MD, PhD, FMedSci, FSB, FRCP, FRCPEd

bias

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“Conflicts of interest should always be disclosed.”

This is what I wrote in the ‘RULES’ of this blog when I first started it almost 4 years ago. Sadly, very few people writing comments observe this rule. Perhaps, I just thought, I did not observe it either? So, here are my conflicts of interest: none.

Not true!!! I hear some people say. But it is!

I have no financial interest in any ‘Big Pharma’ or  ‘TINY CAM’, and I get not a penny for writing this blog.

How do I pay for my living? Mind your own business… well, on second thought, even that must not be a secret: I get a small pension and have some savings.

Still not convinced?

Perhaps it’s time to define what ‘conflicts of interests’ are. According to Wikipedia, they can be defined as  situations in which a person or organization is involved in multiple interests, financial interest, or otherwise, one of which could possibly corrupt the motivation of the individual or organization.

So, not having financial benefits from my current work does not necessarily mean that I have no conflicts of interest. The above definitions vaguely mentions ‘or otherwise’ – and that could be important. What could this mean in the context of this blog?

Well, I might have very strong beliefs, for instance (for instance, very strong beliefs that acupuncture is by definition nonsense [see below]). We all know that strong beliefs can corrupt motivation (and a lot more). And if I ask myself, do you have strong beliefs?, I have to say: Yes, absolutely!

I believe that:

  • good evidence is a prerequisite for progress in healthcare,
  • good evidence must be established by rigorous research,
  • we should not tolerate double standards in healthcare,
  • patients deserve to be treated with the best available treatments,
  • making therapeutic claims that are not supported by sound evidence is wrong.

These strong beliefs might make me biased in the eyes of many who comment on this blog. In Particular, we recently had a bunch of acupuncturists who went on the rampage attacking me personally the best they could. However, a rational analysis of my beliefs can hardly produce evidence for bias against anything other than the promotion of unproven therapies to the unsuspecting public.

The above mentioned acupuncturists seem to think that I have always been against acupuncture for the sake of being against acupuncture. However, this is not true. The proof for this statement is very simple: I have published quite a bit of articles that concluded positively – even (WOULD YOU BELIEVE IT?) about acupuncture for back pain! A prominently published meta-analysis of 2005 (with me as senior author) concluded:  “Acupuncture effectively relieves chronic low back pain.” (This of course was 11 years ago when the evidence was, in fact, positive; today, this seems to have changed – just like the NICE guidelines [probably not a coincidence!])

Conflicts of interest? No, not on my side, I think.

But what about the ‘other side’?

The unruly horde of acupuncturists (no, this is not an ad hominem attack, it’s a fact) who recently made dozens of ad hominem attacks against me, what about them?

  • They earn their money with acupuncture.
  • They have invested in acupuncture training often for long periods of time.
  • They have invested in practice equipment etc.
  • Some of them sell books on acupuncture.
  • Others run courses.
  • And all of them very clearly and demonstrably  have strong beliefs about acupuncture.

I think the latter point constitutes by far the most important conflict of interest in this context.

And this is where the somewhat trivial story has an unexpected twist and gets truly bizarre:

I have just leant that the same group of conflicted acupuncturists are now planning to publicly attack the panel of experts responsible for drafting the NICE guidelines. The reason? They feel that this panel had significant conflicts of interest that led them to come out against acupuncture.

Perhaps I should mention that I was not a member of this group, but I suspect that some of its members might have links to the pharmaceutical industry. It is almost impossible to find top experts in any area of medicine who do not have such links. You either gather experts with potential conflicts of interest, or you get non-experts without them. Would that bias them against acupuncture or any other alternative therapy? I very much doubt it.

What I do not doubt for a minute is that conflicts of interest are of major importance in these discussions. And by that I mean the more than obvious (but nevertheless undeclared) conflicts of interest of the acupuncturists. It seems that those with the strongest conflicts of interest shout the loudest about the non-existent or irrelevant conflict of interest of those who do not happen to share their quasi-religious belief in acupuncture.

The ‘ALT MED HALL OF FAME’ is filling up very nicely. Remember: so far, I have honoured the following individuals for (almost) never publishing anything else but positive results (in brackets are the main alternative therapies of each researcher and the countries where they are currently based):

Peter Fisher (homeopathy, UK)

Simon Mills (herbal medicine, UK)

Gustav Dobos (various, Germany)

Claudia Witt (homeopathy, Germany and Switzerland)

George Lewith (acupuncture, UK)

John Licciardone (osteopathy, US)

Today, I am about to admit another female to our club of alt med elite (the group was in danger of getting a bit too male-dominated) : Prof Nicola Robinson from the School of Health and Social Care, London South Bank University, UK. She may not be known to many of my readers; therefore I better provide some extra information. Her own institution wrote her up as follows:

Professor Nicola Robinson joined London South Bank University in March 2011 as Professor of Traditional Chinese Medicine and Integrated Health. Previously she was Professor of Complementary Medicine, University of West London. Professor Robinson’s former posts include; Consultant Epidemiologist Brent and Harrow Health Authority, Senior lecturer in Primary Healthcare University College London, Lecturer at Charing Cross and Westminster Hospital Medical School and Research Fellow at the London School of Hygiene and Tropical Medicine.

She graduated from Leicester University with a BSc (Hons) in Biological Sciences, and her PhD from Manchester University was in Immunology. She has been a registered acupuncturist since 1982. In 1985 Nicola was awarded an RD Lawrence Fellowship by Diabetes UK and in 1993 she was given an Honorary Membership of the Faculty of Public Health Medicine for her contribution to epidemiology and health services research. 

In 2004, Nicola was awarded a Winston Churchill Traveling Fellowship to visit China, to explore educational and research initiatives in Traditional Chinese Medicine at various universities and hospitals. Nicola has a keen interest in complementary medicine and its assimilation and integration into mainstream health care and has been involved in various research initiatives with professional groups. 

