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

conflict of interest

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As you can imagine, I get quite a lot of ‘fan-post’. Most of the correspondence amounts to personal attacks and insults which I usually discard. But some of these ‘love-letters’ are so remarkable in one way or another that I answer them. This short email was received on 20/3/19; it belongs to the latter category:

Dr Ernst,

You have been trashing homeopathy ad nauseum for so many years based on your limited understanding of it. You seem to know little more than that the remedies are so extremely dilute as to be impossibly effective in your opinion. Everybody knows this and has to confront their initial disbelief.

Why dont you get some direct understanding of homeopathy by doing a homeopathic proving of an unknown (to you) remedy? Only once was I able to convince a skeptic to take the challenge to do a homeopathic proving. He was amazed at all the new symptoms he experienced after taking the remedy repeatedly over several days.

Please have a similar bravery in your approach to homeopathy instead of basing your thoughts purely on your speculation on the subject, grounded in little understanding and no experience of it.

THIS IS HOW I RESPONDED

Dear Mr …

thank you for this email which I would like to answer as follows.

Your lines give the impression that you might not be familiar with the concept of critical analysis. In fact, you seem to confuse my criticism of homeopathy with ‘trashing it’. I strongly recommend you read up about critical analysis. No doubt you will then realise that it is a necessary and valuable process towards generating progress in healthcare and beyond.

You assume that I have limited understanding of homeopathy. In fact, I grew up with homeopathy, practised homeopathy as a young doctor, researched the subject for more than 25 years and published several books as well as over 100 peer-reviewed scientific papers about it. All of this, I have disclosed publicly, for instance, in my memoir which might interest you.

The challenge you mention has been taken by me and others many times. It cannot convince critical thinkers and, frankly, I am surprised that you found a sceptic who was convinced by what essentially amounts to little more than a party trick. But, as you seem to like challenges, I invite you to consider taking the challenge of the INH which even offers a sizable amount of money, in case you are successful.

Your final claim that my thoughts are based purely on speculation is almost farcically wrong. The truth is that sceptics try their very best to counter-balance the mostly weird speculations of homeopaths with scientific facts. I am sure that, once you have acquired the skills of critical thinking, you will do the same.

Best of luck.

Edzard Ernst

This paper notes that, according to the World Naturopathic Federation (WNF), the naturopathic profession is based on two fundamental philosophies of medicine (vitalism and holism) and seven principles of practice (healing power of nature; treat the whole person; treat the cause; first, do no harm; doctor as teacher; health promotion and disease prevention; and wellness). The philosophy, theory, and principles are translated to clinical practice through a range of therapeutic modalities. The WNF has identified seven core modalities: (1) clinical nutrition and diet modification/counselling; (2) applied nutrition (use of dietary supplements, traditional medicines, and natural health care products); (3) herbal medicine; (4) lifestyle counselling; (5) hydrotherapy; (6) homeopathy, including complex homeopathy; and (7) physical modalities (based on the treatment modalities taught and allowed in each jurisdiction, including yoga, naturopathic manipulation, and muscle release techniques).

The ‘scoping’ review was to summarize the current state of the research evidence for whole-system, multi-modality naturopathic medicine. Studies were included, if they met the following criteria:

  • Controlled clinical trials, longitudinal cohort studies, observational trials, or case series involving five or more cases presented in any language
  • Human studies
  • Multi-modality treatment administered by a naturopath (naturopathic clinician, naturopathic physician) as an intervention
  • Non-English language studies in which an English title and abstract provided sufficient information to determine effectiveness
  • Case series in which five or more individual cases were pooled and authors provided a summative discussion of the cases in the context of naturopathic medicine
  • All human research evaluating the effectiveness of naturopathic medicine, where two or more naturopathic modalities are delivered by naturopathic clinicians, were included in the review.
  • Case studies of five or more cases were included.

Thirty-three published studies with a total of 9859 patients met inclusion criteria (11 US; 4 Canadian; 6 German; 7 Indian; 3 Australian; 1 UK; and 1 Japanese) across a range of mainly chronic clinical conditions. A majority of the included studies were observational cohort studies (12 prospective and 8 retrospective), with 11 clinical trials and 2 case series. The studies predominantly showed evidence for the efficacy of naturopathic medicine for the conditions and settings in which they were based. Overall, these studies show naturopathic treatment results in a clinically significant benefit for treatment of hypertension, reduction in metabolic syndrome parameters, and improved cardiac outcomes post-surgery.

The authors concluded that to date, research in whole-system, multi-modality naturopathic medicine shows that it is effective for treating cardiovascular disease, musculoskeletal pain, type 2 diabetes, polycystic ovary syndrome, depression, anxiety, and a range of complex chronic conditions. Overall, these studies show naturopathic treatment results in a clinically significant benefit for treatment of hypertension, reduction in metabolic syndrome parameters, and improved cardiac outcomes post-surgery.

