Rapid Responses to:

PRIMARY CARE:
G T Lewith, A D Watkins, M E Hyland, S Shaw, J A Broomfield, G Dolan, and S T Holgate
Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised controlled clinical trial
BMJ 2002; 324: 520 [Abstract] [Full text]
*Rapid Responses: Submit a response to this article

Rapid Responses published:

[Read Rapid Response] The distortions of language
Robert W Leckridge   (1 March 2002)
[Read Rapid Response] Comparing Apples with Oranges
Meryl W Dorey   (2 March 2002)
[Read Rapid Response] Naked?
Tom G McPhee   (2 March 2002)
[Read Rapid Response] A pilot design of diluted power. It might prove effectiveness, but it does not disprove efficacy.
David Reilly   (2 March 2002)
[Read Rapid Response] Isopathy
Karl Traintinger   (2 March 2002)
[Read Rapid Response] Precise definitions and understanding of intervention required
Susan Muller, Supervision not yet decided.   (2 March 2002)
[Read Rapid Response] Errors of understanding
Stephen Joseph Gordon   (3 March 2002)
[Read Rapid Response] Homeopathy or 'allopathic homeopathy'?
John P Heptonstall   (4 March 2002)
[Read Rapid Response] Respecting the complexity of the homeopathic approach.
Elizabeth A. Thompson   (5 March 2002)
[Read Rapid Response] Headlines
Kathy E Ryan   (5 March 2002)
[Read Rapid Response] sensational headline!
Mandi S Martin   (7 March 2002)
[Read Rapid Response] Typing error?
Adam Jacobs   (8 March 2002)
[Read Rapid Response] Publication bias on homeopathy by BMJ
AntonH Kramer   (11 March 2002)
[Read Rapid Response] Trial Allergic Asthma
George Vithoulkas   (14 March 2002)
[Read Rapid Response] Studies comparing homoeopathy and placebo are unhelpful
John M Weiner   (15 March 2002)
[Read Rapid Response] Homeopathic immunotherapy in asthmatics allergic to house dust mite
Dr S K Agarwal   (17 March 2002)
[Read Rapid Response] Isopathy versus homeopathy
Menachem Oberbaum, Itzchak N. Slotki   (19 March 2002)
[Read Rapid Response] Really a test of homeopathy?
Elaine Weatherley-Jones   (23 March 2002)
[Read Rapid Response] Homeopathic medicine: a synonym for placebo? Is there any place for preventive medicine?
alberto loizzo, Luisa Lopez, Salvatore Dell' Aquila and Antonio Contu   (2 April 2002)
[Read Rapid Response] Throwing the baby out with the bath water
Paul M Coplan   (3 April 2002)
[Read Rapid Response] Response to Responses
George T LEWITH, Michael Hyland and Stephen Holgate   (12 April 2002)
[Read Rapid Response] What is homeopathy?
Emma Lou Dilts   (1 May 2002)
[Read Rapid Response] Homeopathy and allergic asthma
S K Agarwal   (2 May 2002)
[Read Rapid Response] Study criticizes Isopathy, not Homeopathy
Mitchell A. Fleisher, M.D., D.Ht., F.A.A.F.P.   (13 August 2002)
[Read Rapid Response] Which is the definition of homeopathy ?
andrea valeri, 41037 mirandola (modena) italy   (21 August 2002)

The distortions of language 1 March 2002
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Robert W Leckridge,
Associate Specialist
Glasgow Homeopathic Hospital G12 0XQ

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Re: The distortions of language

The "Conclusion" in the abstract states "Homeopathic immunotherapy is not effective in the treatment of patients with asthma". The last sentence of the article itself states "In conclusion, in this double blind, randomised controlled trial of homeopathic immunotherapy we have failed to confirm that this treatment is therapeutically efficacious in allergic asthma.."

These two conclusions are NOT the same.

The conclusion of the article is a reasonable one to make. In THIS trial WE HAVE FAILED TO CONFIRM captures the point exactly. To extrapolate that to the conclusion quoted in the abstract suggests that NO homeopathic immunotherapy is EVER effective in patients with asthma is not logical.

What if a different potency or different frequency of dosing were to show a difference for example? This trial only used 3 doses of 30c over 24 hours. There are many other different regimes used in practice. This trial actually doesn't show that those other regimes don't work.

Sadly, this loose use of language then generates front page headlines like the one on today's BMJ "Homeopathy for dust mite allergies? No, it's a waste of time." which further extrapolates from the conclusion of the abstract to claim that ANY USE of HOMEOPATHY in treating dust mite allergies is "a waste of time". This is an even less defensible position.

So, from article, to conclusion, to conclusion of abstract, to front page headline we lose the truth and develop generalisations with are not only wrong but are unscientific.

Comparing Apples with Oranges 2 March 2002
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Meryl W Dorey,
National President, The Australian Vaccination Network, Inc.
PO Box 177, Bangalow NSW 2479, AUSTRALIA

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Re: Comparing Apples with Oranges

Homoeopathy is a system of healing that has been around for over 200 years. It does not operate the way that allopathic medicine does.

Allopaths treat symptoms. They say that if patient A displays a certain set of symptoms, then a specific drug will be used to treat them. All patients are treated simply based upon their symptom picture. Sometimes, a history is taken to ensure that a patient is not allergic to a certain drug and if they are, another one will be substituted. But generally, allopathy will treat symptoms rather than the whole person.

Homoeopathy treats the person. If a person has asthma, a homoeopath will generally spend at least 1 hour on a first visit, getting an idea of this person's history and lifestyle. What is their diet like? What other problems have they been treated for in the past? Do they have any emotional issues? Then, and only then, a remedy will be prescribed based not upon the symptoms they are currently displaying but upon what the homoeopath feels is causing those symptoms. Only then can someone truly be cured.

This study does not compare homoeopathic and allopathic treatments of asthma. It sets out with the intention of proving that homoeopathy does not work. To accomplish this, it using non-homoeopathic treatments and methods.

I have never heard of a homoeopath using potentised allergens to treat an allergy though possibly, in some cases, this might be an effective treatment? But certainly, if you took 242 people with asthma and treated them homoeopathically, you might very well find that they would require 242 different remedies.

How is it possible therefore, that something as obviously ill-constructed and conceived as this study could be published in a peer-reviewed journal with the outstanding reputation which the British Medical Journal has always held?

Where were the peer-reviewers when this was submitted? Do you have any homoeopaths as reviewers or was this looked at by people who are as ignorant of the practice of homoeopathy as the authors of this study obviously are?

When I read something of this nature in your Journal, it truly makes me wonder what other studies make it through the peer review process for absolutely no good reason?

Thank you,

Meryl Dorey
National President
The Australian Vaccination Network, Inc.

Naked? 2 March 2002
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Tom G McPhee,
Final Year Medical Student
Glasgow

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Re: Naked?

Translation: The emperor may well have been shown to be naked in this one instance, but are we really to expect that he is always naked? Indeed I suspect that if you squint hard enough you will be able to see the memory of his last fitting indelibly imprinted on his skin.

A pilot design of diluted power. It might prove effectiveness, but it does not disprove efficacy. 2 March 2002
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David Reilly,
Consultant Physician, Glasgow Homoeopathic Hospital
G12 ONR

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Re: A pilot design of diluted power. It might prove effectiveness, but it does not disprove efficacy.

Editor, as principal author for the earlier asthma trail (1) that Lewith et al (2) allude to, I hope you might allow me on behalf of my team to make some comments on this very interesting pilot study of a new design of trial in isopathy in asthma.

