Pygeum africanum for the treatment of patients with benign prostatic hyperplasia: A systematic review and quantitative meta-analysis

PURPOSE: To conduct a systematic review and quantitative meta-analysis of t he therapeutic efficacy and tolerability of Pygeum africanum in men with sy mptomatic benign prostatic hyperplasia. METHODS: Studies were identified through the search of Medline (1966 to 200 0), Embase, Phytodok, the Cochrane Library, bibliographies of identified tr ials and review articles, and contact with relevant authors and drug compan ies. Randomized trials were included if participants had symptomatic benign prostatic hyperplasia, the intervention was a preparation of P. africanum alone or in combination with other phytotherapeutic agents, a control group received placebo or other pharmacologic therapies for benign prostatic hyp erplasia, and treatment duration was at least 30 days. Two investigators in dependently extracted key data on design features, subject characteristics, and therapy allocation. RESULTS: A total of 18 randomized controlled trials involving 1,562 men met the inclusion criteria and were analyzed. Many studies did not report resu lts in a method that permitted metaanalysis. Only 1 of the studies reported a method of treatment allocation concealment, although 17 were double-blin ded. The mean study duration was 64 days (range 30 to 122). Compared with p lacebo in 6 studies, P. africanum provided a moderately large improvement i n the combined outcome of urologic symp- toms and flow measures as assessed by an effect size defined by the difference of the mean change for each ou tcome divided by the pooled standard deviation for each outcome (-0.8 SD [9 5% confidence interval (CI): -1.4 to -0.3]). Summary estimates of individua l outcomes were also improved by P. africanum. Men were more than twice as likely to report an improvement in overall symptoms (risk ratio = 2.1, 95% CI: 1.40 to 3.1). Nocturia was reduced by 19% and residual urine volume by 24%; peak urine flow was increased by 23%. Adverse effects due to P. africa num were mild and similar to placebo. The overall dropout rate was 12% and was similar for P, africanum (13%), placebo (11%), and other controls (8%; P = 0.4 versus placebo and P = 0.5 versus other controls). CONCLUSIONS: The literature on P. africanum for the treatment of benign pro static hyperplasia is limited by the short duration of studies and the vari ability in study design, the use of phytotherapeutic preparations, and the types of reported outcomes. However, the evidence suggests that P. africanu m modestly, but significantly, improves urologic symptoms and flow measures . Further research is needed using standardized preparations of P. africanu m to determine its long-term effectiveness and ability to prevent complicat ions associated with benign prostatic hyperplasia. (C) 2000 by Excerpta Med ica, Inc.