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

Abstract

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.

Combined metabolomics and transcriptomics analysis of rats under neuropathic pain and pain-related depression

“…Our results showed a significant increase in indole sulfate, 5-hydroxy indole-3-acetic acid, 3hydroxy anthranilic acid, xanthine and uric acid in the ACC after peripheral nerve injury, which was consistent with most studies. Furthermore, deficiencies in pantothenic acid and vitamin B6 have been associated with pro-inflammatory responses and various symptoms, including arthritic pain, depression, and insomnia (Ueland et al, 2017;Menzies et al, 2021;Ghavidel-Parsa et al, 2022). In line with this, our results demonstrated decreased levels of panthenol and PNP (a form of vitamin B6) in the ACC following peripheral nerve injury.…”

The Role of VARVIMAX™ In the Treatment of Chronic Inflammation and Pain in Arthritis and Fibromyalgia

“…Patients with rheumatoid arthritis who were supplemented with vitamin B6 experienced lower levels of IL-6 and TNF-α in their serum, and vitamin B6 has been shown to suppress IL-1β production [49]. A "randomized controlled trial" evaluating the efficacy of fibromyalgia provided opposite results [50]. According to this study, there was no notable distinction observed in the treatment of fibromyalgia between placebo and vitamin B6.…”

Nutrition and Chronobiology as Key Components of Multidisciplinary Therapeutic Interventions for Fibromyalgia and Associated Chronic Fatigue Syndrome: A Narrative and Critical Review

“…Vitamin B12 also improved anxiety scores. The authors postulate that vitamin B12 has a strong potential to be considered at least an adjunctive therapy in FM [114]. Frequent injections of high-concentrate vitamin B12 combined with individual daily doses of oral folic acid may result in blood saturations high enough to provide relief in a subgroup of patients with FM and/or CFS (Regland et al, 2015).…”