they are currently cleared only for general gynecologic indications and not for disorders and symptoms related to menopause, urinary incontinence, or sexual function.¹⁸

The FDA stated that “we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions [vaginal laxity; vaginal atrophy, dryness, or itching; pain during sexual intercourse; pain during urination; decreased sexual sensation], or any symptoms related to menopause, urinary incontinence, or sexual function.” The FDA noted that serious complications have been reported, including vaginal burns, scarring, pain during sexual intercourse, and recurring, chronic pain. The FDA issued letters to 7 companies regarding concerns about the marketing of their devices for off-label use and promotion.

Several societies have responded. ACOG reaffirmed its 2016 position statement on fractional laser treatment of vulvovaginal atrophy.¹⁹ JoAnn Pinkerton, MD, Executive Director of The North American Menopause Society (NAMS), and Sheryl Kingsberg, PhD, President of NAMS, alerted their members that both health care professionals and consumers should tread cautiously, and they encouraged scrutiny of existing evidence as all energy-based treatments are not created equal.²⁰ They noted that some research does exist and cited 2 randomized, sham-controlled clinical trials that have been published.

Looking forward

Various novel technologic therapies are entering the gynecologic market. ObGyns must critically evaluate these emerging technologies with a keen understanding of their underlying mechanism of action, the level of scientific evidence, and the treatment’s proposed therapeutic value.

Radiofrequency energy devices appear to be better positioned to treat urinary incontinence and vaginal relaxation syndrome because of their capability for deep tissue penetration. Current data show that laser technology has excellent promise for the treatment and management of GSM. Both technologies warrant further investigation in long-term randomized, sham-controlled trials that assess efficacy and safety with validated instruments over an extended period. In addition, should these technologies prove useful in the overall treatment armamentarium for gynecologic conditions, the question of affordability and insurance coverage needs to be addressed.

ObGyns must advocate for female sexual wellness and encourage a comprehensive multidisciplinary team approach for offering various therapies. Ultimately, responsible use of evidence-based innovative technology should be incorporated into the treatment paradigm.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

In recent years, an increasing number of laser and radiofrequency device outpatient treatments have been heralded as safe and effective interventions for various gynecologic conditions. Laser devices and radiofrequency technology rapidly have been incorporated into certain clinical settings, including medical practices specializing in dermatology, plastic surgery, and gynecology. While this developing technology has excellent promise, many clinical and research questions remain unanswered.

Illustration: Kimberly Martens for OBG Management

Concerns about energy-based vaginal treatments

Although marketing material often suggests otherwise, most laser and radiofrequency devices are cleared by the US Food and Drug Administration (FDA) only for nonspecific gynecologic and hematologic interventions. However, both laser and radiofrequency device treatments, performed as outpatient procedures, have been touted as appropriate interventions for many conditions, including female sexual dysfunction, arousal and orgasmic concerns, vaginal laxity, vaginismus, lichen sclerosus, urinary incontinence, and vulvar vestibulitis.

Well-designed studies are needed. Prospective, randomized sham-controlled trials of energy-based devices are rare, and most data in the public domain are derived from case series. Many studies are of short duration with limited follow-up. Randomized controlled trials therefore are warranted and should have stringent inclusion and exclusion criteria. Body dysmorphic syndrome, for example, should be a trial exclusion. Study design for research should include the use of standardized, validated scales and long-term follow-up of participants.

Which specialists have the expertise to offer treatment? Important ethical and medical concerns regarding the technology need to be addressed. A prime concern is determining which health care professional specialist is best qualified to assess and treat underlying gynecologic conditions. It is not uncommon to see internists, emergency medicine providers, family physicians, plastic surgeons, psychiatrists, and dermatologists self-proclaiming their gynecologic “vaginal rejuvenation” expertise.

In my experience, some ObGyns have voiced concern about the diverse medical specialties involved in performing these procedures. Currently, no standard level of training is required to perform them. In addition, those providers lack the training needed to adequately and accurately assess the potential for confounding, underlying gynecologic pathology, and they are inadequately trained to offer patients the full gamut of therapeutic interventions. Many may be unfamiliar with female pelvic anatomy and sexual function and a multidisciplinary treatment paradigm.

