Weiser M, Strösser W, Klein P
Biologische Heilmittel Heel GmbH, Baden-Baden, Germany.
Arch Otolaryngol Head Neck Surg. 1998 Aug;124(8):879-85. doi: 10.1001/archotol.124.8.879.
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.
Randomized (1:1) double-blind controlled clinical trial.
Fifteen study centers (general practice) in Germany between November 1995 and November 1996.
A total of 119 patients with vertigo of various origins (from whom 105 patients could be analyzed as intended per protocol).
Frequency, duration, and intensity of vertigo attacks.
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.
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.
在一项确证性等效性试验中，比较顺势疗法药物（Vertigoheel，Heel公司，新墨西哥州阿尔伯克基）与盐酸倍他司汀（活性对照药）治疗各种原因引起眩晕患者的疗效和安全性。
随机（1:1）双盲对照临床试验。
1995年11月至1996年11月期间德国的15个研究中心（全科医疗）。
共119例各种原因引起眩晕的患者（其中105例患者可按方案进行意向性分析）。
眩晕发作的频率、持续时间和强度。
顺势疗法和传统治疗均使眩晕发作的平均频率、持续时间和强度在临床上有显著降低。顺势疗法药物与倍他司汀的治疗等效性经统计学确立。
关于主要疗效变量，顺势疗法药物与倍他司汀之间的治疗等效性具有统计学意义（确证性分析）。两种药物在6周治疗期内均降低了眩晕发作的频率、持续时间和强度。此外，两个治疗组中眩晕特异性主诉均显著减少。
