methodology
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].
Although the use of so-called alternative medicine (SCAM) is said to be rising among older adults, many do
not discuss these healthcare practices with their primary care practitioners (PCPs). This recent US survey sought to determine the prevalence of SCAM use and to identify factors associated with SCAM disclosure among patients ages 65 and older.
Participants completed an anonymous survey, which evaluated their SCAM use over the past year and disclosure of SCAM to a PCP. Additional questions queried demographics, patient health, and relationships with one’s PCP. Analyses included descriptive statistics, chi-square tests, and logistic regression.
One hundred seventy-three participants answered surveys (response rate=23%). The Main findings were as follows:
- Sixty percent reported the use of at least one form of SCAM in the past year.
- Among those using SCAM, 64% disclosed use to their PCP.
- Patients disclosed supplements/herbal products and naturopathy/homeopathy/acupuncture at a higher rate than bodywork techniques and mind-body practices (71.9% and 66.7% vs. 48% and 50%).
- The only factor significantly associated with disclosure was trust in one’s PCP (odds ratio=2.97; confidence interval=1.01–8.73).
- The most commonly used types of SCAM were herbal products/dietary supplements (37.0%), mind-body therapies (28.9%), bodywork techniques (26.6%), and naturopathy/acupuncture/homeopathy (8.7%).
The authors concluded that clinicians may improve SCAM disclosure rates in older adults by inquiring about all types of SCAM and continuing to invest in their patient relationships, specifically by building trust.
The one-year prevalence of SCAM use – 60% – is extraordinary and considerably higher than in other surveys. How can this be explained?
I think that two factors might have played a role: firstly the survey was tiny, and secondly, its response rate was dismal. People who have no interest in SCAM would probably have not responded. Thus the prevalence figure is way too high and the survey is not representative of any population.
Having said that, I believe that some of the conclusions are still correct. As I have pointed out so often already:
- doctors need to ask their patients about SCAM usage;
- once they have identified a SCAM user, they need to advise him/her responsibly;
- to do that, they need to know about SCAM;
- as most doctors have little knowledge about the subject, they need to learn;
- failing to do that is not ethical behavior.
This trial investigated the effect of osteopathic visceral manipulation (OVM) on disability and pain intensity in individuals with functional constipation and chronic nonspecific low back pain. It was designed as a randomized controlled trial with a blinded assessor. Seventy-six volunteers with functional constipation and chronic nonspecific low back pain were randomized to two groups: OVM and sham OVM. The primary clinical outcome was pain intensity measured using a numeric rating scale (NRS) and disability measured using the Oswestry Disability Index (ODI). The secondary outcomes were electromyographic signals measured during the flexion-extension cycle, the finger-to-floor distance during complete flexion of the trunk, and the Fear-Avoidance Beliefs Questionnaire (FABQ). All outcomes were determined after six weeks of treatment as well as three months after randomization.
The OVM group reported a reduction in pain intensity after six weeks of treatment and at the three-month evaluation (p < .0002) and the sham group reported a reduction in pain intensity after three-month evaluation (p < .007). For the ODI was also found in the OVM group six weeks after the end of treatment (treatment effect = -6.59, 95% CI: -12.01 to -1.17, p = .01) and at the three-month evaluation (treatment effect = -6.02, 95% CI: -11.55 to -0.49, p = .03). Significant differences were also found for paravertebral muscle activity during the dynamic phases (flexion and extension) six-week evaluations.
The authors concluded that the OVM group demonstrated a reduction in pain intensity and improvement in disability after six-weeks and three-month follow-up while the sham group reduction in pain three-month follow-up.
I have no access to the full paper (if someone can send me the paper, I would update my post accordingly), but from reading the abstract, it seems the reported findings are based on within-group changes. The whole point of having a control group is to compare verum and control. The other point of importance is that it would have been crucial to verify whether patients were able to tell the verum from the sham intervention. If patients were able to tell, they would no longer be blinded and the placebo effect would have not been accounted for. A third point of relevance might be that the study seems tiny and far too small for drawing general conclusions about the value of OVM.
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I have now seen the protocol of the paper – thanks for making it available – and might add the following points to the discussion:
- The sham treatment consisted of “light touches over the different parts of the abdomen, without any deep mobilization or movement. The osteopath applied her hands over the same points with the
same duration as in OVM to give the patient the perception of being treated.” It is likely that patients in the control group could have guessed that they were sham-treated. - The stats issue cannot be resolved on the basis of just the protocol.
