Whitney McKnight

AUSTIN, TEX. – An online, self-reported tool to determine risk of sleep disorders such as insomnia and restless legs syndrome outperformed assessment by a sleep specialist, new data show.

“Our results suggest that [the online survey] may be used in the primary care setting as a screening method for several sleep disorders,” Dr. Michael Morgenstern, a neurologist at the North Shore Long Island Jewish Medical Center, New Hyde Park, N.Y., said during an original investigation session at the annual meeting of the American College of Chest Physicians.

“The SNORE [Sleep Disorder and Narcolepsy Online Reference for Evaluation] online screening tool performs at least as well as the interviewer in detecting the risk of common sleep disorders, and at times it performs better,” Dr. Morgenstern said.

For obstructive sleep apnea and sleep disruption, the online screening tool and sleep physician interview were equal at assessing risk.

In a random, prospective, crossover trial of 53 adult sleep-clinic patients and 24 adult primary care–setting patients, two-thirds of whom were male, the SNORE self-report screening tool demonstrated both high sensitivity and high specificity for determining sleep disorder risks: between 94% and 85%, and 76% and 65%, respectively.

According to the American Academy of Sleep Medicine’s criteria for sleep disorder assessment, sleep specialists accurately determined the risk for insomnia 40.2% of the time, compared with SNORE’s 51.4%.

The online tool also bested a sleep specialist when it came to determining the risk of restless legs syndrome: The tool identified 44.1% of at-risk cases, while the specialist identified 23.3%.

Sleep specialists were slightly better than SNORE at determining patients at risk for sleep apnea: 78% for an interview with a specialist vs. 75.3% using the self-report tool.

Sleep disruption risk was determined equally by either method: 60% by a sleep specialist vs. 60% by SNORE.

Patients in the study were asked to complete the SNORE survey before they were interviewed by a sleep specialist. The sleep specialist was blinded to the patient’s history and survey results. Polysomnography was not included in the assessment, because risk assessment, not diagnosis, was the goal. A third of all participants were randomly assigned to take the SNORE test first or to be interviewed first.

The median overall time necessary to take the entire survey was 6 minutes. If a shortened version was used, the survey took an average of 4 minutes.

Using the survey in the primary care setting could lead to earlier detection and treatment of sleep disorders, Dr. Morgenstern noted, which would aid in overall health.

“For a lot of people who come to a primary care clinic, they don’t think to mention sleep-related symptoms, and the primary care doctor doesn’t really have time to ask about complaints the person isn’t there to talk about,” Dr. Morgenstern said. “But sleep is part of a person’s overall picture of health. Wouldn’t it be great if we had a way to identify issues so patients and providers could talk about it?”

Dr. Morgenstern said he had no relevant financial disclosures.

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – An online, self-reported tool to determine risk of sleep disorders such as insomnia and restless legs syndrome outperformed assessment by a sleep specialist, new data show.

“Our results suggest that [the online survey] may be used in the primary care setting as a screening method for several sleep disorders,” Dr. Michael Morgenstern, a neurologist at the North Shore Long Island Jewish Medical Center, New Hyde Park, N.Y., said during an original investigation session at the annual meeting of the American College of Chest Physicians.

“The SNORE [Sleep Disorder and Narcolepsy Online Reference for Evaluation] online screening tool performs at least as well as the interviewer in detecting the risk of common sleep disorders, and at times it performs better,” Dr. Morgenstern said.

For obstructive sleep apnea and sleep disruption, the online screening tool and sleep physician interview were equal at assessing risk.

In a random, prospective, crossover trial of 53 adult sleep-clinic patients and 24 adult primary care–setting patients, two-thirds of whom were male, the SNORE self-report screening tool demonstrated both high sensitivity and high specificity for determining sleep disorder risks: between 94% and 85%, and 76% and 65%, respectively.

According to the American Academy of Sleep Medicine’s criteria for sleep disorder assessment, sleep specialists accurately determined the risk for insomnia 40.2% of the time, compared with SNORE’s 51.4%.

The online tool also bested a sleep specialist when it came to determining the risk of restless legs syndrome: The tool identified 44.1% of at-risk cases, while the specialist identified 23.3%.

Sleep specialists were slightly better than SNORE at determining patients at risk for sleep apnea: 78% for an interview with a specialist vs. 75.3% using the self-report tool.

Sleep disruption risk was determined equally by either method: 60% by a sleep specialist vs. 60% by SNORE.

Patients in the study were asked to complete the SNORE survey before they were interviewed by a sleep specialist. The sleep specialist was blinded to the patient’s history and survey results. Polysomnography was not included in the assessment, because risk assessment, not diagnosis, was the goal. A third of all participants were randomly assigned to take the SNORE test first or to be interviewed first.

The median overall time necessary to take the entire survey was 6 minutes. If a shortened version was used, the survey took an average of 4 minutes.

Using the survey in the primary care setting could lead to earlier detection and treatment of sleep disorders, Dr. Morgenstern noted, which would aid in overall health.

“For a lot of people who come to a primary care clinic, they don’t think to mention sleep-related symptoms, and the primary care doctor doesn’t really have time to ask about complaints the person isn’t there to talk about,” Dr. Morgenstern said. “But sleep is part of a person’s overall picture of health. Wouldn’t it be great if we had a way to identify issues so patients and providers could talk about it?”

Dr. Morgenstern said he had no relevant financial disclosures.

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – An online, self-reported tool to determine risk of sleep disorders such as insomnia and restless legs syndrome outperformed assessment by a sleep specialist, new data show.

“Our results suggest that [the online survey] may be used in the primary care setting as a screening method for several sleep disorders,” Dr. Michael Morgenstern, a neurologist at the North Shore Long Island Jewish Medical Center, New Hyde Park, N.Y., said during an original investigation session at the annual meeting of the American College of Chest Physicians.

“The SNORE [Sleep Disorder and Narcolepsy Online Reference for Evaluation] online screening tool performs at least as well as the interviewer in detecting the risk of common sleep disorders, and at times it performs better,” Dr. Morgenstern said.

For obstructive sleep apnea and sleep disruption, the online screening tool and sleep physician interview were equal at assessing risk.

In a random, prospective, crossover trial of 53 adult sleep-clinic patients and 24 adult primary care–setting patients, two-thirds of whom were male, the SNORE self-report screening tool demonstrated both high sensitivity and high specificity for determining sleep disorder risks: between 94% and 85%, and 76% and 65%, respectively.

According to the American Academy of Sleep Medicine’s criteria for sleep disorder assessment, sleep specialists accurately determined the risk for insomnia 40.2% of the time, compared with SNORE’s 51.4%.

The online tool also bested a sleep specialist when it came to determining the risk of restless legs syndrome: The tool identified 44.1% of at-risk cases, while the specialist identified 23.3%.

Sleep specialists were slightly better than SNORE at determining patients at risk for sleep apnea: 78% for an interview with a specialist vs. 75.3% using the self-report tool.

Sleep disruption risk was determined equally by either method: 60% by a sleep specialist vs. 60% by SNORE.

Patients in the study were asked to complete the SNORE survey before they were interviewed by a sleep specialist. The sleep specialist was blinded to the patient’s history and survey results. Polysomnography was not included in the assessment, because risk assessment, not diagnosis, was the goal. A third of all participants were randomly assigned to take the SNORE test first or to be interviewed first.

The median overall time necessary to take the entire survey was 6 minutes. If a shortened version was used, the survey took an average of 4 minutes.

Using the survey in the primary care setting could lead to earlier detection and treatment of sleep disorders, Dr. Morgenstern noted, which would aid in overall health.

