The efficacy and safety study of electro-acupuncture for severe chronic functional constipation: study protocol for a multicenter, randomized, controlled trial

Trials

Baoyan Liu³  Lixing Lao²  Shiyan Yan⁴  Xiaohua Zhou¹  Huanfang Xu³  Liyun He⁴  Yuying Cai³  Ye Zhao⁴  Jia Liu⁴  Zhishun Liu³ 

[1] Department of Biostatistics, University of Washington, Office H655E, HSB Box #357232, Seattle, WA 98198, USA;Center for Integrative Medicine, University of Maryland School of Medicine, East Hall, 520 W. Lombard Street, Baltimore, MD 21201, USA;GuangAn Men Hospital, China Academy of Chinese Medical Sciences, No. 5, Beixiange street, Xicheng District Beijing 100053, China;China Academy of Chinese Medical Sciences, No. 16, Dongzhimen Nei Nanxiaojie, Dongcheng District, Beijing 100700, China

关键词: Safety;    Efficacy;    Multicenter RCT;    Electro-acupuncture;    Chronic functional constipation;   

Others  :  1093701
DOI  :  10.1186/1745-6215-14-176

 received in 2013-02-02, accepted in 2013-05-28,  发布年份 2013

【 摘 要 】

Background

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.

Discussion

This trial will evaluate the efficacy and safety of EA for severe chronic functional constipation.

Trial registration

Protocol Registration System of ClinicalTrial.gov, NCT01726504

【 授权许可】

   
2013 Liu et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Stewart WF, Liberman JN, Sandler RS, Woods MS, Stemhagen A, Chee E, Lipton RB, Farup CE: Epidemiology of Constipation(EPOC) study in the United States: relation of clinical subtypes to sociodemographic features. Am J Gastroenterol 1999, 94:3530-3540.
• [2]Lembo A, Camilleri M: Chronic constipation. N Engl J Med 2003, 349:1360-1368.
• [3]Camilleri M, Kerstens R, Rykx A, Vandeplassche L: A placebo-controlled trial of prucalopride for severe chronic constipation. N Engl J Med 2008, 358(22):2344-2354.
• [4]Wenfei D, Lu Y, Yan X, Wang F: Meta analysis of randomized controlled clinical studies of acupuncture for constipation. Chinese Acupuncture and Moxibustion 2012, 32(1):92-96.
• [5]Wang CW, He HB, Li N, Wen Q, Liu ZS: Observation on therapeutic effect of electroacupuncture at Tianshu (ST25) with deep needling technique on functional constipation. Chinese Acupuncture and Moxibustion 2010, 30(9):705-708.
• [6]Wang C, Li N, He H, et al.: Effect of electroacupunctureof Tianshu (ST25) on the rational symptoms of functional constipation patients and evaluation on its efficacy satisfaction: a single-center, prospective, practical and randomized control trial. Acupuncture Research 2010, 35(5):375-379.
• [7]Drossman DA: The functional gastrointestinal disorders and the Rome III process. Gastroenterology 2006, 130:1377-1390.
• [8]Lewis SJ, Heaton KW: Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol 1997, 32(9):920-924.
• [9]Zhang X: World Health Organization (2003). Acupuncture: Review and Analysis of Reports on Controlled Clinical Trials 2003, 1.
• [10]Bader S, Weber M, Becker G: Is the pharmacological treatment of constipation in palliative care evidence based? A systematic literature review. Schmerz 2012 Sep, 26(5):568-586.
• [11]American College of Gastroenterology Chronic Constipation Task Force: An evidence-based approach to the management of chronic constipation in North America. Am J Gastroenterol 2005, 100 Suppl 1:S1-S4.
• [12]Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Hummelsberger J, Irnich D, Weidenhammer W, Willich SN, Linde K: Acupuncture in patients with tension-type headache: randomized controlled trial. BMJ 2005 Aug 13, 331(7513):376-382.
• [13]Diener HC, Kronfeld K, Boewing G, Lungenhausen M, Maier C, Molsberger A, Tegenthoff M, Trampisch HJ, Zenz M, Meinert R, GERAC Migraine Study Group: Efficacy of acupuncture for the prophylaxis of migraine: a multicenter randomised controlled clinical trial. Lancet Neurol 2006 Apr, 5(4):310-316.
• [14]Witt C, Brinkhaus B, Jena S, Linde K, Streng A, Wagenpfeil S, Hummelsberger J, Walther HU, Melchart D, Willich SN: Acupuncture in patients with osteoarthritis of the knee: a randomized trial. Lancet 2005, 366:136-143.
• [15]Shuai P, Zhou XH, Lao L, Li X: Issues of design and statistical analysis in controlled clinical acupuncture trials: an analysis of English-language reports from Western journals. Statistics in Medicine 2012 Mar 30, 31(7):606-618.