progress
An interesting and fully referenced (205 references) article caught my attention; it seems highly relevant to the discussions we are having on this blog. Let me show you the abstract:
Medical misinformation has always existed, but it has recently become more frequent due to the development of the internet and social media. Medical misinformation can cover a wide variety of topics, and studies show that some groups are more likely to be affected by medical misinformation than others, like those with less trust in health care, less health literacy, and a more positive attitude toward alternative medicines. Aspects of the internet, like echo chambers and algorithms, have contributed to the rise of medical misinformation, along with belief in anecdotal evidence and alternative remedies that are not backed by science. Some personal beliefs and a lack of media literacy skills are also contributing to medical misinformation. Medical misinformation causes higher rates of death and negative health outcomes, a lack of trust in medical professionals, and more racism and hate crimes. One possible way to combat the spread of misinformation is education surrounding media literacy. Still, there are gaps in this practice that must be addressed like a lack of high-quality research about different educational programs.
The author also offers the following key points:
- Medical misinformation is becoming an urgent issue for United States citizens—leading to increased deaths,
a lack of trust in health professionals, and hate crimes and racism. - Although this is a worldwide issue, the United States has the second highest rate of misinformation of any
country, behind India. - One piece of misinformation during the COVID-19 pandemic stated that highly concentrated alcohol could
disinfect the body and kill the virus. Studies show that 800 people died, 5,876 were hospitalized, and 60
became completely blind from drinking methanol, thinking it would cure coronavirus. - Studies estimate that only 14% of the United States population has proficient health literacy, which makes it difficult to recognize medical misinformation.
- Media literacy education is being pursued in order to combat the spread of misinformation, but more research is needed in order to understand the long-term effects of this education and what programs are best.
__________________
I would like to stress, as indeeed the author does as well, that medical misinformation is a phenomenon that is by no means confined to the US. Like most information, misinformation has become a global issue. Its dangers cannot be under-estimated. My blog offers an abundance of reports where misinformation in the realm of so-called alternative medicine (SCAM) has caused harm and even death. The author advocates media literacy as a remedy for the problem. I would argue that even more important would be to teach CRITICAL THINKING, a task that has to start at school and must continue well into adult life.
This conclusion is so very obvious that it begs an important question: WHY HAS IT NOT BEEN DONE YEARS AGO? The answer, I fear, is simple: for reasons that are self-evident, governments have little interst in the public being able to think critically. On the contrary, governments across the world foremost want to be re-elected, and critical thinking would be a major obstacle to this aim.
The aim of this study was to establish an international consensus regarding the use of spinal manipulation and mobilisation among infants, children, and adolescents among expert international physiotherapists. Twenty-six international expert physiotherapists in manual therapy and paediatrics voluntarily participated in a 3-Round Delphi survey to reach a consensus via direct electronic mail solicitation using Qualtrics®. Consensus was defined a-priori as ≥75% agreement on all items with the same ranking of agreement or disagreement. Round 1 identified impairments and conditions where spinal mobilisation and manipulation might be utilised. In Rounds 2 and 3, panelists agreed or disagreed using a 4-point Likert scale.
Eleven physiotherapists from seven countries representing five continents completed all three Delphi rounds. Consensus regarding spinal mobilisation or manipulation included:
● Manipulation is not recommended: (1) for infants across all conditions, impairments, and
spinal levels; and (2) for children and adolescents across most conditions and spinal levels.
● Manipulation may be recommended for adolescents to treat spinal region-specific joint
hypomobility (thoracic, lumbar), and pain (thoracic).
● Mobilisation may be recommended for children and adolescents with hypomobility, joint
pain, muscle/myofascial pain, or stiffness at all spinal levels.
The authors of this paper concluded that consensus revealed spinal manipulation should not be performed on infants regardless of condition, impairment, or spinal level. Additionally, the panel agreed that manipulation may be recommended only for adolescents to treat joint pain and joint hypomobility (limited to thoracic and/or lumbar levels). Spinal mobilisation may be recommended for joint hypomobility, joint pain, muscle/myofascial pain, and muscle/myofascial stiffness at all spinal levels among children and adolescents.
Various forms of spinal manipulations are the hallmark therapy of chiropractors. Almost 100% of their patients recieve these interventions. So, what will our friends, the chiros, say about the consensus? Might it be this:
- Physiotherapists are not the experts on spinal manipulation.
