Bartlett H E, Eperjesi F
Opthalmic Research Group, School of Life and Health Sciences, Aston University, Aston Triangle, Birmingham, UK.
Eur J Clin Nutr. 2007 Sep;61(9):1121-7. doi: 10.1038/sj.ejcn.1602626. Epub 2007 Jan 31.
The aim of the study is to determine the effect of lutein combined with vitamin and mineral supplementation on contrast sensitivity in people with age-related macular disease (ARMD).
A prospective, 9-month, double-masked randomized controlled trial.
Aston University, Birmingham, UK and a UK optometric clinical practice.
Age-related maculopathy (ARM) and atrophic age-related macular degeneration (AMD) participants were randomized (using a random number generator) to either placebo (n=10) or active (n=15) groups. Three of the placebo group and two of the active group dropped out.
The active group supplemented daily with 6 mg lutein combined with vitamins and minerals. The outcome measure was contrast sensitivity (CS) measured using the Pelli-Robson chart, for which the study had 80% power at the 5% significance level to detect a change of 0.3 log units.
The CS score increased by 0.07+/-0.07 and decreased by 0.02+/-0.18 log units for the placebo and active groups, respectively. The difference between these values is not statistically significant (z=-0.903, P=0.376).
The results suggest that 6 mg of lutein supplementation in combination with other antioxidants is not beneficial for this group. Further work is required to establish optimum dosage levels.
本研究旨在确定叶黄素联合维生素和矿物质补充剂对年龄相关性黄斑病变(ARMD)患者对比敏感度的影响。
一项为期9个月的前瞻性双盲随机对照试验。
英国伯明翰阿斯顿大学及一家英国验光临床诊所。
年龄相关性黄斑病变(ARM)和萎缩性年龄相关性黄斑变性(AMD)参与者通过随机数字生成器被随机分为安慰剂组(n = 10)或活性组(n = 15)。安慰剂组有3人退出,活性组有2人退出。
活性组每天补充6毫克叶黄素以及维生素和矿物质。结局指标是使用佩利-罗布森视力表测量的对比敏感度(CS),本研究在5%显著性水平下有80%的检验效能检测到0.3对数单位的变化。
安慰剂组和活性组的CS评分分别增加了0.07±0.07和降低了0.02±0.18对数单位。这些值之间的差异无统计学意义(z = -0.903,P = 0.376)。
结果表明,补充6毫克叶黄素并联合其他抗氧化剂对该组患者无益。需要进一步研究以确定最佳剂量水平。