research
Guest post by Norbert Aust, Udo Endruscheit, and Edzard Ernst
How do we know whether a treatment is reasonable or just some so-called alternative medicine (SCAM) that is at best useless? A simple answer is that the former is evidence-based, while the latter is not. But how can we tell the difference? High-quality studies, with independent replications or even a systematic review, are the sort of things we are usually looking for. But there is an underlying assumption, namely that, in science, bogus studies are prevented from polluting the scientific database or, if such trials have emerged, there are ways to identify and eliminate them.
And what if this assumption is wrong?
What if respectable universities and research organizations venture into the realm of pseudoscience either knowingly or because it had slipped their attention?
What if the editorial board of a top journal passes bogus studies to peer review?
What if such a paper is eventually reviewed by a proponent of the implausible therapy?
What if the readers of the article, once it is published, are too lethargic to object and do not write letters to the editor in protest?
And what if skeptics do formulate a protest but the journal editor refuses to publish it?
Well, if all the checks that should prevent faulty results from entering the scientific knowledge fail, we have fake evidence: a study that looks like sound science but that, in fact, is invalid. It is not hard to imagine what would happen if SCAM therapies are supported by seemingly respectable studies published in top journals. The fake evidence would accumulate as part of the body of evidence and eventually enter mainstream clinical practice, education, politics, etc., etc. Thus the reputation of bogus therapies would grow unjustifiably.
If you think this cannot happen, you are in the wrong. After the infamous study by Frass et al about homeopathy as an add-on treatment for lung cancer, another homeopathy paper was published in 2022 by Gaertner et al. in Pediatric Research (PR), a Medline-indexed journal with a two-year impact factor of 3.95 belonging to the nature-group of journals. According to this meta-analysis ‘individualized homeopathy showed a clinically relevant and statistically robust effect in the treatment of ADHD’. Shortly after the publication of this paper, we sent a letter to the editor to point out the shortcomings of this study. Here it is:
Sir,
with this letter we like to comment on the systematic review and meta-analysis on childhood ADHD by Gaertner et al. recently published in your journal.
First off, we are surprised, that your journal that is connected to nature does publish a paper on a treatment that has no a-priory probability at all and thus can only contain false positives if any. And this review is no exception as will be seen presently.
Our concerns are:
Out of the six studies included three were mere pilot trials (Fibert_2019, Jacobs_2005, Oberai_2013, ) which cannot provide any evidence for the shortcomings involved in pilots. Three of the six trials show severe issues in blinding (Fibert_2016, Fibert_2019, Oberai_2013), with two of them concerning both of the participants and the test personnel. This usually leads to massive bias in favour of the treatment [Zitat Cochrane Handbook].
Then we compared data from two trials with the data reported in the review and found some major misrepresentations:
(1) Jacobs et al. report an improvement in the T-score of their main outcome (CGI-P) of 4.1 for homeopathy and 9.1 for controls, that is placebo outperformed the homeopathic intervention. But the authors give an effect size of 0.272 in favour of homeopathy which is the opposite of the findings in the trial.
(2) Oberai et al. report effect sizes for their three main outcomes of 0.22, 0.59 and 0.54 (CPRS-R, CGISS, CGIIS repectively). There is no way that this yields a pooled effect size of 1.436 as given in the review.
We conclude that the positive result obtained by the authors is due to a combination of the inclusion of biased trials unsuitable to build evidence together with some major misreporting of study outcomes.
Our recommendation would be that the authors reconsider their review and improve their report. Maybe the editors would like to add a caution-notice to the paper – if not to withdraw it completely.
In June 2023, a full year after our submission, we were informed that Pediatric Research would not publish our criticism because the priority given to it was not sufficient to justify publication. But we were assured, that the journal would take the matter seriously, that they will investigate this matter and take appropriate editorial action. But as of today (End of June 2023) no expression of concern has been published.
Did the journal receive other comments or criticisms related to the paper in question? No, apparently there were none, at least none was published and the paper remains unchallenged to this day. This means that it might be taken for reliable evidence on the effectiveness of homeopathy and mislead patients, carers, practitioners, decision-makers, etc.
We feel this is unacceptable and therefore again wrote to the editors asking to reconsider their decision. Here is our letter:
Dear …
together with my co-authors we would like to comment your decision about our letter to the editor about an extremely faulty and misleading paper that may well create harm to patients. In fact we find it very hard to accept your decision not to publish our comment.
We understand that Pediatric Research is a high impact journal with a 2-year IF of nearly 4. Your journal is member of COPE and is indexed with quite a few first rank institutions. By all standards, any reader will be convinced that a paper published in Pediatric Research is based on solid research and the results are derived by rigorous methodology and are as reliable as can be. Especially if this paper remains unchallenged by any reader’s comments for a full year after publication. This is your responsibility to the scientific community. And to the children that might receive treatment based on knowledge spread through your journal.
How then can it be, that an article about homeopathy, a thoroughly implausible lore, in the treatment of ADHD is published in Pediatric Research, where the authors come to the conclusion “that individualized homeopathy showed a clinically relevant and statistically robust effect in the treatment of ADHD”?
In our comment we point out that the authors made a lot of errors – to say it mildly. They deny the doubtful quality of the studies they included in their meta-analysis, they did not stick to their own exclusion criteria, the data the authors report do not resemble the findings of the studies they were allegedly taken from, the one study setting the results is a mere pilot study.
The reason you give for our letter not being published is that it was not given enough priority to justify publication. We would like to know: Which issues can conceivably receive higher priority than the fact that a paper in your journal is downright wrong and misleading?
What do you need to deem a comment important? Up to now the paper is unchallenged by any reader’s comments, so apparently there was no other letter to the editor that might be given higher priority than ours.
We ask you to review your decision, or better still, consider a retraction of the paper altogether. If so, an expression of concern should be issued at once. After all, the COPE-guidelines for retraction state “clear evidence, that the findings are unreliable, either as a result of major error (…), or as a result of fabrication (…) or faslification (…)’ as a reason to consider retraction.
Otherwise the malpractice of homeopathy will have a first class evidence that will be helpful to promote homeopathy to parents and their children.
