Skip to main content

Advertisement

SpringerLink
Log in

Cinnarizine/betahistine combination vs. the respective monotherapies in acute peripheral vertigo: a randomized triple-blind placebo-controlled trial

  • Clinical Trial
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Purpose

To compare the efficacy of cinnarizine/betahistine combination with the respective monotherapies in patients with acute peripheral vertigo (APV).

Method

A randomized, triple-blind placebo-controlled phase III trial was performed on 162 patients with APV to compare the efficacy of cinnarizine/betahistine combination with the respective monotherapies. Patients were randomly allocated into three groups (n = 54 each) of Bet. (betahistine and placebo), Cin. (cinnarizine and placebo), and Bet. + Cin. (betahistine and cinnarizine). The first group received cinnarizine tablets (25 mg) plus placebo three times a day, the second group received betahistine tablets (8 mg) plus placebo three times a day, and the third group received betahistine (8 mg) plus cinnarizine (25 mg) combination three times a day. The treatments were continued for 1 week. Patients were followed up to 3 days and 1 week after initiation of the treatments for changes in vertigo severity measured by visual grading scale (VAS), mean vertigo score (MVS), and mean concomitant symptom score (MCSS).

Results

Results showed a significant difference between the groups in VAS (p = 0.001), MVS (p = 0.0001), and MCSS (p = 0.0001) at 1-week follow-up, where the respective values were significantly lower in the Cin. + Bet. group as compared with the respective monotherapies. Efficacy and tolerability of the treatment were found to be higher in the Cin. + Bet. group at 3-day and 1-week follow-up periods (p = 0.0001, for all comparisons). None of the patients reported any side effects during the study.

Conclusion

This study indicated the superiority of the cinnarizine/betahistine combination over the respective monotherapies in the treatment of APV.

Trial registration

IRCT20130710013947N9

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Mira E, Guidetti G, Ghilardi L, Fattori B, Malannino N, Maiolino L, Mora R, Ottoboni S, Pagnini P, Leprini M, Pallestrini E, Passali D, Nuti D, Russolo M, Tirelli G, Simoncelli C, Brizi S, Vicini C, Frasconi P (2003) Betahistine dihydrochloride in the treatment of peripheral vestibular vertigo. Eur Arch Otorhinolaryngol 260:73–77

    Article  Google Scholar 

  2. McClure JA, Lycett P, Baskerville JC (1982) Diazepam as an anti-motion sickness drug. J Otolaryngol 11:253–259

    CAS  PubMed  Google Scholar 

  3. Claes J, Van de Heyning PH (1997) Medical treatment of Meniere’s disease: a review of literature. Acta Otolaryngol Suppl 526:37–42

    Article  CAS  Google Scholar 

  4. Casani AP, Dallan I, Cerchiai N, Lenzi R, Cosottini M, Sellari-Franceschini S (2013) Cerebellar infarctions mimicking acute peripheral vertigo: how to avoid misdiagnosis? Otolaryngol Head Neck Surg 148(3):475–481

    Article  Google Scholar 

  5. Hahn A, Sejna I, Stefflova B, Schwarz M, Baumann W (2008) A fixed combination of cinnarizine/dimenhydrinate for the treatment of patients with acute vertigo due to vestibular disorders: a randomized, reference-controlled clinical study. Clin Drug Invest 28(2):89–99

    Article  CAS  Google Scholar 

  6. Marill KA, Walsh MJ, Nelson BK (2000) Intravenous lorazepam versus dimenhydrinate for treatment of vertigo in the emergency department: a randomized clinical trial. Ann Emerg Med 36:310–319

    Article  CAS  Google Scholar 

  7. Pianese CP, Hidalgo LO, Gonzalez RH, Madrid CE, Ponce JE, Ramirez AM et al (2002) New approaches to the management of peripheral vertigo: efficacy and safety of two calcium antagonists in a 12-week, multinational, double-blind study. Otol Neurotol  23:357–363

