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

causation

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Kinesiology tape KT is fashionable, it seems. Gullible consumers proudly wear it as decorative ornaments to attract attention and show how very cool they are.

Am I too cynical?

Perhaps.

But does KT really do anything more?

A new trial might tell us.

The aim of this study was to investigate whether adding kinesiology tape (KT) to spinal manipulation (SM) can provide any extra effect in athletes with chronic non-specific low back pain (CNLBP).

Forty-two athletes (21males, 21females) with CNLBP were randomized into two groups of SM (n = 21) and SM plus KT (n = 21). Pain intensity, functional disability level and trunk flexor-extensor muscles endurance were assessed by Numerical Rating Scale (NRS), Oswestry pain and disability index (ODI), McQuade test, and unsupported trunk holding test, respectively. The tests were done before and immediately, one day, one week, and one month after the interventions and compared between the two groups.

After treatments, pain intensity and disability level decreased and endurance of trunk flexor-extensor muscles increased significantly in both groups. Repeated measures analysis, however, showed that there was no significant difference between the groups in any of the evaluations.

The authors, physiotherapists from Iran, concluded that the findings of the present study showed that adding KT to SM does not appear to have a significant extra effect on pain, disability and muscle endurance in athletes with CNLBP. However, more studies are needed to examine the therapeutic effects of KT in treating these patients.

Regular readers of my blog will be able to predict what I have to say about this study design: A+B versus B is not a meaningful test of anything. I used to claim that it cannot possibly produce a negative result – and yet, here it seems to have done exactly that!

How come?

The way I see it, there are two possibilities to explain this:

  • the KT has a mildly negative effect on CNLBP; thus the expected positive placebo-effect was neutralised to result in a null-effect overall;
  • the study was under-powered such that the true inter-group difference could not manifest itself.

I think the second possibility is more likely, but it does really not matter at all. Because the only lesson we can learn from this trial is this: inadequate study designs will  hardly ever generate anything worthwhile.

And this is, I think, a lesson that would be valuable for many researchers.

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Reference

2018 Apr;22(2):540-545. doi: 10.1016/j.jbmt.2017.07.008. Epub 2017 Jul 26.

Comparing spinal manipulation with and without Kinesio Taping® in the treatment of chronic low back pain.

 

I have often cautioned my readers about the ‘evidence’ supporting acupuncture (and other alternative therapies). Rightly so, I think. Here is yet another warning.

This systematic review assessed the clinical effectiveness of acupuncture in the treatment of postpartum depression (PPD). Nine trials involving 653 women were selected. A meta-analysis demonstrated that the acupuncture group had a significantly greater overall effective rate compared with the control group. Moreover, acupuncture significantly increased oestradiol levels compared with the control group. Regarding the HAMD and EPDS scores, no difference was found between the two groups. The Chinese authors concluded that acupuncture appears to be effective for postpartum depression with respect to certain outcomes. However, the evidence thus far is inconclusive. Further high-quality RCTs following standardised guidelines with a low risk of bias are needed to confirm the effectiveness of acupuncture for postpartum depression.

What a conclusion!

What a review!

What a journal!

What evidence!

Let’s start with the conclusion: if the authors feel that the evidence is ‘inconclusive’, why do they state that ‘acupuncture appears to be effective for postpartum depression‘. To me this does simply not make sense!

Such oddities are abundant in the review. The abstract does not mention the fact that all trials were from China (published in Chinese which means that people who cannot read Chinese are unable to check any of the reported findings), and their majority was of very poor quality – two good reasons to discard the lot without further ado and conclude that there is no reliable evidence at all.

The authors also tell us very little about the treatments used in the control groups. In the paper, they state that “the control group needed to have received a placebo or any type of herb, drug and psychological intervention”. But was acupuncture better than all or any of these treatments? I could not find sufficient data in the paper to answer this question.

Moreover, only three trials seem to have bothered to mention adverse effects. Thus the majority of the studies were in breach of research ethics. No mention is made of this in the discussion.

In the paper, the authors re-state that “this meta-analysis showed that the acupuncture group had a significantly greater overall effective rate compared with the control group. Moreover, acupuncture significantly increased oestradiol levels compared with the control group.” This is, I think, highly misleading (see above).

Finally, let’s have a quick look at the journal ‘Acupuncture in Medicine’ (AiM). Even though it is published by the BMJ group (the reason for this phenomenon can be found here: “AiM is owned by the British Medical Acupuncture Society and published by BMJ“; this means that all BMAS-members automatically receive the journal which thus is a resounding commercial success), it is little more than a cult-newsletter. The editorial board is full of acupuncture enthusiasts, and the journal hardly ever publishes anything that is remotely critical of the wonderous myths of acupuncture.