Nicola has written over 200 scientific articles in peer reviewed journals, prepared scientific reports and presented research at local, national and international conferences. She is the Editor in Chief of the European Journal of Integrative Medicine (Elsevier) as well as being on the editorial boards of other scientific journals. She has had considerable research experience in various aspects of public health that has covered a wide range of subject arenas including: complementary medicine, cancer, patient public engagement, mental health, diabetes, coronary heart disease, HIV, cystic fibrosis and psychosocial aspects of disease. She has various research links in China and has had successfully supervised both Chinese and UK PhD students.

As always, I conducted a Medline search for ‘Robinson N, alternative medicine’, which generated 50 articles. I excluded those articles that were not on alternative medicine (probably from someone by the same name) and those that had no abstract with conclusions about the value of alternative medicine. Of the rest, I included the most recent 10 papers. Below I show these articles with the appropriate links and the conclusion (in bold).

Integrative treatment for low back pain: An exploratory systematic review and meta-analysis of randomized controlled trials.

Hu XY, Chen NN, Chai QY, Yang GY, Trevelyan E, Lorenc A, Liu JP, Robinson N.

Chin J Integr Med. 2015 Oct 26. [Epub ahead of print]

Integrative treatment that combines CAM with conventional therapies appeared to have beneficial effects on pain and function. However, evidence is limited due to heterogeneity, the relatively small numbers available for subgroup analyses and the low methodological quality of the included trials. Identification of studies of true IM was not possible due to lack of reporting of the intervention details.

Complementary therapy provision in a London community clinic for people living with HIV/AIDS: a case study.

Lorenc A, Banarsee R, Robinson N.

Complement Ther Clin Pract. 2014 Feb;20(1):65-9. doi: 10.1016/j.ctcp.2013.10.003. Epub 2013 Oct 15

Complementary Ttherapies may provide important support and treatment options for HIV disease, but cost effectiveness requires further evaluation.

A review of the use of complementary and alternative medicine and HIV: issues for patient care.

Lorenc A, Robinson N.

AIDS Patient Care STDS. 2013 Sep;27(9):503-10. doi: 10.1089/apc.2013.0175. Review

Clinicians, particularly nurses, should consider discussing CAM with patients as part of patient-centered care, to encourage valuable self-management and ensure patient safety.

Meditative movement for respiratory function: a systematic review.

Lorenc AB, Wang Y, Madge SL, Hu X, Mian AM, Robinson N.

Respir Care. 2014 Mar;59(3):427-40. doi: 10.4187/respcare.02570. Epub 2013 Jul 23. Review

The available evidence does not support meditative movement for patients with CF, and there is very limited evidence for respiratory function in healthy populations. The available studies had heterogeneous populations and provided inadequate sampling information, so clinically relevant conclusions cannot be drawn. Well powered, randomized studies of meditative movement are needed.

Is the diurnal profile of salivary cortisol concentration a useful marker for measuring reported stress in acupuncture research? A randomized controlled pilot study.

Huang W, Taylor A, Howie J, Robinson N.

J Altern Complement Med. 2012 Mar;18(3):242-50. doi: 10.1089/acm.2010.0325. Epub 2012 Mar 2.

This pilot study suggests that TCA could reduce stress and increase the morning rise of the cortisol profile; however, this was not distinguishable from the effect of attention only.

The evidence for Shiatsu: a systematic review of Shiatsu and acupressure.

Robinson N, Lorenc A, Liao X.

BMC Complement Altern Med. 2011 Oct 7;11:88. doi: 10.1186/1472-6882-11-88. Review.

Evidence is improving in quantity, quality and reporting, but more research is needed, particularly for Shiatsu, where evidence is poor. Acupressure may be beneficial for pain, nausea and vomiting and sleep.

Autogenic Training as a behavioural approach to insomnia: a prospective cohort study.

Bowden A, Lorenc A, Robinson N.

Prim Health Care Res Dev. 2012 Apr;13(2):175-85. doi: 10.1017/S1463423611000181. Epub 2011 Jul 26

This study suggests that AT may improve sleep patterns for patients with various health conditions and reduce anxiety and depression, both of which may result from and cause insomnia. Improvements in sleep patterns occurred despite, or possibly due to, not focusing on sleep during training. AT may provide an approach to insomnia that could be incorporated into primary care.

Traditional and complementary approaches to child health.

Robinson N, Lorenc A.

Nurs Stand. 2011 May 25-31;25(38):39-47.

Health visitors had greater knowledge and understanding of TCA than practice nurses or nurse practitioners, often informed by patients and personal experience. Health visitors reported that they discussed TCA with families using a culturally competent and family-centred approach to explain the advantages and disadvantages of TCA. This is probably made possible by their ongoing, close relationship with parents in the home environment and their focus on child health. Other primary care nurses were reluctant to engage with patients on TCA because of concerns about liability, lack of information and practice and policy constraints. Practice nurses and nurse practitioners may be able to improve their holistic and patient-centred practice by learning from health visitors’ experience, particularly cultural differences and safety issues. Nurses and their professional bodies may need to explore how this can be achieved given the time-limited and focused nature of practice-based consultations.

A case study exploration of the value of acupuncture as an adjunct treatment for patients diagnosed with schizophrenia: results and future study design.

Ronan P, Robinson N, Harbinson D, Macinnes D.

Zhong Xi Yi Jie He Xue Bao. 2011 May;9(5):503-14

The study indicates that patients diagnosed with schizophrenia would benefit from acupuncture treatment alongside conventional treatment.

An investigation into the effectiveness of traditional Chinese acupuncture (TCA) for chronic stress in adults: a randomised controlled pilot study.

