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

Aim: The aim of this study was to compare two different dosages of mis oprostol (200 mu g two off three times daily: MISO TID or MISO BID gro ups) with ranitidine (150 mg twice daily: RAN group) in the short-term prevention of acute gastroduodenal lesions induced by naproxen (500 m g twice daily). Patients and 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 m ucosa 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 i n 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 fi ve patients dropped out for nonmedical reasons. With intent-to-treat a nalysis, the percentages of significant gastric lesions was 13, 9, and 46%, respectively, for the MISO TID, MISO BID, and RAN groups (MISO T ID vs RAN, p < 0.01; MISO BID vs RAN, p < 0.01). Nine patients develop ed an ulcer: two in the MISO TID group (one gastric ulcer and one duod enal ulcer); two in the MISO BID group (two gastric ulcers); and five in the RAN group (three gastric ulcers, one duodenal ulcer, and one pa tient had both gastric and duodenal ulcers). Conclusions: These result s show that misoprostol at 400-600 mu g daily is significantly more ef fective than ranitidine in the short-term prevention of naproxen-induc ed gastric lesions. The lower dose retained mucosal protective activit y that was statistically indistinguishable from that of misoprostol at 200 mu g t.i.d.