Homeopathy, Research & The Lancet

 A review of the recent article and editorial against homeopathy published in The Lancet, Aug 2005 Issue.

-- Dr. Manish Bhatia

In its August 27 issue, The Lancet published a meta-analysis which contends that homeopathic remedies are no better than placebo. A lot of debate and many discussions have followed without going into the full details of the meta-analysis and the editorial. This paper tries to review the meta-analysis and the editorial from the homeopathic stand point.

What is the meta-analysis about?

In the August 27 issue, The Lancet published an article titled “Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy”. It was based on a metaanalysis done by Aijing Shang, Karin Huwiler-Müntener, Linda Nartey, Peter Jüni, Stephan Dörig, Jonathan A C Sterne, Daniel Pewsner, and Matthias Egger (of Switzerland’s University of Berne).

The Method Used

Placebo-controlled trials of homoeopathy were identified by a comprehensive literature search, which covered 19 electronic databases, reference lists of relevant papers, and contacts with experts. Trials in conventional medicine matched to homoeopathy trials for disorder and type of outcome were randomly selected from the Cochrane Controlled Trials Register (issue 1, 2003). Data were extracted in duplicate and outcomes coded so that odds ratios below 1 indicated benefit. Trials described as double-blind, with adequate randomization, were assumed to be of higher methodological quality. Bias effects were examined in funnel plots and meta-regression models.

Findings of the meta-analysis

110 homoeopathy trials and 110 matched conventional-medicine trials were analyzed. The median study size was 65 participants (range ten to 1573). 21 homoeopathy trials (19%) and nine (8%) conventional-medicine trials were of higher quality. In both groups, smaller trials and those of lower quality showed more beneficial treatment effects than larger and higher-quality trials. When the analysis was restricted to large trials of higher quality, the odds ratio was 0·88 (95% CI 0·65–1·19) for homoeopathy (eight trials) and 0·58 (0·39–0·85) for conventional medicine (six trials).

Interpretation

Biases are present in placebo-controlled trials of both homoeopathy and conventional medicine. When account was taken for these biases in the analysis, there was weak evidence for a specific effect of homoeopathic remedies, but strong evidence for specific effects of conventional interventions. This finding is compatible with the notion that the clinical effects of homoeopathy are placebo effects.

What did the Lancet editorial say?

The editorial was titled ‘The End of Homeopathy’ and it basically says that homeopathy is nothing but placebo and the doctors should be ‘bold and honest’ to tell this truth about homeopathy to their patients. It also says that the lack of ‘personalized care’ also drives people towards alternative means like homeopathy.

Some more facts about the analysis.

Out of the total 110 studies used, the percentage of studies as per clinical topics was as follows:

Respiratory-tract infections   21 (19%)
Pollinosis and asthma           16 (15%)
Gynaecology and obstetrics 14 (13%)
Surgery and anaesthetics     12 (11%)
Gastroenterology                  12 (11%)
Musculoskeletal disorders    11 (10%)
Neurology                             10 (9%)
Other                                     14 (13%)

Among homoeopathy trials 48 (44%) concerned clinical homoeopathy, 35 (32%) complex homoeopathy, 18 (16%) classical homoeopathy, and eight (7%) isopathy. On page two (p. 727), researchers, led by Aijing Shang, PhD, of the University of Berne, described the four types of homeopathy studies they included in their meta-analysis:

• Studies using "clinical homeopathy".  Patients did not receive a comprehensive homeopathic history and all patients received a single, identical remedy. This accounted for 48, or 44% of the homeopathy studies analyzed in the Lancet meta-analysis.
• Studies using "complex homeopathy". Patients did not receive a comprehensive homeopathic history and all patients received a mixture of different commonly used homeopathic remedies. This accounted for 35, or 32% of the homeopathy studies analyzed.
• Studies using "classical homeopathy". Patients were given a comprehensive patient history and received a single, individualized remedy. This accounted for 18, or 16% of the homeopathy studies analyzed.
• Studies using "isopathy". Patients did not receive a comprehensive homeopathic history and all patients received a diluted substance that was believed to be the cause of the disorder (e.g. pollen in seasonal allergies). This accounted for 8, or 7% of the homeopathy studies analyzed.

