Randomised clinical trial: rifaximin versus placebo for the treatment of functional dyspepsia
Abstract
Summary: Background: Gut dysbiosis may contribute to pain and bloating in patients with functional gastrointestinal disease. Aims: To determine if treatment with rifaximin would improve the symptoms of functional dyspepsia in Chinese patients in a double‐blinded, randomised, placebo‐controlled trial. Methods: Consecutive subjects with a diagnosis of functional dyspepsia as per the Rome III criteria were randomised to receive rifaximin 400 mg or placebo, all taken three times daily for 2 weeks. The investigators and study subjects were blinded to the treatment allocation. Subjects were followed up for 8 weeks. The primary end point was adequate relief of global dyspeptic symptoms ( GDS ). Secondary endpoints were relief of individual dyspeptic symptoms. Results: Eighty‐six subjects were recruited. At week 8, there were significantly more subjects in the rifaximin than in the placebo group who experienced adequate relief of GDS (78% vs. 52%, P = 0.02). A trend favouring rifaximin group was also noted in the preceding 4 weeks. Rifaximin was also superior to placebo in providing adequate relief of belching and post‐prandial fullness/bloating ( PPF ) in subjects at week 4. Subgroup analysis revealed that female subjects had more significant response to rifaximin treatment (adequate relief of GDS at week 4: 76% vs. 42%, P = 0.006; week 8: 79% vs. 47%, P = 0.008), as well as improvements in their belching and PPF at week 4. The incidences of adverse effects were similar in both groups. Conclusions: Treatment with 2 weeks of rifaximin led to adequate relief of global dyspeptic symptoms, belching and post‐prandial fullness/bloating in subjects with functional dyspepsia. The difference was more marked in females. (clinicaltrials.org NCT 01643083).
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Rifaximin has been tested in functional dyspepsia, bloating, and flatulence, and is approved for treating adults with IBS-D.
“Rifaximin has been studied in functional dyspepsia146, abdominal bloating, and flatulence150, and is approved for treatment of adults with IBS-D151.”
From The gut Microbiome in adult and pediatric functional gastrointestinal disorders (2019) · cites this paper as [146]
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The gut Microbiome in adult and pediatric functional gastrointestinal disorders
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- Authors
- Tan, V. P. Y., Liu, K. S. H., Lam, F. Y. F., Hung, I. F. N., Yuen, M. F., & Leung, W. K.
- Affiliations
- Queen Mary Hospital (CN)
- Corresponding author
- Leung, W. K.
- Venue
- Alimentary Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2017-01-23
- Volume
- 45
- Issue
- 6
- Pages
- 767-776
- ISSN
- 0269-2813 (ISSN-L)
- 1365-2036
- OpenAlex
- W2580833039
- Cited by
- 143
- References
- 26
- Citations by year
- 2026: 9 · 2025: 13 · 2024: 10 · 2023: 21 · 2022: 17 · 2021: 21 · 2020: 18 · 2019: 12 · 2018: 11 · 2017: 10 · 2016: 1
- FWCI
- 14.65
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Alimentary Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- The HKU Scholars Hub (University of Hong Kong) (submittedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Health Sciences › Medicine › Surgery › Helicobacter pylori-related gastroenterology studies
- Keywords
- rifaximin, functional dyspepsia, gut dysbiosis, belching, bloating, sex differences in treatment response, Chinese patients
- MeSH terms
- Rifaximin, Adult, Aged, Double-Blind Method, Dyspepsia, Eructation, Female, Gastrointestinal Agents, Hong Kong, Humans, Male, Middle Aged, Pain, Rifamycins, Placebo Effect, Treatment Outcome, Postprandial Period
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