Efficacy and Safety of Xialiqi for the Treatment of Benign Prostatic Hyperplasia in a Randomized Trial.

Background and objective: Benign prostatic hyperplasia (BPH) is a major cause of lower urinary tract symptoms (LUTS) in men aged ≥50 yr. Xialiqi capsules are a traditional Chinese medicine mainly used for the treatment of moderate BPH-related LUTS. Methods: We conducted a multicenter, randomized, double-blind, placebo-controlled clinical trial of Xialiqi treatment for 8 wk in a cohort of 395 patients. Changes in BPH-related LUTS were assessed in terms of the International Prostate Symptom Score (IPSS). Irritative and obstructive IPSS subscores and secondary efficacy indicators, including quality of life (QoL) and International Index of Erectile Function (IIEF-5) scores, were also assessed. Safety and tolerability were assessed in terms of adverse events (AEs) and serious AE. Key findings and limitations: At the final time point of 8 wk, the least-squares treatment difference in IPSS between the Xialiqi and placebo groups was -2.33 (95% confidence interval -3.01 to -1.64). Analysis of covariance results suggested that there was no significant difference between the groups in terms of interactions of subgroups or between parameter subgroups. Results for secondary efficacy measures, including Chronic Prostatitis Symptom Index and QoL scores, revealed greater improvement with Xialiqi than with placebo. Safety results show that Xialiqi was well tolerated and AEs were mild. Limitations include the lack of long-term follow-up. Conclusions and clinical implications: Xialiqi was associated with an improvement in LUTS over an 8-wk period among men with moderate BPH symptoms. Patient summary: We looked at the safety and efficacy of Xialiqi capsules for the treatment of benign enlargement of the prostate gland in a large Chinese population. We found that Xialiqi provides an early improvement in urinary symptoms and prostate enlargement in men with moderate symptoms relating to an enlarged prostate.