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Review confirms safety, efficacy, durability of Stretta radiofrequency treatment for GERD
A recent review article critically assessed endoscopic GERD therapies and determined Stretta radiofrequency therapy should be considered a viable treatment option, while newer endoscopic plication and suturing devices and injectable treatments need further study.
To elucidate their roles in contemporary GERD management, the investigators evaluated research on the efficacy, safety and durability of endoscopic techniques, including Stretta, endoscopic plication or suturing devices and injectable or implantable bulking agents.
They determined that Stretta radiofrequency therapy (Mederi), originally approved by the FDA in 2000, is supported by “a wealth of research” demonstrating its safety, efficacy, durability and repeatability. A meta-analysis of 18 studies (n = 1,441) and four randomized controlled trials, three of which were sham controlled, and one that compared the procedure with proton-pump inhibitor (PPI) therapy, demonstrated “significant improvement in subjective reflux symptom scores,” and improved objective measures of acid reflux, but consistent normalization of pH was not demonstrated.
More recent studies have shown durability of symptom improvement and reduced dependence on PPIs at 8 and 10 years, effective symptom relief and safety after 5 years comparable to Nissen fundoplication (although greater improvements in symptoms and PPI dependence were demonstrated with surgery).
Furthermore, Stretta does not preclude medical or surgical treatments, may provide a treatment option in patients for whom fundoplication failed, and is likely to be the least expensive alternative to medication. The researchers therefore included Stretta in their proposed treatment algorithm for poor surgical candidates or patients who prefer a less invasive alternative to antireflux surgery.
They also included transoral incisionless fundoplication (TIF; EsophyX, Endogastric Solutions; MUSE, Medigus) in their treatment algorithm as a potential option depending on institutional experience. MUSE was approved by the FDA in 2014, and while early data are promising, questions remain regarding its safety and long-term durability. EsophyX, approved in 2007, has also been supported by promising study results, including a systematic review of 15 studies showing overall symptom improvement and a randomized sham controlled trial showing improved regurgitation symptoms. “Additional research raises the issue of poor efficacy and early treatment failure after TIF,” the researchers wrote.
While there may be a role for endoscopic plication or suturing devices, further research is needed to identify appropriate patient populations, they concluded. Similarly, “further research is needed before [injectable or implantable bulking agents] can be considered viable treatment options for GERD,” they wrote. – by Adam Leitenberger
Disclosure: The researchers report no relevant financial disclosures.