title: Double-blind, double-dummy endoscopic comparison of the mucosal protective effects of misoprostol versus ranitidine on naproxen-induced mucosal injury to the stomach and duodenum in rheumatic patients.
abstract: OBJECTIVE
  The aim of this study was to compare two different dosages of misoprostol (200 microg two or three times daily: MISO TID or MISO BID groups) with ranitidine (150 mg twice daily: RAN group) in the short-term prevention of acute gastroduodenal lesions induced by naproxen (500 mg twice daily).
  
  
  METHODS
  Seventy patients (62 females, 8 males, mean age 54 yr) affected by rheumatoid arthritis (54 patients, 77%) or osteoarthritis (16 patients, 23%) with endoscopically normal mucosa were randomized to receive one of the three treatments for 2 wk. The gastroduodenal mucosa damage was scored according to a modified 0-5 endoscopic scale.
  
  
  RESULTS
  Sixty-five patients (21 of 23 patients in the MISO TID group, 22 of 23 patients in the MISO BID group, and 22 of 24 patients in the RAN group) underwent a final endoscopy, while five patients dropped out for nonmedical reasons. With intent-to-treat analysis, the percentages of significant gastric lesions was 13, 9, and 46%, respectively, for the MISO TID, MISO BID, and RAN groups (MISO TID vs RAN, p < 0.01; MISO BID vs RAN, p < 0.01). Nine patients developed an ulcer: two in the MISO TID group (one gastric ulcer and one duodenal ulcer); two in the MISO BID group (two gastric ulcers); and five in the RAN group (three gastric ulcers, one duodenal ulcer, and one patient had both gastric and duodenal ulcers).
  
  
  CONCLUSIONS
  These results show that misoprostol at 400-600 microg daily is significantly more effective than ranitidine in the short-term prevention of naproxen-induced gastric lesions. The lower dose retained mucosal protective activity that was statistically indistinguishable from that of misoprostol at 200 microg t.i.d.
authors.affiliation: Gastrointestinal Unit, L. Sacco University Hospital, Milan, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Bianchi Porro
authors.forename: M
authors.initials: M
authors.lastname: Lazzaroni
authors.forename: M
authors.initials: M
authors.lastname: Petrillo
mesh_terms: D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000139:chemically induced / Q000517:prevention & control; D004386:Duodenum / Q000187:drug effects*; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005753:Gastric Mucosa / Q000187:drug effects*; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D016595:Misoprostol / Q000627:therapeutic use*; D009288:Naproxen / Q000009:adverse effects*; D010003:Osteoarthritis / Q000150:complications / Q000188:drug therapy*; D010919:Placebos; D011899:Ranitidine / Q000627:therapeutic use*; D013276:Stomach Ulcer / Q000139:chemically induced / Q000517:prevention & control
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D010919:Placebos; D016595:Misoprostol; D009288:Naproxen; D011899:Ranitidine