A trial can show either both groups working, or, neither – each scenarios call for different conclusions and debate. In this trial, homoeopathic isopathy worked very well in both groups. It is wrong to summarise such excellent clinical improvements as ‘not effective’. In fact they have clearly shown good clinical effectiveness (i.e. usefulness in the real world). But this positive result raises the second order question – ‘Was there efficacy?’ - (i.e. more than the placebo effect), as described in our earlier trial (1) that the authors make some comparisons with? Unfortunately we won’t know from this study because this study design in this number of people was unable to answer this question. This is not a replication of Reilly et al. It is a changed design in a changed context. The fact it is ‘substantially larger’ does not ensure it is better. The fact it has a ‘wider range’ of outcome measures does not make them more apt.

We expressed the following concerns to the Lewith et al team when asked for an opinion at the design stage, and when re-approached during analysis. As our criticisms were not taken on board we now have complementary, but non-comparable, works.

Our focus was placebo, not asthma. Our concern was efficacy and not effectiveness. We designed for precision and internal validity, not generalisability. So for example we limited observation to 4 weeks post randomisation - which also minimised drop out – and consciously avoided a primary care context. This is all very different from this new work.

Our selection criteria and context were also very different. Our patient recruitment was exclusively restricted to patients already needing to attend a single hospital based specialist centre. As well as changing context effects, this also means that the severity of the patients’ asthma is different in both trials. We did not recruit from the ‘real world’ primary care environment like Lewith et al exactly because you can expect more ‘noise’ and different results (for example a higher placebo response) in the latter, diluting the power of the study. This was demonstrated in our mainly GP recruited and based rhinnitis trial where (as in this study), both groups showed excellent subjective response, and (as in this study) the trial proved underpowered for determining if the groups varied on the subjective measure (3). In that case it was the objective measure that distinguished in homoeopathy’s favour.

We used more rigorous admission criteria, tested in a qualification period, with a full re-diagnosis of asthma in every patient in a laboratory histamine provocation test before being accepted, and again 4 weeks later. This scientific precision is beyond the Lewith et al context, and what proportion of their patients would match this is unknown. Our homoeopathic diagnosis was also far more precise, with an expert with 15 years experience in isopathy examining every patient and choosing the correct isopathic agent. This is not always straight forward, for example when two allergens yield similar skin-test weal reactions. This decision involved a case conference for every patient, with the conventional and homoeopathic specialist each having full power to exclude a patient not meeting their respective criteria.

Seasonal variation is another key factor here. We purposefully avoided the peak of the house dust mite season, delaying recruitment until February, a full five months later than Lewith et al began. We reasoned that isopathy is a weak form of homoeopathy and will be less effective when the body is being maximally externally challenged by the causative allergen. Further we restricted intake to only a 4 week calendar period to ensure a more uniform environmental stimulus throughout the study period, and all patients were from one geographical zone (west-central Scotland). This contrasts starkly with Lewith et al’s 30-32 weeks recruitment period (geographical spread unstated). Clearly in patients in whom house dust mite allergy is playing a key role (the very patients you need) it is important to minimise the variability of environment exposure over the period of study.

So we had a different sort of patient population, studied at a different time of the allergen season. Then we used a radically different core design. Critically, all our patients had a month of single-blinded run-in on placebo. This is another key difference between the studies. Clearly patients who have been a month on placebo, then receiving a second medicine, which 50:50 might be swapped without their knowledge to an active medication, will have a different pattern of baseline and subsequent response to the Lewith et al design (which lacked this element entirely) - how different a pattern, again no one can say. Also this will have generated a very different, and likely more useful, baseline in our work which was used as each patients own control.

Drug administration might be different also. The research nurse phoned me after the trial started asking for help on how to administer the medicine. Lewith et al do not state if they then harmonised with our pattern of 3 doses given over 24 hours to cover the possibility of diurnal variation in receptivity.

Different Outcome Measures were used. Its true that both studies used a VAS (Visual Analogue Scale), but that just means a straight line. How it is labelled, the context in which is completed and the time pattern of its use will all radically change what is measured. Lewith et al used discontinuous recording. In contrast, in Reilly et al the VAS was recorded every day, self-referencing to previous VAS scores, continuously over an intensely observed 8 weeks. How the Lewith et al on-off pattern will change the outcome is unknown. It might well ‘re-set’ the patients reference point each time it is re-started. Peoples memory of symptoms tend to adjust to their more recent experiences. Then our patients were asked to orientate before their daily ‘overall score’ with a set routine of recording a digital score for a number of particular symptoms (cough, wheeze, interference with sleep etc) and this will have helped them focus carefully before filling in the VAS. Finally, the two VAS scales were worded differently. We used - ‘Overall today I felt… Fine……. Terrible (a wording consciously held steady in the 4 trials in our series), Lewith et al labelled their VAS around asthma. The issue here is not if one is better than the other (for good or bad, ours may have an embedded wellness dimension for example), what is important is that they are different. This difference alone would place us in the unsatisfactory situation of being unable to say if the difference in outcome between the 2 trials is real, or context and method determined.

Blinding was very different. Each medicine dose in our study was recoded to a unique number by a third party distant from the clinical team. The use of A/B coding by Lewith et al is very unwise. Over time participants such as the research nurse can unconsciously be guessing (or picking up from real treatment responses) which is which and transmit varying messages to patients.

So we cannot compare these studies. However, Lewith et al do take the debate forward. They have tested a diluted remedy in a study of diluted power, but have shown real world effectiveness of homoeopathy in an every day context for a serious disease. This needs presented and considered for what it is – a pilot of a new design in a new context which could usefully serve as the basis for a power calculation for a second study to determine if the challenging level of clinical gain shown was due entirely to placebo, or was the trend towards a different pattern in the two groups significant?

1. Lewith GT, Watkins AD, Broomfield JA, Dolan G, Holgate ST. Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite:double blind randomised controlled clinical trial. BMJ 2002;324:520-3.

2. Reilly DT, Taylor MA, Campbell J, Beattie N, McSharry C, Aitchison T, Carter R, Stevenson R. Is evidence for homoeopathy reproducible? Lancet 1994;344:1601-06.

3. Taylor MA, Reilly D, Llewellyn-Jones RH, McSharry C, Aitchison TC. Randomised controlled trial of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial series. BMJ 2000;321:471-6.

Isopathy 2 March 2002
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Karl Traintinger
A5112 Lamprechtshausen

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Re: Isopathy

Hallo, your study has nothing to do with classical homoeopathy! Isopathy is not homoeopathy!
Gx KTraintinger

Precise definitions and understanding of intervention required 2 March 2002
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Susan Muller,
Masters student, Division of Nursing, Faculty of Medical & Health Science, University of Auckland
Masters student (research thesis),
Supervision not yet decided.

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Re: Precise definitions and understanding of intervention required

Dear Editor,

The reporting of this study highlights the importance of precise of definitions in evidence based medicine and adherence to them. The word homeopathy, which has been used interchangeably with "immunotherapy", means different things to different people and includes herbalism and injections at acupuncture sites. To some it is merely the administration of a diluted substance.

In addition, this report brings to our attention the importance of researchers and writers having an understanding, preferably a thorough one, of the intervention used. Obvious lack of this detracts from the validity of the study in the eye of the savvy reader.

Yours faithfully,
Sue Muller

Errors of understanding 3 March 2002
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Stephen Joseph Gordon,
Homeopathy Consultant
Queens Square Surgery, Attleborough. Norfolk

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Re: Errors of understanding

Two major problems with this faulted piece of research can be identified from within the wording of its outlined objective: To evaluate the efficacy of homoeopathic immunotherapy on lung function and respiratory symptoms in asthmatic people allergic to house dust mite.

