MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

evidence

As I often said, I find it regrettable that sceptics often say THERE IS NOT A SINGLE STUDY THAT SHOWS HOMEOPATHY TO BE EFFECTIVE (or something to that extent). This is quite simply not true, and it gives homeopathy-fans the occasion to suggest sceptics wrong. The truth is that THE TOTALITY OF THE MOST RELIABLE EVIDENCE FAILS TO SUGGEST THAT HIGHLY DILUTED HOMEOPATHIC REMEDIES ARE EFFECTIVE BEYOND PLACEBO. As a message for consumers, this is a little more complex, but I believe that it’s worth being well-informed and truthful.

And that also means admitting that a few apparently rigorous trials of homeopathy exist and some of them show positive results. Today, I want to focus on this small set of studies.

How can a rigorous trial of a highly diluted homeopathic remedy yield a positive result? As far as I can see, there are several possibilities:

  1. Homeopathy does work after all, and we have not fully understood the laws of physics, chemistry etc. Homeopaths favour this option, of course, but I find it extremely unlikely, and most rational thinkers would discard this possibility outright. It is not that we don’t quite understand homeopathy’s mechanism; the fact is that we understand that there cannot be a mechanism that is in line with the laws of nature.
  2. The trial in question is the victim of some undetected error.
  3. The result has come about by chance. Of 100 trials, 5 would produce a positive result at the 5% probability level purely by chance.
  4. The researchers have cheated.

When we critically assess any given trial, we attempt, in a way, to determine which of the 4 solutions apply. But unfortunately we always have to contend with what the authors of the trial tell us. Publications never provide all the details we need for this purpose, and we are often left speculating which of the explanations might apply. Whatever it is, we assume the result is false-positive.

Naturally, this assumption is hard to accept for homeopaths; they merely conclude that we are biased against homeopathy and conclude that, however, rigorous a study of homeopathy is, sceptics will not accept its result, if it turns out to be positive.

But there might be a way to settle the argument and get some more objective verdict, I think. We only need to remind ourselves of a crucially important principle in all science: INDEPENDENT REPLICATIONTo be convincing, a scientific paper needs to provide evidence that the results are reproducible. In medicine, it unquestionably is wise to accept a new finding only after it has been confirmed by other, independent researchers. Only if we have at least one (better several) independent replications, can we be reasonably sure that the result in question is true and not false-positive due to bias, chance, error or fraud.

And this is, I believe, the extremely odd phenomenon about the ‘positive’ and apparently rigorous studies of homeopathic remedies. Let’s look at the recent meta-analysis of Mathie et al. The authors found several studies that were both positive and fairly rigorous. These trials differ in many respects (e. g. remedies used, conditions treated) but they have, as far as I can see, one important feature in common: THEY HAVE NOT BEEN INDEPENDENTLY REPLICATED.

If that is not astounding, I don’t know what is!

Think of it: faced with a finding that flies in the face of science and would, if true, revolutionise much of medicine, scientists should jump with excitement. Yet, in reality, nobody seems to take the trouble to check whether it is the truth or an error.

To explain this absurdity more fully, let’s take just one of these trials as an example, one related to a common and serious condition: COPD

The study is by Prof Frass and was published in 2005 – surely long enough ago for plenty of independent replications to emerge. Its results showed that potentized (C30) potassium dichromate decreases the amount of tracheal secretions was reduced, extubation could be performed significantly earlier, and the length of stay was significantly shorter. This is a scientific as well as clinical sensation, if there ever was one!

The RCT was published in one of the leading journals on this subject (Chest) which is read by most specialists in the field, and it was at the time widely reported. Even today, there is hardly an interview with Prof Frass in which he does not boast about this trial with truly sensational results (only last week, I saw one). If Frass is correct, his findings would revolutionise the lives of thousands of seriously suffering patients at the very brink of death. In other words, it is inconceivable that Frass’ result has not been replicated!

But it hasn’t; at least there is nothing in Medline.

Why not? A risk-free, cheap, universally available and easy to administer treatment for such a severe, life-threatening condition would normally be picked up instantly. There should not be one, but dozens of independent replications by now. There should be several RCTs testing Frass’ therapy and at least one systematic review of these studies telling us clearly what is what.

But instead there is a deafening silence.

Why?

For heaven sakes, why?

