Optimization of Second Line Treatment Protocol for H Pylori Eradication Clinical Trial
The aim of this study is to evaluate the efficacy of sequential therapy, i.e. 5 days of PPI + amoxicillin followed by 5 days of PPI + two antimicrobial drugs( clarithromycin and tinidazole ) versus quadruple drug regimen( i.e.-14 days of PPI+ bismuth + metronidazole + tetracycline ) as second line treatment of H. pylori .
a total of 101 patients were randomized to 2 groups : 50 in sequential group and 51 patients
in quadruple group . mean age was 43 in both groups. In sequential therapy group 42
patients(84%) completed the treatment , 39 patients returned to follow up . In quadruple
group only 33 patients (64.7%) completed the treatment , 29 of them returned to follow up.
Compliance to the treatment was significant better in sequential group comparative to
quadruple .Sides effects connected to gastro-intestinal tract were reported in 27(65.9%) of
quadruple group patients and in 19(43.2%)of sequential group.
The H pylori was eradicated in 23 of 39 patients in sequential group(59%), and in 19 of the
29 patients in quadruple group(65.5%). no comorbidities like smoking, diabetes or other
influenced the efficacy of eradication.
Sequential therapy showed the same eradication rate as second line treatment of H pylori as
quadruple one, but was associated with better compliance and less adverse effects.
Both treatments protocols failed to show an appropriate eradication rate in population of
Southern Israel .
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment