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

Gaziosmanpasa Research and Education Hospital

Status: Completed

Conditions: Vitamin B 12 Deficiency; Fibromyalgia (FM); Folic Acid Deficiency

Study type: Observational

Funder types: Other

Identifiers

NCT07013305

03

Details and patient eligibility

About

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).

Full description

After the acceptance of the study (after obtaining ethics committee approval), patients who have been followed up for at least 6 months in the physical medicine and rehabilitation outpatient clinic with a diagnosis of fibromyalgia and who use pregabalin will be evaluated retrospectively (1-year records). Blood vitamin B12 and folate (folic acid) levels of the patients before and after antiepileptics (anticonvulsants). use will be determined. Patients will be evaluated whether there is a change in vitamin B12 and folic acid levels due to antiepileptics (anticonvulsants) drug use.

Enrollment: 104 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18-75 years who have been diagnosed with fibromyalgia, whose vitamin B12 and folic acid levels have been analysed, who do not receive vitamin B12 and folic acid treatment, and who do not have diabetes mellitus, liver and kidney failure

Exclusion criteria

• Patients receiving vitamin B12 and folic acid therapy at the time of antiepileptic (anticonvulsant) drugs initiation, patients with hepatic and renal insufficiency