The only logical explanation is that many centres around the world did try Frass’ therapy. Most likely they found it does not work and soon dismissed it. Others might even have gone to the trouble of conducting a formal study of Frass’ ‘sensational’ therapy and found it to be ineffective. Subsequently they felt too silly to submit it for publication – who would not laugh at them, if they said they trailed a remedy that was diluted 1: 1000000000000000000000000000000000000000000000000000000000000 and found it to be worthless? Others might have written up their study and submitted it for publication, but got rejected by all reputable journals in the field because the editors felt that comparing one placebo to another placebo is not real science.

And this is roughly, how it went with the other ‘positive’ and seemingly rigorous studies of homeopathy as well, I suspect.

Regardless of whether I am correct or not, the fact is that there are no independent replications (if readers know any, please let me know).

Once a sufficiently long period of time has lapsed and no replications of a ‘sensational’ finding did not emerge, the finding becomes unbelievable or bogus – no rational thinker can possibly believe such a results (I for one have not yet met an intensive care specialist who believes Frass’ findings, for instance). Subsequently, it is quietly dropped into the waste-basket of science where it no longer obstructs progress.

The absence of independent replications is therefore a most useful mechanism by which science rids itself of falsehoods.

It seems that homeopathy is such a falsehood.

 

 

On this blog, we had many chiropractors commenting that their profession is changing fast and the old ‘philosophy’ is a thing of the past. But are these assertions really true? This survey might provide an answer. A questionnaire was sent to chiropractic students in all chiropractic programs in Australia and New Zealand. It explored student viewpoints about the identity, role/scope, setting, and future of chiropractic practice as it relates to chiropractic education and health promotion. Associations between the number of years in the program, highest degree preceding chiropractic education, institution, and opinion summary scores were evaluated by multivariate analysis of variance tests.

A total of 347 chiropractic students participated. For identity, most students (51.3%) hold strongly to the traditional chiropractic theory but also agree (94.5%) it is important that chiropractors are educated in evidence-based practice. The main predictor of student viewpoints was a student’s chiropractic institution. Chiropractic institution explained over 50% of the variance around student opinions about role/scope of practice and approximately 25% for identity and future practice.

The authors concluded that chiropractic students in Australia and New Zealand seem to hold both traditional and mainstream viewpoints toward chiropractic practice. However, students from different chiropractic institutions have divergent opinions about the identity, role, setting, and future of chiropractic practice, which is most strongly predicted by the institution. Chiropractic education may be a potential determinant of chiropractic professional identity, raising concerns about heterogeneity between chiropractic schools.

Traditional chiropractic theory is, of course, all the palmereque nonsense about ‘95% of all diseases are caused by subluxations of the spine’ etc. And evidence-based practice means knowing that subluxations are a figment of the chiropractic imagination.

Imagine a physician who believes in evidence and, at the same time, in the theory of the 4 humours determining our health.

Imagine a geologist thinking that the earth is flat and also spherical.

Imagine a biologist subscribing to both creationism and evolution.

Imagine a surgeon earning his livelihood with blood-letting and key-hole surgery.

Imagine a doctor believing in vital energy after having been taught physiology.

Imagine an airline pilot considering the use of flying carpets.

Imagine a chemist engaging in alchemy.

Imagine a Brexiteer who is convinced of doing the best for the UK.

Imagine a homeopath who thinks he practices evidence-based medicine.

Imagine a plumber with a divining rod.

Imagine an expert in infectious diseases believing is the miasma theory.

Imagine a psychic hoping to use her skills for winning a fortune on the stock market.

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Once you have imagined all of these situations, I fear, you might know (almost) all worth knowing about chiropractic.

Dr. Dietmar Payrhuber is not famous – no, by no means. I had never heard of him until a watched this TV discussion about homeopathy (it’s in German, and well-worth watching, if you understand the language). I found the discussion totally mesmerising: Payrhuber is allowed to come out with case after case alleging he cured cancer of various types with homeopathy. Prof Frass is also there to defend the indefensible, but hardly intervenes, other than repeatedly and pompously stating that he is a professor with 200 publications who runs a homeopathy clinic at the university hospital of Vienna and therefore he is a cut above.

There are also three very bright and eloquent sceptical disputants who do their best to oppose Payrhuber’s moronic monstrosities. One of them even alerts us (and the broadcaster!) to the fact that some cancer patients might watch this and conclude that homeopathy cues cancer. Yes, TV can be dangerous!

After watching Payrhuber, I felt the urge to learn more about this man. On TV, he mentioned repeatedly his publications, so I first of all conducted a Medline search; it turns out that Medline lists not a single article in his name. However, I did find his (self-published) book: ‘HOMOEOPATHIE UND KREBS’ (HOMEOPATHY AND CANCER). It greatly impressed me – but not in a positive sense.

