List of references supporting the assessment of Viscum album L
Transcrição
List of references supporting the assessment of Viscum album L
13 September 2011 EMA/HMPC/246781/2009 Committee on Herbal Medicinal Products (HMPC) List of references supporting the assessment of Viscum album L., herba Draft The Agency acknowledges that copies of the underlying works used to produce this monograph were provided for research only with exclusion of any commercial purpose. Barnes J, Anderson LA, Philipson JD. Herbal medicines. 3rd edition. Pharmaceutical press 2007; 436-46. Bisset NG. Herbal drugs and phytopharmaceuticals. Medpharm Scientific Pulishers, Stuttgart; 1994; 534-536. Boericke, Materia Medica 9th edition; Sett Dey & Co, Calcutta, 1976; 677. Büssing A, ed. Mistletoe. The Genus Viscum. Amsterdam: Hardwood Academic Publishers; 2000. Chernyshov VP, Heusser P, Omelchenko LI, Chernyshova LI, Vodyanik MA, Vykhovanets EV, Galazyuk LV, Pochinok TV, Gaiday NV, Gumenyuk ME, Zelinsky GM, Schaefermeyer H, Schaefermeyer G. Immunomodulatory and clinical effects of Viscum album (Iscador M and Iscador P) in children with recurrent respiratory infections as a result of the Chernobyl nuclear accident. Am J Ther. 2000 May; 7(3): 195-203. Chernyshov VP, Omelchenko LI, Heusser P, et al. Immunomodulatory actions of Viscum album (Iscador) in children with recurrent respiratory disease as a result of the Chernobyl nuclear accident. Complementary Therapies in Medicine 1997; (5):141-146. Delfosse M. Drigues végétales et Plantes médicinales. Association Pharmaceutique Belge, Bruxelles, 1998; 242-243. Delloman D, Caliş I, Ergun F, Doĝan BS, Buharalioĝlu CK, Kanzik I. Studies on the vascular effects of the fractions and phenolic compounds isloated from Viscum album ssp. album. J. Ethnopharmacol. 2000; 72 (1-2):323-329. Duke JA. Handbook of Medicinal Herbs; CRC Press, Boca Raton (California), 1985; 512. 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7051 E-mail [email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged. Goebell PJ, Otto T, Suhr J, Rübben H. Evaluation of an unconventional treatment modality with mistletoe lectin to prevent recurrence of superficial bladder cancer: a randomized phase II trial. J Urol. 2002; 168(1):72-75. Gray AM, Flatt PR. Insulin-secreting activity of the traditional antidiabetic plant Viscum album (mistletoe). J. Endocrinol. 1999; 160(3):409-414. Hamre HJ, Witt CM, Glockmann A, Tröger W, Willich SN, Kiene H. Use and Safety of Anthroposophic Medications in Chronic Disease A 2-Year Prospective Analysis. Drug Safety 2006; 29(12):1173-1189. Henriettes Herbal. www.henriettesherbal.com (last access on 19 March 2011). Heusser P. Anthroposophic expansion of medicine. Schweiz Rundschau Med Praxis 1998; 87(31-32): 975–983. Horneber MA, Bueschel G, Huber R, Linde K, Rostock M. Mistletoe therapy in oncology. Cochrane Database Syst Rev 2008; (2):CD003297. Huber R, Eisenbraun J, Miletzki B, Adler M, Scheer R, Klein R, Gleiter CH. Pharmacokinetics of natural mistletoe lectins after subcutaneous injection. Eur J Clin Pharmacol. 