Acupuncture in Chronic Migraine: A Randomized Controlled Trial
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Acupuncture in Chronic Migraine: A Randomized Controlled Trial|
- Mean monthly number of headache days with moderate or severe intensity [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
- ≥ 30% or ≥ 50% reduction in mean monthly headache days with moderate or severe intensity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Mean monthly total headache days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Reduction from baseline in the use of acute headache medications [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Short-Form 36-Item Health Survey(SF-36) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Beck Depression Inventory(BDI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Migraine disability assessment questionnaire (MIDAS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Plasma CGRP level [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Each patient had a fixed and classic acupuncture points Ex-HN-3,BL-2,GB-20,EX-HN-5 bilaterally in their 24 sessions.
Acupuncture consisted of 24 sessions of 30 min duration, administrated over 12 weeks (two sessions per week).
Sterile disposable and steel needle (3210) were used .
The needles were manipulated by rotation methods to produce a characteristic sensation know as De Qi.
|Active Comparator: topiramate||
The patients were submitted to the topiramate treatment also for 12 consecutive weeks.
The study phase consists of a 4-week titration and a 8-week maintenance period.
All dosages of topiramate will be initiated at 25 mg/d hs and increased by 25 mg/d weekly to a maximum of 100 mg/day (or to the maximal tolerated dose).
Study drug was administered daily in equally divided twice daily doses.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096420
|Kuang Tien General Hospital|
|Taichung, Taiwan, 433|