Effectiveness and safety of betahistine in treatment naive acute peripheral vertigo patients
Keywords:Betahistine, Vertigo, Naive patients, Dizziness, Videonystagmography, Dizziness handicap inventory
Background: The objective of the study was to assess the effectiveness and safety of oral betahistine in treatment naïve patients with acute peripheral vertigo, administered over 21 days.
Methods: Treatment naïve patients with confirmed peripheral vertigo, based on clinical diagnosis, were enrolled in this open-label, single-arm, interventional study. Patients received 48 mg betahistine (16 mg, TDS) for 21 days, and were followed up on day 1, 3, 7 and 21. Safety and effectiveness were assessed based on clinical response (scale for vestibular vertigo severity level and clinical response evaluation (SVVSLCRE)); frequency and severity of peripheral vertigo (videonystagmography (VNG)); dizziness handicap inventory (DHI).
Results: Overall, 53 (70.67%) out of 75 enrolled patients completed 21 days of treatment and were included in the study. No significant improvement in SVVSLCRE score was noted from baseline to day 1 (p=0.0572), but significant reduction was seen from day 3 onwards and continued till day 21 (p<0.0001). Level wise severity analysis showed that patients with ‘moderate to severe’ category at baseline reported ‘mild’ severity on day 7. A significant reduction in mean change of DHI scale was observed from baseline to day 3, day 7 and day 21 (p<0.0001). No major therapy related serious adverse events were reported. Headache (4.0%) and nausea (2.6%) were the commonly reported adverse events, which were mild in nature.
Conclusions: Findings suggest that 48 mg betahistine (16 mg, TID) therapy is effective in treatment naive patients with acute peripheral vertigo. Reduction in vertigo symptoms score was significant from day 3 to day 21. Betahistine was found to be safe and easily tolerated in these patients.
Bhattacharyya N, Gubbels SP, Schwartz SR, Edlow JA, Kashlan EH, Fife T, et al. Clinical Practice Guideline: Benign Paroxysmal Positional Vertigo (Update). Otolaryngology Head Neck Surg. 2017;156(3S):1-47.
Neuhauser HK. The epidemiology of dizziness and vertigo. Handbook Clin Neurol. 2016;137:67-82.
Strupp M, Dieterich M, Brandt T. The treatment and natural course of peripheral and central vertigo. Deutsches Arzteblatt Int. 2013;110(29-30):505-16.
Escamez LJA, Gamiz MJ, Perez FA, Finana GM. Long-term outcome and health-related quality of life in benign paroxysmal positional vertigo. Eur Arch Otorhinolaryngol. 2005;262:507-11.
Szmytke ZE, Rogula SS, Kowalska SM. Bedside examination for vestibular screening in occupational medicine. Int J Occup Med Environ Health. 2015;28(2):379-87.
Zatonski T, Temporale H, Holanowska J, Krecicki T. Current Views on Treatment of Vertigo and Dizziness. Med Diagn Meth. 2014;3(1).
Alcocer RR, Rodriguez JGL, Romero AN, Nunez JLC, Montoya VR, Deschamps JJ, et al. Use of Betahistine in the treatment of peripheral vertigo. Acta Oto-Laryngology. 2015;35:1205-11.
Lacour M, Sterkers O. Histamine and Betahistine in the treatment of vertigo: elucidation of mechanisms of action. CNS Drugs. 2001;15:853-70.
Parfenov VA, Golyk VA, Matsnev EI, Morozova SV, Melnikov OA, Antonenko LM. Effectiveness of Betahistine (48 mg/day) in patients with vestibular vertigo during routine practice: The virtuoso study. PLoS ONE. 2017;12(3):174114.
Oosterveld WJ. Betahistine dihydrochloride in the treatment of vertigo of peripheral vestibular origin. A double-blind placebo-controlled study. J Laryngol Otol. 1984;98:37-41.
Strupp M, Hupert D, Frenzel C, Wagner J, Hahn A, Jahn K, et al. Long-term prophylactic treatment of attacks of vertigo in Meniere’s disease-comparison of a high with a low dosage of betahistine in an open trial. Acta Otolaryngol. 2008;128:520-4.
Mira E, Guidetti G, Ghilardi L, Fattori B, Malannino N, Maiolino L, et al. Betahistine dihydrochloride in the treatment of peripheral vestibular vertigo. Eur Arch Otorhinolaryngol. 2003;260:73-7.
Benecke H, Garrigues PH, Sidek D, Uloziene I, Sondag E. Effects of Betahistine on Patient-Reported Outcomes in Routine Practice in Patients with Vestibular Vertigo and Appraisal of Tolerability: Experience in the OSVaLD Study. Int Tinnitus J. 2010;16(1):14-24.
Gananca MM, Caovilla HH, Gananca FF. Comparable efficacy and tolerability between twice daily and three times daily Betahistine for Meniere's disease. Acta Otolaryngology. 2009;129(5):487-92.
Pinzon RT, Sanyasi RLR. Betahistine as a treatment for vertigo: A systematic review of randomized controlled trial. Asian J Pharmacy Pharma. 2018;4(1):6-12.
Simple changes of individual studies can improve the reproducibility of the biomedical scientific process as a whole. Available at https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0174114. Accessed on 12 September 2018.
Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990;116(4):424-7.
Miles RD, Zapala DA. Vestibular Function Measurement Devices, Thieme New York Stuttgart. Semin Hear. 2015;36(1):49-74.
Kirtane MV, Biswas A. Efficacy of Betahistine by Patient-Reported Outcomes and its Tolerability Profile in Indian Patients with Vestibular Vertigo. JAPI. 2017;65:18-24.
Rascol O, Hain TC, Brefel C, Benazet M, Clanet M, Montastruc JL. Antivertigo medications and drug-induced vertigo. Drugs. 1995;50:777-91.
Pietkiewicz P, Pepas R, Sułkowski WJ, Blizniewska ZH, Olszewski J. Electronystagmography versus videonystagmography in diagnosis of vertigo. Int J Occupational Med Environmental Health. 2012;25(1):59-65.
Albera R, Ciuffolotti R, Cicco DR, Benedittis DG, Grazioli I, Melzi G, et al. Double-blind, randomized, multicenter study comparing the effect of Betahistine and flunarizine on the dizziness handicap in patients with recurrent vestibular vertigo. Acta Otolaryngol. 2003;123:598-3.
Mira E. Improving the quality of life in patients with vestibular disorders: the role of medical treatments and physical rehabilitation. Int J Clin Pract. 2008;62:109-14.
Strupp M, Hupert D, Frenzel C, Wagner J, Hahn A, Jahn K, et al. Long-term prophylactic treatment of attacks of vertigo in Meniere’s disease: Comparison of a high with a low dosage of Betahistine in an open trial. Acta Otolaryngol. 2008;128:520-4.
Gananca M, Caovilla H, Gazzola J, Ganança F, Gananca C. Betahistine in the treatment of tinnitus in patients with vestibular disorders. Braz J Otorhinolaryngol. 2011;77(4):499-503.
Stambolieva K, Angov G. Effect of treatment with Betahistine dihydrochloride on the postural stability in patients with different duration of benign paroxysmal positional vertigo. Int Tinnitus J. 2010;16(1):32-6.
Aantaa E. Treatment of acute vestibular vertigo. Acta Otolaryngol Suppl. 1991;479:44-7.