Objective Number of reflux episodes, an adjunctive metric on pH-impedance monitoring, is incompletely studied. We aimed to determine if number of reflux episodes associates with therapeutic outcome in regurgitation predominant gastro-oesophageal reflux disease (GERD).
Design We performed post hoc analysis of postintervention pH-impedance data from adult patients with moderate/severe regurgitation despite QD proton pump inhibitor (PPI), randomised to either two times a day PPI or magnetic sphincter augmentation (MSA) in 2:1 allocation. After 6 and 12 months, symptom response was defined by improvement in Foregut Symptom Questionnaire (FSQ) regurgitation score to none or minimal, ≥50% reduction in GERD health-related quality of life (HRQL) score and satisfaction with therapy. Univariate and multivariate analyses were performed to determine predictors of symptom improvement.
Results Of 152 randomised patients, 123 (age 46.9±1.2 year, 43% female) had complete data. Symptom and satisfaction scores significantly improved after MSA compared with two times a day PPI. Both acid exposure time (13.4%±0.7% to 1.3±0.2%, p<0.001) and reflux episodes (86±4 to 48±4, p<0.001) declined with therapy. Reduction to <40 reflux episodes was significantly more frequent in those with symptom response by FSQ regurgitation score, GERD HRQL score and satisfaction with therapy (p≤0.03 for each); <35 episodes performed better on receiver operating characteristic analysis. On multivariate analysis, improvement in regurgitation score remained independently predictive of satisfaction with therapy (p<0.001 for each). In patients crossing over to MSA, >80 episodes pretreatment predicted improvement.
Conclusions Reduction of reflux episodes on pH-impedance to physiological levels associates with improved outcomes, while pathological levels predict improvement with MSA in regurgitation predominant GERD.
Trail registration number ClinicalTrials.gov: NCT02505945.
- ambulatory pH monitoring
- gastroesophageal reflux disease
- anti-reflux therapy
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Contributors Guarantor of the article: CPG. Author roles: BDR: study concept and design, data collection, analysis, manuscript preparation and review; LRV: data analysis, critical review of the manuscript; MDC: data analysis, critical manuscript review; RB: critical review of manuscript; MFV: study concept and design, data collection and critical review of manuscript; CPG: study concept and design, data collection and analysis, manuscript preparation and critical review.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests RB: Consultant for Ethicon EndoSurgery, Intuitive Surgical, Becton Dickinson and Co; MFV: consultant for Medtronic, research support from Diversatek; CPG: consultant for Medtronic, Diversatek, Ironwood, Isothrive and Quintiles.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Ethics approval At each of the 21 participating sites, the protocol was approved by the Institutional Review Board (or equivalent body). Since the present study consists of post hoc analysis of previously collected deidentified pH-impedance data with no links to the original study patients, additional institutional review board approval was not deemed necessary.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available. This is a post hoc analysis of pH-impedance study data from a published clinical study comparing magnetic sphincter augmentation to a two times per day PPI regimen. The original study sponsors (Torax) provided deidentified pH-impedance study data and related clinical data to two study investigators (MFV and CPG) who performed blinded interpretation of the pH-impedance studies for the original study.