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AHRQ Releases First Comparative Effectiveness Review; Certain Drugs Found as Effective as Surgery for Management of GERD

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Press Release Date: December 14, 2005

Drugs can be as effective as surgery for management of gastroesophageal reflux disease (GERD), according to a report released today by the Agency for Healthcare Research and Quality (AHRQ). The report is the first Comparative Effectiveness Review from a new AHRQ program that compares alternative treatments for health conditions.

GERD, one of the most common health conditions among older Americans, results in $10 billion annually in direct health care costs. It occurs when stomach acid enters the esophagus, causing heartburn and potential damage to the esophagus. The study released today compares treatment approaches for chronic uncomplicated GERD, where the condition is likely to require life-long management but does not involve more serious disease of the esophagus.

The report finds that for the majority of patients with uncomplicated GERD, a class of drugs called proton pump inhibitors (PPIs) can be as effective as surgery in relieving the symptoms and improving quality of life. At the same time, although the surgery is sometimes chosen with the goal of removing the need to take medications, the evidence is unclear as to whether a significant number of surgical patients eventually become freed of the use of medications. In the studies reviewed for today's report, 10 percent to 65 percent of patients resumed the use of medications.

"As the first Comparative Effectiveness Review, this report opens a new and promising chapter for helping patients choose the best evidence-based treatment for their own situation," said AHRQ Director Carolyn M. Clancy, M.D. "Today's report will help patients and health care providers make more informed choices when they consider how to manage the symptoms of chronic GERD, and especially when they consider surgery."

The report, Comparative Effectiveness of Management Strategies for Gastroesophageal Reflux Disease, is the first to be released by AHRQ's new Effective Health Care Program. The program was created to help patients and health care providers in selecting among treatments, by reviewing existing studies and comparing the outcomes of different treatments. Nine more comparative effectiveness reviews are currently underway to examine alternative treatments for significant health conditions.

"These reports take a new step by asking not merely which treatments can be effective, but how treatments compare with one another," Dr. Clancy said. "They will provide a useful, balanced source for obtaining the best scientific information to help select the right treatment for the patient."

Today's report reviews treatment alternatives for chronic GERD, including over-the-counter medications; PPI drugs; fundoplication surgery (wrapping the top part of the stomach around the bottom of the esophagus); and endoscopic procedures.

The report notes that its findings apply to patients who have undergone diagnostic testing, and thus there is a high degree of certainty that symptoms are due to GERD. For correctly diagnosed GERD, findings include:

  • For chronic GERD, over-the-counter H2 receptor antagonist medications are not as effective as PPIs, although PPIs have more side effects (headache, diarrhea, abdominal pain). Examples of H2 receptor antagonists include Axid®, Pepcid®, Tagamet®, and Zantac®.
  • PPIs appear to have similar clinical effectiveness when compared to one another for treating GERD. Some statistically significant differences have been reported, but these differences are modest and the clinical implications are unclear. Examples of PPIs include AcipHex®, Nexium®, Prevacid®, Prilosec OTC, and Protonix®. Generic omeprazole is also available.
  • PPIs and fundoplication surgery appear to be similarly effective in relieving symptoms and improving quality of life.
  • The limited evidence suggests that medications and surgery have similar long-term effects for preventing the development of Barrett's esophagus or esophageal adenocarcinoma.
  • Clinical experience with newer endoscopic procedures is increasing, but too little research has been done so far to make meaningful comparisons between PPIs and surgery.

Dr. Clancy emphasized that the findings are meant to help in selecting the best treatment for the patient, but the report does not constitute treatment recommendations, and it does not include cost considerations. It is essential for patients and physicians to discuss how these findings would apply in an individual's case, Dr. Clancy said.

With the report, AHRQ also released plain-language summaries to help consumers and others review the findings quickly and understand them. In creating the program, Congress emphasized the need for conveying the information at different levels of detail for different audiences, with special attention to making the findings useful for consumers.

The report is available at http://www.effectivehealthcare.ahrq.gov. This Web site includes features for the public to participate in the Effective Health Care Program. Users can sign up to receive notification when new reports are available. They can also be notified when draft reports and other features are posted for comment, and comments can be submitted through the Web site. The public is also invited to use the Web site to nominate topics for review by the Effective Health Care Program.

"Transparency and public involvement are central principles for the Effective Health Care Program, and the public is invited to participate through the Web site," Dr. Clancy said.

The GERD report was prepared by the Tufts-New England Medical Center Evidence-based Practice Center, one of 13 such centers working under contract with AHRQ to generate syntheses of evidence regarding health care issues.

For more information, please contact AHRQ Public Affairs: (301) 427-1855 or (301) 427-1922.


 

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