We need established standards. A common vernacular, nosology, classification, and decision-tree assessment paradigm for genitopelvic laxity (related to the condition of the pelvic floor and not simply a loose feeling in the vagina) is lacking, which may make research and peer-to-peer discussions difficult.

Which patients are appropriate candidates? Proper patient selection criteria for energy-based vaginal treatment have not been standardized, yet this remains a paramount need. A comprehensive patient evaluation should be performed and include a discussion on the difference between an aesthetic complaint and a functional medical problem. Assessment should include the patient’s level of concern or distress and the impact of her symptoms on her overall quality of life. Patients should be evaluated for body dysmorphic syndrome and relationship discord. A complete physical examination, including a detailed pelvic assessment, often is indicated. A treatment algorithm that incorporates conservative therapies coupled with medical, technologic, and psychologic interventions also should be developed.

Various energy-based devices are available for outpatient procedures

Although the number of procedures performed (such as vaginal rejuvenation, labiaplasty, vulvar liposculpturing, hymenoplasty, G-spot amplification, and O-Shot treatment) for both cosmetic and functional problems has increased, the published scientific data on the procedures’ short- and long-term efficacy and safety are limited. The American College of Obstetricians and Gynecologists (ACOG) published a committee opinion stating that many of these procedures, including “vaginal rejuvenation,” may not be considered medically indicated and may lack scientific merit or ample supportive data to confirm their efficacy and safety.¹ ObGyns should proceed with caution before incorporating these technologic treatments into their medical practice.

Much diversity exists within the device-technology space. The underpinnings of each device vary regarding their proposed mechanism of action and theoretical therapeutic and tissue effect. In device marketing materials, many devices have been claimed to have effects on multiple tissue types (for example, both vaginal mucosa and vulvar tissue), whereas others are said to have more focal and localized effects (that is, targeted behind the hymenal ring). Some are marketed as a one-time treatment, while others require multiple repeated treatments over an extended period. When it comes to published data, adverse effect reporting remains limited and follow-up data often are short term.

Radiofrequency and laser devices are separate and very distinct technologies with similar and differing proposed utilizations. Combining radiofrequency and laser treatments in tandem or sequentially may have clinical utility, but long-term safety may be a concern for lasers.

Radiofrequency-based devices

Typically, radiofrequency device treatments:

• are used for outpatient procedures
• do not require topical anesthesia
• are constructed to emit focused electromagnetic waves
• are applied to vaginal, vulvar, or vaginal introital or vestibular tissue
• deliver energy to the deeper connective tissue of the vaginal wall architecture.

Radiofrequency device energy can be monopolar, unipolar, bipolar, or multipolar depending on design. Design also dictates current and the number of electrodes that pass from the device to the grounding pad. Monopolar is the only type of radiofrequency that has a grounding pad; bipolar and multipolar energy returns to the treatment tip.

Radiofrequency devices typically are FDA 510(k)-cleared devices for nonspecific electrocoagulation and hemostasis for surgical procedures. None are currently FDA cleared in the United States for the treatment of vaginal or vulvar laxity or genitourinary syndrome of menopause (GSM). These energy-based devices aim to induce collagen contraction, neocollagenesis, vascularization, and growth factor infiltration to restore the elasticity and moisture of the underlying vaginal mucosa. Heat shock protein activation and inflammation activation are thought to be the underlying mechanisms of action.^2–5

Treatment outcomes with 2 radiofrequency devices

Multiple prospective small case series studies have reported outcomes of women treated with the ThermiVa (ThermiAesthetics LLC) radiofrequency system.^3,4 Typically, 3 treatments (with a between-treatment interval of 4 to 6 weeks) were applied. The clinical end point temperature had a range of 40°C to 45°C, which was maintained for 3 to 5 minutes per treated zone during 30 minutes’ total treatment time.

