Monthly Archives: November 2023
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?
Several newspapers have reported that, in the Paris region and in the Alpes-Maritimes, France, some 175 police officers were mobilized yesterday to arrest of Gregorian Bivolaru, 71, the Romanian guru and founder of the Movement for Spiritual Integration Towards the Absolute (Misa), which became the ‘Atman Yoga Federation’ when it expanded outside Romania.
Bivolaru had already been convicted in Romania of rape of a minor and is wanted by Interpol for trafficking women. He has also been the subject of a judicial investigation in France since July 2023 for “human trafficking, “organized gang confinement”, “rape” and “organized gang abuse”. He presents himself as the “spiritual leader” of the Atman yoga federation, which has branches in some 30 countries. Under the guise of teaching tantric yoga, this sect conditions its female followers to accept sexual relations eliminating any notion of consent. The victims were encouraged to accept sexual relations with the group’s leader and to engage in pornographic practices for a fee in France and abroad.
Twenty-six women were released during the police operation. Gregorian Bivolaru was arrested in a house in Ivry-sur-Seine where he used to receive his followers for tantric yoga “sexual initiations”. A dozen women were also held for days in the Paris region, to be handed over to the guru.
Gregorian Bivolaru’s career began in 1990 in Romania, where he first founded Misa. Accused of human trafficking and tax evasion in his home country, he moved to Sweden, where he was granted political asylum in 2005, along with a new identity. A conspiracy theorist, he has always maintained that the proceedings against him were political and that the Romanian legal system was against him.
In 2016, Gregorian Bivolaru was sentenced to six years’ imprisonment in Romania for raping a minor and extradited from France. He remained in custody for just one year. New charges were brought against him in Finland after six women, members of the Atman yoga federation, filed a complaint for “human trafficking”. This led Helsinki to issue an international wanted notice by Interpol, in 2017.
Subsequently, the sect continued to exist, still under the control of Gregorian Bivolaru, based in the Paris region. Former followers claimed that the man financed his activities by forcing his victims to submit to various forms of prostitution in strip clubs and massage parlors, or by forcing them to take part in pornographic films in Romania, Hungary and the Czech Republic.
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The International Federation of Yoga and Meditation, ATMAN, claims on its website that it is a non-profit organisation and the majority of its members are committed to a non-profit and charitable orientation. ATMAN is providing a basis for communication and cooperation between various traditional yoga schools and genuine spiritual paths worldwide, promoting true spiritual values for the benefit of mankind.
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A website for Tara Yoga states that Gregorian Bivolaru, nicknamed ‘Grieg’, “is the author of the yoga course taught in Tara and our sister schools in the ATMAN Federation. Having dedicated his entire life towards helping people awaken to that which is divine, Grieg is recognised by many as having a high level of enlightenment and spiritual power, and as belonging to the highest category of spiritual guides, bodhaka.”
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Tara is one of the ten Maha Vidyas or goddesses of the Tantric pantheon. She is the embodiment of knowledge, grace and compassion. Tara is the guiding star of all spiritual seekers, helping aspirants at any moment as they navigate ‘samsara’, the ocean of illusion, on the path to self-knowledge.
Certain aspects of yoga can be used as a non-pharmacological conservative therapeutic approach to the management of chronic low back pain (CLBP). This overview summarized and evaluated data from current systematic reviews (SRs) on the use of yoga for CLBP.
The researchers searched SRs on the use of yoga for CLBP in nine electronic databases from inception to September 2023. The methodological quality was evaluated using the Assessment of Multiple Systematic Review Scale-2 (AMSTAR-2). The reporting quality of the included SRs was evaluated using the Preferred Reporting Item for Systematic Review and Meta-Analysis-2020 (PRISMA-2020), and the quality of data was graded using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Two independent researchers performed the screening, data extraction, and quality assessment process of SRs.
A total of 13 SRs were included. The results of the AMSTAR-2 indicated that the methodological quality of the included studies was relatively low. The PRISMA-2020 checklist evaluation results indicated that methodological limitations in reporting, especially regarding data processing and presentation, were the main weaknesses. The GRADE assessment indicated that 30 outcomes were rated moderate, 42 were rated low level, and 20 were rated very low level. Downgrading factors were mainly due to the limitations of the included studies.
The authors concluded that yoga appears to be an effective and safe non-pharmacological therapeutic modality for the Management of CLBP. Currently, it may exhibit better efficacy in improving pain and functional disability associated with CLBP. However, the methodological quality and quality of evidence for SRs/MAs in the included studies were generally low, and these results should be interpreted cautiously.
Sorry, but I beg to differ!
