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Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality.

Abstract

BACKGROUND

Experimental models and observational studies suggest that vitamin E supplementation may prevent cardiovascular disease and cancer. However, several trials of high-dosage vitamin E supplementation showed non-statistically significant increases in total mortality.

PURPOSE

To perform a meta-analysis of the dose-response relationship between vitamin E supplementation and total mortality by using data from randomized, controlled trials.

PATIENTS

135,967 participants in 19 clinical trials. Of these trials, 9 tested vitamin E alone and 10 tested vitamin E combined with other vitamins or minerals. The dosages of vitamin E ranged from 16.5 to 2000 IU/d (median, 400 IU/d).

DATA SOURCES

PubMed search from 1966 through August 2004, complemented by a search of the Cochrane Clinical Trials Database and review of citations of published reviews and meta-analyses. No language restrictions were applied.

DATA EXTRACTION

3 investigators independently abstracted study reports. The investigators of the original publications were contacted if required information was not available.

DATA SYNTHESIS

9 of 11 trials testing high-dosage vitamin E (> or =400 IU/d) showed increased risk (risk difference > 0) for all-cause mortality in comparisons of vitamin E versus control. The pooled all-cause mortality risk difference in high-dosage vitamin E trials was 39 per 10,000 persons (95% CI, 3 to 74 per 10,000 persons; P = 0.035). For low-dosage vitamin E trials, the risk difference was -16 per 10,000 persons (CI, -41 to 10 per 10,000 persons; P > 0.2). A dose-response analysis showed a statistically significant relationship between vitamin E dosage and all-cause mortality, with increased risk of dosages greater than 150 IU/d.

LIMITATIONS

High-dosage (> or =400 IU/d) trials were often small and were performed in patients with chronic diseases. The generalizability of the findings to healthy adults is uncertain. Precise estimation of the threshold at which risk increases is difficult.

CONCLUSION

High-dosage (> or =400 IU/d) vitamin E supplements may increase all-cause mortality and should be avoided.

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  • Authors+Show Affiliations

    ,

    The Johns Hopkins School of Medicine, and The Welch Center for Prevention, Epidemiology and Clinical Research, The Johns Hopkins Medical Institutions, Baltimore, Maryland 21205-2223, USA. ermiller@jhmi.edu

    , , , ,

    Source

    Annals of internal medicine 142:1 2005 Jan 04 pg 37-46

    MeSH

    Adult
    Dietary Supplements
    Dose-Response Relationship, Drug
    Humans
    Mortality
    Randomized Controlled Trials as Topic
    Sensitivity and Specificity
    Vitamin E

    Pub Type(s)

    Journal Article
    Meta-Analysis
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    15537682

    Citation

    Miller, Edgar R., et al. "Meta-analysis: High-dosage Vitamin E Supplementation May Increase All-cause Mortality." Annals of Internal Medicine, vol. 142, no. 1, 2005, pp. 37-46.
    Miller ER, Pastor-Barriuso R, Dalal D, et al. Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med. 2005;142(1):37-46.
    Miller, E. R., Pastor-Barriuso, R., Dalal, D., Riemersma, R. A., Appel, L. J., & Guallar, E. (2005). Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Annals of Internal Medicine, 142(1), pp. 37-46.
    Miller ER, et al. Meta-analysis: High-dosage Vitamin E Supplementation May Increase All-cause Mortality. Ann Intern Med. 2005 Jan 4;142(1):37-46. PubMed PMID: 15537682.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. AU - Miller,Edgar R,3rd AU - Pastor-Barriuso,Roberto, AU - Dalal,Darshan, AU - Riemersma,Rudolph A, AU - Appel,Lawrence J, AU - Guallar,Eliseo, Y1 - 2004/11/10/ PY - 2004/11/13/pubmed PY - 2005/2/3/medline PY - 2004/11/13/entrez SP - 37 EP - 46 JF - Annals of internal medicine JO - Ann. Intern. Med. VL - 142 IS - 1 N2 - BACKGROUND: Experimental models and observational studies suggest that vitamin E supplementation may prevent cardiovascular disease and cancer. However, several trials of high-dosage vitamin E supplementation showed non-statistically significant increases in total mortality. PURPOSE: To perform a meta-analysis of the dose-response relationship between vitamin E supplementation and total mortality by using data from randomized, controlled trials. PATIENTS: 135,967 participants in 19 clinical trials. Of these trials, 9 tested vitamin E alone and 10 tested vitamin E combined with other vitamins or minerals. The dosages of vitamin E ranged from 16.5 to 2000 IU/d (median, 400 IU/d). DATA SOURCES: PubMed search from 1966 through August 2004, complemented by a search of the Cochrane Clinical Trials Database and review of citations of published reviews and meta-analyses. No language restrictions were applied. DATA EXTRACTION: 3 investigators independently abstracted study reports. The investigators of the original publications were contacted if required information was not available. DATA SYNTHESIS: 9 of 11 trials testing high-dosage vitamin E (> or =400 IU/d) showed increased risk (risk difference > 0) for all-cause mortality in comparisons of vitamin E versus control. The pooled all-cause mortality risk difference in high-dosage vitamin E trials was 39 per 10,000 persons (95% CI, 3 to 74 per 10,000 persons; P = 0.035). For low-dosage vitamin E trials, the risk difference was -16 per 10,000 persons (CI, -41 to 10 per 10,000 persons; P > 0.2). A dose-response analysis showed a statistically significant relationship between vitamin E dosage and all-cause mortality, with increased risk of dosages greater than 150 IU/d. LIMITATIONS: High-dosage (> or =400 IU/d) trials were often small and were performed in patients with chronic diseases. The generalizability of the findings to healthy adults is uncertain. Precise estimation of the threshold at which risk increases is difficult. CONCLUSION: High-dosage (> or =400 IU/d) vitamin E supplements may increase all-cause mortality and should be avoided. SN - 1539-3704 UR - https://www.unboundmedicine.com/medline/citation/15537682/full_citation L2 - https://www.annals.org/article.aspx?volume=142&issue=1&page=37 DB - PRIME DP - Unbound Medicine ER -