[Umbilicus application of Huobi Powder for ED with kidney deficiency dampness: A randomized controlled clinical trial].

Objective: To prove the clinical efficacy of umbilicus application of Huobi Powder for the treatment of erectile dysfunction (ED) with the traditional Chinese medicine (TCM) syndrome of kidney deficiency dampness by related clinical indexes.

METHODS: This randomized controlled double-blind clinical study included 72 ED patients with the TCM syndrome of kidney deficiency dampness treated by 12-hour application of Huobi Powder (the trial group, n = 36) or placebo (the control group, n = 36) to the umbilicus qd for 28 consecutive days. We recorded the IIEF-5 and Erection Quality Scale (EQS) scores, TCM syndrome indexes, radial rigidity of the erectile penis, and the angle of penile erection before and after treatment. We established a database with the collected data and performed statistical analysis with the SPSS21.0 software.

RESULTS: Statistically significant differences were observed after treatment between the trial and control groups in the TCM syndrome-based efficacy (69.44% vs 36.11%, P <0.01) and Western medicine-based clinical effectiveness (77.78% vs 36.11%, P <0.01). The trial group, as compared with the control, showed remarkably decreased TCM syndrome indexes (18.19 ± 9.12 vs 12.97 ± 11.92, P <0.05), increased IIEF-5 score (13.83 ± 4.91 vs 18.67 ± 3.09, P <0.01), radial rigidity of the erectile penis (［53.43 ± 11.05］% vs ［71.96 ± 12.92］%, P <0.01) and the angle of penile erection (［42.15 ± 11.77］% vs ［66.96 ± 12.34］%, P <0.01), but no significant difference in the EQS score (37.11 ± 16.70 vs 35.33 ± 14.11, P >0.05).

CONCLUSIONS: Umbilicus application of Huobi Powder has a definite clinical effect on ED with the TCM syndrome of kidney deficiency dampness.