methodology
The story about Thomas Rau made me once again look into the plethora of hair-raising nonsense that is being claimed on social media and elsewhere about live-blood analysis (LBA). LBA is a form of ‘dark field microscopy where the sample is illuminated with light that will not be collected by the objective lens and thus will not form part of the image. This generates the appearance of a dark background with bright objects on it. LBA is employed as a diagnostic method used by many practitioners of so-called alternative medicine (SCAM). The procedure is faily simple:
- a drop of blood is taken usually by a finger prick,
- it is then put on a glass plate without anticoagulation,
- the glass plate id placed on a darkfield microscope,
- the blood cells (mostly erythrocytes) are oberved,
- the SCAM practitioner can make patients watch their own blood cells on a TV screen while they are listening to his/her interpretation of the phenomena on display.
LBA is quick and simple – provided you have a dark field microscope – looks very ‘cutting edge’ to a lay person, and commands impressive fees. For all of these reasons, it is popular in the realm of SCAM.
The claims that are being made for LBA are varied and far-reaching, e.g.:
- LBA can allegedly find pleomorphic bacteria in the blood of healthy and diseased humans.
- LBA can allegedly be used to evaluate immune system status.
- LBA can allegedly diagnose diseases or predispositions to diseases such as allergies and chronic diseases, including cancer, cardiovascular disease, immunity-related disorders and many more.
LBA has a long and colorful history, e.g.:
- In the early 1900’s, Béchamp claimed that animal body fluids contained subcellular living particles (i.e., microzymas) that transformed into bacteria upon death and decay of the host (Béchamp, A. The Blood and its Third Anatomical Element. (John Ouseley Ltd, 1912)).
- Enderlein described small entities called endobionts and protits in human blood and believed that these particles underwent a complex life cycle that correlated with disease progression ( Enderlein, G. Bacteria Cyclogeny. (Verlag Walter de Gruyter, 1925)).
- In the 1950’s, Villequez proposed that human blood was infected by a latent parasite similar to bacterial L-forms.
- In the 1960/70s, Tedeschi and Pease reported that the blood of healthy and diseased individuals appeared to be continually infected with bacteria.
For a range of reasons, I am confident that LBA is hocuspocus. In the first 10 years of my career as a scientist, I was a researcher of ‘hemorhelology’, i.e. the flow properties of blood. One of the phenomena of interest in this field is that of red cell aggregation (RCA), the tendency of erythrocytes to reversibly aggregate when left still (i.e. in the absence of shear forces normally provided by the flow of blood). In the course of our research we even developed a method to quantify RCA.
Suffice to say that I think I understand the main phenomenon SCAM practitioners see when they look down their dark field microscope. They see red cells aligning in ‘rouleaux’ similar to stacks of coins. So far, so good! Where they go wrong is the interpretation of this phenomenon. It is the normal tendency of red cells to aggregate. It is not indicative of any of the conditions SCAM practitioners think it to be.
While RCA is well researched and understood, it’s re-branding under the banner of LBA has attracted almost no research at all (and this in itself should make us think: valid methods of diagnosis are invariably well-researched). The little research that did emerge fails to show that LBA is a valid diagnostic tool. Judge for yourself, here are the abstracts of the 3 recent papers on LBA that I managed to find:
BACKGROUND: Dark field microscopy according to Enderlin claims to be able to detect forthcoming or beginning cancer at an early stage through minute abnormalities in the blood. In Germany and the USA, this method is used by an increasing number of physicians and health practitioners (non-medically qualified complementary practitioners), because this easy test seems to give important information about patients’ health status.
OBJECTIVE: Can dark field microscopy reliably detect cancer?
MATERIALS AND METHODS: In the course of a prospective study on iridology, blood samples were drawn for dark field microscopy in 110 patients. A health practitioner with several years of training in the field carried out the examination without prior information about the patients.
RESULTS: Out of 12 patients with present tumor metastasis as confirmed by radiological methods (CT, MRI or ultra-sound) 3 were correctly identified. Analysis of sensitivity (0.25), specificity (0.64), positive (0.09) and negative (0.85) predictive values revealed unsatisfactory results.
CONCLUSION: Dark field micoroscopy does not seem to reliably detect the presence of cancer. Clinical use of the method can therefore not be recommended until future studies are conducted.
CONTEXT: In 1925, the German zoologist Günther Enderlein, PhD, published a concept of microbial life cycles. His observations of live blood using darkfield microscopy revealed structures and phenomena that had not yet been described. Although very little research has been conducted to explain the phenomena Dr. Enderlein observed, the diagnostic test is still used in complementary and alternative medicine.
