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

Monthly Archives: July 2023

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!

It has been reported that a GP has been erased from the medical register after a disciplinary tribunal concluded yesterday that her statements on vaccines amounted to misconduct.

Dr Jayne Donegan, who no longer works as an NHS GP, was found by the tribunal to have ‘encouraged parents to mislead healthcare professionals about their children’s diet or immunization history’. The UK General Medical Council (GMC) brought several allegations against Dr Donegan, about statements made between 2019 and 2020, however, the determination of impaired fitness to practise (FTP) and subsequent erasure was based solely on her suggestions to parents.

The tribunal determined that her misconduct ‘posed an ongoing risk to patient safety given her lack of insight and lack of remediation’ and that ‘public confidence would be undermined’ if such a doctor was allowed to remain in practice. An immediate order of suspension was imposed, which the tribunal determined necessary for the ‘protection of the public’. Other GMC allegations, such as Dr. Donegan’s statements failing to ‘give balanced information on the risks and benefits of immunization’, were proved true by the tribunal but were not determined to be serious misconduct.

Dr. Donegan works as a homeopathic and naturopathic practitioner and has been ‘researching disease ecology and vaccination since 1994’, according to her website. The tribunal considered statements made by Dr. Donegan in a consultation with an undercover reporter and during her lectures on vaccination. She had said that the historical decline in deaths from whooping cough was because of sanitation and surgeons, not vaccinations. She had also suggested to audiences at her lectures that they could avoid answering questions from healthcare professionals about their child’s immunization history. When asked by an audience member about this, Dr. Donegan had said: ‘I thought what am I going to do because if I were you, I could just forge something but I can’t do that because I am a doctor and I would get struck off and I really would get struck off. What can I do? I thought maybe I can do something homeopathic because they are not having it. In the meantime, I wrote “Yes, I’ll get it done” thinking what will I do and they never came back to me, so when the next one went I just said “yes. The main thing is, don’t stick your head above the parapet because you make it difficult for them. If you say they are not vaccinated, they say they can’t go on the trip or they say “They could but the insurers won’t insure us”, so just keep saying “yes” but don’t say I said that.’

The tribunal concluded that comments like this made it clear Dr. Donegan was aware this was a ‘serious matter that could result in her being struck off’, despite her defense that she was simply ‘making people laugh’. The MPTS tribunal chair Mr Julian Weinberg said: ‘The Tribunal considered that honest and accurate communication of an individual’s medical history forms an essential part of ongoing patient healthcare and that any attempt to undermine this risks the safety of patients. It noted that whilst no dishonesty was found against Dr. Donegan, the Tribunal has found that she encouraged parents to be dishonest with healthcare professionals by, for example, forging medical documents/records, thereby undermined this essential quality of the doctor/patient relationship.’ Mr Weinberg highlighted that the tribunal’s findings did not concern ‘the rights or wrongs of her views on immunization’ but rather her encouragement to parents to mislead healthcare professionals.

Dr. Donegan said in response to the decision: ‘I boycotted the GMC’s political show trial against me which ended today. Serious irregularities include bogus dishonesty charges and bogus accusations that I put newborns at risk of serious harm.’ She added: ‘Being struck off by a corrupt GMC is a small price to pay for taking a lawful ethical stand for the safety of British children.’

Apparently, Dr. Donegan even claimed that she is delighted to be struck off the register of medical practitioners – and so, I presume, are many of us reading this post!

Yesterday, the NHS turned 75, and virtually all the newspapers have joined in the chorus singing its praise.

RIGHTLY SO!

Britain is put to shame in cancer survival league | Daily Mail Online

The idea of nationalized healthcare free for all at the point of delivery is undoubtedly a good one. I’d even say that, for a civilized country, it is an essential concept. The notion that an individual who had the misfortune to fall ill might have to ruin his/her livelihood to get treated is absurd and obscene to me.

The NHS was created the same year that I was born. Even though I did not grow up in the UK, I cannot imagine a healthcare system where people have to pay to get or stay healthy. To me, ‘free’ – it is, of course not free at all but merely free at the point of delivery – is a human right just as freedom of speech or the right to a good education.

While reading some of what has been written about the NHS’s 75th birthday, I came across more platitudes than I care to remember. Yes, we are all ever so proud of the NHS but we would be even more proud if our NHS did work adequately. I find it somewhat hypocritical to sing the praise of a system that is clearly not functioning nearly as well as that of comparable European countries (where patients also don’t have to pay out of their own pocket for healthcare). I also find it sickening to listen to politicians paying lip service, while doing little to fundamentally change things. And I find it enraging to see how the conservatives have systematically under-funded the NHS, while pretending to support it adequately.