Where to start?

There are many issues here to choose from:

  • The definition of naturopathy used in this review may be the one of the WHF, but it has little resemblance to the one used elsewhere. German naturopathic doctors, for instance, would not consider homeopathy to be a naturopathic treatment. They would also not, like the WNF does, subscribe to the long-obsolete humoral  theory of disease. The only German professional organisation that is a member of the WNF is thus not one of naturopathic doctors but one of Heilpraktiker (the notorious German lay-practitioner created by the Nazis during the Third Reich).
  • A review that includes observational studies and even case series, while drawing far-reaching conclusions on therapeutic effectiveness is, in my view, little more than embarrassing pseudo-science. Such studies are unable to differentiate between specific and non-specific therapeutic effects and therefore can tell us nothing about the effectiveness of a treatment.
  • A review on a subject such as naturopathy (an approach which, after all, originated in Europe) that excludes studies not published in English (and without an English abstract providing sufficient information to determine effectiveness) is likely to be incomplete.
  • The authors call their review a ‘scoping review’; they nevertheless draw conclusions not about the scope but the effectiveness of naturopathy.
  • Many of the studies included in this review do, in fact, not comply with the inclusion criteria set by the review-authors.
  • The review does not assess or even comment on the risks of naturopathic treatments.
  • Several of the included studies are not investigations of naturopathy but of approaches that squarely fall under the umbrella of integrative or alternative medicine.
  • Of the 33 studies included, only 5 were RCTs, and none of these was free of major limitations.
  • None of the RCTs have been independently replicated.
  • There is a remarkable absence of negative trials suggestion a strong influence of bias.
  • The review lacks any trace of critical thinking.
  • The authors are affiliated to institutions of naturopathy but declare no conflicts of interest.
  • No funding source was named but it seems that it was supported by the WNF; their primary goal is to promote and advance the naturopathic profession.
  • The review appeared in the notorious Journal of Complementary and Alternative Medicine.

Prof Dwyer, the founding president of the Australian ‘Friends of Science in Medicine’, said the study damaged Southern Cross University’s reputation. “At the heart of this is the credibility of Southern Cross University,” he said. “There’s been a stand-off between SCU and the rest of the scientific community in Australia for a number of years and there have been challenges to whether they are really upholding the highest standards of evidence-based medicine.” Professor Dwyer also raised questions about the university’s credibility late last year when it accepted a $10 million donation from vitamin company Blackmore’s to establish a National Centre for Naturopathic Medicine.

My conclusion of naturopathy, as defined by the WNF, is that it is an obsolete form of quackery steeped in concepts of vitalism that should be abandoned sooner rather than later. And my conclusion about the new review agrees with Prof Dwyer’s judgement: it is an embarrassment to all concerned.

A new update of the current Cochrane review assessed the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain. The authors included all randomised controlled trials (RCTs) examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded.

The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardised mean differences (SMD), respectively. Outcomes were examined at 1, 6, and 12 months.

Forty-seven RCTs including a total of 9211 participants were identified. Most trials compared SMT with recommended therapies. In 16 RCTs, the therapists were chiropractors, in 14 they were physiotherapists, and in 5 they were osteopaths. They used high velocity manipulations in 18 RCTs, low velocity manipulations in 12 studies and a combination of the two in 20 trials.

Moderate quality evidence suggested that SMT has similar effects to other recommended therapies for short term pain relief and a small, clinically better improvement in function. High quality evidence suggested that, compared with non-recommended therapies, SMT results in small, not clinically better effects for short term pain relief and small to moderate clinically better improvement in function.

In general, these results were similar for the intermediate and long term outcomes as were the effects of SMT as an adjuvant therapy.

Low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at six and 12 months. Low quality evidence suggested that SMT results in a moderate to strong statistically significant and clinically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically significant better effect than sham SMT at six and 12 months.

(Mean difference in reduction of pain at 1, 3, 6, and 12 months (0-100; 0=no pain, 100 maximum pain) for spinal manipulative therapy (SMT) versus recommended therapies in review of the effects of SMT for chronic low back pain. Pooled mean differences calculated by DerSimonian-Laird random effects model.)

About half of the studies examined adverse and serious adverse events, but in most of these it was unclear how and whether these events were registered systematically. Most of the observed adverse events were musculoskeletal related, transient in nature, and of mild to moderate severity. One study with a low risk of selection bias and powered to examine risk (n=183) found no increased risk of an adverse event or duration of the event compared with sham SMT. In one study, the Data Safety Monitoring Board judged one serious adverse event to be possibly related to SMT.

The authors concluded that SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.

