Acid Reflux

Reports outline acid reflux disease therapy research from Heidelberg University

Acid Reflux Library Library Home This article was published in Biotech Business Week, which you can subscribe to online.

"To date, studies using this device have involved the placement of a single suture to create the plication. The purpose of this study was to evaluate the 12-month safety and efficacy of this procedure using multiple implants to restructure the gastroesophageal (GE) junction. A multicenter, prospective, open-label trial was conducted at four tertiary centers. Eligibility criteria included symptomatic GERD [GERD Health-Related Quality-of-Life (GERD-HRQL) questionnaire, off of medication], and pathologic reflux (abnormal 24-h pH) requiring daily proton pump inhibitor therapy. Patients with Barrett's epithelium, esophageal dysmotility, hiatal hernia >3 cm, and esophagitis (grade III or greater) were excluded. All patients underwent endoscopic full-thickness plication with linear placement of at least two transmural pledgeted sutures in the anterior gastric cardia. Forty-one patients were treated. Twelve months post treatment, 74% of patients demonstrated improvement in GERD-HRQL scores by >or=50%, with mean decrease of 17.6 points compared with baseline (7.8 vs. 25.4, p<0.001). Using an intention-to-treat model, 63% of patients had symptomatic improvements of >or=50%, with mean GERD-HRQL decrease of 15.0 (11.0 vs. 26.0, p<0.001). The need for daily proton pump inhibitor (PPI) therapy was eliminated in 69% of patients at 12 months on a per-protocol basis, and 59% on an intention-to-treat basis. Adverse events included postprocedure abdominal pain (44%), shoulder pain (24%), and chest pain (17%). No long-term adverse events occurred," wrote Renteln D. von and colleagues, Heidelberg University.

The researchers concluded: "Endoscopic full-thickness plication using multiple Plicator implants can be used safely and effectively to improve GERD symptoms and reduce medication use."

von and colleagues published their study in Surgical Endoscopy (Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease using multiple Plicator implants: 12-month multicenter study results. Surgical Endoscopy, 2009;23(8):1866-75).

For additional information, contact D. von Renteln, Teaching Hospital of the Heidelberg University, Dept. of Gastroenterology, Hepatology and Oncology, Klinikum Ludwigsburg, Ludwigsburg, Germany.

Publisher contact information for the journal Surgical Endoscopy is: Springer, 233 Spring Street, New York, NY 10013, USA.

Keywords: Germany, Ludwigsburg, Acid Reflux Disease Therapy, Acid Reflux, Clinical Trial Research, ETHICON GmbH, Endoscopy, Esophagitis, Gastroenterology, Gastroesophageal Reflux Disease, Hiatal Hernia, Medical Device, Pharmaceutical Business, Pharmaceutical Company, Quality of Life, Surgery, Surgical Endoscopy, Therapy, Treatment.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2009, Biotech Business Week via NewsRx.com.