scholarly journals Efficacy of biological drugs in short-duration versus long-duration inflammatory bowel disease: a protocol for a systematic review and an individual-patient level meta-analysis of randomised controlled trials

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e024222 ◽  
Author(s):  
Shomron Ben-Horin ◽  
Yue Zhao ◽  
Jing Guo ◽  
Ren Mao ◽  
Lena Novack ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Disease Duration ◽  
Meta Analysis ◽  
Disease Onset ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Individual Patient Level ◽  
Patient Level ◽  
Inflammatory Bowel

IntroductionCrohn’s disease (CD) and ulcerative colitis (UC) are remitting–relapsing inflammatory diseases often culminating in disease complications and/or need for surgery. Biologic monoclonal antibody drugs (‘Biologics’) are efficacious for both diseases, but there are no systematic assessments of their efficacy if administered early after disease onset (‘top-down’ strategy) vis-à-vis later in the course of disease (‘step-up’ approach).Methods and analysisElectronic databases (MEDLINE, EMBASE/EMBASE classic Cochrane CENTRAL register of controlled trials, the Cochrane IBD Group Specialised Trials Register and Clinicaltrials.gov registry) will be searched to identify all randomised placebo-controlled clinical trials of food and drug administration (FDA)-approved biologics for CD and UC (by March 2016). Two independent reviewers will screen identified papers, extract data and assess the risk of bias according to the Cochrane Handbook for Systematic Reviews of Interventions. Individual-patient-level data (IPD) will be extracted from the identified trials through data-sharing platforms for pharmaceutical companies’ sponsored trials and by contacting principal investigators of independent investigator-initiated trials. We will analyse induction of remission in patients with early-disease (<18 months since disease onset) versus patients with longer disease duration, using a generalised linear mixed effect model and by a two-stage approach using coefficient for the treatment-by-subgroup interaction within each trial. We will perform receiver operator curve analysis of optimal disease duration for response. Analyses will be separate for CD and UC. This first-of-its-kind meta-analysis at IPD level of interaction of disease duration with the response to biologics in UC and CD may elucidate the impact of early initiation of biologics, which is of paramount importance for clinical practice and management strategies of inflammatory bowel disease.Ethics and disseminationThis meta-analysis was approved by the Ethics Committee of the First Affiliated Hospital of Sun Yat-sen University. Findings will be published in peer-reviewed journal and disseminated via scientific meetings and links with organisations.PROSPERO registration numberCRD42018041961.

scholarly journals Side Effects Associated with Probiotic Use in Adult Patients with Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Nutrients ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 2913 ◽  
Author(s):  
Maria Pina Dore ◽  
Stefano Bibbò ◽  
Gianni Fresi ◽  
Gabrio Bassotti ◽  
Giovanni Mario Pes
Keyword(s):  
Systematic Review ◽  
Inflammatory Bowel Disease ◽  
Side Effects ◽  
Randomized Controlled Trials ◽  
Bowel Disease ◽  
Meta Analysis ◽  
Adult Patients ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Inflammatory Bowel

Probiotics demonstrated to be effective in the treatment of inflammatory bowel disease (IBD). However, the safety profile of probiotics is insufficiently explored. In the present systematic review and meta-analysis, we examined the occurrence of side effects related to probiotic/synbiotic use in randomized controlled trials (RCTs) of IBD patients as compared with placebo. Eligible RCTs in adult patients with IBD were identified by accessing the Medline database via PubMed, EMBASE, CENTRAL and the Cochrane central register of controlled trials up to December 2018. Occurrence of side effects was retrieved and recorded. Data were pooled and the relative risks (RRs) with their 95% confidence intervals (CIs) were calculated. The low-moderate study heterogeneity, assessed by the I2 statistic, allowed to use of a fixed-effects modelling for meta-analysis. Nine RCTs among 2337, including 826 patients (442 treated with probiotics/symbiotic and 384 with placebo) were analyzed. Eight were double-blind RCTs, and six enrolled ulcerative colitis (UC) patients. Although the risk for the overall side effects (RR 1.35, 95%CI 0.93–1.94; I2 = 25%) and for gastrointestinal symptoms (RR 1.78, 95%CI 0.99–3.20; I2 = 20%) was higher in IBD patients taking probiotics than in those exposed to placebo, statistical significance was achieved only for abdominal pain (RR 2.59, 95%CI 1.28–5.22; I2 = 40%). In conclusion, despite the small number of RCTs and the variety of probiotic used and schedule across studies, these findings highlight the level of research effort still required to identify the most appropriate use of probiotics in IBD.

