Correction to: Impact of a combined multimodal-aerobic and multimodal intervention compared to standard aerobic treatment in breast cancer survivors with chronic cancer-related fatigue - results of a three-armed pragmatic trial in a comprehensive cohort design.

An amendment to this paper has been published and can be accessed via the original article.

Impact of a combined multimodal-aerobic and multimodal intervention compared to standard aerobic treatment in breast cancer survivors with chronic cancer-related fatigue - results of a three-armed pragmatic trial in a comprehensive cohort design.

BACKGROUND: Cancer-related fatigue (CRF) and insomnia are major complaints in breast cancer survivors (BC). Aerobic training (AT), the standard therapy for CRF in BC, shows only minor to moderate treatment effects. Other evidence-based treatments include cognitive behavioral therapy, e.g., sleep education/restriction (SE) and mindfulness-based therapies. We investigated the effectiveness of a 10-week multimodal program (MT) consisting of SE, psycho-education, eurythmy- and painting-therapy, administered separately or in combination with AT (CT) and compared both arms to AT alone. METHODS: In a pragmatic comprehensive cohort study BC with chronic CRF were allocated randomly or by patient preference to (a) MT, (b) CT (MT + AT) or (c) AT alone. Primary endpoint was a composite score of the Pittsburgh Sleep Quality Index and the Cancer Fatigue Scale after 10 weeks of intervention (T1); a second endpoint was a follow-up assessment 6 months later (T2). The primary hypothesis stated superiority of CT and non-inferiority of MT vs. AT at T1. A closed testing procedure preserved the global α-level. The intention-to-treat analysis included propensity scores for the mode of allocation and for the preferred treatment, respectively. RESULTS: Altogether 126 BC were recruited: 65 were randomized and 61 allocated by preference; 105 started the intervention. Socio-demographic parameters were generally balanced at baseline. Non-inferiority of MT to AT at T1 was confirmed (p < 0.05), yet the confirmative analysis stopped as it was not possible to confirm superiority of CT vs. AT (p = 0.119). In consecutive exploratory analyses MT and CT were superior to AT at T1 and T2 (MT) or T2 alone (CT), respectively. CONCLUSIONS: The multimodal CRF-therapy was found to be confirmatively non-inferior to standard therapy and even yielded exploratively sustained superiority. A randomized controlled trial including a larger sample size and a longer follow-up to evaluate multimodal CRF-therapy is highly warranted. TRIAL REGISTER: DRKS-ID: DRKS00003736 . Recruitment period June 2011 to March 2013. Date of registering 19 June 2012.

The questionnaire on autonomic regulation: a useful concept for integrative medicine?

The concept of autonomic regulation (aR) reflects the relevance of the function of different autonomic systems for health. aR can be captured by questionnaires. We differentiate between a trait or constitutional aR questionnaire version including 12 (short-version) or 18 items, respectively, with three subscales (orthostatic-circulatory, rest/activity and digestive regulation), and an 18-item state aR questionnaire on the preceding week with four subscales (rest/activity, orthostatic-circulatory, thermo- and digestive regulation). The validated questionnaires show satisfying to good reliability and robust validity with clear construct validity. In this article, we summarized the actually available literature on aR and the use of aR questionnaires in clinical and observational studies. We described the relationship of high aR with health and in case of low aR or loss of regulation with disease and functional disorder in the three (four) different subscales and functional systems, such as rest/activity, orthostatic-circulatory or digestive regulation (thermoregulation) with the consecutive therapeutic need. Finally, we gave perspectives of its further application in clinical research.

Colchicum autumnale in Patients with Goitre with Euthyroidism or Mild Hyperthyroidism: Indications for a Therapeutic Regulative Effect-Results of an Observational Study.

Introduction. Goitre with euthyroid function or with subclinical or mild hyperthyroidism due to thyroid autonomy is common. In anthroposophic medicine various thyroid disorders are treated with Colchicum autumnale (CAU). We examined the effects of CAU in patients with goitre of both functional states. Patients and methods. In an observational study, 24 patients with goitre having suppressed thyroid stimulating hormone (TSH) levels with normal or slightly elevated free thyroxine (fT4) and free triiodothyronine (fT3) (group 1, n = 12) or normal TSH, fT3, and fT4 (group 2, n = 12) were included. After 3 months and after 6 to 12 months of CAU treatment, we investigated clinical pathology using the Hyperthyroid Symptom Scale (HSS), hormone status (TSH, fT4, and fT3), and thyroidal volume (tV). Results. After treatment with CAU, in group 1 the median HSS decreased from 4.5 (2.3-11.8) to 2 (1.3-3) (p < 0.01) and fT3 decreased from 3.85 (3.5-4.78) to 3.45 (3.3-3.78) pg/mL (p < 0.05). In group 2 tV (13.9% (18.5%-6.1%)) and TSH (p < 0.01) were reduced. Linear regression for TSH and fT3 in both groups indicated a regulative therapeutic effect of CAU. Conclusions. CAU positively changed the clinical pathology of subclinical hyperthyroidism and thyroidal volume in patients with euthyroid goitre by normalization of the regulation of thyroidal hormones.

