Evidence map›Paper›PMID 22978405›Full record

Trial reportBMC complementary and alternative medicine2012

Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study.

Gaurang R Shah, Manojkumar V Chaudhari, Suresh B Patankar, Shrikant V Pensalwar, Vilas P Sabale, Navneet A Sonawane

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC complementary and alternative medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Bioactivity of the GenusPharmaceuticals (Basel, Switzerland) · 2023
    Review
  7. Review
  8. Review
  9. The genusIranian journal of basic medical sciences · 2019
    Review
  10. Effects of Physical Activity and Ginkgo Biloba on Cognitive Function and Oxidative Stress Modulation in Ischemic Rats.The International journal of angiology : official publication of the International College of Angiology, Inc · 2017
    Article
  11. Pharmacovigilance on sexual enhancing herbal supplements.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2016
    Article
  12. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Gaurang R ShahJivdaya Hospital, Dharmoday bldg, Jivdaya lane, L.B.S. Marg, Ghatkopar (West), Mumbai 400 086, India.
Manojkumar V Chaudhari
Suresh B Patankar
Shrikant V Pensalwar
Vilas P Sabale
Navneet A Sonawane
Lilavati Hospital & Research Centre · INMidas Multispeciality Hospital · INVedic Lifesciences (India) · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEvidence 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.

methods78 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.

resultsIn 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.

conclusionsVigRX 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.

Indexed as

AdultDouble-Blind MethodErectile DysfunctionHumansIndiaMaleMiddle AgedPatient SatisfactionPlant ExtractsPlants, MedicinalSemen AnalysisTestosteroneTreatment OutcomeYoung AdultPlant ExtractsTestosterone

Identifiers

PMID22978405
PMCPMC3478157
OpenAlexW2170601172

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.