[PPT] - Evaluation of Evaluation of complementary/ complementary/ PowerPoint Presentation

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Evaluation of Evaluation of complementary/ complementary/ alternative medicine alternative medicine

Edzard Ernst Complementary Medicine Peninsula Medical School Universities of Exeter & Plymouth, UK Email: Edzard.Ernst@pms.ac.uk Website: www.pms.ac.uk/compmed

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Outline of my lecture

Background
Evaluation of CAM

1)Efficacy/effectiveness 2)Safety

Obstacles
The dilemma
Conclusion

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Background

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The range of complementary medicine The range of complementary medicine

ACUPUNCTURE - diagnosis + therapy AROMATHERAPY – mainly therapy CHIROPRACTIC - diagnosis + therapy HEALING (faith, spiritual, etc) – diagnosis + therapy HERBALISM (phytotherapy) – diagnosis + therapy HOMOEOPATHY - diagnosis + therapy IRIDOLOGY- diagnosis only KINESIOLOGY- diagnosis + therapy MASSAGE – diagnosis + therapy OSTEOPATHY- diagnosis + therapy REFLEXOLOGY- diagnosis + therapy

physical
pharmacological
undefined "energies"

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CAM: common features

Emphasis on holism, “energy” etc
‘Natural’ treatments
‘Safe’ treatments
Individualisation
Self-healing properties of body
Long tradition of usage
Private healthcare

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Why does it matter?

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One-year prevalence of CAM-use in general populations

UK Israel Hungary Canada Italy Finland Australia France US Germany Japan 10 20 30 40 50 60 70 80(%) Thomas, et al. J Pub Health 2004;26:152 Shumueli, et al. Isr Med Assoc J 2004;6:3 Buda, et al. Orv Hetil 2002;143:891

Millar. Can J Pub Health 1997;88:154

Menniti-Ippolito, et al. EJCP 2002;58:61 Vaskilampi, et al. Hodder/Stoughton 2004 MacLennon, et al. Lancet 1996;347:569

Bouchayer. Comp Med Res 1990;4:4

Baines, et al. Adv Data 2004;343:1 Härtel, et al. FKM 2004;11:327 Yamashita, et al. CTM 2002;10:84

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Why is CAM so popular?

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Positive Negative

Philosophical

congruence

Locus of control
Therapeutic

relationship

Desperation
Rejection of

science

Rejection of

establishment

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Evaluation of CAM

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Aim of evaluation

Which form of CAM generates more than harm in which condition?

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1. Efficacy/

Effectiveness

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Hierarchy of evidence

Systematic reviews of RCTs Randomised clinical trials Controlled clinical trails Uncontrolled data (e.g. case reports, case series,

bservational studies)

Ernst E. Complementary Medicine, Peninsula Medical School

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RCTs of CAM: potential problems

Placebos not possible
Double-blinding not possible
Patients with strong preference may not agree to

randomisation

Treatments are complex, individualised etc.
Adequate endpoints do no exist
Therapeutic effects are small
Therapeutic effects are slow
Investigators are not impartial
The notion that CAM defies science
Funds are scarce

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Spiritual healing for chronic pain

Design: Sample: Intervention: Result: double-blind RCT with 4 parallel arms 120 patients with idiopathic chronic pain A) face to face healing by 5 experienced healers B) face to face simulated healing by 5 actors C) distant healing by 5 (hidden) healers D) stimulated distant healing with no human presence Primary outcome measure (pain, McGill) decreased in all groups with no significant inter-group differences

Abbot, Harkness, Ernst, et al. Pain 2001; 9: 79-89

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Random bias
Selection bias

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Hierarchy of evidence

Systematic reviews of RCTs Randomised clinical trials Controlled clinical trails Uncontrolled data (e.g. case reports, case series,

bservational studies)

Ernst E. Complementary Medicine, Peninsula Medical School

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SRs of Spiritual healing

(n = 23 RCTs) The methodological limitations of several studies make it difficult to draw definitive conclusions… However, .. 57% of trials showed a positive treatment effects, the evidence thus far merits further study.

Astin et al. Ann Intern Med 2000; 134: 903

(n = +17 studies) [The new trials]…shift the weight of the evidence against the notion that distant healing is more than a placebo.

