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

bias

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Tasuki is a sort of sash for holding up the sleeves on a kimono. It also retracts the shoulders and keeps the head straight up. By correcting the wearer’s posture, it might even prevent or treat neck pain. The greater the forward head posture, for example, the more frequent are neck problems.  However, there is little clinical evidence to support or refute this hypothesis.

This study was conducted to determine whether Tasuki-style posture supporter improves neck pain compared to waiting-list. It was designed as an individually-randomized, open-label, waiting-list-controlled study. Adults with non-specific chronic neck pain who reported 10 points or more on modified Neck Disability Index (mNDI: range, 0-50; higher points indicate worse condition) were enrolled. Participants were randomly assigned 1:1 to the intervention group or to a waiting-list control group. The primary outcome was the change in mNDI at 1 week.

In total, 50 participants were enrolled. Of these participants, 26 (52%) were randomly assigned to the intervention group and 24 to the waiting-list. Attrition rate was low in both groups (1/50). The mean mNDI change score at 1 week was more favourable for Tasuki than waiting-list (between-group difference, -3.5 points (95% confidence interval (CI), -5.3 to -1.8); P = .0002). More participants (58%) had moderate benefit (at least 30% improvement) with Tasuki than with waiting-list (13%) (relative risk 4.6 (95% CI 1.5 to 14); risk difference 0.45 (0.22 to 0.68)).

The author concluded that this trial suggests that wearing Tasuki might moderately improve neck pain. With its low-cost, low-risk, and easy-to-use nature, Tasuki could be an option for those who suffer from neck pain.

In the previous two posts, we discussed how lamentably weak the evidence for acupuncture and spinal manipulation is regarding the management of pain such as ‘mechanical’ neck pain. Here we have a well-reported study with a poor design (no control for non-specific effects) which seems to suggest that simply wearing a Tasuki is just as effective as acupuncture or spinal manipulation.

What is the lesson from this collective evidence?

Is it that we should forget about acupuncture and spinal manipulation for chronic neck pain?

Perhaps.

Or is it that poor trial designs generate unreliable evidence?

More likely.

Or is it that any treatment, however daft, will generate positive outcomes, if the researchers are sufficiently convinced of its benefit?

Yes, I think so.

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PS

If you had chronic neck pain, would you rather have your neck manipulated, needles stuck into your body, or get a Tasuki? (Spoiler: Tasuki is risk-free, the other two treatments are not!)

 

Together with a co-worker, Prof Walach conducted a systematic review of mistletoe extracts (Rudolf Steiner’s anti-cancer drug) as a treatment for improving the quality of life (QoL) of cancer patients. They included all prospective controlled trials that compared mistletoe extracts with a control in cancer patients and reported QoL or related dimensions.

Walach included 26 publications with 30 data sets. The studies were heterogeneous. The pooled standardized mean difference (random effects model) for global QoL after treatment with mistletoe extracts vs. control was d = 0.61 (95% CI 0.41-0.81, p < 0,00001). The effect was stronger for younger patients, with longer treatment, in studies with lower risk of bias, in randomized and blinded studies. Sensitivity analyses supported the validity of the finding. 50% of the QoL subdomains (e.g. pain, nausea) showed a significant improvement after mistletoe treatment. Most studies had a high risk of bias or at least raise some concern.

The authors concluded that mistletoe extracts produce a significant, medium-sized effect on QoL in cancer. Risk of bias in the analyzed studies is likely due to the specific type of treatment, which is difficult to blind; yet this risk is unlikely to affect the outcome.

This is a surprising conclusion, not least because – as reported on this blog – only a year ago another German team of researchers conducted a similar review and came to a very different conclusion. Here is their abstract again:

Purpose: One important goal of any cancer therapy is to improve or maintain quality of life. In this context, mistletoe treatment is discussed to be highly controversial. The aim of this systematic review is to give an extensive overview about the current state of evidence concerning mistletoe therapy of oncologic patients regarding quality of life and side effects of cancer treatments.

Methods: In September and October 2017, Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, CINAHL and “Science Citation Index Expanded” (Web of Science) were systematically searched.

Results: The search strategy identified 3647 articles and 28 publications with 2639 patients were finally included in this review. Mistletoe was used in bladder cancer, breast cancer, other gynecological cancers (cervical cancer, corpus uteri cancer, and ovarian cancer), colorectal cancer, other gastrointestinal cancer (gastric cancer and pancreatic cancer), glioma, head and neck cancer, lung cancer, melanoma and osteosarcoma. In nearly all studies, mistletoe was added to a conventional therapy. Regarding quality of life, 17 publications reported results. Studies with better methodological quality show less or no effects on quality of life.

