Beweisstück.
https://www.hri-research.org/wp-content/uploads/2014/07/Evidence-Check-2-Homeopathy-report-2010.pdf[*quote*]
House of Commons
Science and Technology
Committee
Evidence Check 2:
Homeopathy
Fourth Report of Session 2009–10
EMBARGOED ADVANCE COPY
Not to be published in full,
or in part, in any form before
11.00 on Monday 22 February 2010
HC 45House of Commons
Science and Technology
Committee
Evidence Check 2:
Homeopathy
Fourth Report of Session 2009–10
Report, together with formal minutes, oral and
written evidence
Ordered by the House of Commons
to be printed 8 February 2010
EMBARGOED ADVANCE COPY
Not to be published in full,
or in part, in any form before
11.00 on Monday 22 February 2010
HC 45
Published on 22 February 2010
by authority of the House of Commons
London: The Stationery Office Limited
£0.00The Science and Technology Committee
The Science and Technology Committee is appointed by the House of Commons
to examine the expenditure, administration and policy of the Government Office
for Science. Under arrangements agreed by the House on 25 June 2009 the
Science and Technology Committee was established on 1 October 2009 with the
same membership and Chairman as the former Innovation, Universities, Science
and Skills Committee and its proceedings were deemed to have been in respect
of the Science and Technology Committee.
Current membership
Mr Phil Willis (Liberal Democrat, Harrogate and Knaresborough)(Chairman)
Dr Roberta Blackman-Woods (Labour, City of Durham)
Mr Tim Boswell (Conservative, Daventry)
Mr Ian Cawsey (Labour, Brigg & Goole)
Mrs Nadine Dorries (Conservative, Mid Bedfordshire)
Dr Evan Harris (Liberal Democrat, Oxford West & Abingdon)
Dr Brian Iddon (Labour, Bolton South East)
Mr Gordon Marsden (Labour, Blackpool South)
Dr Doug Naysmith (Labour, Bristol North West)
Dr Bob Spink (Independent, Castle Point)
Ian Stewart (Labour, Eccles)
Graham Stringer (Labour, Manchester, Blackley)
Dr Desmond Turner (Labour, Brighton Kemptown)
Mr Rob Wilson (Conservative, Reading East)
Powers
The Committee is one of the departmental Select Committees, the powers of
which are set out in House of Commons Standing Orders, principally in
SO No.152. These are available on the Internet via
www.parliament.ukPublications
The Reports and evidence of the Committee are published by The Stationery
Office by Order of the House. All publications of the Committee (including press
notices) are on the Internet at
http://www.parliament.uk/scienceA list of reports from the Committee in this Parliament is included at the back of
this volume.
Committee staff
The current staff of the Committee are: Glenn McKee (Clerk); Richard Ward
(Second Clerk); Dr Christopher Tyler (Committee Specialist); Xameerah Malik
(Committee Specialist); Andy Boyd (Senior Committee Assistant); Camilla Brace
(Committee Assistant); Dilys Tonge (Committee Assistant); Melanie Lee
(Committee Assistant); Jim Hudson (Committee Support Assistant); and Becky
Jones (Media Officer).
Contacts
All correspondence should be addressed to the Clerk of the Science and
Technology Committee, Committee Office, 7 Millbank, London SW1P 3JA. The
telephone number for general inquiries is: 020 7219 2793; the Committee’s e-
mail address is: scitechcom@parliament.uk.Evidence Check 2: Homeopathy
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1
Contents
Report
1
Introduction
Evidence Check inquiries
The inquiry
Structure of the report
2
NHS funding and provision
What is homeopathy?
The policy
Our expectations of the evidence base
Scientific plausibility
Evidence of efficacy
The distinction between efficacy and effectiveness
Homeopathic provings
Summary
The evidence check
Scientific plausibility for a mode of action
Ultra-dilutions
Evidence of efficacy
Effectiveness
Homeopathy on the NHS
Conclusions
3
MHRA licensing
The policy
Our expectations of the evidence base
User-testing of labels for homeopathic products
The Evidence Check
Evidence of efficacy
The purpose of the National Rules Scheme
Labelling of homeopathic products
The role of pharmacies
Conclusions on the licensing regimes
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Conclusions 42
Conclusions and recommendations 43
Formal Minutes 48
Witnesses 51
List of written evidence 51 2
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List of unprinted evidence 53
List of Reports from the Committee during the current Parliament 54 Evidence Check 2: Homeopathy
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1 Introduction
Evidence Check inquiries
1. Since the Science and Technology Committee was reformed in October 2009, we have
been running a novel programme of work that we have called “Evidence Check”. The
purpose of Evidence Check is to examine how the Government uses evidence to formulate
and review its policies. We have focussed on narrow policy areas and asked the
Government to answer two questions: (1) what is the policy? and (2) on what evidence is
the policy based? In December 2009 we published our first Evidence Check on Early
Literacy Interventions. 1
2. This is the second Evidence Check report. It examines the Government’s policies on the
provision of homeopathy through the National Health Service (NHS) and the licensing of
homeopathic products by the Medicines and Healthcare products Regulatory Agency
(MHRA). We selected this topic following the Government’s responses in September 2009
to questions we asked about the evidence base underpinning several different policies. The
Government’s response on homeopathy indicated that scientific evidence was not used to
formulate the licensing regime operated by the MHRA. 2 We were surprised by this
response and decided to broaden the inquiry to include consideration of the evidence base
underpinning the Government’s policy regarding the funding of homeopathy on the NHS.
The inquiry
3. This inquiry had a dual focus on the NHS and the MHRA. In October 2009 we issued a
call for written evidence on:
• Government policy on licensing of homeopathic products;
• Government policy on the funding of homeopathy through the NHS; and
• the evidence base on homeopathic products and services. 3
4. This inquiry was an examination of the evidence behind government policies on
homeopathy, not an inquiry into homeopathy. We do not challenge the intentions of those
homeopaths who strive to cure patients, nor do we question that many people feel they
have benefited from it. Our task was to determine whether scientific evidence supports
government policies that allow the funding and provision of homeopathy through the
NHS and the licensing of homeopathic products by the MHRA.
5. We received around 60 written submissions. Because we had received a response from
the Government on MHRA licensing prior to calling for written submissions, 4 the
1 Science and Technology Committee, Second Report of Session 2009–10, Evidence Check 1: Early Literacy
Interventions, HC 44
2 Ev 60
3 “New Inquiry, Evidence Check: Homeopathy”, House of Commons Science and Technology Committee press notice
No. 11, Session 2008–09
4 Ev 604
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Government’s response on that aspect of the inquiry was available for interested parties to
read and comment on in their written submissions. Additionally, some were received after
the oral evidence sessions had concluded and some of these commented on the oral
evidence. 5 We also received many background papers relating to the inquiry.
6. On 25 November 2009 we took oral evidence from two panels; one focused on NHS
funding and provision of homeopathy and the other on MHRA licensing. The expertise of
the witnesses on each panel spread across both topics and there was overlap on the issues
discussed, particularly in relation to the evidence base. On 30 November 2009 we took oral
evidence from Mike O’Brien QC MP, Minister for Health Services, Professor David
Harper, Chief Scientist at the Department of Health (DH), and Professor Kent Woods,
Chief Executive of the MHRA, on the Government’s policies.
7. We carefully considered all the background documents, written submissions and oral
evidence in drawing up our conclusions and recommendations. We would like to put on
record our thanks to all those who made submissions and gave evidence to the inquiry.
Structure of the report
8. This report is in two parts. Chapter 2 addresses the evidence base for the provision of
homeopathy on the NHS. Chapter 3 examines the evidence base for the MHRA’s licensing
regime for homeopathic products. In each chapter we have adopted the approach we
followed in the first Evidence Check inquiry: we have outlined the Government’s policy,
summarised what we would expect of a good evidence base and then evaluated whether the
Government’s policy is sufficiently evidence-based (the Evidence Check).
5
For example, Ev 189–194Evidence Check 2: Homeopathy
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2 NHS funding and provision
What is homeopathy?
9. Homeopathy is a 200-year old system of medicine that seeks to treat patients with highly
diluted substances that are administered orally. Homeopathy is based on two principles:
“like-cures-like” whereby a substance that causes a symptom is used in diluted form to
treat the same symptom in illness 6 and “ultra-dilution” whereby the more dilute a
substance the more potent it is (this is aided by a specific method of shaking the solutions,
termed “succussion”). 7 It is claimed that homeopathy works by stimulating the body’s self-
healing mechanisms. 8
10. Homeopathic products should not be confused with herbal remedies. Some
homeopathic products are derived from herbal active ingredients, but the important
distinction is that homeopathic products are extremely diluted and administered according
to specific principles.
The policy
11. The Department of Health (DH) told us that it “does not maintain a position” on any
complementary or alternative treatment, including homeopathy. 9 Decisions on the use of
homeopathy are left to the National Health Service (NHS). 10 Primary Care Trusts (PCTs)
are responsible for commissioning care services 11 and are thus currently free to fund
homeopathy.
