Dr Richard Rothstein and colleagues from New Hampshire determined the effectiveness of endoscopic full-thickness plication for gastroesophageal reflux disease (GERD).
Patients with symptomatic GERD requiring proton pump inhibitor (PPI) therapy were entered into a randomized, single-blind, prospective, multicenter trial.
The research team randomly assigned 78 patients to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture.
There were 81 patients who underwent a sham procedure.
|Improvements occurred in 56% of the active group|
Group assignments were revealed following the 3-month evaluation.
The primary end point was 50% improvement or more in GERD health-related quality of life score.
The team's secondary end points included medication use and esophageal acid exposure.
By intention-to-treat analysis, at 3 months, a 50% improvement or more in GERD health related quality of life score occurred in 56% of the active group.
The researchers found that 19% of the sham group had a 50% improvement or more in the GERD health related quality of life score.
Complete cessation of PPI therapy was higher among patients in the active group than in the sham group by intention-to-treat analysis.
The team observed that the percent reduction in median percent time pH of less than 4 was significantly improved within the active group versus baseline.
The researchers did not find this improvement in the sham group.
Between-group analysis revealed the active therapy to be superior to the sham in improving median percent time pH less than 4.
There were no perforations or deaths.
Dr Rothsetein's team concludes, “Endoscopic full-thickness plication more effectively reduces GERD symptoms, PPI use, and esophageal acid exposure than a sham procedure.”