OBJECTIVE: To test the interobserver reliability and test-retest reliability of 2 experienced darkfield specialists who had undergone comparable training in Enderlein blood analysis.
SETTING: Inpatient clinic for internal medicine and geriatrics.
METHODS: Both observers assessed 48 capillary blood samples from 24 patients with diabetes. The observers were mutually blind and assessed their findings according to a specific item randomization list that allowed observers to specify whether Enderlein structures were visible or not.
RESULTS: The interobserver reliability for the visibility of various structures was kappa = .35 (95% CI: .27-.43), the test-retest reliability was kappa = .44 (95% CI: .36-.53).
CONCLUSIONS: This pilot study indicates that Enderlein darkfield analysis is very difficult to standardize and that the reliability of the diagnostic test is low.
Although human blood is believed to be a sterile environment, recent studies suggest that pleomorphic bacteria exist in the blood of healthy humans. These studies have led to the development of “live-blood analysis,” a technique used by alternative medicine practitioners to diagnose various human conditions, including allergies, cancer, cardiovascular disease and septicemia. We show here that bacteria-like vesicles and refringent particles form in healthy human blood observed under dark-field microscopy. These structures gradually increase in number during incubation and show morphologies reminiscent of cells undergoing division. Based on lipid analysis and Western blotting, we show that the bacteria-like entities consist of membrane vesicles containing serum and exosome proteins, including albumin, fetuin-A, apolipoprotein-A1, alkaline phosphatase, TNFR1 and CD63. In contrast, the refringent particles represent protein aggregates that contain several blood proteins. 16S rDNA PCR analysis reveals the presence of bacterial DNA in incubated blood samples but also in negative controls, indicating that the amplified sequences represent contaminants. These results suggest that the bacteria-like vesicles and refringent particles observed in human blood represent non-living membrane vesicles and protein aggregates derived from blood. The phenomena observed during live-blood analysis are therefore consistent with time-dependent decay of cells and body fluids during incubation ex vivo.
So, what does all of this mean?
It means that LBA is not a valid diagnostic tool. Its use carries the serious danger of making false-positive and false-negative diagnoses. LBA has a poor reproducibility and is prone to all sorts of artefacts (including temperature, time, contaminants, method of obtaining the blood sample, etc.) that influence RCA. RCA is a normal and reversible phenomenon that determines the flow properties of blood in vivo. In itself, it is not a sign of any disease or disposition to fall ill.
In a nutshell:
LBA is an ideal tool for quacks to rip off their gullible clients.
The WHO has just released guidelines for non-surgical management of chronic primary low back pain (CPLBP). The guideline considers 37 types of interventions across five intervention classes. With the guidelines, WHO recommends non-surgical interventions to help people experiencing CPLBP. These interventions include:
- education programs that support knowledge and self-care strategies;
- exercise programs;
- some physical therapies, such as spinal manipulative therapy (SMT) and massage;
- psychological therapies, such as cognitive behavioural therapy; and
- medicines, such as non-steroidal anti-inflammatory medicines.
The guidelines also outline 14 interventions that are not recommended for most people in most contexts. These interventions should not be routinely offered, as WHO evaluation of the available evidence indicate that potential harms likely outweigh the benefits. WHO advises against interventions such as:
- lumbar braces, belts and/or supports;
- some physical therapies, such as traction;
- and some medicines, such as opioid pain killers, which can be associated with overdose and dependence.
As you probably guessed, I am particularly intrigued by the WHO’s positive recommendation for SMT. Here is what the guideline tells us about this specific topic:
Considering all adults, the guideline development group (GDG) judged overall net benefits [of spinal manipulation] across outcomes to range from trivial to moderate while, for older people the benefit was judged to be largely uncertain given the few trials and uncertainty of evidence in this group. Overall, harms were judged to be trivial to small for all adults and uncertain for older people due to lack of evidence.
The GDG commented that while rare, serious adverse events might occur with SMT, particularly in older people (e.g. fragility fracture in people with bone loss), and highlighted that appropriate training and clinical vigilance concerning potential harms are important. The GDG also acknowledged that rare serious adverse events were unlikely to be detected in trials. Some GDG members considered that the balance of benefits to harms favoured SMT due to small to moderate benefits while others felt the balance did not favour SMT, mainly due to the very low certainty evidence for some of the observed benefits.
The GDG judged the overall certainty of evidence to be very low for all adults, and very low for older people, consistent with the systematic review team’s assessment. The GDG judged that there was likely to be important uncertainty or variability among people with CPLBP with respect to their values and preferences, with GDG members noting that some people might prefer manual
therapies such as SMT, due to its “hands-on” nature, while others might not prefer such an approach.