My conclusion considering all this is as follows: we ought to be very careful before accepting any ‘evidence’ that is currently being published about the benefits of acupuncture, even if it superficially looks ok. More often than not, it turns out to be profoundly misleading, utterly useless and potentially harmful pseudo-evidence.


Reference

Acupunct Med. 2018 Jun 15. pii: acupmed-2017-011530. doi: 10.1136/acupmed-2017-011530. [Epub ahead of print]

Effectiveness of acupuncture in postpartum depression: a systematic review and meta-analysis.

Li S, Zhong W, Peng W, Jiang G.

Vis a vis the overwhelming evidence to the contrary, why are there so many clinicians (doctors as well as lay practitioners) who still believe that homeopathy is working? And why are there so many patients who still believe that homeopathy is working?

These are questions that puzzle me quite a bit.

Of course, there is no simple, single answer; there are probably dozens. But one reason must be that there are only three possible outcomes after homeopathic treatments, all of which are favourable for homeopathy (at least in the interpretation of proponents of homeopathy). Seen in this light, there simply is no better therapy!

Let me explain:

If a patient consults a homeopath who prescribes a highly diluted homeopathic remedy, she might subsequently:

  1. get better,
  2. get worse,
  3. or experience no change at all.

Analysing these three possibilities, we quickly see that, from the point of view of a convinced homeopath, all are a proof for homeopathy’s effectiveness, and none suggests that the scientific evidence is correct in claiming that highly diluted homeopathic remedies are pure placebos.

SCENARIO 1

In this situation, it is easy to assume that the remedy was the cause for the clinical improvement. Most clinicians of any discipline fall into this trap, and most patients follow them willingly. Yet, we all know that a temporal relationship is not the same as a causal one (the crowing of a cock before dawn is not the cause of the sun rising). Of course, it is conceivable that the treatment was the cause, but there are several other possibilities as well; just think of the placebo effect, regression towards the mean, and the natural history of the disease. In our case, these non-specific effects are most certainly the cause of our patient’s improvement.

SCENARIO 2

Most clinicians in this situation would start wondering whether they have employed the correct therapy for this patient’s condition – not so the homeopath! He would triumphantly exclaim: “excellent, you are experiencing a ‘homeopathic aggravation’. This is a sure sign that I have given you the optimal remedy. Things will get better soon.” A homeopathic aggravation occurs, according to homeopathic logic, because homeopathy follows the ‘like cures like’ principle. The homeopath prescribes the remedy that would normally cause the symptoms from which his patient is suffering. This means it must also cause these symptoms in every patient. Usually these aggravations are not strong enough to be noticed, but when they are, it is interpreted by homeopaths as a triumph of homeopathy.

SCENARIO 3

In this situation, the homeopath has several options. He can claim “but without my remedy you would be much worse by now. The fact that you are not, shows how very effective homeopathy really is. A more humble homeopaths might explain that the optimal remedy is not always easy to find straight away, and he would therefore proceed in prescribing another one. In both cases, the patient is kept paying for more and homeopathy is presented as an effective therapy.

These three scenarios clearly show that there is no conceivable outcome where any homeopathy-fan would need to consider that scientists are correct in stating that homeopathy is ineffective. And this is one of the reasons why the myth of homeopathy’s effectiveness persists.

Hold on … the patient might be dead!

Yes, that is a rather unfortunate situation for any clinician – except for a homeopath, of course. He would simply point out that the patient must have forgotten to take her medicine. A conventional practitioner might get in trouble, if he tried that excuse; one could easily measure blood levels of the prescribed drug and verify the claim. Not so in homeopathy! Because they contain not a single active molecule, homeopathic remedies are undetectable!

We can easily see that there is no better treatment than homeopathy – at least for the homeopath!

 

 

Most people probably think of acupuncture as being used mainly as a therapy for pain control. But acupuncture is currently being promoted (and has traditionally been used) for all sorts of conditions. One of them is stroke. It is said to speed up recovery and even improve survival rates after such an event. There are plenty of studies on this subject, but their results are far from uniform. What is needed in this situation, is a rigorous summary of the evidence.

The authors of this Cochrane review wanted to assess whether acupuncture could reduce the proportion of people suffering death or dependency after acute ischaemic or haemorrhagic stroke. They included all randomized clinical trials (RCTs) of acupuncture started within 30 days after stroke onset. Acupuncture had to be compared with placebo or sham acupuncture or open control (no placebo) in people with acute ischaemic or haemorrhagic stroke, or both. Comparisons were made versus (1) all controls (open control or sham acupuncture), and (2) sham acupuncture controls.

The investigators included 33 RCTs with 3946 participants. Outcome data were available for up to 22 trials (2865 participants) that compared acupuncture with any control (open control or sham acupuncture) but for only 6 trials (668 participants) comparing acupuncture with sham acupuncture.