Watch this space!
There is widespread agreement amongst clinicians that people with non-specific low back pain (NSLBP) comprise a heterogeneous group and that their management should be individually tailored. One treatment known by its tailored design is the McKenzie method (e.g. an individualized program of exercises based on clinical clues observed during assessment) used mostly but not exclusively by physiotherapists.
A recent Cochrane review evaluated the effectiveness of the McKenzie method in people with (sub)acute non-specific low back pain. Randomized clinical trials (RCTs) investigating the effectiveness of the McKenzie method in adults with (sub)acute (less than 12 weeks) NSLBP.
Five RCTs were included with a total of 563 participants recruited from primary or tertiary care. Three trials were conducted in the USA, one in Australia, and one in Scotland. Three trials received financial support from non-commercial funders and two did not provide information on funding sources. All trials were at high risk of performance and detection bias. None of the included trials measured adverse events.
McKenzie method versus minimal intervention (educational booklet; McKenzie method as a supplement to other intervention – main comparison) There is low-certainty evidence that the McKenzie method may result in a slight reduction in pain in the short term (MD -7.3, 95% CI -12.0 to -2.56; 2 trials, 377 participants) but not in the intermediate term (MD -5.0, 95% CI -14.3 to 4.3; 1 trial, 180 participants). There is low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD -2.5, 95% CI -7.5 to 2.0; 2 trials, 328 participants) nor in the intermediate term (MD -0.9, 95% CI -7.3 to 5.6; 1 trial, 180 participants).
McKenzie method versus manual therapy There is low-certainty evidence that the McKenzie method may not reduce pain in the short term (MD -8.7, 95% CI -27.4 to 10.0; 3 trials, 298 participants) and may result in a slight increase in pain in the intermediate term (MD 7.0, 95% CI 0.7 to 13.3; 1 trial, 235 participants). There is low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD -5.0, 95% CI -15.0 to 5.0; 3 trials, 298 participants) nor in the intermediate term (MD 4.3, 95% CI -0.7 to 9.3; 1 trial, 235 participants).
McKenzie method versus other interventions (massage and advice) There is very low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD 4.0, 95% CI -15.4 to 23.4; 1 trial, 30 participants) nor in the intermediate term (MD 10.0, 95% CI -8.9 to 28.9; 1 trial, 30 participants).
The authors concluded that, based on low- to very low-certainty evidence, the treatment effects for pain and disability found in our review were not clinically important. Thus, we can conclude that the McKenzie method is not an effective treatment for (sub)acute NSLBP.
The hallmark of the McKenzie method for back pain involves the identification and classification of nonspecific spinal pain into homogenous subgroups. These subgroups are based on the similar responses of a patient’s symptoms when subjected to mechanical forces. The subgroups include postural syndrome, dysfunction syndrome, derangement syndrome, or “other,” with treatment plans directed to each subgroup. The McKenzie method emphasizes the centralization phenomenon in the assessment and treatment of spinal pain, in which pain originating from the spine refers distally, and through targeted repetitive movements the pain migrates back toward the spine. The clinician will then use the information obtained from this assessment to prescribe specific exercises and advise on which postures to adopt or avoid. Through an individualized treatment program, the patient will perform specific exercises at home approximately ten times per day, as opposed to 1 or 2 physical therapy visits per week. According to the McKenzie method, if there is no restoration of normal function, tissue healing will not occur, and the problem will persist.
Classification:
The postural syndrome is pain caused by mechanical deformation of soft tissue or vasculature arising from prolonged postural stresses. These may affect the joint surfaces, muscles, or tendons, and can occur in sitting, standing, or lying. Pain may be reproducible when such individuals maintain positions or postures for sustained periods. Repeated movements should not affect symptoms, and relief of pain typically occurs immediately following the correction of abnormal posture.
The dysfunction syndrome is pain caused by the mechanical deformation of structurally impaired soft tissue; this may be due to traumatic, inflammatory, or degenerative processes, causing tissue contraction, scarring, adhesion, or adaptive shortening. The hallmark is a loss of movement and pain at the end range of motion. Dysfunction has subsyndromes based upon the end-range direction that elicits this pain: flexion, extension, side-glide, multidirectional, adherent nerve root, and nerve root entrapment subsyndromes. Successful treatment focuses on patient education and mobilization exercises that focus on the direction of the dysfunction/direction of pain. The goal is on tissue remodeling which can be a prolonged process.
The derangement syndrome is the most commonly encountered pain syndrome, reported in one study to have a prevalence as high as 78% of patients classified by the McKenzie method. It is caused by an internal dislocation of articular tissue, causing a disturbance in the normal position of affected joint surfaces, deforming the capsule, and periarticular supportive ligaments. This derangement will both generate pain and obstruct movement in the direction of the displacement. There are seven different subsyndromes which are classified by the location of pain and the presence, or absence, of deformities. Pain is typically elicited by provocative assessment movements, such as flexion or extension of the spine. The centralization and peripheralization of symptoms can only occur in the derangement syndrome. Thus the treatment for derangement syndrome focuses on repeated movement in a single direction that causes a gradual reduction in pain. Studies have shown approximately anywhere between 58% to 91% prevalence of centralization of lower back pain. Studies have also shown that between 67% to 85% of centralizers displayed the directional preference for a spinal extension. This preference may partially explain why the McKenzie method has become synonymous with spinal extension exercises. However, care must be taken to accurately diagnose the direction of pain, as one randomized controlled study has shown that giving the ‘wrong’ direction of exercises can actually lead to poorer outcomes.
Other or Nonmechanical syndrome refers to any symptom that does not fit in with the other mechanical syndromes, but exhibits signs and symptoms of other known pathology; Some of these examples include spinal stenosis, sacroiliac disorders, hip disorders, zygapophyseal disorders, post-surgical complications, low back pain secondary to pregnancy, spondylolysis, and spondylolisthesis.
CONCLUSION:
“Internationally researched” and found to be ineffective!
