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Meta-Analysis
. 2008 Jul 16;2008(3):CD004183.
doi: 10.1002/14651858.CD004183.pub3.

Antioxidant supplements for preventing gastrointestinal cancers

Goran Bjelakovic  1 , Dimitrinka Nikolova, Rosa G Simonetti, Christian Gluud
Affiliations
Meta-Analysis

Antioxidant supplements for preventing gastrointestinal cancers

Goran Bjelakovic et al. Cochrane Database Syst Rev. .

Abstract

Background: Oxidative stress may cause gastrointestinal cancers. The evidence on whether antioxidant supplements are effective in preventing gastrointestinal cancers is contradictory.

Objectives: To assess the beneficial and harmful effects of antioxidant supplements in preventing gastrointestinal cancers.

Search strategy: We identified trials through the trials registers of the four Cochrane Review Groups on gastrointestinal diseases, The Cochrane Central Register of Controlled Trials in The Cochrane Library (Issue 2, 2007), MEDLINE, EMBASE, LILACS, SCI-EXPANDED, and The Chinese Biomedical Database from inception to October 2007. We scanned reference lists and contacted pharmaceutical companies.

Selection criteria: Randomised trials comparing antioxidant supplements to placebo/no intervention examining occurrence of gastrointestinal cancers.

Data collection and analysis: Two authors (GB and DN) independently selected trials for inclusion and extracted data. Outcome measures were gastrointestinal cancers, overall mortality, and adverse effects. Outcomes were reported as relative risks (RR) with 95% confidence interval (CI) based on random-effects and fixed-effect model meta-analysis. Meta-regression assessed the effect of covariates across the trials.

Main results: We identified 20 randomised trials (211,818 participants), assessing beta-carotene (12 trials), vitamin A (4 trials), vitamin C (8 trials), vitamin E (10 trials), and selenium (9 trials). Trials quality was generally high. Heterogeneity was low to moderate. Antioxidant supplements were without significant effects on gastrointestinal cancers (RR 0.94, 95% CI 0.83 to 1.06). However, there was significant heterogeneity (I(2) = 54.0%, P = 0.003). The heterogeneity may have been explained by bias risk (low-bias risk trials RR 1.04, 95% CI 0.96 to 1.13 compared to high-bias risk trials RR 0.59, 95% CI 0.43 to 0.80; test of interaction P < 0.0005), and type of antioxidant supplement (beta-carotene potentially increasing and selenium potentially decreasing cancer risk). The antioxidant supplements had no significant effects on mortality in a random-effects model meta-analysis (RR 1.02, 95% CI 0.97 to 1.07, I(2) = 53.5%), but significantly increased mortality in a fixed-effect model meta-analysis (RR 1.04, 95% CI 1.02 to 1.07). Beta-carotene in combination with vitamin A (RR 1.16, 95% CI 1.09 to 1.23) and vitamin E (RR 1.06, 95% CI 1.02 to 1.11) significantly increased mortality. Increased yellowing of the skin and belching were non-serious adverse effects of beta-carotene. In five trials (four with high risk of bias), selenium seemed to show significant beneficial effect on gastrointestinal cancer occurrence (RR 0.59, 95% CI 0.46 to 0.75, I(2) = 0%).

Authors' conclusions: We could not find convincing evidence that antioxidant supplements prevent gastrointestinal cancers. On the contrary, antioxidant supplements seem to increase overall mortality. The potential cancer preventive effect of selenium should be tested in adequately conducted randomised trials.

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Conflict of interest statement

None known.

