prevention
“We are hugely concerned about the welfare of doctors and healthcare workers with long COVID”. These are the first words of a comprehensive survey of UK doctors with post-acute COVID health complications. It reveals that these doctors experience symptoms such as:
- fatigue,
- headaches,
- muscular pain,
- nerve damage,
- joint pain,
- respiratory problems.
Around 60% of doctors said that post-acute COVID ill health has affected their ability to carry out day-to-day activities on a regular basis. 18% reported that they were now unable to work due to their post-acute COVID ill-health, and only 31% said they were working full-time, compared with more than half before the onset of their illness.
The report demands financial support for doctors and healthcare staff with post-acute COVID, post-acute COVID to be recognized as an occupational disease in healthcare workers, with a definition that covers all of the debilitating disease’s symptoms and for improved access to physical and mental health services to aid comprehensive assessment, appropriate investigations and treatment. The report also calls for greater workplace protection for healthcare staff risking their lives for others and better support for post-acute COVID sufferers to return to work safely if they can, including a flexible approach to the use of workplace adjustments.
In November 2021, an online survey investigating the emotional states of depression, anxiety, stress, compassion satisfaction, and compassion fatigue was administered to 78 Italian healthcare workers (HCWs). Between 5 and 20% of the cohort showed the effects of the adverse psychological impact of the pandemic and more than half of them experienced medium levels of compassion fatigue as well as a medium level of compassion satisfaction. The results also show that those with fewer years of clinical practice might be at greater risk of burnout, anxiety, and stress symptoms and might develop a lower level of compassion satisfaction. Moreover, the factors that potentially contribute to poor mental health, compassion fatigue, and compassion satisfaction seem to differ between residents and specialist physicians.
A cross-sectional study was conducted from September 2021 to April 2022 and targeted all physicians working at King Fahd Hospital of the University, Al Khobar, Saudi Arabia. Patient Health Questionnaire-9 and General Anxiety Disorder-7 were used to elicit self-reported data regarding depression and anxiety, respectively. In addition, sociodemographic and job-related data were collected. A total of 438 physicians responded, of which 200 (45.7%) reported symptoms of depression and 190 (43.4%) of anxiety. Being aged 25-30 years, female, resident, and reporting a reduction in work quality were factors significantly associated with both anxiety and depression. Female gender (AOR = 3.570; 95% CI = 2.283-5.582; P < 0.001), working an average 9-11 hours/day (AOR = 2.130; 95% CI = 1.009-4.495; P < 0.047), and self-perceived reduction in work quality (AOR = 3.139; 95% CI = 2.047-4.813; P < 0.001) were significant independent predictors of anxiety. Female gender (AOR = 2.929; 95% CI = 1.845-4.649; P < 0.001) and self-perceived reduction in work quality (AOR = 3.141; 95% CI = 2.053-4.804; P < 0.001) were significant independent predictors of depression.
An observational, multicenter cross-sectional study was conducted at eight tertiary care centers in India. The consenting participants were HCWs between 12 and 52 weeks post-discharge after COVID-19 infection. The mean age of the 679 eligible participants was 31.49 ± 9.54 years. The overall prevalence of COVID sequelae was 30.34%, with fatigue (11.5%) being the most common followed by insomnia (8.5%), difficulty in breathing during activity (6%), and pain in joints (5%). The odds of having any sequelae were significantly higher among participants who had moderate to severe COVID-19 (OR 6.51; 95% CI 3.46-12.23) and lower among males (OR 0.55; 95% CI 0.39-0.76). Besides these, other predictors for having sequelae were age (≥45 years), presence of any comorbidity (especially hypertension and asthma), category of HCW (non-doctors vs doctors), and hospitalization due to COVID-19.
Such data are scary. Not only will we have a tsunami of long-Covid patients from the general public, and not only do we currently lack effective causal treatments for the condition, but also is the number of HCWs who are supposed to deal with all this drastically reduced.
