MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

bogus claims

Manufacturers of homeopathic remedies are having a hard time, it seems. The following press release has just reached me, and I thought it might be worth sharing it with my readers:

 

Baden-Baden, Germany, May 23, 2014 – Heel Group today announced the cessation of its business activities in the United States and Canada on August 31, 2014.

 

In the USA and Canada, manufacturers of OTC homeopathic medicinal products have been confronted with accusations through class action lawsuits. Heel Inc., the Heel Group’s U.S.-based subsidiary, was also faced with two such attempts recently. Both cases have been settled without conceding the allegations. The financial burden on Heel Inc., however, was substantial.

In a subsequent risk-benefit analysis of its global activities, the Heel Group decided to focus on strengthening its excellent position in South America, Central Europe and Eastern Europe and to withdraw from business activities in the USA and Canada for the time being.

Heel’s operations in both the USA and Canada will accordingly be discontinued as of August 31, 2014.

In the USA, negotiations with MediNatura Inc., a Delaware Corporation, are close to completion by which the Heel Group will transfer its stock in Heel Inc., to MediNatura by the end of August 2014. The transaction does, however, not include any of Heel’s trusted and leading global brands such as Traumeel, Neurexan, Zeel, Oculoheel, Luffeel, Sinusin, Vinceel, Nectadyn, Adrisin, Gripp-Heel, Viburcol, Vertigoheel, Spascupreel, Engystol, and Lymphomyosot*. Completion of the acquisition is subject to standard closing procedures.

As a trailblazer and leader in the field of scientific research into natural healthcare and a leading manufacturer of homeopathic medicines, the Heel Group will continue to invest in research and development on a global scale, also involving the medical-scientific community in North America.

Ralph Schmidt, CEO of the Heel Group: “As a global player, we are continuously reviewing our portfolio. This means that we are sometimes required to focus on specific regions at the expense of others in order to efficiently carry out our ambitious expansion plans. I would not exclude the possibility of re-entering the markets in the USA and Canada with a new business concept.”

It is somewhat sobering from my point of view to realise that all the science proving that homeopathy had no health effects beyond placebo had little effect on the market for homeopathic remedies. If anything, the sales figures seemed to get better and better as the evidence got more and more negative during the last decades. The ‘globulisation’ of the world seemed imminent due to those homeopathic manufacturers who wanted to become ‘global players’ (is there not a homeopathic remedy against megalomania?). It was only the legal actions that seemed to have an effect. The multiple North American class actions were more effective than the science, it seems.

Is there a lesson here? Perhaps! It could be that scientists working on their own are not always powerful enough to improve health care. Particularly when confronted with an alliance of evangelic belief and commercial interests, scientists, sceptics, journalists, lawyers, politicians and other professions might have to co-operate to bring about meaningful change.

 

The question whether infant colic can be effectively treated with manipulative therapies might seem rather trivial – after all, this is a benign condition which the infant quickly grows out of. However, the issue becomes a little more tricky, if we consider that it was one of the 6 paediatric illnesses which were at the centre of the famous libel case of the BCA against my friend and co-author Simon Singh. At the time, Simon had claimed that there was ‘not a jot of evidence’ for claiming that chiropractic was an effective treatment of infant colic, and my systematic review of the evidence strongly supported his statement. The BCA eventually lost their libel case and with it the reputation of chiropractic. Now a new article on this intriguing topic has become available; do we have to reverse our judgements?

The aim of this new systematic review was to evaluate the efficacy or effectiveness of manipulative therapies for infantile colic. Six RCTs of chiropractic, osteopathy or cranial osteopathy alone or in conjunction with other interventions were included with a total of 325 infants. Of the 6 included studies, 5 were “suggestive of a beneficial effect” and one found no evidence of benefit. Combining all the RCTs suggested that manipulative therapies had a significant effect. The average crying time was reduced by an average of 72 minutes per day. This effect was sustained for studies with a low risk of selection bias and attrition bias. When analysing only those studies with a low risk of performance bias (i.e. parental blinding) the improvement in daily crying hours was no longer statistically significant.

The quality of the studies was variable. There was a generally low risk of selection bias but a high risk of performance bias. Only one of the studies recorded adverse events and none were encountered.

From these data, the authors drew the following conclusion: Parents of infants receiving manipulative therapies reported fewer hours crying per day than parents whose infants did not and this difference was statistically significant. Most studies had a high risk of performance bias due to the fact that the assessors (parents) were not blind to who had received the intervention. When combining only those trials with a low risk of such performance bias the results did not reach statistical significance.

Does that mean that chiropractic does work for infant colic? No, it does not!

The first thing to point out is that the new systematic review included not just RCTs of chiropractic but also osteopathy and cranio-sacral therapy.

The second important issue is that the effects disappear, once performance bias is being accounted for which clearly shows that the result is false positive.

The third relevant fact is that the majority of the RCTs were of poor quality. The methodologically best studies were negative.

And the fourth thing to note is that only one study mentioned adverse effects, which means that the other 5 trials were in breach of one of rather elementary research ethics.

What makes all of this even more fascinating is the fact that the senior author of the new publication, George Lewith, is the very expert who advised the BCA in their libel case against Simon Singh. He seems so fond of his work that he even decided to re-publish it using even more misleading language than before. It is, of course, far from me to suggest that his review was an attempt to white-wash the issue of chiropractic ‘bogus’ claims. However, based on the available evidence, I would have formulated conclusions which are more than just a little different from his; something like this perhaps:

The current best evidence suggests that the small effects that emerge when we pool the data from mostly unreliable studies are due to bias and therefore not real. This systematic review therefore fails to show that manipulative therapies are effective. It furthermore points to a serious breach of research ethics by the majority of researchers in this field.

