Qigong is a branch of Traditional Chinese Medicine using meditation, exercise, deep breathing, and other techniques with a view of strengthening the assumed life force ‘qi’ and thus improving health and prolong life. There are several distinct forms of qigong which can be categorized into two main groups, internal qigong, and external qigong. Internal qigong refers to a physical and mental training method for the cultivation of oneself to achieve optimal health in both mind and body. Internal qigong is not dissimilar to tai chi but it also employs the coordination of different breathing patterns and meditation. External qigong refers to a treatment where qigong practitioners direct their qi-energy to the patient with the intention to clear qi-blockages or balance the ﬂow of qi within that patient. According to Taoist and Buddhist beliefs, qigong allows access to higher realms of awareness. The assumptions of qigong are not scientifically plausible and its clinical effectiveness remains unproven.
The aim of this study was to investigate the effects of internal Qigong for the management of a symptom cluster comprising fatigue, dyspnea, and anxiety in patients with lung cancer.
A total of 156 lung cancer patients participated in this trial, and they were randomized to a Qigong group (6 weeks of intervention) or a waitlist control group receiving usual care. A professional coach with 12 years of experience in teaching Qigong was employed to guide the participants’ training. The training protocol was developed according to the “Qigong Standard” enacted by the Chulalongkorn University, Thailand. The training involved a series of simple, repeated practices including body posture/movement, breathing practice, and meditation performed in synchrony. It mainly consisted of gentle movements designed to bring about a deep state of relaxation and included 7 postures. The symptom cluster was assessed at baseline, at the end of treatment (primary outcome), and at 12 weeks, alongside measures of cough and quality of life (QOL).
The results showed no significant interaction effect between group and time for the symptom cluster, the primary outcome measure of this study, overall and for fatigue and anxiety. However, a significant trend towards improvement was observed on fatigue (P = .004), dyspnea (P = .002), and anxiety (P = .049) in the Qigong group from baseline assessment to the end of intervention at the 6th week (within-group changes). Improvements in dyspnea and in the secondary outcomes of cough, global health status, functional well-being and QOL symptom scales were statistically significant between the 2 groups (P = .001, .014, .021, .001, and .002, respectively).
The authors concluded that Qigong did not alleviate the symptom cluster experience. Nevertheless, this intervention was effective in reducing dyspnea and cough, and improving QOL. More than 6 weeks were needed, however, for detecting the effect of Qigong on improving dyspnea. Furthermore, men benefited more than women. It may not be beneficial to use Qigong to manage the symptom cluster consisting of fatigue, dyspnea, and anxiety, but it may be effective in managing respiratory symptoms (secondary outcomes needing further verification in future research). Future studies targeting symptom clusters should ensure the appropriateness of the combination of symptoms.
I am getting very tired of negative trials getting published as (almost) positive ones. The primary outcome measure of this study did not yield a positive result. The fact that some other endpoints suggested a positive might provide an impetus for further study but does not demonstrate Qigong to be effective. I know the first author of this study is a fan of so-called alternative medicine (SCAM), but this should not stop him from doing proper science.
Indian homeopaths aimed at evaluating the efficacy of individualized homeopathy (IH) for atopic dermatitis (AD). They conducted a double-blind, randomized, placebo-controlled, short-term, preliminary trial in an Indian homeopathy hospital. Patients were randomized to either IH (n = 30) or identical-looking placebo (n = 30) using computerized randomization and allocation. Outcomes were patient-oriented scoring of AD (PO-SCORAD; primary endpoint), Dermatological Life Quality Index (DLQI) score, and AD burden score for adults (ADBSA; secondary endpoints), measured monthly for 3 months. An intention-to-treat sample was analyzed after adjusting baseline differences.
On PO-SCORAD, improvement was higher in IH against placebo, but nonsignificant statistically (pmonth 1 = 0.433, pmonth 2 = 0.442, pmonth 3 = 0.229). Secondary outcomes were also nonsignificant – both DLQI and ADBSA (p > 0.05). Four adverse events (diarrhea, injury, common cold) were recorded.
The authors concluded that there was a small, but nonsignificant direction of effect towards homeopathy, which renders the trial inconclusive. A properly powered robust trial is indicated.
- Why use statistics only to ignore its results?
- Why discredit research into so-called alternative medicine (SCAM) in this way?
- Who on earth would publish such misleading conclusions?
This article was published in Complementary Medicine Research which claims to be an international peer-reviewed journal that aims to bridge the gap between conventional and complementary/alternative medicine on a sound scientific basis, promoting their mutual integration. It boasts that “experts of both conventional medicine and complementary/alternative medicine cooperate on the journal’s editorial board, ensuring a high standard of scientific quality”. Its editor is Harald Walach who we have met several times before.
I had a look at the long list of members of the editorial board and was unable to see many ‘experts in conventional medicine’. If that is so, the journal’s peer review process is bound to turn into a farcical procedure where any rubbish will pass.
The journal reminds authors that “published research must comply with internationally-accepted standards for research practice and reporting.” I believe that the internationally accepted standards of research reporting include something about not misleading the public by claiming that the absence of an effect is a small effect in favor of homeopathy. By revealing that there was no significant effect, the authors of this study demonstrate that IH was not effective as a treatment of AD. It is in my mind unethical to try to disguise this result by making it look like a small positive effect or claiming the result was inconclusive.
High standard of scientific quality?
No, quite the opposite!
In the world of homeopathy, Prof Michael Frass is a famous man. He is the First Chairman of the Scientific Society for Homeopathy (WissHom), the president of the Umbrella organization of Austrian Doctors for Holistic Medicine, and the Vicepresident of the Doctors Association for Classical Homeopathy. Frass has featured on this blog before, not least because he has published numerous studies of homeopathy, none of which has ever failed to produce a positive result.
This is not just remarkable, in my view, it defies logic and the laws of nature. Even if homeopathy were a supremely effective therapy – a very broad consensus holds that it is not! – one would occasionally expect some negative results. No treatment works under all circumstances
… that is no treatment except homeopathy, according to Frass.
Recently Frass amazed even the world of oncology by publishing a study suggesting that homeopathy can prolong the survival of lung cancer patients. Every oncologist I know was flabbergasted.
Can this be true? This is the question, many people have been asking for some time in relation to Frass’s research.
