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Acupuncture in Chronic Migraine: A Randomized Controlled Trial

K

Kuang Tien General Hospital

Status

Completed

Conditions

Patients With Chronic Migraine

Treatments

Procedure: acupuncture
Drug: topiramate

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Full 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.

Enrollment

68 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

68 participants in 2 patient groups

acupuncture
Experimental group
Treatment:
Procedure: acupuncture
topiramate
Active Comparator group
Treatment:
Drug: topiramate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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