Most if not all countries are going to be affected by these issues. But the UK public might suffer the most, I fear. The reasons are obvious if you read a previous post of mine: in the UK, we have significantly fewer doctors, nurses, hospital beds, and funding (as well as politicians who care and would be able to do something about the problem) than in other comparable countries. To me, this looks like the emergence of a perfect storm.
This systematic review evaluated all available randomized controlled trials (RCTs) investigating the clinical effects of hydrotherapy according to Kneipp which is characterized by cold water applications. All RCTs on therapy and prevention with Kneipp hydrotherapy were included. Study participants were patients and healthy volunteers of all age groups. MEDLINE (via PubMed), Scopus, Central, CAMbase, and opengrey.eu were systematically searched through April 2021 without language restrictions and updated by searching PubMed until April 6th 2023. The risk of bias was assessed using the Cochrane tool version 1.
Twenty RCTs (N=4247) were included. Due to the high heterogeneity of the RCTs, no meta-analysis was performed. The risk of bias was rated as unclear in most of the domains. Of 132 comparisons, 46 showed significant positive effects in favor of hydrotherapy on chronic venous insufficiency, menopausal symptoms, fever, cognition, emotional function, and sickness absenteeism. However, 81 comparisons showed no differences between groups, and 5 were in favor of the respective control group. Only half of the studies reported safety issues.
The authors concluded that although RCTs on Kneipp hydrotherapy seem to show positive effects in some conditions and outcomes, it remains difficult to ascertain treatment effects due to the high risk of bias and heterogeneity of most of the considered studies. Further high-quality RCTs on Kneipp hydrotherapy are urgently warranted.
This is certainly the best review of the subject so far. It makes it very clear that the evidence for Kneipp hydrotherapy is weak, mostly because of the many flaws in the primary studies. One needs to add, I think, that 20 RCTs are an absurdly small amount considering that many indications this type of therapy is advocated for – many enthusiasts even consider it a panacea.
It follows, I fear, that Kneipp hydrotherapy is almost entirely not evidence-based. This should be bad news for the numerous institutions and Spa towns (mostly in Germany) that live on employing this treatment and telling patients that it is effective. They usually claim that experience shows this to be true. But this was the mantra of medicine ~100 years ago. Since then, we have learned that experience is a very poor guide that regularly leads us up the garden path.
Kneippians will counter that clinical trials are difficult to conduct and expensive to finance. Both arguments are of course true but, considering that an entire industry lives on telling patients something that essentially amounts to a lie (i.e. the claim that it works), it surely is obligatory to overcome these obstacles.
This review assessed the role of homoeopathy in the therapeutic management of substance use disorders (SUD) through a systematic web-based literature search. A comprehensive search was conducted online and manually to identify homoeopathic research studies published between 1993 and 2022 on SUD in international databases and the Central Council of Research in Homoeopathy library. Relevant studies were categorised and assessed in terms of study designs, number of participants, evidence grades and clinical outcome parameters. A total of 21 full-text studies were screened and evaluated. Risk of bias (RoB) was assessed for all studies and model validity was appraised for the included RCTs’.
10 studies were included:
- 3 Randomised Controlled Trials,
- 3 Observational studies,
- 1 Pilot study,
- 1 observational comparative study,
- 1 retrospective cohort study,
- 1 case series.
Three studies have a level of evidence of 1b with an ‘A’ grade of recommendation, which consists of the RCTs only. The most commonly prescribed medicines identified were:
- Arsenic album,
- Nux vomica,
- Lycopodium,
- Pulsatilla,
- Sulphur,
- Staphysagria,
- Belladonna,
- Ipecac,
- Chamomilla,
- Rhustox,
- Phosphorus,
- Lachesis.
A high risk of bias was elicited in most of the observational studies accentuating the need for more robust methodological studies.
The authors concluded that the majority of the studies have a small number of recruitments. Pragmatic studies with larger sample sizes and validated outcome measures may be designed further to validate the
promising role of homoeopathic medicines in SUDs and generate quality evidence.
