Pre- and Post-Treatment Investigation of B12 and Folic Acid (Folate) Levels in Patients Receiving Antiepileptic (Anticonvulsant) Treatment for Fibromyalgia: Retrospective Study

Fibromyalgia is a rheumatological disorder characterised by chronic widespread body pain, second most common after osteoarthritis. The overall prevalence is 2-8% and it is more common in women. Diffuse body pain, fatigue, sleep and cognitive dysfunction occur. The etiology of fibromyalgia is multifactorial and occurs due to central and peripheral pain mechanisms that occur with neuroendocrine imbalance due to psychological and physical stress in people with genetic predisposition. The diagnostic criteria for fibromyalgia were updated by the American College of Rheumatology in 2016 to include a widespread body pain scale and a symptom severity scale. Fibromyalgia treatment consists of drug (antidepressants and antiepileptics) and non-drug treatments. Pregabalin is also used in the treatment of epilepsy by blocking and modulating the α2 δ subunit of voltage-dependent calcium channels. There are studies showing that antiepileptics cause folate and vitamin B12 deficiency in epilepsy patients. In our study, we aimed to retrospectively investigate vitamin B12 and folic acid levels before and after treatment in patients with fibromyalgia using antiepileptics (anticonvulsants).

NCT Number	NCT07013305
Lead Sponsor	Gaziosmanpasa Research and Education Hospital
Conditions	Fibromyalgia (FM), Vitamin B 12 Deficiency, Folic Acid Deficiency
Enrollment	104 participants
Start Date	2025-06-11
Primary Completion	2025-06-25 (estimated)
Study Completion	2025-07-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-26