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When Omeprazole Fails for GERD, Endoscopic Fundoplication Is an Option

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The use of drugs for gastroesophageal reflux disease (GERD) has more than doubled in the past decade…but about 40% of GERD-drug users still experience severe heartburn or regurgitation. And long-term use of the drugs, called proton pump inhibitors or PPIs, such as Prilosec, Prevacid and Nexium, can have bad side effects. These are the reasons some GERD sufferers are resorting to an invasive treatment called laparoscopic antireflux surgery, which involves pumping the abdomen up with carbon dioxide to make it expand and then making several small incisions in it to access and operate on the valve between the stomach and esophagus.

Are you picturing that now? No wonder less than 10% of affected patients and physicians opt for it, preferring to simply put up with less-than-adequate PPI relief. But another GERD procedure that doesn’t involve drugs or surgical incisions is actually available.

It is called transoral incisionless fundoplication (TIF), and it is the only tried-and-true endoscopic alternative to laparoscopic antireflux surgery introduced in the past two decades. (Other techniques have been introduced but were discontinued either because they were ineffective or unsafe.) In TIF, an endoscope is inserted into the mouth through the esophagus to the stomach. Then a tool is passed through the endoscope to place a few stitches in the esophageal sphincter (the valve between the esophagus and stomach) to tighten the sphincter and prevent acid reflux. Patients, on average, spend about a day in the hospital to recover, whereas the hospital stay can range from two to five days for laparoscopic surgery. Recovery is also quicker, with patients often returning to most of their regular activities in a few days instead of weeks.

A recent clinical trial sponsored by the makers of TIF technology (called EsophyX) compared the effectiveness of TIF with omeprazole (Prilosec) to confirm that the procedure could be an alternative for people who do not get adequate relief from PPIs. It included 129 participants who were taking omeprazole but still had GERD symptoms. The participants were randomly assigned to a real TIF procedure and a placebo pill or sham surgery and real omeprazole therapy. They filled out questionnaires about their symptoms before and then periodically for six months after the study began, and the researchers periodically assessed the participants during this time. If severe GERD symptoms continued in a patient after three months, the treatment received was considered a failure, and, for ethical reasons, the participant was offered the alternative treatment.

The results: Although a relatively sizeable proportion of participants who had sham surgery plus omeprazole therapy—45%—reported that their symptoms had improved, a greater proportion of those who received TIF—67%—reported symptom improvement. As for treatment failures, after three months, they included 36% of sham surgery/PPI users but only 11% of patients who received TIF.

Through their periodic health assessments of participants, the researchers found that TIF reduced the incidence of reflux by an average of 30% and improved stomach pH (a measure of acidity). Despite the fact that 45% of participants in the sham surgery/PPI group said that their symptoms had improved, their health assessments showed no actual change in incidence of reflux or stomach pH.

SIDE EFFECTS TO EXPECT

TIF, like all medical interventions, does have some potential side effects, but serious complications are uncommon. In this study, two people in the TIF group experienced temporary stomach pain lasting two to four weeks, two had trouble swallowing for up to a week after the procedure, one patient had chest pain for three days and another had musculoskeletal pain for one day after the procedure.

TIF is available at surgical centers around the country and is being used worldwide as a safer alternative to other forms of GERD surgery. If you have had no luck getting relief from GERD with natural lifestyle remedies, drugstore medications or prescription drugs, or if you are concerned about the long-term effects of PPI use, such as malabsorption of vitamins and bone loss, you may want to discuss TIF with your doctor.

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Source: Source: John G. Hunter, MD, department of surgery, Oregon Health & Science University, Portland. His article was published in Gastroenterology. Date: March 24, 2015 Publication: Bottom Line Health
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