bias
There are plenty of people who find it hard to accept that highly diluted homeopathic remedies are placebos. They religiously believe in the notion that homeopathy works and studiously ignore the overwhelming evidence (plus a few laws of nature). Yet, they pretend to staunchly believe in science and keep on conducting (pseudo?) scientific studies of homeopathy. To me, this seems oddly schizophrenic because, on the one hand, they seem to accept science by conducting trials, while, on the other hand, they reject science by negating the scientific consensus.
The objective of this recent study was to evaluate the quality of life (QoL) of women treated with homeopathy within the Public Health System of Belo Horizonte, Brazil.
The study was designed as a prospective randomized controlled pragmatic trial. The patients were divided into two independent groups, one group underwent homeopathic treatment during a 6-month period, while the other did not receive any homeopathic treatment. In both randomized groups, patients maintained their conventional medical treatment as necessary. The World Health Organization Quality of Life abbreviated questionnaire (WHOQOL-BREF) was used for QoL analysis prior to treatment and 6 months later.
Randomization was successful in that it resulted in similar baseline results in three domains of QoL analysis for both groups. After 6 months’ treatment, the investigators noted a statistically significant difference between groups in the physical domain of WHOQOL-BREF: the average score improved to 63.6 ± (SD) 15.8 in the homeopathy group, compared with 53.1 ± (SD) 16.7 in the control group.
The authors concluded that homeopathic treatment showed a positive impact at 6 months on the QoL of women with chronic diseases. Further studies should be performed to determine the long-term effects of homeopathic treatment on QoL and its determinant factors.
I would not be surprised if the world of homeopathy were to celebrate this trial as yet another proof that homeopathy is effective. I am afraid, however, that I might have to put a damper on their excitement:
THIS STUDY DOES NOT SHOW WHAT YOU THINK IT DOES.
Why not?
Regular readers of this blog will have already guessed it: the trail follows the infamous ‘A+B versus B’ design. Some people will think that I am obsessed with this theme – but I am not; it’s just that, in SCAM, it comes up with such depressing regularity. And as this blog is mainly about commenting on newly published research, I am unable to avoid the subject.
So, let me explain it again.
Think of it in monetary terms: you have an amount X, your friend has the same amount X plus an extra sum Y. Who do you think has more money? You don’t need to be a genius to guess, do you?
The same happens in the above ‘A+B versus B’ trial:
- the patients in group 1 received homeopathy (A) plus usual care (B);
- the patients in group 2 received usual care (B) and nothing else.
You don’t need to be a genius to guess who might have the better outcomes.
Because of homeopathy?
No! Because of the patients’ expectation, the placebo effect, and the extra attention of the homeopaths. They call this trial design ‘pragmatic’. I feel it is an attempt to mislead the public.
So, allow me to re-write the authors’ conclusion as follows:
The effect of a homeopathic consultation and the administration of a placebo generated a positive impact at 6 months on the QoL of women with chronic diseases. This was entirely predictable and totally unrelated to homeopathy. Further studies to determine the long-term effects of homeopathic treatment on QoL and its determinant factors are not needed.
This study was aimed at determining the effectiveness of electroacupuncture or auricular acupuncture for chronic musculoskeletal pain in cancer survivors.
The Personalized Electroacupuncture vs Auricular Acupuncture Comparativeness Effectiveness (PEACE) trial is a randomized clinical trial that was conducted from March 2017 to October 2019 (follow-up completed April 2020) across an urban academic cancer center and 5 suburban sites in New York and New Jersey. Study statisticians were blinded to treatment assignments. The 360 adults included in the study had a prior cancer diagnosis but no current evidence of disease, reported musculoskeletal pain for at least 3 months, and self-reported pain intensity on the Brief Pain Inventory (BPI) ranging from 0 (no pain) to 10 (worst pain imaginable).
Patients were randomized 2:2:1 to:
- electroacupuncture (n = 145),
- auricular acupuncture (n = 143),
- or usual care (n = 72).
Intervention groups received 10 weekly sessions of electroacupuncture or auricular acupuncture. Ten acupuncture sessions were offered to the usual care group from weeks 12 through 24.
The primary outcome was a change in the average pain severity score on the BPI from baseline to week 12. Using a gatekeeping multiple-comparison procedure, electroacupuncture and auricular acupuncture were compared with usual care using a linear mixed model. Noninferiority of auricular acupuncture to electroacupuncture was tested if both interventions were superior to usual care.
