Kienle Gunver Sophia, Glockmann Anja, Grugel Renate, Hamre Harald Johan, Kiene Helmut
Institut für angewandte Erkenntnistheorie und medizinische Methodologie e.V. (IFAEMM), Freiburg i.Br., Deutschland.
Forsch Komplementmed. 2011;18(5):269-82. doi: 10.1159/000331812. Epub 2011 Oct 4.
In 2005 a Health Technology Assessment (HTA) report analyzed efficacy, effectiveness, safety, utilization and costs of Anthroposophic Medicine (AM). After a recent referendum of the ‘Swiss Population pro Complementary Medicine’ (May 2009) this HTA report was updated.
Update of the HTA report by a systematic review.
Methods corresponded to the existing HTA report and the guidelines of the Swiss Federal Office of Public Health. For clinical studies four databases and a specialized journal were searched, and extensive expert consultations were used. Studies were selected according to predefined inclusion criteria, data were extracted, and methodological quality was assessed individually.
70 new clinical studies were found. Altogether, 265 clinical studies investigated efficacy and effectiveness of AM: 38 randomized controlled trials, 36 prospective and 49 retrospective non-randomized controlled trials as well as 90 prospective and 52 retrospective trials without control groups. They investigated a wide spectrum of AM treatments in a multitude of diseases; the whole AM system in 38 trials, non-pharmacological therapies in 10 trials, AM mistletoe products in cancer therapy in 133 trials, and other AM medication treatments in 84 trials. Most studies showed a positive result for AM. Methodological quality differed substantially; some studies showed major limitations, others were reasonably well conducted. Trials with better quality still showed a positive result. External validity was usually high. Side effects or other risks were rare and usually described to be mild or moderate. Studies regarding safety showed a good tolerability altogether.
Trials of varying design and quality in a variety of diseases predominantly describe good clinical outcomes for AM, only marginal side effects, high satisfaction of patients with regard to results and safety and presumably slightly less costs. Further high-quality evaluations are desirable.
2005年，一份卫生技术评估（HTA）报告分析了人智医学（AM）的疗效、有效性、安全性、使用情况及成本。在近期（2009年5月）“瑞士支持补充医学人群”的全民公投之后，这份HTA报告得到了更新。
通过系统综述对HTA报告进行更新。
方法与现有的HTA报告及瑞士联邦公共卫生局的指南一致。针对临床研究，检索了四个数据库及一本专业期刊，并进行了广泛的专家咨询。根据预先设定的纳入标准选择研究，提取数据，并分别评估方法学质量。
发现了70项新的临床研究。总共265项临床研究调查了人智医学的疗效和有效性：38项随机对照试验、36项前瞻性和49项回顾性非随机对照试验，以及90项前瞻性和52项无对照组的回顾性试验。这些研究调查了多种疾病中的广泛人智医学治疗方法；38项试验研究了整个人智医学体系，10项试验研究了非药物疗法，133项试验研究了人智医学槲寄生产品在癌症治疗中的应用，84项试验研究了其他的人智医学药物治疗。大多数研究显示人智医学有积极效果。方法学质量差异很大；一些研究存在重大局限性，另一些则开展得较为合理。质量较好的试验仍显示出积极结果。外部效度通常较高。副作用或其他风险很少见，通常描述为轻度或中度。关于安全性的研究总体显示出良好的耐受性。
针对多种疾病的不同设计和质量的试验主要描述了人智医学良好的临床结果、仅轻微的副作用、患者对结果和安全性的高度满意度以及可能略低的成本。需要进一步进行高质量的评估。