Based on their experience and the evidence presented from the included trials which offered an average of eight treatment sessions, the GDG judged that SMT was likely to be associated with moderate costs, while acknowledging that such costs and the equity impacts from out-of-pocket costs would vary by setting.
The GDG noted that the cost-effectiveness of SMT might not be favourable when patients do not experience symptom improvements early in the treatment course. The GDG judged that in most settings, delivery of SMT would be feasible, although its acceptability was likely to vary across
health workers and people with CPLBP.
The GDG reached a consensus conditional recommendation in favour of SMT on the basis of small to moderate benefits for critical outcomes, predominantly pain and function, and the likelihood of rare adverse events.
The GDG concluded by consensus that the likely short-term benefits outweighed potential harms, and that delivery was feasible in most settings. The conditional nature of the recommendation was informed by variability in acceptability, possible moderate costs, and concerns that equity might be negatively impacted in a user-pays model of financing.
___________________________
This clearly is not a glowing endorsement or recommendation of SMT. Yet, in my view, it is still too positive. In particular, the assessment of harm is woefully deficient. Looking into the finer details, we find how the GDG assessed harms:
WHO commissioned quantitative systematic evidence syntheses of randomized controlled
trials (RCTs) to evaluate the benefits and harms (as reported in included trials) of each of the
prioritized interventions compared with no care (including trials where the effect of an
intervention could be isolated), placebo or usual care for each of the critical outcomes (refer to Table 2 for the PICO criteria for selecting evidence). Research designs other than RCTs
were not considered.
That explains a lot!
It is not possible to establish the harms of SMT (or any other therapy) on the basis of just a few RCTs, particularly because the RCTs in question often fail to report adverse events. I can be sure of this phenomenon because we investigated it via a systematic review:
Objective: To systematically review the reporting of adverse effects in clinical trials of chiropractic manipulation.
Data sources: Six databases were searched from 2000 to July 2011. Randomised clinical trials (RCTs) were considered, if they tested chiropractic manipulations against any control intervention in human patients suffering from any type of clinical condition. The selection of studies, data extraction, and validation were performed independently by two reviewers.
Results: Sixty RCTs had been published. Twenty-nine RCTs did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred. Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors.
Conclusions: Adverse effects are poorly reported in recent RCTs of chiropractic manipulations.
The GDG did not cite our review (or any other of our articles on the subject) but, as it was published in a very well-known journal, they must have been aware of it. I am afraid that this wilfull ignorance caused the WHO guideline to underestimate the level of harm of SMT. As there is no post-marketing surveillance system for SMT, a realistic assessment of the harm is far from easy and needs to include a carefully weighted summary of all the published reports (such as this one).
The GDG seems to have been aware of (some of) these problems, yet they ignored them and simply assumed (based on wishful thinking?) that the harms were small or trivial.
Why?
Even the most cursory look at the composition of the GDG, begs the question: could it be that the GDG was highjacked by chiropractors and other experts biased towards SMT?
The more I think of it, the more I feel that this might actually be the case. One committee even listed an expert, Scott Haldeman, as a ‘neurologist’ without disclosing that he foremost is a chiropractor who, for most of his professional life, has promoted SMT in one form or another.
Altogether, the WHO guideline is, in my view, a shameful example of pro-chiropractic bias and an unethical disservice to evidence-based medicine.
He came to my attention via the sad story recently featured here about patients allegedly being harmed or killed in a Swiss hospital for so-called alternative medicine (SCAM). What I then learned about the doctor in charge of this place fascinated me:
Rau states about himself (my translation):
Early on, Dr Rau focused on natural therapies, in particular homeopathy and dietary changes. The healing success of his patients proved him right, so he studied alternative healing methods with leading practitioners. These included orthomolecular medicine, Chinese and Ayurvedic medicine and European holistic medicine. With his wealth of knowledge and over 30 years of experience, Dr Rau formed his own holistic theory of healing: Swiss Biological Medicine – Dr Rau’s Biological Medicine. It is based on the principles of detoxification, nutrition, digestion and sustainable strengthening of the immune system.
