Spiramycin is comparable to oxytetracycline in eradicating H-pylori when given with ranitidine bismuth citrate and metronidazole

Background: We have consistently achieved about 90% eradication of H.pylori with liquid bismuth, metronidazole and oxytetracycline. Aim: To test eradication and adverse events of ranitidine bismuth citrate ( RBC) when given with metronidazole and either oxytetracycline or spiramycin . Methods: One hundred and eighty-three patients were randomized to one of fo ur 10-day regimens: RBC400OM: RBC 400 mg b.d., oxytetracycline 500 mg q.d.s .; RBC400SM: RBC 400 mg b.d., spiramycin 1 g q.d.s.; RBC200OM: RBC 200 mg q .d.s., oxytetracycline 500 mg q.d.s.; RBC200SM: RBC 200 mg q.d.s., spiramyc in 1 g q.d.s. Additionally, all patients received metronidazole 400 mg q.d. s. A C-14-urea breath test was performed at 8 weeks. Results: Intention-to-treat eradication rates were 94%, 91%, 94% and 89% wi th RBC400OM, RBC400SM, RBC200OM and RBC200SM, respectively (P = 0.81), Erad ication was significantly higher in ulcer patients (97%) than in those with diagnoses other than ulcer (86%) (P = 0.009), There was a strong tendency to better eradication among those who had never smoked (100%) compared with ex-smokers (93%) and smokers (89%) (P = 0.06). Fifty-three per cent experi enced at least one moderate or severe adverse event, and women had more adv erse events than men (P = 0.0002), Conclusions: All four regimens had comparable efficacy and adverse events, Eradication was significantly better in ulcer patients but there was a tren d to better eradication in those who smoked less, used less alcohol and exe rcised more. Adverse events were frequent, perhaps because of the large dos e of metronidazole used, but few patients stopped treatment.