“For a lot of people who come to a primary care clinic, they don’t think to mention sleep-related symptoms, and the primary care doctor doesn’t really have time to ask about complaints the person isn’t there to talk about,” Dr. Morgenstern said. “But sleep is part of a person’s overall picture of health. Wouldn’t it be great if we had a way to identify issues so patients and providers could talk about it?”

Dr. Morgenstern said he had no relevant financial disclosures.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Soy isoflavones are safe for postmenopausal women to take long term, having no treatment effect on endometrial thickness, reproductive hormones, or thyroid function, the results of a 3-year study have shown.

Despite previous reports that soy isoflavones have deleterious effects, they still are often used by postmenopausal women as an alternative to hormone therapy, according to study author, D. Lee Alekel, Ph.D., program director of women’s health at the National Center for Complementary and Alternative Medicine at the National Institutes of Health.

©BananaStock/thinkstockphotos.com

“It behooves us to examine the safety-related outcomes and rates of any adverse events in women consuming over-the-counter soy isoflavone supplements, which could be 100 mg of isoflavones a day or more,” Dr. Alekel said at the annual meeting of the North American Menopause Society. “That’s five times the intake from typical Asian diets, so it’s quite a bit more.”

The findings are from the dual-site, double-blind, placebo-controlled Soy Isoflavones for Reducing Bone Loss (SIRBL) study of women randomly assigned to placebo, or either 80 mg or 120 mg of daily soy isoflavones. No treatment effects on endometrial thickness or circulating hormone concentrations, including thyroid function, were detected using transvaginal ultrasound in any of the study groups (Menopause 2014 [doi: 10.1097/GME.0000000000000280]).

All women in the study were between 48 and 65 years of age at the time of enrollment, had experienced natural onset of menopause, did not smoke, agreed to avoid soy-based foods for the duration of the study, and maintained a healthy weight. The investigators also took into account lactation duration, and excluded from the study any women using hormone therapy or chronic medication. All participants had to have an annual physical, mammogram, gynecologic exam, and breast exam performed by their own physicians in order to remain in the study.

After losing 12% to follow-up, 224 women remained in the intent-to-treat analysis, and 208 women who were compliant with their assigned treatment fully completed the study.

Assessments done at 6, 12, 18, 24, and 36 months showed declines in median endometrial thickness in all three treatment groups: from 1.5 to 1.1 mm at the Iowa site, and from 2.6 to 1.9 mm at the California site. Neither the 80 mg nor the 120 mg dose were found to have a treatment effect (P = .57 and P = 0.43, respectively).

Adverse event rates varied by site, but not treatment arms: a higher rate of upper respiratory tract infections was noted in women studied in Iowa, compared with women enrolled at the second site in southern California (P ≤ .0001). The investigators theorized this difference was due to Iowa having longer, harsher winters. The 80-mg arm had more genitourinary issues (P = .005), primarily urinary tract infections, than did the 120-mg group.

Previous studies also have suggested soy isoflavones have no adverse effect on the endometrium, regardless of the form or dose of isoflavone; however, one study cited by Dr. Alekel “did show that 150 mg of soy taken per day for up to 5 years increased endometrial hyperplasia about 4%, but there was no endometrial carcinoma detected” (Fertil. Steril. 2004 Jul;82:145-8).

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Soy isoflavones are safe for postmenopausal women to take long term, having no treatment effect on endometrial thickness, reproductive hormones, or thyroid function, the results of a 3-year study have shown.

Despite previous reports that soy isoflavones have deleterious effects, they still are often used by postmenopausal women as an alternative to hormone therapy, according to study author, D. Lee Alekel, Ph.D., program director of women’s health at the National Center for Complementary and Alternative Medicine at the National Institutes of Health.

©BananaStock/thinkstockphotos.com

“It behooves us to examine the safety-related outcomes and rates of any adverse events in women consuming over-the-counter soy isoflavone supplements, which could be 100 mg of isoflavones a day or more,” Dr. Alekel said at the annual meeting of the North American Menopause Society. “That’s five times the intake from typical Asian diets, so it’s quite a bit more.”

The findings are from the dual-site, double-blind, placebo-controlled Soy Isoflavones for Reducing Bone Loss (SIRBL) study of women randomly assigned to placebo, or either 80 mg or 120 mg of daily soy isoflavones. No treatment effects on endometrial thickness or circulating hormone concentrations, including thyroid function, were detected using transvaginal ultrasound in any of the study groups (Menopause 2014 [doi: 10.1097/GME.0000000000000280]).

All women in the study were between 48 and 65 years of age at the time of enrollment, had experienced natural onset of menopause, did not smoke, agreed to avoid soy-based foods for the duration of the study, and maintained a healthy weight. The investigators also took into account lactation duration, and excluded from the study any women using hormone therapy or chronic medication. All participants had to have an annual physical, mammogram, gynecologic exam, and breast exam performed by their own physicians in order to remain in the study.

After losing 12% to follow-up, 224 women remained in the intent-to-treat analysis, and 208 women who were compliant with their assigned treatment fully completed the study.

Assessments done at 6, 12, 18, 24, and 36 months showed declines in median endometrial thickness in all three treatment groups: from 1.5 to 1.1 mm at the Iowa site, and from 2.6 to 1.9 mm at the California site. Neither the 80 mg nor the 120 mg dose were found to have a treatment effect (P = .57 and P = 0.43, respectively).

Adverse event rates varied by site, but not treatment arms: a higher rate of upper respiratory tract infections was noted in women studied in Iowa, compared with women enrolled at the second site in southern California (P ≤ .0001). The investigators theorized this difference was due to Iowa having longer, harsher winters. The 80-mg arm had more genitourinary issues (P = .005), primarily urinary tract infections, than did the 120-mg group.

Previous studies also have suggested soy isoflavones have no adverse effect on the endometrium, regardless of the form or dose of isoflavone; however, one study cited by Dr. Alekel “did show that 150 mg of soy taken per day for up to 5 years increased endometrial hyperplasia about 4%, but there was no endometrial carcinoma detected” (Fertil. Steril. 2004 Jul;82:145-8).

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Soy isoflavones are safe for postmenopausal women to take long term, having no treatment effect on endometrial thickness, reproductive hormones, or thyroid function, the results of a 3-year study have shown.

Despite previous reports that soy isoflavones have deleterious effects, they still are often used by postmenopausal women as an alternative to hormone therapy, according to study author, D. Lee Alekel, Ph.D., program director of women’s health at the National Center for Complementary and Alternative Medicine at the National Institutes of Health.

©BananaStock/thinkstockphotos.com

“It behooves us to examine the safety-related outcomes and rates of any adverse events in women consuming over-the-counter soy isoflavone supplements, which could be 100 mg of isoflavones a day or more,” Dr. Alekel said at the annual meeting of the North American Menopause Society. “That’s five times the intake from typical Asian diets, so it’s quite a bit more.”

The findings are from the dual-site, double-blind, placebo-controlled Soy Isoflavones for Reducing Bone Loss (SIRBL) study of women randomly assigned to placebo, or either 80 mg or 120 mg of daily soy isoflavones. No treatment effects on endometrial thickness or circulating hormone concentrations, including thyroid function, were detected using transvaginal ultrasound in any of the study groups (Menopause 2014 [doi: 10.1097/GME.0000000000000280]).

All women in the study were between 48 and 65 years of age at the time of enrollment, had experienced natural onset of menopause, did not smoke, agreed to avoid soy-based foods for the duration of the study, and maintained a healthy weight. The investigators also took into account lactation duration, and excluded from the study any women using hormone therapy or chronic medication. All participants had to have an annual physical, mammogram, gynecologic exam, and breast exam performed by their own physicians in order to remain in the study.

After losing 12% to follow-up, 224 women remained in the intent-to-treat analysis, and 208 women who were compliant with their assigned treatment fully completed the study.

