MD, PhD, FMedSci, FSB, FRCP, FRCPEd

homeopathy

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Highly diluted homeopathic remedies are pure placebos; at least this is what sceptics have been saying for about 200 years. This assumption is based on the fact that homeopathy’s plausibility is close to zero and that the totality of the reliable evidence fails to demonstrate that it works beyond placebo for any condition.

But, if this is true,  why do so many patients swear by homeopathy and experience benefit from it? This question has been answered many times: THE BENEFIT IS NOT DUE TO THE REMEDY BUT TO NON-SPECIFIC EFFECTS OF THE CONSULTATION.

More confirmation for this conclusion comes from an unexpected source.

Indian homeopaths recently published a trial of individualized homeopathy in osteoarthritis. To be more precise, it was a prospective, parallel-arm, double-blind, randomized, placebo-controlled pilot study which was conducted from January to October 2014 involving 60 patients (homeopathy, n = 30; placebo, n = 30). All patients were suffering from acute painful episodes of knee osteoarthritis and visiting the outpatient clinic of Mahesh Bhattacharyya Homeopathic Medical College and Hospital, West Bengal, India.

The results show statistically significant reduction in 3 visual analogue scales (measuring pain, stiffness, and loss of function) and Osteoarthritis Research Society International scores in both groups over 2 weeks (P < .05). However, group differences were not significant (P > .05).

The authors conclude that, overall, homeopathy did not appear to be superior to placebo; still, further rigorous evaluation in this design involving a larger sample size seems feasible in future.

Considering what I wrote above, I would alter these conclusion to something much more reasonable: further studies of homeopathy are certainly feasible. However, they are neither necessary nor desirable.

TO PUT IT DIFFERENTLY: HOMEOPATHY BELONGS IN THE BOOKS OF MEDICAL HISTORY.

Homeopathy has many critics who claim that there is no good evidence for this type of therapy. Homeopaths invariably find this most unfair and point to a plethora of studies that show an effect. They are, of course, correct! There are plenty of trials that suggest that homeopathic remedies do work. The question, however, is HOW RELIABLE ARE THESE STUDIES?

Here is a brand new one which might stand for dozens of others.

In this study, homeopaths treated 50 multimorbid patients with homeopathic remedies identifies by a method called ‘polarity analysis’ (PA) and prospectively followed them over one year (PA enables homeopaths to calculate a relative healing probability, based on Boenninghausen’s grading of polar symptoms).

The 43 patients (86%) who completed the observation period experienced an average improvement of 91% in their initial symptoms. Six patients dropped out, and one did not achieve an improvement of 80%, and was therefore also counted as a treatment failure. The cost of homeopathic treatment was 41% of projected equivalent conventional treatment.

Good news then for enthusiasts of homeopathy? 91% improvement!

Yet, I am afraid that critics might not be bowled over. They might smell a whiff of selection bias, lament the lack of a control group or regret the absence of objective outcome measures. But I was prepared to go as far as stating that such results might be quite interesting… until I read the authors’ conclusions that is:

Polarity Analysis is an effective method for treating multimorbidity. The multitude of symptoms does not prevent the method from achieving good results. Homeopathy may be capable of taking over a considerable proportion of the treatment of multimorbid patients, at lower costs than conventional medicine.

Virtually nothing in these conclusions is based on the data provided. They are pure extrapolation and wild assumptions. Two questions seem to emerge from this:

  1. How on earth can we take this and so many other articles on homeopathy seriously?
  2. When does this sort of article cross the line between wishful thinking and scientific misconduct?

During the next few weeks, I will post several short excerpts from my new book ‘A SCIENTIST IN WONDERLAND‘. Its subtitle already discloses much of what it is all about: ‘A MEMOIRE OF SEARCHING THE TRUTH AND FINDING TROUBLE’.

Some of my critics are likely to claim that I engage in this form of ‘promotion’ because I want to maximise my income by enticing my readers to buy the book. This is partly true, of course: after having worked very hard on this book for about 5 years, I want it to be read (but, at the same time, my critics would be mistaken: I do not expect to get rich on my new book – I am not that naïve; this ‘memoire’ will never be found in any best-seller list, I am sure). So, I suggest (if you do not want me to profit in any way) that you read my memoire after you got it from your library (which obviously would not affect my cash-flow all that much).

So here it is: with much trepidation and even more excitement I present to you the very first, short excerpt (as I said, there will be more).

