Clinical-alimentary tractImprovement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial☆
Section snippets
Methods
We conducted a randomized, double-blinded, sham-controlled trial of radiofrequency energy to the gastroesophageal junction for the treatment of GERD. Reporting methods comply with the CONSORT (consolidated standards of reporting trials) statement.17
Results:
A total of 64 patients were randomized (35 to active treatment and 29 to sham) between May 2000 and February 2001 (Figure 1). All patients received conscious sedation, and the median active treatment procedure time (from starting the initial endoscopy to catheter removal) was 51 minutes. Not all sites fully enrolled their block assignments; random variation created a slight imbalance in the proportion of subjects allotted to active vs. sham treatments. Partial or complete 6-month data were
Discussion
This study found that radiofrequency energy to the gastroesophageal junction significantly and substantially reduced GERD symptoms, improved GERD HRQL, and improved general quality of life at 6 months compared with a sham procedure. The mean posttreatment heartburn symptom scores and quality of life measures in the active treatment group were comparable to their pretreatment values while taking medications. The symptom improvement compared with a sham procedure was comparable to or greater than
References (41)
- et al.
The impact of gastroesophageal reflux disease on health-related quality of life
Am J Med
(1998) - et al.
The burden of selected digestive diseases in the United States
Gastroenterology
(2002) - et al.
Esopmeprazole (40mg) compared with lansoprazole (30mg) 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.
The Stretta procedure for the treatment of GERD6 and 12 month follow-up of the U.S. open label trial
Gastrointest Endosc
(2002) - et al.
Transoral, flexible endoscopic suturing for treatment of GERDa multicenter trial
Gastrointest Endosc
(2001) - et al.
Endoscopic implantation of Plexiglas (PMMA) microspheres for the treatment of GERD
Gastrointest Endosc
(2001) - et al.
Endoscopic implantation of a biopolymer in the lower esophageal sphincter for gastroesophageal refluxa pilot study
Gastrointest Endosc
(2002) - et al.
Healing and relapse of severe peptic esophagitis after treatment with omeprazole
Gastroenterology
(1988) - et al.
Management of heartburn in a large, randomized, community-based studycomparison of four therapeutic strategies
Am J Gastroenterol
(2001)
Step-down management of gastroesophageal reflux disease
Gastroenterology
Development for and results of the use of a gastroesophageal reflux disease activity index as an outcome variable in a clinical trial. VA Cooperative Study Group on Gastroesophageal Reflux Disease (GERD)
Control Clin Trials
Augmentation of lower esophageal sphincter pressure and gastric yield pressure after radiofrequency energy delivery to the gastroesophageal junctiona porcine model
Gastrointest Endosc
Transient lower esophageal sphincter relaxations are no more frequent in patients with gastroesophageal reflux disease than in asymptomatic volunteers
Am J Gastroenterol
Risk factors associated with symptoms of gastroesophageal reflux
Am J Med
Association of obesity with hiatal hernia and esophagitis
Am J Gastroenterol
Hiatal hernia size is the dominant determinant of esophagitis presence and severity in gastroesophageal reflux disease
Am J Gastroenterol
Excess gastroesophageal reflux in patients with hiatus hernia is caused by mechanisms other than transient LES relaxations
Gastroenterology
Symptomatic gastroesophageal refluxincidence and precipitating factors
Am J Dig Dis
Upper gastrointestinal symptoms in North Americaprevalence and relationship to healthcare utilization and quality of life
Dig Dis Sci
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Supported by Curon Medical, Sunnyvale, California. None of the authors act as paid consultants for, are employees of, or hold any equity interest in Curon Medical.