commercial interests
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.
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.
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.
A team of French researchers assessed whether a conflict of interest (COI) might be associated with the direction of the results of meta-analyses of homoeopathy trials. Their analysis (published as a ‘letter to the editor) is complex, therefore, I present here only their main finding.
The team conducted a literature search until July 2022 on PubMed and Embase to identify meta-analyses of randomized clinical trials assessing the efficacy of homoeopathy. They then assessed the existence of potential COI, defined by the presence of at least one of the following criteria:
- affiliation of one or more authors to an academic homoeopathy research or care facility, or to the homoeopathy industry;
- research sponsored or funded by the homoeopathy industry;
- COI declared by the authors.
The researchers also evaluated and classified any spin in meta-analyses conclusions into three categories (misleading reporting, misleading interpretation and inappropriate extrapolation). Two reviewers assessed the quality of meta-analyses and the risk of bias based. Publication bias was evaluated by the funnel plot method. For all the studies included in these meta-analyses, the researchers checked whether they reported a statistically significant result in favour of homoeopathy. Further details about the methods are provided on OSF (https://osf.io/nqw7r/) and in the preregistered protocol (CRD42020206242).
Twenty meta-analyses were included in the analysis (list of references available at https://osf.io/nqw7r/).
- Among the 13 meta-analyses with COI, a significantly positive effect of homoeopathy emerged (OR=0.60 (95% CI 0.50 to 0.70)).
- There was no such effect for meta-analyses without COI (OR=0.96 (95% CI 0.75 to 1.23)).
The authors concluded that in the presence of COI, meta-analyses of homoeopathy trials are more likely
to have favourable results. This is consistent with recent research suggesting that systematic reviews with financial COI are associated with more positive outcomes.
Meta-analyses are systematic reviews (critical assessments of the totality of the available evidence) where the data from the included studies are pooled. For a range of reasons, this may not always be possible. Therefore the number of meta-analyses (20) is substantially lower than that of the existing systematic reviews (>50).
Both systematic reviews and meta-analyses are theoretically the most reliable evidence regarding the value of any intervention. I said ‘theoretically’ because, like any human endeavour, they need to be done in an unbiased fashion to produce reliable results. People with a conflict of interest by definition struggle to be free of bias. As we have seen many times, this would include homoeopaths.
This new analysis confirms what many of us have feared. If proponents of homeopathy with an overt conflict of interest conduct a meta-analysis of studies of homeopathy, the results tend to be more positive than when independent researchers do it. The question that emerges from this is the following:
Are the findings of those researchers who have an interest in producing a positive result closer to the truth than the findings of researchers who have no such conflict?
I let you decide.
After all these years, I am still fascinated by what proponents of homeopathy try to tell others about their trade. Recently I found a long article in this vein. It is aimed at an audience of HEILPRAKTIKER and their patients. It should therefore be responsible, thorough, and evidence-based (yes, I am an optimist).
“With this article”, the authors state, “we aim to provide a comprehensive overview of homeopathy and help people make informed decisions about their health. Whether you already have experience with homeopathy or simply want to inform yourself, we hope that this article will provide you with valuable insights and information” (my translation).
Here I present to you just the relatively short section dedicated to the ‘pros and cons’ of homeopathy. Here we go:
Advantages of homeopathy:
- Holistic approach: homeopathy considers the human being as a whole and takes into account both physical and emotional aspects. It aims to support individual balance and the body’s self-healing powers.
- Gentle and non-invasive treatment: Homeopathic remedies are usually taken as globules, drops, or tablets and are therefore easy and convenient to use. They rarely cause side effects and are generally well tolerated.
- Individualized treatment: In homeopathy, each patient is considered unique and treatment is based on individual symptoms and characteristics. There is no “one-size-fits-all” solution, but a personalized approach.
- Support for chronic diseases: Homeopathy can be an alternative or complementary treatment for chronic conditions where conventional medicines offer limited relief. It can help improve quality of life and promote overall well-being.
Limitations of homeopathy:
- Placebo effect: Much of the effect of homeopathy is attributed to the placebo effect. It is argued that the improvements patients experience occur because of belief in the efficacy of the remedies and positive expectations, rather than due to a specific effect of the diluted substances.
- Lack of scientific evidence: The scientific evidence for the efficacy of homeopathy is limited and controversial. Many studies have failed to demonstrate benefits beyond the placebo effect. There is a lack of well-conducted randomized controlled trials that clearly show the effectiveness of homeopathy.
- Delay or rejection of conventional treatments: In some cases, the choice of homeopathy as the sole method of treatment may lead to delays in the diagnosis and timely treatment of serious or acute illnesses. It is important that serious illnesses are examined by a doctor and treated appropriately.
