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

critical thinking

George Lewith has died on 17 March, aged 67. He was one of the most productive researchers of alternative medicine in the UK; specifically he was interested in acupuncture. If you search this blog, you find several posts that mention him or are entirely dedicated to his work. Undeniably, my own views and research were often very much at odds with those of Lewith.

Wikipedia informs us that Lewith graduated from Trinity College, Cambridge in medicine and biochemistry.  He then went on to Westminster Medical School to complete his clinical studies and began working clinically in 1974. In 1977 Lewith became a member of the Royal College of Physicians. Then, in 1980, he became a member of the Royal College of General Practitioners and, later in 1999, was elected a fellow of the Royal College of Physicians.

He was a Professor of Health Research in the Department of Primary Care at the University of Southampton and a director of the International Society for Complementary Medicine Research. Lewith has obtained a significant number of institutional peer reviewed fellowships at doctoral and post-doctoral level and has been principal investigator or collaborator in research grants totally over £5 million during the last decade.

Between 1980 and 2010, Lewith was a partner at the Centre for Complementary and Integrated Medicine, a private practice providing complementary treatments with clinics in London and Southampton.

A tribute by the British Acupuncture Council is poignant, in my view: “George was a friend not only to all of the acupuncture profession, be it traditional, medical or physiotherapist – he was a member of all three professional bodies – but to the whole of complementary medicine. As well as being a research leader he was also politically savvy, working tirelessly up front and behind the scenes to try to bring acupuncture and CAM further into the mainstream. Nobody did more.”

I find it poignant because it hints at the many differences I (and many others) had with Lewith during the last 25 years that I knew him. George was foremost a proponent of acupuncture. His 1985 book – the first of many – advocated treating many internal diseases with acupuncture!

George did not strike me as someone who had the ability or even the ambition to use science for finding the truth and for falsifying hypotheses; in my view, he employed it to confirm his almost evangelic belief. In the pursuit of this all-important aim he did indeed spend a lot of time and energy pulling strings, including on the political level. George was undoubtedly successful but the question has to be asked to what extent this was due to his tireless work ‘behind the scenes’.

In my view, George was a typical example of someone who first and foremost was an advocate and a researcher second. During my time in Exeter, I have met numerous co-workers who had the same problem. Almost without exception, I found that it is impossible to turn such a person into a decent scientist. The advocacy of alternative medicine always got in the way of objectivity and rationality, qualities that are, of course, essential for good science.

George’s very first publication on acupuncture was a ‘letter to the editor’ published in the BMJ. In it, he announced that he is planning to conduct a trial of acupuncture and stated that “acupuncture will be compared to an equally magical placebo”. Yes, George always had the ability to make me laugh; and this is why I will miss him.

The love-affair of many nurses with complementary medicine is well-known. We have discussed it many times on this blog – see for instance here, here and here. Yet the reasons for it remain somewhat mysterious, I find. Therefore I was interested to see a new paper on the subject.

The aim of this ‘meta-synthesis‘ was to review, critically, appraise and synthesize the existing qualitative research to develop a new, more substantial interpretation of nurses’ attitudes regarding the, use of complementary therapies by patients. Fifteen articles were included in the review.

Five themes emerged from the data relating to nurses’ attitude towards complementary therapies:

  1. the strengths and weaknesses of conventional medicine;
  2. complementary therapies as a way to enhance nursing practice;
  3. patient empowerment and patient-centeredness;
  4. cultural barriers and enablers to integration;
  5. structural barriers and enablers to integration.

Nurses’ support for complementary therapies, the authors of this article claim, is not an attempt to challenge mainstream medicine but rather an endeavour to improve the quality of care available to patients. There are, however, a number of barriers to nurses’ support including institutional culture and clinical context, as well as time and knowledge limitations.

The authors concluded that some nurses promote complementary therapies as an opportunity to personalise care and practice in a humanistic way. Yet, nurses have very limited education in this field and a lack of professional frameworks to assist them. The nursing profession needs to consider how to address current deficiencies in meeting the growing use of complementary therapies by patients.

In my view, there are two most remarkable misunderstandings here:

  1. While it is undoubtedly laudable that nurses “endeavour to improve the quality of care available to patients”, it has to be said that such an endeavour does not require complementary medicine. Are they implying that with conventional medicine the quality of care cannot be improved?
  2. I fail to understand why the lack of good evidential support for most complementary therapies did not emerge as a prominent theme. Are nurses not concerned about the (lack of) evidence that underpins their actions?