Among 360 cancer survivors (mean [SD] age, 62.1 [12.7] years; mean [SD] baseline BPI score, 5.2 [1.7] points; 251 [69.7%] women; and 88 [24.4%] non-White), 340 (94.4%) completed the primary end point. Compared with usual care, electroacupuncture reduced pain severity by 1.9 points (97.5% CI, 1.4-2.4 points; P < .001) and auricular acupuncture reduced by 1.6 points (97.5% CI, 1.0-2.1 points; P < .001) from baseline to week 12. Noninferiority of auricular acupuncture to electroacupuncture was not demonstrated. Adverse events were mild; 15 of 143 (10.5%) patients receiving auricular acupuncture and 1 of 145 (0.7%) patients receiving electroacupuncture discontinued treatments due to adverse events (P < .001).
The authors of this study concluded that, in this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture and auricular acupuncture produced greater pain reduction than usual care. However, auricular acupuncture did not demonstrate noninferiority to electroacupuncture, and patients receiving it had more adverse events.
I think the authors made a mistake in formulating their conclusions. Perhaps they allow me to correct it:
In this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture plus usual care and auricular acupuncture plus usual care produced greater pain reduction than usual care alone.
I know, I must sound like a broken record, but – because it followed the often-discussed ‘A+B versus B’ design – this study does simply not show what the authors conclude. In fact, it tells us very little about any effects caused by the two acupuncture versions per se. The study does not control for placebo effects and therefore its results are consistent with acupuncture itself having no effect at all.
Here is an attempt at explaining the ‘A+B versus B’ study design I posted previously:
As regularly mentioned on this blog, there are several ways to design a study such that the risk of producing a negative result is minimal. The most popular one in SCAM research is the ‘A+B versus B’ design…
Imagine you have an amount of money A and your friend owns the same sum plus another amount B. Who has more money? Simple, it is, of course your friend: A+B will always be more than A [unless B is a negative amount]. For the same reason, such “pragmatic” trials will always generate positive results [unless the treatment in question does actual harm]. Treatment as usual plus acupuncture is more than treatment as usual alone, and the former is therefore more than likely to produce a better result. This will be true, even if acupuncture is a pure placebo – after all, a placebo is more than nothing, and the placebo effect will impact on the outcome, particularly if we are dealing with a highly subjective symptom such as fatigue.
Imagine the two interventions had been a verbal encouragement or pat on the shoulder or a pat on the right shoulder for group 1 and one on the left for group 2. The findings could well have been very similar. To provide evidence that acupuncture PRODUCES PAIN REDUCTION, we need proper tests of the hypothesis. And to ‘determine the effectiveness of electroacupuncture or auricular acupuncture for chronic musculoskeletal pain in cancer survivors’, we need a different methodology.
This is, of course, all very elementary. Nothing elaborate or complicated! Scientists know it; editors know it; reviewers know it. Or at least they should know it. Therefore, I am at a loss trying to understand why even journals of high standing publish IMPROPER tests, better known as pseudo-science.
It is hard not to conclude that they deliberately try to mislead us.
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:
When is lack of scientific integrity a reason for retracting a paper? A case study
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 [4]. 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.
Ethical misconduct
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]
Sanctions
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.
Acknowledgements
My thanks to Jess G. Fiedorowicz, Editor, Journal of Psychosomatic, for his thorough investigation of my complaint.
My complaint
Hi
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
doi:10.1016/S0022-3999(03)
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.
At about five minutes in, she begins to discuss the above trial, having just said she was a non-medical homeopath at the Wellforce Clinic in Sheffield. She is currently listed as Chair of Directors.
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):
Timestamp 05:12
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.
Timestamp 09:02
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.
and:
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.
Best regards.
Alan Henness
The use of homeopathy in oncological supportive care seems to be progressing. The first French prevalence study, performed in 2005 in Strasbourg, showed that only 17% of the subjects were using it. This descriptive study, using a questionnaire identical to that used in 2005, investigated whether the situation has changed since then.
A total of 633 patients undergoing treatment in three anti-cancer centers in Strasbourg were included. The results of the “homeopathy” sub-group were extracted and studied.
Of the 535 patients included, 164 (30.7%) used homeopathy. The main purpose of its use was to reduce the side effects of cancer treatments (75%). Among the users,
- 82.6% were “somewhat” or “very” satisfied,
- 15.5% were “quite” satisfied,
- 1.9% were “not at all” satisfied.
The homeopathic treatment was prescribed by a doctor in 75.6% of the cases; the general practitioner was kept informed in 87% of the cases and the oncologist in 82%. Fatigue, pain, nausea, anxiety, sadness, and diarrhea were improved in 80% of the cases. Hair-loss, weight disorders, and loss of libido were the least improved symptoms. The use of homeopathy was significantly associated with the female sex.
