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

conflict of interest

You may remember my post entitled “How turn a negative trial into a positive one? Simple, just cheat!

No?

Let me remind you by copying the relevant parts of my original post of 20/2/2018:

…The purpose of their study was to examine the feasibility of Sipjeondaebo-tang (Juzen-taiho-to, Shi-Quan-Da-Bu-Tang) for cancer-related anorexia. A total of 32 participants with cancer anorexia were randomized to either Sipjeondaebo-tang group or placebo group. Participants were given 3 g of Sipjeondaebo-tang or placebo 3 times a day for 4 weeks. The primary outcome was a change in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes included Visual Analogue Scale (VAS) of anorexia, FAACT scale, and laboratory tests.

The results showed that anorexia and quality of life measured by FAACT and VAS were improved after 4 weeks of Sipjeondaebo-tang treatment. However, there was no significant difference between changes of Sipjeondaebo-tang group and placebo group.

From this, the authors of the study concluded that sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy.

Well, isn’t this just great? Faced with a squarely negative result, one simply ignores it and draws a positive conclusion!

As we all know – and as trialists certainly must know – controlled trials are designed to compare the outcomes of two groups. Changes within one of the groups can be caused by several factors unrelated to the therapy and are therefore largely irrelevant. This means that “no significant difference between changes of Sipjeondaebo-tang group and placebo group” indicates that the herbal mixture had no effect. In turn this means that a conclusion stating that “sipjeondaebo-tang appears to have potential benefit for anorexia” is just fraudulent.

This level of scientific misconduct is remarkable, even for the notoriously poor ..

END OF QUOTE

This article prompted me to do something I have only done once before: I filed an official complaint with the journal. I received a reply that they would look into it. Then there was silence; then came 2 or 3 emails that they are still considering my complaint. Yesterday, I finally received the following response:

Dear Dr. Ernst,

With reference to our correspondence below, thank you again for raising this matter, we appreciate your careful attention to the reporting of this article.  The authors have apologized for the error and said they did not check the abstract carefully enough when revising the article. The board decided that this may be addressed by publishing a corrigendum; please find the notice attached to this email.  Please let us know if you would like to be acknowledged in the notice for raising this issue, e.g. as follows: “This error in the reporting was brought to the attention of the journal by Prof. Edzard Ernst, Emeritus Professor of Complementary Medicine, University of Exeter.”

I look forward to hearing from you.

Kind regards…

And the attachment reads as follows:

Corrigendum to “Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial”
Dear Dr. Ernst,

With reference to our correspondence below, thank you again for raising this matter, we appreciate your careful attention to the reporting of this article. The authors have apologized for the error and said they did not check the abstract carefully enough when revising the article. The board decided that this may be addressed by publishing a corrigendum; please find the notice attached to this email. Please let us know if you would like to be acknowledged in the notice for raising this issue, e.g. as follows: “This error in the reporting was brought to the attention of the journal by Prof. Edzard Ernst, Emeritus Professor of Complementary Medicine, University of Exeter.”

I look forward to hearing from you.

Kind regards…
Chunhoo Cheon,1 Jeong-Eun Yoo,2 Hwa-Seung Yoo,2 Chong-Kwan Cho,2 Sohyeon Kang,1 Mia Kim,3 Bo-Hyoung Jang,1 Yong-Cheol Shin,1 and Seong-Gyu Ko1

1Department of Preventive Medicine, Korean Medical College, Kyung Hee University, Seoul, Republic of Korea 2Dunsan Korean Medicine Hospital of Daejeon University, Daejeon, Republic of Korea 3Department of Cardiovascular and Neurologic Disease (Stroke Center), College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea

In the article titled “Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial” [1], there was an error in the conclusion of the Abstract where the text reading “Sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy” should be corrected to “In the present study, Sipjeondaebo-tang did not show a significant effect on anorexia in patients with cancer. Further large-scale studies which compensate for the limitations of this study are needed to assess the efficacy”.

References

1. Chunhoo Cheon, Jeong-Eun Yoo, Hwa-Seung Yoo, et al., “Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial,” Evidence-Based Complementary and Alternative Medicine, vol. 2017, Article ID 8780325, 9 pages, 2017. doi:10.1155/2017/8780325


So, what should we make of all this?

On the one hand, it is laudable that the Journal does correct the mistake. Bravo!!!

On the other hand, I find it odd that only the authors seem to be found guilty of an ‘error’. Even if it was just a error – and I am happy to give them the benefit of the doubt – there are other parties involved. The reviewers have a responsibility and so does the editor! Should they not own up to it?

In the end, this sorry tale does not restore my confidence in this Journal, quite the opposite. In view of all this, I have to repeat what I stated in my previous post:

I strongly suggest that:

  1. The journal is de-listed from Medline because similarly misleading nonsense has been coming out of this rag for some time.
  2. The paper is withdrawn because it can only mislead vulnerable patients.

PS

Needless to say that my reply to the above-cited email was to uphold my complaint and urge the Journal to publish an adequate response that includes and explains the failures of the reviewers and the editor. So: watch this space!

