Efficacy and safety of Shulie'an capsules in treating chronic prostatitis: A multicenter, prospective, open-label clinical trial.

BACKGROUND AND

OBJECTIVES

Chronic prostatitis is a highly prevalent urological disorder affecting millions of men globally and significantly impairing quality of life. The aim of this study was to evaluate the efficacy and safety of Shulie'an (SLA) capsules in patients with chronic prostatitis.

METHODS

In this multicenter, prospective, open-label, self-controlled clinical trial, 100 male patients with clinically confirmed chronic prostatitis were enrolled in China. The participants received oral SLA (two capsules per dose, three times daily) for 28 days. The primary endpoint was the change in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score from baseline to endpoint. Secondary endpoints included NIH-CPSI individual domain scores and disappearance rate of traditional Chinese medicine (TCM) symptoms. Safety assessments involved monitoring and recording all adverse events throughout the study period.

RESULTS

After 28 days of treatment, SLA capsules exhibited significant clinical efficacy, with an overall response rate of 91.75%. The mean NIH-CPSI total score reduction was 9.2±5.82 and 15.0±6.79 points on the 14th and 28th day, respectively. Approximately 95.88% of the participants achieved more than 4-point reduction in the NIH-CPSI score from baseline after treating for 28 days. All symptom domains showed statistically significant improvements, with symptoms of pain being the most remarkable (complete resolution rate: 41.57%). Besides, after 28 days of treatment, the total TCM syndrome score of the participants significantly improved, and the treatment was considerably safe with no reported serious adverse events.

CONCLUSION

This study demonstrated that SLA capsules are a promising therapeutic option for chronic prostatitis, significantly improving clinical symptoms and quality of life with a favorable safety profile.