critical thinking
This study investigated the potential benefits of auricular point acupressure on cerebrovascular function and stroke prevention among adults with a high risk of stroke.
A randomized controlled study was performed with 105 adults at high risk for stroke between March and July 2021. Participants were randomly allocated to receive either
- auricular point acupressure with basic lifestyle interventions (n = 53) or
- basic lifestyle interventions alone (n = 52) for 2 weeks.
The primary outcome was the kinematic and dynamic indices of cerebrovascular function, as well as the CVHP score at week 2, measured by the Doppler ultrasonography and pressure transducer on carotids.
Of the 105 patients, 86 finished the study. At week 2, the auricular point acupressure therapy with lifestyle intervention group had higher kinematic indices, cerebrovascular hemodynamic parameters score, and lower dynamic indices than the lifestyle intervention group.
The authors concluded that ccerebrovascular function and cerebrovascular hemodynamic parameters score were greater improved among the participants undergoing auricular point acupressure combined with lifestyle interventions than lifestyle interventions alone. Hence, the auricular point acupressure can assist the stroke prevention.
Acupuncture is a doubtful therapy.
Acupressure is even more questionable.
Ear acupressure is outright implausible.
The authors discuss that the physiological mechanism underlying the effect of APA therapy on cerebrovascular hemodynamic function is not fully understood at present. There may be two possible explanations.
- First, a previous study has demonstrated that auricular acupuncture can directly increase mean blood flow velocity in the middle cerebral artery.
- Second, cerebrovascular hemodynamic function is indirectly influenced by the effect of APA therapy on blood pressure.
I think there is a much simpler explanation: the observed effects are directly or indirectly due to placebo. As regular listeners of this blog know only too well by now, the A+B versus B study design cannot account for placebo effects. Sadly, the authors of this study hardly discuss this explanation – that’s why they had to publish their findings in just about the worst SCAM journal of them all: EBCAM.
Previous research revealed that cognitive abilities are negatively related to right-wing and prejudiced attitudes. No study has, however, investigated if emotional abilities also show such a relationship, although this can be expected based on both classic and recent literature. The aim of the present study was 2-fold:
(a) to investigate the relationship between emotional abilities and right-wing and prejudiced attitudes, and
(b) to pit the effects of emotional and cognitive abilities on these attitudes against each other.
Results from 2 adult samples (n = 409 and 574) in which abilities scores were collected in individual testing sessions, revealed that emotional abilities are significantly and negatively related to social-cultural and economic-hierarchical right-wing attitudes, as well as to blatant ethnic prejudice. These relationships were as strong as those found for cognitive abilities. For economic-hierarchical right-wing attitudes, emotional abilities were even the only significant correlate.
The authors concluded that the study of emotional abilities has the potential to significantly advance our understanding of right-wing and prejudiced attitudes.
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The researchers found that individuals with weaker emotional abilities — particularly emotional understanding and management — tended to score higher on a measure of right-wing authoritarianism and social dominance orientation. Right-wing authoritarianism is a personality trait that describes the tendency to submit to political authority and be hostile towards other groups, while social dominance orientation is a measure of a person’s preference for inequality among social groups.
The results of this study were univocal. People who endorse authority and strong leaders and who do not mind inequality — the two basic dimensions underlying right-wing political ideology — show lower levels of emotional abilities,” said Van Hiel, the lead author of the study. “Those with lower emotional and cognitive abilities were also more likely to agree with blatantly prejudiced statements such as “The White race is superior to all other races.”
Of course, the study only collected correlational data, preventing inferences of causality from being made. “Caution should be exercised in the interpretation of such results,” Van Hiel said. “One cannot discredit any ideology on the basis of such results as those presently obtained. Only in a distant future, we will be able to look back upon our times, and then we can maybe judge which ideologies were the best. Cognitively and emotionally smart people can make wrong decisions as well. The results have been obtained in one particular context. Would similar results be obtained in other contexts besides in a Western country with a long-standing stable democracy? Whether these tendencies are universal, or limited to particular contexts, is very intriguing.”
In the comments section, someone recently alerted us to a most remarkable article. I had a look at it and thought it would be a pity to let it pass without further comment. Here is the abstract:
There are many types of energy around us, including natural and artificial ones, the first of the ground energies due to the imbalance happened from the treatment of man with the ground (mines-the bases of huge buildings); the result of the Earth rotation, the result of geological faults, the flow of groundwater or energies resulting from other factors that result in radiations that harm organisms in general. Also we are continuously increasing the amount of carrier waves needed for the wireless technology of modern communication in the earth’s atmosphere every day. These electromagnetic waves are thousands of times stronger than the level used in the communication in our body cells. The problem is not the saturation of the earth’s atmosphere through quantity, but also a detrimental quality. Even people who avoid using high technology are not immune. No one is immune because these are carrier waves with penetrating properties. our immune systems are continuously trying to correct the distortion in the transfer of inner information in our body; very soon the threshold will be reached when a total collapse of our body defenses will take place. Balancing the activities of daily life, achieving harmony with our inner and outer environments, humanizing modern technology, integrating science and spirits, and discovering the unified scientific reality behind all religions is the work of some science such as Bio Geometry, Bio Design, Radiesthesia, …ext.