2010; 66(9):889-897. Keller K, Hänsel R, Rimpler H, Schneider G. editors. Hagers Handbuch der Pharmazeutischen Praxis. Berlin. Springer-Verlag, 1994; 1160-1179. Kienle GS, Kiene H. Die Mistel in der Onkologie. Schattauer Verlag, Stuttgart, 2003. Kleeberg UR, Suciu S, Bröcker EB, Ruiter DJ, Chartier C, Liénard D, Marsden J, Schadendorf D, Eggermont AMM. Final results of the EORTC 18871/DKG 80-1 randomised phase III trial. rIFN-alpha2b versus rIFN-gamma versus ISCADOR M versus observation after surgery in melanoma patients with either high-risk primary (thickness >3 mm) or regional lymph node metastasis. Eur J Cancer 2004; 40(3):390-402. Lange-Lindberg A-M, Velasco-Garrido M, Busse R. Misteltherapie als begleitende Behandlung zur Reduktion der Toxizität der Chemotherapie maligner Erkrankungen. HTA-Bericht 44. Deutsche Agentur für HTA des Deutschen Instituts für Medizinische Dokumentation und Information, 2006. Leclerc H. Précis de Phytothérapie. Masson et Cie éditeurs, Paris, 1966; 200. Maldacker J. Preclinical investigations with mistletoe (Viscum album L.) extract Iscador. Arzneimittelforschung 2006 Jun; 56(6A):497-507. Piao BK, Wang YX, Xie GR, Mansmann U, Matthes H, Beuth J, Lin HS. Impact of complementary mistletoe extract treatment on quality of life in breast, ovarian and non-small cell lung cancer patients. A prospective randomized controlled clinical trial. Anticancer Res. 2004; 24(1):303-309. Rote Liste 2010 & 2011. Arzneimittelverzeichnis für Deutschland (einschliesslich EU-Zulassungen und bestimmter Medizinprodukte). Rote Liste® Service GmbH, Frankfurt/Main, Germany. Schöffski P, Riggert S, Fumoleau P, et al. Phase I trial of intravenous aviscumine (rViscumin) in patients with solid tumors: a study of the European Organization for Research and Treatment of Cancer New Drug Development Group. Annals of oncology 2004; 15(12):1816-1824. Schöffski P, Breidenbach I, Krauter J, et al. Weekly 24 h infusion of aviscumine (rViscumin): a phase I study in patients with solid tumours. European journal of cancer 2005; 41(10):1431-1438. Schwabe U, Paffrath D. In: Schwabe U, Paffrath D editor(s).Arzneiverordnungs-Report 2002. Springer Verlag Berlin Heidelberg, 2003. List of references supporting the assessment of Viscum album L., herba EMA/HMPC/246781/2009 Page 2/8 Semiglasov VF, Stepula VV, Dudov A, Lehmacher W, Mengs U. The standardised mistletoe extract PS76A2 improves QoL in patients with breast cancer receiving adjuvant CMF chemotherapy: a randomised, placebo-controlled, double-blind, multicentre clinical trial. Anticancer Res. 2004; 24(2C):1293-1302. Semiglasov VF, Stepula VV, Dudov A, Schnitker J & Mengs U. Quality of life is improved in breast cancer patients by Standardised Mistletoe Extract PS76A2 during chemotherapy and follow-up: a randomised, placebo-controlled, double-blind, multicentre clinical trial. Anticancer Res. 2006; 26:15191530. Stein GM. Toxicology of mistletoe and their components. In: Büssing A, ed. Mistletoe. The Genus Viscum. Amsterdam: Hardwood Academic Publishers, 2000; 183-194. Steuer-Vogt MK, Bonkowsky V, Ambrosch P, Scholz M, Neiss A, Strutz J, et al. The effect of an adjuvant mistletoe treatment programme in resected head and neck cancer patients: a randomised controlled clinical trial. Eur J Cancer. 2001; 37(1):9-11. Stoss M, van Wely M, Musielsky H, Gorter RW. Study on local inflammatory reactions and other parameters during subcutaneous mistletoe application in HIV-positive patients and HIV-negative subjects over a period of 18 weeks. Arzneimittelforschung 1999; 49(4):366-373. Tabiasco J, Pont F, Fournié J, Vercellone A. Mistletoe viscotoxins increase natural killer cell-mediated cytotoxicity. Eur J Biochem. 