When compared with any control (11 trials with 1582 participants), findings of lower odds of death or dependency at the end of follow-up and over the long term (≥ three months) in the acupuncture group were uncertain and were not confirmed by trials comparing acupuncture with sham acupuncture. In trials comparing acupuncture with any control, findings that acupuncture was associated with increases in the global neurological deficit score and in the motor function score were uncertain. These findings were not confirmed in trials comparing acupuncture with sham acupuncture.Trials comparing acupuncture with any control showed little or no difference in death or institutional care or death at the end of follow-up.The incidence of adverse events (eg, pain, dizziness, faint) in the acupuncture arms of open and sham control trials was 6.2% (64/1037 participants), and 1.4% of these patients (14/1037 participants) discontinued acupuncture. When acupuncture was compared with sham acupuncture, findings for adverse events were uncertain.

The authors concluded that this updated review indicates that apparently improved outcomes with acupuncture in acute stroke are confounded by the risk of bias related to use of open controls. Adverse events related to acupuncture were reported to be minor and usually did not result in stopping treatment. Future studies are needed to confirm or refute any effects of acupuncture in acute stroke. Trials should clearly report the method of randomization, concealment of allocation, and whether blinding of participants, personnel, and outcome assessors was achieved, while paying close attention to the effects of acupuncture on long-term functional outcomes.

This Cochrane review seems to be thorough, but it is badly written (Cochrane reviewers: please don’t let this become the norm!). It contains some interesting facts. The majority of the studies came from China. This review confirmed the often very poor methodological quality of acupuncture trials which I have frequently mentioned before.

In particular, the RCTs originating from China were amongst those that most overtly lacked rigor, also a fact that has been discussed regularly on this blog.

For me, by far the most important finding of this review is that studies which at least partly control for placebo effects fail to show positive results. Depending on where you stand in the never-ending debate about acupuncture, this could lead to two dramatically different conclusions:

  1. If you are a believer in or earn your living from acupuncture, you might say that these results suggest that the trials were in some way insufficient and therefore they produced false-negative results.
  2. If you are a more reasonable observer, you might feel that these results show that acupuncture (for acute stroke) is a placebo therapy.

Regardless to which camp you belong, one thing seems to be certain: acupuncture for stroke (and other indications) is not supported by sound evidence. And that means, I think, that it is not responsible to use it in routine care.

In the comment section of a recent post, we saw a classic example of the type of reasoning that many alternative practitioners seem to like. In order to offer a service to other practitioners, I will elaborate on it here. The reasoning roughly follows these simple 10 steps:

  1. My treatment works.
  2. My treatment requires a lot of skills, training and experience.
  3. Most people fail to appreciate how subtle my treatment really is.
  4. In fact, only few practitioners manage do it the way it has to be done.
  5. The negative trials of my treatment are false-negative because they were conducted by incompetent practitioners.
  6. In any case, for a whole range of reasons, my treatment cannot be pressed into the straight jacket of a clinical trial.
  7. My treatment is therefore not supported by the type of evidence people who don’t understand it insist upon.
  8. Therefore, we have to rely on the best evidence that is available to date.
  9. And that clearly is the experience of therapists and patients.
  10. So, the best evidence unquestionably confirms that my treatment works.

The case I mentioned above was that of an acupuncturist defending his beloved acupuncture. To a degree, the argument put forward by him sounded (to fellow acupuncturists) reasonable. On closer inspection, however, they seem far less so, perhaps even fallacious. If you are an acupuncturist, you will, of course, disagree with me. Therefore, I invite all acupuncturists to imagine a homeopath arguing in that way (which they often do). Would you still find the line of arguments reasonable?

And what, if you are a homeopath? Then I invite you to imagine that a crystal therapist argues in that way (which they often do). Would you still find the line of arguments reasonable?

And what, if you are a crystal therapist? …

I am not getting anywhere, am I?

To make my point, it might perhaps be best, if I created my very own therapy!

Here we go: it’s called ENERGY PRESERVATION THERAPY (EPT).

I have discovered, after studying ancient texts from various cultures, that the vital energy of our closest deceased relatives can be transferred by consuming their carbon molecules. The most hygienic way to achieve this is to have our deceased relatives cremated and consume their ashes afterwards. The cremation, storage of the ashes, as well as their preparation and regular consumption all have to be highly individualised, of course. But I am certain that this is the only way to preserve their vital force and transfer it to a living relative. The benefits of this treatment are instantly visible.

As it happens, I run special three-year (6 years part-time) courses at the RSM in London to teach other clinicians how exactly to do this. And I should warn you: they are neither cheap nor easy; we are talking of very skilled stuff here.

What! You doubt that my treatment works?

Doubt no more!

