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.