A new book is currently being promoted. It specifically targets cancer patients and misleads them into thinking that alternative therapies offer hope for this vulnerable group of patients. Here is what the press release says:

Endeavoring to provide the 1.2 million Americans diagnosed with cancer annually with alternative treatments co-authors Johanna C. Schipper and Frank J. Vanderlugt announce the launch of “The Natural Cancer Handbook”. The useful book explores how more than fifty alternative treatments work, their price, and where they can be obtained…. Contributing to the war on cancer with a bevy of scientific and anecdotal evidence to support the effectiveness of the treatments the handbook is a respite from the mixed messages patients often endure.

With more than fifty of the most effective alternative cancer treatments listed The Natural Cancer Handbook is the work of two years of research. Used successfully over the last century, the remedies found in the handbook are significantly cheaper than standard cancer treatments and in most cases can be used alongside them.

…The handbook discusses the successful alternative treatments Budwig Diet, Beta 1, 3D Glucan, and the readily available green food supplements such as barley grass, chlorella and spirulina. The Natural Cancer Handbook also explores the benefits of Melatonin, Noni, Resveratrol and the Canadian Resonant Light and the Hulda Clark generators.

Vanderlugt is a Chartered Accountant with a Bachelor of Science in Biology and Schipper has researched cancer extensively and has five years training in medicine.

Let’s just take the first treatment mentioned above; this is what a reliable source like CANCER RESEARCH UK have to say about it:

The Budwig diet was developed by a German biochemist called Johanna Budwig in the 1950s. It involves eating flaxseed mixed with cottage cheese or milk. Flax is a plant grown in many parts of the world. Pressing its seeds produces linseed oil to use in cooking or as a food supplement. The seeds contain high levels of fibre and many vitamins and minerals. You grind the flaxseed, usually in a coffee grinder. As well as flaxseed and cottage cheese, the Budwig diet is rich in fruit, vegetables and fibre. You also have to avoid sugar, meat, and fats such as butter, margarine and salad oil.

There is no reliable scientific evidence to show that the Budwig diet (or any highly specific diet) helps people with cancer. It is important to make sure that you have a well balanced diet when you are ill, especially if you are undernourished. We know from research that a healthy, well balanced diet can reduce the risk of cancer. You can find information about diet, healthy eating and cancer on our News and Resources website.

This is a polite way of telling us that diets such as this one is not balanced and not what cancer patients need; in fact, such diets are not just ineffective, they can be dangerous to cancer patients.

Texts like the Natural Cancer Handbook tend to make me quite angry. I find it deeply immoral to mislead cancer patients in this way, simply to make a profit. The truth could not be simpler: There is and never will be such a thing as an alternative cancer ‘cure’.

The concept assumes that there exists an effective cure which is being suppressed only because it originates from alternative medicine circles. But this assumption is idiotic. As soon as a treatment shows promise, it will be picked up by the scientific and oncologic communities and researched until its therapeutic value is known. At the end of this process, we might have a new option to treat cancer effectively. Many examples exist where a new drug was developed from a plant; taxol is but one of many examples.

Those who deny these simple facts in order to make a fast buck from the desperation of some of the most vulnerable patients are, in my view, charlatans of the worst kind.

The fact that practitioners of alternative medicine frequently advise their patients against immunising their children has been documented repeatedly. In particular, doctors of anthroposophy, chiropractors and homeopaths are implicated in thus endangering public health. Less is known about naturopaths attitude in this respect. Now new data have emerged which confirm some of our worst fears.

This survey aimed at assessing the attitudes, education, and sources of knowledge surrounding childhood vaccinations of 560 students at National College of Natural Medicine in Portland, US. Students were asked about demographics, sources of information about childhood vaccines, differences between mainstream and CAM education on childhood vaccines, alternative vaccine schedules, adverse effects, perceived efficacy, and credibility of information sources.

A total of 109 students provided responses (19.4% response rate). All students surveyed learned about vaccinations in multiple courses and through independent study. The information sources employed had varying levels of credibility. Only 26% of the responding students planned on regularly prescribing or recommending vaccinations for their patients; 82% supported the general concept of vaccinations for prevention of infectious diseases.

The vast majority (96%) of those who might recommend vaccinations reported that they would only recommend a schedule that differed from the standard CDC-ACIP schedule.

Many respondents were concerned about vaccines being given too early (73%), too many vaccines administered simultaneously (70%), too many vaccines overall (59%), and about preservatives and adjuvants in vaccines (72%). About 40% believed that a healthy diet and lifestyle was more important for prevention of infectious diseases than vaccines. 90% admitted that they were more critical of vaccines than mainstream pediatricians, medical doctors, and medical students.

These results speak for themselves and leave me (almost) speechless. The response rate was truly dismal, and it is fair to assume that the non-responding students held even more offensive views on vaccination than their responding colleagues. The findings seem to indicate that naturopaths are systematically trained to become anti-vaxers who believe that their naturopathic treatments offer better protection than vaccines. They are thus depriving many of their patients of arguably the most successful means of disease prevention that exists today. To put it bluntly: naturopaths seem to be brain-washed into becoming a danger to public health.

