Macular Degeneration: Bass EB

Huang HY, Caballero B, Chang S, Alberg A, Semba R, Schneyer C, Wilson RF, Cheng TY, Prokopowicz G, Barnes GJ, Vassy J, Bass EB. · No affiliation provided · Evid Rep Technol Assess (Full Rep). · Pubmed #17764205 links to  free full text

Abstract: OBJECTIVES: To review and synthesize published literature on the efficacy of multivitamin/mineral supplements and certain single nutrient supplements in the primary prevention of chronic disease in the general adult population, and on the safety of multivitamin/mineral supplements and certain single nutrient supplements, likely to be included in multivitamin/mineral supplements, in the general population of adults and children. DATA SOURCES: All articles published through February 28, 2006, on MEDLINE, EMBASE, and the Cochrane databases. REVIEW METHODS: Each article underwent double reviews on title, abstract, and inclusion eligibility. Two reviewers performed data abstraction and quality assessment. Differences in opinion were resolved through consensus adjudication. RESULTS: Few trials have addressed the efficacy of multivitamin/mineral supplement use in chronic disease prevention in the general population of the United States. One trial on poorly nourished Chinese showed supplementation with combined Beta-carotene, vitamin E and selenium reduced gastric cancer incidence and mortality, and overall cancer mortality. In a French trial, combined vitamin C, vitamin E, Beta-carotene, selenium, and zinc reduced cancer risk in men but not in women. No cardiovascular benefit was evident in both trials. Multivitamin/mineral supplement use had no benefit for preventing cataract. Zinc/antioxidants had benefits for preventing advanced age-related macular degeneration in persons at high risk for the disease. With few exceptions, neither Beta-carotene nor vitamin E had benefits for preventing cancer, cardiovascular disease, cataract, and age-related macular degeneration. Beta-carotene supplementation increased lung cancer risk in smokers and persons exposed to asbestos. Folic acid alone or combined with vitamin B12 and/or vitamin B6 had no significant effects on cognitive function. Selenium may confer benefit for cancer prevention but not cardiovascular disease prevention. Calcium may prevent bone mineral density loss in postmenopausal women, and may reduce vertebral fractures, but not non-vertebral fractures. The evidence suggests dose-dependent benefits of vitamin D with/without calcium for retaining bone mineral density and preventing hip fracture, non-vertebral fracture and falls. We found no consistent pattern of increased adverse effects of multivitamin/mineral supplements except for skin yellowing by Beta-carotene. CONCLUSIONS: Multivitamin/mineral supplement use may prevent cancer in individuals with poor or suboptimal nutritional status. The heterogeneity in the study populations limits generalization to United States population. Multivitamin/mineral supplements conferred no benefit in preventing cardiovascular disease or cataract, and may prevent advanced age-related macular degeneration only in high-risk individuals. The overall quality and quantity of the literature on the safety of multivitamin/mineral supplements is limited.

Huang HY, Caballero B, Chang S, Alberg AJ, Semba RD, Schneyer CR, Wilson RF, Cheng TY, Vassy J, Prokopowicz G, Barnes GJ, Bass EB. · Bloomberg School of Public Health and the School of Medicine, Johns Hopkins University, Baltimore, Maryland 21205-2223, USA. · Ann Intern Med. · Pubmed #16880453 links to  free full text

Abstract: BACKGROUND: Multivitamin and mineral supplements are the most commonly used dietary supplements in the United States. PURPOSE: To synthesize studies on the efficacy and safety of multivitamin/mineral supplement use in primary prevention of cancer and chronic disease in the general population. DATA SOURCES: English-language literature search of the MEDLINE, EMBASE, and Cochrane databases through February 2006 and hand-searching of pertinent journals and articles. STUDY SELECTION: Randomized, controlled trials in adults were reviewed to assess efficacy, and randomized, controlled trials and observational studies in adults or children were reviewed to assess safety. DATA EXTRACTION: Paired reviewers extracted data and independently assessed study quality. DATA SYNTHESIS: 12 articles from 5 randomized, controlled trials that assessed efficacy and 8 articles from 4 randomized, controlled trials and 3 case reports on adverse effects were identified. Study quality was rated fair for the studies on cancer, cardiovascular disease, cataracts, or age-related macular degeneration and poor for the studies on hypertension. In a poorly nourished Chinese population, combined supplementation with beta-carotene, alpha-tocopherol, and selenium reduced the incidence of and mortality rate from gastric cancer and the overall mortality rate from cancer by 13% to 21%. In a French trial, combined supplementation with vitamin C, vitamin E, beta-carotene, selenium, and zinc reduced the rate of cancer by 31% in men but not in women. Multivitamin and mineral supplements had no significant effect on cardiovascular disease or cataracts, except that combined beta-carotene, selenium, alpha-tocopherol, retinol, and zinc supplementation reduced the mortality rate from stroke by 29% in the Linxian study and that a combination of 7 vitamins and minerals stabilized visual acuity loss in a small trial. Combined zinc and antioxidants slowed the progression of advanced age-related macular degeneration in high-risk persons. No consistent adverse effects of multivitamin and mineral supplements were evident. LIMITATIONS: Only randomized, controlled trials were considered for efficacy assessment. Special nutritional needs, such as use of folic acid by pregnant women to prevent birth defects, were not addressed. Findings may not apply to use of commercial multivitamin supplements by the general U.S. population. CONCLUSIONS: Evidence is insufficient to prove the presence or absence of benefits from use of multivitamin and mineral supplements to prevent cancer and chronic disease.