Conclusions: With respect to quality of life or reduction of treatment-associated side effects, a thorough review of the literature does not provide any indication to prescribe mistletoe to patients with cancer.

How can this discrepancy be explained? Which of the reviews is drawing the correct conclusion? Here are some relevant details that could help finding an answer to these questions:

  • Walach is a psychologist by training, while the senior author of the 2019 review, Jutta Huebner, is an oncologist.
  • Huebner included only randomised clinical trials (RCTs), whereas Walach included any interventional and non-interventional prospective controlled study.
  • Huebner included 17 RCTs that reported QoL data, while Walach included 26 publications with 30 data sets including 5 non-randomised studies.
  • Several of the primary studies had been published multiple times at different stages of completion. Walach included these as independent data sets, while Huebner included each study only once.
  • Huebner looked at QoL, whereas Walach also considered measurements of self-regulation as outcome measures.
  • Both reviews point out that the methodological quality of the primary studies was often poor; Walach drew a positive conclusion regardless, while Huebner did not and pointed out that studies with better methodology show less or no effects on quality of life or side effects of cancer therapy.
  • Walach’s review was funded by funded by the Förderverein komplementärmedizinische Forschung, Arlesheim, Switzerland, a lobby group for mistletoe therapy, while Huebner’s work was funded by the German Guideline “S3 Leitlinie Komplementärmedizin in der Behandlung von onkologischen PatientInnen (Registernummer 032-055OL)” funded by the German Cancer Aid (Fördernummer 11583) within the German Guideline Program in Oncology and by the working group Prevention and Integrative Oncology of the German Cancer Society.

I am sure there are other important differences, but the ones listed above suffice, I think, to decide which of the two papers is trustworthy and which is not.

Breast cancer and its treatments lead to a decrease in patients’ quality of life (QOL). This systematic review aimed to assess the effectiveness of so-called alternative medicine (SCAM) on the QOL of women with breast cancer.

A total of 28 clinical trials were included in the systematic review, 18 of which were randomized controlled trials (RCTs). Participants included women with breast cancer who were undergoing the first three phases of breast cancer or post-cancer rehabilitation. One study tested a dietary supplement, and the other 27 tested a variety of mind-body techniques (the authors counted the following modalities in this category: acupuncture, hyperthermia, movement therapy (qigong), laser therapy, orthomolecular therapy, osteopathy, phototherapy, healing touch, homeopathy, lymphatic drainage, magnet field therapy, manual therapy, neural therapy, Shiatsu). Twenty-seven studies showed improved QOL.

The authors concluded that the findings may indicate the potential benefits of SCAMs, especially mind-body techniques on QOL in breast cancer patients. Further RCTs or long-term follow-up studies are recommended. Moreover, the use of similar QOL assessment tools allows for more meta-analysis and generalizability of results, especially for the development of clinical guidelines.

This is a somewhat odd paper:

  • it is poorly written,
  • it lumps together SCAMs that do not belong in the same category,
  • it only considered studies published in English,
  • it included studies regardless of study design, even those without any control groups.

Regardless of these consideration, it stands to reason that patients’ QoL can be improved by SCAM. Only a fool would deny that a bit of extra care, kindness, attention and time is good for patients. The relevant questions, however, are quite different:

  1. Is this effect due to the extra attention and care or is it due to specific effects of SCAM?
  2. Which SCAM is best at achieving an improvement of QoL?
  3. Are the truly effective SCAMs better than conventional interventions aimed at improving QoL?

These are by no means academic questions but issues that need to be addressed to improve cancer care, and tackling them is in the best interest of suffering patients. Sadly, none of them can be answered by conducting poor quality systematic reviews of the evidence. Even more sadly, few of the proponents of integrated medicine want to face the music and answer these questions. They seem to prefer to stand in the way of progress, to ignore medical ethics, to blindly and naively integrate any old nonsense from the realm of SCAM (anything from homeopathy to Reiki) into routine care without probing further and without wanting to know the facts.

It is almost as though they are afraid of the truth.

Retraction Watch has alerted us to a “Paper urging use of homeopathy for COVID-19 appears in peer-reviewed public health journal”. The paper in question is readily available on the Internet. Here is its abstract:

Today, humanity is living through the third serious coronavirus outbreak in less than 20 years, following SARS in 2002–2003 and MERS in 2012. While the final cost on human lives and world economy remains unpredictable, the timely identification of a suitable treatment and the development of an effective vaccine remain a significant challenge and will still require time.

