The Journal of Headache and Pain

, Volume 8, Issue 5, pp 306–314 | Cite as

Acupuncture for tension-type headache: a multicentre, sham-controlled, patient-and observer-blinded, randomised trial

  • Heinz G. EndresEmail author
  • Gabriele Böwing
  • Hans-Christoph Diener
  • Stefan Lange
  • Christoph Maier
  • Albrecht Molsberger
  • Michael Zenz
  • Andrew J. Vickers
  • Martin Tegenthoff
Open Access


Acupuncture treatment is frequently sought for tension-type headache (TTH), but there is conflicting evidence as to its effectiveness. This randomised, controlled, multicentre, patient-and observer-blinded trial was carried out in 122 outpatient practices in Germany on 409 patients with TTH, defined as ≥0 headache days per month of which ≤1 included migraine symptoms. Interventions were verum acupuncture according to the practice of traditional Chinese medicine or sham acupuncture consisting of superficial needling at nonacupuncture points. Acupuncture was administered by physicians with specialist acupuncture training. Ten 30-min sessions were given over a six-week period, with additional sessions available for partial response. Response was defined as >50% reduction in headache days/month at six months and no use of excluded concomitant medication or other therapies. In the intent-to-treat analysis (all 409 patients), 33% of verum patients and 27% of sham controls (p=0.18) were classed as responders. Verum was superior to sham for most secondary endpoints, including headache days (1.8 fewer; 95% CI 0.6, 3.0; p=0.004) and the International Headache Society response criterion (66% vs. 55% response, risk difference 12%, 95% CI: 2%-21%; p=0.024).). The relative risk on the primary and secondary response criterion was very similar (∼0.8); the difference in statistical significance may be due to differences in event rate. TTH improves after acupuncture treatment. However, the degree to which treatment benefits depend on psychological compared to physiological effects and the degree to which any physiological effects depend on needle placement and insertion depth are unclear.


Episodic tension-type headache Chronic tension-type headache Verum acupuncture Sham acupuncture Randomised controlled trial 


