Alternative medicine

As a profession, we are brought up on scientific principles - we all accept that Boyle's law works, or that gravity pulls things down instead of making them go up, then why do some of our profession refuse to accept that going beyond Avogadro's number in a dilution, renders that solution devoid of any of the original molecules present? "Because water has a memory!!" they say, "..the original molecule has "imprinted" itself in the water and that's how it acts" Prof. Ernst in his book "Trick or Treatment" debunks this, with the tale of Jaques Benaviste and his paper published in Nature, where he seemed to show water had a memory - don't forget that this is the cornerstone of homeopathy, and if it was proved, then it was plain sailing for the homeopaths. The experiment was shown to have operator bias, and thus false. In his book, Prof. Ernst takes a number of alternative therapies and subjects them to analysis, and shows that on the whole, they are false. Where does this leave pharmacists? We are a profession that (I hope) will only accept that which is true, and has been proven in trials, no matter how distastfull they may be to us. It is the concensus of a large body of evidence, eg The Cochrane Collaboration or Bandolier, that gives us the facts that we use in our daily practice. Prof Ernst does the profession of pharmacy a very great service in giving impartial knowledge that we all can use. I would urge fellow pharmacists to go beyond Prof. Ernst's popular scientific works and read some of his scholarly papers, and the true genius of this man shines through. In writing his letter to the Journal, he has opened up a debate that will run and run. Ezard Ernst has said that - in effect - if the evidence proves this alternative therapy to be worng then it is so!! The homeopaths and their fellow travellers in the CAM (Complementary and Alternate Medicine) field seem to operate on the premise of The Bellman, in Lewis Carrols' " The Hunting of the Snark" - "...what i tell you three times is true." However,.... however, I will leave this posting with a parting shot: 1992 saw the hundreth aniversary of Kekules' discovery of the structure of benzene, how he sat in front of his fire and dreamed that the smoke rising was a snake taking hold of it's tail and thus the essential ring structure of aromatic compounds was born, and experimental evidence seemed to prove it was so. The American Chemical Society decided to mark this anniversary with a special meeting to celebrate how far aromatic chemistry had come since Kekule. The meeting ended up in a brawl!! There were chemists there who disagreed with Kekule's structure,the one that we are all familiar with, and put up equally viable (to them) structures of their own and would brook no argument, which lead to fisticuffs. Thus there is always the element of doubt, however small. Remember, only two things in life are certain - death and taxes!! Regards Bob Dunkley

Edzard Ernst states there is little or no evidence to support homoeopathy and complementary therapies (PJ, 19 July 2008, p69). There are thousands of trials that show that homoeopathy is better than placebo, but these are ignored.

If it is unethical to supply medicines that have not been scientifically proven, should I refuse to dispense selective serotonin reuptake inhibitors as they have recently been shown to be of no greater value than placebo for mild depression (PJ, 1 March 2008, p235)? And how about aspirin or amoxicillin or other effective drugs that have not been clinically trialled?

D. Needleman

Stanmore, Middlesex

Is there some inconsistency here? Your leading article (PJ, 19 July 2008, p58) discussed critically the ethics of supplying homoeopathic products. In the same issue you published a letter (PJ, 19 July 2008, p69) and an article (PJ, 19 July 2008, p75) on the subject by Edzard Ernst, both of which could reasonably be said to take a negative view of homoeopathy.

However, on pA8 and pA12 you carried two colour advertisements for books on, respectively, homoeopathic prescribing and homoeopathic practice, both of which are stated to be published by the Pharmaceutical Press.

If pharmacists should consider the ethics of supplying homoeopathic products, surely that extends to the Pharmaceutical Press.

Miall E. James

Colchester, Essex

Edzard Ernst’s article “Is it ethical for pharmacists to sell unproven or disproven medicines?” (PJ, 19 July 2008, p75) implies a discussion of all unproven medicines. However, we note that he has omitted to mention those over-the-counter allopathic medicines with no evidence of effectiveness. In fact it is a misleading title for what is just another attack on homoeopathy.

Campaigns to persuade the Medicines and Healthcare products Regulatory Agency and the Veterinary Medicines Directorate not to register homoeopathic medicines under the relevant legislation and to persuade consumers not to use homoeopathy have failed. Professor Ernst is now trying a new strategy in attempting to shut off supply by embroiling the pharmacy profession in the debate. He takes a large number of words to make a simple point. He believes it is unethical for pharmacists to prescribe and sell homoeopathic medicines because, in his view, there is no evidence of positive outcomes.

We, as pharmacists, say it is ethical and there is evidence. Professor Ernst believes there is often a gap as wide as a canyon between homoeopaths’ and non-homoeopaths’ views of what constitutes evidence.¹ Would it, therefore, not be more productive to debate the issue of what constitutes evidence rather than cast aspersions on our professional integrity?