The aim of this study is to show that the global collective effort to control the coronavirus pandemic (Covid 19) should also consider alternative therapeutic methods, and national health systems should quickly endorse the validity of proven homeopathic treatments in this war against coronavirus disease.
Subject and methods With the help of mathematics, we will show that the fundamental therapeutic law on which homeopathy is founded can be proved.
Results The mathematical proof of the law of similarity justifies perfectly the use of ultra – high diluted succussed solution products as major tools in the daily practices of homeopathy.
Conclusion It is now time to end prejudice and adopt in this fight against Covid-19 alternative therapeutic techniques and practices that historically have proven effective in corresponding situations.

And the full conclusions from the body of the paper read as follows:

Today, it is imperative that ever-safe medicinal products such as homeopathic ultra – high diluted succussed solutions are tested in this pandemic. Epidemiological research has to be carried out to include homeopathic treatment and compare it to established treatments. Patients should be assigned randomly in two different groups of at least 200–400 individuals, and receive respectively established and homeopathic treatment. The evaluation of the results from both groups could reveal which group has a superior outcome in survival, general health conditions, etc., and to what extent.

If there were a competition for the craziest paper published on so-called alternative medicine (SCAM) during 2020, this one would, I am sure, win by some margin! The authors seem to have little idea of the nature of evidence in healthcare or medicine; and they use mathematics like a drunken man uses a lamp-post: not for enlightenment, but for support.

So, who are the authors of this showcase of pseudoscience?

They are D. Kalliantas, M. Kallianta, Ch. S. Karagianni from the Department of Materials Science and Engineering, School of Chemical Engineering, NTUA, GR15780, Athens, Greece; the National Technical University of Athens, 9 Heroon Polytechniou Str. Zografos Campus, 15780 Athens, Greece; and the School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece.

The first author has previously published weird stuff including a self-published book: Kalliantas D (2008) The Chaos theory of disease. Kallianta A Publications, Eleusis, GreeceOn Medline, I also found this paper by two of the three authors:

Trituration is a mechanical process (a form of comminution) for reducing the particle size of a substance. In this manuscript, six different Raw Solid Materials (RSM) which are used in Homeopathy after successive grindings are studied before they are turned into homeopathic solutions. The impact of trituration, with the presence of α‑lactose monohydrate (milk sugar) seems to be quite great and interesting because of the variety of grain size which largely differentiate the properties of the materials. The grain sizes obtained triturations by hand according to C. Herring’s suggestion leads, finally, measurement scale dimensions. The obtained results can be useful information for all the pharmacy industries, as well as for preparing any kind of powder.

Sadly, this renders my suspicion unlikely that the new article is a hoax in which some pranksters were trying to show that any odd nonsense can pass the peer-review of a scientific journal.

And which journal would publish a paper that looks like a hoax but is none? It is the Journal of Public Health: From Theory to Practice (Springer). On the website, the journal tells us that:

The Journal of Public Health: From Theory to Practice is an interdisciplinary publication for the discussion and debate of international public health issues, with a focus on European affairs. It describes the social and individual factors determining the basic conditions of public health, analyzing causal interrelations, and offering a scientifically sound rationale for personal, social and political measures of intervention. Coverage includes contributions from epidemiology, health economics, environmental health, management, social sciences, ethics, and law.

  • An interdisciplinary publication for the discussion and debate of international public health issues
  • Includes contributions from epidemiology, health economics, environmental health, management, social sciences, ethics, and law
  • Offers a scientifically sound rationale for personal, social and political measures of intervention
  • 94% of authors who answered a survey reported that they would definitely publish or probably publish in the journal again.

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The twice mentioned term SCIENTIFICALLY SOUND does not quite ring true in the present instance, does it?

Spinal manipulative therapy (SMT) is frequently used to manage cervicogenic headache (CGHA). No meta-analysis has investigated the effectiveness of SMT exclusively for CGHA.

The aim of this review was to evaluate the effectiveness of SMT for cervicogenic headache (CGHA). Seven RCTs were eligible. At short-term follow-up, there was a significant, small effect favouring SMT for pain intensity and small effects for pain frequency. There was no effect for pain duration. There was a significant, small effect favouring SMT for disability. At intermediate follow-up, there was no significant effects for pain intensity and a significant, small effect favouring SMT for pain frequency. At long-term follow-up, there was no significant effects for pain intensity and for pain frequency.

The authors concluded that for CGHA, SMT provides small, superior short-term benefits for pain intensity, frequency and disability but not pain duration, however, high-quality evidence in this field is lacking. The long-term impact is not significant.