- Only chiropractors can do them properly.
- And when WE do them, they are very good*!
(* for our income)
This study aims to assess the feasibility of a pragmatic prospective study aiming to report the immediate and delayed (48-hours post-treatment) AEs associated with manual therapies in children aged 5 or younger and to report preliminary data on AEs frequency.
Between July 2021 and March 2022, chiropractors were recruited through purposive sampling and via a dedicated Facebook group for Quebec chiropractors interested in pediatrics. Legal guardians of patients aged 5 or younger were invited to fill out an online information and consent form. AEs were collected using the SafetyNET reporting system, which had been previously translated by the research team. Immediate AEs were collected through a questionnaire filled out by the legal guardian immediately after the treatment, while delayed AEs were collected through a questionnaire sent by email to the legal guardian 48 h after the treatment. Feasibility was assessed qualitatively through feedback from chiropractors and quantitatively through recruitment data.
Overall, a total of 28 chiropractors expressed interest following the Facebook publication, and 5 participated. An additional two chiropractors were enrolled through purposive sampling. In total, 80 legal guardians consented to their child’s participation, and data from 73 children were included for the analysis of AEs. At least one AE was reported in 30% of children (22/73), and AEs were mainly observed immediately following the treatment (16/22). The most common AEs were irritability/crying (11 children) or fatigue/tiredness (11 children). Feasibility analysis demonstrated that regular communication between the research team and clinicians, as well as targeting clinicians who showed great interest in pediatrics, were key factors for successful research.
The authors concluded that their results suggest that it is feasible to conduct a prospective pragmatic study evaluating AEs associated with manual therapies in private practices. Direct communication with the clinicians, a strategic clinicians’ recruitment plan, and the resulting administrative burden should be considered in future studies. A larger study is required to confirm the frequency of AEs reported in the current study.
It is hardly surprising that such a study is ‘feasible’. I could have told the authors that and saved them the trouble of doing the study. What is surprising, in my view, that chiropractors, after ~120 years of existence of the profession, ask whether it is feasible.
I suggest to do the definitive study on a much larger sample, extend the observation period, and recruit a representative rather than self-selected sample of chiros … or – much better – forget about the study and establich a functioning post-marketing surveillance system.
These days, it has become a rare event – I am speaking of me publishing a paper in the peer-reviewed medical literature. But it has just happened: Spanish researchers and I published a meta-analysis on the effectiveness of craniosacral therapy. Here is its abstract:
The aim of this study was to evaluate the clinical effectiveness of craniosacral therapy (CST) in the management of any conditions. Two independent reviewers searched the PubMed, Physiotherapy Evidence Database, Cochrane Library, Web of Science, and Osteopathic Medicine Digital Library databases in August 2023, and extracted data from randomized controlled trials (RCT) evaluating the clinical effectiveness of CST. The PEDro scale and Cochrane Risk of Bias 2 tool were used to assess the potential risk of bias in the included studies. The certainty of the evidence of each outcome variable was determined using GRADEpro. Quantitative synthesis was carried out with RevMan 5.4 software using random effect models.
Fifteen RCTs were included in the qualitative and seven in the quantitative synthesis. For musculoskeletal disorders, the qualitative and quantitative synthesis suggested that CST produces no statistically significant or clinically relevant changes in pain and/or disability/impact in patients with headache disorders, neck pain, low back pain, pelvic girdle pain, or fibromyalgia. For non-musculoskeletal disorders, the qualitative and quantitative synthesis showed that CST was not effective for managing infant colic, preterm infants, cerebral palsy, or visual function deficits.
We concluded that the qualitative and quantitative synthesis of the evidence suggest that CST produces no benefits in any of the musculoskeletal or non-musculoskeletal conditions assessed. Two RCTs suggested statistically significant benefits of CST in children. However, both studies are seriously flawed, and their findings are thus likely to be false positive.
So, CST is not really an effective option for any condition.
Not a big surprise! After all, the assumptions on which CST is based fly in the face of science.