12. Homeopathy was introduced into Britain in the 1830s and has been funded and
provided on the NHS since its inception in 1948. 12 There are four homeopathic hospitals in
the UK, located in London, Bristol, Liverpool and Glasgow. These hospitals fall under the
jurisdiction of their respective PCTs. A homeopathic hospital in Tunbridge Wells was
closed in 2009 following a drop in referrals to the hospital and a review by the West Kent
PCT on the commissioning of homeopathy. 13
13. The Government was unable to tell us how much money the NHS spends on
homeopathy as “data on spending in the area of homeopathy on the National Health
Service has never been routinely collected”. 14 When he gave oral evidence Mike O’Brien,
Minister for Health Services at the DH, was, however, able to say that:
6
We examine the issue of “like-cures-like” in more detail at paragraph 50 and following.
7 “How does homeopathy work?”, British Homeopathic Association,
www.britishhomeopathic.org8 “What is homeopathy?”, The Society of Homeopaths,
www.homeopathy-soh.org9 Ev 61, para 7
10 As above
11 Ev 61, para 11
12 Ev 174, para 2.1
13 Ev 61, para 9; see also paragraph 83 and following.
14 Ev 62, para 186
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In terms of drugs it is £152,000 a year which comes from a budget of £11 billion. It is
approximately 0.001 per cent, we calculated, of the drugs budget. In terms of overall
funding it is very difficult to know. We have done some work to see if we can find
out what it is. We have four hospitals—one in Glasgow, three in England—which
provide homeopathic assistance to people and we do provide some NHS funding for
those, so it would run into several million on that basis, so probably less than 12—
I think I saw that in The Guardian as a quote—so probably less than that but not too
much less. 15
14. In June 2009 the Guardian reported that the NHS had spent £12 million on
homeopathy in the period 2005–08. 16 According to the Society of Homeopaths, the NHS
spends £4 million on homeopathy annually. 17 It appears that these figures do not include
maintenance and running costs of the homeopathic hospitals or the £20 million spent on
refurbishing the Royal London Homeopathic Hospital between 2002 and 2005. 18
15. When we asked Dr Mathie of the British Homeopathic Association (BHA) whether
money spent by the NHS on homeopathy could be usefully redirected elsewhere, he replied
that “there is a need for cost-effectiveness evaluation of homeopathy. There is almost
none”. 19 It is impossible to evaluate the overall cost-effectiveness of homeopathy provided
by the NHS if the cost is unknown. We recommend that the Government determine the
total amount of money spent by the NHS on homeopathy annually over the past 10
years, differentiating homeopathic products, patient referrals and maintenance and
refurbishment of homeopathic hospitals, and publish the figures.
Our expectations of the evidence base
16. The NHS Constitution, which outlines patient rights, states:
You have the right to expect local decisions on funding of [...] drugs and treatments
to be made rationally following a proper consideration of the evidence. 20
17. This statement summarises our own expectations. NHS funding of treatments is
expensive and of high societal importance, and therefore it is crucial that decisions are
made on the best available evidence. We would expect the Government’s policy on NHS
funding and provision of homeopathy to be evidence-based. We outline below our views
on the different types of evidence and their individual importance as a component of the
overall evidence base.
15
Q 244
16 “Critics find NHS's £12m spend on homeopathy hard to swallow”, The Guardian, 10 June 2009
17 Ev 141, para 8.3
18 “New developments: Royal London Homeopathic Hospital redevelopment”, University College London Hospitals
press release, 16 June 2005
19 Q 128
20 Department of Health, “The NHS Constitution for England”, January 2009Evidence Check 2: Homeopathy
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Scientific plausibility
18. Medical interventions are usually supported by explanations for how they work and the
same is true of homeopathy. Scientific explanations for a mechanism of action are
important because they can lead to refinements of medicines: for example, new vaccines
for viruses based on the known mechanisms of immunisation. Understanding a
mechanism of action can also enable the development of entirely new medicines: for
example, the persistent threat of resistance means that new anti-malarial drugs with novel
mechanisms of action are continually required. 21 Our expectation of an explanation for a
mechanism of action is that it is both scientifically plausible and demonstrable. We should,
however, add that, while we comment on explanations for how homeopathy works, it is
not a key part of our Evidence Check. Historically, some medical interventions were
demonstrably effective before anyone understood their modes of action. For example, after
150 years of use, there is still debate about precisely how anaesthetics work. 22 It is more
important to know whether a treatment works—its efficacy—than how it works.
Evidence of efficacy
Randomised controlled trials (RCTs)
19. Randomised Controlled Trials (RCTs) are the best way of determining whether a cause-
effect relationship exists between a treatment and an outcome. 23 Well designed RCTs have
the following important features:
• randomisation: patients should be randomly allocated to placebo (dummy
treatment) 24 or treatment groups—this ensures that there are no systematic
differences between patient groups that may affect the outcome;
• controlled conditions: aside from the treatment given, all patients should be treated
identically, whether in placebo or treatment groups—this excludes other factors
from influencing the outcome;
• intention to treat analysis: patients are analysed within their allocated group even if
they did not experience the intervention—this maintains the advantages of
randomisation which may be lost if patients withdraw or fail to comply;
• double blinding: patients and clinicians should remain unaware of which patients
received placebo or treatment until the study is completed—this eliminates the
possibility of preconceived views of patients and clinicians affecting the outcome;
and
• placebo controlled: if there is no appropriate alternative treatment against which to
compare the test treatment, the intervention under consideration is tested against a
dummy treatment to see if the intervention has any benefit or side effects.
21 T Wells, P Alonso and W Gutteridge, “New medicines to improve control and contribute to the eradication of
malaria”, Nature Reviews, November 2009, vol 8: 879
22 “Anaesthesia”, BBC Medical Notes, 2 May 2006, news.bbc.co.uk
23 “Understanding controlled trials: Why are randomised controlled trials important?”, BMJ,1998, vol 316, p 201
24 Placebos and the placebo effect are considered at paragraph 30 and following.8
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20. In clinical research, it is widely accepted that RCTs are the best way to evaluate the
efficacy of different treatments and distinguish them from placebos. However, some
supporters of homeopathy claim that RCTs are not an appropriate way to test homeopathy
because “they are far less suitable when studying the overall effects of a holistic therapy in a
complex organism with multiple problems”. 25 We do not agree. If homeopathic
products—or any medicinal product—are more than placebos, and all other elements of
the “holistic” care package are the same (controlled), it should be possible to see differential
results between the test substance and the placebo. We consider that conclusions about
the evidence on the efficacy of homeopathy should be derived from well designed and
rigorous randomised controlled trials (RCTs).
Meta-analyses and systematic reviews
21. There may be variation in the results produced by different RCTs, particularly if there
are many trials with low statistical power, that is, small trials with low numbers of
participants. When trials produce varying results, proponents of both sides of an argument
can “cherry-pick” data to support whichever side of the argument they like. This is a
situation we wish to avoid. We can do so by turning to two types of analysis of clinical trials
to help us appraise the evidence: meta-analyses and systematic reviews.
22. Meta-analyses combine the results of trials, increasing the sample size and statistical
power of the data. Meta-analyses may reveal statistically significant trends that were not
apparent by studying the trials individually. When pooling data, it is important to ensure
that the data are comparable. It is preferable that a meta-analysis only include well
designed trials, since these trials produce the most rigorous data. When meta-analyses are
conducted on less well-designed trials, the design flaws should be recognised and the
diminished power of the data acknowledged.
23. Systematic reviews refer to the process of collecting, reviewing and presenting all the
available evidence, for example, by selecting trials listed in the PubMed database 26 that
meet pre-defined criteria. Systematic reviews often, but not always, include a meta-
analysis. 27
24. Properly conducted systematic reviews have the following important features:
• the prior determination and explanation of eligibility criteria (which will allow or
disallow inclusion of published studies) for the systematic review;
• a literature search looking for all potentially relevant published studies;
• examination of the methodology of all potential candidate studies to ensure that
they fit the eligibility criteria; this includes clear rules about the design and
methodology of such studies.
• assembly of the most complete dataset feasible;
25 Ev 135 [Dr Eames], para 3.1
26 “PubMed”, National Centre for Biotechnology Information,
www.ncbi.nlm.nih.gov/pubmed27 “An introduction to meta-analysis”, The Cochrane Collaboration,
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• analysis of the results of included studies, with statistical analysis (meta-analysis) if
appropriate; and
• a critical summary of the systematic review, including identification of the
“confidence intervals” 28 and “statistical significance” 29 of any findings.
25. We expect the conclusions on the evidence for the efficacy of homeopathy to give
particular weight to properly conducted meta-analyses and systematic reviews of RCTs.
The distinction between efficacy and effectiveness
26. It has been suggested that it is useful to draw a distinction between efficacy and
effectiveness. 30 Dr Peter Fisher, Director of the Royal London Homeopathic Hospital,
explained the difference:
In simple terms the distinction is between ideal conditions and real world
conditions—efficacy being ideal conditions and effectiveness being real world
conditions. 31
27. Professor Edzard Ernst, Director of the Peninsula Medical School, gave the following
example:
Efficacy tests whether treatment works under ideal conditions; for instance, a
hypertensive agent may well be effective under ideal conditions and then will not
work in the real world because people experience side-effects. 32
28. The opposite might also occur: a product might not work in “ideal” conditions, but
may appear effective in “the real world”. In the case of homeopathy, arguments have
predominantly centred around whether or not it is a placebo treatment. If homeopathy was
better than a placebo treatment, one would expect tests of efficacy to show that it is
efficacious; and “real world” tests of effectiveness to show that it may or may not be
effective. If homeopathy was a placebo treatment, it would fail tests of efficacy, but with
tests of effectiveness it would appear to be effective for some conditions and some patients,
but not for others.
