Systematic review and meta-analysis: Efficacy of patented probiotic, VSL#3, in irritable bowel syndrome

Connell M1, Shin A1, James-Stevenson T1, Xu H2, Imperiale TF1, Herron J3. Neurogastroenterol Motil. 2018 Aug 1:e13427. doi: 10.1111/nmo.13427. [Epub ahead of print]

Author information

1 Division of Gastroenterology and Hepatology, Indianapolis, Indiana.

2 Department of Biostatistics, Indiana University, Indianapolis, Indiana.

3 Indiana University School of Medicine, Indianapolis, Indiana.


BACKGROUND: VSL#3 is a patented probiotic for which several clinical trials suggest benefits on motor function, bloating, and symptoms of irritable bowel syndrome (IBS).

OBJECTIVES: To quantify effects of VSL#3 on abdominal pain, stool consistency, overall response, abdominal bloating, and quality of life (QOL) in IBS through meta-analysis.

METHODS: MEDLINE (OvidSP and PubMed), EMBASE, Web of Science, and Scopus were searched up to May 2017. Using a fixed effects model, we pooled data from intention-to-treat analyses of randomized trials (RCTs) comparing VSL#3 to placebo in IBS. Data were reported as relative risk (RR), overall mean difference (MD), or standardized MD (SMD) with 95% confidence intervals (CI). Quality of evidence was rated using the GRADE approach.

KEY RESULTS: Among 236 citations, 5 RCTs (243 patients) were included. No significant differences were observed for abdominal pain (SMD = -0.03; 95% CI -0.29 to 0.22), bloating (SMD = -0.15; 95% CI -0.40 to 0.11), proportion of bowel movements with normal consistency (overall MD = 0; 95% CI -0.09 to 0.08), or IBS-QOL (SMD = 0.08; 95% CI -0.22 to 0.39). VSL#3 was associated with a nearly statistically significant increase in overall response (RR = 1.39; 95% CI 0.99-1.98).

CONCLUSIONS & INFERENCES: In this systematic review and meta-analysis, there was a trend toward improvement in overall response with VSL#3, but no clear evidence effectiveness for IBS. However, the number and sample sizes of the trials are small and the overall quality of evidence for 3 of the 5 outcomes was low. Larger trials evaluating validated endpoints in well-defined IBS patients are warranted.

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