Huang W, Howie J, Taylor A, Robinson N.

Complement Ther Clin Pract. 2011 Feb;17(1):16-21. doi: 10.1016/j.ctcp.2010.05.013. Epub 2010 Jun 19

This pilot study suggests that TCA may be successful in treating the symptoms of stress, through a combination of specific and non-specific effects; but may not relate directly to how a person perceives their stress.

I think we have here a very clear case: Prof Robinson has investigated a range of very different alternative therapies for vastly different conditions. She drew 9 positive and one negative conclusions. This renders her ‘Trustworthiness Index’ truly remarkable. I am therefore confident that we all can agree to admit her to the ALT MED HALL OF FAME.

On this blog, I have repeatedly tried to explain why integrative (or integrated) medicine is such a deceptive nonsense; see for instance here, here and here. Today, I have reason to make another attempt: The International Congress on Integrative Medicine & Health.

In 2012, I published an analysis of the ‘3rd European Congress of Integrated Medicine’ which had taken place in December 2010 in Berlin (in Europe they call it ‘integrated’ and in the US ‘integrative’ medicine). For this purpose, I simply read all the 222 abstracts and labelled them according to their contents. The results showed that the vast majority were on unproven alternative therapies and none on conventional treatments.

The abstracts from the International Congress on Integrative Medicine & Health (ICIMH, Green Valley Ranch Resort, Las Vegas, Nevada, USA, May 17–20, 2016) which were just published provide me with the opportunity to check whether this situation has changed. There were around 400 abstracts, and I did essentially the same type of analysis (attributing one subject area to each abstract). And what a tedious task this was! I spotted just two articles of interest, and will report about them shortly.

This time I also assessed whether the conclusions of each paper were positive (expressing something favourable about the subject at hand), negative (expressing something negative about the subject at hand) or neither of the two (surveys, for instance, rarely show positive or negative results).

Here are the results: mind-body therapies were the top subject with 49 papers, followed by acupuncture (44), herbal medicine (37), integrative medicine (36), chiropractic and other manual therapies (26), TCM (19), methodological issues (16), animal and other pre-clinical investigations (15) and Tai Chi (5). The rest of the abstracts were on a diverse array of other subjects. There was not a single paper on a conventional therapy and only 4 focussed on risk assessments.

The 36 articles on integrative medicine deserve perhaps a special mention. The majority of these papers were about using alternative therapies as an add-on to conventional care. They focussed on the alternative therapies used and usually concluded that this ‘integration’ was followed by good results. None of these papers discussed integrative medicine and its assumptions critically, and none of these investigations cast any doubt about the assumption that integrative medicine is a positive thing.

I should also mention that my attributions of the subject areas were not always straight forward. I allowed myself only one subject per paper, but there were, of course, many that could be categorised in more than one subject area ( for instance, a paper on an herbal medicine might be in that category, or in TCM or in pre-clinical). So I tried to attribute the subject that seemed to dominate the abstract in question.

My analysis according to the direction of the conclusions was equally revealing: I categorised 260 papers as positive, 5 as negative and 116 as neither of the two. That means for every negative result there were 52 positive ones. I find this most remarkable.

Essentially, my two analyses of conference abstracts published 6 years apart show the same phenomenon: on the ‘scientific level’, integrative medicine is not about the ‘best of both worlds’ (i. e. the best alternative medicine has to offer integrated with the best conventional medicine offers) – the slogan by which advocates of integrative medicine usually try to ‘sell’ their dubious approach to us. It is almost exclusively about alternative therapies which advocates of integrative medicine aim to smuggle into mainstream healthcare. Critical analysis seems to be unwelcome in this area, and – perhaps worse of all – in the last 6 years, there does not seem to have been any improvement.

And that’s just on the ‘scientific level’, as I said. If you wonder what is happening on the ‘practical level’, you will find that, in the realm of integrative medicine, every quackery under the sun is being promoted at often exorbitant prices to the often gullible and always unsuspecting public. If you don’t believe me, search for ‘integrative medicine clinic’ on the Internet; I promise, you will be surprised!

Personally, I am sometimes amused by the sheer idiocy of all this, but more often I am enraged and ask myself:

  • Why are we allowing quackery to make such a spectacular come-back?
  • Why is hardly anyone voicing strong objections?
  • Is it not our ethical duty to do something about it and try to prevent the worse?

 

While over on my post about the new NICE GUIDELINES on acupuncture for back pain, the acupuncturists’ assassination attempts of my character, competence, integrity and personality are in full swing, I have decided to employ my time more fruitfully and briefly comment on a new piece of acupuncture research.

This new Italian study was to determine the effectiveness of acupuncture for the management of hot flashes in women with breast cancer.

A total of 190 women with breast cancer were randomly assigned to two groups. Random assignment was performed with stratification for hormonal therapy; the allocation ratio was 1:1. Both groups received a booklet with information about climacteric syndrome and its management to be followed for at least 12 weeks. In addition, the acupuncture group received 10 traditional acupuncture treatment sessions involving needling of predefined acupoints.

The primary outcome was hot flash score at the end of treatment (week 12), calculated as the frequency multiplied by the average severity of hot flashes. The secondary outcomes were climacteric symptoms and quality of life, measured by the Greene Climacteric and Menopause Quality of Life scales. Health outcomes were measured for up to 6 months after treatment. Expectation and satisfaction of treatment effect and safety were also evaluated. We used intention-to-treat analyses.

Of the participants, 105 were randomly assigned to enhanced self-care and 85 to acupuncture plus enhanced self-care. Acupuncture plus enhanced self-care was associated with a significantly lower hot flash score than enhanced self-care at the end of treatment (P < .001) and at 3- and 6-month post-treatment follow-up visits (P = .0028 and .001, respectively). Acupuncture was also associated with fewer climacteric symptoms and higher quality of life in the vasomotor, physical, and psychosocial dimensions (P < .05).

