Monthly Archives: March 2021
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?
Like all my books, the new one (this one is in German) is dividing opinions sharply. That has to be expected in the realm of so-called alternative medicine, I suppose. Even though I had hoped to avoid such divisions by discussing the 20 best and the 20 most concerning modalities, there seems to be very little middle ground.
We already discussed the review of our regular Heinrich Huemmer. It was withdrawn by Amazon presumably because it was too offensive and later replaced by his second attempt. Now we have a new review which arguably is even more insulting:
Edzard Ernst ist ein verbitterter, älterer Ex-Wissenschaftler, der in seiner nachuniversitären Ruhestandszeit die Privatfehde mit seinem Erzfeind Prince Charles, wie im Film “Und täglich grüsst das Murmeltier” wieder und wieder aufarbeiten muss. Das letzte traurige Ergebnis gibt’s jetzt hier.
Here is the translation:
Edzard Ernst is an embittered, elderly ex-scientist who, in his post-university retirement, has to rehash the private feud with his nemesis Prince Charles over and over again, as in the movie “And Every Day the Groundhog Greets.” The latest sad result is now available here.
The review was posted on 21/3/2021 by an anonymous person who had not bought or read the book. As it might also be withdrawn by Amazon for being offensive, I thought I better keep it here for posterity. I find it quite nice because it shows the lack of reason that shines through so often when my critics try to form a coherent argument.
So, please allow me to do a quick analysis:
- I cannot very well judge whether I am embittered. Those around me would deny it, however.
- Yes, I suppose I am elderly; the same age as Charles, actually. If ‘elderly’ is used in a derogatory sense, it gets rather unpleasant, if you ask me.
- I am not an ex-scientist. I still do quite a bit of science which, by any standards, makes me a scientist.
- I don’t think I have a ‘private feud’ with Charles. A feud is an argument that has existed for a long time between two people or groups, causing a lot of anger or violence. If anything I am a critic of Charles’ actions related to SCAM. He has never argued back which means that this does not amount to a feud. If it were a feud, it would also not be private. I have always made my criticism public.
- Is Charles my nemesis? Someone’s nemesis is a person or thing that is very difficult for them to defeat. Charles would indeed be very difficult to defeat because he never discusses with people who are not of his opinion. So, perhaps this point is correct? Yes, except, I never expected to ‘defeat’ Charles; I would be entirely happy to make him realise that some of his notions are ill-conceived.
- Do I really have to rehash whatever it is over and over again? I fear that here the book reviewer is mistaken. Charles is one of the world’s most influential proponents of so-called alternative medicine (SCAM). I am one of the leading experts in this field. Therefore it is only to be expected that I regularly come across his activities.
- “The latest sad result is now available here.” This implies that my new book is full of mentions of Charles. The truth is that Charles or his activities are not mentioned even once (at least I did not find anything when checking just mow).
I do find the book review quite revealing. It shows that there must be some (I fear many) people out there who are not willing to even consider an argument deemed to be contrary to their conviction. They close their eyes and ears in motivated ignorance. The funny thing is that this happens even in relation to a book in which I really did try to show some positive sides of SCAM.
In other words, even when I evidently write about the positive aspects of SCAM, the opposition remains stubbornly, closed-minded, and accuses me of closed-mindedness.
Not without irony, that!
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.
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.
By guest blogger Les Rose
This is a follow-up to Edzard’s post back in October last year, about a paper by Christina Ross, entitled “Energy Medicine: Current Status and Future Perspectives”. You will see from the post, and from the paper itself, that it is a curious mish-mash of scraps of real science and a large volume of speculative and invented garbage. Its opening gambit majors on physics, which caught the attention of Richard Rasker, who has a background in medical instrumentation, and whose comments were insightful and excoriating.
Edzard and I wrote to the editors of the journal, pointing out the paper’s misleading content and requesting a retraction. In particular, we asked if the paper had been reviewed by a physicist. Here is what they responded:
“This paper underwent appropriate scientific peer review. We don’t intend to retract the paper, but we encourage you to submit an official Letter to the Editor through the Journal’s website. This approach would give the author of this paper the opportunity to respond to your critiques.”