- The safety of a therapy cannot be ascertained on the basis of such small sample sizes.
- The effectiveness of yoga has not been demonstrated by these data.
- All that has been shown with this review is that the quality of the research in this area is too poor for drawing conclusions.
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.
This study was aimed at evaluating the effectiveness of osteopathic visceral manipulation (OVM) combined with physical therapy in pain, depression, and functional impairment in patients with chronic mechanical low back pain (LBP).
A total of 118 patients with chronic mechanical LBP were assessed, and 86 who met the inclusion criteria were included in the randomized clinical trial (RCT). The patients were randomized to either:
- Group 1 (n=43), who underwent physical therapy (5 days/week, for a total of 15 sessions) combined with OVM (2 days/week with three-day intervals),
- or Group 2 (n=43), which underwent physical therapy (5 days/week, for a total of 15 sessions) combined with sham OVM (2 days/week with three-day intervals).
Both groups were assessed before and after treatment and at the fourth week post-treatment.
Seven patients were lost to follow-up, and the study was completed with 79 patients. Pain, depression, and functional impairment scores were all improved in both groups (p=0.001 for all). This improvement was sustained at week four after the end of treatment. However, improvement in the pain, depression, and functional impairment scores was significantly higher in Group 1 than in Group 2 (p=0.001 for all).
The authors concluded that the results suggest that OVM combined with physical therapy is useful to improve pain, depression, and functional impairment in patients with chronic mechanical low back pain. We believe that OVM techniques should be combined with other physical therapy modalities in this patient population.
OVM was invented by the French osteopath, Jean-Piere Barral. In the 1980s, he stated that through his clinical work with thousands of patients, he discovered that many health issues were caused by our inner organs being entrapped and immobile. According to its proponents, OVM is based on the specific placement of soft manual forces that encourage the normal mobility, tone and function of our inner organs and their surrounding tissues. In this way, the structural integrity of the entire body is allegedly restored.
I am not aware of good evidence to show that OVM is effective – and this, sadly, includes the study above.
In my view, the most plausible explanation for its findings have little to do with OVM itself: sham OVM was applied “by performing light pressure and touches with the palm of the hand on the selected points for OVM without the intention of treating the patient”. This means that most likely patients were able to tell OVM from sham OVM and thus de-blinded. In other words, their expectation of receiving an effective therapy (and not the OVM per se) determined the outcome.
I was alerted to this message on ‘reddit’:
I went in to a chiropractor for a sports injury which was completely unrelated to my neck (wrist). While I was there, the chiropractor insisted on also doing a neck adjustment. To make a very long story short, this adjustment caused a vertebral artery dissection. The injury has left me with lifelong symptoms that I won’t get into here.>Because of tort reform law in Texas, and the $250k cap, I had a very difficult time finding any attorney to represent me even though there’s a mountain of evidence in my favor. My time to file a lawsuit has almost run out (statute of limitations).
Out of principle I want to hold this person accountable. How would I go about at least filing my lawsuit so that I get in within the statute of limitations which is very quickly approaching?
My thought is if I do sue this person within the two year timeframe then I can either self represent, have the option of withdrawing my case, or maybe in the meantime find an attorney to represent me for if/when we go to trial.
Any other advice or things that I should be considering? What would you do?
Thank you
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If anyone can help this person, please do so. I have acted as an expert witness in several such cases and would be happy to do so also in this instance.
Chiropractors will, of course, say that this message is not a proper case report and cannot therefore count as evidence against the safety of chiropractic. I agree that it does not in itself amount to compelling evidence. But I would like to remind the chiros that it is up to them to establish a proper surveillance system for such tragic events which seem to occur far more often than they want us to believe (as discussed ad nauseam on this blog).
How often have we seen it stated on this blog and elsewhere by enthusiasts of so-called alternative medicine (SCAM) that COVID vaccinations were useless or even harmful? Here is some rather compelling evidence that should make them think again.
This population based cohort study investigated the effectiveness of primary covid-19 vaccination (first two doses and first booster dose within the recommended schedule) against post-covid-19 condition (PCC).
All adults (≥18 years) participated from the Swedish Covid-19 Investigation for Future Insights (a Population Epidemiology Approach using Register Linkage (SCIFI-PEARL) project, a register based cohort study in Sweden) with covid-19 first registered between 27 December 2020 and 9 February 2022 (n=589 722) in the two largest regions of Sweden. Individuals were followed from a first infection until death, emigration, vaccination, reinfection, a PCC diagnosis (ICD-10 diagnosis code U09.9), or end of follow-up (30 November 2022), whichever came first. Individuals who had received at least one dose of a covid-19 vaccine before infection were considered vaccinated.