- Difficulties in standardization: Homeopathy involves a variety of remedies used in different potencies and dilutions. This makes standardization and the conduct of reproducible studies difficult. There are also controversial debates about whether the dilutions go beyond the extent to which molecules of the original substance are still present.
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I am sure that you have heard the BS about the alleged advantages of homeopathy often enough. Therefore, I will here not bother to comment on them again. More interesting, in my view, are the limitations of homeopathy, as seen by its proponents. Please allow me, therefore, to discuss them briefly.
- The authors state that “it is argued that the improvements patients experience occur because of belief in the efficacy of the remedies and positive expectations”. This sounds as though this is a mere aberrant opinion or at least an ongoing debate amongst scientists. In fact, it is the scientific consensus supported by tons of evidence.
- This is the same point expressed differently.
- The admission that “the choice of homeopathy as the sole method of treatment may lead to delays in the diagnosis and timely treatment” is yet another way of stating that homeopathy is not effective. What is, however, not expressed clearly enough, in my view, is the fact that homeopathic treatment usually amounts to medical neglect which is unethical and can cause serious harm, in extreme cases even death.
- It is not true that the range of potencies renders “the conduct of reproducible studies difficult”. There are plenty of examples to demonstrate this, for instance, this study. “There are also controversial debates about whether the dilutions go beyond the extent to which molecules of the original substance are still present.” Yes, I did translate this correctly. I am sorry to say that this sentence does make no sense in German or in English.
What I find particularly interesting is that the authors do not mention disadvantages that non-homeopaths would rate as quite important, e.g.:
- The assumptions of homeopathy fly in the face of science.
- Hahnemann strictly forbade homeopathy to be combined with ‘allopathy’ (yet proponents now claim this option to be an advantage).
- Treating a patient with homeopathy violates even the most basic rules of medical ethics.
- Homeopaths have no choice but to lie to their patients on a daily basis.
- Many homeopaths have the nasty habit of advising their patients against using effective treatments, e.g. vaccinations.
- Homeopathy undermines rational thinking in a general way.
In summary, the authors’ “aim to provide a comprehensive overview of homeopathy and help people make informed decisions about their health” has not been reached.
It has recently been reported that a 39-year-old woman (a mother-of-three died) died after immersing herself in a river as part of a cold water therapy session. The woman died after paramedics were called to attend a riverside in Derbyshire. The session was run by Kevin O’Neill of ‘Breatheolution’, whose previous clients include Coleen Rooney and actor Stephen Graham. The woman, who was visiting with two friends after paying up to £200 for a two-hour cold water therapy session, was rushed to hospital where she died.
Mr. O’Neill commented: “I am heartbroken. I’ve not slept and I’m finding it hard to process. I cannot stop thinking about her family. It’s tragic.” An inquest is expected to be opened into the woman’s death. East Midlands Ambulance Service said they were called to Bankside, in Bridgemont. “The caller reported a medical emergency,” a spokesperson said. “We sent a paramedic in a fast response car and a double-crewed ambulance. The air ambulance was also in attendance.”
Derbyshire Fire and Rescue Service, which was called to assist the paramedics, has warned people about the dangers of entering open water. “While we cannot and will not comment or speculate on the circumstances and cause of this tragic death, we would like to remind people of the dangers of entering open water and cold water shock,” said group manager Lee Williams.
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Breatheolution’ has a website where a whole page is dedicated to its leader Kevin O’Neill. I wondered what qualifications Kevin has, but all it tells us about him is this: “I struggled for so long with alcohol and other substance abuse that something had to give, I lost my sister Yvonne in 2019 and I think it was enough trauma to make me think a lot more about my own life”
The website also explains what the cold water sessions are about:
1-2-1 Breath Coaching, practice & Cold water session (river or tank)
2 hours @ £110.00
These sessions are proving popular with those who are not keen on group sessions or just prefer to have a more personal experience. The 2-3 hour sessions will be tailored to you and your breathing and will include potentially life-changing tools and methods to allow you to witness your breathing and physiology differently in the future, its all about feeling and awareness.
Another section of the site is dedicated to celebrities who Kevin seems to have treated. And then there is a video of the treatment. What I did not find anywhere, however, are the conditions that Kevin claims to treat with his cold water therapy.
In any case, it would have been wise for Kevin to read up about the risks of cold water immersion (CWI) before going into business. Perhaps this review would have helped:
In 2012, an estimated 372,000 people (42 per hour) died from immersion, assumed to be drowning. Immersion is the third leading cause of unintentional injury-related death, accounting for 7% of all such deaths (World Health Organization, 2014). These figures are underestimations owing to poor reporting in many Third World countries that have a high number of deaths. The data also do not include life-long morbidity caused by immersion-related injuries, estimated to be a much bigger numerical problem.