Some participants self-reported improvement in vaginal laxity symptoms with the 3 treatments. In addition, women reported subjective improvements in both vaginal atrophy symptoms and sexual function, including positive effect in multiple domains. No serious adverse events were reported in these case series. However, there was no placebo-controlled arm, and validated questionnaires were not used in much of this research.^3,4

In another trial, the ThermiVa system was studied in a cohort of 25 sexually active women with self-reported anorgasmia or increased latency to orgasmic response.⁶ Participants received 3 treatments 4 weeks apart. Approximately three-quarters of the participants reported improved orgasmic responsivity, vaginal lubrication, and clitoral sensitivity. Notably, this research did not use validated questionnaires or a placebo or sham-controlled design. The authors suggested sustained treatment benefits at 9 to 12 months. While repeat treatment was advocated, data were lacking to support the optimal time for repeat treatment efficacy.⁶

A cryogen-cooled monopolar radiofrequency device, the Viveve system (Viveve Medical, Inc) differs from other radiofrequency procedures because it systematically cryogen cools and protects the surface of the vaginal mucosal tissue while heating the underlying structures.

The Viveve system was evaluated in 2 small pilot studies (24 and 30 participants) and in a large, randomized, sham-controlled, prospective trial that included 108 participants (VIVEVE I trial).^5,7,8 Results from both preliminary small studies indicated that participants experienced significant improvement in overall sexual function at 6 months. In one of the small studies (in Japanese women), sustained efficacy at 12 months posttreatment was reported.⁷ Neither small study included a placebo-control arm, but they did include the use of validated questionnaires.

In the VIVEVE I trial (a multicenter international study), treatment in the active group consisted of a single, 30-minute outpatient procedure that delivered 90 J/cm² of radiofrequency energy at the level just behind the hymenal ring behind the vaginal introitus. The sham-treated group received ≤1 J/cm² of energy with a similar machine tip.⁸

Statistically significant improvements were reported in the arousal and orgasm domains of the validated Female Sexual Function Index (FSFI) for the active-treatment group compared with the sham-treated group. In addition, there were statistically significant differences in the FSFI and the Female Sexual Distress Scale–Revised total scores in favor of active treatment. Participants in the active-treatment arm reported statistically significant improvement in overall sexual satisfaction coupled with lowered overall sexual distress.⁸

These data are provocative, since the Viveve treatment demonstrated superior efficacy compared with the sham treatment, and prior evidence demonstrated that medical device trials employing a sham arm often demonstrate particularly large placebo/sham effects.⁹ A confirmatory randomized, sham-controlled multicenter US-based trial is currently underway. At present, the VIVEVE I trial remains the only published, large-scale, randomized, sham-controlled, blinded study of a radiofrequency-based treatment.

New emerging data support the efficacy and safety of this specific radiofrequency treatment in patients with mild to moderate urinary stress incontinence; further studies confirming these outcomes are anticipated. The Viveve system is approved in many countries for various conditions, including urinary incontinence (1 country), sexual function (17 countries), vaginal laxity (41 countries), and electrocoagulation and hemostasis (4 countries, including the United States).

Laser technology devices

Laser (Light Amplification by Stimulated Emission of Radiation) therapy, which uses a carbon dioxide (CO2), argon, YAG, or erbium energy source, also is currently marketed as a method to improve various gynecologic conditions, including genital pelvic relaxation syndrome, vaginal laxity, GSM, lichen sclerosus, and sexual problems such as dyspareunia and arousal or orgasmic disorders.

The CO2 laser therapy device, such as the MonaLisa Touch (DEKA Laser), appears to be very popular and widely available. It delivers fractional CO2 laser energy to the vaginal wall, creating sequential micro traumas that subsequently undergo a healing reaction; the newly healed area has an improved underlying tissue architecture (but at a superficial level). The laser’s proposed mechanism of action is that it ablates only a minute fraction of the superficial lamina propria; it acts primarily to stimulate rapid healing of the tissue, creating new collagen and elastic fibers. There is no evidence of scarring.¹⁰

Treatment outcomes with laser device therapy

Authors of a 2017 study series of CO2 laser treatments in women with moderate to severe GSM found that 84% of participants experienced significant improvement in sexual function, dyspareunia, and otherwise unspecified sexual issues from pretreatment to 12 to 24 months posttreatment.¹¹ These findings are consistent with several other case series and provide supportive evidence for the efficacy and safety of CO2 laser therapy. This technology may be appropriate for the treatment of GSM.

