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.

26 November 2009

Parliamentary Science and Technology Evidence check for Homeopathy

Thanks to ‘Voice of (not so) Young Homeopathy’ for their comments on this week’s Parliamentary Science and Technology Evidence check for Homeopathy here:

http://vonsyhomeopathy.wordpress.com/2009/11/25/uk-parliamentary-science-and-technology-committee-evidence-check/ 

You can watch the whole meeting here:   http://www.parliamentlive.tv/Main/Player.aspx?meetingId=5221

Vo(ns)YH promises a transcript too.

Some funny moments: I thought Goldacre’s comment that he wasn’t interested in Physics quite hilarious given that homeopathy allegedly ‘goes against all its laws’, and Ernst saying that he thought it was the long consultation that helped homeopathic patients REALLY begged the question: ‘is there any evidence for that? and if there is then why does the NHS only allow 10 minutes?’ and David Colquhoun got a dishonourable mention about going around collecting anecdotal evidence.

I’m disappointed that no-one mentioned that only 13% of NHS treatments are backed by solid evidence: http://clinicalevidence.bmj.com/ceweb/about/knowledge.jsp

Update: Here is the evidence supplied to the committee:

http://www.publications.parliament.uk/pa/cm200910/cmselect/cmsctech/memo/homeopathy/contents.htm

26 April 2009

Singh and Ernst’s book ‘Trick or Treatment?’ “has no validity as a scientific examination of alternative medicine.”

From H:MC21: ‘Halloween Science’

A critique of Trick or Treatment? by Simon Singh and Edzard Ernst written by William Alderson on behalf of H:MC21 (Homeopathy: Medicine for the 21st Century); March 2009.

Trick or Treatment? by Simon Singh and Edzard Ernst claims to “examine the various alternative therapies in a scrupulous manner” (p.3). This critique assesses the validity of this claim, both in general and specifically in respect of homeopathy, by analysing the authors’ own arguments and evidence for accuracy, consistency and reliability. Where information is lacking in Trick or Treatment?, the critique incorporates evidence from other primary sources (where possible) or reputable secondary sources. Some conclusions reached on the basis of Ernst and Singh’s own statements are also supported by reference to other sources. All sources are referenced.
RESULTS: We have identified nineteen major faults in the case presented by this book

Evidence: (1) The authors frequently rely on figures, trials, events, quotations, statements, opinions and explanations which are unsupported by reference to sources. (2) This evidence is frequently misleading as a result of being presented out of context. (3) The authors use different criteria when assessing the validity of evidence, depending on whether the evidence supports their views or not.

Science: (4) The authors commit the common fallacy of confusing absence of proof with proof of absence. (5) The importance of theory is minimized or even ignored, when discussing both science in general and individual alternative therapies. (6) The authors assume that orthodox medicine is scientific, but offer no justification for this position. (7) There is evidence that the authors do not understand the principles and practice of orthodox medicine.

Definitions: (8) Alternative medicine is defined in four different ways in the course of the book. (9) Other significant terms, such as ‘science’, ‘disease’, ‘cure’, ‘effectiveness’ and ‘orthodox medicine’ are undefined. (10) This allows arguments to be built on vague preconceptions rather than on clearly defined principles. (11) The differences between orthodox medical and alternative medical definitions is not taken into account, despite their impact on the design of trials. (12) The authors fail to present the ideas of evidence-based medicine accurately. (13) The authors fail to present the nature and development of homeopathy accurately, raising doubts about their presentation of the other therapies. (14) They also call into question the principles of orthodox drug therapy, despite the fact that the tests used by this therapy underpin much of their argument.

Analytical tools: (15) The authors fail to prove that their main tool, the randomised controlled trial (RCT), is valid for testing curative interventions, while presenting evidence that there are serious problems with using it for this purpose. (16) They show that a tool derived from these trials, the meta-analysis, is prone to lack of objectivity, yet they rely on this for some of their conclusions. (17) Their conclusions are also dependent on the concept of the placebo effect, but they make it clear that this effect has no scientific basis and is so unpredictable as to have questionable scientific validity in this context. (18) They acknowledge the importance of individuality in the curative process, but deny its significance for the design of analytical tools. (19) They fail to take into account the need for analysis of evidence from clinical practice.

CONCLUSIONS: Ernst and Singh have failed to provide a secure theoretical or evidential base for their argument, and have used analytical tools inadequate (in this context) for achieving objective and reliable conclusions. The result of these weaknesses is that their argument relies heavily on preconceptions, variable definitions and opinion, a problem exacerbated by a tendency to confirmation bias on the authors’ part. As a result, Trick or Treatment? has no validity as a scientific examination of alternative medicine.

Full report here

20 February 2009

Contribution of homeopathy to the control of an outbreak of dengue in Macaé, Rio de Janeiro

From the International Journal of High Dilution of Research 

“Homeopathy has contributed throughout history [see herehere and here ] to the control and eradication of epidemic diseases. Facing the challenge of controlling an outbreak of dengue, the Secretary of Health of the county of Macaé, Rio de Janeiro, Brazil, in early 2007 carried out a “Homeopathy Campaign against Dengue”. 156,000 doses of homeopathic remedy were freely distributed in April and May 2007 to asymptomatic patients and 129 doses to symptomatic patients treated in outpatient clinics, according to the notion of “epidemic genus”. The remedy used was a homeopathic complex against dengue containing Phosphorus 30cH, Crotalus horridus 30cH and Eupatorium perfoliatum 30cH. The incidence of the disease in the first three months of 2008 fell 93% by comparison to the corresponding period in 2007, whereas in the rest of the State of Rio de Janeiro there was an increase of 128%. While confounding factors were not controlled for, these results suggest that homeopathy may be an effective adjunct in Dengue outbreak prevention.”

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

17 October 2008

RCTs “placed on an undeserved pedestal” – head of NICE

I can’t find any other reference to this information apart from as reported by Pharmatimes:

[update: also here and The Independent  ‘Statistics can help but doctors must also use their judgement’ which includes the pleasing statement: ‘It is scientific judgement – conditioned by the totality [my bold] of the evidence – that lies at the heart of making decisions about the benefits and harms of therapeutic interventions]

‘The chairman of the UK’s National Institute for Health and Clinical Excellence (NICE) has suggested randomised controlled trials (RCTs) should no longer be seen as the be-all and end-all of clinical research.

In a speech last night to the Royal College of Physicians, Professor Sir Michael Rawlins said such studies had been placed “on an undeserved pedestal”. He called for other types of research, including observational studies, to be given greater attention.

Professor Rawlins presides over an organisation that has regularly indicated its discontent with clinical evidence supplied by drug manufacturers. For its part, industry has been vocal in its criticisms of NICE’s cost-effectiveness models. More recently, Professor Rawlins has sharply criticised industry pricing practices
for new drugs.

All the same, some may be surprised at his willingness to question the value of RCTs, generally seen as the most rigorous tests for a new medicine, and talk up the benefits of other types of study.

In his speech Professor Rawlins said clinical trials were:

* Virtually impossible to conduct properly when studying treatments for rare diseases with very few patients

* Often prohibitively expensive. He cited a recent study of 153 trials completed in 2005 and 2006, which showed a median cost of over £3 million, with one trial costing £95 million. One manufacturer has estimated that the average cost per patient of a clinical trial rose from £6,300 in 2005 to £9,900 in 2007

* Even “unnecessary” when, as in the case of Novartis’ Glivec (imatinib) for chronic myeloid leukaemia , a treatment produced a particularly “dramatic” benefit

However, Professor Rawlins also expressed concern about the growing tendency, especially in cancer research, for clinical trials to be stopped early.

“The desire to stop trials early is understandable, but the possibility that an interim analysis is a ‘random high’ may be difficult to avoid,” he said. Moreover, there was “no consensus among statisticians as to how best to handle the problem”.

Prof Rawlins also had some criticism for his medical colleagues, many of whom adopted too rigid an approach to clinical research, he claimed, particularly in the trend towards ranking different types of clinical trial in terms of importance.

Hierarchies attempt to replace judgment with an over-simplistic, pseudo-quantitative, assessment of the quality of the available evidence,” he commented.

Accoording to Professor Rawlins, observational studies, historical controlled trials and case-control studies are also important sources of information.

What is needed is for “investigators to continue to develop and improve their methodologies; for decision-makers to avoid adopting entrenched positions about the nature of evidence; and for both to accept that the interpretation of evidence requires judgment“, he concluded.’

1 September 2008

Homeopathic Arnica as effective as the usual post-operative painkiller

Visit Dr Briffa’s blog for a report on recent research on the comparable effectiveness of homeopathic Arnica D4 (4X) post-operatively after bunion removal compared to the usual painkiller (diclofenac). It was decided that giving placebo would not be ethical.  Treatment with Arnica also gave fewer side-effects, greater mobility and was less costly.

References:

Karow J-H, et al. Efficacy of Arnica Montana D4 for healing of wounds after hallux valgus surgery compared to diclofenac. J Altern Comp Med 2008;14(1):17-25

Dr Briffa: ‘Homeopathic arnica found to be an effective post-operative aid’

Downloadable research on very low dose/high dilution effects

GIRI: ‘Groupe International de Researche sur l’Infinetismal’ / International Research Group on Very Low Dose and High Dilution Effects is a group that ‘organises workshops yearly throughout the world. It convenes systematically in congresses during each of the International Encounters of Monaco. The aim of the GIRI is to bring together pharmacologists, biologists, physicians, chemists and physicists to communicate, exchange experiences and develop joint research projects; the distinctive feature of the research activities of the group is the study of ultra low dose impulses or very high dilutions, homœopathics included. Although the mechanism of action of the very diluted solutions of active principles on biological systems is an important concern of the GIRI, the major interest of the Group is directed towards the possible medicinal and therapeutic relevance of the very low doses. More than one hundred persons are GIRI members, coming from 20 different countries.’