Multimodal therapy concept and aerobic training in breast cancer patients with chronic cancer-related fatigue.

UNLABELLED: HYPOTHESE: Cancer-related fatigue (CRF) and sleep disorders are some of the most wearing and common symptoms in disease-free breast cancer patients (BC). Aerobic training (AT) is the treatment with the best available evidence, even though it seems to be insufficient with regards to improvements in cognitive fatigue. We introduced a new multimodal therapy concept (MM) consisting of psycho-, sleep-education and new approaches based on anthroposophic medicine such as eurythmy and painting therapy. STUDY DESIGN: This pilot study will test the implementation of MM and yield first results of the MM and AE in our centres. METHODS: 31 out of 34 patients suffering from BC and CRF were fully assessed in a ten-week intervention study. 21 patients chose MM and 10 decided on AT. CRF was measured with the help of the Cancer Fatigue Scale (CFS-D), and the global quality of sleep was measured with the Pittsburgh Sleep Quality Index (PSQI). We also captured autonomic regulation (aR) and patients' satisfaction with questionnaires. Statistical analysis was done with SAS 9.1.3 for windows. RESULTS: The new MM therapy can be implemented with high satisfaction among patients. Significant improvements were found in the MM group with regards to CFS-D, global quality of sleep, sleep efficiency (PSQI), aR and rest/activity regulation compared to baseline (all p<0.05). In the AT group aR orthostatic-circulatory and rest/activity regulation improved significantly (p<0.05), too. However, no improvement in cognitive fatigue was seen in either group. CONCLUSION: The multimodal therapy concept was feasible and improved cancer fatigue, sleep quality, autonomic and rest-/activity regulation in breast cancer patients. It may therefore constitute a valuable treatment option in addition to aerobic training for BC patients with CRF. A further study with larger sample size needs to be carried out to assess the efficacy of combined multimodal-aerobic therapy.

Effects of eurythmy therapy in the treatment of essential arterial hypertension: a pilot study.

INTRODUCTION: Although eurythmy therapy (ET) has been used in the context of anthroposophic medicine (AM) for the treatment of, among other conditions, arterial hypertension (AH) for more than 80 years, there are as yet no studies on its effectiveness on disease entity. However, it has been shown that ET can increase heart rate variability comparably to ergometer training. OBJECTIVE: To determine whether a 10-week course of ET has an impact on AH and if so, to determine the strength of the effect. The impact of ET on state-autonomic regulation, self-regulation, internal coherence, and quality of life is also explored. METHODS: Consecutive inclusion of 9 subjects (6 female, 3 male, mean age of 64 years, SD 8.26) with AH diagnosed by their general practitioners. INCLUSION CRITERIA: no or unchanged antihypertensive medication from 4 weeks prior to the start of the study until the end of the study. ET was carried out with weekly instruction along with a daily, home-based program for 10 weeks with specific exercises. Twenty-four-hour blood pressure (BP) measuring was carried out, and the questionnaires were administered before and after the intervention. In addition, after a further 6 months during which 8 of the 9 patients carried on with the exercises of their own accord, the aforementioned parameters were assessed for a third time. RESULTS: Parameters of the 24-hour BP measurements show a moderate, but not significant, improvement immediately after the intervention and 6 months after the intervention. After the 10-week intervention, we saw an improvement of the State-autonomic Regulation questionnaire, the subscale on "Rest/Activity regulation," of the Self-regulation questionnaire, and the subscale "Initiative and Interest" of the Herdecke Quality of Life Questionnaire (HLQ) (all P < .045). After the 6-month post-study observation period, the aforementioned parameters improved further still, and an additional, significant improvement was seen for the Trait-autonomic Regulation subscale "Rest/Activity regulation," the HLQ-sum score, and the HLQ subscales "social interaction," "mental balance," and "physical ability." CONCLUSION: A 10-week course of ET does not result in a significant improvement in BP. The average BP measurements improved post-intervention by an absolute 3.2/2.0 mmHg and after 6 months of independent continuation of ET by 6.3/4.4 mmHg (systolic/diastolic). Despite the small group size, the regulation and quality-of-life parameters improved significantly after the intervention and further still after the 6-month observation period. The results need to be validated with larger patient collectives and control groups.

Does self-regulation and autonomic regulation have an influence on survival in breast and colon carcinoma patients? results of a prospective outcome study.

