Abstract

Introduction: The eradication of Helicobacter pylori infection is of importance in Hungarian health care system. Aims: The aims of the Ph. D. thesis are: 1. The primary, second- and third-line eradication of Helicobacter pylori in outpatient practice; 2. Meta-analysis of the Hungarian and European eradication results; 3. The assessment of the quality of life in functional dyspepsia. Methods: 1. Six primary regimens were evaluated in 3 open, controlled, prospective, single-center trials in duodenal ulcer patients. The regimens given were: a) omeprazole, amoxicillin, metronidazole, n = 48; b) omeprazole, clarithromycin, tinidazole, n = 52; c) pantoprazole, amoxicillin, clarithromycin, n = 48; d) ranitidine bismuth citrate, clarithromycin, n = 51; e) lansoprazole, amoxicillin, clarithromycin, n = 60, and f) ranitidine bismuth citrate, clarithromycin, metronidazole, n = 61 cases). Regimens c) and f) were given in a cross-over manner as second-line treatment in 134 cases. Pantoprazole-based quadruple therapies containing either nitrofurantoin or bismuth subsalicylate were given as third-line regimens in 41 cases. 2. The meta-analysis of the Hungarian full papers and abstracts published between 1993 and 2002 and that of the European abstracts published between 1997 and 2004 at the European Helicobacter Study Group, United European Gastroenterology Week, Digestive Disease Week and World Congresses of Gastroenterology meetings was performed. The pooled eradication rates and combined odds ratios were calculated in groups of similar regimens. 3. The quality of life was assessed by the Functional Digestive Disorders Quality of Life Questionnaire in 123 healthy subjects and patients with Helicobacter pylori positive ( n = 101) and negative ( n = 98) functional dyspepsia patients, treated by regimen c) or cisapride. Results: The eradication rates on an intention-to-treat basis were: a) 51.2%, b) 72.3%, c) 80.8%, d) 80.3%, e) 78.3%, f) 78.7%. Regimens c) and f) given as second-line treatment achieved 65.2%, and 60.3%, respectively. Quadruple treatments obtained 61.9% and 55.0% as third-line therapies. 2. The meta-analysis showed that proton pump inhibitor/ranitidine bismuth citrate based primary triple therapies achieved eradication rates > 80% both in Europe and Hungary. Regimens containing clarithromycin and amoxicillin obtained eradication rates of 81.5% in Hungary and 79.6% in Europe. Combination of clarithromycin and a nitroimidazole was efficient in 82.8% and 84.2%. 3. The quality of life was impaired in functional dyspepsia. Eradication or prokinetic treatment improved significantly ( p = 0.0001) the quality of life after 6 weeks and 1 year. The effect size at 6 weeks was 1.48 and 1.35. Conclusions: Proton pump inhibitor/ranitidine bismuth citrate-based primary therapies achieve eradication rates around 80% in outpatients care setting. Second- and third-line regimens were less efficient. The meta-analysis of the Hungarian and European results proved the validity of the Maastricht consensus statements. Impairment of the quality of life in functional dyspepsia is improved by eradicating the infection or prokinetic therapy.

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