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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.

Acupuncture has been used for chronic constipation, but evidence for its effectiveness remains scarce.To determine the efficacy of electroacupuncture (EA) for chronic severe functional constipation (CSFC).Randomized, parallel, sham-controlled trial. (ClinicalTrials.gov: NCT01726504).15 hospitals in China.Patients with CSFC and no serious underlying pathologic cause for constipation.28 sessions of EA at traditional acupoints or sham EA (SA) at nonacupoints over 8 weeks.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 20.1075 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.Longer-term follow-up was not assessed. Acupuncturists could not be blinded.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.Ministry of Science and Technology of the People's Republic of China through the Twelfth Five-Year National Science and Technology Pillar Program.