When one runs a blog on so-called alternative medicine (SCAM), it is almost inevitable to run into plenty of bullshit. Thus, over the years, I have gotten used to even the most compact versions of it. Yet, this paper – I do recommend you have a glance also at the full text – is truly outstanding.
In case there is someone amongst my readers who understands what the author wants to express, I would be most obliged to learn.
Numerous qualitative studies and a few quantitative studies have linked vaccine hesitancy or refusal with the belief in the efficacy of so-called alternative medicine (SCAM). Yet, large-scale data on this topic are scarce. In this study, the French researchers investigated the factors associated with the coverage rates of seven childhood vaccines or vaccine groups in the ninety-six metropolitan French departments. One of the factors investigated was the local interest in SCAM. In order to assess this interest, they built an Alternative Medicine Index based on departmental internet searches regarding SCAM—internet searches being a reliable indicator of the public’s actual interest in a given topic. They then conducted multiple regression analyses, which showed that this Index is a significant explanatory factor for the departmental variance in vaccination coverage rates, exceeding in importance the effect of other relevant local sociodemographic factors.
A further recent study from France adds to the picture. It presents the results of a survey conducted in July 2021 among a representative sample of the French mainland adult population (n = 3087). Using cluster analysis, the researchers identified five profiles of SCAM attitudes and found that even among the most pro-SCAM group, very few respondents disagreed with the idea that SCAM should only be used as a complement to conventional medicine. They then compared these SCAM attitudes to vaccine attitudes. Attitudes to SCAM had a distinct impact as well as a combined effect on attitudes to different vaccines and vaccines in general. They found that:
- attitudes to SCAM provide a very limited explanation of vaccine hesitancy;
- among the hesitant, pro-SCAM attitudes are often combined with other traits associated with vaccine hesitancy such as distrust of health agencies, radical political preferences, and low income.
Both SCAM endorsement and vaccine hesitancy are more prevalent among the socially disadvantaged. Drawing on these results, the researchers argue that, to better understand the relationship between SCAM and vaccine hesitancy, it is necessary to look at how both can reflect a lack of access and recourse to mainstream medicine and distrust of public institutions.
The fact that the enthusiasm for SCAM is associated with vaccine hesitancy has been discussed on this blog many times before, e.g.:
- Preference of so-called alternative medicine predicts negative attitudes to vaccination
- What are the reasons for opposing COVID vaccinations?
- Intelligence, Religiosity, SCAM, Vaccination Hesitancy – are there links?
- More information on homeopaths’ and anthroposophic doctors’ attitude towards vaccinations
- The anti-vaccination movement is financed by the dietary supplement industry
- Sorry, I was wrong about homeopathy and vaccination
- The UK Society of Homeopaths, a hub of anti-vaccination activists?
- HOMEOPATHY = “the complete alternative to vaccination” ?!?!
- Are anthroposophy-enthusiasts for or against vaccinations?
- Far too many chiropractors believe that vaccinations do not have a positive effect on public health
- Naturopaths’ counselling against vaccinations could be criminally negligent
- HOMEOPATHS AGAINST VACCINATION: “The decision to vaccinate and how you implement that decision is yours and yours alone”
- Use of alternative medicine is associated with low vaccination rates
- Integrative medicine physicians tend to harbour anti-vaccination views
- Vaccination: chiropractors “espouse views which aren’t evidence based”
What seems fairly clear to me is that a cross-correlation exists: an attitude against modern medicine and the ‘scientific establishment’ determines both the enthusiasm for SCAM and the aversion to vaccination. What is, however, far from clear to me is what we could do about it.
Yes, better education seems important – and that’s precisely what I aim at achieving with this blog. Sadly, judging from some of the comments we receive, it does not seem crowned with much success.
Any other ideas?
Menopausal symptoms are systemic symptoms that are associated with estrogen deficiency after menopause. Although widely practiced, homeopathy remains under-researched in menopausal syndrome in terms of quality evidence, especially in randomized trials. The efficacy of individualized homeopathic medicines (IHMs) was evaluated in this double-blind, randomized, placebo-controlled trial in the treatment of the menopausal syndrome.