The preface (in English) is by Jan Scholten (who IS quite famous in the realm of homeopathy); here is a short quote from it:

[Payrhuber’s book] … is an important book for several reasons. The first reason is that it shows that homeopathy is a real healing art. Often homeopathy is seen as good for superficial, light and self-healing diseases such as colds, eczema’s, bronchitis and the like. Together with this view goes the opinion that it is not a real medicine, because it cannot treat „real diseases“. But this shows the opposite: cancer can be healed, cured with homeopathy. It shows that homeopathy can have very profound effect and can really cure deeply. Of course cancer was cured already in the past with homeopathy by famous homeopaths such as Grimmer and Resch. But Dietmar shows that it can be done in a consistent way. Homeopathy cannot be set aside as superficial anymore…

But it gets worse! Payrhuber himself is equally clear that homeopathy can cure cancer; here is a quote that I translated from his German text into English:

The book shows options to treat cancer; this is not an exclusive option of homeopathy. However, it offers an alternative for therapy-resistant and slow-responding cases treated conventionally… The question whether homeopathy is an alternative or a complementary therapy is superfluous. As the cases presented here demonstrate, homeopathy is part of medicine, a method which is more scientific than conventional medicine, because it has clear principles and laws. In certain cases or in certain phases of cancer, homeopathy is quite simply indicated! Homeopathy is holistic and puts the whole patient rather than a local symptom in the centre.

We must not keep homeopathy from cancer patients, because it offers in many cases a cure which cannot be achieved by other means.

(For those who can read German, here is the original: Das Buch zeigt Möglichkeiten auf, Krebs zu behandeln, es stellt keinen Alleinanspruch der Homöopathie dar. Es bietet allerdings alternative Möglichkeiten für therapieresistente und therapieträge Behandlungsverläufe bei konventioneller Therapie an…. 

Es erübrigt sich die Frage, ob Homöopathie eine alternative oder komplementäre Medizin ist. Wie die vorliegenden Fälle zeigen, ist sie ein Teil der Medizin, eine Methode, die „eher wissenschaftlicher ist als die Schulmedizin, weil die Homöopathie deutliche Prinzipien und Gesetze hat“. Die Homöopathie ist in bestimmten Fällen oder in bestimmten Phasen der Behandlung schlicht und einfach indiziert! Sie ist ganzheitlich, setzt den Menschen ins Zentrum und nicht das Lokalsymptom…

Die Homöopathie darf dem Patienten nicht vorenthalten werden, da sie in vielen Fällen Heilungsmöglichkeiten bietet, die auf andere Weise nicht erreicht werden können…)

END OF QUOTE

As I said, Payrhuber is not famous – he is infamous!

This sad story left me with three questions:

  1. Can someone please stop Payrhuber before he does more damage to cancer patients?
  2. And can someone please tell the medical faculty of the university of Vienna (my former employer) that running a homeopathy clinic for cancer patients is not ethical?
  3. Can someone please teach journalists that, in healthcare, giving a voice to dangerous nonsense can do serious harm?

Homeopathy has always enjoyed a special status in Germany, its country of origin. Germans use homeopathy more often than the citizens of most other countries, they spend more money on it, and they even have elevated it to some kind of medical speciality. In 2003, the German medical profession re-considered the requirements for carrying the title of ‘Doctor of Homeopathy’. It was decided that only physicians who already were specialists in one medical field were allowed to be certified with this title after a post-graduate education and training programme of 6 months, or 100 hours of case studies under supervision plus 160 hours of course work. Many German physicians seem to find this rigorously regulated programme attractive, opted for it, and earn good money with it; the number of ‘doctors of homeopathy’ has risen from 2212 to 6712 between 1993 and 2009.

Personally, I find much of this surprising, even laughable, and have repeatedly stated that even the most rigorously regulated education in nonsense can only result in nonsense. 

Luckily, I am not alone. A multidisciplinary group of experts (Muensteraner Kreis) has just filed an official application with the current 121st General Assembly of the German medical profession to completely abolish the title ‘Doctor of Homeopathy’. Our application itself is a lengthy document outlining in some detail the nature of our arguments. Here, I will merely translate its conclusion:

Even though present in science-business, homeopathy is not scientifically founded. Its basis – potentisation and the simile principle – contradicts scientific facts; homeopathy therefore must be categorised as esoteric. The international scientific community does not interpret the clinical studies of homeopathy as a sufficient proof for its efficacy. Giving an esoteric approach to medicine the veneer of credibility by officially establishing the title ‘Doctor of Homeopathy’ contradicts the physicians’ claim of a scientifically-based medicine and weakens the status of the science-based medicine through blurring the boundaries between science and belief. Problems within science-based medicine must be solved internally and cannot be unburdened onto an unscientific approach to medicine. We consider the abolishment of the ‘Doctor of Homeopathy’ to be urgently indicated.