What are the salient points – in simple words?

The study says that there was weak evidence for a specific effect of homoeopathic remedies, but strong evidence for specific effects of conventional interventions.

The studies which were larger and of higher quality showed that homeopathy is no different than placebo, whereas smaller studies show significant results in favor of homeopathy. But publication bias and other factors may account for it. Here is a quote (page 7 of the paper) from the authors:

For example, for the eight trials of homoeopathic remedies in acute infections

of the upper respiratory tract that were included in our sample, the pooled effect indicated a substantial beneficial effect (odds ratio 0·36 [95% CI 0·26–0·50]) and there was neither convincing evidence of funnel-plot asymmetry nor evidence that the effect differed between the trial classified as of higher reported quality and the remaining trials. Such sensitivity analyses might suggest that there is robust evidence that the treatment under investigation works. However, the biases that are prevalent in these publications, as shown by our study, might promote the conclusion that the results cannot be trusted.

What is the uproar about?

Homeopaths believe that homeopathy works. They are not ready to accept the findings of this meta-analysis. They consider the methodology used has many flaws. They also find the title of the editorial ‘The End of Homeopathy’ ridiculous!

What are the flaws then?

Statistically – there are no flaws in the study. The people have done their math right! But then statistics depend upon the numbers from which they are crunched. So the next question is - were the numbers right?  For most part, yes! The people have taken due care in finding the placebo-controlled studies, matching the numbers of homeopathic and conventional medicine studies, their clinical types, relevance and every other statistical aspect. They have even tried to find difference between various ‘types’ pf homeopathy but the statistical difference was not significant.

What’s wrong then?

The premise, the methodology and the trials covered. The premise is that the same methodology can be applied to homeopathy and allopathy. The motive is to compare ‘specific effects’ of homeopathic remedies with conventional medicine. This premise itself is flawed. 

• Homeopathic medicines do not show ‘specific effect’. They show ‘individualized’ effect. What this means is that in homeopathy there are no medicines that can be given to take care of the ‘fever’ or the ‘headache’. The symptoms of the medicine have to match closely with the symptoms of the patient. There are hundreds of medicines in homeopathy that may be used for ‘headache’ depending upon the exact symptoms. If you give a particular remedy (known to cure headache, like Belladona) to 100 people for ‘headache’, without due individualization, you are going to fail in more than 80% of the cases. The cause, the signs, symptoms, modalities and accessory symptoms of the patient should match with the symptom-picture of Belladona. Otherwise, failure is natural.
  
• The skeptics counter this statement by saying that if there are no ‘specifics’ in homeopathy, then why do you suggest ‘Arnica’ for every injury? Again this is a misconception. Arnica will only work if the symptom picture that arises after injury matches that of Arnica. Otherwise some other remedy like Rhus-tox, Ruta, Symphytum, Calc-flour, Aconite, Bellis-p, Calendula, Camphora, Causticum, Cicuta, Conium, Hammamelis, Hypericum, Ledum, Plantago, Pulsatilla, Staph etc may come into play. There are actually more than 217 homeopathic remedies listed for injuries! Still, it is true that homeopaths often suggest arnica in cases of injuries but then conscientious homeopaths also know that in large number of cases such a prescription does not work. This does not show that anything is wrong with the system or the law. It just reflects the personal deficiency of a homeopath.
  
• People can also counter the first statement by saying that in this meta-analysis, there was no significant statistical difference between individualized and non-individualized trials. But look at the numbers again. Only 18 studies, out of the total 110 have been classified as ‘classical’. There has been no reference as to how many of these ‘classical’ trials were of ‘high-quality’. If you consider the sample size of these trials and filter only the ‘high-quality’ trials, on which most of the assumptions of this meta-analysis are based, the remaining sample size will itself become statistically insufficient to draw conclusions or to compare it with conventional medicine trials.
  
