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Randomized Controlled Trial of Magnetic Sphincter Augmentation (MSA) Vs. Omeprazole in Gerd Patients with Regurgitation: Initial Results from the Caliber Trial
Reginald Bell1, John Lipham2, Brian E. Louie3, Valerie Williams4, James D. Luketich5
1SurgOne Foregut Institute, Englewood, CO; 2Upper GI and General Surgery, Keck School of Medicine of USC, Los Angeles, CA; 3Thoracic Surgery, Swedish Medical Center, Seattle, WA; 4Thoracic Surgery, University of Cincinnati Medical Center, Cincinnati, OH; 5Cardiothoracic Surgery, UPMC/University of Pittsburgh Schools of the Health Sciences, Pittsburgh, PA.
Introduction: Typical GERD symptoms include heartburn and regurgitation. While proton pump inhibitor (PPIs) are effective for heartburn, they have been less effective for regurgitation. This study compared magnetic sphincter augmentation (MSA) to double-dose PPIs for regurgitation.
Methods: A multicenter, randomized controlled trial, enrolled patients with troublesome regurgitation as determined by standardized questionnaires despite single-dose PPI (Omeprazole 20 mg, once daily). Patients were randomly assigned (2:1) to either 6 months of double-dose PPIs (20 mg in morning and 20 mg in evening, taken 30 minutes before meals) or MSA. The 6-month follow-up included GERD-specific questionnaires and 24-hour impedance monitoring read by a core lab blinded to treatment assignment. The primary endpoint of patient-reported resolution of moderate or severe regurgitation was assessed at 6 months, with continued follow-up to 12 months. Patients randomized to double-dose PPI were eligible for cross-over to MSA if moderate/severe regurgitation persisted and core lab confirmed an abnormal number reflux episodes. Patients not crossing-over stepped down to single-dose PPI.
Results: At time of this report, enrollment was complete (50 MSA and 100 PPI), with 6-month follow-up available for 69 patients (23 MSA and 46 PPI). Moderate or severe regurgitation was eliminated in 95.0% after MSA versus 4.8% after doubledose PPI. In the MSA group (off PPIs), 95.5% had a normal number of reflux episodes (<57 episodes) compared to 47.7% in the double-dose PPI group. 45.5% of double-dose PPI patients met the cross-over criteria to MSA. Mean number of reflux episodes was 26.5 after MSA compared to 56.4 after double-dose PPIs. Mean GERD Health-Related Quality of Life symptom score improved after MSA (23.3 at baseline on single-dose PPI vs. 2.3 at 6 months off PPIs), whereas the mean score was not significantly changed after double-dose PPIs (25.0 at baseline on single-dose PPI vs. 25.6 at 6 months on double-dose PPI). Mean total % time pH <4 improved between baseline (off PPIs) and 6- months from 12.9 to 2.7 and 11.0 to 4.6 after MSA and double-dose PPIs, respectively. Additionally, complete discontinuation of PPIs was achieved by 95.0% of patients after MSA, and none required daily PPIs. One patient after MSA was readmitted to the hospital for esophageal spasm that resolved with medication. No serious adverse events were reported after PPIs.
Conclusions: At the 6-month follow-up of this interim analysis, MSA was more effective than double-dose PPIs in eliminating troublesome regurgitation, and the number of reflux episodes was significantly less after MSA. Results are consistent with improved barrier function provided by MSA. Based on these initial results, patients with regurgitation should be considered for MSA because PPIs appear to be ineffective for treating regurgitation.
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