The recruits in this trial were patients with asthma who reacted most strongly to house dust mite out of nine aeroallergens--but how many of the patients were reactive to other allergens? What other factors within their daily environment, in possible addition to some the other eight aeroallegens, were they allergic to? Other allergens would have continued as maintaining irritants of their asthma even though their house dust mite reaction was possibly being addressed. The mistake in this trial is to identify the one allergen as the cause of the asthma problem rather than to understand that the patient is immuno-compromised and it is the underlying allergic state that needs addressing - not just one irritant of it. The reaction to house dust mite and the patient's asthma are both symptom expressions of their underlying immuno-compromised condition--the first is not the sole cause of the other.

This first observation leads on to the more profound criticism of this research and this is the mis-use of the word 'homeopathic'. This research is not about 'homeopathic immunotherapy' but 'isopathic immunotherapy' - treating a health condition using ultra-molecular doses of a specific factor which is identified as possibly causing it. Homeopathy however is the science of individualised treatment of patients for their health problems using ultra-molecular doses of substances drawn from the three kingdoms of nature which have been tested and proved as provoking highly similar sets of symptoms to that of the patient overall-- including the symptoms defining their diagnosed condition.

Homeopathy commonly uses remedies produced from substances that may appear to be quite unrelated to the symptom picture of the patient. A simple example would be the use of potentised onion to treat cases of allergic hayfever where symptoms are highly similar to those provoked by inhaling while onion chopping! The difference between homeopathy and isopathy is that homeopathy, through a detailed case-taking, analysis and prescription based on the full individual symptom picture of each patient treats the underlying general allergic state of the immuno-compromised patient. Treating the underlying allergic state potentially means addressing the asthma together with sensitivities to any number of allergens in the patient's environment and not just one specific irritant.

This faulted piece of work raises questions about the understanding of the researchers involved in it, whether they widely consulted with appropriately qualified colleagues beforehand and, unfortunately, the quality of the BMJ's peer-review process prior to the article being published. Why weren't these simple errors in thinking picked up?

I look forward to the day when doctors will consult and collaborate with homeopaths in trialing homeopathy properly ? and effectively. Perhaps then the unnecessary negative press publicity which has resulted from this faulted trial's publication can also be avoided.

Homeopathy or 'allopathic homeopathy'? 4 March 2002
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John P Heptonstall,
Director of the Morley Acupuncture Clinic and Complementary Therapy Centre
Leeds LS27 8EG

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Re: Homeopathy or 'allopathic homeopathy'?

Sir

Having read the inevitable 'homeopathy is useless for asthma' in the national press who had picked up on this study, with no rebuttal of this ridculous statement from the research team who must realise such statements are inaccurate and unhelpful to the public if based purely on their study, I thought it worth the following comments:-

This was not 'homeopathic immunotherapy', it bears little relevance to homeopathy as practised and principled.

'Measurements of lung function and respiratory symptoms were addressed in asthma patients' as stated, but 'asthma' is more than the sum of those symptoms.

'Like was not treated with like' as it is highly unlikely that the subjects suffered exact same, or even similar, total symptoms to facilitate this principle for selection of effective remedy. Isolating dust mite through skin prick testing is not a basis for selection of a 'like treats like' scenario. One first has to confirm that dust mite is particulary responsible for the 'asthma symptoms' in all subjects before that remedy is provided, not merely that one is allergic to it as many people are allergic to the mite yet suffer no asthma. Research which found positive evidence for homeopathy in hayfever is a good example of 'like treating like' where 'pollen treats pollen-based symptoms'.

All subjects received only 3 doses on one day, at the same level, despite vast differences in chronicty, age, lifestyle, variation of signs and symptoms, location and environment, medication regimes etc. this is allopathy not homeopathy.

Both placebo and the intervention created 'large treatment effects' - a very different statement from the national press 'useless'.

'There was a different pattern of response within the homeopathy group, charactersied by alternating deterioration and improvement'...'this pattern is inconsistent with homeopathic theory...'. The finality of this summary omits to remind one that every subject remained on their medical regimes - homeopathy believes that drugs mask symptoms and may merely mocify the condition as opposed to removing the condition from the body. The homeopathic remedy serves to enhance the vital energy to expel the pathogen. Could this alternating pattern illustrate the latter point - that the remedy was trying to expel a pathogen that was aided in its struggle to remain through damage to homeostatic mechanisms caused by the drugs? It would be better to test the theoretical value of homeopathic preparations as they were designed, on subjects not taking drugs, or in the very early stages of drug-taking so the body's 'vital force' is less likely to have been damaged beyond repair.

From my perspective of Traditional Chinese Medicine, 'asthma' (a name for a range of symptoms) is a conglomerate of various signs and symptoms and is very dependent on consitution of the individul; it can result from Heart, or Lung, or Kidney, or Spleen/Stomach, or Liver dysfunction. Each would have similar and dissimilar signs and symptoms according to these categories, and due to age, chronicity, environemnt, social, mental, emotional...etc. variations, hence requires varying prescriptions. For example Kidney type may be worse in Winter or cold weather, between 5 and 7 am/pm, for exercise, for alcohol, and may show few clinically identifiable bronchial symptoms; Lung type may be worse in Autumn, in Windy weather, between 3 and 5 am/pm; liver type may be more affected by environmental allergens such as dust mite, phenols, ethanols etc., and may be worse in windy weather, between 1 and 3 am/pm....

Through Vegatesting I find 'asthma' patients tend to show sensitivities to specific groups of foods; cereals, fish & seafoods, phenols, mite, grasses & pollens (especially where hayfever also exists). If phenols are a problem (and these are used as preservatives in some anti-asthma preparations) subjects with phenol sensitivity may respond less to any therapy. I would expect perhaps 2 out of 10 'asthmatics' to benefit greatly from anti-dust mite methods; the other 8, despite also showing dust mite sensitivity, will have greater problems with other foods/environmental substances such that anti-mite methods show little benefit whilst removal of other substances will be of greater value.

To conclude, I think the study is naive and simplistic and does not take into account either the true natures of either 'asthma', or homeopathy. It is based on allopathic representation of disease and treatment, it fails to account for the idiosyncracies of either immune- functioning or patient individuality and therefore the team can only conclude that

1. Treating an inhomogeneous variety of 'asthma' sufferers who show allergies to house dust mite with homeopathic 30C potencies of dust mite, for one day, is of the same positive value as placebo.

2. The study does not address the potential value of homeopathy for treating asthma.

3. The study is a trial of an 'allopathic homeopathy' method and it clearly shows that method to be of the same value in treating asthma as placebo.

Regards

John H.

Respecting the complexity of the homeopathic approach. 5 March 2002
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Elizabeth A. Thompson,
Consultant Homeopathic Physician
Bristol Homeopathic Hospital BS66PD

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Re: Respecting the complexity of the homeopathic approach.

Dear Editor,

Much interested by the publication of research into Homeopathy, I was perplexed to find emblazoned on the cover "Homeopathy for dust mite allergies? No it's a waste of time."(1) I hurriedly turned to page 520 to see this phrase as part of the conclusions made within the study. No, page 520 made no reference to the phrase and so I turned to the leader - it must have been a quote from the continuing and often heated debate that surrounds homeopathic research. No I could not find it. So I studied the article carefully.

What was clear from the results is that both placebo and verum groups improved over the study period. This was put down to a "trial effect", a term to cover a large and curious area of medicine we refer to as the placebo effect. This trial effect may be due in part to engaging someone in a hopeful process of improvement or recovery. More curious still, was the way the two groups behaved in a different way -improvements were equal but the homeopathic remedy did not seem to be acting just as a placebo. Yet again research is offering us more questions than answers.

The randomised placebo controlled trial does not offer the homeopathic approach due respect. It is a complex intervention and the fundamental teaching behind it is to individualise the remedy. In addition to an individualised remedy in the treatment of asthma, we can also recommend potentised house dust mite with a variety of regimens none of which mirror the regime given in this study.