Childs AL, Bressler NM, Bass EB, Hawkins BS, Mangione CM, Marsh MJ, Miskala PH, Anonymous00092. · SST Coordinating Center, 550 North Broadway, 9th Floor, Baltimore, MD 21205, USA. · Ophthalmology. · Pubmed #15522365 links to  free full text

Abstract: PURPOSE: To present and compare findings from health-related quality-of-life (HRQOL) interviews conducted with patients enrolled in the SST Group B Trial evaluating surgical removal of subfoveal choroidal neovascular lesions associated with age-related macular degeneration versus observation. DESIGN: Randomized clinical trial. PARTICIPANTS: Eligible patients had predominantly hemorrhagic subfoveal choroidal neovascular lesions (total lesion size of >3.5 disc areas, area of blood at least 50% of the lesion area, and at least 75% of blood posterior to the equator) and best-corrected visual acuity (VA) of 20/100 to <20/1600 but at least light perception in the study eye. Three hundred thirty-six patients enrolled after baseline quality-of-life interviews, 168 assigned to each of surgery or observation. METHODS: Clinical and HRQOL data were collected before randomization and at 6, 12, 24, 36, and 48 months after enrollment. Baseline clinical evidence was used to stratify patients as having unilateral or bilateral neovascularization at the time of randomization. The HRQOL interviews included the National Eye Institute Visual Function Questionnaire (NEI-VFQ), the 36-item Short Form Health Survey, and the Hospital Anxiety and Depression Scale. MAIN OUTCOMES MEASURE: Two-year change in NEI-VFQ. RESULTS: At 24 months after enrollment, overall NEI-VFQ scores had a median decrease of 1 point from baseline in the observation arm (95% confidence interval [CI]: -4 to 3 points) and no change in the surgery arm (95% CI: -3 to 3 points) (P = 0.70). Changes from baseline on NEI-VFQ subscales also were similar between treatment arms. Differences in scores by unilateral or bilateral involvement seen at baseline in each treatment arm persisted throughout follow-up for most outcomes. Planned analyses stratified by VA showed trends (P = 0.17) in favor of surgery at 24 months in the patients with baseline VA greater than 20/200 for the NEI-VFQ scale (3.5-point median increase from baseline in the surgery arm [95% CI: -4 to 7] vs. a 1-point median loss from baseline in the observation arm [95% CI: -6 to 4]). CONCLUSIONS: No difference was detected with respect to vision-targeted quality-of-life outcomes for patients randomized to surgery or observation in the SST Group B Trial. This article contains additional online-only material available at www.ophsource.com/periodicals/ophtha.

Miskala PH, Bass EB, Bressler NM, Childs AL, Hawkins BS, Mangione CM, Marsh MJ, Anonymous00090. · SST Coordinating Center, 550 North Broadway, 9th Floor, Baltimore, MD 21205-2010, USA. · Ophthalmology. · Pubmed #15522363 links to  free full text

Abstract: PURPOSE: To describe health-related quality of life (HRQOL), overall and in patients with unilateral or bilateral choroidal neovascularization (CNV), in a clinical trial (Group N Trial) comparing observation and surgical removal of subfoveal CNV secondary to age-related macular degeneration (AMD). DESIGN: Randomized clinical trial. PARTICIPANTS: Eligible patients had untreated subfoveal CNV and AMD, best-corrected visual acuity (VA) of 20/100 to 20/800, classic CNV on fluorescein angiography, and a total subfoveal lesion size of < or =9.0 disc areas in the study eye. METHODS: Health-related quality of life data (the National Eye Institute Visual Function Questionnaire [NEI-VFQ], 36-item Short Form Health Survey [SF-36], and Hospital Anxiety and Depression Scale [HADS]) and clinical data were collected at baseline and at 6, 12, 24, 36, and 48 months. Patients were divided into unilateral and bilateral CNV subgroups based on fluorescein angiographic and clinical evidence. MAIN OUTCOME MEASURE: Two-year change in the NEI-VFQ. RESULTS: Of 454 patients enrolled, 228 were assigned to observation and 226 to surgery. At baseline, median overall NEI-VFQ scores were 67 in the observation group and 69 in the surgery group; by 2 years, the observation group had lost a median of 3 points (95% confidence interval [CI]: -6 to -2), and the surgery group gained a median of 1 point (CI: -1 to 3). The largest difference was observed for the mental health subscale, where the observation group lost a median of 5 points (CI: -5 to 0), and the surgery group gained a median of 5 points (CI: 0-10) by 2 years. Treatment differences in median 2-year changes in NEI-VFQ scores favored surgery by up to 10 points for unilateral cases and up to 8 points for bilateral cases. No treatment difference in 2-year change was observed for the SF-36 physical component summary; 2-year change in the mental component summary favored surgery by 2 points. Few patients (2%-4%) had HADS definite anxiety or depression at baseline or at 24 months. CONCLUSIONS: Although HRQOL outcomes were better in the submacular surgery arm than in the observation arm, surgery (per protocol) is not recommended because VA outcomes (reported elsewhere) were similar in the treatment arms. This article contains additional online-only material available at http://www.ophsource.com/periodicals/ophtha.