The paper is surprising! Most of the studies are not RCTs and thus cannot come even near suggesting a causal effect of homeopathy. The three RCTs are the following:
- Manchanda RK, Janardanan Nair KR, Varanasi R, Oberai P, Bhuvaneswari R, Bhalerao R, et al. A randomised comparative trial in the management of alcohol dependence: Individualised homoeopathy versus standard allopathic treatment. Indian J Res Homoeopathy; 2016.
- Adler UC, Acorinte AC, Calzavara FO, et al. Double-blind evaluation of homeopathy on cocaine craving: A randomised controlled pilot study. J Integr Med. 2018; 16(3):178-184.
- Grover A, Bhushan B, Goel R. Double-blind placebo-controlled trial of homoeopathic medicines in the
management of withdrawal symptoms in opium addicts and its alkaloid derivatives dependents. Indian J Res Homoeopathy. 2009;3:41-4.
All of these 3 studies were assessed by the review authors as having major flaws. Only one is available on Medline:
Background: Brazil is among the nations with the greatest rates of annual cocaine usage. Pharmacological treatment of cocaine addiction is still limited, opening space for nonconventional interventions. Homeopathic Q-potencies of opium and Erythroxylum coca have been tested in the integrative treatment of cocaine craving among homeless addicts, but this setting had not proven feasible, due to insufficient recruitment.
Objective: This study investigates the effectiveness and tolerability of homeopathic Q-potencies of opium and E. coca in the integrative treatment of cocaine craving in a community-based psychosocial rehabilitation setting.
Design, setting, participants, and interventions: A randomized, double-blind, placebo-controlled, parallel-group, eight-week pilot trial was performed at the Psychosocial Attention Center for Alcohol and Other Drugs (CAPS-AD), Sao Carlos/SP, Brazil. Eligible subjects included CAPS-AD patients between 18 and 65 years of age, with an International Classification of Diseases-10 diagnosis of cocaine dependence (F14.2). The patients were randomly assigned to two treatment groups: psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca (homeopathy group), and psychosocial rehabilitation plus indistinguishable placebo (placebo group).
Main outcome measures: The main outcome measure was the percentage of cocaine-using days. Secondary measures were the Minnesota Cocaine Craving Scale and 12-Item Short-Form Health Survey scores. Adverse events were reported in both groups.
Results: The study population comprised 54 patients who attended at least one post-baseline assessment, out of the 104 subjects initially enrolled. The mean percentage of cocaine-using days in the homeopathy group was 18.1% (standard deviation (SD): 22.3%), compared to 29.8% (SD: 30.6%) in the placebo group (P < 0.01). Analysis of the Minnesota Cocaine Craving Scale scores showed no between-group differences in the intensity of cravings, but results significantly favored homeopathy over placebo in the proportion of weeks without craving episodes and the patients’ appraisal of treatment efficacy for reduction of cravings. Analysis of 12-Item Short-Form Health Survey scores found no significant differences. Few adverse events were reported: 0.57 adverse events/patient in the homeopathy group compared to 0.69 adverse events/patient in the placebo group (P = 0.41).
Conclusions: A psychosocial rehabilitation setting improved recruitment but was not sufficient to decrease dropout frequency among Brazilian cocaine treatment seekers. Psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca were more effective than psychosocial rehabilitation alone in reducing cocaine cravings. Due to high dropout rate and risk of bias, further research is required to confirm our findings, with specific focus on strategies to increase patient retention.
This study can hardly be said to show convincing evidence for homeopathy.
This paper is all the more surprising if we consider the affiliations of the authors:
- Clinical Research Unit (H), Aizawl under Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of India, India.
- All India Institute of Ayurveda, New Delhi, India.
- Department of Materia Medica, Madhav Homoeopathic Medical College and Hospital, Madhav Hills,
Opposite Banas River, Abu Road, Rajasthan, India.
It is time, I think, that Indian officials and researchers learn some critical thinking and formulate the conclusions of reviews based on the evidence they produced. This would be a start:
Our review has not generated convincing evidence to suggest that homeopathy is effective in treating SUDs.
