bias
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?
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).
_____________________
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.
___________________________
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.
_______________________________________
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.
In response to yesterday’s post, I received a lengthy comment from ‘Stan’. Several readers have already commented on it. Therefore, I can make my arguments short. In this post, will repeat Stan’s points each followed by my comments (in bold). Here we go:
Seven Reasons Homœopathy is Not Placebo Effect
Sorry, Stan, but your heading is not proper English; I have therefore changed it for the title of this post.
1. Homeopathic remedies work on babies, animals, plants and people in a coma. Biodynamic farmers use homeopathic remedies to repel pests and treat plant diseases. Some organic ranchers rely on homeopathic remedies to treat their herds. Some “placebo by proxy” effect has been shown for children but its doubtful that it could be shown for a herd of cattle or crops in a field. Farmers can’t rely on wishful thinking to stay in business.
As discussed ad nauseam on this blog, homeopathic remedies do not work on babies or animals better than placebos. I don’t know of any studies with “people in a coma” (if you do, Stan, please let me know). The fact that ranchers rely on homeopathy is hilarious but does not prove anything.
2. The correct curative remedy will initially cause a worsening of the condition being cured if it is given in too strong (i.e. too dilute) a dose. A placebo might only cause a temporary improvement of the condition being treated; certainly not an aggravation.
The ‘homeopathic aggravation’ is a myth created by homeopaths. It disappears if we try to systematically research it; see here, for instance.
3. One can do a “proving” of an unknown homeopathic remedy by taking it repeatedly over several days and it will temporarily cause symptoms that one has never experienced previously – symptoms it will cure in a sick person. This is a repeatable scientific experiment used to determine the scope of a new remedy, or confirm the effects of an already proven remedy. A placebo might possibly have an effect if the individual taking it has been “prepared” by being told what they are taking but it likely wouldnt match previously recorded symptoms in the literature.
Homeopathic provings are rubbish and not reproducible when done rigorously; see here.
4. One can treat simple acute (self-limiting) conditions (e.g. minor burns, minor injuries, insect bites, etc.) and see unusually rapid cures with homeopathic remedies. A placebo might only cause a temporary improvement of the condition being treated while taken. Placebos have been found mostly effective in conditions with a strong psychological component like pain.
You mean like using Arnica for cuts and bruises? Sadly, it does not work.
5. One can get homeopathic treatment for long term chronic (non self-limiting) conditions and see a deep lasting cure, as has been documented clinically for a couple centuries. A placebo might only cause a temporary partial improvement of the condition being treated while the placebo is being taken.
You mean like asthma, eczema, or insomnia?
6. There is over 200 years worth of extensive documentation from around the world, of the clinical successes of homeopathy for both acute and chronic conditions of all types. As Dr Hahn has said you have throw out 90% of the evidence to conclude that homeopathy doesnt work. The Sheng et al meta-analysis in 2005 Lancet that was supposedly the death knell of homeopathy used only 8 studies, excluding hundreds of others. Unsurprisingly homeopathy was found wanting. So-called Skeptics see what they want to see in the science. There is relatively little documentation of placebo usage. A few recent studies have been done showing the limited temporary benefits of placebos.
What Hahn wrote is understandably liked by homeopaths but it nevertheless is BS. If you don’t trust me, please rely on independent bodies from across the world.
7. Homeopathic remedies have been shown to have a very weak electromagnetic signature and contain some nano-particles. Some believe this explains their mechanism. An exciting new potential field of research is the subtle cell signalling that has been found to direct the development of stem cells. Scientists have created double-headed planeria worms and this trait has been found to be inherited by their offspring without any change in the genes or epigenetics. Until now we had no idea how a single fertilized ovum could evolve into a complex creature that is bilateral and has multiple cell types. It is possible that the very subtle electromagnetic signature or some other unknown effect of homeopathic remedies is effecting this subtle cell signalling.
The homeopathic nano-myth is nonsense. And so is the rest of your assumptions.