How can we be truly proud of the NHS when it seems to be dying a slow and agonizing death due to political neglect? In the UK, politicians like to be ‘world beating’ with everything, and I am sure some Tories want you to believe that, under their leadership, a world-beating healthcare system has been established in the UK.

Let me tell you: it’s not true. I have personal experience with the healthcare systems of 5 different nations and worked as a doctor in 3 of them. In Austria, France, and Germany for instance, the system is significantly better and no patient’s finances are ruined through illness.

Now there is talk about reform – yet again! Let us please not look towards the US when thinking of reforming the NHS. I have lived for a while in America and can tell you one thing: when it comes to healthcare, the US is not a civilized country. If reform of the NHS is again on the cards, let us please look towards the more civilized parts of the world!

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.

___________________________

This meta-analysis has too many serious flaws to mention. Let me therefore just focus on the main two:

  1. Craniosacral Therapy is not an MBMBT.
  2. 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.

_______________________________

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!

A German paper reported the following horrific story about a Heilpraktiker, an alternative practitioner without a medical degree:

Starting July 7, Torben K. (46) from Solingen will have to answer to the Wuppertal Regional Court. The Heilpraktiker is said to have injected silicone oil into the penis and testicles of a man († 32) at his request. Shortly thereafter, the patient developed health problems and later died.

The prosecution accuses the Heilpraktiker from Solingen of bodily injury resulting in death and violation of the Heilpraktikergesetz.

According to the report, the victim had traveled to Solingen in June 2019, where the defendant had given him the injection in his apartment.

Back home, the 32-year-old patient suddenly developed shortness of breath, had to be hospitalized, then transferred to the university hospital in Giessen. Seven months after the injection, he is dead. According to the indictment, the patient suffered multiple organ failure as a result of blood poisoning.

Three days of trial are scheduled. The defendant faces up to 15 years in prison.

_________________________

I had never heard of intra-testicular injections. So, I did a Medline search and found just two papers of the procedure in human patients:

No 1

Blunt trauma is the most common mechanism of injury to the scrotum and testicle. Surgical exploration with primary repair, hematoma evacuation, and de-torsion are common surgical interventions. A 20-year-old male with no previous medical history presented after a high-speed motor vehicle collision. Ultrasonography demonstrated heterogeneous changes of the tunica albuginea and decreased arterial flow to bilateral testicles. He was subsequently taken to the operating room for surgical exploration, which revealed bilateral mottled testes with questionable viability. Papaverine was injected into each testicle, which resulted in visibly increased perfusion and subsequent preservation of the testicles. Conclusion: Current evidence on the use of papaverine is isolated to testicular torsion. Additional research should be conducted on the use of papaverine in blunt testicular trauma. Papaverine injection may be a valuable treatment option when inadequate perfusion is observed intra-operatively.

No 2:

Purpose: We describe a simple technique to deliver local anaesthetic for percutaneous testis biopsies.

Materials and methods: With the testis held firmly, a 25 gage needle is used to inject lidocaine, without epinephrine, into the skin and dartos superficial to the testis, then the needle is advanced through the tunica albuginea and 0.5 mL to 1.0 mL of lidocaine is injected directly into the testis. The testis becomes slightly more turgid with the injection. A percutaneous biopsy is then immediately performed.

Results: Intra-testicular lidocaine, (without the need of a cord block or any sedation) was used on a total of 45 consecutive patients having percutaneous testicular biopsies. Procedure time was short (averages less than 5 minutes) and anaesthesia was profound. There was no change in the number of seminiferous tubules for evaluation compared to biopsies on men using a cord block. Only 1/45 men had a post-procedure testicular hematoma (this resolved in 4 weeks).

Conclusions: Intra-testicular lidocaine appears to be a simple, rapid and safe method to provide anaesthesia for a percutaneous testis biopsy.

All the other papers on intra-testicular injections were about animal experiments, mostly for exploring means of castration. This renders the above case even more unusual. The Heilpraktiker’s defense might stress that the patient wanted the treatment. That may be so but is it a valid excuse? No, of course not. In my view – and I am just a medic, not a lawyer – the Heilpraktiker is responsible for the treatment regardless of how much the patient insisted on it.

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.

Subscribe via email

Enter your email address to receive notifications of new blog posts by email.

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Archives
Categories