Assessments done at 6, 12, 18, 24, and 36 months showed declines in median endometrial thickness in all three treatment groups: from 1.5 to 1.1 mm at the Iowa site, and from 2.6 to 1.9 mm at the California site. Neither the 80 mg nor the 120 mg dose were found to have a treatment effect (P = .57 and P = 0.43, respectively).

Adverse event rates varied by site, but not treatment arms: a higher rate of upper respiratory tract infections was noted in women studied in Iowa, compared with women enrolled at the second site in southern California (P ≤ .0001). The investigators theorized this difference was due to Iowa having longer, harsher winters. The 80-mg arm had more genitourinary issues (P = .005), primarily urinary tract infections, than did the 120-mg group.

Previous studies also have suggested soy isoflavones have no adverse effect on the endometrium, regardless of the form or dose of isoflavone; however, one study cited by Dr. Alekel “did show that 150 mg of soy taken per day for up to 5 years increased endometrial hyperplasia about 4%, but there was no endometrial carcinoma detected” (Fertil. Steril. 2004 Jul;82:145-8).

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – Patients who consider themselves too sexy for their continuous positive airway pressure devices should reconsider, according to a presenter at the annual meeting of the American College of Chest Physicians.

“Despite the unsexy appearance of a positive airway pressure device in the bedroom, patients who don’t comply with their CPAP [protocols] do not have a better sexual quality of life,” said Dr. Salman Alim, who presented the original investigation during a quality and clinical improvement session.

Sexual quality of life questionnaires were distributed to 52 men being treated at a single site with continuous positive airway pressure (CPAP) for obstructive sleep apnea. The 10-question survey used a scale of 1-8, with 80 being the highest score, to evaluate aspects of the participants’ emotional and physical satisfaction with their sex lives. Patients were considered CPAP-compliant if they used their device 4 or more hours nightly at least 70% of the time before going to sleep.

The compliant cohort of 27 men, whose average age was 59 years, had a sexual quality of life score of about 38. The noncompliant group of 25 men, whose average age was 56 years, had a score of about 48.

After adjusting for confounding variables such as age, body mass index, erectile dysfunction, use of phosphodiesterase inhibitors, and depression, CPAP compliance did not predict one’s sexual quality of life, reported Dr. Alim, who was with Rosalind Franklin University in North Chicago, Ill., at the time of the study and is now with Physicians Regional Healthcare System in Naples, Fla.

“Although this is not a validated survey … the study’s findings can be the basis to develop a hypothesis that can be tested more rigorously. At the least, the results provide clinicians with useful information on counseling patients on adherence with CPAP,” Dr. Mark Rosen, medical director of the American College of Chest Physicians, said in an interview.

The authors of the study said that they had no relevant disclosures.

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – Patients who consider themselves too sexy for their continuous positive airway pressure devices should reconsider, according to a presenter at the annual meeting of the American College of Chest Physicians.

“Despite the unsexy appearance of a positive airway pressure device in the bedroom, patients who don’t comply with their CPAP [protocols] do not have a better sexual quality of life,” said Dr. Salman Alim, who presented the original investigation during a quality and clinical improvement session.

Sexual quality of life questionnaires were distributed to 52 men being treated at a single site with continuous positive airway pressure (CPAP) for obstructive sleep apnea. The 10-question survey used a scale of 1-8, with 80 being the highest score, to evaluate aspects of the participants’ emotional and physical satisfaction with their sex lives. Patients were considered CPAP-compliant if they used their device 4 or more hours nightly at least 70% of the time before going to sleep.

The compliant cohort of 27 men, whose average age was 59 years, had a sexual quality of life score of about 38. The noncompliant group of 25 men, whose average age was 56 years, had a score of about 48.

After adjusting for confounding variables such as age, body mass index, erectile dysfunction, use of phosphodiesterase inhibitors, and depression, CPAP compliance did not predict one’s sexual quality of life, reported Dr. Alim, who was with Rosalind Franklin University in North Chicago, Ill., at the time of the study and is now with Physicians Regional Healthcare System in Naples, Fla.

“Although this is not a validated survey … the study’s findings can be the basis to develop a hypothesis that can be tested more rigorously. At the least, the results provide clinicians with useful information on counseling patients on adherence with CPAP,” Dr. Mark Rosen, medical director of the American College of Chest Physicians, said in an interview.

The authors of the study said that they had no relevant disclosures.

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – Patients who consider themselves too sexy for their continuous positive airway pressure devices should reconsider, according to a presenter at the annual meeting of the American College of Chest Physicians.

“Despite the unsexy appearance of a positive airway pressure device in the bedroom, patients who don’t comply with their CPAP [protocols] do not have a better sexual quality of life,” said Dr. Salman Alim, who presented the original investigation during a quality and clinical improvement session.

Sexual quality of life questionnaires were distributed to 52 men being treated at a single site with continuous positive airway pressure (CPAP) for obstructive sleep apnea. The 10-question survey used a scale of 1-8, with 80 being the highest score, to evaluate aspects of the participants’ emotional and physical satisfaction with their sex lives. Patients were considered CPAP-compliant if they used their device 4 or more hours nightly at least 70% of the time before going to sleep.

The compliant cohort of 27 men, whose average age was 59 years, had a sexual quality of life score of about 38. The noncompliant group of 25 men, whose average age was 56 years, had a score of about 48.

After adjusting for confounding variables such as age, body mass index, erectile dysfunction, use of phosphodiesterase inhibitors, and depression, CPAP compliance did not predict one’s sexual quality of life, reported Dr. Alim, who was with Rosalind Franklin University in North Chicago, Ill., at the time of the study and is now with Physicians Regional Healthcare System in Naples, Fla.

“Although this is not a validated survey … the study’s findings can be the basis to develop a hypothesis that can be tested more rigorously. At the least, the results provide clinicians with useful information on counseling patients on adherence with CPAP,” Dr. Mark Rosen, medical director of the American College of Chest Physicians, said in an interview.

The authors of the study said that they had no relevant disclosures.

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – Why would travel restrictions make the Ebola epidemic worse in West Africa and expand its spread to U.S. shores? What can American intensive care units do to prepare, even if they aren’t designated Ebola centers? And are there lessons medical professionals and policymakers can apply from the successes and failures of the AIDS epidemic 30 years ago?

In a video interview at the annual meeting of the American College of Chest Physicians, Dr. Lewis Rubinson offered answers to those questions and perspectives on the current American response to the Ebola outbreak. Dr. Rubinson recently returned from treating more than 300 Ebola patients in Sierra Leone as a consulting physician for the World Health Organization.

“Honestly, I think if we don’t get it under control in the next few months in West Africa, there will be sporadic cases coming back [to the United States] for as long as we can think of,” cautioned Dr. Rubinson, director of the R. Adams Cowley Trauma Shock Center at the University of Maryland, Baltimore.

AUSTIN, TEX. – Why would travel restrictions make the Ebola epidemic worse in West Africa and expand its spread to U.S. shores? What can American intensive care units do to prepare, even if they aren’t designated Ebola centers? And are there lessons medical professionals and policymakers can apply from the successes and failures of the AIDS epidemic 30 years ago?

In a video interview at the annual meeting of the American College of Chest Physicians, Dr. Lewis Rubinson offered answers to those questions and perspectives on the current American response to the Ebola outbreak. Dr. Rubinson recently returned from treating more than 300 Ebola patients in Sierra Leone as a consulting physician for the World Health Organization.

“Honestly, I think if we don’t get it under control in the next few months in West Africa, there will be sporadic cases coming back [to the United States] for as long as we can think of,” cautioned Dr. Rubinson, director of the R. Adams Cowley Trauma Shock Center at the University of Maryland, Baltimore.