Cervical artery dissection (CeAD), which includes both vertebral artery dissection (VAD) and carotid artery dissection (CAD), is the most serious safety concern associated with cervical spinal manipulation (CSM). This study evaluated the association between CSM and CeAD among US adults.
Through analysis of health claims data, the researchers employed a case-control study with matched controls, a case-control design in which controls were diagnosed with ischemic stroke, and a case-crossover design in which recent exposures were compared to exposures in the same case that occurred 6-7 months earlier. The researchers evaluated the association between CeAD and the 3-level exposure, CSM versus office visit for medical evaluation and management (E&M) versus neither, with E&M set as the referent group.
2337 VAD cases and 2916 CAD cases were identified. Compared to population controls, VAD cases were 0.17 (95% CI 0.09 to 0.32) times as likely to have received CSM in the previous week as compared to E&M. In other words, E&M was about 5 times more likely than CSM in the previous week in cases, relative to controls. CSM was 2.53 (95% CI 1.71 to 3.68) times as likely as E&M in the previous week among individuals with VAD than among individuals experiencing a stroke without CeAD. In the case-crossover study, CSM was 0.38 (95% CI 0.15 to 0.91) times as likely as E&M in the week before a VAD, relative to 6 months earlier. In other words, E&M was approximately 3 times more likely than CSM in the previous week in cases, relative to controls. Results for the 14-day and 30-day timeframes were similar to those at one week.
The authors concluded that, among privately insured US adults, the overall risk of CeAD is very low. Prior receipt of CSM was more likely than E&M among VAD patients as compared to stroke patients. However, for CAD patients as compared to stroke patients, as well as for both VAD and CAD patients in comparison with population controls and in case-crossover analysis, prior receipt of E&M was more likely than CSM.
What seems fairly clear from this and a previous similar analysis by the same authors is, I think, this: retrospective studies of this type can unfortunately not provide us with much reliable information about the risks of spinal manipulation. The reasons for this are manyfold, e.g.: less than exact classifications in patients’ records, or the fact that multiple types of spinal manipulations exist of which only some might be dangerous.
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!
“A Nutrient Mix Designed at the Dr. Rath Research Institute is Effective Against Different Types of Coronavirus.” With these words (and the picture below), the ‘Dr. Rath Research Institute’ recently announced its sensational finding on Twitter.
Clicking on the link they provided, got me to the following article:
In this new study we wanted to find out whether certain natural substances could help fight against SARS-CoV-2 (the virus that causes COVID-19), and another type of coronavirus known as HCoV-229E which infects humans and is associated with the common cold and its symptoms.
The importance of the study relates to the fact that COVID-19 is still a big problem, especially for older people and those with weak immune systems. Current approaches using RNA- and DNA -based vaccines are not effective in preventing the infection and spread of SARS-CoV-2, or its variants such as Omicron. The anti-viral drugs used against the pandemic are similarly not fully effective. It is therefore important to develop other approaches, especially those involving safe, natural substances, that could be used alongside or instead of conventional treatments.
For the study, scientists at the Dr. Rath Research Institute used a combination of natural substances including vitamin C, polyphenols, and other nutrients. They gave the nutrient mix to mice infected with one or other of the two types of coronaviruses, to see if it could reduce the numbers of viral particles and spike proteins in the animals’ lungs.
Based on our earlier work using human cells growing in culture we already knew that the combination of nutrients in this mixture was effective in controlling key cellular mechanisms of SARS-CoV-2 infection, including inhibiting the multiplication of the virus.
We had found that the nutrient mix could inhibit an enzyme, RNA-dependent RNA polymerase (RdRp), which is needed for a virus to make copies of itself. The mix was also effective in preventing viral spike protein from binding to cell surfaces and entering cells. It additionally worked in decreasing the number of so-called ACE2 receptor proteins, which are expressed by cells in the lungs, blood vessels, and other organs, and that help the virus to get into cells.
