Homoeopathy is the tip of the complementary and alternative medicines iceberg. In her recent book ‘Suckers — how alternative medicine makes fools of us all’ (Harville Secker, London, 2008), Rose Shapiro states: “There are as many as one thousand different alternative therapies.”
In reality, we have two systems of healthcare:
1. Evidence-based, following currently approved scientific criteria
2. Placebo or belief-based, following unscientific criteria
The law needs to recognise these. System 1 is the current Medicines and Healthcare products Regulatory Agency licensed area, which excludes homoeopathy and most herbals. System 2 embraces all therapies that cause the establishment so much angst and cost to the taxpayer, through fruitless attempts at detailed regulation of hundreds of therapies and tens of thousands of products.
System 2 should be regulated by compulsory registration of therapies and practitioners. Any physical or psychic practice embraced within therapies seen as unsafe by the registration authority could readily be banned and overt health claims by therapists disallowed. Products associated with system 2 therapies should be regulated by statutory registration with full quantitative composition, manufacturer, distributor and overt or implied health claims disallowed. All products containing substances found to be unsafe after registration could be immediately identified on a master database.
Patient safety must be assured. If manufacturers want products and therapies to become recognised under system 1 then they would have to accept scientific scrutiny and provide evidence with a payment to the MHRA up front.
Recently, psychics, fortune tellers, spiritualist mediums and tarot card readers have been legally compelled to tell their clients and audiences they are offering “an entertainment”. This has warned their followers but not necessarily deterred them. All healthcare practitioners, including GPs and pharmacists using any aspect of system 2’s therapies should display a notice: “(The named therapy) is a scientifically unproven placebo therapy.” Similarly, all products should be clearly labelled: “This is an unproven therapy, for which no health claim is made.”
Any advertisement should carry a similar warning. Publicity in the media should have to refer to the placebo nature of any system 2’s therapy or product.
Finally, recommended dietary allowance-based nutritional supplements should be classed as foods and outside system 2.
Robert Woodward
Liss, Hampshire
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Following Edzard Ernst’s article on whether it is ethical for pharmacists to sell unproven therapies (PJ, 19 July 2008, p75), there have been many letters highlighting the fact that most over-the-counter preparations, not merely complementary medicines, have not undergone vigorous randomised controlled trials and are not evidence-based.
Lee and Steven Kayne’s letter (PJ, 2 August 2008, p126) questioned whether RCTs are the most effective means of judging effectiveness. Bearing this in mind, I suggest there is an evidence base for homoeopathy. In 2005, the Bristol Homoeopathic Hospital published the largest outcome study of homoeopathic treatment. This reported that 70 per cent of follow-up patients experienced improvement in their health and difficult chronic problems reported positive health changes1 (PJ, 26 Nov 2005, p657). Additionally, there are several randomised placebo controlled trials with positive outcomes in favour of homoeopathy.2–5
Pharmacies are the right environment for selling complementary medicines. We are the experts on medicines, therefore, we should be able to advise on all forms of medicines on the market and advise appropriately on interactions, side effects and doses among all categories of medicines. I think if all pharmacies stock homoeopathic remedies and educated themselves on homoeopathy then we would really make a difference in treating the general public’s minor ailments and achieve greater satisfaction.
Rather than criticising and dismissing homoeopathy we need to put our efforts and energies into doing some practice-based research in homoeopathy.
Ananti Shah
Superintendent Pharmacist
Royal London Homeopathic Hospital
References
1. Spence D, Thompson E, Barron S. Homoeopathic treatment for chronic disease: a six-year university hospital based outpatient observational study. Journal of Alternative and Complementary Medicine 2005;5:793–8.
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. Cucherat M, Haugh MC, Gooch M, Boissel JP. Evidence of clinical efficacy of homoeopathy — a meta-analysis of clinical trials. European Journal of Clinical Pharmacology 2000;56:27–33.
4. Jacobs J, Jonas WB, Jimenez-Perez M, Crothers D. Homoeopathy for childhood diarrhoea: combined results and meta-analysis from three randomised controlled clinical trials. Pediatric Infectious Disease Journal 2003;22:229–34.
5. Vickers A, Smith C. Homoeopathic oscillococcinum for preventing and treating influenza and influenza-like syndromes (Cochrane review). In: The Cochrane Library. Chichester:John Wiley and Sons Ltd.
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Edzard Ernst, Robert Woodward and others display determination in their quest for regulatory teeth to support a ubiquity of evidence-based medicine (PJ, 9 August 2008, p160). However, they also seem determined to confuse the abstract notion of treating a population with the business of treating real-life individual patients.
