MULTICENTER PHASE II RANDOMIZED STUDY EVALUATING DOSE-RESPONSE OF ANTIPERISTALTIC EFFECT OF L-MENTHOL SPRAYED ONTO THE GASTRIC MUCOSA FOR UPPER GASTROINTESTINAL ENDOSCOPY
| Autor: | Kenjiro Yasuda, Hajime Honjo, Michio Kaminishi, Sachiyo Nomura, Takashi Hiratsuka, Naoki Hiki, Hisao Tajiri, Terufumi Sakai, Noriya Uedo, Naohisa Yahagi, Masumi Kobari, Hiroaki Suzuki, Kyota Ohno |
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| Rok vydání: | 2011 |
| Předmět: |
medicine.medical_specialty
medicine.diagnostic_test business.industry Gastroenterology Placebo Endoscopy law.invention Clinical trial Dose–response relationship medicine.anatomical_structure Randomized controlled trial law Internal medicine medicine Gastric mucosa Radiology Nuclear Medicine and imaging Adverse effect business Peristalsis |
| Zdroj: | Digestive Endoscopy. 24:79-86 |
| ISSN: | 0915-5635 |
| DOI: | 10.1111/j.1443-1661.2011.01163.x |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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