MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

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When I worked as a junior doctor in a homeopathic hospital, this is what I was told in no uncertain terms: children are ideal patients of homeopathy, because they respond particularly well to it. Most books on the subject confirm this message. The reason for the assumption is as simple as it is simplistic: children are relatively unspoilt by conventional drugs that can hinder the effects of homeopathy.

Many years later, when we conducted one of our clinical trials of homeopathy, we opted for a study with children, because all homeopaths believe in this dogma. For the same reason, it made (homeopathic) sense for the paediatricians of my former medical school (LMU Munich) to run a homeopathic clinic for decades. Not just that, they also taught homeopathy to medical students.

In the course of doing this for such a long time, they did their research and, of course, gathered tons of experience. And what does this wisdom and insight collected over decades reveal? Does it confirm the dogma that kids are excellent homeopathy-responders? Or perhaps does it reject the notion?

The question has just been definitively answered by a (well-hidden) remark in an announcement from the university paediatrics department entitled Integrative Pädiatrie. The original text is below; for those who don’t read German, I will translate:

Our healthcare for children is devoted to a holistic approach which considers biological and psychosocial dimensions of health and disease.

We see positive potential in the use of music, art and humour. Methods from integrative medicine such as mind/body therapies or integrative movement therapy can have curative effects. These and other methods are also being tested in scientific studies.

Homeopathic remedies, however, are not being used in Hanauer’s Paediatric Hospital because, after 200 years of research, it has become clear that the basis of homeopathy is not in accordance with the modern concepts of the natural sciences.

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Unsere Medizin für kranke Kinder ist einer ganzheitlichen Sicht verpflichtet, die neben den biologischen auch psychosoziale Dimensionen von Gesundheit und Krankheit berücksichtigt.

Wir sehen das positive Potential durch den Einsatz von Musik, Kunst oder Humor.  Auch Methoden der “Integrativen Medizin”, wie zum Beispiel die “mind-body-Medizin” oder die Technik der integrativen Bewegungstherapie können eine heilende Wirkung haben. Diese und andere Methoden werden zum Teil auch in wissenschaftlichen Studien geprüft.

Homöopathische Arzneimittel kommen im Dr. von Haunerschen Kinderspital hingegen nicht zum Einsatz, da sich nach über 200 Jahren wissenschaftlicher Forschung klar herausgestellt hat, dass ihre Grundlagen nicht mit dem modernen Verständnis der Naturwissenschaft in Einklang zu bringen sind.

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Let’s be clear what exactly the last paragraph means:

  • This institution has bee open to homeopathy for a very long time.
  • They treated children homeopathically.
  • They conducted research in homeopathy.
  • They taught homeopathy to medical students.
  • Eventually, they could no longer ignore what was before their eyes.
  • They stopped using homeopathy.
  • And they discontinued their course of homeopathy.

Why?

Because highly diluted homeopathic remedies are pure placebos – and that is true for children, adults and even animals.

The Sueddeutsche Zeitung reported yesterday that the Bavarian government has given the go-ahead to a major study of homeopathy, and Die Zeit published a similar article. For those who read German, I append the text from the SZ below. For those who don’t, let me give a short summary.

The study is aimed at clarifying whether the use of homeopathic remedies can reduce the use of antibiotics in humans and animals. The vote was carried because of the CDU delegates being in favour. The debate of the project was, however, controversial. Critics stressed that, at best, the study is superfluous and pointed out that the project is negligent because it implies that homeopathics might be effective, whereas the evidence shows the opposite. A SPD delegate stated that he is ‘open moth’, homeopathy works because of the doctor-patient contact and not because of its remedies which are pure placebos.

The project was tabled because some people had worried about antibiotic resistance and felt that homeopathy might be an answer. Some CSU delegates stated that in ENT medicine, there is evidence that homeopathics can reduce the use of antibiotics. Even in cases of severe sepsis, there was good evidence, they claimed.

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Mit einer medizinischen Studie soll die Staatsregierung klären, ob durch homöopathische Mittel der Einsatz von Antibiotika reduziert werden kann. Dies hat der Landtag am Donnerstag mit den Stimmen der Regierungsfraktionen von CSU und Freien Wählern beschlossen. Bei der namentlichen Abstimmung votierten 120 Abgeordnete für den Antrag und damit acht mehr, als die Koalition selbst stellt. Im Plenum löste der Antrag, der im Zusammenhang mit weiteren Maßnahmen gegen sogenannte multiresistente Keime besprochen wurde, teils kontroverse Debatten aus. Kritiker der Homöopathie betonten, dass die Studie bestenfalls überflüssig sei.

“Das Vorhaben der bayerischen Staatsregierung ist fahrlässig, weil es bereits mit der Fragestellung suggeriert, dass homöopathische Mittel wie Globuli multiresistente Keime bekämpfen könnten”, sagte Dominik Spitzer (FDP). Bisher habe keine wissenschaftliche Studie beweisen können, dass homöopathische Mittel allein gegen Beschwerden wirkten.

Auch die SPD-Abgeordnete Ruth Waldmann hatte bereits vor der Debatte zum Ansinnen der CSU gesagt: “Da bleibt einem der Mund offen stehen.” Wenn an Homöopathie “wirklich nachweislich etwas wirkt, dann ist es der Anteil der sprechenden Medizin, der ganzheitliche Blick auf die Patienten”. Das tue vielen Menschen gut. “Und da bin ich auch dafür, das den Leuten zu lassen”, betonte Waldmann. “Aber bei schwerer Sepsis auch nur daran zu denken, diese Kügelchen womöglich anstelle von Antibiotika zu verabreichen”, das könne sie nicht mehr nachvollziehen.

