Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial
| Autor: | Philip O. Katz, John C. Lipham, Brian E. Louie, Patrick R. Reardon, Adrian Park, Valerie A. Williams, William G. Richards, Shanu N. Kothari, Jon C. Gould, Leena Khaitan, James D. Luketich, Chris Smith, Dan Lister, Ghulam Abbas, Reginald Bell, Lauren McDowell-Jacobs, F. Paul Buckley, Michael Hill, Karen L. Woods, C. Daniel Smith, Christy M. Dunst, Garth R. Jacobsen |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Esophageal pH Monitoring medicine.drug_class Proton-pump inhibitor Gastroenterology Esophageal Sphincter Lower law.invention Young Adult 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine Laryngopharyngeal Reflux medicine Humans Radiology Nuclear Medicine and imaging Adverse effect Aged Cross-Over Studies Intention-to-treat analysis medicine.diagnostic_test business.industry Proton Pump Inhibitors Middle Aged medicine.disease Discontinuation Treatment Outcome 030220 oncology & carcinogenesis Regurgitation (digestion) Gastroesophageal Reflux Magnets Quality of Life GERD Female Laparoscopy 030211 gastroenterology & hepatology medicine.symptom Esophageal pH monitoring business Omeprazole |
| Zdroj: | Gastrointestinal Endoscopy. 89:14-22.e1 |
| ISSN: | 0016-5107 |
| DOI: | 10.1016/j.gie.2018.07.007 |
| Popis: | GERD patients frequently complain of regurgitation of gastric contents. Medical therapy with proton-pump inhibitors (PPIs) is frequently ineffective in alleviating regurgitation symptoms, because PPIs do nothing to restore a weak lower esophageal sphincter. Our aim was to compare effectiveness of increased PPI dosing with laparoscopic magnetic sphincter augmentation (MSA) in patients with moderate-to-severe regurgitation despite once-daily PPI therapy.One hundred fifty-two patients with GERD, aged ≥21 years with moderate-to-severe regurgitation despite 8 weeks of once-daily PPI therapy, were prospectively enrolled at 21 U.S. sites. Participants were randomized 2:1 to treatment with twice-daily (BID) PPIs (N = 102) or to laparoscopic MSA (N = 50). Standardized foregut symptom questionnaires and ambulatory esophageal reflux monitoring were performed at baseline and at 6 months. Relief of regurgitation, improvement in foregut questionnaire scores, decrease in esophageal acid exposure and reflux events, discontinuation of PPIs, and adverse events were the measures of efficacy.Per protocol, 89% (42/47) of treated patients with MSA reported relief of regurgitation compared with 10% (10/101) of the BID PPI group (P .001) at the 6-month primary endpoint. By intention-to-treat analysis, 84% (42/50) of patients in the MSA group and 10% (10/102) in the BID PPI group met this primary endpoint (P .001). Eighty-one percent (38/47) of patients with MSA versus 8% (7/87) of patients with BID PPI had ≥50% improvement in GERD-health-related quality of life scores (P .001), and 91% (43/47) remained off of PPI therapy. A normal number of reflux episodes and acid exposures was observed in 91% (40/44) and 89% (39/44) of MSA patients, respectively, compared with 58% (46/79) (P .001) and 75% (59/79) (P = .065) of BID PPI patients at 6 months. No significant safety issues were observed. In MSA patients, 28% reported transient dysphagia; 4% reported ongoing dysphagia.Patients with GERD with moderate-to-severe regurgitation, especially despite once-daily PPI treatment, should be considered for minimally invasive treatment with MSA rather than increased PPI therapy. (Clinical trial registration number: NCT02505945.). |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect