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Posts Tagged ‘The Lancet’

Homeopathy: the scientific proofs of efficacy

Monday, November 12th, 2007

“The opposite of a fact is falsehood, but the opposite of one profound truth may very well be another profound truth.”
Niels Bohr

“The world of homeopathic research is moving in the direction of investigating its rational, explicable, demonstrable, reproducible aspects and neglecting the more controversial and doubtful aspects. The purpose of this publication is to review the extensive literature available, and draw the reader’s attention to studies that comply with the strictest scientific methodologies.”

This Italian literature review, published in 2002, is available in English translation from the Italian homeopathic pharmacy Guna, and presents a comprehensive review of the trials of the last decade, summarised by an Advisory Board which includes professors in Immunology, Pharmacology, General Surgery, Clinical Morphology and Anatomy, Human Physiology, Psychiatry and Neurology from universities and medical schools in Italy, the US, Germany and Poland. Some salient quotations from the study:

“A number of large-scale studies designed to evaluate the huge amount of homeopathic literature have been conducted, especially in the last 10 years. Organisations and institutes of great international prestige and importance have dealt with the issue of homeopathy. All of them have concluded that homeopathy possesses therapeutic efficacy.” (Overview of Human Clinical Trials, p29)

“… most of the members of the medical profession and the media have failed to perceive the existence of this body of studies, which demonstrate the therapeutic efficacy of homeopathic medicines. The aim of the present volume was to fill this lack of information by a compendium made of some of the latest and most significant literature in the field.
Very briefly, a large body of studies demonstrates that the efficacy of homeopathic medicines is not due to the “mythical” placebo effect, thus finally dispelling a series of superficial, prejudiced attitudes.

“Among these, a set of studies compare homeopathic vs allopathic medicines. These trials were conducted in accordance with Helsinki Declaration on the therapeutic efficacy.
Most of the best studies relate to the branch of homeopathy known as homotoxicology which, with its pragmatic attitude and rejection of therapeutic extremism, seems to meet current demand for integrated medicine most effectively.
These studies demonstrate that the effect of homeopathic medicines may be at least similar to that of the allopathic reference drug used for the same disorder. They also confirm that homeopathic medicines, unlike allopathic drugs, rarely produce side effects. Finally, they show that homeopathic remedies are usually cheaper,and in some cases much cheaper, than the corresponding conventional treatment.

“Everybody is entitled to his own opinion and can deny the evidence, even when faced with the clearest proof. But who hold public and institutional offices and responsibilities have the duty to analyse actively all the body of information that may improve the patient’s quality of life.

[…]

“It may seem paradoxical that tiny amounts of an active constituent (diluted by the very special process of homeopathic production) can produce effects on living beings, but this is evidently a scientific fact.
Science acts on the basis of objective, verifiable observations; if the event demonstrated cannot be interpreted by a theory, it is the theory that needs to be revised. This is the principle behind the progress of science.” (Conclusions, p87-88)

This study was published in 2002. In 2005, the World Health Organisation were in the process of compiling what was believed to be a largely positive report on homeopathy, and which was apparently leaked to The Lancet in advance of its publication of the Shang et al meta-analysis. According to Dr Peter Fisher, Director of Research at the Royal London Homeopathic Hospital and the Queen’s homeopath:

“The same issue of The Lancet featured a leak of the World Health Organisation’s (WHO) draft report on homeopathy. The WHO document was apparently leaked to The Lancet by Dutch and Belgian doctors hostile to homeopathy; their comments and the (hostile) comments of Prof. Edzard Ernst of the University of Exeter were published. Dr Xiaorui Zhang, Traditional Medicine Coordinator of WHO, who is responsible for the report, was also interviewed, but declined to comment on a leaked, confidential draft. This leak came only 2 days after The Times of London published, as its front page lead, a remarkably similar story: a leak of the Smallwood Enquiry on The Role of Complementary and Alternative Medicine in the NHS commissioned by The Prince of Wales’ Foundation for Integrated Health. It is ironic that the editor of The Lancet, Dr Richard Horton, wrote to The Times accusing Prof. Ernst of having ‘broken every code of scientific behaviour’ for leaking the draft report of the Smallwood Enquiry (and incidentally describing complementary medicine as ‘a largely pernicious influence… preying on the fears and uncertainties of the sick’), while simultaneously doing the same to the WHO report in his own journal!