Prelude

There are some people, a fortunate few, who seem to know from an early age where they want to go in life, and have no trouble getting there.

I was not one of them. I was born in Germany in the years immediately following the end of World War II and, like many German children of that era, I was acutely aware of the awkwardness and unease that my elders displayed when it came to discussions that touched on the country’s recent history. Even as a young boy, I was conscious that there was a large and restive skeleton in the nation’s closet, and that it belonged to all of us – even to those of us who had not been alive during the Nazi era were somehow nevertheless its legatees, inextricably bound to it simply by the awareness of its existence.

With time, the growing realization that so many of our peers – teachers, uncles, aunts; perhaps even our own parents – had lent their assent, or worse, their enthusiastic assistance to the Nazi regime robbed their generation of its moral authority and left us, their children, unmoored and adrift.

In a profound sense I felt homeless. An accident of fate had landed me on the planet with a German passport, and with German as my mother tongue, but where did I really belong? Where would I go? What would I do with my life?

There had been physicians in my family for generations and there was always an expectation that I, too, would enter that profession. Yet I felt no strong pull towards medicine. As a young man my only real passion was music, particularly jazz, with its anarchic improvisations and disobedient rhythms; and the fact that it had been banned by the Nazis only made it all the more appealing to me. I would have been perfectly happy to linger indefinitely in the world of music, but eventually, like a debt come due, medicine summoned me, and I surrendered myself to the profession of my forebears.

In hindsight I am glad that my mother nudged me gently yet insistently in the direction of medical school. While music has delighted and comforted me throughout my life, it has been medicine that has truly defined me, stretching, challenging and nourishing me intellectually, even as it tested me on a personal level almost to the limits of my endurance.

Certainly, I had never anticipated that asking basic and necessary questions as a scientist might prove so fiercely controversial, and that as a result of my research I might become involved in ideological wrangling and political intrigue emanating from the highest level.

If I had known the difficulties I would face, the stark choices, the conflicts and machinations that awaited me, would I have chosen to spend my life in medicine? Yes, I would. Becoming a physician and pursuing the career of a scientist has afforded me not only the opportunity to speak out against the dangerous and growing influence of pseudoscience in medicine, but also, paradoxically, has given me both the reason and the courage to look back steadily at the unbearable past.

This is the story of how I finally found where I belong.

As promised, I will try with this post to explain my reservations regarding the new meta-analysis suggesting that individualised homeopathic remedies are superior to placebos. Before I start, however, I want to thank all those who have commented on various issues; it is well worth reading the numerous and diverse comments.

To remind us of the actual meta-analysis, it might be useful to re-publish its abstract (the full article is also available online):

BACKGROUND:

A rigorous and focused systematic review and meta-analysis of randomised controlled trials (RCTs) of individualised homeopathic treatment has not previously been undertaken. We tested the hypothesis that the outcome of an individualised homeopathic treatment approach using homeopathic medicines is distinguishable from that of placebos.

METHODS:

The review’s methods, including literature search strategy, data extraction, assessment of risk of bias and statistical analysis, were strictly protocol-based. Judgment in seven assessment domains enabled a trial’s risk of bias to be designated as low, unclear or high. A trial was judged to comprise ‘reliable evidence’ if its risk of bias was low or was unclear in one specified domain. ‘Effect size’ was reported as odds ratio (OR), with arithmetic transformation for continuous data carried out as required; OR > 1 signified an effect favouring homeopathy.

RESULTS:

Thirty-two eligible RCTs studied 24 different medical conditions in total. Twelve trials were classed ‘uncertain risk of bias’, three of which displayed relatively minor uncertainty and were designated reliable evidence; 20 trials were classed ‘high risk of bias’. Twenty-two trials had extractable data and were subjected to meta-analysis; OR = 1.53 (95% confidence interval (CI) 1.22 to 1.91). For the three trials with reliable evidence, sensitivity analysis revealed OR = 1.98 (95% CI 1.16 to 3.38).

CONCLUSIONS:

Medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.

Since my team had published an RCTs of individualised homeopathy, it seems only natural that my interest focussed on why the study (even though identified by Mathie et al) had not been included in the meta-analysis. Our study had provided no evidence that adjunctive homeopathic remedies, as prescribed by experienced homeopathic practitioners, are superior to placebo in improving the quality of life of children with mild to moderate asthma in addition to conventional treatment in primary care.

