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Author Liu, Z.; Yan, S.; Wu, J.; He, L.; Li, N.; Dong, G.; Fang, J.; Fu, W.; Fu, L.; Sun, J.; Wang, L.; Wang, S.; Yang, J.; Zhang, H.; Zhang, J.; Zhao, J.; Zhou, W.; Zhou, Z.; Ai, Y.; Zhou, K.; Liu, J.; Xu, H.; Cai, Y.; Liu, B.
Title Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial Type of Study RCT
Year 2016 Publication Annals of Internal Medicine Abbreviated Journal Ann Intern Med
Volume 165 Issue 11 Pages 761-769
Keywords AcuTrials; RCT; Gastrointestinal Diseases; Constipation; Fixed Acupuncture Protocol; Restricted Modalities, Acupuncture Only; Electroacupuncture; TCM Acupuncture Style; Acu Versus Sham; Sham Control; Penetrating Sham; Superficial Needling Depth; Near Verum Acupoint Control
Abstract 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.
Address From Guang'anmen Hospital, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing Traditional Chinese Medicine Hospital of Capital Medical University, Dongzhimen Hospital of Beijing University of Chinese Medicine, Huguosi Hospital of Chinese Medicine of Beijing University of Chinese Medicine, Beijing; West China Hospital of Sichuan University, Chengdu, Sichuan; Yueyang Hospital of Integrated Traditional Chinese and Western Medicine of Shanghai University of Traditional Chinese Medicine, Shanghai; The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang; Guangdong Province Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong; The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin; Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, Jiangsu; Heilongjiang Province Academy of Chinese Medical Science, Ha'erbin, Heilongjiang; The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui; Wuhan Integrated Traditional Chinese Medicine and Western Medical Hospital, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, Hubei, China; and Daemen College, Physical Therapy Wound Care Clinic, Amherst, New York
Language English Number of Treatments 8
Treatment Follow-up Frequency 1/WK Number of Participants 1075
Time in Treatment 8 Weeks Condition Constipation
Disease Category Gastrointestinal Diseases OCSI Score
Notes PMID:27618593 Approved yes
Call Number OCOM @ refbase @ Serial 2182
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