This was received on 28th October 2020. Note that they did not answer our question about a review by a physicist. The journal limits letters to 500 words, and the paper warranted rather more analysis than that, so in partnership with Richard, we posted a detailed critique on my own blog. The plan was to refer to the blog post in the letter, which we submitted on 12th November. We suggested that the paper’s poor scientific underpinnings (to put it mildly) should be sufficient reason for retraction. At the very least, we requested that our critique and the paper itself be subjected to proper scientific review, and that our letter be published alongside the paper. Well here we are five months later and still, our letter has not been published.
The journal Global Advances in Health and Medicine specialises in so-called `integrative medicine’, which is a euphemism for shoehorning quackery into mainstream practice without the inconvenience of doing rigorous research. It publishes papers on such groundbreaking disciplines as shamanic journeying and intention host devices. The joint editors are in post at Wake Forest School of Medicine, where Christina L Ross, the author of the paper at issue, is on the staff.
But let’s return to the main story. Our letter was submitted in the usual way via the Manuscript Central website, and its status remains at `awaiting reviewer selection’. We have never heard of a letter to the editor requiring peer review. One month after submitting it, ie 12th December, SAGE Publishing finally acknowledged receiving our letter, and told us it was under review from their legal team and their editors. It seemed odd that it needed legal review. I replied thus on 20th December:
“Thanks for the update. We wrote directly to the editors asking them to retract the paper, but they refused, and advised us to write a letter for publication. This was so that the author could reply publicly. We still want that to happen. I am not sure why this is a legal matter, it is about science. In the interests of transparency, please tell us when our letter will be published.”
By 9th January 2021, there was no reply to this, so I chased up SAGE Publishing, who replied on 12th:
“The status in the system is misleading, as your Letter is not in need of any peer review. As you are aware, SAGE provides Editors and/or authors with the opportunity to respond to any Letters we receive. If they choose to do so, it is our policy that the Letter and any responses are published together all at once. However, before any adequate response can be put together, an investigation of the issues raised must first be completed. Although you are correct that this is not a Legal matter,
the nature of the complaints we have received prompted us to seek their guidance, and we will be publishing a Statement of Concern on this article while finishing this investigation. Your Letter has been waiting out this process, which unfortunately has taken slightly longer than usual due to all of the recent holidays and office closures. I do appreciate that you are anxious to see this matter resolved, and am sorry for any further frustration this has caused. The original author has been given a deadline to provide her comments, and upon receiving her response, your Letter will be published immediately. I expect this will happen within the next 2-3 weeks, but can certainly keep you updated going forward.”
The emphasis is mine. I asked what happens if the author doesn’t wish to respond, and was told that “we would then move forward with publishing your Letter on its own”. The deadline for the author to respond was stated to be “the end of next week”, ie 22nd January. So I was fully expecting the letter to be published a few days after that, and certainly by the end of January. But on 27th I was told that the author did not want to respond, and that they “do not yet have a firm publication date to share, but I have a meeting to discuss this with the Editors this week”. So the assurance highlighted above, about immediate publication, was valueless.
A few days later, on 31st January, an expression of concern was published, stating that several(!) complaints about the science of the paper had been received. By 17th February I was getting somewhat exasperated, and wrote again to the publishing editor:
“I am trying to be patient, but I really don’t see why a letter to the editors can take months to be published, in this day and age. Other journals such as the BMJ publish rapid responses in hours. I realise that our letter is critical of your journal’s peer review process, but delaying publication for so long does not look good. Surely you can publish the letter and respond in some way as publisher of the article in question? Some sort of response seems appropriate, in view of the original author’s silence. As we have raised this issue, readers may well appreciate some insight into your peer review process.
“I note that the journal’s editors are colleagues of the author. How do you manage this conflict of interest?”