They are publishing a book (downloadable here):

“Signals and Images”

Selected papers from the 7th and 8th GIRI Meeting, held in Montpellier, France, November 20-21, 1993, and Jerusalem, Israel, December 10-11, 1994
Edited by Madeleine Bastide, Faculty of Pharmacy, University of Montpellier I, France
Kluver Academic Press

We are now able to propose a book which includes 23 full papers from more than fifty contributors corresponding to the two last GIRI meetings: the 7th (held in Montpellier, France, on 20-21 November 1993) and the 8th (held in Jerusalem, Israel, on 10-11 December 1994). The GIRI gets bigger every year and now includes more than 100 members from 22 different countries. This evolution stimulates more and more researches on this subject often considered as scientific nonsense or a scientific error. All these papers have been reviewed according to the standards of scientific publications and many of them are now published in regular scientific journals. They illustrate perfectly the evolution of the ideas and the new experimental and theoretical approaches of this uncommon research. It becomes obvious that different hypothesis can enlighten the interpretations of these different papers. Part of them can be interpretated according to the classical way of thinking; but the true interpretation of the similia law of homeopathic medicine is quite different from the mechanistic approach.

To help the reader, the papers will be organized into four chapters; each chapter will be introduced by a short analysis of the papers included.

The “Introduction” debates the question of scientific evolution and revolution in the context of modern science.

The 1st chapter “Hormesis” gathers together all the papers related to this concept: these models are often evoked to demonstrate or to explain the similia law although hormesis is always based on a relationship of identity.

The 2nd chapter “In Vitro and in Vivo Experimental Models” includes many experiments which demonstrate low dose or high dilution activity and is introduced by a summary of classical receptology.

The 3rd chapter “Therapeutics and Provings “ discusses the question of analysis of the symptoms in a systemic way of thinking and also includes pathogenetic studies (provings) as well as homeopathic therapeutic studies in humans or in animals.

The last chapter presents an “Epistemologic Approach” which become necessary in order to enlarge the possibility of interpretation of the law of similarity and the high dilution effectiveness considering that these dilutions are above the Avogadro number.

This new field of research is very exciting and introduces new scientific concepts supported by experimental results. Above all, we observe that this nascent science is totally concerned by “living” organisms and as such, it becomes necessary to define what we design as “information” brought by non-molecular high dilutions.

This book presents the brain-storming work of this research group and is one of the starting points of a scientific evolution: ” The proliferation of concurrent variants of the conventional paradigm, the fact of being willing to try anything, the expression of marked discontent, recourse to philosophy and discussion on the theoretical foundations, all signs are many symptoms of a passage from normal research to extraordinary research”. T.S.Kuhn, 1962, The Structure of Scientific Revolutions, The University of Chicago Press, Chicago.MB

30 June 2008

Randomised Controlled Trials are the worst of medicine

Over at spiked-online there is a debate on the Best and Worst of Medicine.  Unsurprisingly, skeptics have nominated homeopathy as one of the worst, but the sheer volume of messages of support for homeopathy managed to get a nomination for best as well.

The debate for the worst of medicine is due on the 17th July.  A clinician sums up the current fundamentalist scientistic backlash against CAM with a damning criticism of the RCT and of those who narrowly support it:

Randomised Controlled Trials are the worst 28 May 2008

The worst thing to happen to medicine is undoubtedly the Randomised Clinical Trial (RCT) – not for the information it does and doesn’t give us but for the way it has been used by government and tunnel visioned researchers to qualify some ridiculous practices under the heading “Evidence Based Medicine”.

As clinicians we are ‘encouraged’ (read ‘forced’) to ignore our clinical skills and acumen in favor of flow chart diagnosis and prescribing. It is virtually never mentioned how much morbidity and mortality modern medicine directly causes – recent analysis in the USA places iatrogenic problems as the country’s third biggest killer!

In addition we are using medicines on complicated people, often with multiple diagnoses and on a variety of drugs – RCTs are conducted in strict (non-clinical) settings using young, relatively fit and healthy people. I am always flabbergasted at the conclusions drawn from these to ‘inform’ normal clinic practice – the information is barely ever transferable!

The best thing to happen to modern medicine is the shake-up of the rigid paradigm that is now being forced on the ‘establishment’ by hoards of patients and practitioners giving a huge range of complementary practices their attention and confidence.

The narrow-minded view taken by a radical few is that we don’t know how these modalities work, therefore they can’t work. This attitude clearly needs to be counterbalanced by the many hundreds of thousands of people who use these treatments and (RCT be damned) find that they work!

Scientific curiosity, informed by actually hearing what people are saying, is the only way forward. Retire any ‘scientist’ who is not actively demonstrating a flexible and curious approach to investigating these complementary therapies, suspending thier predjudice and bias – after all, is this not the DEFINITION of a real scientist?

Geoff Woodin, UK

Edzard Ernst, take note.

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.”

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