Schneider Berthold, Klein Peter, Weiser Michael
Institut für Biometrie, Medizinische Hochschule Hannover, Germany.
Arzneimittelforschung. 2005;55(1):23-9. doi: 10.1055/s-0031-1296821.
The increasing interest in alternative medical practices has led to a number of controlled studies on herbal and homeopathic agents. This paper presents the results of a meta-analysis of four recent clinical trials evaluating the homeopathic preparation Vertigoheel (VH) compared with usual therapies (betahistine, Ginkgo biloba extract, dimenhydrinate) for vertigo in a total of 1388 patients. Two trials were observational studies and the other two were randomised double-blind controlled trials. The duration of treatment (6-8 weeks) and dosage were comparable in all studies. Treatments were evaluated for the variables "number of vertigo episodes", "intensity of episodes" and "duration of episodes". As the studies differed in the age of patients and in the baseline values of vertigo, the individual reductions of number, intensity and duration of episodes were adjusted on equal age and baseline values (total means). An analysis of variance (with studies as random effects) showed no relevant influence of studies on the adjusted reductions and no relevant interaction between studies and treatment effects. The meta-analysis of all four trials showed equivalent reductions with VH and with control treatment: mean reduction of the number of daily episodes 4.0 for VH and 3.9 for control (standard error 0.11 for both groups); mean reduction of the duration (on a scale 0-4) for VH 1.1 and for the control 1.0 (standard error 0.03 for both groups); mean reduction of the intensity (on a scale 0-4) for VH 1.18 and for the control 1.8 (standard error 0.03 for both groups). In the non-inferiority analysis from all trials, VH was non-inferior in all variables. The results show the applicability of meta-analyses on the data from studies with homeopathicdrugs and support the results from the individual studies indicating good efficacy and tolerability of VH in patients with vertigo.
人们对替代医学疗法的兴趣日益浓厚，这引发了一系列针对草药和顺势疗法药物的对照研究。本文呈现了一项荟萃分析的结果，该分析涉及四项近期的临床试验，共1388名眩晕患者，比较了顺势疗法制剂Vertigoheel（VH）与常规疗法（倍他司汀、银杏叶提取物、茶苯海明）治疗眩晕的效果。其中两项试验为观察性研究，另外两项为随机双盲对照试验。所有研究中治疗持续时间（6 - 8周）和剂量具有可比性。对“眩晕发作次数”“发作强度”和“发作持续时间”等变量进行了治疗效果评估。由于各研究中患者年龄和眩晕基线值存在差异，对发作次数、强度和持续时间的个体减少量根据相同年龄和基线值（总体均值）进行了调整。方差分析（将研究视为随机效应）表明，研究对调整后的减少量无相关影响，且研究与治疗效果之间无相关交互作用。对所有四项试验的荟萃分析显示，VH与对照治疗的减少量相当：VH组每日发作次数的平均减少量为4.0，对照组为3.9（两组标准误均为0.11）；VH组发作持续时间（0 - 4级评分）的平均减少量为1.1，对照组为1.0（两组标准误均为0.03）；VH组发作强度（0 - 4级评分）的平均减少量为1.18，对照组为1.8（两组标准误均为0.03）。在所有试验的非劣效性分析中，VH在所有变量上均非劣效。结果表明荟萃分析适用于顺势疗法药物研究的数据，并支持个体研究结果，即VH对眩晕患者具有良好的疗效和耐受性。
