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Homotoxicology is sometimes praised as the ‘best kept detox secret‘, often equated with homeopathy, and even more often not understood at all.

But what is it really?

Homotoxicology is the science of toxins and their removal from the human body. It offers a theory of disease which describes the severity and duration of an illness or disorder based on toxin-loading relative to our body’s ability to detoxify. In other words, it tells you how sick you’ll get when what stays inside progressively overwhelms our ability to get the garbage out. It explains what you can expect to see as you start removing toxins.

And yes, there is a hierarchy of toxic substances. Homotoxicology says you should remove the gentler ones first. As the body strengthens, it will be able to handle the really bad stuff (i.e., heavy metals). This explains why some people do really well on the same detox treatments that take others out at the knees.

Yes, I know!

This sounds very much like promotional BS!!!

So, what is it really, and what evidence is there to support it?

Homotoxicolgy is a therapy developed by the German physician and homeopath Hans Reckeweg. It is strongly influenced by (but not identical with) homoeopathy. Proponents of homotoxicology understand it as a modern extension of homoeopathy developed partly in response to the effects of the Industrial Revolution, which imposed chemical pollutants on the human body.

„Ich möchte einmal die Homöopathie mit der Schulmedizin verschmelzen H.-H. Reckeweg Küstermann/Auriculotherapie_2008.

According to the assumptions of homotoxicology, any human disease is the result of toxins, which originate either from within the body or from its environment. Allegedly, each disease process runs through six specific phases and is the expression of the body’s attempt to cope with these toxins. Diseases are thus viewed  as biologically useful defence mechanisms. Health, on the other hand, is the expression of the absence of toxins in our body. It seems obvious that these assumptions are not based on science and bear no relationship to accepted principles of toxicology or therapeutics. In other words, homotoxicology is not plausible.
The therapeutic strategies of homotoxicology are essentially threefold:

• prevention of further homotoxicological challenges,
• elimination of homotoxins,
• treatment of existing ‘homotoxicoses’.

Frequently used homotoxicological remedies are fixed combinations of homeopathically prepared remedies such as nosodes, suis-organ preparations and conventional drugs. All these remedies are diluted and potentised according to the rules of homoeopathy. Proponents of homotoxicology claim that they activate what Reckeweg called the ‘greater defence system’— a concerted neurological, endocrine, immunological, metabolic and connective tissue response that can give rise to symptoms and thus excretes homotoxins. Homotoxicological remedies are produced by Heel, Germany and are sold in over 60 countries. The crucial difference between homotoxicology and homoeopathy is that the latter follows the ‘like cures like’ principle, while the former does not. As this is the defining principle of homeopathy, it would be clearly wrong to assume that homotoxicology is a form of homeopathy.

Several clinical trials of homotoxicology are available. They are usually sponsored or conducted by the manufacturer. Independent research is very rare. In most major reviews, these studies are reviewed together with trials of homeopathic remedies which is obviously not correct. Our systematic review purely of studies of homotoxicology included 7 studies, all of which had major flaws. We concluded that the placebo-controlled, randomised clinical trials of homotoxicology fail to demonstrate the efficacy of this therapeutic approach.

So, I ask again: what is homotoxicology?

It is little more than homeopathic nonsense + detox nonsense + some more nonsense.

My advice is to say well clear of it.

Dr Alok Pareek has been elected as the World President of the International Homeopathic Medical league (LMHI – Liga Medicorum Homoeopathica Internationalis), the largest, oldest and only association of Medical Homeopaths in the World. He is the first Asian in 4 decades to bring this honour to India. Dr Alok Pareek was elected at the 71st World Congress of the LMHI held in Buenos Aires, Argentina on 23rd August 2016. He was elected unopposed by over 70 member countries. He has been elected for a three year tenure from 2016 to 2019

Dr. Alok Pareek runs a homeopathic hospital together with his father R.S. Pareek in Agra, India with fifty beds, treating around two hundred patients daily. His clinical practice spans thirty years. This extensive experience has given him a wealth of opportunity to carry out and refine homeopathic treatment in a wide range of acute and emergency situations…  Dr. Pareek demonstrates that homeopathy has much to offer in acute and emergency settings. He aims to increase the confidence of practitioners, to improve results and encourage them to offer safe and effective treatment in this important field, enabling homeopathy to take its place alongside conventional approaches within mainstream medicine. “As an Emergency Medicine physician who deals with life threatening diseases on a daily basis, I found Dr. Pareek’s homeopathic approach to be full of well-rounded clinical criteria and plenty of wise advice to the homeopathic doctor. I truly hope to be in medicine long enough to see us practice ‘hand in hand’ and enjoy the great benefits of this marvelous ‘scientific marriage’ in my emergency medicine patients.” Gladys H. Lopez M.D., M.P.H. USA Board Certified in Emergency ­Medicine

These two quotes might give you a fairly good impression of Dr Alok Pareek.

But why do I dedicate an entire post to him?

The reason is that I was alerted to one of his books entitled ‘Cancer is curable with homeopathy’. Even though it is obviously a translation from English, I could not find the original; so you have to bear with me as I translate for you the German abstract copied below:

75 years of homeopathic experience by father and son from India are expressed in this book about the homeopathic cure of cancers. Based on excellently documented cases, it demonstrates how homeopathy is clearly superior to chemotherapy and radiotherapy. We experience how a cure is possible even for such a serious disease as cancer in advanced stages. Dr D. Spinedi (Switzeralnd) estimates the immense experience of the doctors Pareek as ‘essential basic knowledge that should be accessible to all homeopaths’. It is a book that gives courage to both patients and therapists.

Zusammen 75 Jahre homöopathischer Erfahrung von Vater und Sohn Pareek aus Indien mit Tausenden von Patienten finden in diesem Buch ihren Niederschlag in der homöopathischen Heilung von Krebserkrankungen. Anhand exzellent dokumentierter Fallbeispiele wird gezeigt, wie in klassischer Arbeitsweise die Homöopathie der Chemotherapie und der Strahlentherapie deutlich überlegen ist. Wir erleben mit, wie Heilung bei einer so schweren Krankheit wie Krebs auch noch in fortgeschrittenen Stadien durch Homöopathie möglich ist. Dr. D. Spinedi (Schweiz) wertet die immense Erfahrung der Dres. Pareek als “unverzichtbares Grundlagenwissen, das allen Homöopathen zugänglich sein sollte.” Ein Buch, das Patienten wie Therapeuten Mut macht!

It is by Jove not often that I am speechless, but today, that’s exactly what I am.

Evening primrose oil (EPO) is amongst the best-selling herbal remedies of all times. It is marketed in most countries as a dietary supplement. It is being promoted for eczema, rheumatoid arthritis, premenstrual syndrome, breast pain, menopause symptoms, and many other conditions. EPO seems to be a prime example for the fact that, in alternative medicine, the commercial success of a remedy is not necessarily determined by the strength of the evidence but by the intensity and cleverness of the marketing activities.

Evening primrose oil has been extensively tested in clinical trials for a wide range of conditions, including eczema (atopic dermatitis), postmenopausal symptoms, asthma, psoriasis, cellulite, hyperactivity, multiple sclerosis, schizophrenia, obesity, chronic fatigue syndrome, rheumatoid arthritis, and mastalgia. As I have reported previously, these data were burdened with mischief and scientific misconduct, and it is therefore not easy to differentiate between science, pseudoscience and fraud. The results of the more reliable investigations fail to show that it is effective for any condition.  A Cochrane review of 2013, for instance, concluded that supplements of evening primrose oil lack effect on eczema; improvement was similar to respective placebos used in trials.

But now, a new study has emerged that casts doubt on this conclusion. The aim of this double-blinded, placebo-controlled RCT is to evaluate the efficacy and safety of EPO in Korean patients with atopic dermatitis (AD).

Fifty mild AD patients with an Eczema Area Severity Index (EASI) score of 10 or less were randomly divided into two groups. The first group received an oval unmarked capsule containing 450 mg of EPO (40 mg of GLA) per capsule, while placebo capsules identical in appearance and containing 450 mg of soybean oil were given to the other group. Treatment continued for a period of 4 months. EASI scores, transepidermal water loss (TEWL), and skin hydration were evaluated in all the AD patients at the baseline, and in months 1, 2, 3, and 4 of the study.

At the end of month 4, the patients of the EPO group showed a significant improvement in the EASI score, whereas the patients of the placebo group did not. There was a significant difference in the EASI score between the EPO and placebo groups. Although not statistically significant, the TEWL and skin hydration also slightly improved in the EPO patients group. Adverse effect were not found in neither the experimental group nor the control group during the study period.

The authors concluded by suggesting that EPO is a safe and effective medicine for Korean patients with mild AD.

I find this study odd for several reasons:

  • One cannot possibly draw conclusions based on such a small sample.
  • The authors state that a total of 69 mild AD patients were enrolled and randomized into either the control group (14 males and 17 females) or the EPO group (20 males and 18 females). Six patients in the control group and 13 patients in the EPO group dropped out due to follow up loss. No patient dropped out because the disease worsened. Should this not have necessitated an intention-to-treat analysis? And, if 19 patients were lost to follow-up, how do the authors know that their disease did not worsen?
  • The graph shows impressively the lack of a placebo-response. I don’t understand why there was none.
  • The authors state that there were no adverse effects at all. I find this implausible; we know that even taking placebos will prompt patients to report adverse effects.

So, what to make out of this?

I am not at all sure, but one thing is certain: this study does not alter my verdict on EPO; as far as I am concerned, the effectiveness of EPO for AD is unproven.

In Germany, homeopathic firms are – as I recently mentioned – starting to panic. Sales figures have, for the first time since decades, declined. This is undoubtedly the work of all those evil sceptics (including, or perhaps foremost?, my evil self!) who are well-organised and even better-funded.

At least, this is what their new PR-man seems to think.

Christian J Becker has been exceedingly active on Twitter provoking everyone who said a word against homeopathy. He is without any doubt the fiercest PR-defender of German homeopathy since Claus Fritzsche. But just like with the late Fritzsche, all those years ago, I am beginning to worry. Is Mr Becker feeling alright? I see increasingly worrying signs and parallels. Might he be drifting into some sort of a psychopathologic episode?

  • Despite being a novice to this field, he seems to think that a substance which had no therapeutic effect to start with – think of Berlin wall – becomes highly active, if you dilute it at a rate of 1:1000000000000000000000000000000000000000000000000000000000000, for instance. Could this be the first sign of a deeper problem developing?
  • He hints at his suspicion that poor old Fritzsche did, in fact, not commit suicide as generally believed and well-documented. No, he seems to think that he was murdered! By whom? Not the evil sceptics, surely?!
  • He seems persuaded that I am some sort of master mind of the growing German opposition to homeopathy. As I obviously know better, I find his persuasion worrying.
  • A further concern, in my view, is Becker‘s assumption about the huge amounts of money that are behind the criticism of homeopathy. As the big money is demonstrably on the other side, i. e. the homeopathic industry, this loss of reality might be an ominous sign.
  • Similarly, Becker believes that the German government has decided to go against homeopathy. As the opposite is (and always has been) the case, one might ask: do his opinions indicate some type of a paranoid trait?
  • Becker thinks, as already mentioned, that those who speak out against homeopathy are all paid by some sinister source. We all receive big cheques and live a life of Reilly because of this lavish support? This theory supposes that we all act against better knowledge and, deep down, we all know that homeopathics diluted at a rate of 1:1000000000000000000000000000000000000000000000000000000000000 are effective. More loss of reality?, I ask myself.
  • Becker has a strategy that he proudly admits to: he provokes people on Twitter to a point where they lose their nerve and reply something offensive. Armed with this statement, he then recruits a lawyer* and sues them for libel. He tried his trick recently likening several homeopathy-critics to Roland Freisler, the infamous judge of the Nazi era. Such actionable behaviour could be seen as a sign of a man in serious trouble – has Becker lost so much contact with reality that he does not realise that, in court, his insults would harm him and not his opponent?
  • Or perhaps he misunderstood the prime dogma of homeopathy? ‘Like cures like’ does not mean one can cure criticism with aggression. I am sure that Hahnemann, who knew a fair bit about aggression, never said so.
  • One of the most concerning features of homeopathy’s new defender is that Becker thinks anyone might believe him when he implies that, as a professional PR-man, he does a time-consuming PR-job for free. Yes, he did indicate that he conducts PR for homeopathy for a hobby. Would you find such behaviour normal?

So, should we be worried about the state of mind of homeopathy’s staunch defender? It might be too early to issue a final judgement on this question. But I am the first to admit that the signs are somewhat ominous. The man might need our help! Therefore, let me emphatically and empathetically stress this:

Mr Becker, if you read this – and I suspect you will – please stay calm. I know several good physicians who might be able to help you. And I promise, they will not prescribe a single homeopathic remedy!

*if you are one, please note this article is pure satire!

Traditional Chinese Medicine (TCM) is the umbrella term for modalities historically used in ancient China. TCM includes many therapeutic and some diagnostic modalities. Even though, these modalities differ in many respects, they are claimed to have in common that they are based on assumptions most of which originate from Taoist philosophy:

  • The human body is a miniature version of the universe.
  • Harmony between the two opposing forces, yin and yang, means health.
  • Disease is caused by an imbalance between these forces.
  • Five elements—fire, earth, wood, metal, and water—symbolically represent all phenomena, including the stages of human life, and explain the functioning of the body and how it changes during disease.
  • The vital energy, qi or chi, flows through the body in meridians, is essential for maintaining health.

TCM is a construct of Mao Zedong who lumped all historical Chinese treatments together under this umbrella and created the ‘barefoot doctor’ to practice TCM nationwide – not because he believed in TCM, but because China was desperately short of real doctors and needed at least a semblance of healthcare.

Over the past few years, China has been aggressively promoting TCM for expanding its global influence and for a share of the estimated US$50-billion global market (of products of dubious quality). A recent article in ‘Nature’ explains that the WHO’s governing body, the World Health Assembly, is set to adopt the 11th version of the organization’s global compendium — known as the International Statistical Classification of Diseases and Related Health Problems (ICD). For the first time, the ICD will include information about TCM. Chapter 26 of the ICD will feature a classification system on TCM, largely based not on science or facts, but on obsolete nonsense.

The WHO’s support applies to all traditional medicines, but its relationship with Chinese medicine, and with China, has grown especially close, in particular during the tenure of Margaret Chan, who ran the organization from 2006 to 2017 and made sure that several documents favourable to TCM were passed. The WHO’s declarations about traditional medicine are puzzling. Various of these WHO documents call for the integration of “traditional medicine, of proven quality, safety and efficacy”, while being silent as to which traditional medicines and diagnostics are proven. Wu Linlin, a WHO representative in the Beijing office, told Nature that the “WHO does not endorse particular traditional and complementary medicine procedures or remedies”.

But this is evidently not the case and in sharp contrast to the WHO’s actions in other areas. The agency provides, for instance, specific advice on what vaccines and drugs to use and what foods to avoid. With traditional medicines, however, such specifics are missing. The message therefore can only be that the WHO endorses TCM as safe and effective.

The evidence, however, tells us a different story. On this blog, we have repeatedly discussed that:

China’s drug regulator gets more than 230,000 reports of adverse effects from TCM each year, and Chinese herbal medicines carry multiple direct risks:

To this, we have to add the indirect risk of employing useless treatments for otherwise treatable conditions.

