MD, PhD, FMedSci, FSB, FRCP, FRCPEd

anthroposophical medicine

Yes, I have a new book out. It is on homeopathy, and the publisher thought it important enough to issue a press-release. I thought you might be interested in reading it – if nothing else, it could be a welcome distraction from the catastrophic new from America. Here it is:

As a junior doctor, Edzard Ernst worked in a homeopathic hospital, practised homeopathy, and was impressed with its results. As his career progressed and he became a research scientist, he investigated the reasons for this efficacy and began to publish the evidence. This new book Homeopathy – The Undiluted Facts presents what he has learned to a lay audience. As an authoritative guide, it is complemented by an 80-page lexicon on the subject, covering definitions, key ingredients and protagonists in its history from founder Samuel Hahnemann to supporter Prince Charles.

Edzard Ernst says: “Homeopathy has been with us for more than 200 years and today millions of patients and consumers swear use its remedies on a daily basis. While some people seem to believe in it with a quasi-religious fervor, others loath it with a similarly deeply-felt passion. In this climate, it is far from easy for consumers to find simple, factual and reliable material on this subject. My book aims to fill this gap.”

There are many misconceptions and myths surrounding homeopathy which Ernst is able to dispel. In the final chapter, he covers both spurious arguments made by proponents of homeopathy and spurious arguments made by its opponents.

For example, in countering the notion that patients who use homeopathy must be stupid, he points out that many patients consult homeopaths because they have needs which are not met by conventional medicine. During a consultation with a homeopath, patients often experience more sympathy, empathy, and compassion. To dismiss this as stupidity would mean missing a chance to learn a lesson.

Ernst encourages both skepticism and openness to new ideas. He says: “This book is based on the all-important principle that good medicine must demonstrably generate more good than harm. Where this is not the case, I will say so without attempting to hide the truth.”

Would you like to see a much broader range of approaches such as nutrition, mindfulness, complementary therapies and connecting people to green spaces become part of mainstream healthcare?

No?

Well, let me tell you about this exciting new venture anyway!

It is being promoted by Dr Dixon’s ‘College of Medicine’ and claims to be “the only accredited Integrative Medicine diploma currently available in the UK… [It] will provide you with an accredited qualification as an integrative medicine practitioner. The Diploma is certified by Crossfields Institute and supported by the College of Medicine and is the only one currently available in the UK. IM is a holistic, evidence-based approach which makes intelligent use of all available therapeutic choices to achieve optimal health and resilience for our patients. The model embraces conventional approaches as well as other modalities centred on lifestyle and mind-body techniques like mindfulness and nutrition.”

Dr Dixon? Yes, this Dr Michael Dixon.

College of Medicine? Yes, this College of Medicine.

Integrative medicine? Yes, this cunning plan to adopt quackery into real medicine which I have repeatedly written about, for instance here, here and here.

Crossfields Institute? Yes this Crossfields Institute which promotes the Steiner/’Waldorf quackery and has Simon Fielding as the chair of trustees.

Simon Fielding? Yes, the Simon Fielding who “devoted much of his professional life to securing the recognition of osteopathy as an independent primary contact healthcare profession and this culminated in the passing of the Osteopaths Act in 1993. He was appointed by ministers as the first chair of the General Osteopathic Council responsible for bringing the Osteopaths Act into force… He is currently vice-chair of the board of trustees of The College of Medicine… In addition Simon has… served as a long term trustee on the boards of The Prince of Wales’s Foundation for Integrated Health… and was the founder chair of the Council for Anthroposophical Health and Social Care.”

You must admit, this IS exciting!
Now you want to know what modules are within the Diploma? Here they are:

  • The Modern Context of IM: Philosophy, History and Changing Times in Medicine
  • IM Approaches and Management of Conditions (part 1)
  • Holistic Assessment: The Therapeutic Relationship, Motivational Interviewing & Clinical Decision Making in    Integrative Medicine
  • Critical Appraisal of Medicine and IM Research
  • Holistic assessment: Social prescribing, a Community Approach in Integrative Medicine
  • Managing a Dynamic IM Practice and Developing Leadership Skills
  • IM Approaches and Management of Conditions (part 2)
  • Independent Study on Innovation in Integrative Medicine

Sounds terrific, and it reminds me a lot of another course Michael Dixon tried to set up 13 years ago in Exeter. As it concerned me intimately, I wrote about this extraordinary experience in my memoir; here is a short excerpt:

…in July 2003… I saw an announcement published in the newsletter of the Prince of Wales’ Foundation for Integrated Health:

“The Peninsula Medical School aims to become the UK’s first medical school to include integrated medicine at postgraduate level. The school also plans to extend the current range and depth of programmes offered by including healthcare ethics and legislation. Professor John Tooke, dean of the Peninsula Medical School, said: ‘The inclusion of integrated medicine is a patient driven development. Increasingly the public is turning to the medical profession for information about complementary medicines. This programme will play an important role in developing critical understanding of a wide range of therapies’.”