2002; 269(10):2591-600. Urech K, Schaller G, Jäggy C. Viscotoxins, mistletoe lectins and their isoforms in mistletoe (Viscum album L.) extracts Iscador. Arzneimittelforschung 2006; 56(6A):428-434. Van Hellemont J. Fytotherapeutisch Compendium; Algemene Pharmaceutische Bond, Brussel, 1985; 648. Ye F, DU GZ, CuiAQ, Lu XT. Study on the mechanism of compound mistletoe fluidextract in relieving hypertension. J. Trad. Chin. Med. 2009; 29(4):291-295. References accessed but not included to the Assessment Report Balthasar P, Priemer N. Krebshemmende Mistelproteine. Elemente der Naturwissenschaft 1977; 26:2026. Bar-Sela G, Wollner M, Agbarya A, Zwergel L, Maykler I, Sharvit L, et al. Mistletoe as complementary treatment in patients with advanced non-small-cell lung cancer (NSCLC) treated with carboplatin/ gemcitabine combination: a randomized phase II study. ECCO 15-34th ESMO, Berlin, 2009, Poster 302, 1. Ben EE, Eno AE, Ofem OE, Aidem U, Itam EH. Increased plasma total cholesterol and high density lipoprotein levels produced by the crude extract from the leaves of Viscum album (mistletoe). Niger J Physiol Sci. 2006; 21(1-2):55-60. Beuth J, Schierholz J & Schneider B. Unbedenklichkeit und Wirksamkeit der Behandlung mit einem standardisierten Mistelextrakt in der Nachsorge von Mammakarzinom-Patientinnen - Eine retrospektive, kontrollierte, epidemilogische Kohortenstudie. In R. Scheer, S. Alban, H. Becker, U. Holzgrabe, F. H. Kemper, W. Kreis, et al. (Eds.), Die Mistel in der Tumortherapie 2 - Aktueller Stand der Forschung und klinische Anwendung, 2009; 577-586. Essen: KVC Verlag. List of references supporting the assessment of Viscum album L., herba EMA/HMPC/246781/2009 Page 3/8 Beuth J, Schneider B & Schierholz JM. Impact of complementary treatment of breast cancer patients with standardized mistletoe extract during aftercare: a controlled multicenter comparative epidemiological cohort study. Anticancer Res. 2008; 28:523-528. Beuth J, Schierholz J & Schneider B. Safety and efficacy of treatment of breast cancer patients with standardized mistletoe extract: A controlled multicenter comparative cohort study. Phytomedicine 2007; 14(SVII), 39. Bock PR, Hanish J, Friedel WE & Matthes H. Treatment with a fermented mistletoe (Viscum album L.) extract as part of long-term supportive care in patients with primary non-metastatic colorectal carcinomale. Phytomedicine 2007; 14(SVII), 43. Bruneton J. Pharmacognosie, phytochimie, plantes médicinales. Editions Tec & Doc, Paris, 1999; 218220. Bruneton J. Toxic plants. Dangerous to humans and animals. Intercept Ltd, 1999; 503-506. Büssing A, Brückner U, Enser-Weis U, Schnelle M, Schumann A, Schietzel M, et al. Modulation of chemotherapy-associated immunosuppression by intravenous application of Viscum album L. extract (Iscador): a randomised phase II study. European Journal for Integrative Medicine 2008; 1(Suppl. 1), 44-45. De Smet PAGM, et al. Adverse effects of herbal drugs vol 2. Springer, 1993; 87. Delfosse M. Drogues végétales et plants médicinales. Service Scientifique de l’Association Pharmaceutique Belge, Bruxelles, 1998; 242-243. Duke JA. Handbook of medicinal herbs. CRC Press, Michigan, 1988; 512-513. Eisenbraun J, Scheer R, Kröz M, Schad F, Huber R. Quality of life in breast cancer patients during chemotherapy and concurrent therapy with a mistletoe extract. Phytomedicine: International journal of phytotherapy and phytopharmacology 2010. Eisenbraun J. Verbesserung der Lebensqualität durch eine Misteltherapie (abnobaVISCUM©) bei Patienten mit Magenkarzinom: Ergebnisse einer randomisierten, kontrollierten Studie. Zeitschrift für Phytotherapie 2009b; 30(S 