Group 1 (n = 30) received IHMs plus concomitant care, while group 2 (n = 30) had placebos plus concomitant care. The primary outcome measures were the Greene Climacteric Scale (GCS) total score and the menopause rating scale (MRS) total score. The secondary endpoint was the Utian quality of life (UQOL) total score. Measurements were taken at baseline and every month up to 3 months.
Intention-to-treat sample (n = 60) was analyzed. Group differences were examined by two-way (split-half) repeated-measure analysis of variance, primarily taking into account all the estimates measured at monthly intervals, and secondarily, by unpaired t-tests comparing the estimates obtained individually every month. The level of significance was set at p < 0.025 two-tailed. Between-group differences were nonsignificant statistically—GCS total score (F1, 58 = 1.372, p = 0.246), MRS total score (F1, 58 = 0.720, p = 0.4), and UQOL total scores (F1, 58 = 2.903, p = 0.094). Some of the subscales preferred IHMs significantly against placebos—for example, MRS somatic subscale (F1, 56 = 0.466, p < 0.001), UQOL occupational subscale (F1, 58 = 4.865, p = 0.031), and UQOL health subscale (F1, 58 = 4.971, p = 0.030). Sulfur and Sepia succus were the most frequently prescribed medicines. No harm or serious adverse events were reported from either group.
The authors concluded that, although the primary analysis failed to demonstrate clearly that the treatment was effective beyond placebo, some significant benefits of IHMs over placebo could still be detected in some of the subscales in the secondary analysis.
The article was published in the recently re-named JICM, a journal that, when it was still called JCAM, featured regularly on this blog. As such, the paper is remarkable: who would have thought that this journal might publish a trial of homeopathy with a squarely negative result?
Yes, I know, the surprise is tempered by the fact that the authors make much in the conclusions of their article about the significant findings related to secondary analyses. Should we tell them that these results are all but irrelevant?
Better not!
“The decline of homeopathy, the ‘medicine’ that doesn’t cure anything” is the title of a remarkable article in EL PAIS of which I take the liberty of showing you a few key passages:
In the more than 200 years that have passed since its invention, no one has been able to prove that homeopathy is actually capable of curing anything with its alleged medicines that have no active ingredients…
…EL PAÍS reached out to some of its main promoters, such as the pharmaceutical company Boiron, leader in the sector; the Spanish Association of Homeopathy Pharmacists and the Spanish Society of Homeopathic Doctors. In the absence of a response from all three, the explanations are given by experts who are more critical of the discipline.
Many people who used to consume homeopathy were not even aware that this was the case. Fernando Frías, one of the activists who worked to undermine the discipline’s remaining prestige, recalls that people did not believe them when they were told that compounds with diluted Berlin Wall were sold to overcome the feelings of oppression and anxiety. This was actually commercialized under the premise that “like cures like”: if the Berlin Wall oppressed, a piece of it diluted in water should remedy it. “Many were under the impression that it was just a natural therapy and that we were making things up to attack it,” says Frías…
… There has been a lot of debate about how to regulate an alleged drug whose only effect is, in truth, the placebo effect. In 2001, the European Parliament issued a directive that covered its use in countries with a homeopathic tradition; sources explain that this happened due to the pressure exerted by both the industries and the governments of countries where pseudoscience is deep-rooted, such as France (where Boiron is headquartered) or Germany, where its consumption is much higher than in others, such as Spain.
“Having regard to the particular characteristics of these homeopathic medicinal products, such as the very low level of active principles they contain and the difficulty of applying to them the conventional statistical methods relating to clinical trials, it is desirable to provide a special, simplified registration procedure for those homeopathic medicinal products which are placed on the market without therapeutic indications in a pharmaceutical form and dosage which do not present a risk for the patient,” states the directive.
In its more than two centuries of history, this is not the first time that homeopathy loses ground. Still, Frías warns, it cannot be ruled out that at some point something will come up that will make it fashionable again. “Look at the example of chemtrails [the condensation trails left by airplanes that some conspiracy theorists believe are a way of poisoning the population from the air]. It seemed that no one remembered them anymore, but now they’re back,” he says. Frías cites the astrophysicist and disseminator Javier Armentia, who states that beliefs are like a rubber duck: no matter how much they sink, they always resurface. “Especially if there is money behind,” he adds.
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As reported previously, homeopathy and other forms of so-called alternative medicine (SCAM) have come under fire in Spain. In 2017, ‘HOMEOPATHY PLUS‘ reported that “in a reversal of the 2015 Royal Legislative Decree, the Minister of Health has withdrawn homeopathic remedies and outlawed the practice in Spain’s national health services.” In 2018, more than 400 people signed an open letter triggered by the case of a cancer patient who died after preferring homeopathy to regular treatment. “Let’s be clear: pseudoscience kills,” begins the letter. Since then, the struggle of Spanish rational thinkers to stop misleading information about SCAM in general and homeopathy, in particular, has only intensified.