END OF MY TRANSLATION

I think it would be more than a little over-optimistic to assume that the Assembly will swiftly adopt our suggestion. Perhaps this is also not the intention of our application. In Germany (I learnt my homeopathy in this country), homeopathy is still very much protected by powerful lobby groups and financial interests, as well as loaded with heavy emotional baggage. Yet I do hope that our application will start a discussion which, eventually, will bring a rational resolution to the embarrassing anachronism of the ‘Doctor of Homeopathy’ (Arzt fuer Homoeopathie).

The German medical profession might even have the opportunity to be internationally at the forefront of reason and progress.

Today, the BMJ published our ‘head to head‘ article on the above question. Dr Mike Cummings argues the pro-part, while Prof Asbjorn Horbjardsson and I argue against the notion.

The pro arguments essentially are the well-rehearsed points acupuncture-fans like to advance:

  • Some guidelines do recommend acupuncture.
  • Sham acupuncture is not a valid comparator.
  • The largest meta-analysis shows a small effect.
  • Acupuncture is not implausible.
  • It improves quality of life.

Cummings concludes as follows: In summary, the pragmatic view sees acupuncture as a relatively safe and moderately effective intervention for a wide range of common chronic pain conditions. It has a plausible set of neurophysiological mechanisms supported by basic science.12 For those patients who choose it and who respond well, it considerably improves health related quality of life, and it has much lower long term risk for them than non-steroidal anti-inflammatory drugs. It may be especially useful for chronic musculoskeletal pain and osteoarthritis in elderly patients, who are at particularly high risk from adverse drug reactions.

Our arguments are also not new; essentially, we stress that:

  • The effects of acupuncture are too small to be clinically relevant.
  • They are probably not even caused by acupuncture, but the result of residual bias.
  • Pragmatic trials are of little value in defining efficacy.
  • Acupuncture is not free of risks.
  • Regular acupuncture treatments are expensive.
  • There is no generally accepted, plausible mechanism.

We concluded that after decades of research and hundreds of acupuncture pain trials, including thousands of patients, we still have no clear mechanism of action, insufficient evidence for clinically worthwhile benefit, and possible harms. Therefore, doctors should not recommend acupuncture for pain.

Neither Asbjorn nor I have any conflicts of interests to declare.

Dr Cummings, by contrast, states that he is the salaried medical director of the British Medical Acupuncture Society, which is a membership organisation and charity established to stimulate and promote the use and scientific understanding of acupuncture as part of the practice of medicine for the public benefit. He is an associate editor for Acupuncture in Medicine, published by BMJ. He has a modest private income from lecturing outside the UK, royalties from textbooks, and a partnership teaching veterinary surgeons in Western veterinary acupuncture. He has participated in a NICE guideline development group as an expert adviser discussing acupuncture. He has used Western medical acupuncture in clinical practice following a chance observation as a medical officer in the Royal Air Force in 1989.

My question to you is this: WHICH OF THE TWO POSITION IS THE MORE REASONABLE ONE?

Please, do let us know by posting a comment here, or directly at the BMJ article (better), or both (best).

The ‘best homeopathy doctor in Delhi‘  is so ‘marvellous’ that he and his colleagues offer homeopathic treatment for HIV/AIDS:

START OF QUOTE

Antiretroviral Therapy (ART) is recommended for each and every case of AIDS where CD4 count goes less than 350.  Aura Homeopathy does not offer cure for AIDS. However, several research and clinical studies done by various Research centre including few from CCRH (Central Council for Research in Homeopathy, Govt. of India), have prove the supportive role of homeopathic medicines. Homeopathy medicine only relief symptoms but also reduced frequency of opportunistic infections, increase appetite, weight, and sense of well being, etc. At Aura Homeopathy, we apply classical homeopathy protocols on HIV/AIDS patients, as a part of our Clinical trial and Research projects. The results were very encouraging.

At Aura Homeopathy, we have seen an increase in the CD4 count in number of patients, after using Aura homeopathy medicines. Dr.Abhishek recommend’s Homeopathy as supporting line of therapy for all HIV patients.