An evidence-based option is a logical first choice for most conditions but when a patient returns, practitioners must remain free to recommend another option of treatment based on their experience. Whenever a patient drops out of a clinical trial, this is the end-point and they become merely a statistical anomaly.
We cannot say to these patients: “You do not respond as you should to the evidence-based solution, therefore, you must suffer.” Any given treatment option may not suit everybody, but every patient deserves to be treated. It is true the exponents of some alternative therapies need to try harder to make a rational case for their practice.
However, the champions of evidence-based medicine need to look outside their ivory towers once in a while and try to understand the concept of real-life medicine.
Chris Brewer
Medicines Information Pharmacist
North Cumbria University Hospitals NHS Trust
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"Rather than criticising and dismissing homoeopathy we need to put our efforts and energies into doing some practice-based research in homoeopathy."
Been done. The evidence has shown that homeopathy is no better than placebo. Why continue to waste money on it?
The problem with homeopaths is that their system is based entirely upon belief. If you believe that water with zero inactive ingredient will have any effect whatsoever, then you are either blinded by faith, a nitwit, or a charlatan.
How exactly does a homeopathic hospital go about treating broken bones, or cancer, or diabetes? Do you have homeopathic surgeons, who think about removing tumours instead of doing real surgery. How on earth can you justify your position?
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Could you possibly give us an idea of the type of patients you "treat" with your magic water? Are they people with serious conditions, or people with minor, self-limiting conditions.
Also, who's paying the bill for the magic water that your "hospital" uses to treat your patients?
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Peter Dawson, D. Needleman and Miall James (PJ, July 26 2008, p97) present weak arguments on the issue of homoeopathic remedies and do not advance the discussion one iota.
Mr Dawson’s argument for similar standards to be applied to the sale of over-the-counter cold preparations may have some merit. However, the ingredients of cold remedies have undergone proper clinical assessment at some dose, for some condition, at some time.
Their role as promulgated in the glossy “home-remedy” packs may be spurious but they are manufactured to pharmaceutical grade and their adverse events are reportable through the yellow card scheme. Most importantly, for us as scientists, their proposed modes of action follow scientific hypotheses, which are genuinely proveable, not mystical hypotheses invoking energy systems.
The thousands of homoeopathy studies are ignored because none of them reaches a minimum standard of a clinical trial. I challenge Mr Needleman to produce a single randomised double-blind trial that shows homoeopathic products to be superior to placebo.
The results of the Kirsch study on selective serotonin reuptake inhibitors told us what we know: that SSRIs are no more effective than placebo in mild depression. This has been enshrined in the National Institute of Clinical Excellence guidelines since 2004.
If an SSRI prescription is presented and pharmacists know it is not for severe depression and they can somehow replicate the profound placebo effect highlighted in the Kirsch meta-analysis then they can refuse to supply.
However, remember that Kirsch analysed data from 45 randomised trials, so a homoeopathic placebo stand-in needs good data behind it.If Mr Needleman truly believes aspirin has not been clinically trialled, he has overlooked several iterations of the ISIS study, one of the largest randomised double-blind multi-national series of studies undertaken.
What inconsistency is Mr James referring to? Professor Ernst asks pharmacists to consider the scientific credibility of products before being prepared to sell them (PJ, 19 July 2008, p69 and p75). Pharmacists wishing to continue to advocate such products could peruse the advertised tomes and be sure of reading a scientifically disciplined investigation of the subject. If, after reading, they remain convinced they can honestly recommend such products, they have done the least that their ethical standards might require of them.
P. A. Hardy
Wakefield, West Yorkshire
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The Kaynes, bless them, seem to think that cystitis can be treated effectively by placebo, sorry, by homeopathy. I would love to hear how Berberis (a bush) or Cantharis (a beetle) are effective in the treatment of homeopathy. Anecdotes are not evidence.
Do you really believe this nonsense, or are you purely profit-driven?
Edit:
Link: http://dcscience.net/health-and-homeopathy-2001.pd...
(Scroll down to the bottom)
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I continue to be baffled by the fact that many pharmacists, including Ananti Shah (PJ, 16 August 2008, p190) and Chris Brewer (PJ, 16 August 2008, p190), seem to misunderstand my article (PJ, 19 July 2008, p75). I clearly state that homoeopathy was only chosen as an example of an unproven therapy sold in UK pharmacies.
My concern is not primarily about homoeopathy but about the fact that pharmacists behave unethically if they fail to provide customers with the most important facts about the preparations they sell. In the example of homoeopathy, this should be that there is no plausible mode of action, trial data are mixed and the best evidence fails to be positive.