When I stumbled on this announcement I was taken aback. Is Tooke envisaging a course for me to run? Has he forgotten to tell me about it? When I inquired, Tooke informed me that the medical school planned to offer a postgraduate “Pathway in Integrated Health” which had been initiated by Dr Michael Dixon, a general practitioner who had at that stage become one of the UK’s most outspoken proponents of spiritual healing and other dubious forms of alternative medicine, and for this reason was apparently very well regarded by Prince Charles.

A few days after I received this amazing news, Dr Dixon arrived at my office and explained with visible embarrassment that Prince Charles had expressed his desire to establish such a course in Exeter. His Royal Highness had already facilitated its funding which, in fact, came from Nelson’s, the manufacturer of homoeopathic remedies. The day-to-day running of the course was to be put into the hands of the ex-director of the Centre for Complementary Health Studies (CCHS), the very unit I had struggled – and even paid – to be separated from almost a decade ago because of its overtly anti-scientific agenda. The whole thing had been in the planning for several months. I was, it seemed, the last to know – but now that I had learnt about it, Dixon and Tooke urged me to contribute to this course by giving a few lectures.

I could no more comply with this request than fly. Apart from anything else, I was opposed in principle to the concept of “integration.” As I saw it, “integrating” quackery with genuine, science-based medicine was nothing less than a profound betrayal of the ethical basis of medical practice. By putting its imprimatur on this course, and by offering it under the auspices of a mainstream medical school, my institution would be encouraging the dangerous idea of equivalence – i.e., the notion that alternative and mainstream medicine were merely two parallel but equally valid and effective methods of treating illness.

To add insult to injury, the course was to be sponsored by a major manufacturer of homoeopathic remedies. In all conscience, this seemed to me to be the last straw. Study after study carried out by my unit had found homoeopathy to be not only conceptually absurd but also therapeutically worthless. If we did not take a stand on this issue, we might just as well all give up and go home…

END OF QUOTE FROM MY MEMOIR

Dixon’s Exeter course was not a brilliant success; I think it folded soon after it was started. Well, better luck up the road in Bristol, Michael – I am sure there must be a market for quackery somewhere!

Many cancer patients use mistletoe extracts either hoping to cure their cancer or to alleviate its symptoms. The evidence that mistletoe treatment (MT) can achieve either of these goals is mixed but, on the whole, however, it is not positive. Our own systematic review of 2003 concluded that ‘rigorous trials of mistletoe extracts fail to demonstrate efficacy of this therapy’. The more recent Cochrane review concurred: ‘The evidence from RCTs to support the view that the application of mistletoe extracts has impact on survival or leads to an improved ability to fight cancer or to withstand anticancer treatments is weak.’

Patients’ experiences of side effects and the acceptability, tolerability, and perceived benefits of MT have not been assessed critically. The aim of this new article was to systematically review and synthesise the results of qualitative studies of cancer patients’ experiences of using MT.

Electronic searches were conducted in MEDLINE, Embase, PsychLIT, CINAHL, and AMED to identify all qualitative studies of MT. Articles were screened independently by two reviewers and critically appraised using the Critical Appraisal Skills Programme tool. A thematic synthesis of the findings was carried out.

One hundred and seventy-three papers were identified; 156 were excluded at initial screening. Seventeen papers were read in full, 14 of which were excluded. Three articles about patients’ experiences of MT alongside conventional treatment were included in the synthesis, either as a monotherapy (two articles) or as part of a package of anthroposophic treatment (one article). Patients reported demonstrable changes to their physical, emotional, and psychosocial well-being following MT, as well as a reduction in chemotherapy side effects. Self-reported side effects from MT were few, and the studies suggest good adherence to the therapy. Self-injection gave patients a sense of empowerment through involvement in their own treatment.

The authors concluded that ‘given the variation in context of MT delivery across the articles, it is not possible to ascribe changes in patients’ quality of life specifically to MT.’

This might be a polite way of saying that there is no good evidence to suggest that MT positively affects patients’ experiences of side effects and the acceptability, tolerability, and perceived benefits.

Mistletoe is, of course, the ‘flagship’ intervention of Rudolf Steiner’s anthroposophical medicine. About a century ago, his idea was simple (or should this be ‘simplistic’?): the mistletoe plant is a parasite that lives off host trees sapping its resources until, eventually, it might even kill its host – just like cancer threatening the life of a human being. It follows, according to the homeopathy-inspired Steiner and the many followers of his cult that mistletoe is an effective cancer therapy.

