research director foundation for traditional chinese medicine, york, uk

1. Medical Care Research Unit 1 Research Director Foundation for Traditional Chinese Medicine, York, UK

2. Medical Care Research Unit 2 Low back pain – the evidence? Systematic reviews identify weak evidence base, recent examples: “…review did not clearly show that acupuncture is effective….” Cochrane Review 1999 “ ….evidence of ineffectiveness….” Effective Health Care Bulletin, UK National Health Service Centre for Reviews & Dissemination, 2000

3. Medical Care Research Unit 3 Opportunity for funding Bids requested for research into acupuncture for chronic pain in primary care in 1999 Widen access?

4. Medical Care Research Unit 4 Testing the hypothesis that…. ….a population of primary care patients with persistent low back pain, when given access to a primary care acupuncture service, gain more relief from pain than those offered usual management only, for equal or less cost.

5. Medical Care Research Unit 5 Pragmatic research design - evaluating comparative effectiveness Patients with low back pain in primary care Referred by their General Practitioner Randomised to either Acupuncture group to receive routine treatment – up to 10 sessions provided by 6 acupuncturists – as well as usual GP management Comparison group to receive usual GP management Professional acupuncturists Providing up to 10 treatments

6. Medical Care Research Unit 6 Patient eligibility criteria Patients aged 20 to 65 presenting with low back pain Current episode of low back pain of 4 to 52 weeks duration Suitable for primary care management Exclusion criteria . Patients outside age range A current episode of back pain of more than 12 months duration Possible serious spinal pathology or severe or progressive motor weakness. Past spinal surgery (e.g. laminectomy) Patients with litigation pending   Exclusion criteria . Patients outside age range A current episode of back pain of more than 12 months duration Possible serious spinal pathology or severe or progressive motor weakness. Past spinal surgery (e.g. laminectomy) Patients with litigation pending  

7. Medical Care Research Unit 7 Trial sample Size Two patients to be randomised to the acupuncture group for every one to the control group (2:1) Allowing for drop out, 240 patients are expected to give a 90% chance of detecting a difference of 10 points in SF-36 Bodily Pain score at 12 months. SF – 36 (incl. mental health scale) McGill Pain Questionnaire Oswestry LOW BACK PAIN Disability Questionnaire Medication use Adverse events Expectations of treatment Patient satisfaction with acupuncture service A difference, or change, of between 5 and 10 points on SF-36 dimension scores is widely thought to represent a clinically significant benefitSF – 36 (incl. mental health scale) McGill Pain Questionnaire Oswestry LOW BACK PAIN Disability Questionnaire Medication use Adverse events Expectations of treatment Patient satisfaction with acupuncture service A difference, or change, of between 5 and 10 points on SF-36 dimension scores is widely thought to represent a clinically significant benefit

8. Medical Care Research Unit 8 Outcomes at 3, 12 and 24 months Acupuncture safety at 3 months Clinical outcome measures SF-36 (8 sub scales, including Bodily Pain) Oswestry Economic measures (SF-6D, EQ-5D)

9. Medical Care Research Unit 9 Patient recruitment 39 General Practitioners from 16 practices referred 289 patients 48 patients (17%) did not participate Patients chose not to come into the study Patients did not meet criteria Back pain resolved

10. Medical Care Research Unit 10 Demographic profiles (at baseline)

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12. Medical Care Research Unit 12 Traditional diagnosis Diagnosis of syndromes Qi & Blood Stagnation – 88% Bi Syndrome – 28% Kidney Deficiency – 53% Inter-rater reliability Percentage of congruent classifications: range 47% to 80% Cohen’s Kappa: range 0 (“chance”) to 0.67 (“good”)

13. Medical Care Research Unit 13 Acupuncture treatments provided Average 8.6 treatments per patient Commonly selected points Bladder points: BL-23, BL-26, BL-53, BL-40 Gall Bladder points: GB-30, GB-34 Local points: Huatou at L3, L4 and L5, AhShi points Syndrome points: KID-3 Auxiliary techniques and advice

14. Medical Care Research Unit 14 All treatments received

15. Medical Care Research Unit 15 Patients reporting being bothered “quite a lot” or “a great deal” by response (%) Feeling relaxed 85 5 Temporary worsening of symptoms 63 23 Feeling tired/ drowsy 50 3 Feeling energised 40 4

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17. Medical Care Research Unit 17 SF-36 Bodily Pain Scale: adjusted for baseline

18. Medical Care Research Unit 18 Adjusted 24 month SF-36 Bodily Pain

19. Medical Care Research Unit 19 Worry about back pain at 24 months

20. Medical Care Research Unit 20 At 24 months, number pain free months?

21. Medical Care Research Unit 21 At 24 months, have you used medication in the last 4 weeks?

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23. Medical Care Research Unit 23 Treatment Acceptability For the acupuncture group: 90% completed acupuncture course 86% willing to try acupuncture again 86% would recommend to a friend Do you think that the acupuncture helped your back pain? 81% yes, 19% no

24. Medical Care Research Unit 24 At randomisation: do you believe that acupuncture can help your low back pain?

25. Medical Care Research Unit 25 Conclusions It is possible to conduct a pragmatic RCT of individualised acupuncture in primary care Evidence that acupuncture is acceptable and clinically beneficial over the longer-term Results are not due to a “placebo” effect Results can be generalised

26. Medical Care Research Unit 26 Acknowledgements Acupuncturists   Wendy Epstein Alison Gould Liping Han Harriet Lansdown Hugh MacPherson June Tranmer Advisors David Laverick Trevor Sheldon Sally Bell?Syer Patients Research Team   Kate Thomas (PI) Hugh MacPherson Lucy Thorpe John Brazier Mike Campbell Mike Fitter Ann Morgan Jon Nicholl Liz Oswald Mark Roman Helen Wilkinson Funders   NHS Health Technology Assessment Programme