title: Quality of life, immunomodulation and safety of adjuvant mistletoe treatment in patients with gastric carcinoma - a randomized, controlled pilot study.
abstract: BACKGROUND
  Mistletoe (Viscum album L.) extracts are widely used in complementary cancer therapy. Aim of this study was to evaluate safety and efficacy of a standardized mistletoe extract (abnobaVISCUM(®) Quercus, aVQ) in patients with gastric cancer.
  
  
  METHODS
  32 operated gastric cancer patients (stage Ib or II) who were waiting for oral chemotherapy with the 5-FU prodrug doxifluridine were randomized 1:1 to receive additional therapy with aVQ or no additional therapy. aVQ was injected subcutaneously three times per week from postoperative day 7 to week 24 in increasing doses. EORTC QLQ-C30 and -STO22 Quality of Life questionnaire, differential blood count, liver function tests, various cytokine levels (tumor necrosis factor (TNF)-alpha, interleukin (IL)-2), CD 16(+)/CD56(+) and CD 19(+) lymphocytes were analyzed at baseline and 8, 16 and 24 weeks later.
  
  
  RESULTS
  Global health status (p <0.01), leukocyte- and eosinophil counts (p ≤0.01) increased significantly in the treatment group compared to the control group. Diarrhea was less frequently reported (7% vs. 50%, p=0.014) in the intervention group. There was no significant treatment effect on levels of TNF-alpha, IL-2, CD16(+)/CD56(+) and CD 19(+) lymphocytes and liver function tests measured by ANOVA.
  
  
  CONCLUSIONS
  Additional treatment with aVQ is safe and was associated with improved QoL of gastric cancer patients. ClinicalTrials.Gov Registration number NCT01401075.
authors.affiliation: Division of Stomach surgery, Department of Surgery, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.
authors.forename: Kab-Choong
authors.initials: KC
authors.lastname: Kim
authors.forename: Jeong-Hwan
authors.initials: JH
authors.lastname: Yook
authors.forename: Jürgen
authors.initials: J
authors.lastname: Eisenbraun
authors.forename: Byung-Sik
authors.initials: BS
authors.lastname: Kim
authors.forename: Roman
authors.initials: R
authors.lastname: Huber
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects; D002277:Carcinoma / Q000188:drug therapy* / Q000276:immunology*; D016207:Cytokines / Q000276:immunology; D004359:Drug Therapy, Combination; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D056747:Immunomodulation / Q000187:drug effects; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D014784:Mistletoe / Q000737:chemistry*; D010865:Pilot Projects; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000276:immunology*
chemical_list: D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D016207:Cytokines; D010936:Plant Extracts; D005472:Fluorouracil