patient choice
It has been reported, at the German Medical Congress (DÄT) a year ago, that it was decided to delete the additional title of homeopathy from the model further training regulations of the German Medical Association. And Federal Health Minister Karl Lauterbach (SPD) tweeted applause: “Homeopathy has no place in modern medicine.”
Now the ‘ Bundesverband der Pharmaziestudierenden in Deutschland’ (BPhD), the German Pharmacists Organization, even goes a few steps further. The position paper distinguishes between evidence-based medicine (EBM) and unproven therapeutic methods. According to the BPhD, these include homeopathy, but also anthroposophy, traditional Chinese medicine, and traditional medicines.
Among other things, the BPhD is disturbed by the way homeopathy presents itself as an alternative, because an alternative means “a choice between two equally suitable possibilities” to achieve a goal, and this is not the case. Compared to evidence-based medicine (EBM), homeopathy is a “constructed, illusory concept” and “the principles of homeopathic teachings and principles” are to be rejected as “unscientific”. According to the BPhD, a designation as “alternative” for advertising purposes should no longer be allowed.
They would also like to see a demarcation from naturopathy; the clear distinction between homeopathy and phytopharmacy has been lacking up to now. The advertising attribute “natural” should therefore also be banned in order to prevent equalization in advertising, the position paper states.
Like doctors, pharmacy students point to the lack of proof of efficacy beyond the placebo effect. According to the BPhD, the dogma WER HEILT HAT RECHT, “he who heals is right” would “disregard all processes that work towards healing and glorify the result”. The “gold standard” of EBM – randomized, double-blind studies with placebo control – should in future also have to be fulfilled by homeopathic medicines, experience reports are not sufficient, it continues.
Homeopathic medicines are only registered as medicinal products without indication, which requires neither proof of efficacy nor clinical studies. The BPhD, therefore, demands that a warning be placed on the preparations that they have “no proven efficacy beyond the placebo effect”. Up to now, without this warning, patients have been “deceived about the efficacy”, and there is an “urgent need for detailed public information and counseling on homeopathy since its unjustified reputation poses a danger of not seeking treatment”. The BPhD also demands that the status of homeopathic medicines is withdrawn and that the pharmacy obligation for the preparations is abolished…
“In the health professions, no trivialization of unproven therapeutic procedures should be tolerated, as inadequate counseling or ignorance poses a danger to patients,” the BPhD said.
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When I first read this article – I translated and shortened it for those who cannot read German- I was truly dazzled. These are the suggestions that I have been making for around 20 years now, not specifically for Germany but for pharmacists in general. For many years, the Germans seemed the least likely to agree with me. But now they seem to be ahead of everyone else in Europe!
How come?
I suspect and hope that our recent initiative might have something to do with it.
Let’s hope that the pharmacists of other countries follow the German example.
It has recently been reported that a 39-year-old woman (a mother-of-three died) died after immersing herself in a river as part of a cold water therapy session. The woman died after paramedics were called to attend a riverside in Derbyshire. The session was run by Kevin O’Neill of ‘Breatheolution’, whose previous clients include Coleen Rooney and actor Stephen Graham. The woman, who was visiting with two friends after paying up to £200 for a two-hour cold water therapy session, was rushed to hospital where she died.
Mr. O’Neill commented: “I am heartbroken. I’ve not slept and I’m finding it hard to process. I cannot stop thinking about her family. It’s tragic.” An inquest is expected to be opened into the woman’s death. East Midlands Ambulance Service said they were called to Bankside, in Bridgemont. “The caller reported a medical emergency,” a spokesperson said. “We sent a paramedic in a fast response car and a double-crewed ambulance. The air ambulance was also in attendance.”
Derbyshire Fire and Rescue Service, which was called to assist the paramedics, has warned people about the dangers of entering open water. “While we cannot and will not comment or speculate on the circumstances and cause of this tragic death, we would like to remind people of the dangers of entering open water and cold water shock,” said group manager Lee Williams.
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Breatheolution’ has a website where a whole page is dedicated to its leader Kevin O’Neill. I wondered what qualifications Kevin has, but all it tells us about him is this: “I struggled for so long with alcohol and other substance abuse that something had to give, I lost my sister Yvonne in 2019 and I think it was enough trauma to make me think a lot more about my own life”
The website also explains what the cold water sessions are about:
1-2-1 Breath Coaching, practice & Cold water session (river or tank)
2 hours @ £110.00
These sessions are proving popular with those who are not keen on group sessions or just prefer to have a more personal experience. The 2-3 hour sessions will be tailored to you and your breathing and will include potentially life-changing tools and methods to allow you to witness your breathing and physiology differently in the future, its all about feeling and awareness.
Another section of the site is dedicated to celebrities who Kevin seems to have treated. And then there is a video of the treatment. What I did not find anywhere, however, are the conditions that Kevin claims to treat with his cold water therapy.
