V. Savarino et al., Head-to-head comparison of 1-week triple regimens combining ranitidine or omeprazole with two antibiotics to eradicate Helicobacter pylori., ALIM PHARM, 13(5), 1999, pp. 643-649
Background: Triple therapies containing omeprazole and ranitidine have been
shown to be equivalent in eradicating H. pylori infection, but have been a
ssessed either separately or head-to-head, only in small trials.
Aim: To carry out a large randomized controlled study comparing omeprazole
and ranitidine combined with two antibiotic combinations for 1 week.
Methods: Three hundred and twenty H, pylori-positive patients were randomly
subdivided into four equal-sized groups and received one of the following
treatments: OAM = omeprazole 20 mg b.d. + amoxycillin 1 g b,d. + metronidaz
ole 500 mg b.d,: RAM = ranitidine 300 mg b,d. + amoxycillin 1 g b,d, + metr
onidazole 500 mg b,d,: OAC = omeprazole 20 mg b,d, + amoxycillin 1 g b,d, clarithromycin 250 mg t.d.s,; RAC = ranitidine 300 mg b.d. + amoxycillin 1
g b,d, + clarithromycin 250 mg t.d.s. The assessment of H. pylori status w
as performed before and 4 weeks after the end of therapy by means of CLO-te
st. and histology, H. pylori infection was considered to be eradicated when
both tests were negative.
Results: OAM and RAM eradicated H. pylori in 89% and 85% of cases on per pr
otocol (P = 0.48) and in 77% and 75% of cases on intention-to-treat analyse
s (P = 0.71). OAC and RAC eradicated H, pylori in 67% and 70% of cases on p
er protocol (P = 0.68) and in 57% and 64% of cases on intention-to-treat an
alyses (P = 0.41). In contrast, there was significant difference between OA
M and OAC (P < 0.01) and between RAM and RAC (P < 0.05), Side-effects occur
red in 15%, 10%, 17% and 16% of patients with respect to the above four sub
groups.
Conclusions: Omeprazole and ranitidine combined with two antibiotics for 1
week are equally effective in the eradication of H. pylori infection, and t
hese results question the role of profound acid suppression in the eradicat
ion of the bacterium.