Figures

1
1
Recommended dietary allowance, tolerable upper intake level, experimental doses, and regimen used in antioxidant supplements
2
2
Table 05. Bias risk of the trials
3
3
Funnel plot ‐ occurrence of gastrointestinal cancers
4
4
Funnel plot ‐ overall mortality
1.1
1.1. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 1 Occurrence of gastrointestinal cancers in trials with a low or high risk of bias.
1.2
1.2. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 2 Occurrence of gastrointestinal cancers ‐ generation of the allocation sequence.
1.3
1.3. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 3 Occurrence of gastrointestinal cancers ‐ allocation concealment.
1.4
1.4. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 4 Occurrence of gastrointestinal cancers ‐ follow‐up.
1.5
1.5. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 5 Occurrence of all gastrointestinal cancers ‐ different antioxidants.
1.6
1.6. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 6 Occurrence of different gastrointestinal cancers ‐ all antioxidants.
1.7
1.7. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 7 Occurrence of oesophageal cancer.
1.8
1.8. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 8 Occurrence of gastric cancer.
1.9
1.9. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 9 Occurrence of colorectal cancer.
1.10
1.10. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 10 Occurrence of pancreatic cancer.
1.11
1.11. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 11 Occurrence of hepatocellular carcinoma.
1.12
1.12. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 12 Occurrence of biliary tract cancer.
1.13
1.13. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 13 Mortality in trials with a low or high risk of bias.
1.14
1.14. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 14 Mortality after excluding selenium trials.
1.15
1.15. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 15 Mortality ‐ different antioxidants.
1.16
1.16. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 16 Adverse effects ‐ beta‐carotene.
1.17
1.17. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 17 Adverse effects ‐ vitamin E.
1.18
1.18. Analysis
Comparison 1 Antioxidants versus placebo, Outcome 18 Adverse effects ‐ selenium.
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EUROSCAN 2000 {published data only}
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Frank 1995 {published data only}
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Greenberg 1990 {published data only}
    1. Greenberg ER, Baron JA, Stukel TA, Stevens MM, Mandel JS, Spencer SK, et al. A clinical trial of beta carotene to prevent basal‐cell and squamous‐cell cancers of the skin. The Skin Cancer Prevention Study Group. New England Journal of Medicine 1990;323(12):789‐95. [MEDLINE: ] - PubMed
Ishikawa 1995 {published data only}
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Jacobs 2001 {published data only}
    1. Jacobs EJ, Connell CJ, Patel AV, Chao A, Rodriguez C, Seymour J, et al. Vitamin C and vitamin E supplement use and colorectal cancer mortality in a large American Cancer Society cohort. Cancer Epidemiology Biomarkers and Prevention 2001;10(1):17‐23. [MEDLINE: ] - PubMed
Jansen 1999 {published data only}
    1. Jansen MC, Bueno de Mesquita HB, Buzina R, Fidanza F, Menotti A, Blackburn H, et al. Dietary fiber and plant foods in relation to colorectal cancer mortality: the Seven Countries Study. International Journal of Cancer 1999;81(2):174‐9. [MEDLINE: ] - PubMed
Ji 1995 {published data only}
    1. Ji BT, Chow WH, Gridley G, Mclaughlin JK, Dai Q, Wacholder S, et al. Dietary factors and the risk of pancreatic cancer: a case‐control study in Shanghai China. Cancer Epidemiology, Biomarkers & Prevention 1995;4(8):885‐93. [MEDLINE: ] - PubMed
Kirk 2006 {published data only}
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Krishnaswamy 1993 {published data only}
    1. Krishnaswamy K, Prasad MPR, Krishna TP, Pasricha S. A case‐control study of selenium in cancer. Indian Journal of Medical Research 1993;98:124‐8. - PubMed
La Vecchia 2002 {published data only}
    1. Vecchia C. Tomatoes, lycopene intake, and digestive tract and female hormone‐related neoplasms. Experimental Biology and Medicine 2002;227(10):860‐3. - PubMed
Lacroix 1987 {published data only}
    1. Lacroix A, Bhat PV, Karabatsos A, Couture P, Latreille J, Beaulieu R, et al. Plasma levels of retinol in cancer patients supplemented with retinol. Oncology 1987;44(2):108‐14. [MEDLINE: ] - PubMed
Lanza 1996 {published data only}
    1. Lanza E, Schatzkin A, Ballard‐Barbash R, Corle D, Clifford C, Paskett E, et al. The polyp prevention trial II: dietary intervention program and participant baseline dietary characteristics. Cancer Epidemiology, Biomarkers & Prevention 1996;5(5):385‐92. [MEDLINE: ] - PubMed
Lanza 2001 {published data only}
    1. Lanza E, Schatzkin A, Daston C, Corle D, Freedman L, Ballard‐Barbash R, et al. Implementation of a 4‐Y, high‐fiber, high‐fruit‐and‐vegetable, low‐fat dietary intervention: results of dietary changes in the Polyp Prevention Trial. American Journal of Clinical Nutrition 2001;74(3):387‐401. - PubMed
Levi 2000 {published data only}
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Limburg 2005 {published data only}