- “To assess patients’ blinding to treatment allocation, patients are asked post treatment (six weeks after
the start of treatment) to report which study treatment they think that they received (OVM/SOVM). The effect of their reports on outcome will be examined in explorative analysis.” As I have no
access to the results, I still do not know whether blinding was successful.
Psoriasis is a chronic inflammatory skin disorder, affecting the trunk and extensor surfaces of limbs and scalp predominantly. Its prevalence ranges between 0.1 and 11.4% and in India between 0.4 and 2.8%. Psoriasis remains a frequently encountered condition in homeopathy practice, but there is a dearth of evidence supporting its use. 
This 6-month, double-blind, randomized trial was conducted on 51 patients suffering from psoriasis at the National Institute of Homoeopathy, India. Patients were randomized to receive either individualized homeopathic medicines (IHMs; n = 25) in LM potencies or identical-looking placebos (n=26). Psoriasis area and severity index (PASI; primary), psoriasis disability index (PDI), and dermatological life quality index (DLQI; secondary) were measured at baseline, and every 2 months, up to 6 months. The intention-to-treat sample was analyzed using a two-way repeated measure analysis of variance.
Although intra-group changes were significant in both groups, improvements were significantly greater in the IHMs group than in the placebo group regarding the PASI scores after 6 months (F1, 49 = 10.448, P = 0.002). DLQI daily activity subscale scores also yielded similar significant results favoring IHMs against placebos after 6 months (F1, 49 = 5.480, P = 0.023). Improvement in PDI total (F1, 49 = 0.063, P = 0.803), DLQI total (F1, 49 = 1.371, P = 0.247), and all remaining subscales were higher in the IHMs group than placebos after 6 months, but non-significant statistically. Calcarea carbonica, Mercurius solubilis, Arsenicum album, and Petroleum were the most frequently prescribed medicines.
The authors concluded that IHMs exhibited better results than placebos in the treatment of psoriasis. Further research is warranted.
I am unable to access the full text of this paper [in case someone can, please send it to me for further scrutiny]. Judging from just the abstract, I see the following problems with this trial:
- Psoriasis is a genetically determined condition, and I find it hard to believe that homeopathy can change its natural history.
- The symptoms of psoriasis fluctuate and can be influenced by a range of factors, including stress.
- We learn nothing about any concomitant interventions which are always necessary, e.g. creams, or compliance with them.
- It is conceivable that patients in the verum group received inadvertent reassurance which, in turn, reduced stress and improved compliance with external treatments.
- It is unclear whether patients were successfully blinded or whether inadvertent de-blinding occurred.
In any case, I would caution that this trial needs independent replications before we can take its findings seriously.
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Thanks to several readers, I now have the full text and can add the following points:
- The authors report adverse events as follows: ” No adverse events were reported during the treatment period from either group that could be attributed causally to either IHMs or placebos. Some minor events unrelated to study medications, like common cold and injury occurring in both groups were treated with acute homeopathic medicines irrespective of allocated codes, and once those acute phases were over, the patients were returned to originally allocated groups again.” This is odd because homeopaths would expect aggravations in a high percentage of cases.
- I am not sure that I understand the blinding procedure; it is described as follows: “Double-blinding method was adopted by masking the trial participants, investigators, outcome assessors, pharmacists, and data entry operators throughout the trial. Identical-looking vials were coded as either “1” or “2” and contained either medicines or placebos. The codes remained the same for all the randomized participants. Codes were assigned randomly and confidentially by another independent third party. Both medicines and placebos were repacked in identical glass bottles and labeled with code, name of medicine, and potency, and were dispensed according to the random number list. The vials were destined for each patient by the random number chart. The participants got the medicines dispensed personally at the hospital pharmacy. Codes were broken at the end of the trial after the dataset was frozen.”
