2008 - STRETTA CLINICAL Clinical trial: radiofrequency energy delivery in proton pump inhibitor-dependent gastro-oesophageal reflux disease patients
J. P. Galmiche, E. Coron, V. Sebille, G. Cadiot, F. Zerbib, P. Ducrotte, F. Ducrot, P. Pouderoux, J. Arts, M. Le Rhun, T. Piche, S. Bruley Des Varannes
Aliment Pharmacol Ther. 28, July 2008 1147-1158
BACKGROUND: Radiofrequency (RF) energy delivery is an endoscopic procedure developed for the treatment of gastro-oesophageal reflux disease.
AIM: To compare RF and a proton pump inhibitor strategy (PPI) in PPI-dependent patients by carrying out a prospective, randomized trial.
METHODS: Patients with PPI-dependent typical reflux symptoms were randomly allocated to either RF or PPI regimen alone. The primary endpoint, evaluated at 6-month, was defined as the possibility for the patient to stop or to decrease PPI use to < of the effective dose required at baseline.
RESULTS: In the RF group, 18⁄20 patients stopped (n = 3) or decreased (n = 15) PPI use as compared to eight of 16 in the PPI group (P = 0.01). None of the control patients could stop PPI. Health-related quality of life scores were not different between groups. No significant change in oesophageal acid exposure (OAE) was noted between baseline and 6-months after RF. No severe complication was reported.
CONCLUSIONS: Radiofrequency energy delivery is a safe and effective therapeutic option, allowing reduction in or discontinuation of PPI therapy in patients with PPI-dependent symptoms, without loss of quality of life. However, in a majority of patients, PPI therapy cannot be completely stopped. The efficacy of RF does not seem to be related to a decrease in OAE.