Acupuncture for chronic headache in primary care: large, pragmatic, randomised trialBMJ 2004; 328 doi: https://doi.org/10.1136/bmj.38029.421863.EB (Published 25 March 2004) Cite this as: BMJ 2004;328:744
- Andrew J Vickers, assistant attending research methodologist ()1,
- Rebecca W Rees, research officer2,
- Catherine E Zollman, general practitioner3,
- Rob McCarney, research officer4,
- Claire M Smith, senior trials coordinator5,
- Nadia Ellis, lecturer6,
- Peter Fisher, director of research7,
- Robbert Van Haselen, deputy director of research7
- 1 Integrative Medicine Service, Biostatistics Service, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, NY, NY 10021
- 2Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-Centre), Social Science Research Unit, Institute of Education, London WC1H 0NS,
- 3Montpelier Health Centre, Bristol BS6 5PT
- 4Department of Psychological Medicine, Imperial College London, London W2 1PD
- 5Academic Rheumatology, Weston Education Centre, King's College, London SE5 9RJ
- 6Department of Health and Social Sciences, Coventry University, Coventry CV1 5FB
- 7Royal London Homeopathic Hospital, London W1W 5PB
- Correspondence to: A J Vickers
- Accepted 12 June 1998
Objective To determine the effects of a policy of “use acupuncture” on headache, health status, days off sick, and use of resources in patients with chronic headache compared with a policy of “avoid acupuncture.”
Design Randomised, controlled trial.
Setting General practices in England and Wales.
Participants 401 patients with chronic headache, predominantly migraine.
Interventions Patients were randomly allocated to receive up to 12 acupuncture treatments over three months or to a control intervention offering usual care.
Main outcome measures Headache score, SF-36 health status, and use of medication were assessed at baseline, three, and 12 months. Use of resources was assessed every three months.
Results Headache score at 12 months, the primary end point, was lower in the acupuncture group (16.2, SD 13.7, n = 161, 34% reduction from baseline) than in controls (22.3, SD 17.0, n = 140, 16% reduction from baseline). The adjusted difference between means is 4.6 (95% confidence interval 2.2 to 7.0; P = 0.0002). This result is robust to sensitivity analysis incorporating imputation for missing data. Patients in the acupuncture group experienced the equivalent of 22 fewer days of headache per year (8 to 38). SF-36 data favoured acupuncture, although differences reached significance only for physical role functioning, energy, and change in health. Compared with controls, patients randomised to acupuncture used 15% less medication (P = 0.02), made 25% fewer visits to general practitioners (P = 0.10), and took 15% fewer days off sick (P = 0.2).
Conclusions Acupuncture leads to persisting, clinically relevant benefits for primary care patients with chronic headache, particularly migraine. Expansion of NHS acupuncture services should be considered.
Contributors AJV conceived, designed and analysed the study and is its guarantor; RWR, CEZ, CMS, and NE contributed to the original design with particular contributions to outcome assessment (RWR, CMS); patients and treatment (CEZ); acupuncture treatment (NE). RM contributed to design of resource outcome assessment; RM, RvH and PF contributed to development of data collection methods for sensitivity analysis
Funding The trial (ISRCTN96537534) was funded by NHS R&D National Coordinating Centre for Health Technology Assessment (NCCHTA) grant: 96/40/15
Conflict of interest NE provides acupuncture as part of her private physiotherapy practice.
Ethical approval South West Multicentre Research Ethics Committee and appropriate local ethics committees
- Accepted 12 June 1998