PHILADELPHIA — Transoral esophagogastric fundoplication plus placebo demonstrated greater efficacy compared with a sham procedure plus proton pump inhibitors in treating troublesome regurgitation associated with gastroesophageal reflux disease, or GERD, according to clinical trial data presented at the ACG Annual Scientific Meeting.
“Heartburn, we know, responds well to PPIs, but much less is known about treatment response with regurgitation,” Peter J. Kahrilas, MD, department of medicine, Northwestern University, said in a presentation. “In fact, no controlled trial has previously used regurgitation response as a primary outcome.”
Kahrilas and colleagues performed a sham-controlled, multicenter clinical trial (the RESPECT trial) involving 696 GERD patients with troublesome regurgitation that persisted despite taking at least 40 mg PPIs per day. Those patients were screened with three GERD symptom scales on and off PPIs, and those deemed to have the Montreal definition of “troublesome” regurgitation on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring and high-resolution manometry. Finally, 129 patients were randomly assigned to receive either transoral fundoplication (TF) plus 6 months of placebo or a sham procedure plus 6 months of 40 mg omeprazole once or twice daily with assessments at 2, 12 and 26 weeks.
At 6 months 68% of TF patients reported elimination of troublesome regurgitation compared with 46% of sham patients (P=.041), and TF was associated with decreased intraesophageal acid exposure (P<.001) compared with no improvement in pH observed with sham patients. Dysphagia and bloating were improved in both groups, adverse events were similar except postoperative epigastric pain and early treatment failure occurred more commonly in sham patients.
“Troublesome regurgitation was resolved in a greater proportion of patients treated with TF than with omeprazole,” Kahrilas said. “TF appears to be safe without fundoplication side effects. Intraesophageal acid control was improved, and [TF] should be considered in GERD patients with small or absent hiatal hernia who suffer from troublesome regurgitation despite PPI therapy.”
For more information:
Kahrilas PJ. Abstract 41. Presented at: ACG Annual Scientific Meeting, Oct. 20-22, 2014; Philadelphia, PA.
Disclosure: See the abstract for a full list of relevant financial disclosures.