AUSTIN, TEX. – Why would travel restrictions make the Ebola epidemic worse in West Africa and expand its spread to U.S. shores? What can American intensive care units do to prepare, even if they aren’t designated Ebola centers? And are there lessons medical professionals and policymakers can apply from the successes and failures of the AIDS epidemic 30 years ago?

In a video interview at the annual meeting of the American College of Chest Physicians, Dr. Lewis Rubinson offered answers to those questions and perspectives on the current American response to the Ebola outbreak. Dr. Rubinson recently returned from treating more than 300 Ebola patients in Sierra Leone as a consulting physician for the World Health Organization.

“Honestly, I think if we don’t get it under control in the next few months in West Africa, there will be sporadic cases coming back [to the United States] for as long as we can think of,” cautioned Dr. Rubinson, director of the R. Adams Cowley Trauma Shock Center at the University of Maryland, Baltimore.

AUSTIN, TEX. – Why would travel restrictions make the Ebola epidemic worse in West Africa and expand its spread to U.S. shores? What can American intensive care units do to prepare, even if they aren’t designated Ebola centers? And are there lessons medical professionals and policymakers can apply from the successes and failures of the AIDS epidemic 30 years ago?

In a video interview at the annual meeting of the American College of Chest Physicians, Dr. Lewis Rubinson offered answers to those questions and perspectives on the current American response to the Ebola outbreak. Dr. Rubinson recently returned from treating more than 300 Ebola patients in Sierra Leone as a consulting physician for the World Health Organization.

“Honestly, I think if we don’t get it under control in the next few months in West Africa, there will be sporadic cases coming back [to the United States] for as long as we can think of,” cautioned Dr. Rubinson, director of the R. Adams Cowley Trauma Shock Center at the University of Maryland, Baltimore.

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – Why would travel restrictions make the Ebola epidemic worse in West Africa and expand its spread to U.S. shores? What can American intensive care units do to prepare, even if they aren’t designated Ebola centers? And are there lessons medical professionals and policymakers can apply from the successes and failures of the AIDS epidemic 30 years ago?

In a video interview at the annual meeting of the American College of Chest Physicians, Dr. Lewis Rubinson offered answers to those questions and perspectives on the current American response to the Ebola outbreak. Dr. Rubinson recently returned from treating more than 300 Ebola patients in Sierra Leone as a consulting physician for the World Health Organization.

“Honestly, I think if we don’t get it under control in the next few months in West Africa, there will be sporadic cases coming back [to the United States] for as long as we can think of,” cautioned Dr. Rubinson, director of the R. Adams Cowley Trauma Shock Center at the University of Maryland, Baltimore.

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – Why would travel restrictions make the Ebola epidemic worse in West Africa and expand its spread to U.S. shores? What can American intensive care units do to prepare, even if they aren’t designated Ebola centers? And are there lessons medical professionals and policymakers can apply from the successes and failures of the AIDS epidemic 30 years ago?

In a video interview at the annual meeting of the American College of Chest Physicians, Dr. Lewis Rubinson offered answers to those questions and perspectives on the current American response to the Ebola outbreak. Dr. Rubinson recently returned from treating more than 300 Ebola patients in Sierra Leone as a consulting physician for the World Health Organization.

“Honestly, I think if we don’t get it under control in the next few months in West Africa, there will be sporadic cases coming back [to the United States] for as long as we can think of,” cautioned Dr. Rubinson, director of the R. Adams Cowley Trauma Shock Center at the University of Maryland, Baltimore.

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – Extracorporeal membrane oxygenation delivered during cardiopulmonary resuscitation allowed nearly twice as many patients to survive after discharge when compared against typical CPR-only procedures in a small, retrospective study.

“It’s no secret that conventional CPR is not terrifically successful,” Graham Peigh, a second-year medical student at Jefferson Medical College in Philadelphia, said during the Hot Topics in Pulmonary and Critical Care session at the annual meeting of the American College of Chest Physicians. “Extracorporeal membrane oxygenation [ECMO] gives patients a second chance at life.”

Mr. Peigh and his colleagues retrospectively analyzed 100 ECMO procedures performed on adults at a single teaching hospital during 2010-2013 and found that when ECMO was added to CPR, the survival rate to discharge went from 15% as calculated in a previously reported meta-analysis (J. Gen. Intern. Med. 1998;13:805-16) to 29% (P = .04).

When an arrested patient does not respond to CPR, cannulation through the femoral artery and vein can be combined with compressions to improve chances of survival.

In their analysis of ECMO delivered in an academic hospital setting, Mr. Peigh and his colleagues found that in the 24 cases in which ECMO was added to conventional CPR after the patients failed to respond to CPR alone, the survival rate with full neurologic recovery was 29%.

ECMO support was delivered in a number of scenarios, ranging from acute myocardial infarction to malignant arrhythmia to at least one case each of drug overdose induced cardiac arrest, septic shock, postcardiotomy failure, and acute rejection.

The ECMO support was provided for a mean of 5 days. The mean age for all patients studied was 47 years, and 15 were male. All cases followed a 24-hour hypothermia protocol.

Six of the ECMO-CPR patients died post ECMO of anoxic brain injury, stroke, or sepsis while still in the hospital, but the remaining seven patients (54%) survived after discharge and made full neurologic recoveries. The other 11 died during ECMO-CPR. During ECMO-CPR, 11 patients died of anoxic brain injury, stroke, metabolic acidosis, bowel necrosis, and family withdrawal of life support. Predictors of ECMO death were a pre-ECMO creatinine level of 1.7 mg/dL (P = .02) and the presence of acidosis (P = .04).

The ECMO survivor cohort also had what Mr. Peigh said were “encouraging” organ function results, with kidney and liver function remaining essentially unchanged after discharge.“Two of the patients who died of anoxic brain injuries were able to donate multiple organs for transplant,” Mr. Peigh said.

Previously reported ECMO data have shown there is at least a 20% increase in survival without notable neurologic effect, compared with conventional CPR (Lancet 2008;372:554-61; Crit. Care Med. 2011;39:1-7).

However, since these data were derived from centers where code teams were available at all times to treat a high volume of cardiac arrest patients, Mr. Peigh said the results – although indicative of the procedure’s value – “were not generalizable” to all institutions. But he noted that his and his colleagues’ study showed that even in institutions without a dedicated ECMO-CPR code team, ECMO-CPR resulted in demonstrably better outcomes for patients unresponsive to conventional CPR.

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – Extracorporeal membrane oxygenation delivered during cardiopulmonary resuscitation allowed nearly twice as many patients to survive after discharge when compared against typical CPR-only procedures in a small, retrospective study.

“It’s no secret that conventional CPR is not terrifically successful,” Graham Peigh, a second-year medical student at Jefferson Medical College in Philadelphia, said during the Hot Topics in Pulmonary and Critical Care session at the annual meeting of the American College of Chest Physicians. “Extracorporeal membrane oxygenation [ECMO] gives patients a second chance at life.”

Mr. Peigh and his colleagues retrospectively analyzed 100 ECMO procedures performed on adults at a single teaching hospital during 2010-2013 and found that when ECMO was added to CPR, the survival rate to discharge went from 15% as calculated in a previously reported meta-analysis (J. Gen. Intern. Med. 1998;13:805-16) to 29% (P = .04).

When an arrested patient does not respond to CPR, cannulation through the femoral artery and vein can be combined with compressions to improve chances of survival.

In their analysis of ECMO delivered in an academic hospital setting, Mr. Peigh and his colleagues found that in the 24 cases in which ECMO was added to conventional CPR after the patients failed to respond to CPR alone, the survival rate with full neurologic recovery was 29%.

ECMO support was delivered in a number of scenarios, ranging from acute myocardial infarction to malignant arrhythmia to at least one case each of drug overdose induced cardiac arrest, septic shock, postcardiotomy failure, and acute rejection.