Career & studies:
- Medical studies at the University of Bern
- Final medical examinations in Switzerland and the USA
- Subsequent work in rheumatology, internal and general medicine
- Member of the Swiss Medical Association FMH since 1981
- 1981 to 1992 conventional physician & medical director of a Swiss spa centre for rheumatology and rehabilitation medicine
- 1983 to 1992 Doctor at a drug rehabilitation centre
- 1992 to 2019 Establishment of the Paracelsus Clinic Lustmühle as medical director and partner
- until 2020 Head of the academic network and training organisation “Paracelsus Academy”
Rau also states this:
- 2019 mit dem Honorarprofessoren-Titel von der Europäischen Universität in Wien ausgezeichnet (2019, he was awarded the title of homorary professor at the European University in Vienna)
This puzzles me because there is no such institution as the ‘Europäische Universität in Wien’. There is a Central European University but this can hadly be it?!
Now, I am intrigued and see what the ‘honorary professor’ might have published. Sadly, there seems to be nothing on Medline except 2 interviews. In one interview, Rau explains (amongst other things) ‘live blood analysis’, a method that we have repeatedly discussed before (for instance, here and here):
Darkfield microscopy shows a lot. We take 1 drop of blood and look at it under a very large-scale magnification. The blood is life under the glass. Once it’s on the glass, there isn’t oxygen or light or heat. This is a giant stress for the blood. So we see how, over a time, the blood reacts to this stress, and how the blood cells tolerate the stress. You can see the changes. So we take a drop of blood that represents the organism and put it under stress and look at how the cells react to the stress, and then we can see the tolerance and the resistiveness of these cells. Do they have a good cell-membrane face? Do they have good energetic behavior? Do they clot together? Is there a chance for degenerative diseases? Is there a cancerous tendency in this blood? We see tendencies. And that’s what we are interested in, tendencies.
Question: If you saw a cancerous tendency, what would that look like?
Rau: Cancerous tendency is a change in the cells. They get rigid, so to say. They don’t react very well.
Question: And how long does blood live outside the body?
Rau: It can live for several days. But after 1 hour, the blood is already seriously changed. For example, a leukemia patient came to my clinic for another disease. But when we did darkfield, I found the leukemia. We saw that his white blood cells were atypical. Look at this slide—the fact that there are so many white blood cells together is absolutely unusual, and the fact that there are atypical white blood cells. This shows me that the patient has myeloid leukemia. The patient had been diagnosed as having rheumatoid lung pain, but it was absolutely not true. The real cause of his pain was an infiltration of the spinal bone by these lymphocytes.
This is, of course, complete nonsense. As I explained in my blog post, live blood analysis (LBA) is not plausible and there is no evidence to support the claims made for it. It also is by no means new; using his lately developed microscope, Antony van Leeuwenhoek observed in 1686 that living blood cells changed shape during circulation. Ever since, doctors, scientists and others have studied blood samples in this and many other ways.
New, however, is what today’s SCAM practitioners claim to be able to do with LBA. Proponents believe that the method provides information about the state of the immune system, possible vitamin deficiencies, amount of toxicity, pH and mineral imbalance, areas of concern and weaknesses, fungus and yeast infections, as well as just about everything else you can imagine.
LBA is likely to produce false-positive and false-negative diagnoses. A false-positive diagnosis is a condition which the patient does not truly have. This means she will receive treatments that are not necessary, potentially harmful and financially wasteful. A false-negative diagnosis would mean that the patient is told she is healthy, while in fact she is not. This can cost valuable time to start an effective therapy and, in extreme cases, it would hasten the death of that patient. The conclusion is thus clear: LBA is an ineffective, potentially dangerous diagnostic method for exploiting gullible consumers. My advice is to avoid practitioners who employ this technique.
And what does that say about ‘honorary professor’ Rau?
I think I let you answer that question yourself.
Due to the common adverse effects of motion sickness pharmaceuticals (e.g., drowsiness), medication options to treat the condition are limited. Thus many non-pharmacological therapies are being advocated for it. One of them is osteopathy.
The purpose of this study was to explore the potential utility of a nonpharmaceutical method for motion sickness prevention, specifically an osteopathic manipulative technique (OMT). A novel OMT protocol for the reduction of motion sickness symptoms and severity was evaluated using a sham-controlled, counterbalanced, between-subjects study design. The independent variable was OMT treatment administered prior to the motion sickness-inducing procedure (rotating chair). The primary dependent measures were total and subscale scores from the Motion Sickness Assessment Questionnaire.
The OMT treatment group experienced significantly fewer gastrointestinal (mean scores postprocedure, treatment M = 20.42, sham M = 41.67) and sopite-related (mean scores postprocedure, treatment M = 12.81, sham M = 20.68) symptoms than the sham group while controlling for motion sickness susceptibility. There were no differences between groups with respect to peripheral and central symptoms.