Spain is thus joining other European countries in opposing misinformation about homeopathy. Contrary to what some have claimed (for instance, in the comments section of this blog), most of the opponents do not want to restrict the public’s choice. People who wish to use homeopathy should be able to do so (but should pay for it themselves). However, the choice must be based on evidence-based information.
Semen retention is a so-called alternative medicine (SCAM) that involves intentionally avoiding ejaculating. A person can do this by abstaining from any sexual activity, stopping before the point of ejaculation, or teaching themselves to orgasm without ejaculating.
Although this practice may seem new, this is likely only due to recent internet popularity. In fact, semen retention is an ancient practice, believed to boost male physical and spiritual energy.
Some other names for semen retention include:
- coitus reservatus
- seminal conservation
- sexual continence
It is also known as or included in practices called:
- karezza (Italian)
- maithuna (Hindu Tantra)
- sahaja (Hindu Yoga)
- tantra (Hinduism and Buddhism)
- cai Yin pu Yang and cai Yang pu Yin (Taoist)
Semen retention is said to be good for a range of things:
Mental health
- increased motivation
- improved energy and focus
- more self-confidence
- reduced anxiety
- better memory
- improved concentration
Physical health
- clearer skin
- increased testosterone
- more weight loss
- increased muscle mass
- physical rejuvenation
- a deeper voice
Spiritual health
- a greater sense of purpose
- stronger or deeper emotional bonds in relationships
- a stronger sense of overall harmony
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Yes, I agree, this sounds weird!
But is there any evidence?
Yes, e.g.:
Males of some species use mate retention behavior and investment in ejaculate quality as anti-cuckoldry tactics concurrently while others do so in a compensatory fashion. Leivers, Rhodes, and Simmons (2014) reported that men who performed mate retention less frequently produced higher-quality ejaculates, suggesting that humans use these tactics compensatorily. We conducted a conceptual replication of this research in a sample of 41 men (18-33 years; M = 23.33; SD = 3.60). By self-report, participants had not had a vasectomy and had never sought infertility treatment. We controlled for several covariates known to affect ejaculate quality (e.g., abstinence duration before providing an ejaculate) and found no statistically significant relationships between mate retention behavior and four components of ejaculate quality: sperm velocity, sperm concentration, slow motility, and ejaculate volume. The present results provide little support for the hypothesis that human males deploy mate retention behavior and ejaculate quality investment compensatorily. We discuss the limitations of this study and highlight the need for research to address questions about the nature of anti-cuckoldry tactic deployment in humans, especially concerning investment in ejaculate quality.
In species where females mate with multiple males, the sperm from these males must compete to fertilise available ova. Sexual selection from sperm competition is expected to favor opposing adaptations in males that function either in the avoidance of sperm competition (by guarding females from rival males) or in the engagement in sperm competition (by increased expenditure on the ejaculate). The extent to which males may adjust the relative use of these opposing tactics has been relatively neglected. Where males can successfully avoid sperm competition from rivals, one might expect a decrease in their expenditure on tactics for the engagement in sperm competition and vice versa. In this study, we examine the relationship between mate guarding and ejaculate quality using humans as an empirical model. We found that men who performed fewer mate guarding behaviors produced higher quality ejaculates, having a greater concentration of sperm, a higher percentage of motile sperm and sperm that swam faster and less erratically. These effects were found independent of lifestyle factors or factors related to male quality. Our findings suggest that male expenditure on mate guarding and on the ejaculate may represent alternative routes to paternity assurance in humans.
The uncritical application of western psychiatric concepts in non-western societies resulting in culturally invalid psychiatric syndromes, have been extensively documented. Such instances are considered ‘category errors’. In contrast, ‘reverse category errors’ although theoretically postulated, have never been empirically demonstrated. Diagnostic criteria of an established South Asian culture specific neurosis, Dhāt syndrome, were deployed by a psychiatrist of South Asian origin, amongst 47 white Britons in London, UK, presenting for the first time with a clinic diagnosis of ICD-9 Depressive Neurosis (Dysthymic Disroder, ICD-11). The proceedure yielded a new disorder, Semen Retention Syndrome. Based on narrative accounts and quantitative scores on the Hamilton Depression Rating Scale, the evidence suggests that a significant subset of white British subjects diagnosed with Dysthymic Disorder, may in fact be expressing a psychological variation of a previously unknown local White British somatisation phenomena labelled Semen Retention Syndrome. Anxiety and depressive symptoms presented by this subset of subjects were primarily attributed to a core irrational belief and a cognitive error centered around misunderstood concepts of semen physiology. Consequently, the undue focus on mood idioms by both white British patients and their health professionals, leads to a mistaken diagnosis of Mood Disorder, and results in incorrect treatment. The implications of this ethnocentric mode of reasoning raises concerns about existing concepts in psychiatric phenomenology and for official international diagnostic classificatory systems. The paper concludes by arguing that category errors in both directions are instances of cultural iatrogenesis, and underscore the importance of a culturally valid psychiatry.
