Acupuncture in Chronic Migraine: A Randomized Controlled Trial

NCT01096420•Kuang Tien General Hospital

Summary

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).

Detailed Description

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Locations (1)

Kuang Tien General Hospital

Taichung, Taiwan, Taiwan

Key Dates

Start Date

August 1, 2008

Primary Completion Date

August 1, 2010

Completion Date

August 1, 2010

Last Updated

August 14, 2013

Enrollment

ACTUAL participants

Conditions

Patients With Chronic Migraine

Interventions

acupuncture

PROCEDURE

topiramate

DRUG