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Efficacy and Safety of Omega-3 for Treatment of Early-Stage Peyronie's Disease: A Prospective, Randomized, Double-Blind Placebo-Controlled Study

Authors


Mohammad Reza Safarinejad, MD, P.O. Box 19395-1849, Tehran, Iran. Tel: +98 21 22454499; Fax: +98 21 2456845; E-mail: safarinejad@urologist.md

ABSTRACT

Introduction.  Findings from the literature seem to suggest a potential beneficial effect of omega-3 fatty acid (FA) supplementation on Peyronie's Disease (PD). However, there is a lack of evidence to show a clear clinical benefit of omega-3 in patients with PD.

Aim.  To determine the effect of omega-3 FA supplementation on sexual functioning, penile curvature, and plaque characteristics in men with early-stage PD.

Main Outcome Measures.  Subjects were assessed with an International Index of Erectile Function (IIEF-5), Sexual Encounter Profile (SEP) diary questions 2 and 3, and dynamic penile duplex ultrasound before and after intracavernous injection of 20 µg prostaglandin E1. Plaque size, penile curvature, pain during erection, and penile artery spectral traces (end-diastolic velocity [EDV], peak systolic velocity [PSV], and resistivity index [RI] of the left and right cavernous arteries) were also measured. When necessary, signs and symptoms of PD were assessed objectively and/or subjectively.

Methods.  A total of 224 patients with early chronic-stage PD, aged 38–59 years, were randomized to eicosapentaenoic (EPA) and docosahexaenoic acids (DHA), 1.84 g/day (group 1, n = 112) or placebo (group 2, n = 112) for 6 months.

Results.  No significant improvements were observed with regard to the penile curvature, pain during erection, and erectile function. The mean changes from baseline values in penile curvature were +10.6°, and +9.8° in omega-3 and placebo groups, respectively (P = 0.08). Plaque size increased by 69.2% and 67.9% in omega-3 and placebo groups, respectively (P = 0.1). We did not observe any improvement in plaque volume in either group. Improvement in penile pain was found to be similar in both groups. Mean index of IIEF-5 in 6-month treatment period was 8.8 ± 1.6 in the omega-3 group and 8.8 ± 1.4 in the placebo group (P = 0.1).

Conclusions.  These data do not support a beneficial effect of omega-3 supplementation in early-chronic stage PD. Safarinejad MR. Efficacy and safety of omega-3 for treatment of early-stage Peyronie's disease: A prospective, randomized, double-blind placebo-controlled study. J Sex Med 2009;6:1743–1754.

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