A summary of the logical outcomes depending on whether homeopathy is or is not a placebo
Efficacy
Effectiveness
Homeopathy is not a placebo
PASS
EITHER PASS OR FAIL
Homeopathy is a placebo
FAIL
29. The answer to why a medicine can be effective without being efficacious lies with a
phenomenon known as the placebo effect.
28 A confidence interval helps assess the likelihood of a result occurring by chance. A confidence interval represents a
range of values that is believed to encompass the “true” value with high probability (usually 95%).
29 A result is defined as statistically significant if it is unlikely to have occurred by chance, typically when the probability
of obtaining that result by chance is less than 5%.
30 Ev 162 [Dr Relton]
31 Q 116
32 As above10
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Placebos and the placebo effect
30. There is extensive scientific literature on placebos and the placebo effect. 33
31. The most frequently quoted definition of a placebo came from Arthur Shapiro, a
psychiatrist, who in 1964 described a placebo as “any therapeutic procedure which has an
effect on a patient, symptom, syndrome or disease, but which is objectively without specific
activity for the condition being treated”. 34
32. Shapiro then described the placebo effect as “the psychological or psychophysiological
effect produced by placebos”. 35 However, this is rather simplistic and therefore we are
attracted to the definition produced by Dr Howard Brody, Director of the Institute of
Medical Humanities at the University of Texas Medical Branch, who defined the placebo
effect as “a change in a patient’s illness attributable to the symbolic import of a treatment
rather than a specific pharmacologic or physiologic property”. 36 According to this
definition, the placebo effect does not necessarily require a dummy treatment. 37 It is
important to remember that when patients receive an efficacious treatment, they may
benefit from a placebo (non-specific) effect as well as the specific effect of the treatment.
Brody’s definition also allows for a wider range of non-specific effects, such as the doctor-
patient relationship, to be relevant to the placebo effect.
33. To complete the picture, it is worth mentioning that the impact of the placebo effect
may be positive or negative. In common usage, “placebo effect” refers to a positive
response. When there is a negative outcome, it is often referred to as the “nocebo effect”. 33
34. The placebo effect should not be confused with other phenomena. Sometimes patients
just get better and sometimes symptoms fluctuate in severity. If a patient seeks the advice of
a homeopath, GP or any other health specialist, when he or she is feeling most ill with a
condition that would get better of its own accord, for example a common cold, it is
statistically likely that he or she will begin recovery soon after the consultation anyway (the
natural course of a disease). If a patient seeks advice when he or she is suffering badly from
a symptom that fluctuates in severity, for example the pain of osteoarthritis, it is statistically
likely that he or she will experience alleviation of the symptoms soon after the consultation
anyway (regression to the mean). The effects of the natural course of a disease and
regression to the mean should be distinguished from the placebo effect. 38
35. The precise mechanisms of the placebo effect are not well understood. However,
studies have shown the following:
33 J M Anton de Craen, Ted J Kaptchuk, Jan G P Tijssen and J Kleijen, “Placebos and placebo effects in medicine:
historical overview”, Journal of the Royal Society of Medicine, vol 92 (1999), pp 511–515
34 A K Shapiro, “Factors contributing to the placebo effect. Their implications for psychotherapy”, American Journal of
Psychotherapy, vol 18 (1964), pp 73–88
35 As above
36 Brody H. “Placebos and the Philosophy of Medicine. Clinical, Conceptual and Ethical Issues”, University of Chicago
Press, 1980
37 de Craen et al, as above
38 E Ernst and K L Resch, “Concept of true and perceived placebo effects”, BMJ, 1995, vol 311, pp 551–553Evidence Check 2: Homeopathy
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• The placebo effect can be powerful but is usually only effective for relatively minor
ailments. 39
• The placebo effect is unpredictable. It is not possible to characterise who will be a
“placebo responder” (someone who reacts well to placebo treatment). 40 Nor has it
been possible to establish conclusively how many patients experience a placebo
effect.
• The placebo effect is culturally specific. Colours affect the perceived action of a
drug and seem to influence the effectiveness of a drug. For example red, yellow, and
orange are associated with a stimulant effect, while blue and green are related to a
tranquillising effect. 41 The route of administration also has an effect. For example,
one study showed that subcutaneous (injected) placebos were more effective than
oral placebos in the treatment of migraine. 42
36. Professor Ernst summarised the problem with prescribing placebos in the NHS:
I would argue it is unnecessary, unreliable and unethical to prescribe placebos
through the NHS; unnecessary because if you do it well then an active treatment will
also generate a placebo effect. If I give my patient an aspirin for his or her headache
and I do it with empathy, time and understanding this patient will benefit from the
pharmacological effect of the aspirin and she will also benefit from the placebo effect
through the encounter with her clinician. It is unreliable and there is lots of data to
show that placebo effects are notoriously unreliable; somebody who responds today
may not respond tomorrow; responses are not large in effect size and they are not
usually long-lasting. Foremost, it is unethical. 43
37. Despite the power of the placebo effect, there are a number of reasons why pure
placebos are not used routinely (officially) in the medical profession. First, as outlined
above, the placebo effect is unpredictable and highly susceptible to individual patient
expectations and therefore not a reliable treatment on its own. Second, there is a placebo
effect included in the delivery of efficacious treatment so it is not necessary to deliver a
placebo effect in isolation. Third, to maximise the impact of placebos, doctors need to
deceive their patients by, for example, telling them that the placebo pills they are receiving
are in fact a “proper” drug. To a certain extent, the greater the deception the stronger the
placebo effect. The nature of deception can vary between:
•
unintentional deception: where the practitioner prescribes a placebo, sincerely
believing that it is efficacious;
39 Ev 1 [RPSGB], para 3.08
40 A K Shapiro, “Factors contributing to the placebo effect. Their implications for psychotherapy”, American Journal of
Psychotherapy, vol 18 (1964), pp 73–88
41 A J de Craen, P J Roos, S Leonard de Vrie, J Kleijnen, “Effect of colour of drugs: systematic review of perceived effect
of drugs and of their effectiveness”, BMJ,1996 Dec 21–28, vol 313 (7072) pp 1624–6.
42 A J de Craen, J G P Tijssen, J de Gans and J Kleijnen, “Placebo effect in the acute treatment of migraine:
subcutaneous placebos are better than oral placebos”, J Neurol, 2000, vol 247: pp 83–188
43 Q 12612
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• paternalistic deception: where the practitioner prescribes a placebo, knowing it is
not efficacious but believing that it may be beneficial to the patient; and
• dishonest deception: where the practitioner prescribes a placebo, knowing it is not
efficacious, without acting in the patient’s best interest (for example, if they have a
vested interest in the placebo product or merely wish to send the patient away).
38. Deception arguably abuses the doctor-patient relationship and may undermine trust. It
also removes informed patient choice, because the patient is being asked to make decisions
under false pretences. It represents a reversal of the welcome and recent approach to
treating patients as equals who have the right to make fully informed decisions about
treatment options. One could also argue that using placebos is not good medical practice:
placebos treat symptoms, not causes, and doctors should be tackling the causes of disease
wherever possible. Even where only symptomatic relief is required, doctors should rely on
evidence-based, efficacious medicines. Some doctors have argued that they administer
placebos to demonstrate to a patient that the condition is psychological, 44 but this
misunderstands the power of the placebo effect which can make a patient feel better even
when there is a serious underlying condition. (We examine the ethical issues further at
paragraph 93 and following.)
39. We have set out the issue of efficacy and effectiveness at some length to illustrate
that a non-efficacious medicine might, in some situations, be effective (patients feel
better) because of the placebo effect. That is why we put more weight on evidence of
efficacy than of effectiveness.
40. The placebo effect may manifest when any medical intervention is given and therefore
the placebo effect is important in understanding why medical interventions work. We
would expect the Government to have a proper understanding of the power and
complexities of the placebo effect and the ethical issues surrounding its use in a clinical
setting; otherwise it cannot hope to make good decisions relating to patients and public
health.
Patient satisfaction
41. We received submissions from patients and practitioners testifying to the benefits of
homeopathy as well as written submissions citing observational patient studies. We also
received requests to take oral evidence from patients who had benefited from homeopathy.
These submissions and requests led us to consider carefully what kind of evidence reports
of patient satisfaction constituted and whether taking oral evidence from patients was
necessary or appropriate.
