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Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study.
BMC Complement Altern Med. 2012 Sep 15; 12:155.BC

Abstract

BACKGROUND

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 REGISTRATION

Clinical Trial Registry India, CTRI/2009/091/000099, 31-03-2009.

Authors+Show Affiliations

Jivdaya Hospital, Dharmoday bldg, Jivdaya lane, L.B.S. Marg, Ghatkopar (West), Mumbai 400 086, India.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22978405

Citation

Shah, Gaurang R., et al. "Evaluation of a Multi-herb Supplement for Erectile Dysfunction: a Randomized Double-blind, Placebo-controlled Study." BMC Complementary and Alternative Medicine, vol. 12, 2012, p. 155.
Shah GR, Chaudhari MV, Patankar SB, et al. Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study. BMC Complement Altern Med. 2012;12:155.
Shah, G. R., Chaudhari, M. V., Patankar, S. B., Pensalwar, S. V., Sabale, V. P., & Sonawane, N. A. (2012). Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study. BMC Complementary and Alternative Medicine, 12, 155. https://doi.org/10.1186/1472-6882-12-155
Shah GR, et al. Evaluation of a Multi-herb Supplement for Erectile Dysfunction: a Randomized Double-blind, Placebo-controlled Study. BMC Complement Altern Med. 2012 Sep 15;12:155. PubMed PMID: 22978405.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study. AU - Shah,Gaurang R, AU - Chaudhari,Manojkumar V, AU - Patankar,Suresh B, AU - Pensalwar,Shrikant V, AU - Sabale,Vilas P, AU - Sonawane,Navneet A, Y1 - 2012/09/15/ PY - 2011/08/04/received PY - 2012/08/16/accepted PY - 2012/9/18/entrez PY - 2012/9/18/pubmed PY - 2013/2/7/medline SP - 155 EP - 155 JF - BMC complementary and alternative medicine JO - BMC Complement Altern Med VL - 12 N2 - BACKGROUND: 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 REGISTRATION: Clinical Trial Registry India, CTRI/2009/091/000099, 31-03-2009. SN - 1472-6882 UR - https://www.unboundmedicine.com/medline/citation/22978405/Evaluation_of_a_multi_herb_supplement_for_erectile_dysfunction:_a_randomized_double_blind_placebo_controlled_study_ L2 - https://bmccomplementalternmed.biomedcentral.com/articles/10.1186/1472-6882-12-155 DB - PRIME DP - Unbound Medicine ER -