Efficacy and tolerability of a fixed combination of peppermint oil and caraway oil in patients suffering from functional dyspepsia

摘要: Aim: To assess the efficacy and safety of enteric coated capsules containing a fixed combination 90 mg peppermint oil 50 mg caraway (PCC; Enteroplant) in patients with functional dyspepsia. Methods: A total 96 out-patients received one capsule twice daily PCC or placebo for 28 days. Primary variables were intra-individual change (i) pain intensity (ii) sensation pressure, heaviness fullness between days 1 29, investigators’ rating (iii) global improvement (Clinical Global Impressions [CGI] item 2) on day 29. A type I error α=0.05 was controlled by priori ordering hypotheses. Results: All evaluable safety. On average reduced 40% vs. baseline group 22% group. With regards to fullness, 43% reduction observed placebo. In CGI 2, 67% (PCC) 21% (placebo) described as much very improved. all three target parameters, superiority over statistically significant. Six (PCC: 5; placebo: 1) reported adverse events, either unrelated trial, attributable an aggravation disease under investigation. Eructation taste did not occur. Conclusion: These results demonstrate good tolerability favourable risk–benefit ratio treatment dyspepsia.