Saffron for treatment of fluoxetine-induced sexual dysfunction in women: randomized double-blind placebo-controlled study

Objective Saffron (Crocus sativus L.) has shown beneficial aphrodisiac effects in some animal and human studies. The aim of the present study was to assess the safety and efficacy of saffron on selective serotonin reuptake inhibitor-induced sexual dysfunction in women. Methods This was a randomized double-blind placebo-controlled study. Thirty-eight women with major depression who were stabilized on fluoxetine 40?mg/day for a minimum of 6?weeks and had experienced subjective feeling of sexual dysfunction entered the study. The patients were randomly assigned to saffron (30?mg/daily) or placebo for 4?weeks. Measurement was performed at baseline, week 2, and week 4 using the Female Sexual Function Index (FSFI). Side effects were systematically recorded. Results Thirty-four women had at least one post-baseline measurement and completed the study. Two-factor repeated measure analysis of variance showed significant effect of time x treatment interaction [GreenhouseGeisser's corrected: F(1.580, 50.567)?=?5.366, p?=?0.012] and treatment for FSFI total score [F(1, 32)?=?4.243, p?=?0.048]. At the end of the fourth week, patients in the saffron group had experienced significantly more improvement in total FSFI (p?