Meta-analysis of clinical trials of permixon in the treatment of symptomatic benign prostatic hyperplasia.

OBJECTIVES: Permixon is a compound extracted from the fruit of the American dwarf palm tree, Serenoa repens. Controversy regarding the use of phytotherapeutic agents in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia is significant. We analyzed all available clinical trial data of the Permixon preparation to determine its clinical efficacy compared with placebo. METHODS: All published clinical trial data on Permixon (11 randomized clinical trials and 2 open label trials), involving 2859 patients, were used. These trials were disparate in size (from 22 to 592 patients) and duration (from 21 to 180 days). Peak urinary flow rate and nocturia were the two common end points. The statistical analysis was based on a random effects meta-analysis. RESULTS: The average +/- SE placebo effect on the peak urinary flow rate was an increase of 0.51 +/- 0.51 mL/s. The estimated effect of Permixon was a further increase of 2.20 +/- 0.51 mL/s (P <0.001). Placebo was associated with a reduction in the mean number +/- SE of nocturnal urinations of 0.69 +/- 0.15. A further reduction of 0.50 +/- 0.01 episodes of urination (P <0.001) occurred that was attributable to Permixon. Some heterogeneity was found among the studies. Treatment duration did not appear to impact either of these effects. CONCLUSIONS: This meta-analysis of all available published trials of Permixon in the treatment of men with benign prostatic hyperplasia revealed a significant improvement in peak flow rate and reduction in nocturia greater than with placebo.