• The measure of benefit is also controversial. During a correct homeopathic treatment, symptoms are often (not always) known to aggravate initially for a short period. An objective scale measurement and short-term follow-up may show negative results even if the treatment is appropriate. I will clarify this further with an example. Suppose a patient of atopic dermatitis (eczema) comes to a homeopath. After administration of correct homeopathic medicines, the patients’ sense of well-being will improve but there may (not necessarily) be a transient worsening in the symptoms of eczema. This period of aggravation (called homeopathic aggravation) can vary from a few hours to a few months. If an assessment is made during this period on an objective scale based on signs and symptoms of the disease, the results are not going to be in favor of homeopathy. But homeopaths know that such an occurrence is good for the patient and once the short aggravation subsides, there will be full recovery.
  
• Another point of divergence in approach is the homeopathic concept of ‘return of old symptoms’ or ‘Hering’s Law of Cure’. This law states that symptoms disappear in the reverse order of their appearance. Even the conventional medicine knows that when eczema patients are treated with corticosteroids, the rate of development of asthma is very high and that patients of asthma often develop hypertension (approximately three-fourths of children with atopic dermatitis go on to develop hay fever or asthma).  But conventional medicine can not make much sense of it. Homeopaths do not consider disease as an ‘entity’. Instead they consider every disease as a ‘process’. For an allopath the dermatitis, the asthma and the hypertension are separate entities that need different experts and different medication. For a homeopath, this is just one process and the progression of disease from one plane to other is often due to suppression with conventional medicines.
  
  The eczema results due to ‘hypersensitivity’. The symptoms on the skin (inflammation, itching, burning, oozing) are just manifestation of that hypersensitivity. The homeopath asks why this person has developed ‘hypersensitivity’ and tries to treat the ‘cause’ not the eczema. Homeopathy believes if there is no cause for hypersensitivity, there will be no eczema and hence it treats accordingly. The conventional medicine focuses all its force on the ‘local symptoms’ of that hypersensitivity without actually bothering with why the person has developed this hypersensitivity and what will happen to the ‘internal-process’ once the ‘external manifestations’ are removed (suppressed).  Homeopaths know that the ‘process’ continues and manifests on some other organ – most commonly lungs – and develops asthma – which is again a hypersensitivity disorder.

Homeopaths know that such suppressed symptoms can reappear for some time during the process of cure – as disease again moves from more vital organs to less important ones. The understanding and the approach to disease is so diametrically opposite in homeopathy and allopathy that trying to measure and compare their effects on the same scale is nothing but foolishness!

• We have already discussed the flaws within the so-called ‘clinical’ homeopathy. Another point of contention is the mixing of ‘complex homeopathy’ and ‘classical homeopathy’. The medicines used in ‘complex’ homeopathy are often a combination of ‘low-potency’ homeopathic medicines with some therapeutic affinity for a disease or an organ. The problem is that these ‘complexes’ often have and rely on the physiological effect of the drugs substance they contain. They are more like herbal extracts and in principle; they have nothing to do with homeopathy, except that the source of drugs are common. ‘Classical’ homeopaths on the other hand, usually prescribe remedies with no physiological quantity of drug. Mixing these two approaches in itself is a fundamental flaw in this meta-analysis.

The Hidden Questions

The meta-analysis and its publication in Lancet raises many questions. Why homeopathy was chosen as the test subject in comparison with conventional medicine? Why not Chinese Medicine, Ayuerveda, Yoga, Aromatherapy or something else? There are more than 300 alternative systems of medicine!

Is this meta-analysis planned and targeted against homeopathy? Could be! But why? Homeopathy has now come to a stage where it might have started to threaten the conventional medical structure. The number of homeopaths is around half a million now. The number of patients – hundreds of millions. (A recent paper titled ‘Cost effectiveness and efficacy of homoeopathy in primary health care units of government of Delhi’ by Dr Manchanda and Dr Kulashreshtha says: "The average annual patient turnover in an allopathic clinic as against a homoeopathic one was 27,508 patients and 24,943 respectively." – Not much difference there!). In Britain alone, sales of homeopathic medicines have grown by a third in the last five years to 32 million pounds in 2004. Groups like Boiron have annual sales of 300-400 million euros and the sale is growing exponentially throughout the world for all homeopathic pharmaceutical companies.

