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

Abstract

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.