Efficacy and safety of long-term complementary treatment with standardized european mistletoe extract (Viscum album L.) in addition to the conventional adjuvant oncologic therapy in patients with primary non-metastasized mammary carcinoma / results of a multicenter, comparative, epidemiological cohort study in Germany and Switzerland;Wirksamkeit und Sicherheit der komplementaren Langzeitbehandlung mit einem standardisierten Extrakt aus Europaischer Mistel (Viscum album L.) zusatzlich zur konventionellen adjuvanten onkologischen Therapie bei primarem, nicht metastasiertem Mammakarzinom

Arzneimittel-Forschung/Drug Research

Volumn 54, Issue 8, 2004, Pages 456-466

  Bock, Paul R ^a   Friedel, Walter E ^b   Hanisch, Jürgen ^a   Karasmann, Marita ^a   Schneider, Berthold ^c  

^a IFAG Basel AG   (Switzerland)

^b Krankenhaus Bad Bocklet   (Germany)

^c HANNOVER MEDICAL SCHOOL   (Germany)

Author keywords

Iscador ; Mammary carcinoma; Mistletoe, adjuvant therapy, cohort study, efficacy, safety; Viscum album L.

Indexed keywords

ANTINEOPLASTIC AGENT; VISCUM ALBUM EXTRACT; PLANT EXTRACT;

ADULT; AMNESIA; ANOREXIA; ARTICLE; BREAST CARCINOMA; CANCER ADJUVANT THERAPY; CANCER HORMONE THERAPY; CANCER PAIN; CANCER RADIOTHERAPY; CANCER SURGERY; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; COHORT ANALYSIS; COMPARATIVE STUDY; CONCENTRATION LOSS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DISEASE SEVERITY; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; FATIGUE; GASTROINTESTINAL SYMPTOM; GERMANY; HEADACHE; HUMAN; IATROGENIC DISEASE; INFECTION; INSOMNIA; IRRITABILITY; LONG TERM CARE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MUSCLE WEAKNESS; NAUSEA; PHARMACOEPIDEMIOLOGY; PHYSIOTHERAPY; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SWITZERLAND; TREATMENT OUTCOME; VERTIGO; ADJUVANT CHEMOTHERAPY; AGED; BIOASSAY; BREAST TUMOR; DISEASE COURSE; FEMALE; MIDDLE AGED; PHYTOTHERAPY; PROPORTIONAL HAZARDS MODEL; SURVIVAL; VISCUM ALBUM;

VISCUM ALBUM;

ADULT; AGED; ANTINEOPLASTIC AGENTS, PHYTOGENIC; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; COHORT STUDIES; DISEASE PROGRESSION; ENDPOINT DETERMINATION; FEMALE; HUMANS; MIDDLE AGED; MISTLETOE; PHYTOTHERAPY; PLANT EXTRACTS; PROPORTIONAL HAZARDS MODELS; SURVIVAL ANALYSIS;

EID: 4344630940     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1296999     Document Type: Article

References (52)

