Acupuncture in patients with tension-type headache: randomised controlled trialBMJ 2005; 331 doi: https://doi.org/10.1136/bmj.38512.405440.8F (Published 11 August 2005) Cite this as: BMJ 2005;331:376
- Dieter Melchart, director, researcher17,
- Andrea Streng, researcher1,
- Andrea Hoppe, researcher1,
- Benno Brinkhaus, internist4,
- Claudia Witt, epidemiologist4,
- Stefan Wagenpfeil, statistician2,
- Volker Pfaffenrath, neurologist5,
- Michael Hammes, neurologist3,
- Josef Hummelsberger, internist5,
- Dominik Irnich, anaesthetist6,
- Wolfgang Weidenhammer, biostatistician1,
- Stefan N Willich, professor4,
- Klaus Linde ()
- 1 Centre for Complementary Medicine Research, Department of Internal Medicine II, Technische Universität München, Kaiserstr 9, 80801 Munich, Germany
- 2 Institute of Medical Statistics and Epidemiology, Technische Universität München
- 3 Department of Neurology, Technische Universität München
- 4 Institute of Social Medicine, Epidemiology, and Health Economics, Charité University Medical Centre, Berlin, Germany
- 5 Private practice, Munich
- 6 Department of Anesthesiology, University of Munich, Munich
- 7 Division of Complementary Medicine, Department of Internal Medicine, University Hospital Zurich, Switzerland
- Correspondence to: K Linde
- Accepted 27 May 2005
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.
Conclusions 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.
Trial registration number ISRCTN9737659.
Trial centres are listed on bmj.com
Contributors All authors participated in the planning of the protocol and revision of manuscript drafts. DM, KL, AS, BB, and CW were responsible for general trial coordination. AS and AH were responsible for monitoring trial centres' activities. SW, WW, and KL did the statistical analysis. SW was responsible for randomisation. VP provided neurological expertise. MH, JH, and DI developed the acupuncture intervention. SNW and DM had general medical and scientific responsibility. DM, AS, BB, CW, SNW, and KL are guarantors.
Funding Study activities at the Centre for Complementary Medicine Research, Munich, were funded by the following social health insurance funds: Deutsche Angestellten-Krankenkasse (DAK), Hamburg; Barmer Ersatzkasse (BEK), Wuppertal; Kaufmännische Krankenkasse (KKH), Hannover; Hamburg-Münchener Krankenkasse (HaMü), Hamburg; Hanseatische Krankenkasse (HEK), Hamburg; Gmünder Ersatzkasse (GEK), Schwäbisch Gmünd; HZK Krankenkasse für Bauund Holzberufe, Hamburg; Brühler Ersatzkasse, Solingen; Krankenkasse Eintracht Heusenstamm (KEH), Heusenstamm; Buchdrucker Krankenkasse (BK), Hannover. Study activities at the Institute for Social Medicine, Epidemiology and Health Economics, Berlin were funded by the following social health insurance funds: Techniker Krankenkasse (TK), Hamburg; Betriebskrankenkasse (BKK) Bosch; BKK Daimler Chrysler; BKK Bertelsmann; BKK BMW; BKK Siemens; BKK Deutsche Bank; BKK Hoechst; BKK Hypo Vereinsbank; BKK Ford; BKK Opel; BKK Allianz; BKK Vereinsund Westbank; Handelskrankenkasse (HKK).
Competing interests MH, JH, and DI have received fees for teaching acupuncture in courses of professional societies. All other authors: none declared.
Ethical approval The protocol was approved by all relevant local ethics review boards.
- Accepted 27 May 2005