clinical trial
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).
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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.
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.
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Stan, thank you for this entertaining exercise. But, next time, please remember to supply evidence for your statements.
‘Spagyric’ is a so-called alternative medicine (SCAM) based on the alchemy of Paracelsus (1493-1541). Paracelsus borrowed the term from “separate” (spao) and “combine” (ageiro) to indicate that spagyric preparations are based on the “separation”, “extraction” and “recombination” of the active ingredients of a substance. Plant, mineral as well as animal source materials are used.
The production of spagyric remedies is based on a complex process of maceration and fermentation of a plant extract in alcohol. It takes place in dark, thick-walled glass flasks that are hermetically sealed and kept at a controlled temperature of 37 °C for 28 days. The tincture thus obtained is then decanted and the drug residue is removed from the solution, completely dried, and burned to ash to recover the inorganic components of the plant material. The ash is subsequently dissolved in the alcoholic solution of maceration, and the finished spagyric preparation is left for 12 days before use.
Spagyric is not the most popular of all SCAMs but it certainly does have a significant following. One enthusiast claims that “spagyric essences work on a vibrational level in their action upon the emotional/mind and physical spheres and can be employed in numerous situations. Most people seek help to relieve physical symptoms. Even so, it is often necessary to address the emotional and psychological aspects which may predispose the illness or imbalance. In an era where many people are experiencing life-changing events, the ability to transition smoothly is essential for well-being and vitality. Guidance and help are required to maintain homeostasis. These medicines can help the patient to understand the root cause of their illness and learn to regain control of their lives. Some medicine systems appear to be less effective than in previous times. It has been suggested that the energetic frequency of both the earth and human organism are changing. Therefore these systems may no longer be a vibrational match for the changing frequencies. Spagyric Medicine is designed to ‘tune in with’ these current frequencies. Research suggests that the Spagyric essences may instigate improved health by energetically influencing DNA.”
After reading such weird statements, I ask myself, is there any evidence that spagyric remedies work? In my search for robust studies, I was unsuccessful. There does not seem to be a single controlled study on the subject. However, there are fragmentary reports of a study initiated and conducted by a now largely unknown healer named Karl Hann von Weyhern.
Von Weyhern (1882 – 1954) had taken a few semesters of pharmacy and medicine in Freiburg but remained without a degree. In 1930, he became a member of the NSDAP (Hitler’s Nazi party) and in 1940 he joined the SS. Around 1935, he settled in Munich as a non-medical practitioner (Heilpraktiker), and Heinrich Himmler who has a soft spot for SCAM enlisted as one of his patients. By then von Weyhern had by then made a steep career in the Nazi hierarchy, and he managed to convince Himmler that his spagyric remedies could cure tuberculosis, which was still rampant at the time. They decided to carry out experiments in this regard in the Dachau concentration camp.
Thus, von Weyhern was allowed to test spagyric remedies on forcibly recruited concentration camp prisoners. These experiments lasted for about one year and included around 150 patients who, according to von Weyhern’s iridology diagnosis, suffered from tuberculosis. Half of them were treated with spagyric remedies and the others with conventional treatments. At the end of the experiment, 27 persons were reportedly released into everyday concentration camp life as ‘fit for work’. How many of the 150 prisoners lost their lives due to these experiments is not known. Von Weyhern never filed a final report. It is to be feared that the death toll was considerable. [1]
After the war, von Weyhern denied belonging to the SS, claimed that he had ‘sacrificed himself’ for his patients in the concentration camp, merely had to pay a fine, and was ‘denazified’ in 1948. Subsequently, he resumed his work as a ‘Heilpraktiker’ in Olching, a village near Dachau. [1]
Of course, these infamous experiments cannot be blamed on spagyric medicine. Yet, I feel they are nevertheless important, not least because they seem to reveal the only thing remotely resembling something like evidence.
[1] Die Ärzte der Nazi-Führer: Karrieren und Netzwerke : Mathias Schmidt (Hg.), Dominik Groß (Hg.), Jens Westemeier (Hg.): Amazon.de: BooksInfant colic is a sensitive subject for chiropractors in the UK. In case you forgot, here is why. Consequently, the subject has featured regularly on this blog – and now there is new evidence:
A systematic review and meta-analysis were conducted on infantile colic studies that used SO-CALLED alternative medicine (SCAM) techniques as interventions. The outcome measures were hours spent crying and/or sleeping. The authors used the PubMed, Physiotherapy Evidence Database, Cochrane Library, Embase, Web of Science, Scopus, Osteopathic Medicine Digital Database, and Google Scholar databases from inception to 11 November 2022.
