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.
BACKGROUND
Acute unilateral vestibular loss is a balance disorder that is accompanied by vertigo symptoms and concomitant vegetative symptoms, including nausea and vomiting. Patients are frequently confined to bed rest but may continue to experience vertigo symptoms. A well-established antivertiginous therapy consisting of cinnarizine and dimenhydrinate at low doses may offer rapid relief of acute vertigo symptoms due to acute vestibular loss, without inhibiting physiological compensation processes.


OBJECTIVE
The purpose of this study was to compare the clinical efficacy and tolerability of a fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg versus monotherapy with its respective components in the treatment of acute vertigo symptoms due to acute unilateral vestibular loss.


METHODS
In this prospective, single-center, randomized, double-blind, parallel-group clinical study, 50 patients with acute vestibular vertigo were randomly assigned to receive 4 weeks of treatment (1 tablet 3 times daily) with a fixed combination of 20 mg cinnarizine and 40 mg dimenhydrinate, 20 mg cinnarizine alone, or 40 mg dimenhydrinate alone. All patients received a 15% mannitol infusion as standard therapy during the first 6 days of treatment. Efficacy was determined by the patients' assessments of vertigo symptoms after 1 and 4 weeks of treatment using a verbal rating scale (vertigo score) and by vestibulo-ocular and vestibulospinal tests. The primary efficacy criterion was defined as the relief of vertigo symptoms after 1 week of treatment.


RESULTS
After 1 week of treatment, the fixed combination was significantly more effective than 20 mg cinnarizine (P < 0.001) and 40 mg dimenhydrinate (P < 0.01). After 4 weeks, the fixed combination was still significantly more effective than cinnarizine in reducing vertigo symptoms (P < 0.01) and significantly more effective than dimenhydrinate in improving the patients' balance while standing (P < 0.05). The tolerability of the fixed combination was rated good or very good by 100% of the patients (cinnarizine alone, 82.4%; dimenhydrinate alone, 94.4%). No serious adverse events occurred. Four patients in the fixed combination and the cinnarizine groups, and 6 patients in the dimenhydrinate group reported nonserious adverse events.


CONCLUSIONS
The results of this study suggest a distinct benefit in using a fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg versus the respective monotherapies in this population of patients with acute vestibular vertigo.
Scholtz
Arne W
AW
Department of Otorhinolaryngology, University of Innsbruck, Austria.
Schwarz
Mario
M
Baumann
Wolfgang
W
Kleinfeldt
Dieter
D
Scholtz
Heinz-Joachim
HJ
D000208:Acute Disease; D000704:Analysis of Variance; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D002936:Cinnarizine / Q000009:adverse effects / Q000627:therapeutic use*; D004111:Dimenhydrinate / Q000009:adverse effects / Q000627:therapeutic use*; D004234:Diuretics, Osmotic / Q000008:administration & dosage; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008353:Mannitol / Q000008:administration & dosage; D008875:Middle Aged; D009760:Nystagmus, Physiologic / Q000187:drug effects; D013997:Time Factors; D016896:Treatment Outcome; D014717:Vertigo / Q000188:drug therapy* / Q000209:etiology; D015837:Vestibular Diseases / Q000150:complications / Q000503:physiopathology*
D018926:Anti-Allergic Agents; D000932:Antiemetics; D004234:Diuretics, Osmotic; D004338:Drug Combinations; D002936:Cinnarizine; D008353:Mannitol; D004111:Dimenhydrinate