Related trials
ARISE, 2008 - succinobucol vs placebo
PHS II vitamin E, 2008 - vitamin E vs placebo
PHS II vitamin C, 2008 - vitamin C vs placebo
POPADAD (antioxydant), 2008 - combination vs placebo
WACS vitamin E, 2007 - vitamin E vs placebo
WACS vitamin C, 2007 - vitamin C vs placebo
WACS beta-caroten, 2007 - beta carotene 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
PPP, 2001 - vitamin E vs control
AREDS, 2001 - vitamin E vs placebo
HATS, 2001 - combination vs placebo
ASAP, 2000 - vitamin E vs placebo
HOPE, 2000 - vitamin E vs placebo
NSCP (Green) beta carotene, 1999 - beta carotene vs placebo
WHS beta carotene, 1999 - beta carotene vs placebo
GISSI, 1999 - vitamin E vs control
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
|
|
Treatments
Studied treatment |
combination of
30 mg of beta carotene per day and 25,000 IU of retinol
(vitamin A) in the form of retinyl palmitate per day
|
Control treatment |
placebo
|
Patients
Patients |
smokers, former smokers, and workers
exposed to asbestos |
Exclusion criteria |
none |
Baseline characteristics |
Women (%) |
34% |
age (yr) |
58y |
Body mass index |
NA |
|
Method and design
Randomized effectives |
9420 / 8894 (studied vs. control) |
Design |
Parallel groups |
Blinding |
double-blind |
Follow-up duration |
4 y |
Number of centre |
multicenter |
Geographic area |
USA |
Hypothesis |
Superiority |
Primary endpoint |
lung cancer |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
Cardiovascular death
NA / 9420
NA / 8894
1,26 [0,99;1,61]
All cause death
NA / 9420
NA / 8894
1,17 [1,03;1,33]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
Cardiovascular death |
NA / 9420 |
NA / 8894 |
1,26 |
[0,99;1,61] |
text pg1152 |
|
All cause death |
NA / 9420 |
NA / 8894 |
1,17 |
[1,03;1,33] |
table 2 |
|
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
0:
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
Meta-analysis of all similar trials:
antioxydants in cardiovascular prevention for primary prevention
antioxydants in cardiovascular prevention for all type of patients
Reference(s)
-
Omenn GS, Goodman GE, Thornquist MD, Balmes J, Cullen MR, Glass A, Keogh JP, Meyskens FL, Valanis B, Williams JH, Barnhart S, Hammar S.
Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease..
N Engl J Med 1996 May 2;334:1150-5
Pubmed
|
Hubmed
| Fulltext
-
Goodman GE, Thornquist MD, Balmes J, Cullen MR, Meyskens FL Jr, Omenn GS, Valanis B, Williams JH Jr.
The Beta-Carotene and Retinol Efficacy Trial: incidence of lung cancer and cardiovascular disease mortality during 6-year follow-up after stopping beta-carotene and retinol supplements..
J Natl Cancer Inst 2004;96:1743-50
- 10.1093/jnci/djh320
Pubmed
|
Hubmed
| Fulltext
|