complementary medicine: exploring the€¦ · complementary medicine, and • using complementary...

Complementary Medicine: Exploring the Issues U3A City Short Course, June‐July, 2014

Dr Ken Harvey

Complementary Medicine: Exploring the Issues

Short Course (2 of 3 sessions), June 2015, GAA House

Dr Ken Harvey MB BS, FRCPA

Adjunct Associate Professor, School of Public Health and Preventive Medicine

http://www.medreach.com.au

• What is complementary &/or alternative medicine?

• Who uses it, why and what for?

• Regulation: products, promotion, practitioners.

• The current review of the private health insurance rebate for natural therapies.

• How do we know if it works: what is evidence?

• Evidence for and against specific products &/or therapies for certain conditions.

• Sources of good information about complementary medicine, and

• Using complementary medicine wisely.

Issues that could be explored

2


Dr Ken Harvey

Regulation of practitioners

3

http://yescourse.com/store/immunisation-options-for-parents/


44


Dr Ken Harvey


• National registration of some health professions(AHPRA) aims to ensure a minimal level of education and training, appropriate standards of professional behaviour and effective and efficient complaint mechanisms.

• Naturopaths and many other complementary medicine (CM)practitioners have not achieved national registration, in part because of division in their ranks, but also because of their varied training.

• CM practitioners may be members of professional associations but this does not necessarily ensure evidence‐based practice, continuing professional education or good complaint handling processes.

• State based health complaints entities and/or the ACCC are available for complaints about unregistered practitioners but have problems.

5


6


Dr Ken Harvey


7

Options for unregistered practitioners, 2011


Dr Ken Harvey

AHMAC Standing Council on Health, August 2013

• Ministers agreed to strengthen state and territory health complaints mechanisms via:– a single national Code of Conduct for unregistered health

practitioners to be made by regulation in each state and territory, and statutory powers to enforce the Code by investigating breaches and issuing prohibition orders;

– a nationally accessible web based register of prohibition orders; and

– mutual recognition of state and territory issued prohibition orders.

• AHMAC will undertake a public consultation on the terms of the first national Code of Conduct and proposed policy parameters to underpin nationally consistent implementation of the Code, for consideration by Ministers.

9

Code of conduct for unregistered health practitioners (NSW)

3. Health practitioners to provide services in safe and ethical manner

(a) A health practitioner must maintain the necessary competence in his or her field of practice,

(d) A health practitioner must recognise the limitations of the treatment he or she can provide and refer clients to other competent health practitioners in appropriate circumstances.

11. Health practitioners required to have clinical basis for treatments

A health practitioner must not diagnose or treat an illness or condition without an adequate clinical basis.

12. Health practitioners not to misinform their clients

(3) A health practitioner must not make claims, either directly or in advertising or promotional material, about the efficacy of treatment or services provided if those claims cannot be substantiated.

10


Dr Ken Harvey

A National Code of Conduct for health care workers, 2014

• Clause 11 of the NSW Code and Clause 10 of the SA Code states:– ‘A health practitioner must have an

adequate clinical basis for treatment’.

• This clause has not been included in the draft National Code.

• However, clause 9 (c) states: – a health care worker must not make claims

either directly to clients or in advertising or promotional materials about the efficacy of treatment or services he or she provides if those claims cannot be substantiated.

11

A National Code of Conduct for health care workers, 2015

• Recommendations– That a National Code of

Conduct for health care workers in the terms set out in Appendix 1 be approved as the basis for enactment of a nationally consistent code‐regulation regime for all health care workers.

– That jurisdictions enact or amend legislation to give effect to the National Code of Conduct and a nationally consistent code‐regulation regime for health care workers.

– That an independent review of the national code‐regulation regime be initiated by Health Ministers following five years of the regime’s operation or an earlier review if requested by Health Ministers. 12http://tinyurl.com/nyv2pws


Dr Ken Harvey










13

Natural Therapy Review Advisory Committee

• The review’s purpose is to ensure that taxpayer funds that are paid through the private health insurance rebate to subsidise natural therapies are underpinned by a credible evidence base that demonstrates their clinical efficacy, cost effectiveness and safety and quality.

• The Natural Therapy Review Advisory Committee (NTRAC) will use the NHMRC review of natural therapies and will make recommendations to as to which therapies are underpinned by a credible evidence base.

14http://www.health.gov.au/internet/main/publishing.nsf/Content/phi-natural-therapies


Dr Ken Harvey

Private Health Insurance (PHI)

• The government (all taxpayers) currently provides a rebate to the cost of PHI to around 50% of the population who choose (or can afford) PHI.

15

Private Health Insurance (PHI)

• Many private health insurance (PHI) funds provide ancillary (extras) cover for a range of natural therapies.