Despite the weirdness of this concept and the largely negative evidence, MT is hugely popular as a cancer cure, particularly in German-speaking countries. The question I ask myself is this: ISN’T IT TIME THAT THIS NONSENSE STOPS?

Researching and reporting shocking stories like this one can only make me more enemies, I know. Yet I do think they need to be told; if we cannot learn from history, what hope is there?

I first became aware of Sigmund Rascher‘s work when I was studying the effects of temperature on blood rheology at the University of Munich. I then leant of Rascher’s unspeakably cruel experiments on exposing humans to extreme hypothermia in the Dachau concentration camp. Many of his ‘volunteers’ had lost their lives, and the SS-doctor Rascher later became the symbol of a ‘Nazi doctor from hell’. In 1990, R L Berger aptly described Rascher and his sadistic pseudo-science in his NEJM article:

“Sigmund Rascher was born in 1909. He started his medical studies in 1930 and joined both the Nazi party and the storm troopers (the SA) three years later. After a volunteer internship, Rascher served for three years as an unpaid surgical assistant. He was barred temporarily from the University of Munich for suspected Communist sympathies. In 1939, the young doctor denounced his physician father, joined the SS, and was inducted into the Luftwaffe. A liaison with and eventual marriage to Nini Diehl, a widow 15 years his senior who was a one-time cabaret singer but also the former secretary and possibly mistress of the Reichsführer, gained Rascher direct access to Himmler. A strange partnership evolved between the junior medical officer and one of the highest officials of the Third Reich. One week after their first meeting, Rascher presented a “Report on the Development and Solution to Some of the Reichsführer’s Assigned Tasks During a Discussion Held on April 24, 1939.” The title of this paper foretold the character of the ensuing relationship between the two men. Because of Rascher’s servile and ingratiating approach to Himmler, his “connections were so strong that practically every superior trembled in fear of the intriguing Rascher who consequently held a position of enormous power.

Rascher’s short investigative career included a leading role in the infamous high-altitude experiments on humans at Dachau, which resulted in 70 to 80 deaths. He was also involved in testing a plant extract as a cure for cancer. The genesis of this project illustrates Rascher’s style and influence. Professor Blome, the deputy health minister and plenipotentiary for cancer research, favored testing the extract in mice. Rascher insisted on experiments in humans. Himmler sided with Rascher. A Human Cancer Testing Station was set up at Dachau. The deputy health minister collaborated on the project, held approximately 20 meetings with Rascher, and visited the junior officer at Dachau several times.

Another of Rascher’s major research efforts focused on the introduction of a pectin-based preparation, Polygal, to promote blood clotting. He predicted that the prophylactic use of Polygal tablets would reduce bleeding from wounds sustained in combat or during surgical procedures. The agent was also recommended for the control of spontaneous gastrointestinal and pulmonary hemorrhages. Combat wounds were simulated by the amputation of the viable extremities of camp prisoners without anesthesia or by shooting the prisoners through the neck and chest.

Rascher also claimed that oral premedication with Polygal minimized bleeding during major surgical procedures, rendering hemostatic clips or ligatures unnecessary and shortening operating times. He published an enthusiastic article about his clinical experience with Polygal, without specifying the nature of some of the trials in humans. The paper concluded, “The tests of this medicine ‘Polygal 10’ showed no failures under the most varied circumstances.” Rascher also formed a company to manufacture Polygal and used prisoners to work in the factory. A prisoner who was later liberated testified that Rascher’s enthusiasm for Polygal’s antiinfectious properties was probably sparked by news of the introduction of penicillin by the Allies and by his eagerness to reap fame and receive the award established for inventing a German equivalent. He initiated experiments in humans apparently without any preliminary laboratory testing. In one experiment, pus was injected into the legs of prisoners. The experimental group was given Polygal. The controls received no treatment. Information filtered to Dr. Kurt Plotner, Rascher’s physician rival, that the controls were given large, deep subcutaneous inoculations, whereas the victims in the experiments received smaller volumes of pus injected intracutaneously. Plotner reportedly investigated the matter and discovered that the Polygal used was saline colored with a fluorescent dye.

The frequent references to Rascher in top-level documents indicate that this junior medical officer attracted extraordinary attention from Germany’s highest officials. His work was reported even to Hitler, who was pleased with the accounts. Rascher was not well regarded in professional circles, however, and his superiors repeatedly expressed reservations about his performance. In one encounter, Professor Karl Gebhardt, a general in the SS and Himmler’s personal physician, told Rascher in connection with his experiments on hypothermia through exposure to cold air that “the report was unscientific; if a student of the second term dared submit a treatise of the kind [Gebhardt] would throw him out.” Despite Himmler’s strong support, Rascher was rejected for faculty positions at several universities. A book by German scientists on the accomplishments of German aviation medicine during the war devoted an entire chapter to hypothermia but failed to mention Rascher’s name or his work.”