1. Abeloff, M. D., Lichter, A. S., Niederhuber, J. E. et al., Breast. In: Clinical Oncology, Abeloff, M. D., Armitage, J. O., Lichter, A. S. et al. (Hrsg.), S. 2051-2159. Churchill Livingstone, New York (2000)
2. Krebs in Deutschland, Häufigkeiten und Trends, S. 1-104. Arbeitgemeinschaft Bevölkerungsbezogener Krebsregister in Deutschland; Robert Koch Institut, Berlin-Saarbrücken (2002)
3. Kreienberg, R., Möbus, V., Alt, D., Management des Mammakarzinoms, S. 1-471. Springer Verlag, Heidelberg-Berlin etc. (1998)
4. Eifel, P., Axelson, J. A., Costa, J. et al., National Institutes of Health Consensus Development Conference Statement: adjuvant therapy for breast cancer, November 1-3, 2000. J. Natl. Cancer Inst. 93, 979 (2001)
5. Goldhirsch, A., Glick, J. H., Gelber, R. D. et al., Meeting highlights: International consensus panel on the treatment of primary breast cancer. J. Clin. Oncol. 19, 3817 (2001)
6. Margolese, R. G., Fisher, B., Hortobagyi, G. N. et al., Neoplasms of the Breast. In: Cancer Medicine, Bast, R. C. Jr., Kufe, D. W., Pollock, R. E. et al. (Hrsg.), S. 1735-1822. B. C. Decker, Hamilton-London (2000)
7. Partridge, A. H., Burstein, H. J., Winer, E. P., Side Effects of Chemotherapy and Combined Chemohormonal Therapy in Women With Early-Stage Breast Cancer. J. Natl. Cancer Inst. Monographs 30, 135 (2001)
8. Shapiro, C. L., Recht, A., Side Effects of Adjuvant Treatment of Breast Cancer. N. Engl. J. Med. 344, 1997 (2001)
9. Arora, N. K., Gustafson, D. H., Hawkins, R. P. et al., Impact of surgery and chemotherapy in younger women with breast cancer. Cancer 92, 1288 (2001)
10. Crivellari, D., Bonetti, M., Caglistone-Gertsch, M. et al., Burdens and benefits of adjuvant cyclophosphamide, methotrexate, and fluorouracil and tamoxifen for elderly patients with breast cancer: The International Breast Cancer Study Group Trial VII. J. Clin. Oncol. 18, 1412 (2000)
11. Ganz, P. A., Impact of tamoxifen adjuvant therapy. J. Natl. Cancer Inst. Monographs 30, 130 (2001)
12. Ganz, P. A., Desmond, K. A., Leedham, B. et al., Quality of life in long-term, disease-free survivors of breast cancer: a follow up study. J. Natl. Cancer Inst. 94, 39 (2002)
13. Holzner, B., Kemmler, G., Kopp, J. et al., Quality of life in breast cancer patients - not enough attention for long-term survivors? Psychosomatics 42, 117 (2001)
14. Longman, A. J., Braden, C. J., Mishel, M. H., Side effects burden, psychological adjustment, and quality of life in women with breast cancer: pattern of association over time. Oncol. Nurs. Forum 26, 909 (1999)
15. Ernst, E., Cassileth, B. R., How useful are unconventional cancer treatments? Eur. J. Cancer 35, 1608 (1999)
16. Ernst, E., Mistletoe for cancer? Eur. J. Cancer 37, 9 (2001)
17. Jacobson, J. S., Workman, S. B., Kronenberg, F., Research on complementary/alternative medicine for patients with breast cancer: a review of the biomedical literature. J. Clin. Oncol. 18, 668 (2000)
18. Schwabe, U., Paffrath, D., Arzneiverordnungsreport 2003, S. 548-550, Springer Verlag, Berlin-Heidelberg etc. (2004)
19. Moschèn, R., Kemmler, G., Schweigkofler, H. et al., Use of alternative/complementary therapy in breast cancer patients - a psychological perspective. Support Care Cancer 9, 267 (2001)
20. Büssing, A., Biological and pharmacological properties of Viscum Album L. In: Mistletoe, The Genus Viscum, Büssing, A. (Hrsg.), S. 123-183. Harwood Academic Publishers, Amsterdam (2000)
21. Fischer, S., Scheffler, A., Kabelitz, D., Stimulation of the specific immune system by mistletoe extracts. Anticancer Drugs 8, Suppl 1, S33 (1997)
22. Hajto, T., Hostanska, K., Saller, R., Mistletoe therapy from the pharmacologic perspective. Forsch. Komplementärmed. 6, 186 (1999)
23. Stein, G. M., Toxicology of Mistletoe Extracts and their Components. In: Mistletoe, The Genus Viscum, Büssing, A. (Hrsg.), S. 183-194. Harwood Academic Publishers, Amsterdam (2000)
24. Kiene, H., Beurteilung klinischer Studien zur Misteltherapie. In: Grundlagen der Misteltherapie, Scheer, R., Becker, H., Berg, P. A., S. 484-496. Hippokrates Verlag, Stuttgart (1996)
25. Kiene, H., Buschel, G., Hornebar, M., Mistletoe or not mistletoe is still the question. Forsch. Komplementärmed. Klass. Naturheilkd. 8, 309 (2001)
26. Kleijnen, J., Knipschild, P., Mistletoe treatment for cancer: review of controlled trials in humans. Phytomedicine 1, 255 (1994)
27. Gorter, R. W., van Wely, M., Reif, M. et al., Tolerability of an extract of European mistletoe among immunocompromised and healthy individuals. Altern. Ther. Health Med. 5, 37 (1999)
