Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Leave alternative therapists in peace
- John R King (13 March 2007)
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Fairies and leprechauns
- David Colquhoun (16 March 2007)
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Evidence
- George T Lewith (20 March 2007)
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The expertise to evaluate
- Jay Mackinnon MNIMH (28 March 2007)
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Appropriate expertise
- David Colquhoun (29 March 2007)
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Ability to kill elevates homeopathy to a drug
- M. Sue Benford (3 May 2007)
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Phisinc,com
- David Colquhoun (9 May 2007)
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John R King, Consultant Psychiatrist Hill Crest, Redditch, B98 7WG
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David Colquhoun (“NICE should not have to evaluate alternative medicine”) makes a better case than Linda Franck et al. Space researchers do not, after all, waste time trying to disprove the beliefs of flat- earthists. Neither would it be helpful for a Nobel prizewinning chemist to stride into a church and denounce the holy water there as nothing more than H2O. There is a very large and ever expanding array of alternative treatments, some more bizarre than others, which could tie up the resources of NICE for an indefinite period. But if people want to believe in them – or in fairies or leprechauns – they should be left in peace to do so. It is no concern of scientific medicine. Competing interests: None declared |
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David Colquhoun, Prof of Pharmacology UCL UCL WC1E 6BT
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Nobody is proposing to ban fairies or leprechauns. It would be both undesirable and impossible. There does seem to be a case, though, for not providing leprechauns at the tax payers' expense. And really all leprechauns that are sold to the public should have labels that don't make false claims for their powers. Unfortunately the MLRA (Medicines and Leprechauns Regulatory Agency) has let us down in the matter of labelling. I suspect infiltration of the Department of Health by little green men. Competing interests: None declared |
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George T Lewith, Reader in Complementary Medicine University of Southampton, SO16 5ST
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It is interesting that Professor Colquhoun suggests that the National Library for Health, CAM Specialist Library, has accumulated no evidence suggesting homeopathy may be of clinical value over placebo. This, as a point of fact, is entirely incorrect. The Library contains a number of references on homeopathy. This includes evidence from systematic reviews which suggests that homeopathy may not be of value1. However there is equally a systematic review of the much the same data suggesting that homeopathy may have an effect that is greater than placebo2. For specific conditions there is also some positive evidence; for instance for the remedy Oscillococcinum in acute flu-like illness3. What is clear is that the balance of evidence is unclear in relation to homeopathy. Therefore, in view of this conflicting data more research is needed, not less as Colquhoun implies. What is not needed are factually inaccurate statements.
Reference List 1. Shang A, Huwiler-Muntener K, Nartey L, Juni P, Dorig S, Sterne JA et al. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy.. Lancet 2005;366:726-32. 2. Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV et al. Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 1997;350:834-43. 3. Vickers AJ and Smith C. Homeopathic oscillococcinum for preventing and treating influenza and influenza-like syndromes. (1). 2001. Cochrane Library. Ref Type: Data File Competing interests: None declared |
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Jay Mackinnon MNIMH, Medical Herbalist Kingsbarns, Fife KY16 8TB
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Dear Editor, I wish to contribute to the debate between Franck et al. and Colquohoun (1) as to whether the National Institute for Health and Clinical Excellence (NICE) should evaluate complementary and alternative medicine (CAM). It is likely that NICE will evaluate at least some further aspects of CAM sooner or later, given the prevalence of CAM therapies in both the private and public sectors. In this event NICE will require specific expertise on individual CAM therapies in order to maintain its standards of excellence in the appraisal process. Evaluation by NICE is desirable for many practitioners of CAM who wish our services to be free at the point of need and to achieve greater equality of provision. However, CAM research requires evaluation for model validity which assesses the likelihood that the research has adequately addressed the unique theory and therapeutic context of the CAM system (2). NICE has never before required this context-specific expertise and should therefore call upon the professional bodies of practitioners to ensure that evaluation of a CAM treatment includes expertise relevant to the treatment in question. The randomised, placebo-controlled trial is not the only valid and rigorous method of conducting research. Neither is it appropriate to every question or for measuring every type of outcome. RCT may not be the optimal methodology for economic evaluation if data are not collected for long enough to demonstrate the full costs and benefits; if the trial context controls out significant variables or if it is irreproducible in practice. We should not allow methodological preferences to determine which treatments we evaluate; rather we should respond to the challenge of conducting rigorous research relevant to the intended user. At present, most CAM provision is private and thus cost-benefit is judged on an individual basis by the service users (notably, in their thousands) rather than by a national agency. Consequently, research methodology is often more suitable for refining practice than for providing proof of efficacy to policy makers (for example, clinical audits, qualitative studies, outcomes research, case reports). The appropriateness of a particular research methodology or outcome measure for its intended audience is as important as its appropriateness in the treatment modality under investigation. As other respondents have highlighted, it is difficult for practitioners of CAM to obtain research funding, so perhaps a re- distribution of research funds to allow those experienced in a particular field to evaluate it would facilitate future consideration of CAM modalities by NICE. 1. Franck L, Chantler C, Dixon M and Colquhoun D (2007) Should NICE evaluate complementary and alternative medicine? BMJ 334, 506-507. 2. Lewith G, Walach H and Jonas WB (2002) Balanced research strategies for complementary and alternative medicine. In: Lewith G, Jonas WB and Walach H, Clinical Research in Complementary Therapies. Churchill Livingstone; Edinburgh. Competing interests: Member of the National Institute of Medical Herbalists |
