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

survey

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My ‘ALTERNATIVE MEDICINE HALL OF FAME’ is filling up nicely. But I noticed that so far we have nobody from Spain. That can be rectified ever so easily. I think I found the ideal candidate to join this group of illustrious experts who never bring themselves to publish a negative conclusion: JORGE VAS.

Jorge Vas works at the ‘Pain Treatment Unit, Doña Mercedes Primary Health Care Center, Dos Hermanas’ in Spain. I have long noticed his research which is focused on ACUPUNCTURE. From memory, I had the impression that his findings are always positive.

But is this true? To find out, I did a Medline search and found 11 clinical trials of acupuncture in his name, published between 2006 and 2019. Here are the conclusions:

  1. After 2 weeks of treatment, ear acupuncture applied by midwives and associated with standard obstetric care significantly reduces lumbar and pelvic pain in pregnant women, improves quality of life and reduces functional disability.
  2. Individualised acupuncture treatment in primary care in patients with fibromyalgia proved efficacious in terms of pain relief, compared with placebo treatment. The effect persisted at 1 year, and its side effects were mild and infrequent. Therefore, the use of individualised acupuncture in patients with fibromyalgia is recommended.
  3. The use of acupuncture to treat impingement syndrome seems to be a safe and reliable technique to achieve clinically significant results and could be implemented in the therapy options offered by the health services.
  4. …all 3 modalities of acupuncture were better than conventional treatment alone…
  5. Moxibustion treatment applied at acupuncture point BL67 can avoid the need for caesarean section and achieve cost savings for the healthcare system in comparison with conventional treatment.
  6. The application of auriculopressure in patients with non-specific spinal pain in primary healthcare is effective and safe, and therefore should be considered for inclusion in the portfolio of primary healthcare services.
  7. The degree of pain relief experienced by patients from acupuncture justifies a more rigorous study.
  8. Moxibustion at acupuncture point BL67 is effective and safe to correct non-vertex presentation when used between 33 and 35 weeks of gestation. We believe that moxibustion represents a treatment option that should be considered to achieve version of the non-vertex fetus.
  9. Single-point acupuncture in association with physiotherapy improves shoulder function and alleviates pain, compared with physiotherapy as the sole treatment. This improvement is accompanied by a reduction in the consumption of analgesic medicaments.
  10. Acupuncture plus diclofenac is more effective than placebo acupuncture plus diclofenac for the symptomatic treatment of osteoarthritis of the knee.
  11. In the treatment of the intensity of chronic neck pain, acupuncture is more effective than the placebo treatment and presents a safety profile making it suitable for routine use in clinical practice.

Eleven of 11 trials with a positive conclusion!

That surely is a rare feast.

Actually, I cheated a tiny bit. The unabridged sentence from the conclusion of paper N4 was: In the analysis adjusted for the total sample (true acupuncture relative risk 5.04, 95% confidence interval 2.24-11.32; sham acupuncture relative risk 5.02, 95% confidence interval 2.26-11.16; placebo acupuncture relative risk 2.57 95% confidence interval 1.21-5.46), as well as for the subsample of occupationally active patients, all 3 modalities of acupuncture were better than conventional treatment alone, but there was no difference among the 3 acupuncture modalities, which implies that true acupuncture is not better than sham or placebo acupuncture. Thus this (multicentre) study was negative with just a touch of positivity.

But still, look at the range of conditions that respond positively to acupuncture in Vas’ hands. Is there anyone who doubts that Jorge Vas does not deserve to join all these other geniuses in THE ALTERNATIVE MEDICINE HALL OF FAME?

I am sure that Vas has more than merited to join them.

WELCOME JORGE VAS!

There are skeptics who keep claiming that there is no research in so-called alternative medicine (SCAM). And there are plenty of SCAM enthusiasts who claim that there is an abundance of good research in SCAM.

Who is right and who is wrong?

I submit that both camps are incorrect.

To demonstrate the volume of SCAM research I looked into Medline to find the number of papers published in 2020 for the SCAMs listed below:

  • acupuncture 2 752
  • anthroposophic medicine 29
  • aromatherapy 173
  • Ayurvedic medicine 183
  • chiropractic 426
  • dietary supplement 5 739
  • essential oil 2 439
  • herbal medicine 5 081
  • homeopathy 154
  • iridology 0
  • Kampo medicine 132
  • massage 824
  • meditation 780
  • mind-body therapies 968
  • music therapy 539
  • naturopathy 68
  • osteopathic manipulation 71
  • Pilates 97
  • qigong 97
  • reiki 133
  • tai chi 397
  • Traditional Chinese Medicine 15 277
  • yoga 698

I think the list proves anyone wrong who claims there is no (or very little) research into SCAM.

As to the enthusiasts who claim that there is plenty of good evidence, I am afraid, I disagree with them too. The above-quoted numbers are perhaps impressive to some SCAM proponents, but they are not large. To make my point more clearly, let me show you the 2020 volumes for a few topics in conventional medicine:

  • psychiatry 668,492
  • biologicals 300,679
  • chemotherapy 109,869
  • radiotherapy 17,964
  • rehabilitation 21,751
  • rehabilitation medicine 21,751
  • surgery 256,958

I think we can agree that these figures make the SCAM numbers look pitifully small.

But the more important point is, I think, not the quantity but the quality of the SCAM research. As this whole blog is about the often dismal rigor of SCAM research, I do surely not need to produce further evidence to convince you that it is poor, often even very poor.

So, both camps tend to be incorrect when they speak about SCAM research. The truth is that there is quite a lot, but sadly reliable studies are like gold dust.

But actually, when I started writing this post and doing all these Medline searches to produce the above-listed volumes of SCAM research, I was thinking of a different subject entirely. I wanted to see which areas of SCAM were research-active and which are not. This is why I chose terms for my list that do not overlap with others (yet we need to realize that the figures are not precise due to misclassification and other factors). And in this respect, the list is interesting too, I find.