The Effectiveness and Safety of Hyperbaric Oxygen Therapy in Various Phenotypes of Inflammatory Bowel Disease: Systematic Review With Meta-analysis

2021 ◽  
Author(s):  
Jeffrey McCurdy ◽  
Kevin Chin Koon Siw ◽  
Rana Kandel ◽  
Sarah Larrigan ◽  
Greg Rosenfeld ◽  
...  
Keyword(s):  
Systematic Review ◽  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Hyperbaric Oxygen Therapy ◽  
Oxygen Therapy ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Study Quality ◽  
Randomized Controlled ◽  
Inflammatory Bowel

Abstract Background Accumulating evidence suggests that hyperbaric oxygen therapy (HBOT) may be effective for inflammatory bowel disease (IBD). Our systematic review aimed to quantify the effectiveness and safety of HBOT in various IBD phenotypes. Methods We performed a proportional meta-analysis. Multiple databases were systematically searched from inception through November 2020 without language restriction. We included studies that reported effectiveness and/or safety of HBOT in IBD. Weighted summary estimates with 95% confidence intervals (Cis) were calculated for clinical outcomes for each IBD phenotype using random-effects models. Study quality was assessed using the Cochrane evaluation handbook and National Institute of Health criteria. Results Nineteen studies with 809 patients total were eligible: 3 randomized controlled trials and 16 case series. Rates of clinical remission included 87% (95% CI, 10–100) for ulcerative colitis (n = 42), 88% (95% CI, 46–98) for luminal Crohn’s disease (CD, n = 8), 60% (95% CI, 40–76) for perianal CD (n = 102), 31% (95% CI, 16–50) for pouch disorders (n = 60), 92% (95% CI, 38–100) for pyoderma gangrenosum (n = 5), and 65% (95% CI, 10–97) for perianal sinus/metastatic CD (n = 7). Of the 12 studies that reported on safety, 15% of patients (n = 30) had minor adverse events. Study quality was low in the majority of studies due to an absence of comparator arms, inadequate description of concomitant interventions, and/or lack of objective outcomes. Conclusions Limited high-quality evidence suggests that HBOT is safe and associated with substantial rates of clinical remission for multiple IBD phenotypes. Well-designed randomized controlled trials are warranted to confirm the benefit of HBOT in IBD.

scholarly journals Coxib Safety in Patients with Inflammatory Bowel Diseases: A Meta-analysis

2015 ◽  
Vol 6;18 (6;11) ◽  
pp. 599-607 ◽  
Author(s):  
Davide Giuseppe Ribaldone
Keyword(s):  
Inflammatory Bowel Disease ◽  
Relative Risk ◽  
Ankylosing Spondylitis ◽  
Bowel Disease ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Cox 2 ◽  
Cox 2 Inhibitors

Background: Patients with inflammatory bowel diseases (IBD) frequently have extraintestinal manifestations including arthritis, sacroiliitis, and ankylosing spondylitis. While the treatment of these rheumatological conditions with traditional non-steroidal anti-inflammatory drugs (NSAIDs) has been reported to lead to frequent IBD exacerbation, the safety of cyclooxygenase-2 (COX-2) inhibitors (Coxibs) remains unclear. Objectives: Our aim is to carry out a meta-analysis to verify if Coxibs, employed to treat rheumatological manifestations, are associated with an increased risk of exacerbation of IBD compared to placebo. Study Design and Setting: A MEDLINE, SCOPUS, ISI-Web of Knowledge, and EMBASE search of all studies published in English from 1965 to April 15, 2015, was conducted. Articles on the safety of Coxibs in patients with IBD were identified using the terms “Coxibs or cyclooxygenase-2 inhibitors or COX-2 inhibitors AND inflammatory bowel disease.” Methods: The criteria of exclusion of the studies were NSAIDs administration within 2 weeks before starting Coxibs. For the “proportion” meta-analysis, the studies had to report the proportion of patients that had to discontinue the Coxibs therapy due to an exacerbation of IBD; for the “relative risk” meta-analysis, the studies had to be prospective with a comparison between patients taking Coxibs and patients taking placebo. Two authors independently reviewed titles and abstracts of references retrieved from the literature search and selected potentially relevant studies. Differences in opinion were resolved by discussion until consensus was reached. If an agreement failed to be reached, a third author was consulted. The quality of each study was assessed on a 5-point scale adapted from studies by the Quebec Task Force on Whiplash-Associated disorders and Jadad. Results: The search identified 72 publications of which 7 studies reported the proportion of patients with IBD that had to stop the Coxibs therapy because of a worsening of the activity of IBD. The pooled proportion of flare up of IBD in patients that received Coxibs was 14.4% (95% CI: 6.7 – 24.4%). There was no statistically significant difference between patients that assumed Coxibs and those that assumed placebo (total fixed effect relative risk = 0.86, 95% CI: 0.39 – 1.88, P = 0.7). Limitations: A proportion of patients received maintenance therapy with azathioprine or 6-mercaptopurine and these co-interventions could have protected against a Coxib-induced flare; furthermore, the duration of Coxib assumption in the prospective studies is shorter compared to that of the medical practice. Three of the studies included in our meta-analysis had an insufficient quality but due to the higher number of recruited patients, the studies with a better quality had a higher weight in the final result. Moreover, to assess the relative risk of flare up of IBD only randomized controlled trials have been used in the second meta-analysis. Conclusions: This meta-analysis showed that Coxibs are safe in most patients with IBD. Controlled trials of Coxibs compared with NSAIDs would be useful, at least in patients suffering from rheumatic pain refractory to standard treatment. Key words: Acute pain, ankylosing spondylitis, arthritis, coxibs, chronic pain, inflammatory bowel disease, rheumatic manifestations, sacroiliitis

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