Amongst all the implausible treatments to be found under the umbrella of ‘alternative medicine’, Reiki might be one of the worst, i. e. least plausible and outright bizarre (see for instance here, here and here). But this has never stopped enthusiasts from playing scientists and conducting some more pseudo-science.

This new study examined the immediate symptom relief from a single reiki or massage session in a hospitalized population at a rural academic medical centre. It was designed as a retrospective analysis of prospectively collected data on demographic, clinical, process, and quality of life for hospitalized patients receiving massage therapy or reiki. Hospitalized patients requesting or referred to the healing arts team received either a massage or reiki session and completed pre- and post-therapy symptom questionnaires. Differences between pre- and post-sessions in pain, nausea, fatigue, anxiety, depression, and overall well-being were recorded using an 11-point Likert scale.

Patients reported symptom relief with both reiki and massage therapy. Reiki improved fatigue and anxiety  more than massage. Pain, nausea, depression, and well being changes were not different between reiki and massage encounters. Immediate symptom relief was similar for cancer and non-cancer patients for both reiki and massage therapy and did not vary based on age, gender, length of session, and baseline symptoms.

The authors concluded that reiki and massage clinically provide similar improvements in pain, nausea, fatigue, anxiety, depression, and overall well-being while reiki improved fatigue and anxiety more than massage therapy in a heterogeneous hospitalized patient population. Controlled trials should be considered to validate the data.

Don’t I just adore this little addendum to the conclusions, “controlled trials should be considered to validate the data” ?

The thing is, there is nothing to validate here!

The outcomes are not due to the specific effects of Reiki or massage; they are almost certainly caused by:

  • the extra attention,
  • the expectation of patients,
  • the verbal or non-verbal suggestions of the therapists,
  • the regression towards the mean,
  • the natural history of the condition,
  • the concomitant therapies administered in parallel,
  • the placebo effect,
  • social desirability.

Such pseudo-research only can only serve one purpose: to mislead (some of) us into thinking that treatments such as Reiki might work.

What journal would be so utterly devoid of critical analysis to publish such unethical nonsense?

Ahh … it’s our old friend the Journal of Alternative and Complementary Medicine

Say no more!

I have often criticised papers published by chiropractors.

Not today!

This article is excellent and I therefore quote extensively from it.

The objective of this systematic review was to investigate, if there is any evidence that spinal manipulations/chiropractic care can be used in primary prevention (PP) and/or early secondary prevention in diseases other than musculoskeletal conditions. The authors conducted extensive literature searches to locate all studies in this area. Of the 13.099 titles scrutinized, 13 articles were included (8 clinical studies and 5 population studies). They dealt with various disorders of public health importance such as diastolic blood pressure, blood test immunological markers, and mortality. Only two clinical studies could be used for data synthesis. None showed any effect of spinal manipulation/chiropractic treatment.

The authors concluded that they found no evidence in the literature of an effect of chiropractic treatment in the scope of PP or early secondary prevention for disease in general. Chiropractors have to assume their role as evidence-based clinicians and the leaders of the profession must accept that it is harmful to the profession to imply a public health importance in relation to the prevention of such diseases through manipulative therapy/chiropractic treatment.

In addition to this courageous conclusion (the paper is authored by a chiropractor and published in a chiro journal), the authors make the following comments:

Beliefs that a spinal subluxation can cause a multitude of diseases and that its removal can prevent them is clearly at odds with present-day concepts, as the aetiology of most diseases today is considered to be multi-causal, rarely mono-causal. It therefore seems naïve when chiropractors attempt to control the combined effects of environmental, social, biological including genetic as well as noxious lifestyle factors through the simple treatment of the spine. In addition, there is presently no obvious emphasis on the spine and the peripheral nervous system as the governing organ in relation to most pathologies of the human body.

The ‘subluxation model’ can be summarized through several concepts, each with its obvious weakness. According to the first three, (i) disturbances in the spine (frequently called ‘subluxations’) exist and (ii) these can cause a multitude of diseases. (iii) These subluxations can be detected in a chiropractic examination, even before symptoms arise. However, to date, the subluxation has been elusive, as there is no proof for its existence. Statements that there is a causal link between subluxations and various diseases should therefore not be made. The fourth and fifth concepts deal with the treatment, namely (iv) that chiropractic adjustments can remove subluxations, (v) resulting in improved health status. However, even if there were an improvement of a condition following treatment, this does not mean that the underlying theory is correct. In other words, any improvement may or may not be caused by the treatment, and even if so, it does not automatically validate the underlying theory that subluxations cause disease…

Although at first look there appears to be a literature on this subject, it is apparent that most authors lack knowledge in research methodology. The two methodologically acceptable studies in our review were found in PubMed, whereas most of the others were identified in the non-indexed literature. We therefore conclude that it may not be worthwhile in the future to search extensively the non-indexed chiropractic literature for high quality research articles.