It identifies the SCAMs that are remarkably research-inactive:

  • anthroposophic medicine
  • iridology
  • naturopathy
  • osteopathy
  • Pilates
  • qigong

Perhaps more interesting are the areas that show a relatively high research activity:

  • acupuncture
  • dietary supplements
  • essential oils
  • herbal medicine
  • massage
  • meditation
  • mind-body therapies
  • TCM
  • yoga

This, in turn, suggests two things:

  1. It is not true that only commercial interests drive research activity.
  2. The Chinese (TCM and acupuncture) are pushing the ferociously hard to conquer SCAM research.

The last point is worrying, in my view, because we know from several independent studies that Chinese studies are often the flimsiest and least reliable of all the SCAM literature. As I have suggested recently, the unreliability of SCAM research might one day be its undoing: This self-destructive course of SCAM might be applauded by some skeptics. However, if you believe (as I do) that there are a few good things to be found in SCAM, this development can only be regrettable. I fear that the growing dominance of Chinese research will help to speed up this process.

The purpose of this survey (the authors call it a ‘study’) was to evaluate the patient-perceived benefit of yoga for symptoms commonly experienced by breast cancer survivors.

A total of 1,049 breast cancer survivors who had self-reported use of yoga on a follow-up survey, in an ongoing prospective Mayo Clinic Breast Disease Registry (MCBDR), received an additional mailed yoga-focused survey asking about the impact of yoga on a variety of symptoms. Differences between pre-and post- scores were assessed using Wilcoxon Signed Rank Test.

802/1,049 (76%) of women who were approached to participate, consented and returned the survey. 507/802 (63%) reported use of yoga during and/or after their cancer diagnosis. The vast majority of respondents (89.4%) reported some symptomatic benefit from yoga. The most common symptoms that prompted the use of yoga were breast/chest wall pain, lymphedema, and anxiety. Only 9% of patients reported that they had been referred to yoga by a medical professional. While the greatest symptom improvement was reported with breast/chest wall pain and anxiety, significant improvement was also perceived in joint pain, muscle pain, fatigue, headache, quality of life, hot flashes, nausea/vomiting, depression, insomnia, lymphedema, and peripheral neuropathy, (all p-values <0.004).

The authors concluded that data supporting the use of yoga for symptom management after cancer are limited and typically focus on mental health. In this study, users of yoga often reported physical benefits as well as mental health benefits. Further prospective studies investigating the efficacy of yoga in survivorship are warranted.

I have little doubt that yoga is helpful during palliative and supportive cancer care (but all the more doubts that this new paper will further the reputation of research in this area). In fact, contrary to what the conclusions state, there is quite good evidence for this assumption:

  • A 2009 systematic review included 10 clinical trials. Its authors concluded that although some positive results were noted, variability across studies and methodological drawbacks limit the extent to which yoga can be deemed effective for managing cancer-related symptoms.
  • A 2017 systematic review with 25 clinical trials concluded that among adults undergoing cancer treatment, evidence supports recommending yoga for improving psychological outcomes, with potential for also improving physical symptoms. Evidence is insufficient to evaluate the efficacy of yoga in pediatric oncology.
  • A 2017 Cochrane review included 24 studies and found that moderate-quality evidence supports the recommendation of yoga as a supportive intervention for improving health-related quality of life and reducing fatigue and sleep disturbances when compared with no therapy, as well as for reducing depression, anxiety and fatigue, when compared with psychosocial/educational interventions. Very low-quality evidence suggests that yoga might be as effective as other exercise interventions and might be used as an alternative to other exercise programmes.[3]

So, why publish a paper like the one above?

Search me!

To be able to add one more publication to the authors’ lists?

And why would the journal editor go along with this nonsense?

Search me again!

No, hold on: Global Advances in Health and Medicine, the journal that carried the survey, is published in association with Academic Consortium for Integrative Medicine & Health.

Yes, that explains a lot.

As I have pointed out several times before, surveys of this nature are like going into a Mac Donald’s and asking the customers whether they like Hamburgers. You might then also find that “the vast majority of respondents (89.4%) reported”… blah, blah, blah.

The title of the paper is ‘Real-World Experiences With Yoga on Cancer-Related Symptoms in Women With Breast Cancer‘.

 

 

 

PS

NOTE TO MYSELF: never touch a paper with ‘real-world experience’ in the title.

 

The objective of this survey was to determine

  1. which patients’ characteristics are associated with the use of so-called alternative medicine (SCAM) during cancer treatment,
  2. their pattern of use,
  3. and if it has any association with its safety profile.

A total of 316 patients undergoing chemotherapy treatment in cancer centers in Poland between 2017 and 2019 were asked about their use of SCAM.

Patients’ opinion regarding the safety of unconventional methods is related to the use of SCAM. Moreover, patients’ thinking that SCAM can replace conventional therapy was correlated with his/her education. Moreover, the researchers performed analyses to determine factors associated with SCAM use including sociodemographic and clinical characteristics.

Crucially, they also conducted a survival analysis of patients undergoing chemotherapy with 42 months of follow-up. Using Kaplan-Meier curves and log-rank analysis, they found no statistical difference in overall survival between the groups that used and did not use any form of SCAM.

The authors concluded that SCAM use is common among patients undergoing chemotherapy treatment and should be considered by medical teams as some agents may interact with chemotherapy drugs and affect their efficacy or cause adverse effects.

As I have stated before, I find most surveys of SCAM use meaningless. This article is no exception – except for the survival analysis. It would have merited a separate, more detailed paper, yet the authors hardly comment on it. The analysis shows that SCAM users do not live longer than non-users. Previously, we have discussed several studies that suggested they live less long than non-users.

While this aspect of the new study is interesting, it proves very little. There are, of course, multiple factors involved in the survival of cancer patients, and even if SCAM use were a determinant, it is surely less important than many other factors. To get a better impression of the role SCAM plays, we need studies that carefully match patients according to the most obvious prognostic variables (RCTs would be problematic, difficult to do and unethical). Such studies do exist and they too fail to show that SCAM use prolongs survival, some even suggest it might shorten survival.

