Background: The literature of endoluminal treatment of gastroesophageal reflux disease (GERD) widely varies in the level of evidence presented for analysis. Therefore there is a need for a comprehensive evidence-based medicine (EBM) analysis of the current literature evidence of the three FDA-approved modalities used for endoluminal treatment of GERD.
Search strategy: In January 2007, the MEDLINE database was searched for randomized controlled trials (RCTs), and controlled clinical trials of currently available endoluminal treatment of GERD. Database searches combined the specific endoluminal device keywords with the condition-specific keyword (e.g., GERD).
Data collection and analysis: All relevant studies have been categorized according to the evidence they provide according to the guidelines for Levels of Evidence and Grades of Recommendation supplied by the Oxford Centre for Evidence-Based Medicine. MAIN RESULTS AND AUTHORS' CONCLUSION: Sixteen studies met the inclusion criteria, representing 787 patients. The methodological quality of most of the included studies was average; four studies were grade 1b (individual randomized trial), 10 were grade 2b (individual cohort study), and two were grade 3b (individual case-control study) There is grade 1b and 2b evidence demonstrating the EndoCinch plication is effective in reducing GERD symptoms at short-term follow up. However, in the majority of the studies analyzed, the procedure does not significantly reduce the acid exposure in the distal esophagus. The majority of the studies with long-term outcome showed disappointing outcomes, probably due to suture loss in the majority of patients. There is grade 1b and 2b evidence demonstrating that the Stretta procedure is effective in reducing GERD symptoms at short- and mid-term follow up. However, in the majority of the studies analyzed, the procedure did not reduce significantly the acid exposure in the distal esophagus. There is grade 1b and 2b evidence demonstrating that full-thickness plication is effective in reducing GERD symptoms, and acid exposure in the distal esophagus.