This meta-analysis can be criticised for a long list of reasons, the most serious of which, in my view, is that it is bar of even the tiniest critical input. The authors state that there has been no previous meta-analysis on this topic. This might be true, but there has been a systematic review of it (published in the leading journal on the subject) which the authors fail to mention/cite (I wonder why!). It is from 2011 and happens to be one of mine. Here is its abstract:

The objective of this systematic review was to assess the effectiveness of spinal manipulations as a treatment option for cervicogenic headaches. Seven databases were searched from their inception to February 2011. All randomized trials which investigated spinal manipulations performed by any type of healthcare professional for treating cervicogenic headaches in human subjects were considered. The selection of studies, data extraction, and validation were performed independently by 2 reviewers. Nine randomized clinical trials (RCTs) met the inclusion criteria. Their methodological quality was mostly poor. Six RCTs suggested that spinal manipulation is more effective than physical therapy, gentle massage, drug therapy, or no intervention. Three RCTs showed no differences in pain, duration, and frequency of headaches compared to placebo, manipulation, physical therapy, massage, or wait list controls. Adequate control for placebo effect was achieved in 1 RCT only, and this trial showed no benefit of spinal manipulations beyond a placebo effect. The majority of RCTs failed to provide details of adverse effects. There are few rigorous RCTs testing the effectiveness of spinal manipulations for treating cervicogenic headaches. The results are mixed and the only trial accounting for placebo effects fails to be positive. Therefore, the therapeutic value of this approach remains uncertain.

The key points here are:

  • methodological quality of the primary studies was mostly poor;
  • adequate control for placebo effect was achieved in 1 RCT only;
  • this trial showed no benefit of SMT beyond a placebo effect;
  • the majority of RCTs failed to provide details of adverse effects;
  • this means they violate research ethics and should be discarded as not trustworthy;
  • the therapeutic value of SMT remains uncertain.

The new paper was published by chiropractors. Its positive result is not clinically relevant, almost certainly due to residual bias and confounding in the primary studies, and thus most likely false-positive. The conclusions seem to disclose more the bias of the review authors than the truth. Considering the risks of SMT of the upper spine (a subject not even mentioned by the authors), I cannot see that the risk/benefit balance of this treatment is positive. It follows, I think, that other, less risky and more effective treatments are to be preferred for CGHA.

The Society of Homeopaths (SoH) is the UK’s professional organisation of ‘lay-homeopaths’, therapists who treat patients without having studied medicine. They prefer the term ‘professional homeopathy’, but there is little professional about them, it seems. The SoH has a long track record of endangering public health by promoting anti-vaxx nonsense.

A few months ago, it was reported that Linda Wicks, chair of the Society of Homeopaths (S0H), has shared a series of petitions claiming that childhood immunisations are unsafe. Mrs Wicks also posted a petition supporting Andrew Wakefield, the disgraced former doctor who falsely linked the MMR vaccine to autism claiming that the scientific establishment’s rejection of his flawed research was ‘the greatest lie ever told’.

In 2018, I pointed out that the SoH was violating its own code of ethics. At the time, two new members were appointed to the Society’s Public Affairs (PAC) and Professional Standards (PSC)  committees, and both were promoting the deeply anti-vaxx CEASE therapy.

Today, THE TELEGRAPH reports that Sue Pilkington, the SoH’s ‘Head of Standards’, has been promoting anti-vaxx propaganda online. On April 14, she posted anti-vaxx content made by the ‘Children’s Health Defense’ – an organisation accused by NBC News last year as being one of the largest global creators of spreading misinformation’. The page advised that any new vaccine could trigger “lethal” immune reactions.

In a separate post on Facebook, Pilkington shared a post that describes vaccines as “poison” – alongside medical advice declaring that no child should be vaccinated, if any member of their family has a skin disorder. Pilkington also tried to contact Health Secretary Matt Hancock, attempting to share with him a video of content from an American comedian claiming that it’s ‘realistic’ for vaccines to cause autism.

As though this were not enough nonsense, Pilkington also promotes homeopathy as a solution to the current epidemic. On her homeopathy business website, she has section on coronavirus which states the following: “The current primary homeopathic remedy advised for Coronavirus (2019-nCoV) symptoms is Gelsemium with a possible following remedy of Eupatorium Perforatum, Bryonia or Belladonna depending on how the symptoms progress”. Other homeopathic remedies are in common use for people with influenza and pneumonia, according to Pilkington, these do not “prevent viruses” but may “reduce the severity and length of illness”. She also claims that homeopathy has a “great track record of success in epidemics” – referencing both the Spanish influenza pandemic and the bird flu pandemic.