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I was unable to find support for any of the above-listed effects of semen retention. So, claims like “Semen Retention is life-changing, especially for men. Not only, it help you turn into a real alpha male but also offers great health benefits” need to be taken with a pinch of salt. Yet, it did occur to me that semen retention might have one positive outcome:
It reduces the chances of stupid people multiplying!
An explanatory sequential mixed methods study with three separate phases was conducted in Danish patients with lumbar radiculopathy receiving a standardized chiropractic care package (SCCP). Lumbar radiculopathy is pain and other neurological symptoms caused by the pinching of nerve roots where they leave your spinal cord in the lumbar region. 
Phase one of the study was a quantitative analysis based on a survey in a prospective cohort of patients with lumbar radiculopathy in an SCCP from 2018 to 2020. Patients rated their satisfaction with the examination, information, treatment effect, and overall management of their problem on a 0–10 scale. In phase two, six semi-structured interviews conducted in 2021 were used to gain further explanatory insights into the findings from phase one. Data were analyzed using systematic text condensation. In phase three, the quantitative and qualitative data were merged in a narrative joint display to obtain a deeper understanding of the overall results.
Here I am only interested in the patients’ perception of the treatment effect. Of 303 eligible patients, 238 responded to the survey. Of these, 50% were very satisfied with the treatment effect.
The authors stated that patients in their study expected a rapid and persistent decrease in symptoms, which, unfortunately, does not match the prognosis of lumbar radiculopathy. Although the prognosis is considered good, the improvement happens gradually and often with fluctuating pain patterns, and it is not unusual to have milder symptoms for three months or longer.
So, only half of the patients who had chosen to consult chiropractors for their lumbar radiculopathy were very satisfied with the treatment results. In most patients, the symptoms decreased only gradually often with fluctuating pain patterns, and the authors comment that symptoms frequently last for three months or longer with a SCCP.
Impressive?
Might I point out that what is being described here looks to me very much like the natural history of lumbar radiculopathy? About 90% of patients with back pain caused by disc herniation see improvements within three months without therapy. Are the authors aware that their observational study is in accordance with the notion that the SCCP does nothing or very little to help patients suffering from lumbar radiculopathy?
It has been reported, at the German Medical Congress (DÄT) a year ago, that it was decided to delete the additional title of homeopathy from the model further training regulations of the German Medical Association. And Federal Health Minister Karl Lauterbach (SPD) tweeted applause: “Homeopathy has no place in modern medicine.”
Now the ‘ Bundesverband der Pharmaziestudierenden in Deutschland’ (BPhD), the German Pharmacists Organization, even goes a few steps further. The position paper distinguishes between evidence-based medicine (EBM) and unproven therapeutic methods. According to the BPhD, these include homeopathy, but also anthroposophy, traditional Chinese medicine, and traditional medicines.
Among other things, the BPhD is disturbed by the way homeopathy presents itself as an alternative, because an alternative means “a choice between two equally suitable possibilities” to achieve a goal, and this is not the case. Compared to evidence-based medicine (EBM), homeopathy is a “constructed, illusory concept” and “the principles of homeopathic teachings and principles” are to be rejected as “unscientific”. According to the BPhD, a designation as “alternative” for advertising purposes should no longer be allowed.
They would also like to see a demarcation from naturopathy; the clear distinction between homeopathy and phytopharmacy has been lacking up to now. The advertising attribute “natural” should therefore also be banned in order to prevent equalization in advertising, the position paper states.
Like doctors, pharmacy students point to the lack of proof of efficacy beyond the placebo effect. According to the BPhD, the dogma WER HEILT HAT RECHT, “he who heals is right” would “disregard all processes that work towards healing and glorify the result”. The “gold standard” of EBM – randomized, double-blind studies with placebo control – should in future also have to be fulfilled by homeopathic medicines, experience reports are not sufficient, it continues.
Homeopathic medicines are only registered as medicinal products without indication, which requires neither proof of efficacy nor clinical studies. The BPhD, therefore, demands that a warning be placed on the preparations that they have “no proven efficacy beyond the placebo effect”. Up to now, without this warning, patients have been “deceived about the efficacy”, and there is an “urgent need for detailed public information and counseling on homeopathy since its unjustified reputation poses a danger of not seeking treatment”. The BPhD also demands that the status of homeopathic medicines is withdrawn and that the pharmacy obligation for the preparations is abolished…
“In the health professions, no trivialization of unproven therapeutic procedures should be tolerated, as inadequate counseling or ignorance poses a danger to patients,” the BPhD said.
