A randomized, open-label study to evaluate the effectiveness and safety of betahistine dihydrochloride in beta-cyclodextrin versus betahistine dihydrochloride in the treatment of vertigo

ABSTRACT

OBJECTIVE: To compare the effectiveness and safety of Betahistine dihydrochloride (in beta cyclodextrin) with Betahistine dihydrochloride in treating patients with vertigo.DESIGN/METHODS: This was a randomized, open label study enrolling 68 patients, ages 18 to 65 years old, diagnosed clinically with vertigo.RESULTS: Sixty two patients completed the study. EEV scores of both groups continuously decreased to similar levels. EEV scores significantly deceased from baseline to week 4. In group A patients, EEV scores decreased from 9.81+/- 3.73 at baseline to 2.39 +/- 3.46, pGroup A patients reported 2.6 +\- 2.9 side effects while Group B patients reported 2.7 +/- 2.5 side effects (p=0.92). There were more patients who experienced vomiting, abdominal pain, nausea, vomiting and/ or diarrhea in Group B patients (8/32 in Group A vs 16/30 in Group B, p=0.022).CONCLUSION: Betahistine dihydrochloride with beta cyclodextrin and Betahistine dihydrochloride alone are both effective in reducing the symptoms of dizziness from vertiginous syndromes. Betahistine dihydrochloride with beta cyclodextrin appears to have less gastrointestinal side effects than Betahistine dihydrochloride alone.