01), DOI: 10.1055/s-0029-1239850-. Eisenbraun J, Huber R, Kröz M, Schad F & Scheer R. Lebensqualität von Brustkrebs-Patientinnen während der Chemotherapie und einer begleitenden Therapie mit einem Apfelbaum-Mistelextrakt. Die Mistel in der Tumortherapie 2 - Aktueller Stand der Forschung und klinische Anwendung, 2009a; 495507. Eisenbraun J, Huber R, Kröz M, Schad F & Scheer R. Quality of life in breast cancer patients during chemotherapy and concurrent therapy with a mistletoe-extract of the apple tree. Phytomedicine 2007; 14(SVII), 35. Eldorry AK, Shaker MK, Barakat EM, Abdallah H, Khalifa MO & Elbreedy AM. The Effect of a Mistletoe Preparation with Defined Lectin Content in Advanced Hepatocellular Carcinoma Cases. American Association for the Study of Liver Disease, 2008; (IASL Posters), 424. Friedel W, Matthes H, Bock P. Treatment with standardised fermented mistletoe (Viscum album L.) extract Iscador within supportive care in patients with primary colorectal carcinoma. Focus on Alternative and Complementary Therapies 2010; 12:22-23. Friedel WE, Bock PR, Hanisch J & Karasmann M. (2009a). Clinically Relevant Survival Benefit from Supportive Treatment with Fermented European Pine Tree Mistletoe Extract in Primary Malignant Melanoma Patients. Poster: 7th World Congress on Melanoma, Vienna, Austria, 2009. List of references supporting the assessment of Viscum album L., herba EMA/HMPC/246781/2009 Page 4/8 Friedel WE, Bock PR, Hanisch J & Karasmann M. (2009b). Lower Incidence of Metastases by Supportive Treatment with Fermented European Mistletoe (Viscum album L.) Extract from Pine Tree in Primary Malignant Melanoma Patients. Oct 7-11 [poster]. EADV, 18th Congress of the European Academy of Dermatology and Venereology. Friedel WE, Bock PR, Hanisch J & Karasmann M. (2009c). Supportive treatment with fermented European mistletoe (Viscum album L.) extract from pine tree shows clinically relevant survivalbenefit in primary malignant melanoma patients. Oct 7-11 [abstract]. EADV, 18th Congress of the European Academy of Dermatology and Venereology. Friedel WE, Hanisch J, Karasmann M & Bock PR. Improved quality of life and survival prolongation by a long-term supportive treatment with fermented mistletoe (viscum album L.) extract in primary nonmetastatic colorectal cancer. Abstract 23-286: International Multinational Association of Supportive Care in Cancer (MASCC)/ISOO Symposium, Rome, Italy, June 25 - 27, 2009; Support Care Cancer 2009d; 17(857-1039):1007. Friedel WE, Matthes H & Bock PR. Treatment with fermented mistletoe (Viscum album L.) extract as part of long-term supportive care in patients with primary non-metastatic colorectal carcinoma. 20th International Symposium Supportive Care in Cancer St. Gallen, June 28-30 2007. Friedel WE, Matthes H & Bock PR. Improved supportive care with fermented mistletoe (Viscum album L.) extract in patients with primary non-metastatic colorectal carcinoma. ESMO Conference Stockholm (Sweden), 12-16 September 2008. Friedel WE, Matthes H & Bock PR. Fermented European mistletoe (Viscum album L.) extract in supportive care in patients with primary non-metastatic colorectal carcinoma. In R. Scheer, S. Alban, H. Becker, U. Holzgrabe, F. H. Kemper, W. Kreis, et al. (Eds.), Die Mistel in der Tumortherapie 2 Aktueller Stand der Forschung und klinische Anwendung, 2009e; 563-576, Essen: KVC Verlag. Friedel WE, Matthes H, Bock PR & Zänker KS. Systematic Evaluation of the Clinical Effects of Supportive