Customers who walk into a UK pharmacy today are not only unlikely to get such information, they are likely to receive verbal or written material that is wrong or misleading.
I sympathise with the pharmacists’ dilemma, we all want to have the cake and eat it. But one can turn and twist it as one likes, breaking one’s code of ethics is simply unethical.
Edzard Ernst
Peninsula Medical School
University of Exeter
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Oh really - this "world today" against which you rail would appear to be the world extant since the Enlightenment. You deliberately misquote the argument when you say;
" everything should be be explained by science and, if not, then it obviously does not work".
Actually homeopathy doesn't work by any reputable measure, and is scientifically indefensible, so that's why it should be rejected by pharmacists.
True, our refusal to sell will not remove demand, but it will remove a veneer of scientific credibility from a pseuodscience. If anyone disputes whether homeopathy is a pseudoscience, give me a mechanism of its action which can be tested by scientific experimentation.
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The ethical dilemma is whether pharmacists only offer for sale products with a defined standard of evidence of efficacy (which could wipe half the products off their shelves such as all cough linctuses apart from codeine) or provide what customers think they want. I think there are arguments for both cases. Maybe we should ask the general public what they want as service users. Will they get even more variable advice from health food shops if alternative therapies are only available from such outlets?
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From Dr R. J. Woodward, MRPharmS
In reality, we have two systems of healthcare:
1. Evidence-based, following currently approved scientific criteria
2. Placebo or belief-based, following unscientific criteria
The law needs to recognise these. System 1 is the current Medicines and Healthcare products Regulatory Agency licensed area, which excludes homoeopathy and most herbals. System 2 embraces all therapies that cause the establishment so much angst and cost to the taxpayer, through fruitless attempts at detailed regulation of hundreds of therapies and tens of thousands of products.
System 2 should be regulated by compulsory registration of therapies and practitioners. Any physical or psychic practice embraced within therapies seen as unsafe by the registration authority could readily be banned and overt health claims by therapists disallowed. Products associated with system 2 therapies should be regulated by statutory registration with full quantitative composition, manufacturer, distributor and overt or implied health claims disallowed. All products containing substances found to be unsafe after registration could be immediately identified on a master database.
Patient safety must be assured. If manufacturers want products and therapies to become recognised under system 1 then they would have to accept scientific scrutiny and provide evidence with a payment to the MHRA up front.
Recently, psychics, fortune tellers, spiritualist mediums and tarot card readers have been legally compelled to tell their clients and audiences they are offering “an entertainment”. This has warned their followers but not necessarily deterred them. All healthcare practitioners, including GPs and pharmacists using any aspect of system 2’s therapies should display a notice: “(The named therapy) is a scientifically unproven placebo therapy.” Similarly, all products should be clearly labelled: “This is an unproven therapy, for which no health claim is made.”
Any advertisement should carry a similar warning. Publicity in the media should have to refer to the placebo nature of any system 2’s therapy or product. Finally, recommended dietary allowance-based nutritional supplements should be classed as foods and outside system 2.
Robert Woodward
Liss, Hampshire
From Mrs A. Shah, MRPharmS
Lee and Steven Kayne’s letter (PJ, 2 August 2008, p126) questioned whether RCTs are the most effective means of judging effectiveness. Bearing this in mind, I suggest there is an evidence base for homoeopathy. In 2005, the Bristol Homoeopathic Hospital published the largest outcome study of homoeopathic treatment. This reported that 70 per cent of follow-up patients experienced improvement in their health and difficult chronic problems reported positive health changes1 (PJ, 26 Nov 2005, p657). Additionally, there are several randomised placebo controlled trials with positive outcomes in favour of homoeopathy.2–5
Pharmacies are the right environment for selling complementary medicines. We are the experts on medicines, therefore, we should be able to advise on all forms of medicines on the market and advise appropriately on interactions, side effects and doses among all categories of medicines. I think if all pharmacies stock homoeopathic remedies and educated themselves on homoeopathy then we would really make a difference in treating the general public’s minor ailments and achieve greater satisfaction.
Rather than criticising and dismissing homoeopathy we need to put our efforts and energies into doing some practice-based research in homoeopathy.
Ananti Shah
Superintendent Pharmacist
Royal London Homeopathic Hospital
References
1. Spence D, Thompson E, Barron S. Homoeopathic treatment for chronic disease: a six-year university hospital based outpatient observational study. Journal of Alternative and Complementary Medicine 2005;5:793–8.
