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A Randomized Double-blind Controlled Clinical Study

Michael Weiser, MBChB; Wolfgang Strösser, MD, MBChB; Peter Klein, MSc

Arch Otolaryngol Head Neck Surg. 1998;124:879-885.

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.

From the Biologische Heilmittel Heel GmbH, Baden-Baden (Dr Weiser), Clinical Research and Pharma Consulting, Bergisch Gladbach (Dr Strösser), and Datenservice Eva Hönig GmbH, Rohrbach (Mr Klein), Germany.

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