Mistletoe Treatment within Chemo- and/or Radiotherapy Protocols and Long-Term Mistletoe Application in Nonmetastatic Colorectal Carcinoma: Multicenter, Controlled, Observational Cohort Study. Journal of the Society for Integrative Oncology 2009f; 7(04). Grah C. Misteltherapie bei nichtkleinzelligem Bronchialkarzinom. Randomisierte, offene Phase-II-Studie zur Untersuchung der Verträglichkeit und Wirksamkeit von Viscum-album-Extrakt in der palliativen, additiven Behandlung des fortgeschrittenen nichtkleinzelligen GKH Havelhöhe, Akademisches Lehrkrankenhaus der medizinischen Fakultät der Charité, Universitätsmedizin Berlin, 2010a. Grah C, Matthes B, & Happel H. Mistletoe therapy for non-small cell bronchial carcinoma Randomised open phase II study for the examination of the tolerance, safety and effectiveness of Viscum album extract in the palliative, additive treatment of advanced non-small cell bronchial carc. European Respiratory Society Annual Congress, 2010b. Grossarth-Maticek R & Ziegler R. Prospective controlled cohort studies on long-term therapy of breast cancer patients with a mistletoe preparation (Iscador). Forschende Komplementärmedizin 2006a; 13: 285-292. Grossarth-Maticek R & Ziegler R. Prospective controlled cohort studies on long-term therapy of breast cancer patients with a mistletoe preparation (Iscador) - Supplementary materials, 2006a. Retrieved from http://www.karger.com/doi/10.1159/000095378. Grossarth-Maticek R & Ziegler R. Randomised and non-randomised prospective controlled cohort studies in matched-pair design for the long-term therapy of breast cancer patients with a mistletoe preparation (Iscador): a re-analysis. European Journal of Medical Research 2006b; 11(11): 485-495. List of references supporting the assessment of Viscum album L., herba EMA/HMPC/246781/2009 Page 5/8 Institute for Preventive Medicine, and European Center for Peace and Development, Heidelberg, Germany. Retrieved from PM:17182361. Grossarth-Maticek R & Ziegler R. Prospective controlled cohort studies on long-term therapy of cervical cancer patients with a mistletoe preparation (Iscador). Forschende Komplementärmedizin und Klassische Naturheilkunde / Research in Complementary and Classical Natural Medicine 2007a; 14: 140-147. Grossarth-Maticek R & Ziegler R. Prospective controlled cohort studies on long-term therapy of ovarian cancer patients with mistletoe (Viscum album L.) extracts Iscador. Arzneimittel-Forschung/Drug Research 2007b; 57(10): 665-678. Grossarth-Maticek R & Ziegler R. Wirksamkeit und Unbedenklichkeit einer Langzeitbehandlung von Melanompatienten mit einem Mistelpräparat (Iscador). Schweizerische Zeitschrift für Ganzheitsmedizin / Swiss Journal of Integrative Medicine 2007c; 19(6): 325-332. doi: 10.1159/000285940. Grossarth-Maticek R & Ziegler R. Randomized and non-randomized prospective controlled cohort studies in matched pair design for the long-term therapy of corpus uteri cancer patients with a mistletoe preparation (Iscador). European Journal of Medical Research 2008; 13: 107-120. Hekal IA., Samer T & Ibrahim EI. Viscum Fraxini 2, as an adjuvant therapy after resection of superficial bladder cancer: Prospective clinical randomized study. Presented at the 43rd Annual Congress of The Egyptian Urological Association in conjunction with The European Association of Urology November 1014, 2008 Hurghada, Egypt. 