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Diet vs Medication for Patients With IBS in Primary Care
TAKE-HOME MESSAGE
- This trial randomized 459 patients with newly diagnosed IBS in primary care to 8 weeks of a low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) diet (guided by a custom-made smartphone application) or standard medical therapy (otilonium bromide, three times daily). Higher proportions of patients in the diet group than in the medical therapy group enjoyed symptom response (improvement of at least 50 points on the IBS-Symptom Severity Score) at 4 weeks (62% vs 51%) and at 8 weeks (71% vs 61%).
- Among patients with IBS in primary care, a FODMAP-lowering diet application demonstrated higher symptom response rates than spasmolytic medical therapy and should be considered a first-line IBS management option in the primary care setting.
abstract
This abstract is available on the publisher's site.
Access this abstract nowBACKGROUND
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.
Additional Info
Disclosure statements are available on the authors' profiles:
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 Apr 28;[EPub Ahead of Print], F Carbone, K Van den Houte, L Besard, C Tack, J Arts, P Caenepeel, H Piessevaux, A Vandenberghe, C Matthys, J Biesiekierski, L Capiau, S Ceulemans, O Gernay, L Jones, S Maes, C Peetermans, W Raat, J Stubbe, R Van Boxstael, O Vandeput, S Van Steenbergen, L Van Oudenhove, T Vanuytsel, M Jones, J TackFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
The FODMaP Diet better than antispasmodic for IBS
Sugars that are poorly absorbed can cause an osmotic shift of fluid into the gut, causing watery stools. These sugars are also highly fermentable by bacteria in the gut causing gas and bloating. Reducing these sugars by eating a FODMaP diet has been found to improve irritable bowel symptoms.
This is one of the first studies to evaluate this in the primary care setting by directly comparing the FODMaP diet with an antispasmodic medication in 470 participants. The study was an open-label pragmatic trial that evaluated IBS symptoms at 4 and 8 weeks. Compared with prior studies that used nutritionists to educate patients about the diet, this study used an app. The winner was the FODMaP diet, improving symptoms by 71% compared with 61% with the drug. The positive changes were present and equal at both 4 and 8 weeks.
How to prescribe a FODMaP diet?
To be simple, reduce the sugar load. Anyone that brews beer knows that when you combine a sugar (malt) and an organism (yeast), you encourage fermentation, which creates a lot of gas. The same concept is true with FODMaP.
FODMaP is an acronym for the following.
Fermentable
Oligosaccharides: fructans found in wheat, rye, onion, garlic, beans, and some vegetables
Disaccharides: lactose in milk and dairy
Monosaccharides: fructose in high-fructose corn syrup, honey, and some fruits
and
Polyol sweeteners: these end in -ol such as xylitol, sorbitol, etc. Sugarless gum often has xylitol in it that can cause gas and bloating.
The app I find most useful was created by Monash University (one of the pioneers in the FODMaP research), which provides specific guidance and can be found here.
A low-FODMAP diet for primary care patients with irritable bowel syndrome: App-etizing food for thought
The majority of patients with irritable bowel syndrome (IBS) are managed by their primary care provider. Despite this, supportive data for treatments, including the low-FODMAP (fermentable oligo-, di-, monosaccharides, and polyols) diet (LFD), in the primary care setting is lacking. In a large randomized controlled trial (RCT) of over 450 primary care patients with IBS patients from Europe and Australia, Carbone et al compared the efficacy of a dietary intervention guided by a smartphone application with that of standard medical therapy with otilonium bromide, an evidence-based antispasmodic commonly used outside of the US. The diet intervention was a FODMAP-reduced diet in combination with recommendations from the NICE (National Institute for Health and Care Excellence) guidelines for IBS. After 8 weeks, patients in the dietary intervention group were significantly more likely to respond than those in the medical therapy group (71% vs 61%; P = .03).
This study is the first to evaluate the effectiveness of the LFD in primary care patients with IBS. It is also the first to compare the LFD to an evidence-based medical therapy. Importantly, this study is the first to teach the LFD via a smartphone app. Such “digital therapeutics” could help to address the limited access to trained dietitians. This study does have several limitations. It was open-label, which could have influenced responses to the interventions. Furthermore, the smartphone application used in the study is not yet publicly available and otilonium bromide is not available in the US. In summary, this large RCT suggests that an LFD taught by a mobile app can be considered as a first-line therapy for patients with IBS in primary care.