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Retrospective Study showed positive Results in Survival Rate of Patients with Breast Cancer during Mistletoe Therapy Therapy with standardised whole mistletoe extracts (e. g. HELIXOR) is the most established complementary method of treatment in adjuvant cancer therapy and becomes more and more accepted in clinical oncology. The fact that mistletoe therapy increases quality of life of cancer patients if it is applied persistently is largely scientifically recognized (1). However, the improvement of survival rates or prolongation of relapse-free intervals could not be definitely shown by scientifically accepted methods. A retrospective monocentric analysis performed in 3,022 breast cancer patients of the Tumour Ambulance of the Herdecke Hospital (2) showed a 10-year survival of 73.3 % for the patients who were treated with mistletoe extract and whose data could be evaluated (88 % for stage I, 71.6 % for stage II, and 55.6 % for stage III).The higher life expectancy compared to the Munich Cancer Registry (MCR 2001: 10-year survival rate 55 % in total; stage I 90 %, stage II 65 %, stage III < 30 %) can be subsumed as a reference to the efficacy of complementary oncological measures such as mistletoe therapy. Study Design In cooperation with the Tumour Ambulance of the Herdecke Hospital and the Department of Medicinal Biometrics of the Heidelberg University, a retrospective analysis was performed in 3,022 breast cancer patients who were treated in the Herdecke Hospital. Main objective of the study was the determination of the survival rate of breast cancer patients during mistletoe therapy. Further objectives were tolerance of mistletoe therapy as well as the analysis of local recurrences and distant metastases. The investigation was carried out by means of a questionnaire which had been sent to the breast cancer patients by mail, on the condition that a histological diagnosis had been established and that each patient had at least once consulted the Tumour Ambulance for treatment or medical advice since the Herdecke Hospital had been founded (1981). The patients were questioned retrospectively about possible side effects of mistletoe therapy. Further questions concerned adjuvant therapies after surgery such as chemotherapy, hormonal therapy and radiotherapy as well as the occurance of local recurrences and distant metastases. Additional diagnostic information was acquired from the hospital’s patient files (type of surgery, TNM classification, histopathological grading, status of steroid hormone receptors, lymph node status, familial disposition). Result and Summary A complete data record regarding gender, treatment and tumour stage according to UICC guidelines could be compiled in 1,246 of 3,022 patients included in the study. The average age of the patients at time of diagnosis was 49 years. 60 % of the patients were in tumour stage II, 23 % in stage I and 14 % in stage III; the figures for stages 0 and IV were very low so that both subgroups could not be evaluated in a statistically useful way. Lymph node metastases were diagnosed in approx. 50 % of all patients but distant metastases were found in only 3 % of the patients. In more than 60 % of the patients a total mastectomy and in one third a breastconserving surgery was performed. Mistletoe therapy was applied during a period of approx. 31 months. 48 % of the patients felt better during mistletoe therapy and only 5 % felt worse as they did before mistletoe therapy. Almost 80 % of the patients showed slight local reactions at the subcutaneous injection site of mistletoe, fact which can be evaluated as a positive response to the therapy. Survival time of 867 patients could be registered. The 10-year survival rate was 73.3 %. Stratification according to tumour stage showed a 10-year survival rate of 88.1 % for stage I, 71.6 % for stage II, 55.6 % for stage III. Differentiation according to the lymph node status showed a 10-year survival rate of 63.8 % for lymph node-positive patients and 83.7 % for lymph node-negative patients. A comparison of these data with the survival data of breast cancer patients of the Munich Cancer Registry 2001 (10-year survival rate approx. 55 %) showed a clear advantage of the patients treated with mistletoe extract in Herdecke. The survival benefit was particularly evident in tumour stage III (see figure 1). Patients the data of whom were not available or incomplete regarding tumour staging or treatment were classified as drop-outs (1728 patients). Survival time could be evaluated for 465 patients. The 5-year survival rate was 73.1 % and the 10-year survival rate 47.6 %. Literature (1) Schierholz, J.M., Schlodder, D.: Komplementäre Tumortherapie mit Mistelextrakten – eine aktuelle Übersicht [Complementary Tumour Therapy with Mistletoe Extracts – an Up-toDate Survey], Deutsche Zeitschrift für Onkologie 2003; 35: 124-133 (2) Stumpf, C. et al.: Retrospektive Untersuchung zur Therapie mit Mistelextrakten bei Mammakarzinom [Retrospective study of breast cancer patients treated with mistletoe extract], Deutsche Zeitschrift für Onkologie 2005; 37: 106-113 (3) Beuth, J. (Hrsg.): Grundlagen der Komplementäronkologie – Theorie und Praxis [Basics of Complementary Oncology – Theory and Practice]. Hippokrates Verlag in MVS Medizinverlage Stuttgart GmbH & Co. KG 2002 Source: http://www.biometrie.uniheidelberg.de/publikationen/ 46_Mamma_final.pdf Jörg Michael Schierholz, Chemist, Physician, M.D., Ph.D., Associate Prof. 1.0 0.8 UICC I 0.6 UICC II UICC III 0.4 Efficacy of whole mistletoe extracts (e. g. HELIXOR A, M, P) has been proven since several decades of medical experience, summarised in the Viscum album monograph of the Commission C [in the former Federal Health Administration]. The improvement of quality of life of cancer patients, the increase of the host defence capacity and the associated inhibition of tumour growth without impairment of healthy tissue is the scientific background for evidence-based mistletoe therapy. These promising results still will be confirmed by evidence-based instruments such as retrolective cohort studies (EBM level 2). Survival time of mistletoe patients of the Tumour Ambulance of Herdecke Hospital compared to the Munich Cancer Registry 2001 Misteltoe Study Munich Cancer Registry 0.2 Despite all methodical questions concerning selection bias, this retrospective analysis shows a considerable higher survival rate of the patients treated with mistletoe extracts compared to the average figures of the Munich Cancer Registry. The data regarding survival – with or without complete documentation in all investigated groups – show very clearly that the results cannot be due only to the centre effect. This is in confirmation with the experimental and clinical data of mistletoe extracts (3). Figure 1: Survival rate Patients being treated in the Herdecke Hospital usually received mistletoe therapy. A small internal control group (n = 18) of patients without mistletoe therapy showed a survival of 81.6 % (5 years) and 53.2 % (10 years), data comparable to the Munich Cancer Registry 2001. 0 2 4 6 Survival Time [years] UICC I: n = 219 UICC II: n = 531 UICC III: n = 103 8 10 12