Psychophysiological disorders due to work-related stress continue to be highly costly for health systems and approaches for cost-effective and easily accessible interventions are much needed. Both heart rate variability-biofeedback (HRV-Bfb) and mindfulness-based interventions (MBI) have been empirically shown to reduce stress. This study compares these two interventions in the work context to a wait-list-control-group (WLC). In this three-armed randomized controlled trial (RCT), 69 healthy adults employed in the same organization were randomized to participate in HRV-Bfb, MBI or the WLC. Participants were assessed for psychophysiological parameters of stress (stress perception, coping, HRV parameters and cortisol) and stress related symptoms (depressive symptoms, psychological wellbeing, mindfulness and self-compassion). Participants trained using either HRV-Bfb or MBI for 6 weeks on a daily basis. Outcomes were assessed at baseline, after the intervention and at follow-up 12 weeks later. Results did not show any statistically significant differences between HRV-Bfb and MBI groups, and neither of the intervention groups (IGs) differed from the WLC. Findings suggest an overall reduction in stress for all groups, including the WLC, with mostly small to medium effect sizes. However, it is important to note that participants with higher baseline stress levels might benefit more from mindfulness and biofeedback-based stress reduction interventions. The results have to be interpreted with caution due to the relatively small sample size. MBI might have a slightly stronger effect on stress reduction in comparison to HRV-Bfb, as suggested by the effect sizes. This study highlights issues and challenges of the implementation of such interventions in corporate health management.

Background: Integrative medicine (IM) is a patient-centered, evidence-based, therapeutic paradigm which combines conventional and complementary approaches. The use of IM in pediatrics has increased in the past two decades and parents' demand for it is growing. An IM whole systems approach is anthroposophic medicine. Considering the growing demand for integrative approaches in children, it is relevant from a public health perspective to find out which kind of children use IM in Germany and whether they differ from the entirety of pediatric inpatients in Germany. Moreover, it would be interesting to known, whether these patients are willing to travel a longer distance to gain integrative treatment.

Methods: The present study investigates the standard ward documentation datasets of 29,956 patients of all German integrative anthroposophic pediatric inpatient wards from 2005 to 2016 and compares them systematically to collect data of the entirety of all pediatric inpatient wards in Germany. Apart from patients' age and gender, and the ICD-10 admission diagnoses, the geographical catchment area of the hospitals were analyzed.

Results: Sociodemographic characteristics of pediatric inpatients in the integrative anthroposophic departments (IAH) did not differ from the entirety of all pediatric inpatients. Regarding clinical characteristics, higher frequencies were found for endocrine, nutritional and metabolic diseases (IAH: 7.24% vs. 2.98%); mental, behavioral, and neurodevelopmental disorders (IAH: 9.83% vs. 3.78%) and nervous diseases (IAH: 8.82% vs. 5.16%) and lower frequencies for general pediatric diseases such as respiratory diseases (IAH: 17.06% vs. 19.83%), digestive diseases (IAH: 3.90% vs. 6.25%), and infectious and parasitic diseases (IAH: 12.88% vs. 14.82%) in comparison to the entirety of all pediatric inpatients in Germany. The IAH showed a broad catchment area, with most patients being from former, Western federal republic of Germany. Large catchment areas (> 100 km) for the IAH are merely covered by severe and chronic diseases.

Conclusion: Pediatric inpatients of IAH do not differ from the entirety of pediatric inpatients in Germany regarding sociodemographic characteristics but show differences regarding clinical characteristics. Parents are willing to travel further distance to get specialized integrative anthroposophic medical care for children with severe and chronic diseases.

Objectives: Acute gastroenteritis is one of the major causes of hospital admission in childhood. The primary objective of the treatment is rehydration, but conventional drug therapies are limited. Therefore, several pediatricians supplement conventional treatment with complementary and alternative therapies. In the two German departments for pediatric integrative medicine, children suffering from an acute gastroenteritis are treated with supportive therapy based on anthroposophic medicine. However, up to now scientifically validated guidelines for these therapies are lacking.

Design: We consulted an expert pool of 50 physicians with expertise in anthroposophic medicine as well as pediatrics and invited them to participate in an online-based Delphi process. Results were analyzed by means of qualitative content analysis with two independent raters using MAXQDA. Using four rounds of questioning, a consensus-based guideline was developed.

Results: A strong consensus (>90%) or consensus (>75-90%) was achieved for 14 of 16 subsections. The guideline describes disease characteristics, the most useful diagnostics, drug as well as non-drug treatment recommendations and advises for a good physician-patient interaction.