I have seen some daft meta-analyses in my time – this one, however, takes the biscuit. Here is its unaltered abstract:
Although mindfulness-based mind-body therapy (MBMBT) is an effective non-surgical treatment for patients with non-specific low back pain (NLBP), the best MBMBT mode of treatment for NLBP patients has not been identified. Therefore, a network meta-analysis (NMA) was conducted to compare the effects of different MBMBTs in the treatment of NLBP patients.
Methods: PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and Web of Science databases were searched for randomized controlled trials (RCTs) applying MBMBT for the treatment of NLBP patients, with all of the searches ranging from the time of database creation to January 2023. After 2 researchers independently screened the literature, extracted information, and evaluated the risks of biases in the included studies, the data were analyzed by using Stata 16.0 software.
Results: A total of 46 RCTs were included, including 3,886 NLBP patients and 9 MBMBT (Yoga, Ayurvedic Massage, Pilates, Craniosacral Therapy, Meditation, Meditation + Yoga, Qigong, Tai Chi, and Dance). The results of the NMA showed that Craniosacral Therapy [surface under the cumulative ranking (SUCRA): 99.2 and 99.5%] ranked the highest in terms of improving pain and disability, followed by Other Manipulations (SUCRA: 80.6 and 90.8%) and Pilates (SUCRA: 54.5 and 71.2%). In terms of improving physical health, Craniosacral Therapy (SUCRA: 100%) ranked the highest, followed by Pilates (SUCRA: 72.3%) and Meditation (SUCRA: 55.9%). In terms of improving mental health, Craniosacral Therapy (SUCRA: 100%) ranked the highest, followed by Meditation (SUCRA: 70.7%) and Pilates (SUCRA: 63.2%). However, in terms of improving pain, physical health, and mental health, Usual Care (SUCRA: 7.0, 14.2, and 11.8%, respectively) ranked lowest. Moreover, in terms of improving disability, Dance (SUCRA: 11.3%) ranked lowest.
Conclusion: This NMA shows that Craniosacral Therapy may be the most effective MBMBT in treating NLBP patients and deserves to be promoted for clinical use.
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This meta-analysis has too many serious flaws to mention. Let me therefore just focus on the main two:
- Craniosacral Therapy is not an MBMBT.
- Craniosacral Therapy is not effective for NLBP. The false positive result was generated on the basis of 4 studies. All of them have serious methodological problems that prevent an overall positive conclusion about the effectiveness of this treatment. In case you don’t believe me, here are the 4 abstracts:
1) Background and objectives: The study aimed to compare the effectiveness of craniosacral therapy (CST), muscle energy technique (MET), and sensorimotor training (SMT) on pain, disability, depression, and quality of life of patients with non-specific chronic low back pain (NCLBP).
Methodology: In this randomized clinical trial study 45 patients with NCLBP were randomly divided in three groups including CST, SMT, and MET. All groups received 10 sessions CST, SMT, and MET training in 5 weeks. Visual analogue scale (VAS), Oswestry functional disability questionnaire (ODQ), Beck depression inventory-II (BDI-II), and 36-item short form health survey (SF-36) were used to evaluate the pain, disability, depression, and quality of life, respectively, in three times, before treatment, after the last session of treatment, and after 2 months follow up.
Results: The Results showed that VAS, ODI, BDI, and SF-36 changes were significant in the groups SMT, CST and MET (p < 0.001, p < 0.001, p < 0.001). The VAS, ODI, BDI, and SF-36 changes in post-treatment and follow-up times in the CST group were significantly different in comparison to SMT group, and the changes in VAS, ODI, BDI, and SF-36 at after treatment and follow-up times in the MET group compared with the CST group had a significant difference (p < 0.001).
Conclusion: Craniosacral therapy, muscle energy technique, and sensorimotor training were all effective in improvement of pain, depression, functional disability, and quality of life of patients with non-specific chronic low back pain. Craniosacral therapy is more effective than muscle energy technique, and sensorimotor training in post-treatment and follow up. The effect of craniosacral therapy was continuous after two months follow up.
2) Background: Craniosacral therapy (CST) and sensorimotor training (SMT) are two recommended interventions for nonspecific chronic low back pain (NCLBP). This study compares the effects of CST and SMT on pain, functional disability, depression and quality of life in patients with NCLBP.
Methodology: A total of 31 patients with NCLBP were randomly assigned to the CST group (n=16) and SMT (n=15). The study patients received 10 sessions of interventions during 5 weeks. Visual analogue scale (VAS), Oswestry disability index (ODI), Beck depression inventory-II (BDI-II), and Short Form-36 (SF-36) questionnaires were used at baseline (before the treatment), after the treatment, and 2 months after the last intervention session. Results were compared and analyzed statistically.
Results: Both groups showed significant improvement from baseline to after treatment (p < 0.05). In the CST group, this improvement continued during the follow-up period in all outcomes (p < 0.05), except role emotional domain of SF-36. In the SMT group, VAS, ODI and BDI-II increased during follow-up. Also, all domains of SF-36 decreased over this period. Results of group analysis indicate a significant difference between groups at the end of treatment phase (p < 0.05), except social functioning.
Conclusions: Results of our research confirm that 10 sessions of craniosacral therapy (CST) or sensorimotor training (SMT) can significantly control pain, disability, depression, and quality of life in patients with NCLBP; but the efficacy of CST is significantly better than SMT.
3) Background: Non-specific low back pain is an increasingly common musculoskeletal ailment. The aim of this study was to examine the utility of craniosacral therapy techniques in the treatment of patients with lumbosacral spine overload and to compare its effectiveness to that of trigger point therapy, which is a recognised therapeutic approach.
Material and methods: The study enrolled 55 randomly selected patients (aged 24-47 years) with low back pain due to overload. Other causes of this condition in the patients were ruled out. The participants were again randomly assigned to two groups: patients treated with craniosacral therapy (G-CST) and patients treated with trigger point therapy (G-TPT). Multiple aspects of the effectiveness of both therapies were evaluated with the use of: an analogue scale for pain (VAS) and a modified Laitinen questionnaire, the Schober test and surface electromyography of the multifidus muscle. The statistical analysis of the outcomes was based on the basic statistics, the Mann-Whitney U test and Wilcoxon’s signed rank test. The statistical significance level was set at p≤0.05.
