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## Complete Summary

#### GUIDELINE TITLE

The role of vitamin E supplements in the prevention of cardiovascular
disease and cancer.

#### BIBLIOGRAPHIC SOURCE(S)

Alkhenizan A, Palda VA. The role of vitamin E supplements in the
prevention of cardiovascular disease and cancer. London (ON): Canadian
Task Force on Preventive Health Care (CTFPHC); 2003 May. 6 p. \[27
references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

A complete list of planned reviews, updates, and revisions is available
under the What\'s New section at the [Canadian Task Force on Preventive
Health Care (CTFPHC) Web site](http://www.ctfphc.org/).

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Cardiovascular disease and cancer (including lung, esophageal, stomach,
colorectal, urological, and prostate cancer)

#### GUIDELINE CATEGORY

Assessment of Therapeutic Effectiveness\
Prevention

#### CLINICAL SPECIALTY

Cardiology\
Family Practice\
Gastroenterology\
Internal Medicine\
Nutrition\
Oncology\
Preventive Medicine\
Pulmonary Medicine\
Urology

#### INTENDED USERS

Advanced Practice Nurses\
Physicians

#### GUIDELINE OBJECTIVE(S)

To establish evidence-based guidelines for the use of vitamin E in the
prevention of cardiovascular disease (CVD) and cancer

Specifically the guidelines sought to answer the following questions:

-   What is the direct evidence that vitamin E reduces adverse clinical
    outcomes in the general population?

    -   What is the direct evidence that vitamin E reduces total
        mortality?

    -   What is the direct evidence that vitamin E reduces
        cardiovascular outcomes?

    -   What is the direct evidence that vitamin E reduces cancer
        outcomes?

-   What is the optimal dose of vitamin E in the prevention of CVD and
    cancer?

-   What are the short-term and long-term side effects and toxicity of
    vitamin E?

#### TARGET POPULATION

Adults (\>18 years of age, males and nonpregnant females) including
those at risk of cardiovascular disease and cancer, and those with
preexisting cardiovascular disease

#### INTERVENTIONS AND PRACTICES CONSIDERED

Vitamin E supplementation of diet

#### MAJOR OUTCOMES CONSIDERED

-   Overall mortality

-   Cardiac mortality

-   Cancer mortality

-   Incidence of nonfatal myocardial infarction

-   Incidence of lung cancer and other cancers (prostate, urological,
    esophageal, stomach, colorectal).

-   Side effects and toxicity of vitamin E supplements

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

A computerized search of Ovid MEDLINE, PREMEDLINE, the Cochrane
database, and EMBASE for English language articles published between
January 1966 and December 2000 was conducted using the Medical Subject
Heading (MeSH) terms \"coronary disease\", \"vitamin E\",
\"alpha-tocopherol\", \"vitamins\", \"myocardial ischemia\",
\"neoplasms\", \"colonic polyps\", \"polyps\", \"prevention\", \"primary
prevention\", \"side effects\", \"toxicities\", and \"secondary
prevention\". These terms were used in various combinations. Relevant
articles were also retrieved through a manual review of references. The
search was updated for key new evidence in March 2003. Trials were
included if they were randomized controlled trial (RCT) design, looked
at clinical (not surrogate) outcomes of cardiovascular disease (CVD) or
cancer as a primary or a secondary end point, and included only adults
(age \>18 years). Exclusion criteria were studies with sample size
\<100, non-English language publications, and studies with more than 5
different supplements in the vitamin E arm.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**[Levels of Evidence]{.underline}**

**Research Design Rating**

**I**: Evidence from at least one randomized controlled trial (RCT)

**II-1**: Evidence from controlled trial(s) without randomization

**II-2**: Evidence from cohort or case-control analytic studies,
preferably from more than one centre or research group

**II-3**: Evidence from comparisons between times or places with or
without the intervention; dramatic results in uncontrolled experiments
could also be included here

**III**: Opinions of respected authorities, based on clinical
experience, descriptive studies, or reports of expert committees

**Quality (Internal Validity) Rating**

**Good**: A study that meets all design-specific criteria\* well.

**Fair**: A study that does not meet (or it is not clear that it meets)
at least one design-specific criterion\* but has no known \"fatal
flaw.\"

**Poor**: A study that has at least one design-specific\* \"fatal
flaw,\" or an accumulation of lesser flaws to the extent that the
results of the study are not deemed able to inform recommendations.