The publishing editor did not reply directly to this, and passed it to the joint editor in chief Professor Remy Coeytaux. After a further two weeks I still had not heard anything from either party, so again I chased them up. The reply from Professor Coeytaux on 3rd March is worth reading in full:
“I ask for your forgiveness and understanding for the time this process is taking. By way of introduction and explanation, I am the co-Editor-in-Chief who has collaborated with Dr. Christina Ross in the past. Our other co-Editor-in-Chief, Dr. Suzanne Danhauer, has no relationship with the author of the paper in question. As is typical for medical journals, Global Advances in Health and Medicine does not have a policy that precludes members of the same academic institution as the Editors-in-Chief from submitting manuscripts for review and possible publication.
“Manuscripts submitted to the Journal are assigned to either Dr. Danhauer or myself. We then assign the manuscripts to Associate Editors as indicated. Dr. Ross’ manuscript was assigned to Dr. Danhauer. I had no role whatsoever in the peer review process or decision making for this manuscript. Throughout that process, there was no conflict of interest to manage. To re-iterate, Dr. Danhauer had no conflict with Dr. Ross and I had no involvement in any way or at any time in or with the peer review process.
“All of us at the Journal are taking your concerns seriously. Dr. Danhauer and I have complementary scientific expertise. She is a psychologist by training, while I am a physician and epidemiologist by training. We decided that I should be the one to manage the process of arriving at the most appropriate resolution to the concerns that you have brought to our attention. Your Letter to the Editor was assigned to me, and I am personally managing the process of seeking independent input from an additional set of peer reviewers for Dr. Ross’ original paper. By “personally,” I mean that I have not relegated this important task to one of our Associate Editors.
“We have very nearly completed the process on our end. We are awaiting the comments of one final peer reviewer. We expect to have that process completed within the next three weeks.
“I should also note that we believe it is appropriate for us to wait to publish your Letter to the Editor until we have completed our internal review process that we initiated in response to your concerns. It is for this reason that we have not yet published your Letter. I would like to take this opportunity to ask you, please, to send me another copy of your Letter to the Editor after deleting the reference to the internet link. It is the Journal’s policy to not publish such links. I would like to ask you, please, to send the revised letter to me directly in a PDF format via email attachment.
“Thank you for engaging in this scientific discourse and for your patience during the process.”
Some of this is very odd. He admits to being Ross’ collaborator but says this is not a conflict of interest. The journal’s instructions for authors do not say anything about `internet links’. It is perfectly normal for academic papers to use URLs as references. This looks suspiciously like an exercise in damage limitation. Hence I deleted the embedded hyperlink in the text and added the URL as a reference at the end. I replied the next day, and asked whether the current peer reviewers include those from outside the field of complementary and/or alternative medicine. I have not heard anything further from Professor Coeytaux or the publisher.
Is it really so time-consuming to find an authoritative reviewer? I put the word out, and got a response from Professor Jim Al-Khalili OBE FRS FinstP. He is a very well-known TV presenter on science topics, and as well as an eminent physicist and a professor for the public engagement in science. He could not be more appropriate to review this paper, and here is what he said:
“This notion that the body has ‘different kinds of energy’ is utter nonsense and a clear sign that someone does not have a firm background in science. If we do want to explore what different kinds of energy living organisms have then we can say there is kinetic energy due to macroscopic motion controlled by, say, muscles, then there is thermal energy due to vibrations of the molecules within our cells, chemical energy due to the thousands of biochemical reactions taking place inside cells, and finally electromagnetic energy from for example, the tiny induced magnetic fields due to moving charged particles in ion channels. None of these forms of energy is mysterious and the wording in this paper referring to detecting ‘subtle energies’ or resonances is utterly unscientific. While scanners, such as MRI, x-ray, PET or CT machines can image the body by measuring interactions with, for example, magnetic fields or responses to bombarding electromagnetic radiation, there is no mystery here. We know how they work. After all, it was physicists who invented these machines based on our understanding of the laws of physics. To buy into any of the notions in this paper would mean that the whole edifice of modern physics has to be demolished and rebuilt. And if anyone thinks that may be necessary then I would argue they really have not studied science at all and do not understand the scientific method.
