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Prospective randomised trial comparing the efficacy of on-demand therapy with step-down therapy in patients with GERD

Dorota A. Cibor 1Małgorzata Szczepanek Irena Ciećko-Michalska Danuta Owczarek 

1. Uniwersytet Jagielloński, Collegium Medicum, Katedra i Klinika Gastroenterologii, Śniadeckich 10, Kraków 31-531, Poland

Abstract

Introduction: Treatment of not severe gastro-oesophageal reflux disease should be directed towards rapid relief of symptoms and then maintenance of relief using minimum yet effective therapy.

The study was aimed to evaluate the efficacy and cost-effectiveness of on-demand therapy with Omeprazole 20mg in comparison to step-down therapy in patients with GERD.

60 consecutive patients with diagnosed reflux disease were included in the study. Patients with oesophagitis grade C/D according to Los Angeles scale were excluded. All the patients were treated with Omeprazole 20mg for four weeks and then randomized to two groups: 1. taking Omeprazole 20mg on-demand, 2. taking Omeprazole 10mg for 3 months and then Ranitidine 75mg twice a day for 2 months. The intensity of symptoms using Visual Analogue Scale was assessed at the baseline, after 1, 2, 4 and 6 months of therapy.

At the baseline mean intensity of symptoms was 3.3 +/- 1.73. After one month of therapy it decreased to 0.71 +/- 1.0. In the group treated on-demand after 2 months mean intensity of symptoms was 1.47 +/- 1.2, after 4 months 1.88 +/- 1.03 and after 6 months 1.8 +/- 1.09. In the group on step-down therapy after 2 months mean intensity of symptoms was 1.15 +/- 1.09, after 4 months 1.85 +/- 0.87 and after 6 months 2.6 +/- 1.22. The significant difference was observed only in the 6th month (p = 0.0049). Patients in the first group took on average 20mg Omeprazole on every third day. The cost of on-demand therapy was 32 % lower than the cost of step-down therapy.

In 6-month follow-up on-demand therapy shows at the beginning similar efficacy as the step-down therapy, then it becomes more effective. It is also more cost-effective.


 

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Related papers

Presentation: oral+poster at XI Kongres PTG-E, Sesja plenarna 2., by Dorota A. Cibor
See On-line Journal of XI Kongres PTG-E

Submitted: 2004-03-29 03:03
Revised:   2009-06-08 12:55