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Introduction: Several endolumenal approaches to the management of gastroesophageal reflux disease (GERD) have been developed as an intermediate therapy between conservative medical management and the more invasive surgical fundoplication. One such intervention, the Stretta Procedure (Mederi Therapeutics Inc, Greenwich, CT), utilizes application of radiofrequency energy to the lower esophageal sphincter to control gastroesophageal reflux. Multiple studies have debated its short and long-term effectiveness. The objective of this study is to review the published data and perform an in-depth statistical analysis of the efficacy of this procedure in the management of GERD.Methods: A systematic search of the literature, published to date in English and indexed in MEDLINE and PubMed, was carried out in November 2010 with device and condition specific keywords. Studies were selected on the basis of availability of data on at least two of the following parameters: esophageal manometry, pH study, quality of life indices and medication usage. Exclusion criteria included studies involving children or those with a follow-up less than 3 months. Data were presented as weighted mean values based on the number of patients in each included study so that the analysis represented the mean change in each outcome variable over all patients studied. The meta-analysis consisted of weighted t-tests on the difference between mean pre-Stretta and post-Stretta values of various outcome variables. Analysis was restricted to the reported mean values of outcomes for pre-operative and latest post-operative observations for single Stretta procedures and for results summarized across all patients.Results: 20 studies, containing 1441 patients, published between 2001 and 2010 met the inclusion criteria. The mean follow-up was 17.1 months (range 4 to 53 months). Outcome data are outlined in the table below. GERD health related quality of life (HQRL), quality of life reflux and dyspepsia (QOLRAD), heartburn, and patient satisfaction scores were all significantly improved following the Stretta procedure. Esophageal acid exposure and DeMeester score were both significantly reduced following Stretta treatment. Lower esophageal sphincter pressure showed a trend toward increased post-treatment pressures, but failed to reach statistical significance in this analysis.Conclusion: Radiofrequency ablation of the lower esophageal sphincter produces significant improvement in both subjective and objective reflux indices. These findings suggest that the Stretta procedure provides significant symptomatic relief for many patients and represents an alternative to medical treatment and surgical fundoplication in select patients.
Comparison of the Pre-Stretta and Post-Stretta means of the outcome variables

Outcome Variable	Studies(n)	Patients (n)	Mean Follow-up (mo)	Pre-Stretta	Post-Stretta	P-value
GERD-HRQL score	9	433	19.8	26.11	9.25	0.0001
QOLRAD score	4	250	25.2	3.30	4.97	0.0010
Heartburn score	9	525	24.1	3.55	1.19	0.0001
Satisfaction score	5	366	21.9	1.43	4.07	0.0006
Esophageal Acid Exposure (% Ph<4)	11	364	11.9	10.29	6.51	0.0003
Demeester score	7	267	13.1	44.37	28.53	0.0074
LES pressure	7	263	8.7	16.54	20.24	0.0302