Beta Carotene Supplementation and Age-Related Maculopathy in a Randomized Trial of US Physicians

Abstract

Objective-To test whether beta carotene affects age-related maculopathy (ARM) in a large-scale randomized trial.Design-Randomized, double-masked, placebo-controlled trial among 22,071 apparently healthy male U.S physicians aged 40 to 84 years. Participants were randomly assigned to receive beta carotene (50 mg on alternate days) or placebo.Main Outcome Measure-Incident ARM responsible for a reduction in best-corrected visual acuity to 20/30 or worse. Results-After 12 years of treatment and follow-up, there were 162 cases of ARM in the beta carotene group and 170 cases in the placebo group (relative risk [RR], 0.96; 95 percent confidence interval [CI], 0.78 to 1.20). The results were similar for the secondary endpoints of ARM with or without vision loss (275 cases versus 274 cases; RR, 1.01; CI, 0.86 to 1.20) and advanced ARM (63 cases versus 66 cases; RR, 0.97; CI, 0.69 to 1.37).Conclusions-These randomized data with 12 years of treatment in a large population of apparently healthy men indicate that beta carotene supplementation has no beneficial or harmful effect on incidence of ARM.Applications to Clinical Practice-Long-term supplemental use of beta carotene neither decreases nor increases the risk of ARM.

Antioxidant supplements to prevent or slow down the progression of AMD: a systematic review and meta-analysis

“…A total of 21 142 men provided self-reported information on AMD, which was confirmed by medical record review. 11 In the Vitamin E cataract and ARM trial, 1204 men and women aged 55-80 years were randomly allocated vitamin E (335 mg/day) or placebo and followed up for 4 years. 12 In all, 82% of the participants in this study had no evidence of ARM at enrolment which is why this trial is included in the prevention rather than progression of AMD results.…”

Antioxidant supplements to prevent or slow down the progression of AMD: a systematic review and meta-analysis

“…A total of 21 142 men provided self-reported information on AMD, which was confirmed by medical record review. 11 In the Vitamin E cataract and ARM trial, 1204 men and women aged 55-80 years were randomly allocated vitamin E (335 mg/day) or placebo and followed up for 4 years. 12 In all, 82% of the participants in this study had no evidence of ARM at enrolment which is why this trial is included in the prevention rather than progression of AMD results.…”

Projected prevalence of age‐related macular degeneration in Scandinavia 2012–2040

“…A randomized, placebocontrolled trial did not find vitamin E supplements to prevent the development of early AMD (relative risk 1.1, 95% confidence interval 0.7-1.6) (Taylor et al 2002). A randomized, placebo-controlled trial did not find any effect of beta-carotene supplements on development of age-related maculopathy (relative risk 1.0, 95% confidence interval 0.8-1.2) (Christen et al 2007). A recent review of prevention strategies concluded that there are no evidence that lifestyle, diet or dietary supplements are beneficial in delaying or preventing the onset of AMD in healthy individuals, with the exception of smoking cessation (Arroyo et al 2011).…”

Cocoa Flavanol Supplementation and Risk of Age-Related Macular Degeneration

“…The estimated power of this ancillary study was based on the following assumptions: (1) annual event rates for AMD observed in our previous trials of men and women [44][45][46][47][48][49][50] ; (2) the study population of 12 000 women aged 65 years and older and 6000 men aged 60 years and older (initial anticipated population size of the parent COSMOS trial); and (3) average follow-up of 4 years. Under these assumptions, the study was expected to have excellent power (≥90%) to detect reductions of 25% or more in the primary composite end point and adequate power (≥75%) to detect reductions of 20% or more.…”

Antioxidant supplements to prevent or slow down the progression of AMD: a systematic review and meta-analysis

“…A total of 21 142 men provided self-reported information on AMD, which was confirmed by medical record review. 11 In the Vitamin E cataract and ARM trial, 1204 men and women aged 55-80 years were randomly allocated vitamin E (335 mg/day) or placebo and followed up for 4 years. 12 In all, 82% of the participants in this study had no evidence of ARM at enrolment which is why this trial is included in the prevention rather than progression of AMD results.…”

Projected prevalence of age‐related macular degeneration in Scandinavia 2012–2040

“…A randomized, placebocontrolled trial did not find vitamin E supplements to prevent the development of early AMD (relative risk 1.1, 95% confidence interval 0.7-1.6) (Taylor et al 2002). A randomized, placebo-controlled trial did not find any effect of beta-carotene supplements on development of age-related maculopathy (relative risk 1.0, 95% confidence interval 0.8-1.2) (Christen et al 2007). A recent review of prevention strategies concluded that there are no evidence that lifestyle, diet or dietary supplements are beneficial in delaying or preventing the onset of AMD in healthy individuals, with the exception of smoking cessation (Arroyo et al 2011).…”

Cocoa Flavanol Supplementation and Risk of Age-Related Macular Degeneration

“…The estimated power of this ancillary study was based on the following assumptions: (1) annual event rates for AMD observed in our previous trials of men and women [44][45][46][47][48][49][50] ; (2) the study population of 12 000 women aged 65 years and older and 6000 men aged 60 years and older (initial anticipated population size of the parent COSMOS trial); and (3) average follow-up of 4 years. Under these assumptions, the study was expected to have excellent power (≥90%) to detect reductions of 25% or more in the primary composite end point and adequate power (≥75%) to detect reductions of 20% or more.…”

Antioxidant supplements to prevent or slow down the progression of AMD: a systematic review and meta-analysis

“…A total of 21 142 men provided self-reported information on AMD, which was confirmed by medical record review. 11 In the Vitamin E cataract and ARM trial, 1204 men and women aged 55-80 years were randomly allocated vitamin E (335 mg/day) or placebo and followed up for 4 years. 12 In all, 82% of the participants in this study had no evidence of ARM at enrolment which is why this trial is included in the prevention rather than progression of AMD results.…”

Projected prevalence of age‐related macular degeneration in Scandinavia 2012–2040

“…A randomized, placebocontrolled trial did not find vitamin E supplements to prevent the development of early AMD (relative risk 1.1, 95% confidence interval 0.7-1.6) (Taylor et al 2002). A randomized, placebo-controlled trial did not find any effect of beta-carotene supplements on development of age-related maculopathy (relative risk 1.0, 95% confidence interval 0.8-1.2) (Christen et al 2007). A recent review of prevention strategies concluded that there are no evidence that lifestyle, diet or dietary supplements are beneficial in delaying or preventing the onset of AMD in healthy individuals, with the exception of smoking cessation (Arroyo et al 2011).…”

Cocoa Flavanol Supplementation and Risk of Age-Related Macular Degeneration

“…The estimated power of this ancillary study was based on the following assumptions: (1) annual event rates for AMD observed in our previous trials of men and women [44][45][46][47][48][49][50] ; (2) the study population of 12 000 women aged 65 years and older and 6000 men aged 60 years and older (initial anticipated population size of the parent COSMOS trial); and (3) average follow-up of 4 years. Under these assumptions, the study was expected to have excellent power (≥90%) to detect reductions of 25% or more in the primary composite end point and adequate power (≥75%) to detect reductions of 20% or more.…”