For those who can stomach the sickening tale, a very detailed biography of Rascher is available here.

I had hoped to never hear of this monster of a man again – yet, more recently, I came across Rascher in the context of alternative medicine. Rascher had been brought up in Rudolf Steiner’s anthroposophical tradition, and his very first ‘research’ project was on a alternantive blood test developed in anthroposophy.

A close friend of Rascher, the anthroposoph and chemist Ehrenfried Pfeiffer had developed a bizarre diagnostic method using copper chloride crystallization of blood and other materials. This copper chloride biocrystallization (CCBC) became the subject of Rascher’s dissertation in Munich. Rascher first tried the CCBC for diagnosing pregnancies and later for detecting early cancer (incidentally, he conducted this work in the very same building where I worked for many years, about half a century later). The CCBC involves a visual evaluation of copper crystals which form with blood or other fluids; the method is, of course, wide open to interpretation. Bizarrely, the CCBC is still used by some anthroposophical or homeopathic doctors today – see, for instance, this recent article or this website, this website or this website which explains:

“Hierbei werden einige Tropfen Blut mit Kupferchlorid in einer Klimakammer zur Kristallisation gebracht.
Jahrzehntelange Erfahrung ermöglicht eine ganz frühe Hinweisdiagnostik sowohl für alle Funktionsschwächen der Organe, auch z.B. der Drüsen, als auch für eine Krebserkrankung. Diese kann oft so früh erkannt werden, daß sie sich mit keiner anderen Methode sichern läßt.” My translation: “A few drops of blood are brought to crystallisation with copper chloride in a climate chamber. Decades of experience allow a very early diagnosis of all functional weaknesses of the organs and glands as well as of cancer. Cancer can often be detected earlier than with any other method.”

The reference to ‘decades of experience’ is more than ironic because the evidence suggesting that the CCBC might be valid originates from Rascher’s work in the 1930s; to the best of my knowledge no other ‘validation’ of the CCBC has ever become available. With his initial thesis, Rascher had produced amazingly positive results and subsequently lobbied to get an official research grant for testing the CCBC’s usefulness in cancer diagnosis. Intriguingly, he had to disguise the CCBC’s connection to anthroposophy; even though taken by most other alternative medicines, the Nazis had banned the Steiner cult.

Most but not all of Rascher’s research was conducted in the Dachau concentration camp where in 1941 a research unit was established in ‘block 5’ which, according to Rascher’s biographer, Sigfried Baer, contained his department and a homeopathic research unit led by Hanno von Weyherns and Rudolf Brachtel (1909-1988). I found the following relevant comment about von Weyherns: “Zu Jahresbeginn 1941 wurde in der Krankenabteilung eine Versuchsstation eingerichtet, in der 114 registrierte Tuberkulosekranke homöopathisch behandelt wurden. Leitender Arzt war von Weyherns. Er erprobte im Februar biochemische Mittel an Häftlingen.” My translation: At the beginning of 1941, an experimental unit was established in the sick-quarters in which 114 patients with TB were treated homeopathically. The chief physician was von Weyherns. In February, he tested Schuessler Salts [a derivative of homeopathy still popular in Germany today] on prisoners.

Today, all experts believe Rascher’s results, even those on CCBC, to be fraudulent. Rascher seems to have been not merely an over-ambitious yet mediocre physician turned sadistic slaughterer of innocent prisoners, he also was a serial falsifier of research data. It is likely that his fraudulent thesis on the anthroposophic blood test set him off on a life-long career of consummate research misconduct.

Before the end of the Third Reich, Rascher lost the support of Himmler and was imprisoned for a string of offences which were largely unrelated to his ‘research’. He was eventually brought back to the place of his worst atrocities, the concentration camp in Dachau. Days before the liberation of the camp by the US forces, Rascher was executed under somewhat mysterious circumstances. In my view, the CCBC should have vanished with him.

No, this post is not about the pop duo ‘EURYTHMICS’, it is about ‘EURYTHMY’ which pre-dates the pop duo by a few decades.

Eurythmy is a movement therapy of anthroposophic medicine which, according to its proponents, has positive effects on a person’s physical body, spirit, and soul. It is involves expressive movements developed by Rudolf Steiner in conjunction with Marie von Sivers in the early 20th century. It is used as a performance art, in education, especially in Steiner schools, and – as part of anthroposophic medicine – for therapeutic purposes. Here is what one pro-eurymthy website tells us about it:

Eurythmy is one of Rudolf Steiner’s proudest achievements. To better understand what Steiner says about eurythmy, you should read his self-titled “A Lecture on Eurythmy” Not always one to boast, Steiner says:

EURYTHMY has grown up out of the soil of the Anthroposophical Movement, and the history of its origin makes it almost appear to be a gift of the forces of destiny.

