Long-Term Survival of a Patient with Recurrent Dedifferentiated High-Grade Liposarcoma of the Retroperitoneum Under Adjuvant Treatment with Viscum album L. Extract: A Case Report.

CASE PRESENTATION: A 68-year-old male patient underwent a resection of a DDL (T2 N0 M0, FNCLCC grade 2, stage IIIA) in the retroperitoneum. Three months after this first surgery, a recurrence occurred, and was treated with neoadjuvant and adjuvant doxorubicin plus ifosfamide and surgery (resection). A second recurrence-11 months after the second surgery-was treated with surgery and radiotherapy. The patient then began to undergo VAE treatment (0.2 mg-2 mg, subcutaneously, thrice a week). After the VAE treatment was initiated, the patient reported improved quality of life. A third recurrence-12 months after the third surgery-was treated with surgery, radiotherapy, and with an increased dose of VAE (20 mg). Sixty-nine months (5.8 years) after the fourth surgery a fourth recurrence occurred. It was again treated with surgery, along with a month of intravenous VAE infusions and subsequent subcutaneous VAE (20 mg) treatment. Finally, a fifth recurrence-5 months after the fifth surgery-was treated with subcutaneous and intravenous VAE applications and eribulin. The patient died 11 months after the last recurrence; he received a total of 103 months (8.6 years) of VAE treatment and achieved 10.5 years of survival. CONCLUSION: The case presented herein shows a long-time survival and a prolonged recurrence-free interval in a patient with retroperitoneal DDL treated with surgery, chemotherapy, radiotherapy, and VAE injections. On the basis of the antitumoral and immunomodulating effects of VAE and on the reported prolonged survival of VAE-treated patients with other types of tumors, the adjunct VAE treatment is presumed to have contributed to the favorable outcome. Regarding the clinical relevance of VAE treatment, further investigations are needed.

Long-term survival of a patient with an inoperable thymic neuroendocrine tumor stage IIIa under sole treatment with Viscum album extract: A CARE compliant clinical case report.

RATIONALE: Thymic neuroendocrine tumor (TNET) is very rare and characterized by a tendency to invade adjacent structures, frequent metastasis, resistance to therapy, and a poor prognosis. Viscum album extracts (VAE) have shown immunological, apoptogenic, and cytotoxic properties. PATIENT CONCERNS: A 54-year-old Peruvian man was suffering from constant fatigue, cough, dyspnea, and fever for a couple of months. DIAGNOSES: He was diagnosed with TNET (12.8 cm × 10 cm × 7 cm) stage IIIa, G1. Due to the size and extensive invasiveness (vena cava superior, also obstructing 85% of its lumen, pericardium, and pleura), the TNET was inoperable. INTERVENTIONS: We report the case of this patient who declined chemotherapy and was treated instead with sole subcutaneous VAE 3 times per week for 85 months. No other tumor-specific intervention was applied. OUTCOMES: Quality of life (QoL) improved substantially. The patient returned to work, and the tumor remained stable for 71 months. Thereafter, the tumor progressed, and the patient died 90 months after initial diagnosis. Besides self-limited local skin reactions around the application site, no side effects occurred. LESSONS: This is an exceptionally good course of disease of an inoperable, large, obstructing, and invasive TNET with a reduced baseline condition (Karnofsky index: 50-60) due to pronounced symptoms. Given the considerable reduction of symptoms and improved QoL following the onset of VAE therapy and other reports describing long disease stability and improvement of the QoL using VAE in different cancer types, we presume that the VAE treatment was supportive in this case. As TNETs are rare and few trials are available, future treatments of TNETs using VAE should be carefully documented and published to help determine whether further investigation of the use of VAE in TNET treatment is worthwhile.

Bilateral Asynchronous Renal Cell Carcinoma With Lung Metastases: A Case Report of a Patient Treated Solely With High-dose Intravenous and Subcutaneous Viscum album Extract for a Second Renal Lesion.

