Acupuncture in patients with tension-type headache (ART) - a randomised sham-controlled trial
Acupuncture in patients with tension-type headache (ART) - a randomised sham-controlled trial
Objective: To investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache.
Design: Three armed randomised controlled multicentre trial.
Setting: 28 outpatient centres in Germany.
Participants: 270 patients (74% women, mean age 43 (SD 13) years) with episodic or chronic tension-type headache.
Interventions: Acupuncture, minimal acupuncture (superficial needling at non-acupuncture points), or waiting list control. Acupuncture and minimal acupuncture were administered by specialised physicians and consisted of 12 sessions per patient over eight weeks.
Main outcome measure: Difference in numbers of days with headache between the four weeks before randomisation and weeks 9-12 after randomisation, as recorded by participants in headache diaries.
Results: The number of days with headache decreased by 7.2 (SD 6.5) days in the acupuncture group compared with 6.6 (SD 6.0) days in the minimal acupuncture group and 1.5 (SD 3.7) days in the waiting list group (difference: acupuncture v minimal acupuncture, 0.6 days, 95% confidence interval -1.5 to 2.6 days, P = 0.58; acupuncture v waiting list, 5.7 days, 3.9 to 7.5 days, P < 0.001). The proportion of responders (at least 50% reduction in days with headache) was 46% in the acupuncture group, 35% in the minimal acupuncture group, and 4% in the waiting list group.
Conclusion: The acupuncture intervention investigated in this trial was more effective than no treatment but not significantly more effective than minimal acupuncture for the treatment of tension-type headache.
Publication:
Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Hummelsberger J, Irnich D, Weidenhammer W, Willich SN, Linde K. Acupuncture in patients with tension-type headache: randomised controlled trial. BMJ. 2005 Aug 13;331(7513):376-82. Epub 2005 Jul 29.
Principle investigator:
Willich, MD, MPH, MBA
Witt, MD, MBA
Research associate:
Brinkhaus, MD
Statistics:
Wagenfeil, PhD
Coorperation:
Zentrum für naturheilkundliche Forschung, TU München
Data management:
Weber
Icke
Study nurse:
Cree
Bartsch
Project duration:
2001-2005
Project status:
completed
Funding:
Techniker Krankenkasse (statutory health insurance)