The primary outcome was a clinical diagnosis of PCC. Vaccine effectiveness against PCC was estimated using Cox regressions adjusted for age, sex, comorbidities (diabetes and cardiovascular, respiratory, and psychiatric disease), number of healthcare contacts during 2019, socioeconomic factors, and dominant virus variant at time of infection.
Of 299 692 vaccinated individuals with covid-19, 1201 (0.4%) had a diagnosis of PCC during follow-up, compared with 4118 (1.4%) of 290 030 unvaccinated individuals. Covid-19 vaccination with any number of doses before infection was associated with a reduced risk of PCC (adjusted hazard ratio 0.42, 95% confidence interval 0.38 to 0.46), with a vaccine effectiveness of 58%. Of the vaccinated individuals, 21 111 received one dose only, 205 650 received two doses, and 72 931 received three or more doses. Vaccine effectiveness against PCC for one dose, two doses, and three or more doses was 21%, 59%, and 73%, respectively.
The authors concluded that the results of this study suggest a strong association between covid-19 vaccination before infection and reduced risk of receiving a diagnosis of PCC. The findings highlight the importance of primary vaccination against covid-19 to reduce the population burden of PCC.
This study should make the anti-vaxers re-consider their views. Sadly, I have little hope that they will. If they don’t, they provide rational thinkers with yet further evidence that they are cultists who are beyond learning from compelling data.
I was alerted to a new book entitled “Handbook of Space Pharmaceuticals“. It contains a chapter on “Homeopathy as a Therapeutic Option in Space” (yes, I am not kidding!). Here is its abstract (the numbers were inserted by me and refer to the short comments below):
Homeopathy is one of the largest used unorthodox medicinal systems having a wide number of principles and logic to treat and cure various diseases [1]. Many successful concepts like severe dilution to high agitation have been applied in the homeopathic system [2]. Though many concepts like different treatment for same diseases and many more are contradictory to the allopathic system [3], homeopathy has proved its worth in decreasing drug-related side effects in many arenas [4]. Various treatments and researches are carried out on various diseases; mostly homeopathic treatment is used in joint diseases, respiratory diseases, cancer, and gastrointestinal tract diseases [5]. In this chapter, readers will have a brief idea about many meta-analysis results of most common respiratory diseases, i.e., asthma, incurable hypertension condition, rheumatoid arthritis, and diarrhea and a megareview of all the diseases to see their unwanted effects, uses of drugs, concepts, and issues related to homeopathy [6]. Various limitations of homeopathic treatments are also highlighted which can give a clear idea about the future scope of research [7]. Overall, it can be concluded that placebo and homeopathic treatments give almost the same effect [8], but the less severe side effects of homeopathic drugs in comparison to all other treatment groups catch great attention [9].
Apart from the very poor English of the text and the fact that it has as good as nothing to do with the subject of ‘Homeopathy as a Therapeutic Option in Space’, I have the following brief comments:
- I did not know that homeopathy has ‘a wide number of logic’ and had alwas assumed that there is only one logic.
- Successful concepts? Really?
- So, homeopaths believe that the ‘allopathic system’ treats the same diseases uniformly? In this case, they should perhaps read up what conventional medicine really does.
- I am not aware of good evidence showing that homeopathy reduces drug related adverse effects.
- No, homeopathy is used for all symptoms – Hahnemann did not believe in treating disease entities – and mostly for those that are self-limiting.
- I love the term ‘incurable hypertension condition’; can somebody please explain what it is?
- The main limitation is that homeopathy is nonsense and, as such, does not really require further research.
- Not ‘almost’ but ‘exactly’! But thanks for pointing it out.
- Wishful thinking and not true. Firstly, the author forgot about ‘homeopathic aggravations’ in which homeopaths so strongly believe. Secondly, I know of many non-homeopathic treatments that are free of adverse effects when done properly.
Altogether, I am as disappointed by this article as you must be: we were probably all hoping to hear about the discovery showing that homeopathy works splendidly in space – not least because we have known for a while that homeopaths seem to be from a different planet.
NICE helps practitioners and commissioners get the best care to patients, fast, while ensuring value for the taxpayer. Internationally, NICE has a reputation for being reliable and trustworthy. But is that also true for its recommendations regarding the use of acupuncture? NICE currently recommends that patients consider acupuncture as a treatment option for the following conditions:
- chronic (long-term) pain
- chronic tension-type headaches
- migraines
- prostatitis symptoms
- hiccups
Confusingly, on a different site, NICE also recommends acupuncture for retinal migraine, a very specific type of migraine that affect normally just one eye with symptoms such as vision loss lasting up to one hour, a blind spot in the vision, headache, blurred vision and seeing flashing lights, zigzag patterns or coloured spots or lines, as well as feeling nauseous or being sick.