Die CSU-Landtagsfraktion hatte ein Paket von insgesamt fünf Anträgen eingereicht, mit denen sie erreichen will, dass es weniger Todesfälle durch multiresistente Keime gibt. Dazu gehöre es, im Alltag den Antibiotika-Einsatz zu reduzieren, auch in der Landwirtschaft. Fahrlässig eingesetzte Antibiotika werden von Forschern mit als Grund dafür genannt, dass Krankheitserreger resistent werden. In einem dieser Anträge wird die Staatsregierung aufgefordert, per Studie untersuchen zu lassen, wie der Antibiotika-Einsatz reduziert werden kann – und ob dabei womöglich auch homöopathische Präparate eine “positive Rolle” spielen.

Im Bereich der Hals-Nasen-Ohren-Erkrankungen, so die CSU-Abgeordneten, hätten Studien aufzeigen können, “dass durch den Einsatz klassischer Homöopathie sowohl ein Einsatz von Antibiotika vermieden als auch eine Verbesserung der individuellen Infektabwehr erreicht werden konnte”. Auch an schwer septischen Patienten – also Patienten, bei denen das körpereigene Abwehrsystem bereits die Organe und das Gewebe schädigte – habe eine Studie Hinweise darauf gebracht, dass eine homöopathische Behandlung “eine nützliche Behandlungsmethode” darstellen könne.

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The notion that there might be good evidence for the efficacy of homeopathy in ENT and sepsis is clearly mistaken. On this blog, we have even discussed a tragic case of a child dying because of this erroneous belief. Homeopathy does not work in humans nor in animals as an alternative to antibiotics. And, of course, the notion that there is good, reproducible evidence to show that homeopathy effectively cures sepsis is a most dangerous fallacy. (There have been some experiments along these lines in the Dachau concentration camp, but they cannot seriously mean that!)

As far as I know it is as yet unclear what the precise research questions of the Bavarian project are, how much money will be spent on it (I saw a mention of 400 000 Euros), who is going to conduct the research, etc. No doubt, we will learn all this in due course. Meanwhile, if I may be so bold as to recommend someone for designing the research, I can think of nobody better suited than the only person who truly believes that it can produce a positive result: PRINCE CHARLES.

The Federation of European Academies of Medicine (FEAM) and the European Academies’ Science Advisory Council have issued a joint statement today urging the World Health Organisation (WHO) to clarify how Traditional Chinese Medicine (TCM) and other so-called alternative medicines (SCAMs) should be used.

As we discussed previously, the WHO has included TCM diagnoses in the International Classification of Diseases (ICD). The WHO claim this is not an endorsement, but experts point out that the move will promote TCM and mislead the public into thinking that TCM is safe and effective. Thus consumers might use it as an alternative for effective treatments of serious conditions, in which case they would endanger their lives.

Prof George Griffin, the president of FEAM, was quoted saying “We don’t give drugs and surgical treatments unless there is real evidence that they work and do no damage and basically the feeling is that most of the traditional Chinese medicine drugs are unregulated. They are not tested properly for toxicity. They probably vary greatly between batches produced, for example seaweed, which is the latest, and they may be harmful. The other side of the equation is that they may be deluding patients into thinking they are taking appropriate therapies for serious disease.”

“Multiple risks of harm from herbal ingredients have been documented,” the joint statement warns. Sometimes herbal remedies have been adulterated with chemicals. Interaction with conventional drugs can be a serious threat. And acupuncture, they will say, “is not necessarily harmless”. A review in 2017 as well as numerous papers discussed on this blog (for instance here and here) found injuries to vital organs, infections and other adverse reactions.

Although those who use SCAM are being misled to think of them as originating from small scale enterprises, globally it is big business. “The production and delivery of TCM has become a large industry with estimates of $60bn [£46.5bn] a year and an annual growth rate above 10%,” says the statement.

The statement authors “urge the European Commission and member states to do more to ensure that all medical products and procedures are subject to an appropriate level of evaluation for quality, safety and efficacy consistent with standardised testing procedures”.

Here are further important points from the statement:

