Effect of Huashi Tongbi Formula on Erectile Dysfunction with Damp Heat Affecting Pi (Spleen) Pattern: A Multicentre, Randomized, Controlled Noninferiority Trial
Abstract
OBJECTIVE: To evaluate the effect and safety of Chinese herbal compound Huashi Tongbi Formula (HTF) for the treatment of erectile dysfunction (ED) with damp heat affecting Pi (Spleen) pattern, and explore the possible mechanisms based on the analysis of gut microbiota.
METHODS: In this multicentre, randomized, parallel, positive control, noninferiority trial, a total of 162 ED patients with damp heat affecting Pi pattern were randomly divided into a treatment group (108 patients) and a control group (54 patients) in a 2:1 ratio using a random number table method. The treatment group was administered HTF granules (1 bag each time, twice a day). The control group was given sildenafil citrate tablets (50 mg, orally as needed). Both groups were treated for 8 weeks with a 8-week followed-up period. The main indicator was effective rate after 8-week treatment analysed using intention-to-treat (ITT) and per-protocol (PP) methods, and the secondary indicators included International Index of Erectile Function-5 (IIEF-5) score, Erectile Quality Score (EQS), and Chinese medicine syndrome (CMS) score, which were analysed using ITT every 2 weeks during 8-week treatment period, and every 4 weeks during 8-week follow-up period. The 16S rDNA sequencing was used to analyse the impact of HTF on the gut microbiota. The adverse events (AEs) and changes in safety indicators of the two groups were recorded.
RESULTS: A total of 162 patients were included in the ITT analysis, with 23 patients…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 162 participants or records.
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