Professor Ernst cites two systematic reviews ^2,3 and a comparative meta-analysis⁴ to support his assertion that only negative evidence is worthy of consideration. Both reviews are his and so employ his own evaluation criteria, while the comparative study has been subject to methodological criticism.^5,6 Although the latter paper claimed to be based on over 100 homoeopathy studies, the conclusion was based on only eight. Professor Ernst discounts positive evidence, saying that he considered the two articles that he chose to cite “lacked rigour”.

Homoeopathy may be unproven in the view of Professor Ernst and some others, based on scientific principles, but these are not the only measures of effectiveness. Randomised controlled trials (RCTs) are not even the gold standard — merely an accepted standard, until something better comes along. For every article defending the rigour and reliability of RCTs, one finds others raising questions about their utility.^7,8 Although many RCTs do exist in homoeopathy,⁹ the validity of the concept has been questioned.¹⁰

Homoeopathic outcomes are widely studied using patient-oriented outcome, measures under so called “field conditions” not under the rigid standardised dose regimens that form part of RCT methodology.¹¹ It is acknowledged that historical case reports and observational studies do not rate highly on the hierarchy of evidence scales but, nonetheless, they provide support for the administration of homoeopathy in a wide range of conditions and form the basis of the limited claims of effectiveness allowed by the MHRA for homoeopathic medicines registered under UK national rules.

To suggest that homoeopathy is provided for profit alone is a slur on the good name of our profession. We know our limits of competency. Patients demand the right to choose how they are treated and are prescribed homoeopathic medicines under the NHS. Are we to abrogate our dispensing responsibilities too?

Lack of evidence and inaccuracies in the article spoil the central argument. Where is Professor Ernst’s evidence for the statement “most UK pharmacies have shelves full with herbal remedies, aromatherapy oils, flower remedies and homoeopathic products”? And what does he mean by the healthy profit we are supposed to be making?

His statement “most of the remedies for sale do not contain a single molecule of what it says on the package” is misleading. Medicines at the 6c potency level certainly do contain molecules of the specified source material. He says “necessary or relevant information is not available in UK pharmacies”. This again is untrue and seems to be based on anecdotal evidence, which is apparently acceptable to the author in this instance.

Professor Ernst should stick to his areas of expertise. We will make our own professional judgements without his unsolicited advice.

Lee Kayne

Pharmacy Dean

Faculty of Homoeopathy

Steven Kayne

Hon Consultant Pharmacist

Glasgow Homoeopathic Hospital

References

1. Ernst E. The Importance of giving a robust evidence base — a personal view. In: Kayne SB, editor. Homoeopathic Practice. London: Pharmaceutical Press; 2008. p34.

2. Ernst E. A systematic review of systematic reviews of homoeopathy. British Journal of Clinical Pharmacology 2002;54:577–582

3. Altunc U, Pittler MH, Ernst E. Homoeopathy for childhood and adolescence ailments: systematic review of randomised clinical trials. Mayo Clinic Proceedings 2007;82:69–75.

4. 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.

5. Kiene H, Kienle GS, von Schön-Angerer T. Failure to exclude false negative bias: a fundamental flaw in the trial of Shang et al. Journal of Alternative and Complementary Medicines 2005;11:783.

6. Peters D. Shang et al. Carelessness, collusion, or conspiracy? Journal of Alternative and Complementary Medicines 2005;11:779–80.

7. Smith G, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. BMJ 2003;327:1459–61.

8. Searching for gold standards — the construction and governance of RCTs and EBM in psychiatry. Available at tinyurl.com/5hmtbm (Accessed 29 July 2008)

9. Mathie RT. The research evidence base for homoeopathy: a fresh assessment of the literature. Homoeopathy 2003;92:84–91.

10. Weatherley-Jones E, Thompson EA, Thomas KJ. The placebo-controlled trial as a test of complementary and alternative medicine: observations from research experience of individualised homoeopathic treatment. Homoeopathy 2004;93:186–189.

11. Kayne SB. Homoeopathic Pharmacy. 2nd Edition. Edinburgh: Elsevier Churchill Livingstone; 2007. pp281–285.

Edzard Ernst (PJ, 19 July 2008, p75) does himself no favours by continually writing articles on natural medicines. These regularly cite references from his own papers and publications, which detracts greatly from the strength of any argument he puts forward.

Before we clear our shelves of natural medicines perhaps we should all have a look at the BMJ’s Clinical Evidence website. Of the 2,500 commonly used conventional treatments, only 13 per cent were rated as beneficial and 23 per cent likely to be beneficial; 46 per cent are considered as having unknown effectiveness and 4 per cent are likely to be ineffective or harmful. Is it ethical to sell or dispense such conventional treatments, which are of such dubious therapeutic benefit?