    Article  Google Scholar 

  8. Irving C, Richman P, Kaiafas C, Eskin B, Allegra J (2002) Intramuscular droperidol versus intramuscular dimenhydrinate for the treatment of acute peripheral vertigo in the emergency department: a randomized clinical trial. Acad Emerg Med 9:650–653

    Article  Google Scholar 

  9. Ariyasu L, Byl FM, Sprague MS, Adour KK (1990) The beneficial effect of methylprednisolone in acute vestibular vertigo. Arch Otolaryngol Head Neck Surg 116:700–703

    Article  CAS  Google Scholar 

  10. Berisavac II, Pavlović AM, Trajković JJ, Šternić NM, Bumbaširević LG (2015) Drug treatment of vertigo in neurological disorders. Neurol India 63:933–939

    Article  Google Scholar 

  11. Motamed H, Moezzi M, Rooyfard AD, Angali KA, Izadi Z (2017) A comparison of the effects and side effects of oral betahistine with injectable promethazine in the treatment of acute peripheral vertigo in emergency. J Clin Med Res 9(12):994–997

    Article  Google Scholar 

  12. Hahn A, Novotný M, Shotekov PM, Cirek Z, Bognar-Steinberg I, Baumann W (2011) Comparison of cinnarizine/dimenhydrinate fixed combination with the respective monotherapies for vertigo of various origins. Clin drug invest 31(6):371–383

    Article  CAS  Google Scholar 

  13. Schremmer D, Bognar-Steinberg I, Baumann W (1999) Efficacy and tolerability of a fixed combination of cinnarizine and dimenhydrinate in treatment of vertigo. Clin Drug Invest 18:355–368. https://doi.org/10.2165/00044011-199918050-00003

    Article  CAS  Google Scholar 

  14. Scholtz AW, Steindl R, Burchardi N, Bognar-Steinberg I, Baumann W (2012) Comparison of the therapeutic efficacy of a fixed low-dose combination of cinnarizine and dimenhydrinate with betahistine in vestibular neuritis: a randomized, double-blind, non-inferiority study. Clin Drug Invest 32:387–399

    Article  CAS  Google Scholar 

  15. Ramos Alcocer R, Ledezma Rodríguez JG, Navas Romero A, Cardenas Nuñez JL, Rodríguez Montoya V, Deschamps JJ, Liviac Ticse JA (2015) Use of betahistine in the treatment of peripheral vertigo. Acta Otolaryngol 135(12):1205–1211. https://doi.org/10.3109/00016489.2015.1072873

    Article  CAS  PubMed  Google Scholar 

  16. Dolatabadi AA, Larimi SR, Safaie A (2019) Oral piracetam vs betahistine in outpatient management of peripheral vertigo; a randomized clinical trial. Archives of academic emergency medicine 7:1

    Google Scholar 

  17. Kentala E, Rauch SD (2003) A practical assessment algorithm for diagnosis of dizziness. Otolaryngol Head Neck Surg 128(1):54–59. https://doi.org/10.1067/mhn.2003.47

    Article  PubMed  Google Scholar 

  18. Cirek Z, Schwarz M, Baumann W, Novotny M (2005) Efficacy and tolerability of a fixed combination of cinnarizine and dimenhydrinate versus betahistine in the treatment of otogenic vertigo: a double-blind, randomised clinical study. Clin Drug Investig 25(6):377–389

    Article  CAS  Google Scholar 

  19. Strupp M, Dieterich M, Brandt T (2013) The treatment and natural course of peripheral and central vertigo. Dtsch Arztebl Int 110(29–30):505

    PubMed  PubMed Central  Google Scholar 

  20. Kerber KA (2009) Vertigo and dizziness in the emergency department. Emerg Med Clin North Am 27(1):39–50

    Article  Google Scholar 

  21. Kirtane MV, Bhandari A, Narang P, Santani R (2007) Cinnarizine: a contemporary review. Indian Journal of Otolaryngol Head  Neck Surg ;pp.1–9