- The affiliations of the authors are interesting:1 Dept. of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Block GE, Sector 3, Salt Lake, Kolkata 700106, West Bengal, India; affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India
2 Dept. of Repertory, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Block GE,
Sector 3, Salt Lake, Kolkata 700106, West Bengal, India; affiliated to The West Bengal University of
Health Sciences, Govt. of West Bengal, India 3 Dept. of Repertory, The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal, 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal; affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India
4 East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre,
Village and Post Office: Dakshin Gouripur, Police Station Bishnupur, South 24 Parganas 743503, West
Bengal, under Department of Health & Family Welfare, Govt. of West Bengal, India 5 Dept. of Repertory, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, 12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal; affiliated to The West Bengal University
of Health Sciences, Govt. of West Bengal, India.
I think it is safe to repeat that independent replications would be essential.
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.
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.
‘Spagyric’ is a so-called alternative medicine (SCAM) based on the alchemy of Paracelsus (1493-1541). Paracelsus borrowed the term from “separate” (spao) and “combine” (ageiro) to indicate that spagyric preparations are based on the “separation”, “extraction” and “recombination” of the active ingredients of a substance. Plant, mineral as well as animal source materials are used.
The production of spagyric remedies is based on a complex process of maceration and fermentation of a plant extract in alcohol. It takes place in dark, thick-walled glass flasks that are hermetically sealed and kept at a controlled temperature of 37 °C for 28 days. The tincture thus obtained is then decanted and the drug residue is removed from the solution, completely dried, and burned to ash to recover the inorganic components of the plant material. The ash is subsequently dissolved in the alcoholic solution of maceration, and the finished spagyric preparation is left for 12 days before use.
Spagyric is not the most popular of all SCAMs but it certainly does have a significant following. One enthusiast claims that “spagyric essences work on a vibrational level in their action upon the emotional/mind and physical spheres and can be employed in numerous situations. Most people seek help to relieve physical symptoms. Even so, it is often necessary to address the emotional and psychological aspects which may predispose the illness or imbalance. In an era where many people are experiencing life-changing events, the ability to transition smoothly is essential for well-being and vitality. Guidance and help are required to maintain homeostasis. These medicines can help the patient to understand the root cause of their illness and learn to regain control of their lives. Some medicine systems appear to be less effective than in previous times. It has been suggested that the energetic frequency of both the earth and human organism are changing. Therefore these systems may no longer be a vibrational match for the changing frequencies. Spagyric Medicine is designed to ‘tune in with’ these current frequencies. Research suggests that the Spagyric essences may instigate improved health by energetically influencing DNA.”
After reading such weird statements, I ask myself, is there any evidence that spagyric remedies work? In my search for robust studies, I was unsuccessful. There does not seem to be a single controlled study on the subject. However, there are fragmentary reports of a study initiated and conducted by a now largely unknown healer named Karl Hann von Weyhern.
Von Weyhern (1882 – 1954) had taken a few semesters of pharmacy and medicine in Freiburg but remained without a degree. In 1930, he became a member of the NSDAP (Hitler’s Nazi party) and in 1940 he joined the SS. Around 1935, he settled in Munich as a non-medical practitioner (Heilpraktiker), and Heinrich Himmler who has a soft spot for SCAM enlisted as one of his patients. By then von Weyhern had by then made a steep career in the Nazi hierarchy, and he managed to convince Himmler that his spagyric remedies could cure tuberculosis, which was still rampant at the time. They decided to carry out experiments in this regard in the Dachau concentration camp.
Thus, von Weyhern was allowed to test spagyric remedies on forcibly recruited concentration camp prisoners. These experiments lasted for about one year and included around 150 patients who, according to von Weyhern’s iridology diagnosis, suffered from tuberculosis. Half of them were treated with spagyric remedies and the others with conventional treatments. At the end of the experiment, 27 persons were reportedly released into everyday concentration camp life as ‘fit for work’. How many of the 150 prisoners lost their lives due to these experiments is not known. Von Weyhern never filed a final report. It is to be feared that the death toll was considerable. [1]
After the war, von Weyhern denied belonging to the SS, claimed that he had ‘sacrificed himself’ for his patients in the concentration camp, merely had to pay a fine, and was ‘denazified’ in 1948. Subsequently, he resumed his work as a ‘Heilpraktiker’ in Olching, a village near Dachau. [1]
Of course, these infamous experiments cannot be blamed on spagyric medicine. Yet, I feel they are nevertheless important, not least because they seem to reveal the only thing remotely resembling something like evidence.