In my quest to shine more light on it, I was recently alerted to an article by the formidable Austrian investigative journalist, Alwin Schönberger. In 2015, he came across a press release announcing that “HOMEOPATHY HAD BEEN PROVEN TO WORK AFTER ALL” (strikingly similar to one issued in 2018). It came from Austria’s leading manufacturer who was giving an award to an apparently outstanding thesis supervised by Frass. Even today, this piece of research has not been published in the peer-reviewed literature.
Yet, after some difficulties, Schönberger managed to obtain a copy. What he found was surprising, and he thus published his findings in the respected Austrian journal ‘Profil’ (2. Mai 2015 • profil 22).
Frass’s student had been given the task to systematically review all the homeopathy trials published between 2008 and 2012. Contrary to the hype of the press release, the meta-analysis merely suggested a very small effect. When digging deeper, Schönberger found several inconsistencies and mistakes in the analysis. They all were such that they produced a false-positive picture for homeopathy. Upon their correction, homeopathy turned out to be no longer significantly superior to placebo. Frass was then interviewed about it and claimed that the inconsistencies were only ‘errors’ but insisted that homeopathy is not a placebo therapy.
Yes, of course, errors happen in research. But if they all go in one direction and if that direction coincides with the interests of the researchers, we have the right, perhaps even the duty, to be suspicious. The questions that arise from this story are, I think, as follows:
- Have the errors been corrected?
- Are there perhaps other errors in Frass’s research?
- Can we trust anything that Frass says?
- Is it time to consider an official investigation into Frass’s studies of homeopathy?
Guest post by Alan Henness
When I discovered a homeopath admitting on camera that she believed she and her fellow homeopaths had managed to unblind a triple-blinded homeopathy trial they were taking part in, I submitted a complaint to the journal that published the paper on the trial, the university of the researcher who had conducted the trial and the current university of the homeopath who had subsequently moved into research.
The paper concerned is the 2004 paper by Weatherley-Jones et al. A randomised, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome. This was published in the Journal of Psychosomatic Research.
The homeopath was Clare Relton, currently Senior Lecturer in Clinical Trials at the Centre for Primary Care and Public Health at Queen Mary University of London and Honorary Senior Research Fellow, School of Health and Related Research at the University of Sheffield.
She gave a presentation at the 2019 conference of the Homeopathy Research Institute. Billed as an International Homeopathy Research Conference, it was subtitled, Cutting edge research in homeopathy. The videos of the conference were sponsored by homeopathy manufacturing giant, Boiron.
My complaint email (see below) explains what I discovered and sets the context. As a result of the investigation by the journal, the current editor along with two former editors have just published a peer-reviewed paper on my complaint and their investigation:
Misconduct and unethical behaviour
It’s worth noting how serious the Journal of Psychosomatic Research considered the misconduct they identified by Relton and others. From the Results section of the paper:
We found the presentation by Dr. Relton disturbing on multiple grounds. This admission of unethical behavior calls her scientific integrity into question. The premise for her actions rests on an errant assumption widespread among clinicians, based on anecdotal experience, that one possesses an ultimate knowledge of what works and doesn’t work without the need for rigorous study. The history of medicine, unfortunately, has been littered by countless treatments that practitioners believed in and dispensed, only to be later found not beneficial or even harmful . This underscores the importance of rigorous study for treatments where equipoise exists in the scientific community, as it arguably did for the use of homeopathy for chronic fatigue syndrome. Dr. Relton likely did not hold that equipoise herself, but if she had ethical concerns about the study, the appropriate action would have been to not participate in it. Instead, she purports to have enlisted colleagues to deliberately and systematically undermine the study.
In watching the presentation, the purpose of this admission seemed to be to discount the results of a rigorous but essentially negative study in the context of promoting her own ideas related to trial design. While we cannot know for certain that her motivation was to discount the results of this study, what she said clearly seeks to undermine the credibility of a trial whose results challenged her firmly held but untested beliefs about the benefit of a treatment that she had high allegiance to. Regardless of her intent or what actually happened during the trial, Dr. Relton’s presentation is ipso facto evidence of either an admitted prior ethical breach or is itself an ethical breach for the following reasons. Either she indeed undermined an ambitious effort to study of the efficacy of homeopathy for chronic fatigue syndrome, negating the work of all other investigators, study staff, and participants involved in the study as well as the investment of the public, or she is conducting a late and inappropriate attack on the study’s credibility. Her presentation certainly warrants formal censure from the scientific community, and this paper may contribute to that. Despite this clear indictment, after discussing and considering the complaint of Mr. Henness for several months, we ultimately decided not to retract the paper.
They decided not to retract the paper but instead use it for ethical reflection. However, they concluded I had highlighted “undisputable evidence of scientific misconduct” by the homeopaths concerned:
When is lack of scientific integrity a reason for retracting a paper? A case study
Objective: The journal received a request to retract a paper reporting the results of a triple-blind randomized placebo-controlled trial. The present and immediate past editors expand on the journal’s decision not to retract this paper in spite of undisputable evidence of scientific misconduct on behalf of one of the investigators.
Methods: The editors present an ethical reflection on the request to retract this randomized clinical trial with consideration of relevant guidelines from the committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE) applied to the unique contextual issues of this case.
Results: In this case, scientific misconduct by a blinded provider of a homeopathy intervention attempted to undermine the study blind. As part of the study, the integrity of the study blind was assessed. Neither participants nor homeopaths were able to identify whether the participant was assigned to homeopathic medicine or placebo. Central to the decision not to retract the paper was the fact that the rigorous scientific design provided evidence that the outcome of the study was not affected by the misconduct. The misconduct itself was thought to be insufficient reason to retract the paper.
Conclusion: Retracting a paper of which the outcome is still valid was in itself considered unethical, as it takes away the opportunity to benefit from its results, rendering the whole study useless. In such cases, scientific misconduct is better handled through other professional channels.