I was convinced that this trial had been rigorous and thus puzzled why, despite receiving ‘full marks’ from the reviewers, they had not included it in their meta-analysis. I thus wrote to Mathie, the lead author of the meta-analysis, and he explained: For your trial (White et al. 2003), under domain V of assessment, we were unable to extract data for meta-analysis, and so it was attributed high risk of bias, as specified by the Cochrane judgmental criteria. Our designated main outcome was the CAQ, for which we needed to know (or could at least estimate) a mean and SD for both the baseline and the end-point of the study. Since your paper reported only the change from baseline in Table 3 or in the main text, it is not possible to derive the necessary end-point for analysis.

It took a while and several further emails until I understood: our study did report both the primary (Table 2 quality of life) and secondary outcome measure (Table 3 severity of symptoms). The primary outcome measure was reported in full detail such that a meta-analysis would have been possible. The secondary outcome measure was also reported but not in full detail, and the data provided by us would not lend themselves to meta-analyses. By electing not our primary but our secondary outcome measure for their meta-analysis, Mathie et al were able to claim that they were unable to use our study and reject it for their meta-analysis.

Why did they do that?

The answer is simple: in their methods section, they specify that they used outcome measures “based on a pre-specified hierarchical list in order of greatest to least importance, recommended by the WHO“. This, I would argue is deeply flawed: the most important outcome measure of a study is usually the one for which the study was designed, not the one that some guys at the WHO feel might be important (incidentally, the WHO list was never meant to be applied to meta-analyses in that way).

By following rigidly their published protocol, the authors of the meta-analysis managed to exclude our negative trial. Thus they did everything right – or did they?

Well, I think they committed several serious mistakes.

  • Firstly, they wrote the protocol, which forced them to exclude our study. Following a protocol is not a virtue in itself; if the protocol is nonsensical it even is the opposite. Had they proceeded as is normal in such cases and used our primary outcome measure in their meta-analyses, it is most likely that their overall results would not have been in favour of homeopathy.
  • Secondly, they awarded our study a malus point for the criterium ‘selective outcome reporting’. This is clearly a wrong decision: we did report the severity-outcome, albeit not in sufficient detail for their meta-analysis. Had they not committed this misjudgment, our RCT would have been the only one with an ‘A’ rating. This would have very clearly highlighted the nonsense of excluding the best-rated trial from meta-analysis.

There are several other oddities as well. For instance, Mathie et al judge our study to be NOT free of vested interest. I asked Mathie why they had done this and was told it is because we accepted free trial medication from a homeopathic pharmacy. I would argue that my team was far less plagued by vested interest than the authors of their three best (and of course positive) trials who, as I happen to know, are consultants for homeopathic manufacturers.

And all of this is just in relation to our own study. Norbert Aust has uncovered similar irregularities with other trials and I take the liberty of quoting his comments posted previously again here:

I have reason to believe that this review and metaanalysis in biased in favor of homeopathy. To check this, I compared two studies (1) Jacobs 1994 about the treatment of childhood diarrhea in Nicaragua, (2) Walach 1997 about homeopathic threatment of headaches. The Jacobs study is one of the three that provided ‘reliable evidence’, Walach’s study earned a poor C2.2 rating and was not included in the meta-analyses. Jacobs’ results were in favour of homeopathy, Walach’s not.

For the domains where the rating of Walach’s study was less than that of the Jacobs study, please find citations from the original studies or my short summaries for the point in question.

Domain I: Sequence generation:
Walach:
“The remedy selected was then mailed to a notary public who held a stock of placebos. The notary threw a dice and mailed either the homeopathic remedy or an appropriate placebo. The notary was provided with a blank randomisation list.”
Rating: UNCLEAR (Medium risk of bias)

Jacobs:
“For each of these medications, there was a box of tubes in sequentially numbered order which had been previously randomized into treatment or control medication using a random numbers table in blocks of four”
Rating: YES (Low risk of bias)

Domain IIIb: Blinding of outcome assessor
Walach:
“The notary was provided with a blank randomization list which was an absolutely unique document. It was only handed out after the biometrician (WG) had deposited all coded original data as a printout at the notary’s office. (…) Data entry was performed blindly by personnel not involved in the study. ”
Rating: UNCLEAR (Medium risk of bias)

Jacobs:
“All statistical analyses were done before breaking the randomisation code, using the program …”
Rating: YES (Low risk of bias)

Domain V: Selective outcome reporting

Walach:
Study protocol was published in 1991 prior to enrollment of participants, all primary outcome variables were reported with respect to all participants and the endpoints.
Rating: NO (high risk of bias)

