Homeopathy4health

23 July 2010

Observations on Homeopathy Evidence Check

(my emphases)

Observations on the report Evidence Check 2: Homeopathy by the House
of Commons Science and Technology Committee, February 2010

1. Background

1.1. The report Evidence Check 2: Homeopathy was the second to be produced with
the purpose of examining how the UK Government uses evidence to
formulate and review its policies
. It was not an inquiry into homeopathy as
such
. The House of Commons Committee asked two principal questions:
What is the Government’s policy? And on what evidence is that policy
based?
The point was whether the scientific evidence supported the provision
of homeopathy by the NHS and the licensing of homeopathic products
by the MHRA.

1.2. The report received much publicity because of its firm rejection of evidence
for homeopathy’s efficacy on its way to answering these questions. The aim
of this paper is to focus on this one aspect of the Committee’s work, in view of
doubts voiced about the validity of its findings
. Sections 2 – 5 below address
this question.

1.3. The author served on the House of Lords Science and Technology Sub-
Committee which in 1999-2000 inquired into complementary and alternative
medicine (CAM). He was Co-Chairman of what used to be called the Parliamentary
Group for Alternative and Complementary Medicine during the
1990s, and also served on the advisory board to the systematic review of water
fluoridation which was conducted in 1999-2000 by the NHS Centre for
Reviews and Dissemination (CRD) at the University of York. As a user of
homeopathy he has failed to derive much benefit from it, but has supported
its use and development in the UK.

2. The scientific evidence for efficacy

2.1. There have been a number of systematic reviews and meta-analyses in this
field, which as the Committee states are the best sources of evidence. The
most recent review of substance is that by Shang et al in 2005, which it
considered “the most comprehensive to date” and which compared 110
placebo-controlled trials of homoeopathy [authors’ spelling] with 110 trials of
conventional medicine matched for disorder and type of outcome. The
Committee cited a conclusion by the authors [paragraph 69] that “when
analyses were restricted to large trials of higher quality there was no convincing
evidence that homeopathy [sic] was superior to placebo”. They did not
also cite the authors’ interpretation which followed these findings in the
Lancet summary, which stated: “When account was taken for these biases
[common to trials of both homoeopathy and conventional medicine], there
was weak evidence for a specific effect of homoeopathic remedies
, but strong
evidence for specific effects of conventional interventions. This finding is
compatible with the notion that the clinical effects of homoeopathy are
placebo effects.”

2.2. This was no endorsement of homeopathy. But it was some way removed
from the Committee’s conclusion in paragraph 70 of their report, “In our view,
the systematic reviews and meta-analyses conclusively demonstrate that
homeopathic products perform no better than placebos.” It also provides
little support for that part of Professor Ernst’s evidence to the Committee
where he “pointed out that: . . . Shang et al very clearly arrived at a
devastatingly negative overall conclusion
” [67].

2.3. The exaggeration by the Committee of Shang’s conclusions is worrying. It is
difficult to see how a weakly supported positive effect, for which one
explanation (possibly well-founded) is a placebo effect, can be translated into
a conclusive demonstration of this effect, with a “devastatingly” negative
finding
. No such firm claims can be found in Shang, who writes of finding
“no strong” evidence, or “little” evidence, and who ends his paper with
cautions about methodology and about the difficulty of detecting bias in
studies, as well as the role of possible “context effects” in homeopathy.

2.4. The Committee’s overstatement is not helped by claiming Government support
for its interpretation in paragraph 70, based on the Minister’s concession
of no “credible” evidence that homeopathy works beyond placebo. If he
meant persuasive evidence – and his guarded support for further research [75]
supports this – that shows a confusion by the Committee between absence of
evidence and evidence of absence
. If however he was saying that all evidence
was negative, this as Prof. Harper correctly stated [71] runs counter to the
message from most reviews up to and including Shang, which is one of primary
studies of insufficient quantity, rigour, size, homogeneity and power to
give clear-cut answers.

2.5. It is the absence of reliable evidence that remains the problem, and this
includes evidence of an absence of specific effects
(while acknowledging the
problem in proving a negative, an obstacle which did not deflect the
Committee from its conclusive verdict in 70). The Committee itself writes in
69 of no “convincing” evidence from Shang, from higher-quality trials, which
is not consistent with a claim of conclusive (dis)proof. Care with words can
be as important as with figures, and can just as easily mislead.

2.6. In a search for best evidence in the early 2000s this author relied on the bulletin
on homeopathy produced by the NHS CRD at York in 2002, one of an
Effective Health Care series on “the effectiveness of health service
interventions for decision makers”. This bulletin made a systematic
assessment of the evidence to date. It advised “caution” in interpreting this
evidence, and warned that many of the areas researched were “not
representative of the conditions that homeopathic practitioners usually treat”,
and that “the methodological problems of the research” should be considered.
It found “insufficient evidence of effectiveness . . to recommend homeopathy
for any specific condition”. At the same time it could not conclude that
homeopathy performed no better than placebo.

2.7. That was eight years ago. But it is notable that the more recent review by
Shang, on which the Committee relied quite heavily, cited no reference to any
placebo-controlled trial (i.e. of reasonable quality) subsequent to the CRD’s
bulletin, in arriving at a suggestion, but not a conclusion, of a placebo effect.

The House of Commons Committee’s verdict in 70 stands on its own in going
beyond what either review found from the evidence before it.

2.8. In seeking an up-to-date assessment from the NHS CRD, this author was referred
to the German researcher Klaus Linde as among the best of the
objective sources of current evidence on homeopathy. Linde, who was the
lead author of a major review in 1997 cited by the Committee, in turn
recommended the statistician Rainer Lüdtke as an expert with a good
overview of the current literature. Correspondence ensued with both
researchers, who were aware of the Committee’s recent report.