Conclusion: The guideline will help clinicians, as well as family doctors, in their daily routine and make anthroposophic medicine more tangible for parents and health insurance companies.

Background: Pancreatic cancer is a malignant disease with a high mortality rate and severe pain that is challenging to manage. To reduce the excruciating abdominal pain, opioids and adjuvant agents are conventionally used.

Objectives: PRNCPB is a treatment of neural therapy. The number of studies assessing the effect on patients' QoL is limited and inconsistent. With this study, we intended to address this issue.

Study design: A prospective nonrandomized study with a series of cases of unresectable pancreatic cancer was conducted.

Setting: The study was performed at our pain clinic under real life conditions.

Materials and methods: A total number of 16 patients with severe abdominal pain were enrolled in the study all of whom had responded to combined systemic analgesic therapy inadequately and had intolerable side effects contraindicating further increase in dose. The efficacy of this invasive, palliative analgesic procedure was evaluated 35 days after PRNCPB was performed. Primary outcomes were changed in pain intensity using the VAS questionnaire. Secondary outcomes were improved in QoL using the SF-36 questionnaire. Changes in pain medications and adverse reactions were monitored.

Results: After PRNCPB patients experienced a significant decrease (P=0.002) in pain intensity as shown by the VAS score, and a decreased opiate demand. Their QoL scores considering effect sizes also improved (P<0.001). No complications attributable to PRNCPB were observed during the study period. Additionally, no adverse drug reactions were observed.

Limitations: Detection, observation, and reporting bias can be estimated as moderate. Selection bias was not detected.

Conclusion: Our results give preliminary evidence that PRNCPB might be helpful as an additional treatment to conventional pain management in end-stage pancreatic cancer patients. PRNCPB seems to improve QoL in these patients in a time frame of at least 5 weeks after intervention.

Objective: To analyze the short-term thermogenic effects of footbaths with warm water alone (WA) versus when combined with medicinal powders.

Design: Randomized controlled trial with cross-over.

Interventions and outcomes: Seventeen healthy volunteers (mean age 22.1 years, SD = 2.4; 11 female) received three footbaths with WA or WA combined with mustard (MU) or ginger (GI) in a randomized order. Self-perceived warmth (Herdecke warmth perception questionnaire) and actual skin temperatures (thermography) were assessed before (t0), immediately after footbaths (t1), and 10 minutes later (t2). The primary outcome was perceived warmth in the feet. Secondary outcomes were warmth perception in the face, hands and overall, as well as actual skin temperature in the feet, face, and hands.

Results: Perceived warmth at the feet (primary outcome) increased significantly (all p's < .001) for MU and GI at t1 as well as for GI at t2 when compared to t0 with high effect sizes. At t2, GI differed significantly from WA (p < .001) and MU (p = .048). With regards to the secondary measures of outcome, no significant effects were seen for perceived warmth at the face or hands. Overall warmth was significantly higher at t1 compared to t0 (p = .01). Thermography assessments of skin temperature at the feet at t1 increased after all conditions (p < .001). No effects were seen in the face. At the hands, temperature decreased at t1 (p = .02) and t2 compared to t0 (p < .001).

Conclusion: The present study provides preliminary evidence that mustard and ginger increase warmth perception at the feet more than warm water alone, with only the effects for GI enduring at the brief follow-up.

Introduction: Raynaud's phenomenon is the earliest manifestation of systemic sclerosis. Nitroglycerin gel is the only proven topical therapy.

Methods: A 53-year-old woman with systemic sclerosis had topical Rosamarinus officinalis (rosemary) oil, often used in anthroposophic medicine, applied to her hands over 3days and then, separately, olive oil.

Results: Thermography images showed significant warming of fingers after rosemary oil, but not after olive oil, coinciding with the patient's subjective experience.

Conclusions: Topical Rosamarinus officinalis oil had a vasodilator and warming effect in a patient with systemic sclerosis and Raynaud's phenomenon.

Objectives: So far, the effects of vibroacoustic music therapy in cancer patients are unknown. However, used in anthroposophic medicine, it could be an approach to enhance well-being. The goal of this study was to evaluate the immediate effects of a sound-bed music intervention with respect to the subjective well-being as well as body warmth and pain.

Patients and methods: We treated 48 cancer patients with 10 min of sound-bed intervention in a cross-over design. Primary outcome was the total sum of the Basler Mood Questionnaire (BMQ), secondary outcomes were subscales of the BMQ and questions addressing body warmth and pain. The EORTC-QLQ C30 was used as baseline assessment for quality of life (QOL).