A recent US study found that belief in conspiracy theories is rife in health care. The investigators presented people with 6 different conspiracy theories, and the one that was most widely believed was the following:

THE FOOD AND DRUG ADMINISTRATION IS DELIBERATELY PREVENTING THE PUBLIC FROM GETTING NATURAL CURES FOR CANCER AND OTHER DISEASES BECAUSE OF PRESSURE FROM DRUG COMPANIES.

A total of 37% agreed with this statement, 31% had no opinion on the matter, and 32% disagreed. What is more, the belief in this particular conspiracy correlated positively with the usage of alternative medicine.

Essentially, this implies that the current popularity of alternative medicine is at least partly driven by the conviction that there is a sinister plot by the FDA or more generally speaking ‘the establishment’ that prevents people from benefitting from the wonders of alternative treatments.

I think it was Woody Allen who noted that, just because you are paranoid does not mean that they are not following you. So, let’s look for evidence suggesting that the FDA or any similar organisation is suppressing alternative medicine.

A prime candidate is, of course, the often implicated, thoroughly evil ‘BIG PHARMA‘. I am not a fan of the pharmaceutical industry and I know few people who are. But where is the evidence for BIG PHARMA’s conspiracy against alternative medicine? In the many years of researching this sector, I have never come across a jot of evidence to support this notion. On the contrary, BIG PHARMA seems all to keen to jump on to the alternative bandwagon and make a few quick bucks from the gullibility of the consumer.

What about the rest of the medical establishment? All I see is that universities, hospitals, charities and other organisations in health care currently bend over backwards in order to accommodate as much alternative medicine as they possibly can get away with in view of the often embarrassing lack of convincing evidence for the treatments in question. Conspiracy against alternative medicine? I don’t think so.

The closer we look, the more we arrive at the conclusion that the conspiracy against alternative medicine is a myth and a figment of the imagination of those who religiously believe in alternative medicine. They seem to long for an explanation why their favourite therapy is not in even more wide-spread use. Cognitive dissonance seems to prevent them to consider that the lack of evidence has anything to do with this situation. Consequently, they prefer to invent a conspiracy theory.

And this is where an interesting question emerges, in my view: do people who believe that the FDA or other organisations prevent the public from getting more alternative medicine really need more alternative medicine, or do they perhaps just need an effective treatment for their paranoia?

When I first read about agrohomeopathy (i.e. the use of potentised preparations for the health of plants and soils) I thought that it must be a hoax. Then I realised that it was entirely serious (a Google search returns ~28 000 hits for ‘agrohomeopathy’) – serious but nevertheless too weird for words. Because it is so utterly unbelievable, I cite (in italics) the key parts of an article on the subject.

What’s better than ORGANIC or BIODYNAMIC farming? AGROHOMEOPATHY! What is Agrohomeopathy? It’s the specialized area of homeopathy used to treat your garden and crops. Agrohomeopathy is the most chemical free, non-toxic method of growing food and other crops that you can get. Agrohomeopathy makes your plants resistant to disease and pests by strengthening them from the inside out. In nature, it is the weakest of organisms that are attacked and destroyed. Agrohomeopathy helps build up the plant’s basic structure and gives it optimum health, thus reducing and sometimes even eliminating it’s susceptibility. And the skeptics can’t blame THESE effects on placebo, can they?!….

Homeopathic treatment for your crops is a win-win situation. It is backed by decades of research and practice. Try it for yourself and see. And if you have problems or need help, there are experts in the field who are eager to help, who want to get your feedback & experience…

If you think this is far-fetched, rest assured that other sources go even further. Look at this statement, for instance:

Agro-Homeopathy not only treats the disease symptoms of the plant and performs preventive actions, but can also treat traumas retained in the biological memory of the plant, which resulted from conditions such as forced hybridization, moving to places outside their natural habitats , or exaggerated fertilization that maximizes production to the extreme.

So, plants have a ‘biological memory’ that is able to retain information of a past trauma! Fascinating, this gets more fantastic by the minute.

And there is plenty of practical advice too; just consider this helpful hint, if you are a keen gardener: the effects and benefits of homeopathic Silicea are so numerous that an entire article has been devoted to them at: Homeopathic Silica – The Gardener’s Friend. Needless to say, Silicea is one remedy no gardener or farmer should be without…

According to this website, homeopathic silica is a miracle cure; it

  1. Aids germination of seeds
  2. Reduces transplant shock
  3. Strengthens weak and spindly plants
  4. Increases vigour and resistance of plants to pests, moulds, and mildew
  5. Aids water retention in plants growing on arid soils
  6. Stimulates flower growth, both in number and size
  7. Assists seed generation and development
  8. Improves fruit-setting when applied after flowering
  9. Stimulates premature flowering and prevents seed formation when applied in overdose to weeds
  10. Changes the ionisation of soil particles so that water-repellent soil readily absorbs moisture … and more!

The sceptics can indeed not blame ‘THESE effects’ on placebo. Nobody needs to do that because they do not exist! I could not find a single piece of reliable evidence to demonstrate that highly diluted homeopathic remedies can cure diseases of plants.

I hope that a few agrohomeopathic readers of these lines will correct me by showing me solid data – but somehow I doubt it.

An article in the ‘Huffpost Healthy Living’ recently discussed “the top three things that surprise people about acupuncture”. On closer inspection, they turn out to be the top three untruths about acupuncture. Here is (in italics and slightly abbreviated) what the article said.

Acupuncture is not just for pain

…It’s true that acupuncture can work wonders on pain conditions…However, acupuncture can alleviate a wide variety of ailments that have nothing to do with physical pain. Whether you have digestive issues, gynecological conditions, emotional concerns such as anxiety and depression, asthma, seasonal allergies, you name it, acupuncture can help address your symptoms.

