Universidad Autónoma de Nuevo León, Rheumatology Service, Hospital Universitario "Dr. José Eleuterio González", Universidad Autónoma de Nuevo León, Ave. Gonzalitos 235 Norte, Colonia Mitras Centro, Monterrey, Nuevo León, 64020, México.
School of Public Health and Nutrition, Universidad Autónoma de Nuevo León, Ave. Dr. Eduardo Aguirre Pequeño 905, Colonia Mitras Centro, Monterrey, N.L, 64460, México.
Clin Rheumatol. 2021 Aug;40(8):3257-3264. doi: 10.1007/s10067-021-05640-8. Epub 2021 Feb 10.
FM is a chronic musculoskeletal disorder characterized by the presence of generalized pain. There are contradictory results regarding the prevalence and supplementation effect of vitamin D deficiency on FM patients. We aim to determine the safety and efficacy of a 12-week vitamin D supplementation on FM patients.
We conducted a randomized, placebo-controlled, double-blind clinical trial. We included female participants of 18 years old or older, who met 1990 or 2010 ACR criteria for fibromyalgia. The Spanish validated FIQ and the VAS of pain were applied at baseline. The participants were then randomized to receive placebo or 50,000 IU of Vitamin D PO, weekly for 12 weeks.
We included 80 patients. There was no statistical difference in the initial and final FIQ between both groups. The FIQ delta also did not prove to be different at the end of the study. The increase in vitamin D levels in the intervention group was corroborated. Regarding serious adverse effects, none was reported in both groups. There was no statistical difference in minor adverse events.
In this double-blind placebo-controlled randomized study conducted to measure the efficacy and safety of vitamin D exclusively in patients with FM, we found that there is no evidence of a trend in favor of vitamin D treatment, since we did not observe improvement in the VAS of pain or FIQ.
Clinical Trials.gov number: NCT03369379 Key Points • There are conflicting results in vitamin D to treat fibromyalgia. • In this double-blind, randomized controlled trial, we did not find a difference in the VAS nor FIQ with vitamin D supplementation. • The increase in vitamin D levels in the intervention group was corroborated.
纤维肌痛（FM）是一种慢性肌肉骨骼疾病，其特征为全身疼痛。目前，关于维生素 D 缺乏症在 FM 患者中的流行程度和补充效果存在相互矛盾的结果。我们旨在确定为期 12 周的维生素 D 补充对 FM 患者的安全性和疗效。
我们进行了一项随机、安慰剂对照、双盲临床试验。我们纳入了年龄在 18 岁或以上的女性参与者，这些参与者符合 1990 年或 2010 年 ACR 纤维肌痛标准。在基线时应用了西班牙验证的 FIQ 和疼痛 VAS。然后，参与者被随机分为接受安慰剂或 50,000IU 的维生素 D 口服，每周一次，持续 12 周。
我们纳入了 80 名患者。两组在初始和最终 FIQ 之间没有统计学差异。研究结束时，FIQ 差值也没有差异。干预组的维生素 D 水平升高得到了证实。关于严重不良事件，两组均未报告。轻微不良事件也没有统计学差异。
在这项专门针对 FM 患者的维生素 D 疗效和安全性进行的双盲安慰剂对照随机研究中，我们发现没有证据表明维生素 D 治疗有趋势，因为我们没有观察到疼痛 VAS 或 FIQ 的改善。
ClinicalTrials.gov 编号：NCT03369379
关键点
• 关于维生素 D 治疗纤维肌痛的结果存在争议。
• 在这项双盲、随机对照试验中，我们没有发现维生素 D 补充在 VAS 或 FIQ 方面有差异。
• 干预组的维生素 D 水平升高得到了证实。