Every conventional drug has “side effects” that match the symptoms for which it is indicated! Aspirin can cause headaches and fever, ritalin can cause hyperactive effects, radiation can cause cancer. Conventional doctors are just practicing bad homeopathy. They are prescribing Partially similar medicines. If their drugs were homeopathic (i.e. similar) to the patients symptoms on all levels they would be curative. Radiation sometimes does cure cancer instead of just suppressing it per usual.
Even if this were true, what would it prove? Certainly not that homeopathy works!
Dr Hahneman did forbid mixing homeopathy and conventional medicine. In his day doctors commonly used extensive blood letting and extreme doses of mercury. Its not Quite as bad now.
You evidently did not read Hahnemann’s writings.
Just because we dont know how extremely dilute homeopathic remedies work, doesn’t discount that they Do work. Homeopathy seems to fly in the face of Known science. In no way is it irrational or unscientific. There are lots of phenomena in the universe that cant be explained yet, like dark energy and dark matter effects and even consciousness!
Not knowing how a treatment works has not stopped science to test whether it works (e.g. Aspirin). In the case of homeopathy, the results of these endeavors were not positive.
The assumption that the moon is made of cheese also flies in the face of science; do you perhaps think that this makes it true?
The actions of homeopathy can and have been well-explained: they are due to placebo effects.
________________________
Stan, thank you for this entertaining exercise. But, next time, please remember to supply evidence for your statements.
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.
__________________________
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.
A ‘manifesto’ is not something that I come across often in my area of research, i.e. so-called alternative medicine (SCAM). This one is in German, I, therefore, translated it for you:
Manifesto for healthy medicine
With the Manifesto for healthy medicine, we, the citizens and patients alliance weil’s hilft! (‘BECAUSE IT HELPS’) demand a fundamental change in our healthcare system, towards a diverse medicine that focuses on people and health. Be part of it! Sign the manifesto and become part of the movement.
It’s of paramount importance, the Manifesto for healthy medicine. About the way we live. It’s about our health. It’s about you and it’s about me.
We want our healthcare system to actually focus on health.
We want a medicine that doesn’t ask what’s missing, but what is possible.
We want a medicine that cares about people, that takes care, gets to the bottom of things, and uses innovative technologies to do so.
We want more bio, so that the chemistry is right, and we want naturopathic procedures and naturally effective medicines to be recognized, promoted, and researched further.
We want research that creates knowledge because, in addition to studies, it also takes into account the experience of physicians and the needs of patients.
We want carers and doctors to be able to work in a way that is good for their patients and for themselves.
We want people from all healthcare professions to work together as equals.
We want a medicine that creates awareness for a good and healthy life because climate protection also begins in one’s own body.
We want an integrative medicine that puts people at the center and self-evidently combines conventional and natural healing methods.
And we want this medicine to be accessible and affordable for everyone.
We fight for a healthy medicine of the future.
Be part of it!
(sorry, if some of it might sound badly translated but the German original is in parts pure gibberish)
_____________________
Who writes such tosh composed of every thinkable platitude and then pompously calls it a MANIFESTO?
BECAUSE IT HELPS! (weil’s hilft!) is a citizens’ movement that demands a change in the health care system – towards the needs and preferences of patients, towards a holistic view of people, and a focus on health instead of disease. The sensible combination of natural medicine and conventional medicine, an integrative medicine, makes an indispensable contribution to this. This is because it relies fully on the patients and involves them as active partners in the treatment. Modern medicine of the future, therefore, needs the equal cooperation of natural medicine and conventional medicine – in the everyday life of physicians and patients, in the reimbursement by the health insurance companies as well as in research and teaching.
On the information platform www.weils-hilft.de weil’s hilft! informs about current developments in integrative medicine, provides background information, and publishes a podcast once a month. The movement is also active on social media at www.facebook.com/weilshilft and www.instagram.com/weilshilft.
weil’s hilft! is supported by the health and patient organizations GESUNDHEIT AKTIV, KNEIPP-BUND, and NATUR UND MEDIZIN. Together, the alliance represents the interests of more than 220,000 people.
