Treatment outcomes in patients with globus: A randomized control trial of psychoeducation, neuromodulators, and proton pump inhibitors.

Background: Globus is a persistent or intermittent nonpainful sensation of a lump or foreign body, which markedly affect patient's quality of life. Treatment options for globus are limited and unsatisfying. This study aims to compare the effects of cognitive-behavioral-theory-based psychoeducation (CBT), neuromodulators (NMD), and proton pump inhibitor (PPI) on treatment outcomes in patients with globus.

Methods: Eligible patients were randomly received CBT, 0.5 mg flupenthixol and 10 mg melitracen; NMD, or omeprazole 20 mg; PPI, for 4 weeks. The primary endpoint was the reduction in symptom scores; Glasgow Edinburgh Throat Scale (GETS). The secondary endpoints included treatment efficacy on Reflux Symptom Index (RSI), Hospital Anxiety Depression Scale (HADS), and quality of life (QoL) based on a 36-item short-form health survey (SF-36). Treatment compliance and adverse effects were recorded.

Key Results: Forty patients were completed study. Baseline characteristics between the groups were comparable. By the end of treatment, both CBT and NMD provided greater reduction in GETS than PPI (CBT vs PPI; 6.46 ± 8.56 vs 0.21 ± 5.42; p = 0.031, NMD vs PPI; 6.92 ± 9.85 vs 0.21 ± 5.42; p = 0.036). The improvement of RSI, HADS, and SF-36 among the groups was similar. Neuromodulators caused more adverse events.

Conclusions & Inferences: Both CBT and NMD provided equally effective treatment and better than PPI in patients with globus determined by the reduction in GETS. The improvement in RSI, HADS, and QoL of the three groups was not different. Given less of adverse effect than NMD, CBT should be considered as a substantial treatment.