Results: Both groups demonstrated a significant reduction of pain measured with the VAS scale and the Laitinen questionnaire. Moreover, the resting bioelectric activity of the multifidus muscle decreased significantly in the G-CST group. The groups did not differ significantly with regard to the study parameters.
Conclusions: 1. Craniosacral therapy and trigger point therapy may effectively reduce the intensity and frequency of pain in patients with non-specific low back pain. 2. Craniosacral therapy, unlike trigger point therapy, reduces the resting tension of the multifidus muscle in patients with non-specific lumbosacral pain. The mechanism of these changes requires further research. 3. Craniosacral therapy and trigger point therapy may be clinically effective in the treatment of patients with non-specific lumbosacral spine pain. 4. The present findings represent a basis for conducting further and prospective studies of larger and randomized samples.
4) Background: Non-specific low back pain is an increasingly common musculoskeletal ailment. The aim of this study was to examine the utility of craniosacral therapy techniques in the treatment of patients with lumbosacral spine overload and to compare its effectiveness to that of trigger point therapy, which is a recognised therapeutic approach.
Material and methods: The study enrolled 55 randomly selected patients (aged 24-47 years) with low back pain due to overload. Other causes of this condition in the patients were ruled out. The participants were again randomly assigned to two groups: patients treated with craniosacral therapy (G-CST) and patients treated with trigger point therapy (G-TPT). Multiple aspects of the effectiveness of both therapies were evaluated with the use of: an analogue scale for pain (VAS) and a modified Laitinen questionnaire, the Schober test and surface electromyography of the multifidus muscle. The statistical analysis of the outcomes was based on the basic statistics, the Mann-Whitney U test and Wilcoxon’s signed rank test. The statistical significance level was set at p≤0.05.
Results: Both groups demonstrated a significant reduction of pain measured with the VAS scale and the Laitinen questionnaire. Moreover, the resting bioelectric activity of the multifidus muscle decreased significantly in the G-CST group. The groups did not differ significantly with regard to the study parameters.
Conclusions: 1. Craniosacral therapy and trigger point therapy may effectively reduce the intensity and frequency of pain in patients with non-specific low back pain. 2. Craniosacral therapy, unlike trigger point therapy, reduces the resting tension of the multifidus muscle in patients with non-specific lumbosacral pain. The mechanism of these changes requires further research. 3. Craniosacral therapy and trigger point therapy may be clinically effective in the treatment of patients with non-specific lumbosacral spine pain. 4. The present findings represent a basis for conducting further and prospective studies of larger and randomized samples.
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I REST MY CASE
“A Nutrient Mix Designed at the Dr. Rath Research Institute is Effective Against Different Types of Coronavirus.” With these words (and the picture below), the ‘Dr. Rath Research Institute’ recently announced its sensational finding on Twitter.
Clicking on the link they provided, got me to the following article:
In this new study we wanted to find out whether certain natural substances could help fight against SARS-CoV-2 (the virus that causes COVID-19), and another type of coronavirus known as HCoV-229E which infects humans and is associated with the common cold and its symptoms.
The importance of the study relates to the fact that COVID-19 is still a big problem, especially for older people and those with weak immune systems. Current approaches using RNA- and DNA -based vaccines are not effective in preventing the infection and spread of SARS-CoV-2, or its variants such as Omicron. The anti-viral drugs used against the pandemic are similarly not fully effective. It is therefore important to develop other approaches, especially those involving safe, natural substances, that could be used alongside or instead of conventional treatments.
For the study, scientists at the Dr. Rath Research Institute used a combination of natural substances including vitamin C, polyphenols, and other nutrients. They gave the nutrient mix to mice infected with one or other of the two types of coronaviruses, to see if it could reduce the numbers of viral particles and spike proteins in the animals’ lungs.
Based on our earlier work using human cells growing in culture we already knew that the combination of nutrients in this mixture was effective in controlling key cellular mechanisms of SARS-CoV-2 infection, including inhibiting the multiplication of the virus.
We had found that the nutrient mix could inhibit an enzyme, RNA-dependent RNA polymerase (RdRp), which is needed for a virus to make copies of itself. The mix was also effective in preventing viral spike protein from binding to cell surfaces and entering cells. It additionally worked in decreasing the number of so-called ACE2 receptor proteins, which are expressed by cells in the lungs, blood vessels, and other organs, and that help the virus to get into cells.
In this latest study the nutrient mix was administered daily to mice infected with either SARS-CoV-2 or HCoV-229E, to see if it could reduce infectivity in terms of the amounts of viral particles and spike proteins found in the lungs. Infected mice in the control group were fed a normal diet without nutrient supplementation. The amounts of viral particles and spike proteins in the lungs were evaluated using special molecular-based tests. We also examined the effects of the nutrient mix on the presence of immune cells in the lungs, as an indication of tissue inflammation.
The results showed that, compared to mice in the control group, the nutrients significantly reduced the amounts of viral particles and spike proteins in the lungs of infected mice. Moreover, the mix was equally effective in mice infected with either of the two types of coronaviruses. This indicates that the nutrients affected common mechanisms of infection and were not specific to a particular type of virus. It also explains the results of our previous studies, which showed that the nutrient mix was effective in stopping SARS-CoV-2 and several of its mutated forms, including Omicron variants, from entering the cells.
Crucially, we found the nutrient mix affected not only the virus itself; it also reduced the ability of the virus to enter cells by decreasing the number of ACE2 receptors on cell surfaces. In the presence of inflammation, which is commonly associated with infections, there were similarly less ACE2 receptors on cells. Nutrient anti-inflammatory effects were also observed in the lung tissue of the mice.
In conclusion, our study showed that the nutrient mix could help reduce the infectivity of SARS-CoV-2 and the associated common cold virus HCoV-229E in mice at different stages of infectivity. The fact that different mechanisms were affected simultaneously demonstrates the superior efficacy of nutrients compared to drugs, the latter of which usually target only a single mechanism and allow the virus to escape by mutating.
