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BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic is a threat to ongoing clinical trials necessitating regular face-to-face, in-person meetings, particularly in participants with a high risk of complications. Guidance on how to handle and safely continue such trials is lacking. Chronically ill elderly individuals require-in addition to protection from infection-regular physical exercise and social contact to remain healthy. Solutions on how to handle these conflicting necessities are needed. The ENTAIER-randomised controlled trial was investigating the influence of mindful movements on fall risk, fear of falling, mobility, balance, life quality, and other outcomes. The study population was planned to comprise of 550 chronically ill elderly individuals with a high risk of falling. The movements were regularly performed in coached groups over 6 months. After the trial began, COVID-19 lockdowns stopped all in-person meetings, and it was expected that the limitations of this pandemic would continue for a long term. Therefore, the exercise programme, which involved complex movements and was typically conducted face-to-face in groups, had to be substituted by a telemedicine programme within a short timeframe. The objectives, therefore, were to identify challenges and tasks that could to be resolved and steps that could to be taken to achieve high-quality, efficacy, safety, and enable human encounter and motivation. METHODS: We proceeded with four steps: 1) A literature review on the quality and feasibility issues of telemedicine in general, and specifically, in exercise training in elderly individuals. 2) Participation in two international telemedicine task forces on integrative medicine, particularly, mind-body medicine. 3) Interviews with study therapists, (for practical purposes, eurythmy therapists and Tai Chi teachers are summarized here as therapists) personnel, and international experts on providing mindful movement exercises and other physiotherapies via live telecommunication technology, and with scientists and patient representatives. 4) Final evaluation by the core trial team and subsequent planning and implementation of changes in the trial organisation. RESULTS: Various tasks and challenges were identified: for the technical equipment for therapists and patients; for the ability of therapists and trial participants to adequately manage the technology and telemedicine intervention; the reservations and concerns about the technology among therapists and participants; safety and data protection in using the technology; and study design. The two major options found on how to continue the trial in the COVID-19 situation were a complete switch to telemedicine and a partial switch in the form of risk management implemented into the former design. CONCLUSIONS: The management of an ongoing clinical trial in a national or international crisis with a minimum of available time and extra financial resources, alongside with two checklists on steps and procedures for trial continuation and telemedicine implementation, may be informative for other researchers or healthcare providers faced with similar challenges and making similar decisions in the current situation or similar future scenarios. TRAIL REGISTRATION: www.drks.de . DRKS00016609. Registered July 30, 2019.

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BACKGROUND: In elderly poeple, multimorbidity and polypharmacy increase while sensory, motor and cognitive functions decrease. Falls occur in 30% of people aged 65 years and older at least once per year, with injuries at 10-20%. Reducing falls and enhancing physical, emotional and cognitive capacities are essential for healthy aging despite chronic disease. Eurythmy therapy (EYT) and Tai Chi train balance, mobility and concentrative and sensory capacities. METHODS: In eight trial sites (academic or community hospitals), 550 outpatients aged 65 years and older with chronic disease and increased risk of falling (history of imbalance, Berg Balance Scale (BBS) score ≤ 49) will be randomly assigned (1:1:1) to receive either EYT or Tai Chi (each provided in one-hour group sessions, twice, later once per week plus practice at home, for over 24 weeks) added to standard care or standard care alone. Standard care includes a detailed written recommendation on fall prevention and the visit of a primary care doctor. Seniors living a reclusive life or economically disadvantaged elderly will be particularly addressed. A motivation and communication concept supports the trial participants' compliance with trial procedures and practicing. Public and patient representatives are involved in the planning and conduction of the trial. Falls will be documented daily in a diary by the participants. These falls as well as injuries and complications will be ascertained during monthly phone visits. The falls efficacy scale, BBS, cognition (MoCA), Mood (GDS-15), quality of life (SF12), instrumental activities of daily living (IADL), use of medical and non-medical services (FIMA) and adherence will be assessed at months 3, 6, and 12 and inner correspondence with practices (ICPH) at month 6. The trial is funded by the Federal Ministry of Education and Research (BMBF 01GL1805). DISCUSSION: This study will determine whether EYT and Tai Chi reduce falls, injurious falls, fear of falling and healthcare utilisation and improve mobility, cognition, mood, quality of life and functional independence. A reduction of fall risk and fear of falling and an improvement of mobility, autonomy, quality of life, mood, and cognition are highly relevant for older people to cope with aging and diseases and to reduce healthcare costs. TRAIL REGISTRATION: www.drks.de. DRKS00016609. Registered 30th July 2019.