The authors had additional ethical concerns:
Apart from the intention of ‘circumventing the blind’, there is another unethical aspect to the behavior of Dr. Relton, namely the fact that patients were systematically subject to an intervention (carcinosin administration) that was not part of the original research protocol and to which they did not consent as part of the study. Although the systematic administration of carcinosin was not part of the study protocol, it was administered only to patients taking part in the study, and because they took part in the study. Presumably, these patients were not properly informed, or maybe even misinformed, about the rationale of a double-blind trial design and/or the true reason for administrating carcinosin. Apparently, ‘deep listening and deep understanding’ does not necessarily need to be accompanied by an honest and open attitude towards patients that participate in research. Dr. Relton stated in her lecture ‘I’m not trained to be deceiving people’, but that is exactly what she did. Not only did she deceive patients, but also the researchers and study leaders that she is supposed to collaborate with as a colleague. [emphasis in original]
The authors said:
The authors are of the opinion that in case the misconduct was not conducted by or on behalf of the principal investigator – as is the case here -, the initiative for further action should lie with them. Not only is the principal investigator the one that was deceived, but they are in a better position to report the misconduct to the institution and funding body. If the principal investigator is responsible for the misconduct, the editor is probably the only one that can initiate further action, in which case the researcher’s institution should be informed and requested to take appropriate action.
It will be interesting to see what further action, if any, is taken by Weatherley-Jones as is suggested.
I had already brought my concerns to the attention of both the University of Sheffield and Queen Mary University of London. The former concluded:
This is to confirm that the University of Sheffield has now completed its assessment of this matter, and it has been agreed that it would not be appropriate for the University of Sheffield to undertake a research misconduct investigation of the allegation against Clare Relton, since she is not a current member of University staff, nor was she a member of staff at the time of the clinical trial in question.
In relation to the potential concerns about the reliability of the published research findings, the University is satisfied that the Journal of Psychosomatic Research is consulting with the authors and taking steps to address the concerns as appropriate. The University will therefore be taking no further action.
I received no response from Queen Mary University of London, despite their Principal being copied in on all the relevant correspondence.
I will be writing again to both and Weatherley-Jones now the paper has been published.
My thanks to Jess G. Fiedorowicz, Editor, Journal of Psychosomatic, for his thorough investigation of my complaint.
The results of a trial were published in the Journal of Psychosomatic Research in 2004 (see attached copy):
A randomised, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome
Elaine Weatherley-Jones a,*, Jon P Nicholl a, Kate J Thomas a, Gareth J Parry a, Michael W McKendrickb, Stephen T Green b, Philip J Stanley c, Sean PJ Lynch d
a Medical Care Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK
b Communicable Diseases Directorate, Royal Hallamshire Hospital, Sheffield, UK
c Seacroft Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK
d St. James’s University Hospital, University of Leeds, Beckett Street, Leeds, UK
* Corresponding author. Tel.: +44-114-222-0744; fax: +44-114-222-0749.
E-mail address: e.weatherley-jones@sheffield.
The paper is indexed in PubMed here.
Elaine Weatherley-Jones is listed as the Corresponding author at the Medical Care Research Unit, School of Health and Related Research, University of Sheffield as are others.
One of the homeopaths involved in providing treatment was Clare Relton, currently Senior Lecturer in Clinical Trials at the Centre for Primary Care and Public Health at Queen Mary University of London.
The full list of those involved in providing treatment during the trial is given as:
The Homeopathic Trials Group: Homeopaths— Gill de Boer, MBChB, MFHom, Maryjoan Foster, RSHom, Susanne Hartley, RSHom, Jane Howarth, BRCPHom, Pat Mayborne RSHom, Georgina Ramsayer RSHom, Clare Relton, RSHom, Pat Strong, MBBS, MFHom, Angela Zajac, BSc, RSHom, BRCPHom.
Dr Relton gave a talk at the Conference in London of the Homeopathy Research Institute held 14 to 16 June 2019. The video of her talk has recently been published: https://www.
I invite you to watch all 30 minutes of it.
She then goes on to describe how she took part as one of the homeopaths in the trial and relates how she came up with “a cunning way of circumventing the blinding”.
I offer the following transcript of the segment of her talk where she discusses this (all transcription errors are mine):
So while I was still a homeopath in the Wellforce clinic, a researcher from the University of Sheffield which was actually only five minutes away from my clinic which was really handy came along and said, “I’ve got some money from Lord Sainsbury to do a trial of chronic fatigue syndrome of homoeopathy” and she described the design and I remember thinking, “not sure what that’s going to show”.
But anyway there were ten homeopaths recruited in Sheffield and Leeds and we saw patients with chronic fatigue syndrome.
A lot of us were getting patients with chronic fatigue syndrome anyway and particularly if they were never been well since glandular fever couple of doses of carcinosin 30 or 200 and they seem to make a really good recovery.
So we’re pretty confident about taking part in this trial.
So there were 130 or 140 patients recruited to the trial and then allocated to the homeopaths: there were five at our clinic and I was one of them.
Patients would arrive; you would do the normal thing, have the consultation with them. They seemed a bit standoffish, they were quite distant – I couldn’t work out why.
And then at the end of the consultation I had to say to them “well there’s a 50% chance that whatever I prescribe you is going to be a placebo”, which sort of sort of lowered the temperature in the in the in the Consulting room because you know they came because they have chronic fatigue; they came… didn’t come because they wanted to take part in an experimental game.
So we would ring the pharmacy up and tell them our prescription. Helios Pharmacy would then send out either placebo or the real remedy according to the allocation of the patient.
The patient would come back four weeks later and if they were better, great and if they weren’t it was really, really difficult. So, had I got the wrong prescription or were they on placebo?
So after about six months of this we started working out there was a cunning way of circumventing the blinding and we worked out, well if we give them all a dose of carcinosin they’re going to have some reaction: there’s going to be a dream there’s going to be some change and if when they come back at the second appointment they haven’t changed then we know they’re on placebo. So don’t bother doing all that trying to find the right remedy; just use all your other amazing skills you have as a homeopath: the deep listening we have the deep understanding of what we know about what’s toxic in our systems, about diet and counselling.
So that’s what we did. Because we’re homeopaths. We’re trained to treat people I’m not trained to be deceiving people. That’s what I do, that’s what I did then; that’s what all my colleagues did.
So ok, so the trial ended and at the end the results came out I’m sure quite a few of us are familiar with it.
There were two groups, so there was a group… everybody in the patient… everybody in the trial received treatment… a course of treatment by a homeopath and 50% of them received a placebo remedy 50% the real remedy, the verum.