Since CST is nonetheless being used by many healthcare professionals, it is, I feel, important to state and re-state that CST is an implausible intervention that is not supported by clinical evidence. Hopefully then, one day, these practitioners will remember that their ethical obligation is to treat their patients not according to their beliefs but according to the best available evidence. And, hopefully, our modest paper will have helped rendering healthcare a little less irrational and somewhat more effective.
Jennifer Jacobs started publishing peer-reviewed papers on homeopathy in the early 1990s. This happens to be around the same time as I did. So, we both have about 30 years of research into homeopathy behind us.
Jennifer just authored a paper entitled “Thirty Years of Homeopathic Research – Lessons Learned“. Here is its abstract:
Conducting double-blind randomized controlled trials is difficult, even in the allopathic medical system. Doing so within the paradigm of classical homeopathy is even more challenging. More than thirty years of experience in carrying out such trials has taught me much about the pitfalls to avoid as well as the factors that can lead to success. The initial steps of putting together a research protocol, securing funding, and obtaining human subjects’ approval can be daunting. After that comes developing questionnaires and surveys, hiring study personnel, and recruitment of subjects. The actual implementation of the research comes with its own set of possible missteps. Sample size determination, entry criteria, as well as type, frequency and duration of treatment are all crucial. Finally, statistical analysis must be performed to a high standard and a manuscript prepared to submit for publication. Even then there can be one or more manuscript revisions to make, based on feedback from reviewers, before a study is actually published. The entire process can take at least two years and is usually much longer.
Mistakes at any one of these steps can damage the outcome, as well as the impact of the study. With examples from my body of research, I will discuss some of the things that I wish I had done differently, as well as those that turned out to be correct. Homeopathic research is held to a much higher standard than conventional trials. Any flaws in study design, implementation, and analysis can be used by critics to negate the results. I am hopeful that the next generation of homeopathic researchers will learn from my experiences and carry on with great success.
Jennifer’s example motivated me to follow suit and contribute some very brief thoughts about my 30 years of homeopathy research and the lessons I have learnt:
Conducting double-blind randomized controlled trials is difficult in any area of medicine. Yet these types of studies are by far the best way to find out which treatments work and which don’t. Therefore, they need doing, regardless of the obstacles they may pose.
In homeopathy, we now have a large body of such trials. Sadly, not all of them are reliable. Those that are, according to accepted criteria, tend to fail to show that homeopathy works better than a placebo. Understandably, homeopaths are disappointed with this overall result and have made numerous attempts to invalidate it.
The main problem with research into homeopathy is not the research methodology. It is well established for clinical trials and can be easily modified to fit all the demands made by individualised treatment or other pecularities that may apply to homeopathy. The main problem is the homeopath who finds it impossible to accept the truth, namely that highly diluted homeopathic remedies are pure placebos and any observed benefits of homeopathy are due to non-specific effects such as the empathetic encounter or a placebo response.
The lesson to be learned from the past is that, in medicine, even the most obsessive belief, conviction or wishful thinking will eventually have to give way to the scientific evidence. In the case of homeopathy, this process has taken an extraordinary amount of time and effort but, finally, we are almost there and the writing is on the wall for everyone to see.
Two resumes of 30 years of work, research and experience!
And what a difference between them!
Who do you think gets closer to the truth,
Jennifer or I?
Current interventions for posttraumatic stress disorder (PTSD) are efficacious, yet effectiveness may be limited by adverse effects and high withdrawal rates. Acupuncture is an intervention with some positive preliminary but methodologically flawed data for PTSD. Therefore a new study compared verum acupuncture with sham acupuncture (minimal needling) on clinical and physiological outcomes.
This was a 2-arm, parallel-group, prospective blinded randomized clinical trial hypothesizing superiority of verum to sham acupuncture. The study was conducted at a single outpatient-based site, the Tibor Rubin VA Medical Center in Long Beach, California, with recruitment from April 2018 to May 2022, followed by a 15-week treatment period. Following exclusion for characteristics that are known PTSD treatment confounds, might affect biological assessment, indicate past nonadherence or treatment resistance, or indicate risk of harm, 93 treatment-seeking combat veterans with PTSD aged 18 to 55 years were allocated to group by adaptive randomization and 71 participants completed the intervention protocols.
