title: Quantitative Risk-Benefit Analysis of Probiotic Use for Irritable Bowel Syndrome and Inflammatory Bowel Disease.
abstract: Probiotics have seen widespread use for a variety of gastrointestinal problems, especially in two common disorders: irritable bowel syndrome and inflammatory bowel disease. Since a wide variety of probiotic preparations has been used, and despite a large number of studies performed, a great deal of heterogeneity exists among them. Straightforward evidence-based recommendations for the use of probiotics in irritable bowel syndrome and inflammatory bowel disease have thus been difficult to formulate. In an effort to improve understanding of the risk-benefit balance of probiotics in these conditions, this study (1) queried the US FDA Adverse Event Reporting System (FAERS) database for all reported adverse drug events related to probiotics in 2013, and (2) constructed risk-benefit planes for both irritable bowel syndrome and inflammatory bowel disease using a geometric approximation of the confidence region between risk and benefit. The results show that adverse events from probiotics vary widely by disease, and when they occur, they are mild and may be difficult to distinguish from the natural history of the underlying disorders they are used to treat. The risk-benefit plane for irritable bowel syndrome straddles the risk-benefit threshold, so patients can expect a balance between a low chance of risk and also a low chance of benefit. The risk-benefit plane for inflammatory bowel disease largely lies above the risk-benefit threshold, so patients may expect more benefit than risk in most cases. More standardized and high-quality research is needed to improve our understanding of risk and benefit for these complex biopharmaceuticals.
authors.affiliation: Section of Pediatric Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Indiana University School of Medicine, 410 W. 10th Street, Indianapolis, IN, 46202, USA. webjr@iu.edu.|Section of Children's Health Services Research, Department of Pediatrics, Indiana University School of Medicine, 410 W. 10th Street, Indianapolis, IN, 46202, USA. webjr@iu.edu.|Section of Pediatric and Adolescent Comparative Effectiveness Research, Department of Pediatrics, Indiana University School of Medicine, 410 W. 10th Street, Indianapolis, IN, 46202, USA. webjr@iu.edu.
authors.forename: William E
authors.initials: WE
authors.lastname: Bennett
mesh_terms: D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000178:diet therapy*; D043183:Irritable Bowel Syndrome / Q000178:diet therapy*; D019936:Probiotics / Q000009:adverse effects* / Q000627:therapeutic use*; D018570:Risk Assessment