Acupuncture for the treatment of diarrheal-predominant irritable bowel syndrome: study protocol for a pilot randomized controlled trial
Open Access
- 7 April 2021
- journal article
- research article
- Published by Springer Science and Business Media LLC in Trials
- Vol. 22 (1), 1-9
- https://doi.org/10.1186/s13063-021-05211-x
Abstract
Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal diseases. Although acupuncture has become a common alternative therapy for IBS, there is insufficient evidence for its effectiveness. This study was designed to assess the efficacy and feasibility of acupuncture in the treatment of IBS. This is a multicenter randomized controlled clinical trial. According to the ratio of 1:1:1, 90 patients with irritable bowel syndrome will be randomly divided into specific acupoints (SA) group, non-specific acupoints (NSA) group, and non-acupoints (NA) group. All patients will be treated with acupuncture 12 times within 4 weeks and followed up for 8 weeks. The primary outcome is the response rate, the percentage of patients whose average value of worst abdominal pain is 30% better and the days of loose stool is 50% less than the baseline, at week 4 after randomization. The secondary outcomes include the response rates at other time points, IBS Symptom Severity Scale (IBS-SSS), Patient Health Questionnaire-9 depression scale (PHQ-9), IBS-Quality of Life scale (IBS-QOL), IBS Adequate Relief (IBS-AR), Abdominal Pain Score, Abdominal Bloating Score, Bristol Stool Score (BBS), blinding assessment, and credibility evaluation. Adverse events will be monitored and recorded during the trial. Chictr.org.cn ChiCTR2000030670. Registered on 9 March 2020.Funding Information
- National Key Research and Development Program of China (2019YFC1712103)
This publication has 31 references indexed in Scilit:
- Bulking agents, antispasmodics and antidepressants for the treatment of irritable bowel syndromeEmergencias, 2011
- A Treatment Trial of Acupuncture in IBS PatientsThe American Journal of Gastroenterology, 2009
- Effect of electro-acupuncture on substance P, its receptorand corticotropin-releasing hormone in rats with irritablebowel syndromeWorld Journal of Gastroenterology, 2009
- Guidelines on the irritable bowel syndrome: mechanisms and practical managementGut, 2007
- Clinical trial: dextofisopam in the treatment of patients with diarrhoea‐predominant or alternating irritable bowel syndromeAlimentary Pharmacology & Therapeutics, 2007
- Functional Bowel DisordersGastroenterology, 2006
- Personal view: adequate relief as a primary endpoint in irritable bowel syndromeAlimentary Pharmacology & Therapeutics, 2006
- Therapeutic roles of acupuncture in functional gastrointestinal disordersAlimentary Pharmacology & Therapeutics, 2004
- Bulking agents, antispasmodic and antidepressant medication for the treatment of irritable bowel syndromePublished by Wiley ,2002
- The PHQ-9Journal of General Internal Medicine, 2001