The methodological quality of the randomized control trials ranged from fair to high. The authors focused on five studies with 422 babies using the following interventions: cranial, visceral, or structural osteopathy or chiropractic manipulation or mobilization. These treatments failed to decrease the crying time (mean difference -1.08, 95% CI -2.17 to 0.01, I2 = 92%) and to increase the sleeping time (mean difference 1.11, 95% CI -0.20 to 2.41; I2: 91%), compared with no intervention. The quality of the evidence was rated as very low for both outcome measures.The authors concluded that osteopathy and chiropractic treatment failed to reduce the crying time and increase sleeping time in babies with infantile colic, compared to no additional intervention.The 5 included studies were the following:
- Miller JE, Newell D, Bolton JE. Efficacy of chiropractic manual therapy on infant colic: A pragmatic single-blind, randomized controlled trial. J Manipulative Physiol Ther. 2012;35(8):600–7.
- Castejón-Castejón M, Murcia-González MA, Todri J, Lena O, Chillón-Martínez R. Treatment of infant colic with craniosacral therapy. A randomized controlled trial. Complement Ther Med. 2022;71(February 2021).
- Olafsdottir E, Forshei S, Fluge G, Markestad T. Randomised controlled trial of infantile colic treated with chiropractic spinal manipulation. Arch Dis Child. 2001;84(2):138–41.
- Holm LV, Jarbøl DE, Christensen HW, Søndergaard J, Hestbæk L. The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial. Chiropr Man Ther. 2021;29(1):1–11.
- Hayden C, Mullinger B. A preliminary assessment of the impact of cranial osteopathy for the relief of infantile colic. Complement Ther Clin Pract. 2006;12(2):83–90.
This means that, in recent years, several new studies have emerged. I find this surprising: there is no plausible mechanism of action and the previous reviews were negative.
Why flog a dead horse?
But – come to think of it – this is a question one might ask about most of the research into cranial, visceral, or structural osteopathy or chiropractic manipulation or mobilization.
Low back pain is the leading cause of years lived with disability globally, but most interventions have only short-lasting, small to moderate effects. Cognitive functional therapy (CFT) is an individualized approach that targets unhelpful pain-related cognitions, emotions, and behaviors that contribute to pain and disability. Movement sensor biofeedback might enhance treatment effects.
This study aimed to compare the effectiveness and economic efficiency of CFT, delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling low back pain.
RESTORE was a randomized, three-arm, parallel-group, phase 3 trial, done in 20 primary care physiotherapy clinics in Australia. The researchers recruited adults (aged ≥18 years) with low back pain lasting more than 3 months with at least moderate pain-related physical activity limitation. Exclusion criteria were serious spinal pathology (eg, fracture, infection, or cancer), any medical condition that prevented being physically active, being pregnant or having given birth within the previous 3 months, inadequate English literacy for the study’s questionnaires and instructions, a skin allergy to hypoallergenic tape adhesives, surgery scheduled within 3 months, or an unwillingness to travel to trial sites. Participants were randomly assigned (1:1:1) via a centralized adaptive schedule to
- usual care,
- CFT only,
- CFT plus biofeedback.
The primary clinical outcome was activity limitation at 13 weeks, self-reported by participants using the 24-point Roland Morris Disability Questionnaire. The primary economic outcome was quality-adjusted life-years (QALYs). Participants in both interventions received up to seven treatment sessions over 12 weeks plus a booster session at 26 weeks. Physiotherapists and patients were not masked.