  • We agree with the underlying principle that the proponents of TCM and other CAM should be invited to seek the same rigorous assessment as is applied to innovative, evidence-based medicines (from state-of-the-art clinical trials) developed and regulated worldwide.
  • We accept that WHO has tried to make clear that their chapter in ICD-11 on TCM does not refer to, nor endorse, any specific form of treatment (Anon 2019a). However, because of the perceived encouragement created by ICD-11 inclusion of  TCM as a core principle and system of medicine, the qualification may be misconstrued or ignored.
  • We agree that there have been examples where traditional medicine, Chinese or otherwise, has been subjected to thorough preclinical investigation and proven in rigorous clinical trials to contribute significant health benefit. The example of artemisinin therapy for malaria is notable (WHO, 2015). The success of artemisinin as an anti-malaria agent is due to meticulous research in pharmacognosy and medicinal chemistry, combined with clinical trials. Many of the artemisia TCM preparations tested originally had little reproducibility of activity. The compound that has been approved by medicinal product agencies is a chemically modified version of the naturally occurring molecule in order to improve its pharmacokinetic properties. It is well known that many natural products have significant pharmacological activities and provided the basis for much of modern medicine. And, there may be many more such leads to therapeutic benefit. But, none of this means that other claims can be accepted uncritically, even if the objective to ensure access for all to the benefits of medicine is worthy.
  • European patients may be encouraged to self-administer unregulated products or seek unregulated diagnostic procedures outside of the remit and responsibility of public health services. This raises issues for efficacy, particularly if patients delay seeking evidence-based healthcare. There are also serious safety concerns. Multiple risks of harm from herbal ingredients have been documented (e.g. see Byard et al. 2017; Zhou et al. 2019) and in the absence of an approved framework for quality and formulation, adulteration and dose variation may bring additional health risks (Ching et al. 2018). Interaction with other medications is,
    additionally, a serious threat. It is also noteworthy that, contrary to common assumptions, acupuncture is not necessarily harmless (Chan et al. 2017). It is not our present purpose to review the evidence on TCM or to make judgement on particular practices, rather to emphasise the need for consistency in applying common standards to all of medicine. Although there is a very large literature on TCM, we note that clinical studies often fail to meet expected methodological criteria and highquality evidence is often lacking (for example as concluded from a systematic review of the literature on use of Chinese herbal medicines for rheumatoid arthritis, Pan et al. 2017). Follow-up surveillance and procedures for assessing liability, where necessary, may also be weak.
  • European patients may be encouraged to seek diagnosis according to the proffered TCM precepts through public health services, thereby causing additional pressures on limited resources. It is likely that there will be increasing demands for these services across the EU. The European Commission, the EMA and Member State health authorities must revisit their regulatory strategies to ensure that appropriate, evidence-based patient information is readily accessible.
  •  There should be consistent proof underlying the regulatory requirements for scrutiny to demonstrate efficacy, safety and quality for all products and practices for human medicine. There must be verifiable and objective evidence, commensurate with the nature of the claims being made. In the absence of such evidence, a product should be neither approvable nor registrable by national regulatory agencies for the designation medicinal product. The current EU Directive on Traditional Herbal Medical Products (Directive 2004/24/EC amending Directive 2001/83/EC) was established to provide a simplified regulatory approval process for traditional herbal medicines, and national procedures are overseen by the national competent authorities. However, designated categories within this legislation allow treatment based on traditional or well-established use in the absence of robust evidence. Medicinal herbal products registered by the European Medicines Agency for traditional use have the requirement of “bibliographical or expert evidence to the effect that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years in the Community”5. Thus, the regulation is essentially to ensure that the product is harmless and there is no real requirement for demonstration of effect. As recommended in our previous assessment of homeopathy (EASAC, 2017) it would now be timely to reassess the validity and value of continuing to allow these simpler regulatory approval categories to apply.
  • Diagnostic procedures should also be evidence-based and include validated diagnostic instruments to provide objective, reliable, reproducible assessment and reduce inter-rater variability. Whatever the diagnostic approach utilised, practitioners should be appropriately trained and audited by professional bodies.
  • Similarly, use of other TCM procedures such as acupuncture should be evidence-based to demonstrate efficacy and safety, and subject to professional standards.
  • Evidence-based public health systems and medical insurance systems should not reimburse products and practices unless they are demonstrated to be efficacious and safe by rigorous pre-marketing testing: a robust evidence base is essential for all medicines.
  • The composition of standardised TCM remedies should be labelled in a similar way to other health products. That is, there should be an accurate, clear, verifiable and simple description of the ingredients and their amounts present in the formulation. TCM diagnostic and therapeutic procedures should, likewise, be clearly explained in patient information literature.
  • Advertising and marketing of TCM products and services must conform to established standards of accuracy and clarity6. Promotional claims for efficacy, safety and quality should not be made without demonstrable and reproducible evidence

A team of 42 authors from various disciplines (mostly medicine and philosophy) have published an appeal to broaden the definition of evidence. They reached several overlapping conclusions with implications for policy and practice in research and clinical care, which they summarised as follows:

1. ‘Evidence’ is typically evidence of causation. Common terms used in EBM, such as ‘intervention’, ‘outcome’ or ‘increased risk’, are relevant to evidence-based decision making only insofar as they point to causal matters: causal interventions and their effects. Although there is growing reluctance to make causal claims in areas of uncertainty, the correct response to such uncertainty is not to avoid talking about causation but instead to improve our methods of understanding it.

2. Establishing causation often requires the use of multiple methods since no single method will be universally applicable or perfect for this purpose. This means that statistical approaches, in particular randomised controlled trials and systematic reviews, cannot uncover all causally relevant information, contrary to their widespread assumed status as the universal gold standards of EBM.

3. An understanding of causal mechanisms can help to determine whether an intervention works (ie, its efficacy shown in experiment or effectiveness in clinical practice). In addition, we should strive to understand how an intervention works (ie, its mechanism) and how it can be made to work (ie, the conditions under which it works best). Understanding mechanisms is essential for both of these. For instance, a medical intervention that works experimentally might not do so when combined with a negatively interacting substance.

4. Although animal experiments can shed light on causal mechanisms, other types of evidence can add to our understanding. This is because causal mechanisms are complex, involving multiple causal interactions of various factors. These factors play roles in the effectiveness of the treatment and in interactions between the treatment and the individual patient.

5. Given the multiplicity of methods (cf 2) and a wide interpretation of what counts as a mechanism (cf 3 and 4), causation should be understood in non-reductionist terms. That is, the scope of relevant causal interactions extends beyond the molecular, pharmacological and physiological levels of interaction. Any thorough causal account should also include higher-level factors, such as the behaviour of tissues, whole organs and individuals, including psychological and social factors.

6. ‘Causal evidence’ should be extended to include different types of evidence, including case studies and case reports, which can in some cases provide valuable information for understanding causation and causal mechanisms. This is particularly important when dealing with rare disorders, marginal groups or outliers.

7. Patient narratives and phenomenological approaches are useful tools for looking beyond evidence such as symptoms and outcomes, and to elucidate the core causes or sources for chronic and unexplained conditions.

