Silviu Albu1, Felician Chirtes2, Veronica Trombitas2, Alina Nagy3, Luigi Marceanu4, Gregorio Babighian5, Franco Trabalzini5. 1. Second Department of Otolaryngology, Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca, Cluj-Napoca, Romania; Ro-Neuro Clinic Cluj-Napoca, Romania. Electronic address: silviualbu63@gmail.com. 2. Second Department of Otolaryngology, Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca, Cluj-Napoca, Romania. 3. Ro-Neuro Clinic Cluj-Napoca, Romania. 4. University of Medicine and Pharmacy Brasov, Romania. 5. Operative Unit of Otolaryngology and Otosurgery, Padua University, Padua, Italy.
Abstract
PURPOSE: The objective of our randomized, double-blind study was to compare the effectiveness of intratympanic (IT) dexamethasone versus high-dosage of betahistine in the treatment of patients with intractable unilateral Meniere disease (MD). MATERIALS AND METHODS: Sixty six patients with definite unilateral MD were randomly divided in two groups: Group A received a combination of IT dexamethasone (DX) and identical-appearing placebo pills while Group B received a combination of high-dosage betahistine and IT saline. Intratympanic injections were repeated for three times with an interlude of 3days. High-dosage of betahistine entailed 144mg/day. Mean outcome measures consisted of vertigo control, pure tone average (PTA), speech discrimination score, Functional Level Score, Dizziness Handicap Inventory and Tinnitus Handicap Inventory. RESULTS:Fifty nine patients completed the study and were available at 12months for analysis. In Group A complete vertigo control (class A) was attained in 14 patients (46.6%) and substantial control (class B) in 7 patients (20%). In Group B, 12 patients (41%) achieved complete vertigo control (class A), 5 patients (17%) substantial control (class B). There is no statistical difference in vertigo control between the two treatment groups. In Group A hearing was unchanged in 14 patients and improved in 4 patients, while in Group B hearing was unchanged in 16 patients and improved in 2 patients. CONCLUSIONS: Our preliminary results demonstrate that high-dosage of betahistine achieved similar outcomes as IT dexamethasone in the control of vertigo and hearing preservation.
RCT Entities:
PURPOSE: The objective of our randomized, double-blind study was to compare the effectiveness of intratympanic (IT) dexamethasone versus high-dosage of betahistine in the treatment of patients with intractable unilateral Meniere disease (MD). MATERIALS AND METHODS: Sixty six patients with definite unilateral MD were randomly divided in two groups: Group A received a combination of IT dexamethasone (DX) and identical-appearing placebo pills while Group B received a combination of high-dosage betahistine and IT saline. Intratympanic injections were repeated for three times with an interlude of 3days. High-dosage of betahistine entailed 144mg/day. Mean outcome measures consisted of vertigo control, pure tone average (PTA), speech discrimination score, Functional Level Score, Dizziness Handicap Inventory and Tinnitus Handicap Inventory. RESULTS: Fifty nine patients completed the study and were available at 12months for analysis. In Group A complete vertigo control (class A) was attained in 14 patients (46.6%) and substantial control (class B) in 7 patients (20%). In Group B, 12 patients (41%) achieved complete vertigo control (class A), 5 patients (17%) substantial control (class B). There is no statistical difference in vertigo control between the two treatment groups. In Group A hearing was unchanged in 14 patients and improved in 4 patients, while in Group B hearing was unchanged in 16 patients and improved in 2 patients. CONCLUSIONS: Our preliminary results demonstrate that high-dosage of betahistine achieved similar outcomes as IT dexamethasone in the control of vertigo and hearing preservation.
Authors: Mohammed Hassan Elkomy; Shahira F El-Menshawe; Adel Ahmed Ali; Abdelkhalik Ali Halawa; Ahmed S G Srag El-Din Journal: Drug Deliv Transl Res Date: 2018-02 Impact factor: 4.617