Steiner, Rudolf. A Lecture on Eurythmy, 1923

Clearly, Steiner felt that eurythmy was something very special, and of great importance. As such, eurythmy is a tool of Anthroposophy used to reveal and bring about a certain “spiritual impulse” in our age:


Read
Online
For it is the task of the Anthroposophical Movement to reveal to our present age that spiritual impulse which is suited to it.I speak in all humility when I say that within the Anthroposophical Movement there is a firm conviction that a spiritual impulse of this kind must now, at the present time, enter once more into human evolution. And this spiritual impulse must perforce, among its other means of expression, embody itself in a new form of art. It will increasingly be realised that this particular form of art has been given to the world in Eurythmy.

Steiner, Rudolf. A Lecture on Eurythmy

 

The question is, of course,  whether as a therapy eurythmy works. A recent publication might give an answer.

The aim of this systematic review was to update and summarize the relevant literature on the effectiveness of eurythmy in a therapeutic context since 2008. It is thus an up-date of a previously published review. This paper  found 8 citations which met the inclusion criterion: 4 publications referring to a prospective cohort study without control group (the AMOS study), and 4 articles referring to 2 explorative pre-post studies without control group, 1 prospective, non-randomized comparative study, and 1 descriptive study with a control group. The methodological quality of studies ranged in from poor to good, and in sample size from 5 to 898 patients. In most studies, EYT was used as an add-on, not as a mono-therapy. The studies described positive treatment effects with clinically relevant effect sizes in most cases.

For the up-date, different databases like PubMed, MEDPILOT, Research Gate, The Cochrane Library, DIMDI, Arthe and also the journal databases Der Merkurstab and the European Journal of Integrative Medicine were searched for prospective and retrospective clinical trials in German or English language. There were no limitations for indication, considered outcome or age of participants. Studies were evaluated with regard to their description of the assembly process and treatment, adequate reporting of follow-ups, and equality of comparison groups in controlled trials.

Eleven studies met the inclusion criteria. These included two single-arm, non-controlled pilot studies, two publications on the same non-randomized controlled trial and one case study; six further studies referred to a prospective cohort study, the Anthroposophic Medicine Outcome Study. Most of these studies described positives treatment effects with varying effect sizes. The studies were heterogynous according to the indications, age groups, study design and measured outcome. The methodological quality of the studies varied considerably.

The authors who all come from the Institute of Integrative Medicine, anthroposophical University of Witten/Herdecke in Germany draw the following conclusions: Eurythmy seems to be a beneficial add-on in a therapeutic context that can improve the health conditions of affected persons. More methodologically sound studies are needed to substantiate this positive impression.

I am puzzled! How on earth could they reach this conclusion? There is not a single trial that would  allow to establish cause and effect!!! The way I read the evidence from the therapeutic trials included in this and the previous reviews, the only possible conclusion is that EURYTHMY IS A WEIRD THERAPY FOR WHICH THERE IS NOT GOOD EVIDENCE WHATSOEVER.

Anthroposophic medicine is based on Rudolf Steiner’s mystical ideas. It is popular in Germany and is slowly also spreading to other countries.  Anthroposophic drugs are prepared according to ancient notions of alchemy and are fly in the face of modern pharmacology. Anthroposophic doctors treat all sorts of diseases, and their treatments  include anthroposophic medications, and a range of other modalities.

A recent paper reported a secondary analysis from an observational study of 529 children with respiratory or ear infections (RTI/OM) <18 years from Europe and the USA. Their caregivers had chosen to consult physicians offering either anthroposophic (A-) or conventional (C-) treatment for RTI/OM.

During the 28-day follow-up antibiotics were prescribed to 5.5% of A-patients and 25.6% of C-patients (P < 0.001); the unadjusted odds ratio for non-prescription in A- versus C-patients was 6.58 (95%-CI 3.45-12.56); after adjustment for demographics and morbidity it was 6.33 (3.17-12.64). Antibiotic prescription rates in recent observational studies with similar patients in similar settings, ranged from 31.0% to 84.1%. Compared to C-patients, A-patients also had much lower use of analgesics, somewhat quicker symptom resolution, and higher caregiver satisfaction. Adverse drug reactions were infrequent (2.3% in both groups) and not serious.

What can we conclude from these data?

Not a lot, I fear!