    1. Limburg PJ, Wei W, Ahnen DJ, Qiao Y, Hawk ET, Wang G, et al. Randomized, placebo‐controlled, esophageal squamous cell cancer chemoprevention trial of selenomethionine and celecoxib. Gastroenterology 2005;129(3):863‐73. [MEDLINE: ] - PubMed
Macrae 1999 {published data only}
    1. Macrae F. Wheat bran fiber and development of adenomatous polyps: evidence from randomized, controlled clinical trials. American Journal of Medicine 1999;106(1 A):38S‐42S. - PubMed
Marotta 2003 {published data only}
    1. Marotta F, Barretto R, Tajiri H, Bertuccelli J, Safran P, Bobadilla J, et al. Atrophic/metaplastic changes of gastric mucosa: a preliminary interventional trial comparing different antioxidant supplements. International Congress Series 2003;1255:291‐4.
Marotta 2004 {published data only}
    1. Marotta F, Barreto R, Tajiri H, Bertuccelli J, Safran P, Yoshida C, et al. The aging/precancerous gastric mucosa: a pilot nutraceutical trial. Annals of the New York Academy of Sciences 2004;1019:195‐9. [MEDLINE: ] - PubMed
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    1. Muto Y, Moriwaki H, Ninomiya M, Adachi S, Saito A, Takasaki KT, et al. Prevention of second primary tumors by an acyclic retinoid, polyprenoic acid, in patients with hepatocellular carcinoma. Hepatoma Prevention Study Group. New England Journal of Medicine 1996;334(24):1561‐7. [MEDLINE: ] - PubMed
Newsome 2000 {published data only}
    1. Newsome PN, Beldon I, Moussa Y, Delahooke TE, Poulopoulos G, Hayes PC, et al. Low serum retinol levels are associated with hepatocellular carcinoma in patients with chronic liver disease. Alimentary Pharmacology & Therapeutics 2000;14(10):1295‐301. [MEDLINE: ] - PubMed
Nomura 1987a {published data only}
    1. Nomura A, Heilbrun LK, Morris JS, Stemmermann GN. Serum selenium and the risk of cancer, by specific sites: case‐control analysis of prospective data. Journal of the National Cancer Institute 1987;79(1):103‐8. [MEDLINE: ] - PubMed
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    1. Pan WH, Wang CY, Huang SM, Yeh SY, Lin WG, Lin DI, et al. Vitamin A, Vitamin E or beta‐carotene status and hepatitis B‐related hepatocellular carcinoma. Annals of Epidemiology 1993;3(3):217‐24. [MEDLINE: ] - PubMed
Podmore 1998a {published data only}
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    1. Qu CX, Kamangar F, Fan JH, Yu B, Sun XD, Taylor PR, et al. Chemoprevention of primary liver cancer: a randomized, double‐blind trial in Linxian, China. Journal of the National Cancer Institute 2007;99(16):1240‐7. [MEDLINE: ] - PubMed
Rocchi 1997 {published data only}
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Russo 1997 {published data only}
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Sasazuki 2003 {published data only}
    1. Kim MK, Sasaki S, Sasazuki S, Okubo S, Hayashi M, Tsugane S. Lack of long‐term effect of vitamin C supplementation on blood pressure. Hypertension 2002;40(6):797‐803. [MEDLINE: ] - PubMed
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Schatzkin 1996 {published data only}
    1. Schatzkin A, Lanza E, Freedman LS, Tangrea J, Cooper MR, Marshall JR, et al. The polyp prevention trial I: rationale, design, recruitment, and baseline participant characteristics. Cancer Epidemiology, Biomarkers & Prevention 1996;5(5):375‐83. [MEDLINE: ] - PubMed
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    1. Simone F, Pappalardo G, Maiani G, Guadalaxara A, Bugianesi R, Conte AM, et al. Accumulation and interactions of beta‐carotene and alpha‐tocopherol in patients with adenomatous polyps. European Journal of Clinical Nutrition 2002;56(6):546‐50. [MEDLINE: ] - PubMed
Siriwardena 2007 {published data only}
    1. Siriwardena AK, Mason JM, Balachandra S, Bagul A, Galloway S, Formela L, et al. Randomised, double blind, placebo controlled trial of intravenous antioxidant (n‐acetylcysteine, selenium, vitamin C) therapy in severe acute pancreatitis. Gut 2007;56(10):1439‐44. [MEDLINE: ] - PMC - PubMed
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Terry 2000 {published data only}
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Whelan 1999 {published data only}
    1. Whelan RL, Horvath KD, Gleason NR, Forde KA, Treat MD, Teitelbaum SL, et al. Vitamin and calcium supplement use is associated with decreased adenoma recurrence in patients with a previous history of neoplasia. Diseases of the Colon and Rectum 1999;42(2):212‐7. [MEDLINE: ] - PubMed
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References to ongoing studies

APPOSE 2001 {published data only}
    1. Costello AJ. A randomized, controlled chemoprevention trial of selenium in familial prostate cancer: rationale, recruitment, and design issues. Urology 2001;57(4):182‐4. [MEDLINE: ] - PubMed
HGPIN 2006 {published data only}
    1. Marshall JR, Sakr W, Wood D, Berry D, Tangen C, Parker F, et al. Design and progress of a trial of selenium to prevent prostate cancer among men with high‐grade prostatic intraepithelial neoplasia. Cancer Epidemiology, Biomarkers & Prevention 2006;15(8):1479‐84. [MEDLINE: ] - PubMed
PHS II 2000 {published data only}
    1. Christen WG, Gaziano JM, Hennekens CH. Design of Physicians' Health Study II a randomized trial of beta‐carotene, vitamins E and C, and multivitamins, in prevention of cancer, cardiovascular disease, and eye disease, and review of results of completed trials. Annals of Epidemiology 2000;10(2):125‐34. [MEDLINE: ] - PubMed
SELECT 2003 {published data only}
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