| Abstract: | OBJECTIVE: To determine the efficacy and tolerability of a 1‐week treatment regimen consisting of rabeprazole and two antibiotics, clarithromycin and amoxicillin, in the eradication of Helicobacter pylori in an ‘in‐clinical‐practice’ setting. METHODS: Patients selected had unequivocal evidence of H. pylori infection based on urease test and histology of antral and corpus biopsies obtained at endoscopy. Patients with complicated ulcers were not included. Patients received rabeprazole 10 mg b.i.d., clarithromycin 500 mg b.i.d. and amoxicillin 1 g b.i.d. for 1 week and were assessed for successful eradication at least 4 weeks after completion of therapy by repeat gastroscopy and gastric biopsies. Eradication was defined as absence of bacteria in both antral and corpus biopsies tested by histology and urease test. Ulcer patients did not receive continued acid suppression therapy following the 1‐week course of treatment. RESULTS: The study recruited 205 patients of whom 25 were not compliant with the medications or defaulted on follow‐up and were therefore not included in the per‐protocol analysis. Eradication of H. pylori was successful in 166/180 of patients on per‐protocol analysis (92.2% [95% CI: 87.3, 95.7]) and in 169/205 patients on intention‐to‐treat analysis (82.4% [95% CI: 80.5, 90.2]; P = 1.000). There were 47 patients with active ulcers: DU 27, GU 18, DU/GU 2. Overall, ulcer healing was achieved in 42 of 44 (95.5%) patients who had successful eradication of H. pylori infection, but ulcers did not heal in any of the three patients (DU 2, GU 1) who did not eradicate the infection. Of the total group, 199 were assessed for compliance and side‐effects of treatment. Side‐effects were in general mild and tolerable. Of 14 patients who were not compliant with medication, 4 (2.0%) attributed it to side‐effects of treatment (increased abdominal pain, dizziness and taste disturbances) and the remaining 10 did not give specific reasons. The most common side‐effect was bitter taste, reported by 39.2% of patients. Other side‐effects, such as giddiness, increased abdominal pain, lethargy, loose bowel motions and skin rash, were mild and found in only a small percentage of patients. CONCLUSIONS: The rabeprazole 1‐week triple therapy with amoxicillin and clarithromycin is effective in eradicating H. pylori in an ‘in‐clinical‐practice’ setting. The treatment was well tolerated by patients. Good ulcer healing was achieved with short‐course H. pylori eradication therapy without the need for continued acid suppression. |
