Comparative Study of Using Different Dosages and Regimens of Esomeprazole in Treating Helicobacter pylori-related Peptic Ulcer Disease

Proton-pump inhibitor-based triple therapy is currently the mainstay for eradication of H. pylori infection and peptic ulcer disease. Esomeprazole-based triple therapy was verified in many publications to achieve acceptable ulcer healing rate and eradication rate of H. pylori infection. However, comparison of different triple therapy in eradication of H. pylori infection is seldom mentioned. This clinical trial is aimed to compare the effects of two different dosage of esomeprazole (40 mg or 20 mg twice daily) and different antibiotic combination in eradication rate of H. pylori infection and peptic ulcer healing rate. From Feb. 2003 to Oct. 2009, we collected 272 patients (female: 42%; age: 53.8±15.2 yr) with investigated H. pylori related peptic ulcer disease (gastric ulcer or duodenal ulcer) and then randomly assigned all the patients into four groups for treatment. Group A: E 40mg, M 500mg, C 250mg; Group B: E 20mg, M 500mg, C 250mg; Group C: E 40mg, A 1000mg, C 500mg; Group D: E 20mg, A 1000mg, C 500mg (E: esomeprazole, M: metronidazole, C: clarithromycin, A: amoxicillin). Diagnosis of peptic ulcer disease was made via esophagogastroduodenoscopy (EGD). Eradication was confirmed at least four months after completion of treatment by means of urea breath test (UBT), rapid urease test or histology. After treatment, repeated EGD was performed in 170 patients for confirmation of ulcer healing in addition to the rapid urease test or biopsy which is mandatory for confirmation of eradication. Another seven patients who were reluctant to receive secondary EGD underwent UBT only. Based on per-protocol analysis, H. pylori eradication among group A is 89.6%, group B 86.7 %, group C 97.5% and group D 93.2%. Ulcer healing rate among group A is 95.6%, group B 91.1%, group C 97.4% and group D 100%. There was no statistically significant difference in either eradication or ulcer healing rate among 4 groups. By intention-to-treat analysis, H. pylori eradication rates among four groups are much lower and reported 63.2%, 57.4%, 57.4% and 60.3% respectively. Moreover, the per-protocol overall eradication rate was 91.53% (162/177); while overall ulcer healing rate was 95.88% (163/170). Esomeprazole 20 mg based triple therapy appears to be as effective as standard esomeprazole 40 mg based triple therapy. In the era of high health care expenditure, reducing the cost of treatment but not sacrificing efficacy may be worthwhile.