HIGHLY EFFECTIVE TWICE-DAILY TRIPLE THERAPIES FOR HELICOBACTER-PYLORIINFECTION AND PEPTIC-ULCER DISEASE - DOES IN-VITRO METRONIDAZOLE RESISTANCE HAVE ANY CLINICAL RELEVANCE
F. Lerang et al., HIGHLY EFFECTIVE TWICE-DAILY TRIPLE THERAPIES FOR HELICOBACTER-PYLORIINFECTION AND PEPTIC-ULCER DISEASE - DOES IN-VITRO METRONIDAZOLE RESISTANCE HAVE ANY CLINICAL RELEVANCE, The American journal of gastroenterology, 92(2), 1997, pp. 248-253
Objectives: To compare cure rates of Helicobacter pylori (H. pylori) i
nfection, ulcer healing, and side effects of three simplified regimens
of triple therapy in patients with peptic ulcer disease. Methods: Two
hundred thirty-one patients were prospectively randomized to receive
either regimen OAM (omeprazole 20 mg b.i.d., amoxicillin 750 mg b.i.d.
, and metronidazole 400 g b.i.d.), OCM (omeprazole 20 mg b.i.d., clari
thromycin 250 mg b.i.d., and metronidazole 400 mg b.i.d.), or BCM (bis
muth subcitrate 240 mg b.i.d., clarithromycin 250 mg b.i.d., and metro
nidazole 400 mg b.i.d.), all for 10 days. Side effects were reported i
mmediately afterward in a self-administered questionnaire. Upper endos
copy was carried out before treatment and 2 months after treatment. Th
ree antral and three corpus biopsy specimens were analyzed microbiolog
ically and with rapid urease test to determine the presence of H. pylo
ri. Altogether 143 patients (62%) had an active ulcer at start of trea
tment. Metronidazole resistant (M-R) H. pylori strains were found in 3
0% of patients, while none had clarithromycin resistant (C-R) strains.
Results: According to intention-to-treat analysis, H. pylori cure rat
es were 91, 95, and 95% with OAM, OCM, and BCM, respectively (p = 0.63
). In patients with metronidazole-sensitive (M-S) strains versus M-R s
trains, the cure rates were 96 versus 77% with OAM (p = 0.025), 94 ver
sus 94% with OCM, and 94 versus 96% with BCM. Ulcer healing rates were
95, 94, and 92%, respectively (p = 0.91). There were no significant d
ifferences in side effects between the regimens, and only five patient
s (2%) had to stop the treatment prematurely. Conclusions: All treatme
nt regimens were highly effective for cure of H. pylori infection and
for ulcer healing. Metronidazole resistance reduced the efficacy of OA
M, but was of no importance for the efficacy of OCM or BCM. Side effec
ts were of minor importance.