GuangAn Men Hospital, China Academy of Chinese Medical Sciences, No 5, Beixiange street, Xicheng District Beijing 100053, China.
Trials. 2013 Jun 15;14:176. doi: 10.1186/1745-6215-14-176.
Previous research has shown that electro-acupuncture (EA) may be effective for functional constipation. We report a protocol for a randomized controlled trial using EA to confirm the efficacy and safety for severe chronic functional constipation.
METHODS/DESIGN: This is a randomized, controlled trial. A total of 1,034 patients will be randomly allocated into the EA group (n=517) and the sham EA group (n=517). The EA group receives needling at ST25, SP14 and ST37 and the sham EA group receives needling at sham ST25, SP14 and ST37. The primary outcome measure is the changed number of weekly average complete spontaneous bowel movements(CSBMs) during 8 weeks of treatment, compared with baseline. The secondary outcome measures are: 1) the proportion of participants having three or more CSBMs on average per week; 2) the changed number of weekly average CSBMs during weeks 9 to 20; 3) the changed number of weekly average spontaneous bowel movements during 8 weeks of treatment; 4) stool consistency; 5) degree of difficulty in defecation; 6) patient assessment of constipation quality of life questionnaire (PAC-QOL); 7) incidence of adverse events; and 8) usage of medicine for constipation.
This trial will evaluate the efficacy and safety of EA for severe chronic functional constipation.
Protocol Registration System of ClinicalTrial.gov, NCT01726504.
既往研究表明电针（EA）可能对功能性便秘有效。我们报告了一项使用 EA 治疗严重慢性功能性便秘的随机对照试验方案，以确认其疗效和安全性。
方法/设计：这是一项随机对照试验。共有 1034 名患者将被随机分配到 EA 组（n=517）和假 EA 组（n=517）。EA 组接受 ST25、SP14 和 ST37 针刺，假 EA 组接受假针刺 ST25、SP14 和 ST37。主要结局指标是治疗 8 周时每周平均完全自发性排便次数（CSBMs）的变化与基线相比。次要结局指标是：1）每周平均 CSBMs 达到 3 次或以上的参与者比例；2）第 9 至 20 周每周平均 CSBMs 的变化；3）8 周治疗期间每周平均自发性排便次数的变化；4）粪便稠度；5）排便困难程度；6）便秘患者生活质量问卷（PAC-QOL）评估；7）不良事件发生率；8）便秘药物的使用。
本试验将评估 EA 治疗严重慢性功能性便秘的疗效和安全性。
ClinicalTrials.gov 注册系统，NCT01726504。