In view of all this, the WHO’s endorsement of TCM and its obsolete concepts is not just not understandable, it is a dangerous step backwards and, in my view, even intolerable.

Endocrine therapy (ET) is often used to reduce the risk of recurrence in hormone receptor-expressing disease. It is associated with worsening of climacteric symptoms can therefore have a negative impact on the quality of life (QoL) of those affected. Homeopathy is sometimes recommended for management of hot flushes (HF), and a new study aimed to test whether it is effective.

In this multi-centre, double-blind, placebo-controlled RCT, women were included suffering from histologically proven non-metastatic localized breast cancer, with Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) ≤ 1, treated for at least 1 month with adjuvant ET, and complaining about moderate to severe HF. Patients scheduled for chemotherapy, or radiotherapy, or those with associated pathology known to induce HF were excluded. After a 2- to 4-week placebo administration, patients were randomly assigned to receiving the homeopathic medicine complex Actheane® (arm A) or placebo (arm P). Randomization was stratified by adjuvant ET (taxoxifen/aromatase inhibitor) and recruiting site. HF scores (HFS) were calculated as the mean of HF frequencies before randomization, at 4, and at 8 weeks post-randomization (pre-, 4w,- and 8w-) weighted by a 4-level intensity scale. The primary endpoint was the variation between pre- and 4week-HFS. Secondary endpoints included HFS variation between pre- and 8week-HFS. Compliance and tolerance were assessed 8 weeks after randomization, and QoL and satisfaction were assessed at 4- and 8-week post-randomization.

In total, 138 patients were randomized (A, 65; P, 73). Median 4week-HFS absolute variation (A, - 2.9; P, - 2.5 points, p = 0.756) and relative decrease (A, - 17%; P, - 15%, p = 0.629) were not statistically different between the two arms. However, 4week-HFS decreased for 46 (75%) in A vs 48 (68%) patients in P arm. 4week-QoL was stable or improved for respectively 43 (72%) vs 51 (74%) patients (p = 0.470).

The authors concluded that the efficacy endpoint was not reached, and BRN-01 administration was not demonstrated as an efficient treatment to alleviate HF symptoms due to adjuvant ET in breast cancer patients. However, the study drug administration led to decreased HFS with a positive impact on QoL. Without any recommended treatment to treat or alleviate the HF-related disabling symptoms, Actheane® could be a promising option, providing an interesting support for better adherence to ET, thereby reducing the risk of recurrence with a good tolerance profile.

At the start of their abstract, the authors state that homeopathy might allow a better management of hot flushes (HF). Frankly, I fail to see the evidence for this statement. The only study I know of (by a known advocate of homeopathy) showed no effect of homeopathy.

Acthéane is a mixture marketed by Boiron of 5 ingredients:
– Actaea racemosa 4 CH : 0,5 mg
– Arnica montana 4 CH : 0,5 mg
– Glonoinum 4 CH : 0,5 mg
– Lachesis mutus 5 CH : 0,5 mg
– Sanguinaria canadensis 4 CH : 0,5 mg

I am not aware of evidence that this remedy might work.

If there is no plausible rationale for conducting a study, does that not mean it is ethically questionable to do it?

Apart from that, the study seems well-designed. It is not very well presented, but the paper is clear enough. Its results are as one would expect from a rigorous trial of homeopathy. The fact that the authors try to squeeze out some positive messages from this squarely negative study is, of course, pathetic. To mention in the abstract that 4week-HFS decreased for 46 (75%) in A vs 48 (68%) patients (not the primary outcome measure) in P arm is little more than an embarrassing tribute to the sponsor, in my view.

Boiron Canada state on their website that Acteane® is a homeopathic medicine used for the relief of perimenopause and menopause symptoms such as hot flashes, night sweats, sleep disorders, headache, irritability and mood swings.

The benefits of Acteane, a new solution for women:

• Hormone-free
• Soy-free
• Can be associated with other treatments used during perimenopause
• Non-drowsy
• Chewable tablets
• Does not require water

WILL THEY NOW ADD ‘EFFECT-FREE’ TO THEIR LIST?

The AMERICAN INSTITUTE OF HOMEOPATHY (AIH) is the oldest national medical association in the United States. The AIH’s mission is “to promote the science and art of homeopathic medicine, to safeguard the interests of the homeopathic medical profession, to improve the standards of homeopathic medical education, to educate the medical and scientific communities about the scientific basis for homeopathic medicine, and to increase public knowledge and acceptance of homeopathy as a medical specialty.”

The AIH is about to hold its annual conference. This year’s theme is “Tackling Patients with Severe Pathology”. The announcement reads as follows:

Homeopathy has been found to be effective in the great majority of patients suffering from infectious and autoimmune diseases. The limits of homeopathic treatment are encountered in the treatment of patients with Parkinson’s disease, ALS and late-stage cancers. After finding a way to treat patients with Parkinson’s disease with homeopathy, Dr. Saine began to apply this approach to cancer patients in stages III and IV. In this seminar, he will review case analysis, posology and case management for this cohort of patients.

We are fortunate to have the opportunity to learn from Dr. Saine in this seminar. He is recognized as one of the foremost homeopathic teachers and clinicians in the world, with special expertise in extremely difficult cases of severe and advanced pathology.

