Reply

Abstract

As a busy clinician who sees almost exclusively patients with esophageal disease, I share Dr. Radwin’s desire to offer our patients with GERD more and better treatment options. Several points in his letter deserve further consideration. The comparison that Dr. Radwin makes of efficacy and complication rates between Enteryx and surgical fundoplication is inappropriate. Enteryx is indicated for and has been tested in PPI-responsive patients only. Its performance in those with hiatal hernias of greater than 3 cm is not known. Clearly, many of the patients we send to surgery do not fit these criteria. Comparing outcomes data from surgical anti-reflux trials to Enteryx data is comparing apples to oranges. A randomized study comparing the 2 modalities would be a welcome addition to the literature. Because Enteryx to date has only been compared with no therapy, it is difficult to know where to put it in our current algorithms of care. I agree with Dr. Radwin that lumping all of the endoscopic anti-reflux devices into one category is not advisable. It is probable that these devices will have different efficacy and side-effect profiles. In including discussion of the Stretta device, the main point was that in both the Enteryx and the Stretta “sham” trials, it is likely that a good proportion of subjects were unblinded as to their group assignments, due to side effects of the therapy. Unblinding is a possible explanation for why subjective measurements of GERD improved in each study while objective measures did not. Dr. Radwin notes “many tremendous successes” and “infrequent failures” using Enteryx. Given the paucity of literature available on the use of the device, his report of these many cases in a medical journal would be welcome by all of those treating GERD patients. Since almost all existing reports feature less than 100 patients with follow-up of a year or less, Dr. Radwin’s claim of “sufficient peer-reviewed data” is not substantiated by the literature. Dr. Radwin asks, “Has academia with its strict evidence-based process become too onerous to be useful to frontline, practicing gastroenterologists looking for guidance?” Evidence-based medicine is not the province of academics, but rather is the duty of everyone who takes care of patients. In fact, early adopters of a technique such as Enteryx should be the ones clamoring most loudly for rigorous studies of it. After all, these practitioners have staked their patients’ health based on short-term follow-up data. If long-term data show unforeseen complications (a situation hardly novel in the medical literature), their patients will pay the price. With respect to academicians’ attempts to incarcerate clinicians by “ball and chainin the dungeon of the ivory tower” of academia: due to rising property values in Chapel Hill, our ivory tower has gone condo, and our dungeon has been remodeled into garden apartments. Therefore, we are no longer able to keep practitioners captive there. I must admit, however, that I have been called worse than an “intractable custodian of the evidence-based ivory tower.” “Sham” on the Academic Ivory TowerGastroenterologyVol. 129Issue 2PreviewJacques Deviere et al1 recently published 6-month data on the first randomized, single blinded, controlled “sham” trial of Enteryx anti-reflux endoscopic therapy in Gastroenterology (March 2005). Despite some significant inherent methodological complexities, the study is an extraordinary attempt at achieving a controlled experience in a highly selected group of patients with PPI-dependent GERD. The preliminary results, which include an optional crossover for the sham group after 3 months, significantly favor the therapeutic arms utilizing the polymeric implants. Full-Text PDF