END OF QUOTE

When I read this I wanted to be sick; but instead I did something a little more sensible: I conducted a quick Medline search for ‘homeopathy, AIDS’.

It returned 30 articles. Of these, there were just 4 that presented anything remotely resembling data. Here are their abstracts:

1st paper

Allopathic practitioners in India are outnumbered by practitioners of traditional Indian medicine and homeopathy (TIMH), which is used by up to two-thirds of its population to help meet primary health care needs, particularly in rural areas. India has an estimated 2.5 million HIV infected persons. However, little is known about TIMH use, safety or efficacy in HIV/AIDS management in India, which has one of the largest indigenous medical systems in the world. The purpose of this review was to assess the quality of peer-reviewed, published literature on TIMH for HIV/AIDS care and treatment.

Of 206 original articles reviewed, 21 laboratory studies, 17 clinical studies, and 6 previous reviews of the literature were identified that covered at least one system of TIMH, which includes Ayurveda, Unani medicine, Siddha medicine, homeopathy, yoga and naturopathy. Most studies examined either Ayurvedic or homeopathic treatments. Only 4 of these studies were randomized controlled trials, and only 10 were published in MEDLINE-indexed journals. Overall, the studies reported positive effects and even “cure” and reversal of HIV infection, but frequent methodological flaws call into question their internal and external validity. Common reasons for poor quality included small sample sizes, high drop-out rates, design flaws such as selection of inappropriate or weak outcome measures, flaws in statistical analysis, and reporting flaws such as lack of details on products and their standardization, poor or no description of randomization, and incomplete reporting of study results.

This review exposes a broad gap between the widespread use of TIMH therapies for HIV/AIDS, and the dearth of high-quality data supporting their effectiveness and safety. In light of the suboptimal effectiveness of vaccines, barrier methods and behavior change strategies for prevention of HIV infection and the cost and side effects of antiretroviral therapy (ART) for its treatment, it is both important and urgent to develop and implement a rigorous research agenda to investigate the potential risks and benefits of TIMH and to identify its role in the management of HIV/AIDS and associated illnesses in India.

2nd paper (I am a co-author of this one)

The use of complementary and alternative medicine (CAM) is widespread. Yet, little is known about the evidence supporting its use in HIV/AIDS. We conducted a systematic review of randomized clinical trials assessing the effectiveness of complementary therapies for HIV and HIV-related symptoms. Comprehensive literature searches were performed of seven electronic databases. Data were abstracted independently by two reviewers. Thirty trials met our predefined inclusion/exclusion criteria: 18 trials were of stress management; five of Natural Health Products; four of massage/therapeutic touch; one of acupuncture; two of homeopathy. The trials were published between 1989 and 2003. Most trials were small and of limited methodological rigour. The results suggest that stress management may prove to be an effective way to increase the quality of life. For all other treatments, data are insufficient for demonstrating effectiveness. Despite the widespread use of CAM by people living with HIV/AIDS, the effectiveness of these therapies has not been established. Vis à vis CAM’s popularity, the paucity of clinical trials and their low methodological quality are concerning.

3rd paper (author is our old friend Dana Ullman!)

Homeopathic medicine developed significant popularity in the nineteenth century in the United States and Europe as a result of its successes treating the infectious disease epidemics during that era. Homeopathic medicine is a medical system that is specifically oriented to using nanopharmacologic and ultramolecular doses of medicines to strengthen a person’s immune and defense system rather than directly attacking the microbial agents.

To review the literature referenced in MEDLINE and in nonindexed homeopathic journals for placebo-controlled clinical trials using homeopathic medicines to treat people with AIDS or who are human immunodeficiency virus (HIV)-positive and to consider a different theoretical and methodological approach to treating people with the viral infection.

A total of five controlled clinical trials were identified. A double-blinded, placebo-controlled study was conducted on 50 asymptomatic HIV-positive subjects (stage II) and 50 subjects with persistent generalized lymphadenopathy (stage III) in whom individualized single-remedy homeopathic treatment was provided. A separate body of preliminary research was conducted using homeopathic doses of growth factors. Two randomized double-blinded, placebo-controlled studies were conducted with a total of 77 people with AIDS who used only natural therapies over a 8-16-week period. Two other studies were conducted over a 2.5-year period with 27 subjects in an open-label format.