2009; Abstract P8; 120. Kommission E (1984) Aufbereitungsmonographie Visci albi herba. Bundesanzeiger vom 5.12.1984. Kuehn JJ. Viscum album L. Pini in der Behandlung des Non-Hodgkin-Lymphoms - Wirksamkeit und Risikoeinschätzung einer subkutanen Misteltherapie im Rahmen einer retrospektiven Fallkontrollstudie 2009. In R. Scheer (Ed.), Die Mistel in der Tumortherapie 2 - Aktueller Stand der Forschung und klinische Anwendung, 2009; 353-373. Essen: KVC. Kuehn JJ. Treatment responses to viscum album pini (Iscador P) in non-Hodgkin’s lymphoma exploring a new therapeutic route. Medicina (B Aires) 2007a; 67(Suppl II), 107-114. Kuehn JJ. Efficacy and risk estimation of subcutaneous mistletoe treatment (Viscum album L. Pini) in patients with non-Hodgkin’s lymphoma. Phytomedicine 2007b; 14(SVII), 25. Loewe-Mesch A, Kuehn JH, Borho K, Abel U, Bauer C, Gerhard I, et al. Adjuvante simultane Mistel/Chemotherapie bei Mammakarzinom - Einfluss auf Immunparameter, Lebensqualität und Verträglichkeit. Forschende Komplementärmedizin und Klassische Naturheilkunde / Research in Complementary and Classical Natural Medicine, 2008; 15(1), 22-30. Ambulanz fur Naturheilkunde und Integrative Medizin, Abt. Gynakologische Endokrinologie und Fertilitatsstorungen der Universitatsfrauenklinik Heidelberg, Deutschland. Retrieved from PM:18334811. Matthes H, Friedel E, Bock P. Supportive care in pancreatic carcinoma patients with the fermented mistletoe (Viscum album L.) extract Iscador treatment. Focus Altern Complement Ther. 2007; 12:35. Matthes H, Friedel WE & Bock PR. (2007a). Supportive care in pancreatic carcinoma patients treated with a fermented mistletoe (Viscum album L.) extract. ESMO Conference Lugano, 5-8 July 2007. Matthes H, Friedel WE & Bock PR. Fermented mistletoe (Viscum album L.) extract as long-term supportive care in pancreatic carcinoma of UICC stages I-IV. Stockholm (Sweden): ESMO Conference (European Society for Medical Oncology) 12-16 September 2008. Matthes H, Friedel WE & Bock PR. Supportive care in pancreatic carcinom patients treated with a fermented mistletoe (Viscum abum L.) extract. In R. Scheer, S. Alban, H. Becker, U. Holzgrabe, F. H. List of references supporting the assessment of Viscum album L., herba EMA/HMPC/246781/2009 Page 6/8 Kemper, W. Kreis, et al. (Eds.), Die Mistel in der Tumortherapie 2 - Aktueller Stand der Forschung und klinische Anwendung, 2009a; 551-562. Essen: KVC Verlag. Matthes H, Friedel WE & Bock PR. (2010a). Post-operative Treatment of Primary Colorectal Cancer can be optimized by Supportive Long-term Therapy with the Host Tree Specific Fermented Extract of Mistletoe (Viscum album L.) from Oak Tree (quercus). Abstract. Deutscher Krebskongress (DKK), Berlin, Germany. Matthes H, Friedel WE, Bock PR & Zänker KS. Molecular mistletoe therapy: friend or foe in established anti-tumor protocols? A multicenter, controlled, retrospective pharmaco-epidemiological study in pancreas cancer. Curr. Mol. Med. 2010b; 10(4): 430-439. Hospital Havelhohe, Oncology Clinic, Berlin, Germany. Retrieved from PM:20455850. Matthes H, Schad F, Friedel WE & Bock PR. (2009b). Long-term Supportive Treatment with the Fermented Mistletoe (Viscum album L.) Extract from Pine Tree (Host Tree Pinus) in Addition to Conventional Oncological Therapy in Primary Non-metastatic Breast Cancer. Abstract and Poster. European Society of Gynaecological Oncology (ESGO), Belgrade, Serbia. Matthes H, Friedel WE, Hanisch J, Karasmann M & Bock PR. Improvement of the palliative supportive care in pancreatic carcinoma patients with a fermented mistletoe (Viscum album L.) extract treatment. Phytomedicine 2007b; 14(SVII): 54. Samuelsson G. Drugs of natural origin (a textbook of pharmacognosy). 