Evaluation of the Efficiacy of Mecobalamine in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia

Evaluation of the Efficiacy of Mecobalamine in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia

Evaluation of the Efficiacy of Mecobalamine (Vit B12) in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia: Single-blind Randomized Controlled Trial With Three-month Follow up

Fibromyalgia causes long term pain where mostly women are affected. It is not entirely clear how vitamin B12 affects the human pain system, there are however many primary studies that indicate different interesting approaches. Considering that the receptor of NMDA is involved in both long-term pain and vitamin B12 deficiency its of most importance to evaluate whether vitamin B12 decreases the pain sensitivity and the experience of pain i.e hyperalgesia and allodynia, at persons with fibromyalgia.The aim of this study is therefore to evaluate the effect of Mecobalamin (vitamin B12), and describe lived experiences of pain, health, suffering and well-being in women with diagnosed fibromyalgia.

The active substance of vitamin B12 given in the study is Mecobalamin 5mg / ml 2 ml ie 10 mg and is given intramuscularly.

Placebo substance given in the study is Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) given intramuscularly.

Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) is given intramuscularly.

Pain experience measured by a pressure algometry test performed on the shoulder, hip, knee and elbow.

Possible pain change measured by a pressure algometry test performed on the shoulder, hip, knee and elbow.

Subjective experience of pain measured using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome .

Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome.

Ratings of expectation, pain variability, using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome.

Activity level are assessed using questionnaire McGills Pain Questionnarie (MPQ). Short version score 0-45.

Experience of the effect of the drug, assessed using questionnaire Patients´ Global Impression of Change (PGIC).

Qualitative in-depth interviews will be conducted to capture women's lived experiences of pain, health, suffering and well-being.

Inclusion Criteria: Women aged 20-70 years Swedish-speaking Diagnosis of fibromyalgia Safe method of contraception Cobalamin / p (vitamin B12) should be >250 pmol/L < 800 pmol/L Given consent to participate. Exclusion Criteria: Previous treatment with B12 Known hypersensitivity to the active substance Mecobalamin or an additive Vegan as veganism can lead to B12 deficiency Neuroleptics Known heart, kidney or liver disease Reynaud's phenomenon (white fingers) Known neuropathy (impaired sensation) Breastfeeding Pregnancy or plan pregnancy