title: Pycnogenol® (extract of French maritime pine bark) for the treatment of chronic disorders.
abstract: BACKGROUND
  Oxidative stress has been implicated in the development of a number of conditions including cancer, arthritic disorders and cardiovascular disease. Pycnogenol(®), a herbal dietary supplement derived from French maritime pine bark extract, is standardised to contain 70% procyanidin which is a powerful antioxidant. Pycnogenol(®) is marketed as a supplement for preventing or treating a wide range of chronic conditions.
  
  
  OBJECTIVE
  To assess the efficacy and safety of Pycnogenol(®) for the treatment of chronic disorders.
  
  
  METHODS
  We searched CENTRAL (until 18 September 2010), MEDLINE (until 18 September 2010) and EMBASE (until 13 October 2010) as well as three trial registries. We also contacted the manufacturer of Pycnogenol(®) and hand-searched bibliographies of included studies.
  
  
  METHODS
  Randomised controlled trials evaluating the effectiveness of Pycnogenol(®) in adults or children with any chronic disorder were included. We assessed clinical outcomes directly related to the disorder (stratified as participant- and investigator-reported) and all-cause mortality as primary outcomes. We also assessed adverse events and biomarkers of oxidative stress.
  
  
  METHODS
  Two authors independently assessed trial eligibility, extracted all data and assessed risk of bias. A third author additionally extracted information on outcomes and results. With three exceptions, results for outcomes across studies could not be pooled.
  
  
  RESULTS
  This review includes 15 trials with a total of 791 participants that have evaluated Pycnogenol(®) for the treatment of seven different chronic disorders. These included asthma (two studies; N = 86), attention deficit hyperactivity disorder (one study; N = 61), chronic venous insufficiency (two studies; N = 60), diabetes mellitus (four studies; N = 201), erectile dysfunction (one study; N = 21), hypertension (two studies; N = 69) and osteoarthritis (three studies; N = 293). Two of the studies were conducted exclusively in children; the others involved adults.Due to small sample size, limited numbers of trials per condition, variation in outcomes evaluated and outcome measures used, as well as the risk of bias in the included studies, no definitive conclusions regarding the efficacy or safety of Pycnogenol(®) are possible.
  
  
  CONCLUSIONS
  Current evidence is insufficient to support Pycnogenol(®) use for the treatment of any chronic disorder. Well-designed, adequately powered trials are needed to establish the value of this treatment.
authors.affiliation: Division of Human Nutrition, Stellenbosch University,Tygerberg, South Africa.
authors.forename: Anel
authors.initials: A
authors.lastname: Schoonees
authors.forename: Janicke
authors.initials: J
authors.lastname: Visser
authors.forename: Alfred
authors.initials: A
authors.lastname: Musekiwa
authors.forename: Jimmy
authors.initials: J
authors.lastname: Volmink
mesh_terms: D000328:Adult; D000975:Antioxidants / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy; D002648:Child; D002908:Chronic Disease / Q000188:drug therapy*; D003920:Diabetes Mellitus / Q000188:drug therapy; D007172:Erectile Dysfunction / Q000188:drug therapy; D005260:Female; D005419:Flavonoids / Q000627:therapeutic use*; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D008297:Male; D010003:Osteoarthritis / Q000188:drug therapy; D010936:Plant Extracts; D016032:Randomized Controlled Trials as Topic; D014689:Venous Insufficiency / Q000188:drug therapy
chemical_list: D000975:Antioxidants; D005419:Flavonoids; D010936:Plant Extracts; C024070:pycnogenols