Acupuncturists go to school for a long time

People tend to be unaware of the extent to which acupuncturists train to become licensed in their profession. Many assume becoming an acupuncturist is similar to becoming a massage therapist or Reiki practitioner or yoga instructor… At minimum, a licensed acupuncturist in the United States has been to three years of graduate school. Four years is more common. They hold master’s degrees. Some acupuncturists with doctorates have studied at the graduate level for five-plus years. Upon graduating from an accredited school, all acupuncturists must pass multiple board exams to become licensed in their state. In addition to the academic and state requirements for practicing acupuncture, many acupuncturists seek hands-on training and mentorship in the form of apprenticeships and continuing education seminars.

Acupuncture is relaxing

Acupuncture needles are surprisingly thin. They do not bear any resemblance to needles that are used for injections or to draw blood… In most cases, the insertion of acupuncture needles does not hurt…Once the needles are in, they start working their magic, which is where the relaxation part comes in. Acupuncture helps shift your body out of sympathetic mode (fight or flight) and into parasympathetic mode (rest and digest). It mellows out the nervous system, decreases muscular tension, and helps quiet internal chatter…

AND NOW THE FACTS:

1) There is not a single condition for which the evidence is truly compelling demonstrating that acupuncture is more than a placebo. Certainly there is no good evidence that acupuncture works for digestive issues, gynecological conditions, emotional concerns such as anxiety and depression, asthma or seasonal allergies.

2) In most countries, anyone can call themselves an acupuncturist, regardless of background or training.

3) The relaxing element of an acupuncture session is foremost the fact that patients lie down and have to keep still for 20 minutes or so. The insertion of needles does cause mild pain in many patients, and the claim about parasympathetic mode is mostly phantasy.

I despair about the nonsense that is published about alternative medicine on a daily basis – not because I have an axe to grind, but because it misleads patients into making wrong therapeutic decisions.

It is not often that we see an article of the great George Vithoulkas, the ‘über-guru‘ of homeopathy, in a medical journal. In fact, this paper, which he co-authored with several colleagues, seems to be a rare exception: in his entire career, he seems to have published just 15 Medline- listed articles most of which are letters to the editor.

According to Wikipedia, Vithoulkas has been described as “the maestro of classical homeopathy” by Robin Shohet; Lyle Morgan says he is “widely considered to be the greatest living homeopathic theorist”; and Scott Shannon calls him a “contemporary master of homeopathy.” Paul Ekins credited Vithoulkas with the revival of the credibility of homeopathy.

In his brand new paper, Vithoulkas provides evidence for the notion that homeopathy can treat infertility. More specifically, the authors present 5 cases of female infertility treated successfully with the use of homeopathic remedies.

Really?

Yes, really! The American Medical College of Homeopathy informs us that homeopathy has an absolute solution that can augment your probability of conception. Homeopathic treatment of Infertility addresses both physical and emotional imbalances in a person. Homeopathy plays a role in treating Infertility by strengthening the reproductive organs in both men and women, by regulating hormonal balance, menstruation and ovulation in women, by escalating blood flow into the pelvic region, by mounting the thickness of the uterine lining and preventing the uterus from contracting hence abating chances of a miscarriage, and by increasing quality and quantity of sperm count in men. It can also be advantageous in reducing anxiety so that the embryo implantation can take place in a favourable environment. Homoeopathy is a system of medicine directed at assisting the body’s own healing process.

Imagine: the 5 women in Vithoulkas ‘study’ wanted to have children; they consulted homeopaths because they did not get pregnant in a timely fashion. The homeopaths prescribed individualised homeopathy and treated them for prolonged periods of time. Eventually, BINGO!, all of the 5 women got pregnant.

What a hoot!

It beggars belief that this result is being credited to the administration of homeopathic remedies. Do the authors not know that, in many cases, it can take many months until a pregnancy occurs? Do they not think that the many women they treated unsuccessfully for the same problem should raise some doubts about homeopathy? Do they really believe that their remedies had any causal relationship to the 5 pregnancies?

Vithoulkas was a recipient of the Right Livelihood Award in 1996. I hope they did not give it to him in recognition of his scientific achievements!

 

 

Guest Post by Jan Willem Nienhuys

The so-called Swiss government report of 2011 on homeopathy was actually an expanded translation of a 2006 book, which in itself was an expanded version of a document submitted to a Swiss committee (PEK) in charge of evaluation of alternative medicine. It has been severely criticised. A summary of criticisms with links can be found on the RationalWiki item to which we may add the Zeno’s Blog. I present here the results of my scrutiny of chapter 10 (1), although I base my report on the original German edition.

This chapter by itself shows a familiar result: the better the investigation, the less evidence in favor of homeopathy it shows. It shows also how homeopaths systematically distort unfavorable results by mispresenting them. Chapter 10 deals with clinical investigations of homeopathy. The authors restrict their attention to an odd assortment of diseases such as acute rhinitis, allergic rhinitis, allergic asthma, sinusitis, adenoid vegetations, pharyngitis, tonsillitis, influenza-like infection and otitis media, together denoted as ‘upper respiratory tract infections/allergic reactions’ or URTI/A for short.

The number of papers reviewed is very small. The authors looked at much more than randomized clinical trials. Apparently their search did not extend further than 2003, but then they might have found over 150 papers, of which about one third double blind randomized trials that compared how well highly diluted homeopathy and placebo cured one of the indicated diseases. They managed to miss 25 papers mentioned in earlier meta-analyses and about four papers that are summarized in Pubmed.