The authors concluded that the results suggest that the treatment may prevent gastrointestinal (nausea) and sopite-related symptoms (sleepiness). These preliminary findings support further exploration of OMT for the prevention of motion sickness. A more precise evaluation of the mechanism of action is needed. Additionally, the duration of the effects needs to be investigated to determine the usefulness of this technique in training and operational settings.
Motion sickness is one of those conditions for which many forms of so-called alternative medicine (SCAM) have been tried and found in dodgy studies to be promissing, e.g.:
And now even OMT!
But before we rush into doing further research on this topic, we should perhaps ask whether the trial really does show OMT to be effective. Unfortunately, the article is behind a paywall, and I can therefore only speculate and ask whether the sham procedure was credible. Was the success of patient-blinding tested? I suspect it wasn’t. If that is so, it could mean that the OMT itself was not the reason for the results but that patient expectation caused the reported outcomes.
In any case, if nothing else, this paper shows yet again that the notion of OMT being an option purely for spinal problems is fantasy. Its advocates try everything to get it accepted as a cure all.
I don’t know why, but it was only recently that I came across RESEARCH.COM!
In case you don’t know what it is: essentially, it is a platform that offers rankings of:
- Universities,
- Journals,
- Conferences,
- Scientists
Research.com “really cares about the quality and visibility of research and our mission is to offer leading researchers better exposure of their achievements. Our rankings of scientists are based on transparent procedures based on well-established metrics gathered from trusted sources of data.
Our best scholars ranking is a credible list of leading scientists from the discipline of Medicine, established by means of a thorough analysis of 166,880 researchers determined from various bibliometric data sources. For the field of Medicine, as many as 68936 scientists were investigated.”
Like Oscar Wilde, I can resist everything except temptation. So, I typed in my name and found this:
World ranking: 938
National ranking: 103
D-Index: 140
Citations: 71,715
Obviously, I was pleased but also have to admit that I am unsure of what a ‘D-Index’ is and how it is derived (something that can be looked up, I’m sure).
Still tempted, I ventured to find the rankings of other researchers of so-called alternative medicine (SCAM). So, I spent quite some time searching the more well-known names in this field.
And the result? ZERO!
As far as I was able to determine, none of my fellow SCAM researchers have a ranking at all.
Does that mean that I am the only ‘leading’ scientist in my field?
Emboldened by this thought, I tried to find out whether any Exeter researcher is ranked higher than I am. The answer is YES: Andrew Hattersley is on rank 41. I know Andrew; he is a great scientist and person and deserves to be very high up on the list.
[I should add perhaps that I found the research.com site rather difficult to navigate. If I made errors, could someone more gifted than I please put me right?]____________________
In what way is any of this relevant?
In no way!
Yesterday, somone commented on this blog: “What have any of you so called scientists done for humans, on this site, besides throw your credentials around? Nothing, you are lifelong college students too scared to join real world.”
Now the author of these lines can be happy in the belief that he is correct.
Every now and then, I come across a paper that is so remarkable that I feel like copying it for you in its full and untouched beauty. The recent article entitled “Revisiting the therapeutic potential of homeopathic medicine Rhus Tox for herpes simplex virus and inflammatory conditions” falls in this category. Let me present to you its unchanged abstract as recently published in the ‘J Ayurveda Integr Med’:
Background: Herpes simplex virus type-1 and type-2 cause a viral disease named Herpes. Genital herpes is mainly caused by HSV-2 with symptoms of painful and itchy blisters on the vagina, cervix, buttocks, anus, penis, or inner thighs with blisters that rupture and convert into sores. The homeopathic remedy Rhus Tox has been widely used to treat herpes and has shown invitro anti-inflammatory effects in previous studies.
Purpose: The presented review focuses on relapses and harmful effects caused by acyclovir in modern medicine and the probable antiherpetic activity of Rhus Tox on HSV infection based on its pathophysiology, preclinical findings, on primary cultured mouse chondrocytes, mouse cell line MC3T3e1 and a comparative study of Natrum Mur with Rhus Tox on HSV infection.
Study design: The design of the study focuses mainly on the descriptive data available in various literature articles.
Method: Databases such as PubMed, Google Scholar, Medline and ScienceDirect were used to search the articles. Articles are selected from 1994 to 2022 focusing solely on the competence of Rhus Tox against herpes. Keywords used for the study are antiviral, Herpes, Rhus Tox, in vitro and homeopathy.
Results: The review includes fifteen articles, including 4 full-text articles on HSV, 6 in vitro studies of homeopathic compounds performed on the herpes virus, and 5 articles based on the pathophysiology and effects of Rhus tox. The review article proposes the anti-inflammatory and antiviral action of the homeopathic remedy Rhus Tox which can be used in crisis conditions when the physician doubts the simillimum, as it prevents further outbreaks of HSV infection.