One misunderstanding requires some explanations; case reports are usually not considered suitable evidence for effect of treatment, even if the cases relate to patients who ‘recovered’ with treatment. The reasons for this are multiple, such as:

  • Individual cases, usually picked out on the basis of their uniqueness, do not reflect general patterns.
  • Individual successful cases, even if correctly interpreted must be validated in a ‘proper’ research design, which usually means that presumed effect must be tested in a properly powered and designed randomized controlled trial.
  • One or two successful cases may reflect a true but very unusual recovery, and such cases are more likely to be written up and published as clinicians do not take the time to marvel over and spend time on writing and publishing all the other unsuccessful treatment attempts.
  • Recovery may be co-incidental, caused by some other aspect in the patient’s life or it may simply reflect the natural course of the disease, such as natural remission or the regression towards the mean, which in human physiology means that low values tend to increase and high values decrease over time.
  • Cases are usually captured at the end because the results indicate success, meaning that the clinical file has to be reconstructed, because tests were used for clinical reasons and not for research reasons (i.e. recorded by the treating clinician during an ordinary clinical session) and therefore usually not objective and reproducible.
  • The presumed results of the treatment of the disease is communicated from the patient to the treating clinician and not to a third, neutral person and obviously this link is not blinded, so the clinician is both biased in favour of his own treatment and aware of which treatment was given, and so is the patient, which may result in overly positive reporting. The patient wants to please the sympathetic clinician and the clinician is proud of his own work and overestimates the results.
  • The long-term effects are usually not known.
  • Further, and most importantly, there is no control group, so it is impossible to compare the results to an untreated or otherwise treated person or group of persons.

Nevertheless, it is common to see case reports in some research journals and in communities with readers/practitioners without a firmly established research culture it is often considered a good thing to ‘start’ by publishing case reports.

Case reports are useful for other reasons, such as indicating the need for further clinical studies in a specific patient population, describing a clinical presentation or treatment approach, explaining particular procedures, discussing cases, and referring to the evidence behind a clinical process, but they should not be used to make people believe that there is an effect of treatment…

For groups of chiropractors, prevention of disease through chiropractic treatment makes perfect sense, yet the credible literature is void of evidence thereof. Still, the majority of chiropractors practising this way probably believe that there is plenty of evidence in the literature. Clearly, if the chiropractic profession wishes to maintain credibility, it is time seriously to face this issue. Presently, there seems to be no reason why political associations and educational institutions should recommend spinal care to prevent disease in general, unless relevant and acceptable research evidence can be produced to support such activities. In order to be allowed to continue this practice, proper and relevant research is therefore needed…

All chiropractors who want to update their knowledge or to have an evidence-based practice will search new information on the internet. If they are not trained to read the scientific literature, they might trust any article. In this situation, it is logical that the ‘believers’ will choose ‘attractive’ articles and trust the results, without checking the quality of the studies. It is therefore important to educate chiropractors to become relatively competent consumers of research, so they will not assume that every published article is a verity in itself…

END OF QUOTES

YES, YES YES!!!

I am so glad that some experts within the chiropractic community are now publishing statements like these.

This was long overdue.

How was it possible that so many chiropractors so far failed to become competent consumers of research?

Do they and their professional organisations not know that this is deeply unethical?

Actually, I fear they do and did so for a long time.

Why then did they not do anything about it ages ago?

I fear, the answer is as easy as it is disappointing:

If chiropractors systematically trained to become research-competent, the chiropractic profession would cease to exist; they would become a limited version of physiotherapists. There is simply not enough positive evidence to justify chiropractic. In other words, as chiropractic wants to survive, it has little choice other than remaining ignorant of the current best evidence.

I hear this argument so regularly that it might be worth analysing it (yet again) a bit closer.

It is used with the deepest of convictions by proponents of all sorts of quackery who point out that science does not know or explain everything – and certainly not their (very special) therapy. Science is just not sophisticated enough, they say; in fact, a few years ago, it could not even explain how Aspirin works. And just like Aspirin, their very special therapy – let’s call it energy healing (EH) for the sake of this post – does definitely and evidently work. There even is ample proof:

  • Patients get better after using EH, and surely patients don’t lie.
  • Patients pay for EH, and who would pay for something that does not work?
  • EH has survived hundreds of years, and ineffective therapies don’t.
  • EH practitioners have tons of experience and therefore know best.
  • They are respected by very important people and organisations.
  • EH is even reimbursed by some insurance companies.

You have all heard the argument, I’m sure.

How to respond?

The ‘proofs’ listed above are simply fallacies; as such they do not need more detailed discussions, I hope.

But how can we refute the notion that science is not yet sufficiently advanced to explain EH?

The simplest approach might be to explain that science has already tested EH and found it to be ineffective. There really is nothing more to say. And the often-quoted example of Aspirin does clearly not wash. True, a few decades ago, we did not know how it worked. But we always knew that it worked because we conducted clinical trials, and they generated positive results. These findings we the main reasons why scientists wanted to find out how it works, and eventually they did (and even got a Nobel Prize for it). Had the clinical trials not shown effectiveness, nobody would have been interested in alleged mechanisms of action.

With EH, things are different. Rigorous clinical trials of EH have been conducted, and the totality of this evidence fails to show that EH works. Therefore, chasing after a mechanism of action would be silly and wasteful. It’s true, science cannot explain EH, but this is not because it is not yet sophisticated enough; it is because there is nothing to explain. EH has been disproven, and waffling about ‘science is not yet able to explain it’ is either a deliberate lie or a serious delusion.

So far so good. But what if EH had not been submitted to clinical trials?

