Acupuncture Randomized Trials (ART) in patients with migraine or
tension-type headache--design and protocols.
Melchart D, Linde K, Streng A, Reitmayr S, Hoppe A, Brinkhaus B,
Becker-Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Willich SN,
Weidenhammer W.
Zentrum fur naturheilkundliche Forschung,
II. Medizinische Klinik und Poliklinik, TU Munchen, Germany.
BACKGROUND
AND OBJECTIVE: We report the design and essentials of the protocols of two
Acupuncture Randomized Trials (ART) investigating whether acupuncture is more
efficacious than no treatment and minimal acupuncture in the interval
treatment of migraine and tension-type headache. DESIGN: Randomized
controlled multicenter trials with three treatment arms and a total
observation period of 28 weeks. SETTING: 30 practitioners and outpatient
units in Germany specialized in acupuncture treatment. PATIENTS: Per study
300 patients with migraine and episodic or chronic tension-type headache,
respectively (diagnosis according to the criteria of the International
Headache Society). INTERVENTIONS: Patients are randomly assigned to receive
either (1) semi-standardized acupuncture (150 patients), (2) standardized
minimal acupuncture (75 patients), or (3) no interval treatment for 12 weeks
followed by semi-standardized acupuncture (75 patients, waiting list
control). Acupuncture treatment consists of 12 sessions per patient over a
period of 8 weeks. MAIN OUTCOME MEASURE: Main outcome measure in the migraine
trial is the difference between the number of days with headache of moderate
or severe intensity during the 4 weeks before randomization and weeks 9 to 12
after randomization. In the study on tension-type headache the main outcome
measure is similar to that described above, but for the number of headache
days regardless of intensity. OUTLOOK: The results of these two studies
(available in 2004) will provide health care providers and policy makers with
the information needed to make scientifically sound assessments of
acupuncture therapy. Copyright 2003 S.
Karger GmbH, Freiburg