Aromatherapy is popular and pleasant – but does it have real health effects? The last time I tried to find an answer to this question was in 2012. At that time, our systematic review concluded that “the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.” But 5 years can be a long time in research, and more up-to-date information would perhaps be helpful.

This systematic review of 2017 aimed to provide an analysis of the clinical evidence on the efficacy of aromatherapy specifically for depressive symptoms on any type of patients. The authors searched 5 databases for relevant studies Outcome measures included scales measuring depressive symptoms levels. Twelve randomized controlled trials (RCTs) were included. Aromatherapy was administered by inhalation (5 studies) or massage (7 studies). Seven RCTs showed improvement in depressive symptoms. The quality of half of the studies was low, and the administration protocols varied considerably among the studies. Different assessment tools were employed in the studies. In 6 of the RCTs, aromatherapy was compared to no intervention.

Despite these caveats, the authors concluded that aromatherapy showed potential to be used as an effective therapeutic option for the relief of depressive symptoms in a wide variety of subjects. Particularly, aromatherapy massage showed to have more beneficial effects than inhalation aromatherapy.

Apart from the poor English, this paper is irritating because of the almost total lack of critical input. Given that half of the trials were of poor quality (only one was given the full points on the quality scale) and many totally failed to control for placebo-effects, I think that calling aromatherapy an effective therapeutic option for the relief of depressive symptoms is simply not warranted. In fact, it is highly misleading and, given the fact that depression is a life-threatening condition, it seems unethical and dangerous.

Considering these facts, my conclusion remains that “the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition, including depression.”

On 13 March, the UK Charity Commission published the following announcement:

This consultation is about the Commission’s approach to deciding whether an organisation which uses or promotes CAM therapies is a charity. For an organisation to be charitable, its purposes must be exclusively charitable. Some purposes relate to health and to relieve the needs of the elderly and disabled.

We are seeking views on:

  • the level and nature of evidence to support CAM
  • conflicting and inconsistent evidence
  • alternative therapies and the risk of harm
  • palliative alternative therapy

Last year, lawyers wrote to the Charity Commission on behalf of the Good Thinking Society suggesting that, if the commission refused to revoke the charitable status of organisations that promote homeopathy, it could be subject to a judicial review. The commission responded by announcing their review which will be completed by 1 July 2017.

Charities must meet a “public benefit test”. This means that they must be able to provide evidence that the work they do benefits the public as a whole. Therefore the consultation will have to determine what nature of evidence is required to demonstrate that a CAM-promoting charity provides this benefit.

In a press release, the Charity Commission stated that it will consider what to do in the face of “conflicting or inconsistent” evidence of a treatment’s effectiveness, and whether it should approach “complementary” treatments, intended to work alongside conventional medicine, differently from “alternative” treatments intended to replace it. In my view, however, this distinction is problematic and often impossible. Depending on the clinical situation, almost any given alternative therapy can be used both as a complementary and as an alternative treatment. Some advocates seem to cleverly promote their therapy as complementary (because this is seen as more acceptable), but clearly employ it as an alternative. The dividing line is often far too blurred for this distinction to be practical, and I have therefore long given up making it.

John Maton, the commission’s head of charitable status, said “Our consultation is not about whether complementary and alternative therapies and medicines are ‘good’ or ‘bad’, but about what level of evidence we should require when making assessments about an organisation’s charitable status.” Personally, I am not sure what this means. It sounds suspiciously soft and opens all sorts of escape routes for even the most outright quackery, I fear.

Michael Marshall of the Good Thinking Society said “We are pleased to see the Charity Commission making progress on their review. Too often we have seen little effective action to protect the public from charities whose very purpose is the promotion of potentially dangerous quackery. However, the real progress will come when the commission considers the clear evidence that complementary and alternative medicine organisations currently afforded charitable status often offer therapies that are completely ineffective or even potentially harm the public. We hope that this review leads to a policy to remove such misleading charities from the register.”

On this blog, I have occasionally reported about charities promoting quackery (for instance here, here and here) and pointed out that such activities cannot ever benefit the public. On the contrary, they are a danger to public health and bring many good charities into disrepute. I would therefore encourage everyone to use this unique occasion to write to the Charity Commission and make their views felt.