8. Causation has a non-negligible temporal aspect. Whether of long or short duration, a causal interaction cannot be fully understood from a ‘snapshot’, but requires both backwardlooking perspectives (towards the origin) and forward-looking perspectives (towards the outcome).

These points are well worth considering, in my view. As we have often discussed on this blog, causation is the key. The authors see their paper as a philosophical analysis that ought to have a direct impact on the practice of medicine. If we are to understand what is meant by ‘evidence’, what is the ‘best available evidence’ and how to apply it in the context of medicine, they write, we need to tackle the problem of causation head on. In practice, this means understanding the context in which evidence is obtained, as well as how the evidence might be interpreted and applied when making practical clinical decisions. It also means being explicit about what kind of causal knowledge can be gained through various research methods. The possibility that mechanistic and other types of evidence can be used to add value or initiate a causal claim should not be ignored. 

Their plea has much scope for being misunderstood by enthusiasts of so-called alternative medicine (SCAM). And I am keen to hear what you think about the 8 points raised here.

Guest post by Norbert Aust

 

Edzard invited me to review a recent paper on homeopathic treatment of women with pre-menstrual syndrome which he recently discussed on this blog (PMS) [1]. This is what I found:

With this study by Yakir et al. all requirements for low risk of bias are obviously met (blinding, randomisation, allocation concealment etc.) which would make it a high quality study. However, I would like to raise three concerns with increasing severity in that order:

  1. Publication history seems odd with a paper of today to report a trial from twenty years ago
  2.  It is unclear what the reported data imply for the condition of the women, therefore, it is hardly clear what the changes before to after really imply.
  3. A deeper analysis of the data points in the direction of small study bias.

(1) Trial and publication history

  • A first test of homeopathy for PMS was performed in the years 1992 to 1994 by the same team of researchers: 19 women finished the test in an outpatient clinic in Jerusalem/Israel before the trial was aborted for lack of funding.
  • A second trial was performed between 1996 and 1999 where 96 women completed the test.
  • The first trial of 19 women was published as pilot study in 2001 [2], well after data collection of the main study was completed.
  • In 2001 or 2002 the main trial was reported at a conference “Future Directions and Current Issues of research in Homeopathy”, which took place in Freiburg/Germany in 2002. The report was included in the proceedings book [3].
  • In the years 2015 to 2017 a Dutch team updated the original manuscript.
  • Now, a full 20 years after data collection was completed and 18 years after data evaluation was done, the current paper was published in a peer reviewed journal.

This seems odd. The homeopathic community is desperately looking for high quality trials with positive outcomes and here is one that is left ignored for a very long time. And why the authors elected to publish the pilot study in 2001 when the main study was at least very near to completion is unclear. The authors claim that the study was part of the PhD thesis of the lead author in 2002, but do not explain why this paper was not then published in a peer reviewed journal.

Honestly, I do not know what to make of it.

(2) Implication of data

The main outcome measure was assessed by the modified Moos Menstrual Distress Questionnaire, a 37 item questionnaire which the women completed daily for five months, two before treatment for baseline data, three for follow up after treatment. Each item had five options rated 0 to 4. Data from the last 12 days before menses were used for evaluation. However, the authors are not very clear about their procedure:

“Premenstrual symptom (PM) scores were defined as the total scores of 37 pre-specified symptoms in the MDQ during the last 12 premenstrual days ... The mean scores of all women for the various MDQ parameters were calculated before and after treatment, separately in both intervention groups.”

So the authors averaged 24 and 36 questionnaires respectively with a total rating between 0 and 4 X 37 = 148 points. But the scores as reported range between 0 and 2.00. So what are they? And if we do not know what they represent, what does the difference before to after treatment indicate?

Besides the implausible magnitude of the scores, there is a question what they would indicate. Apparently the scores combine two dimensions, namely intensity and duration of the syndrome. The data included 12 days for each cycle. It is hard to believe that any woman would suffer that long from her PMS condition. So any score might indicate an individual duration either long with low intensity or the opposite, a short period of extreme intensity. The score does not offer any clue as to what happened – and a reduction might not indicate an improvement at all: if a long period of low intensity before treatment is modified to a very short period of intense symptoms afterwards the woman might not really consider it an improvement, even if the score may be smaller.

The authors could have used other measures that would be more illuminating – maximum rating per cycle or number of days with a score exceeding a certain threshold – then their data would be much more illuminating on what really happened.

By the way: there is no hint about the timely scatter of the score of the individual women, which would allow us to judge the developments. And the sample size calculation seems to be performed post hoc: It was not included in the conference paper [3] and yields exactly the number of patients included in the study.

(3) Data evaluation

Let us assume for now that the scores transport some real meaning and a reduced score is connected to an improved condition of the patient. Even then there are questions.

The authors report that the mean of this ominous PMS score was reduced for the verum group from 0.443 to 0.287, a reduction by 0.156 score points, whereas the placebo group saw an smaller improvement from 0.426 at baseline to 0.340, a reduction by 0.086 points only. This implies a solid improvement by 35 % with verum, while the control group achieved an improvement of 20 % only. The authors include an image with all the mean PMS-Scores for all the women arranged for verum and controls (Fig. 3 in [3]). The black squares represent the baseline data for each woman, the light squares give the score after treatment (Fig 3 from [1]).

Even at first glance, the data do not look that different. Even with placebo, some women show marked improvement, though more frequent with verum. However, more women under verum encounter aggravation than under placebo, but a few women of the control group had this more intensely. About the same number of women in both groups reached low final scores.

