title: A pilot, randomized, placebo-controlled, double-blind phase 0/biomarker study on effect of artepillin C-rich extract of Brazilian propolis in frequent colorectal adenoma polyp patients.
abstract: OBJECTIVE
  Brazilian propolis, a folk medicine, is used worldwide as an alternative medicine to prevent colon cancer. The objective of the study was to test in a small pilot biomarker study in a high-risk group the safety and efficacy of propolis for colon cancer prevention, which has not been evaluated in humans.
  
  
  METHODS
  Subjects with adenoma polyps recently removed from the colon were randomly assigned to a propolis group of 15 and a placebo group of 16. In a double-blind study, the propolis group received capsules containing 165 μmol artepillin C and 150 μmol other polyphenols per day for 3 months. Prior to and at the end of the experiments, their blood was analyzed using biochemical tests, and specimens from the normal-appearing sigmoid colon mucosa were biopsied endoscopically to examine the levels of 8-hydroxy-2'-deoxyguanosine (8-OHdG) and mRNA expressions of proliferating cell nuclear antigen, cyclin D1, and Bax.
  
  
  RESULTS
  Propolis extract significantly increased the mRNA level of cyclin D1 in the sigmoid colon mucosa, and the other biomarkers remained unchanged. Blood biochemical tests showed significantly higher activity of creatine phosphokinase (CPK), 143 ± 52 units/ml in the propolis group and 104 ± 38 units/ml in the placebo group (p = 0.026), at the end of the study. The increase in CPK activity in the propolis group was due to the increase of the myocardial band form of CPK. On the other hand, laxative treatment prior to endoscopic biopsy significantly increased 8-OHdG levels.
  
  
  CONCLUSIONS
  The results from our pilot study did not provide evidence that Brazilian propolis was effective in preventing changes occurring during early stages of colon cancer. In contrast, propolis may have detrimental side effects on muscle tissue, including myocardial cells.
authors.affiliation: Department of Molecular-Targeting Cancer Prevention, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Ishikawa
authors.forename: Miho
authors.initials: M
authors.lastname: Goto
authors.forename: Nariaki
authors.initials: N
authors.lastname: Matsuura
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Murakami
authors.forename: Chiho
authors.initials: C
authors.lastname: Goto
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Sakai
authors.forename: Kazuki
authors.initials: K
authors.lastname: Kanazawa
mesh_terms: D000080242:8-Hydroxy-2'-Deoxyguanosine; D018256:Adenomatous Polyps / Q000188:drug therapy*; D000368:Aged; D015415:Biomarkers / Q000097:blood; D001938:Brazil; D003106:Colon / Q000187:drug effects / Q000473:pathology; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000517:prevention & control; D003402:Creatine Kinase / Q000097:blood; D019938:Cyclin D1 / Q000235:genetics / Q000378:metabolism; D003849:Deoxyguanosine / Q000031:analogs & derivatives / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007417:Intestinal Polyps / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010666:Phenylpropionates / Q000032:analysis / Q000627:therapeutic use*; D010865:Pilot Projects; D010936:Plant Extracts / Q000627:therapeutic use; D059808:Polyphenols / Q000032:analysis / Q000627:therapeutic use; D018809:Proliferating Cell Nuclear Antigen / Q000235:genetics / Q000378:metabolism; D011429:Propolis / Q000737:chemistry*; D012333:RNA, Messenger / Q000235:genetics / Q000378:metabolism
chemical_list: D015415:Biomarkers; D010666:Phenylpropionates; D010936:Plant Extracts; D059808:Polyphenols; D018809:Proliferating Cell Nuclear Antigen; D012333:RNA, Messenger; D019938:Cyclin D1; C102259:artepillin C; D000080242:8-Hydroxy-2'-Deoxyguanosine; D011429:Propolis; D003402:Creatine Kinase; D003849:Deoxyguanosine