152 S.-H. Park et al. found in 8/176 (4.5%) subjects in the rebamipide group and 7/156 (4.4%) in the misoprostol group. The cumulative incidences of peptic ulcer in the rebamipide and misoprostol groups did not differ (Odds ratio: 0.98, p = 0.9796) (Table 3). Table 1. Demographic characteristics of enrolled patients Characteristics Rebamipide Misoprostol MLS: modified Lanza score, statistical analysis by chi-square test Table 2. Daily minimum NSAID dosages Number Sex (M:F) Age (mean ± SE) H. pylori-positive Pre MLS 0 1 2 3 4 5 Countries China Korea Thailand 207 54:153 48 ± 11 48.5% 128 38 27 12 1 0 86 76 45 NSAID Diclofenac Aceclofenac Naproxen Sulindac Ibuprofen Fenoprofen Mixed 203 67:136 46 ± 12 41.7% 137 29 17 15 5 0 88 77 38 Minimum daily dosage 75 mg/day 100 mg/day 500 mg/day 100 mg/day 400 mg/day 600 mg/day p value 0.1244 0.3754 0.2342 0.2633 Gastric mucosal damage, as evaluated by modified Lanza score, did not differ between the misoprostol and rebamipide groups (p = 0.2284) (Table 3). The high-risk subgroup included patients with age more than 65 years, concurrent anticoagulation treatment, history of peptic ulcer or bleeding, concurrent corticosteroid therapy, and more than double the standard dose of NSAID. The cumulative incidence of peptic ulcer in this subgroup was 4.0% for rebamipide and 3.9% for misoprostol. Prevention of NSAID-induced peptic ulcer did not differ between the rebamipide and misoprostol groups (Table 4). Cumulative incidences of dyspeptic and abdominal symptoms Diarrhea was the most frequent adverse event, and was significantly more common in the misoprostol group (21.2%) than in the rebamipide group (1.9%). Lower abdominal pain and bloating were significantly more common in the miso- prostol group than in the rebamipide group, (7.7% vs. 14.8%, p = 0.0228 and 10.1% vs 20.7%, p = 0.00229). The cumulative incidence of dyspeptic and abdominal symptoms such as diarrhea and lower abdominal pain in the rebamipide group was significantly lower than in the misoprostol group (Table 5). Rebamipide n (%) Misoprostol n (%) 75 (36.2) 86 (41.5) 13 (6.3) 6 (2.9) 5 (2.4) 3 (1.4) 19 (9.1) 76 (37.4) 57 (28.1) 19 (9.4) 10 (4.9) 7 (3.4) 5 (2.5) 29 (14.3) All patients n (%) 151 (36.8) 143 (34.9) 32 (7.8) 16 (3.9) 12 (2.9) 8 (2.0) 48 (11.7) Mixed: More than 2 NSAIDs Statistical analysis by chi-square test (n.s.: not significant) Table 3. Effects of rebamipide on endoscopic appearance of NSAID-induced gastric mucosal injury Gastric ulcer Duodenal ulcer Peptic ulcer MLS 0/1/2 MLS 3/4/5 OR: Odds ratio 95%CI: 95% Confidence Interval Ulcer: A and H stage ulcer only Rebamipide n = 176 (%) 7 (3.9) 1 (0.5) 8 (4.5) Misoprostol n = 156 (%) 3 (1.9) 4 (2.5) 7 (4.4) OR (95% CI) 0.47 (0.10–1.73) 4.60 (0.67–90.54) 0.98 (0.33–2.81) 99/25/23 (83.5) 18/4/7 (16.5) 102/26/12 (89.7) 13/0/3 (10.3) p value n.s. p value 0.2847 0.1741 0.9796 0.2284 J. Clin. Biochem. Nutr.