Verum and sham were provided as 1-hour sessions, twice weekly, and participants were given 15 weeks to complete up to 24 sessions. The primary outcome was pretreatment to posttreatment change in PTSD symptom severity on the Clinician-Administered PTSD Scale-5 (CAPS-5). The secondary outcome was pretreatment to posttreatment change in fear-conditioned extinction, assessed by fear-potentiated startle response. Outcomes were assessed at pretreatment, midtreatment, and posttreatment. General linear models comparing within- and between-group were analyzed in both intention-to-treat (ITT) and treatment-completed models.
A total of 85 male and 8 female veterans (mean [SD] age, 39.2 [8.5] years) were randomized. There was a large treatment effect of verum (Cohen d, 1.17), a moderate effect of sham (d, 0.67), and a moderate between-group effect favoring verum (mean [SD] Δ, 7.1 [11.8]; t90 = 2.87, d, 0.63; P = .005) in the intention-to-treat analysis. The effect pattern was similar in the treatment-completed analysis: verum d, 1.53; sham d, 0.86; between-group mean (SD) Δ, 7.4 (11.7); t69 = 2.64; d, 0.63; P = .01). There was a significant pretreatment to posttreatment reduction of fear-potentiated startle during extinction (ie, better fear extinction) in the verum but not the sham group and a significant correlation (r = 0.31) between symptom reduction and fear extinction. Withdrawal rates were low.
The authors concluded that the acupuncture intervention used in this study was clinically efficacious and favorably affected the psychobiology of PTSD in combat veterans. These data build on extant literature and suggest that clinical implementation of acupuncture for PTSD, along with further research about comparative efficacy, durability, and mechanisms of effects, is warranted.
I am not sure that the authors’ enthusiastic verdict is correct. Its lead author was even quoted stating that his study, which used improved controls, was needed to “definitively” support acupuncture for PTSD. He noted that “acupuncture ought to be considered a potential first-line treatment for PTSD.”
While the study is an improvement on the previous research in this area, it is by no means compelling. My main point of criticism is the nature of the sham acupuncture. Such controls are used to account for placebo effects which, of course, can be considerable in the case of acupuncture.
For this concept to work adequately, the patient and the therapist need to be blinded. In the case of acupuncture, therapist blinding is difficult (but not impossible). In this study, therepists were not blinded. Thus they could have influenced the outcome by verbal and non-verbal clues given to the patient. As acupuncturists inevitably have an interest in the positive result of their study, this effect seems inevitable to me.
More important, however, is the adequate blinding of the patient. In this study, it was attempted by using shallow needling as a sham intervention. Yet, shallow needling can easily distinguished from real acupuncture by the patient. At the very least, patients should be asked what treatment – sham or real – they thought they had received. This did not happen, and we therefore might assume that the effect of patient de-blinding – combined with the confounder described above – was sufficient to bring about the relatively small effect sizes observed by the authors.
One might argue that this does not really matter; all that counts is to alleviate the suffering of the patients, never mind by what mechanism. I think, this would be erroneous. It matters because, if acupuncture itself is ineffective (which I suggest), settling for acupuncture as a first line therapy for PTSD is in nobody’s interest and a disservice to severely suffering patients. It would inhibit meaningful research aimed at finding an optimal therapy (one that works beyond placebo) and be a waste of resources.
The aim of this systematic review and network meta-analysis was to identify the optimal dose and modality of exercise for treating major depressive disorder, compared with psychotherapy, antidepressants, and control conditions.
The screening, data extraction, coding, and risk of bias assessment were performed independently and in duplicate. Bayesian arm based, multilevel network meta-analyses were performed for the primary analyses. Quality of the evidence for each arm was graded using the confidence in network meta-analysis (CINeMA) online tool. All randomised trials with exercise arms for participants meeting clinical cut-offs for major depression were included.
A total of 218 unique studies with a total of 495 arms and 14 170 participants were included. Compared with active controls (eg, usual care, placebo tablet), moderate reductions in depression were found for
- walking or jogging,
- strength training,
- mixed aerobic exercises,
- and tai chi or qigong.
The effects of exercise were proportional to the intensity prescribed. Strength training and yoga appeared to be the most acceptable modalities. Results appeared robust to publication bias, but only one study met the Cochrane criteria for low risk of bias. As a result, confidence in accordance with CINeMA was low for walking or jogging and very low for other treatments.