To put this into a more solid state I digitized the above image and did a short analysis of the PMS scores. Here is what I found:

before after improvement*
Placebo
mean ** 0 .43 0.34 0.09
lower quartile 0.19 0.11 0.00
median 0.35 0.19 0.09
upper quartile 0.53 0.42 0.17
Verum
mean ** 0.45 0.29 0.16
lower quartile 0.19 0.14 -0.01
median 0.39 0.27 0.10
upper quartile 0.64 0.40 0.21

* Please note: The data given for the difference are quartiles and medians of the individual changes that occurred, not the changes of the quartiles and medians.

** The data for the mean values are given to check for accuracy which is good.

This table shows, that the inter-quartile portion of the women in both groups faired about the same with a slight advantage for placebo below median and for verum above. The difference in the mean values is due to the outliers, namely by a surplus 5 women in verum group who encountered a marked improvement under verum and a surplus of three women who suffered a marked deterioration under placebo.

Mere chance or not? Small study bias, where the impact of outliers dominate the outcome? Hard to say. This result differs greatly from the pilot study, where most of the women under verum achieved marked improvements and no deterioration occurred, while only minor improvement and some aggravations were recorded.

Conclusion 

The quality of the study looks fine, but the result is not as solid as it seems. The positive outcome is affected by the development of about 10 % of the combined study population only. This might indicate some kind of small study bias and would require replication by a rigorous trial with an increased number of participants – preferably independent from the original team.

References

[1] Yakir M, Klein-Laansma CT, Kreitler S et al.: A Placebo-Controlled Double-Blind Randomized Trial with individualizes Homeopathic Treatment using a Symptom Cluster Approach in Women with Premenstrual Syndrome. Homeopathy, doi 10.1055/s-0039-1691834 https://www.ncbi.nlm.nih.gov/pubmed/31434111

[2] Yakir M, Kreitler S, Brzezinski A et al.: Effects of homeopathic treatment in women with premenstrual syndrome: a pilot study, British Homeopathic Journal (2001); 90: 148-153 http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.1014.5054&rep=rep1&type=pdf

[3] Yakir M, Kreitler S, Brzezinski A, Vithoulkas G, Bentwich Z: ‘Successful treatment of premenstrual syndrome by classical homeopathy’ in: Walach H.: Future directions and current issues of research in homeopathy’ (Conference proceedings), Freiburg/Germany 2002, S. 134-143

Reiki has been a regular topic on this blog (see for instance here, here and here). In my recent book (Alternative medicine, a critical assessment of 150 modalities), I evaluated it as follows:

Reiki is a form of paranormal or energy healing popularised by Japanese Mikao Usui (1865-1926). Rei means universal spirit (sometimes thought of as a supreme being) and ki is the assumed universal life energy.

  1. Reiki is based on the assumptions of Traditional Chinese Medicine and the existence of ‘chi’, the life-force that determines our health.
  2. Reiki practitioners believe that, with their hands-on healing method, they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind.
  3. There is no scientific basis for such notions, and reiki is therefore not plausible.
  4. Reiki is used for a number of conditions, including the relief of stress, tension and pain.
  5. There have been several clinical trials testing the effectiveness of reiki. Unfortunately, their methodological quality is usually poor.
  6. A systematic review summarising this evidence concluded that the evidence is insufficient to suggest that reiki is an effective treatment for any condition. Therefore, the value of reiki remains unproven.[1] And a Cochrane review found that there is insufficient evidence to say whether or not Reiki is useful for people over 16 years of age with anxiety or depression or both.[2]
  7. Reiki appears to be generally safe, and serious adverse effects have not been reported. Some practitioners advise caution about using reiki in people with psychiatric illnesses because of the risk of bringing out underlying psychopathology.

 

 

PLAUSIBILITY Negative
EFFICACY Negative
SAFETY Positive
COST Positive
RISK/BENEFIT BALANCE Negative

 

[1] https://www.ncbi.nlm.nih.gov/pubmed/?term=lee+pittler+ernst%2C+reikiv

[2] https://www.ncbi.nlm.nih.gov/pubmed/25835541

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Now a new study has been published. Will it overturn my assessment?

This within-subject design experiment was conducted to test the feasibility and efficacy of Reiki to provide pain relief among paediatric patients undergoing hematopoietic stem cell transplantation (HSCT).

Paediatric patients undergoing HSCT during the inpatient phase in the Stem Cell Transplantation Unit were eligible to participate to the study. Short and medium effects were assessed investigating the increase or decrease of patient’s pain during three specific time periods of the day: morning of the Reiki session versus assessment before Reiki session (within subjects control period), assessment before Reiki session versus assessment after Reiki session (within subjects experimental period) and assessment after Reiki session versus morning the day after Reiki session (within subject follow-up period). The long-term effects were verified comparing the pain evolution in the day of the Reiki session with the following rest day.

The effect of 88 Reiki therapy sessions in nine patients was analysed following a short, medium, and long-term perspective. Repeated-measures analysis of variance revealed a significant difference among the three periods. A decrease of the pain occurred in the experimental period in short and medium term, while in the follow-up period, the pain level remained stable.

The authors concluded that this study demonstrates the feasibility of using Reiki therapy in pediatric cancer patients undergoing HSCT. Furthermore, these findings evidence that trained paediatric oncology nurses can insert Reiki into their clinical practice as a valid instrument for diminishing suffering from cancer in childhood.

This is basically an observational study without a control group. Therefore it cannot possibly test the efficacy of Reiki. The conclusion that Reiki is a valid instrument for diminishing suffering from cancer in childhood is therefore simply incorrect. The only rational verdict therefore remains this: REIKI FAILS TO GENERATE MORE GOOD THAN HARM.

The sooner we stop misleading the public about it, the better for us all.