Laser technology shows excellent promise for the treatment of GSM symptoms by virtue of its superficial mechanism of action. In addition, several trials have demonstrated efficacy and safety in breast cancer patient populations.¹² This is particularly interesting since breast cancer treatments, such as aromatase inhibitors (considered a mainstay of cancer treatment), can cause severe atrophic vaginitis. Breast cancer survivors often avoid minimally absorbed local vaginal hormonal products, and over-the-counter products (moisturizers and lubricants) are not widely accepted. Hence, a nonhormonal treatment for distressing GSM symptoms is welcomed in this population.

Pagano and colleagues recently studied 82 breast cancer survivors in whom treatment with vaginal moisturizers and lubricants failed.¹² Participants underwent 3 laser treatment cycles approximately 30 to 40 days apart; they demonstrated improvements in vaginal dryness, vaginal itchiness, stinging, dyspareunia, and reduced sensitivity.

Microablative fractional CO2 laser may help reestablish a normative vaginal microbiome by altering the prevalence of lactobacillus species and reestablishing a normative postmenopausal vaginal flora.¹³

The tracking and reporting of adverse events associated with laser procedures has been less than optimal. In my personal clinical experience, consequences from both short- and long-term laser treatments have included vaginal canal agglutination, worsening dyspareunia, and constricture causing vaginal hemorrhage.

Cruz and colleagues recently conducted a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy of fractional CO2 laser compared with topical estriol and laser plus estriol for the treatment of vaginal atrophy in 45 postmenopausal women.¹⁴ They found statistically significant differences in dyspareunia, dryness, and burning compared with baseline levels in all 3 treatment groups. Results with the fractional CO2 laser treatment were deemed to be similar to those of the topical estriol and the combined therapy.¹⁴

By contrast, an erbium (Er):YAG laser, such as the IntimaLase (Fotona, LLC) laser, functions by heating the pelvic tissue and collagen within the introitus and vaginal canal.^15,16 When the underlying collagen is heated, the fibers are thought to thicken and shorten, which may result in immediate contracture of the treated tissue. Additionally, this process stimulates the existing collagen to undergo remodeling and it also may cause neocollagen deposition.¹⁵ In a general review of gynecologic procedures, after 1 to 4 treatment sessions (depending on the study), most patients reported improved sexual satisfaction or vaginal tightness.¹⁵

Although trials have included small numbers of patients, early evidence suggests some lasers with reportedly deeper penetration may be useful for treatment of vaginal laxity, but further studies are needed. In smaller studies, the Er:YAG laser has shown efficacy and safety in the treatment of stress urinary incontinence and improved lower urinary tract symptoms, quality of life, and sexual function.^16,17

Insurance does not cover energy-based treatment costs

Currently, both laser and radiofrequency device treatments are considered fee-for-service interventions. Radiofrequency and laser treatments for gynecologic conditions are not covered by health insurance, and treatment costs can be prohibitive for many patients. In addition, the long-term safety of these treatments remains to be studied further, and the optimal time for a repeat procedure has yet to be elucidated.

The FDA cautions against energy-based procedures

In July 2018, the FDA released a statement of concern reiterating the need for research and randomized clinical trials before energy-based device treatments can be widely accepted, and that they are currently cleared only for general gynecologic indications and not for disorders and symptoms related to menopause, urinary incontinence, or sexual function.¹⁸

The FDA stated that “we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions [vaginal laxity; vaginal atrophy, dryness, or itching; pain during sexual intercourse; pain during urination; decreased sexual sensation], or any symptoms related to menopause, urinary incontinence, or sexual function.” The FDA noted that serious complications have been reported, including vaginal burns, scarring, pain during sexual intercourse, and recurring, chronic pain. The FDA issued letters to 7 companies regarding concerns about the marketing of their devices for off-label use and promotion.

Several societies have responded. ACOG reaffirmed its 2016 position statement on fractional laser treatment of vulvovaginal atrophy.¹⁹ JoAnn Pinkerton, MD, Executive Director of The North American Menopause Society (NAMS), and Sheryl Kingsberg, PhD, President of NAMS, alerted their members that both health care professionals and consumers should tread cautiously, and they encouraged scrutiny of existing evidence as all energy-based treatments are not created equal.²⁰ They noted that some research does exist and cited 2 randomized, sham-controlled clinical trials that have been published.