Who, for heaven sake, is this foremost homeopathic teachers and clinicians in the world, Dr Saine?, I asked myself after reading this (and even more so after listening to the rather spectacular video provided with the announcement). Here is what I found out about him:

Dr. Saine is a 1982 graduate of the National College of Naturopathic Medicine in Portland, Oregon. He is board-certified in homeopathy (1988) by the Homeopathic Academy of Naturopathic Physicians and has been teaching and lecturing on homeopathy since 1985. He is considered one of the world’s foremost experts on the subject of homeopathy.

And this is what non-doctor* Saine writes about medicine etc.:

The Organon of Medicine is a blueprint on how to practice medicine rationally and wisely through an integration of all the fundamental principles of medicine into a comprehensive whole. Unfortunately, to the detriment of the sick, very few homeopaths have delved, as Hahnemann did, into the practice of lifestyle medicine and the use of complementary care to homeopathy.

With rare exceptions, patients will present with a portion of their disease that ensues from an unhealthy environment or ways of living. The role of the physician is to determine in the equation of disease what is primarily due to an untuned vital force versus a causa occasionalis, as both will have to be addressed in due time.

After reading and listening to all this I am mildly shocked.

It does not seem to me that the AIH is fit for purpose. Neither am I convinced that non-doctor Saine should be let near any patient, let alone one with cancer or another severe pathology.

There should be a law protecting patients from this sort of thing!

[*in the context of healthcare, a doctor is for me someone who has studied medicine]

Samuel Hahnemann invented homeopathy about 200 years ago. His placebos were better than (or not as bad as) the ‘heroic’ medicine of his time which frequently was more dangerous than the disease it aimed to cure. Thus, homeopathy took Germany by storm. When, about 100 years ago, medicine finally became scientific and was able to offer more and more effective treatments, the popularity of homeopathy began to wane. Yet, before its natural demise, during the Third Reich, it received a significant boost from Nazi-greats such as Hess and Himmler. After this nightmare was over, German homeopathy went into another slow decline. But when the New Age movement and the current boom in alternative medicine reached Germany, homeopathy seemed to thrive once again.

In the 1990s evidence-based medicine (EBM) grew into one of the central concepts of medicine. In Germany, however, EBM had a relatively hard time to get established. This might be one of the reasons why homeopathy continued to prosper, despite the arrival of ever clearer evidence that highly diluted homeopathic remedies are pure placebos. While, in the UK, we had an increasingly lively debate about the uselessness of homeopathy, Germany remained the promised land of homeopathy. Sales figures of homeopathics continued to increase steadily and reached a level of about half a billion Euros per annum.

The golden age of German homeopathy had dawned:

  • The media, often sponsored by homeopathic interest groups, kept on promoting homeopathy largely unopposed.
  • The mighty Carstens Stiftung worked tirelessly to promote it.
  • Homeopathy became established in many medical schools.
  • Homeopathy was available and often advertised in almost all pharmacies.
  • The public was convinced that homeopathy worked.
  • The Heilpraktiker adopted homeopathy fully.
  • The medical and other conventional healthcare professions embraced it to a large degree.
  • The adult education institutes (Volkshochschulen) offered courses.
  • Politicians were squarely on the side of homeopathy,
  • Health insurances, paid for it.

Of course, there were also some (and always had been) opposing voiced and organisations, such as the GWUP (the German sceptic organisation), for example. But somehow, they remained relatively low-key. When, every now and then, courageous journalists dared to think of a critical take on homeopathy, they had to search far and wide to find a German-speaking expert who was willing or able to tell them the truth: that homeopathy is neither biologically plausible nor evidence-based and therefore an expensive, potentially harmful waste of money that makes a mockery of EBM. During this period, journalists (far too) often asked me for some critical comments. I hardly ever published my research in German, but they nevertheless would find me via my Medline-listed papers. I often felt like a very lone voice in a German desert.

For the German homeopathic industry, I evidently was more than just a lone voice. Unbeknown to me, they clubbed together and financed a PR-man/journalist (at the tune of Euro 30 000/year) to write as many defamatory articles about me as he could muster. First, I was bewildered by his activity, then I tried to communicate with him (only to get mis-quoted), and eventually I ignored his writings. Yet, a German investigative journalist found Fritzsche’s one-sided activities offensive and started investigating. His research and subsequent article disclosed the fact that he was being paid by the homeopathic industry. Once I learn about this scandal, I wrote to some of the financiers directly and asked for an explanation. As a result, they discontinued their sponsorship. Shortly afterwards, Fritzsche committed suicide.

At heart, I have always been an optimist and strongly believe that in medicine the truth, in this case the evidence, will always prevail, no matter what obstacles others might put in its way. Recent developments seem to suggest that I might be right.