Among the papers they missed is an extremely strong support for the claim ‘homeopathy works for URTI/A’. For example Riverón-Garrote et al. (2) did a placebo controlled double blind randomized clinical trial of homeopathy (apparently individualised) for asthma. Of about 33 verum patients 32 improved, whereas of about 30 placebo patients only 4 improved. The so-called p-value for such a result is less than 10–11. One wonders why this result wasn’t published in Science or Nature, but only in an obscure Spanish language homeopathic journal. Maybe the paper was excluded because it didn’t state that it was about allergic asthma, but note that in about three quarters of all asthma some kind of allergy is implicated.

Of course this pales in comparison to the paper by Friese and Zabalotnyi (3). Again a double blind randomised clinical trial with 72 sinusitis sufferers for both verum and placebo. But here 71 out of 72 verum patients were free of complaints after three weeks, or at least improved, whereas this was the case for only 8 of the placebo patients. Fisher’s Exact Test gives p = 2.47 times 10-29 (one tailed). A remarkable result, because it is well known that over 80% of sinusitis cases cures spontaneously within two weeks. Maybe placebos are dangerous in the hands of homeopaths. Again one wonders why Friese and Zabalotnyi didn’t share the Nobel prize in, say, 2008, and why it is necessary at all to meticulously analyse papers in which homeopathy shows a marginal advantage.

Instead, Maxion-Bergemann et al. include in their survey a paper by Bahemann (4). We quote the summary of the paper from the internet: ‘In homeopathic practice, Kalium bromatum is known as a remedy in the case of paranoid delusions, e. g. if someone suffers from the delusion of being the object of divine revenge, of being damned, or of being pursued. It is also a very important remedy in the case of nocturnal fears in children as well as in the case of convulsions, when they are hereditary, when they occur in childbed, or during teething. The following case demonstrates the successful treatment of a severe mononucleosis after studying the Materia medica.’ Mononucleosis isn’t even mentioned in the list given that specifies URTI/A. Maybe it was included because one of the symptoms of mononucleosis is a sore throat. Apparently the mononucleosis patient was given Kalium Bromatum (Maxion-Bergemann et al. state that it is Kalium Chromatum 200C, presumably Chromatum and Bromatum don’t differ too much to bother) because of something remarkable the patient said during the anamnesis. The reason for giving Kalium bromatum 200C in cases of paranoia might be that an overdose of bromide can induce psychoses. The homeopathic Materia Medica contains quite a few ‘symptoms’ from accidental poisonings reported in old medical literature; potassium bromide was liberally used in the nineteenth century for the calming of seizure and nervous disorders, according to Wikipedia.

More impressive in the list of 13 RCTs of Maxion-Bergemann are two of the largest ‘homeopathic’ trials known, namely of the remedy Oscillococcinum. These trials cannot be taken seriously. The first one, by Ferley et al. (5), has one glaring fault. They started with 478 ‘influenza’-patients (237 verum), tried to make 149 family physicians note down when the patients recovered, and then elected to restrict their attention to the 63 patients (39 verum) that recovered within 48 hours and therefore probably didn’t have flu at all. Coincidentally this was the only possibility out of 14 that gave a ‘significant’ result: correctly computed, p is just below 0.05. (Ferley et al. based their computation on 462 patients with 228 verum and applied a chi-squared test without continuity correction). It is hardly credible that they set this 48-hour criterion in advance, because even if the remedy worked, the risk of having too few subjects to get a significant result would have been considerable. But if one picks out one result among many possibilities, one should correct for multiple outcome. So the Ferley et al. investigation is at most an exploratory result in need of independent confirmation.

This ‘confirmation’ was undertaken soon afterwards, namely in the beginning of 1991, but the results were only published in 1998 and cannot be found on Pubmed (6). In this paper the definitions are somewhat different, but Papp et al. report that of 334 patients (167 verum) a total of 57 (32 verum) were cured in 48 hours. Now 25 versus 32 is not remarkable at all. One doesn’t need any elaborate computation for this. Calculation gives p=0.4. So one might think that the Ferley hypothesis was soundly refuted. But Papp et al. used something they call ‘the Krauth test’, probably some kind of automated post hoc fishing trip to select the best criteria to distinguish the placebo and verum groups. They claim that this ‘test’ gives p=0.0028. They specifically refer to ‘the null hypothesis (the number of patients free of symptoms after 48 hours is equal in both treatment groups)’, so their computation is wrong. The most remarkable thing about Papp et al. is that nobody seems to have to have noticed the large discrepancy between what the numbers say and the claim of the paper.

Another paper with ‘positive’ results is the 1994 study of Reilly et al. (7), number 28 in Maxion-Bergemann et al. The group of Reilly investigated allergic diseases treated by what they called homeopathy. The typical Reilly experiment consists of administering a highly diluted causative agent such as pollen or house dust mite or cat hairs or bird feathers to persons suffering from pollen allergy (seasonal rhinitis) or allergic asthma. However for true homeopathy one uses a substance that has been the subject of a so-called proving, and the remedy is chosen of the totality of all patient ‘symptoms’ – including things like sleeping position and fear of thunderstorms – sufficiently matches the symptoms of the proving. Let me call Reilly’s method ultra-isopathy. Reilly was already discussing this study on a symposium in 1990, but that paper is not clear. It is about 28 asthma patients, and only 24 were analysed. This small number in itself is already reason enough not to consider it. The main analysis was by comparing a subjective measure of wellbeing, the Visual Analog Scale (VAS). Here we find a significant difference (p=0.003) in favor of ultra-isopathy. However, in the small print we see that change in the very important FEV1-value (Forced Expiratory Volume in 1 second) was non-significant (p=0.08) but this refers only to the 18 patients that took such a test before and after the experiment.