This paper is currently being celebrated (mostly) by chiropractors who think that it vindicates their treatments as being both effective and safe. However, I am not sure that this is entirely true. Here are a few reasons for my scepticism:

  • SMT is as good as other recommended treatments for back problems – this may be so but, as no good treatment for back pain has yet been found, this really means is that SMT is as BAD as other recommended therapies.
  • If we have a handful of equally good/bad treatments, it stand to reason that we must use other criteria to identify the one that is best suited – criteria like safety and cost. If we do that, it becomes very clear that SMT cannot be named as the treatment of choice.
  • Less than half the RCTs reported adverse effects. This means that these studies were violating ethical standards of publication. I do not see how we can trust such deeply flawed trials.
  • Any adverse effects of SMT were minor, restricted to the short term and mainly centred on musculoskeletal effects such as soreness and stiffness – this is how some naïve chiro-promoters already comment on the findings of this review. In view of the fact that more than half the studies ‘forgot’ to report adverse events and that two serious adverse events did occur, this is a misleading and potentially dangerous statement and a good example how, in the world of chiropractic, research is often mistaken for marketing.
  • Less than half of the studies (45% (n=21/47)) used both an adequate sequence generation and an adequate allocation procedure.
  • Only 5 studies (10% (n=5/47)) attempted to blind patients to the assigned intervention by providing a sham treatment, while in one study it was unclear.
  • Only about half of the studies (57% (n=27/47)) provided an adequate overview of withdrawals or drop-outs and kept these to a minimum.
  • Crucially, this review produced no good evidence to show that SMT has effects beyond placebo. This means the modest effects emerging from some trials can be explained by being due to placebo.
  • The lead author of this review (SMR), a chiropractor, does not seem to be free of important conflicts of interest: SMR received personal grants from the European Chiropractors’ Union (ECU), the European Centre for Chiropractic Research Excellence (ECCRE), the Belgian Chiropractic Association (BVC) and the Netherlands Chiropractic Association (NCA) for his position at the Vrije Universiteit Amsterdam. He also received funding for a research project on chiropractic care for the elderly from the European Centre for Chiropractic Research and Excellence (ECCRE).
  • The second author (AdeZ) who also is a chiropractor received a grant from the European Chiropractors’ Union (ECU), for an independent study on the effects of SMT.

After carefully considering the new review, my conclusion is the same as stated often before: SMT is not supported by convincing evidence for back (or other) problems and does not qualify as the treatment of choice.

Osteopathy is a tricky subject:

  • Osteopathic manipulations/mobilisations are advocated mainly for spinal complaints.
  • Yet many osteopaths use them also for a myriad of non-spinal conditions.
  • Osteopathy comprises two entirely different professions; in the US, osteopaths are very similar to medically trained doctors, and many hardly ever employ osteopathic manual techniques; outside the US, osteopaths are alternative practitioners who use mainly osteopathic techniques and believe in the obsolete gospel of their guru Andrew Taylor Still (this post relates to the latter type of osteopathy).
  • The question whether osteopathic manual therapies are effective is still open – even for the indication that osteopaths treat most, spinal complaints.
  • Like chiropractors, osteopaths now insist that osteopathy is not a treatment but a profession; the transparent reason for this argument is to gain more wriggle-room when faced with negative evidence regarding they hallmark treatment of osteopathic manipulation/mobilisation.

A new paper authored by osteopaths is an attempt to shed more light on the effectiveness of osteopathy. The aim of this systematic review evaluated the impact of osteopathic care for spinal complaints.  Only randomized controlled trials conducted in high-income Western countries were considered. Two authors independently screened the titles and abstracts. Primary outcomes included ‘pain’ and ‘functional status’, while secondary outcomes included ‘medication use’ and ‘health status’.

Nineteen studies were included and qualitatively synthesized. Nine studies were from the US, followed by Germany with 7 studies. The majority of studies (n = 13) focused on low back pain.

In general, mixed findings related to the impact of osteopathic care on primary and secondary outcomes were observed. For the primary outcomes, a clear distinction between US and European studies was found, where the latter RCTs reported positive results more frequently. Studies were characterized by substantial methodological differences in sample sizes, number of treatments, control groups, and follow-up.

The authors concluded that “the findings of the current literature review suggested that osteopathic care may improve pain and functional status in patients suffering from spinal complaints. A clear distinction was observed between studies conducted in the US and those in Europe, in favor of the latter. Today, no clear conclusions of the impact of osteopathic care for spinal complaints can be drawn. Further studies with larger study samples also assessing the long-term impact of osteopathic care for spinal complaints are required to further strengthen the body of evidence.”

Some of the most obvious weaknesses of this review include the following:

  • In none of the studies employed blinding of patients, care provider or outcome assessor occurred, or it was unclear. Blinding of outcome assessors is easily implemented and should be standard in any RCT.
  • In three studies, the study groups differed to some extent at baseline indicating that randomisation was not successful..
  • Five studies were derived from the ‘grey literature’ and were therefore not peer-reviewed.
  • One study (the UK BEAM trial) employed not just osteopaths but also chiropractors and physiotherapists for administering the spinal manipulations. It is therefore hardly an adequate test of osteopathy.
  • The study was funded by an unrestricted grant from the GNRPO, the umbrella organization of the ‘Belgian Professional Associations for Osteopaths’.

