Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly? A Randomized Multi-centre Follow-up.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Headache Days
研究概览
简要总结
It is a common belief that patients with MOH rarely respond of preventative medications whilst overusing acute medications. However, no randomized trial has been done previously to prove such statement. Based on some clinical experiences, our hypothesis are patients with probably MOH may benefit from use of preventive medications better than treatment with abrupt withdrawal or no specific treatment.
详细描述
This randomized multi-centre study started January 2004, and patients with probably MOH have been included from five different University hospitals in Norway. The last patient was included November 9th 2006, final inclusion date was December 31th 2006. At this time a total of 64 patients with probable MOH according to the International Classification of Headache Disorders, 2nd Edition (2004) were included.
The included patients were randomized to one out of three possible options:
- Abrupt withdrawal of the acute medication(s) they have been overusing. After 3 month: use of preventative medication (best choice)in those who need such treatment, 12 month follow-up.
- Start with preventative medication (best choice) directly without abrupt withdrawal, 12 month follow-up.
- No specific treatment (controls), 5 month follow-up.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fulfill 8.2.7 probably medication-overuse headache according to the International Classification of Headache Disorders, 2th Edition (2004)
排除标准
- •No benefit of all available preventative medications
- •no benefit of abrupt withdrawal lasting more than 3 weeks of acute medication that has been overused
- •cluster headache
- •chronic paroxysmal hemicrania
- •hemicrania continua, pregnancy
- •use of pain killers for other reasons than headache
- •other reasons for chronic daily headache than medication-overuse
研究组 & 干预措施
Prophylaxis from the start
Use of preventive drugs from the start without abrupt withdrawal
干预措施: Betablockers or other preventive drugs based on primary headache type (Drug)
Abrupt withdrawal
Device: Abrupt withdrawal. Standard out-patients detoxication program including telephone call after 2 weeks and rescue medicine up to 2 days/week
干预措施: Betablockers or other preventive drugs based on primary headache type (Drug)
Controls
Active control: No instruction for abrupt withdrawal or prophylactic treatment. The controls finished the study period after 5 months observation, and were then offered the optimal type of treatment
干预措施: Betablockers or other preventive drugs based on primary headache type (Drug)
结局指标
主要结局
Headache Days
时间窗: 5 month
Change in Headache days per month
次要结局
- Headache Index(5-month follow-up)