BACKGROUND: Bilateral asynchronous renal cell carcinoma (RCC) is infrequent. Immunotherapy is the first-line treatment for advanced RCC not controlled by locoregional therapy. Viscum album extracts (VAE) have been shown to improve quality of life as well as immunological and antineoplastic properties in different types of cancers. CASE REPORT: A 67-year-old man was diagnosed with Fuhrman grade 3/4 RCC, stage pT1bN0M0 in the right kidney. During the subsequent 6 years, he underwent a right nephrectomy and two metastasectomies (lung). Then an RCC lesion of the left kidney was detected. The patient refused a second nephrectomy and was treated solely with high-dose intravenous and subsequent subcutaneous VAE. A central necrotic area and a peritumoral halo were seen on an ultrasound follow-up from month 7. The patient showed no further progression of RCC during the next 2.5 years. CONCLUSION: As far as we are aware of, this is the first report of a patient with metastatic RCC with an RCC lesion of the second kidney treated solely with high-dose intravenous and subcutaneous VAE, associated with 2.5 years of progression-free survival and a good quality of life. The use of VAE in RCC should be carefully documented and published to determine future research.

Intralesional and subcutaneous application of Viscum album L. (European mistletoe) extract in cervical carcinoma in situ: A CARE compliant case report.

RATIONALE: Carcinoma in situ (CIS) of the uterine cervix is a premalignant condition of squamous epithelium. The standard treatments are excision and ablation procedures; for women with positive margins, hysterectomy is recommended. PATIENT CONCERNS: A 47-year-old Peruvian woman with recurrent candidal vaginitis had been diagnosed with colpocervicitis and squamous metaplasia 8 years ago, which were not treated. DIAGNOSES: The patient was diagnosed with CIS after cervical conization procedure. She refused radical hysterectomy and opted for integrative medicine treatment. INTERVENTIONS: She was treated with intralesional and subcutaneous Viscum album L. extract (VAE) injections. VAE is a widely used herbal cancer treatment with cytotoxic, apoptogenic, and immunological effects, but it has not been investigated in cervical CIS. OUTCOMES: Ending month 5 of treatment, complete remission of cervical CIS was observed. The patient is still in remission after 30 months (until publication). LESSONS: This is the first report on complete remission of cervical CIS after intralesional and subcutaneous injection with VAE. Prospective studies should evaluate to what degree the treatment effect is reproducible.

On caring and sharing-Addressing psychological, biographical, and spiritual aspects in integrative cancer care: A qualitative interview study on physicians' perspectives.

BACKGROUND: Patients confronted with a cancer diagnosis experience a variety of existential needs encompassing emotional, psychological, and spiritual areas of being. A patient-centered care approach addressing such existential issues is recognized as an essential aspect of health care. The aim of this study is to explore what role psychological, biographical, and spiritual factors play for experienced doctors working in integrative cancer care. METHOD: The qualitative study was based on in-depth interviews with 35 purposively sampled doctors, all practicing integrative oncology in the field of anthroposophic medicine in hospitals and/or office-based practices in Germany and other countries. Data were analyzed using structured content analysis. RESULTS: Psychological, biographical, and spiritual factors are important issues in integrative cancer care. Prevailing themes identified in this study were enabling patients to participate in life, promoting autonomy and coping, stabilizing patients emotionally and cognitively, overcoming the disease, and-primarily if addressed by patients-integrating spiritual issues. Doctors offered conversation, counseling, and time, but also referred to art, music, literature, and nature, so that patients' ongoing emotional, psychological, and spiritual needs could be explored and addressed. Doctors' attitudes with regard to existential issues were seen as important, as was maintaining an attitude of openness towards existential issues. CONCLUSION: Doctors in integrative cancer care utilize different methods to explore the needs of patients and employ a variety of treatment methods that address not just patients' medical issues but their existential concerns as well.

