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Non-pharmacological treatments for irritable bowel syndrome: study protocol of an umbrella review of systematic review and meta-analyses.

ABSTRACT: INTRODUCTION:Non-pharmacological treatments are used in the management of irritable bowel syndrome, and their effectiveness has been evaluated in multiple meta-analyses. The robustness of the results in the meta-analyses was not evaluated. We aimed to assess whether there is evidence of diverse biases in the meta-analyses and to identify the treatments without evidence of risk of bias. METHODS AND ANALYSIS:We will search MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science and CINAHL Plus for meta-analyses that evaluate the effectiveness of non-pharmacological treatments. The time of publication will be limited from inception to December 2018. The credibility of the meta-analyses will be evaluated by assessing between-study heterogeneity, small-study effect and excess significance bias. The between-study heterogeneity will be assessed using the Cochrane's Q test, and the extent of the heterogeneity will be classified using the I2 statistics. The existence of a small-study effect in a meta-analysis will be evaluated using the funnel plot method and confirmed by Egger's test. Excess significance bias will be evaluated by comparing the expected number of clinical studies with positive findings with the observed number. ETHICS AND DISSEMINATION:No formal ethical approval is required since we will use publicly available data. We will disseminate the findings of the umbrella review through publication in a peer-reviewed journal and conference presentations. PROSPERO REGISTRATION NUMBER:CRD42018111516.

SUBMITTER: Jin S

PROVIDER: S-EPMC6475190 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Non-pharmacological treatments for irritable bowel syndrome: study protocol of an umbrella review of systematic review and meta-analyses.

Jin Song S Li Yi-Fan YF Qin Di D Luo Dan-Qing DQ Guo Hong H Gao Xiu-Hua XH Yue Ling L Zheng Hui H

BMJ open 20190320 3

<h4>Introduction</h4>Non-pharmacological treatments are used in the management of irritable bowel syndrome, and their effectiveness has been evaluated in multiple meta-analyses. The robustness of the results in the meta-analyses was not evaluated. We aimed to assess whether there is evidence of diverse biases in the meta-analyses and to identify the treatments without evidence of risk of bias.<h4>Methods and analysis</h4>We will search MEDLINE, EMBASE, Cochrane Central Register of Controlled Tri ...[more]

PMID: 30898835

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Project description:Visceral pain is a leading symptom for patients with irritable bowel syndrome (IBS) that affects 10% - 20 % of the world population. Conventional pharmacological treatments to manage IBS-related visceral pain is unsatisfactory. Recently, medications have emerged to treat IBS patients by targeting the gastrointestinal (GI) tract and peripheral nerves to alleviate visceral pain while avoiding adverse effects on the central nervous system (CNS). Several investigational drugs for IBS also target the periphery with minimal CNS effects.In this paper, reputable internet databases from 1960 - 2016 were searched including Pubmed and ClinicalTrials.org, and 97 original articles analyzed. Search was performed based on the following keywords and combinations: irritable bowel syndrome, clinical trial, pain, visceral pain, narcotics, opioid, chloride channel, neuropathy, primary afferent, intestine, microbiota, gut barrier, inflammation, diarrhea, constipation, serotonin, visceral hypersensitivity, nociceptor, sensitization, hyperalgesia.Certain conventional pain managing drugs do not effectively improve IBS symptoms, including NSAIDs, acetaminophen, aspirin, and various narcotics. Anxiolytic and antidepressant drugs (Benzodiazepines, TCAs, SSRI and SNRI) can attenuate pain in IBS patients with relevant comorbidities. Clonidine, gabapentin and pregabalin can moderately improve IBS symptoms. Lubiprostone relieves constipation predominant IBS (IBS-C) while loperamide improves diarrhea predominant IBS (IBS-D). Alosetron, granisetron and ondansetron can generally treat pain in IBS-D patients, of which alosetron needs to be used with caution due to cardiovascular toxicity. The optimal drugs for managing pain in IBS-D and IBS-C appear to be eluxadoline and linaclotide, respectively, both of which target peripheral GI tract.Conventional pain managing drugs are in general not suitable for treating IBS pain. Medications that target the GI tract and peripheral nerves have better therapeutic profiles by limiting adverse CNS effects.

Project description:ObjectivesEvidence-based treatment guidelines have been unable to provide evidence-based guidance on the effects of acupuncture for irritable bowel syndrome (IBS) because the only previous systematic review included only small, heterogeneous, and methodologically unsound trials. We conducted a new systematic review and meta-analysis of randomized controlled trials (RCTs) to estimate the effects of acupuncture for treating IBS.MethodsMEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, Cumulative Index to Nursing and Allied Health, and the Chinese databases Sino-Med, CNKI, and VIP were searched through November 2011. Eligible RCTs compared acupuncture with sham acupuncture, other active treatments, or no (specific) treatment, and evaluated acupuncture as an adjuvant to another treatment. Our outcomes were overall IBS symptom severity and health-related quality of life. Dichotomous data were pooled to provide a relative risk (RR) of substantial improvement after treatment, and continuous data were pooled to provide a standardized mean difference (SMD) in post-treatment scores between groups.ResultsA total of 17 RCTs (N=1,806) were included. We found no evidence of an improvement with acupuncture relative to sham acupuncture on symptom severity (SMD=-0.11, 95% confidence interval (95% CI): -0.35 to 0.13; 4 RCTs) or quality of life (SMD=-0.03, 95% CI: -0.27 to 0.22; 3 RCTs). Because of the homogeneity of the results of the sham-controlled trials, results were unaffected by restriction to the four sham-controlled RCTs that used adequate randomization, blinding, and had few withdrawals/dropouts. Among RCTs that did not use a placebo control, acupuncture was more effective than pharmacological therapy (RR of symptom improvement=1.28, 95% CI: 1.12 to 1.45; 5 RCTs) and no (specific) treatment (RR = 2.11, 95% CI: 1.18 to 3.79; 2 RCTs). There was no difference between acupuncture and Bifidobacterium (RR=1.07, 95% CI: 0.90 to 1.27; 2 RCTs) or between acupuncture and psychotherapy (RR=1.05, 95% CI: 0.87 to 1.26; 1 RCT). Acupuncture as an adjuvant to another Chinese medicine treatment was statistically significantly better than the other treatment alone, in trials with a high risk of bias (RR=1.17, 95% CI: 1.02 to 1.33; 4 RCTs).ConclusionsSham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control on IBS symptom severity or IBS-related quality of life. In comparative effectiveness Chinese trials, patients reported greater benefits from acupuncture than from pharmacological therapies. Future trials may help clarify whether or not these reportedly greater benefits of acupuncture relative to pharmacological therapies are due entirely to patients' preferences for acupuncture or patients' greater expectations of improvement on acupuncture relative to drugs.

Dataset Information

Non-pharmacological treatments for irritable bowel syndrome: study protocol of an umbrella review of systematic review and meta-analyses.

Publications

Non-pharmacological treatments for irritable bowel syndrome: study protocol of an umbrella review of systematic review and meta-analyses.

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