“Basically, the science that this paper challenges is the very science that has allowed us to understand the workings of the body in the first place. You cannot call upon science (quantum field theory) to justify unscientific ideas that would mean that quantum field theory has to be thrown away. Also, using scientific jargon to make something sound clever when it’s not should not fool anyone, and certainly not serious scientific research journals.”
One has to wonder how Ross obtained a degree in physics. I sent this to Professor Coeytaux on 22nd March, pointing out how quick and easy it was to get such a review. I said that the paper had obviously not received “appropriate scientific review”, and asked for a response by return explaining the status of our letter. You guessed it, I have heard nothing.
I always try to go for the ball and not the player, but it’s worth looking in a bit more detail at Christina Ross’ academic credentials. She styles herself as Dr, but her PhD is from Akamai University in Hawaii. Although the university proudly displays a statement of accreditation, it is from the Accreditation Service for International Schools Colleges and Universities (ASIC). This is not listed by the US Department of Education as a recognised accreditation body. It is actually a UK company that validates visas for international students, but its credibility is quite doubtful:
“The legitimacy of ASIC’s international accreditation service is unclear and some of its internationally-accredited institutions have been deemed ‘diploma mills’ offering worthless qualifications.”
Ross is also a `Board Certified Polarity Practitioner’. Americans love the term `board certified’, it lends considerable gravitas. But anyone can set up a board and issue certificates. What is polarity therapy? Well, as is usual with quackery, it is a personality cult, which combines various evidence-free modalities and doesn’t clearly say what use it is. I don’t think I need to look into `Certified Energy Medicine Practitioner’ any further.
So this is what happens when pseudoscience is called out in academia. SAGE Publishing is obviously not a bit concerned about science, despite their assurances, or they would never have launched a journal such as this. The editors do not worry about conflicts of interest or scientific evidence. They try to obfuscate when detailed criticism is published. The author does not even attempt to defend what she has written. I assume all of them are hoping that we will get weary of this and give up. They are wrong about that as well.
As often mentioned in previous posts, the ‘Heilpraktiker’ is a recognized healthcare professional in Germany that was established during the Third Reich. Despite the fact that a Heilpraktiker doesn’t necessarily undergo any meaningful medical training, they are permitted to do almost all the treatments a medically trained practitioner can carry out. This situation has created a two-tier healthcare system in Germany which many experts find unacceptable. Reports of patients being seriously harmed are reported with depressing regularity.
It has been reported that a German woman suffering from cancer discontinued her conventional oncological treatments and had herself treated with preparations made from snake venom. After she died of her cancer, the practitioner of so-called alternative medicine (SCAM), a Heilpraktiker, was ordered to pay compensation for pain and suffering. The practitioner must now pay 30,000 Euros in compensation for pain and suffering to her son. This was decided by a court in Munich in a landmark ruling on Thursday. The boy’s father had originally demanded 170,000 Euros.
The deceased patient had been suffering from cervical cancer with a good prognosis. She decided to abandon radiation and chemotherapy and instead opted for preparations made from snake venom, which she received from her SCAM practitioner.
“The defendant did not actively advise her patient to discontinue the life-saving radiation therapy,” the court found, but “she did not oppose her decision, which as a Heilpraktiker would have been her duty.” In the court’s view, the Heilpraktiker should have advised her patient to resume chemotherapy. “This continued omission by the defendant over a period of weeks was irresponsible and, from the point of view of a responsible healthcare practitioner, utterly incomprehensible.” In addition to damages for pain and suffering, the Heilpraktiker was ordered to pay damages for lost child support, among other things. The court did not allow an appeal against the verdict.
The case seems unusual in that the court found a SCAM practitioner guilty not because of administering a bogus or harmful treatment, but because of failing to provide essential advice. This could have consequences for many legal cases in the future.
If I understand it correctly, it means that, according to German law, healthcare practitioners can be held responsible not just for what they were doing, but also for what they were not doing, and that this form of neglect extends not just to treatments and procedures, but also to advice. If that is true, a German homeopath treating an asthma patient, for instance, could be sued if he fails to advise that his patient also takes essential conventional medications.