In any case, it would have been wise for Kevin to read up about the risks of cold water immersion (CWI) before going into business. Perhaps this review would have helped:
In 2012, an estimated 372,000 people (42 per hour) died from immersion, assumed to be drowning. Immersion is the third leading cause of unintentional injury-related death, accounting for 7% of all such deaths (World Health Organization, 2014). These figures are underestimations owing to poor reporting in many Third World countries that have a high number of deaths. The data also do not include life-long morbidity caused by immersion-related injuries, estimated to be a much bigger numerical problem.
There is no strict definition of ‘cold water’. Given that some of the hazardous responses to cold water appear to peak on immersion somewhere between 15 and 10°C, it is reasonable to say that cold water is water <15°C (Tipton et al. 1991). However, the thermoneutral water temperature for a resting naked individual is ∼35°C, so it is possible for individuals to become very cold, with time, on immersion in water below this temperature. The corresponding temperature for those exercising (including shivering) is ∼25°C (Tipton & Golden, 1998).
Historically, the threat associated with CWI was regarded in terms of hypothermia or a reduction in deep body temperature below 35°C. This belief was established as a result of the Titanic disaster and supported by data obtained during maritime conflicts of World War II. However, more recently, a significant body of statistical, anecdotal and experimental evidence has pointed towards other causes of death on immersion. For example, in 1977 a Home Office Report revealed that ∼55% of the annual open water deaths in the UK occurred within 3 m of a safe refuge (42% within 2 m), and two-thirds of those who died were regarded as ‘good swimmers’. This evidence suggests more rapid incapacitation than can occur with whole-body cooling and consequent hypothermia.
The following four stages of immersion have been associated with particular risks (Golden & Hervey, 1981; Golden et al. 1991); the duration of these stages and the magnitude of the responses evoked within them vary significantly, depending on several factors, not least of which is water temperature:
- Initial immersion (first 3 min), skin cooling;
- Short-term immersion (3 min plus), superficial neuromuscular cooling;
- Long-term immersion (30 min plus), deep tissue cooling (hypothermia); and
- Circum-rescue collapse: immediately before, during or soon after rescue.
As a result of laboratory-based research, the initial responses to immersion, or ‘cold shock’, were identified as particularly hazardous (Tipton, 1989), accounting for the majority of immersion deaths (Tipton et al. 2014). These deaths have most often been ascribed to drowning, with the physiological responses of a gasp and uncontrollable hyperventilation, initiated by the dynamic response of the cutaneous cold receptors, resulting in the aspiration of the small volume of water necessary to initiate the drowning process (Bierens et al. 2016). Relatively little is known about the minimal rates of change of cold receptor temperature necessary to cause cold shock. The response has been reported to begin in water as warm as 25°C but is easy to suppress consciously at that temperature. In laboratory conditions, the respiratory frequency response (an indication of respiratory drive) peaks on naked immersion in a water temperature between 15 and 10°C, and is no greater on immersion in water at 5°C (Tipton et al. 1991). The corresponding average rates of change of chest skin temperature over the first 20 s of these immersions was 0.42 (water temperature 15°C), 0.56 (water temperature 10°C) and 0.68°C s−1 (water temperature 5°C). This suggests that an average rate of change in chest skin temperature between 0.42 and 0.56°C s−1 on the first 20 s of immersion is sufficient to evoke a maximal respiratory cold shock response.
More recently, it has been suggested (Shattock & Tipton, 2012) that a larger number of deaths than once thought may be attributable to arrhythmias initiated on immersion by the coincidental activation of the sympathetic and parasympathetic division of the autonomic nervous system by stimulation of cutaneous cold receptors around the body [sympathetic activation (cold shock)] and in the oronasal region on submersion or with wave splash [vagal stimulation (diving response)]. This ‘autonomic conflict’ is a very effective way of producing dysrhythmias and arrhythmias even in otherwise young and healthy individuals, particularly, but not necessarily, if a prolonged breath hold is involved in the immersion (Tipton et al. 1994). It seems that predisposing factors, such as long QT syndrome, ischaemic heart disease or myocardial hypertrophy, are necessary for fatal arrhythmias to evolve (Shattock & Tipton, 2012); many of these factors, including drug-induced long QT syndrome, are acquired. Non-fatal arrhythmias could still indirectly lead to death if they cause incapacitation and thereby drowning (Tipton, 2013). The hazardous responses associated with the cold shock response are presented in Fig. 2.