In the last few years, several individuals in Germany have, from entirely different angles, taken a fresh look at the evidence on homeopathy and found it to be desperately wanting. Independent of each other, they published articles and books about their research and insights. Here are 5 examples:

Die Homöopathie-Lüge: So gefährlich ist die Lehre von den weißen KügelchenChristian Weymayr, Nicole Heißmann, 2012

In Sachen Homöopathie: Eine Beweisaufnahme, Norbert Aust, 2013

Homöopathie neu gedacht: Was Patienten wirklich hilft, Natalie Grams, 2015

Der Glaube an die Globuli: Die Verheißungen der HomöopathieNorbert Schmacke, Bernd Hontschik, 2015

Der wahrscheinlich teuerste Zucker der Welt: Was Sie über Homöopathie und Alternativmedizin wissen sollten, Oliver Grunau, 2017

Inevitably, these individuals came into contact with each other and subsequently founded several working-groups to discuss their concerns and coordinate their activities. Thus the INH and the Muensteraner Kreis were born. So, now we have at least three overlapping groups of enthusiastic, multidisciplinary experts who voluntarily work towards informing the German public that paying for homeopathy out of public funds is unethical, nonsensical and not in the interest of progress:

  • the GWUP,
  • the INH
  • and the Muensteraner Kreis.

No wonder then, that the German homeopathic industry and other interested parties got worried. When they realised that (presumably due to the work of these altruistic enthusiasts) the sales figures of homeopathics in Germany had, for the first time since many years, started declining, they panicked.

Their reaction was, as far as I can see, similar to their previous response to criticism: they started a media campaign in an attempt to sway public opinion. And just like before, they have taken to employing PR-people who currently spend their time defaming all individuals voicing criticism of homeopathy in Germany. Their prime targets are those experts who are most exposed to activities of responsibly informing the public about homeopathy via lectures, publications social media, etc. All of us currently receive floods of attack, insults and libellous defamations. As before (innovation does not seem to be a hallmark of homeopathy), these attacks relate to claims that:

  • we are incompetent,
  • we do not care about the welfare of patients,
  • we are habitual liars,
  • we are on the payroll of the pharmaceutical industry,
  • we aim at limiting patient choice,
  • we do what we do because we crave the limelight.

So, what is going to happen?

I cannot read tea leaves but am nevertheless sure of a few things:

  • The German homeopathy lobby will not easily give up; after all, they have half a billion Euros per year to lose.
  • They will not argue on the basis of science or evidence, because they know that neither are in their favour.
  • They will fight dirty and try to defame everyone who stands in their way.
  • They will use their political influence and their considerable financial power.

AND YET THEY WILL LOSE!

Not because we are so well organised or have great resources – in fact, as far as I can see, we have none – but because, in medicine, the evidence is invincible and will eventually prevail. Progress might be delayed, but it cannot be halted by those who cling to an obsolete dogma.

Osteopathy is a form of manual therapy invented by the American Andrew Taylor Still (1828-1917). Today, US osteopaths (doctors of osteopathy or DOs) practise no or little manual therapy; they are fully recognised as medical doctors who can specialise in any medical field after their training which is almost identical with that of MDs. Outside the US, osteopaths practice almost exclusively manual treatments and are considered alternative practitioners. This post deals with the latter category of osteopaths.

Still defined his original osteopathy as a science which consists of such exact, exhaustive, and verifiable knowledge of the structure and function of the human mechanism, anatomical, physiological and psychological, including the chemistry and physics of its known elements, as has made discoverable certain organic laws and remedial resources, within the body itself, by which nature under the scientific treatment peculiar to osteopathic practice, apart from all ordinary methods of extraneous, artificial, or medicinal stimulation, and in harmonious accord with its own mechanical principles, molecular activities, and metabolic processes, may recover from displacements, disorganizations, derangements, and consequent disease, and regained its normal equilibrium of form and function in health and strength.

Based on such vague and largely nonsensical statements, traditional osteopaths feel entitled to offer treatments for most human diseases, conditions and symptoms. The studies they produce to back up their claims tend to be as poor as Still’s original assumptions were fantastic.

Here is an apt example:

The aim of this new study was to study the effect of osteopathic manipulation on pain relief and quality of life improvement in hospitalized oncology geriatric patients.

The researchers conducted a non-randomized controlled clinical trial with 23 cancer patients. They were allocated to two groups: the study group (OMT [osteopathic manipulative therapy] group, N = 12) underwent OMT in addition to physiotherapy (PT), while the control group (PT group, N = 12) underwent only PT. Included were postsurgical cancer patients, male and female, age ⩾65 years, with an oncology prognosis of 6 to 24 months and chronic pain for at least 3 months with an intensity score higher than 3, measured with the Numeric Rating Scale. Exclusion criteria were patients receiving chemotherapy or radiotherapy treatment at the time of the study, with mental disorders (Mini-Mental State Examination [MMSE] = 10-20), with infection, anticoagulation therapy, cardiopulmonary disease, or clinical instability post-surgery. Oncology patients were admitted for rehabilitation after cancer surgery. The main cancers were colorectal cancer, osteosarcoma, spinal metastasis from breast and prostatic cancer, and kidney cancer.

The OMT, based on osteopathic principles of body unit, structure-function relationship, and homeostasis, was designed for each patient on the basis of the results of the osteopathic examination. Diagnosis and treatment were founded on 5 models: biomechanics, neurologic, metabolic, respiratory-circulatory, and behaviour. The OMT protocol was administered by an osteopath with clinical experience of 10 years in one-on-one individual sessions. The techniques used were: dorsal and lumbar soft tissue, rib raising, back and abdominal myofascial release, cervical spine soft tissue, sub-occipital decompression, and sacroiliac myofascial release. Back and abdominal myofascial release techniques are used to improve back movement and internal abdominal pressure. Sub-occipital decompression involves traction at the base of the skull, which is considered to release restrictions around the vagus nerve, theoretically improving nerve function. Sacroiliac myofascial release is used to improve sacroiliac joint movement and to reduce ligament tension. Strain-counter-strain and muscle energy technique are used to diminish the presence of trigger points and their pain intensity. OMT was repeated once every week during 4 weeks for each group, for a total of 4 treatments. Each treatment lasted 45 minutes.

