Contributing to Global Health: Development of a Consensus-Based Whole Systems Research Strategy for Anthroposophic Medicine.

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.

Efficacy of a Nasal Spray from Citrus limon and Cydonia oblonga for the Treatment of Hay Fever Symptoms-A Randomized, Placebo Controlled Cross-Over Study.

Nasal spray from lemon and quince (LQNS) is used to treat hay fever symptoms and has been shown to inhibit histamine release from mast cells in vitro. Forty-three patients with grass pollen allergy (GPA) were randomized to be treated either with placebo or LQNS for one week, respectively, in a cross-over study. At baseline and after the respective treatments patients were provoked with grass pollen allergen. Outcome parameters were nasal flow measured with rhinomanometry (primary), a nasal symptom score, histamine in the nasal mucus and tolerability. In the per protocol population absolute inspiratory nasal flow 10 and 20 min after provocation was higher with LQNS compared to placebo (-37 ± 87 mL/s; p = 0.027 and -44 ± 85 mL/s; p = 0.022). The nasal symptom score showed a trend (3.3 ± 1.8 in the placebo and 2.8 ± 1.5 in the LQNS group; p = 0.070) in favor of LQNS; the histamine concentration was not significantly different between the groups. Tolerability of both, LQNS and placebo, was rated as very good. LQNS seems to have an anti-allergic effect in patients with GPA. Copyright © 2016 John Wiley & Sons, Ltd.

[The Königsteiner Empfehlung of 2012 - essential alterations and modifications]. / Die Königsteiner Empfehlung von 2012 - Wesentliche Neuerungen und Änderungen.

BACKGROUND: Since 1974, the recommendation for assessment of hearing impairment caused by noise - formerly known as "Königsteiner Merkblatt" (now: "Königsteiner Empfehlung") - has been representing the state of the art for the assessment of the occupational disease BK-No. 2301. It was updated several times, the last time in 2012. It provides a summary of the current medical knowledge. A new measurement for the entire working life - the Effective Noise Dose by Liedtke - was introduced. Otoacoustic emissions (OAE) are now the crucial tests in order to detect a hair cell dysfunction. As from now the tinnitus has to be put under a more comprehensive examination. On the strength of post experience the previous speech audiometry (Freiburger Test) is reliable, it was retrained. In future the indication for hearing aids will be oriented towards the aid guidelines of the legal health insurance. The questionnaire for the expert opinion was revised and the fee was adapted.

Changes in hemodynamics and tissue oxygenation saturation in the brain and skeletal muscle induced by speech therapy - a near-infrared spectroscopy study.

Arts speech therapy (AST) is a therapeutic method within complementary medicine and has been practiced for decades for various medical conditions. It comprises listening and the recitation of different forms of speech exercises under the guidance of a licensed speech therapist. The aim of our study was to noninvasively investigate whether different types of recitation influence hemodynamics and oxygenation in the brain and skeletal leg muscle using near-infrared spectroscopy (NIRS). Seventeen healthy volunteers (eight men and nine women, mean age ± standard deviation 35.6 ± 12.7 years) were enrolled in the study. Each subject was measured three times on different days with the different types of recitation: hexameter, alliteration, and prose verse. Before, during, and after recitation, relative concentration changes of oxyhemoglobin (Δ[O2Hb]), deoxyhemoglobin (Δ[HHb]), total hemoglobin (Δ[tHb]), and tissue oxygenation saturation (StO2) were measured in the brain and skeletal leg muscle using a NIRS device. The study was performed with a randomized crossover design. Significant concentration changes were found during recitation of all verses, with mainly a decrease in Δ[O2Hb] and ΔStO2 in the brain, and an increase in Δ[O2Hb] and Δ[tHb] in the leg muscle during recitation. After the recitations, significant changes were mainly increases of Δ[HHb] and Δ[tHb] in the calf muscle. The Mayer wave spectral power (MWP) was also significantly affected, i.e., mainly the MWP of the Δ[O2Hb] and Δ[tHb] increased in the brain during recitation of hexameter and prose verse. The changes in MWP were also significantly different between hexameter and alliteration, and hexameter and prose. Possible physiological explanations for these changes are discussed. A probable reason is a different effect of recitations on the sympathetic nervous system. In conclusion, these changes show that AST has relevant effects on the hemodynamics and oxygenation of the brain and muscle.

Effects of changes in colored light on brain and calf muscle blood concentration and oxygenation.

Color light therapy is a therapeutic method in complementary medicine. In color therapy, light of two contrasting colors is often applied in a sequential order. The aim of this study was to investigate possible physiological effects, i.e., changes in the blood volume and oxygenation in the brain and calf muscle of healthy subjects who were exposed to red and blue light in sequential order. The hypothesis was that if a subject is first exposed to blue and then red light, the effect of the red light will be enhanced due to the contrastingly different characteristics of the two colors. The same was expected for blue light, if first exposing a subject to red and then to blue light. Twelve healthy volunteers (six male, six female) were measured twice on two different days by near-infrared spectroscopy during exposure to colored light. Two sequences of colored light were applied in a controlled, randomized, crossover design: first blue, then red, and vice versa. For the brain and muscle, the results showed no significant differences in blood volume and oxygenation between the two sequences, and a high interindividual physiological variability. Thus, the hypothesis had to be rejected. Comparing these data to results from a previous study, where subjects were exposed to blue and red light without sequential color changes, shows that the results of the current study appear to be similar to those of red light exposure. This may indicate that the exposure to red light was preponderant and thus effects of blue light were outweighed.