_______________________
One could easily disclose the funny side of this, the utter stupidity of the arguments, the platitudes, fallacies, misunderstandings, ignorance, etc. Yes, that would hardly be difficult. But it would ignore how worrying this and similar movements are. They systematically misinform consumers with the sole aim of persuading them that the integration of unproven or disproven treatments into medical routine is in their interest. Yet, if we only scratch the surface of their arguments, we realize that it is exclusively in the interest of those who profit from this type of misinformation.
There are debates in acupuncture-related systematic reviews and meta-analyses on whether searching Chinese databases to get more Chinese-language studies may increase the risk of bias and overestimate the effect size, and whether the treatment effects of acupuncture differ between Chinese and non-Chinese populations.
For this meta-epidemiological study, a team of investigators searched the Cochrane Library from its inception until December 2021, and identified systematic reviews and meta-analyses with acupuncture as one of the interventions. Paired reviewers independently screened the reviews and extracted the information. They repeated the meta-analysis of the selected outcomes to separately pool the results of Chinese- and non-Chinese-language acupuncture studies and presented the pooled estimates as odds ratios (OR) with 95% confidence interval (CI). They calculated the Ratio of ORs (ROR) by dividing the OR of the Chinese-language trials by the OR of the non-Chinese-language trials, and the ROR by dividing the OR of trials addressing Chinese population by the OR of trials addressing non-Chinese population. The researchers thus explored whether the impact of a high risk of bias on the effect size differed between studies published in Chinese- and in non-Chinese-language, and whether the treatment effects of acupuncture differed between Chinese and non-Chinese populations.
The researchers identified 84 Cochrane acupuncture reviews involving 33 Cochrane groups, of which 31 reviews (37%) searched Chinese databases. Searching versus not searching Chinese databases significantly increased the contribution of Chinese-language literature both to the total number of included trials (54% vs. 15%) and the sample size (40% vs. 15%). When compared with non-Chinese-language trials, Chinese-language trials were associated with a larger effect size (pooled ROR 0.51, 95% CI 0.29 to 0.91). The researchers also observed a higher risk of bias in Chinese-language trials in blinding of participants and personnel (97% vs. 51%) and blinding of outcome assessment (93% vs. 47%). The higher risk of bias was associated with a larger effect estimate in both Chinese language (allocation concealment: high/unclear risk vs. low risk, ROR 0.43, 95% CI 0.21 to 0.87) and non-Chinese-language studies (blinding of participants and personnel: high/unclear risk vs. low risk, ROR 0.41, 95% CI 0.23 to 0.74). However, the team found no evidence that the higher risk of bias would increase the effect size of acupuncture in Chinese-language studies more often than in non-Chinese-language studies (the confidence intervals of all ROR in the high-risk group included 1, Table 3). The researchers further found acupuncture appeared to be more effective in Chinese than in non-Chinese populations.
The authors concluded that the findings of this study suggest the higher risk of bias may lead to an overestimation of the treatment effects of acupuncture but would not increase the treatment effects in Chinese-language studies more often than in other language studies. The difference in treatment effects of acupuncture was probably associated with differences in population characteristics.
The authors discuss that, although searching Chinese databases can substantially increase the number of eligible studies and sample size in acupuncture reviews, the potentially higher risk of bias is an argument that needs to be considered in the inclusion of Chinese-language studies. Patients, investigators, and guideline panels should be cautious when adopting evidence from acupuncture reviews where studies with a high risk of bias contributed with a high weight to the meta-analysis.
The authors observed larger treatment effects of acupuncture in Chinese-language studies than in studies published in other languages. Although the treatment effects of acupuncture tended to be greater in studies with a high risk of bias, this potential overestimation did not differ between studies published in Chinese and in other languages. In other words, the larger treatment effects in Chinese-language studies cannot be explained by a high risk of bias. Furthermore, our study found acupuncture to be more effective in Chinese populations than in other populations, which could at least partly explain the larger treatment effects observed in Chinese-language studies.
I feel that this analysis obfuscates more than it clarifies. As we have discussed often here, acupuncture studies by Chinese researchers (regardless of what language they are published in) hardly ever report negative results, and their findings are often fabricated. It, therefore, is not surprising that their effect sizes are larger than those of other trials.
