Comparison between Omeprazole Plus Baclofen and Omeprazole Plus Placebo in the Treatment of Laryngopharyngeal Reflux
Alena Santeerapharp MD*, Pannipa Wiryaamornchai MD*, Niran Hunchaisri MD*
Affiliation : * Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand
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.
Keywords : Laryngopharyngeal reflux (LPR), Baclofen, Omeprazole, Reflux symptom index (RSI), Reflux findings score (RFS)