2.9. Both Linde and Lüdtke hold that the Committee’s conclusion in 70 that
reviews “conclusively demonstrate” a placebo effect is overstated and
unsustainable on present evidence. They have further criticisms of the way in
which evidence has been addressed.

2.10. Both are critical of Prof. Ernst’s evidence to the Committee as highlighted in
67. Prof. Linde confirms that his own 1999 re-analysis weakened the findings
of his 1997 review and probably “at least overestimated the effects of
homeopathic treatments”, but that his paper was “not ‘negative’” as stated by
Ernst
. He writes that “A more accurate interpretation is that the ‘re-analyses’
[by himself and 5 others, referred to by Ernst] show that the (positive)
evidence is not fool-proof. This applies still today (for example, to the Shang
analysis)”. Lüdtke draws attention to his own paper in 2002 which criticised
many statistical errors in Ernst’s 2000 re-analysis in the same journal, vitiating
Ernst’s negative conclusion, a published criticism which received no mention
in Ernst’s own evidence to the Committee
. Ernst was correct to state in
evidence elsewhere that the re-analyses of Linde came to a “less than positive”
conclusion, and that further reviews “failed to conclude that homeopathy is
effective”. The Committee, while adopting Ernst’s more absolute
conclusions, has not resolved the contradiction between his statements.

2.11. Lüdtke, like Shang, has also drawn attention to the pitfalls in research into
homeopathy, in a chapter in ‘New directions in homeopathy research’ (Witt C,
Albrecht H, eds.) published in 2009. He counsels against including all types
of homeopathy trials of reasonable quality in one review (such reviews tend to
suggest that homeopathic medicines are not efficacious), since the pooling of
so many different kinds of trial and type of homeopathy makes findings
unreliable
. He advocates restricting systematic reviews to clearly defined
health conditions or to single homeopathic medicines, concluding that “the
heterogeneity of trials is high and the meta-analysis results are not robust
against small changes in study design or statistical analysis”. In a paper
published in 2008 he has argued that Shang’s conclusions do not hold when
slightly different selection criteria are applied, e.g. by redefining how large is a
“large” study, or by including treatment trials but excluding prevention trials.
Size is not the only factor in arriving at robust conclusions.

2.12. Context effects may play a part, according to both Shang and Lüdtke.
Shang’s “powerful alliances” between patient and carer, based on “shared
strong beliefs”, may not be as distinctive or as peculiar to homeopathy as the
nature of the homeopathic consultation, with its wider range of questions than
are addressed in a conventional context, and the lifestyle recommendations
referred to by Lüdtke that often flow from it. There is overlap here with the
placebo effect (see 4 below); but homeopathy as “a complex medical system
of its own” may be responsible for some broader effects.

2.13. Linde writes that the “undecided fraction” to which he belongs is confused by
“the notorious lack of predictable reproducibility” on the one side, and by
“too many anomalous results in high quality studies to rule out a relevant
phenomenon”
on the other.

3. Other evidential considerations

3.1 A conventional argument against CAM treatments is often that they are risky
because they deny or delay a proper diagnosis and the adoption of tried and
tested conventional treatments [105; 108; Ev 26-27]. But this is not an
argument about (as here) homeopathy per se, and its side-effects which at such
high dilutions are as implausible as its efficacy is claimed to be. The potential
for harm however is real enough: but only if patients have not been in contact
with their own doctors, which happens in a minority of cases; if homeopaths
are not adequately trained to recognise ‘red flags’, and give bad advice; and if
conventional treatment is likely to be successful and/or acceptably risk-free in
the particular case, and indeed more successful than a homeopathic approach
.

3.2. The argument for adopting one kind of treatment and not the other relates
therefore to issues of practice, communication and training as well as of
comparative efficacy (for patient choice see 6.1 below). These are highly
important; but it is not legitimate to deploy the argument as the Committee
did as a factor in the intrinsic risk/benefit ratio of a therapy
, which it is not,
adducing it as an additional negative element instead of as part of an efficacy
argument which has already been addressed. (Suppose high-quality trials
establish homeopathy’s superiority over conventional treatment for a
condition: this, with homeopathy’s negligible side-effects, would make the
conventional option the risky one.)

3.3. Nor is the argument even-handed if examination of true side-effects in homeopathic
and conventional treatment is not addressed when discussing the
comparative merits of the two approaches, patient satisfaction, and
government policy. Shang et al gave “the exclusive focus on beneficial effects”
as one of several limitations of their study. The extent of adverse
clinical effects is as much a part of the evidence base as is benefit. If the
Committee had looked at these it might have cast a different light on policy
towards homeopathy in the NHS, and would almost certainly have highlighted
public disquiet about some of the more aggressive conventional treatments
as a reason for many patients preferring a CAM approach. This is a
significant omission.

3.4. There may be no good conventional treatment for a condition. Alternatively,
the standard treatment may be contraindicated. The Committee has not
considered these reasons why some patients may welcome the continued
provision of homeopathy.

4. The placebo effect

4.1. The placebo effect, addressed at some length by the Committee (30–40), is not
in dispute. Yet much about it is unknown
. It may be premature to assume
that patient expectations of modern medicine, with its erudition, structures,
scientific approach and rituals which give it the intellectual and moral high
ground in Western society, are of lesser force than those of a treatment which
is commonly thought of as “implausible”, and not only by scientists. Belief in
white coats is not weak
. Furthermore patients are likely to resort to CAM on
grounds of principle or safety as well as efficacy. The placebo as an
explanation is sometimes reached for too readily off the shelf, when its applicability
to the relevant condition, treatment and patient population is poorly
understood. This gap in argument has not been closed by the Committee.
The placebo effect in homeopathy needs more work before conclusions can be
confidently drawn.