At enrolment (T0), the patients were evaluated for pain intensity and quality of life by an external examiner. All patients were re-evaluated every week (T1, T2, T3, and T4) for pain intensity, and at the end of the study treatment (T4) for quality of life.

The OMT added to physiotherapy produced a significant reduction in pain both at T2 and T4. The difference in quality of life improvements between T0 and T4 was not statistically significant. Pain improved in the PT group at T4. Between-group analysis of pain and quality of life did not show any significant difference between the two treatments.

The authors concluded that our study showed a significant improvement in pain relief and a nonsignificant improvement in quality of life in hospitalized geriatric oncology patients during osteopathic manipulative treatment.

GOOD GRIEF!

Where to begin?

Even if there had been a difference in outcome between the two groups, such a finding would not have shown an effect of OMT per se. More likely, it would have been due to the extra attention and the expectation in the OMT group (or caused by the lack of randomisation). The A+B vs B design used for this study  does not control for non-specific effects. Therefore it is incapable of establishing a causal relationship between the therapy and the outcome.

As it turns out, there were no inter-group differences. How can this be? I have often stated that A+B is always more than B alone. And this is surely true!

So, how can I explain this?

As far as I can see, there are two possibilities:

  1. The study was underpowered, and thus an existing difference was not picked up.
  2. The OMT had a detrimental effect on the outcome measures thus neutralising the positive effects of the extra attention and expectation.

And which possibility does apply in this case?

Nobody can know from these data.

Integrative Cancer Therapies, the journal that published this paper, states that it focuses on a new and growing movement in cancer treatment. The journal emphasizes scientific understanding of alternative and traditional medicine therapies, and the responsible integration of both with conventional health care. Integrative care includes therapeutic interventions in diet, lifestyle, exercise, stress care, and nutritional supplements, as well as experimental vaccines, chrono-chemotherapy, and other advanced treatments. I feel that the editors should rather focus more on the quality of the science they publish.

My conclusion from all this is the one I draw so depressingly often: fatally flawed science is not just useless, it is unethical, gives clinical research a bad name, hinders progress, and can be harmful to patients.

I remember reading this paper entitled ‘Comparison of acupuncture and other drugs for chronic constipation: A network meta-analysis’ when it first came out. I considered discussing it on my blog, but then decided against it for a range of reasons which I shall explain below. The abstract of the original meta-analysis is copied below:

The objective of this study was to compare the efficacy and side effects of acupuncture, sham acupuncture and drugs in the treatment of chronic constipation. Randomized controlled trials (RCTs) assessing the effects of acupuncture and drugs for chronic constipation were comprehensively retrieved from electronic databases (such as PubMed, Cochrane Library, Embase, CNKI, Wanfang Database, VIP Database and CBM) up to December 2017. Additional references were obtained from review articles. With quality evaluations and data extraction, a network meta-analysis (NMA) was performed using a random-effects model under a frequentist framework. A total of 40 studies (n = 11032) were included: 39 were high-quality studies and 1 was a low-quality study. NMA showed that (1) acupuncture improved the symptoms of chronic constipation more effectively than drugs; (2) the ranking of treatments in terms of efficacy in diarrhoea-predominant irritable bowel syndrome was acupuncture, polyethylene glycol, lactulose, linaclotide, lubiprostone, bisacodyl, prucalopride, sham acupuncture, tegaserod, and placebo; (3) the ranking of side effects were as follows: lactulose, lubiprostone, bisacodyl, polyethylene glycol, prucalopride, linaclotide, placebo and tegaserod; and (4) the most commonly used acupuncture point for chronic constipation was ST25. Acupuncture is more effective than drugs in improving chronic constipation and has the least side effects. In the future, large-scale randomized controlled trials are needed to prove this. Sham acupuncture may have curative effects that are greater than the placebo effect. In the future, it is necessary to perform high-quality studies to support this finding. Polyethylene glycol also has acceptable curative effects with fewer side effects than other drugs.

END OF 1st QUOTE

This meta-analysis has now been retracted. Here is what the journal editors have to say about the retraction:

After publication of this article [1], concerns were raised about the scientific validity of the meta-analysis and whether it provided a rigorous and accurate assessment of published clinical studies on the efficacy of acupuncture or drug-based interventions for improving chronic constipation. The PLOS ONE Editors re-assessed the article in collaboration with a member of our Editorial Board and noted several concerns including the following:

