Kienle G S, Berrino F, Büssing A, Portalupi E, Rosenzweig S, Kiene H
Institute for Applied Epistemology and Medical Methodology, Bad Krozingen/Freiburg, Germany.
Eur J Med Res. 2003 Mar 27;8(3):109-19.
Mistletoe preparations are among the most widely used unconventional cancer therapies in Central Europe. Their clinical effectiveness, however, is controversial.
To investigate whether prospective controlled clinical trials provide evidence for efficacy of mistletoe therapy in cancer.
Systematic review.
Search of 11 electronic databases, reference lists and expert consultations. Criteria based analysis was performed to assess methodological quality of the studies.
Twenty-three studies were identified: 16 randomized, 2 quasi-randomized and 5 non-randomized. Cancer sites included breast, lung, stomach, colon, rectum, head and neck, kidney, bladder, melanoma, glioma, and genital. Among these studies, statistically significant positive outcomes were reported for survival (n = 8), tumor remission (n = 1), overall quality of life (QOL) (n = 3), and QOL in relation to side effects during cytoreductive therapy (n = 3). Further, positive trends were reported for survival (n = 8), disease-free-survival (n = 1), and tumor remission (n = 2). Several studies reported no effect on survival (n = 4), disease-free-survival (n = 1), recurrence (n = 2), remission (n = 3), and QOL (n = 1). One study showed a negative trend for disease-free-survival. However, methodological quality of the studies was sometimes far below the standard that is today regarded as optimal or necessary. In view of substantial heterogeneity of the studies and potential positive and negative biases, we considered effect size estimation by quantitative synthesis to be unreliable and decided on a non-quantitative synthesis and discussion. Mistletoe therapy was well tolerated, and no major side effects were noted.
Among 23 identified studies evaluated for clinically relevant outcome measures, 12 studies showed one or more statistically significant, positive results, another 7 studies showed at least one positive trend, 3 showed no effect and 1 had a negative trend. All studies, however, suffered from methodological shortcomings to some degree, and many of the studies are not conclusive. As several reasonably well conducted studies indicate beneficial effects, further properly designed trials should be encouraged. Future controlled studies should take into account the methodological limitations and potential biases of these past mistletoe trials.
在中欧，槲寄生制剂是使用最为广泛的非传统癌症治疗方法之一。然而，其临床疗效存在争议。
探讨前瞻性对照临床试验是否能为槲寄生疗法治疗癌症的疗效提供证据。
系统评价。
检索11个电子数据库、参考文献列表并咨询专家。采用基于标准的分析方法评估研究的方法学质量。
共纳入23项研究，其中16项为随机对照试验，2项为准随机对照试验，5项为非随机对照试验。癌症部位包括乳腺、肺、胃、结肠、直肠、头颈部、肾脏、膀胱、黑色素瘤、胶质瘤和生殖器。在这些研究中，报告了生存（n = 8）、肿瘤缓解（n = 1）、总体生活质量（QOL）（n = 3）以及与细胞减灭治疗期间副作用相关的生活质量（n = 3）方面具有统计学意义的阳性结果。此外，报告了生存（n = 8）、无病生存（n = 1）和肿瘤缓解（n = 2）方面的阳性趋势。多项研究报告对生存（n = 4）、无病生存（n = 1）、复发（n = 2）、缓解（n = 3）和生活质量（n = 1）无影响。一项研究显示无病生存呈负趋势。然而，这些研究的方法学质量有时远低于当今被视为最佳或必要的标准。鉴于研究的实质性异质性以及潜在的正负偏差，我们认为通过定量综合进行效应量估计不可靠，因此决定进行非定量综合和讨论。槲寄生疗法耐受性良好，未观察到重大副作用。
在针对临床相关结局指标评估的23项纳入研究中，12项研究显示一项或多项具有统计学意义的阳性结果，另外7项研究显示至少一项阳性趋势，3项研究显示无影响，1项研究显示负趋势。然而，所有研究在某种程度上都存在方法学缺陷，许多研究尚无定论。由于几项实施良好的研究表明了有益效果，应鼓励进一步开展设计合理的试验。未来的对照研究应考虑这些既往槲寄生试验的方法学局限性和潜在偏差。
