Document Detail

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.
MedLine Citation:
PMID:  9128319     Owner:  NLM     Status:  MEDLINE    
AIM: 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). 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 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.
G Bianchi Porro; M Lazzaroni; M Petrillo
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The American journal of gastroenterology     Volume:  92     ISSN:  0002-9270     ISO Abbreviation:  Am. J. Gastroenterol.     Publication Date:  1997 Apr 
Date Detail:
Created Date:  1997-05-16     Completed Date:  1997-05-16     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0421030     Medline TA:  Am J Gastroenterol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  663-7     Citation Subset:  IM    
Gastrointestinal Unit, L. Sacco University Hospital, Milan, Italy.
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MeSH Terms
Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
Anti-Ulcer Agents / therapeutic use*
Arthritis, Rheumatoid / complications,  drug therapy*
Double-Blind Method
Duodenal Ulcer / chemically induced,  prevention & control
Duodenum / drug effects*
Endoscopy, Gastrointestinal*
Gastric Mucosa / drug effects*
Intestinal Mucosa / drug effects*
Middle Aged
Misoprostol / therapeutic use*
Naproxen / adverse effects*
Osteoarthritis / complications,  drug therapy*
Ranitidine / therapeutic use*
Stomach Ulcer / chemically induced,  prevention & control
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 0/Anti-Ulcer Agents; 0/Placebos; 22204-53-1/Naproxen; 59122-46-2/Misoprostol; 66357-35-5/Ranitidine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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