And the results… both groups got better and the group that received the real remedy improved better than the group that received the placebo but was the difference clinically significant? Not quite. How many trials do we have that? So this trial was so much realisation, so many questions came out of my experience being inside, inside a double-blind placebo randomised controlled trial. What is seen as the… you know the… summit of evidence-based medicine in terms of rigorousness, I just thought “what is this doing?” I don’t know what… I don’t know what this has shown.
This is what’s called an explanatory trial and I thought well it’s explaining nothing to me, apart from the fact that the system for designing and conducting randomised controlled trials at the moment isn’t working.
So lots of questions.
The paper states:
Patients were successfully blinded to their group allocation, and therefore we have assumed that whatever the reasons for nonresponse, they are the same for the treatment arm and the placebo arm and that the data are comparable. Therefore, intention to treat analyses was done on actual data plus imputed missing item data, but all unit missing data were excluded from analyses.
Checking of double blinding showed that prediction of treatment group was made by neither homeopaths (j =. 07, P c.60) nor patients (j = 0.11, P c.48).
The trial was of a triple-blind design but there is no mention of the deliberate attempts to circumvent the blinding in the paper. The effects on participants by the actions – inadvertent or otherwise – of Relton and her colleagues are not considered and not known.
I believe the actions of Relton, the other four homeopaths at her clinic whom she clearly implicates in this circumvention of blinding, and possibly the remaining four homeopaths if they were all known to each other and in contact with each other since they were all in the same area of Leeds/Sheffield, compromised the trial design, rendered the results unreliable and seriously undermined the integrity of the paper and its conclusions. I do not believe it matters whether or not they were in fact able to circumvent the blinding, but it does matter that Relton and others believed they had because she admits it led to different behaviour on their part resulting in contamination of the results.
I believe the actions amount to misconduct.
I note additional criticism of this paper by Prof Edzard Ernst (see attached).
I ask that Sheffield University investigate this matter and that along with Queen Mary University of London and the Editor-in-chief of the Journal of Psychosomatic Research, Jess Fiedorowicz, MD, PhD, decide what actions to take. I ask that consideration is given to retracting this unsound paper.
Please consider this email as a formal complaint against Dr Clare Relton and others.
Please acknowledge receipt by return and keep me informed of your progress in investigating this matter and of your conclusions and outcome.
If you require any further information, please do not hesitate to contact me.
The author of this study introduces the subject by stating that Reiki is a biofield energy therapy that focuses on optimizing the body’s natural healing abilities balancing the life force energy or qi/chi. Reiki has been shown to reduce stress, pain levels, help with depression/anxiety, increase relaxation, improve fatigue, and quality of life.
Despite the fact that the author seems to have no doubt about the effectiveness of Reiki, she decided single-handedly to conduct a study of it – well, not a real study but a ‘pilot study’:
In this pilot randomized, double-blinded, and placebo-controlled study, the effects of Reiki on heart rate, diastolic and systolic blood pressure, body temperature, and stress levels were explored in an effort to gain objective outcome measures and to understand the underlying physiological mechanisms of how Reiki may be having these therapeutic effects on subjective measures of stress, pain, relaxation, and depression/anxiety.
Forty-eight subjects were block-randomized into three groups (Reiki treatment, sham treatment, and no treatment). The changes in pre-and post-treatment measurements for each outcome measure were analyzed through analysis of variance (ANOVA) post hoc multiple comparison test, which found no statistically significant difference between any of the groups. The p-value for the comparison of Reiki and sham groups for heart rate was 0.053, which is very close to being significant and so, a definitive conclusion can not be made based on this pilot study alone.
The author concluded that a second study with a larger sample size is warranted to investigate this finding further and perhaps with additional outcome measures to look at other possible physiological mechanisms that may underlie the therapeutic effects of Reiki.
I have a few questions about this paper:
- If a researcher already knows that a treatment works, why do a study?
- If she nevertheless does a study, why a pilot that is not meant for evaluating effects but for testing the feasibility?
- Why does the author calculate effects instead of evaluating the feasibility of his project?
- Why does the author try to interpret a negative outcome as though it signifies an almost positive effect?
- Why did someone who knows how to do research at the Ohio Wesleyan University (the author’s affiliation) not give her some guidance?
- Why did the reviewers of this paper let it pass?
- Why does any journal publish such rubbish?
Oh, the embarrassment!
It’s a journal for which I once (a long time ago) served on the editorial board.
The objective of this review (entitled ‘Systematic Review on the Use of Homeopathy in Dentistry:
Critical Analysis of Clinical Trials‘) was to map the literature on homeopathy in dentistry and to evaluate the effectiveness of using homeopathy in dental practice through the critical analysis of clinical studies.
The search for scientific articles in any language, year, and place of publication was made in the databases of Public Medline (PUBMED), Web of Science, Cochrane, and Virtual Health Library; the articles selected were later classified according to the type of study. Gray literature was accessed through Google Scholar. Clinical trials were analyzed for methodological quality. Two trained reviewers accomplished the entire process independently.
Of the 281 studies retrieved by means of the search, 44 met the eligibility criteria. The included papers were:
- literature reviews (56.8%),
- clinical trials (34.1%),
- cross-sectional studies (6.8%),
- laboratory research (6.8%),
- longitudinal observational studies (4.5%).
The clinical trials were published from 1965 to 2019, using homeopathy in several dental specialties:
- Orofacial Pain,
- Pediatric Dentistry,
- dental anxiety.
Qualitative failures, in all criteria investigated, and positive influences of the individual prescriptions on the results of treatments reported were observed.
The authors concluded that there is still a scarcity of studies about homeopathy and dentistry. The clinical trials selected showed positive effects on oral health; however, when they were critically evaluated, it was possible to recognize qualitative failures, mainly relative to double-blinding. It is necessary to encourage research on the subject, using standardized methodological procedures, to obtain better evaluation of the clinical applicability.
According to the authors, their review adhered to the PRISMA guideline of systematic reviews. This is, however, not the case. The authors correctly point out that the primary studies had many flaws: methodological failures were observed in the clinical trials, mainly related to double-blinding (66.7%). Significant failures were also observed in similarity (61.1%), randomization (27.8%), description of losses and exclusions (27.8%), and exclusion criteria (27.8%). They do not seem to realize that flaws of this nature and frequency should prevent positive conclusions.
