Cargando…
Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study
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-c...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2012
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3478157/ https://www.ncbi.nlm.nih.gov/pubmed/22978405 http://dx.doi.org/10.1186/1472-6882-12-155 |
_version_ | 1782247271968014336 |
---|---|
author | Shah, Gaurang R Chaudhari, Manojkumar V Patankar, Suresh B Pensalwar, Shrikant V Sabale, Vilas P Sonawane, Navneet A |
author_facet | Shah, Gaurang R Chaudhari, Manojkumar V Patankar, Suresh B Pensalwar, Shrikant V Sabale, Vilas P Sonawane, Navneet A |
author_sort | Shah, Gaurang R |
collection | PubMed |
description | 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 |
format | Online Article Text |
id | pubmed-3478157 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-34781572012-10-23 Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study Shah, Gaurang R Chaudhari, Manojkumar V Patankar, Suresh B Pensalwar, Shrikant V Sabale, Vilas P Sonawane, Navneet A BMC Complement Altern Med Research Article 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 BioMed Central 2012-09-15 /pmc/articles/PMC3478157/ /pubmed/22978405 http://dx.doi.org/10.1186/1472-6882-12-155 Text en Copyright ©2012 Shah et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Shah, Gaurang R Chaudhari, Manojkumar V Patankar, Suresh B Pensalwar, Shrikant V Sabale, Vilas P Sonawane, Navneet A Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study |
title | Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study |
title_full | Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study |
title_fullStr | Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study |
title_full_unstemmed | Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study |
title_short | Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study |
title_sort | evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3478157/ https://www.ncbi.nlm.nih.gov/pubmed/22978405 http://dx.doi.org/10.1186/1472-6882-12-155 |
work_keys_str_mv | AT shahgaurangr evaluationofamultiherbsupplementforerectiledysfunctionarandomizeddoubleblindplacebocontrolledstudy AT chaudharimanojkumarv evaluationofamultiherbsupplementforerectiledysfunctionarandomizeddoubleblindplacebocontrolledstudy AT patankarsureshb evaluationofamultiherbsupplementforerectiledysfunctionarandomizeddoubleblindplacebocontrolledstudy AT pensalwarshrikantv evaluationofamultiherbsupplementforerectiledysfunctionarandomizeddoubleblindplacebocontrolledstudy AT sabalevilasp evaluationofamultiherbsupplementforerectiledysfunctionarandomizeddoubleblindplacebocontrolledstudy AT sonawanenavneeta evaluationofamultiherbsupplementforerectiledysfunctionarandomizeddoubleblindplacebocontrolledstudy |