Jacobs:
No prior publication of protocol, but a pilot study exists. However this was published in 1993 only after the trial was performed in 1991. Primary outcome defined (duration of diarrhea), reported but table and graph do not match, secondary outcome (number of unformed stools on day 3) seems defined post hoc, for this is the only one point in time, this outcome yielded a significant result.
Rating: YES (low risk of bias)

Domain VI: Other sources of bias:

Walach:
Rating: NO (high risk of bias), no details given

Jacobs:
Imbalance of group properties (size, weight and age of children), that might have some impact on course of disease, high impact of parallel therapy (rehydration) by far exceeding effect size of homeopathic treatment
Rating: YES (low risk of bias), no details given

In a nutshell: I fail to see the basis for the different ratings in the studies themselves. I assume bias of the authors of the review.

Conclusion

So, what about the question posed in the title of this article? The meta-analysis is clearly not a ‘proof of concept’. But is it proof for misconduct? I asked Mathie and he answered as follows: No, your statement does not reflect the situation at all. As for each and every paper, we selected the main outcome measure for your trial using the objective WHO classification approach (in which quality of life is clearly of lower rank than severity). This is all clearly described in our prospective protocol. Under no circumstances did we approach this matter retrospectively, in the way you are implying. 

Some nasty sceptics might have assumed that the handful of rigorous studies with negative results were well-known to most researchers of homeopathy. In this situation, it would have been hugely tempting to write the protocol such that these studies must be excluded. I am thrilled to be told that the authors of the current new meta-analysis (who declared all sorts of vested interests at the end of the article) resisted this temptation.

On this blog and elsewhere, I have repeatedly cast doubt on the efficacy of homeopathy – not because I have ‘an axe to grind’, as some seem to believe, but because

  1. the assumptions which underpin homeopathy fly in the face of science,
  2. the clinical evidence fails to show that it works beyond a placebo effect.

But was I correct?

A new systematic review and meta-analysis seems to indicate that I was mistaken. It tested the hypothesis that the outcome of an individualised homeopathic treatment (homeopaths would argue that this is the only true approach to homeopathy) is distinguishable from that with placebos.

The review’s methods, including literature search strategy, data extraction, assessment of risk of bias and statistical analysis, were strictly protocol-based. Judgment in seven assessment domains enabled a trial’s risk of bias to be designated as low, unclear or high. A trial was judged to comprise ‘reliable evidence’ if its risk of bias was low or was unclear in one specified domain. ‘Effect size’ was reported as odds ratio (OR), with arithmetic transformation for continuous data carried out as required; OR > 1 signified an effect favouring homeopathy.

Thirty-two eligible RCTs studied 24 different medical conditions in total. Twelve trials were classed ‘uncertain risk of bias’, three of which displayed relatively minor uncertainty and were designated reliable evidence; 20 trials were classed ‘high risk of bias’. Twenty-two trials had extractable data and were subjected to meta-analysis; OR = 1.53 (95% confidence interval (CI) 1.22 to 1.91). For the three trials with reliable evidence, sensitivity analysis revealed OR = 1.98 (95% CI 1.16 to 3.38).

The authors arrived at the following conclusion: medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.

One does not need to be a prophet to predict that the world of homeopathy will declare this article as the ultimate proof of homeopathy’s efficacy beyond placebo. Already the ‘British Homeopathic Association’ has issued the following press release:

Clinical evidence for homeopathy published

Research into the effectiveness of homeopathy as an individualised treatment has produced results that may surprise many from the worlds of science and medicine. The conclusions are reported cautiously, but the new publication is the first of its type to present evidence that medicines prescribed in individualised homeopathy may have specific effects.

The paper, published in the peer-reviewed journal Systematic Reviews,1 reports a rigorous systematic review and meta-analysis of 32 randomised controlled trials (RCTs) in which homeopathic medicines were prescribed on an individual basis to each participant, depending on their particular symptoms.

The overall quality of the RCT evidence was found to be low or unclear, preventing the researchers from reaching decisive conclusions. Three RCTs were identified as “reliable evidence”.

The study was led by Dr Robert Mathie, research development adviser for the British Homeopathic Association, in partnership with a number of collaborators, including colleagues at the Robertson Centre for Biostatistics, University of Glasgow, who independently verified the statistical methods and findings.

