title: Viscum album L. extracts in breast and gynaecological cancers: a systematic review of clinical and preclinical research.
abstract: 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.
  
  
  CONCLUSIONS
  VAE shows some positive effects in breast and gynaecological cancer. More research into clinical efficacy is warranted.
authors.affiliation: Institute for Applied Epistemology and Medical Methodology, Freiburg, Germany. gunver.kienle@ifaemm.de
authors.forename: Gunver S
authors.initials: GS
authors.lastname: Kienle
authors.forename: Anja
authors.initials: A
authors.lastname: Glockmann
authors.forename: Michael
authors.initials: M
authors.lastname: Schink
authors.forename: Helmut
authors.initials: H
authors.lastname: Kiene
mesh_terms: D000818:Animals; D001943:Breast Neoplasms / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D004353:Drug Evaluation, Preclinical; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy*; D006801:Humans; D014784:Mistletoe; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D010936:Plant Extracts