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BACKGROUND: Whole medicine and health systems like traditional and complementary medicine systems (T&CM) are part of healthcare around the world. One key feature of T&CM is its focus on patient-centered and multimodal care and the integration of intercultural perspectives in a wide range of settings. It may contribute to good health and well being for people as part of the Sustainable Development Goals of the United Nations. The authentic, rigorous, and fair evaluation of such a medical system, with its inherent complexity and individualization, imposes methodological challenges. Hence, we propose a broad research strategy to test and characterize its possible contribution to health. METHODS: To develop a research strategy for a specific T&CM system, Anthroposophic Medicine (AM), applying multimodal integrative healthcare based on a four-level concept of man, we used a three-phase consensus process with experts and key stakeholders, consisting of (1) premeeting methodological literature and AM research review and interviews to supplement or revise items of the research strategy and tailor them to AM research, (2) face-to-face consensus meetings further developing and tailoring the strategy, and (3) postmeeting feedback and review, followed by finalization. RESULTS: Currently, AM covers many fields of medical specialties in varied levels of healthcare settings, such as outpatient and inpatient; primary, secondary, and tertiary care; and health education and pedagogy. It is by definition integrated with conventional medicine in the public healthcare system. It applies specific medicines, nursing techniques, arts therapies, eurythmy therapy, rhythmical massage, counseling, and psychotherapy, and it is provided by medical doctors, nurses, therapists, midwives, and nutritionists. A research strategy authentic to this level of complexity should comprise items with a focus on (I) efficacy and effectiveness, divided into (a) evaluation of the multimodal and multidisciplinary medical system as a whole, or of complex multimodal therapy concept, (b) a reasonable amount of methodologically rigorous, confirmatory randomized controlled trials on exemplary pharmacological and nonpharmacological therapies and indications, (c) a wide range of interventions and patient-centered care strategies with less extensive formats like well-conducted small trails, observational studies, and high-quality case reports and series, or subgroup analyses from whole-system studies, or health service research; (II) safety; (III) economics; (IV) evidence synthesis; (V) methodologic issues; (VI) biomedical, physiological, pharmacological, pharmaceutical, psychological, anthropological, and nosological issues as well as innovation and development; (VI) patient perspective and involvement, public needs, and ethics; (VII) educational matters and professionalism; and (IX) disease prevention, health promotion, and public health. CONCLUSION: The research strategy extends to and complements the prevailing hierarchical system by introducing a broad "evidence house" approach to evaluation, something many health technology assessment boards today support. It may provide transparent and comprehensive insight into potential benefits or risks of AM. It can serve as a framework for an evidence-informed approach to AM for a variety of stakeholders and collaborating networks with the aim of improving global health.

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BACKGROUND: Anthroposophic Mistletoe therapy is a widely used complementary cancer treatment. OBJECTIVE: To evaluate prospective clinical trials on the effectiveness of anthroposophic mistletoe therapy for cancer. DESIGN: Systematic review. MATERIAL AND METHODS: Search of 9 electronic databases, reference lists and extensive expert consultations. Criteria-based assessment of methodological study quality. RESULTS: 16 randomized (RCT) and 9 non-randomized (N-RCT) controlled trials were identified that investigated mistletoe treatment of malignant diseases. Statistically significant benefit for survival was reported in 8 of 17 trials (in 5 of 10 RCTs), for disease-free survival and tumour recurrence in none of 2 RCTs, for remission of tumour and malignant effusion in 1 RCT and 1 N-RCT of 4 controlled trials, for quality of life (QoL) in 3 of 5 RCTs, and for QoL and reduction of side effects of cytoreductive therapies (chemotherapy, radiation or surgery) in 5 of 7 trials (3 of 5 RCTs). Methodological quality of the controlled trials differed substantially; some had major limitations while others were reasonably well conducted. 12 single-arm cohort studies were identified. 5 of 7 studies found substantial tumour remission in various cancers, one study reported remission of CIN, and 4 studies remission of malignant pleural effusion or ascites. Quality of reporting in cohort studies was mostly reasonably good. Mistletoe application was well tolerated. CONCLUSIONS: Regarding quality of studies and consistency of results, the best evidence for efficacy of mistletoe therapy exists for improvement of QoL and reduction of side effects of cytotoxic therapies (chemotherapy, radiation). Survival benefit has been shown but not beyond critique. Tumour remissions are described in cohort studies that investigate the application of high dose or local mistletoe extracts. As several reasonably well-conducted studies indicate beneficial effects, further properly designed trials should be encouraged to investigate clinical efficacy and its possible dependency on the mode of application.