“What we found from the statistics,” says Dr Mathie, “is that the effect of individualised treatment using homeopathic medicines was significantly greater than placebos, and that this effect was retained when we included only the three trials with reliable evidence. This tentatively provides proof of concept that homeopathic medicines have clinical treatment effects.”

Surprised? I was stunned and thus studied the article in much detail (luckily the full text version is available online). Then I entered into an email exchange with the first author who I happen to know personally (to his credit, he responded regularly). In the end, this conversation helped me to better understand the review’s methodology; but it also resulted in me being very much underwhelmed by the reliability of the authors’ conclusion.

Normally I would now explain why. But, in this particular case, I thought it would be interesting and helpful to give others the opportunity to examine the article and come up with their own comments. Subsequently I will add my criticisms.

SO PLEASE TAKE SOME TIME TO STUDY THIS PAPER AND TELL US WHAT YOU THINK.

Dietary supplements (DS) are heavily promoted usually with the claim that they have stood the test of time and that they are natural and hence harmless. Unsurprisingly, their use has become very wide-spread. A new study determined the use of DSs, factors associated with DS use, and reasons for use among U.S. college students.

College students (N = 1248) at 5 U.S. universities were surveyed. Survey questions included descriptive demographics, types and frequency of DS used, reasons for use and money spent on supplements. Supplements were classified using standard criteria. Logistic regression analyses examined relationships between demographic and lifestyle factors and DS use.

Sixty-six percent of college students surveyed used DS at least once a week, and 12% consumed 5 or more supplements a week. Forty-two percent used multivitamins/multiminerals, 18% vitamin C, 17% protein/amino acids and 13% calcium at least once a week. Factors associated with supplement use included dietary patterns, exercise, and tobacco use. Students used supplements to promote general health (73%), provide more energy (29%), increase muscle strength (20%), and enhance performance (19%).

The authors of this survey concluded that college students appear more likely to use DS than the general population and many use multiple types of supplements weekly. Habits established at a young age persist throughout life. Therefore, longitudinal research should be conducted to determine whether patterns of DS use established early in adulthood are maintained throughout life. Adequate scientific justification for widespread use of DS in healthy, young populations is lacking.

Another new study investigated the use of DSs in 334 dancers from 53 countries, who completed a digitally based 35-question survey detailing demographic information and the use of DSs. Supplement use was prevalent amongst this international cohort, with 48% reporting regular DSs use. Major motives for supplement use were to improve health, boost immunity, and reduce fatigue. Forty-five percent believed that dancing increased the need for supplementation, whilst 30% recognized that there were risks associated with DSs.

The most frequently consumed DSs were vitamin C (60%), multivitamins (67%), and caffeine (72%). A smaller group of participants declared the use of whey protein (21%) or creatine (14%). Supplements were mainly obtained from pharmacies, supermarkets, and health-food stores. Dancers recognized their lack of knowledge in DSs use and relied on peer recommendations instead of sound evidence-based advice from acknowledged nutrition or health care professionals.

The authors concluded that this study demonstrates that DSs use is internationally prevalent amongst dancers. Continued efforts are warranted with regard to information dissemination.

Finally, a third study investigated use of DSs in patients in Japan. This survey was completed by 2732 people, including 599 admitted patients, 1154 ambulatory patients, and 979 healthy subjects who attended a seminar about DSs. At the time of the questionnaire, 20.4% of admitted patients, 39.1% of ambulatory patients, and 30.7% of healthy subjects were using DSs, which including vitamin/mineral supplements, herbal extracts, its ingredients, or food for specified health uses.

The primary purpose for use in all groups was health maintenance, whereas 3.7% of healthy subjects, 10.0% of ambulatory patients, and 13.2% of admitted patients used DSs to treat diseases. In addition, 17.7% of admitted patients and 36.8% of ambulatory patients were using DSs concomitantly with their medications. However, among both admitted patients and ambulatory patients, almost 70% did not mention DSs use to their physicians. Overall, 3.3% of all subjects realized adverse effects associated with DSs.

The authors concluded that communication between patients and physicians is important to avoid health problems associated with the use of DSs.

There is little doubt, DSs are popular with all sorts of populations and have grown into a multi billion dollar industry. There is also no doubt that the use of only very few DSs are evidence-based (and if so, in only relatively rare situations). And there can be no doubt that many DSs can do harm. What follows is simple: for the vast majority of DSs the benefits do not demonstrably out-weigh the risks.

If that is true, we have to ask ourselves: Why are they so popular?