The first study was conducted by the Regional Research Institute for Homeopathy in Mumbai, India, under the Central Council for Research in Homeopathy, with the approval of the Ministry of Health and Family Welfare, Government of India. The second body of studies was conducted in clinic settings in California, Oregon, Arizona, Hawaii, New York, and Washington.

The first study found no statistically significant improvement in CD4 T-lymphocytes, but did find statistically significant pretest and post-test results in subjects with stage III AIDS, in CD4 (p = 0.008) and in CD8 (p = 0.04) counts. The second group of studies found specific physical, immunologic, neurologic, metabolic, and quality-of-life benefits, including improvements in lymphocyte counts and functions and reductions in HIV viral loads.

As a result of the growing number of people with drug-resistant HIV infection taking structured treatment interruptions, homeopathic medicine may play a useful role as an adjunctive and/or alternative therapy.

4th paper

In 1996, [name removed] was convicted on charges of conspiracy and introducing an unapproved drug into interstate commerce and the 2nd U.S. Circuit Court of Appeals upheld the conviction. [Name removed]’s company, Writers and Researchers Inc. sold a drug called 714X to individuals and physicians, promoting it as a nontoxic therapy for AIDS, cancer, and other chronic diseases. The Food and Drug Administration (FDA) warned [name removed] that his marketing was illegal because the product had not been proven safe and effective for use in treating disease. [Name removed] argued that the product was a homeopathic drug, revealed by FDA tests to contain 94 percent water, and a mixture of nitrate, ammonium, camphor, chloride, ethanol, and sodium. The courts found that 714X was subject to FDA scrutiny because it was touted as a cure for cancer and AIDS.

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So, what does this collective evidence tell us?

I think it makes it abundantly clear that there is no good reason to suggest that HIV/AIDS patients can be helped in any way by homeopathy. On the contrary, homeopathy might distract them from essential conventional care and it would needlessly harm their bank balance. It follows that claims to the contrary are bogus, unethical, reckless, and possibly even criminal.

Yesterday, I saw a Tweet stating:

Homeopath in Cornwall specialising in Women’s Health #fertility #naturalconception #pcos #pms

It was followed by a list of specific indications:

  • Pregnancy
  • Infertility
  • PCOS
  • PMS
  • Fibroids
  • Depression
  • Anxiety and much more…

I responded to this Tweet by tweeting:

Homeopath in Cornwall specialising in misleading women

Minutes later I received a response from a homeopathy-fan:

That could be called libel Edzard. I would be careful.

So, should I be careful, and if so why?

Reading the thinly veiled threat, I wasn’t exactly shaking in my boots with fear (I was deeply involved in helping Simon Singh in his defence against the BCA’s libel action), but I nevertheless wanted to be sure of my position and conducted some ‘rough and ready’ searches for recent evidence to suggesting that homeopathy is effective for any of the conditions mentioned above. Here is what I found:

  • Pregnancy. Yes, there is an RCT! It concluded that “homeopathy does not appear to prevent excessive body mass gain in pregnant women…” And another one concluding that “neither Pentazocine, or Chamomilla recutita offer substantial analgesia during labor.”
  • Infertility. No RCT or other sound evidence.
  • PCOS. Nothing
  • PMS. No clinical trials.
  • Fibroids. No clinical trials
  • Depression. Even leading homeopaths seem to agree that there is no good evidence.
  • Anxiety. Again, I could not find any sound evidence.

Don’t get me wrong, these statements are not based on full systematic reviews; that would take a while and hardly seems worth it. (If you want a good systematic review, I recommend this one; it concluded: “Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.“) But my quick glance at the evidence is enough, I think, to justify my statement that the above claims by a homeopath are misleading. In fact, I believe that I could have used much stronger terminology without the slightest risk of being sued.

PERHAPS NEXT TIME!

Lock 10 bright people into a room and tell them they will not be let out until they come up with the silliest idea in healthcare. It is not unlikely, I think, that they might come up with the concept of visceral osteopathy.

In case you wonder what visceral osteopathy (or visceral manipulation) is, one ‘expert’ explains it neatly: Visceral Osteopathy is an expansion of the general principles of osteopathy which includes a special understanding of the organs, blood vessels and nerves of the body (the viscera). Visceral Osteopathy relieves imbalances and restrictions in the interconnections between the motions of all the organs and structures of the body. Jean-Piere Barral RPT, DO built on the principles of Andrew Taylor Still DO and William Garner Sutherland DO, to create this method of detailed assessment and highly specific manipulation. Those who wish to practice Visceral Osteopathy train intensively through a series of post-graduate studies.  The ability to address the specific visceral causes of somatic dysfunction allows the practitioner to address such conditions as gastroesophageal reflux disease (GERD), irritable bowel (IBS), and even infertility caused by mechanical restriction.