“In our opinion, the Professional Standards Authority (PSA) has a simple choice to make: remove the SoH and their uninformed vaccination paranoia from the register, or continue to allow homeopaths to make these dangerous claims with the tacit approval of the PSA.” said Michael Marshall, projector director of the Good Thinking Society.

A government health spokesperson was quoted in today’s TELEGRAPH article stating this: “Vaccine misinformation in any form – book, film, website or otherwise – is completely unacceptable.” The spokesperson added that NICE does not recommend homeopathy for the treatment of any health condition and noted that vaccines “save lives and are a foundation of public health.”

 

As parts of Australia are going back into lock-down because of the increasingly high COVID-19 infection rates, the Chiropractic Board of Australia (CBA) has issued a statement on chiropractors’ claims regarding immunity:

The Board is particularly concerned that during the ongoing COVID-19 pandemic there are claims in advertising that suggest spinal adjustments and/or manipulation can boost or improve general immunity or the immune system.

There is insufficient acceptable evidence to support such claims in advertising. Acceptable evidence mostly encompasses empirical data from formal research or systematic studies, in the form of peer-reviewed publications. Information about what constitutes acceptable evidence for advertising can be found in the Advertising resources section of the Ahpra website.

Advertising that there is a relationship between manual therapy (e.g. spinal adjustments and/or manipulation) and achieving general wellness or boosting or improving immunity contravenes the National Law and the Guidelines for advertising regulated health services.

Although many claims do not directly reference spinal adjustments and/or manipulation preventing or protecting from COVID-19, there is currently greater awareness of immunity issues and the public is seeking information on ways to prevent or protect themselves from the disease. Consequently, there is a greater risk that claims about spinal adjustments and/or manipulation boosting or improving general immunity may be interpreted to be claims about boosting or improving immunity to COVID-19.

Making claims in advertising that spinal adjustments and/or manipulation can boost or improve general immunity or the immune system is likely to result in regulatory action being taken by the Board.

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“… IS LIKELY TO RESULT IN REGULATORY ACTION …”???

Come on, pull the other one!

Bogus claims have been made by chiropractors since ages.

Bogus claims are what chiropractors thrive on.

Without them, they would go bust.

Every now and then some regulator makes some noises reminding chiropractors that bogus claims are bogus. But have they EVER taken any action?

Have they ever even INTENDED to take action?

I doubt it.

In fact, statements of this nature seem to be the chiropractic way of sanctioning false claims. The somewhat paradoxical way this works is as follows: chiropractors make bogus claims all the time; we all got so much used to them that hardly anyone bats an eyelash. But every now and then the bogus nature of the claims become noticeable to the wider public – like now with COVID-19 – and some people or organisations take offence. This is clearly not good for the chiro-business or image. Therefore, the professional chiro organisations step in by issuing a statement – like the one above – condemning the claims and threatening action. All the chiros know, of course, what this is about and change absolutely nothing. The desired effect is guaranteed: chiros can carry on as before, but the image is saved and the business can continue.

I very much doubt that, in the coming weeks, the CBA will do much about the many Australian chiropractors who will continue to mislead the public about COVID-19 or any other issues.

Nice window dressing perhaps, but no substance at all.

If you disagree with my view, please send me the details of any decisive regulatory action which the CBA took regarding immunity claims, and I will delete this post.

Amongst all the many bizarre treatments so-called alternative medicine (SCAM) has to offer, distant healing is probably one of the least plausible. Essentially, it involves healers sending healing ‘energy’ to far remote patients. This energy is then supposed to stimulate the patients’ ability to heal themselves.

In my recent book, I summarise it as follows:

Distant healing is a form of ‘energy healing’ where the healer operates at a distance from the patient. This distance can be considerable; proponents of distant healing see no obstacle in healing even over very large distances.

      1. The term ‘energy’ must be put in inverted commas, because the underlying concepts have nothing in common with the energy defined in physics. Real energy is measurable and quantifiable.
      2. ‘Energy’ as used in alternative medicine describes a nebulous concept of a life-force that originates from the obsolete notions of vitalism. This type of ‘energy’ is neither measurable nor quantifiable.
      3. In distant healing, the healer, who often works for free, sends ‘healing energy’ across space in the belief that it is received by the patient and thus stimulates her self-healing potential. This process does not require the physical presence of the patient.
      4. Proponents of distant healing offer various modes of action for their treatment; some claim, for instance, that quantum physics provides a scientific explanation as to how it works.
      5. The assumptions that underpin distant healing are not biologically plausible.
      6. There has been some research testing whether distant healing is effective. Most of the studies available to date have serious methodological flaws. One review of 8 clinical trials showed that the majority of the rigorous trials do not to support the hypothesis that distant healing has specific therapeutic effects. The results of two studies furthermore suggest that distant healing can be associated with adverse effects.[1] And another review concluded that the evidence to date does not yet provide confidence in its clinical efficacy.[2]
      7. Reading the literature published by proponents of distant healing, one cannot help but being impressed by the amount of pseudo-scientific language that is being employed to mislead the reader.