4.2. Empathy in a consultation is more than a matter of time given [81]: it also involves
personality and training. This author has on occasion felt better heard
in a ten-minute GP consultation than in an hour with a CAM therapist,
although the latter have generally shown up well. The better comparator in
CAM situations is probably the specialist consultation, since most patients will
have initially visited their GPs. Nor is it always the fluctuating or selflimiting
conditions [43, 81], as the Committee suggests, that send patients to
unconventional providers; claimed relief from chronic complaints after a long
period of failure with conventional treatment is not uncommon
.

4.3. The surveys of homeopathic patients referred to in 80 suggest that selfreported
benefit was not only at a high level but persisted beyond the limits of
any placebo effect which, as the Committee states, is usually short-lived
.

5. The Committee’s witnesses

5.1. The Committee in two sessions called twelve witnesses to give oral evidence,
all but one with relevant affiliations. Selection of witnesses can affect
outcomes in the same way as selection of written evidence
. It is therefore
legitimate to examine the choices made.

5.2. It is not easy to see why a journalist doctor was invited to appear in preference
to some other non-representative contributors to the inquiry. The written
submission by Dr. Goldacre [Ev. 8] was notably short on supporting evidence,
but contained unqualified statements on the ineffectiveness of homeopathy,
forcefully expressed (“extreme quackery” was mentioned)
. By contrast, the
submission by the Complementary Medicine Research Group from the
Department of Health Sciences at the University of York presented a wellargued
summary with 68 references [Ev. 143]. In this appears the statement
“To date there are eight systematic reviews that provide evidence that the
effects of homeopathy are beyond placebo when used as a treatment for [five
childhood conditions]”
. This claim from a mainstream academic centre, rated
joint first nationally for health services research in the latest Research
Assessment Exercise, stands in stark contradiction to Prof. Ernst’s referenced
claims, noted above, and to Dr. Goldacre’s unreferenced statements
. It would
have been illuminating if the Committee had probed the Group about this,
face to face as a witness, and attempted some resolution before agreeing in
unequivocal terms with the two witnesses who were invited to appear and
were quoted favourably. The Committee criticised the supporters of homeopathy for their “selective
approaches” to evidence [73]. They could fairly be accused of the same.

Unfortunately they did not (presumably) have the scope to solicit the views of
Dr. Linde from Germany, which would have differed from those of Prof. Ernst
with regard to the evidence.

5.3. Only one Primary Care Trust submitted a paper, and it was invited to give
oral evidence on its decision that homeopathy did not provide value for
money. Given the number of PCTs countrywide this is rather surprising. It
might be wondered if some form of publication bias was in play, with the
many PCTs who were happy with provision of homeopathy seeing no need to
defend the status quo
. At least one writer complained of the short timescale
for submissions [Ev. 128]. It would have been interesting to know what steps
the Committee took to obtain a range of views about the evidence
, and
whether West Kent was the only PCT to have done an assessment of the kind
referred to in Ev. 134. Only a negative PCT view was recorded; and despite
the Committee’s unequivocal conclusion even West Kent conceded “limited
evidence in favour of homeopathy”.

6. Societal questions

6.1. Since doctors exist for patients and not the other way round it is not selfevident
that scientific evidence, important as it is, should be the sole
determinant of what is provided to the public.
If the patient is ultimately in
the driving seat (s)he might wish on broader grounds than proven efficacy to
finance this type of treatment rather than that (or in addition to that) from the
public purse. This gives scope for political judgements which can set a
government at odds with its medical advisers. This should be no surprise to
a parliamentary scientific committee which sits at the border of these two
worlds.

6.2. In the purely scientific field it is interesting that the present Committee should
feel “troubled” [71] by two senior government scientists coming to different
conclusions about the weight of homeopathic evidence. Such disagreement
in interpretation is quite common in scientific debate, although life is
undoubtedly easier where there is consensus. Premature consensus,
however, has its own dangers, as is generally recognised. The Committee
appears to require the scientists metaphorically to retire to a jury room and
not come out until they agree [64, 72], presumably with the Committee’s view.
This seems a step too far.

6.3. Pre-existing structures have some de facto claims. It is reasonable to decide
that if something were not in existence one would not call it into being, but if
it is already there one would not abolish it. While theoreticians might debate
this, society as a whole can accept it. It is more easy to accept where the
institution claims a minuscule proportion of the health and research budgets,
which must be the case with homeopathy whatever precise figure the
government comes to at the Committee’s request.

7. Conclusion

7.1. The evidence for homeopathy is not impressive, except possibly in terms of
lack of adverse effects. The Committee however has been less than rigorous
in its approach to this evidence.
Its choice of witnesses favoured a medical
media opponent of homeopathy over a research centre of excellence. It was
unwise to rely heavily on the interpretations of one professor of CAM, some
of whose statements are unsound or in conflict with other statements of his,
and who is not without his critics in the worlds of research and academia
whose views were given less prominence.
The 2005 review by Shang et al has
been inaccurately represented as ruling out specific effects of homeopathy, in
a summary statement by the Committee that goes beyond present evidence.
The Committee’s own statements show confusion between unconvincing
evidence of a specific effect and disproof of it
. The true risk profile of
homeopathy, compared with conventional treatment, was not considered.

7.2. These limitations make the Committee’s report an unreliable source of
evidence about homeopathy.
The jury must still be regarded as out on its
efficacy and risk/ benefit ratio. Whether more research should be done, and
of what kind, is another question. But there can be no ethical objection to it
since the principal questions have not, as the Committee claimed, “been
settled already” [78].

Earl Baldwin of Bewdley.
June 2010.

11 February 2009

CAM can provide significant health improvements to NHS patients

Hospital Healthcare Europe reports:

A year-long pilot scheme in Northern Ireland has found that complementary and alternative medicine (CAM) can offer significant health improvements to NHS patients.