The unique composition and efficacy of our nutrient mix has been awarded US and international patents. While more research is needed in order to fully confirm its efficacy in human clinical trials, the application of this safe micronutrient combination as soon as possible should ultimately benefit people worldwide and save on healthcare costs.
So, the claim that a Nutrient Mix is “Effective Against Different Types of Coronavirus” rests on some lousy experiments on rats?
Might we call this misleading or dishonest?
And what is the Dr. Rath Research Institute?
Could it belong to the Dr. Rath Foundation?
The very foundation that once published this about me:
Professor Edzard Ernst: A Career Built On Discrediting Natural Health Science?
Professor Edzard Ernst, a retired German physician and academic, has recently become a prominent advocate of plans that could potentially outlaw the entire profession of naturopathic doctors in Germany. Promoting the nonsensical idea that naturopathic medicine somehow poses a risk to public health, Ernst attacks its practitioners as supposedly having been educated in “nonsense”. Tellingly, however, given that he himself has seemingly not published even so much as one completely original scientific trial of his own, Ernst’s apparent attempts to discredit natural healthcare approaches are largely reliant instead on his analysis or review of handpicked negative studies carried out by others.
SAY NO MORE!
This randomized, double-blind, placebo-controlled trial investigated whether supplementing older adults with monthly doses of vitamin D alters the incidence of major cardiovascular events.
A total of 21 315 participants aged 60-84 years were enrolled. Exclusion criteria were self-reported hypercalcemia, hyperparathyroidism, kidney stones, osteomalacia, sarcoidosis, taking >500 IU/day supplemental vitamin D, or being unable to give consent because of language or cognitive impairment.
The trial participants received 60 000 IU/month of vitamin D3 (n=10 662) or placebo (n=10 653) taken orally for up to five years. 16 882 participants completed the intervention period: placebo 8270 (77.6%); vitamin D 8552 (80.2%). The main outcome for this analysis was the occurrence of a major cardiovascular event, including myocardial infarction, stroke, and coronary revascularisation, determined through linkage with administrative datasets. Each event was analyzed separately as secondary outcome. Flexible parametric survival models were used to estimate hazard ratios and 95% confidence intervals.
21 302 people were included in the analysis. The median intervention period was five years. 1336 participants experienced a major cardiovascular event (placebo 699 (6.6%); vitamin D 637 (6.0%)). The rate of major cardiovascular events was lower in the vitamin D group than in the placebo group (hazard ratio 0.91, 95% confidence interval 0.81 to 1.01), especially among those who were taking cardiovascular drugs at baseline (0.84, 0.74 to 0.97; P for interaction=0.12), although the P value for interaction was not significant (<0.05). Overall, the difference in standardized cause-specific cumulative incidence at five years was −5.8 events per 1000 participants (95% confidence interval −12.2 to 0.5 per 1000 participants), resulting in a number needed to treat to avoid one major cardiovascular event of 172. The rate of myocardial infarction (hazard ratio 0.81, 95% confidence interval 0.67 to 0.98) and coronary revascularisation (0.89, 0.78 to 1.01) was lower in the vitamin D group, but there was no difference in the rate of stroke (0.99, 0.80 to 1.23). The incidence of adverse events was similar in the two groups.
The authors concluded that vitamin D supplementation might reduce the incidence of major cardiovascular events, particularly myocardial infarction and coronary revascularisation. This protective effect could be more marked in those taking statins or other cardiovascular drugs at baseline. Subgroup analyses in other large trials might help to clarify this issue. In the meantime, these findings suggest that conclusions that vitamin D supplementation does not alter risk of cardiovascular disease are premature.
This is an impressive study and a disappointing result. That vitamin D supplementation might reduce the incidence of major cardiovascular events was known before; thus we would not have needed such an expensive study to arrive at this conclusion. That the protective effect might be more marked in patients taking statins or other cardiovascular drugs seems odd, in my view. Could it be, I ask myself, that the protective effect is unrelated to cardiovascular drugs but simply more marked in those individuals who are at a higher than average risk of cardiovascular events?
In any case, the protective effect is small and seems to be of questionable clinical relevance.
I missed this paper when it first came out in 2022. Yet, it seems potentially quite important and I, therefore, feel like discussing it here:
President of the UNESCO Committee on Bioethics Stefan Semplici called on the governments of all countries to ensure free and wider access of their citizens to alternative medicine and pay for this therapy through health insurance. Alternative medicine based on tradition – traditional medicine, in many poor countries is the only treatment option for the population. In developed countries, and especially in China and India, it enjoys well-deserved prestige (for example, acupuncture and herbal medicine) and is often integrated into the public health system.
The International Committee on Bioethics of UNESCO announced the recognition of these alternative therapies as an option for medical practice and, at the same time, as part of the identity of the cultural traditions of various nations. The UNESCO Universal Declaration on Bioethics and Human Rights includes the right to the highest attainable standard of health (Article 14), the right to respect for pluralism and cultural diversity (Article 12) and traditional knowledge (Article 17). The purpose of this document is to establish criteria for the respect and acceptability of different types of medicine without compromising the assurance of quality and patient safety that is essential in all treatments.
In order to adapt the traditions of traditional therapies to advances in medicine, this international organization calls on governments and the scientific community to collaborate with practitioners of alternative therapies to evaluate their effectiveness and safety and develop therapeutic standards and protocols for integrating traditional medicine into healthcare system. The UNESCO International Bioethics Committee believes that these methods should be seen as complementary to modern medicine, and not just an alternative to it.
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The United Nations Educational, Scientific and Cultural Organization (UNESCO) is an agency of the United Nations aimed at promoting world peace and security through international cooperation in education, arts, sciences, and culture. UNESCO’s International Bioethics Committee (IBC) is a body of 36 independent experts that follows progress in the life sciences and its applications in order to ensure respect for human dignity and freedom.
I have to say that I rarely have seen an announcement in so-called alternative medicine (SCAM) that is more confusing and less well thought through. The UNESCO Committee on Bioethics wants:
- alternative therapies as an option for medical practice,
- the highest attainable standard of health,
- to collaborate with practitioners of alternative therapies to evaluate their effectiveness and safety.
