A systematic review of the quality of homeopathic clinical trials.
A systematic review of the quality of homeopathic clinical trials.
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DOI：
10.1186/1472-6882-1-12
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发表时间：
2001-01-01
影响因子：
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通讯作者：
Lyons, J S
中科院分区：
文献类型：
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作者：
Jonas, W B;Anderson, R L;Lyons, J S
背景：虽然一些顺势疗法临床试验的综述已经完成，但所有的方法都依赖于与顺势疗法实践不同的对抗疗法诊断分类。此外，尚无文献综述使用已建立和验证的质量标准来直接比较对抗疗法和顺势疗法文献。方法：在一项系统综述中，我们比较了顺势疗法临床试验研究的质量和使用经过验证的系统中立方法的常规疗法研究样本。选取1945-1995年间以英文发表的所有顺势疗法平行治疗组的临床试验。所有这些都是用一套既定的33个效度标准进行评估的，这些标准先前在不同医疗系统的广泛卫生干预措施中得到了验证。标准包括统计结论、内部效度、结构效度和外部效度。准则应用的信度大于0.95。结果：59项研究符合纳入标准。其中79%来自同行评议的期刊，29%使用安慰剂对照，51%使用随机分配，86%没有考虑潜在的混杂变量。主要的效度问题是在测量中，96%的人没有报告被筛选对象的比例，64%的人没有报告损耗率。在报道了这一情况的研究中，17%的受试者退出了研究。在研究条件中几乎没有重复或重叠，大多数研究相对较小，在单一地点进行。与传统疗法研究相比，顺势疗法研究的总体质量较差，近年来仅略有改善。结论：顺势疗法的临床研究显然还处于起步阶段，大多数研究采用了较差的采样和测量技术，受试者少，地点单一，无重复。如果有足够的研究专长、支持和方法，即使在“整体”范式中，这些问题中的许多也是可以纠正的。
BACKGROUND: While a number of reviews of homeopathic clinical trials have been done, all have used methods dependent on allopathic diagnostic classifications foreign to homeopathic practice. In addition, no review has used established and validated quality criteria allowing direct comparison of the allopathic and homeopathic literature.METHODS: In a systematic review, we compared the quality of clinical-trial research in homeopathy to a sample of research on conventional therapies using a validated and system-neutral approach. All clinical trials on homeopathic treatments with parallel treatment groups published between 1945-1995 in English were selected. All were evaluated with an established set of 33 validity criteria previously validated on a broad range of health interventions across differing medical systems. Criteria covered statistical conclusion, internal, construct and external validity. Reliability of criteria application is greater than 0.95.RESULTS: 59 studies met the inclusion criteria. Of these, 79% were from peer-reviewed journals, 29% used a placebo control, 51% used random assignment, and 86% failed to consider potentially confounding variables. The main validity problems were in measurement where 96% did not report the proportion of subjects screened, and 64% did not report attrition rate. 17% of subjects dropped out in studies where this was reported. There was practically no replication of or overlap in the conditions studied and most studies were relatively small and done at a single-site. Compared to research on conventional therapies the overall quality of studies in homeopathy was worse and only slightly improved in more recent years.CONCLUSIONS: Clinical homeopathic research is clearly in its infancy with most studies using poor sampling and measurement techniques, few subjects, single sites and no replication. Many of these problems are correctable even within a "holistic" paradigm given sufficient research expertise, support and methods.