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Clinical Summary

Magnetic sphincter augmentation tops PPIs for regurgative reflux

Takeaway

  • Magnetic sphincter augmentation (MSA) is superior to proton pump inhibitor (PPI) therapy for reducing regurgitation in patients with gastroesophageal reflux disease (GERD).

Why this matters

  • PPIs are often ineffective for treating regurgitation, despite a common belief that medications are sufficient therapy.

Study design

  • Researchers in this prospective, multicentre 2:1 trial studied patients with moderate to severe regurgitation despite once-daily PPI therapy, randomly assigning them to treatment with either a twice-daily PPI (omeprazole 20 mg; n=102) or laparoscopic MSA (n=50).
  • Patients in the PPI treatment group who showed no improvement were offered MSA at 6 months.
  • Funding: Ethicon, Inc.

Key results

  • All patients who received MSA and and those who crossed over to the MSA group after PPI therapy (n=75) had similar outcomes and experienced no serious adverse events.
  • MSA controlled regurgitation in 96% (n=72) of patients, independent of preoperative PPI response.
  • Only 19% (8/43) of patients who received PPIs without MSA reported regurgitation control.
  • 81% of MSA-treated patients had ≥50% improvement in GERD health-related QoL scores, and 91% discontinued daily PPI use.
  • Other benefits included reduced dysphagia (from 15% to 7%), bloating (55% to 25%), and esophageal acid exposure time (10.7% to 1.3%) at 1 year.

Limitations

  • Follow-up was limited to 1 year.

References


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