[The effect of Helicobacter pylori eradication on prokinetic treatment on the quality of life in functional dyspepsia].

INTRODUCTION: The quality life is impaired in functional dyspepsia. Little is known, however, about the impact of different therapies on the quality of life in this condition.

AIM OF STUDY: The scope of this study is to detect the change-over time of the quality of life under two different treatments in functional dyspepsia.

METHODS: One-hundred-one Helicobacter pylori positive and 98 Helicobacter pylori negative functional dyspepsia patients have been enrolled in a prospective, controlled study. Organic digestive diseases were excluded by endoscopy and abdominal ultrasound. The quality of life was assessed by a disease-specific questionnaire developed by the MAPI Research Institute, Lyon, France, translated and validated in Hungarian. Helicobacter pylori positive patients received one week triple regimen consisting in 2 x 40 mg pantoprazole + 2 x 1000 mg amoxicillin + 2 x 500 mg clarithromycin followed by on-demand ranitidine (1-2 x 150 mg) during 1 year of follow-up. Control 13C-urea breath test was performed 6 weeks after eradication. Helicobacter pylori negative patients received 3 x 10 mg cisapride for 6 weeks followed by on-demand prokinetic for 1 year. The questionnaire was self-administered at baseline, after 6 weeks and 1 year.

RESULTS: The eradication rate of Helicobacter pylori was of 76.4% on an 'intention-to treat' and 82.6% on 'per protocol' analysis. In patients with successful eradication, the standardized and transformed quality of life score increased after 6-8 weeks from 56.2 + 9.8 (95% confidence interval: 53.9-58.4) to 70.8 + 10.7 (68.3-73.5) (p = 0.0001) and to 75.3 + 9.3 (73.2-77.5) at 1 year (p = 0.005). In the patients with failed eradication, the quality of life has not been changed significantly (p = 0.76). The quality of life scores increased in Helicobacter pylori negative cases from 60.0 + 9.8 (58.0-62.0) to 73.3 + 9.6 (71.3 + 75.4) after 6 weeks (p = 0.0001) and to 76.5 + 8.5 (74.5 - 78.4) at 1 year (p = 0.56). The effect size was large in both groups and there were no differences between the treatment arms either at 6-8 weeks (p = 0.11) or after 1 year (p = 0.43).

CONCLUSIONS: Eradication of Helicobacter pylori infection and prokinetic treatment lead to significant improvement of the quality of life in functional dyspepsia. The disease-specific questionnaire was sensitive enough to capture the changes over time induced by the given therapies.