Looking forward

Various novel technologic therapies are entering the gynecologic market. ObGyns must critically evaluate these emerging technologies with a keen understanding of their underlying mechanism of action, the level of scientific evidence, and the treatment’s proposed therapeutic value.

Radiofrequency energy devices appear to be better positioned to treat urinary incontinence and vaginal relaxation syndrome because of their capability for deep tissue penetration. Current data show that laser technology has excellent promise for the treatment and management of GSM. Both technologies warrant further investigation in long-term randomized, sham-controlled trials that assess efficacy and safety with validated instruments over an extended period. In addition, should these technologies prove useful in the overall treatment armamentarium for gynecologic conditions, the question of affordability and insurance coverage needs to be addressed.

ObGyns must advocate for female sexual wellness and encourage a comprehensive multidisciplinary team approach for offering various therapies. Ultimately, responsible use of evidence-based innovative technology should be incorporated into the treatment paradigm.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

In recent years, an increasing number of laser and radiofrequency device outpatient treatments have been heralded as safe and effective interventions for various gynecologic conditions. Laser devices and radiofrequency technology rapidly have been incorporated into certain clinical settings, including medical practices specializing in dermatology, plastic surgery, and gynecology. While this developing technology has excellent promise, many clinical and research questions remain unanswered.

Illustration: Kimberly Martens for OBG Management

Concerns about energy-based vaginal treatments

Although marketing material often suggests otherwise, most laser and radiofrequency devices are cleared by the US Food and Drug Administration (FDA) only for nonspecific gynecologic and hematologic interventions. However, both laser and radiofrequency device treatments, performed as outpatient procedures, have been touted as appropriate interventions for many conditions, including female sexual dysfunction, arousal and orgasmic concerns, vaginal laxity, vaginismus, lichen sclerosus, urinary incontinence, and vulvar vestibulitis.

Well-designed studies are needed. Prospective, randomized sham-controlled trials of energy-based devices are rare, and most data in the public domain are derived from case series. Many studies are of short duration with limited follow-up. Randomized controlled trials therefore are warranted and should have stringent inclusion and exclusion criteria. Body dysmorphic syndrome, for example, should be a trial exclusion. Study design for research should include the use of standardized, validated scales and long-term follow-up of participants.

Which specialists have the expertise to offer treatment? Important ethical and medical concerns regarding the technology need to be addressed. A prime concern is determining which health care professional specialist is best qualified to assess and treat underlying gynecologic conditions. It is not uncommon to see internists, emergency medicine providers, family physicians, plastic surgeons, psychiatrists, and dermatologists self-proclaiming their gynecologic “vaginal rejuvenation” expertise.

In my experience, some ObGyns have voiced concern about the diverse medical specialties involved in performing these procedures. Currently, no standard level of training is required to perform them. In addition, those providers lack the training needed to adequately and accurately assess the potential for confounding, underlying gynecologic pathology, and they are inadequately trained to offer patients the full gamut of therapeutic interventions. Many may be unfamiliar with female pelvic anatomy and sexual function and a multidisciplinary treatment paradigm.

We need established standards. A common vernacular, nosology, classification, and decision-tree assessment paradigm for genitopelvic laxity (related to the condition of the pelvic floor and not simply a loose feeling in the vagina) is lacking, which may make research and peer-to-peer discussions difficult.

Which patients are appropriate candidates? Proper patient selection criteria for energy-based vaginal treatment have not been standardized, yet this remains a paramount need. A comprehensive patient evaluation should be performed and include a discussion on the difference between an aesthetic complaint and a functional medical problem. Assessment should include the patient’s level of concern or distress and the impact of her symptoms on her overall quality of life. Patients should be evaluated for body dysmorphic syndrome and relationship discord. A complete physical examination, including a detailed pelvic assessment, often is indicated. A treatment algorithm that incorporates conservative therapies coupled with medical, technologic, and psychologic interventions also should be developed.

