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Effect of vitamin B6 on pain, disease severity, and psychological profile of fibromyalgia patients; a randomized, double-blinded clinical trial.

  • 2022-07-13
  • BMC musculoskeletal disorders 23(1)
    • Banafsheh Ghavidel-Parsa
    • Arvin Naeimi
    • Faeze Gharibpoor
    • Nazila Sattari
    • Atefeh Jafari
    • Irandokht Shenavar Masooleh
    • Ali Montazeri

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 90
Population
FM patients whose diagnosis was confirmed by a rheumatologist based on the 2016 American College of Rheumatology (ACR)
Methods
randomized, double-blinded, placebo-controlled trial, 80 mg daily vitamin B6 or placebo in a 1:1 ratio
Blinding
Double-blind

Background

Given the role of vitamin B6 on pronociceptive/antinociceptive neurotransmitters balance, metabolic reactions, and inflammation, it is important to clarify the effect of vitamin B6 on pain and psychological disturbance in fibromyalgia (FM). This study aimed to evaluate whether an 80-mg daily dose of vitamin B6 improves pain, disease severity and psychological symptoms of FM compared to a placebo.

Methods

This randomized, double-blinded, placebo-controlled trial was performed on the FM patients whose diagnosis was confirmed by a rheumatologist based on the 2016 American College of Rheumatology (ACR). 90 Patients were randomized to receive either vitamin B6 (80 mg daily) or placebo in a 1:1 ratio, with a permuted block size of 30 stratified by disease severity. Primary outcomes included 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)). The mean differences in outcomes (before and after treatment) were compared between the vitamin B6 and placebo groups using an independent T-test. An ANCOVA model adjusted for baseline outcome value was also provided to compare the outcomes between the two groups.

Results

Of 90 eligible patients, 60 patients (31 patients in vitamin B6 and 29 in the placebo group) completed the trial. Overall, the FIQR, pain-VAS, and HADS-anxiety scores improved after treatment in both vitamin B6 and placebo groups; However, there was no statistically significant intergroup difference regarding primary outcomes. ANCOVA model also showed no difference in the treatment effects.

Conclusions

Our results showed no priority for vitamin B6 over placebo in FM patients. Considering the potential ameliorating role of vitamin B6 on pain and psychological symptoms, acknowledgment of vitamin B6 as a relatively safe adjuvant treatment needs larger future studies.

Trial registration

Iranian Registry of Clinical Trials: IRCT20200920048782N2 on 2021/10/04.

Research Insights

  • Vitamin B6→Improved Fibromyalgia Impact

    there was no statistically significant intergroup difference regarding primary outcomes

    Effect
    Neutral
    Effect size
    Small
    Dose
    80 mg daily
  • Vitamin B6→Reduced Anxiety

    there was no statistically significant intergroup difference regarding primary outcomes

    Effect
    Neutral
    Effect size
    Small
    Dose
    80 mg daily
  • Vitamin B6→Reduced Pain

    there was no statistically significant intergroup difference regarding primary outcomes

    Effect
    Neutral
    Effect size
    Small
    Dose
    80 mg daily
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