Endoscopic gastroplication for the treatment of gastro-oesophageal reflux disease: a randomised, sham-controlled trial.
BACKGROUND
Endoscopic treatment for gastro-oesophageal reflux disease (GORD) is rapidly emerging, but there is a great need for randomised controlled trials to evaluate the efficacy.


METHODS
A single-centre, double-blind, randomised, sham-controlled trial of endoscopic gastroplication by the Endocinch suturing system.


METHODS
60 patients with GORD were randomly assigned to three endoscopic gastroplications (n = 20), a sham procedure (n = 20) or observation (n = 20). The research nurse and patients in the active and sham groups were blinded to the procedure assignment. After 3 months, open-label active treatment was offered to all patients.


METHODS
The primary outcome measures were proton pump inhibitor (PPI) use and GORD symptoms, and secondary measures were quality of life, 24-h oesophageal acid exposure, oesophageal manometry and adverse events. Follow-up assessments were performed at 3, 6 and 12 months.


RESULTS
At 3 months, the percentage of patients who had reduced drug use by > or =50% was greater in the active treatment group (65%) than in the sham (25%) or observation groups (0%) (p<0.02). Symptoms (heartburn and to a lesser extent regurgitation) improved more in the active group than in the sham group. Three Short Form-20 quality of life subscales (role function, general health and bodily pain perception) improved in the active group versus sham. Oesophageal acid exposure was modestly decreased after active treatment (p<0.02), but not significantly greater than after the sham procedure (p = 0.61). The active treatment effects on PPI use, symptoms and quality of life persisted after 6 and 12 months of open-label follow-up (n = 41), but 29% of patients were retreated in this period. No serious adverse events occurred.


CONCLUSIONS
Endoscopic gastroplication, using the Endocinch device, reduced acid-inhibitory drug use, improved GORD symptoms and improved the quality of life at 3 months compared with a sham procedure. The effects persisted up to 12 months. However, the reduction in oesophageal acid exposure was not greater after endoscopic treatment than after a sham procedure.
Schwartz
M P
MP
Department of Gastroenterology, University Medical Centre, PO Box 85500, 3508 GA Utrecht, The Netherlands. m.p.schwartz@umcutrecht.nl
Wellink
H
H
Gooszen
H G
HG
Conchillo
J M
JM
Samsom
M
M
Smout
A J P M
AJ
D000863:Antacids / Q000627:therapeutic use; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004947:Esophagus / Q000378:metabolism; D005260:Female; D005745:Gastric Acidity Determination; D005764:Gastroesophageal Reflux / Q000188:drug therapy / Q000601:surgery*; D005773:Gastroscopy / Q000379:methods*; D006356:Heartburn / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors; D011788:Quality of Life; D013270:Stomach / Q000601:surgery*; D016896:Treatment Outcome
D000863:Antacids; D054328:Proton Pump Inhibitors