\*General design-specific criteria are outlined in Harris RP, Helfand M,
Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, Atkins D. Current Methods of
the U.S. Preventive Services Task Force: A Review of the Process. Am J
Prev Med 2001;20(suppl 3):21-35.

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The evidence was systematically reviewed using the methodology of the
Canadian Task Force on Preventive Health Care. Recommendations were
based on studies included in the evidentiary tables.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Recommendations Grades for Specific Clinical Preventive Actions**

**A**: The Canadian Task Force (CTF) concludes that there is **good**
evidence to recommend the clinical preventive action.

**B**: The CTF concludes that there is **fair** evidence to recommend
the clinical preventive action.

**C**: The CTF concludes that the existing evidence is **conflicting**
and does not allow making a recommendation for or against use of the
clinical preventive action; however, other factors may influence
decision-making.

**D**: The CTF concludes that there is **fair** evidence to recommend
against the clinical preventive action.

**E**: The CTF concludes that there is **good** evidence to recommend
against the clinical preventive action.

**I**: The CTF concludes that there is **insufficient** evidence (in
quantity and/or quality) to make a recommendation; however, other
factors may influence decision-making.

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Comparison with Guidelines from Other Groups\
External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

**External Peer Review**

The Canadian Task Force on Preventive Health Care sent the final review
and recommendations to selected external expert reviewers and their
feedback was incorporated.

**Comparison with Guidelines from Other Groups**

The 2003 recommendations of the US Preventive Services Task Force on the
use of supplements of vitamins A, C, or E; multivitamins with folic
acid; or antioxidant combinations for the prevention of cancer or
cardiovascular disease were also reviewed.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Recommendation grade **\[A, B, C, D, E\]** and level of evidence **\[I,
II-1, II-2, II-3, III, good, fair, poor\]** are indicated after each
recommendation. Definitions for these grades and levels are repeated
following the recommendations.

The Canadian Task Force on Preventive Health Care (CTFPHC) concludes
that there is insufficient evidence to recommend for or against the use
of routine vitamin E supplementation for the primary prevention of
cardiovascular disease (CVD) events in the general population and in
male smokers **(Grade I recommendation)** (\"MRC/BHF Heart Protection
Study,\" 2002 **\[I, good\]**; de Gaetano, 2001 **\[I, fair\]**; Virtamo
et al., 1998 **\[I, fair\]**).

The CTFPHC concludes that there is good evidence to recommend against
the use of vitamin E for the secondary prevention of CVD in patients
with established CVD or risk factors for CVD **(Grade D
recommendation)** (\"MRC/BHF Heart Protection Study,\" 2002 **\[I,
good\]**; Yusuf et al., 2000 **\[I, good\]**; Virtamo et al., 1998
**\[I, fair\]**; Rapola et al., 1997 **\[I, fair\]**; \"Dietary
supplementation,\" 1999 **\[I, fair\]**; Stephens, et al. 1996 **\[I,
fair\]**).

The CTFPHC concludes that there is good evidence to recommend against
the use of routine vitamin E supplementation for the prevention of lung
cancer **(Grade D recommendation)**, (\"The effect of vitamin E,\" 1994
**\[I, good\]**; \"MRC/BHF Heart Protection Study,\" 2002 **\[I,
good\]**).

The CTFPHC concludes that there is insufficient evidence to recommend
for or against the use of routine vitamin E supplementation for the
prevention of cancers in the general population **(Grade I
recommendation)**, (\"MRC/BHF Heart Protection Study,\" 2002 **\[I,
good\]**;\"The effect of vitamin E,\" 1994 **\[I, fair\]**; Blot et al.
1993 **\[I, fair\]**; Albanes et al., 2000 **\[I, fair\]**; Virtamo et
al., 2000 **\[I, fair\]**; Heinonen et al., 1998 **\[I, fair\]**).