The authors concluded that acupuncture in association with enhanced self-care is an effective integrative intervention for managing hot flashes and improving quality of life in women with breast cancer.

This hardly needs a comment, as I have been going on about this study design many times before: the ‘A+B versus B’ design can only produce positive findings. Any such study concluding that ‘acupuncture (or whatever other intervention) is effective’ can therefore not be a legitimate test of a hypothesis and ought to be categorised as pseudo-science. Sadly, this problem seems more the rule than the exception in the realm of acupuncture research. That’s a pity really… because, if there is potential in acupuncture at all, this sort of thing can only distract from it.

I think the JOURNAL OF CLINICAL ONCOLOGY, its editors and reviewers, should be ashamed of having published such misleading rubbish.

Polycystic ovarian syndrome (PCOS) is a common condition characterised by oligo-amenorrhoea, infertility and hirsutism. Conventional treatment of PCOS includes a range of oral pharmacological agents, lifestyle changes and surgical modalities. Some studies have suggested that acupuncture might be helpful but the evidence is often flawed and the results are mixed. What is needed in such a situation is, of course, a systematic review.

The aim of this new Cochrane review was to assess the effectiveness and safety of acupuncture treatment of oligo/anovulatory women with polycystic ovarian syndrome (PCOS). The authors identified relevant studies from databases including the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, EMBASE, PsycINFO, CNKI and trial registries. The data are current to 19 October 2015.

They included randomised controlled trials (RCTs) that studied the efficacy of acupuncture treatment for oligo/anovulatory women with PCOS. We excluded quasi- or pseudo-RCTs. Primary outcomes were live birth and ovulation (primary outcomes), and secondary outcomes were clinical pregnancy, restoration of menstruation, multiple pregnancy, miscarriage and adverse events. We assessed the quality of the evidence using GRADE methods.

Two review authors independently selected the studies, extracted data and assessed risk of bias. They calculated Mantel-Haenszel odds ratios (ORs) and mean difference (MD) and 95% confidence intervals (CIs).

Five RCTs with 413 women were included. They compared true acupuncture versus sham acupuncture (two RCTs), true acupuncture versus relaxation (one RCT), true acupuncture versus clomiphene (one RCT) and electroacupuncture versus physical exercise (one RCT). Four of the studies were at high risk of bias in at least one domain. No study reported live birth rate. Two studies reported clinical pregnancy and found no evidence of a difference between true acupuncture and sham acupuncture (OR 2.72, 95% CI 0.69 to 10.77, two RCTs, 191 women, very low quality evidence). Three studies reported ovulation. One RCT reported number of women who had three ovulations during three months of treatment but not ovulation rate. One RCT found no evidence of a difference in mean ovulation rate between true and sham acupuncture (MD -0.03, 95% CI -0.14 to 0.08, one RCT, 84 women, very low quality evidence). However, one other RCT reported very low quality evidence to suggest that true acupuncture might be associated with higher ovulation frequency than relaxation (MD 0.35, 95% CI 0.14 to 0.56, one RCT, 28 women). Two studies reported menstrual frequency. One RCT reported true acupuncture reduced days between menstruation more than sham acupuncture (MD 220.35, 95% CI 252.85 to 187.85, 146 women). One RCT reported electroacupuncture increased menstrual frequency more than no intervention (0.37, 95% CI 0.21 to 0.53, 31 women). There was no evidence of a difference between the groups in adverse events. Evidence was very low quality with very wide CIs and very low event rates. Overall evidence was low or very low quality. The main limitations were failure to report important clinical outcomes and very serious imprecision.

The authors concluded that, thus far, only a limited number of RCTs have been reported. At present, there is insufficient evidence to support the use of acupuncture for treatment of ovulation disorders in women with PCOS.

This is, in my view, a rigorous assessment of the evidence leading to a clear conclusion. Foremost, I applaud the authors from the Faculty of Science, University of Technology Sydney for using such clear language. Such clarity seems to be getting a rare event in reviews of alternative medicine. To demonstrated this point, here are the most recent 5 systematic reviews which came up on my screen when I searched today Medline for ‘complementary alternative medicine, systematic review’.

The combination of TGP and LEF in treatment of RA presented the characteristics of notably decreasing the levels of laboratory indexes and higher safety in terms of liver function. However, this conclusion should be further investigated based on a larger sample size.

Compared to control groups, both MA and EA were more effective in improving AHI and mean SaO2. In addition, MA could further improve apnea index and hypopnea index compared to control.

CHM as an adjunctive therapy is associated with a decreased risk of in-hospital mortality compared with WT in patients with AKI. Further studies with high quality and large sample size are needed to verify our conclusions.

clinicians may consider Tai Chi as a viable complementary and alternative medicine for chronic pain conditions.

As an important supplementary treatment, TCM may provide benefits in repair of injured spinal cord. With a general consensus that future clinical approaches will be diversified and a combination of multiple strategies, TCM is likely to attract greater attention in SCI treatment.

I think the phenomenon is fairly obvious: authors of such papers are far too often not able or willing to express the bottom line of their work openly. As systematic reviews are supposed to be the ultimate type of evidence, this trend is very worrying, I think. In my view, such conclusions merely display the bias of the authors. If the evidence is not convincingly positive (which it very rarely is), authors have an ethical obligation to clearly say so.

If they don’t do it, journal editors have the duty to correct the error. If neither of these actions happen, funding agencies should make sure that such teams get no further research money until they can demonstrate that they have learnt the lesson.

This may sound a bit drastic but I think such steps would be both necessary and urgent. The problem is now extremely common, and if we do not quickly implement some effective preventative measures, our scientific literature will become contaminated to the point of becoming useless. This surely would be a disaster that affects us all.