In this latest study the nutrient mix was administered daily to mice infected with either SARS-CoV-2 or HCoV-229E, to see if it could reduce infectivity in terms of the amounts of viral particles and spike proteins found in the lungs. Infected mice in the control group were fed a normal diet without nutrient supplementation. The amounts of viral particles and spike proteins in the lungs were evaluated using special molecular-based tests. We also examined the effects of the nutrient mix on the presence of immune cells in the lungs, as an indication of tissue inflammation.
The results showed that, compared to mice in the control group, the nutrients significantly reduced the amounts of viral particles and spike proteins in the lungs of infected mice. Moreover, the mix was equally effective in mice infected with either of the two types of coronaviruses. This indicates that the nutrients affected common mechanisms of infection and were not specific to a particular type of virus. It also explains the results of our previous studies, which showed that the nutrient mix was effective in stopping SARS-CoV-2 and several of its mutated forms, including Omicron variants, from entering the cells.
Crucially, we found the nutrient mix affected not only the virus itself; it also reduced the ability of the virus to enter cells by decreasing the number of ACE2 receptors on cell surfaces. In the presence of inflammation, which is commonly associated with infections, there were similarly less ACE2 receptors on cells. Nutrient anti-inflammatory effects were also observed in the lung tissue of the mice.
In conclusion, our study showed that the nutrient mix could help reduce the infectivity of SARS-CoV-2 and the associated common cold virus HCoV-229E in mice at different stages of infectivity. The fact that different mechanisms were affected simultaneously demonstrates the superior efficacy of nutrients compared to drugs, the latter of which usually target only a single mechanism and allow the virus to escape by mutating.
The unique composition and efficacy of our nutrient mix has been awarded US and international patents. While more research is needed in order to fully confirm its efficacy in human clinical trials, the application of this safe micronutrient combination as soon as possible should ultimately benefit people worldwide and save on healthcare costs.
So, the claim that a Nutrient Mix is “Effective Against Different Types of Coronavirus” rests on some lousy experiments on rats?
Might we call this misleading or dishonest?
And what is the Dr. Rath Research Institute?
Could it belong to the Dr. Rath Foundation?
The very foundation that once published this about me:
Professor Edzard Ernst: A Career Built On Discrediting Natural Health Science?
Professor Edzard Ernst, a retired German physician and academic, has recently become a prominent advocate of plans that could potentially outlaw the entire profession of naturopathic doctors in Germany. Promoting the nonsensical idea that naturopathic medicine somehow poses a risk to public health, Ernst attacks its practitioners as supposedly having been educated in “nonsense”. Tellingly, however, given that he himself has seemingly not published even so much as one completely original scientific trial of his own, Ernst’s apparent attempts to discredit natural healthcare approaches are largely reliant instead on his analysis or review of handpicked negative studies carried out by others.
SAY NO MORE!
This randomized, double-blind, placebo-controlled trial investigated whether supplementing older adults with monthly doses of vitamin D alters the incidence of major cardiovascular events.
A total of 21 315 participants aged 60-84 years were enrolled. Exclusion criteria were self-reported hypercalcemia, hyperparathyroidism, kidney stones, osteomalacia, sarcoidosis, taking >500 IU/day supplemental vitamin D, or being unable to give consent because of language or cognitive impairment.
The trial participants received 60 000 IU/month of vitamin D3 (n=10 662) or placebo (n=10 653) taken orally for up to five years. 16 882 participants completed the intervention period: placebo 8270 (77.6%); vitamin D 8552 (80.2%). The main outcome for this analysis was the occurrence of a major cardiovascular event, including myocardial infarction, stroke, and coronary revascularisation, determined through linkage with administrative datasets. Each event was analyzed separately as secondary outcome. Flexible parametric survival models were used to estimate hazard ratios and 95% confidence intervals.