In such cases, the above line of argument would not work very well.

For instance, as far as I know, there is not a single rigorous clinical trial of crystal healing (CH). Does that mean that perhaps CH-proponents are correct when claiming that it does evidently work and science simply cannot yet understand how?

No, I don’t think so.

Like most of the untested alternative therapies, CH is not based on plausible assumptions. In fact, the implausibility of the underlying assumptions is the reason why such treatments have not and probably never will be submitted to rigorous clinical trials. Why should anyone waste his time and our money running expensive tests on something that is so extremely unlikely? Arguably doing so would even be unethical.

With highly implausible therapies we need no trials, and we do not need to fear that science is not yet sufficiently advance to explain them. In fact, science is sufficiently advanced to be certain that there can be no explanation that is in line with the known laws of nature.

Sadly, some truly deluded fans of CH might still not be satisfied and respond to our reasoning that we need a ‘paradigm shift’. They might say that science cannot explain CH because it is stuck in the straightjacket of an obsolete paradigm which does not cater for phenomena like CH.

Yet this last and desperate attempt of the fanatics is not a logical refuge. Paradigm shifts are not required because some quack thinks so, they are needed only if data have been emerging that cannot possibly be explained within the current paradigm. But this is never the case in alternative medicine. We can explain all the experience of advocates, positive results of researchers and ‘miracle’ cures of patients that are being reported. We know that the experiences are real, but are sure that their explanations of the experience are false. They are not due to the treatment per se but to other phenomena such as placebo effects, natural history, regression towards the mean, spontaneous recovery, etc.

So, whichever way we turn things, and whichever way enthusiasts of alternative therapies twist them, their argument that ‘SCIENCE IS NOT YET ABLE TO EXPLAIN’ is simply wrong.

The UK ‘COLLEGE OF MEDICINE’ has recently (and very quietly) renamed itself; it now is THE COLLEGE OF MEDICINE AND INTEGRATED HEALTH (COMIH). This takes it closer to its original intentions of being the successor of the PRINCE OF WALES FOUNDATION FOR INTEGRATED MEDICINE (PWFIM), the organisation that had to be shut down amidst charges of fraud and money-laundering. Originally, the name of COMIH was to be COLLEGE OF INTEGRATED HEALTH (as opposed to disintegrated health?, I asked myself at the time).

Under the leadership of Dr Michael Dixon, OBE (who also led the PWFIM into its demise), the COMIH pursues all sots of activities. One of them seems to be publishing ‘cutting-edge’ articles.

A recent and superb example is on the fascinating subject of ‘holistic dentistry‘:

START OF QUOTE

Professor Sonia Williams … explores how integrated oral health needs to consider the whole body, not just the dentition…

Complementary and alternative approaches can also be considered as complementary to ‘mainstream’ care, with varying levels of evidence cited for their benefit.

Dental hypnosis (British Society of Medical and Dental Hypnosis) can help support patients including those with dental phobia or help to reduce pain experience during treatment.

Acupuncture in dentistry (British Society of Dental Acupuncture) can, for instance, assist with pain relief and allay the tendency to vomit during dental care.  There is also a British Homeopathic Dental Association.

For the UK Faculty of General Dental Practitioners, holistic dentistry refers to strengthening the link between general and oral health.

For some others, the term also represents an ‘alternative’ form of dentistry, which may concern itself with the avoidance and elimination of ‘toxic’ filling materials, perceived potential harm from fluoride and root canal treatments and with treating dental malocclusion to put patients back in ‘balance’.

In the USA, there is a Holistic Dental Association, while in the UK, there is the British Society for Mercury-free Dentistry. Unfortunately the evidence base for many of these procedures is weak.

Nevertheless, pressure to avoid mercury in dental restorative materials is becoming mainstream.

In summary, integrated health and care in dentistry can mean different things to different people. The weight of evidence supports the contention that the mouth is an integral part of the body and that attention to the one without taking account of the other can have adverse consequences.

END OF QUOTE

Do I get this right? ‘Holistic dentistry’ in the UK means the recognition that my mouth belongs to my body, and the adoption of a few dubious treatments with w ‘weak’ evidence base?

Well, isn’t this just great? I had no idea that my mouth belongs to my body. And clearly the non-holistic dentists in the UK are oblivious to this fact as well. I am sooooooo glad we got this cleared up.

Thanks COMIH!!!

And what about the alternative treatments used by holistic dentists?

The British Society of Medical and Dental Hypnosis (Scotland) inform us on their website that a trained medical and dental hypnotherapists can help you to deal with a large variety of challenges that you face in your everyday life e.g.

Asthma Migraines
Anxiety & Stress Smoking Cessation
Dental Problems Insomnia
Weight Problems Psychosexual Disorders
Depression Pain Management
Irritable Bowel  And many other conditions

I hasten to add that, for most of these conditions, the evidence fails to support the claims.

The British Society of Dental Acupuncture claim on their website that the typical conditions that may be helped by acupuncture are:

  • TMJ (jaw joint) problems
  • Facial pain
  • Muscle spasm in the head and neck
  • Stress headaches & Migraine
  • Rhinitis & sinusitis
  • Gagging
  • Dry mouth problems
  • Post-operative pain
  • Dental anxiety

I hasten to add that, for most of these conditions, the evidence fails to support the claims.