 

The notorious tendency of pharmacist to behave like shop-keepers when it comes to the sale of bogus remedies has been the subject of this blog many times before. In my view, this is an important subject, and I will therefore continue to report about it.

On the website of the AUSTRALIAN JOURNAL OF PHARMACY (AJP), we find interesting new data on Australian pharmacists’ love affair with bogus alternative medicine. The AJP recently ran a poll asking readers: “Do you stock Complementary Medicines (CMs) in your pharmacy?” The results of this little survey so far show that 54% of all participating pharmacists say they stock CMs, including homeopathic products. About a quarter (28%) of respondents stock CMs but not homeopathic products. And 9% said they “only stock evidence-based CMs”. Three percent completely refuse to stock CMs, while 2% stock them but with clear in-store labels saying that they may not work. One person stated they stock CMs but have recently decided to no longer do so.

The President of the Pharmaceutical Society of Australia (PSA) Joe Demarte commented on these findings: “The latest survey results, showing over 40% of pharmacists are adhering to PSA’s Code of Ethics on complementary medicines, are very encouraging… However it’s disappointing that some pharmacists are still stocking homeopathy products, which are not supported by PSA’s Code of Ethics or our Position Statement on Complementary Medicines… Irrespective of the products stocked in a pharmacy, the important thing is when discussing the use of complementary medicines with consumers, pharmacists must ensure that consumers are provided with the best available information about the current evidence for efficacy, as well as information on any potential side effects, drug interactions and risks of harm… It’s important for pharmacists to provide a fair, honest and balanced view of the current evidence available on all complementary medicines,” Demarte added.

NSW pharmacist Ian Carr, who is a member of the Friends of Science in Medicine group, commented that many pharmacists may not have much choice when it comes to stocking complementary and alternative medicines. “CMs policy is not being filtered through the professional assessment of the pharmacist… It’s basically a business deal with the franchise, and as a pharmacist taking on a franchise you’ve basically got to sign those rights away about what you get to sell. Some of the chains offer basically everything that is available, no questions asked. As an independent pharmacist I am able to make my own decisions about what to stock… We’ve got a ‘de-facto’ corporatisation happening with marketing groups and franchises, and I’m concerned the government will look at this trend and ask, why are we not deregulating the industry to reflect the apparent reality of pharmacy today? We’re only playing into the hands of people who want deregulation… We should be telling people in no uncertain terms that if something is on the shelf it doesn’t mean it’s been assessed or approved by the TGA… There is no doubt that there has been a long-term relationship between the supplement industry and pharmacy. But it was also a few decades ago that researchers started applying the concept of evidence-based medicine to healthcare generally. That should have been the point where we said, ‘we’re not just going to be a conduit for your products without questioning their basis in evidence’. That’s where we lost the plot. The question now is: where do we draw that line? I’m really trying to say to my fellow pharmacists: Please let us reassess the unquestioning support of the CM industry, or we’ll all be tarred with the same brush. I and many others are concerned about – and fighting for – the reputation of the pharmacy profession.”

A BMC Complementary and Alternative Medicine survey by researchers from Alfred Hospital in Melbourne found that 92% thought pharmacists should provide safety information about CMs, while 93% thought it important for pharmacists to be knowledgeable about CMs. This shows a huge divide between what is happening in Australian pharmacy on the one side and ethical demands or public opinion on the other side. What is more, there is little reason to believe that the situation in other countries is fundamentally different.

And did you notice this little gem in the comments above?  “…over 40% of pharmacists are adhering to PSA’s Code of Ethics…” – the PSA president finds this ‘VERY ENCOURAGING’.

When I saw this, I almost fell off my chair!

Does the president know that this means that 60% of his members are violating their own code of ethics?

Is that truly VERY ENCOURAGING, I ask myself.

My answer is no, this is VERY WORRYING.

 

A recently published study was aimed at evaluating the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). This 24-week, randomized, double-blind, placebo-controlled trial included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score≥5 on a visual analogue scale (VAS: range 0 to 10) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI).

The EAPP global score (VAS: range 0 to 50) decreased by 12.82 in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10) reduction in three EAPP modalities: dysmenorrhea (3.28;), non-cyclic pelvic pain (2.71), and cyclic bowel pain (3.40). Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). The placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen.

The authors concluded that potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain.