The only sensible conclusion from this messy and regrettable situation, in my view, is to be very cautious and exclude them from systematic reviews.
How often do we hear that chiropractic is safe because numerous trials reported no adverse events? This systematic review tested whether there has been a change in the reporting of adverse events associated with spinal manipulation in randomized clinical trials (RCTs) since 2016.
Databases were searched from March 2016 to May 2022: MEDLINE (Ovid), Embase, CINAHL, ICL, PEDro, and Cochrane Library. Domains of interest (pertaining to adverse events) included: completeness and location of reporting; nomenclature and description; spinal location and practitioner delivering manipulation; methodological quality of the studies and details of the publishing journal. Frequencies and proportions of studies reporting on each of these domains were calculated. Univariable and multivariable logistic regression models were fitted to examine the effect of potential predictors on the likelihood of studies reporting on adverse events.
5399 records were identified by the electronic searches, of which 154 (2.9%) were included in the analysis. Of these, 94 (61.0%) reported adverse events with only 23.4% providing an explicit description of what constituted an adverse event. Reporting of adverse events in the abstract has increased (n=29, 30.9%) while reporting in the results section has decreased (n=83, 88.3%) over the past 6 years. Spinal manipulation was delivered to 7518 participants in the included studies. No serious adverse events were reported in any of these studies.
The authors concluded as follows: while the current level of reporting of adverse events associated with spinal manipulation in RCTs has increased since our 2016 publication on the same topic, the level remains low and inconsistent with established standards. As such, it is imperative for authors, journal editors and administrators of clinical trial registries to ensure there is more balanced reporting of both benefits and harms in RCTs involving spinal manipulation.
This article is clearly relevant to our discussions about adverse events after spinal manipulation. However, I find it far too uncritical. This might be due to the affiliations of some of the authors:
- Integrative Spinal Research Group, Department of Chiropractic Medicine, University Hospital Balgrist and University of Zurich, Zurich, Switzerland.
- Department of Chiropractic, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, New South Wales, Australia.
Interestingly, the authors stated that they have no conflict of interest. Also interesting is the fact that they do not cite our paper from 2012. I, therefore, take the liberty of doing it:
Objective: To systematically review the reporting of adverse effects in clinical trials of chiropractic manipulation.
Data sources: Six databases were searched from 2000 to July 2011. Randomised clinical trials (RCTs) were considered, if they tested chiropractic manipulations against any control intervention in human patients suffering from any type of clinical condition. The selection of studies, data extraction, and validation were performed independently by two reviewers.
Results: Sixty RCTs had been published. Twenty-nine RCTs did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred. Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors.
Conclusions: Adverse effects are poorly reported in recent RCTs of chiropractic manipulations.
In percentage terms the results are similar. What is very different is that the authors of the new paper merely lament that the level remains low and inconsistent with established standards, while we make it clear in the abstract that adverse effect reporting is poor and in the paper identify this deficit as a violation against research ethics and thus as a form of scientific misconduct.
In view of all this, let me re-phrase the last sentence of the authors’ conclusion:
it is imperative for authors, journal editors, and administrators of clinical trial registries to ensure that researchers adhere to accepted ethical standards and that scientific misconduct no longer gets published.
Seventeen years after S.K. lost his thyroid gland to cancer, he was promised a miracle by Kyung Chun Oh, an acupuncturist based in the Toronto area: acupuncture could regrow the vital organ. Oh told his patient it would only work if S.K. stopped the thyroid medication he’d been on since his surgery in 2003.
Within just a few months the patient had to be admitted to hospital with a life-threatening case of hypothyroidism. His thyroid had not regenerated. “It was fortunate that the patient did not die,” a college panel wrote in a disciplinary decision, suspending Oh’s license for 12 months. “Telling the patient that he should not take his thyroid medication was irresponsible and had disastrous repercussions.”