The authors of the study are a little more optimistic than I; they conclude that this analysis from a prospective observational study under routine primary care conditions showed a very low use of antibiotics and analgesics/antipyretics in children treated for RTI/OM by physicians offering AM therapy, compared to current practice in conventional therapy settings (antibiotics prescribed to 5% versus 26% of A- and C-patients, respectively, during days 0–28; antipyretics prescribed to 3% versus 26%). The AM treatment entailed no safety problem and was not associated with delayed short-term recovery. These differences could not explained by differences in demographics or baseline morbidity. The low antibiotic use is consistent with findings from other studies of paediatric RTI/OM in AM settings.

They are clearly careful to avoid causal inferences; but are they implying them? I would like to know what you think.

 

The principal aim of this survey was to map centres across Europe that provide public health services and operating within the national health system in integrative oncology.

Information was received from 123 (52.1 %) of the 236 centres contacted. Forty-seven out of 99 responding centres meeting inclusion criteria (47.5 %) provided integrative oncology treatments, 24 from Italy and 23 from other European countries. The number of patients seen per year was on average 301.2 ± 337. Among the centres providing these kinds of therapies, 33 (70.2 %) use fixed protocols and 35 (74.5 %) use systems for the evaluation of results. Thirty-two centres (68.1 %) were research-active.

The alternative therapies most frequently provided were acupuncture 26 (55.3 %), homeopathy 19 (40.4 %), herbal medicine 18 (38.3 %) and traditional Chinese medicine 17 (36.2 %); anthroposophic medicine 10 (21.3 %); homotoxicology 6 (12.8 %); and other therapies 30 (63.8 %).

Treatments were mainly directed to reduce adverse reactions to chemo-radiotherapy (23.9 %), in particular nausea and vomiting (13.4 %) and leucopenia (5 %). The alternative treatments were also used to reduce pain and fatigue (10.9 %), to reduce side effects of iatrogenic menopause (8.8 %) and to improve anxiety and depression (5.9 %), gastrointestinal disorders (5 %), sleep disturbances and neuropathy (3.8 %).

The authors concluded that mapping of the centres across Europe is an essential step in the process of creating a European network of centres, experts and professionals constantly engaged in the field of integrative oncology, in order to increase, share and disseminate the knowledge in this field and provide evidence-based practice.

DISSEMINATE KNOWLEDGE?

EVIDENCE-BASED PRACTICE?

WHAT KNOWLEDGE?

WHAT EVIDENCE-BASED PRACTICE?

Where is the evidence that homeopathy or homotoxicology or Chinese medicine are effective for any of the conditions listed above? The answer, of course, is that it does not exist.

I fear the results of this survey show foremost one thing: ‘integrative oncology’ is little else but a smokescreen behind which quacks submit desperate patients to bogus treatments.

Poor sleep quality during pregnancy is a frequent problem. Drug treatment can be problematic due to possible adverse effects for mother and embryo/foetus. Many pregnant women prefer natural treatments and assume that ‘natural’ equals harmless.

In the present study, the sedative effects of Bryophyllum pinnatum were investigated. This remedy is a phytotherapeutic medication predominantly used in anthroposophic medicine. In previous clinical studies on its tocolytic effect, B. pinnatum showed a promising risk/benefit ratio for mother and child. A recent analysis of the prescribing pattern for B. pinnatum in a network of anthroposophic physicians revealed sleep disorders as one of the most frequent diagnosis.

In this prospective, multi-centre, observational study, pregnant women suffering from sleep problems were treated with B. pinnatum (350mg tablets, 50% leaf press juice, Weleda AG, Arlesheim, dosage at physician’s consideration). Sleep quality, daily sleepiness and fatigue were assessed with the aid of standardised questionnaires, at the beginning of the treatment and after 2 weeks. Possible adverse effects perceived by the patients during the treatment were recorded.

The results show that the number of wake-ups, as well as the subjective quality of sleep was significantly improved at the end of the treatment with B. pinnatum. The Epworth Sleeping Scale decreased, indicating a reduction in tiredness during the day. There was, however, no evidence for a prolongation of the sleep duration, reduction in the time to fall asleep, as well as change in the Fatigue Severity Scale after B. pinnatum. No serious adverse drug reactions were detected.

From these data, the authors concluded that B. pinnatum is a suitable treatment of sleep problems in pregnancy. The data of this study encourage further clinical investigations on the use of B. pinnatum in sleep disorders.

Clinical trials of anthroposophic remedies, i.e. remedies which are based on the school of medicine founded by Rudolf Steiner, are very rare. Therefore this trial could be important.

B. pinnatum is a plant used in traditional Tai medicine against hypertension, and to some extend this makes sense: it contains cardiac glycosides which might help lowering elevated blood pressure. The reason for its use as a hypnotic, however, is not clear.