It would be valuable to have the opinion of legal experts on this point and on the question of how the law in other counties would apply in such matters.
The Chinese have made several attempts to persuade us that their traditional remedies are effective for COVID-19 infections. Here is yet another one. This review summarised the evidence of the therapeutic effects and safety of Chinese herbal medicine (CHM) used with or without conventional western therapy for COVID-19. All clinical studies of the therapeutic effects and safety of CHM for COVID-19 were included. The authors
- summarized the general characteristics of included studies,
- evaluated the methodological quality of the randomized controlled trials (RCTs) using the Cochrane risk of bias tool,
- analyzed the use of CHM,
- used Revman 5.4 software to present the risk ratio (RR) or mean difference (MD) and their 95% confidence interval (CI) to estimate the therapeutic effects and safety of CHM.
A total of 58 clinical studies were identified including;
- 10 RCTs,
- 1 non-randomized controlled trials,
- 11 retrospective studies with a control group,
- 12 case-series,
- 24 case-reports.
All of the studies had been performed in China. No RCTs of high methodological quality were identified. The most frequently tested oral Chinese patent medicine, Chinese herbal medicine injection, or prescribed herbal decoction were:
- Lianhua Qingwen granule/capsule,
- Xuebijing injection,
- Maxing Shigan Tang.
The pooled analyses showed that there were statistical differences between the intervention group and the comparator group (RR 0.42, 95% CI 0.21 to 0.82, six RCTs; RR 0.38, 95% CI 0.23 to 0.64, five retrospective studies with a control group), indicating that CHM plus conventional western therapy appeared to be better than conventional western therapy alone in reducing aggravation rate.
In addition, compared with conventional western therapy, CHM plus conventional western therapy had the potential advantages in increasing the recovery rate and shortening the duration of fever, cough, and fatigue, improving the negative conversion rate of nucleic acid test, and increasing the improvement rate of chest CT manifestations and shortening the time from receiving the treatment to the beginning of chest CT manifestations improvement.
For adverse events, the pooled data showed that there were no statistical differences between the CHM and the control groups.
The authors concluded that current low certainty evidence suggests that there maybe a tendency that CHM plus conventional western therapy is superior to conventional western therapy alone. The use of CHM did not increase the risk of adverse events.
One of the principles to remember here is this: RUBBISH IN, RUBBISH OUT. If you meta-analyze primary data that are rubbish, your findings can only be rubbish as well.
All one needs to know about the primary data entered into the present analysis is that there were no rigorous RCTs… not one! That means the evidence is, as the authors rightly but modestly conclude of LOW CERTAINTY. My conclusions would have been a little different:
- In terms of safety, the dataset is too small and unreliable to make any judgment.
- In terms of efficacy, there is no sound data that CHM has a positive effect.
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.
I am currently working on a project that involves studying a lot of what our heir to the throne – or is the ‘the heir to our throne? – as done, said and written about so-called alternative medicine (SCAM). Unavoidably, this meant reading his 2010 book HARMONY, A NEW WAY OF LOOKING AT OUR WORLD. In it, Prince Charles states that “… I cannot bear to see people suffer unnecessarily when, so often, a complementary treatment can be beneficial…” This is a statement that Charles has made several times before.
Each time I come across it, I have to think of some of my own patients. It’s a long time since I was a clinician, yet one patient, in particular, often comes to my mind.
He had been a young man healthy, happily married, nice kids, good job, etc. Then one day, he was inattentive or distracted and drove his car full with his wife and kids across a red signal at an unguarded railway crossing. They were all killed instantly.
But almost miraculously, he survived and had just relatively minor injuries which we hoped to put right. So, his body was about to be fine, but his mind was not. Just before being dismissed from the hospital, he tried to commit suicide by jumping out of the 4th-floor window of his room. He survived that too, and we were looking after him and his multiple injuries. As he had lost a lot of blood, he received several blood transfusions. One had been infected and he contracted HIV. He did not survive.
Does Charles know what he is talking about?
How often does he see truly suffering patients?