There is no strict definition of ‘cold water’. Given that some of the hazardous responses to cold water appear to peak on immersion somewhere between 15 and 10°C, it is reasonable to say that cold water is water <15°C (Tipton et al. 1991). However, the thermoneutral water temperature for a resting naked individual is ∼35°C, so it is possible for individuals to become very cold, with time, on immersion in water below this temperature. The corresponding temperature for those exercising (including shivering) is ∼25°C (Tipton & Golden, 1998).
Historically, the threat associated with CWI was regarded in terms of hypothermia or a reduction in deep body temperature below 35°C. This belief was established as a result of the Titanic disaster and supported by data obtained during maritime conflicts of World War II. However, more recently, a significant body of statistical, anecdotal and experimental evidence has pointed towards other causes of death on immersion. For example, in 1977 a Home Office Report revealed that ∼55% of the annual open water deaths in the UK occurred within 3 m of a safe refuge (42% within 2 m), and two-thirds of those who died were regarded as ‘good swimmers’. This evidence suggests more rapid incapacitation than can occur with whole-body cooling and consequent hypothermia.
The following four stages of immersion have been associated with particular risks (Golden & Hervey, 1981; Golden et al. 1991); the duration of these stages and the magnitude of the responses evoked within them vary significantly, depending on several factors, not least of which is water temperature:
- Initial immersion (first 3 min), skin cooling;
- Short-term immersion (3 min plus), superficial neuromuscular cooling;
- Long-term immersion (30 min plus), deep tissue cooling (hypothermia); and
- Circum-rescue collapse: immediately before, during or soon after rescue.
As a result of laboratory-based research, the initial responses to immersion, or ‘cold shock’, were identified as particularly hazardous (Tipton, 1989), accounting for the majority of immersion deaths (Tipton et al. 2014). These deaths have most often been ascribed to drowning, with the physiological responses of a gasp and uncontrollable hyperventilation, initiated by the dynamic response of the cutaneous cold receptors, resulting in the aspiration of the small volume of water necessary to initiate the drowning process (Bierens et al. 2016). Relatively little is known about the minimal rates of change of cold receptor temperature necessary to cause cold shock. The response has been reported to begin in water as warm as 25°C but is easy to suppress consciously at that temperature. In laboratory conditions, the respiratory frequency response (an indication of respiratory drive) peaks on naked immersion in a water temperature between 15 and 10°C, and is no greater on immersion in water at 5°C (Tipton et al. 1991). The corresponding average rates of change of chest skin temperature over the first 20 s of these immersions was 0.42 (water temperature 15°C), 0.56 (water temperature 10°C) and 0.68°C s−1 (water temperature 5°C). This suggests that an average rate of change in chest skin temperature between 0.42 and 0.56°C s−1 on the first 20 s of immersion is sufficient to evoke a maximal respiratory cold shock response.
More recently, it has been suggested (Shattock & Tipton, 2012) that a larger number of deaths than once thought may be attributable to arrhythmias initiated on immersion by the coincidental activation of the sympathetic and parasympathetic division of the autonomic nervous system by stimulation of cutaneous cold receptors around the body [sympathetic activation (cold shock)] and in the oronasal region on submersion or with wave splash [vagal stimulation (diving response)]. This ‘autonomic conflict’ is a very effective way of producing dysrhythmias and arrhythmias even in otherwise young and healthy individuals, particularly, but not necessarily, if a prolonged breath hold is involved in the immersion (Tipton et al. 1994). It seems that predisposing factors, such as long QT syndrome, ischaemic heart disease or myocardial hypertrophy, are necessary for fatal arrhythmias to evolve (Shattock & Tipton, 2012); many of these factors, including drug-induced long QT syndrome, are acquired. Non-fatal arrhythmias could still indirectly lead to death if they cause incapacitation and thereby drowning (Tipton, 2013). The hazardous responses associated with the cold shock response are presented in Fig. 2.
Figure 2. A contemporary view of the initial responses to immersion and submersion in cold water (‘cold shock’)
The problems encountered in short-term immersions are primarily related to physical incapacitation caused by neuromuscular cooling (Castellani & Tipton, 2015). The arms are particularly susceptible because of their high surface area to mass ratio. Low muscle temperatures affect chemical and physical processes at the cellular level. This includes metabolic rate, enzymatic activity, calcium and acetylcholine release and diffusion rate, as well as the series elastic components of connective tissues (Vincent & Tipton, 1988). Maximal dynamic strength, power output, jumping and sprinting performance are related to muscle temperature, with reductions ranging from 4 to 6% per degree Celsius reduction in muscle temperature down to 30°C (Bergh & Ekblom, 1979). At nerve temperatures below ∼20°C, nerve conduction is slowed and action potential amplitude is decreased (Douglas & Malcolm, 1955). Nerve block may occur after exposure to a local temperature of between 5 and 15°C for 1–15 min. This can lead to dysfunction that is equivalent to peripheral paralysis and can, again, result in drowning owing to the inability to keep the airway clear of the water (Clarke et al. 1958; Basbaum, 1973; Golden & Tipton, 2002; Fig. 3).