The state of acupuncture research has long puzzled me. The first thing that would strike who looks at it is its phenomenal increase:

  • Until around the year 2000, Medline listed about 200 papers per year on the subject.
  • From 2005, there was a steep, near-linear increase.
  • It peaked in 2020 when we had a record-breaking 20515 acupuncture papers currently listed in Medline.

Which this amount of research, one would expect to get somewhere. In particular, one would hope to slowly know whether acupuncture works and, if so, for which conditions. But this is not the case.

On the contrary, the acupuncture literature is a complete mess in which it gets more and more difficult to differentiate the reliable from the unreliable, the useful from the redundant, and the truth from the lies. Because of this profound confusion, acupuncture fans are able to claim that their pet-therapy is demonstrably effective for a wide range of conditions, while skeptics insist it is a theatrical placebo. The consumer might listen in bewilderment.

Yesterday (18/1/2021), I had a quick (actually, it was not that quick after all) look into what Medline currently lists in terms of new acupuncture research published in 2021 and found a few other things that are remarkable:

  1. There were already 100 papers dated 2021 (today, there were even 118); that corresponds to about 5 new articles per day and makes acupuncture one of the most research-active areas of so-called alternative medicine (SCAM).
  2. Of these 100 papers, only 7 were clinical trials (CTs). In my view, clinical trials would be more important than any other type of research on acupuncture. To see that they amount to just 7% of the total is therefore disappointing.
  3. Twelve papers were systematic reviews (SRs). It is odd, I find, to see almost twice the amount of SRs than CTs.
  4. Eighteen papers referred to protocols of studies of SRs. In particular protocols of SRs are useless in my view. It seems to me that the explanation for this plethora of published protocols might be the fact that Chinese researchers are extremely keen to get papers into Western journals; it is an essential boost to their careers.
  5. Seven papers were surveys. This multitude of survey research is typical for all types of SCAM.
  6. Twenty-four articles were on basic research. I find basic research into an ancient therapy of questionable clinical use more than a bit strange.
  7. The rest of the articles were other types of publications and a few were misclassified.
  8. The vast majority (n = 81) of the 100 papers were authored exclusively by Chinese researchers (and a few Korean). In view of the fact that it has been shown repeatedly that practically all acupuncture studies from China report positive results and that data fabrication seems rife in China, this dominance of China could be concerning indeed.

Yes, I find all this quite concerning. I feel that we are swamped with plenty of pseudo-research on acupuncture that is of doubtful (in many cases very doubtful) reliability. Eventually, this will create an overall picture for the public that is misleading to the extreme (to check the validity of the original research is a monster task and way beyond what even an interested layperson can do).

And what might be the solution? I am not sure I have one. But for starters, I think, that journal editors should get a lot more discerning when it comes to article submissions from (Chinese) acupuncture researchers. My advice to them and everyone else:

if it sounds too good to be true, it probably is!

The authors of this review wanted to determine similarities and differences in the reasons for using or not using so-called alternative medicine (SCAM) amongst general and condition-specific populations, and amongst populations in each region of the globe.

Quantitative or qualitative original articles in English, published between 2003 and 2018 were reviewed. Conference proceedings, pilot studies, protocols, letters, and reviews were excluded. Papers were appraised using valid tools and a ‘risk of bias’ assessment was also performed. Thematic analysis was conducted. Reasons were coded in each paper, then codes were grouped into categories. If several categories reported similar reasons, these were combined into a theme. Themes were then analysed using χ2 tests to identify the main factors related to reasons for CAM usage.

A total of 231 publications were included. Reasons for SCAM use amongst general and condition-specific populations were similar. The top three reasons were:

  • (1) having an expectation of benefits of SCAM (84% of publications),
  • (2) dissatisfaction with conventional medicine (37%),
  • (3) the perceived safety of SCAM (37%).

Internal health locus of control as an influencing factor was more likely to be reported in Western populations, whereas the social networks was a common factor amongst Asian populations (p < 0.05). Affordability, easy access to SCAM and tradition were significant factors amongst African populations (p < 0.05). Negative attitudes towards SCAM and satisfaction with conventional medicine were the main reasons for non-use (p < 0.05).

The authors concluded that dissatisfaction with conventional medicine and positive attitudes toward SCAM, motivate people to use SCAM. In contrast, satisfaction with conventional medicine and negative attitudes towards SCAM are the main reasons for non-use.

At this point, I thought: so what? This is all very obvious and does not necessitate an extensive review of the published literature. What it actually shows is that the realm of SCAM is obsessed with conducting largely useless surveys, a phenomenon, I once called ‘survey mania‘. But a closer look at the review does reveal some potentially interesting findings.

In less developed parts of the world, like Africa, SCAM use seems to be determined by affordability, accessibility and tradition. This makes sense and ties in with my impression that consumers in such countries would give up SCAM as soon as they can afford proper medicine.

This notion seems to be further supported by the reasons for not using SCAM. Asian consumers claim overwhelmingly that this is because they consider SCAM ineffective and unsafe.

In our review of 2011 (not cited in the new review), we looked at some of the issues from a slightly different angle and evaluated the expectations of SCAM users. Seventy-three articles met our inclusion criteria of our review. A wide range of expectations emerged. In order of prevalence, they included:

  • the hope to influence the natural history of the disease;
  • the desire to prevent disease and promote health/general well-being;
  • the hope of fewer side effects;
  • the wish to be in control over one’s health;
  • the hope for symptom relief;
  • the ambition to boost the immune system;
  • the hope to receive emotional support;
  • the wish to receive holistic care;
  • the hope to improve quality of life;
  • the expectation to relief of side effects of conventional medicine;
  • the desire for a good therapeutic relationship;
  • the hope to obtain information;
  • the hope of coping better with illness;
  • the expectation of supporting the natural healing process;
  • the availability of SCAM.