Results: Patients had lower QOL values than the EORTC reference samples (p < .001, d = 0.90). The primary outcome increased after music (p < .001, d = 0.47), no changes were seen in the control condition (p = .73, d = 0.04), the time by condition interaction was significant (p < .05).

Secondary outcomes: Increase after music for the BMQ subscales inner balance (p < .001, d = 0.73), vitality (p < .001, d = 0.51) and vigilance (p < .001, d = 0.37) as well as for the additional questions satisfaction (p < .001, d = 0.43), current mood (p < .001, d = 0.43), body warmth (p < .05, d = 0.44) and warmth distribution (p < .01, d = 0.49). No significant changes were seen in pain levels and social extroversion.

Conclusion: Sound-bed intervention improved momentary well-being and caused self-perceived physiological changes associated with relaxation beyond the benefits of simple resting time (control condition). Thus, it might be a promising approach to improve well-being in cancer patients.

Objective: Despite attempts to increase calmness in the Newborn Intensive Care Unit (NICU), preterm neonates still experience stress. The question arises how to further promote the infants' wellbeing. Therefore, the immediate effects of pentatonic live music on preterm infants and their mothers were examined.

Design and methods: In a two-centre randomized controlled trial with crossover design preterm infants were exposed sequentially to two conditions: live pentatonic harp music (LPHM) used in Anthroposophic Medicine or standard care. The order of the conditions was randomized within each subject. The primary outcome was change of the number of oxygen desaturations < 90%/h, whereas secondary outcomes were: heart rate, respiratory rate, oxygen saturation, heart rate variability (HRV), the perfusion index, pulse-transit-time and maternal anxiety and others not reported on in this article.

Results: 21 preterm infants were randomized (14 girls), mean gestational age at measurement 35 + 0 weeks (SD 1 week). The primary outcome parameter showed no significant changes. Regarding the secondary outcomes the comparison of the pre-post-differences between the conditions showed significant effects for the HRV parameters pNN₅₀ (ΔpNN₅₀ = 1.46%, z = -2.47, p = .001) and SDNN (ΔSDNN=-0.06 ms, z = -2.25, p = .002). The music intervention significantly increased the values of pNN₅₀ (Mdn 1.2% vs. 2.6%, p = 0.04) and marginally those of SDNN (Mdn 31.7 ms vs. 36.4 ms, p = 0.05). No changes were found in the other parameters.

Conclusions: While the use of music in the NICU had no effect on the number of oxygen desaturations, it increased two HRV parameters indicative of infants' parasympathetic tone.

Introduction: Viscum album extract (European mistletoe), containing immuno-active compounds with dose-dependent cytotoxic activity, is being used as an adjuvant cancer treatment in Europe. Few studies have yet been done with high-dose, fever-inducing Viscum album treatment.

Objective: To explore whether subcutaneous injections of high-dose Viscum album have a preventive effect on risk of recurrence of bladder cancer.

Methods: We retrospectively analyzed the case records of patients with resectable bladder cancer who underwent initiation of high-dose Viscum album treatment at our clinic between January 2006 and December 2012.

Main outcome measures: We calculated tumor recurrence and progression risk and explored case records to assess whether treatment had a likely, possible, or unlikely beneficial effect.

Results: Eight patients were identified, 7 of whom had nonmuscle-invasive bladder cancer and 1 with muscle-invasive cancer. Four patients had frequently recurring tumors before treatment. Among the 8 patients, 28 episodes of recurrence were observed. Median tumor-free follow-up duration was 48.5 months. High-dose Viscum album showed a possible beneficial effect in 5 of 8 patients, could not be assessed in 2 patients, and had an uncertain effect in 1 patient. No tumor progression was observed. Treatment was generally well tolerated and no patient stopped treatment because of side effects.

Conclusion: High-dose Viscum album treatment may have interrupted frequently recurring tumors in individual patients with recurrent bladder cancer. Prospective studies are needed to assess whether this treatment offers an additional, bladder-sparing preventive option for patients with intermediate- to high-risk nonmuscle-invasive bladder cancer.. Treatment was generally well tolerated and no patient stopped treatment because of side effects.

Background and aim: Extracts of Viscum album (European mistletoe) have immune-stimulatory and cytotoxic effects, with trials showing a well-established effect on the quality of life and prolonged survival in patients with advanced pancreatic cancer. Regression of tumours following intratumoural injection with Viscum album extract has been documented in individual cases. However, its influence on colon polyps has not been investigated.