Figure 3. The ‘physiological pathways to drowning’ after immersion or submersion in cold water, with possible interventions for partial mitigation (dashed)
Abbreviations: EBA, emergency breathing aid; IS, immersion suit; and LJ, lifejacket. Reproduced with permission, from Tipton (2016b).
Even in ice-cold water, the possibility of hypothermia does not arise for at least 30 min in adults. Hypothermia affects cellular metabolism, blood flow and neural function. In severe hypothermia, the patient will be deeply unconscious. The progressive signs and symptoms (approximate deep body temperature) are shivering (36°C), confusion, disorientation, introversion (35°C), amnesia (34°C), cardiac arrhythmias (33°C), clouding of consciousness (33–30°C), loss of consciousness (30°C), ventricular fibrillation (28°C) and death (25°C) (Bierens et al. 2016). There is great variability between deep body temperature and the signs and symptoms of hypothermia. For example, although the deep body temperature associated with death is often quoted as 25°C, the lowest temperature recorded to date after accidental exposure to cold (air) and with full recovery was 12.7°C in a 28-month-old child (Associated Press, 2014). The coldest adult survivor of CWI followed by submersion had a body temperature of 13.7°C (Gilbert et al. 2000). There is also a large amount of variation in the rate at which people cool on immersion in cold water, owing to a combination of thermal factors (including water temperature and water movement, internal and external insulation) and non-thermal factors (including body size and composition, blood glucose, motion illness, racial and sex differences; Haight & Keatinge, 1973; Gale et al. 1981; White et al. 1992; Mekjavic et al. 2001; Golden & Tipton, 2002).
The most significant practical consequence of hypothermia in water is loss of consciousness; this prevents individuals from undertaking physical activity to maintain a clear airway and avoid drowning. Thus, once again, drowning is often the end-point (Fig. 3).
About 17% of those who die as a result of immersion die immediately before, during or after rescue (Golden et al. 1991). The deaths immediately before rescue are intriguing and probably related to behavioural changes at this time or the relief and psychophysiological alterations associated with imminent rescue, including a reduction in circulating stress hormone concentration and an increase in vagal tone. Death during rescue is most commonly associated with a collapse in arterial pressure when lifted vertical from the water and kept in that position for some time (Golden et al. 1991).
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The tragic death of the woman should perhaps remind us that
- there is no SCAM or wellness treatment that is entirely harmless,
- and there are only few ‘would-be gurus’ who know what they are doing.
Exceptionally, this post is unrelated to so-called alternative medicine (SCAM). It addresses a new and worrisome development in UK healthcare. The UK has fewer doctors per population than most other developed countries. This shortage has now reached a level where it puts patients in danger. Recently, the government has unveiled a new NHS plan aimed to fix the problem.
The apprenticeship scheme could allow one in 10 doctors to start work without a traditional medical degree, straight after their A-levels. A third of nurses are also expected to be trained under the “radical new approach”. It is the centerpiece of a long-delayed NHS workforce strategy, following warnings that staff shortages in England could reach half a million without action to find new ways to train and recruit health workers. Amanda Pritchard, the head of NHS England, said: “This radical new approach could see tens of thousands of school-leavers becoming doctors and nurses or other key healthcare roles, after being trained on the job over the next 25 years.” She added that the plan offered a “once-in-a-generation opportunity to put the NHS on a sustainable footing”.
The “medical doctor degree apprenticeship” involves the same training and standards as traditional education routes, including a medical degree and all the requirements of the General Medical Council. Candidates will be expected to have similar A-levels as those for medical school, with qualifications in sciences, as well as options for graduates with non-medical degrees. The key difference behind such models is that apprentice medics would be available on the wards almost immediately, working under supervision, while being paid.
The medical degree apprenticeship is due to launch this autumn.
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I am impressed!
Sadly, not in a positive way.
In fact, I cannot remember having ever heard of a more stupid idea for dealing with doctor shortages.
As incompetent amateurs, do the Tories really think that a similar level of incompetence might work also in healthcare?
Such shortages have happened before.
They are regrettable and need swift and firm action.
The only countermeasure that works is to train more doctors.
REAL DOCTORS!
