WebMD Medical News
Laura J. Martin, MD
May 17, 2011 -- Patients weighing whether to take daily medication or undergo a surgical procedure to treat acid reflux disease may take comfort in the results of a new study finding that both treatments appear to control the worst symptoms of the disease in many people.
The study, which is published in the Journal of the American Medical Association, randomly assigned more than 500 people with gastroesophageal reflux disease (GERD) that had been controlled with the drug Nexium to either continue on that medication or try a minimally invasive surgery that corrects acid backup.
The study was funded by AstraZeneca, the maker of Nexium.
After five years, 92% of people in the medication group and 85% in the surgery group reported having no GERD symptoms, or symptoms so mild they could easily live with them.
And both treatments also appeared to be relatively safe, with similar, low numbers of serious adverse events.
“We have shown that the treatment of gastroesophageal reflux has dramatically improved during the last decade, both surgical and medical treatment,” says study researcher Jean-Paul Galmiche, MD, professor of gastroenterology at Nantes University in France.
Previous studies have shown lower long-term success rates for either surgery or drugs called proton pump inhibitors, such as Nexium. Based on those trials, study researchers expected about 70% of patients in each group would achieve remission of their symptoms.
But Galmiche says two things probably improved patient outcomes in each arm of the study. In the medication group, if patients experienced worsening symptoms, doctors could increase and split their dose for better control. Patients who had surgery had their procedures done at academic medical centers where the surgeons were experienced and well-trained.
Independent experts say important cautions apply: The study doesn’t apply to everyone with GERD, and those ideal treatment conditions, especially for surgical patients, may be difficult to find in the real world.
“The interesting thing about this trial is that to get in it, you had to have responded to [the medication] to begin with,” says Kenneth DeVault, MD, a gastroenterologist and GERD specialist who is chair of the division of internal medicine at the Mayo Clinic in Jacksonville, Fla.
DeVault, who was not involved in the research, says that means the trial results probably wouldn’t apply to the 20%-40% of people with GERD whose reflux symptoms, including heartburn and regurgitation, aren’t really helped with medication.
Still, for others, Galmiche says the study may offer some guidance about the pros and cons of choosing one treatment over the other.
“The treatments are not exactly similar in terms of results,” he says. “They are not superior, but they are not exactly similar.”
For the study, patients diagnosed with gastoesophageal reflux disease were recruited at academic medical centers in 11 European countries. Most patients enrolled in the study had had GERD for five years or less.
Before they split the patients into treatment groups, researchers gave all participants 40 milligrams of Nexium daily for three months to test their response to the drug.
Those that reported relief of their symptoms were randomly assigned to receive either 20 milligrams of Nexium once daily -- a dose that could be increased to 40 milligrams a day if their symptoms came back -- or lapraroscopic surgery that treats acid reflux by tightening a loose muscle that acts like a valve at the top of the stomach.
“They basically pull the top of the stomach around the esophagus, so they are tightening the sphincter,” says Mouen Khashab, MD, assistant professor of medicine and director of therapeutic endoscopy at Johns Hopkins University in Baltimore.
Five years later, 92% of the 266 people in the study who were taking the Nexium, and 85% of the 288 people in the surgery group, continued to have either no symptoms or bearable reflux symptoms.
The main differences between the groups were that patients taking medication continued to experience mild GERD symptoms, including regurgitation, heartburn, and abdominal pain.
Study participants who’d had the surgery, on the other hand, reported more complete resolution of those symptoms, but more difficulty swallowing and trouble belching, a problem that can lead to bloating.
Those are differences that may be meaningful to patients who are choosing one treatment over the other, experts say.
In reading the study, Walter W. Chan, MD, MPH, an instructor of medicine at Harvard Medical School and a gastroenterologist at Brigham and Women’s Hospital in Boston, says it seemed to him like the surgical patients had better resolution of their symptoms.
“I think it’s a well-done, well-designed study. I just don’t think that you can draw the conclusion that taking medication one or two times a day is just as good as undergoing surgery,” he tells WebMD.
And Chan notes that there have been concerns about the safety of proton pump inhibitors when they are taken long-term. Some studies have suggested they may increase the risk of fractures and infections, for example.
Other experts noted that the surgical results achieved in the study depend on finding an experienced surgeon and having the procedure done at a medical center that does many of them.
“It generally works very well if you chose the patients correctly and send the patients to the right surgeon,” says Khashab.
But the procedure does have risks, he says. In some cases, the repair may be too tight and gas can’t escape from the stomach, a problem called gas-bloat syndrome. Patients may also experience difficulty getting food to go down into the stomach, or dysphagia. Those problems can be corrected with a revision procedure.
And the fix may not be permanent. Most patients will see their symptoms return five to 10 years after their procedure. In those cases, the wrap can be tightened with another procedure, or they may return to taking medication.
Another consideration may be cost.
Several studies that have compared the out-of-pocket costs for patients taking proton pump inhibitor medications and acid reflux surgery find that the surgery costs more, even when costs are stretched over years.
In a Canadian study published in 2011, for example, which followed patients who either took proton pump inhibitors or had surgery to correct their acid reflux for three years, the surgery cost about $3,000 more than the medical costs, including doctors’ visits, incurred taking the medication.
For people who aren’t ready to try medications or surgery, experts said lifestyle interventions, including smoking cessation and dietary changes, can be helpful.
Sadly, doctors say those options aren’t often discussed.
In one survey of doctors who treat GERD, only 4% spoke to their patient about smoking cessation, and only 25% discussed dietary changes, says Kenneth W. Altman, MD, associate professor of otolaryngology at the Mount Sinai School of Medicine in New York.
SOURCES:Galmiche, J. Journal of the American Medical Association, May 18, 2011.Goeree, R. Value in Health, March 2011.
Grant, A. Health Technology Assessment, 2008.Jean-Paul Galmiche, MD, professor of gastroenterology, Nantes University, France.Kenneth DeVault, MD, chair, division of internal medicine, Mayo Clinic, Jacksonville, Fla.Mouen Khashab, MD, assistant professor of medicine; director of therapeutic endoscopy, Johns Hopkins University, Baltimore.Walter W. Chan, MD, MPH, instructor of medicine, Harvard Medical School; gastroenterologist, Brigham and Women’s Hospital, Boston.Kenneth W. Altman, MD, associate professor or otolaryngology, Mount Sinai School of Medicine, New York.
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