“Dr Horton also wrote an open letter to the UK Secretary of State for Health, Patricia Hewitt and the Chairman of the National Institute for Clinical Excellence (NICE) Prof. Sir Michael Rawlings, calling for the use of homeopathy in the NHS to be reviewed in light of this publication.”

What we appear to be looking at here is a very deliberate attempt to discredit homeopathy, allowing prejudice to hold sway over the results of scientific studies and making a mockery of evidence-based medicine. Not only are these individuals attempting to mislead the medical profession and general public, but are trying to deprive them of the right to choose and use a healthcare modality which is rapidly being reliably demonstrated as at least as effective as conventional medicine, and in some instances, more so. Futher, one that is also proving itself to be considerably cheaper than the present model and highly unlikely to kill upwards of 106,000 people per annum (in the US alone – Journal of the American Medical Association 2000;284:483-485) just through the side effects of the medication.

If The Lancet remains true to previous form in its next issue on homeopathy, then it doesn’t look like it has much future as a respected scientific journal under its present stewardship. That’s a shame, as it’s one of the oldest peer-reviewed medical journals in the world (founded in 1823). Homeopathy will survive, as it has done for longer than The Lancet despite all previous attempts to suppress it, because the truth has a way of finding its way out regardless.

If you support freedom of choice in healthcare and have had good experience of homeopathic treatment, you can register your support by signing the “homeopathy worked for me” declaration.

“In a time of universal deceit, telling the truth becomes a revolutionary act.”
George Orwell



PEKing out the bias

Sunday, November 11th, 2007

Lancet Vol 366, Issue 9487, 27 August 2005 

“Research is subordinated (not to a long-term social benefit) but to an immediate commercial profit. Currently, disease (not health) is one of the major sources of profit for the pharmaceutical industry, and the doctors are willing agents of those profits.”
Dr Pierre Bosquet, Nouvelle Critique, France, May 1961

As The Lancet prepares to publish another issue on homeopathy, this seems a suitable moment to republish a blog entry from 18 months ago which described the highly irregular context forming the backdrop to the publication of the seriously flawed study (Shang et al. ‘Are the clinical effects of homeopathy placebo effects? Comparative study of placebo controlled trials of homeopathy and allopathy’ The Lancet 2005;366 (9487):726-733) which claimed to support the conclusion that the effects of homeopathy are no more than placebo.

Further details on the study itself, analyses of it’s principal failings, and the reaction it provoked among serious researchers can be found on the Myths and Misconceptions page.

The Shang et al meta-analysis was an offshoot from a Swiss government study, the Programm Evaluation Komplementärmedizin (PEK), which was designed to allow politicians to assess whether or not five complementary therapies – anthroposophical medicine, homeopathy, neural therapy, phytotherapy and traditional Chinese herbal therapy – should be included in the list of services covered by the Swiss compulsory health insurance scheme (KLV). The cost of complementary therapies were, until 1998, reimbursed under the basic national scheme, but a change in the regulations in 1998 put the decision over which therapies were or were not valid for reimbursement in the hands of the Swiss Department of Internal Affairs (EDI). Public outcry forced the government to back-peddle and the five most popular therapies were reinstated in the KLV scheme from 1999 to 2005, on condition that each therapy was provided by FMH-certified physicians only, and that a simultaneous study in each therapy’s effectiveness was carried out (the PEK study). The decision on whether the therapies were retained within the basic health insurance scheme after 2005 would depend on the demonstration of their efficacy, appropriateness and cost effectiveness.

The study was set up under the Federal Office of Social Insurance (BSV) with a well-defined management structure and review board of internationally-acknowledged experts. It received widespread praise for the quality of its design and the degree of cooperation and transparency amongst its participants. As each area of the study began publishing their findings, the project was cited as an exemplar for future CAM research.

But as the extent of the findings in favour of the five therapies began to become clear, in 2004 PEK’s management structure was abruptly changed and the control of the study was passed to the Federal Office of Health (BAG). From that point onward, many attempts were made to interfere with and derail its emerging conclusions. Transparency was immediately compromised. Economic data showing the cost benefits of CAM were suppressed. The economist preparing to present the results of his work was dismissed without reason and placed under a gagging order. Other departments were prevented from publishing their work.