The Subjective Dimension of Integrative Cancer Care: A Qualitative Study Exploring the Perspectives, Themes, and Observations of Experienced Doctors from the Area of Anthroposophic Medicine.

BACKGROUND: Integrative cancer care (ICC) is used by approximately 50% of cancer patients to complement oncologic treatments and to address unmet needs. One ICC practice is anthroposophic medicine, integrating conventional and complementary cancer care. It specifically provides mistletoe therapy (MT), but also intensive counselling, natural remedies, creative and movement therapies, nursing procedures, nutrition, and others. The objective of this study was to explore perceptions, themes, goals, procedures, and observations of experienced AM doctors with regard to the subjective dimensions of ICC. METHOD: A guideline-based qualitative interview study was conducted with 35 AM doctors working in hospitals and office-based practices in Germany and other countries. Structured qualitative content analysis was applied to examine the data. Triangulation was done with published studies investigating patients' perspectives on AM and MT. RESULTS: The interviewed doctors integrated conventional and holistic cancer concepts. Overarching therapeutic themes were: to enable patients to live with or overcome their disease, to find their own way through their disease, and to possibly reframe their situation. A broad variety of therapeutic goals were pursued, depending on the situation and priorities of the particular patient. Doctors described varying levels of patients' improved strength; increased vitality, thermal comfort, and recovery; relief from suffering, particularly in the areas of fatigue, appetite, sleep, pain, infections, and reactions to toxic anti-cancer therapies. The doctors also described how they perceived changes of patients' emotional level, their coping, autonomy, functional abilities, and finding their own way to deal with the disease. This is consistent with patients' perspectives described in published studies. CONCLUSION: Themes, goals, and described benefit of ICC from doctors' and patients' perspective may be an important complementation of conventional cancer care, as it meets important needs, distresses and conditions of patients which often stay unmet and unrelieved. Further research should investigate these goals and procedures.

Individualized Integrative Cancer Care in Anthroposophic Medicine: A Qualitative Study of the Concepts and Procedures of Expert Doctors.

Background Cancer patients widely seek integrative oncology which embraces a wide variety of treatments and system approaches. Objective To investigate the concepts, therapeutic goals, procedures, and working conditions of integrative oncology doctors in the field of anthroposophic medicine. Methods This qualitative study was based on in-depth interviews with 35 highly experienced doctors working in hospitals and office-based practices in Germany and other countries. Structured qualitative content analysis was applied to examine the data. Results The doctors integrated conventional and holistic cancer concepts. Their treatments aimed at both tumor and symptom control and at strengthening the patient on different levels: living with the disease, overcoming the disease, enabling emotional and cognitive development, and addressing spiritual or transcendental issues according to the patient's wishes and initiatives. Therapeutic procedures were conventional anticancer and symptom-relieving treatments, herbal and mineral remedies, mistletoe therapy, art therapies, massages and other external applications, nutrition and lifestyle advice, psychological support, and multiple forms of empowerment. The approach emphasised good patient-doctor relationships and sufficient time for patient encounters and decision-making. Individualization appeared in several dimensions and was interwoven with standards and mindlines. The doctors often worked in teams and cooperated with other cancer care-related specialists. Conclusion Integrative cancer care pursues an individualized and patient-centered approach, encompassing conventional and multimodal complementary interventions, and addressing, along with physical and functional needs, the emotional and spiritual needs of patients. This seems to be important for tumor and symptom control, and addresses major challenges and important goals of modern cancer care.

Intravenous Mistletoe Treatment in Integrative Cancer Care: A Qualitative Study Exploring the Procedures, Concepts, and Observations of Expert Doctors.

