Effects of Ban-Xia-Hou-Pu-Tang and Western medicine on patients with globus sensation: A randomized controlled trial.

Background: Globus is a non-painful sensation of a lump in the throat and can affect almost half of the general population. There is a lack of a clear etiology so there is no consensus on the treatment regimen for globus. Ban-Xia-Hou-Pu-Tang (BXHPT) is a highly effective recipe for the treatment of Plum Pit Qi (), which is a condition that is described by traditional Chinese medicine (TCM) texts that bears a striking resemblance to globus. This study determines the TCM constitution of patients with globus and compares the clinical efficacy of a combination of BXHPT and western medicines and western medicines alone for the treatment of the globus sensation.

Methods: This is a single-blind, randomized, placebo-controlled trial that involves 92 patients who were diagnosed with globus pharyngeus. Patients were equally allotted to Group A (Western medicines plus BXHPT) or Group B (Western medicines plus placebo) and completed questionnaires that included a Constitution in Chinese Medicine Questionnaire (CCMQ), a Reflux Symptom Index (RSI), a Glasgow Edinburgh Throat Score (GETS), a Beck Anxiety Inventory (BAI) and a Beck Depression Inventory II (BDI-II). The Reflux Finding Score (RFS) was also measured by an otolaryngologist based on the results of trans-nasal laryngoscopy. Creatinine and alanine levels transaminase were measured to ensure hepatic and renal safety.

Results: A significant reduction in RFS, RSI, GETS, BAI, and BDI scores was observed for both groups. Differences in RFS were significant between Group A and Group B at week 2 (8.03±1.57 vs 10.12±1.75, p <0.001) and at week 4 (7.43±1.16 vs 9.17±1.80, p =0.007).

Conclusion: Western medicines, including fexofenadine, famotidine and acetylcysteine, alleviate the discomfort of globus and the addition of BXHPT can reduce the RFS score without hepatic or renal safety concerns.