RCT: Triple vs Sequential vs Concomitant Therapy H Pylori
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
Triple therapy (TT) comprising proton pump inhibitor (PPI), amoxicillin 1g and clarithromycin
500mg twice daily has long been considered one of the standard treatment for H. pylori
infection as initial studies demonstrated success rates of > 90% on per protocol analysis
(PP) and > 80% on intention to treat (ITT) analysis. However increasing bacterial resistance,
especially to clarithromycin, has been reported and there are concerns that the efficacy of
TT has decreased. Sequential therapy (ST) is an alternative first line therapy that consists
of 5 days of treatment with a PPI and amoxicillin followed by 5-day treatment with the PPI
and clarithromycin and metronidazole. The rationale for this approach is that amoxicillin may
weaken the bacterial cell wall in the initial phase of treatment, and prevent the development
of drug efflux channels that inhibit clarithromycin from binding to ribosomes and thus help
to improve the efficacy of clarithromycin in the second phase of treatment. A recent
meta-analysis based on mainly European studies showed that the success rate of ST compared to
TT was 92.8 - 96% vs. 76.2 - 78.8%. Concomitant therapy (CT) is another alternative first
line treatment that consists of 10 days of PPI, amoxicillin, clarithromycin and
metronidazole. The rationale for using CT as a first line treatment option is to address the
possibility of clarithromycin resistance which is increasingly encountered in clinical
practice. Currently there are no randomized controlled studies that compared TT with ST in
Singapore, although both regimens are being used in routine clinical practice. The hypothesis
is that ST is superior to TT as first line treatment for H. pylori infection.
The study aim to compare 10-day TT versus 10-day ST versus 10-day CT as first line treatment
for H. pylori infection in Singapore.