Neither does your front cover offer enough respect to physicians like myself and others, trying to answer these difficult questions of efficacy and safety for homeopathy. Why did both groups improve? Is the placebo effect still masking a treatment effect? Was the wrong remedy given leading to a transient aggravation of symptoms seen coming and going within the study period as a wave like phenomena, only then to settle and match placebo effects? Did the remedy need repeating before the end of the 16 week study period? We cannot conclude that homeopathy is a waste of time for dust mite allergies or for asthma - not yet anyway and in a scientific journal of this standing it is best to avoid opinion.

Dr E.A.Thompson
Consultant Homeopathic Physician and Honorary Senior Lecturer in Division of Oncology.
Research Lead. United Bristol Healthcare Trust.

1. Lewith GT, Watkins AD, Hyland ME, Shaw S, Broomfield JA, Dolan G et al. Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised controlled clinical trial. BMJ 2002; 324(7336):520.

Headlines 5 March 2002
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Kathy E Ryan,
Homeopathic doctor
Dept Homeopathy, Old Swan Health Centre, Liverpool L13 2BY

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Re: Headlines

The declaration that homeopathy for dust mite allergy is 'a waste of time'jumps out of the latest BMJ cover. Last year, when Reilly's work on homeopathy for rhinitis, which indicated benefit, was published in the BMJ, there was no splash 'Homeopathy works'.

Several meta-analyses have concluded an effect of homeopathy over placebo. Why does one trial make headlines?

sensational headline! 7 March 2002
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Mandi S Martin,
Homeopath
Bliss health Clinic London W11

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Re: sensational headline!

re: BMJ volume 324; page 520. Primary Care: ‘Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised trial

Having read the above article I felt the need to express my disappointment at the way this subject matter has been presented.

Having been a homeopath for some time, with a very integrated approach, I am a little confused about what homeopathic prescription was used in this double blind trial. I understand that house mite dust was potentised for this study. What exactly is meant by ‘homeopathic immunotherapy’?

The suggestion that patients received ‘standard homeopathic intervention’ is a contradiction in terms as good homeopathic treatment is based upon treating each patient as an individual case.

Whilst I read and understood the results and the discussion of this study, my feelings towards the cover piece ‘Homeopathy for dust mite allergies? No, it’s a waste of time p520 is that it is more than a little misleading and sensationalist journalism.

The homeopathic treatment for patients with dust mite allergies would rarely be to potentise house mite dust itself. Homeopaths in general would not use this ‘homeopathic immunotherapy’ when treating allergies of any kind. In treating patients with these allergies, a thorough case taking would suggest the correct remedy and each patient would be treated individually. My personal experience with treating patients with homeopathy for asthma and dust mite allergies has been very positive and the suggestion that it is a ‘waste of time’ is rather deceptive.

When will there be funding and support available for a homeopathic/placebo double blind randomised controlled trial that is run by professional homeopaths and scientists together using an integrated approach? The public are frequently turning to homeopathy and seem to experience improved conditions, surely that is a good enough reason to work together to find

Typing error? 8 March 2002
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Adam Jacobs,
Director
Dianthus Medical Limited, SW19 3TZ

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Re: Typing error?

In the subsection of the results section headed 'Clinical efficacy of homoeopathy', Lewith et at tell us that there was 'no significant difference between the groups in either of the two primary outcome variables', and then quote a confidence interval for the difference in the improvement in FEV1 between the groups of 0.136 to 0.693. If the confidence interval for the difference does not include zero, then this implies that the difference was significant.

Please forgive me if this sounds like nitpicking, but the conclusions of the study would be greatly altered if the numbers are correct and the text is wrong. Which version is correct?

Publication bias on homeopathy by BMJ 11 March 2002
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AntonH Kramer,
homeopathic doctor
Utrecht Netherlands NL-3582-GM

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Re: Publication bias on homeopathy by BMJ

To the BMJ,

Dear collegues, readers,

Of all the respectable collegues that performed this trial there seems to be not one trained as homeopathic doctor. Would any of these collegues accept a research in their field by an untrained team ?!

Searching the BMJ in its own website I find 25 articles in the last ten years on homeopathy; 23 are 'Rapid Responses', only two are articles of the BMJ, both in march 2002, both negative about homeopathy; there have been important investigations that are positive on homeopathy but BMJ failed to publish them. Publication bias, so well known in this field !

In more than 15 years practice I never used house dust mite in any potency and still I claim good results in a reasonable percentage of my patients. In fact the method used in this trial is a very poor en deluted extract of homeopathy.

I am glad that BMJ offers the possibility to discuss homeopathy. Hopefully the positive outcomes of studies will be published to in the future.

Friendly greetings, A. H. Kramer.

Trial Allergic Asthma 14 March 2002
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George Vithoulkas
Alonissos 37005, Greece

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Re: Trial Allergic Asthma

Dear Editor,

This trial on homeopathy is a typical example of serious misconception of the principles of homeopathy . It is similar to testing the effectiveness of antibiotics on anxiety neurosis and finding that they have no effect on such a condition and then concluding--through a succession of reports in the press--that conventional medicine is useless.

It has to be stated clearly that homeopathy does not claim to cure all cases of asthma, especially those of long standing and even worse with emphysema. But if attempts to cure are made, then for each case we have to find the individual , the personal, the correct remedy. There is no way that such cases can be benefitted by one remedy or one allergen.

The trial tested some ideas on isopathy not of homeopathy. Isopathy may have an effect in some very specific and limited cases but not in the general population of allergic people.

It is a shame that BMJ a few months ago rejected a critique of mine that tried to put an order to the trials for homeopathy. It is also disheartening that good and acceptable research testing the effectiveness of homeopathy was rejected by the journal and irrelevant trials of this type were eagerly and uncritically accepted. Such practice may prove to be dangerous not only for sick people but also for medicine in general.

Sincerely

G.Vithoulkas
Prof.Honoris Causa
Prof.Kiev Medical Academy
Director International Academy of Classical Homeopathy

Studies comparing homoeopathy and placebo are unhelpful 15 March 2002
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John M Weiner,
Visiting Allergist
St Vincents Hospital, Fitzroy, Victoria 3065, Australia

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Re: Studies comparing homoeopathy and placebo are unhelpful

Why do we need another study comparing homoeopathy with placebo(1)? The word placebo is a language construct for an apparently inert product, just as the word homoeopathy is a similar language construct for treatment using an apparently active product. We know that both may have positive effects on an illness, and occasionally one of the two interventions will be more effective when compared to the other. But when both are studied against an effective active treatment (2,3), no difference is found between them.

Therefore, clinicians must decide whether to prescribe effective active treatment that is significantly better than placebo or homoeopathy. For mild illness where the active treatment leads to small benefits or high risks, a placebo or homoeopathy can be chosen. For severe illness where the active treatment leads to large benefits, the active treatment can be chosen. There will be a grey zone.

Our debate should really be about the extent of this grey zone. This zone is certainly different in Australia than in the United Kingdom, where five times more general practitioners are involved with homoeopathy (4,5). Why? Differences in health funding? Availability and costs of active treatments? Cultural differences? These are some of the questions worth studying, rather than spending our resources on further trials of homoeopathy versus placebo.

John Weiner
Visiting Allergist
St Vincent’s Hospital, Fitzroy, Victoria, Australia

1. Lewith GT, Watkins AD, Hyland ME, Shaw S, Broomfield JA, Dolan G, Holgate ST. Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double-blind randomised controlled clinical trial. BMJ 2002;324:520.

2. Fisher P, Scott DL. A randomised controlled trial of homeopathy in rheumatoid arthritis. Rheumatology 2001;40:1052-5.

3. Cialdella P, Boissel JP, Belon P, Groupe de recherché ASTRHO. [Homeopathic specialties as substitutes for benzodiazepines: double-blind vs. placebo study] Therapie 2001;56:397-402.

