scholarly journals The Inflammatory Bowel Disease Questionnaire in Randomized Controlled Trials of Treatment for Ulcerative Colitis: Systematic Review and Meta-Analysis

2020 ◽  
Vol 7 (2) ◽  
pp. 189-205
Author(s):  
Aaron Yarlas ◽  
Stephen Maher ◽  
Martha Bayliss ◽  
Andrew Lovley ◽  
Joseph C Cappelleri ◽  
...  
Nutrients ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 2913 ◽  
Author(s):  
Maria Pina Dore ◽  
Stefano Bibbò ◽  
Gianni Fresi ◽  
Gabrio Bassotti ◽  
Giovanni Mario Pes

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.


Author(s):  
Jeffrey McCurdy ◽  
Kevin Chin Koon Siw ◽  
Rana Kandel ◽  
Sarah Larrigan ◽  
Greg Rosenfeld ◽  
...  

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.


2021 ◽  
Vol 11 ◽  
Author(s):  
Irene Marafini ◽  
Edoardo Troncone ◽  
Irene Rocchetti ◽  
Giovanni Monteleone

The ongoing COVID-19 pandemic has raised concerns about the risk of SARS-CoV-2 infection in patients with Crohn’s disease (CD) and patients with ulcerative colitis (UC) taking immunosuppressants or biologics. We conducted a systematic review and meta-analysis to assess the risk of respiratory infections in patients with inflammatory bowel disease (IBD) treated with vedolizumab. We searched PubMed, EMBASE and Scopus to identify randomized controlled trials (RCT) comparing vedolizumab to placebo in patients with IBD. Outcomes were the rate of respiratory tract infections (RTI), upper respiratory tract infections (URTI) and lower respiratory tract infections (LRTI) among patients receiving vedolizumab as compared with placebo. Pooled rates were reported as Odds Ratios (OR) with 95% Confidence Interval (CI). Eight RCT involving 3,287 patients (1873 CD and 1415 UC) were analyzed; 2,493 patients received vedolizumab and 794 received placebo. The rates of RTI and URTI were statistically higher in vedolizumab-treated patients compared to placebo [OR = 1.63; 95% CI (1.07–2.49); OR = 1.64 95% CI (1.07–2.53) respectively]. UC patients, but not CD patients, receiving vedolizumab had a higher risk to develop RTI and URTI [OR = 1.98; 95% CI (1.41–2.77); OR = 2.02; 95% CI (1.42–2.87)] compared to placebo-treated patients. The number of LRTI was small in both treatment groups. Data confirm the good safety profile of vedolizumab even though RTI were more frequent in patients receiving vedolizumab and the risk of URTIs was significantly higher in patients with UC.


Author(s):  
Marla C Dubinsky ◽  
Marco DiBonaventura ◽  
Haiyun Fan ◽  
Andrew G Bushmakin ◽  
Joseph C Cappelleri ◽  
...  

Abstract Background Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We examined the effect of tofacitinib induction treatment on Inflammatory Bowel Disease Questionnaire (IBDQ) items in adults with moderate to severe UC. Methods Data were pooled from the randomized, 8‑week, double-blind, phase 3 OCTAVE Induction 1 and 2 studies. The IBDQ was self-administered by patients at baseline, week 4, and week 8, with higher scores indicating better health-related quality of life (HRQoL). Change from baseline in IBDQ items was analyzed for 10 mg of tofacitinib twice daily (BID) vs placebo using a linear mixed-effects model, with no multiplicity adjustment performed. Effect sizes were calculated. Subgroup analyses by tumor necrosis factor inhibitor (TNFi) experience were performed. Results Significant improvements (nominal P < 0.05) were observed in all IBDQ items with 10 mg of tofacitinib BID vs placebo at weeks 4 and 8. For the overall population, the largest treatment differences across all items were reported for “bowel movements been loose” at weeks 4 and 8, and “problem with rectal bleeding” at week 8 (mean treatment differences all 1.1; both in bowel symptoms domain). These items also showed the largest effect sizes. Treatment benefits were generally slightly numerically higher in TNFi-experienced vs TNFi-naïve patients. Conclusions Tofacitinib induction therapy improved all IBDQ items vs placebo in patients with UC, reflecting improvements in HRQoL, with greatest benefits reported in bowel symptoms domain items (Funded by Pfizer Inc; OCTAVE Induction 1 and OCTAVE Induction 2; ClinicalTrials.gov, NCT01465763 and NCT01458951, respectively).


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