The ECMO support was provided for a mean of 5 days. The mean age for all patients studied was 47 years, and 15 were male. All cases followed a 24-hour hypothermia protocol.

Six of the ECMO-CPR patients died post ECMO of anoxic brain injury, stroke, or sepsis while still in the hospital, but the remaining seven patients (54%) survived after discharge and made full neurologic recoveries. The other 11 died during ECMO-CPR. During ECMO-CPR, 11 patients died of anoxic brain injury, stroke, metabolic acidosis, bowel necrosis, and family withdrawal of life support. Predictors of ECMO death were a pre-ECMO creatinine level of 1.7 mg/dL (P = .02) and the presence of acidosis (P = .04).

The ECMO survivor cohort also had what Mr. Peigh said were “encouraging” organ function results, with kidney and liver function remaining essentially unchanged after discharge.“Two of the patients who died of anoxic brain injuries were able to donate multiple organs for transplant,” Mr. Peigh said.

Previously reported ECMO data have shown there is at least a 20% increase in survival without notable neurologic effect, compared with conventional CPR (Lancet 2008;372:554-61; Crit. Care Med. 2011;39:1-7).

However, since these data were derived from centers where code teams were available at all times to treat a high volume of cardiac arrest patients, Mr. Peigh said the results – although indicative of the procedure’s value – “were not generalizable” to all institutions. But he noted that his and his colleagues’ study showed that even in institutions without a dedicated ECMO-CPR code team, ECMO-CPR resulted in demonstrably better outcomes for patients unresponsive to conventional CPR.

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – Extracorporeal membrane oxygenation delivered during cardiopulmonary resuscitation allowed nearly twice as many patients to survive after discharge when compared against typical CPR-only procedures in a small, retrospective study.

“It’s no secret that conventional CPR is not terrifically successful,” Graham Peigh, a second-year medical student at Jefferson Medical College in Philadelphia, said during the Hot Topics in Pulmonary and Critical Care session at the annual meeting of the American College of Chest Physicians. “Extracorporeal membrane oxygenation [ECMO] gives patients a second chance at life.”

Mr. Peigh and his colleagues retrospectively analyzed 100 ECMO procedures performed on adults at a single teaching hospital during 2010-2013 and found that when ECMO was added to CPR, the survival rate to discharge went from 15% as calculated in a previously reported meta-analysis (J. Gen. Intern. Med. 1998;13:805-16) to 29% (P = .04).

When an arrested patient does not respond to CPR, cannulation through the femoral artery and vein can be combined with compressions to improve chances of survival.

In their analysis of ECMO delivered in an academic hospital setting, Mr. Peigh and his colleagues found that in the 24 cases in which ECMO was added to conventional CPR after the patients failed to respond to CPR alone, the survival rate with full neurologic recovery was 29%.

ECMO support was delivered in a number of scenarios, ranging from acute myocardial infarction to malignant arrhythmia to at least one case each of drug overdose induced cardiac arrest, septic shock, postcardiotomy failure, and acute rejection.

The ECMO support was provided for a mean of 5 days. The mean age for all patients studied was 47 years, and 15 were male. All cases followed a 24-hour hypothermia protocol.

Six of the ECMO-CPR patients died post ECMO of anoxic brain injury, stroke, or sepsis while still in the hospital, but the remaining seven patients (54%) survived after discharge and made full neurologic recoveries. The other 11 died during ECMO-CPR. During ECMO-CPR, 11 patients died of anoxic brain injury, stroke, metabolic acidosis, bowel necrosis, and family withdrawal of life support. Predictors of ECMO death were a pre-ECMO creatinine level of 1.7 mg/dL (P = .02) and the presence of acidosis (P = .04).

The ECMO survivor cohort also had what Mr. Peigh said were “encouraging” organ function results, with kidney and liver function remaining essentially unchanged after discharge.“Two of the patients who died of anoxic brain injuries were able to donate multiple organs for transplant,” Mr. Peigh said.

Previously reported ECMO data have shown there is at least a 20% increase in survival without notable neurologic effect, compared with conventional CPR (Lancet 2008;372:554-61; Crit. Care Med. 2011;39:1-7).

However, since these data were derived from centers where code teams were available at all times to treat a high volume of cardiac arrest patients, Mr. Peigh said the results – although indicative of the procedure’s value – “were not generalizable” to all institutions. But he noted that his and his colleagues’ study showed that even in institutions without a dedicated ECMO-CPR code team, ECMO-CPR resulted in demonstrably better outcomes for patients unresponsive to conventional CPR.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Relizen, a nonhormonal purified pollen extract with demonstrated efficacy in treating vasomotor symptoms of menopause, had negligible effects on the CYP2D6 enzyme at five times the recommended daily dose, according to a poster presentation.

Because tamoxifen is metabolized into endoxifen, the active metabolite in the CYP2D6 enzyme, the findings could mean women with severe hot flashes who are taking tamoxifen now have a viable treatment option that won’t increase their risk of death from breast cancer.

“Tamoxifen creates some of the worst hot flashes we will ever see,” Dr. Steven R. Goldstein, professor of obstetrics and gynecology at New York University, said in an interview at this year’s annual meeting of the North American Menopause Society. Even so, because systemic estrogen is contraindicated in women using either tamoxifen or raloxifene for the treatment or chemoprevention of breast cancer, and questions remain about the safety of phytoestrogens, many of these women forgo the commonly prescribed estrogen-based treatments for menopausal symptoms.

Instead, some physicians will prescribe off-label low doses of antidepressants to treat vasomotor symptoms in this patient population. However, a 2010 population-based cohort study of 2,430 Canadian women taking tamoxifen concurrently with an SSRI showed that the risk of death from breast cancer increased 24%-91% in those taking paroxetine in particular, depending on the increasing overlap of tamoxifen treatment and antidepressant use (BMJ 2010;340:c693 [doi:10.1136/bmj.c693]). Last year, the Food and Drug Administration approved the vasomotor symptoms of menopause as an indication for the SSRI paroxetine (Paxil, Brisdelle), but required Noven, the drug’s manufacturer, to state paroxetine’s countering effect on tamoxifen’s efficacy.

Until now, according to Dr. Goldstein, fears over estrogen and SSRI’s potential ill-effects have meant that many women have chosen to “tough it out” when it comes to hot flashes, night sweats, and other symptoms.

The importance of his study, he said, is that because Relizen (Sérélyspharma, France), a powdered, pollen cytoplasmic extract harvested in southern Sweden, doesn’t affect the CYP enzyme system, it’s safe to give to tamoxifen patients. “It is the only nonpharmacologic product that I have ever been aware of that has a double-blind, randomized, placebo-controlled, parallel study showing that it reduces vasomotor symptoms and improves quality of life in menopausal women,” Dr. Goldstein said.

In an in vitro study of Relizen’s effect on the isoenzyme CYP2D6 in pooled human liver microsomes, Dr. Goldstein and his colleagues tested the supplement against quinidine, a known CYP2D6 inhibitor. The end point was the conversion of bufuralol to 1-OH-bufuralol in the CYP enzyme system. Six concentrations of each compound were tested, with all reactions being performed in triplicate. The Relizen concentrations ranged from 1.65 mcg/mL to 400 mcg/mL, five times the Relizen recommended daily dose of 80 mcg/mL. The quinidine concentrations ranged from 2.06 nM to 500 nM.

The study compound’s inhibition of CYP2D6 was negligible, ranging from –6.53% to 10.67%, compared with quinidine’s CYP2D6 linear dose-related increase from –7.07% at 2.06 nM to 84.05% at 500 nM.

