Clinical trial data on endoscopic treatments for gastroesophageal reflux disease, or GERD, is not up to par with the available research on pharmaceutical or surgical options, according to the Agency for Healthcare Research & Quality.

"Published experience with all of the approved endoscopic procedures has been outpaced by clinical experience," states AHRQ's first comparative effectiveness review, released Dec. 14. "Although these devices are already commercially available, their long-term efficacy and safety have not yet been established."

Endoscopic GERD treatments on the U.S. market include Curon's Stretta radiofrequency device, Bard's EndoCinch suturing system and NDO Surgical's NDOplicator . The AHRQ report also evaluates data for Boston Scientific's Enteryx biopolymer injection system, which was removed from the market in September in a Class I recall action (¹ 'The Gray Sheet' Oct. 3, 2005, In Brief).

The report is the first published under AHRQ's Effective Healthcare Program, funded under Sec. 1013 of the Medicare Modernization Act. The reports are meant to "take a new step by asking not merely which treatments can be effective, but how treatments compare with one another," said AHRQ Director Carolyn Clancy, MD. Breast cancer screening technologies are among the topics currently under review.

The GERD management analysis finds that proton pump inhibitor (PPI) drugs are as effective as surgery for treating GERD. However, AHRQ found no trials comparing endoscopic therapies to PPIs. AHRQ encourages further investigation in this area.

Three non-randomized studies comparing endoscopic procedures with surgery suggested greater patient satisfaction with surgery, but the longest follow-up was only eight months. The report notes that "all three studies had significant bias that may invalidate the results."

AHRQ identified only two randomized, sham-controlled studies on endoscopic procedures, which suffered from "small size and short duration," according to the report.

The 22 endoscopic studies that the agency considered in the review generally showed the treatments to effect some symptom improvements and a reduction in the need for PPIs; however, the long-term benefits remain unclear, the authors note.

The review observes that Boston Scientific reported 26 adverse events for Enteryx, including five deaths, between 2002 and 2005, and Curon reported 26 adverse events for Stretta, including three deaths, from 2000 to 2005.

AHRQ's concerns about lack of data on endoscopic procedures mirror conclusions from a February 2004 BlueCross BlueShield Technology Evaluation Center's assessment of the treatments (² Also see "GERD Treatments Need Further Study, BlueCross BlueShield Assessment Finds" - Medtech Insight, 29 March, 2004., p. 22).

AHRQ will initiate a new process next year for creating additional comparative effectiveness studies that are broader in scope. The agency will hold a public listening session on Jan. 11 and keep a docket open to solicit suggestions for areas of research that affect all populations covered by CMS.

Inaugural AHRQ Comparative Review Questions GERD Device Therapy Data

More from Archive

More from Medtech Insight