Rebamipide and Misoprostol: Multicenter RCT-STORM 153 Table 4. Effect of rebamipide on endoscopic appearance of NSAID-induced gastric mucosal injury in high-risk subjects Rebamipide n = 151 (%) 5 (3.3) 1 (0.7) 6 (4.0) Misoprostol n = 154 (%) 2 (1.3) 4 (2.6) 6 (3.9) OR(95%CI) 0.38 (0.05–1.81) 3.99 (0.58–78.68) 0.97 (0.30–3.19) p value 0.2574 0.2174 0.9723 Table 5. Cumulative incidences of dyspeptic and abdominal symptoms determined from patients diaries Gastric ulcer Duodenal ulcer Peptic ulcer OR: Odds ratio 95%CI: 95% Confidence Interval Ulcer: A and H stage ulcer only Number of dyspeptic and abdominal symptoms Diarrhea Low abdominal pain Low abdominal symptoms Nausea Bloating Satiety Fullness Vomiting Epigastric pain Acid regurgitation Total dyspeptic symptoms Total Statistical analysis by chi-square test (n.s.: not significant) Rebamipide (%) 4 (1.9) 16 (7.7) 20 20 (9.7) 21 (10.1) 19 (9.2) 21 (10.1) 5 (2.4) 28 (13.5) 11 (5.3) 125 145 Misoprostol (%) 43 (21.2) 30 (14.8) 73 20 (9.9) 42 (20.7) 18 (8.9) 32 (15.8) 9 (4.4) 40 (19.7) 11 (5.4) 172 245 p value <.0001 0.0228 <.0001 n.s. 0.0029 n.s. n.s. n.s. n.s. n.s. 0.0509 0.0083 Discussion NSAIDs are widely used for the relief of pain and inflammation in patients with rheumatoid arthritis or other inflammatory diseases. NSAIDs, which can induce gastro- pathies such as dyspepsia and epigastric pain due to peptic ulceration, can unfortunately worsen the quality of life of patients, and result in serious, life-threatening ulcers. NSAIDs inhibit prostaglandin synthesis; this is the principal mechanism responsible for both their anti-inflammatory effects and gastrointestinal toxicity. Inhibition of PG synthesis abrogates a number of PG-dependent mucosal defense mechanisms such as mucosal blood flow and bicarbonate secretion [11]. This study has certain limitations: it was not performed in double-blind fashion, and multiple agents rather than a single agent were used. The main reason we performed a placebo study instead of a comparative study is that it was difficult to obtain permission to perform the study from the Ethics Committees of each center of the three Asian countries involved. In addition, 12-week administration resulted in a Vol. 40, No. 2, 2007 relatively high drop-out rate: 33 patients (15.9%) in the rebamipide group and 48 patients (23.6%) in the misoprostol group. The major reason for patient drop-out was request by patients for discontinuation of participation in the study: 20.9% of patients discontinued the study since they exhibited improvement and therefore no longer needed administration of NSAIDs. This was followed by low level of compliance with test drugs, and abdominal symptoms. In particular, 16 subjects (including 12 patients in the misoprostol group) dropped out due to interaction of dyspeptic and abdominal symptoms (Fig. 2). In this study, 6 NSAIDs were administered at the minimum daily dose. If subjects were administered less than minimum daily dose, they were not included in analysis due to low level of drug compliance. Various NSAIDs were used in each center in Korea, China, and Thailand. Thus, a total of 6 types of NSAIDs with similar propensity to induce gastrointestinal complications were used in this study. The subjects of this study included patients who re-started administration of NSAIDs after more than 4 weeks of discontinuation of NSAIDs, as well as those who received