28. Huber, R., Thoma, D., Klein, R. et al., Klinische Wirkungen und Nebenwirkungen eines lektinreichen (Mistelextrakt Q spezial) und eines lektinarmen (Mistelextrakt pini) Mistelpräparates - Ergebnisse einer randomisierten, placebokontrollierten Phase I Studie bei Gesunden. In: Die Mistel in der Tumor-therapie - Grundlagenforschung und Klinik, Scheer, R., Bauer R. H., Becker, P. A. et al., S. 473-484. KVC Publishers, Essen (2001)
29. Van Wely, M., Stoss, M., Gorter, R. W., Toxicity of a standardized mistletoe extract in immunocompromised and healthy individuals. Am. J. Ther. 6, 37 (1999)
30. Hanisch, J., Bock, P. R., Karasmann, M., Standard operating procedures and the operational manual for retrolective cohort studies according to the IFAG-standard (Retrospect™), Manual. IFAG, Basel (2000)
31. Feinstein, A. R., Clinical Epidemiology, The Architecture of Clinical Research, S. 1-811. W. B. Saunders, Philadelphia (1985)
32. Schneider, B., Analysis of therapeutic efficacy in observational cohort studies. Cancer Chemother. Pharmacol. 47, 35 (2001)
33. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to human medicinal products. Official Journal of the European Communities L 311, 67-128 (2001)
34. German Cochrane Center, Evidence hierarchy. www.cochrane.de/deutsch/ ccevidenzhierarchie.htm (2002)
35. Oxford Centre for Evidence-based Medicine, Levels of Evidence and Grades of Recommendation, www.cebm.net/levels_of_evidence.asp (2001)
36. Benson, K., Hartz, A. J., A comparison of observational studies and randomized clinical trials. N. Engl. J. Med. 342, 1878 (2000)
37. Concato, J., Shah, N., Horwitz, R. I., Randomized, controlled trials, observational studies, and the hierarchy of research design. N. Engl. J. Med. 342, 1887 (2000)
38. Feinstein, A. R., The role of observational studies in the evaluation of therapy. Stat. Med. 3, 341 (1984)
39. Hlatky, M. A., Califf, R. M., Harrell-Fe, J., Comparison of predictions based on observational data with the results of randomized controlled clinical trials of coronary artery bypass surgery. J. Am. Coll. Cardiol. 11, 237 (1988)
40. Rosati, R. A., Lee, K. L., Califf, R. M. et al., Problems and Advantages of an Observational Data Base Approach to Evaluating the Effect of Therapy on Outcome. Circulation 65, Suppl. II, 27 (1982)
41. Dold, U., Edler, L. H. Mäurer, C. et al., Krebszusatztherapie beim fortgeschrittenen nichtkleinzelligen Bronchialkarzinom, Multizentrische kontrollierte Studie zur Prüfung der Wirksamkeit von Mistelextrakt und Polyerga. Thieme Verlag, Stuttgart-New York (1991)
42. Steuer-Vogt, M. K., Bonkowsky, V., Ambrosch, P. et al., The effect of an adjuvant mistletoe treatment program in resected head and neck cancer patients: a randomised controlled clinical trial. Eur. J. Cancer 37, 23 (2001)
43. Gutsch, J., Berger, H., Scholz, G. et al., Prospective study in radically operated breast cancer with polychemotherapy, Helixor and untreated control. Dtsch. Zschr. Onkol. 21, 94 (1988)
44. Grossarth-Maticek, R., Kiene, H., Baumgartner, S. M. et al., Use of Mistelextrakt, an extract of European mistletoe (Viscum album), in cancer treatment: prospective nonrandomized and randomized matched-pair studies nested within a cohort study. Altern. Ther. Health Med. 7, 57 (2001)
45. Lenartz, D., Dott, U., Menzel, J. et al., Survival of glioma patients after complementary treatment with galactoside-specific lectin from mistletoe. Anticancer Res. 20, 2073 (2000)
46. Edler, L., Randomisierte klinische Studien zur Misteltherapie bei Krebs: Ergebnisse, Erfahrungen und Perspektiven. In: Grundlagen der Misteltherapie, Scheer, R., Becker, H., Berg, P. A. Hippokrates Verlag, Stuttgart (1996)
47. Schumacher, K., Schneider, B., Reich, G. et al., Post surgical complementary therapy of primary breast carcinoma with a lectin-standardized mistletoe extract - an epidemiological, controlled, multicenter, retrolective cohort study. German J. Oncol. 34, 106 (2002)
48. Finelli, A., Limberg, R., Scheithe, K., Mistel-Lektin bei Patienten mit Tumorerkrankungen. Medizin im Bild 1, 1 (1998)
49. Borrelli, E., Valutazione della qualità di vita in pazienti affette da adenocarcinoma mammario sottoposte a terapia con Viscum album. La Medicina Biologica 17, 27 (1999)
50. Heiny, B. M., Additive Therapie mit standardisiertem Mistelextrakt reduziert die Leukopenie und verbessert die Lebensqualität von Patientinnen mit fortgeschrittenem Mammakarzinom unter palliativer Chemotherapie (VEC-Schema). Krebsmedizin 12, 1 (1991)
51. Wetzel, D., Results of a randomized placebo-controlled multicentre study with PS76A2 (standardized mistletoe preparation) in patients with breast cancer receiving chemotherapy. Phytomedicine 7, Suppl. 2, 34 (2000)
52. Stein, G. M., Berg, P. A., Adverse effects during therapy with mistletoe extracts. In: Mistletoe, The Genus Viscum, Bussing, A. (Hrsg.), S. 195-208. Harwood Academic Publishers, Amsterdam (2000)