The British Homeopathic Dental Association claim on their website that studies have shown improved bone healing around implants with Symphytum and reduced discomfort and improved healing time with ulcers and beneficial in oral lichen planus.

I hasten to add that none of these claims are not supported by sound evidence.

The COMIH article is entitled “The mouth reflects whole body health – but what does integrated care mean for dentists?’ So, what does it mean? Judging from this article, it means an amalgam (pun intended) of platitudes, bogus claims and outright nonsense.

Pity that they did not change their name to College of Medicine and Integrated Care – I could have abbreviated it as COMIC!

It’s still ‘HOMEOPATHIC AWARENESS WEEK’. What better time for introducing you to one of the most bewildering aspect of this bizarre therapy?

Homeopathy is not just being promoted as a treatment for humans and animals, it is also advocated for plants. There are plenty of websites about this that give concrete advice such as this one: “Try the key symptom of a remedy that you would normally give to a person, on plants. For example, in cases of freezing where the leaves turn to a light or silvery colour, use Aconite 200 CH. When the leaves are more of a reddish colour use Belladonna 200 CH. Just like with a feverish child. If the child is pale then you know it is an Aconite fever. If is extremely red on the other hand, like a hot tomato, then the remedy is Belladonna. And you see this on the leaves too. You simply convert it one to one.”

Given this school of thought within homeopathy (not even Hahnemann would have dreamt this up), it seems only logical to use plants also for attempts to prove that highly diluted homeopathic remedies are more than pure placebos.

Weird?

Not to homeopaths!

Not even to some academic researchers within the realm of homeopathy.

The authors of this systematic review evaluated publications on plant-based test systems. A literature search was conducted in online databases and specific journals, including publications from 2008 to 2017 dealing with plant-based test systems in homeopathic basic research. To be included, they had to contain statistical analysis and fulfil quality criteria according to a pre-defined manuscript information score (MIS). Publications scoring at least 5 points (maximum 10 points) were assumed to be adequate. They were analysed for the use of adequate controls, outcome and reproducibility.

Seventy-four publications on plant-based test systems were found. Thirty-nine publications were either abstracts or proceedings of conferences and were excluded. From the remaining 35 publications, 26 reached a score of 5 or higher in the MIS. Adequate controls were used in 13 of these publications. All of them described specific effects of homeopathic preparations. The publication quality still varied: a substantial number of publications (23%) did not adequately document the methods used. Four reported on replication trials. One replication trial found effects of homeopathic preparations comparable to the original study. Three replication trials failed to confirm the original study but identified possible external influencing factors. Five publications described novel plant-based test systems. Eight trials used systematic negative control experiments to document test system stability.

The authors concluded that, regarding research design, future trials should implement adequate controls to identify specific effects of homeopathic preparations and include systematic negative control experiments. Further external and internal replication trials, and control of influencing factors, are needed to verify results. Standardised test systems should be developed.

Really, just one (!) replication trial found effects of homeopathic preparations comparable to the original study? And yet the authors do not arrive at the only possible conclusion that is based on the actual data presented?

THE AVAILABLE EVIDENCE FAILS TO SHOW THAT PLANT-BASED TEST SYSTEMS PROVIDE SOUND EVIDENCE TO SUGGEST THAT THEY ARE USEFUL OR THAT HIGHLY DILUTED HOMEOPATHICS ARE DIFFERENT FROM PLACEBOS.

But there are other things which seem odd here. The very first two sentences of the abstract of the above article read as follows: Plant-based test systems have been described as a useful tool for investigating possible effects of homeopathic preparations. The last reviews of this research field were published in 2009/2011.

This is odd because there is a very similar review dated 2015 (what is more, it is by some of the authors who also did the new review); it concluded: Plant models appear to be a useful approach for investigating basic research questions relating to homeopathic preparations, but more independent replication trials are needed in order to verify the results found in single experiments. Adequate controls and SNC experiments should be implemented on a routine basis to exclude false-positive results.

Why do the authors mislead us so badly?

Ahh, I see! They are affiliated to the following institutions:

  • Centre for Complementary Medicine, Faculty of Medicine, Institute for Infection Prevention and Hospital Epidemiology, University of Freiburg, Germany
  • Institute of Integrative Medicine, University of Witten/Herdecke, Witten, Germany
  • Institute of Complementary Medicine, University of Bern, Switzerland.
  • Hiscia Institute, Arlesheim, Switzerland
  • Crystal Lab, Landgoed Roepaen, Ottersum, Netherlands.

Could they have an interest in perpetuating the notion of homeopathy (for plants)?

Could it be that these researchers are less than objective?

So what?

No reason to make a fuss, because no harm done!

Not entirely true: some might choke laughing about the idea of treating plants with highly diluted, shaken water.

This week, I find it hard to decide where to focus; with all the fuzz about ‘Homeopathy Awareness Week’ it is easy to forget that our friends, the chiros are celebrating  Chiropractic Awareness Week (9-15 April). On this occasion, the British Chiropractic Association (BCA), for instance, want people to keep moving to make a positive impact on managing and preventing back and neck pain.

