Efficacy and tolerability of a fixed low-dose combination of cinnarizine and dimenhydrinate in the treatment of vertigo: a 4-week, randomized, double-blind, active- and placebo-controlled, parallel-group, outpatient study.

BACKGROUND: Most cases of vertigo are attributable to both peripheral and central vestibular disorders. Therefore, it would be of interest to determine whether a combination therapy having both peripheral and central actions would translate into more efficient symptom relief. OBJECTIVE: This study was conducted to evaluate the efficacy and tolerability of a fixed low-dose combination of cinnarizine 20 mg + dimenhydrinate 40 mg in the treatment of vertigo of central, peripheral, or combined central/peripheral origin. METHODS: This was a prospective, multicenter, randomized, double-blind, active- and placebo-controlled, parallel-group, outpatient study in men and women (age >30 years) with central, peripheral, or combined central/peripheral vestibular vertigo. Patients who assessed > or =1 vertigo symptom as being of medium intensity (> or =2) on a 5-point visual analog scale (from 0 = no symptoms to 4 = very severe symptoms) and who had abnormal vestibulospinal movement patterns on cramocorpography were eligible. Patients were randomly assigned to receive 1 tablet of the fixed combination of cinnarizine 20 mg + dimenhydrinate 40 mg, cinnarizine 50 mg, dimenhydrinate 100 mg, or placebo 3 times daily for 4 weeks. The primary efficacy end point was the decrease in mean vertigo score (MVS), which was composed of 12 individual vertigo symptoms, each assessed on the 5-point visual analog scale after 4 weeks of treatment. RESULTS: The study enrolled 246 patients, of whom 239 were evaluable for efficacy. Approximately two thirds of the efficacy population were female and one third male. The mean age was 51.3 years, and the mean duration of vertigo was 2.6 years. The least squares mean (SD) change from baseline in MVS was significantly greater in the group receiving the fixed combination (1.37 [0.66]) than in any of the comparator groups (cinnarizine 50 mg: 0.87 [0.53]; dimenhydrinate 100 mg: 0.83 [0.66]; placebo: 0.76 [0.48]; all comparisons, P < 0.001). The differences were clinically relevant, based on the Mann-Whitney estimator. The incidence of vertigo-associated nausea was significantly reduced in the fixed-combination group relative to the comparator groups (P< or = 0.016). Thirty-four patients reported adverse events, 6 each in the fixed combination and placebo groups, 12 in the cinnarizine group, and 10 in the dimenhydrinate group. None of these adverse events were considered serious. After 4 weeks of treatment, the tolerability of treatment was rated as very good or good by 57 (96.6%) patients in the fixed-combination group; the values for cinnarizine, dimenhydrinate, and placebo were 54 (93.1%), 42 (72.4%), and 50 (87.7%), respectively. CONCLUSIONS: In this study, the fixed low-dose combination of cinnarizine 20 mg + dimenhydrinate 40 mg was effective, clinically beneficial, and well tolerated in patients with vestibular vertigo of central and/or peripheral origin. It was significantly more effective in reducing the MVS compared with placebo and the routinely prescribed higher doses of cinnarizine (50 mg) and dimenhydrinate (100 mg).

[Image-fusion-guided radioisotope I-125 stereotactic brachytherapy of acoustic neurinoma--new surgical method]. / Akusztikus neurinoma kezelése képfúzió-vezérelt szövetközi 125-jód-izotóp-besugárzással--új mútéti eljárás.

Gamma knife and multi leaf collimator Linac have recently gained significant space in the treatment of acoustic neurinomas. As our neurosurgical department does not own gamma knife or Linac, we have successfully pursued the 125Iodine interstitial irradiation of three acoustic neurinomas. Our patients were elderly people with poor general condition, therefore we decided to undertake interstitial irradiation because of the low tolerance for surgery. The follow-up period until March 2002, lasted five, 23 and 40 months in the three cases. At the end of the follow-up period the audiometrical examination stated slight enhancement of hearing in case one and case two. In case one, the tumor volume, as measured on the control MRI was 5.32 cm3, which meant a 21% shrinkage in contrast to the 6.74 cm3 target volume at the brachytherapy. In case two, the shrinkage was even more apparent. The tumor volume measured on the control MRI examination was 6.64 cm3, which was a 42% shrinkage of the 11.45 cm3 target volume at the moment of brachytherapy. Due to financial reasons, gamma knife and Linac are not available for many countries and neurosurgical institutes. In the absence of the above mentioned radiosurgical methods, we have shown brachytherapy as a new alternative and solution in the treatment of acoustic neurinoma in three patients.