Liu Zhishun, Liu Yan, Xu Huanfang, He Liyun, Chen Yuelai, Fu Lixin, Li Ning, Lu Yonghui, Su Tongsheng, Sun Jianhua, Wang Jie, Yue Zenghui, Zhang Wei, Zhao Jiping, Zhou Zhongyu, Wu Jiani, Zhou Kehua, Ai Yanke, Zhou Jing, Pang Ran, Wang Yang, Qin Zongshi, Yan Shiyan, Li Hongjiao, Luo Lin, Liu Baoyan
Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
JAMA. 2017 Jun 27;317(24):2493-2501. doi: 10.1001/jama.2017.7220.
Electroacupuncture involving the lumbosacral region may be effective for women with stress urinary incontinence (SUI), but evidence is limited.
To assess the effect of electroacupuncture vs sham electroacupuncture for women with SUI.
DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized clinical trial conducted at 12 hospitals in China and enrolling 504 women with SUI between October 2013 and May 2015, with data collection completed in December 2015.
Participants were randomly assigned (1:1) to receive 18 sessions (over 6 weeks) of electroacupuncture involving the lumbosacral region (n = 252) or sham electroacupuncture (n = 252) with no skin penetration on sham acupoints.
The primary outcome was change from baseline to week 6 in the amount of urine leakage, measured by the 1-hour pad test. Secondary outcomes included mean 72-hour urinary incontinence episodes measured by a 72-hour bladder diary (72-hour incontinence episodes).
Among the 504 randomized participants (mean [SD] age, 55.3 [8.4] years), 482 completed the study. Mean urine leakage at baseline was 18.4 g for the electroacupuncture group and 19.1 g for the sham electroacupuncture group. Mean 72-hour incontinence episodes were 7.9 for the electroacupuncture group and 7.7 for the sham electroacupuncture group. At week 6, the electroacupuncture group had greater decrease in mean urine leakage (-9.9 g) than the sham electroacupuncture group (-2.6 g) with a mean difference of 7.4 g (95% CI, 4.8 to 10.0; P < .001). During some time periods, the change in the mean 72-hour incontinence episodes from baseline was greater with electroacupuncture than sham electroacupuncture with between-group differences of 1.0 episode in weeks 1 to 6 (95% CI, 0.2-1.7; P = .01), 2.0 episodes in weeks 15 to 18 (95% CI, 1.3-2.7; P < .001), and 2.1 episodes in weeks 27 to 30 (95% CI, 1.3-2.8; P < .001). The incidence of treatment-related adverse events was 1.6% in the electroacupuncture group and 2.0% in the sham electroacupuncture group, and all events were classified as mild.
Among women with stress urinary incontinence, treatment with electroacupuncture involving the lumbosacral region, compared with sham electroacupuncture, resulted in less urine leakage after 6 weeks. Further research is needed to understand long-term efficacy and the mechanism of action of this intervention.
clinicaltrials.gov Identifier: NCT01784172.
涉及腰骶部的电针疗法可能对压力性尿失禁（SUI）女性有效，但证据有限。
评估电针疗法与假电针疗法对SUI女性的疗效。
设计、设置和参与者：在中国12家医院进行的多中心随机临床试验，于2013年10月至2015年5月招募了504名SUI女性，数据收集于2015年12月完成。
参与者被随机分配（1:1）接受18次（为期6周）涉及腰骶部的电针治疗（n = 252）或假电针治疗（n = 252），假电针在非穴位处不穿透皮肤。
主要结局是通过1小时护垫试验测量的从基线到第6周漏尿量的变化。次要结局包括通过72小时膀胱日记测量的平均72小时尿失禁发作次数（72小时失禁发作次数）。
在504名随机参与者中（平均[标准差]年龄，55.3[8.4]岁），482名完成了研究。电针组基线时的平均漏尿量为18.4克，假电针组为19.1克。电针组的平均72小时失禁发作次数为7.9次，假电针组为7.7次。在第6周时，电针组的平均漏尿量减少幅度（-9.9克）大于假电针组（-2.6克），平均差异为7.4克（95%置信区间，4.8至10.0；P <.001）。在某些时间段，电针组从基线开始的平均72小时失禁发作次数的变化大于假电针组，第1至6周组间差异为1.0次发作（95%置信区间，0.2 - 1.7；P = 0.01），第15至18周为2.0次发作（95%置信区间，1.3 - 2.7；P <.001），第27至30周为2.1次发作（95%置信区间，1.3 - 2.8；P <.001）。电针组治疗相关不良事件的发生率为1.6%，假电针组为2.0%，所有事件均为轻度。
在压力性尿失禁女性中，与假电针疗法相比，涉及腰骶部的电针疗法在治疗6周后导致的漏尿量更少。需要进一步研究以了解该干预措施的长期疗效和作用机制。
clinicaltrials.gov标识符：NCT01784172。
