Selenium supplementation for prevention of colorectal adenomas and risk of associated type 2 diabetes

Patricia A. Thompson, Erin L. Ashbeck, Denise Roe, Liane Fales, Julie Buckmeier, Fang Wang, Achyut K Bhattacharyya, Chiu-Hsieh Hsu, Hsiao-Hui Chow, Dennis J. Ahnen, C. Richard Boland, Russell I. Heigh, David E. Fay, Stanley R. Hamilton, Elizabeth T Jacobs, Maria Elena Martinez, David S Alberts, Michael P Lance

Research output: Contribution to journalArticle

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Abstract

Background: Selenium supplementation may help to prevent colorectal cancer; as precursors of colorectal cancer, colorectal adenomas are a surrogate for colorectal cancer. Selenium supplementation may increase risk of type 2 diabetes (T2D). Methods: The Selenium and Celecoxib (Sel/Cel) Trial was a randomized, placebo controlled trial of selenium 200 mg daily as selenized yeast and celecoxib 400mg once daily, alone or together, for colorectal adenoma prevention. Men and women between age 40 and 80 years were eligible following colonoscopic removal of colorectal adenomas. The primary outcome was adenoma development. Celecoxib was suspended because of cardiovascular toxicity in other trials, but accrual continued to selenium and placebo. A total of 1621 participants were randomly assigned to selenium or placebo, of whom 1374 (84.8%) were available for analysis. All statistical tests were two-sided. Results: In the respective placebo and selenium arms of 689 and 685 participants, adenoma detection after medians of 33.6 (range = 0.0-85.1 months) and 33.0 months (range = 0.0-82.6 months) were 42.8% and 44.1% (relative risk [RR] = 1.03, 95% confidence interval [CI] = 0.91 to 1.16, P = .68). In participants with baseline advanced adenomas, adenoma recurrence was reduced by 18% with selenium (RR=0.82, 95% CI=0.71 to 0.96, P = .01). In participants receiving selenium, the hazard ratio for new-onset T2D was 1.25 (95% CI=0.74 to 2.11, P = .41), with a statistically significantly increased risk of selenium-associated T2D among older participants (RR=2.21; 95% CI=1.04 to 4.67, P = .03). Conclusions: Overall, selenium did not prevent colorectal adenomas and showed only modest benefit in patients with baseline advanced adenomas. With limited benefit and similar increases in T2D to other trials, selenium is not recommended for preventing colorectal adenomas in selenium-replete individuals.

Original languageEnglish (US)
Article numberdjw152
JournalJournal of the National Cancer Institute
Volume108
Issue number12
DOIs
StatePublished - Dec 1 2016

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Selenium
Adenoma
Type 2 Diabetes Mellitus
Celecoxib
Placebos
Confidence Intervals
Colorectal Neoplasms
Randomized Controlled Trials
Yeasts

ASJC Scopus subject areas

  • Medicine(all)
  • Oncology
  • Cancer Research

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Selenium supplementation for prevention of colorectal adenomas and risk of associated type 2 diabetes. / Thompson, Patricia A.; Ashbeck, Erin L.; Roe, Denise; Fales, Liane; Buckmeier, Julie; Wang, Fang; Bhattacharyya, Achyut K; Hsu, Chiu-Hsieh; Chow, Hsiao-Hui; Ahnen, Dennis J.; Boland, C. Richard; Heigh, Russell I.; Fay, David E.; Hamilton, Stanley R.; Jacobs, Elizabeth T; Martinez, Maria Elena; Alberts, David S; Lance, Michael P.

In: Journal of the National Cancer Institute, Vol. 108, No. 12, djw152, 01.12.2016.

Research output: Contribution to journalArticle

Thompson, Patricia A. ; Ashbeck, Erin L. ; Roe, Denise ; Fales, Liane ; Buckmeier, Julie ; Wang, Fang ; Bhattacharyya, Achyut K ; Hsu, Chiu-Hsieh ; Chow, Hsiao-Hui ; Ahnen, Dennis J. ; Boland, C. Richard ; Heigh, Russell I. ; Fay, David E. ; Hamilton, Stanley R. ; Jacobs, Elizabeth T ; Martinez, Maria Elena ; Alberts, David S ; Lance, Michael P. / Selenium supplementation for prevention of colorectal adenomas and risk of associated type 2 diabetes. In: Journal of the National Cancer Institute. 2016 ; Vol. 108, No. 12.
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title = "Selenium supplementation for prevention of colorectal adenomas and risk of associated type 2 diabetes",
abstract = "Background: Selenium supplementation may help to prevent colorectal cancer; as precursors of colorectal cancer, colorectal adenomas are a surrogate for colorectal cancer. Selenium supplementation may increase risk of type 2 diabetes (T2D). Methods: The Selenium and Celecoxib (Sel/Cel) Trial was a randomized, placebo controlled trial of selenium 200 mg daily as selenized yeast and celecoxib 400mg once daily, alone or together, for colorectal adenoma prevention. Men and women between age 40 and 80 years were eligible following colonoscopic removal of colorectal adenomas. The primary outcome was adenoma development. Celecoxib was suspended because of cardiovascular toxicity in other trials, but accrual continued to selenium and placebo. A total of 1621 participants were randomly assigned to selenium or placebo, of whom 1374 (84.8{\%}) were available for analysis. All statistical tests were two-sided. Results: In the respective placebo and selenium arms of 689 and 685 participants, adenoma detection after medians of 33.6 (range = 0.0-85.1 months) and 33.0 months (range = 0.0-82.6 months) were 42.8{\%} and 44.1{\%} (relative risk [RR] = 1.03, 95{\%} confidence interval [CI] = 0.91 to 1.16, P = .68). In participants with baseline advanced adenomas, adenoma recurrence was reduced by 18{\%} with selenium (RR=0.82, 95{\%} CI=0.71 to 0.96, P = .01). In participants receiving selenium, the hazard ratio for new-onset T2D was 1.25 (95{\%} CI=0.74 to 2.11, P = .41), with a statistically significantly increased risk of selenium-associated T2D among older participants (RR=2.21; 95{\%} CI=1.04 to 4.67, P = .03). Conclusions: Overall, selenium did not prevent colorectal adenomas and showed only modest benefit in patients with baseline advanced adenomas. With limited benefit and similar increases in T2D to other trials, selenium is not recommended for preventing colorectal adenomas in selenium-replete individuals.",
author = "Thompson, {Patricia A.} and Ashbeck, {Erin L.} and Denise Roe and Liane Fales and Julie Buckmeier and Fang Wang and Bhattacharyya, {Achyut K} and Chiu-Hsieh Hsu and Hsiao-Hui Chow and Ahnen, {Dennis J.} and Boland, {C. Richard} and Heigh, {Russell I.} and Fay, {David E.} and Hamilton, {Stanley R.} and Jacobs, {Elizabeth T} and Martinez, {Maria Elena} and Alberts, {David S} and Lance, {Michael P}",
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AU - Thompson, Patricia A.