Background. Mistletoe therapy (MT) is widely used in patient-centered integrative cancer care. The objective of this study was to explore the concepts, procedures, and observations of expert doctors, with a focus on intravenous MT. Method. A qualitative interview study was conducted with 35 highly experienced doctors specialized in integrative and anthroposophic medicine. Structured qualitative content analysis was applied. For triangulation, the results were compared with external evidence that was systematically collected, reviewed, and presented. Results. Doctors perform individualized patient assessments that lead to multimodal treatment approaches. The underlying goal is to help patients to live with and overcome disease. Mistletoe infusions are a means of accomplishing this goal. They are applied to stabilize disease, achieve responsiveness, induce fever, improve quality of life, and improve the tolerability of conventional cancer treatments. The doctors reported long-term disease stability and improvements in patients' general condition, vitality, strength, thermal comfort, appetite, sleep, pain from bone metastases, dyspnea in pulmonary lymphangitis carcinomatosa, fatigue, and cachexia; chemotherapy was better tolerated. Also patients' emotional and mental condition was reported to have improved. Conclusion. Individualized integrative cancer treatment including MT aims to help cancer patients to live well with their disease. Further research should investigate the reported observations.

High-Dose Viscum album Extract Treatment in the Prevention of Recurrent Bladder Cancer: A Retrospective Case Series.

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.

Viscum Album in the Treatment of a Girl With Refractory Childhood Absence Epilepsy.

Viscum album (European mistletoe) extracts have known immunomodulatory effects but little data exist on anticonvulsant activity despite its usefulness having been reported for centuries. A 4½-year-old girl with childhood absence epilepsy and global developmental delay was treated with different antiepileptic drugs and ketogenic diet but failed to become seizure free over a 2-year period. She also received different herbal remedies as part of an integrative medicine approach. Initial improvement occurred on valproate-ethosuximide, a further improvement was seen after adding clobazam to valproate. Final cessation of absence activity occurred after a dose increase of V album. She was still seizure free at the 12-month follow-up. V album appears to have been a necessary adjunct treatment for this child to become seizure free. We call on physicians to report their experiences of V album in epilepsy and suggest further study.

Disappearance of an advanced adenomatous colon polyp after intratumoural injection with Viscum album (European mistletoe) extract: a case report.

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.

From Reductionism to Holism: Systems-oriented Approaches in Cancer Research.

Somatic mutation theory of cancer has directed cancer research during the last century. A deluge of information on cellular, molecular, and genetic behavior was uncovered, but so was a mind-numbing complexity that still challenges research and concepts, and expectations in the war on cancer have by and large not been fulfilled. A change of paradigm beyond reductionism has been called for, especially as research ubiquitously points at the importance of tissue, microenvironment, extracellular matrix, embryonic and morphogenetic fields, and fields of tissue maintenance and organization in the processes of carcinogenesis, cancer control, and cancer progression, as well as in the control of cellular and genetic behavior. Holistic, organismic systems concepts open new perspectives for cancer research and treatment, as well as general biological understanding.

La teoría del cáncer por mutación somática ha dirigido la investigación sobre el cáncer durante el último siglo. Se ha descubierto un aluvión de información sobre las conductas celular, molecular y genética, pero también su abrumadora complejidad, que continúa poniendo a prueba la investigación y los conceptos y, en general, no se han cumplido las expectativas en la guerra contra el cáncer. Se ha pedido un cambio de paradigma más allá del reduccionismo, especialmente porque la investigación señala la importancia indudable de los campos tisulares, microambientales, de la matriz extracelular, embriónicos y morfogenéticos, y de los campos de mantenimiento y organización tisular en los procesos de carcinogenia, control canceroso y progresión cancerosa, así como en el control de la conducta celular y genética. Los conceptos de los sistemas holísticos y orgánicos abren nuevas perspectivas para la investigación y el tratamiento del cáncer, además de impulsar la comprensión biológica en general.

[Clinical research on anthroposophic medicine:update of a health technology assessment report and status quo]. / Klinische Forschung zur Anthroposophischen Medizin - update eines «Health Technology Assessment¼-Berichts und status quo.

