Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
Department of Endocrinology, Changi General Hospital, Singapore, Singapore.
High Blood Press Cardiovasc Prev. 2022 Jul;29(4):337-351. doi: 10.1007/s40292-022-00526-5. Epub 2022 Jun 29.
Although low vitamin D levels are associated with statin-associated muscle symptoms (SAMS), it remains unclear if vitamin D supplementation leads to symptom improvement.
We performed a systematic review to evaluate the association of vitamin D supplementation with resolution of SAMS.
We searched Medline (PubMed), Embase and Cochrane Library till 12 December 2021. Full length articles that reported on the association between vitamin D supplementation in adult patients with SAMS were included.
We identified 8 interventional studies comprising 669 participants. Majority of the participants were of Caucasian ethnicity and the mean age of participants ranged from 59.5 to 64.8 years old. The studies recruited patients with initial mean pre-treatment vitamin D levels ranging from 17.8 to 22.0ng/mL. Follow up duration ranged from 2 to 24 months and mean post-treatment vitamin D levels ranged from 34.3 to 56.0ng/mL. We found that vitamin D supplementation was associated with improved statin tolerance in 509 out of 606 (83.9%) patients across the 7 studies which reported patient numbers after supplementation (95% CI = 0.81-0.87, I2 = 72% n = 7). None of the studies were randomized controlled trials (RCTs) and hence placebo effect of vitamin D could not be ruled out. Nocebo effect of statin was also not assessed by any of the studies.
Vitamin D supplementation in patients with mild-moderate vitamin D insufficiency was associated with improvement of SAMS. However, quantitative efficacy analysis was not possible and this observed association is likely confounded by nocebo and placebo effects. RCTs are required to conclusively assess the utility of vitamin D supplementation in improving SAMS.
尽管维生素 D 水平低与他汀类药物相关的肌肉症状（SAMS）有关，但目前尚不清楚维生素 D 补充是否会导致症状改善。
我们进行了一项系统评价，以评估维生素 D 补充与 SAMS 缓解的关系。
我们检索了 Medline（PubMed）、Embase 和 Cochrane Library，直到 2021 年 12 月 12 日。纳入了报告 SAMS 成年患者维生素 D 补充与 SAMS 之间关系的全文文章。
我们确定了 8 项干预性研究，共纳入 669 名参与者。大多数参与者为白种人，参与者的平均年龄为 59.5 至 64.8 岁。研究招募的患者初始平均治疗前维生素 D 水平为 17.8 至 22.0ng/ml。随访时间从 2 到 24 个月不等，平均治疗后维生素 D 水平为 34.3 至 56.0ng/ml。我们发现，在 7 项报告补充后患者数量的研究中，维生素 D 补充与 606 名患者中的 509 名（83.9%）患者的他汀类药物耐受性改善相关（95%CI=0.81-0.87，I2=72%，n=7）。这些研究均非随机对照试验（RCTs），因此不能排除维生素 D 的安慰剂效应。也没有研究评估他汀类药物的反安慰剂效应。
在轻度至中度维生素 D 不足的患者中补充维生素 D 与 SAMS 的改善有关。然而，无法进行定量疗效分析，这种观察到的关联可能受到反安慰剂和安慰剂效应的影响。需要 RCT 来明确评估维生素 D 补充改善 SAMS 的效用。
