Jagannath Vanitha A, Fedorowicz Zbys, Asokan G V, Robak Edward W, Whamond Liz
Department of Paediatrics, KIMS Bahrain Medical Center, Um al Hassam Ave, Adliya, Manama, Bahrain, PO Box 175829.
Cochrane Database Syst Rev. 2010 Dec 8(12):CD008422. doi: 10.1002/14651858.CD008422.pub2.
Multiple sclerosis is a disease of the central nervous system characterized by demyelination of the nerve sheaths which can result in varying levels of disability. Disease occurrence and progression are considered by some to be associated with low serum levels of vitamin D. Studies investigating vitamin D supplementation in MS patients have illustrated a noticeable improvement in the course of the disease.
To evaluate the safety and effectiveness of vitamin D in the management of multiple sclerosis.
We searched the Cochrane Multiple Sclerosis Group Trials Register comprising references identified from comprehensive electronic database searches and hand searches of relevant journals and abstract books of conferences.
Randomised and quasi-randomised controlled trials comparing vitamin D with placebo or any other treatment for the management of multiple sclerosis.
Two review authors selected trials for inclusion, assessed the risk of bias and extracted data independently. Disagreements were resolved by consensus. Trialists were contacted for clarification of study details.
We included a single trial (49 participants) conducted over 52 weeks, which treated 25 patients with escalating doses of vitamin D compared with control (24). The trial provided some evidence of the potential benefit of the intervention on several outcomes i.e. the annualised relapse rate; EDSS scores; suppression of T-cell proliferation and illustrated a measure of comparative safety in the relative absence of any adverse events or of high serum calcium levels over the study period. This was a low powered trial with a potential high risk of bias which may ultimately impose limits on the applicability of the available evidence to the MS population as a whole.
AUTHORS' CONCLUSIONS: The current level of evidence for the effectiveness of vitamin D supplementation in the management of people with MS is based on a single RCT with potential high risk of bias, which does not at present allow confident decision-making about the use of Vitamin D in MS. Therefore, until further high quality evidence is available, clinicians may wish to consider relevant MS guidelines on vitamin D supplementation when making decisions about the care of people with multiple sclerosis. Adequately powered, multi-centred RCTs with a focus on clinical as well as immunological and MRI outcomes that are meaningful to people with MS, and are able to provide insight into the benefits of Vitamin D in people with MS, are still required.
多发性硬化症是一种中枢神经系统疾病，其特征是神经鞘脱髓鞘，可导致不同程度的残疾。一些人认为疾病的发生和进展与血清维生素D水平低有关。对多发性硬化症患者补充维生素D的研究表明，疾病进程有明显改善。
评估维生素D治疗多发性硬化症的安全性和有效性。
我们检索了Cochrane多发性硬化症研究组试验注册库，其中包括通过全面电子数据库检索以及对相关期刊和会议摘要书籍进行手工检索确定的参考文献。
比较维生素D与安慰剂或其他任何治疗方法治疗多发性硬化症的随机和半随机对照试验。
两位综述作者选择纳入试验，独立评估偏倚风险并提取数据。分歧通过协商解决。与试验者联系以澄清研究细节。
我们纳入了一项为期52周的单一试验（49名参与者），该试验将25名患者用递增剂量的维生素D进行治疗，并与对照组（24名）进行比较。该试验提供了一些证据，表明该干预措施对几个结果可能有益，即年化复发率；扩展残疾状态量表（EDSS）评分；抑制T细胞增殖，并表明在研究期间相对没有任何不良事件或高血清钙水平的情况下具有一定程度的比较安全性。这是一项低效能试验，存在潜在的高偏倚风险，这最终可能会限制现有证据对整个多发性硬化症人群的适用性。
目前关于补充维生素D治疗多发性硬化症患者有效性的证据水平基于一项单一的随机对照试验，该试验存在潜在的高偏倚风险，目前尚无法就多发性硬化症中维生素D的使用做出可靠决策。因此，在获得进一步的高质量证据之前，临床医生在做出关于多发性硬化症患者护理的决策时，可能希望考虑有关维生素D补充的相关多发性硬化症指南。仍然需要进行足够效能的、多中心的随机对照试验，重点关注对多发性硬化症患者有意义的临床以及免疫学和磁共振成像结果，并能够深入了解维生素D对多发性硬化症患者的益处。