BACKGROUND AND OBJECTIVE: In 2005 a Health Technology Assessment (HTA) report analyzed efficacy, effectiveness, safety, utilization and costs of Anthroposophic Medicine (AM). After a recent referendum of the 'Swiss Population pro Complementary Medicine' (May 2009) this HTA report was updated. DESIGN: Update of the HTA report by a systematic review. METHODS: Methods corresponded to the existing HTA report and the guidelines of the Swiss Federal Office of Public Health. For clinical studies four databases and a specialized journal were searched, and extensive expert consultations were used. Studies were selected according to predefined inclusion criteria, data were extracted, and methodological quality was assessed individually. RESULTS: 70 new clinical studies were found. Altogether, 265 clinical studies investigated efficacy and effectiveness of AM: 38 randomized controlled trials, 36 prospective and 49 retrospective non-randomized controlled trials as well as 90 prospective and 52 retrospective trials without control groups. They investigated a wide spectrum of AM treatments in a multitude of diseases; the whole AM system in 38 trials, non-pharmacological therapies in 10 trials, AM mistletoe products in cancer therapy in 133 trials, and other AM medication treatments in 84 trials. Most studies showed a positive result for AM. Methodological quality differed substantially; some studies showed major limitations, others were reasonably well conducted. Trials with better quality still showed a positive result. External validity was usually high. Side effects or other risks were rare and usually described to be mild or moderate. Studies regarding safety showed a good tolerability altogether. CONCLUSION: Trials of varying design and quality in a variety of diseases predominantly describe good clinical outcomes for AM, only marginal side effects, high satisfaction of patients with regard to results and safety and presumably slightly less costs. Further high-quality evaluations are desirable.

Safety of higher dosages of Viscum album L. in animals and humans--systematic review of immune changes and safety parameters.

BACKGROUND: Viscum album L extracts (VAE, mistletoe) and isolated mistletoe lectins (ML) have immunostimulating properties and a strong dose-dependent cytotoxic activity. They are frequently used in complementary cancer treatment, mainly to improve quality of life, but partly also to influence tumour growth, especially by injecting VAE locally and in high dosage. The question is raised whether these higher dosages can induce any harm or immunosuppressive effects. METHODS: Systematic review of all experiments and clinical studies investigating higher dosages of VAE in animals and humans (Viscum album > 1 mg in humans corresponding to > 0.02 mg/kg in animals or ML > 1 ng/kg) and assessing immune parameters or infections or adverse drug reactions. RESULTS: 69 clinical studies and 48 animal experiments reported application of higher doses of VAE or ML and had assessed immune changes and/or harm. In these studies, Viscum album was applied in dosages up to 1500 mg in humans and 1400 mg/kg in animals, ML was applied up to 6.4 µg/kg in humans and in animals up to 14 µg/kg subcutaneously, 50 µg/kg nasally and 500 µg/kg orally. A variety of immune parameters showed fluctuating or rising outcomes, but no immunosuppressive effect. Side effects consisted mainly of dose-dependent flu-like symptoms (FLS), fever, local reactions at the injection site and various mild unspecific effects. Occasionally, allergic reactions were reported. After application of high doses of recombinant ML, reversible hepatotoxicity was observed in some cases. CONCLUSIONS: Application of higher dosages of VAE or ML is not accompanied by immunosuppression; altogether VAE seems to exhibit low risk but should be monitored by clinicians when applied in high dosages.

Review article: Influence of Viscum album L (European mistletoe) extracts on quality of life in cancer patients: a systematic review of controlled clinical studies.

