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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.

OBJECTIVES

To assess the efficacy and safety of Pycnogenol(®) for the treatment of chronic disorders.

SEARCH 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.

SELECTION CRITERIA

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.

DATA COLLECTION AND ANALYSIS

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.

MAIN 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.

AUTHORS' 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+Show Affiliations

Division of Human Nutrition, Stellenbosch University,Tygerberg, South Africa.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, U.S. Gov't, Non-P.H.S.
Review
Systematic Review

Language

eng

PubMed ID

22513958

Citation

Schoonees, Anel, et al. "Pycnogenol® (extract of French Maritime Pine Bark) for the Treatment of Chronic Disorders." The Cochrane Database of Systematic Reviews, 2012, p. CD008294.
Schoonees A, Visser J, Musekiwa A, et al. Pycnogenol® (extract of French maritime pine bark) for the treatment of chronic disorders. Cochrane Database Syst Rev. 2012.
Schoonees, A., Visser, J., Musekiwa, A., & Volmink, J. (2012). Pycnogenol® (extract of French maritime pine bark) for the treatment of chronic disorders. The Cochrane Database of Systematic Reviews, (4), CD008294. https://doi.org/10.1002/14651858.CD008294.pub4
Schoonees A, et al. Pycnogenol® (extract of French Maritime Pine Bark) for the Treatment of Chronic Disorders. Cochrane Database Syst Rev. 2012 Apr 18;(4)CD008294. PubMed PMID: 22513958.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pycnogenol® (extract of French maritime pine bark) for the treatment of chronic disorders. AU - Schoonees,Anel, AU - Visser,Janicke, AU - Musekiwa,Alfred, AU - Volmink,Jimmy, Y1 - 2012/04/18/ PY - 2012/4/20/entrez PY - 2012/4/20/pubmed PY - 2012/7/24/medline SP - CD008294 EP - CD008294 JF - The Cochrane database of systematic reviews JO - Cochrane Database Syst Rev IS - 4 N2 - 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. OBJECTIVES: To assess the efficacy and safety of Pycnogenol(®) for the treatment of chronic disorders. SEARCH 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. SELECTION CRITERIA: 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. DATA COLLECTION AND ANALYSIS: 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. MAIN 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. AUTHORS' 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. SN - 1469-493X UR - https://www.unboundmedicine.com/medline/citation/22513958/Pycnogenol®__extract_of_French_maritime_pine_bark__for_the_treatment_of_chronic_disorders_ L2 - https://doi.org/10.1002/14651858.CD008294.pub4 DB - PRIME DP - Unbound Medicine ER -