Jh. Liu et al., ENTERIC-COATED PEPPERMINT-OIL CAPSULES IN THE TREATMENT OF IRRITABLE-BOWEL-SYNDROME - A PROSPECTIVE, RANDOMIZED TRIAL, Journal of gastroenterology, 32(6), 1997, pp. 765-768
To determine the efficacy and tolerability of an enteric-coated pepper
mint-oil formulation (Colpermin), we conducted a prospective, randomiz
ed, double-blind, placebo-controlled clinical study in 110 outpatients
(66 men/44 women; 18-70 years of age) with symptoms of irritable bowe
l syndrome. Patients took one capsule (Colpermin or placebo) three to
four times daily, 15-30 min before meals, for 1 month. Fifty-two patie
nts on Colpermin and 49 on placebo completed the study. Forty-one pati
ents on Colpermin (79%) experienced an alleviation of the severity of
abdominal pain (29 were pain-free); 43 (83%) had less abdominal disten
sion, 43 (83%) had reduced stool frequency, 38 (73%) had fewer borbory
gmi, and 41 (79%) less flatulence. Corresponding figures for the place
bo group were: 21 patients (43%) with reduced pain (4 were pain free),
14 (29%) with reduced distension, 16 (32%) with reduced stool frequen
cy, 15 (31%) with fewer borborygmi, and 11 (22%) with less flatulence.
Symp tom improvements after Colpermin were significantly better than
after placebo (P < 0.05; Mann-Whitney U-test). One patient on Colpermi
n experienced heartburn (because of chewing the capsules) and one deve
loped a mild transient skin rash. There were no significant changes in
liver function test results. Thus, in this trial, Colpermin was effec
tive and well tolerated.