Background: Spiramycin (Rovamycin) is a well-established macrolide antibiotic with good anti-Helicobacter pylori activity in vitro. It is acid-stable and found in high concentration in various body fluids and cells after oral administration. Its anti-H. pylori activity in vivo has not yet been tested.
Methods: Twenty-five consecutive patients with endoscopically verified peptic ulcer and a positive biopsy urease test were given spiramycin tables 1.5 MIU instead of oxytetracycline 500 mg q.d.s. in our triple therapy regimen with bismuth subnitrate suspension 10 mL (150 mg bismuth subnitrate) q.d.s. and metronidazole 400 mg t.d.s. for 10 days. Bismuth was taken between meals and spiramycin and metronidazole with meals. Re-endoscopy and 14C-urea breath test were performed 4 weeks after completion of therapy. Those who were H. pylori negative according to the breath test returned for 1-year follow-up.
Results: Per protocol analysis at 4 weeks showed that 21 out of 23 patients were H. pylori negative and had healed ulcers. These 21 patients were persistingly H. pylori negative and had no ulcers at 1-year follow-up. H. pylori eradication and ulcer healing rates were thus 91.3%; 95% confidence interval from 72.0% to 98.9%. Side-effects limiting daily activity were significantly less frequent than we have experienced previously using oxytetracycline in triple therapy.
Conclusions: Spiramycin appears to be an alternative to tetracycline in the triple therapy of H. pylori infection. Further studies to position spiramycin as an anti-H. pylori drug are warranted.