• The ancillary benefits provided by different funds are currently a commercial decision; they take no account of clinical effectiveness and vary widely with respect to the services covered and the maximum money refunded per service per person per year.

16


Dr Ken Harvey

Private Health Insurance: Natural therapies covered

17


• While natural therapies only provide a relatively small proportion (6.5 per cent) of all ancillary benefits paid, they are growing at a much greater rate than other services.

• For example, between September 2000 and September 2013, the number of dental services funded doubled whereas natural therapies services increased nine fold.

18

http://phiac.gov.au/wp-content/uploads/2014/02/benefitsAUS.zip


Dr Ken Harvey

NHMRC Natural TherapiesWorking Committee

• The NHMRC are currently reviewing the evidence for the effectiveness of “natural therapies” such as massage, aromatherapy, homeopathy, naturopathy, reflexology and western herbalism for NTRAC.

• They are undertaking a systematic review of available evidence on their effectiveness in treating a variety of clinical conditions in humans and also assess evidence provided by stakeholders.

http://www.nhmrc.gov.au/your-health/complementary-and-alternative-medicines 19

Types of evidence

20

Meta-analysis


Dr Ken Harvey

NHMRC assessment of evidence

• Randomised controlled clinical trials– the medicine is compared with a substance

that has no effect (placebo) in a group of people with the health condition (placebo‐controlled trial), or the medicine is compared with an effective standard treatment (controlled trial).

– each participant is given either the medicine or the placebo/other treatment at random (randomised trial) .

– participants (and researchers) do not know whether they are taking the medicine or the placebo/other treatment until the study is finished (double‐blinded trial).

21


• Randomised controlled clinical trials (cont.)– there are enough participants to be

reasonably confident that, if there is a bigger change in the health condition in one group, this is not just due to chance.

– the correct statistical methods are used to analyse the results and ascertain whether the results could have been caused by chance;

• P < 0.05; 95% confidence intervals.

– Ideally independent of vested interests (low bias).

– peer reviewed.

– published in reputable journals.

– replicated. 22


Dr Ken Harvey


• The results of individual studies need to be replicated in other independent studies, to make sure the effects seen were not just due to chance.

• The most reliable information comes from research that combines the results of all available similar studies (systematic reviews) and analyses the results together (meta‐analysis).

23

What is a systematic review?

A collation of all the evidence that fits pre‐specified eligibility criteria in order to answer a specific research question. It uses:• A clearly stated set of objectives with pre‐defined

eligibility criteria for including studies;

• An explicit, reproducible methodology;

• A systematic search that attempts to identify all studies that would meet the eligibility criteria;

• An assessment of the validity of the findings of the included studies, for example through the assessment of risk of bias; and

• A systematic presentation, and synthesis, of the characteristics and findings of the included studies

including meta‐analysis of the data. 24


Dr Ken Harvey

NHMRC First Report: Homeopathy

• The NHMRC was concerned that unconventional products and procedures are often promoted to improve people’s health when there is little or no evidence of their benefit, except for the benefits people experience when they believe that a treatment is effective (the placebo effect).

• Sometimes patients may be misled into rejecting practices and treatments that are proven to be effective.

• There is disagreement about whether homeopathy is effective 25

Why?

Homeopathy

26

The New Melbourne Homeopathic Hospital 1885-1934St Kilda Road, Melbourne

(In 1934 it became Prince Henry’s allopathic hospital)

Samuel Hahnemann (1755-1843): The Father of Homeopathy


Dr Ken Harvey

Homeopathic remedy

27

Each tablet is medicated with 278 μg of each of: • Aconitum napellus (wolfsbane) 3C, • Allium cepa (onion), 2C, • Arsenicum album (arsenic) 6C, • Euphrasia officinalis (eyebright) 4C,• Hepar sulfuris (calcium sulphide) 6C, • Kali bichromicum (potassium

dichromate) 3C, • Natrum muriaticum (table salt) 3C, • Nux vomica (strychnine) 5C, • Pulsatilla (pasque flower) 3X.

10:23 Campaign AgainstHomeopathy ‐Melbourne

28


Dr Ken Harvey


• Three main sources of information:– published systematic reviews,

– information provided by homeopathy interest groups and the public

– clinical practice guidelines and government reports on homeopathy published in other countries.

• The assessment was guided by a committee of experts appointed in 2012 (The NHMRC Homeopathy Working Committee).

29


• For each health condition, all the available evidence was grouped together to form a body ofevidence on that condition.

• A body of evidence was considered more reliable if it included studies that were high quality, well designed and with enough participants to make its results meaningful.

• A body of evidence was considered less reliable if there were very few studies, or if the studies were poor quality, badly designed, or included too few participants.

• The quality of evidence found was generally low.

