Randomised clinical trial: a comparison between a GerdQ-based algorithm and an endoscopy-based approach for the diagnosis and initial treatment of GERD

Abstract

Background: The diagnosis of gastro-oesophageal reflux disease (GERD) remains challenging. An algorithm, facilitated by a questionnaire, may provide a more structured and cost-effective care of patients.

Aim: To compare symptom control achieved with empirical therapy for GERD, in an algorithm based on the GerdQ (new structured pathway, NSP), with that of current care after endoscopy (ordinary clinical pathway, OCP).

Methods: Patients with symptoms of GERD, but without alarm features, were randomised in an open, parallel-group study and followed for 4-8 weeks. In the NSP, GerdQ score was used as a basis for both diagnosis and a treatment algorithm. Patients with high likelihood of GERD were treated empirically with a PPI whereas patients with low likelihood of GERD received therapy chosen by the clinician. In the OCP, diagnosis and treatment were based on endoscopy or pH-metry findings. The statistical hypothesis was non-inferiority of NSP to OCP.

Results: A total of 147 patients (86.5%) in the NSP and 133 patients (80.1%) in the OCP arm were responders. Overall, NSP was non-inferior to OCP, but not superior (P = 0.14). Patients with high likelihood of GERD had significantly better symptom relief in the NSP (P = 0.03), whereas those with low likelihood of GERD showed a numerical difference in favour of an endoscopy-based approach (OCP). NSP saved 146 € per patient.

Conclusions: A symptom-based approach using GerdQ reduced health care costs without loss in efficacy. Patients with high likelihood GERD benefited from empirical treatment. An algorithm based on GerdQ may provide physicians with a tool for a more structured care of patients (ClinicalTrials.gov NCT00842387).

© 2012 Blackwell Publishing Ltd.