One member of the PEK steering committee, Dr med Peter Heusser, was so disgusted by what he witnessed that he has written an account of what happened, Medizin und Macht am Beispiel des Programms Evaluation Komplementärmedizin PEK (currently only available in German, but machine-translated here), and this brief summary is drawn largely from his account.

The Swiss authorities – both the government and the Federal Office of Health (BAG) – tried to sweep the PEK study under the carpet. A conference scheduled for April 2005 to present and discuss its results had to be cancelled because the Federal Office of Health prevented the publication of the study data. Some collaborators were even coerced into deleting all PEK-related data from their computers. The final meeting of the PEK international review board (six professors from Switzerland, Germany, Denmark and the UK responsible for the scientific quality of the study), scheduled for June 2005 for a final assessment of the project, was cancelled. (The review board eventually produced a summary report in September, which is highly critical of the political interference in the study.) Many contributors had their contracts terminated before their work could be completed. The recommendation in the final draft that homeopathy, anthroposophical medicine and herbal medicine should stay in the compulsory health insurance scheme was deleted in the final publication.

The Swiss government pre-emptively decided to exclude all CAM therapies from the compulsory health insurance scheme as of 30 June 2005, effectively ignoring not just the weight of scientific findings and economic benefits (which could save SFr millions on the health budget) which were emerging from the still-to-be-completed PEK study, but also the weight of Swiss public opinion.

In this context, the appearance of the Shang et al meta-analysis in The Lancet two months later – notably pre-empting the final report from the PEK international review board – can do little else but appear even more biased and reverse-engineered than it does already in its own right (see Myths and Misconceptions). A letter to The Lancet from the Swiss Association of Homeopathic Physicians raising objections to the study was not even granted publication.

None of this – aside from the initial frenzy surrounding the announcement of the conclusions of the meta-analysis on homeopathy – appears to have raised so much as a whisper from the English-speaking international media. Even in Switzerland it was only reported piecemeal so the full extent of what happened was not readily apparent.

Perhaps it’s worth noting that Switzerland is ranked as 8th most competitive nation in the 2005 World Competitiveness Yearbook. (In comparison, the UK came 22nd.) And it’s also ranked 8th in terms of the major exporting countries of chemical and pharmaceutical products. Around 5% of current global pharmaceutical R&D is attributable to Swiss companies. Just one of these companies, Roche Holding AG, parent company of Roche Pharmaceuticals, the manufacturers of the anti-viral drug Tamiflu, reported 2006 net income which was greater than the entire gross domestic product – that is, the value of all final goods and services produced within a nation in a given year – of the bottom 119 nations of the World Bank’s 183-nation rankings in 2005.

Since many university medical research laboratories would cease to exist without the support of the pharmaceutical industry, it’s perhaps no surprise that “at the end of 2004, professors of the medical faculties had expressed the intention at a meeting of the Swiss Academy of Medical Sciences … to do everything in their power to prevent complementary medicine remaining in the basic insurance. A dean voiced the prevailing opinion: “We must provide hand grenades [literal quotation, personal communication of a participant of that conference] against complementary medicine.”” (Dr med Peter Heusser).

Against the backdrop of more and more high-quality studies demonstrating the clinical effectiveness of homeopathy in practice, it will be interesting to see if The Lancet can recover its scientific credibility this time around, or whether this will turn out to be yet another ill-conceived attempt at a hatchet job jumping on the Colquhoun-Goldacre bandwagon.

“The prerequisite for today’s medical policy is naturally the currently predominant system of medicine. The sick are the source of income, therefore it is necessary for sick people to be there, yes, it proves advantageous if one makes the people artificially sick.”
Dr med Steintl: ‘International Medical Policy’, 1938, Berlin



Lancet lanced!

Thursday, September 22nd, 2005

“I know that most men, including those at ease with problems of greatest complexity, can seldom accept even the simplest and most obvious truth if it would be such as oblige them to admit the falsity of conclusions which they have delighted in explaining to colleagues, which they have proudly taught to others, and which they have woven, thread by thread, into the fabric of their lives.”
Leo Tolstoy

The UK Society of Homeopaths have now published their critique of last month’s much-publicised Lancet meta-analysis (Shang et al. Are the clinical effects of homeopathy placebo effects? Lancet 2005;366 (9487):726-733) purporting to be the “final word” on the validity of homeopathy as a “real” therapeutic intervention. (See also last month’s post and Myths and Misconceptions.)

