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

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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)?

________________________________________________________________

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.

Researchers from the National Institute of Homoeopathy (an autonomous organisation under the Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy, Government of India) tested a Dysentery Compound (DC), a ‘bowel nosode’, against individualized homeopathy (IH) in the treatment of irritable bowel syndrome (IBS). For this purpose, they used an open, randomized (1:1), parallel arms, pragmatic, non-inferiority, pilot trial with 60 IBS patients. IBS Quality of Life (IBS-QOL) questionnaire was used as the primary outcome measure; assessed at baseline and after 3 months.

Six subjects dropped out. Groups were comparable at baseline (all p>0.01). Though intra-group changes were higher favouring IH over DC, group differences were statistically non-significant (all p>0.01). Non-inferiority was not demonstrated by DC against IH over 3 months (mean difference= −3.3, SE=5.2, lower 95% confidence limit −11.9, t= −0.453, p=0.674). No adverse events were reported from either group.

The authors concluded that non-inferiority of DC against IH in treatment of IBS was not demonstrated though it appeared as safe; still, being a pilot trial, no definite conclusion could be drawn. Further exploration of both efficacy and effectiveness of either of the therapies is necessary by adequately powered trials and independent replications.

This trial is a treasure trove of methodological flaws. Here I want to focus on merely one of them: The idea of conducting a non-inferiority study of two treatments, none of which have previously been shown to be effective.

Most clinical trials are ‘superiority studies’ designed to test whether one treatment is more effective than another one. This is fundamentally different in non-inferiority or equivalence studies. They aim to test whether one treatment is as effective as another therapy that has already been fully researched and is generally accepted to be effective for the condition in question. This approach avoids the ethical problems that can arise in superiority studies from giving placebos to patients who require an effective treatment for their condition. Equivalence studies can have many of the features of superiority studies but require a different statistical approach and usually need much larger sample sizes.

This means that the new study never had the slightest chance to generate a result that was in any way meaningful. Such a waste of resources is hardly surprising in the realm of homeopathy; over the years, we have become used to it. But, coming from the National Institute of Homeopathy, it is significant. On their website, the Institute claims this:

The mission of National Institute of Homoeopathy is to foster excellence in Homoeopathic Medical Education and Research, to educate and train undergraduate, post graduate students and research scholars of homoeopathy in accordance with highest professional standards and ethical values unfettered by the barriers of nationality, language, culture, plurality, religion and to meet the healthcare needs of the community through dissemination of knowledge and service. 

Excellence in homeopathic research?

Well, you could have fooled me!

 

I was alerted to this recent and most interesting announcement by the Australian Government:

From 1 April 2019 the following natural therapies will be excluded from the definition of private health insurance general treatment and will no longer receive the private health insurance rebate as part of a general treatment policy: Alexander technique, aromatherapy, Bowen therapy, Buteyko, Feldenkrais, Western herbalism, homeopathy, iridology, kinesiology, naturopathy, Pilates, reflexology, Rolfing, shiatsu, tai chi, and yoga.

Rules have been made to exclude these natural therapies from the definition of general treatment under section 121-10 of the Private Health Insurance Act 2007. Insurers will then not be able to offer benefits for these therapies as part of a complying health insurance policy.

Insurers can offer incentives to purchasers of private health insurance as long as the incentives meet the requirements of the Private Health Insurance (Complying Product) Rules. These incentives could include services provided by a natural therapist. It will be up to each insurer to decide whether to offer this type of incentive.

Consumers will still be able to choose to access these natural therapies outside the private health insurance system.

Why is this important?

A review chaired by the former Commonwealth Chief Medical Officer found there is no clear evidence demonstrating the efficacy of the excluded natural therapies.

This review was informed by an evaluation of the evidence undertaken by the National Health and Medical Research Council (NHMRC). NHMRC was tasked with reviewing scientific literature examining the effectiveness and, where available, the safety and cost effectiveness of 17 natural therapies. This was conducted in line with NHMRC’s approach to assessing evidence, and was undertaken for the specific purpose of informing the Australian Government’s Natural Therapies Review.

Changing coverage for the excluded natural therapies will ensure taxpayer funds are spent appropriately and are not directed to therapies that do not demonstrate evidence of clinical efficacy.

Who will benefit?

Around 54 per cent of the Australian population is covered by general treatment (extras) insurance. Changing coverage for the excluded natural therapies will remove costs from the system and contribute to reducing private health insurance premium growth.

What impact will this change have on private health insurance?

This change will contribute to reducing private health insurance premium price increases.

_____________________________________________________________________

The attempt to make health insurance more evidence based is no doubt laudable. I therefore commend this decision and hope other countries are following suit. Despite my general agreement, I feel compelled to make a few critical comments:

  1. Some of the banned treatments are not entirely devoid of good evidence. I am thinking of herbalism and tai chi, for instance.
  2. Iridology is a diagnostic technique and not a ‘natural therapy’.
  3. The term ‘natural therapy’ is of debatable value: not all of the listed modalities are natural (nothing natural about homeopathy, for instance). Personally, I much prefer ‘so-called alternative medicine (SCAM).
  4. I can think of many more SCAMs that should be on this list.

It will be fascinating to see whether the stated prediction that the ban will reduce health insurance premiums will be borne out by data. Many SCAM enthusiasts have in the past argued that it will have the opposite effect. Therefore, it would seem very important that the economic effects of this decision are being accurately monitored and that, in time, the results are analysed and published.

