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

Carbone, Florencia; Van den Houte, Karen; Besard, Linde; Tack, Celine; Arts, Joris; Caenepeel, Philip; Piessevaux, Hubert; Vandenberghe, Alain; Matthys, Christophe; Biesiekierski, Jessica; Capiau, Luc; Ceulemans, Steven; Gernay, Olivier; Jones, Lydia; Maes, Sophie; Peetermans, Christian; Raat, Willem; Stubbe, Jeroen; Van Boxstael, Rudy; Vandeput, Olivia; Van Steenbergen, Sophie; Van Oudenhove, Lukas; Vanuytsel, Tim; Jones, Michael; Tack, Jan

doi:10.26181/23984046.v1

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

journal contribution

posted on 2023-08-18, 06:00 authored by Florencia Carbone, Karen Van den Houte, Linde Besard, Celine Tack, Joris Arts, Philip Caenepeel, Hubert Piessevaux, Alain Vandenberghe, Christophe Matthys, Jessica BiesiekierskiJessica Biesiekierski, Luc Capiau, Steven Ceulemans, Olivier Gernay, Lydia Jones, Sophie Maes, Christian Peetermans, Willem Raat, Jeroen Stubbe, Rudy Van Boxstael, Olivia Vandeput, Sophie Van Steenbergen, Lukas Van Oudenhove, Tim Vanuytsel, Michael Jones, Jan Tack

Background: In Europe, IBS is commonly treated with musculotropic spasmolytics (eg, otilonium bromide, OB). In tertiary care, a low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet provides significant improvement. Yet, dietary treatment remains to be explored in primary care. We evaluated the effect of a smartphone FODMAP-lowering diet application versus OB on symptoms in primary care IBS. Methods: IBS patients, recruited by primary care physicians, were randomised to 8 weeks of OB (40 mg three times a day) or diet and followed for 24 weeks. We compared IBS Symptom Severity Score and the proportion of responders (improvement ≥50 points) in all patients and the subgroup fulfilling Rome IV criteria (Rome+). We also evaluated treatment efficacy, quality of life, anxiety, depression, somatic symptom severity (Patient Health Questionnaire (PHQ15, PHQ9)) and treatment adherence and analysed predictors of response. Results: 459 primary care IBS patients (41±15 years, 76% female, 70% Rome+) were randomised. The responder rate after 8 weeks was significantly higher with diet compared with OB (71% (155/218) vs 61% (133/217), p=0.03) and more pronounced in Rome+ (77% (118/153) vs 62% (98/158), p=0.004). Patients allocated to diet (199/212) were 94% adherent compared with 73% with OB (148/202) (p<0.001). The significantly higher response rate with diet was already observed after 4 weeks (62% (132/213) vs 51% (110/215), p=0.02) and a high symptom response persisted during follow-up. Predictors of response were female gender (OR=2.08, p=0.04) for diet and PHQ15 (OR=1.10, p=0.02) for OB. Conclusion: In primary care IBS patients, a FODMAP-lowering diet application was superior to a spasmolytic agent in improving IBS symptoms. A FODMAP-lowering diet should be considered the first-line treatment for IBS in primary care.

History

Publication Date

2022-10-07

Journal

Gut

Volume

71

Issue

11

Pagination

7p. (p. 2226-2232)

Publisher

BMJ Publishing Group

ISSN

0017-5749

Rights Statement

© Author(s) (or their employer(s)) 2022. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.