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BACKGROUND: Mistletoe preparations are among the most widely used unconventional cancer therapies in Central Europe. Their clinical effectiveness, however, is controversial. OBJECTIVE: To investigate whether prospective controlled clinical trials provide evidence for efficacy of mistletoe therapy in cancer. DESIGN: Systematic review. MATERIAL AND METHODS: Search of 11 electronic databases, reference lists and expert consultations. Criteria based analysis was performed to assess methodological quality of the studies. RESULTS: 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. CONCLUSIONS: 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.

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In Switzerland public attention was caught by a health economic analysis of health insurance's reimbursement of complementary medical procedures. Objectives of the study were 1) cost development, 2) health status development of insured citizens, 3) substitutional/additional use of complementary medical procedures. However, several conceptual, methodical and statistical flaws limit the conclusions that can be drawn from this study: The analysis claimed to be based on a large randomized trial. However, the attempt to achieve an unbiased equality in experimental and control group through stratified sampling grossly failed. Effects of complementary medical procedures on health status were inappropriately assessed and only based on 10 patients. The question whether complementary medicine is being used as a substitution or addition to conventional medicine was not even explored (the published result is based on a misleading interpretation of the health insurance's database). Finally, statements on cost developments were not based on estimations, but resulted from methodical and statistical artifacts. Furthermore, the study suffered from several other weaknesses, like a 50% dropout rate, an inadequate description of statistical procedures, an extremely reduced statistical power, and a lack of clear distinction between experimental and retrospective analyses. Therefore, no valid conclusions can be drawn from this study.

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In 1955, Henry K. Beecher published the classic work entitled "The Powerful Placebo." Since that time, 40 years ago, the placebo effect has been considered a scientific fact. Beecher was the first scientist to quantify the placebo effect. He claimed that in 15 trials with different diseases, 35% of 1082 patients were satisfactorily relieved by a placebo alone. This publication is still the most frequently cited placebo reference. Recently Beecher's article was reanalyzed with surprising results: In contrast to his claim, no evidence was found of any placebo effect in any of the studies cited by him. There were many other factors that could account for the reported improvements in patients in these trials, but most likely there was no placebo effect whatsoever. False impressions of placebo effects can be produced in various ways. Spontaneous improvement, fluctuation of symptoms, regression to the mean, additional treatment, conditional switching of placebo treatment, scaling bias, irrelevant response variables, answers of politeness, experimental subordination, conditioned answers, neurotic or psychotic misjudgment, psychosomatic phenomena, misquotation, etc. These factors are still prevalent in modern placebo literature. The placebo topic seems to invite sloppy methodological thinking. Therefore awareness of Beecher's mistakes and misinterpretations is essential for an appropriate interpretation of current placebo literature.

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Since 1955, when HK Beecher published his classic "The Powerful Placebo," it generally has been accepted that 35% of patients with any of a wide variety of disorders can be treated with placebos alone. In recent years, average cure rates of 70%, and up to 100%, also have been quoted. Like pharmacological preparations, placebos are credited with possessing time-effect curves; cumulation and carry-over effects; differentiated actions depending on color, size, or packaging; even toxic effects. It has been postulated that placebos can prolong life, that their effects occur in surgery as well as in medicine, and that they are mediated by endorphins. In this article source material that forms the scientific basis for such claims is examined. Analysis shows that the studies on which such ideas are based, except perhaps in bronchial asthma, do not in any way justify the conclusions drawn from them. The truth is that the placebo effect is counterfeited by a variety of factors including the natural history of the disease, regression to the mean, concomitant treatments, obliging reports, experimental subordination, severe methodological defects in the studies, misquotations, etc; even, on occasion, by the fact that the supposed placebo is actually not a placebo, but has to be acknowledged as having a specific action on the condition for which it is being given. A further reason for misjudgment is the lack of clarity of the placebo concept itself. Experimental subordination and conditioning are other areas of insufficient conceptual differentiation. The authors conclude that the literature relating to the magnitude and frequency of the placebo effect is unfounded and grossly overrated, if not entirely false. They pose the question whether the existence of the so-called placebo effect is itself not largely-or indeed totally-illusory.

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