So, what does this paper actually demonstrate? In my view, it shows that:
- the peer-review process at the JACM continues to be a joke;
- poor quality trials run by enthusiasts tend to produce false-positive results;
- in so-called alternative medicine (SCAM), people get away with publishing even the most obvious falsehoods.
Tuina is a massage therapy that originates from Traditional Chinese Medicine. Many of the techniques used in tuina resemble those of a western massage like gliding, kneading, vibration, tapping, friction, pulling, rolling, pressing, and shaking. Tuina involves a range of manipulations usually performed by the therapist’s finger, hand, elbow, knee, or foot. They are applied to muscle or soft tissue at specific locations of the body.
The aim of Tuina is to enhance the flow of the ‘vital energy’ or ‘chi’, that is alleged to control our health. Proponents of the therapy recommend Tuina for a range of conditions, including paediatric ones. Paediatric Tuina has been widely used in children with acute diarrhea in China. However, due to a lack of high-quality clinical evidence, the benefit of Tuina is not clear.
This study aimed to assess the effect of paediatric Tuina compared with sham Tuina as add-on therapy in addition to usual care for 0-6-year-old children with acute diarrhea.
Eighty-six participants aged 0-6 years with acute diarrhea were randomized to receive Tuina plus usual care (n = 43) or sham Tuina plus usual care (n = 43). The primary outcomes were days of diarrhea from baseline and times of diarrhea on day 3. Secondary outcomes included a global change rating (GCR) and the number of days when the stool characteristics returned to normal. Adverse events were assessed.
Tuina treatment in the intervention group was performed on the surface of the children’s body using moderate pressure (Fig. 1a). Tuina treatment in the control group was different: the therapist used one hand to hold the child’s hand or put one hand on the child’s body, while the other hand performed manipulations on the therapist’s own hand instead of the child’s hand or body (Fig. (Fig.11b).
Tuina was associated with a reduction in times of diarrhea on day 3 compared with sham Tuina in both ITT and per-protocol analyses. However, the results were not significant when adjusted for social-demographic and clinical characteristics. No significant difference was found between groups in days of diarrhea, global change rating, or number of days when the stool characteristics returned to normal.
The authors concluded that in children aged 0-6 years with acute diarrhea, pediatric Tuina showed significant effects in terms of reducing times of diarrhea compared with sham Tuina. Studies with larger sample sizes and adjusted trial designs are warranted to further evaluate the effect of pediatric Tuina therapy.
This study was well-reported and has interesting features, such as the attempt to use a placebo control and blinding (whether blinding was successful is a different matter and was not tested in the trial). It is, therefore, all the more surprising that the essentially negative result is turned into a positive one. After adjustment, the differences disappear (a fact which the authors hardly mention in the paper), which means they are not due to the treatment but to group differences and confounding. This, in turn, means that the study shows not the effectiveness but the ineffectiveness of Tuina.
As though the UK does not have plenty of organisations promoting so-called alternative medicine (SCAM)! Obviously not – because a new one is about to emerge.
In mid-January, THE COLLEGE OF MEDICINE AND INTEGRATED HEALTH (COMIH) will launch the Integrated Medicine Alliance bringing together the leaders of many complementary health organisations to provide patients, clinicians and policy makers with information on the various complementary modalities, which will be needed in a post COVID-19 world, where:
- patient choice is better respected,
- requirements for evidence of efficacy are more proportionate to the seriousness of the disease and the safety of the intervention,
- and where benefit versus risk are better balanced.
We already saw this in 2020 with the College advocating from the very beginning of the year that people should think about taking Vitamin D, while the National Institute for Clinical Excellence continued to say the evidence was insufficient, but the Secretary of State has now supported it being given to the vulnerable on the basis of the balance between cost, benefit and safety.
Elsewhere we learn more about the Integrated Medicine Alliance (IMA):
The IMA is a group of organisations and individuals that have been brought together for the purpose of encouraging and optimising the best use of complementary therapies alongside conventional healthcare for the benefit of all.
The idea for this group was conceived by Dr Michael Dixon in discussion with colleagues associated with the College of Medicine, and the initial meeting to convene the group was held in February 2019.
The group transitioned through a number of titles before settling on the ‘Integrated Medicine Alliance’ and began work on developing a patient leaflet and a series of information sheets on the key complementary therapies.
It was agreed that in the first instance the IMA should exist under the wing of the College of Medicine, but that in the future it may develop into a formal organisation in its own right, but inevitably maintaining a close relationship with the College of Medicine.
The IMA also offers ‘INFORMATION SHEETS’ on the following modalities:
- Alexander Technique
- Herbal Medicine
- Tai Chi
- Yoga Therapy
I find those leaflets revealing. They tell us, for example that the Reiki practitioner channels universal energy through their hands to help rebalance each of the body’s energy centres, known as chakras. About homeopathy, we learn that a large corpus of evidence has accumulated which stands the most robust tests of modern science. And about naturopathy, we learn that it includes ozone therapy but is perfectly safe.
Just for the fun of it – and free of charge – let me try to place a few corrections here:
- Reiki healers use their hands to perform what is little more than a party trick.
- The universal energy they claim to direct does not exist.
- The body does not have energy centres.
- Chakras are a figment of imagination.
- The corpus of evidence on homeopathy is by no means large.
- The evidence is flimsy.
- The most robust tests of modern science fail to show that homeopathy is effective beyond placebo.
- Naturopathy is a hotchpotch of treatments most of which are neither natural nor perfectly safe.
One does wonder who writes such drivel for the COMIH, and one shudders to think what else the IMA might be up to.
This is an analysis that I have long hesitated to conduct. The reason for my hesitation is simple: some people might think it is vindictive, revengeful or ad hominem. After reflecting about it for years, I have now decided to go ahead with it (sorry, it’s a bit lengthy). This case study is not meant to be vindictive, but offers an important insight into the power of conflicts of interest in SCAM that are not financial but ideological. I think it is crucial that people are aware of and consider such conflicts carefully, and I can’t see how else I might demonstrate my point so plainly.