[1] https://www.ncbi.nlm.nih.gov/pubmed/12778776

[2] https://www.ncbi.nlm.nih.gov/pubmed/26665044

Considering its implausibility, it hardly comes as a surprise that Prof Walach studied distant healing in some detail. In fact, he published three studies of it:

2001: Chronically ill patients treated by spiritual healing improve in quality of life: results of a randomized waiting-list controlled study. Wiesendanger H, Werthmüller L, Reuter K, Walach H.

Objective: Little is known about the effects of distant healing in chronically ill patients, the population most likely to see a healer in practice. This study investigated whether distant healing as found in normal practice with patients representative of those seeking treatment from healers changes patients’ quality of life substantially.

Method: Randomized, waiting-list controlled study of distant healing (anonymous, amulet, and allowing for personal contact) in chronically ill patients.

Outcome measure: Patient-reported quality of life as expressed by the sum of all MOS SF-36 health survey items.

Results: Sixty patients were treated by various methods of distant healing over 5 months; 59 patients were put on a waiting list (control). Quality of life improved significantly (p < 0.0005) in the treated group (10 points), while it remained stable in the control group. Positive expectation was significantly correlated with outcome.

Conclusion: Chronically ill patients who want to be treated by distant healing and know that they are treated improve in quality of life.

2002: Distant Healing and Diabetes Mellitus. A Pilot Study M Ebneter 1M BinderO KristofH WalachR Saller

Background: The Institut für Grenzgebiete der Psychologie und Psychohygiene, Freiburg (IGPP) in cooperation with the Abteilung Naturheilkunde, University Hospital, Zürich investigated whether Distant Healing has a beneficial effect on patients with diabetes mellitus regarding the state of the disease and quality of life.

Objective: The goal of the pilot study was to observe the progression of the disease with various medical and psychological measures and to explore which of them might be sensitive for measuring possible treatment effects.

Patients and methods: 14 diabetic patients were observed for a period of 16 weeks. Within this time they underwent a treatment of 4 consecutive weeks (weeks 9-12) by 5 experienced and trustworthy healers each. Patients were informed about the duration of the treatment but not about the time point of its beginning. Patients and healers never met and there was no contact between researchers and patients during the study period.

Results: With regard to medical parameters, reduction in fructosamine level was observed during the healing period, increasing fructosamine level after the end of the healing period. Sensitivity, measured only at the beginning and at the end of the study period, decreased significantly. The other parameters showed some significant changes but there was no correlation to the Distant Healing intervention. Regarding the psychological data, only improvements were observed.

Conclusions: The results indicate the possibility that a Distant Healing intervention could have certain effects on patients with diabetes mellitus.

2008: Effectiveness of Distant Healing for Patients With Chronic Fatigue Syndrome: A Randomised Controlled Partially Blinded Trial (EUHEALS) Harald Walach 1Holger BoschGeorge LewithJohannes NaumannBarbara SchwarzerSonja FalkNiko KohlsErlendur HaraldssonHarald WiesendangerAlain NordmannHelgi TomassonPhil PrescottHeiner C Bucher

Background: Distant healing, a form of spiritual healing, is widely used for many conditions but little is known about its effectiveness.

Methods: In order to evaluate distant healing in patients with a stable chronic condition, we randomised 409 patients with chronic fatigue syndrome (CFS) from 14 private practices for environmental medicine in Germany and Austria in a two by two factorial design to immediate versus deferred (waiting for 6 months) distant healing. Half the patients were blinded and half knew their treatment allocation. Patients were treated for 6 months and allocated to groups of 3 healers from a pool of 462 healers in 21 European countries with different healing traditions. Change in Mental Health Component Summary (MHCS) score (SF-36) was the primary outcome and Physical Health Component Summary score (PHCS) the secondary outcome.