Between Oct 23, 2018, and Aug 3, 2020, the researchers assessed 1011 patients for eligibility. After excluding 519 (51·3%) ineligible patients, they randomly assigned 492 (48·7%) participants; 164 (33%) to CFT only, 163 (33%) to CFT plus biofeedback, and 165 (34%) to usual care. Both interventions were more effective than usual care (CFT only mean difference –4·6 [95% CI –5·9 to –3·4] and CFT plus biofeedback mean difference –4·6 [–5·8 to –3·3]) for activity limitation at 13 weeks (primary endpoint). Effect sizes were similar at 52 weeks. Both interventions were also more effective than usual care for QALYs, and much less costly in terms of societal costs (direct and indirect costs and productivity losses; –AU$5276 [–10 529 to –24) and –8211 (–12 923 to –3500).
The authors concluded that CFT can produce large and sustained improvements for people with chronic disabling low back pain at considerably lower societal cost than that of usual care.
This is a well-designed and well-reported study. It shows that CFT is better than usual care. The effect sizes are not huge and seem similar to many other treatments for chronic LBP, including the numerous so-called alternative medicine (SCAM) options that are available.
Faced with a situation where we have virtually dozens of therapies of similar effectiveness, what should we recommend to patients? I think this question is best and most ethically answered by accounting for two other important determinants of usefulness:
- risk
- cost.
CFT is both low in risk and cost. So is therapeutic exercise. We would therefore need a direct comparison of the two to decide which is the optimal approach.
Until we have such a study, patients might just opt for one or both of them. What seems clear, meanwhile, is this: SCAM does not offer the best solution to chronic LBP. In particular, chiropractic, osteopathy, or acupuncture – which are neither low-cost nor risk-free – are, contrary to what some try so very hard to convince us of, sensible options.
I found this acupuncture study from the Department of Oral and Maxillofacial Sciences, “Sapienza” University of Rome, Rome, Italy. As this seems to be a respectable institution, I had a look. What I found was remarkable! Let me show you the abstract in its full beauty:
Background: Pain related to Temporomandibular Disorders (TMD) is severe, negatively affecting patients’ quality of life, and often resistant to conventional treatments. Abdominal Acupuncture (AA) is known to be particularly effective for pain, especially chronic and musculoskeletal pain, but it is still poorly studied and never investigated in TMD patients. Objectives: To analyze the efficacy of AA for the treatment of patients with subacute and chronic pain related to TMD and non-responding to previous conventional therapies (occlusal splint, medications, physical therapy).
Methods: Twenty-eight patients, 24 F and four M (mean age 49.36 years), were recruited from January 2019-February 2021. All patients underwent AA treatment: two sessions per week for four weeks, for a total of eight sessions. At the beginning of therapy (T0) and at the end of the cycle (T1) the following data were evaluated: maximum mouth opening (MMO); cranio-facial pain related to TMD (verbal numeric scale, VNS); pain interference with normal activities and quality of life of patients (Brief Pain Inventory, BPI); oral functioning (Oral Behavior Checklist, OBC); impression of treatment effectiveness (Patients’ Global Impression of Improvement, PGI-I Scale). Statistical comparison of data before and after the AA treatment was performed by Wilcoxon’s signed-rank test (significance level p < 0.05).
Results: The MMO values were significantly improved after one cycle of AA (p = 0.0002). In addition, TMD-related pain had a statistically significant decline following AA treatment (all p < 0.001). Patients’ general activity and quality of life (BPI) were described as improved following a course of AA, with statistically significant values for all aspects considered (all p < 0.05).
Conclusion: Abdominal acupuncture resulted in effective treatment of subacute/chronic resistant pain related to TMD, capable of improving mandibular function and facial pain, and reduced the interference of pain affecting patients’ quality of life.
_____________________
Shocked?
Me too!
This study did not include a control group. Such uncontrolled studies are not necessarily useless. In areas where there is no prior evidence, they can be a reasonable starting point for further research. In the case of TMD/acupuncture, however, this does not imply. Here we already have about a dozen controlled trials. This means an uncontrolled study cannot possibly contribute to our knowledge. This means that the present study is useless. And that, in turn, means it is unethical.
But even if we ignore all this, the study is very misleading. It concludes that acupuncture improved TMD. This, however, can be doubted!
- What about placebo?
- What about regression toward the mean?
- What about the natural history of the condition?
Bad science is regrettable and dangerous, as it
- wastes resources,
- misleads vulnerable patients,
- violates ethics,
- and undermines trust in science.
I fear that the Italian group has just provided us with a prime example of these points.