4. Pirotta MV, Cohen MM, Kotsirilos V, Farish SJ. Complementary therapies: have they become accepted in general practice? Med J Aust 2000;172:102-3

5. Perry R, Dowrick C. Homeopathy and general practice: an urban perspective. Br Homeopath J 2000;89:13-6.

Homeopathic immunotherapy in asthmatics allergic to house dust mite 17 March 2002
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Dr S K Agarwal,
Head, Department of Chest Diseases,
Institute of Medical Sciences, BHU, Varanasi

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Re: Homeopathic immunotherapy in asthmatics allergic to house dust mite

The authors(1) have used ultramolecular preparation of house dust mite for immunotherapy (oral) in dilutions in which there were no molecules of active ingredient present and have concluded that homeopathic immunotherapy was ineffective in the treatment of patients with asthma. This is nothing but comparison of one placebo with another. There should be some active ingredient present for immunotherapy to be effective. The authors should have taken noninvasive markers of inflammation of asthma like exhaled NO, urinary leukotriene E4 etc., to assess the difference in the two groups.

References: 1. Lewith GT, Watkins DA, Hyland ME et al. Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomized controlled clinical trial. BMJ, 2002, 324:520 (2 March)

Isopathy versus homeopathy 19 March 2002
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Menachem Oberbaum,
Head of the Center of Integrated Complmentary Medicine
Shaare Zedek Medical Center, Jerusalem 91031, Israel,
Itzchak N. Slotki

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Re: Isopathy versus homeopathy

Dear Sir,

We read with interest the excellent paper of Lewith et al.1 Their well- designed study is one of the few examining homeopathy that stands up to scientific scrutiny.

However, we wish to offer some comments. First, one must not forget that isopathic medicine is one of the most controversial fields in homeopathy and even the most ardent supporter of this method would admit that, even if it works, its therapeutic effect is modest at best. Therefore, performing this study during the peak of the house dust mite season, when the subject is exposed to the maximal allergic challenge, is unlikely to yield very impressive results. Similarly to expect an effect from 3 single doses of an isopathic remedy over a period of 16 weeks is overly optimistic. Some authors recommend prescribing 30C potencies of normal homeopathic remedies once a week and isopathic remedies even more frequently, but certainly not as little as once in 6 weeks.2 Anyone wishing to test the activity of an isopathic remedy should do so in a mild pathological condition, bearing in mind that, even then, the treatment might be ineffective.

A good illustration of the different outcome after classical homeopathic treatment from that after isopathy can be seen in the work of Yakir et al.3 In this study, which was a part of a doctoral thesis, the researchers compared a group treated with a variant of classical homeopathy to a group treated with placebo, and a group treated with isopathy (folliculinum) to a group treated with placebo in women suffering from premenstrual syndrome. Whereas the women treated with classical homeopathy showed a significant improvement compared with those receiving placebo, the women treated with isopathy showed a non-significant aggravation, which might, at best, be interpreted as indicating a slight initial aggravation by the isopathic treatment, as expected after administering a homeopathic remedy (unpublished results). This study has since been repeated on a larger scale with similar results (manuscript in preparation).

A second point is that we feel that the claim of Lewith et al that their paper is a follow up study of the trial of Reilly et al4 is untenable. Without detracting from the qualities of the current paper, it differs in many respects from that of Reilly et al. The studies were performed in different seasons, the patient selection criteria of Reilly et al were stricter and therefore the groups more homogenous. The observation time in Reilly’s study was shorter, which is an advantage when using isopathic medicines and that trial also included a run-in period on placebo while Lewith’s did not. Moreover, each group used different blinding methods and outcome measurements. These are just some of the differences between the two studies. Therefore it is extremely difficult, if not impossible, to compare them.

References

1. G T Lewith, A D Watkins, M E Hyland et al. Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomized controlled clinical trial. BMJ 2002; 324: 520-523.

2. Jouanny J. The essentials of homeopathic therapeutics. Laboratoires Boiron. Lyon. 1985:96

3. Yakir M, Kreitler S, Brzezinski et al. Effects of homeopathic treatment in women with premenstrual syndrome: a pilot study. Br Homeopath J 2001;90:148-53

4. Reilly DT, Taylor MA, Campbell J, Beattie N, McSharry C, Aitchison T, Carter R, Stevenson R. Is evidence for homoeopathy reproducible? Lancet 1994;344:1601-06

Dr. Menachem Oberbaum The Center of Integrated Complementary Medicine Shaare Zedek Medical Center Jerusalem, Israel

Itzchak N. Slotki Adult Nephrology Unit Shaare Zedek Medical Center Jerusalem, Israel

Really a test of homeopathy? 23 March 2002
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Elaine Weatherley-Jones,
Senior Research Fellow
University of Sheffield

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Re: Really a test of homeopathy?

Dear Editor

As a senior health services researcher, I was disappointed by the lack of rigour in the sensationalist headlines “Homeopathy for dust mite allergies? No it's a waste of time.” deriving from the recent paper by Lewith et al.(1) and by limitations of the conclusions drawn by the authors from their interesting study. As a practising homeopath, I was disheartened to see that yet again, one study that failed to demonstrate evidence of efficacy is considered sufficient reason to reject homeopathy as a potential treatment for asthma.

As a number of respondents have pointed out, the treatment regime used in the study does not represent homeopathy as it is routinely practiced, in particular, the lack of individual consultations and the blanket prescription of a single remedy, so I question whether this was in fact really a trial of homeopathy.

In asking questions about any intervention, but perhaps more so in a complex intervention such as homeopathy (which is not simply about dispensing pills), it is essential to distinguish between trials of efficacy and trials of effectiveness. Efficacy trials ask the question “Does the homeopathic remedy itself work?”. Such trials are designed to be explanatory, and test statistical significance between different treatment arms of a study. Effectiveness trials ask the question “Is homeopathy an effective intervention for condition x, compared to what is usually (or can be) offered?”. Such trials are pragmatic and principally test for clinically significant effects of treatments.

To test the efficacy of homeopathic remedies, the ‘gold standard’ RCT explanatory design seems most appropriate, but the model on which it is based may well be too simplistic to test individualised homeopathic treatment as it is practised. Assuming a linear additive effect where treatment outcome=natural course+specific effect of treatment+non-specific effect of treatment overlooks the possibility of interaction between specific and non-specific effects (2). Nevertheless, while the mechanism of homeopathy is considered scientifically implausible, placebo trials of homeopathy will still be demanded (3).

Placebo trials of homeopathy may, while designed to examine efficacy, nevertheless produce results which have relevance for clinical effectiveness. Lewith’s assertion that improvements in both treatment and placebo groups were “trial effects” is insufficient explanation. However, without an appropriate comparison group (standard asthma care, for example), it is not possible to interpret conclusively the effects of either homeopathy or placebo.

In a recent RCT, placebo controlled trial of individualised homeopathy for over 100 patients with chronic fatigue syndrome (CFS), primarily intended to test efficacy, we found that a majority of people in both treatment and placebo groups showed some improvement on standardised fatigue scale scores. Some evidence of efficacy of individually prescribed homeopathic remedies was shown, but what was more interesting was that in comparison to a study of cognitive behaviour therapy (CBT) vs. relaxation therapy for CFS, the proportion of the patients in our study who showed some improvement was comparable to the proportion of patients benefiting from CBT.(4). Our CFS study did not have a ‘no-treatment’ group, so the comparative effectiveness could not be established, therefore, the clinical relevance of these differences is not clear, but the results do indicate that an improvement in both treatment and placebo groups in an RCT requires further explanation than simply “trial effect”. Further this CFS study adds to the argument for comparative studies that ask clinically relevant questions that homeopaths, other clinicians and patients want answers to.

The unfortunate press that Lewith et al has generated detracts from the issue that complementary and alternative medicine (CAM) use is increasing (5) and therefore research that’s relevant to patients and clinicians is needed. Designing research based on the right questions and in collaboration with practitioners of the therapy is essential.