I think this perplexing situation merits a look at the evidence. Here I quote the conclusions of recent, good quality, and (where possible) independent reviews:
- Chronic pain: Acupuncture is efficacious for reducing pain in patients with LBP… Further research needs to be done to evaluate acupuncture’s efficacy in these conditions, especially for abdominal pain, as many of the current studies have a risk of bias due to lack of blinding and small sample size.
- Chronic tension-type headaches (TTH): Acupuncture may be an effective and safe treatment for TTH patients. Due to low or very low certainty of evidence and high heterogeneity, more rigorous RCTs are needed to verify the effect and safety of acupuncture in the management of TTH.
- Migraines: Many studies suggest that acupuncture is a safe, helpful and available alternative therapy that may be beneficial to certain migraine patients. Nevertheless, further large-scale RCTs are warranted to further consolidate these findings and provide further support for the clinical value of acupuncture. Despite previous studies that have analyzed the effects of acupuncture on migraine, there is still a need for further investigation to ensure that the incorporation of acupuncture into migraine treatment management will have a positive outcome on patients.
- Prostatitis: This meta-analysis indicated that acupuncture has measurable benefits on CP/CPPS, and security has also been ensured. However, this meta-analysis only included 10 RCTs; thus, RCTs with a larger sample size and longer-term observation are required to verify the effectiveness of acupuncture further in the future.
- Hiccups: All of these studies sought to determine the effectiveness of different acupuncture techniques in the treatment of persistent and intractable hiccups. All four studies had a high risk of bias, did not compare the intervention with placebo, and failed to report side effects or adverse events for either the treatment or control groups.
- Retinal migraine: no evidence
So, what do we make of this? I think that, on the basis of the evidence:
- a positive recommendation for all types of chromic pain is not warranted;
- a positive recommendation for the treatment of TTH is questionable;
- a positive recommendation for migraine is questionable;
- a positive recommendation for prostatitis is questionable;
- a positive recommendation for hiccups is not warranted;
- a positive recommendation for retinal migraine is not warranted.
But why did NICE issue positive recommendations despite weak or even non-existent evidence?
SEARCH ME!
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The case of a 2.5-year-old boy who accidentally ingested a 25% sodium chlorite solution was reported. The solution had been recommended to the grandfather as a “bowel cure” by a naturopath. Although the boy tried to spit the solution out again, he was unable to do so or only partially succeeded. Vomiting and diarrhoea soon set in and the child’s condition deteriorated rapidly.
On admission to hospital, a greyish-pale skin colour, lip cyanosis and an oxygen saturation of 67% were already apparent. The child had to be intubated. Blood gas analysis revealed marked methaemoglobinaemia, which was treated with methylene blue and ascorbic acid. Erythrocyte concentrates were also transfused due to haemolytic anaemia. In the oesophagogastroduodenoscopy the next day, the gastric mucosa was completely covered with bloody erosions. Later, aspiration pneumonia was suspected and antibiotics with piperacillin and tazobactam i.v. were administered for five days. After clinical restitution, the child was discharged.
The author added the following comment:
Several health authorities (including in the USA, Switzerland, Canada and the UK) have issued warnings about MMS in recent years and in some cases have also taken specific measures to protect consumers. In July 2012, the German Federal Institute for Risk Assessment (BfR) strongly advised against the consumption and use of MMS.
In February 2015, the Federal Institute for Drugs and Medical Devices (BfArM) classified two MMS products as requiring authorisation. These were considered to be so-called presentation drugs because the manufacturer made clear healing promises and stated medicinal purposes. Furthermore, precise dosage information and references to the possibility of severe side effects such as diarrhoea and nausea were given, as well as references to the book “The Breakthrough” by Jim Humble, in which the use and effectiveness of MMS is described for malaria and cancer, for example. This means that the products would have to be authorised as medicinal products and could then only be placed on the market if the pharmaceutical company had proven their efficacy, quality and safety.
In addition, the BfArM categorised both products as questionable medicinal products in accordance with Section 5 of the German Medicinal Products Act because their use is associated with harmful effects that go beyond an acceptable level.
On this blog, we have repeatedly discussed the MMS, e.g.:
- Miracle Mineral Solution (MMS) = potentially lethal
- MMS-salesman Andreas Kalcker has been arrested in Argentina
- Beware of the ‘Bleach Boys’ – hydrogen peroxide and chlorine dioxide
I urge everyone who might be tempted to try MMS to think again.
