[Huanshao Capsules for erectile dysfunction with spleen and kidney deficiency: A multicentered clinical trial].

Objective: To investigate the clinical efficacy and safety of Huanshao Capsules (HSC) in the treatment of ED with spleen and kidney deficiency.

METHODS: This randomized open multicentered positive drug controlled clinical trial included 248 cases of ED with spleen and kidney deficiency, which were assigned to a trial and a control group of equal number to be treated with HSC at the dose of 3 capsules tid and Wuziyanzong Pills at 6 g bid, respectively, both for 4 weeks. We recorded and compared the IIEF-5 scores, traditional Chinese medicine (TCM) symptom scores, and hepatic and renal functions between the two groups of patients before and at 2 and 4 weeks after medication.

RESULTS: The clinical observation was completed in 240 of the patients. Based on the IIEF-5 scores of the patients, the total effectiveness rate was significantly higher in the trial than in the control group (76.6% vs 67.8%, P < 0.05). The TCM symptom scores were decreased by ≥95% in 14 cases (11.7%), ≥70% in 97 cases (80.8%) and ≥30% in 9 cases (7.5%) in the trial group as compared with ≥95% in 7 cases (5.8%), ≥70% in 84 cases (70.0%) and ≥30% in 29 cases (24.2%) in the control, with remarkably better improvement in the former than in the latter group (P < 0.05). Before and at 2 and 4 weeks after medication, the IIEF-5 scores were 13.04 ± 4.02, 15.95 ± 3.22 and 20.06 ± 2.17, and the TCM symptom scores were 16.64 ± 5.26, 10.08 ± 4.89 and 3.05 ± 2.18 respectively in the trial group, both significantly improved at 4 weeks in comparison with those in the control (P < 0.05). No abnormality was observed in urine and blood tests or hepatic and renal functions before and after treatment, nor obvious adverse events were found in the two groups of patients during the medication.

CONCLUSIONS: Huanshao Capsules can safely and effectively improve the IIEF-5 scores and clinical symptoms of ED patients with spleen and kidney deficiency, and therefore deserve a wide clinical application.