Study of the effect of B1, B6 and B12 vitamins combination on pain and somatic symptoms in patient with fibromyalgia.

The purpose of this study is to investigate the effect of the combination of vitamins B1, B6 and B12 on pain and physical symptoms of patients with fibromyalgia.

Phase 3 clinical trial with placebo control group, double-blind and randomized with 4 permutation blocks method, with a total sample size of64.

This study will be conducted in subspecialty clinic of Razi hospital of Rasht under a rheumatology specialist. Diagnosis of patients is based on ACR 2010. All patients will complete and sign informed consent, then the patients will be randomized into two groups using Permuted block randomization. Patients will complete the inventories of visual analog scale, revised fibromyalgia impact questionnaire and 12item short form health survey at the beginning of the study and 1 month later. All data will be analyzed by special statistical software.

Inclusion criteria: Patients must meet the American College of Rheumatology criteria for fibromyalgia (ACR2010). A rheumatologist confirms diagnosis of fibromyalgia. Exclusion criteria: Age younger than 18 or older than 70 years old Pregnancy. Cases of chronic liver disease, severe renal failure Breast feeding History of sensitivity to B1 vitamin, B6 vitamin and B12 vitamin Consumption of group B Vitamin supplements

The intervention group will receive a combination pill containing vitamins B1, B6 and B12 once a day for one month, and the control group will receive a placebo similar to the mentioned pill once a day for one month.

Disease severity, pain intensity and quality of life in patients with fibromyalgia

In order to avoid bias in the selection of patients, the sequencing and distribution of patients into groups A and B is done by Statistics. Then, the type of intervention or placebo of groups A and B is done by someone outside the team of evaluators and analysts. To randomize people in two groups, the method of 4 permutation blocks is used. Considering group A and group B, the randomization process will be as follows. Randomization was done with SAS version 9 software. Seed: 67563107250670 Block sizes: 4 Actual list length: 64 block identifier, block size, sequence within block, treatment • 1, 4, 1, Group B • 1, 4, 2, Group A • 1, 4, 3, Group B • 1, 4, 4, Group A • 2, 4, 1, Group A • 2, 4, 2, Group B • 2, 4, 3, Group B Considering that the current study is double-blind, and the drug and placebo are presented to the performers and patients in similar and non-transparent envelopes, interventional concealment or the fact that groups A and B are placebos means that the allocation is concealed. For this purpose, the choice of intervention or placebo group A and B is done after distributing the names of the patients and by a person who is not aware of the sequence.

In this study, in order to avoid bias in the selection of patients, the sequencing and distribution of patients into groups A and B is done by Statistics specialist. Then the type of intervention or placebo group A and B is done by someone outside the team of evaluators and analysts. Also, a colleague outside the group of plan executives, evaluators and analysts is asked to pack the original drug and the placebo, which have the same appearance and quality, in the amount needed for one month (60 pieces) in exactly the same envelopes, dark and closed. place and name them as A and B according to the type of intervention or placebo, and give them to the project managers. In this way, neither the people under study nor the presenters and analysts know about the intervention and placebo groups.