Efficacy and safety of acupuncture on the treatment of functional constipation: Study protocol for a randomized controlled trial

Abstract

ObjectiveThis trial is aimed at evaluating the efficacy and safety of acupuncture on treating FC. MethodsWe describe the protocol for a randomized, patient-assessor-blinded, sham controlled trial. Seventy-two eligible patients will be randomly assigned to the intervention group (acupuncture) or the control group (sham acupuncture). All treatment will be given 26 sessions of acupuncture or sham acupuncture over 8 weeks (5 times per week in the first 2 weeks, 3 times per week during weeks 3–6, and 2 times per week during weeks 7 and 8). Each treatment will last for 20 min. The primary outcome is the change in mean complete spontaneous bowel movements (CSBMs) per week. The secondary outcomes are patient assessment of constipation quality of life questionnaire (PAC-QOL), self-rating anxiety scale (SAS), and the dosage of the medication. All adverse events will be recorded in detail and managed by corresponding researchers as quickly as possible. Outcomes will be evaluated at baseline (1 week before treatment), 2 weeks after intervention begins, 6 weeks after intervention begins, 8 weeks after intervention begins, 4 weeks follow-up, and 12 weeks follow-up. DiscussionThe results of this study will provide the evidence of the efficacy and safety of acupuncture as a traditional treatment methods for functional constipation. Trial registrationChinese Clinical Trial Registry, ChiCTR-INR-17011472. Registered on 23 May 2017.