Considering this last point, the authors’ honesty in admitting that no clear conclusions of the impact of osteopathic care for spinal complaints can be drawn is remarkable and deserves praise.

Considering that the evidence for osteopathy is even far worse for non-spinal conditions (numerous trials exist for all sorts of other conditions, but they tend to be flimsy and usually lack independent replications), it is fair to conclude that osteopathy is NOT an evidence-based therapy.

A recent blog-post pointed out that the usefulness of yoga in primary care is doubtful. Now we have new data to shed some light on this issue.

The new paper reports a ‘prospective, longitudinal, quasi-experimental study‘. Yoga group (n= 49) underwent 24-weeks program of one-hour yoga sessions. The control group had no yoga.

Participation was voluntary and the enrolment strategy was based on invitations by health professionals and advertising in the community (e.g., local newspaper, health unit website and posters). Users willing to participate were invited to complete a registration form to verify eligibility criteria.

The endpoints of the study were:

  • quality of life,
  • psychological distress,
  • satisfaction level,
  • adherence rate.

The yoga routine consisted of breathing exercises, progressive articular and myofascial warming-up, followed by surya namascar (sun salutation sequence; adapted to the physical condition of each participant), alignment exercises, and postural awareness. Practice also included soft twists of the spine, reversed and balance postures, as well as concentration exercises. During the sessions, the instructor discussed some ethical guidelines of yoga, as for example, non-violence (ahimsa) and truthfulness (satya), to allow the participant to have a safer and integrated practice. In addition, the participants were encouraged to develop their awareness of the present moment and their body sensations, through a continuous process of self-consciousness, keeping a distance between body sensations and the emotional experience. The instructor emphasized the connection between breathing and movement. Each session ended with a guided deep relaxation (yoga nidra; 5–10 min), followed by a meditation practice (5–10 min).

The results of the study showed that the patients in the yoga group experienced a significant improvement in all domains of quality of life and a reduction of psychological distress. Linear regression analysis showed that yoga significantly improved psychological quality of life.

The authors concluded that yoga in primary care is feasible, safe and has a satisfactory adherence, as well as a positive effect on psychological quality of life of participants.

Are the authors’ conclusions correct?

I think not!

Here are some reasons for my judgement:

  • The study was far to small to justify far-reaching conclusions about the safety and effectiveness of yoga.
  • There were relatively high numbers of drop-outs, as seen in the graph above. Despite this fact, no intention to treat analysis was used.
  • There was no randomisation, and therefore the two groups were probably not comparable.
  • Participants of the experimental group chose to have yoga; their expectations thus influenced the outcomes.
  • There was no attempt to control for placebo effects.
  • The conclusion that yoga is safe would require a sample size that is several dimensions larger than 49.

In conclusion, this study fails to show that yoga has any value in primary care.

PS

Oh, I almost forgot: and yoga is also satanic, of course (just like reading Harry Potter!).

 

As you know, I have repeatedly written about integrative cancer therapy (ICT). Yet, to be honest, I was never entirely sure what it really is; it just did not make sense – not until I saw this announcement. It left little doubt about the nature of ICT.

As it is in German, allow me to translate it for you [the numbers added to the text refer to my comments below]:

ICT is a method of treatment that views humans holistically [1]. The approach is characterised by a synergistic application (integration) of all conventional [the actual term used is a derogatory term coined by Hahnemann to denounce the prevailing medicine of his time], immunological, biological and psychological insights [2]. In this spirit, also personal needs and subjective experiences of disease are accounted for [3]. The aim of this special approach is to offer cancer patients an individualised, interdisciplinary treatment [4].

Besides surgery, chemotherapy and radiotherapy, ICT also includes hormone therapy, hyperthermia, pain management, immunotherapy, normalisation of metabolism, stabilisation of the psyche, physical activity, dietary changes, as well as substitution of vital nutrients [5].

With ICT, the newest discoveries of cancer research are being offered [6], that support the aims of ICT. Therefore, the aims of the ICT doctor include continuous research of the world literature on oncology [7]…

Likewise, one has to start immediately with measures that help prevent metastases and tumour progression [8]. Both the maximization of survival and the optimisation of quality of life ought to be guaranteed [9]. Therefore, the alleviation of the side-effects of the aggressive therapies are one of the most important aims of ICT [10]…

HERE IS THE GERMAN ORIGINAL

Die integrative Krebstherapie ist eine Behandlungsmethode, die den Menschen in seiner Ganzheit sieht und sich dafür einsetzt. Ihre Behandlungsweise ist gekennzeichnet durch die synergetische Anwendung (Integration) aller sinnvollen schulmedizinischen, immunologischen, biologischen und psychologischen Erkenntnisse. In diesem Sinne werden auch die persönlichen Bedürfnisse und die subjektiven Krankheitserlebnisse berücksichtigt. Ziel dieser besonderen Therapie ist es, dass dem Krebspatienten eine individuell eingerichtete und interdisziplinär geplante Behandlung angeboten wird.

