Background: Helicobacter pylori (H. pylori) is implicated in the pathogenesis of functional dyspepsia (FD). There is conflicting data regarding the benefit of H. pylori eradication for symptom relief in FD.
Aims: To study the benefit of eradicating H. pylori in patients with FD as compared to standard medical treatment (SMT). Secondary aims were to find efficacy of H. pylori eradication therapy, recurrence of H. pylori after eradication, and predictors of efficacy.
Methods: Consecutive adult patients of FD (ROME IV) with H. pylori infection presenting in the outpatient department of our hospital were enrolled. Patients with Global Overall Symptom (GOS) scale > 2 and H. pylori infection were included. Patients were randomized into two groups: group 1 received H. pylori eradication therapy and group 2 received SMT. Treatment success was defined as symptom relief (GOS score < 2 and reduction by at least 2 points at 6 months) and H. pylori eradication was defined as stool antigen negative at 4 weeks.
Results: Of 329 participants with FD, 253 were H. pylori positive (rapid urease test and stool antigen test) (76.89%). After exclusions, 202 were randomized into two groups of 101 each. Thirty-two patients in group 1 and 31 in group 2 had treatment success (31.7% vs. 30.7%, p=1.000). The efficacy of H. pylori eradication therapy was 74.46% (70/94). H. pylori reinfection rate was 26.02% (19/73).
Conclusions: H. pylori eradication therapy does not provide additional benefit in symptom relief in patients with FD as compared with SMT.
Trial registration: NCT04697641 (retrospectively registered on www.clinicaltrials.gov in January 2021).
Keywords: Epigastric pain syndrome; Functional dyspepsia; GOS scale; H. pylori eradication therapy; Likert scale; Non-ulcer dyspepsia; Postprandial distress syndrome; Rapid urease test; Rome IV criteria; Stool antigen test; Triple therapy.
© 2021. Indian Society of Gastroenterology.