Effect of vitamin B12 on the symptom severity and psychological profile of fibromyalgia patients; a prospective pre-post study

Abstract

Background 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. Methods 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. Results 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. Conclusions 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. Trial registration 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).

What Do We Know about Nociplastic Pain?

“…Nonetheless, qualitative sensory tests have also been mentioned as a method of assessing NcplP in orofacial pain conditions [ 41 ]. Some inconsistency can be noted when comparing different diagnostic criteria for pain assessment in fibromyalgia, i.e., the 1990 American College of Rheumatology (ACR) criteria [ 32 , 42 ], the 2011 ACR Fibromyalgia Survey criteria [ 15 , 20 , 38 , 43 , 44 , 45 ], and the 2016 ACR criteria [ 33 , 37 , 46 , 47 ].…”

Efficacy of mecobalamin (vitamin B12) in the treatment of long-term pain in women diagnosed with fibromyalgia: protocol for a randomised, placebo-controlled trial

“… 17 A recent study showed that sublingual vitamin B 12 had positive effect on patients with fibromyalgia. 18 …”

“…Vitamin B 12 nasal drops have been tested with positive results on patients with myalgic encephalomyelitis (ME)/chronic fatigue (CF)/fibromyalgia (ME/CF syndrome) 17. A recent study showed that sublingual vitamin B 12 had positive effect on patients with fibromyalgia 18…”

A web-based educational therapy intervention associated with physical exercise to promote health in fibromyalgia in Brazil: the Amigos De Fibro (Fibro Friends) study protocol

“…Studies also point to the presence of fibromyalgia in men [ 4 – 6 ]. Although the prevalence of fibromyalgia does not have the same notoriety as other rheumatologic conditions, its annual economic impact is considered very high [ 7 , 8 ]. People diagnosed with fibromyalgia also make greater use of health services, especially in medical consultations in primary care and specialized care in several countries [ 1 , 9 ].…”