21 302 people were included in the analysis. The median intervention period was five years. 1336 participants experienced a major cardiovascular event (placebo 699 (6.6%); vitamin D 637 (6.0%)). The rate of major cardiovascular events was lower in the vitamin D group than in the placebo group (hazard ratio 0.91, 95% confidence interval 0.81 to 1.01), especially among those who were taking cardiovascular drugs at baseline (0.84, 0.74 to 0.97; P for interaction=0.12), although the P value for interaction was not significant (<0.05). Overall, the difference in standardized cause-specific cumulative incidence at five years was −5.8 events per 1000 participants (95% confidence interval −12.2 to 0.5 per 1000 participants), resulting in a number needed to treat to avoid one major cardiovascular event of 172. The rate of myocardial infarction (hazard ratio 0.81, 95% confidence interval 0.67 to 0.98) and coronary revascularisation (0.89, 0.78 to 1.01) was lower in the vitamin D group, but there was no difference in the rate of stroke (0.99, 0.80 to 1.23). The incidence of adverse events was similar in the two groups.
The authors concluded that vitamin D supplementation might reduce the incidence of major cardiovascular events, particularly myocardial infarction and coronary revascularisation. This protective effect could be more marked in those taking statins or other cardiovascular drugs at baseline. Subgroup analyses in other large trials might help to clarify this issue. In the meantime, these findings suggest that conclusions that vitamin D supplementation does not alter risk of cardiovascular disease are premature.
This is an impressive study and a disappointing result. That vitamin D supplementation might reduce the incidence of major cardiovascular events was known before; thus we would not have needed such an expensive study to arrive at this conclusion. That the protective effect might be more marked in patients taking statins or other cardiovascular drugs seems odd, in my view. Could it be, I ask myself, that the protective effect is unrelated to cardiovascular drugs but simply more marked in those individuals who are at a higher than average risk of cardiovascular events?
In any case, the protective effect is small and seems to be of questionable clinical relevance.
The current secondary analysis based on the WHO database (VigiBase) of individual case safety reports (ICSRs) focuses on the suspected cutaneous adverse drug reactions (ADRs) linked to traditional medicines (TMs).
All the ICSRs reported between 1st January 2016 and 30th June 2021 from the UN Asia region in VigiBase where at least one TM was suspected to cause cutaneous ADRs were included in the study. Data regarding demographic details, suspected drug, adverse reaction as per MedDRA term, the seriousness of the reaction, de-challenge, re-challenge, and clinical outcome for suspected cutaneous ADRs associated with TM were obtained from VigiBase and analyzed for frequency of reported events and suspected medicines.
A total of 3,523 ICSRs with 5,761 ADRs related to “skin and subcutaneous tissue disorders” were included in the analysis. Amongst these, 6.8% of ICSRs were reported as serious.
The most common ADRs were:
- pruritus (29.6%),
- rash (20.3%),
- urticaria (18.9%),
- hyperhidrosis (3.3%).
Artemisia argyi H.Lév. and Vaniot. (14.9%), Ginkgo biloba L. (5.1%), Vitis vinifera L. (4%), Vitex agnus-castus L. (3.8%), Silybum marianum (L.), Gaertn (3.5%), and Viscus album L. (2.7%) were some commonly suspected TMs for cutaneous ADRs. There were 46 cases of Stevens-Johnson syndrome and toxic epidermal necrolysis reported with TMs during the study period. Death was reported in 5 ICSRs.
The authors concluded that TMs are linked with various cutaneous ADRS ranging from pruritus to toxic epidermal necrolysis which may have serious consequences. TMs listed as suspected offending agents in this analysis, should be kept in mind while dealing with suspected cutaneous ADRs. Clinicians should be more vigilant in detecting and reporting events associated with TMs.
Herbal remedies have a reputation for being time-tested, gentle, harmless, and benign. Reports such as this one might make us doubt this cliche. More importantly, they should force us to ask whether the remedy we are tempted to try truly does generate more good than harm. In most instances, I fear, the answer is not positive.
Maintenance of cognitive abilities is of critical importance to older adults, yet only a few effective strategies to slow down cognitive decline currently exist. Multivitamin supplementation is used to promote general health; however, it is unclear whether it favorably affects cognition in older age. This study aimed to examine the effect of daily multivitamin/multimineral supplementation on memory in older adults.
