Tags

Type your tag names separated by a space and hit enter

Cancer incidence and mortality after treatment with folic acid and vitamin B12.
JAMA 2009; 302(19):2119-26JAMA

Abstract

CONTEXT

Recently, concern has been raised about the safety of folic acid, particularly in relation to cancer risk.

OBJECTIVE

To evaluate effects of treatment with B vitamins on cancer outcomes and all-cause mortality in 2 randomized controlled trials.

DESIGN, SETTING, AND PARTICIPANTS

Combined analysis and extended follow-up of participants from 2 randomized, double-blind, placebo-controlled clinical trials (Norwegian Vitamin Trial and Western Norway B Vitamin Intervention Trial). A total of 6837 patients with ischemic heart disease were treated with B vitamins or placebo between 1998 and 2005, and were followed up through December 31, 2007.

INTERVENTIONS

Oral treatment with folic acid (0.8 mg/d) plus vitamin B(12) (0.4 mg/d) and vitamin B(6) (40 mg/d) (n = 1708); folic acid (0.8 mg/d) plus vitamin B(12) (0.4 mg/d) (n = 1703); vitamin B(6) alone (40 mg/d) (n = 1705); or placebo (n = 1721).

MAIN OUTCOME MEASURES

Cancer incidence, cancer mortality, and all-cause mortality.

RESULTS

During study treatment, median serum folate concentration increased more than 6-fold among participants given folic acid. After a median 39 months of treatment and an additional 38 months of posttrial observational follow-up, 341 participants (10.0%) who received folic acid plus vitamin B(12) vs 288 participants (8.4%) who did not receive such treatment were diagnosed with cancer (hazard ratio [HR], 1.21; 95% confidence interval [CI], 1.03-1.41; P = .02). A total of 136 (4.0%) who received folic acid plus vitamin B(12) vs 100 (2.9%) who did not receive such treatment died from cancer (HR, 1.38; 95% CI, 1.07-1.79; P = .01). A total of 548 patients (16.1%) who received folic acid plus vitamin B(12) vs 473 (13.8%) who did not receive such treatment died from any cause (HR, 1.18; 95% CI, 1.04-1.33; P = .01). Results were mainly driven by increased lung cancer incidence in participants who received folic acid plus vitamin B(12). Vitamin B(6) treatment was not associated with any significant effects.

CONCLUSION

Treatment with folic acid plus vitamin B(12) was associated with increased cancer outcomes and all-cause mortality in patients with ischemic heart disease in Norway, where there is no folic acid fortification of foods.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00671346.

Authors+Show Affiliations

Department of Heart Disease, Haukeland University Hospital, Jonas Liesvei 65, Bergen, Norway 5021. marta.ebbing@helse-bergen.noNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19920236

Citation

Ebbing, Marta, et al. "Cancer Incidence and Mortality After Treatment With Folic Acid and Vitamin B12." JAMA, vol. 302, no. 19, 2009, pp. 2119-26.
Ebbing M, Bønaa KH, Nygård O, et al. Cancer incidence and mortality after treatment with folic acid and vitamin B12. JAMA. 2009;302(19):2119-26.
Ebbing, M., Bønaa, K. H., Nygård, O., Arnesen, E., Ueland, P. M., Nordrehaug, J. E., ... Vollset, S. E. (2009). Cancer incidence and mortality after treatment with folic acid and vitamin B12. JAMA, 302(19), pp. 2119-26. doi:10.1001/jama.2009.1622.
Ebbing M, et al. Cancer Incidence and Mortality After Treatment With Folic Acid and Vitamin B12. JAMA. 2009 Nov 18;302(19):2119-26. PubMed PMID: 19920236.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cancer incidence and mortality after treatment with folic acid and vitamin B12. AU - Ebbing,Marta, AU - Bønaa,Kaare Harald, AU - Nygård,Ottar, AU - Arnesen,Egil, AU - Ueland,Per Magne, AU - Nordrehaug,Jan Erik, AU - Rasmussen,Knut, AU - Njølstad,Inger, AU - Refsum,Helga, AU - Nilsen,Dennis W, AU - Tverdal,Aage, AU - Meyer,Klaus, AU - Vollset,Stein Emil, PY - 2009/11/19/entrez PY - 2009/11/19/pubmed PY - 2009/12/16/medline SP - 2119 EP - 26 JF - JAMA JO - JAMA VL - 302 IS - 19 N2 - CONTEXT: Recently, concern has been raised about the safety of folic acid, particularly in relation to cancer risk. OBJECTIVE: To evaluate effects of treatment with B vitamins on cancer outcomes and all-cause mortality in 2 randomized controlled trials. DESIGN, SETTING, AND PARTICIPANTS: Combined analysis and extended follow-up of participants from 2 randomized, double-blind, placebo-controlled clinical trials (Norwegian Vitamin Trial and Western Norway B Vitamin Intervention Trial). A total of 6837 patients with ischemic heart disease were treated with B vitamins or placebo between 1998 and 2005, and were followed up through December 31, 2007. INTERVENTIONS: Oral treatment with folic acid (0.8 mg/d) plus vitamin B(12) (0.4 mg/d) and vitamin B(6) (40 mg/d) (n = 1708); folic acid (0.8 mg/d) plus vitamin B(12) (0.4 mg/d) (n = 1703); vitamin B(6) alone (40 mg/d) (n = 1705); or placebo (n = 1721). MAIN OUTCOME MEASURES: Cancer incidence, cancer mortality, and all-cause mortality. RESULTS: During study treatment, median serum folate concentration increased more than 6-fold among participants given folic acid. After a median 39 months of treatment and an additional 38 months of posttrial observational follow-up, 341 participants (10.0%) who received folic acid plus vitamin B(12) vs 288 participants (8.4%) who did not receive such treatment were diagnosed with cancer (hazard ratio [HR], 1.21; 95% confidence interval [CI], 1.03-1.41; P = .02). A total of 136 (4.0%) who received folic acid plus vitamin B(12) vs 100 (2.9%) who did not receive such treatment died from cancer (HR, 1.38; 95% CI, 1.07-1.79; P = .01). A total of 548 patients (16.1%) who received folic acid plus vitamin B(12) vs 473 (13.8%) who did not receive such treatment died from any cause (HR, 1.18; 95% CI, 1.04-1.33; P = .01). Results were mainly driven by increased lung cancer incidence in participants who received folic acid plus vitamin B(12). Vitamin B(6) treatment was not associated with any significant effects. CONCLUSION: Treatment with folic acid plus vitamin B(12) was associated with increased cancer outcomes and all-cause mortality in patients with ischemic heart disease in Norway, where there is no folic acid fortification of foods. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00671346. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/19920236/Cancer_incidence_and_mortality_after_treatment_with_folic_acid_and_vitamin_B12_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2009.1622 DB - PRIME DP - Unbound Medicine ER -