Figure 2. A contemporary view of the initial responses to immersion and submersion in cold water (‘cold shock’)
The problems encountered in short-term immersions are primarily related to physical incapacitation caused by neuromuscular cooling (Castellani & Tipton, 2015). The arms are particularly susceptible because of their high surface area to mass ratio. Low muscle temperatures affect chemical and physical processes at the cellular level. This includes metabolic rate, enzymatic activity, calcium and acetylcholine release and diffusion rate, as well as the series elastic components of connective tissues (Vincent & Tipton, 1988). Maximal dynamic strength, power output, jumping and sprinting performance are related to muscle temperature, with reductions ranging from 4 to 6% per degree Celsius reduction in muscle temperature down to 30°C (Bergh & Ekblom, 1979). At nerve temperatures below ∼20°C, nerve conduction is slowed and action potential amplitude is decreased (Douglas & Malcolm, 1955). Nerve block may occur after exposure to a local temperature of between 5 and 15°C for 1–15 min. This can lead to dysfunction that is equivalent to peripheral paralysis and can, again, result in drowning owing to the inability to keep the airway clear of the water (Clarke et al. 1958; Basbaum, 1973; Golden & Tipton, 2002; Fig. 3).
Figure 3. The ‘physiological pathways to drowning’ after immersion or submersion in cold water, with possible interventions for partial mitigation (dashed)
Abbreviations: EBA, emergency breathing aid; IS, immersion suit; and LJ, lifejacket. Reproduced with permission, from Tipton (2016b).
Even in ice-cold water, the possibility of hypothermia does not arise for at least 30 min in adults. Hypothermia affects cellular metabolism, blood flow and neural function. In severe hypothermia, the patient will be deeply unconscious. The progressive signs and symptoms (approximate deep body temperature) are shivering (36°C), confusion, disorientation, introversion (35°C), amnesia (34°C), cardiac arrhythmias (33°C), clouding of consciousness (33–30°C), loss of consciousness (30°C), ventricular fibrillation (28°C) and death (25°C) (Bierens et al. 2016). There is great variability between deep body temperature and the signs and symptoms of hypothermia. For example, although the deep body temperature associated with death is often quoted as 25°C, the lowest temperature recorded to date after accidental exposure to cold (air) and with full recovery was 12.7°C in a 28-month-old child (Associated Press, 2014). The coldest adult survivor of CWI followed by submersion had a body temperature of 13.7°C (Gilbert et al. 2000). There is also a large amount of variation in the rate at which people cool on immersion in cold water, owing to a combination of thermal factors (including water temperature and water movement, internal and external insulation) and non-thermal factors (including body size and composition, blood glucose, motion illness, racial and sex differences; Haight & Keatinge, 1973; Gale et al. 1981; White et al. 1992; Mekjavic et al. 2001; Golden & Tipton, 2002).
The most significant practical consequence of hypothermia in water is loss of consciousness; this prevents individuals from undertaking physical activity to maintain a clear airway and avoid drowning. Thus, once again, drowning is often the end-point (Fig. 3).
About 17% of those who die as a result of immersion die immediately before, during or after rescue (Golden et al. 1991). The deaths immediately before rescue are intriguing and probably related to behavioural changes at this time or the relief and psychophysiological alterations associated with imminent rescue, including a reduction in circulating stress hormone concentration and an increase in vagal tone. Death during rescue is most commonly associated with a collapse in arterial pressure when lifted vertical from the water and kept in that position for some time (Golden et al. 1991).
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The tragic death of the woman should perhaps remind us that
- there is no SCAM or wellness treatment that is entirely harmless,
- and there are only few ‘would-be gurus’ who know what they are doing.
The German Heilpraktiker (HP), a non-medically trained practitioner of so-called alternative medicine (SCAM), has repeatedly been the subject of my posts. In a nutshell: the profession was created by the Nazis and was originally destined to disappear within one generation. But this did not happen, and today there are ~100 000 HPs who are allowed to treat almost any condition without mandatory training or experience. Many HP schools exist but you can also become an HP without formal training.
Now a report has been published by undercover journalists investigating these HP schools in Germany. Here I have summarized a few crucial passages for you (if you read German, I strongly recommend reading the original article):
There are more than 150 HP schools in Germany. On average, training costs several thousand euros. There is no uniform and state regulation for the training. The curricula are mostly created by the schools themselves.
In addition to medical and psychological content, the schools often offer seminars that are not based on scientific knowledge. The curricula sometimes include courses such as astrology, homeopathy, or so-called quantum healing. HP organizations give indeed training guidelines. However, these are not met by about 83% of the schools.
The students were isolated at the HP school from their environment and urged to break off contact with their families. “Without us you are nothing. That came so often and I then, unfortunately, believed in it, because I was alone. If I had had no one else from school, then I would really have been completely alone,” explains a former student in an interview. “During that time, I also thought for the first time: Are we in some kind of cult here?
The school’s principal rejects the cult accusation: “We have been confronted with the allegation that we are a cult for some time and have always dealt with it very openly because we are not a cult. The principal also denies other accusations made by former students, saying that the allegations of suggestion, coercion, compulsion, or sweeping statements are simply false. He said he would be happy to face them “in a personal conversation outside the public eye to answer their questions.”