30


Dr Ken Harvey


• The NHMRC concluded that there were no health conditions for which there was reliable evidence that homeopathy was effective.

• This conclusion is similar to that of a 2010 UK House of Commons Science and Technology Select Committee, which also looked at the scientific evidence and stated:

– “In our view, the systematic reviews and meta‐analyses conclusively demonstrate that homeopathic products perform no better than placebos”.

31

http://consultations.nhmrc.gov.au/public_consultations/homeopathy_health

Industry response

• Australian homoeopathic organisations expressed concern at the limitations of the NHMRC evaluation which considered only systematic reviews of homeopathy rather than searching for all published studies of homeopathy.

• They were concerned that the NHMRC evaluation excluded observational and outcomes studies that examined effectiveness of treatments in real‐world conditions.

• The noted that although this evidence may in some instances be of a lower quality, it did not support a conclusion that homoeopathic treatment equates to placebo treatment.

• They also emphasised that, “the absence of evidence does not mean absence of effect”.

32http://www.asbrm.com.au/images/ASBRM_News_LetterV5_June2014.pdf


Dr Ken Harvey

Possible Implications

33


34


Dr Ken Harvey


35


36

HLT60612 - Advanced Diploma of Homoeopathy (Release 1)


Dr Ken Harvey


37


38http://www.youtube.com/watch?v=p2FT8kNCYMs


Dr Ken Harvey



• Services subsidised under Medicare by health professionals regulated by AHPRA under the National Registration and Accreditation Scheme (NRAC) will not be affected by the review.

• These include Chinese Traditional Medicine, Chiropractic and Osteopathy.

http://www.health.gov.au/internet/main/publishing.nsf/Content/phi-natural-therapies 40


Dr Ken Harvey

Should AHPRA registered practitioners be exempt?

41


42http://www.universalhealth.com.au/services/pdf/chiropractic_paediatric.pdf

http://www.malchiro.com.au/testimonials.html


Dr Ken Harvey


43 43

The National Law (s.133) prohibits advertising that:

• Is false, misleading or deceptive or is likely to be so,

• Offers a gift, discount or other inducement to attract a user of the health service without stating the terms and conditions of the offer,

• Uses testimonials or purported testimonials,

• Creates an unreasonable expectation of beneficial treatment, and/or

• Encourages the indiscriminate or unnecessary use of health services.


Dr Ken Harvey




• The current review of the private health insurance rebate for natural therapies;.

• How do we know if it works: what’s evidence?





45

What’s evidence?

• Friends, colleagues, social media (and testimonials) might say, “It worked for me”.

• But the plural of anecdote is not evidence.

• There are a number of reasons why consumers (and practitioners) convince themselves that a treatment is effective when it is not including:

– Placebo effect (patient’s expectation regarding an intervention),

– The natural history of disease (symptoms may wax and wane) ,

– Confirmation bias (seeing what you expect to see),

– Cognitive dissonance (ignoring results not in accord with expectations),

– Endorsement by “celebrities” who receive multi‐million payments (be especially suspicious).

• In short, personal evaluation is quick, convincing and often wrong, while blinded, controlled clinical trials are slow, complex, and costly.

• However, the latter are important as they often show that initially promising results are not replicated by larger and better conducted studies.

46


Dr Ken Harvey

SensaSlim: Promotion

47

SensaSlim: Promotion

48


Dr Ken Harvey

ACCC v SensaSlim July 21, 2011

21st July 2011

• The Federal Court ordered SensaSlim to publish a notice on their web site including a statement that they had,– “falsely representing that the SensaSlim Solution

was the subject of a large worldwide clinical trial when in fact no such trial was conducted, etc.”

49

Research: Slim by chocolate

• Sixteen subjects (5 men, 11 women) were divided into 3 groups:– Low‐carb diet

– Low‐carb diet plus 43 g bar dark chocolate

– Usual diet (control).

• 18 different measurements were performed over 3 weeks:– weight, cholesterol, sodium, blood protein

levels, sleep quality, well‐being, etc.

• Both treatment groups lost about 2.2 kg but the chocolate group lost weight 10% faster and had better cholesterol and well‐being scores (P < 0.05). 50

http://instituteofdiet.com


Dr Ken Harvey

International Press Release: Slim by Chocolate

51

Chocolate diet hoax: How to fake a weight loss trend

• A HEALTH writer sick of seeing stories about miracle weight loss tricks decided to see how easy it was to turn bad science into a bogus diet headline.

• The writer styled himself as Johannes Bohannon PhD, lead author of a ground‐breaking German study and research director at The Institute of Diet and Health, for which he set up a worryingly simplistic website.

• “It was, in fact, a fairly typical study for the field of diet research,” writes Bohannon. The study design (small number of participants and many measurements) was a recipe for false positives.

