1. School of Healthcare FACULTY OF MEDICINE AND HEALTH The long road to influencing evidence-based NHS decision making; the NICE low back pain story Kate Thomas Professor of Complementary and Alternative Medicine Research

2. Is our evidence good enough? Good enough for whom? Target audience Right research question Right research design

3. Overview NICE CG88 Low back pain management What is NICE? What does CG88 say? What evidence shaped the acupuncture recommendation? What lessons can we learn? www.nice.org.uk/CG88

4. About NICE Who they are The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health. What they do NICE produces guidance in three areas of health: public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector health technologies - guidance on the use of new and existing medicines, treatments and procedures within the NHS clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS. Using NICE guidance can help the NHS cut costs while at the same time maintaining and even improving services.

5. What the guidelines cover Background Scope Evidence review Key priorities for implementation Information, education and patient preferences Pharmacological therapies Non-pharmacological therapies Surgery Costs and savings

6. Background Low back pain affects around one-third of the UK adult population each year Around 20% of people with low back pain will consult their GP Helping people to self-manage their low back pain and return to their normal activities is a key focus

7. Scope Guideline covers the early treatment and management of persistent or recurrent low back pain, defined as non- specific low back pain that has lasted for more than 6 weeks, but for less than 12 months It does not cover the management of severe disabling low back pain that has lasted over 12 months

8. What is non-specific low back pain? Non-specific low back pain is defined in the guideline as: “tension, soreness and/or stiffness in the lower back region for which it isn’t possible to identify a specific cause of the pain”

9. Keep diagnosis under review at all times AND Promote self-management AND Offer drug treatments as appropriate AND Offer one of the treatment options listed on the next slide Principles of management

10. Offer one of the following treatment options, taking patient preference into account:  an exercise programme  a course of manual therapy  a course of acupuncture If improvement is not satisfactory, consider offering another of these After this, consider referral for combined physical and psychological treatment Treatment options in the care pathway

11. Acupuncture Consider offering a course of acupuncture needling comprising up to a maximum of 10 sessions over a period of up to 12 weeks. “Acupuncture refers to the insertion of a solid needle into any part of the human body for disease prevention, therapy or maintenance of health. There are various other techniques often used with acupuncture, which may or may not be invasive.” Acupuncture Regulation Working Group report (September 2003).

12. Non-pharmacological therapies Do not offer Laser therapy Interferential therapy Therapeutic ultrasound TENS Lumbar supports Traction Injections of therapeutic substances into the back for non- specific low back pain.

13. Recommendations with significant costs Costs (£ per year) Acupuncture48,208 Manual therapy31,575 Group combined physical and psychological treatment programme20,635 Exercise programme1,708 Estimated cost of implementation102,126 Costs per 100,000 population

14. Recommendations with significant cost savings Savings (£ per year) Reduction in injections of therapeutic substances into the back66,546 Reduction in MRI scans23,389 Reduction in X-rays2,732 Reduction in use of radiofrequency facet joint denervation5,022 Reduction in other physical therapies3,501 Estimated saving from implementation101,190 Savings per 100,000 population

15. Low Back Pain: full guideline (May 2009) Identifying the evidence The Guideline Development Group agreed that only randomized controlled trials and systematic reviews (of RCTs) should be considered for selection. RCTs with less than 20 participants in each intervention arm excluded Primary outcomes of interest - pain, disability and psychological distress. Studies were included in the cost-effectiveness evidence review if: An incremental cost-effectiveness analysis is performed with results presented as cost per Quality Adjusted Life Year (QALY) The study and costing perspective is that of the UK health service

16. Non-pharmacological interventions - Clinical questions Clinical question: What is the effectiveness and cost effectiveness of sequential interventions (manual therapy, exercise and acupuncture) on pain, functional disability and psychological distress, in people with chronic non-specific back pain of between six weeks and one year? Clinical question: What is the effectiveness of acupuncture compared with usual care or sham on pain, functional disability or psychological distress? 4 RCTs and 1 systematic review on acupuncture

17. Furlan, A. D., Van-Tulder, M. W., Cherkin, D. C. et al, 2005 One systematic review assessed the effects of acupuncture for the treatment of non-specific LBP This was a high quality systematic review with a very low risk of bias. With regards to acupuncture versus sham therapy the conclusions show some positive results of acupuncture, the magnitude of the effects was generally small.

