Acupuncture for Chronic Severe Functional Constipation:A Randomized, Controlled Trial ONLINE FIRST

Zhishun Liu, MD, PhD; Shiyan Yan, PhD; Jiani Wu, MD; Liyun He, MD, PhD; Ning Li, MD; Guirong Dong, MD; Jianqiao Fang, MD, PhD; Wenbin Fu, MD; Lixin Fu, MD, PhD; Jianhua Sun, MD, PhD; Linpeng Wang, MD; Shun Wang, MD; Jun Yang, MD; Hongxing Zhang, MD; Jianbin Zhang, MD, PhD; Jiping Zhao, MD; Wei Zhou, MD; Zhongyu Zhou, MD; Yanke Ai, PhD; Kehua Zhou, MD, DPT; Jia Liu, MD, PhD; Huanfang Xu, MD, PhD; Yuying Cai, MD, PhD; and Baoyan Liu, MD

Background: Acupuncture has been used for chronic constipation, but evidence for its effectiveness remains scarce.

Objective: To determine the efficacy of electroacupuncture (EA) for chronic severe functional constipation (CSFC).

Design: Randomized, parallel, sham-controlled trial. (ClinicalTrials.gov: NCT01726504)

Setting: 15 hospitals in China.

Participants: Patients with CSFC and no serious underlying pathologic cause for constipation.

Intervention: 28 sessions of EA at traditional acupoints or sham EA (SA) at nonacupoints over 8 weeks.

Measurements: The primary outcome was the change from baseline in mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1 to 8. Participants were followed until week 20.

Results: 1075 patients (536 and 539 in the EA and SA groups, respectively) were enrolled. The increase from baseline in mean weekly CSBMs during weeks 1 to 8 was 1.76 (95% CI, 1.61 to 1.89) in the EA group and 0.87 (CI, 0.73 to 0.97) in the SA group (between-group difference, 0.90 [CI, 0.74 to 1.10]; P < 0.001). The change from baseline in mean weekly CSBMs during weeks 9 to 20 was 1.96 (CI, 1.78 to 2.11) in the EA group and 0.89 (CI, 0.69 to 0.95) in the SA group (between-group difference, 1.09 [CI, 0.94 to 1.31]; P <0.001). The proportion of patients having 3 or more mean weekly CSBMs in the EA group was 31.3% and 37.7% over the treatment and follow-up periods, respectively, compared with 12.1% and 14.1% in the SA group (P < 0.001). Acupuncture-related adverse events during treatment were infrequent in both groups, and all were mild or transient.

Limitations: Longer-term follow-up was not assessed. Acupuncturists could not be blinded.

Conclusion: Eight weeks of EA increases CSBMs and is safe for the treatment of CSFC. Additional study is warranted to evaluate a longer-term treatment and follow-up.

Primary Funding Source: Ministry of Science and Technology of the People's Republic of China through the Twelfth Five-Year National Science and Technology Pillar Program.