Relizen’s apparent clinical utility in women at high risk of death from breast cancer is the “low-hanging fruit,” Dr. Goldstein said. “The tamoxifen patient has no other place to go. But if a woman is 51 years old and she comes to me and says she has hot flashes, now I have multiple options. I can give her hormones, I can give her 7.5 mg of paroxetine, or I can give her Relizen. This is just another arrow in my quiver.”

In the placebo-controlled study of Relizen, 65% of the active treatment group of 32 peri- and postmenopausal women reported decreased vasomotor symptoms by the end of the 12 week trial, compared with 38% of the placebo group (Climacteric 2005; 8:162-70).

“I know [Relizen] is effective, and it’s tested against placebo,” Dr. Goldstein said. “But is it as strong as estrogen? I have no clue. A head-to-head trial is not going to happen.”

Relizen has been widely available in Europe under a variety of names, including Femal, since 1999, and has had no reported adverse effects, according to the manufacturer. JDS Pharmaceuticals (Noven) began distributing the supplement in the United States earlier this year.

Dr. Goldstein is a paid consultant for JDS Pharmaceuticals, a division of Noven. The study was sponsored by the supplement manufacturer, Sérélyspharma(France). JDS Pharmaceuticals (Noven) is the licensed distributor of Relizen in the United States.

NATIONAL HARBOR, MD. – Relizen, a nonhormonal purified pollen extract with demonstrated efficacy in treating vasomotor symptoms of menopause, had negligible effects on the CYP2D6 enzyme at five times the recommended daily dose, according to a poster presentation.

Because tamoxifen is metabolized into endoxifen, the active metabolite in the CYP2D6 enzyme, the findings could mean women with severe hot flashes who are taking tamoxifen now have a viable treatment option that won’t increase their risk of death from breast cancer.

“Tamoxifen creates some of the worst hot flashes we will ever see,” Dr. Steven R. Goldstein, professor of obstetrics and gynecology at New York University, said in an interview at this year’s annual meeting of the North American Menopause Society. Even so, because systemic estrogen is contraindicated in women using either tamoxifen or raloxifene for the treatment or chemoprevention of breast cancer, and questions remain about the safety of phytoestrogens, many of these women forgo the commonly prescribed estrogen-based treatments for menopausal symptoms.

Instead, some physicians will prescribe off-label low doses of antidepressants to treat vasomotor symptoms in this patient population. However, a 2010 population-based cohort study of 2,430 Canadian women taking tamoxifen concurrently with an SSRI showed that the risk of death from breast cancer increased 24%-91% in those taking paroxetine in particular, depending on the increasing overlap of tamoxifen treatment and antidepressant use (BMJ 2010;340:c693 [doi:10.1136/bmj.c693]). Last year, the Food and Drug Administration approved the vasomotor symptoms of menopause as an indication for the SSRI paroxetine (Paxil, Brisdelle), but required Noven, the drug’s manufacturer, to state paroxetine’s countering effect on tamoxifen’s efficacy.

Until now, according to Dr. Goldstein, fears over estrogen and SSRI’s potential ill-effects have meant that many women have chosen to “tough it out” when it comes to hot flashes, night sweats, and other symptoms.

The importance of his study, he said, is that because Relizen (Sérélyspharma, France), a powdered, pollen cytoplasmic extract harvested in southern Sweden, doesn’t affect the CYP enzyme system, it’s safe to give to tamoxifen patients. “It is the only nonpharmacologic product that I have ever been aware of that has a double-blind, randomized, placebo-controlled, parallel study showing that it reduces vasomotor symptoms and improves quality of life in menopausal women,” Dr. Goldstein said.

In an in vitro study of Relizen’s effect on the isoenzyme CYP2D6 in pooled human liver microsomes, Dr. Goldstein and his colleagues tested the supplement against quinidine, a known CYP2D6 inhibitor. The end point was the conversion of bufuralol to 1-OH-bufuralol in the CYP enzyme system. Six concentrations of each compound were tested, with all reactions being performed in triplicate. The Relizen concentrations ranged from 1.65 mcg/mL to 400 mcg/mL, five times the Relizen recommended daily dose of 80 mcg/mL. The quinidine concentrations ranged from 2.06 nM to 500 nM.

The study compound’s inhibition of CYP2D6 was negligible, ranging from –6.53% to 10.67%, compared with quinidine’s CYP2D6 linear dose-related increase from –7.07% at 2.06 nM to 84.05% at 500 nM.

Relizen’s apparent clinical utility in women at high risk of death from breast cancer is the “low-hanging fruit,” Dr. Goldstein said. “The tamoxifen patient has no other place to go. But if a woman is 51 years old and she comes to me and says she has hot flashes, now I have multiple options. I can give her hormones, I can give her 7.5 mg of paroxetine, or I can give her Relizen. This is just another arrow in my quiver.”

In the placebo-controlled study of Relizen, 65% of the active treatment group of 32 peri- and postmenopausal women reported decreased vasomotor symptoms by the end of the 12 week trial, compared with 38% of the placebo group (Climacteric 2005; 8:162-70).

“I know [Relizen] is effective, and it’s tested against placebo,” Dr. Goldstein said. “But is it as strong as estrogen? I have no clue. A head-to-head trial is not going to happen.”

Relizen has been widely available in Europe under a variety of names, including Femal, since 1999, and has had no reported adverse effects, according to the manufacturer. JDS Pharmaceuticals (Noven) began distributing the supplement in the United States earlier this year.

Dr. Goldstein is a paid consultant for JDS Pharmaceuticals, a division of Noven. The study was sponsored by the supplement manufacturer, Sérélyspharma(France). JDS Pharmaceuticals (Noven) is the licensed distributor of Relizen in the United States.

NATIONAL HARBOR, MD. – Relizen, a nonhormonal purified pollen extract with demonstrated efficacy in treating vasomotor symptoms of menopause, had negligible effects on the CYP2D6 enzyme at five times the recommended daily dose, according to a poster presentation.

Because tamoxifen is metabolized into endoxifen, the active metabolite in the CYP2D6 enzyme, the findings could mean women with severe hot flashes who are taking tamoxifen now have a viable treatment option that won’t increase their risk of death from breast cancer.

“Tamoxifen creates some of the worst hot flashes we will ever see,” Dr. Steven R. Goldstein, professor of obstetrics and gynecology at New York University, said in an interview at this year’s annual meeting of the North American Menopause Society. Even so, because systemic estrogen is contraindicated in women using either tamoxifen or raloxifene for the treatment or chemoprevention of breast cancer, and questions remain about the safety of phytoestrogens, many of these women forgo the commonly prescribed estrogen-based treatments for menopausal symptoms.

Instead, some physicians will prescribe off-label low doses of antidepressants to treat vasomotor symptoms in this patient population. However, a 2010 population-based cohort study of 2,430 Canadian women taking tamoxifen concurrently with an SSRI showed that the risk of death from breast cancer increased 24%-91% in those taking paroxetine in particular, depending on the increasing overlap of tamoxifen treatment and antidepressant use (BMJ 2010;340:c693 [doi:10.1136/bmj.c693]). Last year, the Food and Drug Administration approved the vasomotor symptoms of menopause as an indication for the SSRI paroxetine (Paxil, Brisdelle), but required Noven, the drug’s manufacturer, to state paroxetine’s countering effect on tamoxifen’s efficacy.

Until now, according to Dr. Goldstein, fears over estrogen and SSRI’s potential ill-effects have meant that many women have chosen to “tough it out” when it comes to hot flashes, night sweats, and other symptoms.

The importance of his study, he said, is that because Relizen (Sérélyspharma, France), a powdered, pollen cytoplasmic extract harvested in southern Sweden, doesn’t affect the CYP enzyme system, it’s safe to give to tamoxifen patients. “It is the only nonpharmacologic product that I have ever been aware of that has a double-blind, randomized, placebo-controlled, parallel study showing that it reduces vasomotor symptoms and improves quality of life in menopausal women,” Dr. Goldstein said.