The answer, I think, is because of the very phenomenon I am constantly trying to fight on this blog – IRRESPONSIBLE CHARLATANS PULLING WOOL OVER CONSUMERS EYES.

A German homeopathic journal, Zeitschrift Homoeopathie, has just published the following interesting article entitled HOMEOPATHIC DOCTORS HELP IN LIBERIA. It provides details about the international team of homeopaths that travelled to Liberia to cure Ebola. Here I take the liberty of translating it from German into English. As most of it is fairly self-explanatory, I abstain from any comments of my own – however, I am sure that my readers will want to add their views.

In mid-October, an international team of 4 doctors travelled to the West African country for three weeks. The mission in a hospital in Ganta, a town with about 40 000 inhabitants on the border to Guinea, ended as planned on 7 November. The exercise was organised by the World Association of Homeopathic Doctors, the Liga Medicorum Homoeopathica Internationalis (LMHI), with support of by the German Central Association of Homeopathic Doctors. The aim was to support the local doctors in the care of the population and, if possible, also to help in the fight against the Ebola epidemic. The costs for the three weeks’ stay were financed mostly through donations from homeopathic doctors.

“We know that we were invited mainly as well-trained doctors to Liberia, and that or experience in homeopathy was asked for only as a secondary issue”, stresses Cornelia Bajic, first chairperson of the DZVhA (German Central Association of Homeopathic Doctors). The doctors from India, USA, Switzerland and Germany were able to employ their expertise in several wards of the hospital, to help patients, and to support their Liberian colleagues. It was planned to use and document the homeopathic treatment of Ebola-patients as an adjunct to the WHO prescribed standard treatment. “Our experience from the treatment of other epidemics in the history of medicine allows the conclusion that a homeopathic treatment might significantly reduce the mortality of Ebola patients”, judges Bajic. The successful use of homeopathic remedies has been documented for example in Cholera, Diphtheria or Yellow Fever.

Overview of the studies related to the homeopathic treatment of epidemics

In Ganta, the doctors of the LMHI team treated patients with “at times most serious diseases, particularly inflammatory conditions, children with Typhus, meningitis, pneumonias, and unclear fevers – each time only under the supervision of the local doctor in charge”, reports Dr Ortrud Lindemann, who also worked obstetrically in Ganta. The medical specialist reports after her return: “When we had been 10 days in the hospital, the successes had become known, and the patients stood in queues to get treated by us.” The homeopathic doctors received thanks from the Ganta hospital for their work, it was said that it had been helpful for the patients and a blessing for the employees of the hospital.

POLITICAL CONSIDERATIONS MORE IMPORTANT THAN MEDICAL TREATMENT? 

This first LMHI team of doctors was forbidden to care for patients from the “Ebola Treatment Unit”. The decision was based on an order of the WHO. A team of Cuban doctors was also waiting in vain for being allowed to work. “We are dealing here with a dangerous epidemic and a large number of seriously ill patients. And despite a striking lack of doctors in West Africa political considerations are more important than the treatment of these patients”, criticises the DZVhA chairperson Bajic. Now a second team is to travel to Ganta to support the local doctors.

THIS POST IS DEDICATED TO HRH, THE PRINCE OF WALES WHO CELEBRATES HIS 66TH BIRTHDAY TODAY AND HAS SUPPORTED HOMEOPATHY ALL HIS LIFE

Like Charles, many people are fond of homeopathy; it is particularly popular in India, Germany, France and parts of South America. With all types of health care, it is important to make therapeutic decisions in the knowledge of the crucial facts. In order to aid evidence-based decision-making, I will summarise a few things you might want to consider before you try homeopathy – either by buying homeopathic remedies over the counter, or by consulting a homeopath.

