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

Banafsheh Ghavidel-Parsa; Arvin Naeimi; Faeze Gharibpoor; Nazila Sattari; Atefeh Jafari; Irandokht Shenavar Masooleh; Ali Montazeri

doi:10.1186/s12891-022-05637-7

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

BMC Musculoskelet Disord. 2022 Jul 13;23(1):664. doi: 10.1186/s12891-022-05637-7.

Authors

Banafsheh Ghavidel-Parsa¹, Arvin Naeimi², Faeze Gharibpoor³, Nazila Sattari², Atefeh Jafari⁴, Irandokht Shenavar Masooleh¹, Ali Montazeri⁵

Affiliations

¹ Rheumatology Research Center, Razi Hospital, School of Medicine, Guilan University of Medical Science, Rasht, Iran.
² Student Research Committee, Deputy of Research and Technology, Guilan University of Medical Sciences, Namjoo St, Rasht, 41446-66949, Guilan, Iran.
³ Student Research Committee, Deputy of Research and Technology, Guilan University of Medical Sciences, Namjoo St, Rasht, 41446-66949, Guilan, Iran. faezegharibpoor@gmail.com.
⁴ Department of Clinical Pharmacy, School of Pharmacy, Guilan University of Medical Sciences, Rasht, Iran.
⁵ Population Health Research Group, Health Metrics Research Center, Iranian Institute for Health Sciences Research, ACECR, Tehran, Iran.

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.

Keywords: Fibromyalgia; Pain; Pyridoxine; Vitamin B6.

Publication types

Randomized Controlled Trial

MeSH terms

Double-Blind Method
Fibromyalgia* / diagnosis
Fibromyalgia* / drug therapy
Humans
Iran
Pain / drug therapy
Pain / etiology
Severity of Illness Index
Treatment Outcome
Vitamin B 6 / therapeutic use

Substances

Vitamin B 6