AU - Ashbeck, Erin L.

AU - Roe, Denise

AU - Fales, Liane

AU - Buckmeier, Julie

AU - Wang, Fang

AU - Bhattacharyya, Achyut K

AU - Hsu, Chiu-Hsieh

AU - Chow, Hsiao-Hui

AU - Ahnen, Dennis J.

AU - Boland, C. Richard

AU - Heigh, Russell I.

AU - Fay, David E.

AU - Hamilton, Stanley R.

AU - Jacobs, Elizabeth T

AU - Martinez, Maria Elena

AU - Alberts, David S

AU - Lance, Michael P

PY - 2016/12/1

Y1 - 2016/12/1

N2 - Background: Selenium supplementation may help to prevent colorectal cancer; as precursors of colorectal cancer, colorectal adenomas are a surrogate for colorectal cancer. Selenium supplementation may increase risk of type 2 diabetes (T2D). Methods: The Selenium and Celecoxib (Sel/Cel) Trial was a randomized, placebo controlled trial of selenium 200 mg daily as selenized yeast and celecoxib 400mg once daily, alone or together, for colorectal adenoma prevention. Men and women between age 40 and 80 years were eligible following colonoscopic removal of colorectal adenomas. The primary outcome was adenoma development. Celecoxib was suspended because of cardiovascular toxicity in other trials, but accrual continued to selenium and placebo. A total of 1621 participants were randomly assigned to selenium or placebo, of whom 1374 (84.8%) were available for analysis. All statistical tests were two-sided. Results: In the respective placebo and selenium arms of 689 and 685 participants, adenoma detection after medians of 33.6 (range = 0.0-85.1 months) and 33.0 months (range = 0.0-82.6 months) were 42.8% and 44.1% (relative risk [RR] = 1.03, 95% confidence interval [CI] = 0.91 to 1.16, P = .68). In participants with baseline advanced adenomas, adenoma recurrence was reduced by 18% with selenium (RR=0.82, 95% CI=0.71 to 0.96, P = .01). In participants receiving selenium, the hazard ratio for new-onset T2D was 1.25 (95% CI=0.74 to 2.11, P = .41), with a statistically significantly increased risk of selenium-associated T2D among older participants (RR=2.21; 95% CI=1.04 to 4.67, P = .03). Conclusions: Overall, selenium did not prevent colorectal adenomas and showed only modest benefit in patients with baseline advanced adenomas. With limited benefit and similar increases in T2D to other trials, selenium is not recommended for preventing colorectal adenomas in selenium-replete individuals.

AB - Background: Selenium supplementation may help to prevent colorectal cancer; as precursors of colorectal cancer, colorectal adenomas are a surrogate for colorectal cancer. Selenium supplementation may increase risk of type 2 diabetes (T2D). Methods: The Selenium and Celecoxib (Sel/Cel) Trial was a randomized, placebo controlled trial of selenium 200 mg daily as selenized yeast and celecoxib 400mg once daily, alone or together, for colorectal adenoma prevention. Men and women between age 40 and 80 years were eligible following colonoscopic removal of colorectal adenomas. The primary outcome was adenoma development. Celecoxib was suspended because of cardiovascular toxicity in other trials, but accrual continued to selenium and placebo. A total of 1621 participants were randomly assigned to selenium or placebo, of whom 1374 (84.8%) were available for analysis. All statistical tests were two-sided. Results: In the respective placebo and selenium arms of 689 and 685 participants, adenoma detection after medians of 33.6 (range = 0.0-85.1 months) and 33.0 months (range = 0.0-82.6 months) were 42.8% and 44.1% (relative risk [RR] = 1.03, 95% confidence interval [CI] = 0.91 to 1.16, P = .68). In participants with baseline advanced adenomas, adenoma recurrence was reduced by 18% with selenium (RR=0.82, 95% CI=0.71 to 0.96, P = .01). In participants receiving selenium, the hazard ratio for new-onset T2D was 1.25 (95% CI=0.74 to 2.11, P = .41), with a statistically significantly increased risk of selenium-associated T2D among older participants (RR=2.21; 95% CI=1.04 to 4.67, P = .03). Conclusions: Overall, selenium did not prevent colorectal adenomas and showed only modest benefit in patients with baseline advanced adenomas. With limited benefit and similar increases in T2D to other trials, selenium is not recommended for preventing colorectal adenomas in selenium-replete individuals.

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