Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands.
J Neurol Sci. 2012 Mar 15;314(1-2):71-7. doi: 10.1016/j.jns.2011.10.028. Epub 2011 Nov 16.
To assess whether an intensive multifactorial treatment can reduce cognitive decrements and cognitive decline in screen-detected type 2 diabetes.
The multinational ADDITION-study, a cluster-randomized parallel group trial in patients with screen-detected type 2 diabetes, compared the effectiveness of intensive multifactorial treatment (IT; lifestyle advice and strict regulation of metabolic parameters) with routine care (RC) on cardiovascular outcome. In The Netherlands randomization was stratified according to practice organization. Allocation was concealed from patients. The present study assessed the effect of IT on cognition through two neuropsychological assessments (NPA) on two occasions. The assessments took place three and six years after the start of the intervention. Non-diabetic controls served as reference group. The first NPA was performed in 183 patients (IT: 97; RC: 86) and 69 controls. The second NPA was performed in 135 patients (IT: 71; RC: 64) and 55 controls. Primary outcome was a composite score, including the domains memory, information-processing speed and attention and executive function. Comparisons between the treatment groups were performed with multi-level analyses.
The first NPA showed no differences between the treatment groups (mean difference composite z-score: 0.00; 95%-CI -0.16 to 0.16; IT vs RC). Over the next three years cognitive decline in the diabetic groups was within the range of the reference group and did not differ between the treatment arms (difference decline between diabetic groups -0.12; -0.24 to 0.01; IT vs RC).
Six years of IT in screen-detected type 2 diabetes had no benefit on cognitive functioning over RC.
评估强化多因素治疗是否可以减少屏幕检测到的 2 型糖尿病患者的认知减退和认知下降。
这项多国的 ADDITION 研究是一项针对屏幕检测到的 2 型糖尿病患者的集群随机平行组试验，比较了强化多因素治疗（IT；生活方式建议和严格调节代谢参数）与常规护理（RC）对心血管结局的效果。在荷兰，根据实践组织进行了随机分组。患者并不知道分组情况。本研究通过两次神经心理评估（NPA）在两个时间点评估 IT 对认知的影响。评估在干预开始后 3 年和 6 年进行。非糖尿病对照作为参考组。第一次 NPA 在 183 名患者（IT：97；RC：86）和 69 名对照中进行。第二次 NPA 在 135 名患者（IT：71；RC：64）和 55 名对照中进行。主要结局是一个综合评分，包括记忆、信息处理速度和注意力以及执行功能等领域。通过多水平分析比较治疗组之间的差异。
第一次 NPA 显示治疗组之间没有差异（治疗组复合 z 评分差异：0.00；95%置信区间-0.16 至 0.16；IT 与 RC）。在接下来的三年中，糖尿病组的认知下降在参考组的范围内，两组之间的治疗效果没有差异（糖尿病组之间的差异下降-0.12；-0.24 至 0.01；IT 与 RC）。
在屏幕检测到的 2 型糖尿病患者中进行 6 年的 IT 治疗，在常规护理的基础上对认知功能没有益处。
