Acupuncture in Chronic Migraine: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Mean monthly number of headache days with moderate or severe intensity
研究概览
简要总结
The aim of this study was to investigate the efficacy and tolerance of acupuncture treatment compared with pharmacologic treatment in patients with chronic migraines.Besides, the investigators tested whether the clinical effects of acupuncture in chronic migraine prophylaxis are mediated by changes of the plasma CGRP (Calcitonin gene-related peptide).
详细描述
Subjects who completed the prospective baseline periods and meet met the prespecified entry criteria will be randomized into 2 groups: acupuncture treatment, and topiramate treatment group.
Subjects will be allowed to continue taking acute migraine medications for the treatment of breakthrough attacks during the trial, but any migraine preventive medications will be prohibited.
Written informed consent was obtained from all participants before entering the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18 to 75 years old
- •Patients were required to have a diagnosis of chronic migraine with or without medication overuse that satisfied the ICHD-2 criteria during the last 3 months prior to trial entry, with an established migraine history for at least 1 year.
排除标准
- •Patients did not fulfill the criteria of ≧ 15 days or response to triptans or ergots on at least 8 days in prospective baseline periods .
- •The presence of headaches other than chronic migraine (such as another primary chronic headache or any secondary headache).
- •Migraine prophylaxis agents during last 3 months including β-blockers, anti-depressants, calcium channel blockers, anti-epileptic agents or cycle-modulating hormonal drugs.
- •Migraine onset after age 50 or the age at onset of CM > 60 years.
- •History of hepatic disorder, nephrolithiasis or other severe illness.
- •Cognitive impairment interfering with the subject's ability to follow instructions and describe symptoms.
- •Prior fearful experience of acupuncture.
- •Bleeding diathesis or anticoagulation.
- •Pregnant or nursing.
研究组 & 干预措施
acupuncture
干预措施: acupuncture (Procedure)
topiramate
干预措施: topiramate (Drug)
结局指标
主要结局
Mean monthly number of headache days with moderate or severe intensity
时间窗: 3 months
a day with headache pain that lasts ≧ 4 h with peak severity of moderate or severe intensity, or any severity or duration if the subject takes and response to a triptan or ergot.
次要结局
- Reduction from baseline in the use of acute headache medications(3 months)
- Short-Form 36-Item Health Survey(SF-36)(3 months)
- Beck Depression Inventory(BDI)(3 months)
- ≥ 30% or ≥ 50% reduction in mean monthly headache days with moderate or severe intensity(3 months)
- Mean monthly total headache days(3 months)
- Migraine disability assessment questionnaire (MIDAS)(3 months)
- Plasma CGRP level(3 months)
研究者
Chun-pai Yang
MD
Kuang Tien General Hospital