Zur integrativen Krebstherapie gehört neben der operativen Tumorbeseitigung, Chemotherapie und Strahlentherapie auch die Hormontherapie, Hyperthermie, Schmerzbeseitigung, Immuntherapie, Normalisierung des Stoffwechsels, Stabilisierung der Psyche, körperliche Aktivierung, Umstellung der Ernährung sowie die Ergänzung fehlender lebensnotwendiger Vitalstoffe.

Mit dieser Behandlungsmethode werden auch die neuesten Entdeckungen der Krebsforschung angeboten, die die Ziele der Integrativen Krebstherapie unterstützen. Deshalb sind die ständigen Recherchen der umfangreichen Ergebnisse der Onkologie-Forschung in der medizinischen Weltliteratur auch Aufgabe der Mediziner in der Integrativen Krebstherapie…

Ebenso sollte auch sofort mit den Maßnahmen begonnen werden, die helfen, dieMetastasen Bildung und Tumorprogredienz zu verhindern. Nicht nur die Maximierung des Überlebens, sondern auch die Optimierung der Lebensqualität sollen gewährleistet werden. Deshalb ist auch die Linderung der Nebenwirkungen der aggressiven Behandlungsmethoden eines der wichtigsten Ziele der Integrativen Krebstherapie….

MY COMMENTS

  1. Actually, this describes conventional oncology!
  2. Actually, this describes conventional oncology!
  3. Actually, this describes conventional oncology!
  4. Actually, this describes conventional oncology!
  5. Actually, this describes conventional oncology!
  6. Actually, this describes conventional oncology!
  7. Actually, this describes conventional oncology!
  8. Actually, this describes conventional oncology!
  9. Actually, this describes conventional oncology!
  10. Actually, this describes conventional oncology!

ICT might sound fine to many consumers. I can imagine that it gives confidence to some patients. But it really is nothing other than the adoption of the principles of good conventional cancer care?

No!

But in this case, ICT is just a confidence trick!

It is a confidence trick that allows the trickster to smuggle no end of SCAM into routine cancer care!

Or did I miss something here?

Am I perhaps mistaken?

Please, do tell me!

Excellent journals always publish excellent science!

If this is what you believe, you might want to read a study of chiropractic just published in the highly respected SCIENTIFIC REPORTS.

The objective of this study was to investigate whether a single session of chiropractic care could increase strength in weak plantar flexor muscles in chronic stroke patients. Maximum voluntary contractions (strength) of the plantar flexors, soleus evoked V-waves (cortical drive), and H-reflexes were recorded in 12 chronic stroke patients, with plantar flexor muscle weakness, using a randomized controlled crossover design. Outcomes were assessed pre and post a chiropractic care intervention and a passive movement control. Repeated measures ANOVA was used to asses within and between group differences. Significance was set at p < 0.05. Following the chiropractic care intervention there was a significant increase in strength (F (1,11) = 14.49, p = 0.002; avg 64.2 ± 77.7%) and V-wave/Mmax ratio (F(1,11) = 9.67, p = 0.009; avg 54.0 ± 65.2%) compared to the control intervention. There was a significant strength decrease of 26.4 ± 15.5% (p = 0.001) after the control intervention. There were no other significant differences. Plantar flexor muscle strength increased in chronic stroke patients after a single session of chiropractic care. An increase in V-wave amplitude combined with no significant changes in H-reflex parameters suggests this increased strength is likely modulated at a supraspinal level. Further research is required to investigate the longer term and potential functional effects of chiropractic care in stroke recovery.

In the article we find the following further statements (quotes in bold, followed by my comments in normal print):

  • Data were collected by a team of researchers from the Centre for Chiropractic Research at the New Zealand College of Chiropractic. These researchers can be assumed to be highly motivated in generating a positive finding.
  • The entire spine and both sacroiliac joints were assessed for vertebral subluxations, and chiropractic adjustments were given where deemed necessary, by a New Zealand registered chiropractor. As there is now near-general agreement that such subluxations are a myth, the researchers treated a non-existing entity.
  • The chiropractor did not contact on a segment deemed to be subluxated during the control set-up and no adjustive thrusts were applied during any control intervention. The patients therefore were clearly able to tell the difference between real and control treatmentsParticipants were not checked for blinding success.
  • Maximum isometric plantarflexion force was measured using an isometric strain gauge. Such measurements crucially depend on the motivation of the patient.
  • The grant proposal for this study was reviewed by the Australian Spinal Research Foundation to support facilitation of funding from the United Chiropractic Association. Does this not mean the researchers had a conflict of interest?
  • The authors declare no competing interests. Really? They were ardent subluxationists supported by the United Chiropractic Association, an organisation stating that chiropractic is concerned with the preservation and restoration of health, and focuses particular attention on the subluxation, and subscribes to to the obsolete concept of vitalism: we ascribe to the idea that all living organisms are sustained by an innate intelligence, which is both different from and greater than physical and chemical forces. Further, we believe innate intelligence is an expression of universal intelligence.