OBJECTIVE: To evaluate controlled clinical studies on the efficacy and effectiveness of Viscum album for quality of life (QoL) in cancer. MATERIALS AND METHODS: The authors conducted a search of 7 electronic databases and reference lists and had extensive consultations with experts. They carried out a criteria-based assessment of methodological study quality. RESULTS: The authors identified 26 randomized controlled trials (RCTs) and 10 non-RCTs that investigated the influence of V album extracts (VAEs) on QoL in malignant diseases; 26 studies assessed patient-reported QoL. Questionnaires were mostly well established and validated. Half of the studies investigated VAEs concomitant with chemotherapy, radiotherapy, or surgery. Some studies were well designed, whereas others had minor or major methodological weaknesses. Among the 26 RCTs, 22 reported a QoL benefit, 3 indicated no difference, and 1 did not report any result. All the non-RCTs reported a QoL benefit. Of the studies with higher methodological quality, most reported a benefit, whereas 1 found no difference. Improvements were mainly in regard to coping, fatigue, sleep, exhaustion, energy, nausea, vomiting, appetite, depression, anxiety, ability to work, and emotional and functional well-being in general and, less consistently, in regard to pain, diarrhea, general performance, and side effects of conventional treatments. VAEs were well tolerated. CONCLUSIONS: VAEs seem to have an impact on QoL and reduction of side effects of conventional therapies (chemotherapy, radiation) in experimental trials as well as in routine daily application. The influence on fatigue especially should be investigated further.

Clinical research in anthroposophic medicine.

Anthroposophic medicine includes special medications and special artistic and physical therapies. More than 200 clinical studies of varying design and quality have been conducted on anthroposophic treatment. Half of these studies concern anthroposophic mistletoe therapy for cancer. Clinical effects of mistletoe products include improvement of quality of life, reduction of side effects from chemotherapy and radiation, and possibly increased survival. Apart from cancer therapy, the largest studies of anthroposophic treatment have been 2 naturalistic system evaluations: In German outpatients with mental, musculoskeletal, respiratory, and other chronic conditions, anthroposophic treatment was followed by sustained improvements of symptoms and quality of life. In primary care patients from 4 European countries and the United States treated for acute respiratory and ear infections by anthroposophic or conventional physicians, anthroposophic treatment was associated with reduced use of antibiotics and antipyretics, quicker recovery, and fewer adverse reactions; these differences remained after adjustment for relevant baseline differences.

Viscum album L. extracts in breast and gynaecological cancers: a systematic review of clinical and preclinical research.

BACKGROUND: Viscum album L. extracts (VAE, European mistletoe) are a widely used medicinal plant extract in gynaecological and breast-cancer treatment. METHODS: Systematic review to evaluate clinical studies and preclinical research on the therapeutic effectiveness and biological effects of VAE on gynaecological and breast cancer. Search of databases, reference lists and expert consultations. Criteria-based assessment of methodological study quality. RESULTS: 19 randomized (RCT), 16 non-randomized (non-RCT) controlled studies, and 11 single-arm cohort studies were identified that investigated VAE treatment of breast or gynaecological cancer. They included 2420, 6399 and 1130 patients respectively. 8 RCTs and 8 non-RCTs were embedded in the same large epidemiological cohort study. 9 RCTs and 13 non-RCTs assessed survival; 12 reported a statistically significant benefit, the others either a trend or no difference. 3 RCTs and 6 non-RCTs assessed tumour behaviour (remission or time to relapse); 3 reported statistically significant benefit, the others either a trend, no difference or mixed results. Quality of life (QoL) and tolerability of chemotherapy, radiotherapy or surgery was assessed in 15 RCTs and 9 non-RCTs. 21 reported a statistically significant positive result, the others either a trend, no difference, or mixed results. Methodological quality of the studies differed substantially; some had major limitations, especially RCTs on survival and tumour behaviour had very small sample sizes. Some recent studies, however, especially on QoL were reasonably well conducted. Single-arm cohort studies investigated tumour behaviour, QoL, pharmacokinetics and safety of VAE. Tumour remission was observed after high dosage and local application. VAE application was well tolerated. 34 animal experiments investigated VAE and isolated or recombinant compounds in various breast and gynaecological cancer models in mice and rats. VAE showed increase of survival and tumour remission especially in mice, while application in rats as well as application of VAE compounds had mixed results. In vitro VAE and its compounds have strong cytotoxic effects on cancer cells. CONCLUSION: VAE shows some positive effects in breast and gynaecological cancer. More research into clinical efficacy is warranted.

