Premium
MULTICENTER PHASE II RANDOMIZED STUDY EVALUATING DOSE–RESPONSE OF ANTIPERISTALTIC EFFECT OF L‐MENTHOL SPRAYED ONTO THE GASTRIC MUCOSA FOR UPPER GASTROINTESTINAL ENDOSCOPY
Author(s) -
HIKI NAOKI,
KAMINISHI MICHIO,
YASUDA KENJIRO,
UEDO NORIYA,
KOBARI MASUMI,
SAKAI TERUFUMI,
HIRATSUKA TAKASHI,
OHNO KYOTA,
HONJO HAJIME,
NOMURA SACHIYO,
YAHAGI NAOHISA,
TAJIRI HISAO,
SUZUKI HIROAKI
Publication year - 2012
Publication title -
digestive endoscopy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.5
H-Index - 56
eISSN - 1443-1661
pISSN - 0915-5635
DOI - 10.1111/j.1443-1661.2011.01163.x
Subject(s) - menthol , medicine , peristalsis , placebo , gastroenterology , adverse effect , chemistry , alternative medicine , organic chemistry , pathology
Aim: Peppermint oil solution was found to be effective for reducing gastric spasm during upper gastrointestinal endoscopy. The aim of the present study was to assess whether the gastric peristalsis‐suppressing effect is dose‐dependently induced by L‐menthol, the major constituent of peppermint oil, and to determine the recommended dose of an L‐menthol preparation. Methods: In this phase II, multicenter, double‐blind, dose–response study, 131 eligible patients were randomly assigned to receive 20 mL of 0.4% L‐menthol ( n = 32), 0.8% L‐menthol ( n = 35), 1.6% L‐menthol ( n = 30), or placebo ( n = 34). The primary efficacy measure was the proportion of subjects with no peristalsis in two time periods, 75 to 105 s after treatment and immediately before the completion of endoscopy. Results: The peristalsis‐suppressing effect of L‐menthol increased dose dependently (5.6%, 32.0%, 47.4% and 52.9% in the 0%, 0.4%, 0.8% and 1.6% groups, respectively: P < 0.001, one‐tailed Cochran‐Armitage trend test). As compared with the placebo group, the proportion of subjects with no peristalsis after administration was significantly higher in the 0.8% group ( P = 0.015) and 1.6% group ( P = 0.009). Adverse events in the L‐menthol dose groups occurred with similar frequencies in the placebo group. Conclusion: L‐menthol suppresses peristalsis in a dose‐dependent manner, and the dose–response reaches a plateau at 0.8% L‐menthol. Further Phase III studies are needed to establish the superiority of 0.8% L‐menthol over placebo.