  22. Scholtz AW, Ilgner J, Loader B, Pritschow BW, Weisshaar G (2016) Cinnarizine and dimenhydrinate in the treatment of vertigo in medical practice. Wien Klin Wochenschr 128(9–10):341–347

    Article  CAS  Google Scholar 

  23. Scholtz AW, Schwarz M, Baumann W, Kleinfeldt D, Scholtz HJ (2004) Treatment of vertigo due to acute unilateral vestibular loss with a fixed combination of cinnarizine and dimenhydrinate: a double-blind, randomized, parallel-group clinical study. Clin Ther 26(6):866–877

    Article  CAS  Google Scholar 

  24. Parfenov VA, Golyk VA, Matsnev EI, Morozova SV, Melnikov OA, Antonenko LM, Sigaleva EE, Situkho MI, Asaulenko OI, Popovych VI, Zamergrad MV (2017) Effectiveness of betahistine (48 mg/day) in patients with vestibular vertigo during routine practice: the VIRTUOSO study. PLoS One 12(3):e0174114

    Article  Google Scholar 

  25. Morozova SV, Alekseeva NS, Lilenko SV, Matsnev EI, Melnikov OAE (2015) Effects and safety profile of betahistine in patients in the Russian contingent of OSVaLD, an open-label observational study in vestibular vertigo. Int j  Gen Med 8:47

  26. Melnikov OA, Lilenko SV, Nauta J, Ouwens MJ (2015) Betahistine plus piracetam dual therapy versus betahistine monotherapy for peripheral vestibular vertigo: a confounder-corrected subanalysis of the OSVaLD study. Curr Med Res Opin 31(11):1951–1962

    CAS  PubMed  Google Scholar 

  27. Deering RB, Prescott P, Simmons RL, Downey LJ (1986) A double-blind crossover study comparing betahistine and cinnarizine in the treatment of recurrent vertigo in patients in general practice. Curr Med Res Opin 10(4):209–214

    Article  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Guilan Road Trauma Research Center, Guilan University of Medical Sciences, Rasht, Iran

    Payman Asadi, Seyyed Mahdi Zia Ziabari & Karim Vatanparast

  2. Neurosciences Research Center, Tabriz University of Medical Sciences, Tabriz, Iran

    Alireza Majdi

  3. Department of Neurosurgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran

    Seyed Ahmad Naseri Alavi

Authors
  1. Payman Asadi
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Seyyed Mahdi Zia Ziabari
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Alireza Majdi
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Karim Vatanparast
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Seyed Ahmad Naseri Alavi
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

Peyman Asadi: data collection, supervision of the research, idea procurement

Seyed Mehdi Zia Ziabari: data collection, supervision of the research, idea procurement

Alireza Majdi: writing, supervision of the research, idea procurement, final approval of the manuscript

Karim Vatanparast: data collection, supervision of the research, idea procurement

Seyed Ahmad Naseri Alavi: supervision of the research, idea procurement, writing, drafting, analysis of the article, final approval of the manuscript

Corresponding author

Correspondence to Seyed Ahmad Naseri Alavi.

Ethics declarations

Written informed consent was obtained from all of the patients. The Ethics committee of Guilan University of Medical Sciences approved this study under “IR.GUMS.REC.1397.360” code.

Conflict of interest

The authors declare that they have no conflict of interest.

Additional information

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

ESM 1

(DOCX 13.4 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Asadi, P., Zia Ziabari, S.M., Majdi, A. et al. Cinnarizine/betahistine combination vs. the respective monotherapies in acute peripheral vertigo: a randomized triple-blind placebo-controlled trial. Eur J Clin Pharmacol 75, 1513–1519 (2019). https://doi.org/10.1007/s00228-019-02741-x

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00228-019-02741-x

Keywords

Search

Navigation