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Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial
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     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

    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.

    Methods

    Recruitment took place between November 1999 and January 2001. Figure 1 shows the flow of participants through the trial. Compliance of patients was good: only three patients in the control group reported receiving acupuncture outside the study. Acupuncture patients received a median of nine (interquartile range 6-11) treatments, with a median of one treatment per week. The dropout rate was close to that expected and approximately balanced between groups. Patients who dropped out were similar to completers in terms of sex, diagnosis, and chronicity, but they were slightly younger (43 v 46 years, P = 0.01) and had higher headache score at baseline (29.3 v. 25.6, P = 0.04). Table 1 shows baseline characteristics by group for the 301 patients who completed the trial: the groups are highly comparable. Thirty one of the patients who withdrew provided three month data, and an additional 45 provided a global assessment. Only 6% of patients (12 in each group) provided no data for headache after randomisation.

    Fig 1 Flow of participants through the trial.

    Table 1 Baseline characteristics. Values are numbers (percentages) of participants unless otherwise indicated

    Table 2 shows results for medical outcomes for patients completing 12 month follow up. In the primary analysis mean headache scores were significantly lower in the acupuncture group. Scores fell by 34% in the acupuncture group compared with 16% in controls (P = 0.0002). This result was highly robust to sensitivity analysis for missing data (smallest difference between groups of 3.85, P = 0.002; see appendix on bmj.com). When we used the prespecified cut-off point of 35% as a clinically significant reduction in headache score, 22% more acupuncture patients improved than controls, equivalent to a number needed to treat of 4.6 (95% confidence interval 9.1 to 3.0). The difference in days with headache of 1.8 days per four weeks is equivalent to 22 fewer days of headache per year (8 to 38). The effects of acupuncture seem to be long lasting; although few patients continued to receive acupuncture after the initial three month treatment period (25, 10, and 6 patients received treatment after 3, 6, and 9, months, respectively), headache scores were lower at 12 months than at the follow up after treatment. Medication scores at follow up were lower in the acupuncture group, although differences between groups did not reach significance for all end points. In an unplanned analysis we summed and scaled all medication taken by patients after randomisation and compared groups with adjustment for baseline scores. Use of medication use fell by 23% in controls but by 37% in the acupuncture group (adjusted difference between groups 15%; 95% confidence interval 3%, 27%; P = 0.01). SF-36 data generally favoured acupuncture (table 3), although differences reached significance only for physical role functioning, energy, and change in health.

    Table 2 Headache and medication outcomes. Higher scores indicate greater severity of headache and increased use of medication. Differences between groups are calculated by analysis of covariance. Values are means (SD) unless otherwise indicated

    Table 3 Health status as scored on the SF-36: values are means (SD)

    We conducted interaction analyses to determine which patients responded best to acupuncture. Although improvements in mean headache score over control were much larger for migraine patients (4.9; 95% confidence interval 2.4, 7.5, n = 284) than for patients who did not meet the criteria for migraine (1.1; 95% confidence interval - 2.4 to 4.5, n = 17), the small numbers of patients with tension-type headache preclude us from excluding an effect of acupuncture in this population. The interaction term for baseline score and group was positive and significant (P = 0.004), indicating larger effects of treatment on patients with more severe symptoms, even after controlling for regression to the mean. Predicted improvements in headache score for each quartile of baseline score in acupuncture patients are 22%, 26%, 35%, and 38%; figure 2 shows comparable data for days with headache. Neither age nor chronicity nor sex influenced the results of acupuncture treatment.

    Fig 2 Frequency of headache at baseline and after treatment. Red dots are actual values for patients in the acupuncture group; blue squares are for controls. The straight line represents no change: observations above the line improved. The curved lines are regression lines (upper red line for acupuncture, lower blue line for controls) that can be used as predictions. Some outliers have been removed

    Table 4 shows data on use of resources. Patients in the acupuncture group made fewer visits to general practitioners and complementary practitioners than those not receiving acupuncture and took fewer days off sick. Confirming the excellent safety profile of acupuncture,15 the only adverse event reported was five cases of headache after treatment in four subjects.

    Table 4 Use of resources. Values are means (SD)

    Discussion

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