In order to get to the bottom of the treatment methods, the reporter also had herself treated by the principal of the school in an undercover self-experiment. In the first session, she determined that the reporter’s sciatica had been passed on to her by her mother, which is why she should sever her ties with her. In the second session, she recommended that she no longer visit her cancer-stricken grandfather. When the principal learned that the ill grandpa was of the zodiac sign Cancer, she concluded, “Cancer gets cancer.” The cancer, she said, was due to the fact that he had done nothing for his soul. And further, the patient runs the risk of adopting the grandfather’s cancer symptoms when she visits him.
The Hamburg health authority, which is listed as a “supervisory authority” on the school’s homepage, explains in response to an inquiry that no official supervision exists for HP schools. To obtain permission for opening a school, no training is necessary. Neither possible training courses nor institutions offering such training courses are regulated by the state.
The journalist also asked the Federal Health Ministry whether it sees the need for action and legal control. The Ministry’s response was evasive: “If necessary,” the HP law should be reformed in the future.
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This is shocking news for many Germans who believe that HPs are well-trained healthcare professionals. However, those who have read my recently published book cannot be surprised. Poor training is only one of a myriad of deficits of HPs. It is time that the government realizes that the current is unacceptable and endangers public health. It is time, in other words, that the government does something about the HP profession.
According to a German court ruling, the homeopathic remedy Meditonsin for colds may no longer be advertised with certain statements. The Higher Regional Court in Hamm, Germany made it clear that it shares the opinion of the Regional Court in Dortmund, which had sentenced the marketing company to desist from making statements such as “rapid and reliable reduction of the intensity of the typical cold symptoms”. Such statements falsely generate the impression that therapeutic success can be expected with certainty. The court made it clear that the company’s appeal against the previous ruling was unlikely to be successful. The company subsequently withdrew its appeal today – and the judgment is now legally binding.
The lawsuit filed by a consumer organization was thus successful. It had criticized several statements as unfair and inadmissible advertising. The Dortmund court shared this view in September 2022 – and according to the spokesman, the Higher Regional Court in Hamm now followed the argumentation of the lower court.
The statements that
- “good efficacy and tolerability were once again impressively confirmed by a pharmacy-based observational study”,
- and “all cold complaints showed a clear improvement in the course of the disease”,
were deemed to be misleading advertising. They must therefore be omitted, the ruling stated.
Meditonsin is currently being advertised as follows:
For support of the immune system at the first signs of a cold to help the body build up the defense against pathogens effectively.
In addition, conditions are made more difficult for the intruders – through an effective medicine: the well-known Meditonsin® supports your defenses and naturally fights the onset of inflammation of the ears, nose and throat with pure homeopathic ingredients.
If applied early and correctly, Meditonsin® helps to ensure that the typical unpleasant symptoms have no chance to develop. Because Meditonsin® is particularly well tolerated and protects the organism, it is for both adults and children alike – a family medicine in the best sense.
Meditonsin contains two homeopathic ingredients in the D5 and one in the D8 dilution. To the best of my knowledge, there is no sound evidence that the remedy is effective for anything.
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.
It is not only practitioners of so-called alternative medicine (SCAM) who can be fraudulent charlatans. The study of medicine does not protect you from joining in. Here is an impressive case in point:
It has been reported that a former doctor convicted of fraudulently submitting nearly $120 million in claims related to the 1-800-GET-THIN Lap-Band surgery business has been sentenced to seven years in federal prison.
Julian Omidi, 58, of West Hollywood was sentenced Monday by U.S. District Court Judge Dolly M. Gee. The judge also imposed a five-year probation period on Surgery Center Management LLC, an Omidi-controlled Beverly Hills-based company. In the coming weeks, Gee is expected to hold a separate hearing to decide on restitution and forfeiture in the case, along with setting a fine for the Beverly Hills company.
“Mr. Omidi made millions at the expense of the multiple victim companies he defrauded, and he violated his oath to ‘do no harm’ by callously misleading patients about the need for a sleep study and subsequent weight loss surgery,” said Donald Alway, the assistant director in charge of the FBI’s Los Angeles field office.
Omidi controlled several entities in the GET-THIN network. Prosecutors say Omidi incentivized employees to ensure patients underwent sleep studies and then falsified the results to show that patients had obstructive sleep apnea to help them qualify for insurance coverage for the weight loss surgery. Those results were then filed with insurance companies to pre-approve the Lap-Band weight-loss surgeries. The 1-800-GET-THIN business received approximately $41 million for those procedures, according to prosecutors. While not all patients were approved to receive the surgery, prosecutors say GET-THIN would bill the patient roughly $15,000 for each sleep study, totaling $27 million in payments from insurance providers.