The claim that homeopathy has a role in oncology does not seem to go away. Some enthusiasts say it can be used as a causal therapy, while others insist it might be a helpful symptomatic adjuvant. Almost all oncologists agree that homeopathy has no place at all in cancer care.
Who is right?
This systematic review included clinical studies from 1800 until 2020 to evaluate evidence of the effectiveness of homeopathy on physical and mental conditions in patients during oncological treatment.
In February 2021 a systematic search was conducted searching five electronic databases (Embase, Cochrane, PsychInfo, CINAHL and Medline) to find studies concerning use, effectiveness, and potential harm of homeopathy in cancer patients.
From all 1352 search results, 18 studies with 2016 patients were included in this SR. The patients treated with homeopathy were mainly diagnosed with breast cancer. The therapy concepts included single and combination homeopathic remedies (used systemically or as mouth rinses) of various dilutions. The outcomes assessed were:
- the influence on toxicity of cancer treatment (mostly hot flashes and menopausal symptoms),
- the time to drain removal in breast cancer patients after mastectomy,
- survival,
- quality of life,
- global health,
- subjective well-being,
- anxiety and depression,
- safety and tolerance.
The included studies reported heterogeneous results: some studies described significant differences in quality of life or toxicity of cancer treatment favoring homeopathy, whereas others did not find an effect or reported significant differences to the disadvantage of homeopathy or side effects caused by homeopathy. The majority of the studies had low methodological quality.
The authors concluded that, the results for the effectiveness of homeopathy in cancer patients are heterogeneous, mostly not significant and fail to show an advantage of homeopathy over other active or passive comparison groups. No evidence can be provided that homeopathy exceeds the placebo effect. Furthermore, the majority of the included studies shows numerous and severe methodological weaknesses leading to a high level of bias and are consequently hardly reliable. Therefore, based on the findings of this SR, no evidence for positive effectiveness of homeopathy can be verified.
This could not be clearer. Some might argue that, of course, homeopathy cannot change the natural history of cancer, but it might improve the quality of life of those patients who believe in it via a placebo response. I would still oppose this notion: there are many effective treatments in the supportive treatment of cancer, and it seems much better to use those options and tell patients the truth about homeopathy.
A “null field” is a scientific field where there is nothing to discover and where observed associations are thus expected to simply reflect the magnitude of bias.
This analysis aimed to characterize a null field using a known example, homeopathy (a pseudoscientific medical approach based on using highly diluted substances), as a prototype. The researchers identified 50 randomized placebo-controlled trials of homeopathy interventions from highly cited meta-analyses. The primary outcome variable was the observed effect size in the studies. Variables related to study quality or impact were also extracted.
The mean effect size for homeopathy was 0.36 standard deviations (Hedges’ g; 95% confidence interval: 0.21, 0.51) better than placebo, which corresponds to an odds ratio of 1.94 (95% CI: 1.69, 2.23) in favor of homeopathy. 80% of studies had positive effect sizes (favoring homeopathy). The effect size was significantly correlated with citation counts from journals in the directory of open-access journals and CiteWatch. We identified common statistical errors in 25 studies.
The authors concluded that a null field like homeopathy can exhibit large effect sizes, high rates of favorable results, and high citation impact in the published scientific literature. Null fields may represent a useful negative control for the scientific process.
The paper is perhaps not the easiest to comprehend but once you got the idea, you will agree with me that it is BRILLIANT. I warmly recommend it to all fans of homeopathy – in fact, if I could I’d offer it to King Charles as a present for the coronation.
Its authors are among the most prominent medical epidemiologist of our time with affiliations that speak for themselves:
- Department of Epidemiology and Population Health, Stanford University, Stanford, CA, USA; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA.
- 2Department of Epidemiology and Population Health, Stanford University, Stanford, CA, USA.
- 3Department of Epidemiology and Population Health, Stanford University, Stanford, CA, USA; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA; Department of Biomedical Data Science, Stanford University, Stanford, CA, USA; Department of Statistics, Stanford University, Stanford, CA, USA.
It is, of course, a pity that the article is behind a paywall – but fortunately, the senior author, John Ioannidis, published his email address together with the abstract: [email protected]. So, if you have trouble understanding the point of the analysis, I suggest you ask for a reprint to get your head around it. I promise it’s worth it.
