Acupuncture in patients with tension-type headache: randomised controlled trial

doi:10.1136/bmj.38512.405440.8F

BMJ 2005;331:376-382 (13 August), doi:10.1136/bmj.38512.405440.8F (published 29 July 2005)

Paper

Acupuncture in patients with tension-type headache: randomised controlled trial

Dieter Melchart, director, researcher¹^,7, 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, epidemiologist¹

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 Klaus.Linde{at}lrz.tu-muenchen.de

Objective To investigate the effectiveness of acupuncture comparedwith minimal acupuncture and with no acupuncture in patientswith 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 (superficialneedling at non-acupuncture points), or waiting list control.Acupuncture and minimal acupuncture were administered by specialisedphysicians and consisted of 12 sessions per patient over eightweeks.

Main outcome measure Difference in numbers of days with headachebetween the four weeks before randomisation and weeks 9-12 afterrandomisation, as recorded by participants in headache diaries.

Results The number of days with headache decreased by 7.2 (SD6.5) days in the acupuncture group compared with 6.6 (SD 6.0)days in the minimal acupuncture group and 1.5 (SD 3.7) daysin the waiting list group (difference: acupuncture v minimalacupuncture, 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% reductionin days with headache) was 46% in the acupuncture group, 35%in the minimal acupuncture group, and 4% in the waiting listgroup.

Conclusions The acupuncture intervention investigated in thistrial was more effective than no treatment but not significantlymore effective than minimal acupuncture for the treatment oftension-type headache.

Trial registration number ISRCTN9737659.

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Rapid Responses:

Read all Rapid Responses

Relaxation and massage often helpful: Kevan R Wylie
bmj.com, 12 Aug 2005 [Full text]
Covering title a misrepresentation: Sharif M Elleithy
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Another useful waste of time? Hitching a ride on the back of placebo.: David Reilly
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Acupuncture in patients with tension-type headache: beliefs in the technique do matter: Ulrich Ronellenfitsch
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Acupuncture, botulinum toxine, tiger balm or placebo?: Harald G. De Cauwer
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Was it a good idea to publish the study-design before the end of the study ?: Dieter Wettig, PhD, MD
bmj.com, 23 Aug 2005 [Full text]
Re: Was it a good idea to publish the study-design before the end of the study ?: Dieter Wettig, PhD, MD, et al.
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Acupuncture is no better than no treatment for headaches: misleading covering title: Michal R. Pijak
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Were acupunctural effects recorded?: Alexander Macdonald
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Reply from authors: Klaus Linde, et al.
bmj.com, 15 Sep 2005 [Full text]
Re: Reply from authors: Dieter Wettig, PhD, MD, et al.
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ICH-GP: Mahmood Ahmad
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