Ernst. WKW 2003: 241

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Systematic reviews of CAM: potential problems

Primary data are flawed
Primary data are scarce
Publication bias
Heterogeneity
Investigators are not impartial
Funds are scarce

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(Cochrane) Reviews of CAM Modalities

Cochrane Non- Cochrane Total Non-herbal supplements 71 46 117 Herbal remedies 23 79 102 Acupuncture 10 69 79 Chiropractic 2 33 35 Homeopathy 4 34 38 Other 53 171 224 Total 163 332 495

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Ginkgo for dementia

Ernst, Pittler Perfusion 2005; 18: 388

Design: Sample: Results: systematic review 10 RCTs

Methodological quality was often

excellent

Totality of this evidence suggest

efficacy in delaying clinical deterioration

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2. Safety

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Evaluating the safety of CAM: potential problems

General opinion (CAM is safe)
Safety is not an issue in CAM research
CAM community is not cooperative
There is no ‘post-marketing’ surveillance
There are no reliable data
Investigators are not impartial
Funds are non-existent

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Adverse effects of CAM

Abbot, White, Ernst. Nature 1996; 381: 361

Survey of large sample of British CAM users

Therapy reporting adverse effects Spinal manipulation 15.8 % (~50%) Acupuncture 12.5 % (7-11%) Homoeopathy 9.8 % (~20%) Herbal medicine 7.6 % (depends)

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Specific research question

Ginkgo biloba has been associated

with complications of bleeding

Does ginkgo affect haemostasis
as a monotherapy?
through herb-drug interactions?

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Ginkgo: case reports of bleeding

Ernst et al. Perfusion 2005; 18: 52

Design: Searches: Inclusion: Results: Conclusions: systematic review 5 electronic databases clinical reports of bleeding associated with ginkgo monopreparations

12 articles were found
methodological quality often poor
likelihood of causality was low

“causality between ginkgo biloba intake and bleeding is unlikely”

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Ginkgo: RCTs testing effects on coagulation

Savovic, Wider, Ernst Evid Based Int Med 2005; 2: 167

Design: Searches: Inclusion: Results: Conclusions: systematic review 6 electronic databases RCTs assessing at least 1 coagulation parameter

8 RCTs were found (2 on interactions)
most were of good methodological quality
no significant changes were observed

“evidence does not demonstrate that extracts

f ginkgo biloba causes significant changes in

blood coagulation parameters”

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Obstacles

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CAM research: direction of conclusions

Giovannini, et al. FKM 2004

10- 9- 8- 7- 6- 5- 4- 3- 2- 1-

Germany

10.0 2.5 4.0 1.3 2.0 0.8 0.4 4.5

UK Italy France Spain NL Belgium USA n=137 n=183 n=39 n=47 n=24 n=17 n=17 n=183

(n = 652, year 2002)

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CAM: the “black and white” view Opponents: CAM is a waste of time, regardless of evidence Proponents: CAM is useful, regardless

f evidence

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Homeopathic treatment for chronic disease

Spence DS, et al. J Alt Comp Med 2005; 11: 793

Design: Sample: Endpoint: Results: Conclusion: Observational study 6544 chronic out-patients 7-point Likert scale 71% of all patients perceived positive changes “The results show that homeopathic treatment is a valuable intervention”

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5 10 15 20 25 30 35 40 45 50 1st Qtr 2nd Qtr

symptom time treatment

} PTE

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Perceived therapeutic effect (PTE)

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5 10 15 20 25 30

Natural course of disease Concommitant treatments Regression towards the mean Therapist-patient interaction Social desirability Placebo-effect (expectation) Specific therapeutic effect

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The “perceived therapeutic effect”

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The dilemma A form of CAM is ineffective but nevertheless helps patients

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What counts is that it helps patients

The Times. 11 Dec 2004

Waxman J, oncologist at Imperial College London: “I’m all for healers. I’ve seen my patients look and feel better as a result. Who cares how it works as long as it does?”

Six counter-arguments:

1. therapy could also do harm
2. endorsement leads to use as an alternative
3. even effective therapies have a placebo-effect
4. doctors should not delegate empathy
5. therapy costs £100 per session
6. endorsement of mystical nonsense undermines rationality

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It follows:

The use of an ineffective CAM is

rarely justified.

Prescribe a treatment with specific

effects and maximize non-specific effects simultaneously.

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Conclusion

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Royal Society 2006

“CAM, like conventional medicines, should be subject to careful evaluation

f their effectiveness and safety. It is

important that treatments…are properly tested and that patients do not receive misleading information…NHS provision for CAM…should be confined to treatments that are supported by…evidence of both effectiveness and safety”

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Email: Edzard.Ernst@pms.ac.uk Website: www.pms.ac.uk/compmed

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