RATIONALE: Saffron (Crocus sativus L.) has shown aphrodisiac effects in some animal and human studies. OBJECTIVES: To assess the efficacy and tolerability of saffron in fluoxetine-related sexual dysfunction. METHODS: This was a 4-week randomized double-blind placebo-controlled study. Thirty-six married male patients with major depressive disorder whose depressive symptoms had been stabilized on fluoxetine and had subjective complaints of sexual impairment entered the study. The patients were randomly assigned to saffron (15 mg twice per day) or placebo for 4 weeks. International Index of Erectile Function scale was used to assess sexual function at baseline and weeks 2 and 4. RESULTS:Thirty patients finished the study. Baseline characteristics as well as baseline and final depressive symptoms scores were similar between the two groups. Effect of time × treatment interaction on the total score was significant [Greenhouse-Geisser-corrected, F (1.444, 40.434) = 6.154, P = 0.009]. By week 4, saffron resulted in significantly greater improvement in erectile function (P < 0.001) and intercourse satisfaction domains (P = 0.001), and total scores (P < 0.001) than the placebo group. Effect of saffron did not differ significantly from that of placebo in orgasmic function (P = 0.095), overall satisfaction (P = 0.334), and sexual desire (P = 0.517) domains scores. Nine patients (60%) in the saffron group and one patient (7%) in the placebo group achieved normal erectile function (score > 25 on erectile function domain) at the end of the study (P value of Fisher's exact test = 0.005). Frequency of side effects were similar between the two groups. CONCLUSIONS:Saffron is a tolerable and efficacious treatment for fluoxetine-related erectile dysfunction.
RCT Entities:
RATIONALE: Saffron (Crocus sativus L.) has shown aphrodisiac effects in some animal and human studies. OBJECTIVES: To assess the efficacy and tolerability of saffron in fluoxetine-related sexual dysfunction. METHODS: This was a 4-week randomized double-blind placebo-controlled study. Thirty-six married male patients with major depressive disorder whose depressive symptoms had been stabilized on fluoxetine and had subjective complaints of sexual impairment entered the study. The patients were randomly assigned to saffron (15 mg twice per day) or placebo for 4 weeks. International Index of Erectile Function scale was used to assess sexual function at baseline and weeks 2 and 4. RESULTS: Thirty patients finished the study. Baseline characteristics as well as baseline and final depressive symptoms scores were similar between the two groups. Effect of time × treatment interaction on the total score was significant [Greenhouse-Geisser-corrected, F (1.444, 40.434) = 6.154, P = 0.009]. By week 4, saffron resulted in significantly greater improvement in erectile function (P < 0.001) and intercourse satisfaction domains (P = 0.001), and total scores (P < 0.001) than the placebo group. Effect of saffron did not differ significantly from that of placebo in orgasmic function (P = 0.095), overall satisfaction (P = 0.334), and sexual desire (P = 0.517) domains scores. Nine patients (60%) in the saffron group and one patient (7%) in the placebo group achieved normal erectile function (score > 25 on erectile function domain) at the end of the study (P value of Fisher's exact test = 0.005). Frequency of side effects were similar between the two groups. CONCLUSIONS: Saffron is a tolerable and efficacious treatment for fluoxetine-related erectile dysfunction.