[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.