Background: Ranitidine bismuth citrate (RBC) 400 mg when given twice daily (b.d.) for 4 weeks with clarithromycin 250 mg four times daily (q.d.s.) for the first 2 weeks effectively heals duodenal ulcers and eradicates Helicobacter pylori.
Aims: To compare two dosage regimens of clarithromycin, 250 mg q.d.s. and 500 mg b.d., used with ranitidine bismuth citrate (Pylorid) 400 mg b.d., for the eradication of H. pylori and for symptom relief in patients with active duodenal ulcers.
Subjects: 236 patients with active duodenal ulcer and confirmed H. pylori infection.
Methods: In a randomized, double-blind, parallel group, multi-centre study, RBC was given with clarithromycin for 2 weeks followed by 2 weeks treatment with RBC alone to allow for ulcer healing. Ulcer status was assessed by endoscopy at entry. H. pylori status was assessed by CLO Test and 13C-urea breath test (UBT) at entry and UBT alone 4 weeks after the end of treatment. At entry, during the study and at follow-up, ulcer symptoms were recorded on a scale of none, mild, moderate or severe.
Results: 176 patients had an evaluable UBT at least 4 weeks post-treatment. H. pylori eradication rates were 96.2% for the RBC plus clarithromycin b.d. regimen and 91.8% for the RBC plus clarithromycin q.d.s. regimen (observed data). Four weeks post-treatment, 92% of patients receiving RBC b.d. plus clarithromycin q.d.s. and 89% receiving RBC b.d. plus clarithromycin b.d. were considered symptom successes (none or mild symptoms).
Conclusions: RBC 400 mg b.d. plus clarithromycin 500 mg b.d. was as effective as RBC 400 mg b.d. plus clarithromycin 250 mg q.d.s. in eradicating H. pylori and both regimens were well tolerated. The simpler dual therapy in a b.d. regimen might well encourage greater patient compliance.