All of these aspects, issues and notions might be interesting, even fascinating to some, but we should not forget three important caveats:

  • Firstly, SCAM is such a diverse area that any of the above generalisations are highly problematic; the reasons and expectations of someone trying acupuncture may be entirely different from those of someone using homeopathy, for instance.
  • Secondly (and more importantly), the ‘survey mania’ of SCAM researchers has not generated the most reliable data; in fact, most of the papers are hardly worth the paper they were printed on.
  • Thirdly (and even more importantly, in my view), why should any of this matter? We have known about some of these issues for at least 3 decades. Has this line of research changed anything? Has it prevented consumers getting exploited by scrupulous SCAM entrepreneurs? Has it made consumers, politicians or anyone else more aware of the risks associated with SCAM? Has it saved many lives? I doubt it!

Some consumers believe that research is by definition reliable, and patients are even more prone to this error. When they read or hear that ‘RESEARCH HAS SHOWN…’ or that ‘A RECENT STUDY HAS DEMONSTRATED…’, they usually trust the statements that follow. But is this trust in research and researchers justified? During 25 years that I have been involved in so-called alternative medicine (SCAM), I have encountered numerous instances which make me doubt. In this post, I will briefly discuss some the many ways in which consumers can be mislead by apparently sound evidence (for an explanation as to what is and what isn’t evidence, see here).

ABSENCE OF EVIDENCE

I have just finished reading a book by a German Heilpraktiker that is entirely dedicated to SCAM. In it, the author makes hundreds of statements and presents them as evidence-based facts. To many lay people or consumers, this will look convincing, I am sure. Yet, it has one fatal defect: the author fails to offer any real evidence that would back up his statements. The only references provided were those of other books which are equally evidence-free. This popular technique of making unsupported claims allows the author to make assertions without any checks and balances. A lay person is usually unable or unwilling to differentiate such fabulations from evidence, and this technique is thus easy and poular for misleading us about SCAM.

FAKE-EVIDENCE

On this blog, we have encountered this phenomenon ad nauseam: a commentator makes a claim and supports it with some seemingly sound evidence, often from well-respected sources. The few of us who bother to read the referenced articles quickly discover that they do not say what the commentator claimed. This method relies on the reader beeing easily bowled over by some pretend-evidence. As many consumers cannot be bothered to look beyond the smokescreen supplied by such pretenders, the method usually works surprisingly well.

An example: Vidatox is a homeopathic cancer ‘cure’ from Cuba. The Vidatox website clains that it is effective for many cancers. Considering how sensational this claim is, one would expect to find plenty of published articles on Vidatox. However, a Medline search resulted in one paper on the subject. Its authors drew the following conclusion: Our results suggest that the concentration of Vidatox used in the present study has not anti-neoplastic effects and care must be taken in hiring Vidatox in patients with HCC. 

The question one often has to ask is this: where is the line between misleading research and fraud?

SURVEYS

There is no area in healthcare that produces more surveys than SCAM. About 500 surveys are published every year! This ‘survey-mania’ has a purpose: it promotes a positive message about SCAM which hypothesis-testing research rarely does.

For a typical SCAM survey, a team of enthusiastic researchers might put together a few questions and design a questionnaire to find out what percentage of a group of individuals have tried SCAM in the past. Subsequently, the investigators might get one or two hundred responses. They then calculate simple descriptive statistics and demonstrate that xy % use SCAM. This finding eventually gets published in one of the many third-rate SCAM journals. The implication then is that, if SCAM is so popular, it must be good, and if it’s good, the public purse should pay for it. Few consumers would realise that this conclusion is little more that a fallacious appeal to popularity.

AVOIDING THE QUESTION

Another popular way of SCAM researchers to mislead the public is to avoid the research questions that matter. For instance, few experts would deny that one of the most urgent issues in chiropractic relates to the risk of spinal manipulations. One would therefore expect that a sizable proportion of the currently published chiropractic research is dedicated to it. Yet, the opposite is the case. Medline currently lists more than 3 000 papers on ‘chiropractic’, but only 17 on ‘chiropractic, harm’.

PILOT-STUDIES

A pilot study is a small scale preliminary study conducted in order to evaluate feasibility, time, cost, adverse events, and improve upon the study design prior to performance of a full-scale research project. Yet, the elementary preconditions are not fulfilled by the plethora of SCAM pilot studies that are currently being published. True pilot studies of SCAM are, in fact, very rare. The reason for the abundance of pseudo-pilots is obvious: they can easily be interpreted as showing encouragingly positive results for whatever SCAM is being tested. Subsequently, SCAM proponents can mislead the public by claiming that there are plenty of positive studies and therefore their SCAM is supported by sound evidence.

‘SAFE‘ STUDY-DESIGNS

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. In this study, for instance, cancer patients who were suffering from fatigue were randomised to receive usual care or usual care plus regular acupuncture. The researchers then monitored the patients’ experience of fatigue and found that the acupuncture group did better than the control group. The effect was statistically significant, and an editorial in the journal where it was published called this evidence “compelling”. Due to a cleverly over-stated press-release, news spread fast, and the study was celebrated worldwide as a major breakthrough in cancer-care.

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.

A more obvious method for generating false positive results is to omit blinding. The purpose of blinding the patient, the therapist and the evaluator of the group allocation in clinical trials is to make sure that expectation is not a contributor to the result. Expectation might not move mountains, but it can certainly influence the result of a clinical trial. Patients who hope for a cure regularly do get better, even if the therapy they receive is useless, and therapists as well as evaluators of the outcomes tend to view the results through rose-tinted spectacles, if they have preconceived ideas about the experimental treatment.