Here are 10 convincing arguments for it:

  1. EPT works, I have 10 years of experience and seen hundreds of cases.
  2. EPT requires a lot of skills, training and experience.
  3. Most people fail to appreciate how subtle EPT really is.
  4. In fact, only few practitioners manage do EPT the way it has to be done.
  5. The negative trials of EPT are false-negative because they were conducted by incompetent practitioners.
  6. In any case, for a whole range of reasons, EPT cannot be pressed into the straight jacket of a clinical trial.
  7. EPT is therefore not supported by the type of evidence people who don’t understand it insist upon.
  8. Therefore, we have to rely on the best evidence that is available to date.
  9. And that clearly is the experience of therapists and patients.
  10. So, the best evidence unquestionably confirms that EPT works.

Convinced?

No?

You do surprise me!

Why then are you convinced of the effectiveness of acupuncture, homeopathy, etc?

Can I tempt you to run a little (hopefully instructive) thought-experiment with you? It is quite simple: I will tell you about the design of a clinical trial, and you will tell me what the likely outcome of this study would be.

Are you game?

Here we go:

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Imagine we conduct a trial of acupuncture for persistent pain (any type of pain really). We want to find out whether acupuncture is more than a placebo when it comes to pain-control. Of course, we want our trial to look as rigorous as possible. So, we design it as a randomised, sham-controlled, partially-blinded study. To be really ‘cutting edge’, our study will not have two but three parallel groups:

1. Standard needle acupuncture administered according to a protocol recommended by a team of expert acupuncturists.

2. Minimally invasive sham-acupuncture employing shallow needle insertion using short needles at non-acupuncture points. Patients in groups 1 and 2 are blinded, i. e. they are not supposed to know whether they receive the sham or real acupuncture.

3. No treatment at all.

We apply the treatments for a sufficiently long time, say 12 weeks. Before we start, after 6 and 12 weeks, we measure our patients’ pain with a validated method. We use sound statistical methods to compare the outcomes between the three groups.

WHAT DO YOU THINK THE RESULT WOULD BE?

You are not sure?

Well, let me give you some hints:

Group 3 is not going to do very well; not only do they receive no therapy at all, but they are also disappointed to have ended up in this group as they joined the study in the hope to get acupuncture. Therefore, they will (claim to) feel a lot of pain.

Group 2 will be pleased to receive some treatment. However, during the course of the 6 weeks, they will get more and more suspicious. As they were told during the process of obtaining informed consent that the trial entails treating some patients with a sham/placebo, they are bound to ask themselves whether they ended up in this group. They will see the short needles and the shallow needling, and a percentage of patients from this group will doubtlessly suspect that they are getting the sham treatment. The doubters will not show a powerful placebo response. Therefore, the average pain scores in this group will decrease – but only a little.

Group 1 will also be pleased to receive some treatment. As the therapists cannot be blinded, they will do their best to meet the high expectations of their patients. Consequently, they will benefit fully from the placebo effect of the intervention and the pain score of this group will decrease significantly.

So, now we can surely predict the most likely result of this trial without even conducting it. Assuming that acupuncture is a placebo-therapy, as many people do, we now see that group 3 will suffer the most pain. In comparison, groups 1 and 2 will show better outcomes.

Of course, the main question is, how do groups 1 and 2 compare to each other? After all, we designed our sham-controlled trial in order to answer exactly this issue: is acupuncture more than a placebo? As pointed out above, some patients in group 2 would have become suspicious and therefore would not have experienced the full placebo-response. This means that, provided the sample sizes are sufficiently large, there should be a significant difference between these two groups favouring real acupuncture over sham. In other words, our trial will conclude that acupuncture is better than placebo, even if acupuncture is a placebo.

THANK YOU FOR DOING THIS THOUGHT EXPERIMENT WITH ME.

Now I can tell you that it has a very real basis. The leading medical journal, JAMA, just published such a study and, to make matters worse, the trial was even sponsored by one of the most prestigious funding agencies: the NIH.

Here is the abstract:

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Musculoskeletal symptoms are the most common adverse effects of aromatase inhibitors and often result in therapy discontinuation. Small studies suggest that acupuncture may decrease aromatase inhibitor-related joint symptoms.

Objective:

To determine the effect of acupuncture in reducing aromatase inhibitor-related joint pain.

Design, Setting, and Patients:

Randomized clinical trial conducted at 11 academic centers and clinical sites in the United States from March 2012 to February 2017 (final date of follow-up, September 5, 2017). Eligible patients were postmenopausal women with early-stage breast cancer who were taking an aromatase inhibitor and scored at least 3 on the Brief Pain Inventory Worst Pain (BPI-WP) item (score range, 0-10; higher scores indicate greater pain).

Interventions:

Patients were randomized 2:1:1 to the true acupuncture (n = 110), sham acupuncture (n = 59), or waitlist control (n = 57) group. True acupuncture and sham acupuncture protocols consisted of 12 acupuncture sessions over 6 weeks (2 sessions per week), followed by 1 session per week for 6 weeks. The waitlist control group did not receive any intervention. All participants were offered 10 acupuncture sessions to be used between weeks 24 and 52.

