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.
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.
Bianchi Porro
G
G
Gastrointestinal Unit, L. Sacco University Hospital, Milan, Italy.
Lazzaroni
M
M
Petrillo
M
M
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
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D010919:Placebos; D016595:Misoprostol; D009288:Naproxen; D011899:Ranitidine