The authors concluded that exercise is an effective treatment for depression, with walking or jogging, yoga, and strength training more effective than other exercises, particularly when intense. Yoga and strength training were well tolerated compared with other treatments. Exercise appeared equally effective for people with and without comorbidities and with different baseline levels of depression. To mitigate expectancy effects, future studies could aim to blind participants and staff. These forms of exercise could be considered alongside psychotherapy and antidepressants as core treatments for depression.
As far as I can see, there are two main problems with these findings:
- Because too many of the studies are less than rigorous, the results are not quite as certain as the conclusions would seem to imply.
- Patients suffering from a major depressive disorder are often unable (too fatigued, demotivated, etc.) to do and/or keep up vigorous excerise over any length of time.
What I find furthermore puzzling is that, on the one hand, the results show that – as one might expect – the effects are proportional to the intensity of the excercise but, on the other hand tai chi and qugong which are both distinctly low-intensity turn out to be effective.
Nonetheless, this excellent paper is undoubtedly good news and offers hope for patients who are in desperate need of effective, safe and economical treatments.
The French ‘National Assembly’ has yesterday adopted a major law aimed at reinforcing the prevention and combat against sectarian aberrations in France. This marks a significant step forward in strengthening the protection of citizens against abuse and manipulation by charlatans, gurus and other sectarian movements.
This bill, the result of particularly fruitful work and debate in both chambers, reflects the Government’s commitment to meeting the expectations of the victims of these sectarian movements.
Some of the key measures voted through by parliamentarians include:
- The enshrinement in law of the powers of MIVILUDES (Interministerial Mission of Vigilance and Combat against Sectarian Aberrations);
- The reinforcement of the penal response with the creation of the offence of placing or maintaining in a state of psychological or physical subjection;
- The creation of an offence of incitement to abandon or refrain from treatment, or to adopt practices which clearly expose the person concerned to a serious health risk;
- Support for victims, with the extension of the categories of associations that can bring civil action;
- Information for the judiciary, with the introduction of an “amicus curiae” role for certain government departments in legal cases relating to cults.
Despite sometimes heated debates, particularly around article 4, fuelled by the opinion of the Conseil d’Etat, the adoption of this law by the National Assembly bears witness to a shared desire to protect the rights and freedoms of individuals while providing better protection for our fellow citizens against sectarian aberrations.
This bill is part of a multi-annual national strategy for 2023-2027 resulting from the conference on sectarian aberrations held in spring 2023. It is a major step towards strengthening the penal arsenal and protecting victims.
_______________
Sabrina Agresti-Roubache, Secretary of State for Citizenship and Urban Affairs, commented:
“Long-awaited by victim support associations, this text aims to strengthen our legal arsenal in the fight against sectarian aberrations. I’m delighted that all the articles have been adopted, particularly Article 4, which creates an offence of incitement to abandon or abstain from treatment. There have been some passionate debates in the Chamber, but I’d like to reiterate the basis of this bill: the State is not fighting against beliefs, opinions or religions, but against all forms of sectarian aberrations, these dangerous behaviors which represent a threat to our social cohesion and put lives at risk.”
_______________
Obviously, we shall have to see how the new law will be applied. But, in any case, it is an important step into the right direction and could put an end to much of so-called alternative medicine that endangers the health of French consumers.
Other nations should consicer following the Franch example.
Mercury is a highly toxic chemical that threatens the health of humans and the environment. When it is released into the environment, it enters the food chain where it accumulates, particularly in fish. Exposure to high levels of mercury can cause harm to the brain, lungs, kidneys and the immune system. For these reasons, dental amalgam fillings which contain mercury have long been criticized. This is particularly true in the realm of so-called alternative medicine (SCAM) where, as discussed repeatedly, amalgam has long been a subject of both concern and misinformation, e.g.:
- Is removal of dental amalgam a good idea?
- Dental Amalgam
- Three Trends In “Alternative Dentistry” Part 3: Amalgam Removal and Avoidance
- Three Trends In “Alternative Dentistry” Part 1: The Concept of Projections—Of Meridians and Temporo-Mandibular Joint Dysfunction (TMJD)
- Holistic dentistry?
In the EU, dental amalgam might soon be merely of historical interest.
