Double-blind, randomized, multicenter study comparing the effect of betahistine and flunarizine on the dizziness handicap in patients with recurrent vestibular vertigo.
OBJECTIVE
The aim of this double-blind, randomized, multicenter study was to compare the efficacy of betahistine dihydrochloride (BH) and flunarizine (FL) using the Dizziness Handicap Inventory (DHI), a validated self-assessment questionnaire that has not previously been used in a clinical trial to evaluate antivertigo drugs.


METHODS
Patients with recurrent vertigo of peripheral vestibular origin and who were severely handicapped by vertigo were randomized to an 8-week course of treatment with oral BH 48 mg daily or oral FL 10 mg daily. The efficacy endpoints were the total DHI score and the physical, functional and emotional subscores.


RESULTS
Fifty-two patients completed the study. After 8 weeks of treatment the mean total DHI score and the physical subscore were significantly lower in the BH group compared to the FL group (7.5 and 3.6 points, respectively). The mean total DHI score as well as the three subscores decreased significantly after 4 and 8 weeks in both treatment groups.


CONCLUSIONS
This study showed that at 8 weeks BH is significantly more effective than FL in terms of improving the total DHI score and the physical subscore. It was also established that the DHI is a useful and reliable method for evaluating the efficacy of antivertigo drugs.
Albera
Roberto
R
Second Department of Otorhinolaryngology, San Giovanni Battista Hospital, University of Turin, Turin, Italy.
Ciuffolotti
Roberto
R
Di Cicco
Maurizio
M
De Benedittis
Giuseppe
G
Grazioli
Irene
I
Melzi
Gabriella
G
Mira
Eugenio
E
Pallestrini
Eugenio
E
Passali
Desiderio
D
Serra
Agostino
A
Vicini
Claudio
C
D000328:Adult; D000368:Aged; D001621:Betahistine / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005444:Flunarizine / Q000008:administration & dosage / Q000627:therapeutic use*; D017442:Histamine Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008575:Meniere Disease / Q000150:complications / Q000209:etiology; D008875:Middle Aged; D012008:Recurrence; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D014717:Vertigo / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology
D017442:Histamine Agonists; D014665:Vasodilator Agents; D005444:Flunarizine; D001621:Betahistine