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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

cardiovascular prevention - antioxydants - primary prevention

cardiovascular prevention - antioxydants - all type of patients


Related trials

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POPADAD (antioxydant), 2008 - combination vs placebo

ARISE, 2008 - succinobucol vs placebo

PHS II vitamin E, 2008 - vitamin E vs placebo

WACS beta-caroten, 2007 - beta carotene vs placebo

WACS vitamin E, 2007 - vitamin E vs placebo

WACS vitamin C, 2007 - vitamin C vs placebo

WHS vitamin E, 2005 - vitamin E vs placebo

SUVIMAX, 2005 - combination vs placebo

PHS II beta carotene, 2003 - combination vs placebo

Tepel, 2003 - acetylcysteine vs placebo

WAVE (Waters), 2002 - combination vs placebo

HPS antioxidant, 2002 - combination vs placebo

HATS, 2001 - combination vs placebo

PPP, 2001 - vitamin E vs control

AREDS, 2001 - vitamin E vs placebo

HOPE, 2000 - vitamin E vs placebo

ASAP, 2000 - vitamin E vs placebo

WHS beta carotene, 1999 - beta carotene vs placebo

GISSI, 1999 - vitamin E vs control

NSCP (Green) beta carotene, 1999 - beta carotene vs placebo

MVP, 1997 - combination vs placebo

PHS beta carotene, 1996 - beta carotene vs placebo

CARET beta carotene, 1996 - beta carotene vs placebo

CHAOS, 1996 - vitamin E vs placebo



See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of antioxydants
  • All clinical trials of beta carotene
  •  

    WHS beta carotene study, 1999

    [NCT00000479] download pdf: beta carotene | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment beta carotene 50mg four times daily
    Control treatment placebo
    Remarks factorial edsign testing aspirin, vitamin E, and b-carotene

    Patients

    Patients female health professionals, aged 45 years or older and without a history of cancer (except nonmelanoma skin cancer), coronary heart disease, or cerebrovascular disease
    Baseline characteristics
    Women (%) 100% 

    Method and design

    Randomized effectives 19939 / 19937 (studied vs. control)
    Design Factorial plan
    Blinding double-blind
    Follow-up duration 2.1y (range 0 - 2.72y)
    Premature discontinuation Premature discontinuation for futility
    Geographic area USA
    Hypothesis Superiority
    Primary endpoint not defined

    Remarks / Comments

    terminated early because of the null findings on b-carotene and cancer incidence after 12 years in the Physicians’ Health Study



    Results

    Endpoint Studied treat.
    n/N
    Control treat.
    n/N
    Graph RR [95% CI]

    Coronary event

    42 / 19939
    50 / 19937
    0,84 [0,56;1,27]

    Cardiovascular death

    14 / 19939
    12 / 19937
    classic 1,17 [0,54;2,52]

    cardiovascular events

    116 / 19939
    102 / 19937
    1,14 [0,87;1,48]

    All cause death

    59 / 19939
    55 / 19937
    1,07 [0,74;1,55]

    stroke (fatal and non fatal)

    61 / 19939
    43 / 19937
    classic 1,42 [0,96;2,09]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 42 / 19939 (0,2%) 50 / 19937 (0,3%) 0,84 [0,56;1,27]   2947
    Cardiovascular death 14 / 19939 (0,1%) 12 / 19937 (0,1%) 1,17 [0,54;2,52]   2947
    cardiovascular events 116 / 19939 (0,6%) 102 / 19937 (0,5%) 1,14 [0,87;1,48]   2947
    All cause death 59 / 19939 (0,3%) 55 / 19937 (0,3%) 1,07 [0,74;1,55]   2947
    stroke (fatal and non fatal) 61 / 19939 (0,3%) 43 / 19937 (0,2%) 1,42 [0,96;2,09]   2947
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 2947: Lee IM, Cook NR, Manson JE, Buring JE, Hennekens CHBeta-carotene supplementation and incidence of cancer and cardiovascular disease: the Women's Health Study.J Natl Cancer Inst 1999 Dec 15;91:2102-6
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 2,11‰ 2,51‰ -0,4‰
    Cardiovascular death 0,70‰ 0,60‰ 0,1‰
    cardiovascular events 5,82‰ 5,12‰ 0,7‰
    All cause death 2,96‰ 2,76‰ 0,2‰
    stroke (fatal and non fatal) 3,06‰ 2,16‰ 0,9‰

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for primary prevention

    antioxydants in cardiovascular prevention for all type of patients



    Reference(s)

    Trials register # NCT00000479
    • Lee IM, Cook NR, Manson JE, Buring JE, Hennekens CH. Beta-carotene supplementation and incidence of cancer and cardiovascular disease: the Women's Health Study.. J Natl Cancer Inst 1999 Dec 15;91:2102-6
      Pubmed | Hubmed | Fulltext
    • Lee IM, Cook NR, Gaziano JM, Gordon D, Ridker PM, Manson JE, Hennekens CH, Buring JE. Vitamin E in the primary prevention of cardiovascular disease and cancer: the Women's Health Study: a randomized controlled trial.. JAMA 2005;294:56-65 - 10.1001/jama.294.1.56
      Pubmed | Hubmed | Fulltext
    • Buring JE, Hennekens CH.. The Women’sHealth Study: rationale and background. . J Myocardial Ischemia 1992;4:30–40
      Pubmed | Hubmed | Fulltext

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