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. Author manuscript; available in PMC: 2015 May 5.
Published in final edited form as: J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):109. doi: 10.1097/MPG.0b013e31823df69b

Does VSL#3 Really Improve Symptoms in Children with Irritable Bowel Syndrome?

Robert J Shulman 1, E O'Brian Smith 1
PMCID: PMC4419702  NIHMSID: NIHMS339769  PMID: 22064630

To The Editor

We read with great interest the report by Guandalini et al. on the effectiveness of the probiotic VSL#3 in improving symptoms in children with irritable bowel syndrome (IBS) 1. However, a number of issues impair interpretation of the results. The crossover design of the study is extremely problematic. A number of studies evaluating probiotics have shown that their beneficial effects on IBS symptoms extend weeks beyond the treatment period 2-5. In patients with ulcerative colitis, VSL#3 exerts a significant effect on stool pH at least 15 days after administration ceases, a time when the organisms are no longer recoverable in feces based on studies in patients with IBS, albeit using older methodology 6, 7. Thus, there very likely was a carryover effect between the two study periods, clouding interpretation of the results. Indeed, this is one of the reasons that an expert panel does not recommend the use of crossover trials for IBS 8. Additional causes of concern include: lack of a CONSORT flow diagram, lack of intention to treat data analysis, and failure to use a two-way ANOVA (to account for group).

Footnotes

No conflicts of interest to disclose.

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