Clarithromycin or amoxycillin plus high-dose ranitidine in the treatment of Helicobacter pylori-positive functional dyspepsia.

OBJECTIVE

This study was intended to investigate the effect of ranitidine in dual anti-Helicobacter pylori therapy. Simultaneously, it was to evaluate the potential effect of H. pylori eradication on the symptomatology of H. pylori-positive dyspepsia.

PATIENTS AND METHODS

Fifty-four patients with H. pylori infection and symptoms of non-ulcer dyspepsia were randomly assigned to treatment with either amoxycillin 500 mg four times daily plus ranitidine 300 mg four times daily, clarithromycin 500 mg twice daily plus ranitidine 300 mg twice daily, clarithromycin 500 mg four times daily plus ranitidine 300 mg twice daily or clarithromycin 500 mg four times daily plus ranitidine 300 mg four times daily for a period of 12 days. In addition, ranitidine 150 mg twice daily was given for a further 16 days.

RESULTS

Eradication of H. pylori using the assigned treatments was achieved in 47% (seven out of 15), 50% (five out of 10), 70% (seven out of 10) and 77% (10 out of 13) of patients, respectively. Failure of therapy with clarithromycin was associated with primary or acquired resistance after treatment in 91% (10 out of 11). Symptom improvement was significant (P = 0.0001) and similar in all of the four treatment groups up to week 8. As regards H. pylori status, no differences in the mean symptom score improvement could be found between patients with eradication and those with persistent infection (12.3-7.0, P = 0.0001, n = 29 compared with 13.0-6.5, P = 0.004, n = 19). After 1 year the symptom score had increased both in patients with persistent H. pylori (9.1) and in those remaining free of infection (10.0). No reinfection could be found.

CONCLUSION

These results suggest that clarithromycin plus high-dose ranitidine is a combination which achieves reasonably high H. pylori eradication rates. However, treatment failure inevitably leads to clarithromycin resistance. The improvement of non-ulcer dyspepsia symptoms during acute therapy is independent of H. pylori eradication. Long-term benefit of H. pylori eradication with respect to the symptoms of functional dyspepsia was not observed.