But, as I have pointed out many times before, the fact that a treatment is based on erroneous assumptions does not necessarily mean that it does not work. What we need to decide is evidence. And here we are lucky; a recent paper provides just that.

The purpose of this systematic review was to identify and critically appraise the scientific literature concerning the reliability of diagnosis and the clinical efficacy of techniques used in visceral osteopathy.

Only inter-rater reliability studies including at least two raters or the intra-rater reliability studies including at least two assessments by the same rater were included. For efficacy studies, only randomized-controlled-trials (RCT) or crossover studies on unhealthy subjects (any condition, duration and outcome) were included. Risk of bias was determined using a modified version of the quality appraisal tool for studies of diagnostic reliability (QAREL) in reliability studies. For the efficacy studies, the Cochrane risk of bias tool was used to assess their methodological design. Two authors performed data extraction and analysis.

Extensive searches located 8 reliability studies and 6 efficacy trials that could be included in this review. The analysis of reliability studies showed that the diagnostic techniques used in visceral osteopathy are unreliable. Regarding efficacy studies, the least biased study showed no significant difference for the main outcome. The main risks of bias found in the included studies were due to the absence of blinding of the examiners, an unsuitable statistical method or an absence of primary study outcome.

The authors (who by the way declared no conflicts of interest) concluded that the results of the systematic review lead us to conclude that well-conducted and sound evidence on the reliability and the efficacy of techniques in visceral osteopathy is absent.

It is hard not to appreciate the scientific rigor of this review or to agree with the conclusions drawn by the French authors.

But what consequences should we draw from all this?

The authors of this paper state that more and better research is needed. Somehow, I doubt this. Visceral osteopathy is not plausible and the best evidence available to date does not show it works. In my view, this means that we should declare it an obsolete aberration of medical history.

To this, the proponents of visceral osteopathy will probably say that they have tons of experience and have witnessed wonderful cures etc. This I do not doubt; however, the things they saw were not due to the effects of visceral osteopathy, they were due to chance, placebo, regression towards the mean, the natural history of the diseases treated etc., etc. And sometimes, experience is nothing more that the ability to repeat a mistake over and over again.

  • If it looks like a placebo,
  • if it behaves like a placebo,
  • if it tests like a placebo,

IT MOST LIKELY IS A PLACEBO!!!

And what is wrong with a placebo, if it helps patients?

GIVE ME A BREAK!

WE HAVE ALREADY DISCUSSED THIS AD NAUSEAM. JUST READ SOME OF THE PREVIOUS POSTS ON THIS SUBJECT.

The ‘European Scientific Cooperative on Anthroposophic Medicinal Products‘ claim that there is a need for a regulatory framework for anthroposophic medicinal products (AMPs) in Europe. The existing regulatory requirements for conventional medicinal products are not appropriate for AMPs. Special registration procedures exist in some countries for homeopathic products and in the European Union for herbal products. However, these procedures only apply to a proportion of AMPs and the particular properties of AMPs are only in part accounted for. Suitable registration procedures especially for AMPs exist only in Germany and Switzerland.

The European Commission has acknowledged the existence of therapy systems, whose products have no adequate regulation, and it has proposed that the suitability of a separate legal framework for products of certain traditions such as Anthroposophic Medicine should be assessed. This statement should be seen in the context of developments in international trade, whereby representatives of therapy systems such as Traditional Chinese Medicine and Ayurveda wish to market their products in Europe.

It seems obvious that the safety of AMPs must be demonstrated, if regulators are to comply with the wishes of the AMP-industry. In other words, they require evidence. As luck has it, a recent paper provides just what they need.

The main objective of this analysis was to determine the frequency of adverse drug reactions (ADRs) to AMPs, relative to the number of AMP prescriptions.

The researchers conducted a prospective pharmacovigilance study with the patients of physicians in outpatient care in Germany. Diagnoses and prescriptions were extracted from the electronic medical records. A total of 38 German physicians trained in AM were asked to link all AMP prescriptions to the respective indications (diagnoses), and to document all serious ADRs as well as all ADRs of intensity III–IV. In addition, a subgroup of 7 ‘prescriber physicians’ agreed to also document all non-serious ADRs of any intensity. The study was conducted under routine care conditions with ADRs identified at ordinary follow-up consultations, without any additional scheduled follow-up visits. Physicians were remunerated with 15 Euro for each ADR report but not for their regular participation; patients received no remuneration. Patients were eligible for this analysis, if they had one or more AMP prescription in the years 2001–2010, followed by one or more physician visit.