Various energy-based devices are available for outpatient procedures

Although the number of procedures performed (such as vaginal rejuvenation, labiaplasty, vulvar liposculpturing, hymenoplasty, G-spot amplification, and O-Shot treatment) for both cosmetic and functional problems has increased, the published scientific data on the procedures’ short- and long-term efficacy and safety are limited. The American College of Obstetricians and Gynecologists (ACOG) published a committee opinion stating that many of these procedures, including “vaginal rejuvenation,” may not be considered medically indicated and may lack scientific merit or ample supportive data to confirm their efficacy and safety.¹ ObGyns should proceed with caution before incorporating these technologic treatments into their medical practice.

Much diversity exists within the device-technology space. The underpinnings of each device vary regarding their proposed mechanism of action and theoretical therapeutic and tissue effect. In device marketing materials, many devices have been claimed to have effects on multiple tissue types (for example, both vaginal mucosa and vulvar tissue), whereas others are said to have more focal and localized effects (that is, targeted behind the hymenal ring). Some are marketed as a one-time treatment, while others require multiple repeated treatments over an extended period. When it comes to published data, adverse effect reporting remains limited and follow-up data often are short term.

Radiofrequency and laser devices are separate and very distinct technologies with similar and differing proposed utilizations. Combining radiofrequency and laser treatments in tandem or sequentially may have clinical utility, but long-term safety may be a concern for lasers.

Radiofrequency-based devices

Typically, radiofrequency device treatments:

• are used for outpatient procedures
• do not require topical anesthesia
• are constructed to emit focused electromagnetic waves
• are applied to vaginal, vulvar, or vaginal introital or vestibular tissue
• deliver energy to the deeper connective tissue of the vaginal wall architecture.

Radiofrequency device energy can be monopolar, unipolar, bipolar, or multipolar depending on design. Design also dictates current and the number of electrodes that pass from the device to the grounding pad. Monopolar is the only type of radiofrequency that has a grounding pad; bipolar and multipolar energy returns to the treatment tip.

Radiofrequency devices typically are FDA 510(k)-cleared devices for nonspecific electrocoagulation and hemostasis for surgical procedures. None are currently FDA cleared in the United States for the treatment of vaginal or vulvar laxity or genitourinary syndrome of menopause (GSM). These energy-based devices aim to induce collagen contraction, neocollagenesis, vascularization, and growth factor infiltration to restore the elasticity and moisture of the underlying vaginal mucosa. Heat shock protein activation and inflammation activation are thought to be the underlying mechanisms of action.^2–5

Treatment outcomes with 2 radiofrequency devices

Multiple prospective small case series studies have reported outcomes of women treated with the ThermiVa (ThermiAesthetics LLC) radiofrequency system.^3,4 Typically, 3 treatments (with a between-treatment interval of 4 to 6 weeks) were applied. The clinical end point temperature had a range of 40°C to 45°C, which was maintained for 3 to 5 minutes per treated zone during 30 minutes’ total treatment time.

Some participants self-reported improvement in vaginal laxity symptoms with the 3 treatments. In addition, women reported subjective improvements in both vaginal atrophy symptoms and sexual function, including positive effect in multiple domains. No serious adverse events were reported in these case series. However, there was no placebo-controlled arm, and validated questionnaires were not used in much of this research.^3,4

In another trial, the ThermiVa system was studied in a cohort of 25 sexually active women with self-reported anorgasmia or increased latency to orgasmic response.⁶ Participants received 3 treatments 4 weeks apart. Approximately three-quarters of the participants reported improved orgasmic responsivity, vaginal lubrication, and clitoral sensitivity. Notably, this research did not use validated questionnaires or a placebo or sham-controlled design. The authors suggested sustained treatment benefits at 9 to 12 months. While repeat treatment was advocated, data were lacking to support the optimal time for repeat treatment efficacy.⁶

A cryogen-cooled monopolar radiofrequency device, the Viveve system (Viveve Medical, Inc) differs from other radiofrequency procedures because it systematically cryogen cools and protects the surface of the vaginal mucosal tissue while heating the underlying structures.

The Viveve system was evaluated in 2 small pilot studies (24 and 30 participants) and in a large, randomized, sham-controlled, prospective trial that included 108 participants (VIVEVE I trial).^5,7,8 Results from both preliminary small studies indicated that participants experienced significant improvement in overall sexual function at 6 months. In one of the small studies (in Japanese women), sustained efficacy at 12 months posttreatment was reported.⁷ Neither small study included a placebo-control arm, but they did include the use of validated questionnaires.