  1. Homeopathy was invented by Samuel Hahnemann, a charismatic German doctor, about 200 years ago. At the time, our understanding of the laws of nature was woefully incomplete, and therefore Hahnemann’s ideas seemed far less implausible than they actually are. Moreover, the conventional treatments of this period were often more dangerous than the disease they were supposed to cure; consequently homeopathy was repeatedly shown to be better than ‘allopathy’ (a term coined by Hahnemann to insult conventional medicine). Thus Hahnemann’s treatments were an almost instant worldwide success. When, about 100 years later, more and more effective conventional therapies were discovered, homeopathy all but disappeared, only to be re-discovered in developed countries as the baby-boomers started their recent love-affair with alternative medicine.
  2. Many consumers confuse homeopathy with herbal medicine; yet the two are fundamentally different. Herbal medicines are plant extracts with potentially active ingredients. Homeopathic remedies may be based on plants (or any other material as well) but are typically so dilute that they contain absolutely nothing. The most frequently used dilution (homeopaths call them ‘potencies’) is a ‘C30′; a C30-potency has been diluted 30 times at a ratio of 1:100. This means that one drop of the staring material is dissolved in 1 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 drops of diluent – and that equates to one molecule of the original substance per all the molecules of many thousand universes.
  3. Homeopaths know all of this, of course, and they thus claim that their remedies do not work via pharmacological effects but via some ‘energy’ or ‘vital force’. They are convinced that the process of preparing the homeopathic dilutions (they shake the mixtures at each dilution step) transfers some ‘vital energy’ from one to the next dilution. They cite all sorts of fancy theories to explain how this ‘energy transfer’ might come about, however, none of them has ever been accepted by mainstream scientists.
  4. Homeopathic remedies are usually prescribed according to the ‘like cures like’ principle. For instance, if you suffer from runny eyes, a homeopath might prescribe a remedy made of onion, because onion make our eyes water. This and all other basic assumptions of homeopathy contradict the known laws of nature. In other words, we do not just fail to understand how homeopathy works, but we understand that it cannot work unless the known laws of nature are wrong.
  5. The clinical trials of homeopathy are broadly in agreement with these insights from basic science. Today, more than 200 such studies have been published; if we look at the totality of this evidence, we have to conclude that it fails to show that homeopathic remedies are anything other than placebos.
  6. This is, of course, in stark contrast to what many enthusiasts of homeopathy insist upon; they swear by homeopathy and claim that it has helped them (or their pet, aunt, child etc.) repeatedly. Nobody doubts their accounts; in fact, it is indisputable that many patients do get better after taking homeopathic remedies. The best evidence available today clearly shows, however, that this improvement is unrelated to the homeopathic remedy per se. It is the result of an empathetic, compassionate encounter with a homeopath, a placebo-response or other factors which experts often call ‘context effects’.
  7. The wide-spread notion that homeopathy is completely free of risks is not correct. The remedy itself might be harmless (except, of course, for the damage it creates to your finances, and the fact that irrational nonsense about ‘vital energy’ etc. undermines rationality in general) but this does not necessarily apply to the homeopath. Whenever homeopaths advise their patients, as they often do, to forgo effective conventional treatments for a serious condition, they endanger lives. This phenomenon is documented, for instance, in relation to the advice of many homeopaths against immunisations. Any treatment that has no proven benefit, while carrying a finite risk, cannot generate more good than harm.

Acute tonsillitis (AT) is an upper respiratory tract infection which is prevalent, particularly in children. The cause is usually a viral or, less commonly, a bacterial infection. Treatment is symptomatic and usually consists of ample fluid intake and pain-killers; antibiotics are rarely indicated, even if the infection is bacterial by nature. The condition is self-limiting and symptoms subside normally after one week.

Homeopaths believe that their remedies are effective for AT – but is there any evidence? A recent trial seems to suggest there is.

It aimed, according to its authors, to determine the efficacy of a homeopathic complex on the symptoms of acute viral tonsillitis in African children in South Africa.

The double-blind, placebo-controlled RCT was a 6-day “pilot study” and included 30 children aged 6 to 12 years, with acute viral tonsillitis. Participants took two tablets 4 times per day. The treatment group received lactose tablets medicated with the homeopathic complex (Atropa belladonna D4, Calcarea phosphoricum D4, Hepar sulphuris D4, Kalium bichromat D4, Kalium muriaticum D4, Mercurius protoiodid D10, and Mercurius biniodid D10). The placebo consisted of the unmedicated vehicle only. The Wong-Baker FACES Pain Rating Scale was used for measuring pain intensity, and a Symptom Grading Scale assessed changes in tonsillitis signs and symptoms.

The results showed that the treatment group had a statistically significant improvement in the following symptoms compared with the placebo group: pain associated with tonsillitis, pain on swallowing, erythema and inflammation of the pharynx, and tonsil size.

The authors drew the following conclusions: the homeopathic complex used in this study exhibited significant anti-inflammatory and pain-relieving qualities in children with acute viral tonsillitis. No patients reported any adverse effects. These preliminary findings are promising; however, the sample size was small and therefore a definitive conclusion cannot be reached. A larger, more inclusive research study should be undertaken to verify the findings of this study.

