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A Comparative Study of Efficacy and Safety of Two Eradication Regimens for Helicobacter pylori Infection
Carmen Monica PREDA, Doina PROCA, Irina SANDRA, Larisa Elena FULGER, Boroka Claudia HOREANGA, Mircea MANUC, Teodora MANUC, Catalin Andrei DUTEI, Mihaela BARBU, Letitia TUGUI, Adriana-Corina ANDREI, Bogdan Ionut SLAVULETE and Mircea DICULESCU
Introduction: Helicobacter pylori infection is one of the most frequent diseases around the world, affecting about half of the world population. The infection is known to be associated with upper gastrointestinal diseases. The aim of this paper is to identify which of the following two first-line therapy options (ECA vs ECM – see abbreviations below) is more efficient and to assess the improvement in the quality of life among these patients.
Material and Methods: 96 patients with proven Helicobacter pylori infection were divided in two treatment groups, as follows: 47 patients received a 10-day triple therapy with esomeprazole 80 mg/day, amoxicillin 2000 mg/day and clarithromycin 1000 mg/day (ECA) and the rest of 49 received a 10-day sequential therapy: esomeprazole 40 mg and amoxicillin 1000 mg twice daily for five days, followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg (ECM) twice daily for another five days. Assessment of Helicobacter pylori infection was performed using the stool antigen test one month after the patient finished therapy. At the beginning of the study and at the follow-up visit, every subject was asked to complete the Gastrointestinal Quality of Life Index (GIQLI).
Results: Twenty three patients did not come for the follow-up visit (24% drop-out rate). The ECA therapy group had an efficacy rate of 94%, while the rate of the ECM treated group was 95% (per protocol analysis). There was no significant difference regarding the baseline characteristics between the two groups. The entire group treatment tolerability was approximately 85%, with no statistical difference between groups (p-value = 0.824). Quality of life improvement was 11.18 points in the ECA treated group and 13.4 points in the ECM treated group (p=NS). Regarding the quality of life improvement, the results were positive, irrespective of type of peptic disease, but the most important results were obtained in peptic ulcer disease, functional dyspepsia and chronic gastritis.
Conclusions: Both ECA and ECM regimens are almost equally effective in Helicobacter pylori eradication and significantly improve the quality of life irrespective of type of peptic disease. The limitation of this study was the significant drop-out rate (24%) that may have overestimated the results.
Keywords: Helicobacter pylori, antibiotics, first-line therapy, quality of life.