Omidi and his Beverly Hills-based company, Surgery Center Management, were found guilty of 28 counts of wire fraud, three counts of mail fraud, and one count of conspiracy to commit money laundering. Omidi was also found guilty of two counts of making false statements relating to healthcare matters, one count of aggravated identity theft, and two counts of money laundering after a 48-day trial in downtown Los Angeles.
“As found by the jury, the defendant Julian Omidi deliberately and repeatedly acted with an eye towards business and profits, rather than in the interest of GET-THIN’s medical patients, by inducing patients to undergo medical treatment premised on fraud rather than medical necessity, including surgeries that carry significant risks and life-long health impacts,” said U.S. Atty. Martin Estrada. A series of Los Angeles Times columns from 2010 to 2014 detailed how five patients died after they received Lap-Band surgeries at clinics affiliated with 1-800-GET-THIN. During a 2009 inspection, the Department of Health and Human Services found unsanitary conditions, inoperative scrub sinks, one-time-only equipment being reused, and several other deficiencies. The inspector shut down the clinic for a day, but further action was not taken at the time.
Omidi’s medical license was revoked in 2009, and he was arrested. In 2014, federal agencies seized more than $110 million from the 1-800-GET-THIN network in securities and funds.
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This is a spectacular case, of course. Yet, I fail to see how it differs in principle from the many instances we see on a daily basis in the realm of SCAM. Let me give you just a few examples:
- A chiropractor diagnoses subluxation and subsequently treats his patient with a series of spinal manipulations.
- A naturopath uses iridology to diagnose a weakness of the liver and subsequently treats it with herbal remedies.
- An acupuncturist diagnoses a blockage of chi and follows it up with a series of acupuncture sessions.
- A Heilpraktiker employs bioresonance to diagnose an intoxication which he then treats with a detox program.
The strategy is always the same:
- Charlatans use bogus diagnostic methods.
- They make bogus diagnoses with them.
- They then start expensive and often dangerous treatments.
- They make good money by defrauding the system.
Could someone please explain what the difference in principle is between the case of the fraudulent surgeon and the average SCAM practitioner?
Imagine you have caught a cold. You think it is not necessary to see a doctor, but you want to take something that helps your body to get better. What is your choice of remedy? There are many options provided by conventional medicine as well as by so-called alternative medicine (SCAM).
Many people opt for SCAM to address health issues or prevent diseases. Yet, the evidence for SCAMs is either lacking or controversial due to methodological weaknesses. Thus, practitioners and patients primarily rely on subjective references rather than credible evidence from systematic research.
This study investigated whether cognitive and personality factors explain the differences in belief in SCAM and homeopathy. The researchers investigated the robustness of 21 predictors when examined together to obtain insights into some key determinants of such beliefs in a sample of 599 participants (60% female, 18-81 years). A combination of predictors explained 20% of the variance in SCAM belief. These predictors were:
- ontological confusions,
- spiritual epistemology,
- agreeableness,
- death anxiety,
- gender.
Approximately 21% of the variance in belief in homeopathy was explained by the following predictors:
- ontological confusions,
- illusory pattern perception,
- need for cognitive closure,
- need for cognition,
- honesty-humility,
- death anxiety,
- gender,
- age.
The authors concluded that some of the predictors from previous research replicated whereas others did not. Demographics and certain cognitive variables seem to be key determinants associated with beliefs in SCAM and homeopathy. Those individual differences and cognitive biases might result in a different perception of the world. However, variables related to abilities did not predict the beliefs. Thus, they might not be a result of inability but rather of ignorance.
Previous studies have shown that SCAM believers tend to believe in paranormal phenomena and conspiracies. I think that, in the discussion sections of this blog, we have ample evidence for this to be true. Paranormal beliefs are usually built on a magical worldview without reasoned review, which is shared by SCAM proponents. Such beliefs advocate emotional criteria for truth instead of data and logical considerations. Another belief, namely spirituality, is closely related to paranormal beliefs and religiosity and also associated with being a SCAM user. Lindeman found that SCAM belief could be best explained by intuitive reasoning, paranormal beliefs, and ontological confusions, defined as category mistakes in which properties of living and lifeless entities are mixed.
The authors point out that their results do not replicate previous findings that showed predictive value of certain cognitive variables such as cognitive style. An explanation could be that rather inattention to accuracy than the inability to consider empirical evidence fosters the beliefs. People might simply not be aware of the absence of evidence. Another possibility is that people are aware of the absence of evidence but are reluctant to engage with it. Practitioners and patients often claim “whatever works is good” or “the main thing is that it works”. Thus, it is ignorance rather than a lack of capacity to appropriately process the evidence.
