Pre- and Post-Treatment Investigation of B12 and Folic Acid (Folate) Levels in Patients Receiving Antiepileptic (Anticonvulsant) Treatment for Neuropathic Pain: Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 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
Neuropathic pain (NeP) is a disorder of the nervous system resulting from altered mechanisms operating at the peripheral nervous system, spinal cord and supraspinal levels and is defined by the International Association for the Study of Pain as pain resulting from nervous system pathologies that cause changes in the function, chemistry and structure of neurons . NeP affects 2-8% of the world population and can have a significant impact on the patient's functional abilities and quality of life. NeP can be caused by spinal cord injury, brain and spinal cord tumours and other diseases affecting the nervous system. NeP can be secondary to extremely common conditions such as diabetes, stroke, cancer, herpes zoster virus infection and autoimmune disease. These recommendations were finalised in 2019 and published in April 2020. Following the GRADE system, the recommendations suggest first-line treatment options including serotonin-noradrenaline reuptake inhibitors (duloxetine and venlafaxine), gabapentin, tricyclic antidepressants, and the specialised use of topical lidocaine and transcutaneous electrical nerve stimulation for peripheral neuropathic pain. Pregabalin, tramadol and combination therapy (combining antidepressants with gabapentinoids) are recommended as second-line treatments. Highly concentrated capsaicin patches and botulinum toxin A are recommended as second-line treatments, especially for focal peripheral neuropathic pain. Third-line treatment options include high-frequency repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex (motor cotex-1/M1), spinal cord stimulation (for failed back surgery syndrome and painful diabetic polyneuropathy) and strong opioids as a last resort in the absence of alternatives. In addition, psychotherapy, including cognitive behavioural therapy and mindfulness, is recommended as second-line treatment in combination with other therapies.
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 analyse vitamin B12 and folic acid levels before and after treatment in patients using antiepileptics (anticonvulsants) for neuropathic pain.
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 neuropathic pain 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 pregabalin use will be determined. Patients will be evaluated whether there is a change in vitamin B12 and folic acid levels due to 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-90 years who have been diagnosed with neuropathic pain, 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 neuropathic pain will be screened retrospectively. Patients who applied to the physical medicine and rehabilitation clinic with a diagnosis of neuropathic pain 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 neuropathic pain will be screened retrospectively. Patients who applied to the physical medicine and rehabilitation clinic with a diagnosis of neuropathic pain 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 neuropathic pain (pre-treatment), will be screened retrospectively. Patients who applied to the physical medicine and rehabilitation clinic with a diagnosis of neuropathic pain 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 neuropathic pain (post-treatment), will be screened retrospectively. Patients who applied to the physical medicine and rehabilitation clinic with a diagnosis of neuropathic pain 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)