Independent analysis of the findings showed:

  • Patients receiving acupuncture treatment reported an average 33% improvement in their health and wellbeing
  • Patients receiving chiropractic and osteopathy treatment reported an average 38% improvement in their health and wellbeing
  • Patients receiving homeopathic treatment reported an average 54% improvement in their health and wellbeing

Founder of Get Well UK, Boo Armstrong, says of the results: “The results from this project speak for themselves – complementary therapies improve health and save money. These findings are consistent with other service evaluation from across the UK. A personalised health service will need protocols to include complementary therapies.”  Full report

26 June 2008

So much homeopathic research evidence should be made widely available ‘for the sake of scientific progression’

Dr Manjir Samanta-Laughton, author of ‘Punk Science’, attended the Scientific Research in Homeopathy Conference hosted by the Complementary Medical Association, held at the University of Westminster on June 18th 2008.

Here are the Complementary Medical Association’s links (some yet to be activated) to the presentations by Dr Alex Tournier, Karin Mont, Dr Rob Verkerk, Oliver Dowding, Claire Haresnape, Dr Lionel Milgrom and Stephen Gordon.

Dr Samanta-Laughtons response to the conference is on her Amazon blog:

I got invited to the most amazing conference last week as a VIP guest courtesy of Jayney Goddard and the Complementary Medical Association. Well it threw me for a loop! I had no idea there were so many RCT trials and evidence of homeopathy. Or that there were real scientific investigations into the actual mechanisms of homeopathy as eloquently demonstrated by Dr Lionel Milgrom, a Fellow of the Royal Society of Chemists. As this was the inaugural conference of its kind, I have one question – where have you been all my life? Why has this information been so hard to find? For the sake of scientific progression, this sort of information should be widely available.”

As she says in ‘Punk Science’: “The paradigm of science has come to a grinding halt. Some are complaining that there are no big discoveries to find. Although technology advances at a rapid pace, these are simply improvements on previous discoveries. There have been no radical changes in the way we see the universe for decades…until now!  The time is right for a change in science; for the next big discovery. This revolution will place consciousness at the very heart of an intelligent universe.”

15 June 2008

Homeopathy, Medicine, Science and Cognitive Dissonance

Given that more and more people globally are using homeopathy with benefit for all kinds of ill-health; its effectiveness in treating epidemics: cholera, influenza (here and here); its integration into the Indian medical system; and the World Health Organisation reporting that it is the number 2 medical system in the world (but you won’t find that report anywhere, it’s been buried), I can only conclude that the reason why conventional medics and scientists might genuinely (rather than wilfully because of love of science itself, self-interest or pharmaceutical allegiances taking priority over the health of patients) refuse to use and investigate homeopathy is because they are suffering from what is termed ‘cognitive dissonance’. www.learningandteaching.info describes it well:

Cognitive dissonance is a psychological phenomenon which refers to the discomfort felt at a discrepancy between what you already know or believe, and new information or interpretation. It therefore occurs when there is a need to accommodate new ideas, and it may be necessary for it to develop so that we become “open” to them. Neighbour (1992) makes the generation of appropriate dissonance into a major feature of tutorial (and other) teaching: he shows how to drive this kind of intellectual wedge between learners’ current beliefs and “reality”.  
Beyond this benign if uncomfortable aspect, however, dissonance can go “over the top”, leading to two interesting side-effects for learning:

  • if someone is called upon to learn something which contradicts what they already think they know — particularly if they are committed to that prior knowledge — they are likely to resist the new learning. Even Carl Rogers recognised this. Accommodation is more difficult than Assimilation, in Piaget’s terms.             
  • and—counter-intuitively, perhaps—if learning something has been difficult, uncomfortable, or even humiliating enough, people are less likely to concede that the content of what has been learned is useless, pointless or valueless. To do so would be to admit that one has been “had”, or “conned”.

Ordeal is therefore an effective — if spurious — way of conferring value on an educational (or any other) experience. “No pain, no gain”, as they say.

  • the more difficult it is to get on a course, the more participants are likely to value it and view it favourably regardless of its real quality.
  • ditto, the more expensive it is.
  • the more obscure and convoluted the subject, the more profound it must be. This has of course been exploited for years to persuade us of the existence of the emperor’s clothes, particularly by French “intellectuals” and “post-structuralists”. (I recently came across the wonderful phrase “intellectual flatulence” which perfectly describes such rubbish.)

It is not, however, so much the qualities of the course which are significant, as the amount of effort which participants have to put in: so the same qualification may well be valued more by the student who had to struggle for it than the student who sailed through.”

As medicine and science is very hard to get into and arduous to study, it seems to fulfill several of the above criteria.

12 June 2008

Homeopathy works – more scientific investigation merited

The Daily Mail reports:

“Homeopathy really does work and doctors should recognise its healing effects, say researchers.

A study found that allergy sufferers who were given homeopathic treatment were ten times more likely to be cured than those given a dummy pill instead.

Doctors should be more positive about the alternative medicine, which is the only complementary therapy available on the NHS, the researchers said.

Their study attempts to settle the controversy over homeopathic treatment, which critics say is not effective because of the tiny level of active substance used in most remedies.

It works on the principle that a substance which in large doses will cause the symptoms of an illness can be used in minute doses to relieve the same symptoms.

Critics argue that the active substance is so diluted that homeopathic remedies have no more effect than placebo or dummy treatment.

The study put homeopathy to the test in 50 patients suffering from nasal allergies. They were given either a homeopathic preparation or a placebo.

Each day for four weeks patients recruited from general practices and a hospital in London measured their nasal air flow and recorded symptoms such as blocked, runny or itchy nose, sneezing or eye irritation.