Although the figures are still very small compared to the conventional medical structure, still the growth has defied the logic of most. The editorial of The Lancet rightly said – “The more dilute the evidence for homoeopathy becomes, the greater seems its popularity.” Is someone trying to nip us in the bud?? People should think about it.

Another question is that should we at all give so much weight to the article because it has been published in The Lancet. I don’t think so. All this article has done is that it has renewed the interest of the scientific community in homeopathy, which should work in our favor in the long run!

What to do now?

Nothing special! Just keep curing the patients. The proof of the pudding lies in its eating. So we should bring these ‘theoretical scientists’ to India and keep them in a zoo. Eh...sorry, I meant to say that we should show them some real good pathological cures of dermatitis, tonsillitis, sinusitis, fibroadenomas, ovarian cysts, hypothyroidism, sciatica, alopecia areata, migraine, otitis media, renal stones, chronic laryngitis, pneumonia, peptic ulcers, chronic fatigue syndrome, ADD/ADHD etc., which they will find difficult to attribute to any ‘placebo’!!

But hopefully, this controversy will also help in starting more research for homeopathy.

This is the beginning of homeopathy, not its end!

The Feedback ..or the Fight Back!

From various corners of earth, people have given comments against this meta-analysis. We have gathered some interesting ones below:

"Furthermore, a single remedy selection for a given conventionally-diagnosed condition is not homeopathy, yet there are numerous conventionally-judged high quality studies that were so designed. The analogy would be to test the effects of penicillin for all patients with symptoms of an apparent infection. The quality of the studies would otherwise be excellent in design. However, penicillin will not work for patients with viral infections or bacterial infections resistant to its effects or for persons with fevers from other non-infectious causes - and it thus might show benefit only for a subset of patients with symptoms of infections, i.e., the ones with true penicillin-sensitive infections. How would penicillin fare in a meta-analysis of studies designed to ignore the intrinsic nature of penicillin in benefiting patients?" said Iris Bell, M.D., Ph.D.

Joyce Frye DO, MBA commented that the study's authors seemed to begin their work with a bias. "While their analysis clearly showed effects of homeopathic treatment - they found ways to disregard those. Out of the millions of trials in conventional medicine, their primary outcome relied on the comparison of ridiculously small numbers--8 trials of homeopathy and 6 trials of conventional medicine. They began their work with the assumption 'that the effects observed in placebo-controlled trials of homoeopathy could be explained by a combination of methodological deficiencies and biased reporting'. Sound research is not conducted from this starting position."

Among other topics, the Lancet challenges the plausibility of homeopathic effects given that homeopathic remedies are often administered in dilutions in excess of Avogadro's number. Dr. Rustum Roy, Ph.D. distinguished material scientist from Penn State University commented that the chemistry argument made in this study and by conventional medicine in general is false science. "The underpinning of the editorial content of the Lancet as it relates to homeopathy relies on a quaint old idea from the nineteenth century that the ONLY way that the property of water can be affected or changed is by incorporating foreign molecules. This is the Avogadro-limit high-school level chemistry argument. To a materials scientist this notion is absurd, since the fundamental paradigm of materials-science is that the structure-property relationship is the basic determinant of everything. It is a fact that the structure of water and therefore the informational content of water can be altered in infinite ways"

Another fundamental concern is that the paper gives no clue about the nature of the 14 trials selected for the key analysis: whether they were mainly therapeutic or prophylactic, for example, and whether the homeopathic interventions were classical, ‘clinical’ or complex homeopathy, or isopathy. Knowledge of these would potentially make a great difference to the inferences that should be drawn. Given the heterogeneity of homeopathy trials, it seems unlikely that the design and methods of just 8 can be representative of 110. Nor are we offered proper summary data on the odds ratios for effectiveness in the two sets of 110 trials overall; without such information, it is impossible to gauge the impact of having narrowed the analysis to just 8+6 trials.

