COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Effect of Helicobacter pylori eradication on glycaemia control in patients with type 2 diabetes mellitus and comparison of two therapeutic regimens.

BACKGROUND AND STUDY AIMS: The eradication rate of Helicobacter pylori (H. pylori) has been reported as being lower in patients with type 2 diabetes mellitus (DM) than in those without DM. The aim of the study was to assess the efficacy of the two H. pylori eradication regimens in patients without and with type 2 DM and to study the effect of H. pylori treatment on glycaemia control.

PATIENTS AND METHODS: A total of 93 consecutive type 2 DM (non-insulin users) and 98 non-diabetic age- and sex-matched patients were enrolled. Patients were randomly assigned to one of the two treatment protocols all given twice daily: (a) a 14-day quadruple therapy comprising of omeprazole 20mg, metronidazole 500mg, amoxicillin 1g and bismuth subcitrate 240mg (OMAB) and (b) a 14-day triple regimen comprising of omeprazole 20mg plus clarithromycin 500mg and amoxicillin 1g (OCA). Cure was defined as a negative (13)C-urea breath test at least 6weeks after treatment.

RESULTS: The H. pylori eradication rate with the OCA regimen was 63% in patients with type 2 DM (non-insulin users) and 87.7% in the control group (p=0.017). The H. pylori eradication rate with the OMAB regimen was 38.2% in patients with type 2 DM and 55.1% in the control group (p<0.001). Mean decrease of fasting plasma glucose and HbA1c level shows no statistically significant difference after H. pylori eradication.

CONCLUSION: This study suggests that the eradication rate of H. pylori with OCA or OMAB treatment is lower in patients with type 2 diabetes than in non-diabetics and H. pylori treatment in patients with type 2 DM has no role in the control of the glycaemia. The triple therapy (OCA) is superior to the quadruple protocol (OMAB) in H. pylori eradication of both DM and non-DM cases.

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