42. Our key consideration was whether evidence of patient satisfaction would add any
insight into whether homeopathy works beyond placebo. This is an issue that the House of
Lords Science and Technology Committee considered in detail during its 1999–2000
inquiry on complementary and alternative medicines (CAM). It reported:
44
House of Lords, Complementary and Alternative Medicine, Sixth Report of the Select Committee on Science and
Technology, Session 1999–2000, HL Paper 123, para 3.21Evidence Check 2: Homeopathy
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We have heard many conflicting opinions on the idea that high levels of patient
satisfaction could be used as evidence for a therapy's efficacy. It has been argued by
some that such satisfaction is very important [...] because much of CAM emphasises
patients’ participation in the therapy and evaluation of its effects. Many other
witnesses have asserted that although patient satisfaction has its place it is not
sufficient to justify accepting that a therapy works so that objective rather than
subjective evidence is needed. The Academy of Medical Sciences explained why this
may be: “It needs to be emphasised that patient satisfaction is not in itself a sufficient
estimate of clinical benefit. While it is very important that patients be satisfied with
the efforts made on their behalf, it is at least equally important that they should
obtain objective benefit. The two do not always go together. For example, patients
with peripheral vascular disease, if they go to a practitioner who allows them to
continue smoking will show a high patient satisfaction although their outcome will
be poor. In contrast, if they are made to stop smoking they are likely to be dissatisfied
but their outcome will be much better”. 45
43. Another example of how patient satisfaction may not correlate to the medical
intervention might be if a patient seeks treatment for a common cold. The patient’s
perception of the quality of the consultation and whether a course of treatment has been
prescribed may contribute to patient satisfaction, irrespective of whether the treatment
itself is effective; the patient would have become better anyway. The House of Lords
Committee concluded:
patient satisfaction has its place as part of the evidence base for CAM but its position
is complicated, as Sir Michael Rawlins [Chairman of NICE], explained: “The
difficulty, of course, is that very often the anecdotal evidence relates to conditions
where there is fluctuation in the clinical course and people who start an intervention
at a time when there is a natural resolution of the disease, very understandably, are
likely to attribute cause and effect when it may not be. But, on the other hand, there
are some anecdotes that are quite clearly important.” Therefore, ideally studies
should include patient satisfaction as one of a number of measures in evaluating a
treatment, but it alone cannot be taken as a proof or otherwise of a treatment's
efficacy or as evidence to justify provision. 46
44. We have already outlined that treatments may seem effective irrespective of whether
they are efficacious. Patient satisfaction therefore, does not help us to distinguish between
efficacious and placebo treatments; on that basis, it is of less relevance to resolving this
issue than randomised controlled trials, and meta-analyses and systematic reviews of
RCTs. We agree that patient satisfaction may be relevant to the consideration of the
effectiveness of treatments in the real world, rather than efficacy, but its main contribution
would be to identify that research may be needed to establish whether there is a real effect.
45 HL Paper (1999–2000) 123, paras 4.21–4.27
46 HL Paper (1999–2000) 123, para 4.2714
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Homeopathic provings
45. A homeopathic “proving” is the method by which homeopaths determine what
symptoms or diseases a product could be used to treat. A proving records the effects of
substances, either at concentrated doses or in ultra-dilutions, when given to healthy
individuals. Homeopaths use the symptom profiles of substances to prescribe homeopathic
remedies to patients on the like-cures-like principle. For example, a proving may
demonstrate that coffee keeps people awake and so coffee is used to make a homeopathic
remedy to treat insomnia. 47
46. Provings are not designed to provide evidence of efficacy and homeopaths do not claim
that they do.
Summary
47. Our expectations of the evidence base relevant to government policies on the
provision of homeopathy are straightforward. We would expect the Government to
have a view on the efficacy of homeopathy so as to inform its policy on the NHS
funding and provision of homeopathy. Such a view should be based on the best
available evidence, that is, rigorous randomised controlled trials and meta-analyses and
systematic reviews of RCTs. If the effects of homeopathy can be primarily attributed to
the placebo effect, we would expect the Government to have a view on the ethics of
prescribing placebos.
The evidence check
Scientific plausibility for a mode of action
48. Both critics and supporters of homeopathy have questioned the scientific plausibility of
any direct physiological mode of action. For example, the Royal Pharmaceutical Society of
Great Britain (RPSGB), which is firmly in the “critic” camp, 48 argues that “no plausible
scientific reason has yet been proposed as to why it should work”. 49 The Prince’s
Foundation for Integrated Health, which is more supportive of homeopathy, 50 also notes:
“any specific mechanism of action based on extreme dilution is implausible and regarded
as unsupportable by the majority of scientists working in this field”. 51
49. There appear to be two main concerns. The first is the principle of like-cures-like and
the second is about how ultra-dilutions could retain characteristics of the active ingredient.
We deal with each in turn.
47 “What is homeopathy?”, The Society of Homeopaths,
www.homeopathy-soh.org48 Ev 5, para 3.10
49 Ev 3, para 3.01
50 Ev 179, para 11
51 Ev 179, para 10Evidence Check 2: Homeopathy
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Like-cures-like principle
50. The principle of like-cures-like was described by Dr Peter Fisher as analogous to the
principle of toxicology hormesis. 52 Professor Edward Calabrese, a toxicology expert from
the University of Massachusetts, has described hormesis as “a dose-response relationship
phenomenon characterized by low-dose stimulation and high-dose inhibition”. 53 In other
words, the impact of toxins on physiology depends on dose: substances that are toxic in
high doses may be beneficial in low doses. For example, “as the dose of a carcinogen
decreases, it reaches a point where the agent actually may reduce the risk of cancer below
that of the control group”. 54 And this has been likened to the like-cures-like principle
central to homeopathy, 55 whereby a substance that causes a particular symptom will cure
that symptom if administered at a low dose.
51. There are two aspects of the argument that the like-cures-like principle is based on
hormesis that concern us.
a) Over-extrapolation: it is not good scientific practice to conclude that because some
substances are harmful at high doses and beneficial at low doses, that all substances
behave in the same way; and
b) Provings using ultra-dilutions: the similarity with hormesis breaks down further if
provings are carried out using ultra-dilutions. Hormesis is a dose-response: it provides
no rationale for expecting an ultra-dilution to cause symptoms in “healthy” people and
the same ultra-dilution to cure those symptoms in “unwell” people.
52. We have a further concern about the like-cures-like principle. It is not reasonable to
lump “symptoms” into categories independent of physiological causation. For example,
there are many different kinds of stimulants—caffeine, nicotine, amphetamines—but the
metabolic pathways they use to cause stimulation differ. The principle of like-cures-like
overlooks this complication, by holding that any kind of stimulant could, at low enough
doses, counteract insomnia. But insomnia is caused by different things, such as pain,
hormonal changes, psychological disorders or jet lag as well as the use of stimulants.
Treating the symptoms and ignoring the causes is simply not good medical practice.
53. Finally, there are examples of practice. We are concerned by some homeopathic
products. For example, it is possible to buy homeopathic products made from body parts
such as hip joints and colons, animals such as iguana and dragonfly, and different kinds of
sunlight. We are doubly concerned that it is also possible to buy products derived from
precious archaeological features such as the Great Wall of China and Stonehenge. 56 We do
not understand what symptoms could be induced (and therefore be treated) by these
products under the like-cures-like principle.
52 Ev 22, para 10
53 Edward J Calabrese and Linda A Baldwin, “HORMESIS: The Dose-Response Revolution”, Annual Review of
Pharmacology and Toxicology, April 2003, 43, 175–197
54 Edward J Calabrese, “Hormesis: a revolution in toxicology, risk assessment and medicine”, European Molecular
Biology Organization, Vol 5 (2004), pp S37–S40
55 “What is homeopathy?”, The Society of Homeopaths,
www.homeopathy-soh.org56 “Helios remedy list 21/1/2010”, Helios Homeopathy Ltd.,
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54. We conclude that the principle of like-cures-like is theoretically weak. It fails to
provide a credible physiological mode of action for homeopathic products. We note
that this is the settled view of medical science. 57
Ultra-dilutions
55. Under the homeopathic principles, “the greater the dilution, the more potent the
medicine”. 58 Dr Peter Fisher, Director of the Royal London Homeopathic Hospital,
described how homeopathic dilutions are made:
[They] are prepared by a process of sequential dilution with vigorous shaking at each
stage of dilution, known as succussion. Dilution is usually in steps of 1:10 or 1:100,
referred to as x or d (decimal) or c (centesimal) respectively. 59
56. For example, a 30C dilution indicates that the solution has been diluted in the ratio of
1:100, thirty times successively; one drop of the original solution would be diluted with 100
drops of water and the resulting solution would be diluted again, and so on until 30
dilutions had taken place. According to the Prince’s Foundation for Integrated Health, in
some homeopathic products “not even a single molecule of the original substance remains
in the diluted medicine prescribed to the patient”. 60
57. Dr Fisher stated that the process of “shaking is important” 61 but was unable to say how
much shaking was required. He said “that has not been fully investigated” 62 but did tell us
that “You have to shake it vigorously [...] if you just stir it gently, it does not work”. 63
58. A number of theories have been proposed to explain how water that does not contain a
single molecule of the active ingredient can retain the properties of that ingredient and
have a physiological action on the patient. The most frequently mentioned in the written
evidence is the theory of “molecular memory”, which proposes that water can retain some
imprint of substances previously dissolved in it. Some of the explanations for how water
might remember substances dissolved in it cite electromagnetic properties, 64 frequency
imprinting, 65 quantum physics 66 and supra-molecular behaviour of water (that is, large-
scale interactions). 67
59. There are enormous difficulties presented by the notion that water can “remember”
substances that have previously been dissolved in it. When substances are dissolved in
57 For example Ev 91, para 3.3 [Professor Colquhoun], Ev 117, para 13–14 [Dr Lewis] and Ev 131, para 7 [Professor
Marks]
58 “About homeopathy”, British Homeopathic Association,
www.britishhomeopathic.org59 Ev 21, para 4
60 Ev 179, para 8
61 Q 155
62 Q 157
63 Q 158
64 Ev 128 [Ms Waters]
65 Ev 103 [Mr Smith]
66 “What is homeopathy?”, The Society of Homeopaths,
www.homeopathy-soh.org67 Ev 96 [Dr Milgrom], para 5.6Evidence Check 2: Homeopathy
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water, the water molecules will form structures around the solute molecules; but the
hydrogen bonds between water molecules are far too weak and short-lived to hold that
structure once the solute has been removed. It is not surprising that experiments that claim
to have demonstrated the memory of water have failed to be reproducible. 68 The notion
that water could hold imprints of solutions previously dissolved in it is so far removed
from current scientific understanding that, as Professor David Colquhoun, Professor of
Pharmacology at UCL, put it: “If homeopathy worked the whole of chemistry and physics
would have to be overturned”. 69 Professor Jayne Lawrence, Chief Scientific Adviser to the
RPSGB, put it a little less dramatically:
I think it probably would be revolutionary if homeopathy was proved to be right,
because it does go against a lot of fundamental understanding of science as it stands
at the moment. 70
60. Even if water could retain a memory of previously dissolved substances we know of no
explanation for why the sugar-based homeopathic pills routinely dispensed would retain
such a memory.