The authors of this study are well aware of the limitations of their research:
“As with most cross-sectional studies using questionnaires, our results are based on self-reports. Additionally, single items were used for measuring belief strength. Even if multi-item measures often have advantages, single items can be advantageous in terms of practical benefits, e.g., adapting to subjects’ limited attention and time resources. There are several single item measures successfully used to measure diverse concepts including attitudes. Also, the variance on those items in our sample shows that participants were able to reflect their beliefs and rank them on the scale provided. Another limitation is that the findings are based on regression analyses, which do not provide insight into causality. Thus, the relationship remains correlational. Even if our sample was broader than in many other psychological studies—it was slightly unbalanced, especially in comparison to the German population. It over-represented educated individuals which may lead to an inadequate variation of the cognitive variables if we consider the relationship between cognition and education. However, education and the cognitive variables are only weakly correlated. Thus, it can be assumed that the unbalanced sample did not affect the distribution of cognitive variables to a great extent.”
I came across an article entitled “Consent for Paediatric Chiropractic Treatment (Ages 0-16)“. Naturally, it interested me. Here is the full paper; I have only inserted a few numbers in square brackets which refer to my comments below:
By law, all Chiropractors are required to inform you of the risks and benefits of chiropractic spinal manipulation and the other types of care we provide. Chiropractors use manual therapy alongside taking a thorough history, and doing a neurological, orthopaedic and chiropractic examination to both diagnose and to treat spinal, cranial and extremity dysfunction. This may include taking joints to the end range of function, palpating soft tissues (including inside the mouth and the abdomen), mobilisation, soft tissue therapy and very gentle manipulation [1]. Our Chiropractors have been educated to perform highly specific types of bony or soft tissue manipulation and we strive to follow a system of evidence-based care [2]. At the core of our belief system is “Do No Harm”. We recognise that infants and children are not tiny adults. The force of an adjustment used in a child is at least less than half of what we might use with a fully grown adult. Studies by Hawk et al (2016) and Marchand (2013) agreed that Chiropractors use 15 – 35 x less force in the under 3-month age group when compared to medical practitioners doing manipulation (Koch, 2002) [3]. We also use less force in all other paediatrics groups, especially when compared to adults (Marchand, 2013). In addition to using lower force, depth, amplitude and speed in our chiropractic adjustments [4], we utilise different techniques. We expect all children under the age of 16 years to be accompanied by a responsible adult during appointments unless prior permission to treat without a consenting adult e.g., over the age of 14 has been discussed with the treating chiropractor.
Risks
- Research into chiropractic care for children in the past 70 years has shown it to have a low risk of adverse effects (Miller, 2019) [5]. These effects tend to be mild and of short duration e.g., muscular or ligament irritation. Vorhra et al (2007) found the risk of severe of adverse effects (e.g. fracture, quadriplegia, paraplegia, and death) is very, very rare and was more likely to occur in individuals where there is already serious underlying pathology and missed diagnosis by other medical profession [6]. These particular cases occurred more than 25 years ago and is practically unheard of now since research and evidence-based care has become the norm [7].
- The most common side effect in infants following chiropractic treatment includes fussiness or irritability for the first 24 hours, and sleeping longer than usual or more soundly. (Miller and Benfield, 2008) [8]
- In older children, especially if presenting with pain e.g., in the neck or lower back, the greatest risk is that this pain may increase during examination due to increasing the length of involved muscles or ligaments [9]. Similarly, the child may also experience pain, stiffness or irritability after treatment (Miller & Benfield, 2008) [10]. Occasionally children may experience a headache.[11] We find that children experience side effects much less often than adults.[12]
Benefits
- Your child might get better with chiropractic care. [13] If they don’t, we will refer you on [14].
- Low risk of side effects and very rare risk of serious adverse effects [15].
- Drug-free health care. We are not against medication, but we do not prescribe [16].
- Compared with a medical practitioner, manual therapy carried out by a chiropractor is 20 x less likely to result in injury (Koch et al 2002, Miller 2009).[17]
- Children do not often require long courses of treatment (>3 weeks) unless complicating factors are present.[18]
- Studies have shown that parents have a high satisfaction rate with Chiropractic care [19].
- Physical therapies are much less likely to interfere with biomedical treatments. (McCann & Newell 2006) [20]
- You will have a better understanding of diagnosis of any complain and we will let you know what you can do to help.[21]
We invite you to have open discussions and communication with your treating chiropractor at all times. Should you need any further clarification please just ask.
References
- Hawk, C. Shneider, M.J., Vallone, S and Hewitt, E.G. (2016) – Best practises recommendations for chiropractic care of children: A consensus update. JMPT, 39 (3), 158-168.
