M Weiser1, W Strösser, P Klein. 1. Biologische Heilmittel Heel GmbH, Baden-Baden, Germany. weiser.michael@heel.de
Abstract
OBJECTIVE: To compare the efficacy and safety of a homeopathic remedy (Vertigoheel, Heel Inc, Albuquerque, NM) vs betahistine hydrochloride (active control) in the treatment of patients with vertigo of various origins in a confirmative equivalence trial. DESIGN: Randomized (1:1) double-blind controlled clinical trial. SETTING:Fifteen study centers (general practice) in Germany between November 1995 and November 1996. SUBJECTS: A total of 119 patients with vertigo of various origins (from whom 105 patients could be analyzed as intended per protocol). MAIN OUTCOME MEASURES: Frequency, duration, and intensity of vertigo attacks. RESULTS: Both homeopathic and conventional treatments showed a clinically relevant reduction in the mean frequency, duration, and intensity of the vertigo attacks. The therapeutic equivalence of the homeopathic remedy and betahistine was established statistically. CONCLUSIONS: Concerning the main efficacy variable, therapeutic equivalence between the homeopathic remedy and betahistine could be shown with statistical significance (confirmative analysis). Both remedies reduced the frequency, duration, and intensity of vertigo attacks during a 6-week treatment period. Also, vertigo-specific complaints were significantly reduced in both treatment groups.
RCT Entities:
OBJECTIVE: To compare the efficacy and safety of a homeopathic remedy (Vertigoheel, Heel Inc, Albuquerque, NM) vs betahistine hydrochloride (active control) in the treatment of patients with vertigo of various origins in a confirmative equivalence trial. DESIGN: Randomized (1:1) double-blind controlled clinical trial. SETTING: Fifteen study centers (general practice) in Germany between November 1995 and November 1996. SUBJECTS: A total of 119 patients with vertigo of various origins (from whom 105 patients could be analyzed as intended per protocol). MAIN OUTCOME MEASURES: Frequency, duration, and intensity of vertigo attacks. RESULTS: Both homeopathic and conventional treatments showed a clinically relevant reduction in the mean frequency, duration, and intensity of the vertigo attacks. The therapeutic equivalence of the homeopathic remedy and betahistine was established statistically. CONCLUSIONS: Concerning the main efficacy variable, therapeutic equivalence between the homeopathic remedy and betahistine could be shown with statistical significance (confirmative analysis). Both remedies reduced the frequency, duration, and intensity of vertigo attacks during a 6-week treatment period. Also, vertigo-specific complaints were significantly reduced in both treatment groups.