18. Brinkhaus, B., Witt, C. M., Jena, S. et al, 2006 The results of the study showed a statistically significant difference in pain scores between the acupuncture and no acupuncture groups (P <0.001 at 8 weeks). However, no significant difference in pain between the acupuncture and minimal acupuncture groups was found at 8, 26 and 52 weeks (the acupuncture group did have slightly better outcomes than the minimal acupuncture group). This was a well conducted RCT with a low risk of bias.

19. (Haake, Michael, Müller, Hans Helge, Schade, Brittinger Carmen et al, 2007 The results of the study showed a statistically significant difference in pain between the two acupuncture groups together (verum and sham) and the conventional treatment where ½ the patients receiving acupuncture benefited compared to only a ¼ who received conventional treatment. However, there was no significant difference in pain scores between verum acupuncture and sham acupuncture (3.4% difference, P =0.39). This was a well conducted RCT with a low risk of bias.

20. Witt, Claudia M., Jena, Susanne, Selim, Dagmar et al, 2006. The results of the study showed that acupuncture, in addition to usual care, gave a clinically relevant benefit for pain, function and quality of life at 3 months among patients with chronic low back pain compared to usual care alone. The authors conclude that acupuncture should be considered a viable option in the management of patients with chronic LBP. This was a RCT with a high risk of bias.

21. Thomas, K. J., MacPherson, H., Ratcliffe, J. et al, 2005 The results showed that acupuncture does give a greater long-term benefit compared to usual care. Acupuncture was significantly more effective in reducing pain at 24 months than usual care (P =0.032). The study also showed that traditional acupuncture care delivered in a primary care setting was safe and acceptable to patients with non-specific low back pain. This was a well conducted RCT with a low risk of bias.

22. Health economics Two studies were identified Ratcliffe, J., Thomas, K. J., MacPherson, H. et al, 2006; Witt, Claudia M., Jena, Susanne, Selim, Dagmar et al, 2006. Witt et al was excluded only because the setting was Germany and because it took a Low Back Pain societal perspective. In the absence of a UK-based study it would have been included.

23. Ratcliffe, J., Thomas, K. J., MacPherson, H. et al, 2006 The costing perspective was that of the UK health service. The mean cost (Standard Deviation) of care for the acupuncture group as £460 (£376) compared to £345 (£550). The mean incremental health gain from acupuncture at 24 months was 0.027 QALYs, leading to a base case estimate of £4,241 per QALY gained. This NHS based costs per QALY analysis indicates that we can be 90% certain that acupuncture is cost-effective compared with usual care at 24 months using £20,000/QALY as the threshold of acceptability.

24. CG88 evidence conclusion Evidence suggests that seeing an acupuncturist was better than usual care but that there is not much difference between acupuncture and sham. However, sham acupuncture is used as an active form of treatment by some practitioners, therefore this should be considered as a possible treatment. “The strongest evidence comes from the Thomas paper who included the correct population and was well conducted.” “A well-conducted UK based cost effectiveness analysis study showed acupuncture to be a cost effective treatment.”

25. Was the design robust? Assessment by NICE Media reports 2006 “Acupuncture more effective for treating back pain than traditional methods on the NHS”. The Independent, 15 September 2006, p28. “Why acupuncture is better for back pain than a trip to the GP”. Daily Mail, 15 September 2006, p47. “Acupuncture is best remedy for back pain”. Daily Express, 15 September 2006, p4. BMJ rapid response Small clinical benefit demonstrated Cost-effectiveness of placebo

26. ‘Learned’ responses; Acupuncture or tree-hugging? “Pragmatic trials such as this of Thomas et al. may seriously mislead healthcare policy, and even the most rigorous cost- analysis may only demonstrate the cost-effectiveness of placebo for a self-limiting condition. To put it bluntly, hugging a tree may even be more cost-effective (and safer) than acupuncture.” BMJ.com rapid response E Ernst

