RANDOMISED CLINICAL TRIAL
Randomised clinical trial: a comparison between a GerdQ-based algorithm and an endoscopy-based approach for the diagnosis and initial treatment of GERD
Article first published online: 18 APR 2012
© 2012 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 35, Issue 11, pages 1290–1300, June 2012
How to Cite
Jonasson, C., Moum, B., Bang, C., Andersen, K. R. and Hatlebakk, J. G. (2012), Randomised clinical trial: a comparison between a GerdQ-based algorithm and an endoscopy-based approach for the diagnosis and initial treatment of GERD. Alimentary Pharmacology & Therapeutics, 35: 1290–1300. doi: 10.1111/j.1365-2036.2012.05092.x
- Issue published online: 1 MAY 2012
- Article first published online: 18 APR 2012
- Manuscript Revised: 22 MAR 2012
- Manuscript Accepted: 22 MAR 2012
- Manuscript Revised: 14 MAR 2012
- Manuscript Received: 2 MAR 2012
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.
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).
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.
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.
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).