The study is unusual in several ways. For instance, contrary to most trials of homeopathy, its protocol had been published in ‘Homeopathy’ in August 2016. Here is the abstract:

BACKGROUND:

Endometriosis is a chronic inflammatory disease that causes difficult-to-treat pelvic pain. Thus being, many patients seek help in complementary and alternative medicine, including homeopathy. The effectiveness of homeopathic treatment for endometriosis is controversial due to the lack of evidences in the literature. The aim of the present randomized controlled trial is to assess the efficacy of potentized estrogen compared to placebo in the treatment of chronic pelvic pain associated with endometriosis.

METHODS/DESIGN:

The present is a randomized, double-blind, placebo-controlled trial of a homeopathic medicine individualized according to program ‘New Homeopathic Medicines: use of modern drugs according to the principle of similitude’ (http://newhomeopathicmedicines.com). Women with endometriosis, chronic pelvic pain and a set of signs and symptoms similar to the adverse events caused by estrogen were recruited at the Endometriosis Unit of Division of Clinical Gynecology, Clinical Hospital, School of Medicine, University of São Paulo (Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo – HCFMUSP). The participants were selected based on the analysis of their medical records and the application of self-report structured questionnaires. A total of 50 women meeting the eligibility criteria will be randomly allocated to receive potentized estrogen or placebo. The primary clinical outcome measure will be severity of chronic pelvic pain. Statistical analysis will be performed on the intention-to-treat and per-protocol approaches comparing the effect of the homeopathic medicine versus placebo after 24 weeks of intervention.

DISCUSSION:

The present study was approved by the research ethics committee of HCFMUSP and the results are expected in 2016.

END OF QUOTE

As far as I can see, this study has no major flaws (I do not have access, however, to the full article). It seems to suggest that highly diluted homeopathic remedies are efficacious. I am aware of the fact that this will be difficult to accept for many readers of this blog.

So, what should we make of this new trial?

Should we recommend homeopathic estrogen to women suffering from endometriosis? I don’t think so. On the contrary, I recommend a healthy dose of scepticism. Clinical trials can produce false results sometimes by chance or through fraud. In any case, we hardly ever rely on the findings of a single study. The sensible course of action always is to wait for an independent replication (and, of course, study the full text of the paper).

 

One phenomenon that can be noted more frequently than any other in alternative medicine research is that studies arrive at wrong or misleading conclusions. This is more than a little disappointing, not least because it is the conclusion of a trial that is often picked up by health writers and others who in turn mislead the public. On this blog, we must have seen hundreds of examples of this irritating phenomenon. Here is yet another one. This study, a randomized, parallel, open-label exploratory trial, evaluated and compared the effects of systemic manual acupuncture, periauricular electroacupuncture and distal electroacupuncture for treating patients with tinnitus. It included patients who suffered from idiopathic tinnitus for more than two weeks were recruited. They were divided into three groups:

  1. systemic manual acupuncture group (MA),
  2. periauricular electroacupuncture group (PE),
  3. distal electroacupuncture group (DE).

Nine acupoints (TE 17, TE21, SI19, GB2, GB8, ST36, ST37, TE3 and TE9), two periauricular acupoints (TE17 and TE21), and four distal acupoints (TE3, TE9, ST36, and ST37) were selected. The treatment sessions were performed twice weekly for a total of 8 sessions over 4 weeks. Outcome measures were the tinnitus handicap inventory (THI) score and the loud and uncomfortable visual analogue scales (VAS). Demographic and clinical characteristics of all participants were compared between the groups upon admission using one-way analysis of variance (ANOVA). One-way ANOVA was used to evaluate the THI, VAS loud, and VAS uncomfortable scores. The least significant difference test was used as a post-hoc test. In total, 39 subjects were eligible for analysis. No differences in THI and VAS loudness scores were observed between groups. The VAS uncomfortable scores decreased significantly in MA and DE compared with those in PE. Within the group, all three treatments showed some effect on THI, VAS loudness scores and VAS uncomfortable scores after treatment except DE in THI. The authors concluded that there was no statistically significant difference between systemic manual acupuncture, periauricular electroacupuncture and distal electroacupuncture in tinnitus. However, all three treatments had some effect on tinnitus within the group before and after treatment. Systemic manual acupuncture and distal electroacupuncture have some effect on VAS. Neither of the three treatments tested in this study have been previously proven to work. Therefore, it is quite simply nonsensical to compare them. Comparative studies are indicated only with therapies that have a solid evidence-base. They are called ‘superiority trials’ and require a different statistical approach as well as much larger sample sizes. In other words, this study was an unethical waste of resources from the outset. With this in mind, there is only one conclusion that fits the data: there was no statistically significant difference between the three types of acupuncture. The data are therefore in keeping with the notion that all three are placebos. Alternatively one might conclude more clearly for those who are otherwise resistant to learning a lesson: POORLY DESIGNED CLINICAL TRIALS ARE UNETHICAL AND NEVER LEND THEMSELVES TO MEANINGFUL CONCLUSIONS.