When I first read these lines, I asked myself: who on earth wrote such nonsense? It was certainly not written by someone who understands healthcare, SCAM, and evidence-based medicine.
As discussed almost permanently on this blog, most forms of SCAM have not been shown to generate more good than harm. This means that employing them ‘as an option in medical practice’ cannot possibly produce ‘the highest attainable standards of health’. In fact, the UNESCO plan would lead to lower not higher standards. How can a committee on bioethics not realize that this is profoundly unethical?
Collaboration with practitioners of alternative therapies to evaluate SCAM’s effectiveness and safety sounds a bit more reasonable. It ignores, however, that tons of evidence already exist but fail to be positive. Why do these experts in bioethics not advocate to first make a sober assessment of the published literature?
I must say that the initiative of the UNESCO Committee on Bioethics puzzles me a lot and disturbs me even more.
I’d be keen to learn what you think of it.
This article by a Postgraduate Trainee (Dept. of Case Taking and Repertory, National Institute of Homoeopathy, Govt. of India) an Assistant Professor (Dept. of Surgery, National Institute of Homoeopathy Govt. of India) and another Assistant Professor (Dept. of Obstetrics & Gynaecology, Midnapore Homoeopathic Medical College & Hospital, Govt. of West Bengal) might not be available online (Clinical Medicine and Health Research Journal, Volume 03, Issue 03, May – June 2023 Page No. 444-446) but it is I think worth discussing. Here is its abstract:
Warts are one of the common dermatological disorders caused by human papilloma viruses encountered in our day to day life. These are cutaneous or mucosal infection needs proper care and treatment to prevent its transmission and complete healing. Although mostly warts are dealt with the therapeutic approach, i.e. on the basis of its peculiar type and location but it can even be successfully treated by constitutional approach. This article is regarding a case of warts treated successfully with Rhus Tox followed by Ferrum Met selected as the simillimum and proved its effectiveness in a short period of time.
As the abstract is not very informative, let me show you also some sections from the paper itself:
The patient presented with warts on right wrist for 1 year. There were plane warts at back of wrist, which was smooth, slightly elevated and skin coloured. There was no history of warts or other benign skin disease in the family. This case treated with individualized homoeopathic medicine showed complete resolution of the warts. There is no cure for wart in conventional medicine except removal of them with various methods. Although it does not rule out the chance of recurrence, later on may deep organic disease. That is why a substantial number of warts patients resort to Complementary and Alternative Medicine (CAM), especially homoeopathy.
In this case, Ferrum Metallicum 0/1 was selected as a ‘similimum’ based on totality of symptoms, repertorial analysis and consultation with Homoeopathic Materia Medica, which was given more priority in this case. After seeing improvement, succeeding potency was prescribed. After Ferrum Met 0/4 all her complaints including warts disappeared. Thus, the outcome of this case of Plane Warts of the lady shows the success of individualized homoeopathic medicine in treatment of wart.
Conclusion:
This case report suggests homoeopathic treatment as a promising complementary or alternative therapy and emphasizes the need of repertorisation in individualized homoeopathic prescription. This case shows a positive role of homoeopathic in treating Warts. However, this is a single case study and requires well designed studies which may be taken up for future scientific validation.
This case report reminded me of an exciting and quite lovely story: at Exeter, we once conducted a wart study. It was a placebo-controlled, double-blind trial where the verum group received distant healing and the controls nothing at all. After planning the study, I was no longer involved in its running. As I happened to have a wart at the time, I offered myself to my team as a patient. They checked me out and admitted me into the study. For the next weeks, I either received the distant healing energy or nothing; neither I nor my team knew which. My wart was photographed and measured regularly.
And then it happened: shortly after the treatment period was over, my wart had gone. Everyone was excited, especially the UK healing scene. But we had to wait until the trial was finished, the results were calculated, and the random code was opened. The result: no difference between verum and placebo! We concluded that distant healing from experienced healers had no effect on the number or size of patients’ warts.
And my own, very personal wart?
It had disappeared spontaneously – I had been in the control group!
I know Indian homeopaths have a thing about healing warts (we discussed this before) but I am afraid the conclusions of this new paper ought to be re-written:
This case report does not suggest that homeopathic treatment is a promising complementary or alternative therapy. It shows the natural history of the condition in the disappearance of warts.
Serbian tennis player Novak Djokovic has made tennis history by winning a record 23rd Grand Slam tournament at the French Open in Paris. The controversial star is well-known for promoting wellness fads and pseudoscience and was spotted wearing a ‘nanotechnology patch’ throughout the tournament in Paris. Djokovic claimed that it was the “biggest secret of his career” and without the device, he would not have achieved what he has professionally.
What on earth is that? You may well ask.
Here is the answer to that question from the manufacturer of the device:
Taopatch uses nanotechnology material. Nanotechnology it is the study and application of exceedingly small things, in the range of 1 to 100 nanometers. It has become important in many fields: chemistry, biology, physics, engineering, medicine, and others. Taopatch® is a small disk, 1 cm in diameters and less than 1 mm thick, containing nanoparticles called “quantum dots” with a hypoallergenic coating. These quantum dots “pick up” infrared radiation from the body and emit another radiation in the range of visible light, like that used by the low-level and ultra-low-level laser therapy (Scoppa et al., 2016) plus far Infrared, near Infrared and nourishing UV light. These photons exert a favorable effect when applied to sensitive points of the human body (acupuncture points). These devices have been certified by an independent laboratory to be free of any substances having a pharmacological action that may be released and absorbed by subjects who place the devices on the skin.
