Antioxidant vitamins supplementation and mortality: a randomized trial in head and neck cancer patients.
There has been concern that long-term supplementation with high-dose antioxidant vitamins, especially vitamin E (alpha-tocopherol), may increase all-cause mortality. We conducted a randomized controlled trial with alpha-tocopherol (400 IU/day) and beta-carotene (30 mg/day) supplements among 540 head and neck cancer patients treated by radiation therapy. Supplementation with beta-carotene was discontinued during the trial. The supplements were given during radiation therapy and for 3 additional years. During the follow-up (median 6.5 years), 179 deaths were recorded. All death certificates were obtained. All-cause and cause-specific mortality rates were compared between the 2 arms of the trial by Cox regression. All-cause mortality was significantly increased in the supplement arm: hazard ratio: 1.38, 95% confidence interval 1.03-1.85. Cause-specific mortality rates tended to be higher in the supplement arm than in the placebo arm. Our results concur with previous reports to suggest that high-dose vitamin E could be harmful.
Bairati
Isabelle
I
Laval University Cancer Research Center, Quebec City, Quebec, Canada.
Meyer
François
F
Jobin
Edith
E
Gélinas
Michel
M
Fortin
André
A
Nabid
Abdenour
A
Brochet
François
F
Têtu
Bernard
B
D000975:Antioxidants / Q000627:therapeutic use*; D019587:Dietary Supplements; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D010919:Placebos; D016019:Survival Analysis; D014815:Vitamins / Q000008:administration & dosage / Q000627:therapeutic use*; D024502:alpha-Tocopherol / Q000627:therapeutic use; D019207:beta Carotene / Q000627:therapeutic use
D000975:Antioxidants; D010919:Placebos; D014815:Vitamins; D019207:beta Carotene; D024502:alpha-Tocopherol