1. Complementary and integrative Medicine; George Lewith – Professor of Health Research www.cam-research-group.co.uk School for Primary Care Research The Research Agenda

2. 2 What is CAM? A complex whole system intervention, but so is much of conventional medicine Individualised and prioritises patient-centred needs Involves mind body, hands on and medication based therapies, e.g. –Acupuncture/massage –Nutritionals, herbals and homeopathics

3. 3 Uses unique and unconventional conceptual frameworks to diagnose and attribute disease causation (TCM) Using the pharmaceutical model may lead to inappropriate research designs; –Placebo for spiritual healing –Placebos for acupuncture –Undervaluing the unique power of the CAM consultation

4. 4 How much do we really know? BMJ Clinical Evidence http://clinicalevidence.bmj.com/ceweb/about/knowledge.jsp Commonly used interventions supported by good evidence from 2500 treatments. “The figures suggest that the research community has a large task ahead and that most decisions about treatments still rest on the individual judgments of clinicians and patients.”

5. 5 Patient use is widespread in chronic illness Arthritis 70% IBS 50% Inflammatory bowel disease 30% Fibromyalgia 90% And managing chronic illness medically is expensive

6. 6 Patient’s view Practitioners’ “mindlines” Gabbay & Le May BMJ 329, 2004

7. 7 Fonnebo et al, BMC Medical Research Methodology, 2007

8. 8 The relationship between the research question and the corresponding study design (Witt 2009)

9. 9 RAWLINS 2008. NICE Decisions about the use of therapeutic interventions, whether for individuals or entire healthcare systems, should be based on the totality of the available evidence. The notion that evidence can be reliably or usefully placed in ‘hierarchies’ is illusory. Decision makers need to exercise judgement about whether (and when) evidence gathered from experimental or observational sources is fit for purpose. Recommends more complex observational studies and Bayesian analysis.

10. 10 The challenges of investigating complementary medicine (Kings Fund Report 2008) The context of the intervention The importance of a person centred not a disease centred approach The complex relationship between cause and effect Understanding the non specific (placebo) effects and therapy specific effects Being both pragmatic and rigorous about our research endeavours Creating consensus around an open minded and patient (public ) centred research strategy

11. 11 The context of the intervention Equipoise may influence outcomes from RCT’s Availability of treatment and belief may affect our research

12. 12 Context and equipoise (Kaptchuck, White & Lewith for Acupuncture) Kaptchuck et alWhite & Lewith ConditionIBS >200OA hip/knee >200 InterventionRA vs SN FactorDose of ‘ practitioner ’ and empathy in the consultation OutcomeSignificantInsignificant ConfoundersConsent and belief destroy equipoise and confound outcome

13. 13 A person centred approach? RA treated with homeopathy (RCT) Patients randomised to consultation (± homeopathy) vs non consultation (± homeopathy) Homeopathic consultations produce a significant change in EULAR

14. 14 “I’d like to go and see someone that was going to deal with actually being ill, because that’s what he [the homeopath] did, he …kind of took the illness thing into perspective”

15. 15 Do we understand how it works? Acupuncture for addiction, pain and nausea may invoke different physiological mechanisms needing different types of trials. Homeopathy may work differently in acute and chronic illness. Healing may all be about hope and expectation. Mind body therapies may simply allow us to reframe chronic illness.

16. 16 What exactly should we evaluate? Developing model validity (best Practice for Chinese Herbal Medicines) Individualised or patented herbal preparations? Systematically review papers for TCM diagnosis and herbal frequency of use Develop an expert consensus around the herbs, their preparation dosage and treatment duration

17. 17 Improvement in outcome measures at 3 months from baseline in the acupuncture in routine care trials

18. 18 Being both pragmatic and rigorous about our research designs The ATEAM trail evaluated dose and cost effectiveness of Alexander Technique for back pain (BMJ 2008) Using qualitative methods to understand the patients needs and perspective Pragmatic and comparative randomised trial to evaluate risk, cost and clinical benefit Determining how beliefs impact treatment outcome and managing this process Determining cost effectiveness Understanding the process (mechanism)

19. 19 No ExerciseExercise ControlGroup1Group5 MassageGroup2Group6 6ATGroup3Group7 24ATGroup4Group8 RCT Design

20. 20 Creating consensus around an open, involved and patient centred (public) research strategy Defining the public health questions Maximising (ethically) the safe and non specific effects of treatment Interpreting evidence thoughtfully Not assuming the absence of evidence is negative

21. 21 12 months individual groups function Differenc e Roland score Control: 9.2 24AT 45%***; E 18%*/-; E+M 26%*; E+6AT 32%** E+24AT 46%**

22. 22 Some thoughts CAM interventions are complex whole systems. Are they different to good conventional practice? Practitioners like me are often taught dogma so make inappropriate assumptions about efficacy. I suspect this often happens for all medical interventions Evaluating widely available treatments requires a different strategy to new pharmaceuticals. Great care is needed in defining the research question. We have the technology to do this but do we have the understanding?

23. 23 www.cam-research-group.co.uk www.nspcr.ac.uk/index.cfm School for Primary Care Research