Acupuncture for chronic headache in primary care large, pragmatic, randomized trial.

Acupuncture for chronic headache in primary care large, pragmatic, randomized trial.
15 March 2004
Andrew J Vickers, assistant attending research methodologist1, 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
BMJ

1 Integrative Medicine Service, Biostatistics Service, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, NY, NY 10021, 2 Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-Centre), Social Science Research Unit, Institute of Education, London WC1H 0NS, 3 Montpelier Health Centre, Bristol BS6 5PT, 4 Department of Psychological Medicine, Imperial College London, London W2 1PD, 5 Academic Rheumatology, Weston Education Centre, King's College, London SE5 9RJ, 6 Department of Health and Social Sciences, Coventry University, Coventry CV1 5FB, 7 Royal London Homeopathic Hospital, London W1W 5PB

Correspondence to: A J Vickers vickersa@mskcc.org

Abstract

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.

Introduction

Migraine and tension-type headache give rise to notable health,1 2 economic,2 and social costs.2 3 Despite the undoubted benefits of medication,4 many patients continue to experience distress and social disruption. This leads patients to try, and health professionals to recommend, non-pharmacological approaches to headache care. One of the most popular approaches seems to be acupuncture. Each week 10% of general practitioners in England either refer patients to acupuncture or practise it themselves,5 and chronic headache is one of the most commonly treated conditions.6
A recent Cochrane review of 26 randomised trials of acupuncture for headache concluded that, although existing evidence supports the value of acupuncture, the quality and amount of evidence are not fully convincing.7 The review identifies an urgent need for well planned, large scale studies to assess the effectiveness and cost effectiveness of acupuncture under "real" conditions. In 1998 the NHS National Coordinating Centre for Health Technology Assessment commissioned us to conduct such a trial (trial number ISRCTN96537534). Our aim was to estimate the effects of acupuncture in practice8: we established an acupuncture service in primary care; we then sought 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." This reflects two real decisions: that made by general practitioners when managing the care of headache patients and that made by NHS entities when commissioning health services.

© 2004 BMJ Publishing Group Ltd.

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