medical ethics
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.
An article about chiropractic caught my attention. Let me show you its final section which, I think, is relevant to what we often discuss on this blog:
If chiropractic treatment is unscientific, then why do I feel better? Because lots of things alleviate pain. Massage, analgesia and heat – but also a provider who listens, empathises and bothers to examine a patient. Then there is the placebo effect. For centuries, doctors have recognised that different interventions with unclear pathways result in clinical improvement. Among the benefits patients attributed to placebo 100 years ago: “I sleep better; my appetite is improved; my breathing is better; I can walk further without pain in my chest; my nerves are steadier.” Nothing has changed. Pain is a universal assignment; no one has a monopoly on its relief.
The chiropractic industry owes its existence to a ghost. Its founder, David Palmer, wrote in his memoir The Chiropractor that the principles of spinal manipulation were passed on to him during a séance by a doctor who had been dead for half a century. Before this, Palmer was a “magnetic healer”.
Today, chiropractors preside over a multibillion-dollar regulated industry that draws patients for various reasons. Some can’t find or afford a doctor, feel dismissed, or worse, mistreated. Others mistrust the medical establishment and big pharma. Still others want natural healing. But none of these reasons justifies conflating a chiropractor with a doctor. The conflation feels especially hazardous in an environment of health illiteracy, where the mere title of doctor confers upon its bearer strong legitimacy.
Chiropractors don’t have the same training as doctors. They cannot issue prescriptions or order advanced imaging. They do not undergo lifelong peer review or open themselves to monthly morbidity audits.
I know that doctors could do with a dose of humility, but I can’t find any evidence (or the need) for the assertion on one website that chiropractors are “academic overachievers”. Or the ambit claim that most health professionals have no idea how complicated the brain is, but chiropractors do.
Forget doctors, patients deserve more respect.
My friend’s back feels better for now. When it flares, I wonder if she will seek my advice – and I am prepared to hear no. Everyone is entitled to see a chiropractor. But no patient should visit a chiropractor thinking that they are seeing a doctor.
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I would put it more bluntly:
- chiropractors are poorly trained; in particular, they do not learn to question their own, often ridiculous beliefs;
- they are poorly regulated; in the UK, the GCC seems to protect the chiros rather than the public;
- chiropractors regularly disregard essential rules of medical ethics, e.g. informed consent;
- many try to mislead us by pretending they are physicians;
- their hallmark intervention, spinal manipulation, can cause considerable harm;
- it generates hardly any demonstrable benefit for any condition;
- chiropractors also cause considerable harm, e.g. by interfering with real medicine, e.g. vaccinations;
- thus, in general, chiropractors do more harm than good;
- yes, everyone is entitled to see a chiropractor, but before they do, reliable information should be mandatory.
The Amercian Medical Association (AMA) recently published a lengthy article on naturopathy in the US. Here are some excerpts:
There are three types of health professionals who offer naturopathic treatment:
- Naturopathic doctors. These nonphysicians graduate from a four-year, professional-level program at an accredited naturopathic medical school, earning either the doctor of naturopathy (ND) degree or the doctor of naturopathic medicine (NMD) degree.
- Traditional naturopaths, who have obtained education through some combination of a mentorship program with another professional or at an alternative clinic, distance-learning program or classroom schooling on natural health, or other holistic studies.
- Other health professionals such as chiropractors, massage therapists, dentists, nurses, nutritionists, or physicians who practice under a professional license but include some naturopathic methods in their practice and who may have studied on their own or taken courses on naturopathic methods.
At least 24 states and the District of Columbia regulate the practice of naturopathy. In order to be licensed, naturopaths in these states must earn an ND or NMD from an accredited naturopathic program and pass the Naturopathic Physicians Licensing Exam. Three states—Florida, South Carolina and Tennessee—prohibit the practice of naturopathy. In states that neither license nor prohibit the practice of naturopathy, traditional naturopaths and NDs alike may practice without being subject to state regulation.
Postgraduate training is neither common nor required of graduates of naturopathic schools, except in Utah … less than 10% of naturopaths participate in an approved residency, and such residencies last only a year and lack a high degree of standardization.
