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 NCT01643083).
RCT Entities:
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 NCT01643083).
Authors: Christopher J Black; Peter A Paine; Anurag Agrawal; Imran Aziz; Maria P Eugenicos; Lesley A Houghton; Pali Hungin; Ross Overshott; Dipesh H Vasant; Sheryl Rudd; Richard C Winning; Maura Corsetti; Alexander C Ford Journal: Gut Date: 2022-07-07 Impact factor: 31.793
Authors: Lucas Wauters; Ram Dickman; Vasile Drug; Agata Mulak; Jordi Serra; Paul Enck; Jan Tack; Anna Accarino; Giovanni Barbara; Serhat Bor; Benoit Coffin; Maura Corsetti; Heiko De Schepper; Dan Dumitrascu; Adam Farmer; Guillaume Gourcerol; Goran Hauser; Trygve Hausken; George Karamanolis; Daniel Keszthelyi; Carolin Malagelada; Tomislav Milosavljevic; Jean Muris; Colm O'Morain; Athanassos Papathanasopoulos; Daniel Pohl; Diana Rumyantseva; Giovanni Sarnelli; Edoardo Savarino; Jolien Schol; Arkady Sheptulin; Annemieke Smet; Andreas Stengel; Olga Storonova; Martin Storr; Hans Törnblom; Tim Vanuytsel; Monica Velosa; Marek Waluga; Natalia Zarate; Frank Zerbib Journal: United European Gastroenterol J Date: 2021-04 Impact factor: 4.623