There can, of course, be several reasons for the evidence being not positive:

  • there can be a paucity of data
  • the results might be contradictory
  • the trials might be open to bias
  • some of the primary data might look suspicious

In all of these cases, the evidence would be not convincingly positive, and it would be wrong and unhelpful not to be frank about it. Beating about the bush, like so many authors nowadays do, is misleading, unhelpful, unethical and borderline fraudulent. Therefore it constitutes a disservice to everyone concerned.

Edzard Ernst – why he changed his mind! This is the title of a blog which I just found. It is such fun to read that I must show it to you in full [I added a few numbered footnotes in square brackets]:

BBC Radio 4 gave Professor Edzard Ernst a 15 minute slot to explain “Why I Changed My Mind’ on Wednesday 4th May 2016. It was repeated on 12th May 2016. He was interviewed by Dominic Lawson [1]. The programme demonstrates the lengths to which the BBC is prepared to go in order under undermine Alternative Medicine, and Homeopathy, in particular [2].

Lawson set the tone. Ernst, he stated, is hated by alternative health practitioners, the Prince of Wales tried to get him sacked, and he eventually lost his academic post because of the criticism he attracted for his work. Ernst was left to agree with this dreadfully unfair and unreasonable treatment [3]. So Ernst was then led to explain his ‘change of mind’ about homeopathy. As a friend and colleague of mine said,

“Ernst (says) that as a German, he was raised on Homeopathy, and later treated his patients with homeopathy. And it worked! But when he approached it ‘scientifically’, he concluded that it’s merely placebo.”

So let’s be clear. Ernst’s experience of homeopathy has  been that it does work [4], but that the science he has looked at does not demonstrate that it works. (Even this is wrong [5], but leave that for now!) So people do get better as the result of homeopathic treatment, but ‘science’, or at least Ernst’s science [6], does not understand why it should [7]. Ernst also said that he was convinced, at the time, that he was ‘helping patients’.

Lawson then asked his most difficult question (sic). If he knew that homeopathy worked, why did it work? Ernst’s response was that it was charlatanism and quackery, and was “quite puzzling’ really [8]. So as homeopathy worked, but science said it should not work [8], he went on to study this in his post at Exeter University.

Lawson, in the great tradition of BBC impartiality [2], (sic), continued to lead him on. “When did you decide that homeopathy was useless, delusional?”

Ernst said that when he ‘did the science’ it became clear that homeopathy is placebo.

Now, lets look at this word, placebo. The Oxford English Dictionary defines ‘the placebo effects’ as”

“A beneficial effect produced by a placebo drug or treatment, which cannot be attributed to the properties of the placebo itself, and must therefore be due to the patient’s belief in that treatment”

So by using the term ‘placebo’ Ernst is once again saying the homeopathy has a ‘beneficial effect’ on patients who are ill [9]. Lawson did ask Ernst whether there was anything wrong using placebo if this brought positive benefits to patients. Ernst said that people got better anyway! (Is it really is a simple as this?) [7]

Lawson, now thoroughly convinced of Ernst’s arguments, asked his whether he thought homeopaths were lying. With some apparent grace, Ernst said that lying was a strong term, by the were ‘deluded’, and ‘treated homeopathy as a religion’.

Lawson came back, asking why there were lots of qualified doctors who believe in homeopathy, and whether they should they be struck off, or stopped from practising? No, said Ernst, they were just not thinking critically, and needed to be educated out of their delusions.

Presumably, for both Lawson and Ernst, using a medical therapy that worked and brought benefit to patients [7], but which science could not explain, should be restricted, if not banned altogether.

Lawson’s final question clearly demonstrated his impartiality. “Can we justify homeopathy, or any other kind of quackery? (My emphasis). “No”, said Ernst, predictably!

The BBC regularly broadcasts these kind of anti-homeopathy, anti-alternative-medicine programmes, with never an attempt to redress the balance [2]. They will never broadcast a programme that provides an alternative medical view. The BBC appears to be firmly in the camp of the conventional medical establishment [2], and committed to providing time to anti-homeopaths without any ‘right of reply’.

Why, for example, was there no question about the quality of the ‘science’ Ernst is associated with?  Certainly, his science has come under serious scrutiny. For instance, I blogged about “The contribution of Professor Edzard Ernst to disinformation about Homeopathy” in September 1915 [!!!]. This followed an assessment made by Professor Robert Kahn about the quality of Ernst’s science. This was his conclusion [10].

“I have never seen a science writer so blatantly biased as Edzard Ernst: his work should not be considered of any worth at all, and discarded.”

Kahn’s paper shows, in his view, how ‘science’ has been taken over by ideology, (or as I suggested the financial interests of Big Corporations like Big Pharma). He revealed that in order to demonstrate homeopathy is ineffective over 95% of scientific research into homeopathy has to be discarded or removed! [10]

There was, of course, no mention of this in the BBC programme! [11]

So if Ernst’s change of mind was ‘scientific’, it was based on bad science [12], the kind of science much discussed in this blog, bought science, cheque book science, the kind of science based on university faculties funded by the pharmaceutical industry [13]. Ernst’s funding dried up when his academic position had become untenable [14], and he lost the support of his financial backers [15]. As my friends and colleague said, in response to the programme:

“Ernst’s religion is Science, not the well being of the patients. I wonder how many listeners will
be influenced by him as he does come across as an experienced and rational man?” 

I agree with her assessment. Anyone can come over as an ‘experience and rational man’ when given an uncritical platform, such as this BBC programme proved to be. Certainly, Peter Fisher, the Queen’s homeopath, was one of his main critics. Why, Lawson asked Ernst, did homeopathy have ‘such a grip’ on the Royal Family? Ernst did not know, but he did know that “when they get really ill they do not go to a homeopathy, otherwise they would not get so old!”

