2. How to design Homeopathy clinical randomised. 3. Review of the evidence for homeopathic treatment of insomnia and Fibromyalgia Syndrome

Transcription

1 Three talks 1. What type of evidence is needed? 2. How to design Homeopathy clinical randomised controlled trials that work 3. Review of the evidence for homeopathic treatment of insomnia and Fibromyalgia Syndrome Dr Clare Relton BA, MSc, PhD, FSHom Research Fellow School of Health & Related Research (ScHARR)

2 What type of evidence is needed?... to inform decisions by publicly funded healthcare system about the provision of homeopathy Dr Clare Relton BA, MSc, PhD, FSHom Research Fellow School of Health & Related Research (ScHARR)

3 Outline Journey from homeopath to Health Services Researcher (clinical trial design) NHS perspective on research What type of homeopathy evidence exist Priorities for publicly funded health system decision makers

4 Background: Homeopath... NHS Women s clinic (Menopause/PMS) Homeopathy service Women who could not take HRT Audited published outcomes (Relton, 2005) Acceptable and effective homeopathy service Chronic Fatigue Syndrome trial Double blind placebo randomised controlled trial of homeopathy (Weatherley-Jones, 2004) Recruitment? Behaviour?

5 UK House of Lords 6 th Science & Technology Select Committee Report on Complementary & Alternative Medicine (CAM) (2000) Prioritise research into efficacy, safety and cost effectiveness Make research relevant Dept of Health funded research training fellowships for homeopaths, acupuncturists etc.

6 MSc Health Services Research Review evidence homeopathic treatment Menopause: X RCTs: Jacobs 2005, Thompson 2005 Observational studies: Clover, 2003, Thompson 2003, Thomas 2001, Relton 2005; 1000 s case reports Lack of rigorous evidence to inform NHS decision making re provision of homeopathy

7 PhD thesis What type of clinical trial design can provide the information needed to make decisions about the provision of homeopathy in a publicly funded healthcare system?...or any healthcare intervention?

8 UK National Health Service (NHS) Founded in 1948 Homeopathy embedded from start World s largest publicly funded healthcare system ( 98.6 billion )

9 UK NHS and CAM context (Thomas 2001) 22 mil. CAM visits in total 2.1 mil. NHS CAM visits (10%) 14 mil. NHS A & E visits 160 mil. NHS primary care visits 42 mil. NHS outpatient visits

10 UK Department of Health Health Technology Assessment (HTA) Methodology programme funded 60+ projects est. cost of 9 mn National Institute for Health and Clinical Excellence (NICE) - reviews National Institute for Health Research (NIHR) Health Technology Assessment programme funds evidence production

11 National Institute for Health and Clinical Excellence (NICE): reviewing the evidence Set up in 1999 assesses & evaluates the evidence publishes clinical appraisals of particular treatments for the NHS Appraisals based primarily on cost effectiveness and use data primarily from clinical trials

12 Clinical Evidence (BMJ)

13 HTA & MRC: producing research National Institute for Health Research (NIHR) Health Technology Assessment & Medical Research Council (MRC) commission and fund priority areas which require research primarily pragmatic randomised controlled trials often using mixed (qualitative and quantitative methods)

14 Informing NHS decision making Multiple questions Multiple stakeholders Prioritise their questions differently

15 Patients Multiple stakeholders Homeopaths/ healthcare professionals Scientists (academics/researchers) Funders & commissioners Publicly funded healthcare systems (NHS etc) Health care insurers (BUPA etc)

16 Different priorities Patients does it work for me?, is it safe for my child/ grandfather?, is it cost effective for my family?, can I use other treatments alongside? Scientists/EBM better than placebo? Funders and commissioners is it acceptable?, is it safe?, is it cost effective?

17 Does it (homeopathy) work? Untangling the debate (Relton, 2008) Work? effective for x, y, z; better than other treatments, safe by itself, safe to combine, cost effective? Homeopathy? homeopathic remedies, treatment by a homeopath, the principles of homeopathy, the whole therapeutic system

18 Homeopathy: NHS perspective Is it acceptable, is it safe, is it cost effective? Homeopathy, what do we mean? Principles of homeopathy?? Therapeutic system of homeopathy? Homeopathic remedies Homeopaths s

19 Confusion A systematic review of systematic reviews of homeopathy (Ernst, 2002) primary evidence reviewed was systematic reviews of trials of homeopathic medicines switched between: homeopath homeopathy homeopathic medicines homeopathy s two principles,

20 Informing NHS decision making Rigorous evidence of: Acceptability Safety Cost effectiveness Generalisable/ relevant Healthcare by homeopaths (including homeopathic remedies)

21 What evidence is there? Homeopathic remedies: 160+ randomised controlled trials (RCTs) vs placebo Healthcare delivered by homeopaths: 3 RCTs, 50+ observational studies, 1 HTA of cost effectiveness (Börnhoft, 1998) (& in the grey literature there are many100,000s case reports) (English language publications only) Principles of homeopathy Law of similars: Teixeira 1999; Law of minimum dose: in vitro, in vivo exps

22 Clinical Evidence (BMJ)

23 Types of clinical evidence Remedies Homeopaths Principles Acceptable I ; II Safe Cost effective Combinable Effective vs placebo? Effective vs comparator? ~ Effective for condition a,b,c...

24 Conclusion Journey from homeopath to trial design raised many questions NHS perspective on research cost effectiveness Homeopathy evidence base use with clarity... and can be strengthened Priorities for publicly funded health system decision makers pragmatic trials of homeopathy (homeopaths + remedies)

25 References Bornhoft G et al. Effectiveness, Safety and Cost-Effectiveness of Homeopathy in General Practice Summarized Health Technology Assessment, Forsch Komplementärmed 2006;13(suppl 2):19 29 House of Lords 6th Report (2000), Session Select Committee on Science & Technology: Complementary & Alternative Medicine. London. The Stationery Office. Jacobs, J., Herman P., Herron, K. et al. (2005), Homeopathy for menopausal symptoms in breast cancer survivors: a preliminary randomized controlled trial, Journal of Alternative & Complementary Medicine, 11, 1, Relton, C., Weatherley-Jones, E. (2005), Homeopathy service in a NHS community menopause clinic: audit of clinical outcomes, Journal of the British Menopause society, 11, 2, Relton, C., O Cathain, A., Thomas, K.J. (2008), Homeopathy : Untangling the debate, Homeopathy, 97,

26 References Teixeira, M.Z., (1999), Similitude in modern pharmacology, British Homeopathic Journal 88, Thomas, K., Coleman, P. (2004), Use of complementary or alternative medicine in a general population in Great Britain. Results from the National Omnibus Survey. Journal of Public Health 26, 2, Thompson, E.A., Montgomery, A., Douglas, D. et al. (2005), A pilot randomised double blind placebo-controlled trial of individualised homeopathy for symptoms of oestrogen withdrawal in breast cancer survivors. Journal of Alternative & Complementary Medicine, 11,1, Weatherley-Jones E, Nicholl J, Thomas KJ, et al. (2004a), A randomised, controlled, triple-blind study of the efficacy of homeopathic treatment for Chronic Fatigue Syndrome trial, Journal of Psychosomatic Research, 56,