Predictors of Early and Late Response to Esomezol and Lifestyle Modification in Adults With Laryngopharyngeal Reflux Disease: A Prospective, Multicenter, Open-Label Cohort Study

Abstract

Objectives. This study aimed to assess predictors of the response to varying durations of proton pump inhibitor (PPI) use and lifestyle modification treatment for laryngopharyngeal reflux disease (LPRD).Methods. Between October 2014 and June 2016, a prospective, multicenter, open-label, single-cohort, intention-to-treat, observational study was conducted at eight referral hospitals across the Republic of Korea to examine predictors of early and late response to treatment in adult patients (age ≥19 years) with LPRD. Participants underwent standard treatment (PPI [Esomezol] and lifestyle modification) for 3 months. Response to treatment was defined as greater than 50% improvement in reflux symptom index score. The primary outcome was potential predictors of treatment response at 1 and 3 months. The secondary outcome was potential predictors distinguishing early from late responders.Results. In total, 394 patients were enrolled. Improved sleep habits was a positive predictor (odds ratio [OR], 1.785; 95% confidence interval [CI], 1.06–3.007; <i>P</i>=0.029), while initial alcohol consumption (OR, 0.587; 95% CI, 0.355–0.969; <i>P</i>=0.037) and past medication history (OR, 0.438; 95% CI, 0.215–0.891; <i>P</i>=0.005) were negative predictors of response after 1 month of treatment. High pre-reflux finding score was a positive predictor (OR, 1.187; 95% CI, 1.049– 1.344; <i>P</i>=0.007), while male sex (OR, 0.516; 95% CI, 0.269–0.987; <i>P</i>=0.046), higher depression score (OR, 0.867; 95% CI, 0.784–0.958; <i>P</i>=0.005), and past thyroid hormone medication history (OR, 0.161; 95% CI, 0.033–0.788; <i>P</i>=0.024) were negative predictors of response after 3 months of treatment. Past medication history (OR, 0.438; 95% CI, 0.215–0.891; <i>P</i>=0.023) was the only negative predictor for early responders compared to late responders.Conclusion. Adult patients with LPRD and a history of prior medication use may require longer treatment durations to achieve a therapeutic response. Future research should explore the incorporation of diverse treatment approaches to improve treatment outcomes for patients exhibiting negative prognostic indicators.