The anti-vaccination attitudes of alternative practitioners such as chiropractors, homeopaths and naturopaths are well documented and have been commented upon repeatedly here. But most of these clinicians are non-doctors; they have not been anywhere near a medical school, and one might therefore almost excuse them for their ignorance and uneducated stance towards immunisations. As many real physicians have recently taken to practicing alternative therapies under the banner of ‘integrated medicine’, one may well ask: what do these doctors think about vaccinations?

This study tried to answer the question by evaluating the attitudes and practices regarding vaccination of members of the American Board of Integrative and Holistic Medicine (ABIHM). Prospective participants were 1419 diplomats of the ABIHM. The survey assessed members’ (1) use of and confidence in the vaccination recommendations of the Centers for Disease Control and Prevention (CDC) and of medical-specialty associations, (2) confidence in the manufacturing safety of vaccines and in manufacturer’s surveillance of adverse events, and (3) attitudes toward vaccination mandates. The questionnaire included 33 items, with 5 open-ended questions that provided a space for comments.

The survey was completed by 290 of 1419 diplomats (20%). Its findings showed a diversity of opinions in many vaccination issues. Integrative medicine physicians were less likely to administer vaccinations than physicians in traditional allopathic medicine. Among the 44% who provide vaccinations, 35% used alternative schedules regularly. Integrative medicine physicians showed a greater support of vaccination choice, were less concerned about maintaining herd immunity, and were less supportive of school, day care, and employment mandates. Toxic chemical and viral contaminants were of greater concern to a higher percentage of integrative medicine physicians. Integrative medicine physicians were also more likely to accept a connection between vaccinations and both autism and other chronic diseases. Overall, there was dissatisfaction with the Vaccine Adverse Event Reporting System as well as the vaccination recommendations of the CDC and their primary specialty.

The authors concluded that significant variations in the vaccination attitudes and practices of integrative medicine physicians. This survey provides benchmark data for future surveys of this growing specialty and other practitioners. It is important for public health leaders and the vaccination industry to be aware that integrative medicine physicians have vaccination attitudes and practices that differ from the guidelines of the CDC and the Advisory Council on Immunization Practices.

Now we know!

Physicians practicing integrative medicine (the 80% who did not respond to the survey were most likely even worse) not only use and promote much quackery, they also tend to endanger public health by their bizarre, irrational and irresponsible attitudes towards vaccination.

From bad to worse!

A new study published in JAMA investigated the long-term effects of acupuncture compared with sham acupuncture and being placed in a waiting-list control group for migraine prophylaxis. The trial was a 24-week randomized clinical trial (4 weeks of treatment followed by 20 weeks of follow-up). Participants were randomly assigned to 1) true acupuncture, 2) sham acupuncture, or 3) a waiting-list control group. The trial was conducted from October 2012 to September 2014 in outpatient settings at three clinical sites in China. Participants 18 to 65 years old were enrolled with migraine without aura based on the criteria of the International Headache Society, with migraine occurring 2 to 8 times per month.

Participants in the true acupuncture and sham acupuncture groups received treatment 5 days per week for 4 weeks for a total of 20 sessions. Participants in the waiting-list group did not receive acupuncture but were informed that 20 sessions of acupuncture would be provided free of charge at the end of the trial. Participants used diaries to record migraine attacks. The primary outcome was the change in the frequency of migraine attacks from baseline to week 16. Secondary outcome measures included the migraine days, average headache severity, and medication intake every 4 weeks within 24 weeks.

