title: Prevention of nonsteroidal anti-inflammatory drug-induced small-intestinal injury by prostaglandin: a pilot randomized controlled trial evaluated by capsule endoscopy.
abstract: BACKGROUND
  There is no known preventive agent against nonsteroidal anti-inflammatory drug (NSAID) induced small-intestinal injury.
  
  
  OBJECTIVE
  To evaluate by capsule endoscopy whether coadministration of prostaglandin (PG) can prevent small-intestinal damage induced by short-term NSAID treatment.
  
  
  METHODS
  Single-blind, randomized, controlled trial.
  
  
  METHODS
  All procedures were performed at Nippon Medical School.
  
  
  METHODS
  Thirty-four healthy male volunteers.
  
  
  METHODS
  All subjects were randomly assigned to 2 groups: an NSAID-control group, who underwent NSAID (diclofenac sodium, 25 mg 3 times daily) and omeprazole (20 mg once daily) treatment, and an NSAID-PG group, who received PG (misoprostol, 200 microg 3 times daily) in addition to the same NSAID-omeprazole treatment. Eligible subjects, 15 per group, underwent capsule endoscopy before and 14 days after treatment.
  
  
  METHODS
  The number of mucosal breaks at capsule endoscopy.
  
  
  RESULTS
  NSAID treatment significantly increased the mean (SD) number of mucosal breaks per subject, from a basal level of 0.1 +/- 0.3 up to 2.9 +/- 6.3 lesions in the NSAID-control group (P = .012). In contrast, there was no significant change in the mean number of mucosal breaks before and after PG cotreatment (P = 0.42). Thus, the mean number of posttreatment mucosal breaks per subject was significantly higher in the NSAID-control group than in the NSAID-PG group (P = .028). There was a significant increase in the percentage of subjects in the NSAID-control group, with at least 1 mucosal break after treatment (from 6.7% to 53.3%), whereas there was no change in the incidence of mucosal breaks in the NSAID-PG group, which remained at 13.3%. (P = .002).
  
  
  CONCLUSIONS
  Single-center, open-label study.
  
  
  CONCLUSIONS
  PG cotherapy reduced the incidence of small-intestinal lesions induced by a 2-week administration of diclofenac sodium.
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan. s-fujimori@nms.ac.jp
authors.forename: Shunji
authors.initials: S
authors.lastname: Fujimori
authors.forename: Tsuguhiko
authors.initials: T
authors.lastname: Seo
authors.forename: Katya
authors.initials: K
authors.lastname: Gudis
authors.forename: Akihito
authors.initials: A
authors.lastname: Ehara
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Kobayashi
authors.forename: Keigo
authors.initials: K
authors.lastname: Mitsui
authors.forename: Masaoki
authors.initials: M
authors.lastname: Yonezawa
authors.forename: Shu
authors.initials: S
authors.lastname: Tanaka
authors.forename: Atsushi
authors.initials: A
authors.lastname: Tatsuguchi
authors.forename: Choitsu
authors.initials: C
authors.lastname: Sakamoto
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D053704:Capsule Endoscopy; D004008:Diclofenac / Q000009:adverse effects*; D006801:Humans; D007410:Intestinal Diseases / Q000139:chemically induced* / Q000517:prevention & control; D007413:Intestinal Mucosa / Q000187:drug effects / Q000293:injuries; D007421:Intestine, Small / Q000187:drug effects / Q000293:injuries; D008297:Male; D008875:Middle Aged; D016595:Misoprostol / Q000627:therapeutic use*; D009853:Omeprazole / Q000008:administration & dosage; D011459:Prostaglandins E, Synthetic / Q000627:therapeutic use*; D054328:Proton Pump Inhibitors / Q000008:administration & dosage; D016037:Single-Blind Method; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D011459:Prostaglandins E, Synthetic; D054328:Proton Pump Inhibitors; D016595:Misoprostol; D004008:Diclofenac; D009853:Omeprazole