The authors concluded that with a prevalence of 30.7%, homeopathy is the most used complementary medicine in integrative oncology in Strasbourg. Over 12 years, we have witnessed an increase of 83% in its use in the same city. Almost all respondents declare themselves satisfied and tell their doctors more readily than in 2005.
There is one (possibly only one) absolutely brilliant statement in this abstract:
The use of homeopathy was significantly associated with the female sex.
Why do I find this adorable?
Because to claim that any of the observed outcomes of this study are causally related to homeopathy seems like claiming that homeopathy turns male patients into women.
PS
In case you do not understand my clumsy attempt at humor and satire, rest assured: I do not truly believe that homeopathy turns men into women, and neither do I believe that it improves fatigue, pain, nausea, anxiety, sadness, and diarrhea. Remember: correlation is not causation.
Research into both receptivity to falling for bullshit and the propensity to produce it have recently emerged as active, independent areas of inquiry into the spread of misleading information. However, it remains unclear whether those who frequently produce bullshit are inoculated from its influence. For example, both bullshit receptivity and bullshitting frequency are negatively related to cognitive ability and aspects of analytic thinking style, suggesting that those who frequently engage in bullshitting may be more likely to fall for bullshit. However, separate research suggests that individuals who frequently engage in deception are better at detecting it, thus leading to the possibility that frequent bullshitters may be less likely to fall for bullshit.
Canadian psychologists conducted three studies (N = 826) attempting to distinguish between these competing hypotheses, finding that frequency of persuasive bullshitting (i.e., bullshitting intended to impress or persuade others) positively predicts susceptibility to various types of misleading information and that this association is robust to individual differences in cognitive ability and analytic cognitive style.
This seems to make sense – at least in the contest of so-called alternative medicine (SCAM). Those promoting bullshit are the ones that fall for bullshit.
Think of Prince Charles, for instance. In his book HARMONY and on many other occasions he insists on promoting homeopathy and other SCAM, like for example iridology, osteopathy or detox. He even advocates homeopathy for animals and he proudly tells us that, on his farms, he has instructed the personnel to give his cows homeopathy. Thus he is a good example of someone who is frequently bullshitting with the intend to impress or persuade others while, at the same time, being highly susceptible to various other types of misleading information, such as iridology.
Charles is a good example because we all know about the alternative bee under the royal bonnet. But he is certainly not alone, quite to the contrary. If you look around you, I am sure you will find that there are no end of bullshitters who fall for bullshit. Before bullshit became a term used even in scientific journals, they used to say ‘one can never kid a kidder’, but the new research by the Canadian psychologists seems to suggest that the assumption is not entirely correct.
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.
This study compared the effectiveness of two osteopathic manipulative techniques on clinical low back symptoms and trunk neuromuscular postural control in male workers with chronic low back pain (CLBP).
Ten male workers with CLBP were randomly allocated to two groups: high-velocity low-amplitude (HVLA) manipulation or muscle energy techniques (MET). Each group received one therapy per week for both techniques during 7 weeks of treatment.
Pain and function were measured by using the Numeric Pain-Rating Scale, the McGill Pain Questionnaire, and the Roland Morris Disability Questionnaire. The lumbar flexibility was assessed by Modified Schober Test. Electromyography (EMG) and force platform measurements were used for evaluation of trunk muscular activation and postural balance, respectively at three different times: baseline, post-intervention, and 15 days later.
Both techniques were effective (p < 0.01) in reducing pain with large clinical differences (-1.8 to -2.8) across immediate and after 15 days. However, no significant effect between groups and times was found for other variables, namely neuromuscular activation, and postural balance measures.
The authors concluded that both techniques (HVLA thrust manipulation and MET) were effective in reducing back pain immediately and 15 days later. Neither technique changed the trunk neuromuscular activation patterns nor postural balance in male workers with LBP.
There is, of course, another conclusion that fits the data just as well: both techniques were equally ineffective.