Personally, I agree only with the latter part of the conclusion and very much doubt that this study was able to “determine the efficacy” of the homeopathic product used. The authors themselves call their trial a “pilot study”. Such projects are not meant to determine efficacy but are usually designed to determine the feasibility of a trial design in order to subsequently mount a definitive efficacy study.

Moreover, I have considerable doubts about the impartiality of the authors. Their affiliation is “Department of Homoeopathy, University of Johannesburg, Johannesburg, South Africa”, and their article was published in a journal known to be biased in favour of homeopathy. These circumstances in itself might not be all that important, but what makes me more than a little suspicious is this sentence from the introduction of their abstract:

“Homeopathic remedies are a useful alternative to conventional medications in acute uncomplicated upper respiratory tract infections in children, offering earlier symptom resolution, cost-effectiveness, and fewer adverse effects.”

A useful alternative to conventional medications (there are no conventional drugs) for earlier symptom resolution?

If it is true that the usefulness of homeopathic remedies has been established, why conduct the study?

If the authors were so convinced of this notion (for which there is, of course, no good evidence) how can we assume they were not biased in conducting this study?

I think that, in order to agree that a homeopathic remedy generates effects that differ from those of placebo, we need a proper (not a pilot) study, published in a journal of high standing by unbiased scientists.

Whenever I give a public lecture about homeopathy, I explain what it is, briefly go in to its history, explain what its assumptions are, and what the evidence tells us about its efficacy and safety. When I am finished, there usually is a discussion with the audience. This is the part I like best; in fact, it is the main reason why I made the effort to do the lecture in the first place.

The questions vary, of course, but you can bet your last shirt that someone asks: “We know it works for animals; animals cannot experience a placebo-response, and therefore your claim that homeopathy relies on nothing but the placebo-effect must be wrong!” At this stage I often despair a little, I must admit. Not because the question is too daft, but because I did address it during my lecture. Thus I feel that I have failed to get the right message across – I despair with my obviously poor skills of giving an informative lecture!

Yet I need to answer the above question, of course. So I reiterate that the perceived effectiveness of homeopathy relies not just on the placebo-effect but also on phenomena such as regression towards the mean, natural history of the condition etc. I also usually mention that it is erroneous to assume that animals cannot benefit from placebo-effects; they can be conditioned, and pets can react to the expectations of their owners.

Finally, I need to mention the veterinary clinical evidence which – just like in the case of human patients – fails to show that homeopathic remedies are better than placebos for treating animals. Until recently, this was not an easy task because no systematic review of randomised placebo-controlled trials (RCTs) of veterinary homeopathy was available. Now, I am happy to announce, this situation has changed.

Using Cochrane methods, a brand-new review aimed to assess risk of bias and to quantify the effect size of homeopathic interventions compared with placebo for each eligible peer-reviewed trial. Judgement in 7 assessment domains enabled a trial’s risk of bias to be designated as low, unclear or high. A trial was judged to comprise reliable evidence, if its risk of bias was low or was unclear in specified domains. A trial was considered to be free of vested interest, if it was not funded by a homeopathic pharmacy.

The 18 RCTs found by the researchers were disparate in nature, representing 4 species and 11 different medical conditions. Reliable evidence, free from vested interest, was identified in only two trials:

  1. homeopathic Coli had a prophylactic effect on porcine diarrhoea (odds ratio 3.89, 95 per cent confidence interval [CI], 1.19 to 12.68, P=0.02);
  2. individualised homeopathic treatment did not have a more beneficial effect on bovine mastitis than placebo intervention (standardised mean difference -0.31, 95 per cent CI, -0.97 to 0.34, P=0.35).

The authors conclusions are clear: Mixed findings from the only two placebo-controlled RCTs that had suitably reliable evidence precluded generalisable conclusions about the efficacy of any particular homeopathic medicine or the impact of individualised homeopathic intervention on any given medical condition in animals.

My task when lecturing about homeopathy has thus become a great deal easier. But homeopathy-fans are not best pleased with this new article, I guess. They will try to claim that it was a biased piece of research conducted, most likely, by notorious anti-homeopaths who cannot be trusted. So who are the authors of this new publication?

They are RT Mathie from the British Homeopathic Association and J Clausen from one of Germany’s most pro-homeopathic institution, the ‘Karl und Veronica Carstens-Stiftung’.

DOES ANYONE BELIEVE THAT THIS ARTICLE IS BIASED AGAINST HOMEOPATHY?

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