Comparison of the “step down” and the “step up” approach in the treatment of patients with symptomatic gastro-esophageal reflux disease (GERD): Results of a randomized open-label pilot study with omeprazole in Northwest Greece (EN)

K. Mpatsis,S. Sidiropoulos, N. Georgandas,E.V. Tsianos, Andromachi H. Katsanou, G. Baltayannis,

Alexandra Christodoulopoulou, A. Karokis,N. Tzambouras, Aggeliki Karagiorgou,, K.H. Katsanos, Chrysoula Tasolambrou,

SUMMARY INTRODUCTION: Gastro-esophageal reflux disease (GERD) is a potentially serious condition that affects 20- 40% of the adult population at least once a month. Effective management of the disease remains a challenge. The literature is split between two therapeutic approaches, the “step up” and the “step down” approach. A prospective open-label clinical trial was conducted in the area of Northwest Greece to compare the clinical effectiveness, in terms of relief of symptoms, and the level of improvement in the quality of life of patients between the two approaches. METHODS: Patients who fulfilled the inclusion and exclusion criteria and underwent an upper gastrointestinal tract endoscopy were randomly assigned into the “step down” or “step up” therapeutic approach. Patients’ GERD diagnoses with heartburn being the predominant symptom was assisted by the use of the Carlsson questionnaire. Demographic and quality-of-life data were also assessed. A second visit was carried out 4 weeks later and the patients’ GERD symptoms were evaluated. Clinical effectiveness was assessed as the percentage of patients presenting relief of symptoms at 4 weeks (acute phase treatment) and after 7 months (acute and maintenance period). Quality-of-life assessments were made with the use of the Gastrointestinal Symptom Rating Scale (GSRS). This is a preliminary analysis of the comparison of the clinical effectiveness of the “step down” and “step up” therapeutic approaches. RESULTS: Ninety-two patients were enrolled in the study, eighty of whom were finally eligible for analysis. Thirtyseven patients were included in the “step down” and fortythree in the “step up” approach. No statistically significant differences in the presence of GERD symptoms, demographic data and the scores of the Carlsson and GSRS questionnaires were detected between the two groups at the initial visit. After 4 weeks of treatment, there was a statistically significant difference between the two groups in the percentage of patients presenting relief of symptoms (71% in “step down” vs. 47% in “step up”). Furthermore, there was a considerable reduction in the number of days with GERD symptoms in both groups, which was more evident in the “step down” therapeutic approach. (EN)

info:eu-repo/semantics/article

info:eu-repo/semantics/publishedVersion

Ελληνική Γαστροεντερολογική Εταιρία

Annals of Gastroenterology

Αγγλική γλώσσα

2007-03-19

http://www.annalsgastro.gr/index.php/annalsgastro/article/view/204

Hellenic Society of Gastroenterology (EN)

1792-7463

1108-7471

Annals of Gastroenterology; Volume 16, No 2 (2003) (EN)