Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study
Evidence is lacking for multi-ingredient herbal supplements claiming therapeutic effect in sexual dysfunction in men. We examined the safety and efficacy of VigRX Plus (VXP) -- a proprietary polyherbal preparation for improving male sexual function, in a double blind, randomized placebo-controlled, parallel groups, multi-centre study.
Methods:
78 men aged 25--50 years of age; suffering from mild to moderate erectile dysfunction (ED), participated in this study.
Subjects were randomized to receive VXP or placebo at a dose of two capsules twice daily for 12 weeks. The international index of erectile function (IIEF) was the primary outcome measure of efficacy.
Other efficacy measures were: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), Serum testosterone, Semen analysis, Investigator's Global assessment and Subjects'opinion.
Results:
In subjects receiving VXP, the IIEF-Erectile Function (EF) scores improved significantly as compared to placebo. After 12 weeks of treatment, the mean (sd) IIEF-EF score at baseline increased from 16.08 (2.87) to 25.08 (4.56) in the VXP group versus 15.86 (3.24) to 16.47 (4.25) in the placebo group (P <0.0001).
Similar results were observed in each of the remaining four domains of the IIEF (orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction).There was a significant difference for VXP versus placebo comparison of mean (sd) EDITS scores of patients: 82.31(20.23) vs 36.78(22.53) and partners :(82.75(9.8) vs 18.50(9.44);P <0.001. Thirty-five out of 39 (90%) subjects from the VXP group and one (3%) from the placebo group wished to continue with the treatment they received.
Investigator's global assessment rated VXP therapy as very good to excellent in more than 50% patients and placebo therapy as fair to good in about 25% of patients. Incidence of side effects and subject's rating for tolerability of treatment was similar in both groups.
Conclusions:
VigRX Plus was well tolerated and more effective than placebo in improving sexual function in men.Trial RegistrationClinical Trial Registry India, CTRI/2009/091/000099, 31-03-2009
Author: Gaurang R ShahManojkumar V ChaudhariSuresh B PatankarShrikant V PensalwarVilas P SabaleNavneet A Sonawane Credits/Source: BMC Complementary and Alternative Medicine 2012, 12:155
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