Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Dec 6, 2018; 6(15): 961-984
Published online Dec 6, 2018. doi: 10.12998/wjcc.v6.i15.961
Probiotic Medilac-S® for the induction of clinical remission in a Chinese population with ulcerative colitis: A systematic review and meta-analysis
Ghania Sohail, Xiaoyu Xu, Mary C Christman, Thomas A Tompkins
Ghania Sohail, Xiaoyu Xu, Thomas A Tompkins, Lallemand Health Solutions Inc., Montreal, QC H4P 2R2, Canada
Mary C Christman, MCC Statistical Consulting, Gainesville, FL 32605, United States
Author contributions: Sohail G and Xu X contributed to acquisition of data, interpretation of data, drafting and revising the article; Christman MC contributed to analysis and interpretation of the data, drafting and revising the article; Tompkins TA contributed to study concept, data evaluation, critical revisions; final manuscript as submitted was reviewed and approved by all authors.
Conflict-of-interest statement: Sohail G, Xu X and Tompkins TA declare that they are paid employees of Lallemand Health Solutions Inc. (Montreal, QC), a company that studies, manufactures and sells probiotics globally, business-to-business, but not to consumers.
PRISMA 2009 Checklist statement: This systematic review with meta-analysis was prepared and revised according to the PRISMA 2009 guidelines and checklist.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Correspondence to: Thomas A Tompkins, PhD, Research Director, Lallemand Health Solutions Inc., 6100 Avenue Royalmount, Montreal, QC H4P 2R2, Canada.
Telephone: +1-514-2835428
Received: August 28, 2018
Peer-review started: August 28, 2018
First decision: October 5, 2018
Revised: October 16, 2018
Accepted: November 14, 2018
Article in press: November 15, 2018
Published online: December 6, 2018

To assess the effects of probiotic Medilac-S® as adjunctive therapy for the induction of remission of ulcerative colitis (UC) in a Chinese population through a systematic review and meta-analysis.


A systematic literature search was conducted to find randomized, controlled trials in a Chinese population with at least two study arms - a control arm which receives a conventional, oral aminosalicylate drug, and a treatment arm, which administers the same conventional drug in conjunction with the probiotic Medilac-S®per os. Both English and Chinese databases were searched, including PubMed, EMBASE, Google Scholar, Chinese National Knowledge Infrastructure, Wanfang Data, and VIP Search, and study data was extracted onto standardized abstraction sheets. Meta-analyses were conducted for primary and secondary outcomes of interest using a fixed or random effects model. The primary outcome was the induction of clinical remission and the secondary outcomes included changes in Sutherland index, endoscopic and histological scores, proportion of reported clinical symptoms and adverse events (AEs). For outcomes with sufficient data, the type of conventional drug therapy was also assessed to determine if the effects of combination therapy with Medilac-S® was influenced by drug type. All tests were conducted using a type I error rate of 0.05 and all confidence intervals (CI) were based on a 95% confidence level. Review protocol was uploaded to PROSPERO (CRD42018085658 upon completion).


Fifty-three clinical trials with a total of 3984 participants were identified and included in the review. Medilac-S® adjunctive therapy significantly improved induction of clinical remission (RR = 1.21; 95%CI: 1.18-1.24; P < 0.0001) with the estimated likelihood of effective treatment, on average, 21% higher for those consuming the probiotic. Sutherland index scores showed the control mean was on average 3.10 (CI: 2.41-3.78; P = 0.0428) units greater than the treatment mean, thereby demonstrating significant improvement in participants taking the probiotic. Similarly, a significant difference was seen between the overall reduction of endoscopic and histological scores of control and treatment arm participants, with score decreases in the control groups 0.71 (CI: 0.3537-1.0742) and 1.1 (CI: 0.9189-1.2300) units smaller than treatment group score decreases. The proportion of participants reporting clinical symptoms, (abdominal pain, tenesmus, blood and mucous in stool, and diarrhea) was significantly reduced after combination therapy with Medilac-S® (P < 0.0001) and estimated to be on average 44% (RR = 0.44, CI: 0.32-0.59), 53% (RR = 0.53, CI: 0.38-74), 40% (RR = 0.40, CI: 0.28-0.58) and 47% (RR = 0.47 CI: 0.36-0.42) respectively, of the proportion of individuals reporting the aforementioned symptoms after conventional therapy alone. The risk of AEs was also significantly reduced with adjunctive Medilac-S® therapy. The proportion of individuals in the treatment groups reporting AEs was an estimated 72% of the proportion of individuals in the control groups reporting AEs (RR = 0.72, CI: 0.55-0.94, P = 0.0175). Upon comparing effect means for different drug types in conjunction with Medilac-S®, evidence of significant variability (P < 0.0001) was observed, and sulfasalazine was found to be the most effective drug in both primary and secondary outcomes.


Evidence suggests Medilac-S® adjunctive therapy should be considered standard care for UC in a Chinese population because it aids in the induction of clinical remission, improves symptoms of the gastrointestinal tract and reduces risk of AEs.

Keywords: Clinical remission, Systematic review, Meta-analysis, Mesalazine, Sulfasalazine, Ulcerative colitis, Medilac-S®

Core tip: Growing evidence demonstrates the important role of probiotics in the treatment of ulcerative colitis (UC), however past reviews evaluating the efficacy of probiotics as UC treatment often demonstrate significant heterogeneity, making it difficult to interpret results accurately. In this systematic review and meta-analysis, only one disease state, one probiotic and one population are reviewed and a focused analysis is conducted on the effects of the probiotic Medilac-S® in conjunction with conventional drug therapy to improve symptoms of UC and induce clinical remission within a Chinese population.