title: Randomised clinical trial: rifaximin versus placebo for the treatment of functional dyspepsia.
abstract: Gut dysbiosis may contribute to pain and bloating in patients with functional gastrointestinal disease.
  
  
  
  To determine if treatment with rifaximin would improve the symptoms of functional dyspepsia in Chinese patients in a double-blinded, randomised, placebo-controlled trial.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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 NCT01643083).
authors.affiliation: Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong.
authors.forename: V P Y
authors.identifier: 0000-0002-5721-8807
authors.initials: VP
authors.lastname: Tan
authors.affiliation: Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong.
authors.forename: K S H
authors.identifier: 0000-0002-4181-8808
authors.initials: KS
authors.lastname: Liu
authors.affiliation: Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong.
authors.forename: F Y F
authors.initials: FY
authors.lastname: Lam
authors.affiliation: Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong.
authors.forename: I F N
authors.initials: IF
authors.lastname: Hung
authors.affiliation: Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong.
authors.forename: M F
authors.initials: MF
authors.lastname: Yuen
authors.affiliation: Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong.
authors.forename: W K
authors.initials: WK
authors.lastname: Leung
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004415:Dyspepsia / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D004884:Eructation / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D005260:Female; D005765:Gastrointestinal Agents / Q000494:pharmacology / Q000627:therapeutic use*; D006723:Hong Kong / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D015990:Placebo Effect; D019518:Postprandial Period / Q000187:drug effects / Q000502:physiology; D012294:Rifamycins / Q000494:pharmacology / Q000627:therapeutic use*; D000078262:Rifaximin; D016896:Treatment Outcome
chemical_list: D005765:Gastrointestinal Agents; D012294:Rifamycins; D000078262:Rifaximin