Dr. Elaine Weatherley-Jones Ph.D., C.Psychol., RSHom. Senior Research Fellow Medical Care Research Unit University of Sheffield Registered Homeopath The Cavendish Centre for Cancer Care

(1) Lewith GT, Watkins AD, Hyland, ME, Shaw S, Broomfield JA, Dolan G, Holgate ST .Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised controlled clinical trial.BMJ 2002; 324: 520

(2) Kleijnen J, de Craen AJ, van Everdingen J, Krol L. Placebo effect in double-blind clinical trials: a review of interactions with medications.Lancet. 1994 Nov 12;344(8933):1347-9.

(3) Linde K, Hondras M, Vickers A, Riet Gt G, Melchart D. Systematic reviews of complementary therapies - an annotated bibliography. Part 3: Homeopathy. BMC Complement Altern Med 2001;1(1):4

(4) Deale A, Chalder T, Wessely S. Cognitive behavior therapy for chronic fatigue syndrome: a randomized controlled trial.Am J Psychiatry. 1997 154(3):408-14.

(5) Thomas KJ, Nicholl JP, Coleman P. Use and expenditure on complementary medicine in England: a population based survey. Complement Ther Med. 2001;9(1):2-11.

Homeopathic medicine: a synonym for placebo? Is there any place for preventive medicine? 2 April 2002
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alberto loizzo,
Senior investigator
Istituto Superiore di Sanita', via Regina Elena 299, 00161 Roma, Italy,
Luisa Lopez, Salvatore Dell' Aquila and Antonio Contu

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Re: Homeopathic medicine: a synonym for placebo? Is there any place for preventive medicine?

Sir, With reference to the papers on “homeopathy” and “randomised controlled trials”, which appeared in BMJ, 2002, 324:520-524, and 498-499 we observe that homeopathy is often considered by modern “orthodox” medicine as a form of irrational acceptance of magic devices. On the one hand, modern science is willing to accept homeopathy only in one case, i.e., only when the homeopathic drug or procedure can demonstrate its effectiveness according to the accepted rules of evidence-based medicine. On the other hand, we must admit that “randomised controlled trials may be efficient arbiters of clinical effectiveness, but they are not particularly good for resolving philosophical disputes”.

However, we think that a new contribution to the discussion can be given on a scientific –not only philosophical- ground, but this contribution should be viewed from a different point of view. We think that we can produce an enrichment of both medical orthodox and homeopathic disciplines if we produce a deeper understanding of the real reasons of an (apparently) irresolvable debate. In this line, we suggest operating two preliminary distinctions, referring to the definition of: a) the terms, and b) the temporal windows.

a) The terms “homeopathic drug” and “homeopathic medicine” are often used as a synonym. This can be questionable. Medical disciplines are made of at least three components. First, the drug: up to now, we think that nobody has given clear demonstration that a homeopathic drug is effective in itself. Second, the relationship between the doctor and the patient: this ensures adherence to prescriptions, in any species of medicine. Third, hygienic prescriptions given by the doctor: physical activity, balanced dietary regimen, avoiding alcohol and smoking, and so on. We must remember that decades of preventive medicine studies showed that adherence to dietary and lifestyle prescriptions reduces several risk factors bound to major life-limiting diseases. This was obtained in experimental animals 1, and, when applied to particular communities in men, has limited costs, provided correct conditions are applied 2. Paradoxically, patients tend to follow lifestyle suggestions more tightly when these are prescribed by a homeopathic doctor than a modern “orthodox” one 3, perhaps because patients in the former case feel to be an active part of the therapy. Therefore we should be aware that, if we exclude the efficacy of the first component (i.e., if we accept the term “homeopathic drug” as a synonym of placebo) we should evaluate the importance of the second and third components. Is the adherence to prescriptions accepted in patients following homeopathic medicine better than traditional patients? And again: can adherence to dietary and lifestyle prescriptions be considered a form of “preventive medicine”?

b) In our opinion both meta-analysis and clinical trials can be ineffective tools to investigate the eventual effects of homeopathic medicine. Experimental tools need a correct scenery, but also must be applied within appropriate temporal windows. Clinical trials of 6-24 months length can appreciate effects induced by drugs, which are presumed to revert or to stop diseases which “proceed” at a known speed. If we suspect that homeopathic medicine mimic some effects of preventive medicine, we should consider whether an adequate temporal window should be wider than 24 months, maybe including the whole life of patients. This can be attained for rat studies, but it would require different (epidemiological?) approaches, rather than larger clinical trials, or better statistical devices 4, for men.

In conclusion, we think that wise doctors use antibiotics against infective diseases and insulin for diabetes, whether they follow modern “ orthodox ” medicine or homeopathic medicine in adult people (homeopathic medicine for paediatric patients requires further and separate discussions). But we suggest doctors and sanitary structures belonging to any methodological currents to find more time to explain to their patients how preventive medicine is a low-cost mean to ameliorate health in the general population. Thus, diseases could be reduced, and financial resources become relatively more abundant.

The question remains: is the diffusion of homeopathic medicine due to the “placebo effect” alone, or is it also due to the effectiveness of preventive medicine?

Alberto Loizzo,MD, Istituto Superiore di Sanita’, Roma Luisa Lopez, MD, PhD, Istituto Superiore di Sanita’, Roma, and E Litta Rehabilitation Centre for Developmental Disabilities, Grottaferrata Salvatore Dell’ Aquila, MD, PhD, Centre for Alternative Medicine, University of Urbino

Antonio Contu, PhD, Department of Hygiene and Public Health, University of Cagliari

References.

1 Kritchevsky D. The effect of over- and under-nutrition on cancer. Eur J Cancer Prev 1995;4:445-451

2 Franke RW, Chasin BH. Kerala State, India: radical reform as development. Int J Health Serv 1992;22:139-56

3 Bignami G. The physician-patient relationship in the contexts of different medicines. Ann Ist Super Sanita 1999;35:499-504 (Ital.)

4 Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Are the clinical effects of homeopathy placebo effects? A meta- analysis of placebo-controlled trials. Lancet 1997;350:834-843

Throwing the baby out with the bath water 3 April 2002
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Paul M Coplan,
Adjunct Assistant Professor
Univ of Pennsylvania School of Medicine

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Re: Throwing the baby out with the bath water

Dear Editor,

Lewith et al. have made a valuable contribution to evidence-based medicine by determining that one homeopathic remedy at one dosage level for the treatment of asthma associated with house dust mite is not effective . However, the authors have provided insufficient data to support their conclusion that homeopathic immunotherapy is not effective in the treatment of patients with asthma.

The data from the trial support a conclusion that the specific remedy did not improve patient outcomes but do not support the conclusions of the study that homeopathic immunotherapy, in its entirety, is not effective in the treatment of patients with asthma. This would be equivalent to concluding that all oral therapy for cardiovascular disease is not effective if one randomised clinical trial indicated one drug at one dosage level was ineffective.

The specific homeopathic remedy that is evaluated is a 30C potency of house dust mite. The theory on which Samuel Hahneman founded homeopathy is based on the understanding that the symptoms experienced by a person are an attempt by the organism to re-create balance or homeostasis. By using a substance that creates the same symptoms in the person as the person is experiencing, the process of homeostasis can be facilitated, hence the name “homeo”, or similar, in homeopathic. Classical homeopathy utilizes in-depth interview to record the patient’s symptoms in all aspects of their life. The individual’s global symptom complex is compared to a homeopathic Materia Medica to identify the remedy that provides the closest match between the patient’s symptoms and the symptoms created by the substance used in the remedy. This results in unique and individualized prescriptions that may require an iterative process of several remedies or dosage levels over time to find that which is optimal.