61. We consider the notion that ultra-dilutions can maintain an imprint of substances
previously dissolved in them to be scientifically implausible.
62. When we asked Professor David Harper, Chief Scientist at the DH, about the scientific
plausibility of homeopathy, he agreed with our assessment that there was “a lack of
scientific plausibility in how homeopathic remedies might work”. 71 However, he added
“that is not to say there should not be research into like cures like or molecular memory. I
think that is a different thing.” 72
63. We would challenge Professor Harper’s comment that research funding should be
directed towards exploring theories that are not scientifically plausible. Research funding
is limited and highly competitive. The Government should continue its policy of
funding the highest quality applications for important scientific research determined
on the basis of peer review.
64. The Government Chief Scientific Adviser, Professor John Beddington, has told us in
unequivocal terms that he is of the view that there is no evidence base for homeopathy. 73
We recommend that the Government Chief Scientific Adviser and Professor Harper,
Chief Scientist at the DH, get together to see if they can reach an agreed position on the
question of whether there is any merit in research funding being directed towards the
claimed modes of action of homeopathy.
68 “Could water really have a memory?”, BBC News, 25 July 2008,
www.news.bbc.co.uk69 Ev 92, para 3.3
70 Q 104
71 Q 200
72 Q 200; we examine the question of research at paragraph 74 and following.
73 Oral evidence taken before the Innovation, Universities, Science and Skills Committee on 5 November 2008, HC
(2007–08) 999–iii, Q29718
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Evidence of efficacy
65. Lack of scientific plausibility is disappointing, but does not necessarily mean that a
treatment does not work. What is important is how a treatment performs when tested
fairly against a placebo treatment or other treatments. We consider that the best evidence is
provided by randomised controlled trials, meta-analyses and systematic reviews of RCTs.
66. We received conflicting opinions on whether homeopathic products are efficacious
(that is, whether they work better than a placebo treatment). The British Homeopathic
Association (BHA) told us that:
Four out of five comprehensive systematic reviews of RCTs in homeopathy have
reached the qualified conclusion that homeopathy differs from placebo. 74
67. Professor Edzard Ernst, Director of the Complementary Medicine Group at the
Peninsula Medical School, disputed this summary of the evidence in detail. The systematic
reviews to which the BHA refers are: Kleijnen et al, 1991; 75 Boissel et al, 1996; 76 Cucherat et
al, 2000; 77 Linde et al, 1997; 78 and Shang et al, 2005. 79 Professor Ernst pointed out that:
1. The Kleijnen review is now 18 years old and thus outdated.
2. Boissel et al merely combined p-values 80 of the included studies. This article is now
also outdated. Furthermore it is not unambiguously positive.
3. Cucherat et al is the publication of the Boissel document which was a EU-
sponsored report. [The authors themselves noted that “there is some evidence that
homeopathic treatments are more effective than placebo; however, the strength of
this evidence is low because of the low methodological quality of the trials.” 81 ]
4. Linde et al has been re-analysed by various authors, including Linde himself, and
all of the 6 re-analyses (none of which were cited in the BHA’s submission) have
come out negative.
5. Shang et al very clearly arrived at a devastatingly negative overall conclusion. 82
74 Ev 37, para 2.1
75 J Kleijnen, P Knipschild, G Ter Riet, “Clinical trials of homoeopathy”, BMJ, vol 302 (1991), pp 316–332
76 JP Boissel, M Cucherat, M Haugh, E Gauthier, “Critical literature review on the effectiveness of homoeopathy:
overview of the homoeopathic medicine trials”, Homoeopathic Medicine Research Group, Report of the Commission
of the European Communities, Directorate-General XII–Science, Research and Development E–RTD Actions: Life
Sciences and Technologies–Medical Research, Brussels, Belgium, 1996
77 M Cucherat, M C Haugh, M Gooch, J P Boissel, “Evidence of clinical efficacy of homeopathy. A meta-analysis of
clinical trials”, European Journal of Clinical Pharmacology, vol 56 (2000), pp 27–33
78 K Linde, N Clausius,G Ramirez, D Melchart, F Eitel, L V Hedges et al., “Are the clinical effects of homoeopathy
placebo effects? A meta-analysis of placebo-controlled trials”, Lancet 1997, vol 350, pp 834–843
79 A Shang, K Huwiler-Muntener, L Nartey, P Juni, S Dorig, J A Sterne et al., “Are the clinical effects of homoeopathy
placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy”, Lancet 2005, vol
366, pp 726–732
80 P-values represent the probability that an observed or greater difference occurred by chance, if it is assumed that
there is in fact no real difference between the effects of the interventions. If this probability is less than 1/20 (which
is when the P value is less than 0.05), then the result is conventionally regarded as being statistically significant.
81 M Cucherat et al., as above
82 Ev 51, para 2Evidence Check 2: Homeopathy
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68. Professor Ernst also commented on the BHA’s claims about reviews that offered
positive reviews for allergies, 83 upper respiratory tract infections 84 and rheumatic diseases 85
were equally flawed: the “review” on allergies was a lecture series, not a systematic review;
the “reviews” on upper respiratory tract infections were health technology assessments, not
systematic reviews, and mostly contained uncontrolled data; and the “review” on
rheumatic diseases was not conclusive. 86 Finally, he pointed out that the BHA had omitted
several systematic reviews and meta-analyses, each of which “must have been known to the
BHA” and “all of them arrived at negative conclusions”. 87
69. The review which we consider the most comprehensive to date is that by Shang et al. 88
The review compared 110 placebo-controlled trials of homeopathy matched according to
disorder and type of outcome to trials of conventional medicine. The study only included
trials that were controlled, included randomised assignment to treatment or placebo
groups and were accompanied by sufficient data for odds ratio calculations. 89 The authors
concluded that “when analyses were restricted to large trials of higher quality there was no
convincing evidence that homeopathy was superior to placebo”. 90
70. In our view, the systematic reviews and meta-analyses conclusively demonstrate that
homeopathic products perform no better than placebos. The Government shares our
interpretation of the evidence. We asked the Minister, Mike O’Brien, whether the
Government had any credible evidence that homeopathy works beyond the placebo effect
and he responded: “the straight answer is no”. 91
71. We were troubled that the Chief Scientist at the DH seemed to be out of step with the
accepted scientific consensus on the question of efficacy. Unlike the Minister, 92 he did not
agree that there was no credible evidence that homeopathy worked beyond the placebo
effect. He stated that “the majority of independent scientists feel that the evidence is weak
or absent” 93 and that there are “real difficulties” in drawing conclusions on efficacy because
of a “lack of agreement between experts working in the field”. 94 However, we could find no
83 P Bellavite, R Ortolaini, F Pontarolo et al, “Immunology and homeopathy. 4. Clinical studies–Part 2”, eCAM, vol 3
(2006), pp 397–409
84 G Bornhöft, U Wolf, K von Ammon, M Righetti, S Maxion-Bergemann, S Baumgartner et al, “Effectiveness, safety
and cost-effectiveness of homeopathy in general practice–summarised health technology assessment”, Forsch
Komplementmed, vol 13 (Suppl 2), 2006, pp 19–29; and P Bellavite, R Ortolaini, F Pontarolo et al, “Immunology and
homeopathy. 4. Clinical studies–Part 1”, eCAM, vol 3 (2006), pp 397–409
85 W B Jonas, K Linde,G Ramirez, “Homeopathy and rheumatic disease”, Rheum Dis Clin North Am, vol 26 (2000), pp
117–123
86 Ev 53, para 4
87 Ev 53, para 5
88 A Shang, K Huwiler-Muntener, L Nartey, P Juni, S Dorig, J A Sterne et al. “Are the clinical effects of homoeopathy
placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy”, Lancet, vol 366
(2005), pp 726–732
89 An odds ratio indicates how likely it is that an event will occur compared to likelihood that the event will not
happen. This can be used to show the strength of a relationship between treatment and outcome.
90 Shang A et al, as above
91 Q 175
92 Qq 174–75
93 Q 176
94 Q 17720
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support from independent experts for the idea that there is good evidence for the efficacy
of homeopathy.
