Randomised Clinical Trial

Yoga vs a Low-FODMAP Diet in Patients With Irritable Bowel Syndrome

D. Schumann; J. Langhorst; G. Dobos; H. Cramer

Disclosures

Aliment Pharmacol Ther. 2018;47(2):203-211. 

In This Article

Results

Patients

A total of 208 patients completed the telephone screening, of which 144 were excluded due to a lack of interest, scheduling problems or the failure to meet the study inclusion criteria (Figure 1). Sixty-four patients completed the assessment by the study physician; at which point five were excluded, leaving 59 patients who were enrolled in the study and randomised to either the yoga group (n = 30) or the FODMAP group (n = 29). A total of 7 patients; 3 in the yoga group (2 due to scheduling problems and 1 to a loss of interest) and 4 in the FODMAP group (2 due to difficulties with the diet, 1 due to scheduling problems and 1 due to the relapse of a major depressive episode) withdrew from the study. All patients were analysed on an intention-to-treat basis. No group differences in sociodemographic or clinical characteristics were found (Table S2). Patients in the yoga group attended an average of 14.87 ± 7.99 (61.94%) of the 24 yoga classes. Patients additionally practiced a mean 96.30 ± 38.22 further minutes of yoga per week at home. Patients in the FODMAP group attended 2.62 ± 0.68 (87.36%) of the 3 study meetings. Compliance with the nutritional advice given was self-reported to be 70.7 ± 32.0 on a 100 mm VAS scale and 67.6 ± 2.26 (mean ± standard deviation) as scored by the study nutritionist according to patients' food diaries.

Figure 1.

CONSORT study flow chart

Outcomes

Primary outcome. No statistically significant group differences were found at week 12 (Δ = 31.80, 95% CI −11.90; 75.50, P = .151) or at week 24 (Δ = 33.41, 95% CI −4.21; 71.04, P = .081) according to the IBS-SSS. From week 0 to week 12, the IBS-SSS total score decreased from 263.02 ± 74.49 to 196.86 ± 86.08 in the yoga group and from 259.73 ± 80.39 to 163.55 ± 94.51 in the FODMAP group. This resulted in statistically significant changes within both the yoga and the FODMAP group at week 12 (yoga: P < .001; FODMAP: P < .001) and week 24 (yoga: P < .001; FODMAP: P < .001) (Figure 2, Figure 3, Figure 4, Figure 5). Explorative subgroup analysis revealed no statistically significant differences in the interventions' effectiveness by reason of patients' IBS subtypes (data not shown). The results of these analyses are limited by the small number of participants in each IBS subgroup. The five subscales of IBS-SSS were analysed in detail (Table S3). Significant within-group improvements were observed in 3 of the 5 categories in Yoga including duration of pain, bowel satisfaction and interference with life and for the same categories in the FODMAP group and also for abdominal distension. Between-group comparison of Yoga and FODMAP group showed no significant differences besides in the category abdominal distension at week 12 (P = .040), but not at Week 24.

Figure 2.

Scatterplot of changes in patients' total irritable bowel syndrome severity scores (IBS-SSS) at week 12 and 24 for the yoga and low-FODMAP groups

Figure 3.

Results of the primary outcome measure; patients' Irritable bowel syndrome severity symptom scores (IBS-SSS) at week 0, after 12 weeks and after 24 weeks for the yoga and low-FODMAP groups

Figure 4.

Irritable bowel syndrome symptom severity scores (IBS-SSS) at week 0, after 12 weeks and 24 weeks for each patient in the yoga group

Figure 5.

Irritable bowel syndrome symptom severity scores (IBS-SSS) at week 0, after 12 weeks and 24 weeks for each patient in the low-FODMAP group

Secondary outcomes. The study's secondary outcomes are summarised in the supportive information in Table S3. No statistically significant between-group differences were found on the SF-36, except for the physical component summary subscale, which showed a statistically significant improvement in the yoga group. The CPSS and PSQ did not reveal between-group differences, but within-group comparison showed statistically significant improvements for both groups, using the CPSS, but only for the yoga group using the PSQ. The IBS-QOL showed a statistically significant between-group difference only on one subscale; namely a decrease in quality of life at week 12, related to FODMAP group patients' avoidance of some foods (P = .005).

The HADS questionnaire revealed significantly lower scores in the yoga group, compared to the FODMAP group, within the subscale for anxiety (HADS-A) after 12 weeks (P = .025). Within the HADS-D subscale for depression, no statistically significant between-group differences were found at either week 12 or week 24.

Scores for the BAQ showed no statistically significant between-group differences at week 12 (P = .064), but a significant difference was found at week 24 in favour of the yoga group (P = .017). The subscale relating to the importance of interoceptive awareness (BRS-1) showed no statistically significant between-group differences at either time points and the subscale measuring perceived mind-body-connection (BRS-2) showed significant between-group differences at week 12 in favour of the yoga group (P = .027).

According to the patients' food diaries, at week 12, 82.4% of patients in the yoga group experienced adequate relief of their IBS symptoms vs 78.6% in the FODMAP group, although no statistically significant between-group differences were found (P = 1.000). These findings must be interpreted with care, as not all patients completed their food diaries adequately; with only 17 patients in the yoga and 14 patients in the FODMAP group answering the 'Adequate Relief' question. Global improvements at week 12 are shown in Figures S6 and S7.

Clinical Relevance

Sixteen patients in the yoga group reached a clinically relevant decrease of at least 50 points in their IBS-SSS total scores at week 12, compared to 21 in the FODMAP group (P = .180). One patient in the yoga group was in clinical remission at week 12, based on a score lower than 75 points, compared with 6 patients in the FODMAP group (P = .052). At week 24, a total of 3 patients in each group were in clinical remission (P = 1.000).

Safety

Three patients in the FODMAP group reported adverse events during the study intervention. One serious event related to a major depressive episode experienced by one patient, with two nonserious events (a mild self-reported depressive episode and an unwanted loss of weight) reported by another. Two patients in the yoga group reported adverse events: with one serious event relating to a newly diagnosed deep leg vein thrombosis and one nonserious event relating to back pain caused by heavy lifting. None of these events were adjudged to relate to the study interventions.

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