In contrast, in recent times “pop” homeopathy has sprung up that espouses one remedy for one symptom, perhaps for the same reasons that fast food has become popular in recent times. The authors have evaluated the latter and concluded the former does not work. I urge designers of future trials of homeopathy to evaluate the therapy as administered by a skilled practitioner. Double-blind randomisation may be achieved by having a practitioner(s) prescribe therapies to each patient independent of randomisation, yet whether the prescribed therapy or a placebo is given to the patient depends on randomisation.

Response to Responses 12 April 2002
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George T LEWITH,
Senior Research Fellow
University of Southampton, Mail Point OPH, Royal South Hants Hospital, Southampton, SO14 0YG,
Michael Hyland and Stephen Holgate

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Re: Response to Responses

As Feder and Katz suggest in their editorial, homeopathy is a topic that arouses strong emotions both by those supporting homeopathy, the ‘believers’ and the ‘non believers’ 1. The front cover quotes our research as showing that homeopathy is a “waste of time”. This type of response to a scientific paper is not helpful. Although we did not find a therapeutic difference between homeopathic immunotherapy (isopathy) and placebo we did find a statistically significant difference. When compared to placebo, patients symptoms on their quality of life diaries, PEF and mood deteriorated then improved, then deteriorated and then improved, but ended up at the same point as the placebo group. We are currently unsure whether this finding is incidental (a type I error) or reduplicable.

We have tested the model of homeopathic immunotherapy (HIT) suggested by Reilly et al 2. The term HIT was first used by Reilly et al in 1994 and described this form of isopathy and we have continued to use this definition2. This model is not generalisable into current homeopathic practice and, therefore, we are not in a position to know whether “homeopathy is a waste of time”. However, Reilly et al reported that isopathy had a therapeutic effect, but we have not been able to replicate this therapeutic effect in a larger study. Thus, we have shown in contrast to Reilly et al., that isopathy, used in this dosage regime, is not therapeutic. We have not shown that homeopathy is not therapeutic.

Feder and Katz go on to suggest that the mechanisms underpinning homeopathy are best understood through laboratory experimentation1. We dispute this and feel that clinical investigations involving complex biological systems in human beings offer insights that are impossible to achieve in a laboratory environment. We feel that laboratory work is vital, but must develop hand in hand with rigorous clinical science in both humans and animals. We have suggested some hypothesis that might explain the oscillatory effects but these theories will need further confirmation as part of rigorous, randomised, controlled clinical trials3,4. We also hope that Feder and Katz’s suggestion about pragmatic studies does not represent a retreat from rigour.

We were concerned by the small size of David Reilly’s initial study of HIT in asthma and the apparent lack of “trial effect” (ie an improvement over time in the placebo group) reported in the 1994 paper2. It is unusual to see a worsening of asthma in the placebo arm of a clinical trial. Although our study owes much of the design to David Reilly’s earlier work, it was not intended to be a mere reduplication. We did cooperate with David Reilly in the design of this study and his input was helpful. There are some specific points which may have been overlooked in the rapid response comments. The full text of the BMJ article is only published on the web. In this text we make it clear that three split doses of house dust mite at a 30C potency were used. Furthermore, we rigorously re-diagnosed each asthmatic throughout the study and our research team had communication with Dr Reilly in order to double-check that we were following exactly the same protocol in relation to drug dosage and a number of other methodological issues.

It has been suggested that a hospital-based study would select a different population of patients when compared to a general practice-based study, and that the latter was likely to be under-powered because of greater “noise” in a general practice population. There is no evidence that this is the case, and although single centre studies are less variable than multi-centre studies, there are many high quality studies designed to evaluate the clinical efficacy of asthma treatments that have been carried out in general practice. We selected a group of asthmatics who had variable asthma so we could measure any change from baseline. We cannot see how our study population differed so significantly from David Reilly’s. Like us, Taylor et al5 avoided the pollen season. Their study on perennial rhinitis, which used isopathic doses of house dust mite extract, did not avoid the house dust mite season and David Reilly was second author on that paper so he must have been aware of this at the design stage. We feel that avoiding the hay fever was of greater importance in terms of seasonal variation in our study, as did Taylor et al5.

We used exactly the same outcome measure (VAS) defined as important in each of the three isopathy studies2,5,6. The use of the asthma VAS on alternate weeks, as described in the full text, was designed to avoid patient data recording fatigue and produce greater patient compliance with data recording. We believe that the information we obtained as a consequence was more precise than would have been the case had we used daily recordings over 20 weeks. We believe that we have followed much the same patient inclusion criteria as that described by Reilly et al in 1994, although we were not aware that each patient was subjected to an individual case conference with possibly unreported and unreproducible inclusion and exclusion criteria2. Our process of randomisation involved minimisation; each treatment group was therefore carefully balanced at randomisation. Because of this we were unable to give each bottle an individual number. We report that both nurses and patients were unable to guess trial allocation, therefore we have no reason to believe that our blinding allocation was anything other than completely secure. We disagree with the comments about a different follow-up period. Had we used a different time point for analysis we might have obtained different results and possibly a significant clinical effect for homeopathy over placebo. We would argue that our method of analysis and length of follow- up took into account the homeopathic response to HIT over a period of 4 months and therefore is less open to misinterpretation. The only major methodological difference between our study and the 1994 study is the lack of a placebo run-in period. We believe that this is unlikely to have made a significant difference in the outcome of our trial.

It remains possible that homeopathic immunotherapy may be effective in rhinitis. There are two good studies published which indicate that this might be the case5,6, although there are other equally rigorous negative studies which have tried and failed to replicate the results7. It is possible that Reilly et al may have over-interpreted one small HIT study on asthma. We accept that no two clinical trials are exactly the same, but we do believe that our study is comparable with the previous HIT asthma study. It comes to different conclusions about treatment effect. It does report, however, that homeopathy and placebo have different effects, and if this observation proves to be consistent in further studies, then the model of HIT may have achieved what it set out to demonstrate; ie that placebo and ultramolecular homeopathic potencies have effects that appear to differ on living systems. What they are and their robustness requires careful further work rather than more debate.

George T Lewith

Michael Hyland

Stephen Holgate

References

1. Feder G, Katz T. Randomised controlled trials for homoeopathy. Editorial. BMJ. 2002; 324: 498-499.

2. Reilly D, Taylor MA, Beattie NGM, Campbell JH, McSharry C, Aitchison TC et al. Is evidence for homoeopathy reproducible? Lancet. 1994; 344: 1601-6.

3. Hyland ME, Lewith GT. Oscillatory effects in a homeopathic clinical trial: an explanation using complexity theory, and implications for clinical practice. Homeopathy, in submission.

4. Hyland, M. E. (2001.) A two-phase network theory of asthma causation: a possible solution to the impact of genes, hygiene and air quality. Clinical and Experimental allergy, 31, 1485-1492.

5. Taylor MA, Reilly D, Llewellyn-Jones RH, McSharry C, Aitchison TC, Lancaster T, et al. Randomised controlled trial of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial series. BMJ. 2000; 321: 471-6.

6. Reilly DT, Taylor MA, McSharry C, Aitshison T. Is homoeopathy a placebo response? Controlled trial of homoeopathic potency, with pollen in hayfever as model. Lancet. 1986; 2: 881-6

7. Aabel S. No beneficial effect of isopathic prophylactic treatment for birch pollen allergy during a low-pollen season: a double-blind, placebo-controlled clinical trial of homeopathic Betula 30c. Br Homeopath J. 2000; 89: 169-73.

What is homeopathy? 1 May 2002
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Emma Lou Dilts

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Re: What is homeopathy?