… naturopaths are required to get at least 1,200 hours of direct patient contact, physicians get 12,000–16,000 hours of clinical training…
ND programs emphasize naturopathic principes—for example, the healing power of nature—and naturopathic therapeutics such as botanical medicine, homeopoathy and hydrotherapy. Coursework in naturopathic therapeutics is combined with, and taught alongside, coursework in sciences. But there are no specifications around the number of hours required in each area … naturopathic students may lack exposure to key clinical scenarios in the course of their training … naturopathic students’ clinical experience is typically gained through outpatient health care clinics, as naturopathic medical schools typically do not have significant hospital affiliation. This means there is no guarantee that a naturopathic student completing a clinical rotation will see patients who are actually sick or hospitalized, and they may not be exposed to infants, children, adolescents or the elderly. It has been said that naturopaths tend to treat the “worried well.”
… Naturopaths claim they are trained as primary care providers and, as such, are educated and trained to diagnose, manage and treat many conditions, including bloodstream infections, heart disease and autoimmune disorders. Yet their education and training falls several years and thousands of hours short of what physicians get.
…The AMA believes it is the responsibility of policymakers to ensure that naturopaths’ claims that they can treat a broad range of conditions are backed by facts—facts that include the specific education and training necessary to ensure patient safety.
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The AMA is clearly cautious here. A less polite statement might simply stress that naturopaths are taught a lot of nonsense which they later tend to administer to their unsuspecting patients. On this blog, we have repeatedly discussed the danger naturopaths present to public health in the US and elsewhere, e.g.:
- How reliable are the claims made by naturopathic influencers?
- Naturopath jailed for selling fraudulent vaccination documents
- Naturopath fined for misdiagnosing and treating a rectal tumor for hemorrhoids
- Naturopaths are ‘not bound by science,’ lawyer argues
- Vaccination rates of Canadian healthcare professionals: those of chiropractors and naturopaths are at the lowest
- Is veterinary naturopathy animal abuse?
- Naturopathic ‘cancer specialist’ using coffee enemas found guilty
- Patients consulting chiropractors, homeopaths, or naturopaths are less likely to agree to the flu jab
- A naturopath responsible for the death of two cancer patients was sentenced to two years
- A naturopath in court after two of his cancer patients died
- Many naturopaths, homeopaths, and chiropractors are a risk to public health
- Naturopath treats autism with fecal transplants
- A naturopath promoting fake news about COVID vaccinations
- Naturopathy (according to the WNF) = quackery steeped in obsolete fantasies
- Canadian naturopaths may no longer call themselves ‘medically trained’
- Naturopaths’ counselling against vaccinations could be criminally negligent
- Naturopathy for cancer … claims that have the potential to be lethal
- Severe liver injury due to naturopaths’ prescription of Epsom salt
- Naturopaths should not treat children
- Some naturopaths are clearly a danger to public health
- Death of a child through naturopathy
Claims that naturopaths are a viable alternative to evidence-based medicine are wrong, irresponsible and dangerous. Regulators must be reminded that they have the duty to protect the public from charlatans and should therefore ensure that no false therapeutic or diagnostic claims can be made by naturopaths.
Looking at some ancient papers of mine, I came across a short BMJ paper from 1994. Here is a passage from it:
… A standard letter (on departmental letterhead) was written (in German) to all 189 firms that we identified as marketing herbal drugs in Germany. It asked (among other questions) for reprints of articles reporting controlled clinical trials on the company’s product(s).
Only 19 replies had reached us six weeks later. Four of these included at least one reprint. Twelve respondents regretted not knowing of clinical trials on their drug(s). In three cases we had written to a wrong address (one
instance) or to a firm which did not market phytomedicines (two instances).
These data, though far from conclusive, do not give the impression that research is in proportion to either prevalence or financial tumover of herbal remedies…
I wonder what the results would be, if we repeated this little excercise today, 30 years afteer the original investigation. I fear that the findings would be much the same or perhaps even worse. I also suspect that they would be similar regardless of the country we chose. Those who sell herbal remedies have very little incentive to do expensive clinical trials to test whether the products they earn their money with actually work. They may be doing well without it and ask themselves, why spend money on research that might not show what we hope and could easily turn out to jeopardize our financial success?