So, is B pinnatum really a ‘suitable treatment of sleep problems in pregnancy’? I doubt it for the following reasons:

  • the effects documented in this study are far from convincing,
  • we would need much more solid data to issue such a general recommendation,
  • cardiac glycosides can cause very serious adverse effects,
  • the sample size of the study is at least one dimension too small for assuming that it is safe,
  • we know nothing about its potential to cause harm to the foetus.

Personally, I find it irresponsible to draw conclusions such as the ones above on the basis of data which are flimsy to the extreme. I ask myself, to what extend wishful thinking might be a regrettable characteristic for the entire field of anthroposophic medicine.

Cancer patients are understandably desperate and leave no stone unturned to improve their prognosis. Thus they become easy prey of charlatans who claim that this or that alternative therapy will cure them or improve their outlook. One of the most popular alternative cancer therapies is mistletoe, a treatment dreamt up by Rudolf Steiner on the basis of the ‘like cures like’ principle: the mistletoe plant grows on a host tree like a cancer in the human body. One of many websites on this subject, for instance, states:

Mistletoe therapy

  • integrates with conventional cancer treatments
  • can be used for a wide range of cancers
  • may be started at any stage of the illness….

potential benefits…include:

  • Improved quality of life
  • generally feeling better
  • increased appetite and weight
  • less tired/more energy
  • reduced pain
  • better sleep pattern
  • felling more hopeful and motivated
  • reduced adverse effects from chemo and radiotherapy
  • reduced risk of cancer spread and recurrence
  • increased life expectancy.

Mistletoe extracts have been shown in studies to:

  • stimulate the immune system
  • cause cancer cell death
  • protect healthy cells against harmful effects of radiation and chemotherapy.

In fact, the debate about the efficacy of mistletoe either as a cancer cure, a supportive therapy, or a palliative measure is often less than rational and seems never-ending.

The latest contribution to this saga comes from US oncologists who published a phase I study of gemcitabine (GEM) and mistletoe in advanced solid cancers (ASC). The trial was aimed at evaluating: (1) safety, toxicity, and maximum tolerated dose (MTD), (2) absolute neutrophil count (ANC) recovery, (3) formation of mistletoe lectin antibodies (ML ab), (4) cytokine plasma concentrations, (5) clinical response, and (6) pharmacokinetics of GEM.

A total of 44 study participants were enrolled; 20 were treated in stage I (mistletoe dose escalation phase) and 24 in stage II (gemcitabine dose escalation phase). All patients had stage IV disease; the majority had received previous chemo-, hormonal, immunological, or radiation therapy, and 23% were chemotherapy-naïve.

Patients were treated with increasing doses of a mistletoe-extract (HELIXOR Apis (A), growing on fir trees) plus a fixed GEM dose in stage I, and with increasing doses of GEM plus a fixed dose of mistletoe in stage II. Response in stage IV ASC was assessed with descriptive statistics. Statistical analyses examined clinical response/survival and ANC recovery.

The results show that dose-limiting toxicities were neutropenia, thrombocytopenia, acute renal failure, and cellulitis, attributed to mistletoe. GEM 1380 mg/m2 and mistletoe 250 mg combined were the MTD. Of the 44 patients, 24 developed non-neutropenic fever and flu-like syndrome. GEM pharmacokinetics were unaffected by mistletoe. All patients developed ML3 IgG antibodies. ANC showed a trend to increase between baseline and cycle 2 in stage I dose escalation.

6% of patients showed a partial response, and 42% had stable disease. Of the 44 study participants, three died during the study, 10 participants requested to terminate the study, 23 participants progressed while on study, one terminated the study due to a dose limiting toxicity, 6 left due to complicating disease issues which may be tied to progression, and one voluntarily withdrew.

An attempt was made to follow study subjects once they terminated study treatment until death. At the last attempt to contact former participants, three were still alive and five others were lost to follow-up. The median time to death of any cause was approximately 200 days. Compliance with mistletoe injections was high.

The authors explain that a partial response rate of 6% is comparable to what would be expected from single agent gemcitabine in this population of patients with advanced, mostly heavily pretreated carcinomas. The median survival from study enrollment of about 200 days is within the range of what would be expected from single agent gemcitabine.

The authors concluded that GEM plus mistletoe is well tolerated. No botanical/drug interactions were observed. Clinical response  is similar to GEM alone.

These results are hardly encouraging but they originate from just one (not particularly rigorous) study and might thus not be reliable. So, what does the totality of the reliable evidence tell us? Our 2003 systematic review of 10 RCTs found that none of the methodologically stronger trials exhibited efficacy in terms of quality of life, survival or other outcome measures. Rigorous trials of mistletoe extracts fail to demonstrate efficacy of this therapy.