At this point I began to wonder on what knowledge Ernst used to know how the Royal Family were being treated, and scientific basis his belief that their longevity was nothing to do with homeopathy? The question was never asked, so we will, I fear, never know! [16] [1] you can listen to the programme here

[2] a serious allegation for which no evidence is provided, and I suppose none exists

[3] this is the truth

[4] not true, my experience was that patients got better for which there are good, scientifically sound explanations that do not involve homeopathy

[5] no, it’s not

[6] the best available evidence today which has little to do with ‘my’ science; might this be a little attempt at an ad hominem?

[7] no, science does understand the phenomena involved well: placebo, regression towards the mean, natural history of the disease etc.

[8] a wilful misinterpretation of my words

[9] no, this is not what I said, homeopathic remedies are ineffective and the observed effects are due to other phenomena

[10] not Kahn but Hahn; and his criticism is laughable, see here

[11] the programme is a series of interviews with people who have changed their mind on an important subject; such questions do not belong there

[12] any proof for that other than Hahn?

[13] false and libellous allegation

[14] no, when HRH had filed his complaint; this is all described in detail in my memoir

[15] poor logic: if I had been funded by the ‘enemies of homeopathy’, my funding should have increased

[16] anyone who follows the news bulletins about the Royals will know where they go when seriously ill.

I just came across this website entitled 11 HARD QUESTIONS ABOUT CHIROPRACTIC PHYSICIANS. The title fascinated me; I am always in favour of addressing hard questions. I therefore read the 11 questions with interest; and I quite liked them. However, the answers provided by the author, a chiropractor of course, struck me as being more than a little uncritical towards chiropractic (feel free to click on the above link and see for yourself). Therefore, I decided to try my own answers (except for No 5). And then – being in the swing of it – I added a few more supplementary questions as well.

In other words, the first 11 questions are the ones posed by the chiro but the 4 additional ones are mine, and so are all the answers. Here we go:

 

Question No 1: What can a chiropractic physician do for me that another doctor can’t?

Nothing.

Question No 2: Does chiropractic therapy really work?

No. The best evidence available today fails to show that chiropractic spinal manipulations work for any condition. If one is generous, one might make an exception for back pain, but even for this symptom, the evidence is flimsy.

Question No 3: What other types of health problems can chiropractic treatment help?

None.

Question No 4: What does a chiropractic physician do to find my problem?

He/she often uses non-validated diagnostic techniques that are prone to give fantasy-results. You might also get extensive X-rays – mostly because the chiropractor wants to pay for the expensive equipment.

Question No 5: What therapies do chiropractic physicians use?
Chiropractic physicians may use manual and physical therapies including manipulation of the spine and joints of the arms and legs. Supportive therapies may also include massage, myofascial release, and therapeutic modalities such as ultrasound, electric stimulation and diathermy. Rehabilitative measures are often used such as specific corrective exercises to stabilize your problem. (This is the only answer I roughly agreed with, and I therefore left it unchanged.)

Question No 6: What is the standard length of treatment?

This depends mainly on the patient’s ability to pay. As a rule of thumb, as many treatments as possible will be given. Many chiros even advocate ‘maintenance treatment’ which means you receive regular spinal manipulations even when there is nothing wrong with you. The little porky they give you as an explanation is that this prevents future illnesses.

Question No 7: Is chiropractic care covered by insurance?

Because of very active lobbying by chiro interest groups, it may well be.

Question No 8: If I need a referral, how do I ask my doctor to refer me to a chiropractic physician?

Chiros are presently trying very hard to be accepted as ‘primary care physicians’; this means you can consult them directly without the need of a referral.

Question No 9: If I go see a chiropractor do I need to keep on going?

Only if you believe the nonsense about maintenance treatment they often tell you (see above) for which there is not a jot of convincing evidence.

Question No 10: What training do chiropractors have?

Not enough to realise that their spinal adjustments fail to generate more good than harm.

Question No 11: How should I select a good chiropractic physician?

If you are ill, it’s best to see are real doctor and avoid chiros.

AND NOW MY SUPPLEMENTARY QUESTIONS

No 1 Are chiros really physicians?

The definition of a physician is : ‘A person trained and licensed to practice medicine; a medical doctor’. Therefore, the answer is no.

No 2 What are the risks of spinal manipulations or adjustments, the main treatments used by chiros?

~50% of all patients have mild to moderate adverse effects that last 2-3 days.

In addition, several hundred cases of severe complications have been noted, including strokes and deaths.

No 3 How are such adverse outcomes monitored?

There is no effective monitoring system at all.

No 4 Is such an omission responsible or ethical?

No.

Reiki is one of the most popular types of ‘energy healing’. Reiki healers believe to be able to channel ‘healing energy’ into patients’ body thus enabling them to get healthy. If Reiki were not such a popular treatment, one could brush such claims aside and think “let the lunatic fringe believe what they want”. But as Reiki so effectively undermines consumers’ sense of reality and rationality, I feel I should continue informing the public about this subject – despite the fact that I have already reported about it several times before, for instance here, here, here, here, here and here.

A new RCT, published in a respected journal looks interesting enough for a further blog-post on the subject. The main aim of the study was to investigate the effectiveness of two psychotherapeutic approaches, cognitive behavioural therapy (CBT) and a complementary medicine method Reiki, in reducing depression scores in adolescents. The researchers from Canada, Malaysia and Australia recruited 188 adolescent depressed adolescents. They were randomly assigned to CBT, Reiki or wait-list. Depression scores were assessed before and after 12 weeks of treatments/wait list. CBT showed a significantly greater decrease in Child Depression Inventory (CDI) scores across treatment than both Reiki (p<.001) and the wait-list control (p<.001). Reiki also showed greater decreases in CDI scores across treatment relative to the wait-list control condition (p=.031).  Male participants showed a smaller treatment effects for Reiki than did female participants. The authors concluded that both CBT and Reiki were effective in reducing the symptoms of depression over the treatment period, with effect for CBT greater than Reiki.