This recent article is truly remarkable:
There is a faction within the chiropractic profession passionately advocating against the routine use of X-rays in the diagnosis, treatment and management of patients with spinal disorders (aka subluxation). These activists reiterate common false statements such as “there is no evidence” for biomechanical spine assessment by X-ray, “there are no guidelines” supporting routine imaging, and also promulgate the reiterating narrative that “X-rays are dangerous.” These arguments come in the form of recycled allopathic “red flag only” medical guidelines for spine care, opinion pieces and consensus statements. Herein, we review these common arguments and present compelling data refuting such claims. It quickly becomes evident that these statements are false. They are based on cherry-picked medical references and, most importantly, expansive evidence against this narrative continues to be ignored. Factually, there is considerable evidential support for routine use of radiological imaging in chiropractic and manual therapies for 3 main purposes: 1. To assess spinopelvic biomechanical parameters; 2. To screen for relative and absolute contraindications; 3. To reassess a patient’s progress from some forms of spine altering treatments. Finally, and most importantly, we summarize why the long-held notion of carcinogenicity from X-rays is not a valid argument.
Not only is low dose radiation not detrimental, but it also protects us from cancer, according to the authors:
Exposures to low-dose radiation incites multiple and multi-hierarchical biopositive mechanisms that prevent, repair or remove damage caused mostly by endogenous reactive oxygen species (ROS) and H2O2 from aerobic metabolism. Indeed, non-radiogenic (i.e. naturally occurring) molecular damage occurs daily at rates many orders of magnitude greater than the rate of damage caused by low-dose radiation such as diagnostic X-rays. It is estimated that the endogenous genetic damage caused on a daily basis from simply breathing air is about one million times the damage initially resulting from an X-ray. We concur that “it is factually preposterous to have radiophobic cancer concerns from medical X-rays after considering the daily burden of endogenous DNA damage.”
And, of course, radiological imaging makes sense in cases of non-specific back pain due to ‘malalignment’ of the spine:
Pressures to restrict the use of “repeat” (i.e. follow-up) X-rays for assessing patient response to treatment shows a complete disregard for the evidence discussed that definitively illustrates how modern spine rehabilitation techniques and practices successfully re-align the spine and pelvis for a wide variety of presenting subluxation/deformity patterns. The continued anti-X-ray sentiment from “consensus” and opinion within chiropractic needs to stop; it is antithetical to scientific reality and to the practice of contemporary chiropractic practice. We reiterate a quote from the late Michael A. Persinger: “what is happening in recent years is that facts are being defined by consensus. If a group of people think that something is correct, therefore it’s true, and that’s contradictory to science.”
Thus, the authors feel entitled to conclude:
Routine and repeat X-rays in the nonsurgical treatment of patients with spine disorders is an evidence-based clinical practice that is warranted by those that practice spine-altering methods. The evidence supporting such practices is based on definitive evidence supporting the rationale to assess a patient’s spinopelvic parameters for biomechanical diagnosis, to screen for relative and absolute contraindications for specific spine care methods, and to re-assess the spine and postural response to treatment.
The traditional and underlying presumption of the carcinogenicity from X-rays is not a valid notion because the LNT is not valid for low-dose exposures. The ALARA radiation protection principle is obsolete, the threshold for harm is high, low-dose exposures prevent cancers by stimulating and upregulating the body’s innate adaptive protection mechanisms, the TCD concept in invalid, and aged cohort studies assumed to show cancers resulting from previous X-rays are not generalizable to the wider population because they represent populations predisposed to cancers.
Red flags, or suspected serious underlying disease is a valid consideration warranting screening imaging by all spine care providers. We contend, however, that as long as the treating physician or rehabilitation therapist is practicing evidence-based methods, proven to improve spine and postural parameters in order to provide relief for the myriad of spinal disorders, spinal X-rays are unequivocally justified. Non-surgical spine care guidelines need to account for proven and evolving non-surgical methods that are radiographically guided, patient-centered, and competently practiced by those specialty trained in such methods. This is over and above so-called “red flag only” guidelines. The efforts to universally dissuade chiropractors from routine and repeat X-ray imaging is neither scientifically justified nor ethical.
There seems to be just one problem here: the broad consensus is against almost anything these authors claim.
Oh, I almost forgot: this paper was authored and sponsored by CBP NonProfit.
“The mission of Chiropractic BioPhysics® (CBP®) Non-Profit is to provide a research based response to these changing times that is clinically, technically, and philosophically sound. By joining together, we can participate in the redefinition and updating of the chiropractic profession through state of the art spine research efforts. This journey, all of us must take as a Chiropractic health care profession to become the best we can be for the sake of the betterment of patient care. CBP Non-Profit’s efforts focus on corrective Chiropractic care through structural rehabilitation of the spine and posture. Further, CBP Non-Profit, Inc. has in its purpose to fund Chiropractic student scholarships where appropriate as well as donate needed chiropractic equipment to chiropractic colleges; always trying to support chiropractic advancement and education.”