72. The Government Chief Scientific Adviser, Professor John Beddington, was publicly
unequivocal about the evidence base for homeopathy when he appeared before us in
2008, 95 but the Chief Scientist at the DH appeared to take a different position. We
recommend that the Government Chief Scientific Adviser and Professor Harper get
together to see if they can reach an agreed position on the question of whether there is
any good evidence for the efficacy of homeopathy and whether there is a genuine
scientific controversy over the efficacy of homeopathy and publish this.
73. We regret that advocates of homeopathy, including in their submissions to our
inquiry, choose to rely on, and promulgate, selective approaches to the treatment of the
evidence base as this risks confusing or misleading the public, the media and policy-
makers.
More research?
74. Robert Wilson, Chairman of the British Association of Homeopathic Manufacturers
(BAHM), acknowledged the robust criticisms of the evidence for the efficacy of
homeopathy. He told us that there is a “need to have more research into homeopathy;
research that can stand up to some of the criticisms that have been placed at it”. 96 Dr
Robert Mathie, Research Development Adviser for the BHA, shared this view:
The British Homeopathic Association strongly supports patient choice for
treatments that are evidence-based and would propose the development of much
greater research in order to secure that evidence base. 97
75. When asked whether there was room for research using public money on the efficacy
of homeopathy, the Minister said:
Is it worth researching into? I think there is an argument for doing that, yes, given
there is NHS money being spent on it and has been over a considerable period of
time, so the straight answer to your question is yes. 98
Professor David Harper, in contrast, told us that:
If you are talking about randomised clinical trials, I personally do not think that it is
an issue of conducting more randomised clinical trials because there are a whole lot
that have been done and meta-analyses. 99
76. Dr Ben Goldacre, a medical doctor and journalist, also disagreed:
95 Oral evidence taken before the Innovation, Universities, Science and Skills Committee on 5 November 2008, HC
(2007–08) 999–iii, Q297
96 Q 111
97 Q 162
98 Q 199
99 Q 201Evidence Check 2: Homeopathy
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There have now been around 200 trials of homeopathy against placebo sugar pills
and, taken collectively, they show that there is no evidence that homeopathy pills are
any better than a placebo. [...] it is not worth doing any more placebo controlled
trials because you would be throwing good money after bad and you would have to
have a huge number of very strongly positive trials to outweigh all of the negative
ones. 100
77. There has been enough testing of homeopathy and plenty of evidence showing that
it is not efficacious. Competition for research funding is fierce and we cannot see how
further research on the efficacy of homeopathy is justified in the face of competing
priorities.
78. It is also unethical to enter patients into trials to answer questions that have been
settled already. Given the different position on this important question between the
Minister and his Chief Scientist, we recommend that the Government Chief Scientific
Adviser, Professor John Beddington, investigate whether ministers are receiving
effective advice and publish his own advice on this question.
Effectiveness
79. We proceed on the basis that homeopathy is not supported by evidence of efficacy and
is therefore no more than a placebo treatment, albeit a popular one. But before we discuss
government policy in relation to the evidence, it is important to consider what evidence
there is on the effectiveness of homeopathy.
Patient satisfaction
80. One aspect of effectiveness is patient satisfaction. The popularity of homeopathy
indicates that many patients are satisfied. Dr Hugh Nielson, Consultant at the Department
of Homeopathic Medicine at the Old Swan Health Centre, highlighted several patient
outcome surveys including:
• An observational survey of over 6,500 patients over a 6-year period conducted by
Bristol Homeopathic Hospital. 70% of follow-up patients reported improved health,
50% reported a major improvement. 101
• A survey of 500 patients at the Royal London Homeopathic Hospital showing that
many patients were able to reduce or stop conventional medication following
homeopathic treatment. For example, 72% of patients reported being able to stop or
reduce their conventional medication. 102
81. Although these surveys show that homeopathy makes some people feel better, it does
not, as we have explained, mean that homeopathy is efficacious. The high levels of patient
satisfaction could be attributed to the placebo effect, particularly enhanced by three factors:
100 Q 87
101 Ev 158, para 3.1
102 Ev 158, para 3.222
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a) Homeopaths treat the kinds of illnesses that clear up on their own (self-limiting) or are
susceptible to placebo responses;
b) Individuals who have been treated by homeopaths usually chose homeopathy as a
treatment; in other words, they have invested in the process of undergoing
homeopathic treatment, probably because they already know that they like it. That
means that it is a self-selecting group; and
c) Homeopathic consultations are long and empathetic. 103 In 2001, a systematic review
found that that “physicians who adopt a warm, friendly, and reassuring manner are
more effective than those who keep consultations formal and do not offer
reassurance”. 104 Homeopathic consultations may therefore have a positive impact on
patients’ perception of the intervention and result in a more powerful placebo effect.
82. We do not doubt that homeopathy makes some patients feel better. However,
patient satisfaction can occur through a placebo effect alone and therefore does not
prove the efficacy of homeopathic interventions.
Cost-effectiveness
83. Patient satisfaction alone may not be sufficient to warrant the expenditure of public
money on homeopathy. What is important is how the costs and benefits of particular
treatments stack up against each other. At a national level it is not possible to evaluate the
cost-effectiveness of homeopathy as the cost has not been determined. 105 However, one
Primary Care Trust (PCT) has assessed the cost-effectiveness of homeopathy at a local
level. In 2007, the NHS West Kent Primary Health Care Trust (PCT), which was
responsible for a homeopathic hospital, initiated a review to assess whether the
commissioning of homeopathy represented value for money. The consultation process
included:
• a systematic review of the high quality evidence base;
• production of a consultation document and related questionnaire—sent to a random
sample of 1000 of the PCT’s registered patient population in addition to those who
requested it directly or received a copy through their personal connection with
homeopathy or the Tunbridge Wells Homeopathic Hospital (TWHH);
• a series of public meetings; and
• an audit of all GPs in West Kent. 106
84. The original public consultation process was challenged in the courts and found to be
sufficient. NHS West Kent explained to us that the review “was not about whether
homeopathy works but rather whether the NHS, in light of competing priorities, should
103 Q 116 [Professor Ernst]
104 Z di Blasi, E Harkness, E Ernst, A Georgiou, J Kleijnen, “Influence of context effects on health outcomes: a systematic
review”, Lancet., vol 357, no. 9258 (Mar 10, 2001), pp 757–62.
105 See paragraph 13.
106 Ev 35, para 1.6Evidence Check 2: Homeopathy
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fund it”. 107 The PCT concluded that homeopathy did not represent value for money and
took the decision to cease funding for TWHH. It now operates a policy “not to fund
routine homeopathy treatment”. 108
85. We asked Dr James Thallon, Medical Director of NHS West Kent, whether the review
could be replicated by other PCTs. He considered that:
our process in terms of its quality and the way that it is done with scrutiny is a good
roadmap for other organisations to adopt, and we would be very happy to act as a
guide to other commissioning organisations that wish to follow this path. 109
We then asked Dr Thallon whether the DH should circulate the review to other PCTs. He
responded:
I certainly do not think the issue of the decommissioning of non-evidence based
practice should be beneath the Department of Health to help commissioning
organisations with. Yes, I would have thought there could well be a role for the
Department of Health in helping other organisations get to the point we have got to
should they choose to do so. 110
Dr Thallon did, however, distinguish between PCTs with homeopathic hospitals and those
without:
We are in a particular circumstance because there is a homeopathic hospital within
our geographical locality and that is why we had to go to the lengths we did in order
to prove the case, [...] to do this in every locality would be a diversion of otherwise
scarce resources. 111
86. We were impressed with NHS West Kent’s review of the commissioning of
homeopathy and consider that it provides a good model for other commissioning
organisations, particularly those that fund homeopathic hospitals. We recommend that
the Department of Health circulate NHS West Kent’s review of the commissioning of
homeopathy to those PCTs with homeopathic hospitals within their areas. It should
recommend that they also conduct reviews as a matter of urgency, to determine
whether spending money on homeopathy is cost effective in the context of competing
priorities.
Should NICE evaluate homeopathy?
87. Another approach to aiding PCTs would be to have the National Institute of Health
and Clinical Excellence (NICE) evaluate homeopathy and produce guidance on whether it
107 Ev 34, para 1.4
108 Ev 37, para 7.1
109 Q 146
110 Q 147
111 Q 14624
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should be commissioned. We heard several calls for NICE to evaluate homeopathy,
including from the British Medical Association 112 and the RPSGB. 113 NICE told us that:
Topics for guidance development are referred to NICE by the Secretary of State for
Health, in line with national priorities established for the NHS—for example; policy
importance (i.e. whether the topic falls within a government priority area) and
whether there is inappropriate variation in practice across the country. 114
88. We consider the issue of NICE evaluation important because it ensures patient safety
and evidence-based practice. Additionally there is variation in practice across the country
with some PCTs funding homeopathy and others not.
89. We asked the Minister whether homeopathy should be evaluated by NICE and he
responded:
I have no objection to NICE evaluating this but they do have a couple of problems
with it. Firstly, they have a large queue of drugs that they need to evaluate and there
are greater priorities. Secondly, there is a somewhat limited evidential base and
before evaluating things NICE want to see an evidential base, and for the reasons we
have already discussed it simply is not there at the moment. 115
90. NICE takes the approach that if there is no good evidence for the efficacy or cost
effectiveness of a treatment then the NHS should not use it. This is based in part on the fact
that scarce NHS resources should be directed at those treatments that have been shown to
work in a cost-effective manner. We accept that NICE has a large queue of drugs to
evaluate and that it may have greater priorities than evaluating homeopathy. However,
we cannot understand why the lack of an evidence base for homeopathy might prevent
NICE evaluating it but not prevent the NHS spending money on it. This position is not
logical.