Main Outcomes and Measures:

The primary end point was the 6-week BPI-WP score. Mean 6-week BPI-WP scores were compared by study group using linear regression, adjusted for baseline pain and stratification factors (clinically meaningful difference specified as 2 points).

Results:

Among 226 randomized patients (mean [SD] age, 60.7 [8.6] years; 88% white; mean [SD] baseline BPI-WP score, 6.6 [1.5]), 206 (91.1%) completed the trial. From baseline to 6 weeks, the mean observed BPI-WP score decreased by 2.05 points (reduced pain) in the true acupuncture group, by 1.07 points in the sham acupuncture group, and by 0.99 points in the waitlist control group. The adjusted difference for true acupuncture vs sham acupuncture was 0.92 points (95% CI, 0.20-1.65; P = .01) and for true acupuncture vs waitlist control was 0.96 points (95% CI, 0.24-1.67; P = .01). Patients in the true acupuncture group experienced more grade 1 bruising compared with patients in the sham acupuncture group (47% vs 25%; P = .01).

Conclusions and Relevance:

Among postmenopausal women with early-stage breast cancer and aromatase inhibitor-related arthralgias, true acupuncture compared with sham acupuncture or with waitlist control resulted in a statistically significant reduction in joint pain at 6 weeks, although the observed improvement was of uncertain clinical importance.

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Do you see how easy it is to deceive (almost) everyone with a trial that looks rigorous to (almost) everyone?

My lesson from all this is as follows: whether consciously or unconsciously, SCAM-researchers often build into their trials more or less well-hidden little loopholes that ensure they generate a positive outcome. Thus even a placebo can appear to be effective. They are true masters of producing false-positive findings which later become part of a meta-analysis which is, of course, equally false-positive. It is a great shame, in my view, that even top journals (in the above case JAMA) and prestigious funders (in the above case the NIH) cannot (or want not to?) see behind this type of trickery.

“Non-reproducible single occurrences are of no significance to science”, this quote by Karl Popper often seems to get forgotten in medicine, particularly in alternative medicine. It indicates that findings have to be reproducible to be meaningful – if not, we cannot be sure that the outcome in question was caused by the treatment we applied.

This is thus a question of cause and effect.

The statistician Sir Austin Bradford Hill proposed in 1965 a set of 9 criteria to provide evidence of a relationship between a presumed cause and an observed effect while demonstrating the connection between cigarette smoking and lung cancer. One of his criteria is consistency or reproducibility: Consistent findings observed by different persons in different places with different samples strengthens the likelihood of an effect.

By mentioning ‘different persons’, Hill seems to also establish the concept of INDEPENDENT replication.

Let me try to explain this with an example from the world of SCAM.

  1. A homeopath feels that childhood diarrhoea could perhaps be treated with individualised homeopathic remedies.  She conducts a trial, finds a positive result and concludes that the statistically significant decrease in the duration of diarrhea in the treatment group suggests that homeopathic treatment might be useful in acute childhood diarrhea. Further study of this treatment deserves consideration.
  2. Unsurprisingly, this study is met with disbelieve by many experts. Some go as far as doubting its validity, and several letters to the editor appear expressing criticism. The homeopath is thus motivated to run another trial to prove her point. Its results are consistent with the finding from the previous study that individualized homeopathic treatment decreases the duration of diarrhea and number of stools in children with acute childhood diarrhea.
  3. We now have a replication of the original finding. Yet, for a range of reasons, sceptics are far from satisfied. The homeopath thus runs a further trial and publishes a meta-analysis of all there studies. The combined analysis shows a duration of diarrhoea of 3.3 days in the homeopathy group compared with 4.1 in the placebo group (P = 0.008). She thus concludes that the results from these studies confirm that individualized homeopathic treatment decreases the duration of acute childhood diarrhea and suggest that larger sample sizes be used in future homeopathic research to ensure adequate statistical power. Homeopathy should be considered for use as an adjunct to oral rehydration for this illness.

To most homeopaths it seems that this body of evidence from three replication is sound and solid. Consequently, they frequently cite these publications as a cast-iron proof of their assumption that individualised homeopathy is effective. Sceptics, however, are still not convinced.

Why?

The studies have been replicated alright, but what is missing is an INDEPENDENT replication.

To me this word implies two things:

  1. The results have to be reproduced by another research group that is unconnected to the one that conducted the three previous studies.
  2. That group needs to be independent from any bias that might get in the way of conducting a rigorous trial.

And why do I think this latter point is important?

Simply because I know from many years of experience that a researcher, who strongly believes in homeopathy or any other subject in question, will inadvertently introduce all sorts of biases into a study, even if its design is seemingly rigorous. In the end, these flaws will not necessarily show in the published article which means that the public will be mislead. In other words, the paper will report a false-positive finding.