Dr Adrian White was a co-worker of mine for about 10 years. He became a trusted colleague, my ‘right hand’ man and even my deputy at my Exeter department. When I discovered that my trust had been misplaced, I did not prolong his contract (I will not dwell on this episode, those who are interested find it in my memoir). Adrian then got a senior research fellowship with Prof John Campbell (not my favourite colleague at Exeter) at the department of general practice where he continued his research on acupuncture for about 10 more years largely unsupervised.
Adrian had been an acupuncturist body and soul (in fact, I had never before met anyone so utterly convinced of the value of this therapy). When he joined my team, he was scientifically naive, and we spent many month trying to teach him how to think like a scientist. Initially, he found it very difficult to think critically about acupuncture. Later, I thought the problem was under control. Yet, most of his research in my department was guided by me and tightly supervised (i.e. I made sure that out studies were testing rather than promoting SCAM, and that our reviews were critical assessments of the existing evidence).
Thus there exist two separate and well-documented periods of a pro-acupuncture researcher:
- 10 years guided by me and members of my team;
- 10 years largely unsupervised.
What could be more tempting than to compare Adrian’s output during these two periods?
To do this, I looked up all of Adrian’s 120 publications on acupuncture and selected those 52 articles that generated factual new data (mostly clinical trials or systematic reviews). As it happens, they are numerically distributed almost equally within the two periods. The endpoints for my analysis were the directions of the conclusions of his papers. I therefore extracted, dated, and rated the 52 articles as follows:
- P = positive from the point of view of an acupuncture advocate,
- N = negative from the point of view of an acupuncture advocate.
- P/N = not clearly pointing in either direction.
To render this exercise transparent (occasionally, I was not entirely sure about my ratings), I copied all the 52 conclusions and provided links to the original papers so that anyone inferested is able to check easily.
Here are my findings. Articles 1 – 27 were published AFTER Adrian had left my department; articles 28 – 52 are his papers from the time while he worked with me.
- A definitive three-arm trial is feasible. Further follow-up reminders, minimum data collection and incentives should be considered to improve participant retention in the follow-up processes in the standardised advice and exercise booklet arm. (2016) P/N
- The available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long-term studies, more than one year in duration, are lacking. (2016) P
- The available results suggest that acupuncture is effective for treating frequent episodic or chronic tension-type headaches, but further trials – particularly comparing acupuncture with other treatment options – are needed. (2016) P
- Acupuncture during pregnancy appears to be associated with few AEs when correctly applied. (2014) P
- Although pooled estimates suggest possible short-term effects there is no consistent, bias-free evidence that acupuncture, acupressure, or laser therapy have a sustained benefit on smoking cessation for six months or more. However, lack of evidence and methodological problems mean that no firm conclusions can be drawn. Electrostimulation is not effective for smoking cessation. Well-designed research into acupuncture, acupressure and laser stimulation is justified since these are popular interventions and safe when correctly applied, though these interventions alone are likely to be less effective than evidence-based interventions. (2014) P
- The current evidence suggests that acupuncture may have some effects on drug dependence that have been missed because of choice of outcome in many previous studies, and future studies should use outcomes suggested by clinical experience. Body points and electroacupuncture, used in the original clinical observation, justify further research. (2013) P
- Acceptability is very high and may be maximised by taking a number of factors into account: full information should be provided before treatment begins; flexibility should be maintained in the appointment system and different levels of contact between fellow patients should be fostered; sufficient space and staffing should be provided and single-sex groups used wherever possible. (2012) P
- This is the first evaluation of nurse-led group (multibed) acupuncture clinics for patients with knee osteoarthritis to include a 2 year follow-up. It shows the practicability of offering a low-cost acupuncture service as an alternative to knee surgery and the service’s success in providing long-term symptom relief in about a third of patients. Using realistic assumptions, the cost consequences for the local commissioning group are an estimated saving of £100 000 a year. Sensitivity analyses are presented using different assumptions. (2012) P
- There is no consistent, bias-free evidence that acupuncture, acupressure, laser therapy or electrostimulation are effective for smoking cessation, but lack of evidence and methodological problems mean that no firm conclusions can be drawn. Further, well designed research into acupuncture, acupressure and laser stimulation is justified since these are popular interventions and safe when correctly applied, though these interventions alone are likely to be less effective than evidence-based interventions. (2011) P/N
- Eight (8) of 10 international acupuncture experts were able to reach consensus on the syndromes, symptoms, and treatment of postmenopausal women with hot flashes. The syndromes were similar to those used by practitioners in the ACUFLASH clinical trial, but there were considerable differences between the acupuncture points. This difference is likely to be the result of differences in approach of training schools, and whether it is relevant for clinical outcomes is not well understood. (2011) P
- 70% of those patients eligible to participate volunteered to do so; all participants had clinically identified MTrPs; a 100% completion rate was achieved for recorded self-assessment data; no serious adverse events were reported as a result of either intervention; and the end of treatment attrition rate was 17%. A phase III study is both feasible and clinically relevant. This study is currently being planned. (2010) P
- In conclusion, the results from all studies are in agreement with the hypothesis that acupuncture needling relieves hot flushes. There are few data however supporting the hypothesis that the effect of acupuncture is point specific. Future research should investigate whether there is a biological effect of needling on hot flushes or not, whether tailored treatment is superior to standardised treatment, and ways of delivering treatment that causes least discomfort and least cost. (2010) P
- Acupuncture can contribute to a more rapid reduction in vasomotor symptoms and increase in health-related quality of life in postmenopausal women but probably has no long-term effects. (2010) P
- within the context of this pilot study, the sham acupuncture intervention was found to be a credible control for acupuncture. This supports its use in a planned, definitive, randomised controlled trial on a similar whiplash injured population. (2009) N/P
- factors other than the TCM syndrome diagnoses and the point selection may be of importance regarding the outcome of the treatment. (2009) N/P
- Acupuncture plus self-care can contribute to a clinically relevant reduction in hot flashes and increased health-related quality of life in postmenopausal women. (2009) P
- the authors conclude that acupuncture could be a valuable non-pharmacological tool in patients with frequent episodic or chronic tension-type headaches. (2009) P