Both groups reported that they got better – but on average patients who received homeopathy had a 28 per cent improvement in nasal air flow compared with 3 per cent among those in the placebo group.

The study was carried out by doctors in Glasgow, led by Dr David Reilly of the Glasgow Homeopathic Hospital, one of five specialist hospitals in Britain. He said the difference in results from the two treatments was statistically significant.

Dr Reilly said this was the fourth trial carried out by his hospital, all with similar results. In addition, there were positive findings in 70 per cent of a further 180 clinical trials.

‘I hope this will encourage doctors to examine the volume of evidence supporting homeopathy – they might be quite surprised at the positive outcome in many trials,’ he said.

He added that it would take consistent scientific investigation to persuade some doctors, but attitudes were changing.

About 20 per cent of doctors in Scotland have basic homeopathic training compared with one per cent 15 years ago.

‘It isn’t just about the remedies, which can be put to the test in trials, but about a greater holistic approach in encouraging self-healing and self-recovery.'”

Dr Bob Leckridge, president of the Faculty of Homeopathy – the body for doctors, vets, nurses and other health professionals – said: ‘This latest research builds on existing evidence that homeopathy works, something that hundreds of doctors and their patients have known for 200 years.’

22 May 2008

‘There is a good and growing body of research showing beyond doubt that homeopathy is better than placebo’

Courtesy of HMC21:

 

There is a good and growing body of research showing beyond doubt that homeopathy is better than placebo; in fact so much, that this leaflet can only provide a minute selection. There is a list of sources of further, detailed information at the end of the summary. Different types of research have been used to study effectiveness of homeopathic remedies, and all have provided positive evidence, although in the case of RCTs not consistently.

 

Laboratory research                                                                         (including tests on animals and plants)

This research is important because there can be no placebo effect, but there are ethical problems when it involves subjecting animals to toxic substances and procedures. We include animal studies here and leave it to you to decide whether you want to use them or not.

·         Belon P, Cumps J, Ennis M, Mannaioni PF, Roberfroid M, Sainte-Laudy J, Wiegant FAC, ‘Histamine dilutions modulate basophil activation’, Inflamm. Res., 2004, 53:181-188. In a study including four research centres in Europe the effect of potentised high dilutions of histamine were confirmed. Researchers were able to document that these dilutions of histamine inhibit basophile degranulation. Results cannot be explained through molecular theories.

·         Brizzi, M. et al., ‘Biostatistical Insight into the As2O3 High Dilution Effects on the Rate and Variability of Wheat Seedling Growth’, Forsch Komplementärmed Klass Naturheilkd, 2005,12:277-283. Plant-based bioassays are suitable for basic research – lacking the placebo effect and ensuring large data samples for structured statistical analyses. A team of researchers at the University of Bologna carried out a structured experiment, performed blind over nine weeks, using wheat seeds previously stressed with a sub lethal dose of As2O3 (arsenic trioxide). The seeds were then treated with either potentized As2O3 (5x, 15x, 25x, 35x, 45x), potentized water (equivalent potencies) or diluted As2O3 (10-5, 10-15, 10-25, 10-35, 10-45). The working variable was the stem length, measured after 4, 5, 6 and 7 days. Results: Some potencies (As2O3 45x and water 45x) induced a relevant increase in seedling growth and/or a variability decrease. Diluted As2O3 did not induce any significant results. Conclusions: Confirmation of a significant stimulating effect on seedling growth and a significant decrease of variability was obtained with ultra-high dilutions at the 45x potency. The model of wheat germination and growth has been confirmed to be a good tool for basic research in homeopathy.

·         J. Bildet, M. Guyot, F. Bonini, et al., ‘Demonstrating the Effects of Apis mellifica and Apium virus Dilutions on Erythema Induced by U.V. Radiation on Guinea Pigs’,  Berlin Journal of Research in Homeopathy, 1990, 1:28. Albino guinea pigs were exposed to small doses of X-ray that cause reddening of the skin. Studies showed that Apis mellifica 7c or 9c had a protective effect and a roughly 50% curative effect on X-ray-induced redness of the skin. Apis mellifica (honeybee) is a homeopathic medicine for redness, swelling, and itching, common symptoms of bee venom.

·         Endler, P.C. et al., ‘The Effect of Highly Diluted Agitated Thyroxine on the Climbing Activity of Frogs’,  Veterinary and Human Toxicology, 1994, 36:56. Thyroxine 30x (thyroid hormone) was placed in the water of tadpoles. When compared to tadpoles who were given a placebo, the study showed morphogenesis of the tadpoles into frogs was slowed for those who were exposed to the homeopathic doses. Thyroid hormone in crude doses is known to speed up morphogenesis; it makes sense from a homeopathic perspective that homeopathic doses would slow it down. See doi:10.1016/j.homp.2007.11.002 at http://dx.doi.org for a further experiment in 2006 which confirmed this research.

 

Meta-analyses                          (the statistical amalgamation, summary, and review of previous quantitative research)

·         Linde, K. et al.,  ‘Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled trials’, The Lancet, 1997, 350:834-843: Meta-analysis of 89 trials of homeopathic medicine versus placebo. Result: significantly in favour of homeopathy (OR 2,45 (95% CI 2,05-2,93)). This meta-analysis included 186 placebo-controlled studies of homeopathy published until mid-1996, of which data for analysis could be extracted from 89 studies. The main conclusion was that the results “were not compatible with the hypothesis that the effects of homeopathy are completely due to placebo”.

·         Homeopathic Medicine Research Group, Report to the European Commission directorate general XII: science, research and development, vol. 1 (short version), Brussels: European Commission, 1996:16-17. This is an overview of clinical research in homeopathy which identified 184 controlled clinical trials. They selected the highest quality randomized control trials, which included a total of 2617 patients for a meta-analysis. This meta-analysis resulted in a p-value of 0.000036 (which means that results are highly significant) indicating that homeopathy is more effective than placebo. The researchers concluded that the “hypothesis that homeopathy has no effect can be rejected with certainty”.

