Additional treatment with mistletoe extracts for patients with breast cancer compared to conventional cancer therapy alone - efficacy and safety, costs and cost-effectiveness, patients and social aspects, and ethical assessment.

Background: 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. Aim and methods: 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. Results: 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.

"Same same but different"? On the questionable but crucial differentiation between ethical and social aspects in health technology assessment.

INTRODUCTION: In health technology assessment (HTA), the demarcation of ethical and social aspects in two separate domains is a given fact. While an overlapping of ethical and social aspects is possible, this also raises theoretical and methodological questions, such as why overlaps happen (on the basis of which understanding of ethical and social aspects), or whether they are legitimate from a methodological point of view. METHODS: We analyzed, on a basis of purposive sampling, a) two well-known HTA frameworks (HTA Core Model, INTEGRATE-HTA), b) methodological literature about ethical and/or social aspects in HTA, and c) published HTA reports from the German DAHTA database and the international CRD database regarding statements on the understanding (definition/characterization) and relationship between ethical and social aspects. RESULTS: The frameworks use identical definitions for ethical aspects but deviate when it comes to social aspects. Methodological papers do not always provide a definition of social and ethical aspects. In the context of ethical aspects, they often refer back to ethics as a base discipline that deals with the motives and consequences of good and bad actions for ethical aspects, while for social aspects, there is orientation towards already existing checklists and methods, without reference to a base discipline such as sociology. The analyzed HTA reports barely offered details on their understanding of ethical or social aspects (7% of n = 33). DISCUSSION: The problem of defining/characterizing and differentiating ethical and social aspects exists in both theory and practice. The impression is that little attention is paid to demarcations and overlaps, and that also the methodological literature has not yet thoroughly addressed the issue. While there are also pragmatic reasons for the possible ambiguity between the ethical and the social domains, deeper epistemological issues related to the multi-/interdisciplinarity nature of HTA will have to be considered, too, such as the danger of "disciplinary capture" (pressure on some domains and their basic disciplines, e.g., ethics, to adopt the concepts and standards of other domains that are more dominant in HTA, e.g., efficacy assessment/evidenced-based medicine). CONCLUSION: The domains in HTA reports should be better described epistemologically and brought into a coherent relationship with each other. This is important to avoid unreasonable overlapping and possible problematic redundancy. Further, this could help with questions of adequate expertise and methods for the processing of all relevant information for solid technology assessment.