Conclusion: The homeopathic medicine Rhus Tox has no cytotoxicity observed under in vitro conditions and can be used to treat herpes infection. Further studies are needed to confirm the results under in vitro and in vivo conditions as well as in clinical trials.
Considering that the paper was based on ‘descriptive data available in various literature articles’, the conclusion that “Rhus Tox … can be used to treat herpes infection” is surprising, to say the least.
In the paper itself we find many more baffling statements, e.g.:
- Modern medicines target only specific organs at a time, but there is a risk of widespread infection which influence complications such as meningitis or HSV-2 radiculopathy which are not observed after the use of homeopathy as the disease progression does not involve vital organs and the disease level stays on the skin layer itself.
- Homeopathy treats patients holistically taking into consideration all the physical, mental and characteristic ailments of the patient. Rhus tox can effectively relieve all the symptoms of herpes infection, including pain, blisters, redness, restlessness, etc. Rhus Tox can effectively penetrate the capsid structure of the infected cells and cure the patient. Rhus tox in different potencies is currently being used to treat inflammatory and viral diseases
- In homeopathy, many treatments have been clinically proven to have some impact, and in individual cases a solution for herpes viruses. Homeopathy can prevent further outbreaks of herpes simplex infection.
- Homeopathy strengthens immunity to fight infections and contributes to mental, physical, and social well-being, hence complementary therapies should be used along with the traditional antiviral drugs to give maximum comfort to the patient.
I am sure that some readers of the paper are impressed. These statments leave little doubt about the notion that homeopathy is the best thing since sliced bread. What a pity though that, for none of them, the authors (who incedently are affiliated with prestigeous sounding institutions: Homeopathic Materia Medica Department, Bharti Vidyapeeth, Homoeopathic Medical College and Hospital, Dept. of Postgraduate & Research Centre, Pune-Satara Road, Dhankawadi, Pune, 411043, India, ICMR-National AIDS Research Institute, 73 G MIDC Bhosari, Pune, India, ICMR-National AIDS Research Institute, 73 G MIDC Bhosari, Pune, India) provide any evidence whatsoever.
Homeopathy, it seems to me, is a cult characterised not just by a total lack of active ingredients but also by an equally total void of proper evidence supporting the delusions of its proponents.
So-called alternative medicine (SCAM) interventions are often being discussed as possible treatments for long COVID symptoms. However, comprehensive analysis of current evidence in this setting is still lacking. This review aims to review existing published studies on the use of SCAM interventions for patients experiencing long COVID through a systematic review.
A comprehensive electronic literature search was performed in multiple databases and clinical trial registries from September 2019 to January 2023. RCTs evaluating efficacy and safety of SCAM for long COVID were included. Methodological quality of each included trial was appraised with the Cochrane ‘risk of bias’ tool. A qualitative analysis was conducted due to heterogeneity of included studies.
A total of 14 RCTs with 1195 participants were included in this review. Study findings demonstrated that SCAM interventions could benefit patients with long COVID, especially those suffering from neuropsychiatric disorders, olfactory dysfunction, cognitive impairment, fatigue, breathlessness, and mild-to-moderate lung fibrosis. The main interventions reported were self-administered transcutaneous auricular vagus nerve stimulation, neuro-meditation, dietary supplements, olfactory training, aromatherapy, inspiratory muscle training, concurrent training, and an online breathing and well-being program.
The authors concluded that SCAM interventions may be effective, safe, and acceptable to patients with symptoms of long COVID. However, the findings from this systematic review should be interpreted with caution due to various methodological limitations. More rigorous trials focused on SCAM for long COVID are warranted in the future.
The review’s aim is, in my view, nonsense. SCAM is a diverse field which means that the review must capture a wide range of therapies each represented by just one or two primary studies. In turn, this means that general conclusions across all SCAM will be highly questionable, if not misleading.
Furthermore, I find these conclusions odd and irresponsibly misleading. My main reason for this is the poor methodological quality of the primary studies:
- Four trials were considered to have unknown bias risk for generating the random sequence due to insufficient information about the specific method of randomization used.
- Only 5 of the trials provided appropriate random allocation concealment.
- Only 5 trials were blinded to both participants and personnel.
- Three trials were rated as unknown risk of bias since insufficient information was provided.1
- Four trials failed to performed outcome assessment blinding.
- One trial did not report detailed information about drop-out cases and was defined as high risk of bias.
