Abstract

Objective: This study aimed to assess the efficacy of the compound formula Qianlong Shutong Formula (QLSTF) in the treatment of benign prostatic hyperplasia (BPH) and its impact on hepatic and renal function. This assessment was conducted through randomized controlled trials and animal experimentation. Methods: A total of 160 BPH patients aged between 50 and 70 years were randomly allocated into two groups: The tamsulosin hydrochloride sustained-release capsules group (n=80) and the QLSTF + tamsulosin hydrochloride sustained-release capsules group (n=80). Both groups received a 12-week treatment regimen. In the animal experiments, 12 Sprague Dawley rats were categorized into three groups: The control group (n=4), the model group (n=4), and the QLSTF group (n=4). The latter group received herbal treatment for a duration of 28 days. Results: The current results showed, substantial improvements were observed in the clinical symptoms and signs of BPH within both drug groups. Additionally, no adverse effects on hepatic or renal function were detected. The QLSTF group exhibited a total effective rate of 90.41%, while the control group recorded 77.33%. During the course of treatment, three patients experienced dizziness, and two patients reported nausea and reduced appetite. However, these adverse reactions subsided after a rest period of 4-6h. Conclusion: Our findings underscore the advantages and safety of orally administered QLSTF. In the treatment of BPH, the combined treatment approach using QLSTF demonstrated a higher clinical efficacy rate when compared to the use of tamsulosin hydrochloride sustained-release capsules alone.

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