Does he know that faked empathy might be seen as offensive?
On what evidential basis does he assume that so-called alternative medicine (SCAM) would bring any benefit to severely ill patients?
Does he assume to know better than the clinicians treating the ‘people suffering unnecessarily?
Does he realize that his words are an insult to those who actually do see patients suffer and empathize with them?
Does he know what it means to do everything possible to help patients?
Does he realize that this is achieved by employing the most effective treatments currently available?
Does he know that the most effective treatments would almost never include SCAM?
I am sorry, but sometimes Charles’s musings about SCAM do get under my skin.
It has been reported that the Middlesex University is cutting its ties with the UK’s biggest provider of homeopathy training after it peddled vaccine misinformation and encouraged the use of homeopathic potions made with phlegm to protect against and treat Covid-19. The Centre for Homeopathic Education (CHE) had been validated by the Middlesex University since 2004 and was the only UK homeopathy college to offer a University-accredited degree in homeopathy.
Now the CHE has been criticized for its “actively anti-scientific teaching”. Robbie Turner, a director at the Royal Pharmaceutical Society, said the unproven medicines being promoted by the college were “highly risky”. He added: “It is not just irresponsible, it’s downright dangerous.”
In webinars offered by the CHE Online, the lecturer Robin Murphy claimed the idea that vaccination was effective at eradicating disease was “delusional” and told students how to buy or make homeopathic “nosodes” made from bodily material of an infected Covid patient. He said the nosodes could help prevent and treat even the most severe cases of Covid, recommended their use among healthcare workers and carers exposed to the virus, and claimed he had helped administer the remedies to up to 200 people, including children. “I treated a 14-year-old girl and I gave her the nosode … she got fevers and chills. I followed up with mercury and between the nosode and mercury, that took care of the case,” he said.
In another case, Murphy said a client locked her son in his bedroom after he was exposed to Covid-19 to make him take the remedy. “If the husband comes home with a positive test and is sick … get the dose to everybody in the family,” Murphy said. “We’ve seen it work. A couple of my patients locked their son in the bedroom and wouldn’t let him come out. We gave him the remedies and everyone’s fine.”
He began the session with a “disclaimer”. “This is medical and historical information and blah blah blah and all this and that,” he said as the slide was shown. “This is for your own information … I feel we’re on solid ground to really help people like this.” Murphy is a regular lecturer at the CHE and director of the Lotus Health Institute in Virginia in the US. His other courses include one on 5G “toxicity”, promoting the debunked theory that 5G is dangerous.
Michael Marshall, project director at the Good Thinking Society, described claims that the vaccine “alternatives” were effective as “tremendously dangerous” and said it was “very concerning” that homeopaths were being taught their use by an accredited college. He said the teachings were “actively anti-science. For some people, the worst-case scenario is that they go on and contract and spread that disease. It fundamentally undermines public health messaging and puts the public at risk.”
The CHE was the largest homeopathy training provider in the UK providing a range of courses including, until last week, a bachelor of science degree validated by Middlesex. Under the 17-year partnership, the university — ranked 121st in the UK in the Good University Guide — would receive a £700 registration fee per student on the part-time, four-year course, and up to £3,500 went to the college in annual tuition fees.
A spokesperson for the University said it was “alarmed to hear about the allegations.” Middlesex declared it is terminating the partnership with immediate effect.
Osteopathic manipulative treatment (OMT) is popular, but does it work? On this blog, we have often discussed that there are good reasons to doubt it.
This study compared the efficacy of standard OMT vs sham OMT for reducing low back pain (LBP)-specific activity limitations at 3 months in persons with nonspecific subacute or chronic LBP. It was designed as a prospective, parallel-group, single-blind, single-center, sham-controlled randomized clinical trial. 400 patients with nonspecific subacute or chronic LBP were recruited from a tertiary care center in France starting and randomly allocated to interventions in a 1:1 ratio.