So, in essence, what we have here is an under-powered study sponsored by vitalists and conducted by subluxationists treating a mythical entity with dubious interventions without controlling for patients’ expectation pretending their false-positive findings are meaningful.

I cannot help wondering what possessed the SCIENTIFIC REPORTS to publish such poor science.

Did we not have a flurry of systematic reviews of homeopathy in recent months?

And were they not a great disappointment to homeopaths and their patients?

Just as we thought that this is more than enough evidence to show that homeopathy is not effective, here comes another one.

This new review evaluated RCTs of non-individualised homeopathic treatment (NIHT) in which the control group received treatments other than placebo (OTP). Specifically, its aim was to determine the comparative effectiveness of NIHT on health-related outcomes for any given condition.

For each eligible trial, published in the peer-reviewed literature up to the end of 2016, the authors assessed its risk of bias (internal validity) using the seven-domain Cochrane tool, and its relative pragmatic or explanatory attitude (external validity) using the 10-domain PRECIS tool. The researchers grouped RCTs by whether these examined homeopathy as an alternative treatment (study design 1a), adjunctively with another intervention (design 1b), or compared with no intervention (design 2). RCTs were sub-categorised as superiority trials or equivalence/non-inferiority trials. For each RCT, a single ‘main outcome measure’ was selected to use in meta-analysis.

Seventeen RCTs, representing 15 different medical conditions, were eligible for inclusion. Three of the trials were more pragmatic than explanatory, two were more explanatory than pragmatic, and 12 were equally pragmatic and explanatory. Fourteen trials were rated ‘high risk of bias’ overall; the other three trials were rated ‘uncertain risk of bias’ overall. Ten trials had data that were extractable for meta-analysis. Significant heterogeneity undermined the planned meta-analyses or their meaningful interpretation. For the three equivalence or non-inferiority trials with extractable data, the small, non-significant, pooled effect size was consistent with a conclusion that NIHT did not differ from treatment by a comparator (Ginkgo biloba or betahistine) for vertigo or (cromolyn sodium) for seasonal allergic rhinitis.

The authors concluded that the current data preclude a decisive conclusion about the comparative effectiveness of NIHT. Generalisability of findings is restricted by the limited external validity identified overall. The highest intrinsic quality was observed in the equivalence and non-inferiority trials of NIHT.

I do admire the authors’ tenacity in meta-analysing homeopathy trials and empathise with their sadness of the multitude of negative results they thus have to publish. However, I do disagree with their conclusions. In my view, at least two firm conclusions ARE possible:

  1. This dataset confirms yet again that the methodological quality of homeopathy trials is lousy.
  2. The totality of the trial evidence analysed here fails to show that non-individualised homeopathy is effective.

In case you wonder why the authors are not more outspoken about their own findings, perhaps you need to read their statement of conflicts of interest:

Authors RTM, YYYF, PV and AKLT are (or were) associated with a homeopathy organisation whose significant aim is to clarify and extend an evidence base in homeopathy. RTM holds an independent research consultancy contract with the Deutsche Homöopathie-Union, Karlsruhe, Germany. YYYF and AKLT belong to Living Homeopathy Ltd., which has contributed funding to some (but not this current) HRI project work. RTM and PV have no other relationships or activities that could appear to have influenced the submitted work. JRTD had no support from any organisation for the submitted work; in the last 3 years, and for activities outside the submitted study, he received personal fees, royalties or out-of-pocket expenses for advisory work, invitational lectures, use of rating scales, published book chapters or committee membership; he receives royalties from Springer Publishing Company for his book, A Century of Homeopaths: Their Influence on Medicine and Health. JTRD has no other relationships or activities that could appear to have influenced the submitted study.

If one had wanted to add insult to injury, one could have added that, if, despite such conflicts of interest, the overall result of this new review turned out to be not positive, the evidence must be truly negative.

Simply put, in the realm of SCAM, we seem to have two types of people:

  1. those who don’t care a hoot about evidence;
  2. those who try their best to follow the evidence.

The first group is replete with SCAM enthusiasts who make their decisions based purely on habit, emotion, intuition etc. They are beyond my reach, I fear. It is almost exclusively the second group for whom I write this blog.

