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Beta-carotene was tested as a potential cancer
preventive in two large NCI-funded randomized trials
in persons at high risk of developing lung cancer.
Contrary to expectations, the incidence of lung cancer
increased among the former and current smokers who
took beta-carotene.
The magnitude of increased risk in these trials
represented approximately six cancers per 1000
participants in the intervention groups, compared with
five cancers per 1000 participants in the control
groups, a difference too small to be apparent in any
observational epidemiologic study, wrote Peter
Greenwald, director of the NCI Division of Cancer
Prevention, in the Jan. 1, 2003, issue of the Journal
of the National Cancer Institute.
If the randomized, controlled trials had not been
carried out, specific dietary guidelines based on
epidemiologic evidence might have been considered,
an action that would likely have caused harm to public
health, Greenwald wrote.
The beta-carotene story
thus demonstrates clearly that although epidemiologic
evidence can provide a basis for developing
hypotheses of benefits of food constituents, these
hypotheses must then be tested in randomized, largescale
clinical trials.
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