Following AREDS’ findings could improve patient’s quality of life, researcher says

The reduction of social costs related to the disease also would be substantial.

Issue: December 1, 2002

ByMichela Cimberle

MONTREUX, Switzerland – Last year’s Age-Related Eye Disease Study told the medical community and public about the benefits of high-dose antioxidant and zinc supplementation.

According to Johanna M. Seddon, MD, who reviewed AREDS findings at the Club Jules Gonin meeting here, taking these supplements can reduce the rate of progression of age-related macular degeneration by up to 25%.

AREDS also implies that supplements can reduce the burden of visual loss and related psychosocial effects.

A questionnaire that was used as part of the study found that patients with advanced AMD had lower scores for vision-related quality of life, and they were more depressed compared to those without AMD.

“AMD causes high levels of emotional distress and reduced quality of life due to the severe impairment experienced in most instrumental activities of daily living and discretionary activities like reading, watching TV and socializing. Mobility and independence are severely jeopardized,” said Dr. Seddon, an associate professor of ophthalmology at Harvard Medical School and director of the Epidemiology Unit for Macular Degeneration Research at Massachusetts Eye and Ear Infirmary.

The impact of depression in this particular older population has been evaluated in several studies. A 33%-to-35% rate of depressive disorders has been found in patients with advanced AMD. Depression is related to vision-specific disabilities and tends to increase with the progressive decline of visual function over time and with vision loss in the second eye, Dr. Seddon said.

“An estimated 1.3 million Americans over the age of 55 are likely to develop advanced AMD in the next 5 years,” she said. “If they all took the AREDS combination of supplemental vitamins and zinc, the 25% risk reduction in progression to advanced AMD would prevent more than 329,000 people from developing advanced AMD. More than 329,000 people could enjoy a better quality of life and, at the same time, this would represent a substantial reduction of the social costs related to the disease. Beside the direct costs of medical care, consideration should be given to the many indirect and potential social costs due to the impact of the disease on the quality of life of these patients and their families.”

Physicians should recommend to patients with intermediate AMD the AREDS combination of vitamin and mineral supplements to halt progression and associated loss of vision, she added.

AREDS revisted

Dr. Seddon reviewed the design and results of AREDS.

“Patients with intermediate AMD until now have had no demonstrated option to slow the progression of disease and associated visual loss. The purpose of the AREDS, which is a multicenter, randomized clinical trial sponsored by the National Institutes of Health and the National Eye Institute, was to determine if vitamin and mineral supplementation may benefit these patients,” she said.

This study confirms nutritional studies that she began in 1985, which showed a protective effect for antioxidants.

The study involved 11 clinical centers and 3,640 individuals with intermediate AMD or advanced AMD in one eye. The median follow-up was 6.3 years.

Patients were randomized into four groups, assigned to placebo, zinc only, antioxidants only (vitamins C, E and betacarotene) and a combination of both antioxidants and zinc.

“The results were all in the direction of a beneficial or protective effect. In particular, the group receiving both anti- oxidants and zinc had a statistically significant reduction in risk of developing advanced AMD. The rate of reduction at 5 years was 25% for this particular combination group. A 19% reduction in visual loss of three or more lines was also demonstrated with this combination of supplements,” Dr. Seddon said.

No side effects so far

Dr. Seddon discussed concerns about the potential side effects of zinc.

“In all our patients, a small dose of copper was added to the regimen. That prevented any copper-deficiency anemia that can occur with high doses of zinc. Alterations of the cholesterol profile were also monitored in the study. We observed that there was no difference between the patients taking zinc and those who were not taking it. As for possible effects on cognitive functions and dementia, again we haven’t found any significant difference between groups,” she said.

Self-management skills

In related news, a recently published study found that boosting AMD patients’ problem-solving skills can help them cope with depression due to their vision loss. Patients who took a 6-week self-management course benefited significantly compared to control patients. The study appered in the November issue of Archives of Ophthalmology.

Please see our brief coverage of the study on the Web at www.osnsupersite.com/view.asp?ID=3914. Look for a more complete report on the study in the January 1, 2003, issue of Ocular Surgery News.

The National Eye Institute
Visual Functioning Questionnaires

The National Eye Institute Visual Functioning Questionnaires (NEI VFQ) were developed as tools to measure one’s vision-specific health-related quality of life (HRQOL).

The VFQ-25, and the larger scale from which it was developed, the 51-item NEI-VFQ, have been used to demonstrate self-perceived visual impairment in patients with a variety of ocular disorders, including recovered optic neuritis, glaucoma and age-related macular degeneration.

Signs and symptoms of visual impairment are strongly related to overall HRQOL.

In addition to questions on general health and specific questions on visual quality and ocular discomforts, the 25 items of the VFQ include questions about common activities such as driving, reading the newspaper, cooking and moving in different environments, like movie theaters and restaurants, with which people with visual impairments may experience difficulty.

The VFQ is now being used in clinical trials to compare the benefits of different treatments, and by pharmaceutical companies to evaluate new medications against those already on the market. The VFQ may also be helpful if it becomes necessary to document the need for low-vision assistance when standard measures, like a visual acuity test, simply do not reflect one’s day-to-day problems with vision.

For Your Information:

Johanna M. Seddon, MD, can be reached Massachusetts Eye and Ear Infirmary, 243 Charles St., Boston, Massachusetts 02114; (617) 573-4010; fax: (617) 573-3570; e-mail: johanna_seddon@meei.harvard.edu.