Dong LM, Childs AL, Mangione CM, Bass EB, Bressler NM, Hawkins BS, Marsh MJ, Miskala P, Jaffee HA, McCaffrey LA, Anonymous00315. · Wilmer Clinical Trials and Biometry, The Wilmer Ophthalmologic Institute, 550 N. Broadway, 9th Floor, Baltimore, MD 21205-2010, USA. · Am J Ophthalmol. · Pubmed #15234287 No free full text.

Abstract: PURPOSE: To describe the effect of subfoveal choroidal neovascularization (CNV) from age-related macular degeneration (AMD) on health-related quality of life (HRQOL) of patients at enrollment in two randomized clinical trials; to examine the relation of visual acuity to HRQOL; to compare HRQOL scores between participants with unilateral and bilateral CNV independent of other characteristics. DESIGN: Randomized clinical trials. METHODS: Two Submacular Surgery Trials (SST) recruited patients with AMD and either new subfoveal CNV (Group N Trial) or predominantly hemorrhagic CNV (Group B Trial). Health-related quality of life interviews included the National Eye Institute Visual Function Questionnaire [NEI-VFQ], the SF-36 Health Survey, and the Hospital Anxiety and Depression Scale [HADS]. Linear correlation and regression analyses were used to relate baseline HRQOL scores to visual acuity and bilateral disease. RESULTS: Interview data were analyzed for 789 AMD patients: 454 patients in the Group N Trial and 335 patients in the Group B Trial. Participants reported poor vision-related functioning in many domains measured by the NEI-VFQ (mean overall scores of 65 for Group N and 63 for Group B). Visual acuity of the better eye was strongly associated with NEI-VFQ scores but not with SF-36 or HADS scores. After adjusting for visual acuity of the better eye and other factors, bilateral cases had NEI-VFQ overall scores six points lower than unilateral cases in Group N Trial and 10 points lower than unilateral cases in the Group B Trial. CONCLUSIONS: Subfoveal CNV profoundly affects vision-related quality of life. The effect is more pronounced with bilateral disease, even after controlling for visual acuity.

Miskala PH, Hawkins BS, Mangione CM, Bass EB, Bressler NM, Dong LM, Marsh MJ, McCaffrey LD, Anonymous00023. · Submacular Surgery Trials Coordinating Center, Wilmer Clinical Trials and Biometry, Baltimore, MD 21205, USA. · Arch Ophthalmol. · Pubmed #12695250 links to  free full text

Abstract: BACKGROUND: The National Eye Institute Visual Function Questionnaire (NEI-VFQ) measures vision-targeted quality of life, but it is unclear whether it is sensitive to changes within individuals over time. OBJECTIVE: To determine the responsiveness of the NEI-VFQ to "within-individual" changes in visual acuity in patients who had subfoveal choroidal neovascularization in at least one eye secondary to age-related macular degeneration, ocular histoplasmosis syndrome, or idiopathic causes, and who participated in randomized trials of submacular surgery. METHODS: Trained telephone interviewers administered the NEI-VFQ as part of annual follow-up data collection for pilot trials and larger clinical trials of submacular surgery. Best-corrected visual acuity was measured by local vision examiners at 12 months after enrollment and, typically, by central "traveling" vision examiners at 24 months after enrollment. Changes in visual acuity and NEI-VFQ scores from 12 to 24 months were analyzed using linear regression methods. RESULTS: Two-hundred eighteen patients had both interviews and visual acuity measurements at 12 and 24 months after enrollment. Changes in the overall NEI-VFQ score and in 9 of the subscales (near activities, dependency, driving, role difficulties, distance activities, mental health, general vision, peripheral vision, and social functioning) were related to changes in visual acuity of the better-seeing eye based on linear regression analysis (P<.05). In our analysis, a 3-line decrease in the visual acuity of the better-seeing eye was associated with 3.6- to 16.2-point decreases in the overall NEI-VFQ score and 9 subscale scores. CONCLUSIONS: Most of the NEI-VFQ subscales were responsive to changes in the visual acuity of the better-seeing eye over a 12-month interval in this patient population. Thus, the NEI-VFQ can be used to measure change in vision-targeted quality of life over time to augment clinical measurements of visual acuity.