In terms of patient safety, I believe this is the question we should be asking over the summer. Our dispensary shelves might have a few gaps in the autumn.

Ian Jackson

Mansfield, Nottinghamshire

Professor Ernst argues that we should stop selling homoeopathic medicines because it is unethical to sell something that is not effective. He bases his arguments on trials of homoeopathy versus placebo. Perhaps homoeopathy cannot be proven to be more effective than placebo, but any practitioner of medicine knows that placebos can be very effective, especially in reducing pain, helping sleep and reducing the perceived severity of symptoms. For many conditions, the body will heal itself if the patient can relax sufficiently. I have no hesitation in prescribing and using homoeopathic remedies where appropriate, even though as a scientist I find them difficult to rationalise. I would argue that homoeopathy is as effective as the most powerful placebo and we are quite within our ethical boundaries in using it.

I read with interest the considerations of Edzard Ernst (PJ, 19 July 2008, p69 and p75) pertaining to the lack of scientific evidence to support the use of homoeopathic remedies and whether pharmacists ought to be selling them.

Following that argument we should remove all cough syrups from our shelves since their efficacy has been shown to be nothing more than placebo.

As a pharmacist, I believe the role entrusted to me is to ensure anyone wishing to take any substance, whether it is over-the-counter medication, alternative remedy or something prescribed by a physician, does so in the best way in order for him or her to gain benefit from it. I do not think it is my place to remove free will any more than I should select what people consume in the way of nutrition.

It is a sad reflection of the world today where we think everything should be be explained by science and, if not, then it obviously does not work. When I sell homoeopathic remedies, I explain to the customer that we do not know how they work but in many cases they do provide relief where conventional therapies have failed or have undesirable side effects to accompany the satisfactory outcome.

Finally, why should anyone who spends such a long time to achieve the highest level of understanding of substances within the body relinquish an area that can generate income outside of NHS constraints to other less qualified retailers, since our refusal to sell will not remove the demand.

Elspeth Kirton

Barbados

David Pruce seems to confuse regulation and law with ethics and morals.

Regulation is important but it will not resolve the ethical dilemma I referred to (PJ, 19 July 2008, p69 and p75). Mr Pruce states that “pharmacists should assist patients in making an informed decision, and provide them with the necessary and relevant information that is available”.

This is a deviation from the actual text of the code of ethics, which states that pharmacists “must assist patients in making informed decisions by providing them with the necessary and relevant information”, with no mention of availability of information.

The Royal Pharmaceutical Society seems to think it is not important or relevant to tell consumers that homoeopathic products and Bach Flower remedies contain no active molecules and are clinically unproven, possibly even disproven. Perhaps it should ask its customers whether they agree. It may learn that honesty and transparency count more than it had assumed.

I find it difficult to decide whether Mr Pruce and the Society do not understand this ethical dilemma or whether they are trying to put up a smokescreen, and hoping the problem might disappear.

Meanwhile, in the poll conducted on PJ Online, 57 per cent of pharmacists answered “no” to the question “Is it ethical to sell homoeopathic or other remedies that have no evidence base to support their effectiveness?” (poll accessed 30 July 2008, number of votes = 131).

Considering that this vote is against their commercial interest, I find this result remarkable and clearer than the Society’s position.

Edzard Ernst

Peninsula Medical School

Exeter

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.

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

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

 

This forum is not the correct forum to review the evidence base for therapies -  and particularly homeopathy. Readers may however be interested to know that the oft quoted Bristol study which basically discovered that people self reported clinical improvement after an intervention. "The outcome score was assessed during the consultation, with patients being asked to rate their overall improvement or deterioration compared to their status at first visit."

Hardly objective, not controlled, no comparator. I imagine we could get similar data from any intervention - or even a chat with a mate over a pint.

(Spence DS, Thompson EA, Barron SJ. Homeopathic treatment for chronic disease: a 6-year, university-hospital outpatient observational study. J Altern Complement Med 2005; 11: 793-798. (Full text available at http://www.liebertonline.com/toc/acm/11/5))

I also have to disagree with my learned colleague Mr Hardy.  Whilst the results of the Kirsch paper were widely reported SSRIs as being the same efficacy as placebo this was not in fact what the authors reported not what their study showed. In fact SSRIs were consistently more effective than placebo but that this did not reach the arbitrary point for "clinical effectiveness" set by NICE in it's clinical guidelines. 

May I take the liberty or recommending www.badscience.net and especially http://www.badscience.net//?p=490 as a starter on the science that may (or may not) lie behind homeopathy? Although 200 years after the therapy was invented we are still awaiting good evidence - and, despite the oft quoted percentages from BMJs Clinical Evidence most interventions actually undertaken do have a sound evidence base.