·         Ullman D, ‘Controlled Clinical Trials Evaluating the Homeopathic Treatment of People with Human Immunodeficiency Virus or Acquired Immune Deficiency Syndrome’, The Journal of Alternative and Complementary Medicine, vol. 9, no. 1, 2003, pp. 133–141. A review of placebo-controlled clinical trials using homeopathic medicines to treat people with AIDS or who are HIV-positive found five controlled clinical trials. Results showed statistically significant results in subjects with stage III AIDS, and specific physical, immunologic, neurologic, metabolic, and quality-of-life benefits, including improvements in lymphocyte counts and functions and reductions in HIV viral loads in patients receiving homeopathic treatment.

 

Randomised Controlled Trials (RCTs)           (where one group of subjects is given the treatment being tested,

                                                                                       while a control group is given either a current treatment or a placebo)

Dozens of individual RCTs have been carried out, sometimes repeatedly, researching the effectiveness of homeopathy for a range of conditions. Many are covered in the meta-analyses discussed above.  See the websites below for details.

 

Non-controlled clinical study             (comparison of new or different types of treatments with current treatments)

·         Witt, C. et al., ‘Outcome and costs of homoeopathic and conventional treatment strategies: A comparative cohort study in patients with chronic disorders’, Complementary Therapies in Medicine, 2005, 13, pp. 79-86. Researchers at the Institute for Social Medicine, Epidemiology and Health Economics, Charite University Medical Center, Berlin, Germany and the Institute for Statistics and Econometrics, Economics, University of Hamburg, Germany  conducted an evaluation of  the effectiveness of homeopathy versus conventional treatment in routine case. Patients with selected chronic diagnoses received either homeopathy or conventional treatment.  Severity of symptoms was assessed by patients and physicians on a scale of 0 to 10, at baseline, 6 and 12 months; costs were also compared. The analyses of 493 patients (315 adults, 178 children) indicated greater improvement in patients’ assessments after homoeopathic versus conventional treatment (adults: homeopathy from 5.7 to 3.2; conventional from 5.9 to 4.4; p = 0.002; children homeopathy from 5.1 to 2.6; conventional from 4.5 to 3.2). The conclusion was that patients having homeopathic treatment had a better outcome overall compared with patients on conventional treatment, whereas total costs in both groups were similar.

 

Clinical outcome survey              (secondary analysis of data collected routinely by clinical services, in order to

                                                        judge the effectiveness of interventions; allows the study of large databases of patients)

·         Spence DS, Thompson EA, Barron SJ, ‘Homeopathic Treatment for Chronic Disease: A 6-Year, University-Hospital Outpatient Observational Study’, Journal of Alternative and Complementary Medicine, 2005, 11:793-798. In one of the largest studies ever carried out, over 70% of the 6500 patients involved reported significant benefits from homeopathic treatment. The results come from a 6 year study of 6500 consecutive patients seen in the outpatient clinic of the Bristol Homeopathic Hospital in the UK, a UK National Health Service Hospital. Patients with a wide range of conditions such as eczema, asthma, migraine, irritable bowel syndrome, menopause, arthritis, depression and chronic fatigue syndrome were included in the study, all patients having been referred by their General Practitioner or a hospital specialist after unsuccessful conventional treatment.

 

Good Sources of Research Information:

·         Bianci, Prof. Ivo et.al. (2002) Homeopathy: The scientific proofs of its efficacy.  This excellent report has detailed information about many trials and comparative studies, including cost comparisons, and is based on international research. It can be downloaded as an e-book at: http://www.guna.it/eng/ricerca/Homeopathy%20the%20scientific%20proofs%20of%20efficacy.pdf

·         www.homeopathic.com is the website of Dana Ullman’s Homeopathic Educational Services and provides a wealth of good research information.

·         An Overview of Positive Homeopathy Research and Surveys; March 2007. This document has been produced by the European Network of Homeopathy Researchers and can be downloaded from the Research page of the Society of Homeopaths’ website (www.homeopathy-soh.org).

·         www.thehomeopath.org.uk is the website of homeopath Ralf Jeutter PhD RSHom, and has detailed research information.

 

Skeptics are advised to comment on their own blogs. I will accept links. H4H

7 May 2008

‘Is an alternative just the tonic?’ Northern Ireland’s ‘Get Well UK’ project

Although Homeopathy is under threat on the mainland, BBC Northern Ireland and The Belfast Telegraph  report on succesful homeopathic treatment in a trial of alternative therapies in two Northern Ireland GP clinics (Get Well UK):

BBC Northern Ireland: “Northern Ireland is said to use more prescription drugs than any other UK region. While tablets may alleviate symptoms, they can be addictive and have side effects. A BBC NI documentary looks at the alternatives:

Londonderry woman Frances Gillen was addicted to prescription drugs for more than 20 years. The legacy of the Troubles and raising five children by herself took its toll. After being caught up in gunfire, she slid into depression and refused to leave home for years.

It affected me… I stayed in the house for the guts of three years, or maybe more, without going out. The only place I would have gone to was to go over to the doctors,” she said.  “It got that I would not even wash myself. I got the TV brought up into my room. “I didn’t want to commit suicide but I really didn’t want to go on if this was life, if this was my life… the quicker the better, I could go.

However, her life was turned around when she tried homeopathy as part of a pilot scheme being run in two centres in Northern Ireland.  The Get Well Scheme allowed GPs to refer patients to complementary therapists, with the NHS paying for their treatment.

Within weeks, Frances felt her depression lift and she started to resume normal life; she also came off all prescription medication.

“Now I feel like 16 again… well 30,” she joked.