I find it most disappointing that these days even respected journals publish such RCTs without the necessary critical input. This study may appear to be rigorous but, in fact, it is hardly worth the paper it was printed on.

The results show that Reiki produced worse results than CBT. That I can well believe!

However, the findings also suggest that Reiki was nevertheless “effective in reducing the symptoms of depression”, as the authors put it in their conclusions. This statement is misleading!

It is based on the comparison of Reiki with doing nothing. As Reiki involves lots of attention, it can be assumed to generate a sizable placebo effect. As a proportion of the patients in the wait list group are probably disappointed for not getting such attention, they can be assumed to experience the adverse effects of their disappointment. The two phenomena combined can easily explain the result without any “effectiveness” of Reiki per se.

If such considerations are not fully discussed and made amply clear even in the conclusions of the abstract, it seems reasonable to accuse the journal of being less than responsible and the authors of being outright misleading.

As with so many papers in this area, one has to ask: WHERE DOES SLOPPY RESEARCH END AND WHERE DOES SCIENTIFIC MISCONDUCT BEGIN?

A recent comment to a blog-post about alternative treatments for cancer inspired me to ponder a bit. I think it is noteworthy because it exemplifies so many of the comments I hear in the realm of alternative medicine on an almost daily basis. Here is the comment in question:

“Yes…it appears that the medical establishment have known for years that chemotherapy a lot of the time kills patients faster than if they were untreated…what’s more, it worsens a person’s quality of life in which many die directly of the severe effects on the endocrine, immune system and more…cancers often return in more aggressive forms metastasising with an increased risk of apoptosis. In other words it makes things worse whereas there are many natural remedies which not only do no harm but accumulating evidence points to their capacity to fight cancer…some of it is bullshit whilst some holds some truth!! So turning away from toxic treatments that kill towards natural approaches that are showing more hope with the backing of trials kinda reverses the whole argument of this article.”

The comment first annoyed me a bit, of course, but later it made me think and consider the differences between conspiracy theories, assumptions, opinions, evidence and scientific facts. Let’s tackle each of these in turn.

CONSPIRACY THEORIES

A conspiracy theory is an explanatory or speculative theory suggesting that two or more persons, or an organization, have conspired to cause or cover up, through secret planning and deliberate action, an event or situation typically regarded as illegal or harmful.

Part of the above comment bears some of the hallmarks of a conspiracy theory: “…the medical establishment have known for years that chemotherapy a lot of the time kills patients faster than if they were untreated…” The assumption here is that the conventional healthcare practitioners are evil enough to knowingly do harm to their patients. Such conspiracy theories abound in the realm of alternative medicine; they include the notions that

  • BIG PHARMA is out to kill us all in order to maximize their profits,
  • the ‘establishment’ is suppressing any information about the benefits of alternative treatments,
  • vaccinations are known to be harmful but nevertheless being forced on to our children,
  • drug regulators are in the pocket of the pharmaceutical industry,
  • doctors accept bribes for prescribing dangerous drugs
  • etc. etc.

In a previous blog-post, I have discussed the fact that the current popularity of alternative medicine is at least partly driven by the conviction that there is a sinister plot by ‘the establishment’ that prevents people from benefitting from the wonders of alternative treatments. It is therefore hardly surprising that conspiracy theories like the above are voiced regularly on this blog and elsewhere.

ASSUMPTION

An assumption is something taken for granted or accepted as true without proof.

The above comment continues stating that “…[chemotherapy] makes things worse whereas there are many natural remedies which not only do no harm but accumulating evidence points to their capacity to fight cancer…” There is not proof for these assertions, yet the author takes them for granted. If one were to look for the known facts, one would find the assumptions to be erroneous: chemotherapy has saved countless lives and there simply are no natural remedies that will cure any form of cancer. In the realm of alternative medicine, this seems to worry few, and assumptions of this or similar nature are being made every day. Sadly the plethora of assumptions or bogus claims eventually endanger public health.

OPINION

An opinion is a judgment, viewpoint, or statement about matters commonly considered to be subjective.

The above comment continues with the opinion that “…turning away from toxic treatments that kill towards natural approaches that are showing more hope with the backing of trials kinda reverses the whole argument of this article.” In general, alternative medicine is based on opinions of this sort. On this blog, we have plenty of examples for that in the comments section. This is perhaps understandable; evidence is usually in short supply, and therefore it often is swiftly replaced with often emotionally loaded opinions. It is even fair to say that much of alternative medicine is, in truth, opinion-based healthcare.

EVIDENCE

Evidence is anything presented in support of an assertion. This support may be strong or weak. The strongest type of evidence is that which provides direct proof of the truth of an assertion.

One remarkable feature of the above comment is that it is bar of any evidence. In a previous post, I have tried to explain the nature of evidence regarding the efficacy of medical interventions:

The multifactorial nature of any clinical response requires controlling for all the factors that might determine the outcome other than the treatment per se. Ideally, we would need to create a situation or an experiment where two groups of patients are exposed to the full range of factors (e. g. placebo effects, natural history of the condition, regression towards the mean), and the only difference is that one group does receive the treatment, while the other one does not. And this is precisely the model of a controlled clinical trial.

Such studies are designed to minimise all possible sources of bias and confounding. By definition, they have a control group which means that we can, at the end of the treatment period, compare the effects of the treatment in question with those of another intervention, a placebo or no treatment at all.