- Marchand, A. (2013) – A Proposed model with possible implications for safety and technique adaptations for chiropractic spinal manipulative therapy for infants and children. JMPT, 5, 1-14
- Koch L. E., Koch, H, Graumann-Brunnt, S. Stolle, D. Ramirez, J.M., & Saternus, K.S. (2002) – Heart rate changes in response to mild mechanical irritation of the high cervical cord region in infants. Forensic Science International, 128, 168-176
- Miller J (2019) – Evidence-Based Chiropractic Care for Infants: Rational, Therapies and Outcomes. Chapter 11: Safety of Chiropractic care for Infants p111. Praeclarus Press
- Vohra, S. Johnston, B.C. Cramer, K, Humphreys, K. (2007) – Adverse events associated with paediatric spinal manipulation: A Systematic Review. Pediatrics, 119 (1) e275-283
- Miller, J and Benfield (2008) – Adverse effects of spinal manipulative therapy in children younger than 3 years: a retrospective study in a chiropractic teaching clinic. JMPT Jul-Aug;31(6):419-23.
- McCann, L.J. & Newell, S.J. (2006). Survey of paediatric complementary and alternative medicine in health and chronic disease. Archives of Diseases of Childhood, 91, 173-174
- Corso, M., Cancelliere, C. , Mior., Taylor-Vaise, A. Côté, P. (2020) – The safety of spinal manipulative therapy in children under 10 years: a rapid review. Chiropractic Manual therapy 25: 12
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- “taking joints to the end range of function” (range of motion, more likely) is arguably not “very gently”;
- “we strive to follow a system of evidence-based care”; I do not think that this is possible because pediatric chiropractic care is hardy evidence-based;
- as a generalizable statement, this seems to be not true;
- ” lower force, depth, amplitude and speed”; I am not sure that there is good evidence for that;
- research has foremost shown that there might be significant under-reporting;
- to blame the medical profession for diagnoses missed by chiropractors seems odd;
- possibly because of under-reporting;
- possibly because of under-reporting;
- possibly because of under-reporting;
- possibly because of under-reporting;
- possibly because of under-reporting;
- your impressions are not evidence;
- your child might get even better without chiropractic care;
- referral rates of chiropractors tend to be low;
- possibly because of under-reporting;
- chiropractors have no prescription rights but some lobby hard for it;
- irrelevant if we consider the intervention useless and thus obsolete;
- any evidence for this statement?;
- satisfaction rates are no substitute for real evidence;
- that does not mean they are effective, safe, or value for money;
- this is perhaps the strangest statement of them all – do chiropractors think they are the optimal diagnosticians for all complaints?
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According to its title, the paper was supposed to deal with consent for chiropractic pediatric care. It almost totally avoided the subject and certainly did not list the information chiropractors must give to parents before commencing treatment.
Considering the arguments that the article did provide has brought me to the conclusion that chiropractors who treat children are out of touch with reality and seem in danger of committing child abuse.
Social prescribing (SP) has been mentioned here several times before. It seems important to so-called alternative medicine (SCAM), as some enthusiasts – not least King Charles – are trying to use it as a means to smuggle nonsensical treatments into routine healthcare.
SP is supposed to enable healthcare professionals to link patients with non-medical interventions available in the community to address underlying socioeconomic and behavioural determinants. The question, of course, is whether it has any relevant benefits.
This systematic review included all randomised controlled trials of SP among community-dwelling adults recruited from primary care or community setting, investigating any chronic disease risk factors defined by the WHO (behavioural factors: smoking, physical inactivity, unhealthy diet and excessive alcohol consumption; metabolic factors: raised blood pressure, overweight/obesity, hyperlipidaemia and hyperglycaemia). Random effect meta-analyses were performed at two time points: completion of intervention and follow-up after trial.
The researchers identified 9 reports from 8 trials totalling 4621 participants. All studies evaluated SP exercise interventions which were highly heterogeneous regarding the content, duration, frequency and length of follow-up. The majority of studies had some concerns about the risk of bias. A meta-analysis revealed that SP likely increased physical activity (completion: mean difference (MD) 21 min/week, 95% CI 3 to 39, I2=0%; follow-up ≤12 months: MD 19 min/week, 95% CI 8 to 29, I2=0%). However, SP may not improve markers of adiposity, blood pressure, glucose and serum lipid. There were no eligible studies that primarily target unhealthy diet, smoking or excessive alcohol-drinking behaviours.
The authors concluded that SP exercise interventions probably increased physical activity slightly; however, no benefits were observed for metabolic factors. Determining whether SP is effective in modifying the determinants of chronic diseases and promotes sustainable healthy behaviours is limited by the current evidence of quantification and uncertainty, warranting further rigorous studies.
Great! Regular exercise improves physical fitness.
But do we need SP for this?
Don’t get me wrong, I have nothing against connecting patients with social networks to improve their health and quality of life. I do, however, object if SP is used to smuggle unproven or disproven SCAMs into EBM. In addition, I ask myself whether we really need the new profession of a ‘link worker’ to facilitate SP. I remember being taught that a good doctor should look after his/her patients holistically, and surely that includes mentioning and facilitating social networks for those who need them.