4th edition. Apothekar societeten 1999; 378-380. Schulz V, Hänsel R, Blumenthal M, Tyler V.E. Rational phytotherapy: a reference guide for physicians and pharmacists 5th ed. Springer, Berlin, 2004; 144-145, 388-391. Stauder GM, Matthes H, Friedel WE & Bock PR. Use of fermented mistletoe (Viscum album L.) extract from oak tree (Quercus) as supportive treatment for patients with pancreatic cancer. Clin. Onc. 2009a, 27(Suppl), Abstr e 15656. Stauder G, Friedel WE & Bock PR. Fermented mistletoe (Viscum album L.) extract from oak tree as supportive treatment improves quality of life in patients with pancreatic cancer of any stage. Abstract 23-314: International Multinational Association of Supportive Care in Cancer (MASCC)/ISO. Support Care Cancer 2009b; 17(857-1039), 1021. Stauder G, Friedel WE & Bock PR. Improved quality of life and survival time by supportive long-term treatment with fermented mistletoe (Viscum album L.) extract from oak tree in patients with pancreatic cancer of any stage. Abstract P0303: 11th World Congress of Gastrointestinal Cancer, Annuals of Oncology 2009c; 20(Suppl. 7). Steuer-Vogt MK, Bonkowsky V, Scholz M, Fauser C, Licht K & Ambrosch P. Einfluss eines ML-1normierten Mistelextraktes auf die Lebensqualität bei Patienten mit Kopf-Hals-Karzinomen. HNO, 2006; 54 (4), 277-286. Stumpf C, Rieger S, Fischer IU, Schietzel M. Retrospektive Untersuchung zur Therapie mit Mistelextrakten bei Patienten mit kolorektalem Karzinom. Deutsche Zeitschrift für Onkologie 2007; 39: 12-22. Tröger W, Jezdic S, Zdrale Z, et al. Quality of Life and Neutropenia in Patients with Early Stage Breast Cancer: A Randomized Pilot Study Comparing Additional Treatment with Mistletoe Extract to Chemotherapy Alone. Breast Cancer: Basic and Clinical Research 2009b; 3:35-45. List of references supporting the assessment of Viscum album L., herba EMA/HMPC/246781/2009 Page 7/8 Tröger W & Matijasevic M. Study report: Additional therapy with Helixor and Iscador in breast cancer patients receiving chemotherapy: A prospective randomized open-label study 2008, (Vol. phase III, 1681). Tröger W, Matijasevic M, Zdrale Z, Tisma N & Jezdic S. Additional therapy with mistletoe extracts in breast cancer patients receiving chemotherapy: a prospective randomized open label pilot study. In R. Scheer, S. Alban, H. Becker, U. Holzgrabe, FH. Kemper, W. Kreis, et al. (Eds.), Die Mistel in der Tumortherapie 2 - Aktueller Stand der Forschung und klinische Anwendung, 2009a; 509-521. Essen: KVC-Verlag. Tröger W. Additional therapy with mistletoe extracts in breast cancer patients receiving chemotherapy. A prospective randomized open label pilot study. Phytomedicine 2007; 14(SVII): 36. Vester F, Bohne L, El-Fouly M. Zur Kenntnis der Inhaltsstoffe von Viscum album. IV. Biologisches Verhalten einzelner Proteinfraktionen. Hoppe-Seyler's Z f Physiol Chem. 1968; 349:495-511. Ziegler R & Grossarth-Maticek R. Individual Patient Data Meta-analysis of Survival and Psychosomatic Self-regulation from Published Prospective Controlled Cohort Studies for Long-term Therapy of Breast Cancer Patients with a Mistletoe Preparation (Iscador). Evidence-based complementary and alternative medicine. eCAM, 20087; (2):157-166. doi: 10.1093/ecam/nen025. List of references supporting the assessment of Viscum album L., herba EMA/HMPC/246781/2009 Page 8/8