Rhythmical massage therapy in chronic disease: a 4-year prospective cohort study.

OBJECTIVE: Rhythmical massage therapy is used in 24 countries but has not yet been studied in outpatient settings. The objective was to study clinical outcomes in patients receiving rhythmical massage therapy for chronic diseases. DESIGN: Prospective 4-year cohort study. SETTING: Thirty-six (36) medical practices in Germany. PARTICIPANTS: Eighty-five (85) outpatients referred to rhythmical massage therapy. OUTCOME MEASURES: Disease and Symptom Scores (physicians' and patients' assessment, respectively, 0-10) and SF-36. Disease Score was measured after 6 and 12 months, and other outcomes after 3, 6, 12, 18, 24, and 48 months. RESULTS: Most common indications were musculoskeletal diseases (45% of patients; primarily back and neck pain) and mental disorders (18%, primarily depression and fatigue). Median disease duration at baseline was 2.0 years (interquartile range 0.5-6.0). Median number of rhythmical massage therapy sessions was 12 (interquartile range 9-12), and median therapy duration was 84 (49-119) days. All outcomes improved significantly between baseline and all subsequent follow-ups. From baseline to 12 months, Disease Score improved from (mean +/- standard deviation) 6.30 +/- 2.01 to 2.77 +/- 1.97 (p < 0.001), Symptom Score improved from 5.76 +/- 1.81 to 3.13 +/- 2.20 (p < 0.001), SF-36 Physical Component score improved from 39.55 +/- 9.91 to 45.17 +/- 9.88 (p < 0.001), and SF-36 Mental Component score improved from 39.27 +/- 13.61 to 43.78 +/- 12.32 (p = 0.028). All these improvements were maintained until the last follow-up. Adverse reactions to rhythmical massage therapy occurred in 4 (5%) patients; 2 patients stopped therapy because of adverse reactions. CONCLUSIONS: Patients receiving rhythmical massage therapy had long-term reduction of chronic disease symptoms and improvement of quality of life.

[Anthroposophic medicine: health technology assessment report - short version]. / Anthroposophische Medizin: Health Technology Assessment Bericht - Kurzfassung.

BACKGROUND AND OBJECTIVE: The aim of this Health Technology Assessment Report was to analyse the current situation, efficacy, effectiveness, safety, utilization, and costs of Anthroposophic Medicine (AM) with special emphasis on everyday practice. DESIGN: Systematic review. MATERIAL AND METHODS: Search of 20 databases, reference lists and expert consultations. Criteriabased analysis was performed to assess methodological quality and external validity of the studies. RESULTS: AM is a complementary medical system that extends conventional medicine and provides specific pharmacological and non-pharmacological treatments. It covers all areas of medicine. 178 clinical trials on efficacy and effectiveness were identified: 17 RCTs, 21 prospective and 43 retrospective NRCTs, 50 prospective and 47 retrospective cohort studies/case-series without control groups. They investigated a wide range of AM-treatments in a variety of diseases, 90 x mistletoe in cancer. 170 trials had a positive result for AM. Methodological quality differed substantially; some studies showed major limitations, others were reasonably well conducted. Trials of better quality still showed a positive result. External validity was usually high. Side effects or other risks are rare. AM-patients are well educated, often female, aged 30-50 years, or children. The few economic investigations found less or equal costs in AM because of reduced hospital admissions and less prescriptions of medications. CONCLUSION: Trials of varying design and quality in a variety of diseases predominantly describe good clinical outcome for AM, little side effects, high satisfaction of patients and presumably slightly less costs. More research and more methodological expertise and infrastructure are desirable.