In an in vitro study of Relizen’s effect on the isoenzyme CYP2D6 in pooled human liver microsomes, Dr. Goldstein and his colleagues tested the supplement against quinidine, a known CYP2D6 inhibitor. The end point was the conversion of bufuralol to 1-OH-bufuralol in the CYP enzyme system. Six concentrations of each compound were tested, with all reactions being performed in triplicate. The Relizen concentrations ranged from 1.65 mcg/mL to 400 mcg/mL, five times the Relizen recommended daily dose of 80 mcg/mL. The quinidine concentrations ranged from 2.06 nM to 500 nM.

The study compound’s inhibition of CYP2D6 was negligible, ranging from –6.53% to 10.67%, compared with quinidine’s CYP2D6 linear dose-related increase from –7.07% at 2.06 nM to 84.05% at 500 nM.

Relizen’s apparent clinical utility in women at high risk of death from breast cancer is the “low-hanging fruit,” Dr. Goldstein said. “The tamoxifen patient has no other place to go. But if a woman is 51 years old and she comes to me and says she has hot flashes, now I have multiple options. I can give her hormones, I can give her 7.5 mg of paroxetine, or I can give her Relizen. This is just another arrow in my quiver.”

In the placebo-controlled study of Relizen, 65% of the active treatment group of 32 peri- and postmenopausal women reported decreased vasomotor symptoms by the end of the 12 week trial, compared with 38% of the placebo group (Climacteric 2005; 8:162-70).

“I know [Relizen] is effective, and it’s tested against placebo,” Dr. Goldstein said. “But is it as strong as estrogen? I have no clue. A head-to-head trial is not going to happen.”

Relizen has been widely available in Europe under a variety of names, including Femal, since 1999, and has had no reported adverse effects, according to the manufacturer. JDS Pharmaceuticals (Noven) began distributing the supplement in the United States earlier this year.

Dr. Goldstein is a paid consultant for JDS Pharmaceuticals, a division of Noven. The study was sponsored by the supplement manufacturer, Sérélyspharma(France). JDS Pharmaceuticals (Noven) is the licensed distributor of Relizen in the United States.

NATIONAL HARBOR, MD. – Relizen, a nonhormonal purified pollen extract with demonstrated efficacy in treating vasomotor symptoms of menopause, had negligible effects on the CYP2D6 enzyme at five times the recommended daily dose, according to a poster presentation.

Because tamoxifen is metabolized into endoxifen, the active metabolite in the CYP2D6 enzyme, the findings could mean women with severe hot flashes who are taking tamoxifen now have a viable treatment option that won’t increase their risk of death from breast cancer.

“Tamoxifen creates some of the worst hot flashes we will ever see,” Dr. Steven R. Goldstein, professor of obstetrics and gynecology at New York University, said in an interview at this year’s annual meeting of the North American Menopause Society. Even so, because systemic estrogen is contraindicated in women using either tamoxifen or raloxifene for the treatment or chemoprevention of breast cancer, and questions remain about the safety of phytoestrogens, many of these women forgo the commonly prescribed estrogen-based treatments for menopausal symptoms.

Instead, some physicians will prescribe off-label low doses of antidepressants to treat vasomotor symptoms in this patient population. However, a 2010 population-based cohort study of 2,430 Canadian women taking tamoxifen concurrently with an SSRI showed that the risk of death from breast cancer increased 24%-91% in those taking paroxetine in particular, depending on the increasing overlap of tamoxifen treatment and antidepressant use (BMJ 2010;340:c693 [doi:10.1136/bmj.c693]). Last year, the Food and Drug Administration approved the vasomotor symptoms of menopause as an indication for the SSRI paroxetine (Paxil, Brisdelle), but required Noven, the drug’s manufacturer, to state paroxetine’s countering effect on tamoxifen’s efficacy.

Until now, according to Dr. Goldstein, fears over estrogen and SSRI’s potential ill-effects have meant that many women have chosen to “tough it out” when it comes to hot flashes, night sweats, and other symptoms.

The importance of his study, he said, is that because Relizen (Sérélyspharma, France), a powdered, pollen cytoplasmic extract harvested in southern Sweden, doesn’t affect the CYP enzyme system, it’s safe to give to tamoxifen patients. “It is the only nonpharmacologic product that I have ever been aware of that has a double-blind, randomized, placebo-controlled, parallel study showing that it reduces vasomotor symptoms and improves quality of life in menopausal women,” Dr. Goldstein said.

In an in vitro study of Relizen’s effect on the isoenzyme CYP2D6 in pooled human liver microsomes, Dr. Goldstein and his colleagues tested the supplement against quinidine, a known CYP2D6 inhibitor. The end point was the conversion of bufuralol to 1-OH-bufuralol in the CYP enzyme system. Six concentrations of each compound were tested, with all reactions being performed in triplicate. The Relizen concentrations ranged from 1.65 mcg/mL to 400 mcg/mL, five times the Relizen recommended daily dose of 80 mcg/mL. The quinidine concentrations ranged from 2.06 nM to 500 nM.

The study compound’s inhibition of CYP2D6 was negligible, ranging from –6.53% to 10.67%, compared with quinidine’s CYP2D6 linear dose-related increase from –7.07% at 2.06 nM to 84.05% at 500 nM.

Relizen’s apparent clinical utility in women at high risk of death from breast cancer is the “low-hanging fruit,” Dr. Goldstein said. “The tamoxifen patient has no other place to go. But if a woman is 51 years old and she comes to me and says she has hot flashes, now I have multiple options. I can give her hormones, I can give her 7.5 mg of paroxetine, or I can give her Relizen. This is just another arrow in my quiver.”

In the placebo-controlled study of Relizen, 65% of the active treatment group of 32 peri- and postmenopausal women reported decreased vasomotor symptoms by the end of the 12 week trial, compared with 38% of the placebo group (Climacteric 2005; 8:162-70).

“I know [Relizen] is effective, and it’s tested against placebo,” Dr. Goldstein said. “But is it as strong as estrogen? I have no clue. A head-to-head trial is not going to happen.”

Relizen has been widely available in Europe under a variety of names, including Femal, since 1999, and has had no reported adverse effects, according to the manufacturer. JDS Pharmaceuticals (Noven) began distributing the supplement in the United States earlier this year.

Dr. Goldstein is a paid consultant for JDS Pharmaceuticals, a division of Noven. The study was sponsored by the supplement manufacturer, Sérélyspharma(France). JDS Pharmaceuticals (Noven) is the licensed distributor of Relizen in the United States.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Relizen, a nonhormonal purified pollen extract with demonstrated efficacy in treating vasomotor symptoms of menopause, had negligible effects on the CYP2D6 enzyme at five times the recommended daily dose, according to a poster presentation.

Because tamoxifen is metabolized into endoxifen, the active metabolite in the CYP2D6 enzyme, the findings could mean women with severe hot flashes who are taking tamoxifen now have a viable treatment option that won’t increase their risk of death from breast cancer.

“Tamoxifen creates some of the worst hot flashes we will ever see,” Dr. Steven R. Goldstein, professor of obstetrics and gynecology at New York University, said in an interview at this year’s annual meeting of the North American Menopause Society. Even so, because systemic estrogen is contraindicated in women using either tamoxifen or raloxifene for the treatment or chemoprevention of breast cancer, and questions remain about the safety of phytoestrogens, many of these women forgo the commonly prescribed estrogen-based treatments for menopausal symptoms.

