title: Phytotherapeutic interventions in the management of biochemically recurrent prostate cancer: a systematic review of randomised trials.
abstract: OBJECTIVE
  To evaluate the evidence from randomised trials for the efficacy and safety of phytotherapeutic interventions in the management of biochemically recurrent (BCR) prostate cancer, indicated by prostate-specific antigen (PSA) progression, numbers progressing to/time to initiation of androgen-deprivation therapy or salvage therapy.
  
  
  METHODS
  MEDLINE (Ovid), EMBASE (Ovid), AMED (Ovid), CINAHL (EBSCO) and the Cochrane Library databases were searched. Clinical trials investigating phytotherapeutic interventions as dietary supplements or dietary components, including multi-component herbal formulations, in men with BCR prostate cancer were located. Eight of nine authors contacted for further information responded. Methodological quality was assessed using the Cochrane Collaboration's risk of bias assessment tool. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for reporting systematic reviews was followed.
  
  
  RESULTS
  Of 23 full-text articles assessed for eligibility, five met the criteria for inclusion. Two studies were placebo controlled; two were active control trials; and one a high-/low-dose trial. The interventions were administered as isolated phytochemicals (sulphoraphane), phytotherapeutic extracts [Pomi-T (pomegranate, turmeric, green tea and broccoli sprout extract), soy, lycopene, and POMx (pomegranate extract)], or plant-derived dietary items (soy and lycopene). All studies found serum PSA levels to stabilise, decrease or rise more slowly in a significant number of men, and three studies reported stabilising or lengthening of PSA-doubling time. Studies were generally of good quality, but sample sizes were predominantly small, and durations short.
  
  
  CONCLUSIONS
  High-quality studies in this area are lacking. Sulphoraphane, lycopene, soy isoflavones, POMx, and Pomi-T are safe and well tolerated. There is limited evidence that they can affect PSA dynamics. No recommendation can be made for the use of these agents in managing prostate cancer morbidity and mortality until high-quality, fully powered studies are available. Recommendations are made for improving reproducibility and translation of findings with regard to study population, study endpoints, design, and the reporting of phytotherapeutic interventions.
authors.affiliation: Department of General Practice, University of Melbourne, Parkville, Vic., Australia.
authors.forename: Margaret Diana
authors.initials: MD
authors.lastname: van Die
authors.affiliation: Integria (MediHerb), Warwick, Qld, Australia.|New York Chiropractic College, Seneca Falls, NY, USA.
authors.forename: Kerry M
authors.initials: KM
authors.lastname: Bone
authors.affiliation: Department of General Practice, University of Melbourne, Parkville, Vic., Australia.
authors.forename: Jon
authors.initials: J
authors.lastname: Emery
authors.affiliation: Department of General Practice, University of Melbourne, Parkville, Vic., Australia.|Peter MacCallum Cancer Centre, East Melbourne, Vic., Australia.
authors.forename: Scott G
authors.initials: SG
authors.lastname: Williams
authors.affiliation: Department of General Practice, University of Melbourne, Parkville, Vic., Australia.
authors.forename: Marie V
authors.initials: MV
authors.lastname: Pirotta
authors.affiliation: The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Channing J
authors.initials: CJ
authors.lastname: Paller
mesh_terms: D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D001937:Brassica; D002338:Carotenoids / Q000627:therapeutic use; D030024:Curcuma; D006801:Humans; D017879:Isothiocyanates / Q000627:therapeutic use; D000077276:Lycopene; D029561:Lythraceae; D008297:Male; D008517:Phytotherapy / Q000009:adverse effects; D010936:Plant Extracts / Q000627:therapeutic use; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D013025:Glycine max; D013454:Sulfoxides; D013662:Tea
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017879:Isothiocyanates; D010936:Plant Extracts; D013454:Sulfoxides; D013662:Tea; D002338:Carotenoids; D017430:Prostate-Specific Antigen; C016766:sulforaphane; D000077276:Lycopene
keywords: biochemical recurrence; clinical trials; herbal medicine; phytotherapy; prostate cancer; systematic review