Belfast Telegraph: “Traditionally Northern Ireland has always used more prescription drugs than anywhere else in the UK. We’re fond of our medicines and we’re fond of going to our doctors. The doctor has always been at the centre of our society. Attitudes, however, are changing and for decades patients are now turning to ancient forms of medicine such as acupuncture and aromatherapy — among other therapies.

In 2006 the government controversially decided to do the same and announced a new initiative — the Get Well Scheme. The trial provided complementary therapies to patients within two health centres in Northern Ireland, the Holywood Arches Health Centre in east Belfast and the Shantallow Health Centre in Londonderry, with the treatment paid for by the NHS.

Its aim was to see if complementary therapies could help the health service be more cost-effective by making patients feel better without the use of expensive prescription drugs.

It was designed to help people with problems such as depression and anxiety.

Then we meet Anne McCloskey, a straight-talking GP from the Shantallow Health Centre whose view on complementary medicine differs but changes over time.

In part, her conversion is due to the case of one remarkable patient featured in the film.

Every GP, Anne McCloskey says, has a set of what is referred to as ‘heart-sink’ patients; those who make the GP’s heart sink as soon as they walk through the door. Some ‘heart-sinks’ will visit their GP as often as every second day and, no matter what the GP does, they continue to decline despite there being no clear cause of sickness.

Dr McCloskey’s ‘heart-sink’ patient was Frances Gillen. For over two decades Frances had been suffering from depression which she says began as a result of ‘Troubles-related’ anxiety coupled by the stress of bringing up a large family.

In the film she recalls an incident in which she was almost hit by gunfire and, as a result, refused to leave the house for a number of years.

Frances became heavily dependent on prescription drugs and was one of the first patients Dr McCloskey referred to the Get Well Scheme and her subsequent story is a success.” 

4 May 2008

Homeopathy ‘as effective’ as standard care for eczema

I know it’s been reported on other blogs but I thought I’d include it on mine as well, for completeness sake.

UK GP website Pulse reports:

Homeopathy is as effective as conventional therapy in children with eczema, concludes the first prospective cohort study to compare the treatments.

The German study in 118 children with eczema found conventional treatment by GPs was equally as effective as homeopathic treatment in relieving symptoms and improving quality of life.

Symptom scores, as assessed by patients or their parents at one year, were not significantly different, although physician scores for eczema signs and symptom scores were significantly improved in the homoeopathically treated group.

The authors said this trial in primary care provided good evidence for the use of homeopathy for the treatment of eczema and gave a ‘more realistic picture’ of eczema therapy than that seen in a placebo-controlled randomised controlled trial.”

The research is published in the latest issue of Complementary Therapies in Medicine journal. Which describes itself as:

“Complementary Therapies in Medicine is an international, peer-reviewed journal that has considerable appeal to anyone who seeks objective and critical information on complementary therapies or who wishes to deepen their understanding of these approaches. It will be of particular interest to healthcare practitioners including family practitioners, complementary therapists, nurses, and physiotherapists; to academics including social scientists and CAM researchers; to healthcare managers; and to patients.

Complementary Therapies in Medicine aims to publish valid, relevant and rigorous research and serious discussion articles with the main purpose of improving healthcare. The journal believes that good healthcare needs to be based on clinical judgement and the available evidence on what is safe and effective, integrating conventional and complementary therapies as appropriate.

Complementary Therapies in Medicine publishes a variety of articles including primary research, reviews and opinion pieces. Recognising that some forms of CAM present novel and complex interventions, the journal encourages the exploration of the methodology of research. It believes that researchers should always aim at employing high ethical and methodological standards, and also welcomes small or exploratory studies that make a contribution to the area. Well conducted studies with negative outcomes are also welcome if they inform patient care. The journal welcomes considered opinion pieces that reflect genuine disagreements but remain respectful of the views of others.

Each issue features original, high quality research on complementary medicine, an abstracts sections with details of recently published research of high importance, as well as information and experiences on intregrating complementary medicine into mainstream care.”

Sounds like my kind of journal.

29 April 2008

Eighth new homeopathy hospital in Indian state opened by Finance minister

The New India Press reports that more people in the growing Indian economy will benefit from cost-effective homeopathic treatment in the state of Andhra Pradesh:

TIRUPATI: Finance Minister K Rosaiah inaugurated Positive Homeopathy Clinic here on Monday. It is the eighth homeopathy hospital set up by Dr Manu’s Group in the State.

Speaking on the occasion, Rosaiah said homeopathy was a costeffective system of medicine. The Centre and the State Government are making every effort to promote the Indian systems of medicine.

Ayush is one step in this direction. The State Government launched Rajiv Arogyasri scheme to provide corporate medicare to the poor people. The novel health scheme was appreciated by other states, he said.

The Finance Minister appreciated Positive Homeopathy Hospital chairman Sreekar Manu for setting up the hospital in Tirupati to provide better medicare to people.

Sreekar Manu said the main objective of the hospital was to provide quality medicare to people at an affordable cost. Former Assembly speaker Agarala Eswar Reddy, hospital directors AM Reddy, Kiran Kumar, Tariq Mahmood and others were present.”

As I reported before “Homeopathy is integrated into the general system of health care in India and our study shows that one in ten consumers have consulted a homeopath in the last year.” Global TGI Barometer January 2008 Issue 33

27 March 2008

Wholesale scorn on complementary medicine is unscientific.