Six sessions (1 every 2 weeks) of standard OMT or sham OMT delivered by osteopathic practitioners. For both
experimental and control groups, each session lasted 45 minutes and consisted of 3 periods: (1) interview focusing on pain location, (2) full osteopathic examination, and (3) intervention consisting of standard or sham OMT. In both groups, practitioners assessed 7 anatomical regions for dysfunction (lumbar spine, root of mesentery, diaphragm, and atlantooccipital, sacroiliac, temporomandibular, and talocrural joints) and applied sham OMT to all areas or standard OMT to those that were considered dysfunctional.
The primary endpoint was the mean reduction in LBP-specific activity limitations at 3 months as measured by the self-administered Quebec Back Pain Disability Index. Secondary outcomes were the mean reduction in LBP-specific activity limitations; mean changes in pain and health-related quality of life; number and duration of sick leave, as well as the number of LBP episodes at 12 months, and the consumption of analgesics and nonsteroidal anti-inflammatory drugs at 3 and 12 months. Adverse events were self-reported at 3, 6, and 12 months.
A total of 200 participants were randomly allocated to standard OMT and 200 to sham OMT, with 197 analyzed in each group; the median (range) age at inclusion was 49.8 (40.7-55.8) years, 235 of 394 (59.6%) participants were women, and 359 of 393 (91.3%) were currently working. The mean (SD) duration of the current LBP episode had been 7.5 (14.2) months. Overall, 164 (83.2%) patients in the standard OMT group and 159 (80.7%) patients in the sham OMT group had the primary outcome data available at 3 months.
The mean (SD) Quebec Back Pain Disability Index scores were:
- 31.5 (14.1) at baseline and 25.3 (15.3) at 3 months in the OMT-group,
- 27.2 (14.8) at baseline and 26.1 (15.1) at 3 months in the sham group.
The mean reduction in LBP-specific activity limitations at 3 months was -4.7 (95% CI, -6.6 to -2.8) and -1.3 (95% CI, -3.3 to 0.6) for the standard OMT and sham OMT groups, respectively (mean difference, -3.4; 95% CI, -6.0 to -0.7; P = .01). At 12 months, the mean difference in mean reduction in LBP-specific activity limitations was -4.3 (95% CI, -7.6 to -1.0; P = .01), and at 3 and 12 months, the mean difference in mean reduction in pain was -1.0 (95% CI, -5.5 to 3.5; P = .66) and -2.0 (95% CI, -7.2 to 3.3; P = .47), respectively. There were no statistically significant differences in other secondary outcomes. Four and 8 serious adverse events were self-reported in the standard OMT and sham OMT groups, respectively, though none was considered related to OMT.
The authors concluded that standard OMT had a small effect on LBP-specific activity limitations vs sham OMT. However, the clinical relevance of this effect is questionable.
This study was funded the French Ministry of Health and sponsored by the Département de la Recherche Clinique et du Développement de l’Assistance Publique-Hôpitaux de Paris. It is of exceptionally good quality. Its findings are important, particularly in France, where osteopaths have become as numerous as their therapeutic claims irresponsible.
In view of what we have been repeatedly discussing on this blog, the findings of the new trial are unsurprising. Osteopathy is far less well supported by sound evidence than osteopaths want us to believe. This is true, of course, for the plethora of non-spinal claims, but also for LBP. The French authors cite previously published evidence that is in line with their findings: In a systematic review, Rubinstein and colleagues compared the efficacy of manipulative treatment to sham manipulative treatment on LBP-specific activity limitations and did not find evidence of differences at 3 and 12 months (3 RCTs with 573 total participants and 1 RCT with 63 total participants). Evidence was considered low to very low quality. When merging the present results with these findings, we found similar standardized mean difference values at 3months (−0.11 [95% CI, −0.24 to 0.02]) and 12 months (−0.11 [95% CI, −0.33 to 0.11]) (4 RCTs with 896 total participants and 2 RCTs with 320 total participants).
So, what should LBP patients do?
The answer is, as I have often mentioned, simple: exercise!
And what will the osteopaths do?
The answer to this question is even simpler: they will find/invent reasons why the evidence is not valid, ignore the science, and carry on making unsupported therapeutic claims about OMT.