A total of 44,662 patients with 311,731 AMP prescriptions, comprising 1722 different AMPs, were included. One hundred ADRs to AMPs occurred, caused by 83 different AMPs. ADR intensity was mild, moderate, and severe in 50% (n = 50/100), 43%, and 7% of cases, respectively; one ADR was serious. ADRs of any intensity occurred in 0.071% (n = 67/94,734) of AMP prescriptions and in 0.502% (n = 65/12,956) of patients prescribed AMPs. The highest ADR frequency was 0.290% of prescriptions for one specific AMP. Among all patients, serious ADRs occurred in 0.0003% (n = 1/311,731) of prescriptions and 0.0022% (n = 1/44,662) of patients.

The authors concluded that in this analysis from a large sample, ADRs to AMP therapy in outpatient care were rare; ADRs of high intensity as well as serious ADRs were very rare.

Most AMPs are highly diluted, and therefore, one would not expect frequent or serious ADRs. Yet, I still find these incidence figures mysterious. The reason is simple: even the ARDs of pure placebos (such as most AMPs) are known to be much more frequent. In other words, the nocebo-effects of drugs are much more common than these results seem to reflect.

This, I think, leads to one of two possible conclusions:

  1. AMPs are somehow miraculously exempt from the known facts of ADRs.
  2. There is something fundamentally wrong with this study.

I let you decide which is the case.

Oh, I almost forgot. At the end of this paper there is a not unimportant note:

The EvaMed study was funded by the Software AG-Stiftung. This analysis and publication was commissioned by the European Scientific Cooperative on Anthroposophic Medicinal Products (http://www.escamp.org) with financial support from foundations (Christophorus-Stiftung, Damus-Donata-Stiftung, Ekhagastiftelsen, Mahle-Stiftung, Software AG-Stiftung) and manufacturers (Wala, Weleda). The sponsors had no influence on the planning or conduct of the EvaMed study; the collection, preparation, analysis or interpretation of data for this paper; nor on the preparation, review or approval of the manuscript.

By guest blogger Norbert Aust

The Germany based Informationsnetzwerk Homöopathie (“Information network Homeopathy”, INH) is a group of critics of homeopathy, with doctors, pharmacists, and other scientists as members.

Among other activities we are running a few websites to provide sound information not so much to the academic but to the more layman public and patients on what homeopathy really is all about. This should counterbalance the very positive impressions created by promotion and marketing activities of providers of homeopathic services, that is, manufacturers, pharmacies and practitioners. We want to offer some reliable source of information which otherwise is seldom to be found in Germany. And we want to strip homeopathy of its reputation of being an effective therapy – and of course have it banned from pharmacies, universities and public health insurance. But this is another issue.

More than once we were asked if our pages were available in English – and now we are happy to announce that we started to transcribe some of our content. We – that is Udo Endruscheit, Sven Rudloff and myself – are working on that project one piece at a time. We started with a series of quite new articles originally published in German about the FAQs that can be found on the website of the Homeopathic Research Institute (HRI). We feel, this might be of interest for some of the English readers too. As these FAQs are available in more than just English or German, HRI seems to try to set some standard of arguments to rebuke their critics and provide arguments in favour of homeopathy – with some doubtful, some very doubtful and many outright wrong points. (BTW: If someone feels inclined to translate our English (or German) versions to yet another language, please proceed. Just give us credit and let us have some link to the site where you publish the translation.)

You may find our articles on two of our sites, namely the INH-website for just reading and my blog, where you can comment and discuss them. In the future, my blog will contain a more in depth analysis and the INH-website will provide a more easy to read version – but this is to be in the future.

Here are the links:

HRI FAQ #1: There is no evidence my blog; INH-Website.

HRI FAQ #2: No good positive trials my blog; INH-Website.

HRI FAQ #3: It’s impossible my blog; INH-Website.

In future, all my English articles will be found here but right now there are only the three listed above.

This of course is work in process and sooner – or more probable later – all our articles that we feel may find interest with a more international public will be translated into English. However, if any of you readers would want to have a special article of ours translated at once, please feel free to contact me by commenting on my blog or by email (dr.norbert.aust(at)t(minus)online(dot)de – just drop the dots before the (at) and replace what is in brackets with the proper signs).

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