Instead, some physicians will prescribe off-label low doses of antidepressants to treat vasomotor symptoms in this patient population. However, a 2010 population-based cohort study of 2,430 Canadian women taking tamoxifen concurrently with an SSRI showed that the risk of death from breast cancer increased 24%-91% in those taking paroxetine in particular, depending on the increasing overlap of tamoxifen treatment and antidepressant use (BMJ 2010;340:c693 [doi:10.1136/bmj.c693]). Last year, the Food and Drug Administration approved the vasomotor symptoms of menopause as an indication for the SSRI paroxetine (Paxil, Brisdelle), but required Noven, the drug’s manufacturer, to state paroxetine’s countering effect on tamoxifen’s efficacy.

Until now, according to Dr. Goldstein, fears over estrogen and SSRI’s potential ill-effects have meant that many women have chosen to “tough it out” when it comes to hot flashes, night sweats, and other symptoms.

The importance of his study, he said, is that because Relizen (Sérélyspharma, France), a powdered, pollen cytoplasmic extract harvested in southern Sweden, doesn’t affect the CYP enzyme system, it’s safe to give to tamoxifen patients. “It is the only nonpharmacologic product that I have ever been aware of that has a double-blind, randomized, placebo-controlled, parallel study showing that it reduces vasomotor symptoms and improves quality of life in menopausal women,” Dr. Goldstein said.

In an in vitro study of Relizen’s effect on the isoenzyme CYP2D6 in pooled human liver microsomes, Dr. Goldstein and his colleagues tested the supplement against quinidine, a known CYP2D6 inhibitor. The end point was the conversion of bufuralol to 1-OH-bufuralol in the CYP enzyme system. Six concentrations of each compound were tested, with all reactions being performed in triplicate. The Relizen concentrations ranged from 1.65 mcg/mL to 400 mcg/mL, five times the Relizen recommended daily dose of 80 mcg/mL. The quinidine concentrations ranged from 2.06 nM to 500 nM.

The study compound’s inhibition of CYP2D6 was negligible, ranging from –6.53% to 10.67%, compared with quinidine’s CYP2D6 linear dose-related increase from –7.07% at 2.06 nM to 84.05% at 500 nM.

Relizen’s apparent clinical utility in women at high risk of death from breast cancer is the “low-hanging fruit,” Dr. Goldstein said. “The tamoxifen patient has no other place to go. But if a woman is 51 years old and she comes to me and says she has hot flashes, now I have multiple options. I can give her hormones, I can give her 7.5 mg of paroxetine, or I can give her Relizen. This is just another arrow in my quiver.”

In the placebo-controlled study of Relizen, 65% of the active treatment group of 32 peri- and postmenopausal women reported decreased vasomotor symptoms by the end of the 12 week trial, compared with 38% of the placebo group (Climacteric 2005; 8:162-70).

“I know [Relizen] is effective, and it’s tested against placebo,” Dr. Goldstein said. “But is it as strong as estrogen? I have no clue. A head-to-head trial is not going to happen.”

Relizen has been widely available in Europe under a variety of names, including Femal, since 1999, and has had no reported adverse effects, according to the manufacturer. JDS Pharmaceuticals (Noven) began distributing the supplement in the United States earlier this year.

Dr. Goldstein is a paid consultant for JDS Pharmaceuticals, a division of Noven. The study was sponsored by the supplement manufacturer, Sérélyspharma(France). JDS Pharmaceuticals (Noven) is the licensed distributor of Relizen in the United States.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Relizen, a nonhormonal purified pollen extract with demonstrated efficacy in treating vasomotor symptoms of menopause, had negligible effects on the CYP2D6 enzyme at five times the recommended daily dose, according to a poster presentation.

Because tamoxifen is metabolized into endoxifen, the active metabolite in the CYP2D6 enzyme, the findings could mean women with severe hot flashes who are taking tamoxifen now have a viable treatment option that won’t increase their risk of death from breast cancer.

“Tamoxifen creates some of the worst hot flashes we will ever see,” Dr. Steven R. Goldstein, professor of obstetrics and gynecology at New York University, said in an interview at this year’s annual meeting of the North American Menopause Society. Even so, because systemic estrogen is contraindicated in women using either tamoxifen or raloxifene for the treatment or chemoprevention of breast cancer, and questions remain about the safety of phytoestrogens, many of these women forgo the commonly prescribed estrogen-based treatments for menopausal symptoms.

Instead, some physicians will prescribe off-label low doses of antidepressants to treat vasomotor symptoms in this patient population. However, a 2010 population-based cohort study of 2,430 Canadian women taking tamoxifen concurrently with an SSRI showed that the risk of death from breast cancer increased 24%-91% in those taking paroxetine in particular, depending on the increasing overlap of tamoxifen treatment and antidepressant use (BMJ 2010;340:c693 [doi:10.1136/bmj.c693]). Last year, the Food and Drug Administration approved the vasomotor symptoms of menopause as an indication for the SSRI paroxetine (Paxil, Brisdelle), but required Noven, the drug’s manufacturer, to state paroxetine’s countering effect on tamoxifen’s efficacy.

Until now, according to Dr. Goldstein, fears over estrogen and SSRI’s potential ill-effects have meant that many women have chosen to “tough it out” when it comes to hot flashes, night sweats, and other symptoms.

The importance of his study, he said, is that because Relizen (Sérélyspharma, France), a powdered, pollen cytoplasmic extract harvested in southern Sweden, doesn’t affect the CYP enzyme system, it’s safe to give to tamoxifen patients. “It is the only nonpharmacologic product that I have ever been aware of that has a double-blind, randomized, placebo-controlled, parallel study showing that it reduces vasomotor symptoms and improves quality of life in menopausal women,” Dr. Goldstein said.

In an in vitro study of Relizen’s effect on the isoenzyme CYP2D6 in pooled human liver microsomes, Dr. Goldstein and his colleagues tested the supplement against quinidine, a known CYP2D6 inhibitor. The end point was the conversion of bufuralol to 1-OH-bufuralol in the CYP enzyme system. Six concentrations of each compound were tested, with all reactions being performed in triplicate. The Relizen concentrations ranged from 1.65 mcg/mL to 400 mcg/mL, five times the Relizen recommended daily dose of 80 mcg/mL. The quinidine concentrations ranged from 2.06 nM to 500 nM.

The study compound’s inhibition of CYP2D6 was negligible, ranging from –6.53% to 10.67%, compared with quinidine’s CYP2D6 linear dose-related increase from –7.07% at 2.06 nM to 84.05% at 500 nM.

Relizen’s apparent clinical utility in women at high risk of death from breast cancer is the “low-hanging fruit,” Dr. Goldstein said. “The tamoxifen patient has no other place to go. But if a woman is 51 years old and she comes to me and says she has hot flashes, now I have multiple options. I can give her hormones, I can give her 7.5 mg of paroxetine, or I can give her Relizen. This is just another arrow in my quiver.”

In the placebo-controlled study of Relizen, 65% of the active treatment group of 32 peri- and postmenopausal women reported decreased vasomotor symptoms by the end of the 12 week trial, compared with 38% of the placebo group (Climacteric 2005; 8:162-70).

“I know [Relizen] is effective, and it’s tested against placebo,” Dr. Goldstein said. “But is it as strong as estrogen? I have no clue. A head-to-head trial is not going to happen.”

Relizen has been widely available in Europe under a variety of names, including Femal, since 1999, and has had no reported adverse effects, according to the manufacturer. JDS Pharmaceuticals (Noven) began distributing the supplement in the United States earlier this year.

Dr. Goldstein is a paid consultant for JDS Pharmaceuticals, a division of Noven. The study was sponsored by the supplement manufacturer, Sérélyspharma(France). JDS Pharmaceuticals (Noven) is the licensed distributor of Relizen in the United States.

[email protected]

On Twitter @whitneymcknight