**[Definitions]{.underline}**:

**Levels of Evidence - Research Design Rating**

**Research Design Rating**

**I**: Evidence from at least one randomized controlled trial (RCT)

**II-1**: Evidence from controlled trial(s) without randomization

**II-2**: Evidence from cohort or case-control analytic studies,
preferably from more than one centre or research group

**II-3**: Evidence from comparisons between times or places with or
without the intervention; dramatic results in uncontrolled experiments
could also be included here

**III**: Opinions of respected authorities, based on clinical
experience, descriptive studies, or reports of expert committees

**Quality (Internal Validity) Rating**

**Good**: A study that meets all design-specific criteria\* well.

**Fair**: A study that does not meet (or it is not clear that it meets)
at least one design-specific criterion\* but has no known \"fatal
flaw.\"

**Poor**: A study that has at least one design-specific\* \"fatal
flaw,\" or an accumulation of lesser flaws to the extent that the
results of the study are not deemed able to inform recommendations.

\*General design-specific criteria are outlined in Harris RP, Helfand M,
Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, Atkins D. Current Methods of
the U.S. Preventive Services Task Force: A Review of the Process. Am J
Prev Med 2001;20(suppl 3):21-35.

**Recommendations Grades for Specific Clinical Preventive Actions**

**A**: The Canadian Task Force (CTF) concludes that there is **good**
evidence to recommend the clinical preventive action.

**B**: The CTF concludes that there is **fair** evidence to recommend
the clinical preventive action.

**C**: The CTF concludes that the existing evidence is **conflicting**
and does not allow making a recommendation for or against use of the
clinical preventive action; however, other factors may influence
decision-making.

**D**: The CTF concludes that there is **fair** evidence to recommend
against the clinical preventive action.

**E**: The CTF concludes that there is **good** evidence to recommend
against the clinical preventive action.

**I**: The CTF concludes that there is **insufficient** evidence (in
quantity and/or quality) to make a recommendation; however, other
factors may influence decision-making.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=5697)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

*Maneuver*: Vitamin E for the primary prevention of cardiovascular
disease (CVD)

*Level of Evidence*:\
I, good (one study); I, fair (two studies)

*Maneuver*: Vitamin E for the secondary prevention of CVD in patients
with established CVD or risk factors for CVD

*Level of Evidence*:\
I, good (two studies); I, fair (four studies)

*Maneuver*: Vitamin E for the prevention of lung cancer

*Level of Evidence*:\
I, good (two studies)

*Maneuver*: Vitamin E for the prevention of other cancers (esophageal,
stomach, colorectal, urological, and prostate)

*Level of Evidence*:\
I, good (one study); I, fair (five studies)

Refer to the \"Major Recommendations\" field.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

The guideline recommendations may provide guidance to health care
providers on the use of Vitamin E for prevention of cardiovascular
events and cancer.

#### POTENTIAL HARMS

Not stated

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

The Canadian Task Force on Preventive Health Care (CTFPHC) recognizes
that in many cases, patient-specific factors need to be considered and
discussed, such as the value the patient places on the clinical
preventive action; its possible positive and negative outcomes; and the
context and/or personal circumstances of the patient (medical and
other). In certain circumstances where the evidence is complex,
conflicting, or insufficient, a more detailed discussion may be
required.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Staying Healthy

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Alkhenizan A, Palda VA. The role of vitamin E supplements in the
prevention of cardiovascular disease and cancer. London (ON): Canadian
Task Force on Preventive Health Care (CTFPHC); 2003 May. 6 p. \[27
references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2003 May

#### GUIDELINE DEVELOPER(S)

Canadian Task Force on Preventive Health Care - National Government
Agency \[Non-U.S.\]

#### SOURCE(S) OF FUNDING

The Canadian Task Force on Preventive Health Care (CTFPHC) is funded
through a partnership between the Provincial and Territorial Ministries
of Health and Health Canada.