I, therefore, fear that SP is taking something valuable out of the hands of doctors. And the irony is that SP is favoured by those who are all too quick to turn around and say: LOOK AT HOW FRIGHTFULLY REDUCTIONIST AND HEARTLESS DOCTORS HAVE BECOME. WE NEED MORE HOLISM IN MEDICINE AND THAT CAN ONLY BE PROVIDED BY SCAM PRACTITIONERS!
In Germany, so-called alternative medicine (SCAM) is used by about 6o% of the population. The type and extent of in-patient complementary care are, however, largely unknown.
The objective of this study was, therefore, to conduct a survey on SCAM procedures in Bavarian acute care hospitals by screening the websites of all respective facilities in order to cover a broad range of SCAMs.
In 2020, an independent and comprehensive website screening of all 389 Bavarian acute hospitals, including all departments, was conducted by two independent raters. SCAMs offered were analyzed in total as well as separately by specialty.
Among all 389 Bavarian acute care hospitals, 82% offered at least one and 66% at least three different SCAMs on their website. Relaxation techniques (52%), acupuncture (44%), massage (41%), movement-, art-, and music therapy (33%, 30%, and 28%), meditative movement therapies like yoga (30%), and aromatherapy (29%) were offered most frequently. Separated by specialty, SCAMs were most common in psychiatry/psychosomatics (relaxation techniques 69%, movement and art therapy 60% each) at 87%, and in gynecology/obstetrics (most common acupuncture 64%, homeopathy 60%, and aromatherapy 41%) at 72%.
The stated areas of application of SCAM included:
- use as a stand-alone therapy (65%; n=254),
- for prevention (7%; n=27),
- as support for conventional therapy (7%; n=27)
- as preparation before drug therapy or surgery (5%; n=18).
The authors concluded that the vast majority of Bavarian acute care hospitals also seem to conduct complementary medicine procedures in therapy, especially for psychological indications and in obstetrics and gynaecology, according to the hospital websites. How often these procedures are used in inpatient or outpatient settings as well as evidence on effectiveness of the applied procedures should be investigated in further studies.
In my view, this article invites several points of criticism.
Something that irritates me regularly is the fact that much of SCAM research takes years to be published. If a given research project is important, it would seem unethical to sit on it for so long. If it is not important, it is unethical to conduct it in the first place. In the above case, we are dealing with a survey of SCAM use, and we know that SCAM use is strongly influenced by fashion which means it changes fast and frequently. I would therefore argue that data that are now three years old are of limited interest.
Another point is the lack of a definition or range of treatments included. The authors state they looked for whatever form of SCAM the websites mentioned (herbal medicine is popular in Germany, yet absent in this survey; this suggests that the survey method has created a blind spot). Yet, they include as SCAM things like massage (which in Germany is entirely mainstream), physiotherapeutic exercise (Bewegungstherapie), and biofeedback all of which are arguably conventional treatments. This means that the true prevalence figures of SCAM use are not nearly as high as they pretend.
My main criticism would be that the authors abstain from any comments about the evidence for the SCAMs they monitored. They stated that this was beyond the scope of the project. As the research was supported by the Bavarian government, it would nevertheless have been essential, in my view, to dedicate a few words about the fact that many of the SCAMs and their uses are not evidence-based.
Essentially, this survey is in the tradition of hundreds of previous SCAM prevalence surveys that show a high degree of popularity of SCAM and thus imply that
IF SCAM IS SO VERY POPULAR, IT MUST BE GOOD;
AND IF IT’S GOOD, WE MUST HAVE MORE OF IT.
PS
It is often said that SCAM researchers are relatively free of financial conflicts of interest. Let me show you the complete list of conflicts declared by the authors of this survey.
- JL: received funding for this project from the Bavarian State Ministry of Health and Care; Further research support: Steigerwald Arzneimittelwerke GmbH, Falk Foundation; TechLab, Dr. Willmar Schwabe; Repha GmbH biologic drugs; Lecture fees: Falk Foundation, Repha GmbH biologic drugs; Celgene GmbH; Dr. Willmar Schwabe; Medice Arzneimittel, Galapagos Biopharma; consultant/expert: Medizinverlage Stuttgart; Steigerwald Arzneimittelwerke GmbH; Repha GmbH; Ferring Arzneimittel GmbH; Dr. Willmar Schwabe
- TK: received funding for this project from the Bavarian State Ministry of Health and Care, beyond that there are no other conflicts of interest
- CL: Lecture fees: Celgene GmbH, Roche GmbH, Novartis Pharma GmbH, BMS GmbH & Co. KGaA, Mundipharma GmbH Co. KG, Merck KGaA.