The definition that was previously known to me for homeopathic medicine, included a much more compex way of subscribing medicine. My menstrual cramps were miracously healed with colocynthis wich, tried on my friend, had no effect at all. Where were the experienced homeopaths in this research? Was there more than one? Did homeopathy change while my back was turned yesterday? It use to need a full analysis of symptoms for it to be correctly chosen. Normally, the day before yesterday, homeopathy was made of a substance that, when taken in large amounts by a HEALTHY person, gives certain symptoms wich can be cured if taken in small amounts. Since when do dust mites create asthma in HEALTHY people? The day before yesterday?

Please correct me if I am mistaking, I was not there yesterday. Was my previous definition of homeopathy correct? Has it changed? If it has, I'm inventing a new word for the homeopathy of my days: pre-homeopathy. That one worked.

Homeopathy and allergic asthma 2 May 2002
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S K Agarwal,
Head, Department of Chest Diseases,
Institute of Medical Sciences, BHU, Varanasi,India

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Re: Homeopathy and allergic asthma

The authors(1) have used ultramolecular preparation of house dust mite for immunotherapy (oral) in dilutions in which there were no molecules of active ingredient present and have concluded that homeopathic immunotherapy was ineffective in the treatment of patients with asthma. This is nothing but comparison of one placebo with another. There should be some active ingredient present for immunotherapy to be effective. The authors should have taken noninvasive markers of inflammation of asthma like exhaled NO, urinary leukotriene E4 etc., to assess the difference in the two groups.

References: 1. Lewith GT, Watkins DA, Hyland ME et al. Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomized controlled clinical trial. BMJ, 2002, 324:520 (2 March)

Study criticizes Isopathy, not Homeopathy 13 August 2002
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Mitchell A. Fleisher, M.D., D.Ht., F.A.A.F.P.,
clinical faculty member, National Center for Homeopathy
Rockfish Center, Suite 1, P.O. Box 303, Nellysford, Virginina, USA 22958

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Re: Study criticizes Isopathy, not Homeopathy

The major flaw in the study performed in England by Lewith et al. (BMJ, March 2, 2002; vol. 324: 1-5), is that this was not truly an evaluation of homeopathy per se, but of isopathy. Although the house dust mite material used in the study may have been prepared by the homeopathic pharmaceutical process, the medicines thusly produced were not prescribed according to the fundamental principles of homeopathic clinical practice and hence would not be expected to work.

There is a distinct difference between isopathy and homeopathy, but Dr. Lewith and his associates would not be expected to know this for the simple reason that they were not made aware of the distinctions between these therapeutic methodologies in their medical school, residency training and postgraduate CME experiences. This unfortunate educational deficit begs for remediation. This is particularly pertinent given the burgeoning public demand for and availability of CAM therapies, practiced by licensed physicians, in the U.S. and Europe.

Isopathy (derived from “isos pathos” or “equal suffering”) refers to the use of the exact substance which causes an illness as a therapeutic tool for that same illness. It is the principle underlying modern, conventional immunotherapy, e.g., vaccinating with measles in an attempt to prevent measles, injecting pollen extract to try to subdue pollen allergies, etc.

Whereas, homeopathy (derived from “homoios pathos” or “similar suffering”) is founded upon the principle of similars, i.e., a medicinal substance which can produce a certain set of symptoms in healthy persons, in a clinical investigation, can be used to stimulate a curative response in people who are experiencing a similar set of symptoms in an innate disease process. A simple example is the homeopathic use of red onion (Allium cepa is the homeopathic Latin term) for common viral URIs characterized by profuse burning nasal discharge and stinging tears, just the kind of reaction many of us experience when cutting an onion.

In order to select the correct homeopathic medicine in any given case, called the simillimum, one must elicit and evaluate the totality of unique, individualizing, characteristic physical, emotional and mental symptomology and then make a careful analysis of the symptom picture. That homeopathic medicine which possesses the ability to induce the most similar symptom picture to that being experienced by the patient is the one that is chosen for therapeutic intervention and has the greatest probability of stimulating a curative response in that given case. Utilizing the true homeopathic approach is of particular importance when treating complex diseases such as asthma and allergic diatheses, as well as autoimmune disorders, colitis, migraines, etc., if one is to achieve genuine therapeutic benefit.

In isopathic immunotherapy, none of the fundamental steps of case taking and case analysis, that are so critical to the selection of the clinically appropriate homeopathic medicine, are undertaken. It is no small wonder that isopathic immunotherapy, as that employed in the Lewith study, would be ineffective in some cases.

As to why the Lewith study, using an isopathic preparation of house dust mites, showed a response no better than placebo, whereas the Reilly study, utilizing an isopathic preparation of mixed grass pollens, demonstrated significantly greater clinical efficacy than placebo in the asthmatic patients investigated, is a matter for further inquiry. It may be that isopathic mixed grass pollen is a useful remedy, while isopathic house dust mite is not. There may also be other confounding factors that require serious consideration. This is the true spirit of science.

Most sincerely yours,

Mitchell A. Fleisher, M.D., D.Ht., F.A.A.F.P.
Homeopathic Family Medicine & Nutritional Therapy
Rockfish Center, Suite 1, P.O. Box 303, Nellysford, Virginia 22958

Which is the definition of homeopathy ? 21 August 2002
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andrea valeri,
homeopath
via circonvallazione 129\C,
41037 mirandola (modena) italy

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Re: Which is the definition of homeopathy ?

The purpose of Lewith’s paper was to evaluate “ the clinical efficacy of homeopathic potencies of house dust mite (homeopathic immunotherapy) in asthmatic people “ [1]. Results ? “ This randomised placebo controlled trail shows that homoeopathic immunotherapy is no better than placebo for the treatment of people with asthma who are allergic to house dust mite “ [1] .

Immediately, general practice medical journals derived that “Homeopathy Doesn't Help Asthmatics with Dust Mite Allergy “ [2] After severe criticism, Lewith et al. state that “we have shown in contrast to Reilly et al., that isopathy, used in this dosage regime, is not therapeutic. We have not shown that homeopathy is not therapeutic “ [3] . A question arises : what is the real matter of the study ?

In the original article, the author speaks about “ homeopathy” , but in the response the author use the term “ isopathy “. Homeopathy is equivalent to isopathy ? and what about “homeopathic immunoterapy “ ? The reported history of this third term [3] does not help to clarify the confusion.

It seems plain that, in this context, the use of scientific literature definitions does not help. This, really, does not works. Consequently, we have two possibilities :

a- we want to study homeopathy effects in a scientific way ; BUT scientific modern literature does not clearly define the object of the study . This way , it’ s impossible to scientifically study homeopathy . Please, stop asking “scientific evidence “
b- we want to study homeopathy effects in a scientific way ; as modern scientific definitions does not help, we must return to the root, to the homeopathy founder classical text, Hahnemann ‘s Organon [4] .

Paragraph 24 : “ In homeopathy … a medicine is sought which …has the power and the tendency to endenger the artificial state most similar to that of the case of disease in question “ This is the basic homeopathic principle ( simil similibus)

In Lewith’s paper, this principle is not used. To speak about homeopathy, it’s not sufficient using some diluited and potentized substance.

A practical conclusion is : to scientifically investigate homeopathy, it is necessary that trained homeopaths write the initial study design . The competence in homeopathic medicine in no way simpler that in other scientific fields. The discussion of which type of study (experimental or observational) comes after this basic point.

Dr. Andrea Valeri, director, homeopathic medical school of Verona

competing interest : none declared

[1] Lewith GT et al .Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised controlled clinical trial. BMJ 2002 Mar 2;324(7336):520

[2] Homeopathy Doesn't Help Asthmatics with Dust Mite Allergy. Journal Watch General Medicine 2002: 2-2

[3] Lewith GT et al. Response to Responses. bmj.com/cgi/eletters/324/7336/520#21223, 12 Apr 2002

[4] Hahnemann S. Organon of the medical art . Birdcage books 1996