It is possible, even likely, that this has happened with the three trials mentioned above. The fact is that, as far as I know, there is no independent replication of these studies.

In the light of all this, Popper’s axiom as applied to medicine should perhaps be modified: findings without independent replication are of no significance. Or, to put it even more bluntly: independent replication is an essential self-cleansing process of science by which it rids itself from errors, fraud and misunderstandings.

Doctor Jens Wurster is no stranger to this blog; previously I discussed his claim that he has treated more than 1000 cancer patients homeopathically and we could even cure or considerably ameliorate the quality of life for several years in some, advanced and metastasizing cases. So far, his claims were based not on evidence published in peer-reviewed journals (I cannot find a single Medline-listed paper by this man); but now Wurster has published an article in a German Journal (Wurster J. Zusatznutzen der Homöopathie … Deutsche Zeitschrift für Onkologie 2018; 50: 85–91; not Medline-listed, I am afraid). The paper is in German, but it has an English abstract; here it is:

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All over the world, oncology patients receive homeopathic treatment concomitant to conventional treatments, such as chemotherapy and radiation treatment, in order to reduce the side effects of these therapies. It has been shown that cancer patients, who are receiving homeopathic treatment in addition to conventional therapies, have a higher quality of life and a longer survival rate. Studies in cancer cell research have shown the direct effects of highly potentized homeopathic medicines on tumor cell lines. Tumor inhibiting properties of homeopathic medicines have been proven in vivo as well as in vitro. Research projects into complementary medicine (CAMbrella) and research into personalized immunotherapies as well as additive homeopathy open the door to the future of integrative oncology.

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In the article, Wurster states that he has 20 years of experience in treating cancer with homeopathy as an add-on to conventional care, and that he can confirm homeopathy’s effectiveness. He claims that ‘very many’ patients have thus benefitted by experiencing less side-effects of conventional treatments. And he offers two case-reports to illustrate this.

[Nach 20 Jahren klinischer Erfahrung in der Clinica St. Croce im Tessin mit der Behandlung onkologischer Patienten mithilfe der Homöopathie können wir deutlich den Zusatznutzen der Homöopathie in der Onkologie bestätigen [1]. So gelang es unserem Ärzteteam in den zurückliegenden Jahren bei sehr vielen Patienten, durch gezielten Einsatz homöopathischer Mittel die Nebenwirkungen von Chemotherapien oder Bestrahlungen erfolgreich zu reduzieren [1]. Wie dabei Schulmedizin und Homöopathie in der Praxis zusammenwirken, zeigt folgendes Beispiel. ([1] Wurster J. Die homöopathische Behandlung und Heilung von Krebs und metastasierten Tumoren. Norderstedt: Books on Demand; 2015)]

The two case-reports lack detail and are less than convincing, in my view. Both patients have had conventional therapies and Wurster claims that his homeopathic remedies reduced their side-effects. There is no way of verifying this claim, and the improvements might have occurred also without homeopathy.

In the discussion section of his paper, Wurster then elaborates that oncologists throughout Europe are now realising the potential of homeopathy. In support he mentions paediatric oncologists in Klagenfurt who managed to spare pain-killers by giving homeopathics. Similarly, at the Inselspital in Bern, they are offering homeopathic consultations to complement conventional treatments.

[Inzwischen haben auch einige Onkologen erkannt, wie eine gezielt eingesetzte homöopathische Behandlung die Nebenwirkungen von Chemotherapien oder Bestrahlungen reduzieren kann. Wir arbeiten inzwischen mit einigen Onkologen aus ganz Europa zusammen, die den Zusatznutzen der Homöopathie in der Onkologie erlebt haben. In der Kinderonkologie in Klagenfurt beispielsweise konnten mithilfe der Homöopathie Schmerzmittel bei den Kindern eingespart werden. Auch am Inselspital Bern werden zusätzliche homöopathische Konsile in der Kinderonkologie angeboten, um die konventionelle Behandlung begleiten zu können [8].]

At this point, Wurster inserts his reference number 8. As several of his references are either books or websites, this reference to an article in a top journal seems interesting. Here is its abstract:

___________________________________________________________________________________

BACKGROUND:

Though complementary and alternative medicine (CAM) are frequently used by children and adolescents with cancer, there is little information on how and why they use it. This study examined prevalence and methods of CAM, the therapists who applied it, reasons for and against using CAM and its perceived effectiveness. Parent-perceived communication was also evaluated. Parents were asked if medical staff provided information on CAM to patients, if parents reported use of CAM to physicians, and what attitude they thought physicians had toward CAM.

STUDY DESIGN:

All childhood cancer patients treated at the University Children‘s Hospital Bern between 2002-2011 were retrospectively surveyed about their use of CAM.