Archives of Psychiatric Nursing disseminates original, peer-reviewed research that is of interest to psychiatric and mental health care nurses. The field is considered in its broadest perspective, including theory, practice and research applications related to all ages, special populations, settings, and interdisciplinary collaborations in both the public and private sectors. Through critical study, expositions, and review of practice, Archives of Psychiatric Nursing is a medium for clinical scholarship to provide theoretical linkages among diverse areas of practice.

If peer-review, critical study and clinical scholarship are not just empty platitudes, what – if anything – should such a journal publish about Bach flower remedies? Perhaps something like this (straight from my new book)?

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Bach flower remedies were invented in the 1920s by Dr Edward Bach (1886-1936), a doctor homeopath who had previously worked in the London Homeopathic Hospital. They have since become very popular in Europe and beyond.

  1. Bach flower remedies are clearly inspired by homeopathy; however, they are not the same because they do not follow the ‘like cures like’ principle and are they potentised.
  2. They are manufactured by placing freshly picked specific flowers or parts of plants in water which is subsequently mixed with alcohol, bottled and sold.
  3. Like most homeopathic remedies, they are highly dilute and thus do not contain therapeutic amounts of the plant printed on the bottle.
  4. Bach developed 38 different remedies, each corresponding to an emotional state which he believed to be the cause of all illness:

Agrimony – mental torture behind a cheerful face
Aspen – fear of unknown things
Beech – intolerance
Centaury – the inability to say ‘no’
Cerato – lack of trust in one’s own decisions
Cherry Plum – fear of the mind giving way
Chestnut Bud – failure to learn from mistakes
Chicory – selfish, possessive love
Clematis – dreaming of the future without working in the present
Crab Apple – the cleansing remedy, also for self-hatred
Elm – overwhelmed by responsibility
Gentian – discouragement after a setback
Gorse – hopelessness and despair
Heather – self-centredness and self-concern
Holly – hatred, envy and jealousy
Honeysuckle – living in the past
Hornbeam – procrastination, tiredness at the thought of doing something
Impatiens – impatience
Larch – lack of confidence
Mimulus – fear of known things
Mustard – deep gloom for no reason
Oak – the plodder who keeps going past the point of exhaustion
Olive – exhaustion following mental or physical effort
Pine – guilt
Red Chestnut – over-concern for the welfare of loved ones
Rock Rose – terror and fright
Rock Water – self-denial, rigidity and self-repression
Scleranthus – inability to choose between alternatives
Star of Bethlehem – shock
Sweet Chestnut – extreme mental anguish, when everything has been tried and there is no light left
Vervain – over-enthusiasm
Vine – dominance and inflexibility
Walnut – protection from change and unwanted influences
Water Violet – pride and aloofness
White Chestnut – unwanted thoughts and mental arguments
Wild Oat – uncertainty over one’s direction in life
Wild Rose – drifting, resignation, apathy
Willow – self-pity and resentment
Rescue Remedy, a combination remedy made up of five different remedies, is promoted against anxiety and stress.

 

  1. There are only few clinical trials of Bach flower remedies. Collectively, they fail to show that they are effective beyond placebo. A systematic review of all 7 studies concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos.[1]
  2. Since they do not contain any pharmacologically active molecules (other than alcohol), Bach flower remedies are unlikely to cause adverse effects other than those to the consumer’s wallet.
  3. Considering that Bach flower remedies are not effective, their risk/benefit balance cannot be positive.

 

 

PLAUSIBILITY Negative
EFFICACY Negative
SAFETY Positive
COST Negative
RISK/BENEFIT BALANCE Negative

 

[1] https://www.ncbi.nlm.nih.gov/pubmed/20734279

____________________________________________________________

And what did the journal in fact publish? Here is an excerpt from a truly remarkable article that just appeared in the Archives of Psychiatric Nursing:

… Bach Flowers are liquids that come in 10 and 20 ml “mother” bottles. The liquids are the essence of the substance used in the remedy preserved in a small amount of brandy. As is the case with homeopathic remedies, Bach Flowers are essences or energetic remedies.

Two drops from the mother bottle of the specific Bach Flower remedy are placed in a 1 oz glass dropper bottle that is filled with water. Because the Bach system is an energetic plant remedy system, using more than two drops in a bottle is not harmful but is also unnecessary as it is not more useful. The most important part in the use of the system is picking the correct remedy. There are books and the original Bach website (www.bachcentre.com) that provide Bach’s descriptions of the patterns of behaviors and health patterns associated with each of the remedies. For example, those who feel overwhelmed by their responsibilities can try taking “elm.”

The remedies are also powerful healers in infants and children. Behavior changes can be immediate with the use of the right remedy at the right time. The key is getting to know well the specific patterns of each of the 38 healers. The nurse who is knowledgeable of the 38 healers can then better perceive the patterns reflected in the infant’s behavior and then suggest the remedies that parents might want to read about. For example, walnut is used for those experiencing emotional difficulties related to transition and change. When a new infant is born, other children go through significant change and transition in their view of the world which is their family. Walnut can help all of the children if and when they exhibit signs of distress. Walnut is also helpful when infants are teething. Parents often ask whether a person who is allergic to walnuts would be allergic to the walnut flower essence Bach remedy. “The active ingredient in a flower remedy is an energy from the plant, not a physical substance” (Bach Centre, n.d..). It should not cause allergic reactions and should not interfere with the physical action of other remedies and medicines.

Illness is defined by Bach as it is in many healing traditions as the stagnation of energy flow. The remedies help to move people through emotion; they do not suppress emotions. Bach writes that, “the action of these remedies is to raise our vibrations and open up our channels for the reception of our Spiritual Self, to flood our natures with a particular virtue we need, and wash out from us the fault which is causing harm. They are able like beautiful music…to raise our very natures, and bring us nearer to our Souls…They cure not by attacking disease, but by flooding our bodies with the beautiful vibrations of our Higher Nature, in the presence of which disease melts as snow in the sunshine” (Howard & Ramsell, 1990, p. 62).