27. The cost-effectiveness of traditional acupuncture for low back pain: a pragmatic randomised controlled trial Funded by Health Technology Assessment NHS R&D HTA Programme Hugh MacPherson Mike Fitter Foundation for Traditional Chinese Medicine York, UK Kate Thomas Julie Ratcliffe Lucy Thorpe Mike Campbell Jon Nicholl John Brazier Stephen Walters ScHARR, Faculty of Medicine University of Sheffield, UK Mark Roman York & Selby PCT

28. A policy-relevant question …. If given access to an acupuncture service, would primary care patients in York with persistent low back pain, gain more relief from pain than those offered usual management only, at an affordable cost to the NHS.

29. Inclusion Criteria Patients aged 20 to 65 presenting with persistent non-specific low back pain Assessed as suitable for primary care management A current episode of low back pain of at least 4 weeks duration and less than 12 months One paper (Thomas) consisted of population of interest, all the other papers included a population with LBP over longer duration than 12 months (CG88)

30. Cost-effectiveness of acupuncture care for LBP – a pragmatic trial Pragmatic RCT – acupuncture care v. usual GP care Qualified, non-medical acupuncturists - traditional principles Intervention was close to everyday practice, and its precise contents not defined by a rigid protocol Medically defined patient group with shared condition/symptoms Up to 10 sessions of acupuncture care compared with usual GP care clinical 1 o outcome = pain plus cost- effectiveness at 24 months

31. Long time-lines 1996 – pilot study 1999 – full trial commissioned 2005 – study completed; HTA report 2006 – BMJ publications 2009 – NICE guideline acts on findings ??? implementation

32. Implementing the recommendations CG88 Commissioning Fact-sheet Service planning and provision - choice of treatments  Identify gaps in current service provision.  Consider carrying out a survey to identify patient preferences for the various treatment options within your local area. However, this should not be used to offer just one of the treatment options as first choice.

33. Who will deliver the acupuncture?  Identify existing practitioners who are able to provide these treatments or have extended roles, and utilise these in your local area (for example, some physiotherapists have skills in delivering acupuncture).  Ensure that all treatment choices are provided by practitioners who have the appropriate training and skills. CG88 Commissioning Fact-sheet “Acupuncture is a technique used by a wide variety of healthcare practitioners, including specially trained doctors, nurses and physiotherapists, as well as osteopaths, chiropractors and specialist.” Patient leaflet CG88

34. Policy-related research in complementary therapies – the next ten years Cost-effectiveness will remain strong in the policy- related research agenda Clinical expertise / clinical governance will have a raised profile A new emphasis on patient opinions /patient choice ARRC conference 1998 -

36. Low back pain Implementing NICE guidance 2009 NICE clinical guideline 88

37. www.nice.org.uk/CG88 the guideline the quick reference guide ‘Understanding NICE guidance’ costing report and template audit support fact-sheet for commissioners patient information leaflet

38. SF-36 Bodily Pain Scale: adjusted for baseline Diff=5.5 pts p=0.079 Diff=6.0 pts P=0.074 Diff=9.0 pts P=0.015 Pop norm.

39. Cost-effectiveness More health gain Higher costs Less health gain Lower costs    

40. Cost utility (NHS perspective) NHS costs (£) Generic health utilities gained over time (QALYs) Cost per QALY gained NICE appraisal committee has used £20,000 as threshold for what the NHS can afford to pay for additional QALYs.

41. Cost utility over 24 months Using the EQ-5D health status instrument;  Estimated cost per QALY £3,156 If £20,000 is taken as the maximum acceptable cost effectiveness ratio, the use of acupuncture for the treatment of lower back pain appears highly cost-effective.

42. Discussion How do local arrangements for imaging and assessment compare with the guideline recommendations? How does local service provision for the exercise programme compare with the guideline recommendations? What manual therapies are available locally and what care pathways lead to their use? How can patients access combined physical and psychological treatment programmes locally?