Introduction. Given the complexity of the therapeutic management of irritable bowel syndrome (IBS), alternative non-pharmacological therapies are frequently offered to patients. The aim of this study was to conduct a systematic review in order to establish the current evidence base for non-pharmacological interventions (body-directed and mind-body therapies) in the management of IBS. Materials and Methods. The literature was searched in several electronic databases (PubMed (including Medline), Web of Science (Clarivate Analytics), Scopus (Elsevier), ScienceDirect (Elsevier), Cochrane Library (Wiley), and Wiley Online Library (Wiley)) for randomized controlled trials (RCTs) published in the English language from 1990 to 2020. Effectiveness outcomes were examined through the change in overall IBS symptoms or abdominal pain up to 12 months after treatment. Results. 11 studies (parallel-group RCTs) were identified that enrolled 1590 participants in total. Body-directed therapies (acupuncture and osteopathic medicine) showed a beneficial effect compared with standard medical treatment for overall IBS symptoms at 6 months follow-up, while no study found any difference between body-directed and sham therapies for abdominal pain or overall IBS symptoms. It was not possible to conclude whether hypnotherapy was superior to standard medical treatment or supportive therapy for overall IBS symptoms or abdominal pain due to discordant results. Conclusions. Although body-directed therapies such as acupuncture and osteopathic medicine may be beneficial for overall IBS symptoms, higher-quality RCTs are needed to establish the clinical benefit of non-pharmacological interventions for IBS. An important challenge will be the definition of the optimal control groups to be used in non-pharmacological trials.
<p><strong>Background: </strong>Osteopathy is chosen by patients as a treatment for irritable bowel syndrome (IBS) but evidence for its effectiveness is poor. The purpose of this study is to evaluate the effectiveness of osteopathy for IBS at 1 month follow-up in IBS adults.</p><p><strong>Methods: </strong>Design: a multicenter, two-group parallel, randomized, double-blind, placebo-controlled trial. Inclusion criteria: adult IBS patients (Rome IV criteria) with similar baseline symptom severity, and comparable expectations of active and sham osteopathic treatment before. Treatment group included active osteopathic treatment. Control group included sham osteopathic treatment. Randomization was in allocation ratio 1:1. Assessment time was carried as inclusion and baseline assessment (day-1; initial visit V0), day 8, day 15 and follow-up (1 month and 3 months), treatments (day 0, day 8, day 15). Primary endpoint was effectiveness at 1 month (response to treatment defined as at least a 50-point reduction in IBS severity on the IBS-symptom severity score). Secondary endpoint was effectiveness at 3 months (response to treatment) and changes in total IBS quality of life scores up to 3 months. Sample size was 404 individuals to achieve 90% power to detect a 15% difference in treatment response at 1 month between the two groups (20% of patients lost to follow-up).</p><p><strong>Conclusions: </strong>The two-group parallel, randomized, double-blind, placebo-controlled trial (sham therapy) in which the expectations and experiences of patients in the control group are comparable to the experimental group is the most accurate design for demonstrating the effectiveness of osteopathy on IBS symptoms. Future studies could use such a design to assert causality.</p><p><strong>Trial registration:</strong> The trial has been registered in clinicalTrials.gov. Registration number: NCT05230277; registered on 7 February 2022.</p>
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.