  1. 1.
    Olesen J, Bousser M-G, Diener HC et al (2004) The International Classification of Headache Disorders: 2nd edition. Cephalalgia, 24[Suppl 1] 9–160 10.1111/j.1468-2982.2003.00824.xCrossRefGoogle Scholar
  2. 2.
    Göbel H, Petersen-Braun M, Soyka D (1994) The epidemiology of headache in Germany: a nationwide survey of a representative sample on the basis of the headache classification of the International Headache Society. Cephalalgia 14:97–106 10.1046/j.1468-2982.1994.1402097.x, 8062362CrossRefPubMedGoogle Scholar
  3. 3.
    Rasmussen BK (2001) Epidemiology of headache. Cephalalgia 21:774–777 10.1046/j.1468-2982.2001.00248.x, 1:STN:280:DC%2BD3MrkvVKrsA%3D%3D, 11595011CrossRefPubMedGoogle Scholar
  4. 4.
    Schwartz BS, Stewart WF, Simon D, Lipton RB (1998) Epidemiology of tension-type headache. JAMA 279:381–383 10.1001/jama.279.5.381, 1:STN:280:DyaK1c7hvFGlsg%3D%3D, 9459472CrossRefPubMedGoogle Scholar
  5. 5.
    Thomas KJ, Nicholl JP, Fall M (2001) Access to complementary medicine via general practice. Br J Gen Pract 51:25–30 1:STN:280:DC%2BD3M7ntFGntA%3D%3D, 11271869PubMedCentralPubMedGoogle Scholar
  6. 6.
    Wadlow G, Peringer E (1996) Retrospective survey of patients of practitioners of traditional Chinese acupuncture in the UK. Complementary therapies in medicine 4:1–7 10.1016/S0965-2299(96)80048-3CrossRefGoogle Scholar
  7. 7.
    Ezzo J, Berman B, Hadhazy VA, Jadad AR, Lao L, Singh BB (2000) Is acupuncture effective for the treatment of chronic pain? A systematic review. Pain 86:217–225 10.1016/S0304-3959(99)00304-8, 1:STN:280:DC%2BD3c3nsVSlsA%3D%3D, 10812251CrossRefPubMedGoogle Scholar
  8. 8.
    Melchart D, Linde K, Fischer P et al (2001) Acupuncture for idiopathic headache. Cochrane database of systematic reviews (Online), (1):CD001218Google Scholar
  9. 9.
    Endres HG, Zenz M, Schaub C et al (2005) Zur Problematik von Akupunkturstudien am Beispiel der Methodik von gerac. Schmerz 19:201–204, 206, 208–210 passim 10.1007/s00482-004-0345-z, 1:STN:280:DC%2BD2MzhtFyltg%3D%3D, 15959826CrossRefPubMedGoogle Scholar
  10. 10.
    Diener HC (2004) Advances in the field of headache 2003/2004. Current opinion in neurology, 17:271–273 10.1097/00019052-200406000-00006, 15167060CrossRefPubMedGoogle Scholar
  11. 11.
    Anonymous (1998) NIH Consensus Conference. Acupuncture. JAMA 280:1518–1524Google Scholar
  12. 12.
    Molsberger AF, Boewing G, Diener HC et al (2006) Designing an acupuncture study: the nationwide, randomized, controlled, german acupuncture trials on migraine and tension-type headache. Journal of alternative and complementary medicine (New York, N.Y. 12:237–245 10.1089/acm.2006.12.237CrossRefGoogle Scholar
  13. 13.
    Elliott AM, Smith BH, Smith WC, Chambers WA (2000) Changes in chronic pain severity over time: the Chronic Pain Grade as a valid measure. Pain 88:303–308 10.1016/S0304-3959(00)00337-7, 1:STN:280:DC%2BD3M7gtlSkuw%3D%3D, 11068118CrossRefPubMedGoogle Scholar
  14. 14.
    Von Korff M, Ormel J, Keefe FJ, Dworkin SF (1992) Grading the severity of chronic pain. Pain 50:133–149 10.1016/0304-3959(92)90154-4CrossRefGoogle Scholar
  15. 15.
    Smith BH, Penny KI, Purves AM et al (1997) The Chronic Pain Grade questionnaire: validation and reliability in postal research. Pain 71:141–147 10.1016/S0304-3959(97)03347-2, 1:STN:280:DyaK2szlsFarsg%3D%3D, 9211475CrossRefPubMedGoogle Scholar
  16. 16.
    Ware J, Jr., Kosinski M, Keller SD (1996) A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Medical care 34:220–233 10.1097/00005650-199603000-00003, 8628042CrossRefPubMedGoogle Scholar
  17. 17.
    Collins SL, Edwards J, Moore RA, Smith LA, McQuay HJ (2001) Seeking a simple measure of analgesia for mega-trials: is a single global assessment good enough? Pain 91:189–194 10.1016/S0304-3959(00)00435-8, 1:STN:280:DC%2BD3MzmvVCrtQ%3D%3D, 11240091CrossRefPubMedGoogle Scholar
  18. 18.
    Endres HG, Molsberger A, Lungenhausen M, Trampisch HJ (2004) An internal standard for verifying the accuracy of serious adverse event reporting: the example of an acupuncture study of 190,924 patients. European journal of medical research 9:545–551 1:STN:280:DC%2BD2M%2FmtV2msw%3D%3D, 15689300PubMedGoogle Scholar
