29 Feb Minimal Benefit of Flibanserin for Female Hypoactive Sexual Desire Disorder
MedicalResearch.com Interview with:
Dr. Loes Jaspers
Loes Jaspers MD, PhD scientist
Dept. of Epidemiology
Erasmus University Medical Center
Rotterdam, the Netherlands
Medical Research: What is the background for this study? What are the main findings?
Dr. Jaspers: In August 2015, the U.S. Food and Drug Administration approved flibanserin as a medical treatment for women with hypoactive sexual desire disorder (HSDD). The approval was accompanied by considerable attention in the media. Some people were positive about the approval, while others questioned whether benefits outweigh the risks. That is why we systematically reviewed eight clinical trials (five published and three unpublished) that included 5,914 women to examine the efficacy and safety of the medication for treatment of hypoactive sexual desire disorder.
We found that women taking flibanserin experienced one-half additional satisfying sexual event per month, and that they experienced 2-4 times more side-effects, such as dizziness, sleepiness, nausea, and tiredness, compared to placebo. The overall improvement that women reported while taking the drug was low. It ranged from ‘minimal improvement’ to ‘no change’.
The quality of the evidence was graded using established and transparent guidelines, the Grades of Recommendation, Assessment, Development and Evaluation approach (GRADE), which have been adopted by leading scientific organizations globally. Although the studies reviewed were randomized clinical trials, the quality of the evidence was very low, particularly because of limitations in design, the indirectness of evidence, and more favorable efficacy outcomes in published compared with unpublished studies.
Medical Research: What should clinicians and patients take away from your report?
Dr. Jaspers: The findings of this systematic review and meta-analysis suggest that the benefits of flibanserin treatment are marginal, particularly when taking into account the concurrent occurrence of adverse events.
Whether or not flibanserin should be recommended highly depends on the individual situation. Together with their doctor or therapist, women and their partners should weigh the benefits & risks, and organize their thoughts on for instance abstaining from alcohol use, and the potential increase of side-effects with concurrent use of hormonal contraceptives.
Treatment with flibanserin is not the only treatment option available for women with hypoactive sexual desire disorder. Women and their partners could also benefit from other existing treatment options, such as psychological support, couples therapy, and sex therapy.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Jaspers: The women included in the studies were healthy women without chronic disease and without medication use. Also, they were in stable relationships. That is why future studies are needed, especially in other groups of women, particularly those with coexisting illnesses, medication use, and surgical menopause, so that we can better evaluate if flibanserin would be safe and effective for our patients.
Medical Research: Is there anything else you would like to add?
Dr. Jaspers: The study was performed by a research team of 6 epidemiologists and sexologists from the Netherlands (Erasmus University Medical Center, Rotterdam, and Academic Medical Center, Amsterdam) and from Belgium (Free University Brussels).
Citation:
Loes Jaspers MD, PhD scientist (2016). Minimal Benefit of Flibanserin for Female Hypoactive Sexual Desire Disorder MedicalResearch.com
Last Updated on February 29, 2016 by Marie Benz MD FAAD