The Bach remedies move emotions but they do so very gently. Two drops of any remedy diluted in 1 oz of water can be put in the infant’s mouth or on their skin. One way to get to know the Bach Flower remedy system is to try the Rescue Remedy first, a combination of five of the 38 healers used in cases of stress, anxiety, and trauma. Four drops of Rescue Remedy can be put into any size container of water and then given in sips to help infants experiencing intense stress. For example, I once had to participate in the suturing of the forehead of a two-year-old. He was brought to the clinic by his father, a veteran who had seen combat. The child, who was normally curious and friendly, was wild with fear. He thrashed about with his head throwing blood everywhere. The nurses had a standing order to give Rescue Remedy to any patient and so we got permission from the dad and squirted a dropper of the remedy in his mouth while telling him that the flower remedy would help. It did. The child immediately stopped his thrashing. He did not stop crying or saying “no” as he held onto his father’s hand. But he was whimpering rather than thrashing about as we took care of his wound. The trauma and subsequent memory were abated.

____________________________________________________________________

YES, FOR ONCE, I AM SPEACHLESS.

Dr Tony Pinkus has been featured on this blog before. The reason for this is that he claimed – falsely, of course – I have ‘faked’ research data. Recently, he re-appeared on my radar when he (or another spokesperson of his firm) was quoted in The Telegraph accusing me of ‘ignorance’. Subsequently, Mr Ullman published this letter by Pinkus to the TIMES journalist, Rosie Taylor, in the comments section of my previous blog-post:

Dear Rosie,

Its clearly a very slow summer as this is a very old story being peddled by an arch skeptic of homoeopathy who is little more than a charlatan himself.

The well respected researcher Professor Robert Hahn recently stated, at a research conference in London, that, in order to agree with Ernst’s castigation of homoeopathy you would literally have to ignore over 90% of the high quality research material already published.

Ernst has made a name for himself by criticising homoeopathy and attacking HRH The Prince of Wales for his life long support of the therapy. Meanwhile this upstart, with an unhealthy interest in Nazi medicine, has risen to prominence by taking a position as the first professor of complementary medicine in a chair supported wholly by a British philanthropist who provided the money based on his beneficial experiences of homoeopathy.

To comment on a single remedy without context or appreciation of the wider principles of the subject would be akin to understanding how your car works by examining the tread of the near side tyre. As such I refuse to lend currency to his idiocy and your paper’s promotion of it as science. He has no understanding of the principles and continues to demonstrate his ignorance with ludicrous remarks. This is scientism not science.

Under his misguidance of a bunch of ignorant sceptics, a large number or poor and aged patients have been deprived of the benefits of homoeopathy on the NHS, hitherto available since the inception of the system in 1948. Five private hospitals dedicated to homoeopathic practice, that were built by private donations from wealthy benefactors were ceded to the NHS have been lost as a result.

In a crucial time when antibiotics are failing and we need more natural solutions people like Ernst are masquerading as heroes when in fact they are villains.

Kind regards

Tony Pinkus
Director
Ainsworths

_______________________________________________________________

Naturally, I wanted to learn more about a man who can compose such charming letters. Who exactly is he, and what brings him to putting such liable nonsense on paper? Here is how Pinkus describes himself:

Tony Pinkus qualified as a pharmacist in 1980 and accepted the offer to take over Ainsworths Homeopathic Pharmacy when John Ainsworth retired in 1989. Having learnt from John Ainsworth, Tony went on to teach homoeopathic practitioners including doctors, vets, and dentists at both the Faculty of Homoeopathy and The College of Homoeopathic Education amongst others both in the UK and overseas. Tony has co-written five books on the homoeopathic treatment of animals with homoeopathic vet Mark Elliott and herdsman Philip Handsford. He also wrote self-help books for the kits and a self-help, interactive computer program for the OTC range. Tony is the grantee of two Royal Warrants of Appointment to HM The Queen and HRH The Prince of Wales and previously HM The Queen Mother. In this position he is consulted on matters concerning homoeopathic remedies by The Royal Family. 

Interesting?

Not really!

But I did find something that fascinated me: a pilot study of homeopathy for children with autism and ASD which Pinus conducted in 1998 and published in 2015. Here are some excerpts from it:

Over 3000 children received homoeopathic secretin sufficient for the period of the pilot study and each parent received a questionnaire to complete and return. Oral reports were received from 6 weeks to 18 months during which homoeopathic secretin was in continual use. Written reports were received from a number of patients and 159 completed questionnaires were returned, forming the basis of the graph below. This number was less than expected but nonetheless representative of the responses obtained by continued contact with the patient group.

CONCLUSIONS

The results demonstrate an incremental benefit from possible to moderate change observed in 12 key symptoms of ASD over the seven weeks of recording. There is a clear variation in benefit over the symptom range and direct communication faculties improve more significantly than behavior patterns. Eye contact and vocalization being the most profound and immediate changes observed. Continued use beyond the study period maintained the upward trend demonstrated in the first seven weeks. The individual variation in response between patients was also quite large with some children fairing well above average and others below average, hence the results understate the actual picture that can occur, whilst it must be appreciated that secretin will not help all cases. The negative value for a worsening of symptoms was unwise in retrospect as this is generally indicative of a positive outcome with homoeopathic treatment and in experience undervalued the outcome of the symptom when further examined.

