Spiramycin in triple therapy of Helicobacter pylori-associated peptic ulcer disease. An open pilot study with 12-month follow-up.
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.
Berstad
A
A
Department of Medicine, Haukeland University Hospital, Bergen, Norway.
Berstad
K
K
Wilhelmsen
I
I
Hatlebakk
J G
JG
Nesje
L B
LB
Hausken
T
T
D000328:Adult; D000368:Aged; D001729:Bismuth / Q000627:therapeutic use; D001944:Breath Tests; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D010118:Oxytetracycline / Q000627:therapeutic use; D010437:Peptic Ulcer / Q000175:diagnosis / Q000188:drug therapy*; D015572:Spiramycin / Q000627:therapeutic use*; D016896:Treatment Outcome
D008795:Metronidazole; D015572:Spiramycin; C010804:bismuth subnitrate; D001729:Bismuth; D010118:Oxytetracycline