The panel found that Oh had engaged in professional misconduct in multiple ways:
- he had provided unnecessary treatment,
- he had failed to advise his patient to consult a medical doctor when he learned that S.K. was suffering
from symptoms that he knew or ought to have known indicated an urgent medical problem, - he had treated a condition that he ought to have known that he did not have the knowledge, skills, or judgment to treat,
- he had failed to keep records in accordance with the standards of the profession,
- he had falsified a record relating to his practice,
- he had made a claim about a treatment that could not be supported by reasonable professional opinion (the claim that acupuncture combined with cessation of thyroid medicine could regrow a surgically removed thyroid gland, and the claim that S.K.’s thyroid gland was regrowing).
This is clearly an extreme incidence of misconduct and one would hope that such cases occur only rarely. But looking at the points listed above, I get the feeling that similar yet less severe cases of misconduct happen regularly in the practices of SCAM practitioners:
- most so-called alternative medicine (SCAM) treatments are unnecessary,
- SCAM practitioners refer patients only rarely to doctors,
- SCAM practitioners often treat conditions that they fail to understand adequately,
- SCAM practitioners frequently make unreasonable claims.
Assigning shelf life for homeopathic medicine is – according to the authors of this new, ground-breaking study – an important yet debatable issue. Therefore, the present article is aimed at investigating the problem from a Quantum Electrodynamics point of view and suggests ten years to be a moderate estimate of shelf life.
Data were obtained by the following methods:
- dynamic light scattering,
- atomic force microscopy,
- anomalous dielectric dispersion,
- UV,
- electron spin resonance spectrometry.
The results show the formation of nanosized molecular assemblies. These water clusters containing millions to billions of water molecules, which are created by repeated dilution of aqueous solutions, have been photographed.
The authors draw the following conclusions:
- Ultra-high dilutions (UHD) contain dissipative structures.
- These structures are solute specific
- These structures are tremendously persistent
- Therapeutic values of UHDs are found to continue for a very long time (20-25 years)
Summarizing, we can say that the solute, which in this case is the starting material of homeopathic medicine, leaves its highly stable foot prints in the dissipative structure formed in the UHD solution of polar solvent. Unfortunately, no targeted experiments are done yet to find the exact shelf life. Hence, we wish to suggest that as the shelf life (with proper precautionary measures) of the homeopathic medicine are theoretically expected to be very prolonged and supported by clinical experience, let it be accepted as ten years till future targeted experiments give the exact value, which is expected to be higher than this suggested value.
Were these sensational findings published in a journal like NATURE or SCIENCE? No, they emerged in ‘HPATHY‘ (“the World’s No. 1 Homeopathy Website: Since 2001”). That is a great shame, I think, because they might thus not be awarded the Noble Prize that they clearly deserve.
________________
Joking apart, the self life issue is evidently of some concern to homeopaths. Take this ‘study‘, for instance:
Background: Assignment of expiry date to homeopathic medicines is a subject of important concern to its pharmacists and practitioners. This study compares the regulatory framework for the expiry of homeopathic medicines in four countries: Brazil, Germany, India and the United States.
Findings: Different or no expiry periods are variously followed. Whereas Germany, with some exceptions, employs a maximum expiry of 5 years for both potencies and finished products, Brazil adopts a 5-year expiry for finished products only, potencies used in manufacture being exempted from an assigned expiry date. In India, all homeopathic medicines except dilutions and back potencies have a maximum of 5 years’ shelf-life, including those supplied to consumers. In the United States, homeopathic medicines are exempted from expiry dates.
Comments: There is neither a rational basis nor scientific evidence for assigning a short (3-5 years) expiry period for homeopathic medicines as followed in some of the countries, particularly in light of the fact that some studies have shown homeopathic medications to be effective even after 25 years. Homeopathic ultra-dilutions seem to contain non-material activity that is maintained over time and, since these exhibit different chemical properties compared to the original starting material, it is quite possible they possess properties of longer activity than conventional medicines. Regulators should acknowledge this feature and differentiate expiry of homeopathic medicinal products from that of conventional drugs.
____________________
For once, I almost agree with my homeopathic colleagues:
The activity of homeopathic ultra-dilutions is maintained over time.
However, we need to add just a little explanation to this statement:
This activity is zero.