SCIENTIFIC STUDIES AND BENEFITS
Balance, posture, movement, and sports
The upright posture marks a great achievement in its evolutionary path, allowing it to integrate itself more efficiently with the environment. Balance, movement efficiency, and muscle coordination are important for human activity. Electromagnetic fields interact with biological structures and may improve these functions of the organism, as is demonstrated in the following studies. The effect of the Taopatch® on the posture control of 45 healthy subjects and two multiple sclerosis patients was studied by Genua et al. (2015/2016). The purpose of posture is the maintenance of balance. Thus, 15 healthy subjects were given the Taopatch®, 15 a placebo, and 15 were control subjects. The researchers demonstrated an improvement of the relationship between balance and energy expenditure for the subjects using the device relative to placebo and control subjects. These results further suggested the application of nanotechnology devices to rehabilitation protocols and sports. This research is being continued on the use of the devices by multiple sclerosis patients.
A careful analysis of the effect of quantum dot devices (referred to as “H. I. T. postural devices”) was done by Di Summa et al., 2018. The devices were applied to 20 subjects with no equilibrium disorders. The subjects, aged between 25 and 35 years old, underwent standard stabilometric examinations (the study of body sway during quiet standing). The tests showed a statistically significant improvement in posture, meaning an increased accuracy for voluntary movements. The researchers concluded that the electromagnetic devices interact with the human electromagnetic fields, acting on the postural control system’s components.
Malchiodi Albedi et al. (2017) studied the effect of Taopatch® devices on the postural control of a set of 30 female, healthy subjects. As in the previously mentioned study, stabilometric tests were performed. Active patches were applied to 15 subjects, and sham patches to other 15 subjects in a double-blind protocol. The comparison of active patches vs. sham patches (placebos) showed an evident decrease in the sway path for the active patches, strong evidence of improved posture control.
Carbonari et al. (2020) evaluated the effect of occlusal splints and Taopatch® devices on athletes’ muscular performance, balance, and posture. A set of tests were completed: surface electromyography (sEMG), kinesiography, the squat jump and counter movement jump, and the handgrip test. The results demonstrated that the occlusal splint and Taopatch® applied alone or together immediately improved strength and balance.
Help for patients with multiple sclerosis
Lomeo et al. (2019) evaluated the use of nanotechnological devices for posture control, range of motion of the joints, and general well-being on patients affected by Multiple Sclerosis (MS). Two Taopatch® devices were applied to 28 patients. This research showed that this technology improves movement, proprioception, balance, and general well-being.
The protocols included the self-evaluation test SF-36 Health Survey (a questionnaire to indicate the health status), the international index EDSS (Expanded Disability Status Scale, a method of quantifying disability in multiple sclerosis and monitoring changes over time), and several accelerometer tests (lower limbs, lumbar flexion, and head movements).
The SF-36 and EDSS tests clearly indicated an improvement in the well-being of the patients. In particular, the SF-36 test demonstrated ameliorations in physical activity, pain, general health, vitality, social activities, emotional and mental health. The improvements were maintained after one year.
The accelerometer tests showed significant improvements in the left hip, right hip, and lumbar inflections. It is important to note that the improvements appear at three months and are also maintained after one year.
Help for dental care of handicapped subjects
Patients with motor, psychomotor, sensory, or intellectual handicaps may present problems for dental care administration. A group of seven patients with light-moderate handicaps (2 with autism, 2 unable to walk due to a stroke, 1 with Parkinson, 1 with Martin-Bell syndrome, 1 with 21 trisomy) were treated with and without the application of Taopatch® (Sedran et al., 2017). The device permitted better management of the procedure, with less fatigue for the patients and more comfort for the operator.
Improvement of antioxidative defense of cells and cell proliferation in biological models
Reactive oxygen species (ROS) are significant environmental contaminants. At high ROS concentrations, damage to cellular components occurs, such as proteins, lipids, and nucleic acids. The activity of patches containing nanocrystals in the presence of ROS was studied for two biological models, Saccaromyces cerevisiae colonies and Pisum sativum plants. (Benedetti et al., 2018). The patches were exposed to the radiation of specific routers. The treated colonies showed an active defense against reactive oxygen species, and the plant cells increased proliferation. Thus, the results reported in this research suggest extending the application of this technology to fight the effects of various contaminants and reducing the use `of biological and chemical materials for environmental defense.
REFERENCES
Benedetti, S., Degrassi C., De Martino A., Beninati S., Cappello F., Bonivento P. (2018). Improvement of Antioxidative Defense of Cells Exposed to Radio Frequencies by a Nanotechnology Device. Journal of Biomaterials, 2(1), 20-23. doi:10.11648/j.jb.20180201.15
Carbonari, B., Balducci, F., Cesaretti, G., Cesanelli, L., Botticelli, D., Messina, G. (2020). Performance, balance and posture variations with Occlusal Splint and Taopatch® devices. A retrospettive cross-over study. J Sports Med Phys Fitness, epub Jul. 30. doi: 10.23736/S0022-4707.20.11053-3.
Di Summa, F., Capobianco, F.S., Shevchenko, A., De Martino, A., Beninati, S., Baldoni, E., Lumbau, A.M.I., Chessa, G.I. (2018). Improvement of Postural Reprogramming by a Nanotechnology Device. International Journal of Biomedical Materials Research. 6(3), 57-61. doi: 10.11648/j.ijbmr.20180603.11.
Genua, D., Bruno, F., Caldarera, G., Nanotecnologie e Postura. Master’s Thesis. (Italian). UNIVERSITÀ DEGLI STUDI DI PALERMO, SCUOLA DELLE SCIENZE UMANE E DEL PATRIMONIO CULTURALE, MASTER IN POSTUROLOGIA E BIOMECCANICA (2015/2016).
Lomeo, A., Cacciaguerra, C., Garsia, D., Scolaro, A. (2019). The use of nanotechnological devices in degenerative cerebral pathologies: Perspective study on 28 patients with multiple sclerosis (French). Hegel, 9(2), 114-121.
Malchiodi Albedi, G., 1, Corna, S., Aspesi, A., Clerici, D., Parisio, C., Seitanidis, J., Cau, N., Brugliera, L., Capodaglio, P. (2017). Effects of nanotechnology-based devices on postural control in healthy subjects. J Sports Med Phys Fitness, epub Sep 5. Doi: 10.23736/S0022-4707.17.07530-2.