Many different variations of the controlled trial exist so that the exact design can be adapted to the requirements of the particular treatment and the specific research question at hand. The over-riding principle is, however, always the same: we want to make sure that we can reliably determine whether or not the treatment was the cause of the clinical outcome.

Causality is the key in all of this; and here lies the crucial difference between clinical experience and scientific evidence. What clinician witness in their routine practice can have a myriad of causes; what scientists observe in a well-designed efficacy trial is, in all likelihood, caused by the treatment. The latter is evidence, while the former is not.

Don’t get me wrong; clinical trials are not perfect. They can have many flaws and have rightly been criticised for a myriad of inherent limitations. But it is important to realise that, despite all their short-comings, they are far superior than any other method for determining the efficacy of medical interventions.

There are lots of reasons why a trial can generate an incorrect, i.e. a false positive or a false negative result. We therefore should avoid relying on the findings of a single study. Independent replications are usually required before we can be reasonably sure.

Unfortunately, the findings of these replications do not always confirm the results of the previous study. Whenever we are faced with conflicting results, it is tempting to cherry-pick those studies which seem to confirm our prior belief – tempting but very wrong. In order to arrive at the most reliable conclusion about the efficacy of any treatment, we need to consider the totality of the reliable evidence. This goal is best achieved by conducting a systematic review.

In a systematic review, we assess the quality and quantity of the available evidence, try to synthesise the findings and arrive at an overall verdict about the efficacy of the treatment in question. Technically speaking, this process minimises selection and random biases. Systematic reviews and meta-analyses [these are systematic reviews that pool the data of individual studies] therefore constitute, according to a consensus of most experts, the best available evidence for or against the efficacy of any treatment.

SCIENTIFIC FACTS

Scientific facts are verified by repeatable careful observation or measurement (by experiments or other means).

Some facts related to the subject of alternative medicine have already been mentioned:

  • chemotherapy prolongs survival of many cancer patients;
  • no alternative therapy has achieved anything remotely similar.

The comment above that motivated me to write this somewhat long-winded post is devoid of facts. This is just one more feature that makes it so typical of the comments by proponents of alternative medicine we see with such embarrassing regularity.

My last post was about a researcher who manages to produce nothing but positive findings with the least promising alternative therapy, homeopathy. Some might think that this is an isolated case or an anomaly – but they would be wrong. I have previously published about researchers who have done very similar things with homeopathy or other unlikely therapies. Examples include:

Claudia Witt

George Lewith

John Licciardone

But there are many more, and I will carry on highlighting their remarkable work. For example, the research of a German group headed by Prof Gustav Dobos, one of the most prolific investigator in alternative medicine at present.

For my evaluation, I conducted a Medline search of the last 10 of Dobos’ published articles and excluded those not assessing the effectiveness of alternative therapies such as surveys, comments, etc. Here they are with their respective conclusions and publication dates:

SYSTEMATIC REVIEW COMPARING DIFFERENT YOGA STYLES (2016)

RCTs with different yoga styles do not differ in their odds of reaching positive conclusions. Given that most RCTs were positive, the choice of an individual yoga style can be based on personal preferences and availability.

SYSTEMATIC REVIEW OF YOGA FOR WEIGHT LOSS (2016)

Despite methodological drawbacks, yoga can be preliminarily considered a safe and effective intervention to reduce body mass index in overweight or obese individuals.

REVIEW OF INTEGRATIVE MEDICINE IN GYNAECOLOGICAL ONCOLOGY (2016)

…there is published, positive level I evidence for a number of CAM treatment forms.

SYSTEMATIC REVIEW OF MINDFULNESS FOR PSYCHOSES (2016)

Mindfulness- and acceptance-based interventions can be recommended as an additional treatment for patients with psychosis.

RCT OF CABBAGE LEAF WRAPS FOR OSTEOARTHOSIS (2016)

Cabbage leaf wraps are more effective for knee osteoarthritis than usual care, but not compared with diclofenac gel. Therefore, they might be recommended for patients with osteoarthritis of the knee.

SYSTEMATIC REVIEW OF HERBAL MEDICINES FOR COUGH (2015)

This review found strong evidence for A. paniculata and ivy/primrose/thyme-based preparations and moderate evidence for P. sidoides being significantly superior to placebo in alleviating the frequency and severity of patients’ cough symptoms. Additional research, including other herbal treatments, is needed in this area.

SYSTEMATIC REVIEW OF DIETARY APPROACHES FOR METABOLIC SYNDROME (2016)

Dietary approaches should mainly be tried to reduce macronutrients and enrich functional food components such as vitamins, flavonoids, and unsaturated fatty acids. People with Metabolic Syndrome will benefit most by combining weight loss and anti-inflammatory nutrients.

SYSTEMATIC REVIEW OF MIND BODY MEDICINE FOR CORONARY HEART DISEASE (2015)

In patients with CHD, MBM programs can lessen the occurrence of cardiac events, reduce atherosclerosis, and lower systolic blood pressure, but they do not reduce mortality. They can be used as a complement to conventional rehabilitation programs.

CRANIOSACRAL THERAPY (CST) FOR BACK PAIN (2016)

CST was both specifically effective and safe in reducing neck pain intensity and may improve functional disability and the quality of life up to 3 months after intervention.

REVIEW OF INTEGRATED MEDICINE FOR BREAST CANCER (2015)

Study data have shown that therapy- and disease-related side effects can be reduced using the methods of integrative medicine. Reported benefits include improving patients’ wellbeing and quality of life, reducing stress, and improving patients’ mood, sleeping patterns and capacity to cope with disease.

Amazed?

Dobos seems to be an ‘all-rounder’ whose research tackles a wide range of alternative treatments. That is perhaps unremarkable – but what I do find remarkable is the impression that, whatever he researches, the results turn out to be pretty positive. This might imply one of two things, in my view:

I let my readers chose which possibility they deem to be more likely.

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