Rapid communicationEndoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial
Section snippets
Protocol
A multicenter, randomized, patient-blinded, sham-controlled trial was conducted at 15 centers in the United States (13 centers) and Europe (2 centers). Enrolled patients were randomized to undergo either the Plicator procedure or a sham procedure; patients undergoing the sham procedure served as the control group. The study was designed to minimize bias in the comparison of treatment effects up to 3 months, along with long-term follow-up of results of unblinded treatment. Reporting methods
Results
A total of 159 patients were randomized to either the Plicator group (n = 78) or the sham group (n = 81) from February to June 2005. There were no statistically significant differences in baseline patient demographics or data between the active and sham groups (Table 1). At 3 months postintervention, complete questionnaire and medication use data were obtained for 131 patients (Figure 4). Of the 28 patients whose data were not included in the 3-month follow-up analysis, one had incomplete
Discussion
This is the largest randomized, sham-controlled clinical trial of endoscopic therapy for gastroesophageal reflux that has been reported to date. Our primary study end point was a reduction in GERD symptoms of at least 50% using the validated GERD-HRQL score at baseline and following the assigned intervention. The secondary end points included reduction in antisecretory medication use, reduction in distal esophageal acid contact time, and improvement in overall health status utilizing the
References (29)
- et al.
Prevalence and socioeconomic impact of upper gastrointestinal disorders in the United States: results of the US Upper Gastrointestinal Study
Clin Gastroenterol Hepatol
(2005) - et al.
Speed of healing and symptom relief in grade II to IV gastroesophageal reflux disease: a meta-analysis
Gastroenterology
(1997) - et al.
Healing and relapse of severe peptic esophagitis after treatment with omeprazole
Gastroenterology
(1988) - et al.
Long-term omeprazole treatment in resistant gastroesophageal reflux disease: efficacy, safety, and influence on gastric mucosa
Gastroenterology
(2000) - et al.
Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis
Am J Gastroenterol
(2002) - et al.
Five- to eight-year outcome of the first laparoscopic Nissen fundoplications
J Gastrointest Surg
(2001) - et al.
Endoscopic implantation of Enteryx for treatment of GERD: 12-month results of a prospective, multicenter trial
Am J Gastroenterol
(2003) - et al.
The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial
Gastrointest Endosc
(2002) - et al.
Long-term outcomes of endoluminal gastroplication: a U.S. multicenter trial
Gastrointest Endosc
(2005) - et al.
Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial
Gastrointest Endosc
(2001)