This article reports that Medicare is exploring whether to pay for acupuncture. Coverage would be for chronic low-back pain only. In its request for comments on acupuncture, the Department of Health and Human Services said that “in response to the U.S. opioid crisis, HHS is focused on preventing opioid use disorder and providing more evidence-based non-pharmacologic treatment options for chronic pain.” The agency said it hopes “to determine if acupuncture for [chronic low-back pain] is reasonable and necessary under the Medicare program.” A proposal is due by July 15, with a final decision by Oct. 13.

Medicare coverage “is long overdue,” said Tony Y. Chon, director of integrative medicine and health at the Mayo Clinic in Minnesota. “The opioid epidemic is going to be the momentum that’s really needed to push not just acupuncture but other kinds of non-pharmacological interventions to the forefront.”

Some proponents also note that acupuncture is one of the safest interventions available for pain — though some accidents have been reported. Even if it works only for some people, they argue, there is little harm in trying it when other options are not effective.

However, research shows that acupuncture is little more effective than placebo in many cases. When the government’s Agency for Healthcare Research and Quality reviewed research on a wide range of therapies for chronic pain in 2018, it found the “strength of evidence” that acupuncture works for chronic low-back pain is “low.”

The National Center for Complementary and Integrative Health, part of NIH, says “research suggests that acupuncture can help manage certain pain conditions, but evidence about its value for other health issues is uncertain.”

Critics go further, noting that hundreds of years of anatomical studies have not found evidence of the points in the body linked to the “energy channels” that acupuncture claims to be stimulating to provide pain relief. They contend that acupuncture shows all the signs of the placebo effect, with providers and recipients who believe it works and the elaborate ritual of placing the needles in specially selected spots. “The whole thing is a big scam,” said Steven Novella, an assistant professor of neurology at the Yale School of Medicine and editor of the “Science-Based Medicine” website. “The only honest interpretation of the data is that acupuncture is a theatrical placebo.” Novella said that the efficacy attributed to acupuncture could easily be explained by various research biases and that no drug would be allowed on the market based on that level of proof. “We never get that threshold of evidence that you need in medicine, where you get that persistent effect, and it’s replicable” across numerous studies, he said.

The evidence is indeed far from clear. NICE stated that it no longer recommends acupuncture because the evidence is not strong. Others have shown that acupuncture is superior to sham as well as no acupuncture control for back pain, with differences between groups close to .5 SDs compared with no acupuncture control, and close to .2 SDs compared with sham.

A further systematic review stated that acupuncture provides a short-term clinically relevant effect when compared with a waiting list control or when acupuncture is added to another intervention. Yet another systematic review found that acupuncture for chronic nonspecific low back pain was associated with significantly lower pain intensity than placebo but only immediately post-treatment (VAS: -0.59, 95 percent CI: -0.93, -0.25). However, acupuncture was not different from placebo in post-treatment disability, pain medication intake, or global improvement in chronic nonspecific low back pain. Acupuncture did not differ from sham-acupuncture in reducing chronic non-specific neck pain immediately after treatment (VAS: 0.24, 95 percent CI: -1.20, 0.73). Acupuncture was superior to no treatment in improving pain intensity (VAS: -1.19, 95 percent CI: 95 percent CI: -2.17, -0.21), disability (PDI), functioning (HFAQ), well-being (SF-36), and range of mobility (extension, flexion), immediately after the treatment. In general, trials that applied sham-acupuncture tended to produce negative results (i.e., statistically non-significant) compared to trials that applied other types of placebo (e.g., TENS, medication, laser). Results regarding comparisons with other active treatments (pain medication, mobilization, laser therapy) were less consistent Acupuncture was more cost-effective compared to usual care or no treatment for patients with chronic back pain.

The recent Lancet papers excited alternative therapists and their organisations who quickly jumped on the LBP  bandwagon. Others have claimed that my often critical verdicts of alternative therapies for LBP are out of line with this evidence. I am broadly in agreement with the evidence presented in Lancet-paper! But I also want to caution that things are complex.

I have therefore copied the non-pharmacological, non-operative treatments listed in the Lancet-paper together with the authors’ verdicts regarding their effectiveness for both acute and persistent LBP. I feel compelled to point out that the Lancet-paper merely lists the effectiveness of several therapeutic options, and that the value of a treatment is not only determined by its effectiveness. Crucial further elements are a therapy’s cost and its risks, the latter of which also determines the most important criterion: the risk/benefit balance. In my version of the Lancet table, I have therefore added these three variables for non-pharmacological and non-surgical options:

EFFECTIVENESS ACUTE LBP EFFECTIVENESS PERSISTENT LBP RISKS COSTS RISK/BENEFIT BALANCE
Advice to stay active +, routine +, routine None Low Positive
Education +, routine +, routine None Low Positive
Superficial heat +/- Ie Very minor Low to medium Positive (aLBP)
Exercise Limited +/-, routine Very minor Low Positive (pLBP)
CBT Limited +/-, routine None Low to medium Positive (pLBP)
Spinal manipulation +/- +/- vfbmae
sae
High Negative
Massage +/- +/- Very minor High Positive
Acupuncture +/- +/- sae High Questionable
Yoga Ie +/- Minor Medium Questionable
Mindfulness Ie +/- Minor Medium Questionable
Rehab Ie +/- Minor Medium to high Questionable

Routine = consider for routine use

+/- = second line or adjunctive treatment

Ie = insufficient evidence

Limited = limited use in selected patients

vfbmae = very frequent, minor adverse effects

sae = serious adverse effects, including deaths, are on record

aLBP = acute low back pain

So, should Medicare pay for acupuncture or any other SCAM? Please advise!

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