The effect and safety of acupuncture on patients with functional constipation: Protocol for a systematic review and meta-analysis of high quality RCTs

BACKGROUND: Functional constipation (FC) is a prevalent clinical disease that affects a considerable proportion of the population of all ages. Persistent FC significantly reduces quality of life and influences physical and emotional well-being, as well as consumes many substantial healthcare resources. Acupuncture originates from Traditional Chinese Medicine (TCM), and emerging evidence of several randomized controlled trials (RCTs) published suggest that acupuncture has positive effects for FC. Since 2019, several new results of high quality RCTs about acupuncture treatment for FC have been published. Thus a systematic review will be designed to appraise the effectiveness and safety of acupuncture for improvement of FC in patients based on high quality RCTs. METHODS: We carried out a rigorous literature search in English and Chinese electronic database from inception to present. Two reviewers will identify relevant studies, extract and manage trial information, and then assess the risk of bias in included studies by the Cochrane risk of bias assessment tool. Only high quality RCTs will be included. Data will be synthesized by either fixed-effects or random-effects model regarding to a heterogeneity test. The primary outcome measurement will be the change from baseline in mean complete spontaneous bowel movements and stool form. The secondary outcomes involved disappearance rate of symptoms, proportion of responders, mean transit time, health-related quality of life, and safety of intervention. Meta-analysis will be performed by using Cochrane's RevMan software. RESULTS: This systematic review will summarize high quality clinical evidence to assess and appraise the effectiveness and safety of acupuncture treatment for FC patient. EXPECTED CONCLUSION: This systematic review and meta-analysis will provide evidence to determine whether acupuncture treatment is an effective and safe therapy for the prevention and treatment of FC compared with medication treatment.