Results: This trial population had very low quality of life and symptom scores at entry. There were no differences over 6 months in post-treatment MHCS scores between the treated and untreated groups. There was a non-significant outcome (p = 0.11) for healing with PHCS (1.11; 95% CI -0.255 to 2.473 at 6 months) and a significant effect (p = 0.027) for blinding; patients who were unblinded became worse during the trial (-1.544; 95% CI -2.913 to -0.176). We found no relevant interaction for blinding among treated patients in MHCS and PHCS. Expectation of treatment and duration of CFS added significantly to the model.

Conclusions: In patients with CFS, distant healing appears to have no statistically significant effect on mental and physical health but the expectation of improvement did improve outcome.

So, Walach first conducted an RCT and found that patients who were told that they received the healing experienced improvements. These improvements were therefore due to the expectations of these patients and had nothing to do with the distant healing per se. Next Walach conducted a study with diabetics and found that distant healing might have some significant effects. This study not only lacked a control group but its sample size was also tiny. Therefore, he called it a ‘pilot study’ and never followed it up with a proper trial with diabetic patients – all in the good old SCAM tradition of abusing the term. Finally, Walach conducted a multi-centre RCT with 409 CFS-patients and found that distant healing is ineffective. Subsequently, he seems to have stopped initiating further studies of distant healing.

The sequence of publications is remarkable on several levels. To me, it demonstrates the importance of running a proper trial at the outset of conducting research into a subject. This avoids wasting resources and betraying the trust of patients in clinical research. To a more hard-nosed sceptic, it would probably prove how utterly futile it usually is to conduct any studies of treatments that are too implausible for words.

But the story also reveals something more intriguing. I think it displays the mindset of a pseudoscientist in an exemplary fashion. Walach conducted three studies of distant healing. They were all very different in design, patient population, outcome, etc. But they all are entirely consistent with what both common sense and science would have told even the most open-minded scientist: distant healing is neither plausible nor effective beyond placebo. Yet Walach seems to refuse drawing such a conclusion. His last publication on the subject was a qualitative analysis of some of the data from his CFS-RCT. In it he states that our results support data that imply the existence of a psychophysical pathway in healing through spiritual rituals…

If your own studies fail to that a therapy works would you then use weasel-words to promote the idea that your results support data that imply the existence of a psychophysical pathway in healing through spiritual rituals? Or would you openly declare that the therapy in question is useless and therefore potentially dangerous?

Perhaps this is the difference between a scientist and a pseudoscientist?

When tested rigorously, the evidence for so-called alternatives medicine (SCAM) is usually weak or even negative. This fact has prompted many SCAM enthusiasts to become utterly disenchanted with rigorous tests such as the randomised clinical trial (RCT). They seem to think that, if the RCT fails to generate the findings we want, let’s use different methodologies instead. In other words, they are in favour of observational studies which often yield positive results.

This line of thinking is prevalent in all forms of SCAM, but probably nowhere more so that in the realm of homeopathy. Homeopaths see that rigorous RCTs tend not to confirm their belief and, to avoid cognitive dissonance, they focus on observational studies which are much more likely to confirm their belief.

In this context, it is worth mentioning a recent article where well-known homeopathy enthusiasts have addressed the issue of observational studies. Here is their abstract:

Background: Randomized placebo-controlled trials are considered to be the gold standard in clinical research and have the highest importance in the hierarchical system of evidence-based medicine. However, from the viewpoint of decision makers, due to lower external validity, practical results of efficacy research are often not in line with the huge investments made over decades.

Method: We conducted a narrative review. With a special focus on homeopathy, we give an overview on cohort, comparative cohort, case-control and cross-sectional study designs and explain guidelines and tools that help to improve the quality of observational studies, such as the STROBE Statement, RECORD, GRACE and ENCePP Guide.

Results: Within the conventional medical research field, two types of arguments have been employed in favor of observational studies. First, observational studies allow for a more generalizable and robust estimation of effects in clinical practice, and if cohorts are large enough, there is no over-estimation of effect sizes, as is often feared. We argue that observational research is needed to balance the current over-emphasis on internal validity at the expense of external validity. Thus, observational research can be considered an important research tool to describe “real-world” care settings and can assist with the design and inform the results of randomised controlled trails.

Conclusions: We present recommendations for designing, conducting and reporting observational studies in homeopathy and provide recommendations to complement the STROBE Statement for homeopathic observational studies.

In their paper, the authors state this:

It is important to realize three areas where observational research can be valuable. For one, as already mentioned, it can be valuable as a preparatory type of research for designing good randomized studies. Second, it can be valuable as a stand-alone type of research, where pragmatic or ethical reasons stand against conducting a randomized study. Additionally, it can be valuable as the only adequate method where choices are involved: for instance, in any type of lifestyle research or where patients have very strong preferences, such as in homeopathy and other CAM. This might also lead to a diversification of research efforts and a broader, more realistic, picture of the effects of therapeutic interventions.

