House of Commons - Evidence Check 2: Homeopathy - Science and Technology Committee

Evidence Check 2: Homeopathy - Science and Technology Committee Contents

2 NHS funding and provision

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:

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.

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 determiningwhether 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.

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;
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.

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:

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;
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:

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.

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.

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.

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 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.

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]

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 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:

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:

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 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 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 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 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:

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:

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 placebos—should not continue, and NHS doctors should not refer patients to homeopaths.

6 We examine the issue of "like-cures-like" in more detail at paragraph 50 and following. Back

7 "How does homeopathy work?", British Homeopathic Association, www.britishhomeopathic.org Back

8 "What is homeopathy?", The Society of Homeopaths, www.homeopathy-soh.org Back

9 Ev 61, para 7 Back

10 As above Back

11 Ev 61, para 11 Back

12 Ev 174, para 2.1 Back

13 Ev 61, para 9; see also paragraph 83 and following. Back

14 Ev 62, para 18 Back