Placebo Effect of Various Female Sexual Dysfunction Drug Txs Assessed
Level I evidence showed that 67.7% of the treatment effect is accounted for by placebo.
Current treatments for female sexual dysfunction (FSD) appear to be only "minimally superior" to placebo, according to a meta-analysis published in the journal Obstetrics & Gynecology.
Recent randomized controlled trials involving patients with FSD have indicated that up to 40% of women saw improvement in sexual dysfunction symptoms with placebo alone, leading researchers to wonder about the placebo effect of various pharmacologic modalities. For this study, the authors aimed to quantify this effect by conducting a systematic review of various databases to identify studies that included a placebo arm and used Female Sexual Function Index as a clinical outcome.
Eight studies were included in the analysis; across these studies, 2,236 patients were enrolled in the treatment arms while 1,723 patients received placebo. Pharmacologic interventions included flibanserin (Addyi), bupropion, onabotulinum toxin A, intravaginal prasterone, intranasal oxytocin, ospemifene, and bremelanotide.
Results showed that patients receiving pharmacologic treatment had an increase of 5.35 (95% CI 4.13-6.57) on the Female Sexual Function Index compared with 3.62 (95% CI 3.29-3.94) for those who received placebo, demonstrating that 67.7% of the FSD treatment effect is accounted for by placebo. "The pronounced effect of
placebo indicates that available treatment modalities focus on only a single aspect of a multifactorial disease," write the authors.
While the percent of improvement with placebo varied across the studies, a key limitation, it did account for >50% of the treatment effect in 7 of the 8 trials. Another limitation was the "lack of a validated clinically meaningful difference for the scores on the Female Sexual Function Index."
Based on the findings of this study, the authors concluded that "If an efficacious treatment is to be found, the treatment must address all domains of female sexual dysfunction as well as the biopsychologic component of the female sexual experience."
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