Madeleine Bunting (at my least favourite newspaper ‘The Guardian’ since ‘I’m a cuddly junior doctor/you’re-making-it-up-psychiatrist’ Ben Goldacre’s devoid of any twisted homeopathic facts propaganda piece) makes some pertinent points about the state of Sceptic-Woo wars in complementary medicine.  I disagree that homeopathy is ‘just placebo’ as the benefits of homeopathic treatment can be much more profound than just ‘feeling better’ or ‘removal of symptoms’ but otherwise I agree with her thinking:

“Suckers: How Alternative Medicine Makes Fools of Us All; Snake Oil Science; and next month sees another, Trick or Treatment: what these new books have in common is varying degrees of frustration at the seemingly inexorable rise of complementary medicine. It seems the aim of some of these authors is to finish off a burgeoning health industry that they believe is based on charlatans and quacks preying on the gullible and desperate.

The books reflect the growing exasperation in some quarters that public opinion is not as amenable to persuasion and scientific evidence as they would hope. The language gets lurid; the mood music to pronouncements on complementary medicine is increasingly alarmist – we are living in dangerous times, an unEnlightenment looms as tides of irrationality threaten to overwhelm the palisades erected by science. “Reason is a precious but fragile thing,” declared Richard Dawkins in his series, The Enemies of Reason, last autumn. “Reason has liberated us from superstition and given us centuries of progress. We abandon it at our peril.”

What so troubles these science warriors is that it is estimated a third of people in the UK now use complementary medicine, at a cost of £1.5bn a year. In the US, the figures are substantially higher; it has been calculated that more visits are made to healing therapists than to doctors. There is an extraordinary paradox here: a half-century of astonishing conventional medical advances has not succeeded in eliminating complementary medicine. Quite the reverse: the breakthroughs in conventional medicine have been accompanied by the proliferation of other forms of healing – many of which have little or no evidence base to prove their efficacy. Indeed, it only takes a short surf on the web to discover that the wilder shores of this burgeoning industry are, well, pretty wild.

To the science warriors, this bizarre state of affairs can only be explained by irrationality. They bemoan the state of science education and lament how, contrary to expectation, literacy and access to information have failed to eradicate superstition. Meanwhile, in this increasingly sharply polarised debate, complementary medicine practitioners are equally exasperated by what they see as blinkered scientific reductionism.

So it takes a brave scientist to launch into this territory and risk getting attacked from both camps by daring to ask a simple question: is there anything science can learn from complementary medicine? That is precisely what Kathy Sykes is doing in her current television series, Alternative Therapies (the second programme is on BBC2 tonight). As Bristol University’s professor of public engagement in science and the director of the Cheltenham Festival of Science, no one can challenge her credentials as a scientist, yet her scrutiny of particular therapies throws up serious challenges to conventional medicine.

Sykes is too good a scientist to give complementary medicine an easy run. Tonight she examines reflexology, and gives it pretty short shrift. There are 30,000 reflexologists working on a million British feet a year. They base their work on a theory that parts of the sole of the foot correlate to organs in the body. The only problem is that Sykes could find no one, reflexologist or scientist, who could explain how these correlations might work. Furthermore, it turned out that this “ancient” healing system seems to have originated with an imaginative American woman in the 1930s. But patients swear by it. One reflexologist points Sykes to her annual garden party full of babies and children as evidence of the success she has had with infertility problems. This is the point where most scientists snort with derision at the use of personal anecdote as evidence, but Sykes presses on and it takes her into two areas of scientific research. First, she digs up new research on the importance of touch, which can have a profound impact on the brain. Even the hand of a stranger reduces anxiety and that of someone with whom one has a close relationship is even more significant. In fact, Sykes finds some scientific underpinning which goes beyond placebo in many of the therapies she looks at. But it is placebo which emerges as a recurrent and crucially important thread in her quest, and it leads her to the work of several American scientists who are trying to identify what placebo is, who it works for, and why it works.

This is one of the most common charges made against complementary medicine – that most of it is no better than placebo. But there is a way of turning that accusation around: perhaps complementary medicine is an effective way to harness placebo as one of the most powerful – and cheapest – of healing processes. Rather than being derogatory about the phenomenon as “just” placebo, perhaps we should see it as one of the most remarkable and little understood aspects of the human body.

That line of inquiry has taken Sykes to the US several times over the course of the two series she has made. There placebo has become a new frontier in medicine. In a range of studies with startling results – even sham knee surgery can be as effective as the real thing – many factors contribute to placebo: the confidence of the doctor; the social, cultural expectations around the procedure; the empathy and warmth of the patient-doctor relationship; the patient’s degree of faith. Get all these right, and the outcome can be remarkable. Harvard professor Ted Kaptchuk is publishing a study this week which shows that placebo is as good as any conventional treatment available for irritable bowel syndrome. Given that the eight most industrialised nations spend $40bn a year on medication for this condition, that’s revolutionary stuff.

This kind of research into placebo gives some insight into why complementary medicine has boomed and why there are so many people who cite their own experience to passionately defend it. The average consultation with a GP is 4.6 minutes, while the complementary therapist can devote an hour to taking detailed personal histories. That time and relationship provide a context and an opportunity for the ritual and recasting of personal experience which Kaptchuk believes are the crucial elements of placebo.

Complementary medicine is most popular where conventional medicine fails, such as with musculoskeletal conditions and mental health – stress, depression, anxiety (the recent revelations about the inefficacy of Prozac were another reminder of how shaky the science is in a large area of conventional medicine). Several complementary therapies are particularly effective at pain relief – you had to see Sykes’s footage of hypnotism helping a woman to have teeth extracted without anaesthetic to believe it. Kaptchuk argues that pain is not a static given but can be experienced dramatically differently.

Conventional medicine prolongs life but is less successful in prolonging good health – we can expect to spend more years of our life in poor health, as a government report showed last week – and in producing wellbeing. So people are voting with their feet, trying to find other ways to fill the gaps left by conventional medicine. We need scientists to help to identify what they are looking for and why, rather than pouring scorn indiscriminately on the whole field and on the relations between belief, mind and body, of which science still has such a fragmentary understanding.”

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