Effect of Milnacipran Versus Gabapentin or Combination of Both in Fibromyalgia Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Visual analogue scale (VAS) for pain
研究概览
简要总结
Gabapentin and milnacipran (MLN) show strong evidence of reduced pain, increased sleep, and improvement in the quality of life in fibromyalgia (FM) patients.
Most FM trials focus primarily on pain reduction with monotherapy. Polypharmacy is commonly used, but supportive evidence is limited.
The gabapentin-MLN combined therapy may be more effective in female patients with FM than their monotherapy.
详细描述
The aim of the study is to evaluate the analgesic efficacy of gabapentin-MLN as combined or monotherapy on patients with FM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •There are no other criteria rather than age and sex
排除标准
- •Patient refusal.
- •Pregnancy or breastfeeding.
- •Active liver disease
- •Renal impairment (creatinine clearance < 60 mL/min).
- •Documented autoimmune disease.
- •Severe chronic obstructive pulmonary disease.
- •Recent arrhythmia
- •Myocardial infarction
- •Uncontrolled hypertension.
- •Glaucoma.
研究组 & 干预措施
Milnacipran
Patients will receive Milnacipran as a mono-therapy will be administered in increment doses for 3 months
干预措施: Milnacipran (Drug)
Gabapentin
patients will receive Gabapentin as a mono-therapy will be administered in increment doses for 3 months
干预措施: Gabapentin (Drug)
Combined gabapentin/milnacipran
Patients will receive combined gabapentin and milnacipran as a combination therapy will be administered in increment doses for 3 months
干预措施: Combined gabapentin/milnacipran (Drug)
结局指标
主要结局
Visual analogue scale (VAS) for pain
时间窗: 3 months
Assesses the overall pain of fibromyalgia on a 10 cm pain scale with 0 indicating no pain and 10 indicating the worst pain ever
次要结局
- The Fibromyalgia Impact Questionnaire (FIQ).(3 months)
- Leeds Sleep Evaluation Questionnaire(3 months)