2004 - STRETTA CLINICAL Changes in GERD symptom scores correlate with improvement in esophageal acid exposure after the Stretta procedure
Surg Endosc. 2004 Jul;18(7):1038-44
BACKGROUND: Endoscopic radiofrequency energy delivery (Stretta) is effective for managing gastroesophageal reflux disease (GERD) in selected patients. One criticism, however, is a theory that a mechanism of action is partial desensitization of the esophageal body rather than a reduction in esophageal acid exposure. To resolve this question, this study sought to determine if there is a correlation between the improvement in GERD outcomes and esophageal acid exposure after Stretta. METHODS: Subgroup analyses were performed between "responder" and "nonresponder" groups from the U.S. Stretta open label trial ( n = 118), on the basis of posttreatment responses for GERD health-related quality of life (HRQL) heartburn, satisfaction, and proton pump inhibitor use. Outcomes were analyzed within and between subgroups. Pearson correlation coefficient analysis was performed comparing distal esophageal acid exposure with each of the continuous outcomes (GERD-HRQL, heartburn, satisfaction). RESULTS: Responder subgroups had significant improvements in esophageal acid exposure, whereas nonresponders had no change or less improvement in the same. Changes in GERD-HRQL and heartburn severity were correlated with changes in acid exposure ( r = 0.16, p = 0.12 and r = 0.26, p = 0.01, respectively). Changes in satisfaction were negatively correlated with changes in esophageal acid exposure ( r = 0.23, p = 0.02) because satisfaction, as expected, increased as acid exposure decreased.
CONCLUSIONS: Responders had significant improvement in esophageal acid exposure, whereas nonresponders had less or no change. There was a positive correlation between esophageal acid exposure and both GERD-HRQL and heartburn. This evidence suggests that symptomatic improvement after Stretta is attributable to a decrease in esophageal acid exposure and not to desensitization of the esophagus.