And that could be relatively easy, if the evidence were always accessible, understandable, straight forward, conclusive and convincing. But sadly, in SCAM (as in most other areas of healthcare), the evidence is full of apparent and real contradictions. In this situation, it is often difficult even for experts to understand what is going on; for lay people this must be immeasurably more confusing. Yet, it is the lay consumers who often will take the decision to use or not use this or that SCAM. They therefore need our help.

What can consumers do when they are confronted with contradictory evidence?

How can they distinguish right from wrong?

  • Some articles claim that homeopathy works – others say it is just a placebo therapy.
  • Some experts claim that chiropractic is safe – others say it can do serious harm.
  • Some articles claim that SCAM-practitioners are competent – others say this is not true.
  • Some experts claim that SCAM is the future – others stress that it is obsolete.

What can a lay person with no or very little understanding of science do to see through this fog of contradictions?

Let me try to provide consumers with a step by step approach to get closer to the truth by asking a few incisive questions:

  1. WHERE DID YOU READ THE CLAIM? If it was in a newspaper, magazine, website, etc. take it with a pinch of salt (double the dose of salt, if it’s from the Daily Mail).
  2. CAN YOU RETRACE THE CLAIM TO A SCIENTIFIC PAPER? This might challenge you skills as a detective, but it is always well-worth finding the original source of a therapeutic claim in order to judge its credibility. If no good source can be found, I advise caution.
  3. IN WHICH MEDICAL JOURNAL WAS THE CLAIM PUBLISHED? Be aware of the fact that there are dozens of SCAM-journals that would publish virtually any rubbish.
  4. WHO ARE THE AUTHORS OF THE SCIENTIFIC PAPER? It might be difficult for a lay person to evaluate their credibility. But there might be certain pointers; for instance, authors affiliated to a university tend to be more credible than SCAM-practitioners who have no such affiliations or authors working for a lobby-group.
  5. WHAT SORT OF ARTICLE IS THE ORIGINAL SOURCE OF THE CLAIM? Is it a proper experimental study or a mere opinion piece? If possible, try to find a good-quality (perhaps even a Cochrane) review on the subject.
  6. ARE THERE OTHER RESEARCHERS WHO HAVE ARRIVED AT SIMILAR CONCLUSIONS? If the claim is based on just one solitary piece of research or opinion, it clearly weighs less than a consensus of experts.
  7. DO PUBLICATIONS EXIST THAT DISAGREE WITH THE CLAIM? Even if there are several scientific papers from different teams of researchers supporting the claim, it is important to find out whether the claim is shared by all experts in the field.

Eventually, you might get a good impression about the veracity of the claim. But sometimes you also might end up with a bunch of systematic reviews of which several support, while others reject the claim. And all of them could look similarly credible to your untrained eyes. Does that mean your attempt to find the truth of the matter has been frustrated?

Not necessarily!

In this case, you would probably consider the following options:

  1. You could do a simple ‘pea count’; this would tell you whether the majority of reviews is pro or contra the claim. However, this might be your worst bet for arriving at a sound conclusion. The quantity of the evidence usually is far less important than its quality.
  2. If you have no training to judge the quality of a review, you might just go with the most recent and up-to-date review. This, however, would also be fraught with problems, as you can, of course, not be sure that the most recent one is also the least biased assessment.
  3. Perhaps you can somehow get an impression about the respectability of the source. If, for instance, there is a recent Cochrane review, I advise to go with that one.
  4. Look up the profession of the authors of the review. The pope is unlikely to condemn Catholicism; likewise, you will find very few homeopaths who are critical of homeopathy, or chiropractors who are critical of chiropractic, etc. I know this is a very crude ‘last resort’ for replacing an authorative evaluation of the claim. But, if that’s all you have, it is better than nothing. Ask yourself who can normally be trusted more, the SCAM-practitioner or lobbyist who makes a living from the claim or an independent academic who has no such conflict of interest?

If all of this does not help you to decide whether a therapeutic claim is trustworthy or not, my advice has always been to reflect on this: IF IT SOUNDS TOO GOOD TO BE TRUE, IT PROBABLY IS.

 

 

In 2004, my team published a review analysing the diversity of so-called alternative medicine (SCAM) research published in one single year (2002) across 7 European countries (Germany, United Kingdom, Italy, France, Spain, Netherlands, Belgium) and the US. In total 652 abstracts of articles were assessed. Germany and the UK were the only two European countries to publish in excess of 100 articles in that year (Germany: 137, UK: 183). The majority of articles were non-systematic reviews and comments, analytical studies and surveys. The UK carried out more surveys than any of the other countries and also published the largest number of systematic reviews. Germany, the UK and the US covered the widest range of interests across various SCAM modalities and investigated the safety of CAM. We concluded that important national differences exist in terms of the nature of SCAM research. This raises important questions regarding the reasons for such differences.

