Comparison between omeprazole plus baclofen and omeprazole plus placebo in the treatment of laryngopharyngeal reflux

Abstract

Background: At present, baclofen was generally used for treatment of refractory gastroesophageal reflux disease (GERD). Better improvement in the symptoms of GERD, such as heart burn and globus sensation, was demonstrated by administration of baclofen compared to proton-pump inhibitor treatment alone. There was no study about baclofen for the treatment of laryngopharyngeal reflux (LPR) in the English literature. This study was conducted to evaluate the usefulness of baclofen in LPR treatment. Objective: To evaluate the efficacy of baclofen in the treatment of Laryngopharyngeal reflux (LPR). Material and Method: This study was performed in the outpatient clinic of Otorhinolaryngology, Head and Neck surgery department, HRH Princess Maha Chakri Sirindhorn Medical center (MSMC), Srinakharinwirot University. Patients who were diagnosed with LPR were divided into 2 groups by randomized, double blind technique. The study group received omeprazole and baclofen for 1 month. The control group received omeprazole and placebo drug in the same doses. Data were recorded as general characteristics, reflux symptom index (RSI), and reflux finding score (RFS) before and after treatment. RSI and RFS were used for evaluation at the end of the study. Qualitative variables were compared with Fisher’s exact test, whereas quantitative variables were done with Wilcoxon nonparametric test. Drug adverse effects were also recorded. Result: At the end of the study, 30 patients were collected of which 15 patients were in the study group and 15 patients were in the control group. Before treatment, there were no statistical significant differences in age, BMI, RSI and RFS between both groups. After treatment, no significant difference between two groups were detected in RSI at 1 week and 1 month (p-value = 0.598 and 0.552, respectively) and in RFS at 1 month (p-value = 0.979). There were more adverse effects in the study group such as drowsiness, dizziness, nausea and vomiting. Conclusion: Addition of baclofen to omeprazole in the treatment of LPR patients did not show better results than omeprazole alone. © 2017 Medical Association of Thailand. All rights reserved.