- there is consistent evidence that acupuncture provides additional benefit to treatment of acute migraine attacks only or to routine care. There is no evidence for an effect of ‘true’ acupuncture over sham interventions, though this is difficult to interpret, as exact point location could be of limited importance. Available studies suggest that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment, and has fewer adverse effects. Acupuncture should be considered a treatment option for patients willing to undergo this treatment. (2009) P
- We have conducted the first survey of the effects of provision of acupuncture in UK general practice, using data provided by the NHS, and uncovered a wide variation in the availability of the service in different areas. We have been unable to demonstrate any consistent differences in the prescribing or referral rates that could be due to the use of acupuncture in these practices. The wide variation in the data means that if such a trend exists, a very large survey would be needed to identify it. However, we discovered inaccuracies and variations in presentation of data by the PCTs which have made the numerical input, and hence our results, unreliable. Thus the practicalities of access to data and the problems with data accuracy would preclude a nationwide survey. (2008) P
- In conclusion, there is limited evidence deriving from one study that deep needling directly into myofascial trigger points has an overall treatment effect when compared with standardised care. Whilst the result of the meta-analysis of needling compared with placebo controls does not attain statistically significant, the overall direction could be compatible with a treatment effect of dry needling on myofascial trigger point pain. However, the limited sample size and poor quality of these studies highlights and supports the need for large scale, good quality placebo controlled trials in this area. (2009) P
- We conclude that limited evidence supports acupuncture use in treating pregnancy-related pelvic and back pain. Additional high-quality trials are needed to test the existing promising evidence for this relatively safe and popular complementary therapy. (2008) P
- Acupuncture appears to offer symptomatic improvement to some patients with fibromyalgia in a tertiary clinic who have failed to respond to other treatments. In view of its safety, further acupuncture research is justified in this population. (2007) P
- It is speculated that optimal results from acupuncture treatment for osteoarthritis of the knee may involve: climatic factors, particularly high temperature; high expectations of patients; minimum of four needles; electroacupuncture rather than manual acupuncture, and particularly, strong electrical stimulation to needles placed in muscle; and a course of at least 10 treatments. These factors offer some support to criteria for adequate acupuncture used in the recent review. In addition, ethnic and cultural factors may influence patients’ reporting of their symptoms, and different versions of an outcome measure are likely to differ in their sensitivity – both factors which may lead to apparent rather than real differences between studies. The many variables in a study are likely to be more tightly controlled in a single centre study than in multicentre studies. (2007) P
- Any effects of acupressure on smoking withdrawal, as an adjunct to the use of NRT and behavioural intervention, are unlikely to be detectable by the methods used here and further preliminary studies are required before the hypothesis can be tested. (2007) P
- Auricular acupuncture appears to be effective for smoking cessation, but the effect may not depend on point location. This calls into question the somatotopic model underlying auricular acupuncture and suggests a need to re-evaluate sham controlled studies which have used ‘incorrect’ points. Further experiments are necessary to confirm or refute these observational conclusions. (2006) P
- Acupuncture that meets criteria for adequate treatment is significantly superior to sham acupuncture and to no additional intervention in improving pain and function in patients with chronic knee pain. Due to the heterogeneity in the results, however, further research is required to confirm these findings and provide more information on long-term effects. (2007) P
- There is no consistent evidence that acupuncture, acupressure, laser therapy or electrostimulation are effective for smoking cessation, but methodological problems mean that no firm conclusions can be drawn. Further research using frequent or continuous stimulation is justified. (2006) N/P
- Acupuncture is not superior to sham treatment for recovery in activities of daily living and health-related quality of life after stroke, although there may be a limited effect on leg function in more severely affected patients. (2005) N
- The evidence from controlled trials is insufficient to conclude whether acupuncture is an effective treatment for depression, but justifies further trials of electroacupuncture. (2005) N
- Acupuncture effectively relieves chronic low back pain. No evidence suggests that acupuncture is more effective than other active therapies. (2005) N/P
- In view of the small number of studies and their variable quality, doubt remains about the effectiveness of acupuncture for gynaecological conditions. Acupuncture and acupressure appear promising for dysmenorrhoea, and acupuncture for infertility, and further studies are justified. (2003) N
- In conclusion, the results suggest that the procedure using the new device is indistinguishable from the same procedure using real needles in acupuncture naïve subjects, and is inactive, where the specific needle sensation (de qi) is taken as a surrogate measure of activity. It is therefore a valid control for acupuncture trials. The findings also lend support to the existence of de qi, a major concept underlying traditional Chinese acupuncture. (2002) N/P
- There is no clear evidence that acupuncture, acupressure, laser therapy or electrostimulation are effective for smoking cessation. (2002) N
- Collectively, these data imply that acupuncture is superior to various control interventions, although there is insufficient evidence to state whether it is superior to placebo. (2002) N/P
- In conclusion, the incidence of adverse events following acupuncture performed by doctors and physiotherapists can be classified as minimal; some avoidable events do occur. Acupuncture seems, in skilled hands, one of the safer forms of medical intervention. (2001) N/P
- Based on the evidence of rigorous randomised controlled trials, there is no compelling evidence to show that acupuncture is effective in stroke rehabilitation. Further, better-designed studies are warranted. (2001) N
- Although it has already been demonstrated that severe adverse events seem to be uncommon in standard practice, many serious cases of negligence have been found in the present review, suggesting that training system for acupuncturists (including medical doctors) should be improved and that unsupervised self-treatment should be discouraged. (2001) N
- Direct needling of myofascial trigger points appears to be an effective treatment, but the hypothesis that needling therapies have efficacy beyond placebo is neither supported nor refuted by the evidence from clinical trials. Any effect of these therapies is likely because of the needle or placebo rather than the injection of either saline or active drug. Controlled trials are needed to investigate whether needling has an effect beyond placebo on myofascial trigger point pain. (2001) N/P
- Although the incidence of minor adverse events associated with acupuncture may be considerable, serious adverse events are rare. Those responsible for establishing competence in acupuncture should consider how to reduce these risks. (2001) N
- In conclusion, this study does not provide evidence that this form of acupuncture is effective in the prevention of episodic tension-type headache. (2000) N
- The present study provides no strong evidence to support the hypothesis that the acupuncture point SP6 is more tender in women and in men. Recommendations for further investigations are discussed. (2000) N