One striking difference was the fact that, compared to the UK, Germany had published far less research on SCAM that failed to report a positive result (4% versus 14%). Ever since, I have wondered why. Perhaps it has something to do with the biggest sponsor of SCAM research in Germany: THE CARSTENS STIFTUNG?

The Carstens Foundation (CF) was created by the former German President, Prof. Dr. Karl Carstens and his wife, Dr. Veronica Carstens. Karl Carstens (1914-1992) was the 5th President of federal Germany, from 1979 to 1984. Veronica Carstens (1923-2012) was a doctor of Internal Medicine with an interest in natural medicine and homeopathy in particular. She is quoted by the CF stating: „Der Arzt und die Ärztin der Zukunft sollen zwei Sprachen sprechen, die der Schulmedizin und die der Naturheilkunde und Homöopathie. Sie sollen im Einzelfall entscheiden können, welche Methode die besten Heilungschancen für den Patienten bietet.“ (Future doctors should speak two languages, that of ‘school medicine’ [Hahnemann’s derogatory term for conventional medicine] and that of naturopathy and homeopathy. They should be able to decide on a case by case basis which method offers the best chances of a cure for the patient.***)

Together, the two Carstens created the CF with the goal of sponsoring SCAM in Germany. More than 35 million € have so far been spent on more than 100 projects, fellowships, dissertations, an own publishing house, and a patient societyNatur und Medizin” (currently ~23 000 members) with the task of promoting SCAM. Projects the CF proudly list as their ‘milestones’ include: 

  • an outpatient clinic of natural medicine for cancer
  • a project ‘Natural medicine and homeopathy for children and adolescents’.

The primary focus of the CF clearly is homeopathy, and it is in this area where their anti-science bias gets most obvious. I do invite everyone who reads German to have a look at their website and be amazed at the plethora of misleading claims.

Their expert for all things homeopathic is Dr Jens Behnke (‘Referent für Homöopathieforschung bei der Karl und Veronica Carstens-Stiftung: Evidenzbasierte Medizin, CAM, klinische Forschung, Grundlagenforschung’). He is not a medical doctor but has a doctorate from the ‘Kulturwissenschaftlichen Fakultät der Europa-Universität Viadrina’ entitled ‘Wissenschaft und Weltanschauung. Eine epistemologische Analyse des Paradigmenstreits in der Homöopathieforschung’ (Science and world view. An epistemological analysis of the paradigm-quarrel in homeopathy research). His supervisor was Prof Harald Walach who has long been close to the CF.

Behnke claims to be an expert in EBM, clinical research and basic research but, intriguingly, he has not a single Medline-listed publication to his name. So, we only have his dissertation to assess his expertise.

The very 1st sentence of his dissertation is noteworthy, in my view: Die Homöopathie ist eine Therapiemethode, die seit mehr als 200 Jahren praktiziert wird und eine beträchtliche Zahl an Heilungserfolgen vorzuweisen hat (Homeopathy is a therapeutic method, that is being used since more than 200 years and which is supported by a remarkable number of therapeutic successes). In essence, the dissertation dismisses the scientific approach for evaluating homeopathy as well as the current best evidence that shows homeopathy to be ineffective.

Behnke dismisses my own research on homeopathy without even considering it. He first claims to have found an error in one of my systematic reviews and then states: Die Fragwürdigkeit der oben angeführten Methoden rechtfertigt das Übergehen sämtlicher Publikationen dieses Autors im Rahmen dieser Arbeit. Wenn einem Wissenschaftler die aufgezeigte absichtliche Falschdarstellung aufgrund von Voreingenommenheit nachgewiesen werden kann, sind seine Ergebnisse, wenn überhaupt, nur nach vorheriger systematischer Überprüfung sämtlicher Originalpublikationen und Daten, auf die sie sich beziehen, verwertbar. Essentially, he claims that, because he has found one error, the rest cannot be trusted and therefore he is entitled to reject the lot.

In the same dissertation, we read the following: Ernst konstatiert in allen … Arbeiten zur Homöopathie ausnahmslos, dass es keinerlei belastbare Hinweise auf eine Wirksamkeit homöopathischer Arzneimittel über Placeboeffekte hinaus gebe (Ernst states in all publications on homeopathy without exception that no solid suggestions exist at all for an effectiveness of homeopathic remedies). However, it is demonstrably wrong that all of my papers arrive at a negative judgement of homeopathy’s effectiveness; here are three that spring into my mind:

So, applying Behnke’s own logic outlined above, one should argue that, because I have found one error in his research, the rest of what Behnke will (perhaps one day be able to) publish cannot be trusted and therefore I am entitled to reject the lot.

That would, of course, be tantamount to adopting the stupidity of one’s own opponents. So, I will certainly not do that; instead, I will wait patiently for the sound science that Dr Behnke (and indeed the CF) might eventually produce.

 

***phraseology that is strikingly similar to that of Rudolf Hess on the same subject.

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