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FACT
Focus on Alternative and Complementary Therapies

‘How is it for the patient?’ Participating in a sham-controlled acupuncture trial for migraine

Paterson C1, Zheng Z1, Xue C1, Wang Y1
1MRC Health Services Research Collaboration, Department of Social Medicine, University of Bristol, Bristol BS8 2PR, UK
2Division of Chinese Medicine, School of Health Sciences, RMIT University, PO Box 71, Bundoora, Victoria 3083, Australia

Objective

Within a randomised, single-blind, sham-acupuncture controlled trial of acupuncture (Chinese medicine based) for people with chronic migraine: (i) how do participants experience their acupuncture treatment and (ii) what does this tell us about the internal and external validity of the trial design?

Materials and methods

All trial participants who consented to take part in this qualitative study were interviewed twice by an independent researcher who was blind to all trial data, including allocation. The acupuncture practitioner was interviewed once. Interviews, 30–60 min long, explored patients’ experiences of their migraine and its treatment, and their experience of the trial. Interviews were transcribed, coded and analysed both across and within cases.

Results

Over 3 months, 10 participants were interviewed, 60% female, age 23–70 years. All had severe migraine and limited benefit from conventional treatment. They had no organisational problems with the trial and no acupuncture was perceived as obviously ‘sham’. The practitioner was anxious to avoid discussions that might uncover group allocation and patients were equally conscious of being in an ‘experiment’. Consequently communication was friendly but brief. There was little discussion of co-morbidity and life events, the Chinese diagnosis and related insights, or self-help measures. Needling was restricted to the migraine, even when other problems may be relevant (e.g. back pain, menstrual cycle).

Conclusion

Patients received needling but no holistic care. The trial’s internal validity was good. The external validity, or generalisability, was limited because treatment differed in many ways from that described in previous studies of ‘normal’ acupuncture.

Acknowledgements

This work was supported by the MRC Health Services Research Collaboration.

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