- Three study protocols were unavailable and had relevant outcomes that were not reported in the pre-specified way.
Moreover, safety cannot possibly be reliably estimated on the basis of the data. And finally, the statement that SCAM interventions may be effective, as the authors put it, is in my view not a valid conclusion but a silly platitude.
I therefore suggest to re-formulate the conclusion of this review as follows:
At present there is no sound evidence to assume that any SCAM intervention is effective in the management of long COVID.
Mushrooms are somewhat neglected in medical research, I often feel. This systematic review focused on clinical studies testing the effectiveness of mushrooms in cancer care. A total of 39 met the authors’ inclusion criteria. The studies included 12 different mushroom preparations. Some of the findings were encouraging:
- A survival benefit was reported using Huaier granules (Trametes robiniophila Murr) in 2 hepatocellular carcinoma studies and 1 breast cancer study.
- A survival benefit was also found in 4 gastric cancer studies using polysaccharide-K (polysaccharide-Kureha; PSK) as an adjuvant therapy.
- Eleven studies reported a positive immunological response.
- Quality-of-life (QoL) improvement and/or reduced symptom burden was reported in 14 studies using various mushroom supplements.
- Most studies reported adverse effects of grade 2 or lower, mainly nausea, vomiting, diarrhea, and muscle pain.
The authors caution that limitations included small sample size and not using randomized controlled trial design. Many of the reviewed studies were observational. Most showed favorable effects of mushroom supplements in reducing the toxicity of chemotherapy, improving QoL, favorable cytokine response, and possibly better clinical outcomes.
The authors concluded that the evidence is inconclusive to recommend the routine use of mushrooms for cancer patients. More trials are needed to explore mushroom use during and after cancer treatment.
The use of mushrooms for medicinal purposes has a long history in many cultures. Some mushrooms are known to be highly poisonous, some have hallucinogenic effects, and some are assumed to have pharmacological effects that have therapeutic potential. Some mushrooms possess pharmacologic properties such as anti-tumour, immunomodulating, antioxidant, cardiovascular, anti-hypercholesterolemic, anti-viral, anti-bacterial, anti-parasitic, anti-fungal, detoxification, hepatoprotective, and anti-diabetic effects.
Many modern medicines were derived from fungi. The best-known example is penicillin; others include several cancer drugs, statins and immunosuppressants. In Traditional Chinese Medicine, numerous herbal mixtures contain mushrooms; examples are reishi, maitake and shiitake which are all assumed to have anti-cancer properties.
As the review authors point out, there is a paucity of clinical trials testing the effectiveness of mushrooms, and the existing studies tend to be of poor quality. At present, most of our knowledge comes from traditional use or test-tube studies. The adverse effects depend on the specific mushroom in question and, can in some instances, be serious.
Considering the potential and the complexity of mycomedicine, I find it surprising to not see much more research into this subject.
Despite effective vaccines, there is still a need for effective treatments for COVID, especially for people in the community. Dietary supplements have long been used to treat respiratory infections, and preliminary evidence indicates some may be effective in people with COVID-19. This study tested whether a combination of vitamin C, vitamin D3, vitamin K2 and zinc would improve overall health and decrease symptom burden in outpatients diagnosed with COVID-19.
Participants were randomised to receive either vitamin C (6 g), vitamin D3 (1000 units), vitamin K2 (240 μg) and zinc acetate (75 mg) or placebo daily for 21 days and were followed for 12 weeks. An additional loading dose of 50 000 units vitamin D3 (or placebo) was given on day one. The primary outcome was participant-reported overall health using the EuroQol Visual Assessment Scale summed over 21 days. Secondary outcomes included health status, symptom severity, symptom duration, delayed return to usual health, frequency of hospitalisation and mortality.
A total of 90 patients (46 control, 44 treatment) were randomised. The study was stopped prematurely due to insufficient capacity for recruitment. The mean difference (control-treatment) in cumulative overall health was -37.4 (95% CI -157.2 to 82.3), p=0.53 on a scale of 0-2100. No clinically or statistically significant differences were seen in any secondary outcomes.
The authors concluded that, in this double-blind, placebo-controlled, randomised trial of outpatients diagnosed with COVID-19, the dietary supplements vitamin C, vitamin D3, vitamin K2 and zinc acetate showed no clinically or statistically significant effects on the documented measures of health compared with a placebo when given for 21 days. Termination due to feasibility limited our ability to demonstrate the efficacy of these supplements for COVID-19. Further research is needed to determine clinical utility.