Scoppa, F., Gallamini, M., Belloni, G. (2016). Treating Balance Disorders with Ulllt Acupuncture Stimulation: A Further Pilot Study on Normal Subjects Confirms Clinical Applicability of Treatment. J Nov Physiother, 6(285). doi:10.4172/2165-7025.1000285.
Sedran, A., Rizzi R., Sindici, E., Sedran, A. Use of TAOPATCH nanotechnology for dental care on HCP subjects (2017). SIOH Meeting, Milan, 5-6-7 October. University of Turing, Department of Surgical Sciences, Dental School.
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Convinced?
Me neither!
What Novak Djokovic has yet again demonstrated, in my view, is the fact that expectation can influence physical outcomes (and that you don’t need many critical thinking skills to become a tennis star).
This analysis was aimed at quantifying how many studies registered on the Open Science Framework (OSF) up to November 2017 are performed but not shared after at least 4 years. Examining a sample of 315 registrations, of which 169 were research studies, the researchers found that 104 (62%) were published. They estimated that 5550 out of 9544 (58%) registered studies on the OSF are published.
Researchers use registries to make unpublished studies public, and the OSF policy to open registrations after a four-year embargo substantially increases the number of studies that become known to the scientific community. In responses to emails asking researchers why studies remained unpublished logistical issues (e.g., lack of time, researchers changing jobs) were the most common cause, followed by null results, and rejections during peer review.
The authors concluded that their study shows that a substantial amount of studies researchers perform remain unpublished.
I find this truly shocking!
Researchers are able to do research only because they receive financial and other support from elsewhere. Therefore they have an ethical obligation to publish it. The reasons frequently given for not publishing research are nothing well and truly invalid:
- Lack of time is a mere excuse; if researchers had the time to get the grants, permissions, etc. they simply must have the time to finish the job properly.
- Researchers changing jobs is an equally flawed excuse; if someone changes position, he/she is obliged to finish the job they were doing. A surgeon can also not leave mid-surgery because he has a better offer.
- ‘Null results’ is even worse as a reason. Null results are just as important as positive findings – occasionally they are even more important. If researchers fail to realize this, they simply disqualify themselves as researchers.
- ‘Rejections during peer review’ is complete nonsense. Everyone who submits papers for publication gets rejected once in a while. In this case, one learns from the peer-review comments, improves the paper in question, and re-submits it to another journal.
I have seen many studies of so-called alternative medicine (SCAM) that, for this or that reason, never were published. And I feel strongly that this is a serious violation of research ethics – so much so that I would ban researchers who are guilty of this crime from conducting research in the future. I also feel that, in order to receive the necessary support (financial and other), researchers should sign that they will publish their findings within a given time after finishing their study. Failing to comply could then incur a penalty such as paying back part of the funds wasted. I think such measures would very quickly clear up the current intolerable situation.
The General Chiropractic Council (GCC) “regulates chiropractors in the UK to ensure the safety of patients undergoing chiropractic treatment”. One might have assumed that they thus fulfill the important role of controlling the profession. Yet, one would have assumed wrongly. Instead of controlling, the GCC usually prefers promoting the profession. Their recent Chiropractic Patient Satisfaction and Experience is a good example. Let me show you several important sections of this document:
The outcomes reported here highlight two key findings:
• Overwhelmingly, chiropractic patients report high levels of satisfaction and positive experiences with their care. This was true both in the literature that examined international patient cohorts as well as the specific data collected from UK based chiropractic patients.
• A strong therapeutic relationship and good communication between patient and chiropractor underpins high satisfaction scores and a positive experience. This was confirmed both in the international literature and through both quantitative and qualitative analysis of specific data collected from UK based chiropractic patients.
Conclusion
This report shows that both existing literature and de novo data collection from patients receiving chiropractic care in the UK highlight excellent perceived experience and high satisfaction with such care.
Factors such as therapeutic alliance and communication are strongly associated with these positive perceptions by patients although other factors such as treatment beliefs were also significantly associated with satisfaction scores.
Recommendations
• To offer the highest quality of care, both in terms of clinical outcomes and patient experience, chiropractors should be explicitly skilled at curating excellent therapeutic alliances and communication with patients.
• Such skills and competences within chiropractic care delivery should receive higher visibility within the chiropractic profession generally and more specifically through advocacy within leading institutions and core emphasis within chiropractic curricula.
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By changing a few words, I have adapted the above excerpts to become a Customer Satisfaction and Experience Report of a fictitious hamburger joint published by the Hamburger General Council (HGC) of Great Britain which regulates hamburger joints in the UK to ensure the safety of consumers undergoing hamburger nutrition:
The outcomes reported here highlight two key findings:
• Overwhelmingly, customers report high levels of satisfaction and positive experiences with their restaurant. This was true both in the literature that examined international consumer cohorts as well as the specific data collected from UK based customers.
• A strong professional relationship and good communication between customer and service personell underpins high satisfaction scores and a positive experience. This was confirmed both in the international literature and through both quantitative and qualitative analysis of specific data collected from UK based hamburger consumers.
Conclusion
This report shows that both existing literature and de novo data collection from consumers eating hamburgers in the UK highlight excellent perceived experience and high satisfaction with such service.
Factors such as personal alliance and communication are strongly associated with these positive perceptions by consumers although other factors such as appetite were also significantly associated with satisfaction scores.
Recommendations
• To offer the highest quality of service, both in terms of profit and patient experience, hamburger vendors should be explicitly skilled at curating excellent professional alliances and communication with customers.
• Such skills and competences within hamburger delivery should receive higher visibility within the gastronomic trade generally and more specifically through advocacy within leading institutions and core emphasis within servers’ curricula.
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If you get the impression that I am taking the Mickey of the GCC, you are not mistaken. Yet, this post also has slightly more serious purposes. I wanted to 1) show how, in the chiropractic profession, pure BS is often disguised as research, and 2) question whether the GCC is fit for purpose.
On a more constructive note: there are many open questions that urgently need addressing in the realm of chiropractic (e.g. do chiropractors more good than harm?). I, therefore, suggest that the GCC stops publishing idiotic promotional documents disguised as research and gets on with its responsibilities.
