Chinese herb formulae for treatment of erectile dysfunction: a systematic review of randomised controlled clinical trials.

To assess the beneficial and adverse effects of orally therapies of Chinese herb formulae (CHF) for erectile dysfunction (ED), four electronic databases were searched until 23 June 2012. Randomised clinical trials testing CHF or combined with Western medicine therapy (WMT) against placebo, another different CHF and WMT were included. Study selection, data extraction, assessing of bias risk and data analysis were conducted according to the Cochrane handbook. Twenty-one randomised controlled clinical trials (involving 2253 patients) were included, and the bias risks were not low. Funnel plots of comparing CHF to another CHF on the clinical comprehensive effectiveness were asymmetrical. The compositions of CHF used were greatly complex. The analyses showed that some CHF or combined with WMT had significant effects on cure rate, total clinical effective rates, IIEF-5 scores, erectile quality scores, erection angles of penis and recovery times of erection compared with the controls. Eight trials reported mild adverse drug reactions, mostly involving gastrointestinal symptoms. It was concluded that some therapies of CHF may be more effective than the controls for treatment of ED. However, because of the generally not low risks of bias, CHF are not recommended for ED. Further research that demonstrates their mechanisms of action and meaningful efficacies must be carried out by rigorously designed, randomised controlled trials.