It has been announced that the EU Parliament and Council reached a provisional political agreement on the Commission’s proposal to address the remaining uses of mercury in products in the EU in line with commitments set out in the EU’s Zero Pollution Ambition.
In spite of viable mercury-free alternatives, around 40 tonnes of mercury are still used in the EU annually for dental amalgam as current rules only forbid the use of dental amalgam for treating teeth in children under 15 years old as well as pregnant and breastfeeding women.
Negotiators agreed to phase out the use of dental amalgam in the EU by 1 January 2025 except if deemed strictly necessary by the dental practitioner based on the duly justified specific medical needs of the patient.
EU countries that have not yet adjusted their reimbursement system to cover alternatives, may postpone the phase-out up until 30 June 2026, to avoid negative repercussions for low-income individuals that would otherwise be socio-economically disproportionally affected by the phase-out.
The export of dental amalgam will also be prohibited from 1 January 2025, whereas the manufacturing and import into the EU will be banned from 1 July 2026.
After the agreement, rapporteur Marlene Mortler (EPP, Germany) said: “After an intensive week of negotiations, we were able to reach an agreement today to ban dental amalgam containing mercury. This is an important step towards a mercury-free future. I am very pleased with the result – because we have ensured that such dental amalgam may only be used in medically necessary cases. Some Member States have been granted an exemption in order to mitigate the socio-economic consequences of the amalgam phase-out. After all, the ban on dental amalgam must not mean that low-income EU citizens can no longer afford adequate dental treatment in these countries. Another key point of this agreement is the decision that lamps containing mercury may only be exported to countries outside the EU until 30 June 2026. This will ensure that products that are already banned in the EU are not sold to third countries and have environmentally harmful consequences there.”
The deal still has to be adopted by the EU Parliament and Council, after which the new law will be published in the EU Official Journal and enter into force 20 days later.
I have to admit that I came across the ‘ARCIM’ (Academic Research in Complementary and Integrative Medicine) Institute only yesterday when writing the post about Buteyko. Naturally, the institution interested me, and I tried to find out more about it. As pointed out previously, the aim of the ARCIM research institute, founded in 2010, is to research complementary and integrative medicine, in particular anthroposophic medicine, on a scientific basis according to rigorous scientific standards established by the Equator Network criteria (http://www.equator-network.org/).
On the ARCIM’s website we furthermore learn that:
- ARCIM exists since 2010.
- Consists of a team of 8 co-workers.
- Its director is the physician Jan Vagedes.
- Who have published a sizable amount of papers.
- Is funded by the following sponsors: Federal Ministry of Education and Research (BMBF), Mahle-Foundation (Mahle Stiftung), Software AG (Software AG), DAMUS-DONATA e.V.
- Is located in the buildings of the ‘Filderclinic’.
This begs, I think, several questions:
Why is the Federal Ministry of Education and Research sponsoring the ARCIM?
As anthroposophical medicine is based on concepts that fly in the face of science, this seems a legitimate question. Sadly, I have no answer to it.
What is the ‘Filderclinic’?
The Filderklinik in Filderstadt-Bonlanden is one of six anthroposophically orientated hospitals in Germany. It is operated by the non-profit organisation Filderklinik gGmbH. The main founders of the Filderklinik, which has existed since 1975, were Hermann and Ernst Mahle, the founders of the Mahle Group. The Mahle-Stiftung GmbH is the main shareholder and also the largest sponsor of Filderklinik gGmbH. The hospital employs around 915 staff and has 300 beds.
Who is Jan Vagedes?
Jan Vagedes is a specialist for paediatrics and adolescent medicine, neonatology and a doctor for anthroposophic medicine. He studied in and graduated from the LMU in Munich (my alma mater) in 1997. He is the Founder and Scientific Director of the ARCIM Institute, a research associate at the University Children’s Hospital Tübingen, and Head of paediatrics and adolescent medicine at the Filderclinic.
He has no ‘habilitation’ (PhD and in Germany precondition for a professorship). Medline currently lists 42 articles in his name most of which are in 3rd class journals. His first Medline-listed article is dated 2012. As the ARCIM was established in 2010, this means that, when he was appointed as its ‘scientific director’, he had exactly zero published science to his name.
Why did he get the job?
I have absolutely no idea?
(If you know more than I do, I’d be grateful to hear about it.)
