Ayurvedic vs. Conventional Nutritional Therapy Including Low-FODMAP Diet for Patients With Irritable Bowel Syndrome-A Randomized Controlled Trial

Michael Jeitler, Till Wottke, Dania Schumann, Laura M Puerto Valencia, Andreas Michalsen, Nico Steckhan, Martin Mittwede, Elmar Stapelfeldt, Daniela Koppold-Liebscher, Holger Cramer, Manfred Wischnewsky, Vijayendra Murthy, Christian S Kessler, Michael Jeitler, Till Wottke, Dania Schumann, Laura M Puerto Valencia, Andreas Michalsen, Nico Steckhan, Martin Mittwede, Elmar Stapelfeldt, Daniela Koppold-Liebscher, Holger Cramer, Manfred Wischnewsky, Vijayendra Murthy, Christian S Kessler

Abstract

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://ichgcp.net/clinical-trials-registry/NCT03019861, identifier: NCT03019861.

Keywords: Ayurveda; Traditional Indian Medicine; clinical trials; complementary medicine; integrative medicine; irritable bowel syndrome; nutrition – clinical.

Conflict of interest statement

CK and ES participate in training courses on Ayurveda at the European Academy for Ayurveda, Birstein and at Sonne und Mond, Berlin. MM participates in training courses on Ayurveda at the European Academy of Ayurveda, Birstein. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Jeitler, Wottke, Schumann, Puerto Valencia, Michalsen, Steckhan, Mittwede, Stapelfeldt, Koppold-Liebscher, Cramer, Wischnewsky, Murthy and Kessler.

Figures

Figure 1
Figure 1
Flowchart.
Figure 2
Figure 2
Estimated Marginal Means of IBS-SSS with patients' expectations as covariate (with error bars 95% confidence interval). The covariate patients' expectations is evaluated at the value 6.57 (adjusted mean).
Figure 3
Figure 3
3D-surface plot of IBS-SSS reduction with respect to IBS-SSS at pre-intervention and patients' expectations. The higher IBS-SSS at pre-intervention and the larger the patients' expectations, the greater the IBS-SSS reduction.

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