TY - JOUR A1 - Jeitler, Michael A1 - Wottke, Till A1 - Schumann, Dania Alexandra A1 - Puerto Valencia, Laura M. A1 - Michalsen, Andreas A1 - Steckhan, Nico A1 - Mittwede, Martin A1 - Stapelfeldt, Elmar A1 - Liebscher, Daniela Artemis Tahère A1 - Cramer, Holger A1 - Wischnewsky, Manfred A1 - Murthy, Vijayendra A1 - Keßler, Christian T1 - Ayurvedic vs. conventional nutritional therapy including low-FODMAP diet for patients with irritable Bowel syndrome - a randomized controlled trial T2 - Frontiers in medicine N2 - Aims: To compare the effects of Ayurvedic and conventional nutritional therapy in patients with irritable bowel syndrome (IBS). Methods: Sixty-nine patients with IBS were randomized to Ayurvedic (n = 35) or conventional nutritional therapy according to the recommendations of the German Nutrition Society including the low-FODMAP diet (n = 34). Study visits took place at baseline and after 1, 3, and 6 months. The primary outcome was IBS symptom severity (IBS-SSS) after 3 months; secondary outcomes included stress (CPSS), anxiety and depression (HADS), well-being (WHO-5) and IBS-specific quality of life (IBS-QOL). A repeated measures general linear model (GLM) for intent-to-treat-analyses was applied in this explorative study. Results: After 3 months, estimated marginal means for IBS-SSS reductions were 123.8 [95% confidence interval (95% CI) = 92.8–154.9; p < 0.001] in the Ayurvedic and 72.7 (95% CI = 38.8–106.7; p < 0.001) in the conventional group. The IBS-SSS reduction was significantly higher in the Ayurveda group compared to the conventional therapy group (estimated marginal mean = 51.1; 95% CI = 3.8–98.5; p = 0.035) and clinically meaningful. Sixty-eight percentage of the variance in IBS-SSS reduction after 3 months can be explained by treatment, 6.5% by patients' expectations for their therapies and 23.4% by IBS-SSS at pre-intervention. Both therapies are equivalent in their contribution to the outcome variance. The higher the IBS-SSS score at pre-intervention and the larger the patients' expectations, the greater the IBS-SSS reduction. There were no significant group differences in any secondary outcome measures. No serious adverse events occurred in either group. Conclusion: Patients with IBS seem to benefit significantly from Ayurvedic or conventional nutritional therapy. The results warrant further studies with longer-term follow-ups and larger sample sizes. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03019861, identifier: NCT03019861. KW - nutrition - clinical KW - Traditional Indian Medicine KW - irritable bowel syndrome KW - Ayurveda KW - clinical trials KW - complementary medicine KW - integrative medicine Y1 - 2021 UR - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/62024 UR - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-620240 SN - 2296-858X N1 - We acknowledge support from the German Research Foundation (DFG) and the Open Access Publication Fund of Charité - Universitätsmedizin Berlin. VL - 8 IS - art. 622029 SP - 1 EP - 12 PB - Frontiers Media CY - Lausanne ER -