Homeopathy on the NHS
91. Discussions about patient satisfaction, cost-benefit analyses and NICE’s responsibilities
do not resolve what we consider to be the central issue. We have already concluded that
homeopathy acts as a placebo and we now consider whether the NHS should be funding
placebo treatments.
92. The Government is clearly of the view that the NHS should be free to fund the use of
placebo treatments like homeopathy. The Minister told us that:
[D]octors can, if they feel that there is an ethical and efficacious reason for doing so,
prescribe a placebo. It may well be their view that that would assist a particular
112 Ev 194
113 Ev 3, para 2.04
114 Ev 187
115 Q 251Evidence Check 2: Homeopathy
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patient. I think they would have to think carefully about doing it, but I suspect they
could probably justify that. 116
93. In paragraph 38, we laid out a series of reasons why we might consider the use of
placebos to be generally unethical. We shall consider each in turn.
Integrity of the doctor-patient relationship
94. In order to maximise the impact of a placebo treatment, the doctor must deceive the
patient, telling the patient that he or she is receiving a real treatment. The temptation to do
so may be strong, as Dr Goldacre told us:
[C]ircumstances might occur in which it could arguably be desirable to have the
option of prescribing a placebo. There are often situations where an individual may
want treatment, for example, but where medicine has little to offer—lots of back
pain, stress at work, medically unexplained fatigue, and most common colds, to give
just a few examples. Going through a ‘theatre’ of medical treatment, and trying every
medication in the book, will only risk side-effects. A harmless sugar pill in these
circumstances may seem to be the sensible option. 117
95. It was the Minster who most succinctly voiced our concerns about such a practice:
I would not be happy to be misled and I suspect most patients would not. However,
that was not the question you asked me. What you were asking me [...] was whether
it would be unethical for a doctor ever to prescribe a placebo. [...] I thought about it
and I took the view that there might be circumstances, but would you generally do it?
Of course you would not. 118
96. We asked Dr Thallon his opinion and he told us:
I struggle with the notion that it is ethical to prescribe placebos. I am not saying that
it does not happen; I think that a number of the ways in which people behave or
prescribe could be described as prescribing placebos but, in principle, if you
prescribe a drug which you know to have no clinical efficacy on a basis which is
essentially dishonest with a patient, I personally feel that that is unethical
behaviour. 119
97. When doctors prescribe placebos, they risk damaging the trust that exists between
them and their patients.
Patient choice
98. Patient choice is an important concept in modern medicine. Medical practice used to
be highly paternalistic, whereby the doctors would know what was best for patients and
116 Q 190
117 Ev 9
118 Q 193
119 Q 12026
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would prescribe whatever treatments they felt best. Today, doctors are trained to
communicate with patients about their treatments and, while providing advice and
guidance, ultimately enable patients to make informed choices, where possible, over
treatment options and more control over the management of their conditions.
99. Indeed, patient choice was repeatedly cited in written submissions as a reason why
homeopathy should be provided on the NHS. 120 The Minister stated:
I think there is an illiberality in saying that personal choice in an area of significant
medical controversy should be completely denied, and I think the Government
should be cautious about constraining that illiberality, or interfering with it. We
should not take the view that patients should not be able to have homeopathic
medicine when they want it. 121
100. However, patient choice is not simply about patients being able to pick whatever
treatments they like. They must understand the implications of their decisions, which
means that patient choice must be informed choice. As Professor Ernst put it: “patient
choice that is not guided by evidence is not choice but arbitrariness”. 122 The RPSGB echoed
this view:
It is essential [...] that the patient is given the appropriate information to make these
informed choices and as a consequence it should be clear to the patient that there is
no scientific evidence for homeopathy. 123
101. We agree with Professor Ernst and the RPSGB. For patient choice to be real choice,
patients must be adequately informed to understand the implications of treatments.
For homeopathy this would certainly require an explanation that homeopathy is a
placebo. When this is not done, patient choice is meaningless. When it is done, the
effectiveness of the placebo—that is, homeopathy—may be diminished. We argue that
the provision of homeopathy on the NHS, in effect, diminishes, not increases, informed
patient choice.
Personal health budgets
102. In this context, we raised the issue of the DH’s announcement in 2009 of a pilot to test
personal health budgets as a way of giving people greater control over the services they
use. 124 As part of this scheme, patients might be able to use their personal health budget to
spend NHS money on complementary therapies such as homeopathy. 125
103. We asked whether, through personal health budgets, the Government would be
encouraging people to spend NHS money on homeopathy, the Minister replied:
120 For example, Ev 140 [Society of Homeopaths] and Ev 151 [Alliance of Registered Homeopaths], para 4
121 Q 248
122 Q 161
123 Ev 3, para 1.11
124 “Personal Health Budgets”, Department of Health,
www.dh.gov.uk125 “Personal budgets to allow patients to buy homeopathy and acupuncture”, Pulse, 30 October 2009Evidence Check 2: Homeopathy
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It would depend to some extent on two factors. First, there has to be an agreement
on the health package with a GP. Let us say, for the sake of your argument, there was
a GP who believed in homeopathy and, therefore, thought this was the right thing to
do. Secondly, there would have to be a PCT who was prepared to fund that. There
would have to be the agreement of three parties, in effect: the patient, the doctor (the
GP) and the PCT. All would have to agree that that funding would be forthcoming
for homeopathy. In theory it is possible. Is it going to happen in the next few years?
No. Is it possible it could happen in the long term? Theoretically yes, but you would
have to get the three to agree. 126
104. As we understand it, to get homeopathy on the NHS today, the agreement of patient,
GP and PCT is already necessary. We fail to see how this arrangement would change with
the introduction of personal health budgets: the PCT will continue to have a veto over
provision of homeopathy. In our view, the Government should prohibit access to non-
evidence-based treatments if it introduces personal health budgets. We see no convincing
reason to allow patients to spend public money on placebos such as homeopathy. We also
recognise the problem that allowing NHS funding to be spent on non-efficacious and non-
cost effective treatments means that NHS money cannot be spent on efficacious and cost-
effective treatments. We recommend that if personal health budgets proceed beyond the
pilot stage the Government should not allow patients to buy non-evidence-based
treatments such as homeopathy with public money.
Risk of harm to patients
105. The central aim of medicine is making people better. While placebos may be effective
at relieving symptoms (for example, pain), they cannot treat the underlying cause of
symptoms (for example, broken bones). There is a risk that a patient whose symptoms
improve following homeopathic treatment (because of a placebo effect or because the
symptom would have diminished unaided) may delay seeking proper medical diagnosis for
future symptoms that may or may not be for a serious underlying condition. Tracey
Brown, Managing Director of Sense About Science, pointed out that:
there is the issue that even minor conditions can sometimes betray a more serious
condition. For example, constipation. It sounds harmless to be taking sugar pills for
constipation, but actually sometimes that is a symptom of a more serious condition
and diagnosis is necessary. So there is the possibility of delayed diagnosis or people
believing that they are seeking effective treatment when they are not. 127
106. We are aware that large numbers of the public may not be aware what homeopathy
really is. Sense About Science, which is a charity promoting science and evidence for the
public, has monitored public perceptions of homeopathy. In their written submission they
told us:
In 2006 we reviewed discussion about homeopathy and made two observations:
126 Qq 215–16
127 Q 2728
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a) That it was believed to contain an active ingredient, and was often confused with
herbal medicine (and, related to this, that people were often unaware of the mystical
belief in water memory and in ‘like cures like’ on which it is based).
b) That because it was supplied on the National Health Service, it was assumed that it
‘must be effective’ and ‘there must be something in it’. 128
The charity added that it had come across clinicians and researchers who reported that it
was “hard to argue against something that was supplied through the NHS and that
appeared to be officially endorsed”. 129
107. We find this worrying. Patients who do not seek medical advice from properly
qualified doctors run the risk of missing serious underlying conditions while they have
their symptoms treated with a placebo.
108. These are not merely hypothetical concerns. Professor John McLachlan, Professor of
Medical Education at the University of Durham, highlighted in his written submission
several cases where children had died as a result of their parents rejecting conventional
treatments, including for treatable conditions like diabetes. 130 He alerted us to a case in
Australia, where a homeopath and his wife were charged with manslaughter by gross
criminal negligence when their baby daughter died after they continually treated her with
homeopathic remedies instead of conventional medicine. The baby died from eczema
which, when left insufficiently treated, depleted her immune system. 131 In the UK, the
General Medical Council found a doctor guilty of professional misconduct after he advised
a patient to use only homeopathic remedies. The patient subsequently died. 132
109. When the NHS funds homeopathy, it endorses it. Since the NHS Constitution
explicitly gives people the right to expect that decisions on the funding of drugs and
treatments are made “following a proper consideration of the evidence”, patients may
reasonably form the view that homeopathy is an evidence-based treatment.
