Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.
J Clin Pharm Ther. 2011 Feb;36(1):53-63. doi: 10.1111/j.1365-2710.2009.01154.x.
Lowering haemoglobin A(₁c) (HbA(₁c)) has clearly been shown to reduce microvascular complications of diabetes and possibly macrovascular disease and vitamin E has been suggested as a possibly useful intervention. Our aim is to evaluate the effect of vitamin E supplementation on glycaemic control in type 2 diabetes.
Clinical studies of vitamin E were identified from computerized searches of MEDLINE, EMBASE, EBM reviews and the Cochrane Library up until November 2008. Historical searches of reference lists of relevant articles were also undertaken. To be included in our review, a study had to be: (i) a randomized controlled trial comparing vitamin E monopreparation against placebo or no treatment in patients with type 2 diabetes, (ii) lasting at least 8 weeks, and (iii) reporting glycated haemoglobin or HbA(₁c). There was no language restriction. Study selection, data extraction and study quality assessment were performed by three reviewers with disagreement resolved by discussion. Treatment effect was estimated with the mean difference in the changes of HbA(₁c) from baseline to final assessment between the vitamin E and the control groups.
Nine trials involving 418 patients were included in this review. Vitamin E supplementation did not improve glycaemic control in the full set of type 2 diabetes patients. It was effective only in a subgroup of patients with inadequate glycaemic control at baseline (HbA(₁c) ≥ 8%) and in those whose baseline serum vitamin E levels were below normal ranges. The pooled mean difference in the changes of HbA(₁c) was -0.58% (95% CI -0.83% to -0.34%; P < 0.00001) which was the same for both subgroups of patients.
The evidence suggests no beneficial effect of vitamin E supplementation in improving glycaemic control in unselected patients with type 2 diabetes. However, HbA(₁c) may decrease with vitamin E supplementation in patients with inadequate glycaemic control or low serum levels of vitamin E. This shows the importance of targeting therapy. Due to the limitations of the available evidence, further studies are warranted. Also, the safety and long-term benefit of such supplements remain to be determined before its clinical benefit can be established unequivocably.
降低血红蛋白 A₁c(HbA₁c)显然可以减少糖尿病的微血管并发症,并且可能减少大血管疾病,维生素 E 已被认为是一种可能有用的干预措施。我们的目的是评估维生素 E 补充剂对 2 型糖尿病患者血糖控制的影响。
通过计算机搜索 MEDLINE、EMBASE、EBM 综述和 Cochrane 图书馆,直到 2008 年 11 月,确定了维生素 E 的临床研究。还对相关文章的参考文献进行了历史搜索。要纳入我们的综述,研究必须是:(i)一项随机对照试验,比较维生素 E 单制剂与安慰剂或 2 型糖尿病患者无治疗的对照,(ii)持续至少 8 周,(iii)报告糖化血红蛋白或 HbA₁c。没有语言限制。研究选择、数据提取和研究质量评估由三名评审员进行,如果有分歧则通过讨论解决。用维生素 E 组和对照组从基线到最终评估 HbA₁c 的变化的平均差异估计治疗效果。
本综述共纳入 9 项试验,涉及 418 例患者。维生素 E 补充剂并不能改善 2 型糖尿病患者的血糖控制。它仅对基线血糖控制不足(HbA₁c≥8%)的患者亚组和基线血清维生素 E 水平低于正常范围的患者亚组有效。HbA₁c 变化的汇总平均差异为-0.58%(95%CI-0.83%至-0.34%;P<0.00001),这在两个患者亚组中是相同的。
证据表明,维生素 E 补充剂对改善未经选择的 2 型糖尿病患者的血糖控制没有有益作用。然而,HbA₁c 可能会随着维生素 E 补充而降低在血糖控制不足或血清维生素 E 水平较低的患者中。这表明靶向治疗的重要性。由于现有证据的局限性,需要进一步的研究。此外,这种补充剂的安全性和长期益处仍有待确定,在其临床益处得到明确之前。