Cinnarizine/betahistine combination vs. the respective monotherapies in acute peripheral vertigo: a randomized triple-blind placebo-controlled trial
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To compare the efficacy of cinnarizine/betahistine combination with the respective monotherapies in patients with acute peripheral vertigo (APV).
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 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.
This study indicated the superiority of the cinnarizine/betahistine combination over the respective monotherapies in the treatment of APV.
KeywordsAcute peripheral vertigo Cinnarizine Betahistine Combination Monotherapy
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
Compliance with ethical standards
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.
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