My comments to this are as follows:

  1. Observational research can be valuable as a preparatory type of research for designing good randomized studies. This purpose is better fulfilled by pilot studies (which are often abused in SCAM).
  2. Observational research can be valuable as a stand-alone type of research, where pragmatic or ethical reasons stand against conducting a randomized study. Such situations rarely arise in the realm of SCAM.
  3. Observational research can be valuable as the only adequate method where choices are involved: for instance, in any type of lifestyle research or where patients have very strong preferences, such as in homeopathy and other CAM. I fail to see that this is true.
  4. Observational research leads to a diversification of research efforts and a broader, more realistic, picture of the effects of therapeutic interventions. The main aim of research into the effectiveness of SCAM should be, in my view, to determine whether the treatment per se works or not. Observational studies are likely to obscure the truth on this issue.

Don’t get me wrong, I am not saying that observational studies are useless; quite to the contrary, they can provide very important information. But what I am trying to express is this:

  • We should not allow double standards in medical research. The standards and issues of observational research as they exist in conventional medicine must also apply to SCAM.
  • Observational studies cannot easily determine cause and effect between the therapy and the outcome.
  • Observational studies cannot be a substitute for RCTs.
  • Depending on their exact design, observational studies measure the outcome caused by a whole range of factors, including the therapy per se, the placebo-effect, the natural history of the disease, the regression towards the mean.
  • Observational studies are particularly useful in effectiveness research, AFTER the efficacy of a therapy has been established by RCTs.
  • If RCT fail to show that a therapy is effective and observational studies seem to indicate that they work, the therapy in question is probably a placebo.
  • SCAM-enthusiasts’ preference for observational studies is transparently due to motivated reasoning.

Michael Dixon LVOOBEMAFRCGP has been a regular feature of this blog (and elsewhere). He used to be a friend and colleague until … well, that’s a long story. Recently, I came across his (rather impressive) Wikipedia page. To my surprise, it mentions that Dixon

See the source image“has been criticised by professor of complementary medicine and alternative medicine campaigner Edzard Ernst for advocating the use of complementary medicine. Ernst said that the stance of the NHS Alliance on complementary medicine was “misleading to the degree of being irresponsible.”[31] Ernst had previously been sympathetic to building a bridge between complementary and mainstream medicine, co-writing an article with Michael Dixon in 1997 on the benefits of such an approach.[32] Ernst and Dixon write “missed diagnoses by complementary therapists giving patients long term treatments are often cited but in the experience of one of the authors (MD) are extremely rare. It can also cut both ways. A patient was recently referred back to her general practitioner by an osteopath, who was questioning, as it turned out quite correctly, whether her pain was caused by metastates. Good communication between general practitioner and complementary therapist can reduce conflicts and contradictions, which otherwise have the potential to put orthodox medicine and complementary therapy in an either/or situation.”

REFERENCES

31) February 2009, 24. “Academics and NHS Alliance clash over complementary medicine”. Pulse Today.

32) ^ Update – the journal of continuing education for General Practitioners, 7th May 1997

I have little recollection of the paper that I seem to have published with my then friend Michael, and it is not listed in Medline, nor can I find it in my (usually well-kept) files; the journal ‘Update’ does not exist anymore and was obviously not a journal good enough for keeping a copy. But I do not doubt that Wiki is correct.

In fact, it is true that, in 1997, I was still hopeful that bridges could be built between conventional medicine and so-called alternative medicine (SCAM). But I had always insisted that they must be bridges built on solid ground and with robust materials.

Put simply, my strategy was to test SCAM as rigorously as I could and to review the totality of the evidence for and against it. Subsequently, one could consider introducing those SCAMs into routine care that had passed the tests of science.

Dixon’s strategy differed significantly from mine. He had no real interest in science and wanted to use SCAM regardless of the evidence. Since the publication of our paper in 1997, he has pursued this aim tirelessly. On this blog, we find several examples of his activity.

And what happened to the bridges?

I’m glad you ask!

As it turns out, very few SCAMs have so far passed the test of science and hardly any SCAM has been demonstrated to generate more good than harm. The material to build bridges is therefore quite scarce, hardly enough for solid constructions. Dixon does still not seem to be worried about this indisputable fact. He thinks that INTEGRATED MEDICINE is sound enough for providing a way to the future. I disagree and still think it is ‘misleading to the degree of being irresponsible’.

Who is right?

Dixon or Ernst?

Opinions about this differ hugely.

Time will tell, I suppose.

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