Failure to randomise is another source of bias which can mislead us. If we allow patients or trialists to select or chose which patients receive the experimental and which get the control-treatment, it is likely that the two groups differ in a number of variables. Some of these variables might, in turn, impact on the outcome. If, for instance, doctors allocate their patients to the experimental and control groups, they might select those who will respond to the former and those who don’t to the latter. This may not happen with intent but through intuition or instinct: responsible health care professionals want those patients who, in their experience, have the best chances to benefit from a given treatment to receive that treatment. Only randomisation can, when done properly, make sure we are comparing comparable groups of patients. Non-randomisation can easily generate false-positive findings.

It is also possible to mislead people with studies which do not test whether an experimental treatment is superior to another one (often called superiority trials), but which assess whether it is equivalent to a therapy that is generally accepted to be effective. The idea is that, if both treatments produce similarly positive results, both must be effective.  Such trials are called non-superiority or equivalence trials, and they offer a wide range of possibilities for misleading us. If, for example, such a trial has not enough patients, it might show no difference where, in fact, there is one. Let’s consider a simple, hypothetical example: someone comes up with the idea to compare antibiotics to acupuncture as treatments of bacterial pneumonia in elderly patients. The researchers recruit 10 patients for each group, and the results reveal that, in one group, 2 patients died, while, in the other, the number was 3. The statistical tests show that the difference of just one patient is not statistically significant, and the authors therefore conclude that acupuncture is just as good for bacterial infections as antibiotics.

Even trickier is the option to under-dose the treatment given to the control group in an equivalence trial. In the above example, the investigators might subsequently recruit hundreds of patients in an attempt to overcome the criticism of their first study; they then decide to administer a sub-therapeutic dose of the antibiotic in the control group. The results would then seemingly confirm the researchers’ initial finding, namely that acupuncture is as good as the antibiotic for pneumonia. Acupuncturists might then claim that their treatment has been proven in a very large randomised clinical trial to be effective for treating this condition. People who do not happen to know the correct dose of the antibiotic could easily be fooled into believing them.

Obviously, the results would be more impressive, if the control group in an equivalence trial received a therapy which is not just ineffective but actually harmful. In such a scenario, even the most useless SCAM would appear to be effective simply because it is less harmful than the comparator.

A variation of this theme is the plethora of controlled clinical trials in SCAM which compare one unproven therapy to another unproven treatment. Perdicatbly, the results would often indicate that there is no difference in the clinical outcome experienced by the patients in the two groups. Enthusiastic SCAM researchers then tend to conclude that this proves both treatments to be equally effective. The more likely conclusion, however, is that both are equally useless.

Another technique for misleading the public is to draw conclusions which are not supported by the data. Imagine you have generated squarely negative data with a trial of homeopathy. As an enthusiast of homeopathy, you are far from happy with your own findings; in addition you might have a sponsor who puts pressure on you. What can you do? The solution is simple: you only need to highlight at least one positive message in the published article. In the case of homeopathy, you could, for instance, make a major issue about the fact that the treatment was remarkably safe and cheap: not a single patient died, most were very pleased with the treatment which was not even very expensive.

OMISSION

A further popular method for misleading the public is the outright omission findings that SCAM researchers do not like. If the aim is that the public believe the myth that all SCAM is free of side-effects, SCAM researchers only need to omit reporting them in clinical trials. On this blog, I have alerted my readers time and time again to this common phenomenon. We even assessed it in a systematic review. Sixty RCTs of chiropractic were included. Twenty-nine RCTs did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred. Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT.

Most trails have many outcome measures; for instance, a study of acupuncture for pain-control might quantify pain in half a dozen different ways, it might also measure the length of the treatment until pain has subsided, the amount of medication the patients took in addition to receiving acupuncture, the days off work because of pain, the partner’s impression of the patient’s health status, the quality of life of the patient, the frequency of sleep being disrupted by pain etc. If the researchers then evaluate all the results, they are likely to find that one or two of them have changed in the direction they wanted (especially, if they also include half a dozen different time points at which these variables are quatified). This can well be a chance finding: with the typical statistical tests, one in 20 outcome measures would produce a significant result purely by chance. In order to mislead us, the researchers only need to “forget” about all the negative results and focus their publication on the ones which by chance have come out as they had hoped.

FRAUD

When it come to fraud, there is more to chose from than one would have ever wished for. We and others have, for example, shown that Chinese trials of acupuncture hardly ever produce a negative finding. In other words, one does not need to read the paper, one already knows that it is positive – even more extreme: one does not need to conduct the study, one already knows the result before the research has started. This strange phenomenon indicates that something is amiss with Chinese acupuncture research. This suspicion was even confirmed by a team of Chinese scientists. In this systematic review, all randomized controlled trials (RCTs) of acupuncture published in Chinese journals were identified by a team of Chinese scientists. A total of 840 RCTs were found, including 727 RCTs comparing acupuncture with conventional treatment, 51 RCTs with no treatment controls, and 62 RCTs with sham-acupuncture controls. Among theses 840 RCTs, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The percentages of RCTs concealment of the information on withdraws or sample size calculations were 43.7%, 5.9%, 4.9%, 9.9%, and 1.7% respectively. The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.

A survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. Officials are now warning that further evidence malpractice could still emerge in the scandal.

I hasten to add that fraud in SCAM research is certainly not confined to China. On this blog, you will find plenty of evidence for this statement, I am sure.

CONCLUSION

Research is obviously necessary, if we want to answer the many open questions in SCAM. But sadly, not all research is reliable and much of SCAM research is misleading. Therefore, it is always necessary to be on the alert and apply all the skills of critical evaluation we can muster.

 

Misinformation by chiropractors is unfortunately nothing new and has been discussed ad nauseam on this blog. It is tempting to ask whether chiropractors have lost (or more likely never had) the ability to ditinguish real information from misinformation or substantiated from unsubstantiated claims. During the pandemic, the phenomenon of chiropractic misinformation has become even more embarrassingly obvious, as this new article highlights.

Chiropractors made statements on social media claiming that chiropractic treatment can prevent or impact COVID-19. The rationale for these claims is that spinal manipulation can impact the nervous system and thus improve immunity. These beliefs often stem from nineteenth-century chiropractic concepts. The authors of the paper are aware of no clinically relevant scientific evidence to support such statements.