RESULTS:

Data was collected from 133 patients (response rate: 52%). Of those, 53% had used CAM (mostly classical homeopathy) and 25% of patients received information about CAM from medical staff. Those diagnosed more recently were more likely to be informed about CAM options. The most frequent reason for choosing CAM was that parents thought it would improve the patient’s general condition. The most frequent reason for not using CAM was lack of information. Of those who used CAM, 87% perceived positive effects.

CONCLUSIONS:

Since many pediatric oncology patients use CAM, patients’ needs should be addressed by open communication between families, treating oncologists and CAM therapists, which will allow parents to make informed and safe choices about using CAM.

_______________________________________________________________________________________

Any hope that this paper might back up the statements made by Wurster is thus disappointed.

Altogether, this Wurster-paper contains no reliable evidence. The only clinical trial it seems to rely on is the one by Prof Frass which we have discussed previously here and here. The Frass-study is odd in several ways and, before we can take its results seriously, we need to see an independent replication of its findings. In this context, it is noteworthy that my own 2006 systematic review concluded that there is insufficient evidence to support clinical efficacy of homeopathic therapy in cancer care. In view of all this, I feel that the new Wurster-paper provides no reliable evidence and no reason to change my now somewhat dated conclusion of 2006. Moreover, I would insist that those who claim otherwise are unethical and behave irresponsible.

And finally, I need to reiterate what I stated in my previous post: the Wurster-paper indicates that something is amiss with medical publishing. How can it be that, in 2018, the ‘Deutsche Zeitschrift für Onkologie’ (or any other medical journal for that matter) can be so bar of critical thinking to publish such dangerously misleading nonsense? The editors of this journal (Univ.-Prof. Dr. med. Arndt Büssing, Witten/Herdecke; Dr. med. Peter Holzhauer, Bad Trissl und München) and its editorial board members (L. Auerbach, Wien; C. Bahne Bahnson, Kiel; J. Büntzel, Nordhausen; B. Freimüller-Kreutzer, Heidelberg; H.R. Maurer, Berlin; A. Mayr, Starnberg; R. Moss, New York; T. Ostermann, Witten/Herdecke; K. Prasad, Denver; G. Pulverer, Köln; H. Renner, Nürnberg; C.P. Siegers, Lübeck; W. Schmidt, Greifswald; G. Uhlenbruck, Köln; B. Wolf, München; K.S. Zänker, Witten/Herdecke) should ask themselves whether they are taking their moral obligations seriously enough, or whether their behaviour is not a violation of their most fundamental ethical duties.

In our book ‘MORE HARM THAN GOOD‘ we allude to such problems as follows: …Spurious results are frequently paraded by CAM advocates in support of implausible treatments… the more poorly conceived and executed a research project is, the more likely it is to produce false-positive results. These results then may lead to repetitive cycles of unproductive work to explain what was found—often to simply disprove the erroneous results. This is an unfortunate feature of various fields of scientific research, but it has particularly serious implications in medical research. Moreover, researchers who practice and behave as advocates of CAM may unintentionally or deliberately distort or exaggerate weak findings. Invalid CAM research claims tend not to be put to rest; instead they are repeatedly recycled…

And:

The CAM practitioner who promotes untruths has either failed to enlighten themselves as to the facts—this being a central requirement of professional ethics— or has chosen to deliberately deceive patients. Either of these reasons for promulgating falsehoods amounts to a serious breach in terms of virtue ethics. According to almost all forms of ethical theory, the truth-violating nature of CAM renders it immoral in both theory and practice.

The damage that can result from such violations of medical ethics is not merely a matter for the ‘ivory towers of academia’, it can virtually be a matter of life and death.

Why  do most alternative practitioners  show such dogged determination not to change their view of the efficacy of their therapy, even if  good evidence shows that it is a placebo? This is the question that I have been pondering for some time. I have seen many doctors change their mind about this or that treatment in the light of new evidence. In fact, I have not seen one who has not done so at some stage. Yet I have never seen an alternative therapist change his/her mind about his/her alternative therapy. Why is that?

You might say that the answers are obvious:

  • because they have heavily invested in their therapy, both emotionally and financially;
  • because their therapy has ‘stood the test of time’;
  • because they believe what they were taught;
  • because they are deluded, not very bright, etc.;
  • because they need to earn a living.

All of these reasons may apply. But do they really tell the whole story? While contemplating about this question, I thought of something that had previously not been entirely clear to me: they simply KNOW that the evidence MUST be wrong.

Let me try to explain.

Consider an acupuncturist (I could have chosen almost any other type of alternative practitioner) who has many years of experience. He has grown to be a well-respected expert in the world of acupuncture. He sits on various committees and has advised important institutions. He knows the literature and has treated thousands of patients.

This experience has taught him one thing for sure: his patients do benefit from his treatment. He has seen it happening too many times; it cannot be a coincidence. Acupuncture works, no question about it.