A total of 249 participants 18 to 65 years old were enrolled, and 245 were included in the intention-to-treat analyses. Baseline characteristics were comparable across the 3 groups. The mean (SD) change in frequency of migraine attacks differed significantly among the 3 groups at 16 weeks after randomization; the mean (SD) frequency of attacks decreased in the true acupuncture group by 3.2 (2.1), in the sham acupuncture group by 2.1 (2.5), and the waiting-list group by 1.4 (2.5); a greater reduction was observed in the true acupuncture than in the sham acupuncture group (difference of 1.1 attacks; 95% CI, 0.4-1.9; P = .002) and in the true acupuncture vs waiting-list group (difference of 1.8 attacks; 95% CI, 1.1-2.5; P < .001). Sham acupuncture was not statistically different from the waiting-list group (difference of 0.7 attacks; 95% CI, −0.1 to 1.4; P = .07).

The authors concluded that among patients with migraine without aura, true acupuncture may be associated with long-term reduction in migraine recurrence compared with sham acupuncture or assigned to a waiting list.

Note the cautious phraseology: “… acupuncture may be associated with long-term reduction …”

The authors were, of course, well advised to be so atypically cautious:

  • Comparisons to the waiting list group are meaningless for informing us about the specific effects of acupuncture, as they fail to control for placebo-effects.
  • Comparisons between real and sham acupuncture must be taken with a sizable pinch of salt, as the study was not therapist-blind and the acupuncturists may easily have influenced their patients in various ways to report the desired result (the success of patient-blinding was not reported but would have gone some way to solving this problem).
  • The effect size of the benefit is tiny and of doubtful clinical relevance.

My biggest concern, however, is the fact that the study originates from China, a country where virtually 100% of all acupuncture studies produce positive (or should that be ‘false-positive’?) findings and data fabrication has been reported to be rife. These facts do not inspire trustworthiness, in my view.

So, does acupuncture work for migraine? The current Cochrane review included 22 studies and its authors concluded that the available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long-term studies, more than one year in duration, are lacking.

So, maybe acupuncture is effective. Personally, I am not convinced and certainly do not think that the new JAMA study significantly strengthened the evidence.

Prof Walach has featured on this blog before, for instance here, and here. He is a psychologist by training and a vocal and prominent advocate of several bogus treatments, including homeopathy. He also is the editor in chief of the journal ‘Complementary Medicine Research’ and regularly uses this position to sing the praise of homeopathy. There is a degree of mystery about his affiliation: he informed me about 10 months ago that he has left his post at the Europa Universität Viadrina, Frankfurt/Oder (“Dass ich als “ehemaliger Professor” geführt werde liegt daran, dass ich  Ende Januar aufgehört habe. Meine Stelle ist ausgelaufen und ich habe
sie nicht mehr verlängert.”). Yet all, even his recent papers still carry this address.

His latest article is entitled ‘The future of homeopathy’ is no exception. It is remarkable not just because of the mysterious affiliation but also – and mostly – because of its content. Here is my translation of a brief passage from this paper [I added some numbers in square brackets which refer to footnotes below].

START OF MY TRANSLATION

It is entirely undisputed that homeopathy with its therapeutic principles runs against the mainstream of science; and in this, Weymayr [1] is correct. However, to build on this fact a veritable research prohibition, such as the ‘scientability-concept’ suggests, is not just wrong from a science theoretical perspective, but… also discloses a dogmatic and unscientific stance.

If we see things soberly, homeopathy is – from a science theory point of view – an anomaly: empiric data prove that effects appear regularly and more and more frequently [2].  This is being demonstrated with meta-analyses of placebo-controlled clinical trials. And this also shows with our own provings, which conform well with the newly developed standards as well as with the newer provings. Effects are furthermore noted with such frequency in animal and plant-based studies. Contrary to often voiced statements, there are also models which produce replicated effects – for instance the model of children with ADHD which is currently being replicated. Repeatedly high quality pilot studies emerge, such as the one by Gassmann et al., which show that unexpected effects also appear with higher potencies, documented with objective methods. Homeopathy proves itself as useful in large pragmatic trials of which we, however, have far too few. And let’s not forget: homeopathy is pragmatically useful. Even though aggravations do occur occasionally during homeopathic treatments, the claim that homeopathy is dangerous is a careless interpretation of the data. [3]