The investigators explored the internet and social media to collect examples of misinformation from Europe, North America, Australia and New Zealand regarding the impact of chiropractic treatment on immune function. They discussed the potential harm resulting from these claims and explore the role of chiropractors, teaching institutions, accrediting agencies, and legislative bodies.

The authors conclude as follows: In this search of public media in Europe, North America, New Zealand, and Australia, we discovered many cases of misinformation. Claims of chiropractic treatment improving immunity conflict with the advice from authorities and the scientific consensus. The science referenced by these claims is missing, flawed or has no clinical relevance. Consequently, their claims about clinical effectiveness are spurious at best and misleading at worst. However, our examples cannot be used to make statements about the magnitude of the problem among practitioners as our samples were not intended to be representative. For that reason, we also did not include an analysis of the arguments provided in the various postings. In view of the seriousness of the topic, it would be relevant to conduct a systematic study on a representative sample of public statements, to better understand these issues. Our search illustrates the possible danger to public health of misinformation posted on social media and the internet. This situation provides an opportunity for growth and maturation for the chiropractic profession. We hope that individual chiropractors will reflect on and improve their communication and practices. Further, we hope that the chiropractic teaching institutions, regulators, and professional organisations will always demonstrate responsible leadership in their respective domains by acting to ensure that all chiropractors understand and uphold their fiduciary duties.

Several previous papers have found similar things, e.g.: Twitter activity about SMT and immunity increased during the COVID-19 crisis. Results from this work have the potential to help policy makers and others understand the impact of SMT misinformation and devise strategies to mitigate its impact.

The pandemic has crystallised the embarrassment about chiropractic false claims. Yet, the phenomenon of chiropractors misleading the public has long been known and arguably is even more important when it relates to matters other than COVID-19. Ten years ago, we published this paper:

Background: Some chiropractors and their associations claim that chiropractic is effective for conditions that lack sound supporting evidence or scientific rationale. This study therefore sought to determine the frequency of World Wide Web claims of chiropractors and their associations to treat, asthma, headache/migraine, infant colic, colic, ear infection/earache/otitis media, neck pain, whiplash (not supported by sound evidence), and lower back pain (supported by some evidence).

Methods: A review of 200 chiropractor websites and 9 chiropractic associations’ World Wide Web claims in Australia, Canada, New Zealand, the United Kingdom, and the United States was conducted between 1 October 2008 and 26 November 2008. The outcome measure was claims (either direct or indirect) regarding the eight reviewed conditions, made in the context of chiropractic treatment.

Results: We found evidence that 190 (95%) chiropractor websites made unsubstantiated claims regarding at least one of the conditions. When colic and infant colic data were collapsed into one heading, there was evidence that 76 (38%) chiropractor websites made unsubstantiated claims about all the conditions not supported by sound evidence. Fifty-six (28%) websites and 4 of the 9 (44%) associations made claims about lower back pain, whereas 179 (90%) websites and all 9 associations made unsubstantiated claims about headache/migraine. Unsubstantiated claims were made about asthma, ear infection/earache/otitis media, neck pain,

Conclusions: The majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue.

It makes it clear that the misleading information of chiropractors is a serious problem. And I find it disappointing to see that so little has been done about it, and that progress seems so ellusive.

This, of course, begs the question, where does all this misinformation come from? The authors of the new paper stated that beliefs often stem from nineteenth-century chiropractic concepts. This, I believe, is very true and it gives us an important clue. It suggests that, because it is good for business, chiro schools are still steeped in obsolete notions of pseudo- and anti-science. Thus, year after year, they seem to churn out new generations of naively willing victims of the Dunning Kruger effect.

We have often heard it said on this blog and elsewhere that chiropractors are making great strides towards reforming themselves and becoming an evidence-based profession. In view of the data cited above, this does not ring all that true, I am afraid. Is the picture that emerges not one of a profession deeply embroiled in BS with but a few fighting a lost battle to clean up the act?

Today, HRH the Prince of Wales has his 72th birthday. As every year, I send him my best wishes by dedicating an entire post to a brief, updated summary of his achievements in the area of so-called alternative medicine (SCAM).

EARLY INFLUENCE OF LAURENCE VAN DER POST

Aged 18, Charles went on a journey of ‘spiritual discovery’ into the Kalahari desert. His guide was Laurens van der Post (later discovered to be a fraud and compulsive fantasist and to have fathered a child with a 14-year old girl entrusted to him during a sea voyage). Van der Post wanted to awake Charles’ mind and attune it to the ideas of Carl Jung’s ‘collective unconscious’, and it is this belief in vitalism that provides the crucial link to SCAM: virtually every form of SCAM is based on the assumption that some sort of vital force exists. Charles was impressed with van der Post that he made him the godfather of Prince William. After Post’s death, he established an annual lecture in his honour (the lecture series was quickly discontinued after van der Post was discovered to be a fraud).

CHIROPRACTIC and OSTEOPATHY

Throughout the 1980s, Charles lobbied for the statutory regulation of chiropractors and osteopaths in the UK. In 1993, this finally became reality. To this day, these two SCAM professions are  the only ones regulated by statute in the UK.

THE BRITISH MEDICAL ASSOCIATION

In 1982, Prince Charles was elected as President of the British Medical Association (BMA) and promptly challenged the medical orthodoxy by advocating SCAM. In a speech at his inaugural dinner as President, the Prince lectured the medics: ‘Through the centuries healing has been practised by folk healers who are guided by traditional wisdom which sees illness as a disorder of the whole person, involving not only the patient’s body, but his mind, his self-image, his dependence on the physical and social environment, as well as his relation to the cosmos.’ The BMA-officials ordered a full report on alternative medicine which promptly condemned this area as implausible nonsense.

