Zhang Tao, Xun Yun-Qing, Li Bin, Wang Gui-Ling, Wang Lin-Peng, Jia Lian-Cheng, Li Wei-Guang, Liu Xue-Mei, Liu Hui-Lin, Sun Jing-Qing
Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation.
Graduate School, Beijing University of Chinese Medicine.
Medicine (Baltimore). 2020 May 22;99(21):e20376. doi: 10.1097/MD.0000000000020376.
Benign prostatic hyperplasia (BPH) is the most common non-cancerous disease of the prostate and leads to lower urinary tract symptoms in middle-aged and elderly males. Fire needle therapy could improve the lower urinary tract symptoms associated with mild-moderate BPH in clinical practice. The aim of the present pilot study is to assess the preliminary effects of fire needle therapy on mild-moderate BPH.
The present study is a prospective parallel randomized controlled pilot trial. A total of 60 eligible participants will be randomly assigned to a treatment or control group at a 1:1 ratio. The treatment group will receive fire needle therapy and the control group will receive watchful waiting with lifestyle advice and education regarding BPH. Participants will receive intervention for 4 weeks, with a follow-up period of 4 additional weeks. Adverse events will be recorded to assess the safety and tolerability of fire needle therapy for mild-moderate BPH. The primary outcome will be the change in the International Prostate Symptom Score. The secondary outcomes will include the change in the mean number of nightly urinations, the maximum urinary flow rate, the average flow rate, and the prostate volume as measured by a B-mode ultrasound device. All outcome measures will be observed at baseline and at 4 and 8 weeks following the beginning of treatment.
The present study will provide evidence of the preliminary effects of fire needle therapy on mild-moderate BPH and indicate an optimal sample size for future studies.
良性前列腺增生（BPH）是前列腺最常见的非癌性疾病，可导致中老年男性出现下尿路症状。在临床实践中，火针疗法可改善与轻中度BPH相关的下尿路症状。本初步研究的目的是评估火针疗法对轻中度BPH的初步疗效。
本研究是一项前瞻性平行随机对照试验。总共60名符合条件的参与者将以1:1的比例随机分配到治疗组或对照组。治疗组将接受火针疗法，对照组将接受观察等待，并给予有关BPH的生活方式建议和教育。参与者将接受4周的干预，随后还有4周的随访期。将记录不良事件，以评估火针疗法治疗轻中度BPH的安全性和耐受性。主要结局指标将是国际前列腺症状评分的变化。次要结局指标将包括夜间排尿平均次数的变化、最大尿流率、平均尿流率以及通过B超设备测量的前列腺体积。所有结局指标将在基线以及治疗开始后的第4周和第8周进行观察。
本研究将提供火针疗法对轻中度BPH初步疗效的证据，并为未来研究指明最佳样本量。
