Background: Epidemiological studies have indicated that aspirin consum
ption can lower the risk of large-bowel cancer. These studies are not
entirely consistent, however, and their interpretation has been compli
cated by the possibility that cancer symptoms may have led patients to
avoid aspirin or that aspirin may have influenced cancer diagnosis an
d treatment. Purpose: Our purpose was to determine the effect of aspir
in on risk of large-bowel neoplasms in a study in which aspirin use wo
uld not be expected to affect tumor detection and tumor-related sympto
ms would not likely influence aspirin use. A less complicated assessme
nt of the relationship between aspirin and large-bowel tumors should t
hus be possible. Methods: We studied 793 patients enrolled in a clinic
al trial of nutrient supplements to prevent large-bowel adenomas. Unli
ke invasive cancers, adenomas usually do not cause symptoms or detecta
ble gastrointestinal bleeding; thus, adenomas are unlikely to influenc
e aspirin use. Each patient had at least one large-bowel adenoma diagn
osed and removed shortly before study entry and had been judged to be
free of further tumors by colonoscopy. Use of aspirin was assessed by
responses on questionnaires administered 6 and 12 months after enrollm
ent. We performed complete colonoscopies on all patients 1 year after
they entered the study and removed all polyps. Results: Patients who r
eported taking aspirin on both questionnaires (consistent users) had a
lower risk of new adenomas at their 1-year follow-up colonoscopy (odd
s ratio = 0.52; 95% confidence interval = 0.31-0.89) compared with pat
ients who did not report using aspirin on either of the questionnaires
. The apparent protective effect of consistent aspirin use was present
among both men and women and did not appear to be influenced by the n
umber of prior adenomas. Conclusions: These data further support the h
ypothesis that aspirin has an anti-neoplastic effect in the large bowe
l. Nevertheless, the question of whether aspirin should be used to pre
vent large-bowel tumors would be best answered by a randomized control
led clinical trial specifically designed to address this issue.