Six years later, a second report, entitled ‘Complementary Medicine – New Approaches to Good Practice’, heralded U-turn stating that: “the demand for non-conventional therapies had become so pressing that organised medicine in Britain could no longer ignore its contribution“. At the same time, however, the BMA set in motion a further chapter in the history of SCAM by insisting that it was “unacceptable” to allow the unrestricted practice of non-conventional therapies, irrespective of training or experience.

THE FOUNDATION OF INTEGRATED HEALTH

In 1993, Charles founded his lobby group which, after being re-named several times, ended up being called the ‘Foundation for Integrated Health’ (FIH). It was closed down in 2010 amidst allegations of money laundering and fraud. Its chief executive, George Gray, was later convicted and went to jail.

MOSARAF ALI

In 2001, Charles worked on plans to help build a model hospital of integrated medicine. It was to train doctors to combine conventional medicine and SCAMs, such as homeopathy, Ayurvedic medicine and acupuncture, and was to have around 100 beds. The prince’s intervention marked the culmination of years of campaigning by him for the NHS to assign a greater role to SCAM.

INTEGRATIVE MEDICINE

In 2001, Charles published an editorial in the BMJ promoting his ideas around integrative medicine. Its title: THE BEST OF BOTH WORLDS. Ever since, Charles has been internationally recognised as one of the world’s most vociferous champions of integrated medicine.

GERSON DIET

In 2004, Charles publicly supported the Gerson diet as a treatment for cancer. Prof Baum, an eminent oncologists, was invited to respond in an open letter to the British Medical Journal: ” …Over the past 20 years I have treated thousands of patients with cancer and lost some dear friends and relatives to this dreaded disease…The power of my authority comes with knowledge built on 40 years of study and 25 years of active involvement in cancer research. Your power and authority rest on an accident of birth. I don’t begrudge you that authority but I do beg you to exercise your power with extreme caution when advising patients with life-threatening diseases to embrace unproven therapies.”

THE SMALLWOOD REPORT

In 2005, the ‘Smallwood-Report’ was published; it had been commissioned by Charles and paid for by Dame Shirley Porter to inform health ministers. It stated that up to 480 million pounds could be saved, if one in 10 family doctors offered homeopathy as an “alternative” to standard drugs for asthma. Savings of up to 3.5 billion pounds could be achieved by offering spinal manipulation rather than drugs to people with back pain. Because I had commented on this report, Prince Charles’ first private secretary asked my vice chancellor to investigate the alleged indiscretion; even though I was found to be not guilty of any wrong-doing, all local support at Exeter stopped which eventually led to my early retirement.

WORLD HEALTH ORGANISATION

In a 2006 speech, Prince Charles told the World Health Organisation in Geneva that SCAM should have a more prominent place in health care and urged every country to come up with a plan to integrate conventional and alternative medicine into the mainstream. Anticipating Prince Charles’s sermon in Geneva, 13 of Britain’s most eminent physicians and scientists wrote an “Open Letter” which expressed concern over “ways in which unproven or disproved treatments are being encouraged for general use in Britain’s National Health Service.” The signatories argued that “it would be highly irresponsible to embrace any medicine as though it were a matter of principle.”

TRADITIONAL CHINESE MEDICINE (TCM)

In 2007, the People’s Republic of China recorded the visit of Fu Ying, its ambassador in London at the time, to Clarence House, and announced that the Charles had praised TCM. “He hoped that it could be included in the modern medical system . . . and was willing to make a contribution to it.”

HERBAL MEDICINE

In 2009, the Prince held talks with the health Secretary to persuade him to introduce safeguards amid a crackdown by the EU that could prevent anyone who is not a registered health practitioner from selling remedies.

In the same year, Charles urged the government to protect SCAM because “we fear that we will see a black market in herbal products”, as Dr Michael Dixon, medical director of the FIH and Charles’ advisor in SCAM, put it.

UK HEALTH POLITICS

In 2009, the health secretary wrote to the Prince suggesting a meeting on the possibility of a study on integrating SCAM in England’s NHS. The Prince had written to Burnham’s predecessor, Alan Johnson, demanding greater access to SCAM in the NHS alongside conventional medicine. Charles stated that “despite waves of invective over the years from parts of the medical and scientific establishment” he continued to lobby “because I cannot bear people suffering unnecessarily when a complementary approach could make a real difference”.

In June 2014, BBC NEWS published the following text about a BBC4 broadcast entitled ‘THE ROYAL ACTIVIST’ aired on the same day: Prince Charles has been a well-known supporter of complementary medicine. According to a… former Labour cabinet minister, Peter Hain, it was a topic they shared an interest in. He had been constantly frustrated at his inability to persuade any health ministers anywhere that that was a good idea, and so he, as he once described it to me, found me unique from this point of view, in being somebody that actually agreed with him on this, and might want to deliver it. Mr Hain added: “When I was Secretary of State for Northern Ireland in 2005-7, he was delighted when I told him that since I was running the place I could more or less do what I wanted to do. I was able to introduce a trial for complementary medicine on the NHS, and it had spectacularly good results, that people’s well-being and health was vastly improved. And when he learnt about this he was really enthusiastic and tried to persuade the Welsh government to do the same thing and the government in Whitehall to do the same thing for England, but not successfully,” added Mr Hain.

In October 2015, the Guardian obtained the infamous “black spider memos” which revealed that Charles had repeatedly lobbied politicians in favour of SCAM.

THE COLLEGE OF MEDICINE

In 2009, it was announced that the ‘College of Integrated Medicine’ (the successor of the FIH) was to have a second base in India. In 2011, Charles forged a link between ‘The College of Medicine’ and an Indian holistic health centre. The collaboration was reported to include clinical training to European and Western doctors in Ayurveda and homoeopathy and traditional forms of medicine to integrate them in their practice. The foundation stone for the extended campus of the Royal College known as the International Institution for Holistic and Integrated Medicine was laid by Dr Michael Dixon in collaboration with the Royal College of Medicine.