Good advice! In a recent post, I even have concluded that people should “walk (slowly and cautiously) to the office of their preferred therapist, have a little rest there (say hello to the staff perhaps) and then walk straight back home.” The reason for my advice is based on the fact that there is precious little evidence that the spinal manipulations of chiropractors make much difference plus some worrying indications that they may cause serious damage.

It seems to me that, by focussing their PR away from spinal manipulations and towards the many other things chiropractors sometimes do – they often call this ‘adjunctive therapies’ – there is a tacit admission here that the hallmark intervention of chiros (spinal manipulation) is of dubious value.

A recent article entitled ‘Spinal Manipulative Therapy and Other Conservative Treatments for Low Back Pain: A Guideline From the Canadian Chiropractic Guideline Initiative’ seems to confirm this impression. Its objective was to develop a clinical practice guideline on the management of acute and chronic low back pain (LBP) in adults. The specific aim was to develop a guideline to provide best practice recommendations on the initial assessment and monitoring of people with low back pain and address the use of spinal manipulation therapy (SMT) compared with other commonly used conservative treatments.

The topic areas were chosen based on an Agency for Healthcare Research and Quality comparative effectiveness review, specific to spinal manipulation as a non-pharmacological intervention. The panel updated the search strategies in Medline and assessed admissible systematic reviews and randomized controlled trials. Evidence profiles were used to summarize judgments of the evidence quality and link recommendations to the supporting evidence. Using the Evidence to Decision Framework, the guideline panel determined the certainty of evidence and strength of the recommendations. Consensus was achieved using a modified Delphi technique. The guideline was peer reviewed by an 8-member multidisciplinary external committee.

For patients with acute (0-3 months) back pain, we suggest offering advice (posture, staying active), reassurance, education and self-management strategies in addition to SMT, usual medical care when deemed beneficial, or a combination of SMT and usual medical care to improve pain and disability. For patients with chronic (>3 months) back pain, we suggest offering advice and education, SMT or SMT as part of a multimodal therapy (exercise, myofascial therapy or usual medical care when deemed beneficial). For patients with chronic back-related leg pain, we suggest offering advice and education along with SMT and home exercise (positioning and stabilization exercises).

The authors concluded that a multimodal approach including SMT, other commonly used active interventions, self-management advice, and exercise is an effective treatment strategy for acute and chronic back pain, with or without leg pain.

I find this paper most interesting and revealing. Considering that it originates from the ‘Canadian Chiropractic Guideline Initiative’, it is remarkably shy about recommending SMT – after all their vision is “To enhance the health of Canadians by fostering excellence in chiropractic care.” They are thus not likely to be overly critical of the treatment chiropractors use most, i. e. SMT.

Perhaps this is also the reason why, in their conclusion, they seem to have rather a large blind spot, namely the risks of SMT. I have commented on this issue more often than I care to remember. Most recently, I posted this:

The reason why my stance, as expressed on this blog and elsewhere, is often critical about certain alternative therapies is thus obvious and transparent. For none of them (except for massage) is the risk/benefit balance positive. And for spinal manipulation, it even turns out to be negative. It goes almost without saying that responsible advice must be to avoid treatments for which the benefits do not demonstrably outweigh the risks.

 

HAPPY CHIROPRACTIC AWARENESS WEEK EVERYONE!

Since many months, I have noticed a proliferation of so-called pilot studies of alternative therapies. A pilot study (also called feasibility study) is defined as a small scale preliminary study conducted in order to evaluate feasibility, time, cost, adverse events, and improve upon the study design prior to performance of a full-scale research project. Here I submit that most of the pilot studies of alternative therapies are, in fact, bogus.

To qualify as a pilot study, an investigation needs to have an aim that is in line with the above-mentioned definition. Another obvious hallmark must be that its conclusions are in line with this aim. We do not need to conduct much research to find that even these two elementary preconditions are not fulfilled by the plethora of pilot studies that are currently being published, and that proper pilot studies of alternative medicine are very rare.

Three recent examples of dodgy pilot studies will have to suffice (but rest assured, there are many, many more).

Foot Reflexotherapy Induces Analgesia in Elderly Individuals with Low Back Pain: A Randomized, Double-Blind, Controlled Pilot Study

The aim of this study was to evaluate the effects of foot reflexotherapy on pain and postural balance in elderly individuals with low back pain. And the conclusions drawn by its authors were that this study demonstrated that foot reflexotherapy induced analgesia but did not affect postural balance in elderly individuals with low back pain.

Effect of Tai Chi Training on Dual-Tasking Performance That Involves Stepping Down among Stroke Survivors: A Pilot Study.

The aim of this study was to investigate the effect of Tai Chi training on dual-tasking performance that involved stepping down and compared it with that of conventional exercise among stroke survivors. And the conclusions read: These results suggest a beneficial effect of Tai Chi training on cognition among stroke survivors without compromising physical task performance in dual-tasking.

The Efficacy of Acupuncture on Anthropometric Measures and the Biochemical Markers for Metabolic Syndrome: A Randomized Controlled Pilot Study.