In what way is homeopathy an anomaly? I have already years ago argued that the signature of the data does not suggest that we are dealing with a classical local effect. This would be an effect which would conform with the usual criterion of causality and would thus be stable, regular and more and more evident with improved experimentation. It is unnecessary to repeat this argument [4] for the purpose of this editorial. But precisely the question of the classic causal effect is the controversy. And exactly this is the issue used by the new wave of critic of homeopathy which is openly aimed at the demise of homeopathy. This situation occurs because also the homeopaths are victims of the misapprehension  that homeopathy is based on a classic causal process. But this assumption is most likely wrong, and homeopaths would be well-advised on the one side to point to the empiric evidence, and on the other side to practice theoretical chastity making clear that, for the time being, we have not a clue how homeopathy functions. This is the typical situation when a scientific anomaly occurs…

My prognosis would be: if we stop to misunderstand homeopathy as a classic causal phenomenon and instead view and research it as a non-classical phenomenon, homeopathy would have a chance and science would get richer by a new category of phenomena. This approach will prompt criticism, because it renders the world more complex rather than simpler. But this cannot be changed. Perhaps a new era of therapeutics might even emerge which does not abolish the molecular paradigm but makes it appear as one of several possibilities. [5]

END OF MY TRANSLATION

For those of you who can read German, here is the original text with references:

Dass die Homöopathie mit ihren therapeutischen Prinzipien dem Hauptstrom der Wissenschaft immer schon zuwiderlief, ist völlig unbestritten, und darin hat Weymayr recht. Aber auf dieser Tatsache ein regelrechtes «Forschungsverbot» aufbauen zu wollen, wie es das Szientabilitätskonzept vorsieht, das ist nicht nur wissenschaftstheoretisch absolut falsch, wie wir in einer Replik gezeigt haben [2], sondern offenbart auch eine dogmatische und unwissenschaftliche Einstellung.

Wenn man die Sache nüchtern sieht, ist die Homöopathie – wissenschaftstheoretisch betrachtet – eine Anomalie [3]: Empirische Daten belegen, dass immer wieder und insgesamt häufiger als zufällig erwartet Effekte auftreten. Das zeigen Meta-Analysen placebokontrollierter klinischer Studien [4,5,6]. Und das zeigt sich sowohl in unseren eigenen Arzneimittel-Prüfungen [7], die im Übrigen den erst neuerdings entwickelten Standards gut entsprechen [8], als auch in neueren Prüfungen [9]. Auch in Tierexperimenten [10,11,12,13] und in Pflanzenstudien [14,15,16] treten Effekte in solcher Häufigkeit auf. Entgegen oft gehörten Äußerungen gibt es durchaus auch Modelle, die replizierte Effekte ergeben – etwa das Modell homöopathischer Behandlung von Kindern mit Aufmerksamkeitsdefizit-/Hyperaktivitätssyndrom [17,18], das gerade repliziert wird [19]. Immer wieder gibt es qualitativ hochwertige Pilotstudien, wie die unlängst publizierte von Gassmann et al. [20], die zeigen, dass unerwartete Effekte auch unter höheren Potenzen und dokumentiert mit objektiven Methoden zu beobachten sind. Homöopathie erweist sich in großen pragmatischen Studien, von denen es allerdings viel zu wenige gibt, als nützlich [21,22,23]. Und nicht zu vergessen: Homöopathie ist pragmatisch hilfreich [24,25,26,27]. Zwar kommt es bei homöopathischer Behandlung gelegentlich zu einer Erstverschlimmerung [28,29], aber die Behauptung, Homöopathie sei gefährlich [30], ist eine fahrlässige Interpretation der Daten [31].

Inwiefern ist die Homöopathie dann eine Anomalie? Ich habe schon vor Jahren argumentiert, dass die Signatur der Daten in der Homöopathie nicht dafür spricht, dass wir es mit einem klassischen, lokalen Effekt zu tun haben [32]. Das wäre ein Effekt, der dem gewöhnlichen Kriterium der Kausalität entspräche und somit stabil, regelmäßig und bei immer besserer Experimentierkunst immer deutlicher hervorträte. Dieses Argument jetzt wieder aufzurollen, ist im Rahmen eines Editorials müßig. Aber genau die Frage nach einem klassisch-kausalen Effekt ist letztlich der Stein des Anstoßes. Und genau diesen Anstoß nimmt nun die neue Welle der Homöopathiekritik, die erklärtermaßen auf die Abschaffung der Homöopathie abzielt, zu ihrem Anlass. Diese Situation ergibt sich, weil auch die Homöopathen dem Selbstmissverständnis aufsitzen, Homöopathie sei ein klassisch-kausaler Prozess. Das ist höchstwahrscheinlich falsch, und die Homöopathie wäre gut beraten, einerseits auf die empirischen Befunde hinzuweisen und auf der anderen Seite theoretische Enthaltsamkeit zu üben und klarzulegen, dass wir vorläufig keinerlei Ahnung haben, wie Homöopathie funktioniert. Das ist die typische Situation, wenn eine wissenschaftliche Anomalie vorliegt…