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When I first read this article – I translated and shortened it for those who cannot read German- I was truly dazzled. These are the suggestions that I have been making for around 20 years now, not specifically for Germany but for pharmacists in general. For many years, the Germans seemed the least likely to agree with me. But now they seem to be ahead of everyone else in Europe!
How come?
I suspect and hope that our recent initiative might have something to do with it.
Let’s hope that the pharmacists of other countries follow the German example.
On this blog, we have some people who continue to promote conspiracy theories about Covid and Covid vaccinations. It is, therefore, time, I feel, to present them with some solid evidence on the subject (even though it means departing from our usual focus on SCAM).
This Cochrane review assessed the efficacy and safety of COVID‐19 vaccines (as a full primary vaccination series or a booster dose) against SARS‐CoV‐2. An impressive team of investigators searched the Cochrane COVID‐19 Study Register and the COVID‐19 L·OVE platform (last search date 5 November 2021). They also searched the WHO International Clinical Trials Registry Platform, regulatory agency websites, and Retraction Watch. They included randomized controlled trials (RCTs) comparing COVID‐19 vaccines to placebo, no vaccine, other active vaccines, or other vaccine schedules.
A total of 41 RCTs could be included and analyzed assessing 12 different vaccines, including homologous and heterologous vaccine schedules and the effect of booster doses. Thirty‐two RCTs were multicentre and five were multinational. The sample sizes of RCTs were 60 to 44,325 participants. Participants were aged: 18 years or older in 36 RCTs; 12 years or older in one RCT; 12 to 17 years in two RCTs; and three to 17 years in two RCTs. Twenty‐nine RCTs provided results for individuals aged over 60 years, and three RCTs included immunocompromised patients. No trials included pregnant women. Sixteen RCTs had two‐month follow-ups or less, 20 RCTs had two to six months, and five RCTs had greater than six to 12 months or less. Eighteen reports were based on preplanned interim analyses. The overall risk of bias was low for all outcomes in eight RCTs, while 33 had concerns for at least one outcome. 343 registered RCTs with results not yet available were identified.The evidence for mortality was generally sparse and of low or very low certainty for all WHO‐approved vaccines, except AD26.COV2.S (Janssen), which probably reduces the risk of all‐cause mortality (risk ratio (RR) 0.25, 95% CI 0.09 to 0.67; 1 RCT, 43,783 participants; high‐certainty evidence).High‐certainty evidence was found that BNT162b2 (BioNtech/Fosun Pharma/Pfizer), mRNA‐1273 (ModernaTx), ChAdOx1 (Oxford/AstraZeneca), Ad26.COV2.S, BBIBP‐CorV (Sinopharm‐Beijing), and BBV152 (Bharat Biotect) reduce the incidence of symptomatic COVID‐19 compared to placebo (vaccine efficacy (VE): BNT162b2: 97.84%, 95% CI 44.25% to 99.92%; 2 RCTs, 44,077 participants; mRNA‐1273: 93.20%, 95% CI 91.06% to 94.83%; 2 RCTs, 31,632 participants; ChAdOx1: 70.23%, 95% CI 62.10% to 76.62%; 2 RCTs, 43,390 participants; Ad26.COV2.S: 66.90%, 95% CI 59.10% to 73.40%; 1 RCT, 39,058 participants; BBIBP‐CorV: 78.10%, 95% CI 64.80% to 86.30%; 1 RCT, 25,463 participants; BBV152: 77.80%, 95% CI 65.20% to 86.40%; 1 RCT, 16,973 participants).Moderate‐certainty evidence was found that NVX‐CoV2373 (Novavax) probably reduces the incidence of symptomatic COVID‐19 compared to placebo (VE 82.91%, 95% CI 50.49% to 94.10%; 3 RCTs, 42,175 participants).There is low‐certainty evidence for CoronaVac (Sinovac) for this outcome (VE 69.81%, 95% CI 12.27% to 89.61%; 2 RCTs, 19,852 participants).High‐certainty evidence was found that BNT162b2, mRNA‐1273, Ad26.COV2.S, and BBV152 result in a large reduction in the incidence of severe or critical disease due to COVID‐19 compared to placebo (VE: BNT162b2: 95.70%, 95% CI 73.90% to 99.90%; 1 RCT, 46,077 participants; mRNA‐1273: 98.20%, 95% CI 92.80% to 99.60%; 1 RCT, 28,451 participants; AD26.COV2.S: 76.30%, 95% CI 57.90% to 87.50%; 1 RCT, 39,058 participants; BBV152: 93.40%, 95% CI 57.10% to 99.80%; 1 RCT, 16,976 participants).