In the VIVEVE I trial (a multicenter international study), treatment in the active group consisted of a single, 30-minute outpatient procedure that delivered 90 J/cm² of radiofrequency energy at the level just behind the hymenal ring behind the vaginal introitus. The sham-treated group received ≤1 J/cm² of energy with a similar machine tip.⁸

Statistically significant improvements were reported in the arousal and orgasm domains of the validated Female Sexual Function Index (FSFI) for the active-treatment group compared with the sham-treated group. In addition, there were statistically significant differences in the FSFI and the Female Sexual Distress Scale–Revised total scores in favor of active treatment. Participants in the active-treatment arm reported statistically significant improvement in overall sexual satisfaction coupled with lowered overall sexual distress.⁸

These data are provocative, since the Viveve treatment demonstrated superior efficacy compared with the sham treatment, and prior evidence demonstrated that medical device trials employing a sham arm often demonstrate particularly large placebo/sham effects.⁹ A confirmatory randomized, sham-controlled multicenter US-based trial is currently underway. At present, the VIVEVE I trial remains the only published, large-scale, randomized, sham-controlled, blinded study of a radiofrequency-based treatment.

New emerging data support the efficacy and safety of this specific radiofrequency treatment in patients with mild to moderate urinary stress incontinence; further studies confirming these outcomes are anticipated. The Viveve system is approved in many countries for various conditions, including urinary incontinence (1 country), sexual function (17 countries), vaginal laxity (41 countries), and electrocoagulation and hemostasis (4 countries, including the United States).

Laser technology devices

Laser (Light Amplification by Stimulated Emission of Radiation) therapy, which uses a carbon dioxide (CO2), argon, YAG, or erbium energy source, also is currently marketed as a method to improve various gynecologic conditions, including genital pelvic relaxation syndrome, vaginal laxity, GSM, lichen sclerosus, and sexual problems such as dyspareunia and arousal or orgasmic disorders.

The CO2 laser therapy device, such as the MonaLisa Touch (DEKA Laser), appears to be very popular and widely available. It delivers fractional CO2 laser energy to the vaginal wall, creating sequential micro traumas that subsequently undergo a healing reaction; the newly healed area has an improved underlying tissue architecture (but at a superficial level). The laser’s proposed mechanism of action is that it ablates only a minute fraction of the superficial lamina propria; it acts primarily to stimulate rapid healing of the tissue, creating new collagen and elastic fibers. There is no evidence of scarring.¹⁰

Treatment outcomes with laser device therapy

Authors of a 2017 study series of CO2 laser treatments in women with moderate to severe GSM found that 84% of participants experienced significant improvement in sexual function, dyspareunia, and otherwise unspecified sexual issues from pretreatment to 12 to 24 months posttreatment.¹¹ These findings are consistent with several other case series and provide supportive evidence for the efficacy and safety of CO2 laser therapy. This technology may be appropriate for the treatment of GSM.

Laser technology shows excellent promise for the treatment of GSM symptoms by virtue of its superficial mechanism of action. In addition, several trials have demonstrated efficacy and safety in breast cancer patient populations.¹² This is particularly interesting since breast cancer treatments, such as aromatase inhibitors (considered a mainstay of cancer treatment), can cause severe atrophic vaginitis. Breast cancer survivors often avoid minimally absorbed local vaginal hormonal products, and over-the-counter products (moisturizers and lubricants) are not widely accepted. Hence, a nonhormonal treatment for distressing GSM symptoms is welcomed in this population.

Pagano and colleagues recently studied 82 breast cancer survivors in whom treatment with vaginal moisturizers and lubricants failed.¹² Participants underwent 3 laser treatment cycles approximately 30 to 40 days apart; they demonstrated improvements in vaginal dryness, vaginal itchiness, stinging, dyspareunia, and reduced sensitivity.

