Strathprints Home | Open Access | Browse | Search | User area | Copyright | Help | Library Home | SUPrimo

Updated meta-analysis of clinical trials of Serenoa repens extract in the treatment of symptomatic benign prostatic hyperplasia

Boyle, P. and Robertson, C. and Lowe, F. and Roehrborn, C. (2004) Updated meta-analysis of clinical trials of Serenoa repens extract in the treatment of symptomatic benign prostatic hyperplasia. British Journal of Urology International, 93 (6). pp. 751-756. ISSN 1464-4096

Full text not available in this repository. (Request a copy from the Strathclyde author)

Abstract

To determine, by analysing all available clinical trial data, the clinical efficacy against placebo of an extract from the fruit of the American dwarf palm tree, Serenoa repens (Permixon(R), Pierre Fabre Medicament, Castres, France), as there is controversy about the use of phytotherapeutic agents in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). METHODS All clinical trial data published on Permixon, comprising 14 randomized clinical trials and three open-label trials, involving 4280 patients, were analysed. These trials were of different size (22-1100 patients) and duration (21-720 days). The peak urinary flow rate and nocturia were the two common endpoints. The statistical analysis was based on a random-effects meta-analysis. RESULTS Permixon was associated with a mean (SEM) reduction in the International Prostate Symptom Score (IPSS) of 4.78 (0.41). The mean placebo effect on peak urinary flow rate was an increase of 1.20 (0.49) mL/s. The estimated effect of Permixon was a further increase of 1.02 (0.50) mL/s (P = 0.042). Placebo was associated with a reduction in the mean number of nocturnal voids of 0.63 (0.14); there was a further reduction attributable to Permixon of 0.38 (0.07) (P < 0.001). There was some heterogeneity among the studies for nocturia; one over 2 years involving 396 patients and showing no difference between placebo and Permixon had a large effect on the results. CONCLUSIONS This meta-analysis of all available published trials of Permixon for treating men with BPH showed a significant improvement in peak flow rate and reduction in nocturia above placebo, and a 5-point reduction in the IPSS.

Item type: Article
ID code: 17338
Keywords: BPH, Permixon, nocturia, maximum flow, clinical trials, meta-analysis, random effects, imputation, Statistics, Pharmacy and materia medica, Urology
Subjects: Social Sciences > Statistics
Medicine > Pharmacy and materia medica
Department: Faculty of Science > Mathematics and Statistics
Related URLs:
    Depositing user: Strathprints Administrator
    Date Deposited: 26 Apr 2010 16:55
    Last modified: 27 Mar 2014 08:49
    URI: http://strathprints.strath.ac.uk/id/eprint/17338

    Actions (login required)

    View Item