Which is more effective for the treatment of irritable bowel syndrome: an app to increase adherence to a low FODMAPS diet, or an oral antispasmodic agent (otilonium bromide)?
This pragmatic trial found a clinically meaningful benefit of a low FODMAPS diet, implemented using an app, compared with an active medication comparator. Given its safety and low cost, the authors argue (and I agree) that a low FODMAPS diet should be first-line therapy for our patients with IBS. The process includes elimination of FODMAPS from the diet and then reintroducing foods, one at a time, until the offending food or foods are identified. The app used in this Belgian study was in French and Dutch, but there are many highly rated apps available. I found a free "Fast FODMAPS" app in the App store that included food lists, a food search, and other features. Caveat: These apps have not been evaluated in clinical trials.
Plan de l'etude:
Randomized controlled trial (nonblinded)
Both low FODMAPS diets and otilonium bromide (OB) have been shown in randomized trials to have efficacy for the treatment of irritable bowel syndrome (IBS). FODMAPS stands for fermentable oligosaccharides, disaccharides, monosaccharides, and polyols, which are short-chain carbohydrates that are poorly absorbed by some people. This was a pragmatic trial, enrolling primary care patients given a diagnosis of IBS by their physician. Patients with psychiatric comorbidity, who had used a FODMAPS diet, or who had taken OB were excluded. The dietary intervention consisted of an app that provided guidance for a low FODMAPS diet and provided more than 100 recipes; the 40 mg OB intervention was given 3 times daily. Groups were similar at baseline, with a mean age of 41 years, and 76% were female. Analysis was by intention to treat. The primary outcome was a clinically significant improvement of 50 points on the 500-point IBS-Severity Symptom Scale. At 8 weeks, a response was noted by more patients in the FODMAPS group than in the OB group at 4 weeks (62% vs 51%; P = .02; number needed to treat [NNT] = 9) and at 8 weeks (71% vs 61%; P = .03; NNT = 10). The average decline in the score was also significantly higher in the FODMAPS group (-97 vs -77 points; P = .02). There were no differences between groups in overall quality-of-life scales. The authors also prespecified a subgroup analysis of the 309 patients (70%) who met the most recent Rome IV criteria for IBS. The benefit was even greater in these patients in terms of the percentage of responders (77% vs 62%; P = .004; NNT = 7). Adherence was high and was actually better for the diet than for the medication (94% vs 73%).
Mark H. Ebell, MD, MS
University of Georgia