  • Acupuncture and related terms are not mentioned in the literature search terms, there are no listed inclusion or exclusion criteria related to acupuncture, and the outcome measures were not clearly defined in terms of reproducible clinical measures.
  • The study included acupuncture and electroacupuncture studies, though this was not clearly discussed or reported in the Title, Methods, or Results.
  • In the “Routine paired meta-analysis” section, both acupuncture and sham acupuncture groups were reported as showing improvement in symptoms compared with placebo. This finding and its implications for the conclusions of the article were not discussed clearly.
  • Several included studies did not meet the reported inclusion criteria requiring that studies use adult participants and assess treatments of >2 weeks in duration.
  • Data extraction errors were identified by comparing the dataset used in the meta-analysis (S1 Table) with details reported in the original research articles. Errors included aspects of the study design such as the experimental groups included in the study, the number of study arms in the trial, number of participants, and treatment duration. There are also several errors in the Reference list.
  • With regard to side effects, 22 out of 40 studies were noted as having reported side effects. It was not made clear whether side effects were assessed as outcome measures for the other 18 studies, i.e. did the authors collect data clarifying that there were no side effects or was this outcome measure not assessed or reported in the original article. Without this clarification the conclusion comparing side effect frequencies is not well supported.
  • The network geometry presented in Fig 5 is not correct and misrepresents some of the study designs, for example showing two-arm studies as three-arm studies.
  • The overall results of the meta-analysis are strongly reliant on the evidence comparing acupuncture versus lactulose treatment. Several of the trials that assessed this comparison were poorly reported, and the meta-analysis dataset pertaining to these trials contained data extraction errors. Furthermore, potential bias in studies assessing lactulose efficacy in acupuncture trials versus lactulose efficacy in other trials was not sufficiently addressed.

While some of the above issues could be addressed with additional clarifications and corrections to the text, the concerns about study inclusion, the accuracy with which the primary studies’ research designs and data were represented in the meta-analysis, and the reporting quality of included studies directly impact the validity and accuracy of the dataset underlying the meta-analysis. As a consequence, we consider that the overall conclusions of the study are not reliable. In light of these issues, the PLOS ONE Editors retract the article. We apologize that these issues were not adequately addressed during pre-publication peer review.

LZ disagreed with the retraction. YM and XD did not respond.

END OF 2nd QUOTE

Let me start by explaining why I initially decided not to discuss this paper on my blog. Already the first sentence of the abstract put me off, and an entire chorus of alarm-bells started ringing once I read further.

  • A meta-analysis is not a ‘study’ in my book, and I am somewhat weary of researchers who employ odd or unprecise language.
  • We all know (and I have discussed it repeatedly) that studies of acupuncture frequently fail to report adverse effects (in doing this, their authors violate research ethics!). So, how can it be a credible aim of a meta-analysis to compare side-effects in the absence of adequate reporting?
  • The methodology of a network meta-analysis is complex and I know not a lot about it.
  • Several things seemed ‘too good to be true’, for instance, the funnel-plot and the overall finding that acupuncture is the best of all therapeutic options.
  • Looking at the references, I quickly confirmed my suspicion that most of the primary studies were in Chinese.

In retrospect, I am glad I did not tackle the task of criticising this paper; I would probably have made not nearly such a good job of it as PLOS ONE eventually did. But it was only after someone raised concerns that the paper was re-reviewed and all the defects outlined above came to light.

While some of my concerns listed above may have been trivial, my last point is the one that troubles me a lot. As it also related to dozens of Cochrane reviews which currently come out of China, it is worth our attention, I think. The problem, as I see it, is as follows:

  • Chinese (acupuncture, TCM and perhaps also other) trials are almost invariably reporting positive findings, as we have discussed ad nauseam on this blog.
  • Data fabrication seems to be rife in China.
  • This means that there is good reason to be suspicious of such trials.
  • Many of the reviews that currently flood the literature are based predominantly on primary studies published in Chinese.
  • Unless one is able to read Chinese, there is no way of evaluating these papers.
  • Therefore reviewers of journal submissions tend to rely on what the Chinese review authors write about the primary studies.
  • As data fabrication seems to be rife in China, this trust might often not be justified.
  • At the same time, Chinese researchers are VERY keen to publish in top Western journals (this is considered a great boost to their career).
  • The consequence of all this is that reviews of this nature might be misleading, even if they are published in top journals.

I have been struggling with this problem for many years and have tried my best to alert people to it. However, it does not seem that my efforts had even the slightest success. The stream of such reviews has only increased and is now a true worry (at least for me). My suspicion – and I stress that it is merely that – is that, if one would rigorously re-evaluate these reviews, their majority would need to be retracted just as the above paper. That would mean that hundreds of papers would disappear because they are misleading, a thought that should give everyone interested in reliable evidence sleepless nights!

So, what can be done?

Personally, I now distrust all of these papers, but I admit, that is not a good, constructive solution. It would be better if Journal editors (including, of course, those at the Cochrane Collaboration) would allocate such submissions to reviewers who:

  • are demonstrably able to conduct a CRITICAL analysis of the paper in question,
  • can read Chinese,
  • have no conflicts of interest.

In the case of an acupuncture review, this would narrow it down to perhaps just a handful of experts worldwide. This probably means that my suggestion is simply not feasible.

But what other choice do we have?

One could oblige the authors of all submissions to include full and authorised English translations of non-English articles. I think this might work, but it is, of course, tedious and expensive. In view of the size of the problem (I estimate that there must be around 1 000 reviews out there to which the problem applies), I do not see a better solution.

(I would truly be thankful, if someone had a better one and would tell us)

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