scholarly journals Placebo Response Rate in Clinical Trials of Fistulizing Crohn's Disease: Systematic Review and Meta-analysis

2014 ◽  
Vol 12 (12) ◽  
pp. 1981-1990 ◽  
Author(s):  
Alexander C. Ford ◽  
Pavit Luthra ◽  
Stephen B. Hanauer ◽  
Simon P. Travis ◽  
M. Scott Harris ◽  
...  
2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S521-S521
Author(s):  
M Khorshid Fasge ◽  
A Cordie ◽  
S Abd-Elsalam

Abstract Background This systematic review and meta-analysis was designed to estimate the safety and effectiveness of ustekinumab in the treatment for Crohn’s disease (CD) in clinical trials and observational studies. Methods We retrieved all the related publications from PubMed, Cochrane, EBSCO, Google Scholar and EMBASE using a systematic search strategy. We only included the clinical trials and observational studies that were published in English. Results Only 31 studies that met the eligibility criteria out of the 733 identified studies were included. Twenty-one studies reported the clinical response rate; three of these were clinical trials, and the other 18 were cohort studies. The overall clinical response rate in the cohort studies was 0.539, 95% CI (0.419–0.659) with significant heterogeneity (I2 = 96.22%, P < 0.001) and that in the clinical trials was 0.428, 95% CI (0.356–0.501). The pooled clinical remission rate was 0.399, 95% CI (0.295–0.503) in randomised control trials (RCTs) and 0.440, 95% CI (0.339–0.542) in cohort studies. Twenty-one studies reported the incidence of adverse effects. The rate of adverse effects was 0.158, 95% CI (0.109–0.207) in cohort studies and 0.690, 95% CI (0.633–0.748) in RCTs. Three RCTs had an infection rate of 0.275, 95% CI (0.245–0.295), while the 18 cohort studies had a rate of 0.076, 95% CI (0.047–0.105). Only ten studies reported the incidence of injection or infusion reaction; it was 0.035, 95% CI (0.027–0.043) for RCTs and 0.012, 95% CI (0.002–0.022) for cohort studies. Conclusion Ustekinumab is effective in the treatment of CD. However, more research is required on the safety profiles because there was considerable variation among the included studies.


2018 ◽  
Vol 24 (10) ◽  
pp. 2135-2141 ◽  
Author(s):  
Ruben J Colman ◽  
Rachel C Lawton ◽  
Marla C Dubinsky ◽  
David T Rubin

Abstract Background Methotrexate (MTX) is an immunomodulator used for the treatment of pediatric inflammatory bowel disease (IBD). There are currently no RCTs that assess the treatment efficacy of methotrexate within the pediatric IBD patient population. This systematic review and meta-analysis assesses the efficacy of MTX therapy among the existing pediatric literature. Methods A systematic literature search was performed using MEDLINE and the Cochrane library from inception until March 2016. Synonyms for ‘pediatric’, ‘methotrexate’ and ‘IBD’ were utilized as both free text and MESH search terms. The studies included contained clinical remission (CR) rates for MTX treatment of pediatric IBD patients 18 yrs old, as mono- or combination therapy. Case studies with <10 patients were excluded. Quality assessment was performed with the Newcastle-Ottawa Scale. Meta-analysis calculated pooled CR rates. A random-effects meta-analysis with forest plots was performed using R. Results Fourteen (11 monotherapy, 1 combination therapy, 2 both; n = 886 patients) observational studies were eligible out of 202 studies. No interventional studies were identified. The pooled achieved CR rate for pediatric CD patients on monotherapy within 3-6 months was 57.7% (95% CI 48.2-66.6%), (P =0.22; I2 = 29.8%). The CR was 37.1% (95% CI 29.5-45.5%), (P = 0.20; I2 = 37.4%) for maintenance therapy at 12 months. Sub-analysis could not identify CR differences between MTX administration types, thiopurine exposure. Conclusions This meta-analysis demonstrated that, over 50% of pediatric Crohn’s disease patients induced with methotrexate achieved clinical remission, while 12-month remission rate was only 37%. Prospective controlled interventional trials should assess treatment efficacy among patient subgroups.


Nutrients ◽  
2019 ◽  
Vol 11 (11) ◽  
pp. 2657 ◽  
Author(s):  
Jose M. Comeche ◽  
Pablo Caballero ◽  
Ana Gutierrez-Hervas ◽  
Sofia García-Sanjuan ◽  
Iris Comino ◽  
...  

Inflammatory bowel disease (IBD) is a chronic disease mediated by the immune system and is characterized by inflammation of the gastrointestinal tract. One of the possible treatments for this pathology is a change in the type of diet, of which enteral nutrition (EN) is one. This study is to understand how the use of EN can affect the adult population diagnosed with IBD. We conducted a systematic review, meta-analysis, and a meta-regression. On the different databases (MEDLINE, Scopus, Cochrane, LILACS, CINAHL, WOS), we found 363 registers with an accuracy of 12% (44 registers). After a full-text review, only 30 research studies were selected for qualitative synthesis and 11 for meta-analysis and meta-regression. The variables used were Crohn’s disease activity index (CDAI), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). EN has been shown to have efficacy for the treatment of Crohn’s disease and is compatible with other medicines. As for the CDAI or rates of remission, there were no differences between enteral and parenteral nutrition. Polymeric formulas have shown better results with respect to the CRP. The long-term treatment could dilute the good CDAI results that are obtained at the start of the EN treatment.


2020 ◽  
Vol 52 (7) ◽  
pp. 1104-1116
Author(s):  
Dominik Bettenworth ◽  
Arne Bokemeyer ◽  
Lei Kou ◽  
Rocio Lopez ◽  
James F. Bena ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document