NEW YORK (Reuters Health) - In primary care irritable bowel syndrome (IBS) patients, a FODMAP-lowering diet guided by a smartphone app was superior to the spasmolytic otilonium bromide (OB) in improving symptoms, and should be considered a first-line treatment in this setting, researchers suggest.
The FODMAP diet includes low fermentable oligosaccharides, disaccharides, monosaccharides and polyols.
"We consider the study a game-changer for primary care," Drs. Jan Tack and Florencia Carbone of KU Leuven University Hospitals in Belgium told Reuters Health by email. "The app is already available in Belgium, on physician prescription, and we plan to expand it to other countries."
One "major difference" between the study app and other available diet apps for IBS, they noted, is that "the (study) app did not try to mimic the low FODMAP diet as explained by a trained dietitian, with elimination and re-introduction, but aims for overall FODMAP lowering."
As reported in Gut, Drs. Tack, Carbone and colleagues randomized 459 newly diagnosed primary care IBS patients (median age, 41; 76%, women; 70% meeting Rome IV criteria) to 8 weeks of OB (40mg three times a day) or diet.
Among those who met the Rome IV criteria, 153 were randomized to diet and 158 to medication, with similar symptom severity.
Primary outcomes were IBS Symptom Severity Score (IBS-SSS) and the proportion of responders (improvement of at least 50 points) among all patients.
Participants were followed for 24 weeks.
As Drs. Tack and Carbone noted, the diet was not a strict low FODMAP diet; it was designed as a FODMAP-lowering diet in combination with dietary recommendations from the NICE/BDA guidelines for IBS (https://bit.ly/3wgXlqL).
The mobile app also provided general dietary advice and instructions on foods items to avoid or decrease, with suggested alternatives, and recipes for breakfast, lunch, snacks and dinner.
At eight weeks, the responder rate was significantly higher for diet compared with OB (71% vs. 61%) and more pronounced in Rome IV patients (77% vs. 62%).
The change in IBS-SSS from baseline to week 8 was significantly higher in the diet group than in the OB group (−116 vs. −82), which was confirmed in a mixed-model analysis.
Adherence was 94% for the diet versus 73% for OB. The significantly higher response rate with diet was seen after four weeks (62% vs. 51%) and a high symptom response persisted during follow-up.
Predictors of response were female gender (OR, 2.08) for diet and somatic symptom severity score (OR, 1.10) for OB.
Drs. Tack and Carbone added, "The application will be evaluated in many follow-up studies, including studies in other countries (prior to making it available there) and head-to-head comparison in specialist care patients with a traditional dietitian-administered low FODMAP diet."
Razan Hallak, a registered dietitian at Ohio State University Wexner Medical Center in Columbus, commented on the study in an email to Reuters Health, "Relying on a self-management application with no dietitian intervention can have long-term side effects on the patient's relationship with food. This can also lead more patients to look for health- and nutrition-related information on the internet rather than seeking help from healthcare professionals."
"More research is needed to ensure the effectiveness of the self-management diet in providing patients with appropriate recommendations," she noted. "Information on patients' compliance with the diet and the actual FODMAP intake of patients using the self-management application should be collected."
SOURCE: https://bit.ly/3wkHR54 Gut, online April 28, 2022.
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