Combination therapy with clarithromycin and sofalcone for eradication of Helicobacter pylori.

OBJECTIVE

To clarify the efficacy of combination therapy with clarithromycin and sofalcone for eradication of Helicobacter pylori.

DESIGNS: We studied 42 patients with H. pylori-positive gastroduodenal diseases, who were divided into two groups according to treatment period. Group 1 comprised 27 patients (seven with gastric ulcers, 14 with duodenal ulcers and six with gastritis) treated with a combination of clarithromycin (200 mg, three times a day) + sofalcone (100 mg, three times a day) for 3 weeks. Group 2 comprised 15 patients with chronic active gastritis treated with the same doses of clarithromycin + sofalcone but for only 2 weeks (group 2). The H. pylori status of all patients was assessed by culture, rapid urease test and histological examination at the end of treatment and 4 weeks after the end of treatment. The gastritis score, the index of intracellular periodic acid-Schiff-positive substance in the antral mucosa and the ammonia concentration in gastric secretions were also estimated before and after treatment.

RESULTS

In group 1, with over half the patients excluded from the follow-up, H. pylori was eradicated in nine out of 13 patients (69.2%) compared with six out of the complete group of 15 (40.0%) patients in group 2, without serious side effects. In these patients, significant improvements were seen in the gastritis score (P < 0.025), the index of periodic acid-Schiff-positive substances in the antral mucosa (P < 0.025) and the ammonia concentration in gastric secretions (P < 0.02) after treatment.

CONCLUSION

These results suggest that modification of the treatment regimen is needed, with higher doses of clarithromycin and combination therapy with proton-pump inhibition.