  19. 19.
    Schulte-Mattler WJ, Krack P (2004) Treatment of chronic tension-type headache with botulinum toxin A: a randomized, double-blind, placebocontrolled multicenter study. Pain 109:110–114 10.1016/j.pain.2004.01.016, 1:CAS:528:DC%2BD2cXjtVCgurk%3D, 15082132CrossRefPubMedGoogle Scholar
  20. 20.
    Saper JR, Lake AE, 3rd, Cantrell DT, Winner PK, White JR (2002) Chronic daily headache prophylaxis with tizanidine: a double-blind, placebo-controlled, multicenter outcome study. Headache 42:470–482 10.1046/j.1526-4610.2002.02122.x, 12167135CrossRefPubMedGoogle Scholar
  21. 21.
    Holroyd KA, O’Donnell FJ, Stensland M, Lipchik GL, Cordingley GE, Carlson BW (2001). Management of chronic tension-type headache with tricyclic antidepressant medication, stress management therapy, and their combination: a randomized controlled trial. JAMA 285:2208–2215 10.1001/jama.285.17.2208, 1:CAS:528:DC%2BD3MXjslymsLs%3D, 11325322PubMedCentralCrossRefPubMedGoogle Scholar
  22. 22.
    Diener HC, Kronfeld K, Boewing G et al (2006) Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial. Lancet Neurol 5:310–316 10.1016/S1474-4422(06)70382-9, 16545747CrossRefPubMedGoogle Scholar
  23. 23.
    Coeytaux RR, Kaufman JS, Kaptchuk TJ et al (2005) A randomized, controlled trial of acupuncture for chronic daily headache. Headache 45:1113–1123 10.1111/j.1526-4610.2005.00235.x, 16178942CrossRefPubMedGoogle Scholar
  24. 24.
    Vickers AJ, Rees RW, Zollman CE et al (2004) Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial. Br Med J (Clinical research ed 328:744–749 10.1136/bmj.38029.421863.EBCrossRefGoogle Scholar
  25. 25.
    Moerman DE, Jonas WB (2002) Deconstructing the Placebo Effect and Finding the Meaning Response. Ann Intern Med 136:471–476 11900500CrossRefPubMedGoogle Scholar
  26. 26.
    Kaptchuk TJ, Goldman P, Stone DA, Stason WB (2000) Do medical devices have enhanced placebo effects? Clin Epidemid 53:786–792 10.1016/S0895-4356(00)00206-7, 1:STN:280:DC%2BD3cvjvVSrsg%3D%3DCrossRefGoogle Scholar
  27. 27.
    Kaptchuk TJ, Stason WB, Davis RB et al (2006) Sham device v inert pill: randomised controlled trial of two placebo treatments. BMJ (Clinical research ed, 332:391–397 10.1136/bmj.38726.603310.55CrossRefGoogle Scholar
  28. 28.
    Birch S, Jamison RN (1998) Controlled trial of Japanese acupuncture for chronic myofascial neck pain: assessment of specific and nonspecific effects of treatment. Clin J Pain 14:248–255 10.1097/00002508-199809000-00012, 1:STN:280:DyaK1cvivFSnsA%3D%3D, 9758075CrossRefPubMedGoogle Scholar
  29. 29.
    Melchart D, Streng A, Hoppe A et al (2005) Acupuncture in patients with tension-type headache: randomised controlled trial. Br Med J (Clinical research ed 331:376–382 10.1136/bmj.38512.405440.8FCrossRefGoogle Scholar

Copyright information

© Springer-Verlag Italia 2007

Authors and Affiliations

  • Heinz G. Endres
    • 1
    Email author
  • Gabriele Böwing
    • 2
  • Hans-Christoph Diener
    • 3
  • Stefan Lange
    • 4
  • Christoph Maier
    • 5
  • Albrecht Molsberger
    • 2
  • Michael Zenz
    • 6
  • Andrew J. Vickers
    • 7
  • Martin Tegenthoff
    • 8
  1. 1.Department of Medical Informatics, Statistics and Epidemiology, RuhrUniversity BochumBochumGermany
  2. 2.Acupuncture Research GroupDuesseldorfGermany
  3. 3.Department of NeurologyUniversity EssenEssenGermany
  4. 4.Institute for Quality and Efficiency in Health CareCologneGermany
  5. 5.Department of Pain Management, BG-Kliniken BergmannsheilRuhr University BochumBochumGermany
  6. 6.Department of Anaesthesiology, BG-Kliniken BergmannsheilRuhr University BochumBochumGermany
  7. 7.Department of Medicine and Department of Epidemiology and BiostatisticsMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  8. 8.Department of Neurology, BG-Kliniken BergmannsheilRuhr University BochumBochumGermany

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