title: Effect of saffron on fluoxetine-induced sexual impairment in men: randomized double-blind placebo-controlled trial.
abstract: BACKGROUND
  Saffron (Crocus sativus L.) has shown aphrodisiac effects in some animal and human studies.
  
  
  OBJECTIVE
  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.
authors.affiliation: Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran 13337, Iran.
authors.forename: Amirhossein
authors.initials: A
authors.lastname: Modabbernia
authors.forename: Hamid
authors.initials: H
authors.lastname: Sohrabi
authors.forename: Abbas-Ali
authors.initials: AA
authors.lastname: Nasehi
authors.forename: Firoozeh
authors.initials: F
authors.lastname: Raisi
authors.forename: Sepideh
authors.initials: S
authors.lastname: Saroukhani
authors.forename: Amirhossein
authors.initials: A
authors.lastname: Jamshidi
authors.forename: Mina
authors.initials: M
authors.lastname: Tabrizi
authors.forename: Mandana
authors.initials: M
authors.lastname: Ashrafi
authors.forename: Shahin
authors.initials: S
authors.lastname: Akhondzadeh
mesh_terms: D000293:Adolescent; D000328:Adult; D027622:Crocus / Q000737:chemistry*; D003865:Major Depressive Disorder / Q000188:drug therapy; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000139:chemically induced / Q000188:drug therapy*; D005473:Fluoxetine / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010936:Plant Extracts / Q000009:adverse effects / Q000494:pharmacology*; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D013997:Time Factors; D055815:Young Adult
chemical_list: D005473:Fluoxetine; D010936:Plant Extracts; D017367:Selective Serotonin Reuptake Inhibitors