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. Issue 11 (28th April 2022)

• Record Type: Journal Article
• Authors: Carbone, Florencia; Van den Houte, Karen; Besard, Linde; Tack, Céline; 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
• Other Names: author non-byline.; Goorden Alain author non-byline.; Snijkers Alegonda author non-byline.; Leys An author non-byline.; Roelofs Annemiek author non-byline.; Schoolmeesters Bart author non-byline.; Putten Bart Vander author non-byline.; Broek Benjamin Van den author non-byline.; Baade-Joret Birgitta author non-byline.; Huberlant Céline author non-byline.; Peetermans Christian author non-byline.; Humbeek David Van author non-byline.; Brande Dirk Van den author non-byline.; Wyseyr Dirk author non-byline.; Lemmens Els author non-byline.; Brits Ethel author non-byline.; Simons Guido author non-byline.; Baetens Hans author non-byline.; Overmeire Hendrika Van author non-byline.; Tack Hilde author non-byline.; Cupers Ilse author non-byline.; Talboom Ive author non-byline.; Stubbe Jeroen author non-byline.; Docx Jonas author non-byline.; Deseins Judith author non-byline.; Biot Julie author non-byline.; Vancaillie Julie author non-byline.; Vandeloo Kara author non-byline.; Louwies Karlijn author non-byline.; Ceulaer Karolien De author non-byline.; Lemmens Karolien author non-byline.; Scheers Katrien author non-byline.; Verleure Leen author non-byline.; Sutter Lies De author non-byline.; Plancke Lies author non-byline.; Bruyninckx Liesbet author non-byline.; Vanzeir Liesbeth author non-byline.; Vandersmisse Lieve author non-byline.; Wyseur Linde author non-byline.; Vermeersch Lode author non-byline.; Pas Lodewijk author non-byline.; Greef Lore De author non-byline.; Capiau Luc author non-byline.; Braeckel Luc Van author non-byline.; Groote Lut De author non-byline.; Jones Lydia author non-byline.; Groot Maria author non-byline.; Busschots Marianne author non-byline.; Landenne Marie-Hélène author non-byline.; Monstrey Marieke author non-byline.; Haemels Marie-Magdalena author non-byline.; Snellings Marleen author non-byline.; Sisk Maura author non-byline.; Vyver Nathalie Van de author non-byline.; Sannen Nikea author non-byline.; Vandeput Olivia author non-byline.; Gernay Olivier author non-byline.; Thoné Philippe author non-byline.; Narongsack Phouthalack author non-byline.; Vrins Pierre author non-byline.; Geusens Pieterjan author non-byline.; Sauwens Rik author non-byline.; Boxstael Rudy Van author non-byline.; Musch Sigrid author non-byline.; Nous Sigrid author non-byline.; Mazereel Sofie author non-byline.; Maes Sophie author non-byline.; Steenbergen Sophie Van author non-byline.; Biot Stéphanie author non-byline.; Ceulemans Steven author non-byline.; Geeraert Stijn author non-byline.; Caeyers Tine author non-byline.; Vanbelle Vincent author non-byline.; Raat Willem author non-byline.;
• Is Part Of: Gut. Volume 71:Issue 11(2022)
• Page Start: 2226
• Page End: 2232
• Publication Date: 2022-04-28
• Subjects: IRRITABLE BOWEL SYNDROME -- QUALITY OF LIFE -- PRIMARY CARE; Gastroenterology -- Periodicals; 616.33
• DOI: 10.1136/gutjnl-2021-325821
• Languages: English
• ISSNs: 0017-5749

Abstract

Abstract : 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. Trial registration number: NCT04270487 .