In 2020, Charles became the patron of the College of Medicine which, by then, had re-christened itself ‘College of Medicine and Integrated Health’. The College chair, Michael Dixon, was quoted stating: ‘This is a great honour and will support us as an organisation committed to taking medicine beyond drugs and procedures. This generous royal endorsement will enable us to be ever more ambitious in our mission to achieve a more compassionate and sustainable health service.”

DUTCHY ORIGINALS DETOX TINCTURE

In 2011, after the launch of Charles’ range of herbal tinctures, I had the audacity to publicly criticise Charles for selling the Duchy Herbals detox tincture which I named ‘Dodgy Originals Detox Tincture’.

ANTIBIOTIC OVERUSE

In 2016, speaking at a global leaders summit on antimicrobial resistance, Prince Charles warned that Britain faced a “potentially disastrous scenario” because of the “overuse and abuse” of antibiotics. The Prince explained that he had switched to organic farming on his estates because of the growing threat from antibiotic resistance and now treats his cattle with homeopathic remedies rather than conventional medication. As some of you may be aware, this issue has been a long-standing and acute concern to me,” he told delegates from 20 countries “I have enormous sympathy for those engaged in the vital task of ensuring that, as the world population continues to increase unsustainably and travel becomes easier, antibiotics retain their availability to overcome disease… It must be incredibly frustrating to witness the fact that antibiotics have too often simply acted as a substitute for basic hygiene, or as it would seem, a way of placating a patient who has a viral infection or who actually needs little more than patience to allow a minor bacterial infection to resolve itself.”

DUMFRIES HOUSE

In 2017, Charles declared that he will open a centre for SCAM in the recently purchased Dumfries House in Scotland. Currently, the College of Medicine and Integrated Health is offering two-day Foundation Courses at this iconic location. Gabriel Chiu, a US celebrity cosmetic and reconstructive surgeon, and his wife Christine, joined the Prince of Wales as he opened the integrated health and wellbeing centre on the Dumfries House Estate in East Ayrshire in 2019. As he unveiled a plaque, Prince Charles said: “I’m so glad that all of you have been able to get here today, particularly because I could not be more proud to see the opening of this new integrated health centre at Dumfries House. It’s something I’ve been wanting to do for the last 35 years. I’m also so proud of all the team at Dumfries House who built it, an all in-house team.”

HOMEOPATHY

Generations of royals have favoured homeopathy, and allegedly it is because of this influence that homeopathy became part of the NHS in 1948. Homeopathy has also been at the core of Charles’ obsession with SCAM from its beginning. In 2017, ‘Country News’ published an article about our heir to the throne stating that Prince of Wales has revealed he uses homeopathic treatments for animals on his organic farm at Highgrove to help reduce reliance on antibiotics, the article stated. He said his methods of farming tried wherever possible to ‘‘go with the grain of nature’’ to avoid dependency on antibiotics, pesticides and other forms of chemical intervention.

In the same year, it was revealed that UK farmers were being taught how to treat their livestock with homeopathy “by kind permission of His Royal Highness, The Prince Of Wales

In 2019, the Faculty of Homeopathy announced that His Royal Highness The Prince of Wales had accepted to become Patron of the Faculty of Homeopathy. Dr Gary Smyth, President of the Faculty of Homeopathy commented, “As the Faculty celebrates its 175th anniversary this year, it is an enormous honour for us to receive the Patronage of His Royal Highness The Prince of Wales and I am delighted to announce this news today.” Charles’ move amazed observers who saw it as a deliberate protest against the discontinuation of reimbursement of homeopathy by the NHS.

In 2020, Charles fell ill with the corona-virus and happily made a swift recovery. It was widely reported that his recovery was due to homeopathy, a notion denied by Clarence House.

_______________________

Happy Birthday Charles

Governments and key institutions have had to implement decisive responses to the danger posed by the coronavirus pandemic. Imposed change will increase the likelihood that alternative explanations take hold. In a proportion of the general population there may be strong scepticism, fear of being misled, and false conspiracy theories.

The objectives of this survey were to estimate the prevalence of conspiracy thinking about the pandemic and test associations with reduced adherence to government guidelines. The survey was conducted in May 2020 as a non-probability online survey with 2501 adults in England, quota sampled to match the population for age, gender, income, and region.

Approximately 50% of this population showed little evidence of conspiracy thinking, 25% showed a degree of endorsement, 15% showed a consistent pattern of endorsement, and 10% had very high levels of endorsement. Higher levels of coronavirus conspiracy thinking were associated with less adherence to all government guidelines and less willingness to take diagnostic or antibody tests or to be vaccinated. Such ideas were also associated with

  • paranoia,
  • general vaccination conspiracy beliefs,
  • climate change conspiracy belief,
  • a conspiracy mentality, and distrust in institutions and professions.

Holding coronavirus conspiracy beliefs was also associated with being more likely to share opinions.

The authors concluded that, in England, there is appreciable endorsement of conspiracy beliefs about coronavirus. Such ideas do not appear confined to the fringes. The conspiracy beliefs connect to other forms of mistrust and are associated with less compliance with government guidelines and greater unwillingness to take up future tests and treatment.

The authors also state that the coronavirus conspiracy ideas ascribe malevolent intent to individuals, groups, and organisations based on what are likely to be long-standing prejudices. For instance, almost half of participants endorsed to some degree the idea that ‘Coronavirus is a bioweapon developed by China to destroy the West’ and around one-fifth endorsed to some degree that ‘Jews have created the virus to collapse the economy for financial gain’.

The survey did not include questions about so-called alternative medicine (SCAM). This is a great shame, in my view. We know from previous research that people who adhere to conspiracy theories feel strongly that SCAM is being suppressed via some sinister complot by the establishment. Moreover, we know that SCAM enthusiasts tend to believe in vaccination conspiracy theories. One might therefore expect that proponents of SCAM are also prone to conspiracy beliefs about coronavirus.

When reading some of the comments on this blog, I have little doubt that this is, in fact, the case.

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