Reilly attracted more attention with his first experiment in this vein (8). He started out with 79 patients in both the verum and the placebo group. The treatment was ultradiluted grass pollen for hay fever. The analysis was only about 56 verum and 52 placebo (in a diagram 53 placebo are shown). Such a large dropout (32%) is not good. On basis of the VAS-scores Reilly found p=0.02. VAS is only an ordinal scale and it is not at all clear that one person’s 60 mm means the same as another person’s 60 mm, and also not that two patients with respectively 40 mm and 80 mm together can be considered as equivalent to two other patients with 60 mm each. If we distinguish only better / equal / worse, then the numbers for the verum group were 34 / 9 / 13 and for the placebo group 27 / 5 / 21. One can analyse this in various ways: as a 3 by 2 contingency table (p=0.15), or as a 2 by 2 table, namely by joining the middle group either to the right (p=0.10) or to the left (p=0.34). In this manner the difference is less impressive.

Maxion-Bergemann et al. collected 29 articles. I take the liberty of removing from these everything that is not a double blind RCT that compares how well highly diluted homeopathy and placebo cures an URTI/A disease. We also remove all research with 50 or less patients. The more or less openly fraudulent or at least grossly mistaken Oscillococcinum trials I also leave out. In order of appearance we have then Wiesenauer 1985 (9) [8] Reilly 1986 (8) [6] Wiesenauer 1989 (10) [10] De Lange-de Klerk 1994 (11) [1] Aabel 2000 (12) [4] Jacobs 2001 (13) [22] Friese 2001 (14) [24] Lewith 2002 (15) [25] White 2003 (16) [29] The square brackets refer to the numbering in Maxion-Bergemann et al. A short review of these nine articles follows.

Wiesenauer 1985: one standard remedy for hayfever. Randomised 213 patients, analysed only 164. “no statistical significance was achieved” says the abstract on Pubmed. Reilly 1986: this we have discussed already. Ultra-isopathy for hayfever. Randomised 158 patients, analysed 108. Statistically significant, but barely so. Wiesenauer 1989: four groups, each with their own standard remedy or placebo for sinusitis, 152 patients. “There was no remarkable difference in the therapeutic success among the investigated homeopathic drug combinations nor between the active drugs and placebo”, according to the abstract in Pubmed De Lange-de Klerk 1994: this research was reported more extensively in the lead author’s dissertation (17). Individualised homeopathy for recurrent URTI in children. 175 children were randomised and 170 analysed after following them for a year. 128 different remedies/potencies were prescribed and all together 1042 different prescriptions were handed out. The result was a non-significant difference between homeopathy and placebo. One striking aspect of this investigation is that only after all computations were done, it was revealed which of the two groups was the placebo group and which the verum group. So the author or her thesis advisors deliberately made it impossible to fall for the temptation to start a fishing expedition in the data after the code was completely broken. See also Pubmed. Aabel 2000: ultra-isopathy for birch pollen allergy. Strictly speaking this investigation shouldn’t be in this short list because it was partly prophylactic. From Pubmed: “Surprisingly, the verum treated patients fared worse than the placebo group”. No measure of statistical significance is mentioned. Remarkably this article is preceded by a similar article (18) that Maxion-Bergemann et al. apparently weren’t able to locate. Jacobs 2001: 75 children with otitis media were treated with individualised homeopathy or placebo. Pubmed: “differences were not statistically significant”. It seems that Jacobs has indulged in a fishing trip because she mentions a “significant decrease in symptoms at 24 and 64 h after treatment in favor of homeopathy”. But that is wrong. Significance only can have a meaning if it refers to a single outcome that was planned before any patients were seen. Just picking out two results out of many and stating they are ‘significant’ betrays a fundamental ignorance of research methodology. Friese 2001: this article is also published elsewhere (19), at least the numbers are exactly the same according to Pubmed. 97 children randomized for either individual homeopathic treatment or placebo treatment of adenoid vegetations, 82 analysed. Apparently these 82 comprised 41 placebo and 41 verum, and of these 12 and 9 respectively required an operation in the end. This allegedly corresponds to p=0.64, “These results show no statistical significance.” Incidentally, this is the same Friese as reference 3. Lewith 2002: again ultra-isopathy, now for asthma, 242 patients randomised, 202 completed all clinical assessments. The full article can be accessed via Pubmed and elsewhere. The main conclusion is “Homoeopathic immunotherapy is not effective in the treatment of patients with asthma.” The authors notice that the averages in both groups behave somewhat erratic, and they have no explanation for this. White 2003: individualised homeopathy compared to placebo for 96 children with asthma, who are followed for 12 months. The conclusion is that there is no evidence that this kind of homeopathy is better than placebo. In other words, out of nine investigations only one (Reilly 1986) obtains a barely significant result.

But the interpretation of Maxion-Bergemann et al. is totally different: “If only the placebo-controlled, randomized trials with the highest EBM evidence are considered, 12 of 16 trials show a positive result for the homeopathically treated group (significantly positive 8/16 and trend 4/16).” Even in the more restricted subset of nine discussed above they are overly optimistic. They mark Wiesenauer (1985), De Lange-de Klerk (1994), Jacobs (2001) as showing a ‘trend for homeopathy’ and Lewith (2002) is even marked ‘significant’. The meticulous and high quality research of De Lange (1993, 1994) is judged ‘trend for homeopathy’.

