Clinical trial: Radiofrequency energy delivery in proton pump inhibitor-dependent gastro-oesophageal reflux disease patients.
BACKGROUND
Radiofrequency (RF) energy delivery is an endoscopic procedure developed for the treatment of gastro-oesophageal reflux disease.


OBJECTIVE
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 <50% 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.
Coron
E
E
Institut des Maladies de l'Appareil Digestif, CHU Hôtel-Dieu, Nantes.
Sebille
V
V
Cadiot
G
G
Zerbib
F
F
Ducrotte
P
P
Ducrot
F
F
Pouderoux
P
P
Arts
J
J
Le Rhun
M
M
Piche
T
T
Bruley des Varannes
S
S
Galmiche
J P
JP
D000328:Adult; D017115:Catheter Ablation / Q000379:methods*; D016099:Endoscopy, Gastrointestinal / Q000379:methods; D050782:Esophageal pH Monitoring; D005260:Female; D005764:Gastroesophageal Reflux / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D011788:Quality of Life; D012720:Severity of Illness Index; D013223:Statistics as Topic
D054328:Proton Pump Inhibitors