电针治疗女性轻中度压力性尿失禁有效性的Ⅰ期临床研究

A phase 1 clinical study on the efficacy of electroacupuncture for female patients with mild to moderate stress incontinence

目的:初步评价电针中髎、会阳治疗女性轻中度压力性尿失禁的有效性。方法:70例女性轻中度压力性尿失禁患者随机分为试验组和对照组,每组各35例。试验组采用电针中髎、会阳,对照组采用安慰针针刺中髎对照点和会阳对照点,每周治疗3次,连续治疗6周。观察两组患者治疗前后1h尿垫试验漏尿量、72h尿失禁次数和ICIQ-SF得分的变化。结果:治疗后试验组1h尿垫试验漏尿量、72h尿失禁次数及ICIQ-SF得分均较治疗前降低,而对照组仅后两项降低(P<0.05,P<0.01),且试验组3项降低值显著大于对照组(P<0.05,P<0.01)。两组治疗依从性较高,未见明显不良反应。结论:电针中髎、会阳治疗女性轻中度压力性尿失禁具有较好的近期效应,可初步排除安慰效应。

Objective： To preliminarily evaluate the efficacy of electroacupnncture Zhongliao （BL33） and Huiyang （BL35） for female patients with mild to moderate stress incontinence. Methods： Seventy female patients with mild to moderate stress incontinence were randomly divided into treatment group and control group, with 35 cases in each group. The treatment group were received electroacupuncture at BL33 and BL35, while the control group were received sham electroacupuncture at sham locations for BL33 and BL35, with 3 times per week, lasting for 6 weeks. The changes in the volume of urine leakage were measured by a one hour urinal pad test, the frequency of urinary incontinence at 72 hours and the score of ICIQ-SF questionnaire were analyzed before and after the treatment. Results： Compared with those before treatment, the volume of urine leakage were measured by a one hour urinal pad test, the frequency of urinary incontinence at 72 hours and the score of ICIQ-SF questionnaire in both groups decreased after the treatment, while the last two indexes, control group decrease （P〈0.05, P〈0.01）. And these changes in the treatment group were more significant than those in the control group （P〈0.05, P〈0.01）. In both groups, there was good treatment compliance with no obvious adverse event. Conclusion： Electroacupuncture with deep needling at BL33 and BL35 is effective for women with mild to moderate stress urinary incontinence, which is a curative efficacy rather than a placebo effect. There is a short-term effect of electroacupuncture Zhongliao （BL33） and Huiyang （BL35） for female patients with mild to moderate stress incontinence that is irrelevant to placebo effect.