Multicenter phase II randomized study evaluating dose-response of antiperistaltic effect of L-menthol sprayed onto the gastric mucosa for upper gastrointestinal endoscopy

Naoki Hiki, Michio Kaminishi, Kenjiro Yasuda, Noriya Uedo, Masumi Kobari, Terufumi Sakai, Takashi Hiratsuka, Kyota Ohno, Hajime Honjo, Sachiyo Nomura, Naohisa Yahagi, Hisao Tajiri, Hiroaki Suzuki

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)79-86
Number of pages8
JournalDigestive Endoscopy
Volume24
Issue number2
DOIs
Publication statusPublished - 2012 Mar

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Antidiarrheals
Menthol
Gastrointestinal Endoscopy
Gastric Mucosa
Peristalsis
Placebos
Stomach
Spasm
Endoscopy

Keywords

  • endoscopic diagnosis
  • gastric peristalsis
  • L-menthol
  • upper gastrointestinal endoscopy

ASJC Scopus subject areas

  • Gastroenterology
  • Radiology Nuclear Medicine and imaging

Cite this

Multicenter phase II randomized study evaluating dose-response of antiperistaltic effect of L-menthol sprayed onto the gastric mucosa for upper gastrointestinal endoscopy. / 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.

In: Digestive Endoscopy, Vol. 24, No. 2, 03.2012, p. 79-86.

Research output: Contribution to journalArticle

Hiki, N, Kaminishi, M, Yasuda, K, Uedo, N, Kobari, M, Sakai, T, Hiratsuka, T, Ohno, K, Honjo, H, Nomura, S, Yahagi, N, Tajiri, H & Suzuki, H 2012, 'Multicenter phase II randomized study evaluating dose-response of antiperistaltic effect of L-menthol sprayed onto the gastric mucosa for upper gastrointestinal endoscopy', Digestive Endoscopy, vol. 24, no. 2, pp. 79-86. https://doi.org/10.1111/j.1443-1661.2011.01163.x
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. / Multicenter phase II randomized study evaluating dose-response of antiperistaltic effect of L-menthol sprayed onto the gastric mucosa for upper gastrointestinal endoscopy. In: Digestive Endoscopy. 2012 ; Vol. 24, No. 2. pp. 79-86.
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abstract = "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.",
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T1 - Multicenter phase II randomized study evaluating dose-response of antiperistaltic effect of L-menthol sprayed onto the gastric mucosa for upper gastrointestinal endoscopy

AU - Hiki, Naoki

AU - Kaminishi, Michio

AU - Yasuda, Kenjiro

AU - Uedo, Noriya

AU - Kobari, Masumi

AU - Sakai, Terufumi

AU - Hiratsuka, Takashi

AU - Ohno, Kyota

AU - Honjo, Hajime

AU - Nomura, Sachiyo

AU - Yahagi, Naohisa

AU - Tajiri, Hisao

AU - Suzuki, Hiroaki

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N2 - 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.

AB - 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.

KW - endoscopic diagnosis

KW - gastric peristalsis

KW - L-menthol

KW - upper gastrointestinal endoscopy

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