#### GUIDELINE COMMITTEE

Canadian Task Force on Preventive Health Care (CTFPHC)

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Primary Authors*: Abdullah Alkhenizan, MD, CCFP, ABHPM, Consultant,
Department of Family Medicine and Polyclinic, King Faisal Specialist
Hospital and Research Center, Riyadh, Saudi Arabia; Valerie A. Palda,
MD, MSc, FRCPC, Assistant Professor, General Internal Medicine, St.
Michael´s Hospital, Toronto, Ontario

*Task Force Members*: Dr. John W. Feightner, (*Chair*), Professor,
Department of Family Medicine, The University of Western Ontario,
London, Ont.; Dr. Harriet MacMillan, (*Vice-Chair*), Associate
Professor, Departments of Psychiatry & Behavioural Neurosciences, &
Pediatrics, Canadian Centre for Studies of Children at Risk, McMaster
University, Hamilton, Ont.; Drs. Paul Bessette, Professeur titulaire,
Département d\'obstétrique-gynécologie, Université de Sherbrooke,
Sherbrooke, Que.; R. Wayne Elford, Professor Emeritus, Department of
Family Medicine, University of Calgary, Calgary, Alta.; Denice Feig,
Assistant Professor, Dept. of Endocrinology, University of Toronto,
Toronto, Ont.; Joanne Langley, Associate Professor, Department of
Pediatrics, Dalhousie University, Halifax, N.S.; Valerie Palda,
Assistant Professor, Department of General Internal Medicine, University
of Toronto, Toronto, Ont.; Christopher Patterson, Professor, Division of
Geriatric Medicine, Department of Medicine, McMaster University,
Hamilton, Ont.; Bruce A. Reeder, Professor, Department of Community
Health and Epidemiology, University of Saskatchewan, Saskatoon, Sask.

*Resource people*: Nadine Wathen, Coordinator, Ruth Walton, Research
Associate, and Jana Fear, Research Assistant, Canadian Task Force on
Preventive Health Care, Department of Family Medicine, The University of
Western Ontario, London, Ont.

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

A complete list of planned reviews, updates, and revisions is available
under the What\'s New section at the [Canadian Task Force on Preventive
Health Care (CTFPHC) Web site](http://www.ctfphc.org/).

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [Canadian Task Force on Preventive
Health Care (CTFPHC) Web
site](http://www.ctfphc.org/Sections/Vitamin_E.htm).

Print copies: Available from Canadian Task Force on Preventive Health
Care, Clinical Skills Building, 2nd Floor, Department of Family
Medicine, University of Western Ontario, London, Ontario N6A 5C1,
Canada.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Stachenko S. Preventive guidelines: their role in clinical
    prevention and health promotion. Ottawa: Health Canada, 1994.
    Available from the [Canadian Task Force on Preventive Health Care
    (CTFPHC) Web site](http://www.ctfphc.org/ctfphc&methods.htm).

-   CTFPHC history/methodology. Ottawa: Health Canada, 1997. Available
    from the [CTFPHC Web
    site](http://www.ctfphc.org/ctfphc&methods.htm).

-   Quick tables of current recommendations. Ottawa: Health
    Canada, 2003. Available from the [CTFPHC Web
    site](http://www.ctfphc.org/).

-   Alkhenizan, A., Palda, V.A., and the Canadian Task Force on
    Preventive Health Care. The role of vitamin E supplements in the
    prevention of cardiovascular disease and cancer: systematic review
    and recommendations. CTFPHC Technical Report 03-6. May 2003. London,
    ON: Canadian Task Force. Available from the [CTFPHC Web
    site](http://www.ctfphc.org/Sections/Vitamin_E.htm).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on October 18, 2004. The
information was verified by the guideline developer on November 2, 2004.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

Summaries of the Canadian Task Force on Preventive Health Care (CTFPHC)
guidelines are available for public use and may be downloaded from the
NGC Web site and/or transferred to an electronic storage and retrieval
system for personal use. Notification of CTFPHC (telephone:
519-850-2511, e-mail: <John.Feightner@schulich.uwo.ca>) for any other
use of these summaries is appreciated but not required.

### DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008