In several ways I am puzzled by this study. On the other hand, I should congratulate the naturopathic authors for honestly reporting such a squarely negative result. One could, of course, argue that the study was under-powered and that thus the findings are not conclusive. However, the actual survival curve depicting the results show clearly that there was not even the tiniest trend for the supplement to show any effect. In other words, a larger sample would have most likely yielded the same result.
Participants randomised to the treatment arm received:
- Vitamin D3 50 000 units orally once on day 1 of the study (capsule).
- Vitamin K2/D3 120 μg/500 units orally two times per day for 21 days (liquid).
- Vitamin C/Zinc acetate 2 g/25 mg orally three times daily for 21 days (capsule).
I fail to understand why the researchers might have conceived the hypothesis that such a mixture would be effective. Only 90 of a planned 200 participants were enrolled in this study which ran between September 2021 and April 2022. I fail to understand why recruitment was so poor that the study eventually had to be aborted. My speculation is that the naturopaths in charge of running the trial were too inexperienced in conducting such research to make it a success.
The study was supported by the Ottawa Integrative Cancer Centre Foundation and by Mavis and Martin Sacher. All investigational products for this study were provided in-kind by New Roots Herbal. Perhaps in future these sponsors should think again before they support amateurs pretending to be scientists?
According to chiropractic belief, vertebral subluxation (VS) is a clinical entity defined as a misalignment of the spine affecting biomechanical and neurological function. The identification and correction of VS is the primary focus of the chiropractic profession. The purpose of this study was to estimate VS prevalence using a sample of individuals presenting for chiropractic care and explore the preventative public health implications of VS through the promotion of overall health and function.
A brief review of the literature was conducted to support an operational definition for VS that incorporated neurologic and kinesiologic exam components. A retrospective, quantitative analysis of a multi-clinic dataset was then performed using this operational definition.
The operational definition used in this study included:
- (1) inflammation of the C2 (second cervical vertebra) DRG,
- (2) leg length inequality,
- (3) tautness of the erector spinae muscles,
- (4) upper extremity muscle weakness,
- (5) Fakuda Step test,
- radiographic analysis based on the (6) frontal atlas cranium line and (7) horizontal atlas cranium line.
Descriptive statistics on patient demographic data included age, gender, and past health history characteristics. In addition to calculating estimates of the overall prevalence of VS, age- and gender-stratified estimates in the different clinics were calculated to allow for potential variations.
A total of 1,851 patient records from seven chiropractic clinics in four states were obtained. The mean age of patients was 43.48 (SD = 16.8, range = 18-91 years). There were more females (n = 927, 64.6%) than males who presented for chiropractic care. Patients reported various reasons for seeking chiropractic care, including, spinal or extremity pain, numbness, or tingling; headaches; ear, nose, and throat-related issues; or visceral issues. Mental health concerns, neurocognitive issues, and concerns about general health were also noted as reasons for care. The overall prevalence of VS was 78.55% (95% CI = 76.68-80.42). Female and male prevalence of VS was 77.17% and 80.15%, respectively; notably, all per-clinic, age, or gender-stratified prevalences were ≥50%.
The authors concluded that the results of this study suggest a high rate of prevalence of VS in a sample of individuals who sought chiropractic care. Concerns about general health and wellness were represented in the sample and suggest chiropractic may serve a primary prevention function in the absence of disease or injury. Further investigation into the epidemiology of VS and its role in health promotion and prevention is recommended.
This is one of the most hilarious pieces of ‘research’ that I have recently encountered. The strategy is siarmingly simple:
- invent a ficticious pathology (VS) that will earn you plently of money;
- develop criteria that allow you to diagnose this pathology in the maximum amount of consumers;
- show gullible consumers that they are afflicted by this pathology;
- use scare mongering tactics to convince consumers that the pathology needs treating;
- offer a treatment that, after a series of expensive sessions, will address the pathology;
- cash in regularly while this goes on;
- when the consumer has paid enough, declare that your fabulous treatment has done the trick and the consumer is again healthy.
The strategy is well known amongst practitioners of so-called alternative medicine (SCAM), e.g.:
- Traditional acupuncturists diagnose a ficticious imbalance of yin and yang only to normalise it with numerous acupuncture sessions.
- Naturopaths diagnose ficticious intoxications and treat it with various detox measures.
- Iridologists diagnose ficticious abnormalities of the iris that allegedly indicate organ disstress and treat it with whatever SCAM they can offer.
As they say:
No disease can be more surely, effectively, and profitably treated than a condition that the unsuspecting customer did not have in the first place!
PS
Sadly, such behavior exists in convertional medicine occasionally too, but SCAM relies almost entirely on it.
