title: Antiperistaltic effect and safety of L-menthol sprayed on the gastric mucosa for upper GI endoscopy: a phase III, multicenter, randomized, double-blind, placebo-controlled study.
abstract: BACKGROUND
  GI peristalsis during GI endoscopy commonly requires intravenous or intramuscular injection of antispasmodic agents, which sometimes cause unexpected adverse reactions.
  
  
  OBJECTIVE
  Our ultimate goal was to evaluate whether the antiperistaltic effect of L-menthol-based preparations facilitates endoscopic examinations in a clinical setting.
  
  
  METHODS
  Multicenter, randomized, double-blind, placebo-controlled study.
  
  
  METHODS
  Six Japanese referral centers.
  
  
  METHODS
  A total of 87 patients scheduled to undergo upper GI endoscopy were randomly assigned to receive 160 mg of L-menthol (n=45) or placebo (n=42). Both treatments were sprayed endoscopically on the gastric mucosa. The degree of gastric peristalsis was assessed by an independent committee.
  
  
  METHODS
  The proportion of subjects with no peristalsis 90 to 135 seconds after administration and at the end of the endoscopic examination (complete suppression of gastric peristalsis). Other outcomes were the proportion of subjects with no or mild peristalsis (adequate suppression of gastric peristalsis) and the ease of intragastric observation as evaluated by the endoscopist who performed the procedure.
  
  
  RESULTS
  Gastric peristalsis was completely suppressed in 35.6% (21.9, 51.2) of the L-menthol group compared with only 7.1% (1.5, 19.5) of the placebo group (P<.001). In the L-menthol group, 77.8% (62.9, 88.8) (35/45 subjects) of the subjects had no or mild peristalsis at the completion of endoscopy. Minor peristalsis interfered with intragastric examination in only 1 of these 35 patients (2.9%). The incidence of adverse events did not differ significantly between the groups (P=.512).
  
  
  CONCLUSIONS
  Small sample size.
  
  
  CONCLUSIONS
  During upper GI endoscopy, L-menthol sprayed on the gastric mucosa significantly suppresses peristalsis with minimal adverse drug reactions compared with placebo. (
  
  
  BACKGROUND
  NCT00742599.).
authors.affiliation: Department of Gastroenterological Surgery, Gastroenterological Center, Cancer Institute Hospital, Japanese Foundation for Cancer Research, and Department of Gastrointestinal Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Hiki
authors.forename: Michio
authors.initials: M
authors.lastname: Kaminishi
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Yasuda
authors.forename: Noriya
authors.initials: N
authors.lastname: Uedo
authors.forename: Hajime
authors.initials: H
authors.lastname: Honjo
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Matsuhashi
authors.forename: Takashi
authors.initials: T
authors.lastname: Hiratsuka
authors.forename: Chuichi
authors.initials: C
authors.lastname: Sekine
authors.forename: Sachiyo
authors.initials: S
authors.lastname: Nomura
authors.forename: Naohisa
authors.initials: N
authors.lastname: Yahagi
authors.forename: Hisao
authors.initials: H
authors.lastname: Tajiri
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Suzuki
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000930:Antidiarrheals / Q000008:administration & dosage; D004311:Double-Blind Method; D016099:Endoscopy, Gastrointestinal / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D005746:Gastric Emptying / Q000187:drug effects* / Q000502:physiology; D005751:Gastric Lavage / Q000379:methods*; D005753:Gastric Mucosa / Q000187:drug effects*; D006801:Humans; D008297:Male; D008610:Menthol / Q000008:administration & dosage*; D008875:Middle Aged; D012189:Retrospective Studies; D013272:Stomach Diseases / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome; D014741:Video Recording
chemical_list: D000930:Antidiarrheals; D008610:Menthol