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. Cucherat M, Haugh MC, Gooch M, Boissel JP. Evidence of clinical efficacy of homoeopathy — a meta-analysis of clinical trials. European Journal of Clinical Pharmacology 2000;56:27–33.
4. Jacobs J, Jonas WB, Jimenez-Perez M, Crothers D. Homoeopathy for childhood diarrhoea: combined results and meta-analysis from three randomised controlled clinical trials. Pediatric Infectious Disease Journal 2003;22:229–34.
5. Vickers A, Smith C. Homoeopathic oscillococcinum for preventing and treating influenza and influenza-like syndromes (Cochrane review). In: The Cochrane Library. Chichester:John Wiley and Sons Ltd.
From Mr C. F. Brewer, MRPharmS
An evidence-based option is a logical first choice for most conditions but when a patient returns, practitioners must remain free to recommend another option of treatment based on their experience. Whenever a patient drops out of a clinical trial, this is the end-point and they become merely a statistical anomaly.
We cannot say to these patients: “You do not respond as you should to the evidence-based solution, therefore, you must suffer.” Any given treatment option may not suit everybody, but every patient deserves to be treated. It is true the exponents of some alternative therapies need to try harder to make a rational case for their practice.
However, the champions of evidence-based medicine need to look outside their ivory towers once in a while and try to understand the concept of real-life medicine.
Chris Brewer
Medicines Information Pharmacist
North Cumbria University Hospitals NHS Trust
"Rather than criticising and
Could you possibly give
From Mr P. A. Hardy, MRPharmS
Mr Dawson’s argument for similar standards to be applied to the sale of over-the-counter cold preparations may have some merit. However, the ingredients of cold remedies have undergone proper clinical assessment at some dose, for some condition, at some time.
Their role as promulgated in the glossy “home-remedy” packs may be spurious but they are manufactured to pharmaceutical grade and their adverse events are reportable through the yellow card scheme. Most importantly, for us as scientists, their proposed modes of action follow scientific hypotheses, which are genuinely proveable, not mystical hypotheses invoking energy systems.
The thousands of homoeopathy studies are ignored because none of them reaches a minimum standard of a clinical trial. I challenge Mr Needleman to produce a single randomised double-blind trial that shows homoeopathic products to be superior to placebo.
The results of the Kirsch study on selective serotonin reuptake inhibitors told us what we know: that SSRIs are no more effective than placebo in mild depression. This has been enshrined in the National Institute of Clinical Excellence guidelines since 2004.
If an SSRI prescription is presented and pharmacists know it is not for severe depression and they can somehow replicate the profound placebo effect highlighted in the Kirsch meta-analysis then they can refuse to supply.
However, remember that Kirsch analysed data from 45 randomised trials, so a homoeopathic placebo stand-in needs good data behind it.If Mr Needleman truly believes aspirin has not been clinically trialled, he has overlooked several iterations of the ISIS study, one of the largest randomised double-blind multi-national series of studies undertaken.
What inconsistency is Mr James referring to? Professor Ernst asks pharmacists to consider the scientific credibility of products before being prepared to sell them (PJ, 19 July 2008, p69 and p75). Pharmacists wishing to continue to advocate such products could peruse the advertised tomes and be sure of reading a scientifically disciplined investigation of the subject. If, after reading, they remain convinced they can honestly recommend such products, they have done the least that their ethical standards might require of them.
P. A. Hardy
Wakefield, West Yorkshire
The Kaynes, bless them, seem
From Professor E. Ernst, FRCP
My concern is not primarily about homoeopathy but about the fact that pharmacists behave unethically if they fail to provide customers with the most important facts about the preparations they sell. In the example of homoeopathy, this should be that there is no plausible mode of action, trial data are mixed and the best evidence fails to be positive.
Customers who walk into a UK pharmacy today are not only unlikely to get such information, they are likely to receive verbal or written material that is wrong or misleading.
I sympathise with the pharmacists’ dilemma, we all want to have the cake and eat it. But one can turn and twist it as one likes, breaking one’s code of ethics is simply unethical.
Edzard Ernst
Peninsula Medical School
University of Exeter
Oh really - this "world
Oh really - this "world today" against which you rail would appear to be the world extant since the Enlightenment. You deliberately misquote the argument when you say;
" everything should be be explained by science and, if not, then it obviously does not work".
Actually homeopathy doesn't work by any reputable measure, and is scientifically indefensible, so that's why it should be rejected by pharmacists.
True, our refusal to sell will not remove demand, but it will remove a veneer of scientific credibility from a pseuodscience. If anyone disputes whether homeopathy is a pseudoscience, give me a mechanism of its action which can be tested by scientific experimentation.
Ethical dilemma