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Efficacy and tolerability of a fixed combination of peppermint oil and caraway oil in patients suffering from functional dyspepsia
Author(s) -
May B.,
Köhler S.,
Schneider B.
Publication year - 2000
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2000.00873.x
Subject(s) - tolerability , placebo , medicine , adverse effect , clinical trial , anesthesia , surgery , gastroenterology , alternative medicine , pathology
Aim: To assess the efficacy and safety of enteric coated capsules containing a fixed combination of 90 mg peppermint oil and 50 mg caraway oil (PCC; Enteroplant) in patients with functional dyspepsia. Methods: A total of 96 out‐patients received one capsule twice daily of PCC or placebo for 28 days. Primary efficacy variables were the intra‐individual change in (i) pain intensity and (ii) sensation of pressure, heaviness and fullness between days 1 and 29, and the investigators’ rating of (iii) global improvement (Clinical Global Impressions [CGI] item 2) on day 29. A global type I error of α=0.05 was controlled by a priori ordering of hypotheses. Results: All patients were evaluable for efficacy and safety. On day 29, the average intensity of pain was reduced by 40% vs. baseline in the PCC group and by 22% in the placebo group. With regards to pressure, heaviness and fullness, a 43% reduction was observed for PCC vs. 22% for placebo. In CGI item 2, 67% (PCC) vs. 21% (placebo) of the patients were described as much or very much improved. In all three target parameters, the superiority of PCC over placebo was statistically significant. Six patients (PCC: 5; placebo: 1) reported adverse events, either unrelated to the trial, or attributable to an aggravation of the disease under investigation. Eructation with peppermint taste did not occur. Conclusion: These results demonstrate the good tolerability and the favourable risk–benefit ratio of PCC for the treatment of functional dyspepsia.