Mathew Milan C, Ervin Ann-Margret, Tao Jeremiah, Davis Richard M
MetroWest Medical Center, Framingham, Massachusetts, USA.
Cochrane Database Syst Rev. 2012 Jun 13;2012(6):CD004567. doi: 10.1002/14651858.CD004567.pub2.
Age-related cataract is a major cause of visual impairment in the elderly. Oxidative stress has been implicated in its formation and progression. Antioxidant vitamin supplementation has been investigated in this context.
To assess the effectiveness of antioxidant vitamin supplementation in preventing and slowing the progression of age-related cataract.
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 2), MEDLINE (January 1950 to March 2012), EMBASE (January 1980 to March 2012), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to March 2012), Open Grey (System for Information on Grey Literature in Europe) (www.opengrey.eu/), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). There were no date or language restrictions in the electronic searches for trials. The electronic databases were last searched on 2 March 2012. We also checked the reference lists of included studies and ongoing trials and contacted investigators to identify eligible randomized trials.
We included only randomized controlled trials in which supplementation with one or more antioxidant vitamins (beta-carotene, vitamin C and vitamin E) in any form, dosage or combination for at least one year was compared to another antioxidant vitamin or to placebo.
Two authors extracted data and assessed trial quality independently. We pooled results for the primary outcomes, i.e., incidence of cataract and incidence of cataract extraction. We did not pool results of the secondary outcomes - progression of cataract and loss of visual acuity, because of differences in definitions of outcomes and data presentation. We pooled results by type of cataract when data were available. We did not perform a sensitivity analysis.
Nine trials involving 117,272 individuals of age 35 years or older are included in this review. The trials were conducted in Australia, Finland, India, Italy, the United Kingdom and the United States, with duration of follow-up ranging from 2.1 to 12 years. The doses of antioxidant vitamins were higher than the recommended daily allowance. There was no evidence of effect of antioxidant vitamin supplementation in reducing the risk of cataract, cataract extraction, progression of cataract or in slowing the loss of visual acuity. In the pooled analyses, there was no evidence of effect of beta-carotene supplementation in reducing the risk of cataract (two trials) (relative risk (RR) 0.99, 95% confidence interval (CI) 0.91 to 1.08; n = 57,703) or in reducing the risk of cataract extraction (three trials) (RR 1.00, 95% CI 0.91 to 1.10; n = 86,836) or of vitamin E supplementation in reducing the risk of cataract (three trials) (RR 0.97, 95% CI 0.91 to 1.04; n = 50,059) or of cataract extraction (five trials) (RR 0.98, 95% CI 0.91 to 1.05; n = 83,956). The proportion of participants developing hypercarotenodermia (yellowing of skin) while on beta-carotene ranged from 7.4% to 15.8%.
AUTHORS' CONCLUSIONS: There is no evidence from RCTs that supplementation with antioxidant vitamins (beta-carotene, vitamin C or vitamin E) prevents or slows the progression of age-related cataract. We do not recommend any further studies to examine the role of antioxidant vitamins beta-carotene, vitamin C and vitamin E in preventing or slowing the progression of age-related cataract. Costs and adverse effects should be weighed carefully with unproven benefits before recommending their intake above recommended daily allowances.
年龄相关性白内障是老年人视力损害的主要原因。氧化应激被认为与其形成和进展有关。在此背景下,人们对补充抗氧化维生素进行了研究。
评估补充抗氧化维生素在预防和延缓年龄相关性白内障进展方面的有效性。
我们检索了Cochrane中心对照试验注册库(CENTRAL)(其中包含Cochrane眼科和视觉组试验注册库)(《Cochrane图书馆》2012年第2期)、MEDLINE(1950年1月至2012年3月)、EMBASE(1980年1月至2012年3月)、拉丁美洲和加勒比地区健康科学文献数据库(LILACS)(1982年1月至2012年3月)、Open Grey(欧洲灰色文献信息系统)(www.opengrey.eu/)、对照试验元注册库(mRCT)(www.controlled-trials.com)、ClinicalTrials.gov(www.clinicaltrials.gov)以及世界卫生组织国际临床试验注册平台(ICTRP)(www.who.int/ictrp/search/en)。电子检索试验时没有日期或语言限制。电子数据库最后一次检索时间为2012年3月2日。我们还检查了纳入研究和正在进行试验的参考文献列表,并联系研究者以确定符合条件的随机试验。
我们仅纳入了随机对照试验,其中将以任何形式、剂量或组合补充一种或多种抗氧化维生素(β-胡萝卜素、维生素C和维生素E)至少一年的情况与另一种抗氧化维生素或安慰剂进行比较。
两位作者独立提取数据并评估试验质量。我们汇总了主要结局的结果,即白内障发病率和白内障摘除率。由于结局定义和数据呈现方式存在差异,我们未汇总次要结局的结果——白内障进展和视力丧失。如有数据,我们按白内障类型汇总结果。我们未进行敏感性分析。
本综述纳入了9项试验,涉及117272名35岁及以上的个体。这些试验在澳大利亚、芬兰、印度、意大利、英国和美国进行随访时间从2.1年至12年不等。抗氧化维生素的剂量高于推荐每日摄入量。没有证据表明补充抗氧化维生素在降低白内障风险、白内障摘除风险、白内障进展风险或减缓视力丧失方面有效果。在汇总分析中,没有证据表明补充β-胡萝卜素在降低白内障风险方面有效果(两项试验)(相对危险度(RR)0.99,95%置信区间(CI)0.91至1.08;n = 57703)或在降低白内障摘除风险方面有效果(三项试验)(RR 1.00,95%CI 0.91至1.10;n = 86836),也没有证据表明补充维生素E在降低白内障风险方面有效果(三项试验)(RR 0.97,95%CI 0.91至1.04;n = 50059)或在降低白内障摘除风险方面有效果(五项试验)(RR 0.98,95%CI 0.91至1.05;n = 83956)。服用β-胡萝卜素期间出现高胡萝卜素血症(皮肤变黄)的参与者比例在7.4%至15.8%之间。
随机对照试验没有证据表明补充抗氧化维生素(β-胡萝卜素、维生素C或维生素E)可预防或延缓年龄相关性白内障的进展。我们不建议进一步开展研究来检验抗氧化维生素β-胡萝卜素、维生素C和维生素E在预防或延缓年龄相关性白内障进展方面的作用。在建议摄入高于推荐每日摄入量之前,应仔细权衡成本、不良反应与未经证实的益处。