medwireNews: A magnetic device that fits around the esophageal sphincter holds promise for the treatment of gastroesophageal reflux disease (GERD), show long-term study results published in the New England Journal of Medicine.
Three-year findings demonstrated that patients with the device experienced less esophageal acid exposure than before the implant and were able to reduce their use of proton-pump inhibitors.
The treatment could provide an alternative for patients whose condition is not managed by drug therapy and who are unwilling to undergo the current standard surgical treatment, which can often lead to significant side effects, say Robert Ganz (Minnesota Gastroenterology, Plymouth, USA) and co-authors.
The study included 100 patients enrolled in 2009 who had experienced GERD for a median of 10 years. Each patient was implanted with the device, which consists of a string of magnetic beads surrounded by titanium cases that fit around the esophageal sphincter. The beads are designed to increase the sphincter's resistance to the abnormal opening associated with GERD but still open normaly for the passage of food, belching, and vomiting.
Compared with a baseline period when patients were not taking proton-pump inhibitors, 64% achieved normalization or at least a 50% reduction in esophageal acid exposure after surgery.
Additionally, 92% of patients recorded at least a 50% reduction in quality-of-life scores compared with baseline. And 93% reduced their average daily proton-pump inhibitor dose by at least 50% from baseline, with 87% stopping their use altogether.
Furthermore, the number of patients reporting moderate-to-severe regurgitation fell from 57% before implantation to 1% in years 2 and 3 of the study, and 94% reported satisfaction with their condition after 3 years, compared with just 13% during proton-pump inhibitor therapy at baseline.
Dysphagia occurred in 68% of patients, a similar frequency to that observed in patients after surgery of the esophageal sphincter. This led to the removal of the implant in three patients, but symptoms were mild to moderate in the majority of patients and resolved with time. Three further patients had the device removed because of pain, vomiting, or lack of efficacy.
Up to 40% of GERD patients taking proton-pump inhibitors continue to experience symptoms, explain Ganz and colleagues. Their observation that the majority of patients were able to stop proton-pump inhibitor therapy following implantation of the device suggests that it could be suitable for partial responders to drug treatment.
However, they add that their findings should be considered preliminary, and larger studies with longer follow ups are needed to fully assess safety.
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