Nonresorbable copolymer implantation for gastroesophageal reflux disease: a randomized sham-controlled multicenter trial.
OBJECTIVE
This aim was to determine whether endoscopic implantation of a biocompatible nonresorbable copolymer (Enteryx; Boston Scientific Corp, Natick, MA) is a more effective therapy for gastroesophageal reflux disease (GERD) than a sham procedure.


METHODS
In a randomized, single-blind, prospective, multicenter clinical trial, 64 patients with GERD were enrolled whose symptoms were well controlled by proton pump inhibitor (PPI) therapy and rapidly recurred after cessation of PPI therapy. Thirty-two patients were assigned to Enteryx implantation and 32 to a sham procedure consisting of standard upper endoscopy. Patients in both groups with unsatisfactory symptom relief after 3 months were eligible for re-treatment by Enteryx implantation. The primary study end point was > or =50% reduction in PPI use. Secondary end points included > or =50% improvement in GERD score and the proportion of patients not undergoing re-treatment procedure. Follow-up evaluations were performed at 3 and 6 months.


RESULTS
The percentage of Enteryx-treated patients achieving a > or =50% reduction in PPI use (81%) was greater than that of the sham group (53%), with a rate ratio of 1.52 (confidence interval [CI], 1.06-2.28; P=.023). A higher proportion of the Enteryx (68%) than sham group (41%) ceased PPI use completely (rate ratio, 1.67; CI, 1.03-2.80; P=.033). GERD health-related quality of life heartburn score improvement > or =50% was achieved by 67% of the Enteryx group versus 22% of the sham group (rate ratio, 3.05; CI, 1.55-6.33; P <.001). More Enteryx-treated (81%) than sham-treated (19%) patients did not undergo re-treatment (rate ratio, 4.33; CI, 2.23-9.29; P <.001).


CONCLUSIONS
Enteryx implantation more effectively reduces PPI dependency and alleviates GERD symptoms than a sham procedure.
Devière
Jacques
J
Service de Gastro-Entérologie et d'Hépato-Pancréatologie, Université Libre de Bruxelles, Hôpital Erasme, Brussels, Belgium. jdeviere@ulb.ac.be
Costamagna
Guido
G
Neuhaus
Horst
H
Voderholzer
Winfried
W
Louis
Hubert
H
Tringali
Andrea
A
Marchese
Michele
M
Fiedler
Thomas
T
Darb-Esfahani
Patrick
P
Schumacher
Brigitte
B
D000328:Adult; D002299:Cardia; D016145:Endoscopy, Digestive System; D004947:Esophagus; D005260:Female; D005764:Gastroesophageal Reflux / Q000378:metabolism / Q000628:therapy*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007267:Injections; D008297:Male; D008875:Middle Aged; D011145:Polyvinyls / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011379:Prognosis; D011446:Prospective Studies; D019736:Prostheses and Implants / Q000009:adverse effects; D019233:Retreatment; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
D011145:Polyvinyls; C020320:ethylene-vinyl alcohol copolymer