The Cocoa Supplement and Multivitamin Outcomes Study Web (COSMOS-Web) ancillary study (NCT04582617) included 3562 older adults. Participants were randomly assigned to a daily multivitamin supplement (Centrum Silver) or placebo and evaluated annually with an Internet-based battery of neuropsychological tests for 3 y. The prespecified primary outcome measure was change in episodic memory, operationally defined as immediate recall performance on the ModRey test, after 1 y of intervention. Secondary outcome measures included changes in episodic memory over 3 y of follow-up and changes in performance on neuropsychological tasks of novel object recognition and executive function over 3 y.
Compared with placebo, participants randomly assigned to multivitamin supplementation had significantly better ModRey immediate recall at 1 y, the primary endpoint (t(5889) = 2.25, P = 0.025), as well as across the 3 y of follow-up on average (t(5889) = 2.54, P = 0.011). Multivitamin supplementation had no significant effects on secondary outcomes. Based on a cross-sectional analysis of the association between age and performance on the ModRey, it was estimated that the effect of the multivitamin intervention improved memory performance above placebo by the equivalent of 3.1 y of age-related memory change.
The authors concluded that daily multivitamin supplementation, compared with placebo, improves memory. Multivitamin supplementation holds promise as a safe and accessible approach to maintaining cognitive health in older age.
These findings are surprising, not least because similar studies have thus far failed to demonstrate such effects. A 2013 trial, for instance, concluded that, in male physicians aged 65 years or older, long-term use of a daily multivitamin did not provide cognitive benefits.
Judging from the abstract alone (unfortunately, I have no access to the full paper), this seems to be a rigorous trial. It was conducted by multiple researchers of high standing. One is therefore inclined to believe the results.
Yet, one might be wise to be cautious.
Provided that a full analysis of the study does not identify major flaws, I would still want to 1) have a plausible explanation as to the mode of action and 2) see an independent replication before I accept the findings.
PS
The study was partly funded by the National Institutes of Health. The vitamins were provided by Pfizer Inc. and Haleon, the makers of the supplement used in the study.
PPS
I have now seen the full paper [thank you Dan] and can confirm that the study was of high quality. Yet, it also has limitations, of course, e.g.:
- the effect size is modest;
- the study population is selected and thus the results are not generalizable;
- the outcome measures were assessed remotely;
- the success of blinding was not checked [I find it conceivable that some trial participants tried to find out what they were taking, e.g. by tasting the pills].
An article in the German publication T-online is, I think, relevant to us here on this blog. I translated part of it for you:
The suspicion of particularly serious fraud against a doctor from the German Meißen district has been substantiated. Since the beginning of the pandemic, the 66-year-old physician is said to have issued “certificates of convenience” in the thousands throughout Germany, a spokesman for the public prosecutor’s office said. In return for a payment of 25 euros, the doctor from Moritzburg is said to have issued blanket and unjustified certificates stating that the wearing of mouth and nose protection was not medically justifiable. In other cases, the physician stated an unlimited inoculation prohibition or that Corona quick tests were possible only over saliva.
After an initial search in February, the public prosecutor’s office had assumed to be dealing with merely 162 false vaccination and mask certificates. But the extent of the fraud seems to go far beyond that: The accused is now said to have taken in at least 60,000 euros with the fake certificates.
Based on further investigations, the public prosecutor’s office assumes that the medical practitioner has managed to issue false corona attestations “every minute” with so-called collective appointments. These appointments were arranged in cooperation with Heilpraktiker from all parts of Germany and partly even with funeral homes.
On Tuesday, more than 360 police officers searched 140 homes of exemption certificate holders in nine states – mainly in Bavaria. In the process, 174 incorrect Corona attestations were found. They now must face instigations into using illegal health certificates. In addition, the office of a Bavarian Heilpraktiker, as well as a further commercial area, were searched.
This is not the first time that the Moritzburg doctor has come into conflict with the law. The 66-year-old physician considers herself a ‘Reichsbuerger’ (citizen of the Reich, a right-wing extremist). She was a member of the Moritzburg shooting club, and owned eleven weapons. Because they were not all registered and several hundred rounds of ammunition were found in the house, she stood trial for the first time already in 2014.
