Pre- and Post-Treatment Investigation of B12 and Folic Acid (Folate) Levels in Patients Receiving Antiepileptic (Anticonvulsant) Treatment for Fibromyalgia: Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Vitamin B12 level analysed before treatment (pre-treatment) (retrospective)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients receiving vitamin B12 and folic acid therapy at the time of antiepileptic (anticonvulsant) drugs initiation, patients with hepatic and renal insufficiency
结局指标
主要结局
Vitamin B12 level analysed before treatment (pre-treatment) (retrospective)
时间窗: Within 1 month
Vitamin B12 level (pg/mL) among the laboratory parameters analysed before antiepileptic treatment (pre-treatment) for fibromyalgia will be screened retrospectively. Patients who applied to the physical medicine and rehabilitation clinic with a diagnosis of fibromyalgia in the last 6 months (June-December 2024) before the ethics committee application date, who were followed up with this diagnosis and started antiepileptic treatment will be screened within 1 month.
Vitamin B12 level analysed after treatment (post-treatment) (retrospective)
时间窗: Within 1 month
Vitamin B12 level (pg/mL) among the laboratory parameters analysed after antiepileptic treatment (post-treatment) for fibromyalgia will be screened retrospectively. Patients who applied to the physical medicine and rehabilitation clinic with a diagnosis of fibromyalgia in the last 6 months (June-December 2024) before the ethics committee application date, who were followed up with this diagnosis and started antiepileptic treatment will be screened within 1 month.
Folic acid level analysed before treatment (pre-treatment) (retrospective)
时间窗: Within 1 month
Folic acid level (ng/mL), one of the laboratory parameters analysed before antiepileptic treatment for fibromyalgia (pre-treatment), will be screened retrospectively. Patients who applied to the physical medicine and rehabilitation clinic with a diagnosis of fibromyalgia in the last 6 months (June-December 2024) before the ethics committee application date, who were followed up with this diagnosis and started antiepileptic treatment will be screened within 1 month.
Folic acid level analysed after treatment (post-treatment) (retrospective)
时间窗: Within 1 month
Folic acid level (ng/mL), one of the laboratory parameters analysed after antiepileptic treatment for fibromyalgia (post-treatment), will be screened retrospectively. Patients who applied to the physical medicine and rehabilitation clinic with a diagnosis of fibromyalgia in the last 6 months (June-December 2024) before the ethics committee application date, who were followed up with this diagnosis and started antiepileptic treatment will be screened within 1 month.
次要结局
- 25-OH Vitamin D level analysed before treatment (pre-treatment) (retrospective)(Within 1 month)
- 25-OH Vitamin D level analysed after treatment (post-treatment) (retrospective)(Within 1 month)