This study aimed to evaluate the effect of Traditional Chinese Medicine (TCM) on patients with gastric cancer following surgery and adjuvant chemotherapy in Taiwan. The cohort sampling data set was obtained from the Registry of Catastrophic Illness Patient Database, a research database of patients with severe illnesses from the National Health Insurance Research Database, Taiwan. Patients who had received a new diagnosis of gastric cancer and had undergone surgery were enrolled. the researchers matched TCM users and nonusers at a ratio of 1 : 3 based on the propensity score, and TCM users were also grouped into short-term and long-term users.
The number of TCM users and nonusers was 1701 and 5103 after applying the propensity score at a ratio of 1 : 3. Short-term users and long-term TCM users were independently associated with a decreased risk of death with HRs of 0.59 (95% confidence interval (CI), 0.55-0.65) and 0.41 (95% CI, 0.36-0.47), respectively, compared with TCM nonusers. The researchers also obtained similar results when they adjusted for covariates in the main model, as well as each of the additional listed covariates. They also observed similar HR trends in short-term users and long-term TCM users among men and women aged <65 years and ≥65 years. The most commonly prescribed single herb and herbal formula in our cohort were Hwang-Chyi (Radix Hedysari; 11.8%) and Xiang-Sha-Liu-Jun-Zi-Tang (15.5%), respectively.
The authors concluded that TCM use was associated with higher survival in patients with gastric cancer after surgery and adjuvant chemotherapy. TCM could be used as a complementary and alternative therapy in patients with gastric cancer after surgery and adjuvant chemotherapy.
This is an interesting study which seems well-done – except for one fatal mistake: even in the title, the authors imply a causal relationship between TCM and survival. Their conclusion has two sentences; the first one speaks correctly of an association. The second, however, not only implies causality but goes much further in suggesting that TCM should be used to prolong the life of patients. Yet, there are, of course, dozens of factors that could interfere with the findings or be the true cause of the observed outcome.
Anyone with a minimum of critical thinking ability should know that CORRELATION IS NOT CAUSATION; sadly, the authors of this study seem to be the exception.
Several previously published clinical trials have suggested that both acupuncture and sham acupuncture exert significant, non-specific effects on treatment outcomes when compared to no-treatment controls. A recently developed framework (mechanisms in orthodox and complementary and alternative medicine-MOCAM) suggests that the non-specific effects of acupuncture originate from multiple domains (e.g. patient characteristics, acupuncturist skill/technique, the patient-acupuncturist relationship, and the acupuncture environment). However, it remains to be determined precisely how these domains influence the non-specific effects of treatment among patients receiving acupuncture and sham acupuncture in clinical trials.
To address this issue, researchers conducted a systematic review to synthesize existing qualitative evidence on how trial participants randomized to acupuncture and sham acupuncture groups experience non-specific effects, regardless of the types of medical conditions investigated.
This systematic review included primary qualitative studies embedded in randomized controlled trials designed to investigate acupuncture or sham acupuncture interventions. Eligible studies published in English were derived from a search of five international databases. The methodological quality of included studies was evaluated using the Critical Appraisal Skills Programme (CASP) tool. Using a framework synthesis approach, the identified MOCAM framework was adapted based on the synthesis of the available qualitative evidence.
A total of 20 studies of high methodological quality were included. The proposed model indicated that the effects of acupuncture may be increased by:
- maintaining a professional status,
- applying a holistic treatment approach,
- practicing empathy,
- providing patients with an appropriate explanation of the theory behind acupuncture and sham acupuncture.
From the patient’s perspective, the efficacy of treatment can be increased by:
- following the lifestyle modification advice provided by acupuncturists,
- maintaining a positive attitude toward treatment efficacy,
- actively engaging with acupuncturists during the consultation,
- making behavioral changes based on experience gained during the trial.
The authors concluded that the results of this study may provide a basis for improving and standardizing key components of non-specific effects in acupuncture treatment, and for improving the isolation of specific effects in future clinical trials involving acupuncture and sham acupuncture.
The authors also state that having a positive attitude and high expectations regarding treatment efficacy can lead to positive health outcomes, along with a sense of curiosity and altruistic desire to join clinical trials. Indeed, previous clinical trials have reported that higher expectations regarding treatment effects may help to reduce fatigue and alleviate osteoarthritis in both acupuncture and sham acupuncture groups. Similar benefits of positive expectations have also been observed among patients with irritable bowel syndrome in sham acupuncture trials.
SO CLOSE AND YET SO FAR!
So close to admitting that these findings indicate quite strongly that acupuncture is but a theatrical placebo.
