Acupuncture in Chronic Migraine: A Randomized Controlled Trial - Full Text View

Sponsor:	Kuang Tien General Hospital
Information provided by:	Kuang Tien General Hospital
ClinicalTrials.gov Identifier:	NCT01096420

Purpose

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).

Condition	Intervention
Patients With Chronic Migraine	Procedure: acupuncture Drug: topiramate

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Acute Bronchitis Headache Migraine

Drug Information available for: Topiramate

U.S. FDA Resources

Further study details as provided by Kuang Tien General Hospital:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

≥ 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 ]

Estimated Enrollment:	68
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: acupuncture	Procedure: acupuncture 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	Drug: 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.

Arms

Assigned Interventions

Experimental: acupuncture

Procedure: acupuncture

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

Drug: 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.

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096420

Contacts

Contact: Chun pai Yang, MD

886928654977

neuralyung@gmail.com

Locations

Taiwan
Kuang Tien General Hospital	Recruiting
Taichung, Taiwan, 433
Contact: Nai-Hwei Wang, MD 886426885599 fengcheese@gmail.com
Principal Investigator: Chun-Pai Yang, MD

Sponsors and Collaborators

Kuang Tien General Hospital

More Information

No publications provided by Kuang Tien General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yang CP, Chang MH, Liu PE, Li TC, Hsieh CL, Hwang KL, Chang HH. Acupuncture versus topiramate in chronic migraine prophylaxis: a randomized clinical trial. Cephalalgia. 2011 Nov;31(15):1510-21. Epub 2011 Oct 21.

Responsible Party:	Kuang-Tien General Hospital
ClinicalTrials.gov Identifier:	NCT01096420 History of Changes
Other Study ID Numbers:	9713
Study First Received:	March 29, 2010
Last Updated:	March 30, 2010
Health Authority:	Taiwan: Department of Health

Keywords provided by Kuang Tien General Hospital:

chronic migraine
acupuncture
Topiramate
Randomized trial

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Anticonvulsants

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on May 24, 2012