Microablative fractional CO2 laser may help reestablish a normative vaginal microbiome by altering the prevalence of lactobacillus species and reestablishing a normative postmenopausal vaginal flora.¹³

The tracking and reporting of adverse events associated with laser procedures has been less than optimal. In my personal clinical experience, consequences from both short- and long-term laser treatments have included vaginal canal agglutination, worsening dyspareunia, and constricture causing vaginal hemorrhage.

Cruz and colleagues recently conducted a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy of fractional CO2 laser compared with topical estriol and laser plus estriol for the treatment of vaginal atrophy in 45 postmenopausal women.¹⁴ They found statistically significant differences in dyspareunia, dryness, and burning compared with baseline levels in all 3 treatment groups. Results with the fractional CO2 laser treatment were deemed to be similar to those of the topical estriol and the combined therapy.¹⁴

By contrast, an erbium (Er):YAG laser, such as the IntimaLase (Fotona, LLC) laser, functions by heating the pelvic tissue and collagen within the introitus and vaginal canal.^15,16 When the underlying collagen is heated, the fibers are thought to thicken and shorten, which may result in immediate contracture of the treated tissue. Additionally, this process stimulates the existing collagen to undergo remodeling and it also may cause neocollagen deposition.¹⁵ In a general review of gynecologic procedures, after 1 to 4 treatment sessions (depending on the study), most patients reported improved sexual satisfaction or vaginal tightness.¹⁵

Although trials have included small numbers of patients, early evidence suggests some lasers with reportedly deeper penetration may be useful for treatment of vaginal laxity, but further studies are needed. In smaller studies, the Er:YAG laser has shown efficacy and safety in the treatment of stress urinary incontinence and improved lower urinary tract symptoms, quality of life, and sexual function.^16,17

Insurance does not cover energy-based treatment costs

Currently, both laser and radiofrequency device treatments are considered fee-for-service interventions. Radiofrequency and laser treatments for gynecologic conditions are not covered by health insurance, and treatment costs can be prohibitive for many patients. In addition, the long-term safety of these treatments remains to be studied further, and the optimal time for a repeat procedure has yet to be elucidated.

The FDA cautions against energy-based procedures

In July 2018, the FDA released a statement of concern reiterating the need for research and randomized clinical trials before energy-based device treatments can be widely accepted, and that they are currently cleared only for general gynecologic indications and not for disorders and symptoms related to menopause, urinary incontinence, or sexual function.¹⁸

The FDA stated that “we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions [vaginal laxity; vaginal atrophy, dryness, or itching; pain during sexual intercourse; pain during urination; decreased sexual sensation], or any symptoms related to menopause, urinary incontinence, or sexual function.” The FDA noted that serious complications have been reported, including vaginal burns, scarring, pain during sexual intercourse, and recurring, chronic pain. The FDA issued letters to 7 companies regarding concerns about the marketing of their devices for off-label use and promotion.

Several societies have responded. ACOG reaffirmed its 2016 position statement on fractional laser treatment of vulvovaginal atrophy.¹⁹ JoAnn Pinkerton, MD, Executive Director of The North American Menopause Society (NAMS), and Sheryl Kingsberg, PhD, President of NAMS, alerted their members that both health care professionals and consumers should tread cautiously, and they encouraged scrutiny of existing evidence as all energy-based treatments are not created equal.²⁰ They noted that some research does exist and cited 2 randomized, sham-controlled clinical trials that have been published.

Looking forward

Various novel technologic therapies are entering the gynecologic market. ObGyns must critically evaluate these emerging technologies with a keen understanding of their underlying mechanism of action, the level of scientific evidence, and the treatment’s proposed therapeutic value.

Radiofrequency energy devices appear to be better positioned to treat urinary incontinence and vaginal relaxation syndrome because of their capability for deep tissue penetration. Current data show that laser technology has excellent promise for the treatment and management of GSM. Both technologies warrant further investigation in long-term randomized, sham-controlled trials that assess efficacy and safety with validated instruments over an extended period. In addition, should these technologies prove useful in the overall treatment armamentarium for gynecologic conditions, the question of affordability and insurance coverage needs to be addressed.

ObGyns must advocate for female sexual wellness and encourage a comprehensive multidisciplinary team approach for offering various therapies. Ultimately, responsible use of evidence-based innovative technology should be incorporated into the treatment paradigm.

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