Background and ObjectiveVertigo derived from peripheral vestibular disorders is quite frequently encountered in daily clinical practice and can be a severely disabling symptom associated with substantial impairment of health-related quality of life for the affected patients. Betahistine, a structural analogue of histamine and presumably the most widely prescribed anti-vertigo drug worldwide, has previously been shown to be an effective and safe treatment for these patients. The objective of the present study was to evaluate whether the fixed combination of cinnarizine and dimenhydrinate (Arlevert®) is non-inferior and thus a potentially useful alternative to betahistine dihydrochloride in the treatment of patients suffering from peripheral vestibular vertigo.MethodsIn this prospective, multicenter, double-blind, randomized, non-inferiority clinical trial, outpatients from 8 ENT clinics in Austria, Bulgaria, the Czech Republic and Russia were randomly assigned to receive three times daily one tablet of either the fixed combination cinnarizine 20 mg/dimenhydrinate 40 mg or betahistine dihydrochloride 16 mg for 4 weeks. Primary endpoint was the reduction of the mean vertigo score (MVS), a validated 12-item composite score defined as the mean of 6 vertigo symptoms (dystasia and walking unsteadiness, staggering, rotary sensation, tendency to fall, lift sensation, blackout) and 6 trigger factors for vertigo (change of position, bowing, getting up, driving by car/train, head movements, eye movement), after 4 weeks of therapy, as judged by the patient on a 5-point visual analogue scale (VAS). The non-inferiority margin was set to 0.3. Secondary outcomes included the patient’s and investigator’s judgment of global efficacy, the patient’s rating of impairment of daily activities, and safety/tolerability of the treatments.ResultsThree hundred and six patients (mean age 53.5 years, approximately 60% female) were enrolled and randomized to the fixed combination cinnarizine/dimenhydrinate (n = 152) or betahistine (n = 154) groups; 297 patients completed the study and 294 (146 and 148, respectively) were valid for the per-protocol analysis, which was used for the non-inferiority analysis. Treatment with cinnarizine/dimenhydrinate led to a stronger reduction of the MVS [least squares mean (LSM)] after 4-week therapy (primary endpoint) in comparison to betahistine (0.395 vs 0.488; difference: − 0.093, 95% CI − 0.180; − 0.007, p = 0.035); since the upper limit of the two-sided 95% confidence interval was not only below the non-inferiority margin of 0.3, but also entirely below 0, superiority of the fixed combination could be demonstrated. The combination preparation was also more effective after 1 week of therapy and received more favorable patient’s ratings on overall efficacy and impairment of daily activities. Both treatments were very well tolerated. Only 12 patients (3.92%) reported 13 non-serious adverse events; 2 cinnarizine/dimenhydrinate-treated patients discontinued the study prematurely due to adverse events as compared ...

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The objective of the present study was to elaborate the therapeutic algorithm for the treatment of laryngomycosis. We have examined a total of 430 patients suffering from chronic laryngitis including 100 ones (23.2%) having the fungal flora. Mycosis was diagnosed by the microscopic study of the stained preparations with the application of various techniques; moreover, cultivation in elective nutrient media was used. The yeast-like fungi of the genus Candida were identified in 98 (98%) and mold fungi of the genus Aspergillus in the remaining 2 (2%) patients. All these 100 patients were given the antifungal treatment. 98 of them presenting with candidal laryngitis were allocated to three groups. Group A was comprised of 33 patients who received the local treatment alone, group B contained 31 patients given only systemic therapy, and group C included 34 patients undergoing the combined treatment with the use of the medications possessed of both the local and systemic actions. The best clinical results were obtained in the patients of the latter group in which the therapeutic efficiency proved to be as high as 79.4%. It is concluded that all the patients suffering from laryngomycosis are in need of the combined treatment designed to eradicate the causative agent, restore the vocal function, and achieve the stable remission of the chronic inflammatory process in the larynx. The combined treatment with the antimycotic medications exhibiting both the general systemic and local activities during 3 weeks appears to be the optimal therapeutic modality for the management of laryngomycosis. Of special importance is the dynamic follow-up of the treated patients including the control examinations in the course of the treatment (days 7, 14, and 21) to be followed by the mycological study after the termination of therapy and its repetition every 3 months during the subsequent period.