Epigastric symptoms response to low FODMAP diet and aerobic exercise compared with conventional therapy alone in patients with functional dyspepsia attending a tertiary care hospital in Chennai – A randomized controlled trial

Introduction

The prevalence of dyspepsia in the general population is 20% (1). Among them, 80% has normal endoscopic finding. This is termed functional dyspepsia. The overall prevalence of functional dyspepsia is 22% (1). FD is divided into 1. Epigastric pain syndrome and 2. Postprandial distress syndrome.

FODMAPs (Fructo, Oligo, Di-, Monosaccharides, And Polyols) are poorly absorbable and highly fermentable substances that cause bloating and gas sensations same as dyspepsia.

In a study done by Heidi et al (3), on Australian patients with FD. A low FODMAP diet reduced the epigastric symptoms and overall symptoms of FD.

However, there is no evidence of the same in the Indian population.

Early data has shown promising effects of Low FODMAP in diseases other than IBS like FD

In the Indian population in a study by Goyal et al(5) with 105 patients at 4 weeks there was a reduction in FD symptoms in both groups but more in the low FODMAP group (66.7%)

The effect of aerobic exercise in patients with functional dyspepsia is still in debate. However studies have shown symptom improvement with patients on regular exercise. In a study by Siddhesh (4) et al done in Mumbai among 72 patients. Aerobic exercise for 30 mins for 5 days a week for 4 weeks GDSS (Glasgow Dyspepsia Severity Scale) before and after in the experimental population was 15.17 and 5.67 (difference = 9.5). Vs 12.83 and 8.39, respectively (difference = 4.44) in the control population. There was a significant improvement in symptoms in the patients who received exercise.

 There is no trial studying the combined effect of Low FODMAP and aerobic exercise in patients with functional dyspepsia and its outcome.

Methodology

Patients attending the Department of Gastroenterology who have FD under ROME IV criteria will be recruited for the study after providing detailed information on the study and consent obtained. A patient information sheet will be provided to the patient.

At baseline, patients will be assessed for symptoms of FD using the Structured Assessment of Gastrointestinal symptom (SAGIS) and the HRQOL using the Short Form Nepean Index score. The scores will be reassessed in 12 and 24 weeks of the study.

Demographic details, clinical data, and laboratory data will be collected at baseline.

Patients in the intervention group will receive.

-    Education on low FODMAP diet and aerobic exercise

-    Diet chart and exercise chart to follow.

-    Alternate day mobile reminders

-    A calendar to mark the days the diet and exercise were followed.

Reintroduction in the intervention group

-  After 12 weeks patients in the intervention group can be reintroduced to a normal diet gradually. Assessment will be done at 24 weeks with the SAGIS questionnaire to change in the SAGIS score from 12 to 24 weeks in the intervention group after the reintroduction.

Patients in the control group will receive.

-   Education about diet and exercise at baseline

Assessed for SAGIS and Nepean Index at baseline, 12 and 24 weeks.

Endpoints

Primary endpoint

-    Reduction in SAGIS score at 12 weeks from baseline for epigastric symptoms between intervention and control groups.

Secondary endpoint

Overall reduction in SAGI score between intervention group and control group at 12 weeks and 24 weeks.

Reduction in the Short form Nepean Dyspepsia (SF-NDI) Index >50% from baseline between intervention and control group at 12 weeks and 24 weeks

Adherence to diet plan and exercise plan in the intervention group from the calendar

SAGI score from 12 weeks to 24 weeks after reintroduction of high FODMAP in the intervention group.

Statistical analysis

Data will be collected in pre-structured proforma and entered in an Excel sheet/EpiInfo. The data will be analyzed using SPSS version 21.

Descriptive statistics will be expressed in mean and standard deviation.

Parametric tests using the paired students’-test and non-parametric using the Mann-Whitney U test will be done. Categorical variables using the Chi-Squared test

The difference in the treatment and intervention groups will be done using the Students T-test.

References

1. Ford AC, Mahadeva S, Carbone MF, Lacy BE, Talley NJ. Functional dyspepsia. The Lancet. 2020 Nov 21;396(10263):1689-702.
2. Hantoro IF, Syam AF, Mudjaddid E, Setiati S, Abdullah M. Factors associated with health-related quality of life in patients with functional dyspepsia. Health and Quality of Life Outcomes. 2018 Dec;16(1):1-6.
3. Staudacher HM, Nevin AN, Duff C, Kendall BJ, Holtmann GJ. Epigastric symptom response to low FODMAP dietary advice compared with standard dietetic advice in individuals with functional dyspepsia. Neurogastroenterology & Motility. 2021 Nov;33(11):e14148.
4. Rane SV, Asgaonkar B, Rathi P, Contractor Q, Chandnani S, Junare P, Debnath P, Bhat V. Effect of moderate aerobic exercises on symptoms of functional dyspepsia. Indian Journal of Gastroenterology. 2021 Apr;40(2):189-97.
5. Goyal, O., Nohria, S., Batta, S., Dhaliwal, A., Goyal, P. and Sood, A., 2022. Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet versus traditional dietary advice for functional dyspepsia: A randomized controlled trial. Journal of Gastroenterology and Hepatology, 37(2), pp.301-309.
6. Wang B, Luo QQ, Li Q, Cheng L, Chen SL. Daily short message service reminders increase treatment compliance and efficacy in outpatients with functional dyspepsia: a prospective randomized controlled trial. Journal of general internal medicine. 2020 Oct;35(10):2925-31.