Abstract & Commentary
Synopsis: Despite the absence of meaningful clinical trials, the FDA has approved the StrettaTM endoscopic radiofrequency application technique for treatment of gastroesophageal reflux disease (GERD) as of the year 2000. This study demonstrated that this procedure did lead to lessened GERD-related symptoms but not to any decrease in esophageal acid exposure or medication use.
Source: Corley DA, et al. Gastroenterology. 2003;125:668-676.
For obscure reasons, medical device approvals are far less rigorous than FDA approvals for drugs. As a result, the Stretta procedure (radiofrequency applied to the region of the LES) was approved primarily on the basis of relative apparent safety along with the suggestion that results might be more or less equivalent to historical data from fundoplication. There was (and is) no requirement for direct comparison to a placebo or to any active treatment (such as a proton pump inhibitor). The Stretta procedure involves placement of a balloon across the cardioesophageal junction and "cooking" the submucosa with needles affixed to an inflated balloon. Unlike the study that led to approval of the device itself, the present study did compare the radiofrequency technique to endoscopy without intervention (a sham procedure). Step-up therapy was re-instituted after medication withdrawal 21 days postprocedure. Data were available for 56 of 64 patients. Baseline data were similar between the treatment and the control groups. Although symptoms and quality of life were improved after active intervention, there were no statistical differences in PPI use, acid exposure, LES pressure, or the presence of endoscopic esophageal erosions. Complications of the procedure included chest pain, nausea and vomiting, and an episode of bleeding from esophageal ulceration. Oddly enough, a significant number of patients were able to withdraw medications after the sham procedure.
Comment by Malcolm Robinson, MD, FACP, FACG
Although Corley and colleagues put a favorable "spin" on the data, most observers would find this study less than compelling. Several experts have suggested that the Stretta procedure may actually "work" by altering visceral sensation rather than by any other effect on GERD or its acid-related pathophysiology. From the perspective of this reviewer, this procedure is not suitable for wide application. In the long run, it seems likely to be relegated to the same "dustbin" as the Angelchick prosthesis for GERD or gastric freezing for ulcer disease. Device regulation should be strengthened to mirror the rigor of the FDA approval process for drugs. As of now, radiofrequency treatment in GERD still needs to be assessed in comparison to one or more of the fine options that exist for medical and surgical management of GERD.
Dr. Robinson, Medical Director, Oklahoma Foundation for Digestive Research; Clinical Professor of Medicine, University of Oklahoma College of Medicine, Oklahoma City, OK, is Associate Editor of Internal Medicine Alert.