Last Thursday, June 4, the FDA advisory committee voted 18-6 to recommend approval of flibanserin. A step towards FDA approval. Can anyone tell me how this drug would help women to get more tump between the sheets?
I checked the results from nine clinical studies. Most women participating in the trials seem to have ‘successful’ sex three times a month. I merged the data from the clinical trials. I found that flibanserin would give 0.42 times extra successful sex events/month. I don’t see what’s so great about going from having good sex three times to three times and half?
70% of women also experience dizziness, low blood, fainting, headache. Many women quit the studies before they ended, which is an indication that flibanserin was not well tolerated.
If you want more and better sex, I imagine explaining your bed partner what you like and how he can give it to you, may be a better approach to unlock those sexual desires….
This quick studies review reminded me of my dapoxetine review. Equally small, irrelevant clinical effects, but with possible harm. Feel free to collaborate with me on the Open Science Framework. One thing I would like to check is how other therapies for low sex drive compare.
Do randomised clinical trials with inadequate blinding report enhanced placebo effects for intervention groups and nocebo effects for placebo groups? a meta-epidemiological study of PDE-5 inhibitors.
Started: February 2012
Current stage (update 2012-11-20): Analyses of data
Patients’ expectations of treatment effects may contribute to positive (placebo) and negative (nocebo) outcomes. The effect of patient expectations may be pronounced in subjectively assessed conditions, such as male erectile dysfunction. The aim of this project is to examine the magnitude of expectancy in trials of phosphodiesterase-5 inhibitors. We hypothesize that randomized controlled trials with inadequate blinding will report enhanced placebo effects for intervention groups and nocebo effects for placebo groups, compared with adequately blinded studies.
Trudy Bekkering, CEBAM Belgian Center of Evidence-based Medicine, Belgium
Kavita Singh, The Centre for Practice-Changing Research, Ottawa Hospital Research Institute, Ottawa, Canada
The project is part of a PhD and is not supported by a research grant. Therefore we receive financial support through open funding: donations and RocketHub.com. If your company wants to support us, please contact us. If you want to make a contribution, you can also use the Donate button. Thank you.
Current contributors: Peter Leusink, Kaat Peerenboom, Bram Renders, Dirk Peerenboom, Dieter Wijffels and Ive Van Orshoven (Visit the RocketHub Crowdfunding page)
Frederik Feys, Geertruida E Bekkering, Kavita Singh, Dirk Devroey. Do randomised clinical trials with inadequate blinding report enhanced placebo effects for intervention groups and nocebo effects for placebo groups? A protocol for a meta-epidemiological study of PDE-5 inhibitors. Systematic Reviews 2012, 1:54 doi:10.1186/2046-4053-1-54 View Online / PubMed