In case of De Lange it seems clear where this judgement comes from. De Lange had several outcomes (number of sick periods, total duration of sick periods, sum of all dayscores etc., and all these showed roughly the same small non-significant difference in favor of homeopathy. This is not really strange, because these outcomes all measure about the same phenomenon. It is not remarkable that there is a small difference between the averages of the two groups that can only be noticed if the children are followed for a full year. There is not even the beginning of a reason that this has anything to do with the treatment. For example the homeopathy group had ‘significantly’ less pets at home. This might serve as an explanation why they as a group were slightly less sick. One might also speculate that this was retroactively caused by the homeopathic treatment. This is not really more improbable than highly diluted stuff (more than 95% D6 and higher) having an effect.

By convention ‘statistically significant’ is the lower limit where weak conclusions such as ‘worth investigating further’ can be justified, and we repeat: only if it refers to a single outcome measure or endpoint chosen before any data collection has started. De Lange chose recurrent URTI because homeopathy was reputed to be most effective for this type of complaints, especially after investigations such as those of Reilly (1986). If following 170 children for a full year cannot show a clear advantage, then that is simply a negative result. In the case of Lewith the ‘significant for homeopathy’ is probably based on partial results such as that in week 3 ‘homeopathy’ fared better in the asthma VAS. One can just as well point to week 16 where the FEV1 of the placebo group seems much better than in the homeopathy group.

Maxion-Bergemann et al. seem to have been singularly inept in collecting papers on homeopathic trials, and for no apparent reason they decided to look also at a large number of case reports and investigations without control group or blinding, even after investigators as early as 1991 have remarked that henceforth only well designed large double blind RCTs were worth considering. If we restrict our attention to the properly blinded controlled investigations, we see the same thing as in other meta-analyses of homeopathy: there is lots of rubbish in favor of homeopathy, but the good trials say plainly and clearly: homeopathy is ineffective, precisely what can be predicted from the fact that there is nothing in it.

Homeopaths nowadays have a lot to say about RCTs and how they prove homeopathy. RCTs are subtle and complicated scientific tools. It is somewhat strange to see how homeopaths resolutely ignore two centuries of basic science but then argue their cause on the basis of complicated statistics.

Homeopathy is an assortment of wildly different practices and theories. We have seen ultra-isopathy, individualised homeopathy and the practice of giving one standardised remedy for one diagnosis without asking too many personal details from the patient. These standard remedies are often branded mixtures of highly diluted ‘classical’ homeopathy, quite contrary to the opinions of homeopathy’s inventor Hahnemann. There are many more variants of homeopathy and the homeopaths themselves cannot agree which are the correct ones.

Moreover, if a treatment or trial doesn’t work out, then a number of additional hypotheses about homeopathy can be invoked, which is what Maxion-Bergemann et al. do. Homeopathic remedies supposedly are counteracted by lots of regular medications and even by strong tasting or smelling food, such as coffee, parsley, garlic and peppermint. Hahnemann even disapproved of reading in bed and long afternoon naps and prolonged suckling of infants (Organon, section 260). Poor performance of homeopathy can be blamed on something called ‘initial aggravation’ or else on lack of experience of the poorly performing homeopath.

But that these factors are relevant at all is unknown, just like there is no proof at all for the similia principle, nor for the hundred thousands or even millions of ‘symptoms’ associated with highly diluted materials in the homeopathic Materia Medica. If homeopaths really want scientists to share homeopathic beliefs, they should not think up lame excuses for ‘failed’ tests, but for starters they might try to present proofs for all or at least some of their ‘symptoms’. They don’t try very hard and in so far it has been tried, it also has failed (20).

I would like to thank Willem Betz for helpful remarks.

I am a retired mathematician with no other interest than a desire to promote science.

References

1. Stefanie Maxion-Bergemann, Gudrun Bornhöft, Denise Bloch, Christina Vogt-Frank, Marco Righetti, André Thurneysen. (2011) Clinical Studies on the Effectiveness of Homeopathy for URTI/A (Upper Respiratory Tract Infections and Allergic Reactions) in: Homeopathy in Healthcare – Effectiveness, Appropriateness, Safety, Costs. G. Bornhöft and P.F. Mattheiesen (eds.), Berlin etc., Springer 2011, p. 18-157.

2. Riverón-Garrote, M., Fernandez-Argüelles, R.; Morán-Rodríquez, F.; Campistrou-Labaut, J.L. (1998) Ensayo clínico controlado aleatorízado del tratamiento homeopático del asma bronquial, Boletín Mexicano de Homepatía 1998; 31(2):54-61.

3. Friese, K.-H., Zabalotnyi, D.I. (2007) Homöopathie bei akuter Rhinosinusitis, Eine doppelblinde, placebokontrollierte Studie belegt die Wirksamkeit und Verträglichkeit eines homöopathischen Kombinationsarzneimittels, HNO 55(4):271-277.

4. Bahemann A. (2002) Kalium bromatum bei infektiöser Mononukleose. Zeitschrift für Klassische Homöopathie 46:232–233.

5. Ferley J.P., Zmirou D., D’Adhemar D., Balducci F. (1989). A controlled evaluation of a homoeopathic preparation in the treatment of influenza like syndromes. British Journal of Clinical Pharmacology 27:329-335.

6. Papp R., Schuback G., Beck E., Burkard G., Bengel J., Lehrl S., Belon P. (1998). Oscillococcinum in patients with influenza-like syndromes: a placebo-controlled double-blind evaluation. British Homeopathic Journal 87:69-76.