52


Dr Ken Harvey

Chocolate diet hoax: How to fake a weight loss trend

• They produced a paper, “Chocolate with high cocoa content as a weight‐loss accelerator”, and were offered publication in 20 scientific journals within 24 hours.

• They faced no peer review, and after paying out 600 euros, their spot in the International Archives of Medicine was secured. Not a word was changed.

• The results were meaningless, and the health claims that the media blasted out to millions of people around the world are utterly unfounded.

• And that’s the unhelpful truth behind so many dodgy weight loss and other claims for complementary medicines.

53

New drug development

• Pre‐clinical– Animal studies (toxicology)

• Human clinical trials– Phase I

• Healthy human volunteers; dose finding; small numbers (typically 6–60)

– Phase II• In patients; safety/efficacy; dose confirmation

– Phase III• In patients; randomized against placebo or the current standard treatment; safety/efficacy; larger numbers (typically 1000–3000)

• Marketing application (Therapeutic Goods Administration)

• Product licensed for marketing– Phase IV

• Post‐marketing; compared against active treatments, considered for subsidy (PBS). 54


Dr Ken Harvey

U.S. Justice Department Fines

55

Unethical conduct

• Trials manipulated; negative results suppressed.

• Journal articles “ghost‐written”.

• Off‐label promotion.

• Well paid, but undeclared, medical opinion leaders used to promote company products (educational mercenaries).

• Excessive hospitality, kickbacks, bribery.

• Consumer groups manipulated.• Spurious patents and legal challenges to

delay the entry of generics.56 56


Dr Ken Harvey

Clinical trials results need to be published

57http://www.alltrials.net

They also need to be replicated

58

http://www.abc.net.au/worldtoday/content/2015/s4215290.htm

http://tinyurl.com/ngzz9oz


Dr Ken Harvey

Current knowledge:Fish vs supplements

59

Meta‐analysis of calcium ± vitamin D on hip fracture risk in randomized controlled trials

60http://www.ncbi.nlm.nih.gov/pubmed/25495429


Dr Ken Harvey

61http://www.australianclinicaltrials.gov.au/

62


Dr Ken Harvey

Problem reporting

www.mediadoctor.org.au

Problems: media

• Many media stories about new medicines– Overstate benefits

– Understate risks

– Understate costs

– Fail to disclose relevant financial ties.

• 207 stories from 1994 to 1998– 40% did not report benefits quantitatively

• Of those that did, 83% reported only relative benefits

– 53% did not mention potential harm

– 70% did not mention cost of therapy

– 39% disclosed ties where it was relevant.64Moynihan R et al. NEJM 2000;342:1645–50


Dr Ken Harvey

Relative and absolute benefits / risks

• WHI ‐ Risks and benefits of HRT in healthy post‐menopausal women (JAMA 2002; 288: 321–33)

• A randomized, placebo‐controlled, primary prevention trial (planned duration, 8.5 years) in which 16,608 postmenopausal women aged 50‐79 years (the majority over 60 years) with an intact uterus at baseline were recruited by 40 US clinical centres in 1993‐1998.

• It reported the risk of invasive breast cancer increased by 26% (relative risk) with HRT which triggered wide‐spread panic and many women ceased HRT.

• In fact, the risk only increased by 8 cases per 10,000 person years (38 versus 30 per 10 000 person‐years) and absolute risk increase of 0.08%.

• Always ask for the absolute numbers involved, not just the percentage risk or benefit. 65

Evidence: questions to ask

• How strong is the evidence to support the claims being made about the therapy:– levels of evidence?

– trials registered?

– results published?

– replicated by others?

• Could the therapy be shonky?– glowing testimonials but no trial results?

– do those promoting it profit from it?

– listed in Quackwatch?

– complaints upheld by the CRP?

– product removed from the ARTG by the TGA? 66


Dr Ken Harvey


• What’s the size of the potential benefit and risk offered by the therapy, and for what types of patients:– statistically significant?

– clinically significant?

– absolute benefits and risks (not relative)?

– Numbers needed to treat?

– Numbers needed to harm?

• What are the costs of the therapy and are the potential risks and benefits worth the cost?

67

http://www.thennt.com/


• What are the alternatives to the therapy being offered:– watchful waiting?

• research is always progressing.

– non‐drug options such as physiotherapy?

– evidence‐based complementary therapies?

• What do reputable patient support groups and their medical advisors say?

• In short, while there are many ethical responsible and knowledgeable health practitioners and therapeutic goods companies out there….

• I reiterate, ask for (and evaluate) the evidence.

68


Dr Ken Harvey









Last session

69

Last session: Evidence for specific products &/or therapies

70

complementary medicine: exploring the€¦ · complementary medicine, and • using complementary...

Documents