Joseph E Cassara1, Nicholas J Shaheen. 1. Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, University of North Carolina Schools of Medicine and Public Health, Chapel Hill, North Carolina, USA. nshaheen@med.unc.edu
Abstract
PURPOSE OF REVIEW: Endoscopic antireflux procedures have generated much interest among clinicians and patients. These devices utilize a variety of methods in an attempt to decrease reflux of gastric contents. This work reviews the most notable results of endoscopic antireflux procedure studies published in 2005. RECENT FINDINGS: A variety of studies of different technologies have been published this year. Only a few of these studies report data beyond 12 months to establish longer term efficacy. One sham controlled multicenter trial was published this year. After case reports of complications related to Enteryx (Boston Scientific Corp, Natick, Massachusetts, USA) use, this US Food and Drug Administration-approved device was voluntarily removed from the market. SUMMARY: A review of the literature demonstrates a paucity of long-term studies, as well as a lack of data comparing the devices to active medical therapy. The majority of studies are open-label trials with subjective endpoints, and such study designs are very susceptible to placebo effect. No one technology has demonstrated superiority to another. Additional studies with vigorous attention to methodology, safety evaluation, cost analysis and clinically meaningful endpoints will be required.
PURPOSE OF REVIEW: Endoscopic antireflux procedures have generated much interest among clinicians and patients. These devices utilize a variety of methods in an attempt to decrease reflux of gastric contents. This work reviews the most notable results of endoscopic antireflux procedure studies published in 2005. RECENT FINDINGS: A variety of studies of different technologies have been published this year. Only a few of these studies report data beyond 12 months to establish longer term efficacy. One sham controlled multicenter trial was published this year. After case reports of complications related to Enteryx (Boston Scientific Corp, Natick, Massachusetts, USA) use, this US Food and Drug Administration-approved device was voluntarily removed from the market. SUMMARY: A review of the literature demonstrates a paucity of long-term studies, as well as a lack of data comparing the devices to active medical therapy. The majority of studies are open-label trials with subjective endpoints, and such study designs are very susceptible to placebo effect. No one technology has demonstrated superiority to another. Additional studies with vigorous attention to methodology, safety evaluation, cost analysis and clinically meaningful endpoints will be required.