7. Reilly, D.T., Taylor, M.A., Beattie, N.G.M., Campbell, J.H., McSharry C., Aitchison T.C., Carter R., Stevenson R. (1994) Is evidence for homoeopathy reproducible?, Lancet 1994 344:1601-1606.

8. Reilly, D.T., Taylor, M.A., McSharry, C., Aitchison, T. (1986) Is Homoeopathy a Placebo Response?, Controlled Trial of Homoeopathic Potency – With Pollen in Hayfever as Model, Lancet II.2:881-886.

9. Wiesenauer, M., Gaus, W. (1985) Double-blind Trial Comparing the Effectiveness of Galphimia Potentisation D6 (Homoeopathic Preparation), Galphimia Dilution 10-6 and Placebo on Pollinosis, Arzneimittelforschung 35(11):1745-1747.

10. Wiesenauer M, Gaus W, Bohnacker U, Häussler S (1989) Wirksamkeitsprüfung von homöopathischen Kombinationspräparaten bei Sinusitis: Ergebnisse einer randomisierten Doppelblindstudie unter Praxisbedingungen. Arzneimittelforschung 39:620-625.

11. de Lange-de Klerk E.S.M., Blommers J., Kuik D.J., Bezemer P.D., Feenstra L. (1994). Effects of homoeopathic medicines on daily burden of symptoms in children with recurrent upper respiratory tract infections. BMJ 309:1329-1332.

12. Aabel, S. (2000) 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. British Homeopathic Journal 89(4):169-173.

13. Jacobs, J., Springer, D.A., Crothers, D. (2001) Homeopathic treatment of acute otitis media in children, A preliminary randomized placebo-controlled trial. The Pediatric Infectious Disease Journal 20(2):177-183.

14. Friese K.H., Feuchter U., Lüdtke R., Moeller H. (2001) Results of a randomised prospective double-blind trial on the homeopathic treatment of adenoid vegetations. European Journal of General Practice 7:48-54.

15. Lewith, G.T., Watkins, A.D.; Hyland, M.E.; Shaw, S.; Broomfield, J.A.; Dolan, G.; Holgate, S.T. (2002) Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised controlled clinical trial, BMJ 324:520-523.

16. White, A., Slade, P.; Hunt, C.; Hart, A.; Ernst, E. (2003) Individualised homeopathy as an adjunct in the treatment of childhood asthma, A randomised placebo controlled trial. Thorax 58(4):317-321

17. Lange-de Klerk, E.S.M. de, Effects of homoeopathic medicines on children with recurrent upper respiratory tract infections. Vrije Universiteit Amsterdam, 1993 (Dissertation).

18. Aabel, S., Laerum, E.; Dölvik, S.; Djupesland, P. (2000) Is homeopathic ‘immunotherapy’ effective?, A double-blind, placebo-controlled trial with the isopathic remedy Betula 30c for patients with birch pollen allergy. British Homeopathic Journal 89(4):161-168.

19. Friese K.-H., Feuchter U., Möller H. (1997). Die homöopathische Behandling von adenoiden Vegetationen. HNO; 45:618–624.

20. Brien S., Lewith G., Bryant, T. (2003) Ultramolecular homeopathy has no observable clinical effects. A randomized, double-blind, placebo-controlled proving trial of Belladonna 30C.

A recent meta-analysis evaluated the efficacy of acupuncture for treatment of irritable bowel syndrome (IBS) and arrived at bizarrely positive conclusions.

The authors state that they searched 4 electronic databases for double-blind, placebo-controlled trials investigating the efficacy of acupuncture in the management of IBS. Studies were screened for inclusion based on randomization, controls, and measurable outcomes reported.

Six RCTs were included in the meta-analysis, and 5 articles were of high quality.  The pooled relative risk for clinical improvement with acupuncture was 1.75 (95%CI: 1.24-2.46, P = 0.001). Using two different statistical approaches, the authors confirmed the efficacy of acupuncture for treating IBS and concluded that acupuncture exhibits clinically and statistically significant control of IBS symptoms.

As IBS is a common and often difficult to treat condition, this would be great news! But is it true? We do not need to look far to find the embarrassing mistakes and – dare I say it? – lies on which this result was constructed.

The largest RCT included in this meta-analysis was neither placebo-controlled nor double blind; it was a pragmatic trial with the infamous ‘A+B versus B’ design. Here is the key part of its methods section: 116 patients were offered 10 weekly individualised acupuncture sessions plus usual care, 117 patients continued with usual care alone. Intriguingly, this was the ONLY one of the 6 RCTs with a significantly positive result!

The second largest study (as well as all the other trials) showed that acupuncture was no better than sham treatments. Here is the key quote from this trial: there was no statistically significant difference between acupuncture and sham acupuncture.

So, let me re-write the conclusions of this meta-analysis without spin, lies or hype: These results of this meta-analysis seem to indicate that:

  1. currently there are several RCTs testing whether acupuncture is an effective therapy for IBS,
  2. all the RCTs that adequately control for placebo-effects show no effectiveness of acupuncture,
  3. the only RCT that yields a positive result does not make any attempt to control for placebo-effects,
  4. this suggests that acupuncture is a placebo,
  5. it also demonstrates how misleading studies with the infamous ‘A+B versus B’ design can be,
  6. finally, this meta-analysis seems to be a prime example of scientific misconduct with the aim of creating a positive result out of data which are, in fact, negative.

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