BACKGROUND: Cancer Related Fatigue (CRF) and circadian rhythm have a great impact on the quality of life (HRQL) of patients with breast (BC) and colon cancer (CRC). Other patient related outcomes in oncology are measured by new instruments focusing on adaptive characteristics such as sense of coherence or self-regulation, which could be more appropriate as a prognostic tool than classical HRQL. The aim of this study was to assess the association of autonomic regulation (aR) and self-regulation (SR) with survival. METHODS: 146 cancer patients and 120 healthy controls took part in an initial evaluation in 2000/2001. At a median follow up of 5.9 years later, 62 of 95 BC, 17 of 51 CRC patients, and 85 of 117 healthy controls took part in the follow-up study. 41 participants had died. For the follow-up evaluation, participants were requested to complete the standardized aR and SR questionnaires. RESULTS: On average, cancer patients had survived for 10.1 years with the disease. Using a Cox proportional hazard regression with stepwise variables such as age, diagnosis group, Charlson co-morbidity index, body mass index (BMI)) aR and SR. SR were identified as independent parameters with potential prognostic relevance on survival While aR did not significantly influence survival, SR showed a positive and independent impact on survival (OR = 0.589; 95%-CI: 0.354 - 0.979). This positive effect persisted significantly in the sensitivity analysis of the subgroup of tumour patients and in the subscale 'Achieve satisfaction and well-being' and by tendency in the UICC stages nested for the different diagnoses groups. CONCLUSIONS: Self-regulation might be an independent prognostic factor for the survival of breast and colon carcinoma patients and merits further prospective studies.

Reliability and validity of a new scale on internal coherence (ICS) of cancer patients.

BACKGROUND: Current inventories on quality of life used in oncology mainly focus on functional aspects of patients in the context of disease adaptation and treatments (side) effects (EORTC QLQ C30) or generically the status of common functions (Medical Outcome Study SF 36). Beyond circumscribed dimensions of quality of life (i.e., physical, emotional, social, cognitive etc.), there is a lack of inventories which also address other relevant dimensions such as the 'sense of coherence' (SOC) in cancer patients. SOC is important because of its potential prognostic relevance in cancer patients, but the current SOC scale has mainly been validated for psychiatric and psychosomatic patients. Our two-step validation study addresses the internal coherence (ICS) scale, which is based on expert rating, using specific items for oncological patients, with respect to its reliability, validity and sensitivity to chemotherapy. METHODS: The items were tested on 114 participants (57 cancer patients and a matched control group), alongside questions on autonomic regulation (aR), the Hospital Anxiety and Depression Scale (HADS), self-regulation (SRQ) and Karnofsky the Performance-Index (KPI). A retest of 65 participants was carried out after a median time span of four weeks.In the second part of the study, the ICS was used to assess internal coherence during chemotherapy in 25 patients with colorectal carcinoma (CRC) and 17 breast cancer patients. ICS was recorded before, during and 4-8 weeks after treatment. RESULTS: The 10-item scale of 'internal coherence' (ICS) shows good to very good reliability: Cronbach-alpha r = 0.91, retest-reliability r = 0.80. The ICS correlates with r = 0.43-0.72 to the convergence criteria (all p < 0.001). We are able to show decreased ICS-values after the third cycle for CRC and breast cancer patients, with a subsequent increase of ICS scores after the end of chemotherapy. CONCLUSION: The ICS has good to very good reliability, validity and sensitivity to chemotherapy.

[Reduction of endogenous regulation in internal medicine patients]. / Verlust von endogener Regulation bei internistischen Patienten.

BACKGROUND: General health-related questionnaires on quality of life do not satisfactorily distinguish between healthy and sick people. One of the reasons cited for this lack is too much mental influence. This is why we developed a questionnaire on endogenous regulation (eR) that reflects the regulatory state of various vegetative functions. OBJECTIVE: The current study examines whether the short version eR questionnaire is able to distinguish between healthy people and internal medicine patients. PATIENTS AND METHODS: 408 participants were included in the study (284 females, 124 males). Among these were patients with colorectal cancer (n = 49), breast cancer (n = 95), diabetes mellitus (type 1: n = 20, type 2: n = 40), coronary disease (n = 39), rheumatoid illnesses (n = 28) and multimorbid patients (n = 22) as well as a healthy control group (n = 115). In addition to the eR questionnaire the study also used the Hospital Anxiety and Depression Scale (HADS), the short questionnaire on self-regulation and questions on the vegetative status. RESULTS: The healthy control group showed the highest eR, with an estimated average of M = 29.8. Patients with breast cancer, diabetes mellitus type 2, coronary disease and rheumatoid illnesses reveal a significantly lowered eR. Multimorbid patients show the lowest eR. Patients with cancer of the colon and diabetes type 1 were measured at M = 27.9 and M = 27.3 respectively and showed no significantly lowered estimated average compared to the control group. A high eR significantly correlates (p < 0.002) with the following parameters: low levels of anxiety (r = 49) and depression (r = 0.36), high self-regulation (r = 0.34), morning type (r = 0.40), less congestive perspiration (r = 0.38), less shivering (r = 0.23), dysmenorrhoea (r = 0.38) and allergies (r = 0.17). CONCLUSION: Healthy people show the highest, multimorbid patients the lowest eR. Consistent relations to health, illness, heat regulation and personality presence have been shown. Further studies to clarify clinical relevance are necessary.