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David Colquhoun, Prof of Pharmacology UCL UCL WC1E 6BT
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Jay Mackinnon (Medical Herbalist) writer “Evaluation by NICE is desirable for many practitioners of CAM who wish our services to be free at the point of need and to achieve greater equality of provision. However, CAM research requires evaluation for model validity which assesses the likelihood that the research has adequately addressed the unique theory and therapeutic context of the CAM system” This is just the usual plea that CAM should be exempted from the usual rules of evidence. If NICE were to abandon its normal standards, nobody would believe its verdict anyway, so we’d be no further forward. The case of herbalism is particularly simple. Unlike homeopaths, herbalists have no need to invoke magical memory effects, or that the weaker the medicine the greater the effect. Insofar as herbal medicines contain active ingredients, they are just part of regular pharmacology. Or at least they are like pharmacology circa 1920, before international standard preparations were introduced so that biological assays could ensure that different batches of medicine had consistent biological activity. Why anyone should want to set the clock back 100 years beats me. The effect of allowing CAM to be judged by CAM experts has already been seen. The House of Lords report recommended that money be spent on CAM research and the first priority was to find out which CAM procedures had an effect greater than placebo. The Department of Health provided some money, and put its distribution in the hands of “appropriate experts”. The result was that almost all of the money was given to projects that failed to address the first priority, (Focus on Alternative and Complementary Therapies, 2003, 8(4), 397–401). Competing interests: None declared |
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M. Sue Benford, PHIS, Inc. President and Founder 2408 Sovron Ct., Dublin, OH 43016, USA
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A recent article in the March 8, 2007 issue of BMJ asks the question “Should NICE evaluate complementary and alternative medicines.” (BMJ 2007; 334: 507) In the commentary, the author concludes, “. . . NICE has found no good evidence for anything more than placebo effects.” He goes on to claim that, “There is no need to subscribe to the early 19th century pseudoscientific hocus pocus of homoeopathy to treat sick patients.” This oft-cited belief is a prominent argument against the practice of homeopathy. However, recent preliminary evidence, if confirmed, may dispel this viewpoint. It is generally accepted that a drug can be defined by its ability to produce an action via alteration of human or organism biochemistry. One easily-measured action is the drug’s lethal dose (LD). Often used in testing prospective pharmaceutical candidates, LD50, is the Lethal Dose of a chemical that is expected to kill 50% of the population that receives it. Few would dispute that the ability of an agent to kill 50% or more of the organisms exposed to it classifies the agent as having a potent action. In two independent controlled studies, conducted at the Forsyth Institute (Boston) and Indiana University’s Center for Regenerative Biology and Medicine, an unexpected result was obtained during the testing of two ultra-dilute homeopathic remedies (no actual molecules present) in Xenopus laevis tadpoles. During experiments that increased the dosage added to the tadpoles standard medium (1:10 ratio), all the animals in the experimental groups died. After thoroughly evaluating materials and protocols, the research teams were not able to offer a competing hypothesis as to why all the animals died except that it was due to the action of the two remedies. Xenopus are known to be highly sensitive to environmental signals including various radiations, which are purported to be at the core of homeopathic actions. Although these results are preliminary, they provide evidence suggesting the need to consider reclassifying homeopathics from a “placebo” state to an actual drug with potent actions. In any case, further study is strongly recommended. Contact PHISInfo@aol.com for additional information. Competing interests: Our company (www.phisinc.com) created the remedies being tested at the institutions mentioned. |
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David Colquhoun, Professor of Pharmacology UCL WC1E 6BT
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Thanks to Ms Benford for drawing the attention of BMJ readers to her web site http://www.phisinc.com/. The company comes very close indeed to offering to cure cancer with homeopathy. Of course it contains the usual disclaimer which amounts to saying 'anything you read here may be untrue'. Nonetheless, the message is clear. Claims to be able to cure cancer, without good evidence, are illegal both in the USA and in the UK. I have heard that phisinc.com has been referred to the FDA, so visit their site quickly. It may not be there much longer. You'd then miss the chance to "View an extraordinary video that demonstrates a novel new technology that images the bioholographic field of living organisms and detects very early stage cancers." Regardless of legality, claims to be able to cure cancer of this sort are, in my view, plain wicked. Competing interests: None declared |
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