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

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

JOURNAL=Frontiers in Medicine

VOLUME=8

YEAR=2021

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.622029

DOI=10.3389/fmed.2021.622029

ISSN=2296-858X

ABSTRACT=<p><bold>Aims:</bold> To compare the effects of Ayurvedic and conventional nutritional therapy in patients with irritable bowel syndrome (IBS).</p><p><bold>Methods:</bold> Sixty-nine patients with IBS were randomized to Ayurvedic (<italic>n</italic> = 35) or conventional nutritional therapy according to the recommendations of the German Nutrition Society including the low-FODMAP diet (<italic>n</italic> = 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.</p><p><bold>Results:</bold> After 3 months, estimated marginal means for IBS-SSS reductions were 123.8 [95% confidence interval (95% CI) = 92.8–154.9; <italic>p</italic> &lt; 0.001] in the Ayurvedic and 72.7 (95% CI = 38.8–106.7; <italic>p</italic> &lt; 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; <italic>p</italic> = 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.</p><p><bold>Conclusion:</bold> 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.</p><p><bold>Clinical Trial Registration:</bold><ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT03019861" xmlns:xlink="http://www.w3.org/1999/xlink">https://clinicaltrials.gov/ct2/show/NCT03019861</ext-link>, identifier: NCT03019861.</p>