Meine Prognose wäre: Wenn wir aufhören, die Homöopathie als klassisches Phänomen misszuverstehen, und sie stattdessen als ein mögliches nichtklassisches Phänomen betrachten und beforschen, dann hat die Homöopathie eine Chance und die Wissenschaft wird um eine neue Kategorie von Phänomenen reicher. Dieser Ansatz wird Kritik hervorrufen, denn er macht die Welt eher komplexer als einfacher. Aber das lässt sich nicht ändern. Vielleicht kann sogar eine neue Ära der Therapie beginnen, die das molekulare Paradigma nicht abschafft, aber als eine von mehreren Möglichkeiten erscheinen lässt.


Rather than commenting on this text in full detail, I simply want to provide a few explanations [they refer to the numbers in square brackets inserted by me into my translation] in order to facilitate understanding. I hope, however, that my readers will comment as much as they feel like.

1) Weymayr argued that certain fields lack plausibility to a degree that they do not merit being investigated. Here is an abstract of an article by him:

Evidence-based medicine (EbM) has proved to be very useful in healthcare; thanks to its methodology the reliability of our knowledge of the benefits and harms of interventions can be assessed. This at least applies to interventions which are based on a plausible concept for their mechanism of action and which have already achieved positive effects in experiments and simple studies. However, for interventions whose concepts contradict scientific findings EbM has proved to be unsuitable; it has not been able to prevent that they are still regarded as effective amongst wide parts of the population and medical experts. Particularly homeopathy has managed to even present itself as scientifically justified by using EbM. With the aim of highlighting the speculative character of homeopathy and other procedures and of preventing EbM from getting damaged, the concept of scientability is introduced in this article. This concept only approves of clinical studies if the intervention that is to be tested does not contradict definite scientific findings.

2) A scientific anomaly is “something which cannot be explained by currently accepted scientific theories. Sometimes the new phenomenon leads to new rules or theories, e.g., the discovery of x-rays and radiation.

3) Even a minimal amount of critical thinking leads to the conclusion that the claims made about homeopathy in this paragraph are mostly not true or exaggerated. On this blog, there is plenty of evidence to contradict Walach on all the points he made here.

4) Walach’s argument is detailed in this article:

Among homeopaths the common idea about a working hypothesis for homeopathic effects seems to be that, during the potentization process, ‘information’ or ‘energy’ is being preserved or even enhanced in homeopathic remedies. The organism is said to be able to pick up this information, which in turn will stimulate the organism into a self-healing response. According to this view the decisive element of homeopathic therapy is the remedy which locally contains and conveys this information. I question this view for empirical and theoretical reasons. Empirical research has shown a repetitive pattern, in fundamental and clinical research alike: there are many anomalies in high-dilution research and clinical homeopathic trials which will set any observing researcher thinking. But no single paradigm has proved stable enough in order to produce repeatable results independent of the researcher. I conclude that the database is too weak and contradictory to substantiate a local interpretation of homeopathy, in which the remedy is endowed with causal-informational content irrespective of the circumstances. I propose a non-local interpretation to understand the anomalies along the lines of Jung’s notion of synchronicity and make some predictions following this analysis.

5) In a nutshell, Walach seems to be saying:

  • the empirical evidence for homeopathy is strong;
  • nobody understands the mechanisms by which the effects of homeopathy are brought about;
  • if we all claim that homeopathy is a ‘scientific anomaly’ which operates according to Jung’s notion of synchronicity, the discrepancy between strong evidence and lack of plausible explanation disappears and everyone can be happy.

This is wrong for the following reasons, in my view:

  • the evidence is not strong but negative or extremely weak;
  • we understand very well that the effects of homeopathy are due to non-specific effects;
  • therefore there is no need for a new paradigm;
  • Jung’s notion of synchronicity is pure speculation and not applicable to therapeutics.

In summary, Prof Walach would do well to stop philosophising about homeopathy, read up about critical analysis, fine-tune his BS-detector and familiarise himself with Occam’s razor.

 

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