Moderate‐certainty evidence was found that NVX‐CoV2373 probably reduces the incidence of severe or critical COVID‐19 (VE 100.00%, 95% CI 86.99% to 100.00%; 1 RCT, 25,452 participants).
Two trials reported high efficacy of CoronaVac for severe or critical disease with wide CIs, but these results could not be pooled.
mRNA‐1273, ChAdOx1 (Oxford‐AstraZeneca)/SII‐ChAdOx1 (Serum Institute of India), Ad26.COV2.S, and BBV152 probably result in little or no difference in serious adverse events (SAEs) compared to placebo (RR: mRNA‐1273: 0.92, 95% CI 0.78 to 1.08; 2 RCTs, 34,072 participants; ChAdOx1/SII‐ChAdOx1: 0.88, 95% CI 0.72 to 1.07; 7 RCTs, 58,182 participants; Ad26.COV2.S: 0.92, 95% CI 0.69 to 1.22; 1 RCT, 43,783 participants); BBV152: 0.65, 95% CI 0.43 to 0.97; 1 RCT, 25,928 participants). In each of these, the likely absolute difference in effects was fewer than 5/1000 participants.
Evidence for SAEs is uncertain for BNT162b2, CoronaVac, BBIBP‐CorV, and NVX‐CoV2373 compared to placebo (RR: BNT162b2: 1.30, 95% CI 0.55 to 3.07; 2 RCTs, 46,107 participants; CoronaVac: 0.97, 95% CI 0.62 to 1.51; 4 RCTs, 23,139 participants; BBIBP‐CorV: 0.76, 95% CI 0.54 to 1.06; 1 RCT, 26,924 participants; NVX‐CoV2373: 0.92, 95% CI 0.74 to 1.14; 4 RCTs, 38,802 participants).
The authors’ conclusions were as follows: Compared to placebo, most vaccines reduce, or likely reduce, the proportion of participants with confirmed symptomatic COVID‐19, and for some, there is high‐certainty evidence that they reduce severe or critical disease. There is probably little or no difference between most vaccines and placebo for serious adverse events. Over 300 registered RCTs are evaluating the efficacy of COVID‐19 vaccines, and this review is updated regularly on the COVID‐NMA platform (covid-nma.com).
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As some conspiratorial loons will undoubtedly claim that this review is deeply biased; it might be relevant to add the conflicts of interest of its authors:
- Carolina Graña: none known.
- Lina Ghosn: none known.
- Theodoros Evrenoglou: none known.
- Alexander Jarde: none known.
- Silvia Minozzi: no relevant interests; Joint Co‐ordinating Editor and Method editor of the Drugs and Alcohol Group.
- Hanna Bergman: Cochrane Response – consultant; WHO – grant/contract (Cochrane Response was commissioned by the WHO to perform review tasks that contribute to this publication).
- Brian Buckley: none known.
- Katrin Probyn: Cochrane Response – consultant; WHO – consultant (Cochrane Response was commissioned to perform review tasks that contribute to this publication).
- Gemma Villanueva: Cochrane Response – employment (Cochrane Response has been commissioned by WHO to perform parts of this systematic review).
- Nicholas Henschke: Cochrane Response – consultant; WHO – consultant (Cochrane Response was commissioned by the WHO to perform review tasks that contributed to this publication).
- Hillary Bonnet: none known.
- Rouba Assi: none known.
- Sonia Menon: P95 – consultant.
- Melanie Marti: no relevant interests; Medical Officer at WHO.
- Declan Devane: Health Research Board (HRB) – grant/contract; registered nurse and registered midwife but no longer in clinical practice; Editor, Cochrane Pregnancy and Childbirth Group.
- Patrick Mallon: AstraZeneca – Advisory Board; spoken of vaccine effectiveness to media (print, online, and live); works as a consultant in a hospital that provides vaccinations; employed by St Vincent’s University Hospital.
- Jean‐Daniel Lelievre: no relevant interests; published numerous interviews in the national press on the subject of COVID vaccination; Head of the Department of Infectious Diseases and Clinical Immunology CHU Henri Mondor APHP, Créteil; WHO (IVRI‐AC): expert Vaccelarate (European project on COVID19 Vaccine): head of WP; involved with COVICOMPARE P et M Studies (APHP, INSERM) (public fundings).
- Lisa Askie: no relevant interests; Co‐convenor, Cochrane Prospective Meta‐analysis Methods Group.
- Tamara Kredo: no relevant interests; Medical Officer in an Infectious Diseases Clinic at Tygerberg Hospital, Stellenbosch University.