- Acupuncture has not been demonstrated to be efficacious as a treatment for tinnitus on the evidence of rigorous randomized controlled trials. (2000) N
- We conclude that acupuncture continues to be associated with occasional, serious adverse events and fatalities. These events have no geographical limits. Most of these events are due to negligence. Everyone concerned with setting standards, delivering training, and maintaining competence in acupuncture should familiarise themselves with the lessons to be learnt from these untoward events. (2000) N
- Overall, the existing evidence suggests that acupuncture has a role in the treatment of recurrent headaches. However, the quality and amount of evidence is not fully convincing. There is urgent need for well-planned, large-scale studies to assess effectiveness and efficiency of acupuncture under real life conditions. (1999) N/P
- While the frequency of adverse effects of acupuncture is unknown and they may be rare, knowledge of normal anatomy and anatomical variations is essential for safe practice and should be reviewed by regulatory bodies and those responsible for training courses. (1999) N
- In conclusion, the hypothesis that acupuncture is efficacious in the treatment of neck pain is not based on the available evidence from sound clinical trials. Further studies are justified. (1999) N
- Even though all studies are in accordance with the notion that acupuncture is effective for temporomandibular joint dysfunction, this hypothesis requires confirmation through more rigorous investigations. (1999) N
- Acupuncture is not free of risks. All adverse events reported in 1997 would have been avoidable. The absolute number of cases is small, but the degree of underreporting remains unknown. (1999) N
- This form of electroacupuncture is no more effective than placebo in reducing nicotine withdrawal symptoms. (1998) N
- Acupuncture was shown to be superior to various control interventions, although there is insufficient evidence to state whether it is superior to placebo. (1998) N/P
- Considerable variation was observed in the scores awarded by the acupuncture experts. (1998) N
- It is therefore concluded that, according to the data published to date, the evidence that acupuncture is a useful adjunct for stroke rehabilitation is encouraging but not compelling. More and better trials are required to clarify this highly relevant issue. (1996) N
The results are remarkable (particularly considering that one would not expect unbiased studies or reviews of acupuncture to generate plenty of positive conclusions):
0 times N, 5 times N/P, 22 times P – after Adrian had left my department,
17 times N, 7 times N/P, 0 times P – while Adrian worked in my department.
From these figures, it is tempting to calculate the ratios for both periods of negative : positive conclusions:
zero versus infinite
If that is not impressive, I don’t know what is!
Looking just at the positive and the negative papers over the years:
One could discuss these papers in more detail, but I think this is hardly necessary. Just a few highlights perhaps: look at articles No 5, 20 and 27 for examples of turning an essentially negative finding into a positive conclusion. Notice that Adrian conducted a clinical trial of acupuncture for smoking cessation (No 49) while working with me and later published uncritical positive reviews on the subject. Does this not indicate that he distrusted his own study because it had not generated the result he had hoped for?
Of course, my analysis is merely a case study and therefore my findings are not generalisable. However, in my personal experience, the described phenomenon is by no means an exception in SCAM research. I have observed similar phenomena over and over again. Just look at the ALTERNATIVE MEDICINE HALL OF FAME that I created for this blog:
- John Weeks (editor of JCAM)
- Deepak Chopra (US entrepreneur)
- Cheryl Hawk (US chiropractor)
- David Peters (osteopathy, homeopathy, UK)
- Nicola Robinson (TCM, UK)
- 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)
But Adrian’s case might be unique because it allows us to make a longitudinal observation over two decades. And it suggests to me that an ideological bias can (and often is) so strong and indistructable that is re-emerges as soon as it is no longer kept under strict control.
I have long suspected that ideological conflicts of interest have a much more powerful influence in SCAM research than financial ones. Such an overpowering influence might even be characteristic to much of SCAM research. And because it can be so dominant, it seems important to know about. People reading research need to be aware that it originates from a biased source, and funders who finance research would be wise to think twice about supporting researchers who are likely to generate findings that are biased and therefore false-positive. In the final analysis, such research is worse than no research at all.
We are all prone to fall victim to the ‘post hoc ergo propter hoc’ fallacy. It describes the erroneous assumption that something that happened after an event was cased by that event. The fallacy is essentially due to confusing correlation with causation:
- the sun does not rise because the rooster has crowed;
- yellow colouring of the 2nd and 3rd finger of a smoker is not the cause of lung cancer;
- some children developing autism after vaccinations does not mean that autism is caused by vaccination.
As I said, we are all prone to this sort of thing, even though we know better. Scientists, journal editors and reviewers of medical papers, however, should not allow themselves to be fooled by overt cases of the ‘post hoc ergo propter hoc’ fallacy. And if they do, they have lost all credibility – just like the individuals involved in a recent paper on animal homeopathy.
Pododermatitis in penguins usually occurs after changes in normal activity that result from being held captive. It is also called ‘bumlefoot’ (which fails to reflect the seriousness of the condition) and amounts to one of most frequent and important clinical complications in penguins kept in captivity or in rehabilitation centres.
This veterinary case study reports the use of oral homeopathic treatment on acute and chronic pododermatitis in five Magellanic penguins in a zoological park setting. During treatment, the patients remained in the penguins’ living area, and the effect of the treatment on the progression of their lesions was assessed visually once weekly. The treatment consisted of a combination of Arnica montana and Calcarea carbonica.
After treatment, the appearance of the lesions had noticeably improved: in the majority of penguins there was no longer evidence of infection or edema in the feet. The rate of recovery depended on the initial severity of the lesion. Those penguins that still showed signs of infection nevertheless exhibited a clear diminution of the size and thickness of the lesions. Homeopathic treatment did not cause any side effects.
The authors concluded that homeopathy offers a useful treatment option for pododermatitis in captive penguins, with easy administration and without side effects.
So, the homeopathic treatment happened before the recovery and, according to the ‘post hoc ergo propter hoc’ fallacy, the recovery must have been caused by the therapy!
I know, this is a tempting conclusion for a lay person, but it is also an unjustified one, and the people responsible for this paper are not lay people. Pododermitis does often disappear by itself, particularly if the hygenic conditions under which the penguins had been kept are improved. In any case, it is a potentially life-threatening condition (a bit like an infected bed sore in an immobilised human patient) that can be treated, and one should certainly not let a homeopath deal with it.
I think that the researchers who wrote the article, the journal editor who accepted it for publication, and the referees who reviewed the paper should all bow their heads in shame and go on a basic science course (perhaps a course in medical ethics as well) before they are let anywhere near research again.