The modest aim of this pilot study was met insofar that a large sample size, far greater than in any trial to date, reported incremental beneficial improvement to their ASD symptoms over a seven week period with many concurrent reports of a profound change in the child as a whole person. Many children were able to reduce stringent diets or stop taking Ritalin and Risperidone as a consequence of taking secretin. At least one report has been received of a child taking homoeopathic secretin for over seven years

As to why homoeopathy has been less successful than anticipated, the results indicate a clear reason. Each meal that a child consumes acts as a maintaining cause for their symptoms and as such a block to individually chosen treatment. By taking a regular dose of homoeopathic secretin the maintaining cause is offset enabling other remedies to act more significantly. In addition it became apparent that increasing size of dose increases effect (2-6 drops) and this was necessary over longer term use of the remedy. Homoeopathic secretin was also found to potentiate the action of the injected secretin, in particular increasing its longevity from six to nine weeks.

The outcome of this study has been discussed with many homoeopathic practitioners who have as a consequence changed their management of ASD cases. It has also promoted a further clinical pilot study of the use of homoeopathic secretin in autistic adolescents.

_____________________________________________________________________

Pinkus added comments to his pilot study, evidently made at the time of its publication (2015). There I found this remarkable statement: ‘If you look at Wakefields work here it fits in nicely.’

Here I don’t want to comment on the abysmal quality of Pinkus’ study (too obvious to mention, I think). What I do want to mention, however, is the fact that, in his study, I don’t find any mention of an approval from an ethics committee to carry out this study. Could it be that I have missed it? Or might Pinus be in violation of research ethics? If the latter is the case, should the Royal Warrants (see above) not be withdrawn as a matter of urgency? After all, it is Pinkus personally who ‘is the grantee of two Royal Warrants of Appointment to HM The Queen and HRH The Prince of Wales’!

Yes, I have just published another book! It is entitled ALTERNATIVE MEDICINE, A CRITICAL ASSESSMENT OF 150 MODALITIES.

And yes, I would like you to read it! (You don’t need to buy it, go to your library and ask them to order it.)

Therefore, allow me to try and whet your appetite by simply copying the preface of my book here:

 

In their famous editorial of 1998, Angell and Kassirer concluded that “It is time for the scientific community to stop giving alternative medicine a free ride. There cannot be two kinds of medicine — conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work. Once a treatment has been tested rigorously, it no longer matters whether it was considered alternative at the outset. If it is found to be reasonably safe and effective, it will be accepted. But assertions, speculation, and testimonials do not substitute for evidence. Alternative treatments should be subjected to scientific testing no less rigorous than that required for conventional treatments.”[1]

Twenty years later, alternative medicine remains popular and assertions, speculation, and testimonials still substitute for evidence. We are still being inundated with misleading advice, biased opinions, uncritical evaluations, commercially-driven promotion and often even fraudulently wrong conclusions. Consequently, consumers find it hard to access reliable data. As a result, they often make misguided, sometimes even dangerously wrong decisions.

I have researched alternative medicine for more than 25 years. Through this work, I have gathered a wealth of knowledge, facts and experience. In this book, I have summarised the essentials into an easily accessible text. My book offers an introduction into the most important issues around alternative medicine as well as a concise, evidence-based analysis of 150 alternative therapies and diagnostic techniques.

Such information is surely a good thing, but it should nevertheless come with a warning: it may not please everybody! If you are a believer in alternative medicine who does not care about the facts, or an enthusiast for whom alternative medicine has become some sort of a religion, or a person who thinks that science is less important than anecdote, you better return this book to its shelf; reading it will only disquiet you.

If, however, you are looking for the facts about alternative medicine, trust in science, prefer critical assessment to commercial promotion, it might well be a book for you.

I hope that you belong to the latter group and trust it will help you making the right therapeutic decisions for yourself and your family.

[1] http://www.kitsrus.com/pdf/nejm_998.pdf

 

PS

If you want to publish a book review, please contact me and I will see that you get a free e-book.

The use of  so-called alternative medicine (SCAM) for changing the natural history of cancer (rather than for alleviating symptoms) is a dangerous thing. Here is yet another study confirming this statement.

The purpose of this cross-sectional study was to investigate the patterns of SCAM use and its association with time to conventional treatment. The study was performed in Thailand at the Chonburi Cancer Hospital. Chart reviews and interviews were performed for 426 patients with various cancers between May and December 2018.

The results indicated that 45% of all patients reported using SCAMs; herbal products were the most common type. Approximately 34% of these medicines involved unlabelled herbal products with unidentifiable components. The rates of SCAM use were significantly elevated for men and for patients with stage IV cancer. The multivariable linear regression analysis of the relationship between factors and the time until conventional treatment was received revealed that the regression coefficient of the use of SCAM was 56.3 (95% confidence interval [27.9-84.6]). This coefficient corresponded to an additional 56.3 days of time until conventional treatment, relative to patients who did not use SCAM.

The authors concluded that these findings demonstrated that there is a relatively moderate prevalence of CAM use among Thai cancer patients, with most of the CAM treatments involving homemade herbal products. The use of CAM was significantly associated with a prolonged time to conventional treatment. Nevertheless, these findings do not imply that CAM should be banned for all patients, although healthcare providers should recommend that patients aim to use CAM treatments that are considered safe and will not interfere with conventional treatments.

This study would in itself not be very important. Its relevance, in my view, lies in the fact that it is an independent confirmation of many studies published previously showing that cancer patients ought to be cautious about SCAM; for instance:

My recommendation to people who have been diagnosed with cancer is to resist the many temptations and promises of SCAM, discuss the issues with their oncology team, and follow their advice. This may sound a little boring, but it just might save your life.

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