There are other bizarre features of this paper. On reading its text, it seems that only the literature between 1995 and January 2003 was included in the analysis. This would have built on a previous major meta-analysis of homeopathy trials (3). However, on examination of the web-table that lists all the references, it becomes apparent that 62 of the papers analyzed were actually published before 1995. The remaining papers analyzed were published from that year onwards, but some of the main articles during that time have not been included. Inexplicably too, a substantial number of the papers reviewed in the previous meta-analysis are absent from the new one.

Robert Mathie, Research Development Adviser of the BHA and Faculty of Homeopathy

However, the Lancet also reports that a draft report on homeopathy by the World Health Organization says the majority of peer-reviewed scientific papers published over the past 40 years have demonstrated that homeopathy is superior to placebo in placebo-controlled trials. – BBC

It is wonderful that homeopathy has stimulated such an emotional and viperous response from the editors of Lancet. I classify the editorial response as a case of delusional self importance based on weird science and pre-judgment. The response is similar to the Catholic Church’s response to Galileo’s assertion that the earth revolves around the sun and not the other way around. In spite of Lancet’s assertion that the body is a sum of chemical processes and measured only by double blind studies, there is a new more profoundly modern view of the human body based on quantum physics and other advances in science, which is encompassed in homeopathic methodology and preparation.

The world’s survival does not revolve around modern medicine’s older Newtonian beliefs or Lancet. In spite of the enormous amount of resources that modern medicine has consumed and continues to consume and profit from, chronic and acute disease continues to advance at a phenomenal pace. It also means that the structure of medicine is finally straining to a point of collapse. This can only be a demonstration that the fragile underpinnings of modern medicine are crumbling. A simultaneous patient revolt and serious iatrogenic effect with the resultant publicity this has engendered has created the spectacle of medical editors making pathetic emotional pleas.

In all of this, what is clear is that homeopathy will survive. It is not the end but an auspicious beginning

Harold Bothrops, Practitioner

Dear Sirs,
I totally disagree with your article against homeopathy. I am the father of a baby boy aged of 6 months. Since his birth, my wife and I have treated ALL his discomforts with the help of homeopathy and he's ALLWAYS been fine the days after the beginning of the treatment. My point is that you can't explain to a baby the nature of what you are giving him as a treatment or its effects. So you can tell that homeopathy DOES work and is not as good as a placebo. Otherwise and following your article, my wife and I possess mental powers and we should be able to treat our baby with them!
Once again homeopathy is a scapegoat responsible for the economic decline of the medical industry... Trillet

The present debate illustrates the chronic scarcity of viable homeopathic research. This scarcity plagues understanding the true nature of homeopathic science. While it is true that some relatively few quality studies showing results have put homeopathy on the scientific map, no serious researcher would claim that homeopathy has proven its claims completely and beyond doubt. As long as there are very few good studies, the successful treatment outcome which homeopaths and their patients have become accustomed to will not likely be reflected in the statistical data. We still have a long road ahead in substantiating our therapeutic approach, and the current debate will undoubtedly prove a healthy development for our profession.

Liz Bonfig, Administrator, NASH.
Manfred Mueller, NASH President

Summary

All’s Well That Ends Well!

References:

1. thelancet.com
2. http://www.niams.nih.gov/hi/topics/dermatitis/#link_d
3. http://news.bbc.co.uk/1/hi/health/4183916.stm
4. http://www.delhihomeo.com/paperberlin.html

Dr. Manish Bhatia is the Founder Director of Hpathy.com, world’s leading homeopathy portal. He is the chief-editor of ‘Homeopathy 4 Everyone’, world’s most popular homeopathy e-journal. Practicing homeopathy in Jaipur, he is also a Lecturer of homeopathic philosophy at S.K. Homeopathic Medical College, Jaipur. He is also a member of the Center for Advanced Studies in Homeopathy (C.A.S.H.), an international workgroup of leading homeopaths working to promote homeopathic education and research.

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