The aim of this study was to evaluate the efficacy [of acupuncture] over 12 weeks of treatment and 12 weeks of follow-up. And the conclusion: Acupuncture decreases WC, HC, HbA1c, TG, and TC values and blood pressure in MetS.

It is almost painfully obvious that these studies are not ‘pilot’ studies as defined above.

So, what are they, and why are they so popular in alternative medicine?

The way I see it, they are the result of amateur researchers conducting pseudo-research for publication in lamentable journals in an attempt to promote their pet therapies (I have yet to find such a study that reports a negative finding). The sequence of events that lead to the publication of such pilot studies is usually as follows:

  • An enthusiast or a team of enthusiasts of alternative medicine decide that they will do some research.
  • They have no or very little know-how in conducting a clinical trial.
  • They nevertheless feel that such a study would be nice as it promotes both their careers and their pet therapy.
  • They design some sort of a plan and start recruiting patients for their trial.
  • At this point they notice that things are not as easy as they had imagined.
  • They have too few funds and too little time to do anything properly.
  • This does, however, not stop them to continue.
  • The trial progresses slowly, and patient numbers remain low.
  • After a while the would-be researchers get fed up and decide that their study has enough patients to stop the trial.
  • They improvise some statistical analyses with their results.
  • They write up the results the best they can.
  • They submit it for publication in a 3rd class journal and, in order to get it accepted, they call it a ‘pilot study’.
  • They feel that this title is an excuse for even the most obvious flaws in their work.
  • The journal’s reviewers and editors are all proponents of alternative medicine who welcome any study that seems to confirm their belief.
  • Thus the study does get published despite the fact that it is worthless.

Some might say ‘so what? no harm done!’

But I beg to differ: these studies pollute the medical literature and misguide people who are unable or unwilling to look behind the smoke-screen. Enthusiasts of alternative medicine popularise these bogus trials, while hiding the fact that their results are unreliable. Journalists report about them, and many consumers assume they are being told the truth – after all it was published in a ‘peer-reviewed’ medical journal!

My conclusions are as simple as they are severe:

  • Such pilot studies are the result of gross incompetence on many levels (researchers, funders, ethics committees, reviewers, journal editors).
  • They can cause considerable harm, because they mislead many people.
  • In more than one way, they represent a violation of medical ethics.
  • The could be considered scientific misconduct.
  • We should think of stopping this increasingly common form of scientific misconduct.

In the current issue of the Faculty of Homeopathy‘s Simile publication, Dr Peter Fisher, the Queen’s homeopath, re-visits the old story of the ‘Smallwood Report’. To my big surprise, I found the following two paragraphs in his editorial:

A prepublication draft [of the Smallwood report] was circulated for comment with prominent warnings that it was confidential and not to be shared more widely (I can personally vouch for this, since I was one of those asked to comment). Regrettably, Prof Ernst did precisely this, leaking it to The Times who used it as the basis of their lead story. The editor of The Lancet, Richard Horton, certainly no friend of homeopathy, promptly denounced Ernst for having “broken every professional code of scientific behaviour”.

Sir Michael Peat, the Prince of Wales’ Principal Private Secretary, wrote to the vice chancellor of Exeter University protesting at the leak, and the university conducted an investigation. Ernst’s position became untenable, funding for his department dried up and he took early retirement. Thirteen years later he remains sore; in his latest book More Harm than Good? he attacks the Prince of Wales as “foolish and immoral”.

END OF QUOTE

Sadly it is true that Horton wrote these defaming words. Subsequently, I asked him to justify them explaining that they were being used by my university against me. He ignored several of my emails, but eventually he sent a reply. In it, he said that, since the university was investigating the issue, the truth would doubtlessly be disclosed. I remember that I was livid at the arrogance and ignorance of this reply. However, being in the middle of my university’s investigation against me, never did anything about it. Looking back at this part of the episode, I feel that Horton behaved abominably.

But back to Dr Fisher.

Why did his defamatory and false accusation in his new editorial come as a ‘big surprise’ to me?

Should I not have gotten used to the often odd way in which some homeopaths handle the truth?

Yes, I did get used to this phenomenon; but I am nevertheless surprised because I have tried to correct Fisher’s ‘error’ before.

This is from a post about Fisher which I published in 2015:

In this article [available here in archive,org – Admin] which he published as Dr. Peter Fisher, Homeopath to Her Majesty, the Queen, he wrote: There is a serious threat to the future of the Royal London Homoeopathic Hospital (RLHH), and we need your help…Lurking behind all this is an orchestrated campaign, including the ’13 doctors letter’, the front page lead in The Times of 23 May 2006, Ernst’s leak of the Smallwood report (also front page lead in The Times, August 2005), and the deeply flawed, but much publicised Lancet meta-analysis of Shang et al…

If you have read my memoir, you will know that even the hostile 13-months investigation my own university did not find me guilty of the ‘leak’. The Times journalist who interviewed me about the Smallwood report already had the document on his desk when we spoke, and I did not disclose any contents of the report to him…

END OF QUOTE

So, assuming that Dr Peter Fisher has seen my 2015 post, he is knowingly perpetuating a slanderous untruth. However, giving him the benefit of the doubt, he might not have read the post nor my memoir and could be unaware of the truth. Error or lie? I am determined to find out and will send him today’s post with an offer to clarify the situation.