It makes for interesting reading. For instance:

“The authors went to the great trouble of selecting 110 homeopathy trials that met their inclusion criteria, matching them with 110 allopathy trials and then ignored all but 8 trials of homeopathy and 6 of allopathy in their final statistical analysis. Moreover the original stated intention to compare trials of similar condition and outcome has been ignored in the final analysis. The final small subset of trials is not matched at all suggesting that different kinds of trials are being compared, apples are being compared with oranges – a common failing in meta-analyses.”

Apparently the quality of the study has been roundly condemned in conventional, as well as homeopathic circles. Mikel Aickin PhD, Research Professor at the University of Arizona commented: “The Lancet article appears to be part of a recent trend, in which medical journals are publishing articles of exceedingly low quality to justify attacks on controversial therapies.”

Could there possibly have been some bias in the study? The Lancet’s Senior Editor, Zoë Mullan, admitted, “Prof Eggers stated at the outset that he expected to find that homeopathy had no effect other than that of placebo. His “conflict” was therefore transparent. We saw this as sufficient”. That such a study passed the peer-review process is rather telling. With standards like that, who needs science?

And do you reckon this side of the story will make it to prime-time television news and a prominent position in the national daily newspapers like the initial publication did? You bet your bottom dollar it won’t. Seems hard to avoid some fairly cynical conclusions about the agenda from the outset …

“We read the world wrong and say that it deceives us.”
Rabindranath Tagore



Lanced!

Sunday, August 28th, 2005

“I know that most men, including those at ease with problems of greatest complexity, can seldom accept even the simplest and most obvious truth if it would be such as oblige them to admit the falsity of conclusions which they have delighted in explaining to colleagues, which they have proudly taught to others, and which they have woven, thread by thread, into the fabric of their lives.”
Leo Tolstoy

My, but there’s some neat skills being displayed in handling the media relations for today’s announcement of the latest meta-analysis of trials into homeopathy’s effectiveness! (The Lancet Vol 366, 27 August 2005: ‘Are the clinical effects of homeopathy placebo effects? Comparative study of placebo controlled trials of homeopathy and allopathy’.) In the UK at least, it’s being delivered as a kind of “final word” on the subject, as if we can now forget about it and consign it to the dustbins of history. Nice try boys and girls!

Funnily enough, that sort of thing was tried once before. Nearly 100 years ago. And homeopathy’s still with us. I wonder why. As Sir John Weir (1879-1971), Royal Homœopathic Physician serving George V, Edward VIII, George VI and Elizabeth II, once said:
“I suppose not one of us has approached homeopathy otherwise than with doubt and mistrust; but facts have been too much for us.”

The facts that Weir is talking about are not, of course, randomised controlled trials, but the vast number of individual cases and cures recorded throughout homeopathy’s 200-year history. These include many cases that seem rather unlikely candidates for the placebo effect – babies; animals; cures where several remedies were tried before finding the one that worked. In the 1854 London cholera epidemic, the results from homeopathic treatment were so positive that they were deliberately withheld from parliament. The House of Lords asked for an explanation and it was admitted that if the homeopathic figures were to be included in the report, it would “skew the results.” The suppressed report revealed that mortality under homeopathic care was just 9%. Under conventional care it was over 59%. Real results; real lives saved; and a matter of public record, rather than trials and convoluted statistical analyses available only to paying subscribers. You can’t help but wonder why that was never considered the last word on the subject …

It’s fascinating to see what lengths people will go to to try and discredit something which doesn’t fit the “map” we have of the world. It’d be interesting to know who funded this latest report in the Lancet.

(For a much fuller exploration of the subject, see the essay Unscientific Attachment.)

“Reason itself is a matter of faith. It is an act of faith to assert that our thoughts have any relation to reality.”
G K Chesterton



DISCLAIMER
Thanks to the current insanity revolving around homeopathy in this country, in both media and blogosphere, it's become necessary to insult your intelligence by explicitly drawing your attention to the obvious fact that any views or advice in this weblog/website are, unless stated otherwise, the opinions of the author alone and should not be taken as a substitute for medical advice or treatment. If you choose to take anything from here that might be construed as advice, you do so entirely under your own recognisance and responsibility.

smeddum.net - Blog: Confessions of a Serial Prover. Weblog on homeopathy, health and related subjects by homeopathic practitioner Wendy Howard