An open label, randomized, fixed-dose, crossover study comparing efficacy and safety of sildenafil citrate and saffron (Crocus sativus Linn.) for treating erectile dysfunction in men naïve to treatment

Abstract

An open label, randomized, fixed-dose, crossover study comparing efficacy and safety of sildenafil citrate and saffron (Crocus sativus Linn.) for treating erectile dysfunction in men naïve to treatment MR Safarinejad, N Shafiei and S Safarinejad Urology and Nephrology Research Center, Shahid Beheshti University (MC), Tehran, Iran Saffron (Crocus sativus Linn.) have been perceived by the public as a strong aphrodisiac herbal product. However, studies addressing the potential beneficial effects of saffron on erectile function (EF) in men with ED are lacking. Our aim was to evaluate the efficacy and safety of saffron administration on EF in men with ED. After a 4-week baseline assessment, 346 men with ED (mean age 46.6 ± 8.4 years) were randomized to receive on-demand sildenafil for 12 weeks followed by 30 mg saffron twice daily for another 12 weeks or vice versa, separated by a 2-week washout period. To determine the type of ED, penile color duplex Doppler ultrasonography before and after intracavernosal injection with 20 lg prostaglandin E 1 , pudendal nerve conduction tests and impaired sensory-evoked potential studies were performed. Subjects were assessed with an International Index of Erectile Function (IIEF) questionnaire, Sexual Encounter Profile (SEP) diary questions, patient and partner versions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire and the Global Efficacy Question (GEQ) 'Has the medication you have been taking improved your erections?' No significant improvements were observed with regard to the IIEF sexual function domains, SEP questions and EDITS scores with saffron administration. The mean changes from baseline values in IIEF-EF domain were þ 87.6% and þ 9.8% in sildenafil and placebo groups, respectively (P ¼ 0.08). We did not observe any improvement in 15 individual IIEF questions in patients while taking saffron. Treatment satisfaction as assessed by partner versions of EDITS was found to be very low in saffron patients (72.4 vs 25.4, P ¼ 0.001). Mean per patient 'yes' responses to GEQ was 91.2 and 4.2% for sildenafil and saffron, respectively (P ¼ 0.0001). These findings do not support a beneficial effect of saffron administration in men with ED.

Saffron: a natural product with potential pharmaceutical applications

“…It was observed an overall beneficial effect of saffron with significant increase in erectile and orgasmic function, as well as sexual desire and overall satisfaction. In contrast, Safarinejad et al [114] reported no improvement of erectile dysfunction in a crossover study comparing efficacy of sildenafil citrate and saffron, among 346 men who received either sildenafil for 12 weeks followed by 30-mg saffron twice daily for another 12 weeks or vice versa, separated by a 2-week washout period.…”

“…In fact, inconsistent results were found in two clinical trials evaluating the efficacy of saffron on erectile dysfunction. [113,114] In the trial of Shamsa et al, [113] saffron extract was administered orally as a 200-mg tablet daily to 20 male patients for 10 days. It was observed an overall beneficial effect of saffron with significant increase in erectile and orgasmic function, as well as sexual desire and overall satisfaction.…”

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“…No significant improvements were observed in the international index of erectile function domains, Sexual Encounter Profile questions and Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire scores with saffron administration. The authors reported that their findings did not support beneficial effects of saffron administration in men with erectile dysfunction [17] . This might be attributed to the low dose of saffron (30 mg BID) prescribed in comparison to the previous study.…”

A systematic review of randomized controlled trials examining the effectiveness of saffron (Crocus sativus L.) on psychological and behavioral outcomes

“…However, in a larger-scale RCT, no group differences were evidenced in sexual function parameters in 260 infertile men with idiopathic oligoasthenoteratozzspermia (OAT) who had taken 60 mg/d of saffron compared to placebo for 26 weeks [32] . Using an open label, randomized, fixed-dose, crossover study, Safarinejad et al (2010) compared saffron (60 mg/d) to sildenafil (50 mg/d) in 307 men with erectile dysfunction [33] . They found no beneficial effect of saffron administration for 12 weeks (30 mg/d) in men with erectile dysfunction.…”