I will keep you posted.

In recent days, journalists across the world had a field day (mis)reporting that doctors practising integrative medicine were doing something positive after all. I think that the paper shows nothing of the kind – but please judge for yourself.

The authors of this article wanted to determine differences in antibiotic prescription rates between conventional General Practice (GP) surgeries and GP surgeries employing general practitioners (GPs) additionally trained in integrative medicine (IM) or complementary and alternative medicine (CAM) (referred to as IM GPs) working within National Health Service (NHS) England.

They conducted a retrospective study on antibiotic prescription rates per STAR-PU (Specific Therapeutic group Age–sex weighting Related Prescribing Unit) using NHS Digital data over 2016. Publicly available data were used on prevalence of relevant comorbidities, demographics of patient populations and deprivation scores. setting Primary Care. Participants were 7283 NHS GP surgeries in England. The association between IM GPs and antibiotic prescribing rates per STAR-PU with the number of antibiotic prescriptions (total, and for respiratory tract infection (RTI) and urinary tract infection (UTI) separately) as outcome. results IM GP surgeries (n=9) were comparable to conventional GP surgeries in terms of list sizes, demographics, deprivation scores and comorbidity prevalence.

Statistically significant fewer total antibiotics  were prescribed at NHS IM GP surgeries compared with conventional NHS GP surgeries. In contrast, the number of antibiotics prescribed for UTI were similar between both practices.

The authors concluded that NHS England GP surgeries employing GPs additionally trained in IM/CAM have lower antibiotic prescribing rates. Accessibility of IM/CAM within NHS England primary care is limited. Main study limitation is the lack of consultation data. Future research should include the differences in consultation behaviour of patients self-selecting to consult an IM GP or conventional surgery, and its effect on antibiotic prescription. Additional treatment strategies for common primary care infections used by IM GPs should be explored to see if they could be used to assist in the fight against antimicrobial resistance.

The study was flimsy to say the least:

  • It was retrospective and is therefore open to no end of confounders.
  • There were only 9 surgeries in the IM group.

Moreover, the results were far from impressive. The differences in antibiotic prescribing between the two groups of GP surgeries were minimal or non-existent. Finally, the study was financed via an unrestricted grant of WALA Heilmittel GmbH, Germany (“approx. 900 different remedies conforming to the anthroposophic understanding of man and nature”) and its senior author has a long track record of publishing papers promotional for anthroposophic medicine.

Such pseudo-research seems to be popular in the realm of CAM, and I have commented before on similarly futile projects. The comparison, I sometimes use is that of a Hamburger restaurant:

Employees by a large Hamburger chain set out to study the association between utilization of Hamburger restaurant services and vegetarianism. The authors used a retrospective cohort design. The study population comprised New Hampshire residents aged 18-99 years, who had entered the premises of a Hamburger restaurant within 90 days for a primary purpose of eating. The authors excluded subjects with a diagnosis of cancer. They measured the likelihood of  vegetarianism among recipients of services delivered by Hamburger restaurants compared with a control group of individuals not using meat-dispensing facilities. They also compared the cohorts with regard to the money spent in Hamburger restaurants. The adjusted likelihood of being a vegetarian was 55% lower among the experimental group compared to controls. The average money spent per person in Hamburger restaurants were also significantly lower among the Hamburger group.

To me, it is obvious that such analyses must produce a seemingly favourable result for CAM. In the present case, there are several reasons for this:

  1. GPs who volunteer to be trained in CAM tend to be in favour of ‘natural’ treatments and oppose synthetic drugs such as antibiotics.
  2. Education in CAM would only re-inforce this notion.
  3. Similarly, patients electing to consult IM GPs tend to be in favour of ‘natural’ treatments and oppose synthetic drugs such as antibiotics.
  4. Such patients might be less severely ill that the rest of the patient population (the data from the present study do in fact imply this to be true).
  5. These phenomena work in concert to generate less antibiotic prescribing in the IM group.

In the final analysis, all this finding amounts to is a self-fulfilling prophecy: grocery shops sell less meat than butchers! You don’t believe me? Perhaps you need to read a previous post then; it concluded that physicians practicing integrative medicine (the 80% who did not respond to the survey were most likely even worse) not only use and promote much quackery, they also tend to endanger public health by their bizarre, irrational and irresponsible attitudes towards vaccination.

What is upsetting with the present paper, in my view, are the facts that:

  • a reputable journal published this junk,
  • the international press has a field-day reporting this study implying that CAM is a good thing.

The fact is that it shows nothing of the kind. Imagine we send GPs on a course where they are taught to treat all their patients with blood-letting. This too would result in less prescription of antibiotics, wouldn’t it? But would it be a good thing? Of course not!

True, we prescribe too much antibiotics. Nobody doubts that. And nobody doubts that it is a big problem. The solution to this problem is not more CAM, but less antibiotics. To realise the solution we do not need to teach GPs CAM but we need to remind them of the principles of evidence-based practice. And the two are clearly not the same; in fact, they are opposites.

 

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted.


Click here for a comprehensive list of recent comments.

Categories