Conclusions
110. The Government’s position on homeopathy is confused. On the one hand, it accepts
that homeopathy is a placebo treatment. This is an evidence-based view. On the other
hand, it funds homeopathy on the NHS without taking a view on the ethics of providing
placebo treatments. We argue that this undermines the relationship between NHS doctors
and their patients, reduces real patient choice and puts patients’ health at risk. The
Government should stop allowing the funding of homeopathy on the NHS.
111. We conclude that placebos should not be routinely prescribed on the NHS. The
funding of homeopathic hospitals—hospitals that specialise in the administration of
128 Ev 6, para 2.1
129 Ev 7, para 2.3
130 Ev 101, para 8
131 “Parents guilty of manslaughter over daughter's eczema death”, The Sydney Morning Herald, 5 June 2009
132 “Alternative cure doctor suspended”, BBC News, 29 June 2007Evidence Check 2: Homeopathy
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placebos—should not continue, and NHS doctors should not refer patients to
homeopaths.30
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3 MHRA licensing
112. Our inquiry also looked at the Medicines and Healthcare products Regulatory Agency
(MHRA) licensing regimes for homeopathic products.
The policy
113. We started with the MHRA’s purpose. It declares boldly on its website: “What we
regulate: Medicines.” 133 It continues:
Whether it’s a medicine you buy, or one prescribed for you as part of a course of
treatment, it’s reassuring to know that all medicines available in the UK are subject to
rigorous scrutiny by the MHRA before they can be used by patients. This ensures
that medicines meet acceptable standards on safety, quality and efficacy. 13 3
114. Normally, medicines are licensed by the MHRA as follows:
• To begin the process, companies and/or researchers must apply to the MHRA for
permission to test drugs through clinical trials, if these trials are to be conducted in the
UK;
• All the test results from these trials on how well the medicine works and its side effects,
plus details of what the medicine contains, how it works in the body, and who it is
meant to treat, are then sent to the MHRA for detailed assessment; and
• Once the MHRA is satisfied that the medicine works as it should, and that it is
acceptably safe, it is given a marketing authorisation or product licence. 134
115. Homeopathic products are not subject to this process. As we explained in the previous
chapter, homeopathy has a long tradition of use in the UK and homeopathic products were
available before a comprehensive regulatory system was introduced. There are currently
three licensing regimes in operation for which the MHRA has varying degrees of
responsibility. First, the Medicines Act 1968, which required medicines to be licensed
before being allowed onto the UK market, led to Product Licences of Right (PLRs) being
automatically issued to all products already on the market when the Act was implemented
in 1971. 135 Products with PLRs were allowed to stay on the market with their medical
indications attached to them. 136
116. Second, in 1992, the Simplified Scheme for homeopathic medicinal products was
introduced under European Directive 92/73/EC. There is no requirement in the Directive
(and therefore in the Simplified Scheme) for data to demonstrate clinical efficacy of the
product. The scheme is regarded as simplified because its purpose is to ensure the safety
133 “What we regulate: Medicines”, Medicines and Healthcare Products Regulatory Agency,
www.mhra.gov.uk134 “Medicines and Medical Devices Regulation: What you need to know”, Medicines and Healthcare Products
Regulatory Agency, April 2008, pp 5–6
135 Ev 60 [DH]; Q 210 [Professor Woods]
136 Q 210 [Professor Woods]Evidence Check 2: Homeopathy
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and quality of products, not efficacy. Products certified under the Simplified Scheme are
not permitted to make medical claims. 137
117. Third, in 2006, the MHRA sought to address inconsistencies in homeopathic product
licensing, where products with PLRs could make medical claims and products certified
under the Simplified Scheme could not. 138 Following a public consultation (MLX 312), the
MRHA introduced the National Rules Scheme (NRS), the purpose of which, according to
the MHRA website,
is to enable homeopathic medicinal products to be registered with indications for the
relief or treatment of minor symptoms and conditions (those that can ordinarily be
relieved or treated without the supervision or intervention of a doctor). Applications
under the National Rules Scheme must be supported by a dossier of data on quality,
safety and efficacy, together with appropriate product labelling and product
literature. 139
Our expectations of the evidence base
118. On the basis of these licensing arrangements for homeopathic products it is clear to us
that the “rigorous scrutiny” on safety, quality and efficacy applied by the MHRA before
medicines can be used by patients does not apply to homeopathic products. Indeed, in its
response to our evidence check questions the Government stated that the “three elements
of the licensing regime probably lie outside the scope of [the] Inquiry, because government
consideration of scientific evidence was not the basis for their establishment”. 140 It
explained:
Firstly, the Product Licences of Right were granted to all existing marketed
medicines in 1971, under the provisions of the Medicines Act 1968.
Secondly, the Simplified Scheme derives from European Directive 92/73/EC, so
probably lies outside the scope of the Inquiry; and
Thirdly, no scientific evidence was examined in drawing up the National Rules
Scheme, which also derives from a European Directive. Definitions of ‘product
safety’ and ‘product quality’ are commonly understood and did not need to be
embedded in the scheme itself. Therefore, the onus to provide supportive scientific
evidence is on each individual product that manufacturers put through the scheme—
to demonstrate that the product is used as a homeopathic medicine, that it is safe,
and that it is of suitable quality. 141
119. We cannot accept this approach. First, the MHRA, as a regulatory agency, has a
responsibility to scrutinise the safety and quality of the medicines and healthcare products
that it licenses, and to scrutinise the efficacy of products which make any medical claims
137 “Homoeopathic Medicines”, Medicines and Healthcare products Regulatory Agency,
www.mhra.gov.uk138 As above
139 As above
140 Ev 60
141 As above32
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(medical indications). Where there is no evidence of efficacy, or scrutiny of efficacy, we
question whether products should make claims or indeed be subject to any MHRA
processes or endorsement. 142 Second, there are three licensing regimes—the old PLR, the
NRS and normal medicinal licensing—which permit or have permitted medical claims.
When the MHRA allows claims to be made we would expect all their licensing approaches
to be based on the process outlined in paragraph 114, that is, the same process (requiring
evidence of efficacy) that medicines permitted to make medical indications would undergo.
Both of these issues feed through to the labelling of homeopathic products, which enable
informed choice. Third, the NRS process places an “onus to provide supportive scientific
evidence [...] on each individual product that manufacturers put through the scheme”,
which creates the expectation that the MHRA will review the basis of this evidence.
120. The continuation of the PLR scheme is problematic as it allows medical claims to be
made. When consulting on whether to introduce the NRS in 2006, the MHRA explained
that:
It was intended to review PLRs against current standards of quality safety and
efficacy. In 1973, the UK joined the EU, European legislation came into force and the
review of PLRs became mandatory.
By the time of the Review it became obvious that proof of efficacy for homeopathic
products would be difficult if clinical trials were required and homeopathics were
therefore, exempted from the review and PLRs remain in force. Currently almost
3,000 PLRs are extant. 143
The Government has told us that PLR licences are next due for review in September 2013
as legislation requires PLRs to be reviewed over a seven-year-period from 1 September
2006 (following the introduction of the NRS). 144
121. We are concerned that homeopathic products were, and continued to be,
exempted from the requirement for evidence of efficacy and have been allowed to
continue holding Product Licences of Right. We recommend that no PLRs for
homeopathic products are renewed beyond 2013.
User-testing of labels for homeopathic products
122. As we outlined in the previous chapter, patient choice is not real choice unless it is
informed. The DH, in its written submission to this inquiry, stated that:
The Government takes the view that consumers who choose to use homeopathic
medicines should be fully informed about their purpose. 145
142 In this Evidence Check the safety and quality of homeopathic products are not examined as (1) it is unlikely that
water and sugar pills can be directly unsafe and (2) efficacy is the primary consideration of our Evidence check.
143 “Consultation Document MLX 312; Licensing of homeopathics: Proposals for a new National Rules Scheme and for a
review of Product Licences of Right”, Medicines and Healthcare products Regulatory Agency, 20 June 2005
144 Innovation, Universities, Science and Skills Committee, Ninth report of Session 2008–09, Putting Science and
Engineering at the Heart of Government Policy: Government Response to the Innovation, Universities, Science and
Skills Committee's Eighth Report of Session 2008–09, HC 1036, p 4Evidence Check 2: Homeopathy
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Our expectation is that being “fully informed” requires the consumer to have an
understanding of the content and efficacy of the homeopathic product and, moreover, not
to be misled by the label. Therefore we would expect user-testing of labels for homeopathic
products to test whether the participants could determine from the label that:
• the product did not contain any active ingredient (or contained only a few molecules);
and
• the product was not proven to be efficacious in the treatment of any medical complaint.
The Evidence Check
Evidence of efficacy
123. In Chapter 2 we reached the conclusion that homeopathy was not efficacious and any
perceived effectiveness was in fact solely due to the placebo effect. When we took oral
evidence from Professor Woods, Chief Executive of the MHRA, we asked his view on the
efficacy of homeopathy and he responded:
One has to look at the totality of the evidence and in my view there is no single piece
of evidence that gives that reassurance. [...] In aggregate I do not think there is
anything there that one would take as robust evidence of an effect over and above the
placebo effect. 146
124. Professor Woods claimed that the MHRA does not seek evidence of efficacy under the
NRS 147 yet the MHRA’s guidance on the NRS states:
The applicant must submit data on the efficacy of the product which is the subject of
the application. 148