[1] Die Ärzte der Nazi-Führer: Karrieren und Netzwerke : Mathias Schmidt (Hg.), Dominik Groß (Hg.), Jens Westemeier (Hg.): Amazon.de: BooksMassages are experienced as agreeable by most patients. But that does not necessarily mean that it improves our quality of life. This study tests whether it does.
This study compared three massage dosing strategies among inpatients receiving palliative care consultation. It was designed as a three-armed randomized trial examining three different doses of therapist-applied massage to test change in overall quality of life (QoL) and symptoms among hospitalized adult patients receiving palliative care consultation for any indication:
- Arm I: 10-min massage daily × 3 days;
- Arm II: 20-min massage daily × 3 days;
- Arm III: single 20-min massage.
The primary outcome measure was the single-item McGill QoL question. Secondary outcomes measured pain/symptoms, rating of peacefulness, and satisfaction with the intervention. Data were collected at baseline, pre-and post-treatment, and one-day post-last treatment (follow-up). Repeated measure analysis of variance and paired t-test were used to determine significant differences.
A total of 387 patients participated (55.7 (±15.49) years old, mostly women (61.2%) and African-American (65.6%)). All three arms demonstrated within-group improvement at follow-up for McGill QoL (all P < 0.05). No significant between-group differences were found. Finally, repeated measure analyses demonstrated time to predict immediate improvement in distress (P ≤ 0.003) and pain (P ≤ 0.02) for all study arms; however, only improvement in distress was sustained at follow-up measurement in arms with three consecutive daily massages of 10 or 20 minutes.
The authors concluded that massage therapy in complex patients with advanced illness was beneficial beyond dosage. Findings support session length (10 or 20 minutes) was predictive of short-term improvements while treatment frequency (once or three consecutive days) predicted sustained improvement at follow-up.
I like this study because it teaches us an important lesson:
IF ONE DESIGNS A SILLY STUDY, ONE IS LIKELY TO ARRIVE AT A SILLY CONCLUSION.
This study does not have a proper control group. Therefore, we cannot know whether the observed outcomes were due to the different interventions or to non-specific effects such as expectation, the passing of time, etc.
The devil’s advocate conclusion of the findings is thus dramatically different from that of the authors: the results of this trial are consistent with the notion that massage has no effect on QoL, no matter how it is dosed.
Reiki is a Japanese form of energy healing used predominantly for stress reduction and relaxation. It is based on the notion that a mystical “life force energy” flows through us and is what causes us to be alive.
This study was conducted by researchers from the Department of Elderly Care, Vocational School of Health Services, Mardin Artuklu University, Mardin, Turkey, and the Internal Medicine Nursing Department, Mersin University Faculty of Nursing, Mersin, Turkey. Its aim was to determine the effect of Reiki when applied before upper gastrointestinal endoscopy on levels of anxiety, stress, and comfort. It was designed as a single-blind, randomized, sham-controlled study and conducted between February and July 2021.
Patients who were scheduled for gastrointestinal endoscopy and who met the inclusion criteria were randomized into three groups: 
- Reiki,
- sham Reiki,
- control (no intervention).
A total of 159 patients participated in the study. In groups 1 and 2, Reiki and sham Reiki was applied once for approximately 20 to 25 minutes before gastrointestinal endoscopy.
When the Reiki group was compared to the sham Reiki and control groups following the intervention, the decrease in the levels of patient stress (P < .001) and anxiety (P < .001) and the increase in patient comfort (P < .001) were found to be statistically significant.
The authors concluded that Reiki applied to patients before upper gastrointestinal endoscopy was effective in reducing stress and anxiety and in increasing comfort.
As this paper is behind a paywall, I wrote to the authors and asked for a reprint. Unfortunately, I received no reply at all. Thus, I find it difficult to comment. Yet, the study might be important, particularly because there are not many sham-controlled trials of Reiki.
The abstract merely informs us that Reiki was better than sham Reiki. It does not tell us what constituted the sham intervention. Crucially, we also cannot know whether the patients were adequately blinded or whether they were able to tell the sham from the verum.
In the absence of this information, I am merely able to state that Reiki lacks plausibility and is most unlikely, in my view, to have any specific therapeutic effects. This means that the most likely explanation for the extraordinary results of this study is the de-blinding of some of the patients in group 2 or some other source of bias that cannot be identified from just studying the abstract.
PS
If someone can send me the full paper, I’d be more than happy to clarify the apparent mystery.