Will this stop the highly lucrative trade in mistletoe extracts? will it prevent desperate cancer patients being misled about the value of mistletoe treatment? I fear not.

Rudolf Steiner was a weird guy by any stretch of imagination. He was the founding father of anthroposophy, an esoteric “philosophy” that created a new dimension of obtrusiveness. Not only that, he also dabbled in farming methods, devised an educational technique and created an entire school of health care, called anthroposophical medicine. The leading product in its range of homeopathy-inspired “drugs” is a mistletoe-extract which is, according to Steiner, a cure for cancer. His idea was simple: the mistletoe plant is a parasite that lives off host trees sapping its resources until, eventually, it might even kill its host – just like cancer threatening the life of a human being!!!

So, what is more logical than to postulate that extracts from mistletoe are a cure for cancer? Medicine seems simple – particularly, if  you do not understand the first thing about it!

But here comes the odd thing: some ingredients from mistletoe do actually have anti-cancer properties. So, was the old Steiner an intuitive genius who somehow sensed that mistletoe would be a life-saver for cancer patients? Or is all this just pure luck? Or was it perhaps predictable?

Many plants produce molecules that are so toxic that they can kill (cancer) cells, and many conventional cancer drugs were originally derived from plants; the fact that mistletoe has some anti-cancer activity therefore comes as a surprise only to those who have little or no knowledge of phyto-pharmacology.

Ok, mistletoe might have some ingredients which possess pharmacological activity. But to claim that it is a cancer cure is still a huge leap of faith. This fact did not stop promoters of anthroposophical medicine to do just that.

Due to decades of clever promotion, it is now hard in many countries (including for instance Germany) to find cancer patients who have not tried mistletoe; indeed, selling mistletoe preparations to desperate cancer patients has become a mega-business.

But does it actually work?  Do these extracts achieve what proponents advertise?

The claims for mistletoe are essentially twofold:

1) Mistletoe cures cancer.

2) Mistletoe improves the quality of life (QoL) of cancer patients.

The crucial question clearly is: are these claims based on good evidence?

According to our own systematic review, the answer is NO. In 2003, we looked at all the clinical trials and demonstrated that some of the weaker studies implied benefits of mistletoe extracts, particularly in terms of quality of life. None of the methodologically stronger trials exhibited efficacy in terms of quality of life, survival or other outcome measures. The current Cochrane review (of which I am not a co-author) concluded similarly : The evidence from RCTs to support the view that the application of mistletoe extracts has impact on survival or leads to an improved ability to fight cancer or to withstand anticancer treatments is weak.

But both reviews have one major weakness: they included all of the many available extracts of mistletoe – and one cannot deny that there are considerable differences between them. The market leader in this area is Weleda (avid readers of science blogs might remember that this firm has been mentioned before); they produce ISCADOR, the mistletoe extract that has been tested more than any other such preparation.

Perhaps it would be informative to focus specifically on this product then? A German team from the “Center for Integrative Medicine, Faculty of Health, University of Witten/Herdecke” has done just that; despite the fact that these authors are not really known for their critical analyses of anthroposophical medicine, their conclusion is also cautious: The analyzed studies give some evidence that Iscador treatment might have beneficial short-time effects on QoL-associated dimensions and psychosomatic self-regulation.

So, what is the bottom line? Sceptics would say that almost a century of research without a solid proof of efficacy is well and truly enough; one should now call it a day. Proponents of mistletoe treatment, however, insist: we need more and better studies. Well, there is more! A new RCT of Iscador has just been published.

It included chemotherapy-naive advanced non-small-cell lung cancer (NSCLC) patients to assess Iscador’s influence on chemotherapy-related adverse-effects and QoL. Patients with advanced NSCLC were randomised to receive chemotherapy alone or chemotherapy plus Iscador thrice weekly until tumour progression. Chemotherapy consisted of 21-day cycles of carboplatin combined with gemcitabine or pemetrexed. Seventy-two patients were enrolled of whom 65% were in stage IV, and 62% had squamous histology. Median overall survival in both groups was 11 months. Median time to tumour progression was not significantly different between the two groups. Differences in grade 3-4 haematological toxicity were not significant, but more control patients had chemotherapy dose reductions, grade 3-4 non-haematological toxicities, and hospitalisations.

The authors’ conclusion: No effect of Iscador could be found on quality of life or total adverse events. Nevertheless, chemotherapy dose reductions, severe non-haematological side-effects and hospitalisations were less frequent in patients treated with Iscador, warranting further investigation of Iscador as a modifier of chemotherapy-related toxicity.

So, does Steiner’s notion based on the weirdest of intuitions contain some kernel of truth? I am not sure. But for once I do agree with the proponents of mistletoe: we need more and better research to find out.

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