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Trial shows FODMAP diet superior to spasmolytic therapy for IBS symptoms

A FODMAP diet, when compared directly with spasmolytic therapy, provided a significantly greater improvement in IBS patients’ symptoms

The use of a fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet has been shown in a randomised controlled trial to provide much better relief of irritable bowel syndrome (IBS) symptoms compared with using a musculotropic spasmolytic agent.

This was the main result from a study by researchers at the department of Gastroenterology and Hepatology, KU Leuven University Hospitals Leuven, Belgium.

Irritable bowel syndrome has been defined as a functional bowel disorder in which recurrent abdominal pain is associated with defecation or a change in bowel habits. It is a common condition and in one 2020 review, the pooled IBS prevalence among studies that used the Rome IV criteria was 3·8%.

Several treatment options are available for the management of IBS and a 2008 systemic review and meta-analysis concluded that fibre, anti-spasmodics (musculotropic spasmolytics) and peppermint oil were all more effective than placebo in the treatment of IBS.

One particular spasmolytic agent is otilonium bromide (OB) which acts as an L-type calcium channel antagonist in intestinal and colonic smooth muscle cells. OB has been found to be more effective than placebo in IBS with a significant therapeutic benefit after 10 weeks and which is maximal after 15 weeks.

In recent years however, the use of a FODMAP diet has been found to be effective at reducing functional gastrointestinal symptoms in patients with IBS.

Nevertheless, there is uncertainty over whether or not a FODMAP diet provides superior symptomatic relief for patients with IBS compared to the use OB.

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For the current trial, the Belgium team randomised newly treated patients with IBS to either OB 40mg three-times daily or a FODMAP diet and which was made available via a smartphone app and for those without access to a suitable electronic device, the diet instructions were available as a booklet.

The diet itself was not a strict low FODMAP diet, but rather designed as a FODMAP-lowering diet. Consequently, small amount of FODMAPs were allowed, but the app did provide advice on which foods should be avoided or be reduced and offered suitable alternatives.

Patients self-completed several questionnaires, one of which was the IBS symptom Severity scale (IBS-SSS) and this used for the primary outcome, with a responder defined as a patient who improved by ≥50 points on the IBS-SSS compared with baseline after 8 weeks.

FODMAP and improvement in IBS symptom scores

A total of 459 patients were randomised to OB (232) or a FODMAP diet. The mean age of participants randomised to OB was 41.2 years (76% female) which was slightly higher than the mean age of those assigned to the diet (40.6 years). The mean baseline IBS-SSS score was the same (267) in both groups.

After 8 weeks, a significantly higher proportion of participants using the FODMAP diet arm achieved the primary outcome (71% vs 61%, diet vs OD, p = 0.03). In fact, this difference became significant after only 4 weeks (62% vs 51%, diet vs OB, p = 0.02). Numerically, FODMAP diet participants saw a change from baseline in their IBS-SSS score of -97.42 after 8 weeks whereas the OB experienced a smaller mean reduction of only -76.91.

The authors concluded that the FODMAP diet was superior to standard medical therapy and suggested that this simple dietary approach should be considered as a first-line therapy for patients with IBS.

Citation
Carbone F et al. Diet or medication in primary care patients with IBS: the DOMINO study – a randomised trial supported by the Belgian Health Care Knowledge Centre (KCE Trials Programme) and the Rome Foundation Research Institute Gut 2022

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