Institute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health, Health Services Research and Health Technology Assessment, UMIT TIROL - University for Health Sciences, Medical Informatics and Technology, Hall i. T., Austria.
Institute for Ethics, History and Philosophy of Medicine, Hannover Medical School, Hannover, Germany.
Ger Med Sci. 2022 Jul 14;20:Doc10. doi: 10.3205/000312. eCollection 2022.
Chemotherapy is often used in the treatment of breast cancer in women. Side effects such as diarrhea, fatigue, hair loss, fever or disturbances in blood formation impair the women's quality of life. An essential treatment goal of the accompanying mistletoe therapy (MT) used in complementary medicine is to improve the health-related quality of life during cancer therapy.
The HTA report on which this article is based examines the medical efficacy and safety, costs and cost-effectiveness, patient and social aspects, and ethical aspects of MT in women with breast cancer. Systematic reviews were conducted for this purpose. The search period of the literature search ranged from 2004 to October 2020.
A total of 2 evidence-based medical guidelines, 3 randomized trials assessing efficacy and 1 additional non-randomized intervention trial, as well as 3 observational studies assessing safety, a cost analysis, 12 cross-sectional studies on patient aspects and 17 articles on ethical evaluation were included. Improvements in health-related quality of life compared to the control group were small to moderate. Due to the high risk of bias in the studies, it is possible that the difference is not caused by MT. One study with a small sample size showed no effect on progression-free survival after 5 years. Studies on the effect of MT on overall survival are lacking. In seven studies, local skin reactions of low and moderate severity were reported in a median of 25% (range 5 to 94%) of patients, and mild to moderate systemic reactions in a median of 2% (range 0 to 8%) of patients. A comparative cost analysis from Germany reported significantly lower medical costs within 5 years after surgery for patients with MT than for patients without MT, but the underlying observational study did not control for systematic bias. With regard to patient aspects, the frequency of use and the reasons for use from the patient's or practitioner's point of view were mainly investigated. A median of 25% (range 7 to 46%) of patients with breast cancer and 29% (range 29 to 79%) of treatment providers use MT. The main motivations of patients for use were to reduce side effects, strengthen the immune system and take an active role in the treatment process. Patients felt insufficiently advised. Studies on other aspects are lacking. The ethical evaluation was able to identify 6 overarching themes; the central challenge is the insufficient evidence on efficacy and safety.
化疗常用于治疗女性乳腺癌。腹泻、疲劳、脱发、发热或血液形成障碍等副作用会降低女性的生活质量。顺势疗法（MT）作为一种补充医学疗法，其伴随治疗的一个重要目标是改善癌症治疗期间的健康相关生活质量。
本文所依据的 HTA 报告考察了 MT 对乳腺癌女性的医学疗效和安全性、成本和成本效益、患者和社会方面以及伦理方面。为此目的进行了系统评价。文献检索的搜索期为 2004 年至 2020 年 10 月。
共纳入 2 项基于证据的医学指南、3 项评估疗效的随机试验以及 1 项额外的非随机干预试验、3 项评估安全性的观察性研究、1 项成本分析、12 项患者方面的横断面研究和 17 篇伦理评估文章。与对照组相比，健康相关生活质量的改善较小至中等。由于研究中的偏倚风险高，这种差异可能不是由 MT 引起的。一项样本量较小的研究显示，5 年后无进展生存期无影响。缺乏 MT 对总生存期影响的研究。在 7 项研究中，中位数为 25%（范围 5%至 94%）的患者报告了低至中度的局部皮肤反应，中位数为 2%（范围 0%至 8%）的患者报告了轻度至中度全身反应。来自德国的一项比较性成本分析报告称，接受 MT 的患者在手术后 5 年内的医疗费用明显低于未接受 MT 的患者，但基础观察性研究并未控制系统性偏倚。在患者方面，主要从患者或治疗提供者的角度调查了 MT 的使用频率和使用原因。中位数为 25%（范围 7%至 46%）的乳腺癌患者和 29%（范围 29%至 79%）的治疗提供者使用 MT。患者使用 MT 的主要动机是减少副作用、增强免疫系统并在治疗过程中积极参与。患者感到接受的建议不足。其他方面的研究缺乏。伦理评估能够确定 6 个总体主题；核心挑战是疗效和安全性证据不足。