Case presentation: We present the case of a 78-year-old Caucasian male who had undergone hemi-colectomy for a stage IIIC colon cancer but who refused adjuvant chemotherapy. Five years later a newly detected high-grade dysplasia colon adenoma was discovered; however, the adenoma could not be resected endoscopically and the patient did not consent to surgery. Intratumoural injections with Viscum album L extract (Quercus; Iscador®Qu) were administered twice in an attempt to limit tumour growth. Eight months after the second intratumoural injection the adenoma had disappeared and biopsy revealed no intraepithelial dysplasia or adenoma.

Conclusions: This is the first report showing complete regression of a colon adenoma after intratumoural injection with Viscum album extract. Prospective studies should evaluate if the treatment effect is reproducible and if this approach could be a useful pre-operative measure for colon adenomas too large for endoscopic resection.

Background: Treatment decisions for apnoea of prematurity (AOP) are usually based on nursing staff's documentation of pulse oximeter and heart rate alarms.

Objective: In an observational study, to compare the accuracy of oxygen saturation (SpO2) and heart rate alarm documentation, and the resulting interventions by nursing staff, with objectively registered events using polysomnographic and video recording.

Methods: Data on 21 preterm neonates (12 male) with a diagnosis of AOP were analysed. Nursing staff's desaturation (<80% SpO2) and bradycardia (<80/min) alarm documentation was compared with events registered objectively using simultaneous polysomnography. Interventions by nursing staff were evaluated using 24 h video recordings and compared with their chart documentation. Nursing staff had been unaware that the polygraphic and video recordings would be used subsequently for this purpose.

Results: Median (minimum-maximum) postnatal age was 15.5 (3-65) days. 968 SpO2 desaturation events and 415 bradycardias were documented by polysomnography. Nursing staff registered 23% of these desaturation events, and 60% of bradycardias (n=223, and n=133, respectively). Intraclass correlation coefficient (95% CI) between objectively measured desaturation events and those documented by nursing staff was 0.14 (-0.31 to 0.53); and for bradycardias 0.51 (0.11 to 0.78). 225 nursing staff interventions were registered on video, of which 87 (39%) were documented.

Conclusions: The alarm documentation by neonatal intensive care unit staff does not appear to be sufficiently accurate to permit further understanding and treatment of AOP. It is unclear if the alarms missed here would have led to clinical consequences had they been documented.

Background: Pulse oximeter saturation values are usually obtained by averaging over preceding measurements. This study investigates the dynamics between the averaging time and desaturation level, duration and extent.

Methods and results: Prospective observational study of 15 preterm infants. Oxygen saturation was recorded for 168 h using a pulse oximeter. The raw red-to-infrared data were reprocessed using seven different averaging times to determine the number of desaturations below four thresholds and for seven different minimal desaturation durations. The total number of desaturations <80% was 339 with an averaging time of 16 s and 1958 with an averaging time of 3 s (minimal event duration >0 s). There was a significantly lower pulse oximeter saturation nadir with the shorter averaging time, while the maximum duration was significantly longer when using a 16 s averaging time.

Conclusions: When using pulse oximeters, more attention should be given to averaging time and duration of desaturations.

Background: The usefulness of heart rate variability (HRV) as a clinical research and diagnostic tool has been verified in numerous studies. The gold standard technique comprises analyzing time series of RR intervals from an electrocardiographic signal. However, some authors have used pulse cycle intervals instead of RR intervals, as they can be determined from a pulse wave (e.g. a photoplethysmographic) signal. This option is often called pulse rate variability (PRV), and utilizing it could expand the serviceability of pulse oximeters or simplify ambulatory monitoring of HRV.

Methods: We review studies investigating the accuracy of PRV as an estimate of HRV, regardless of the underlying technology (photoplethysmography, continuous blood pressure monitoring or Finapresi, impedance plethysmography).

Results/conclusions: Results speak in favor of sufficient accuracy when subjects are at rest, although many studies suggest that short-term variability is somewhat overestimated by PRV, which reflects coupling effects between respiration and the cardiovascular system. Physical activity and some mental stressors seem to impair the agreement of PRV and HRV, often to an inacceptable extent. Findings regarding the position of the sensor or the detection algorithm are not conclusive. Generally, quantitative conclusions are impeded by the fact that results of different studies are mostly incommensurable due to diverse experimental settings and/or methods of analysis.