- Gabriel Ferrand: none known.
- Mauricia Davidson: none known.
- Carolina Riveros: no relevant interests; works as an epidemiologist.
- David Tovey: no relevant interests; Emeritus Editor in Chief, Feedback Editors for 2 Cochrane review groups.
- Joerg J Meerpohl: no relevant interests; member of the German Standing Vaccination Committee (STIKO).
- Giacomo Grasselli: Pfizer – speaking engagement.
- Gabriel Rada: none known.
- Asbjørn Hróbjartsson: no relevant interests; Cochrane Methodology Review Group Editor.
- Philippe Ravaud: no relevant interests; involved with Mariette CORIMUNO‐19 Collaborative 2021, the Ministry of Health, Programme Hospitalier de Recherche Clinique, Foundation for Medical Research, and AP‐HP Foundation.
- Anna Chaimani: none known.
- Isabelle Boutron: no relevant interests; member of Cochrane Editorial Board.
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And as some might say this analysis is not new, here are two further papers just out:
Objectives To determine the association between covid-19 vaccination types and doses with adverse outcomes of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection during the periods of delta (B.1.617.2) and omicron (B.1.1.529) variant predominance.
Design Retrospective cohort.
Setting US Veterans Affairs healthcare system.
Participants Adults (≥18 years) who are affiliated to Veterans Affairs with a first documented SARS-CoV-2 infection during the periods of delta (1 July-30 November 2021) or omicron (1 January-30 June 2022) variant predominance. The combined cohorts had a mean age of 59.4 (standard deviation 16.3) and 87% were male.
Interventions Covid-19 vaccination with mRNA vaccines (BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna)) and adenovirus vector vaccine (Ad26.COV2.S (Janssen/Johnson & Johnson)).
Main outcome measures Stay in hospital, intensive care unit admission, use of ventilation, and mortality measured 30 days after a positive test result for SARS-CoV-2.
Results In the delta period, 95 336 patients had infections with 47.6% having at least one vaccine dose, compared with 184 653 patients in the omicron period, with 72.6% vaccinated. After adjustment for patient demographic and clinical characteristics, in the delta period, two doses of the mRNA vaccines were associated with lower odds of hospital admission (adjusted odds ratio 0.41 (95% confidence interval 0.39 to 0.43)), intensive care unit admission (0.33 (0.31 to 0.36)), ventilation (0.27 (0.24 to 0.30)), and death (0.21 (0.19 to 0.23)), compared with no vaccination. In the omicron period, receipt of two mRNA doses were associated with lower odds of hospital admission (0.60 (0.57 to 0.63)), intensive care unit admission (0.57 (0.53 to 0.62)), ventilation (0.59 (0.51 to 0.67)), and death (0.43 (0.39 to 0.48)). Additionally, a third mRNA dose was associated with lower odds of all outcomes compared with two doses: hospital admission (0.65 (0.63 to 0.69)), intensive care unit admission (0.65 (0.59 to 0.70)), ventilation (0.70 (0.61 to 0.80)), and death (0.51 (0.46 to 0.57)). The Ad26.COV2.S vaccination was associated with better outcomes relative to no vaccination, but higher odds of hospital stay and intensive care unit admission than with two mRNA doses. BNT162b2 was generally associated with worse outcomes than mRNA-1273 (adjusted odds ratios between 0.97 and 1.42).
Conclusions In veterans with recent healthcare use and high occurrence of multimorbidity, vaccination was robustly associated with lower odds of 30 day morbidity and mortality compared with no vaccination among patients infected with covid-19. The vaccination type and number of doses had a significant association with outcomes.
SECOND EXAMPLE Long COVID, or complications arising from COVID-19 weeks after infection, has become a central concern for public health experts. The United States National Institutes of Health founded the RECOVER initiative to better understand long COVID. We used electronic health records available through the National COVID Cohort Collaborative to characterize the association between SARS-CoV-2 vaccination and long COVID diagnosis. Among patients with a COVID-19 infection between August 1, 2021 and January 31, 2022, we defined two cohorts using distinct definitions of long COVID—a clinical diagnosis (n = 47,404) or a previously described computational phenotype (n = 198,514)—to compare unvaccinated individuals to those with a complete vaccine series prior to infection. Evidence of long COVID was monitored through June or July of 2022, depending on patients’ data availability. We found that vaccination was consistently associated with lower odds and rates of long COVID clinical diagnosis and high-confidence computationally derived diagnosis after adjusting for sex, demographics, and medical history.
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There are, of course, many more articles on the subject for anyone keen to see the evidence. Sadly, I have little hope that the COVID loons will be convinced by any of them. Yet, I thought I should give it nevertheless a try.
