Gharibpoor Faeze, Ghavidel-Parsa Banafsheh, Sattari Nazila, Bidari Ali, Nejatifar Fatemeh, Montazeri Ali
Student Research Committee, Faculty of Medicine, Guilan University of Medical Sciences, Rasht, Iran.
Department of Rheumatology, School of Medicine, Rheumatology Research Center, Razi Hospital, Guilan University of Medical Science, Sardar Jangal St, Rasht, 41448-95655, Guilan, Iran.
BMC Rheumatol. 2022 Sep 1;6(1):51. doi: 10.1186/s41927-022-00282-y.
Fibromyalgia (FM) as a prototypical nociplastic pain condition displays a difficult therapeutic situation in many cases. Given the promising data on the effect of vitamin B12 in improving pain and cognitive functions in various nociplastic pain conditions, we aimed to determine the efficacy of 1000 mcg daily dose of oral vitamin B12 on the symptom severity and psychological profile of FM patients.
This open-label, pre-post study was performed on FM patients whose diagnoses were confirmed by a rheumatologist based on the 2016 American College of Rheumatology (ACR). Patients were instructed to take a daily dose of 1000mcg vitamin B12 for fifty days. Outcome measures including the Revised Fibromyalgia Impact Questionnaire (FIQR), Hospital Anxiety and Depression Scale (HADS), 12-item Short-Form health survey (SF-12), and pain Visual Analog Scale (pain-VAS) were fulfilled by patients before and after the treatment.
Of 30 eligible patients, 28 patients completed the study protocol. Patients were female with a mean age of 47.50 ± 8.47 years. FIQR scores in all domains improved significantly after treatment (total FIQR: 49.8 ± 21.86 vs 40.00 ± 18.36, p value < 0.01; function: 13.17 ± 7.33 vs 10.30 ± 5.84, p value: 0.01; overall: 10.32 ± 6.22 vs 8.25 ± 6.22, p value: 0.03; symptoms: 26.30 ± 10.39 vs 21.44 ± 8.58, p value < 0.01). Vitamin B12 also improved anxiety scores from 9.33 ± 4.30 to 7.70 ± 3.60, p value: 0.01. Depression, pain-VAS, and SF-12 didn't improve following the treatment. The Generalized estimating equations (GEE) analysis showed the improvement in total FIQR score is not cofounded by the improvement of anxiety and patients' baseline characteristics.
This study showed a short course of sublingual vitamin B12, 1000 mcg daily, significantly improves the severity of FM and anxiety score. We postulate that vitamin B12 has a strong potential to consider, at least, as adjunctive therapy of FM.
The study protocol was approved by the ethics committee of Guilan University of Medical Sciences (IR.GUMS.REC.1400.197) in accordance with the World Medical Association's code of ethics (Declaration of Helsinki, revised in Brazil 2013), and registered at an ICMJE and WHO recognized registry of clinical trials ( www.irct.ir ) on 28/08/2021 (registration number: IRCT20200920048782N1).
纤维肌痛（FM）作为一种典型的神经病理性疼痛疾病，在许多情况下治疗情况棘手。鉴于维生素B12在改善各种神经病理性疼痛疾病的疼痛和认知功能方面有可观的数据，我们旨在确定每日口服1000微克维生素B12对FM患者症状严重程度和心理状况的疗效。
本开放标签的前后对照研究针对经风湿病学家根据2016年美国风湿病学会（ACR）标准确诊的FM患者进行。患者被指导每日服用1000微克维生素B12，持续50天。治疗前后，患者完成包括修订的纤维肌痛影响问卷（FIQR）、医院焦虑抑郁量表（HADS）、12项简短健康调查问卷（SF - 12）以及疼痛视觉模拟量表（疼痛 - VAS）等结局指标的评估。
30名符合条件的患者中，28名完成了研究方案。患者均为女性，平均年龄47.50±8.47岁。治疗后FIQR各领域得分均显著改善（FIQR总分：49.8±21.86 vs 40.00±18.36，p值<0.01；功能：13.17±7.33 vs 10.30±5.84，p值：0.01；总体：10.32±6.22 vs 8.25±6.22，p值：0.03；症状：26.30±10.39 vs 21.44±8.58，p值<0.01）。维生素B12还将焦虑得分从9.33±4.30改善至7.70±3.60，p值：0.01。治疗后抑郁、疼痛 - VAS和SF - 12未改善。广义估计方程（GEE）分析显示，总FIQR得分的改善并非由焦虑改善和患者基线特征所混淆。
本研究表明，每日1000微克的舌下含服维生素B12短疗程可显著改善FM的严重程度和焦虑得分。我们推测维生素B12至少有很大潜力作为FM的辅助治疗方法。
本研究方案经吉兰医科大学伦理委员会（IR.GUMS.REC.1400.197）按照世界医学协会伦理准则（2013年在巴西修订的《赫尔辛基宣言》）批准，并于2021年8月28日在ICMJE和WHO认可的临床试验注册机构（www.irct.ir）注册（注册号：IRCT20200920048782N1）。
