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Rifaximin improves functional dyspepsia symptoms
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Two weeks of rifaximin therapy safely improved symptoms in patients — especially women — with functional dyspepsia in a Chinese randomized controlled trial.
“We found that rifaximin is superior to placebo for the relief of global dyspeptic symptoms, post-prandial fullness/bloating and belching,” investigators wrote. “In particular, subgroup analyses revealed that female subjects experienced more remarkable and sustained improvement in their global dyspeptic symptoms, as well as improvement in their post-prandial bloating and belching at week 4.”
In this double blind feasibility study, researchers randomly assigned 86 consecutive patients with functional dyspepsia (mean age, 53.4 years; 76% women) to receive 400 mg rifaximin or placebo three times per day for 2 weeks. Adequate global symptom relief served as the primary endpoint, and relief of individual symptoms was also assessed.
Significantly more patients who received rifaximin reported adequate relief of global symptoms compared with placebo after 8 weeks (78% vs. 52%; OR = 3.16; 95% CI, 1.23-8.09), based on intention-to-treat analysis. Further, there was a trend toward superiority of rifaximin for global symptom relief in the preceding 4 weeks.
Regarding individual symptom relief, rifaximin was superior to placebo for providing adequate relief of belching (85% vs. 63%; OR = 3.32; 95% CI, 1.16-9.53) and post prandial fullness/bloating (80% vs. 59%; OR = 2.82; 95% CI, 1.07-7.44) at week 4. No differences in relief of other GI symptoms were observed.
Finally, subgroup analysis showed women had a more significant response to rifaximin, with 76% experiencing relief of global symptoms compared with 42% in the placebo group at 4 weeks (P = .006) and 79% vs. 47%, respectively, at 8 weeks (P = .008). Women also experienced significant improvements in belching and post-prandial fullness/bloating vs. placebo at 4 weeks, but this was not significant at 8 weeks.
Adverse events were comparable between treatment and placebo groups (20% vs. 30%).
This “is the first study to demonstrate that rifaximin is efficacious in the treatment of functional dyspepsia, particularly for relief of global dyspeptic symptoms and individual dyspeptic symptoms of post-prandial fullness/bloating and belching,” the investigators concluded. “Larger studies to confirm this result and mechanistic studies to determine the drivers of a response to rifaximin are warranted.” – by Adam Leitenberger
Disclosures: The researchers report no relevant financial disclosures.
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