And this is also what the studies tell him. Even the most sceptical scientist cannot deny the fact that patients do get better after acupuncture. So, what is the problem?

The problem is that sceptics say that this is due to a placebo effect, and many studies seem to confirm this to be true. Yet, our acupuncturist completely dismisses the placebo explanation.

Why?

  • Because he has heavily invested in their therapy? Perhaps.
  • Because acupuncture has ‘stood the test of time’? Perhaps.
  • Because he believes what he has been taught? Perhaps.
  • Because he is deluded, not very bright, etc.? Perhaps.
  • Because he needs to earn a living? Perhaps.

But there is something else.

He has only ever treated his patients with acupuncture. He has therefore no experience of real medicine, or other therapeutic options. He has no perspective. Therefore, he does not know that patients often get better, even if they receive an ineffective treatment, even if they receive no treatment, and even if they receive a harmful treatment. Every improvement he notes in his patients, he relates to his acupuncture. Our acupuncturist never had the opportunity to learn to doubt cause and effect in his clinical routine. He never had to question the benefits of acupuncture. He never had to select from a pool of therapies the optimal one, because he only ever used acupuncture.

It is this lack of experience that never led him to think critically about acupuncture. He is in a similar situation as physicians were 200 years ago; they only (mainly) had blood-letting, and because some patients improved with it, they had no reason to doubt it. He only ever saw his successes (not that all his patients improved, but those who did not, did not return). He simply KNOWS that acupuncture works, because his own, very limited experience never forced him to consider anything else. And because he KNOWS, the evidence that does not agree with his knowledge MUST be wrong.

I am of course exaggerating and simplifying in order to make a point. And please don’t get me wrong.

I am not saying that doctors cannot be stubborn. And I am not saying that all alternative practitioners have such limited experience and are unable to change their mind in the light of new evidence. However, I am trying to say that many alternative practitioners have a limited perspective and therefore find it impossible to be critical about their own practice.

If I am right, there would be an easy (and entirely alternative) cure to remedy this situation. We should sent our acupuncturist to a homeopath (or any other alternative practitioner whose practice he assumes to be entirely bogus) and ask him to watch what kind of therapeutic success the homeopath is generating. The acupuncturist would soon see that it is very similar to his own. He would then have the choice to agree that highly diluted homeopathic remedies are effective in curing illness, or that the homeopath relies on the same phenomenon as his own practice: placebo.

Sadly, this is not going to happen, is it?

 

Shiatsu is an alternative therapy that is popular, but has so far attracted almost no research. Therefore, I was excited when I saw a new paper on the subject. Sadly, my excitement waned quickly when I stared reading the abstract.

This single-blind randomized controlled study was aimed to evaluate shiatsu on mood, cognition, and functional independence in patients undergoing physical activity. Alzheimer disease (AD) patients with depression were randomly assigned to the “active group” (Shiatsu + physical activity) or the “control group” (physical activity alone).

Shiatsu was performed by the same therapist once a week for ten months. Global cognitive functioning (Mini Mental State Examination – MMSE), depressive symptoms (Geriatric Depression Scale – GDS), and functional status (Activity of Daily Living – ADL, Instrumental ADL – IADL) were assessed before and after the intervention.

The researchers found a within-group improvement of MMSE, ADL, and GDS in the Shiatsu group. However, the analysis of differences before and after the interventions showed a statistically significant decrease of GDS score only in the Shiatsu group.

The authors concluded that the combination of Shiatsu and physical activity improved depression in AD patients compared to physical activity alone. The pathomechanism might involve neuroendocrine-mediated effects of Shiatsu on neural circuits implicated in mood and affect regulation.

The Journal Complementary Therapies in Medicine also published three ‘Highlights’ of this study:

  • We first evaluated the effect of Shiatsu in depressed patients with Alzheimer’s disease (AD).
  • Shiatsu significantly reduced depression in a sample of mild-to-moderate AD patients.
  • Neuroendocrine-mediated effect of Shiatsu may modulate mood and affect neural circuits.

Where to begin?

1 The study is called a ‘pilot’. As such it should not draw conclusions about the effectiveness of Shiatsu.

2 The design of the study was such that there was no accounting for the placebo effect (the often-discussed ‘A+B vs B’ design); therefore, it is impossible to attribute the observed outcome to Shiatsu. The ‘highlight’ – Shiatsu significantly reduced depression in a sample of mild-to-moderate AD patients – therefore turns out to be a low-light.

3 As this was a study with a control group, within-group changes are irrelevant and do not even deserve a mention.

4 The last point about the mode of action is pure speculation, and not borne out of the data presented.

5 Accumulating so much nonsense in one research paper is, in my view, unethical.

Research into alternative medicine does not have a good reputation – studies like this one are not inclined to improve it.

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