Surgery Superior to Medication for PPI-Refractory Heartburn

Stuart J. Spechler, MD

While protein pump inhibitors (PPI) have a track record of treating gastroesophageal reflux disease (GERD), surgery is seen as the best option for those who do not respond to medication suffering from GERD-related heartburn.

A team of investigators, led by Stuart J. Spechler, MD, Baylor Scott & White Health, examined the success rate between treating PPI-refractory heartburn with medication, surgery, or a placebo.

GERD is an extremely common issue, especially in western countries. It’s estimated that approximately 20% of adults in the US suffer from GERD.

Currently, the most effective treatments for GERD is protein pump inhibitors like Prilosec and esomeprazole. Spechler said the advent of protein pump inhibitors was seen as an ultimate treatment for GERD, but it eventually became apparent that it wouldn’t be the case.

Despite 40% of patients with GERD using protein pump inhibitors, the majority still have symptoms of reflux disease.

“So, it's a very common problem and we really didn't know what to do with those patients,” Spechler said in an interview with MD Magazine®.

Prior to the study the standard procedure was to keep patients on protein pump inhibitors even if they weren’t responding to them.

There are also drugs available that in theory prevent reflux, such as baclofen, and neuromodulators like antidepressant drugs that interfere with pain signals from the esophagus that are being interpreted as pain by the central nervous system.

While these different treatments were available and regularly prescribed, Spechler said there were not a lot of high quality studies proving that they were effective.

There was also a surgical option for patients in fundoplication, but it is also unclear how effective this procedure is in patients who do not respond to protein pump inhibitors.

The study included 78 patients referred to Veterans Affairs gastroenterology clinics for PPI-refractory heartburn. Patients with persistent heartburn underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance-pH monitoring.

The patients found to have reflux-related heartburn were randomly assigned to receive either a surgical treatment (laparoscopic Nissen fundoplication), active medical treatment (omeprazole plus baclofen, with desipramine added depending on symptoms), or control medical treatment (omeprazole plus placebo).

The primary outcome of the study was treatment success, defined as a decrease of 50% or more in the Gastroesophageal Reflux Disease (GERD)—Health Related Quality of Life score at 1 year.

The incidence of treatment success with surgery was 18 of the 27 patients (67%), which was significantly higher than the medical treatment group, which was 7 of 25 (28% P =.007) or control medical treatment, which was 3 of 26 patients (12%; P <.001).

The difference in the incidence of treatment success between the active medical group and the control medical group was 16 percentage points (95% CI,−5-38; P =.17).

In the study, each patient was given 20 mg of omeprazole twice a day taken about 30 minutes before meals.

According to Spechler, these drugs must be taken at very specific times to be effective and roughly 11% of patients who entered the study because they had PPI refractory heartburn responded to the medication when taken at the proper times.

The study, “Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn,” was published online in The New England Journal of Medicine.