Effect of saffron on fluoxetine-induced sexual impairment in men: randomized double-blind placebo-controlled trial

Abstract

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.

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Acknowledgment

This study was Dr. Hamid Sohrabi’s thesis for the degree of Doctor of Medicine. The study was supported by a grant from Tehran University of Medical Sciences to Professor Shahin Akhondzadeh (grant number: 8140). The trial was registered in Iranian Registry of Clinical Trials (registration number: IRCT138711121556N3, http://www.irct.ir/searchresult.php?id=1556&number=3).

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The authors declare no conflict of interests.

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Correspondence to Shahin Akhondzadeh.

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Modabbernia, A., Sohrabi, H., Nasehi, AA. et al. Effect of saffron on fluoxetine-induced sexual impairment in men: randomized double-blind placebo-controlled trial. Psychopharmacology 223, 381–388 (2012). https://doi.org/10.1007/s00213-012-2729-6

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Keywords

  • Crocus sativus
  • Erectile dysfunction
  • Fluoxetine
  • Saffron
  • Sexual dysfunction
  • SSRI