But the problem is by no means confined to herbal manufacturers (who would arguably have an important share to initiate and sponsor research). Even though fundamental questions remain unanswered, research into herbal medicine is scarce across the board.
To see whether this statement is true, I did a very quick Medline search. It showed that, in 2023, just over 13 000 papers on herbal medicine emerged. Of those, just 460 were listed as clinical trials. The latter figure is almost certainly considerably smaller than the true amount because Medline is over-generous in classifying papers as clinical trials. I thus estimate that only around 200 clinical trials of herbal medicine are conducted each year. Considering that we are dealing with thousands of herbs and ten thousands of herbal products, this figure is an embarrassment for the sector – which, as we have seen just days ago, is doing extremely well in finacial terms.
Dry needling is a therapy that is akin to acupuncture and trigger point therapy. It is claimed to be safe – but is this true?
Researchers from Ghent presented a series of 4 women aged 28 to 35 who were seen at the emergency department (ED) with post-dry needling pneumothorax between September 2022 and December 2023. None of the patients had any relevant medical history. All had been treated for a painful left shoulder, trapezius muscle or neck region in outpatient physiotherapist practices. At least three different physiotherapists were involved.
One patient presented to the ER on the same day as the dry needling procedure, the others presented the day after. All mentioned thoracic pain and dyspnoea. Clinical examination in all of these patients was unremarkable, as were their vital signs. Diagnosis was confirmed with ultrasound (US) and chest X-ray (CXR) in all patients. The latter exam showed left-sided apical pleural detachment with a median of 3.65 cm in expiration.
Two patients were managed conservatively. One patient (initial pneumothorax 2.5 cm) was discharged. The US two days later displayed a normally expanded lung. One patient with an initial apical size of 2.8 cm was admitted with 2 litres of oxygen through a nasal canula and discharged from the hospital the next day after US had shown no increase in size. Her control CXR 4 days later showed only minimal pleural detachment measuring 6 mm. The two other patients were treated with US guided needle aspiration. One patient with detachment initially being 4.5 cm showed decreased size of the pneumothorax immediately after aspiration. She was admitted to the respiratory medicine ward and discharged the next day. Control US and CXR after 1 week showed no more signs of pneumothorax. In the other patient, with detachment initially being 5.5 cm, needle aspiration resulted in complete deployment on US immediately after the procedure, but control CXR showed a totally collapsed lung 3 hours later. A small bore chest drain was placed but persistent air leakage was seen. Several trials of clamping the drain resulted in recurrent collapsing of the lung. After CT-scan had shown no structural deformities of the lung, suction was gradually reduced and the drain was successfully removed on the sixth day after placement. The patient was then discharged home. Control CXR 3 weeks later was normal.
The authors concluded that post-dry needling pneumothorax is, contrary to numbers cited in literature, not extremely rare. With rising popularity of the technique we expect complications to occur more often. Patients and referring doctors should be aware of this. In their informed consent practitioners should mention pneumothorax as a considerable risk of dry needling procedures in the neck, shoulder or chest region.
The crucial question, in my view, is this: do the risks of dry-needling out weigh the risks of this form of therapy? Let’s have a look at some of the recent evidence that we discussed on this blog:
- Spinal Manipulation and Electrical Dry Needling for Subacromial Pain Syndrome: A Nonsensical Trial
- Dry needling is useless for rehabilitation after shoulder surgery
- High velocity, low amplitude techniques are not superior to no treatment in the management of tension-type headache
- Which treatments are best for acute and subacute mechanical non-specific low back pain? A systematic review with network meta-analysis
- Acupuncture for chronic pain: the new NICE guideline
- Acupuncture for the Relief of Chronic Pain? A new, thorough synthesis fails to produce strong evidence that acupuncture works
The evidence is clearly mixed and unconvincing. I am not sure whether it is strong enough to afford a positive risk/benefit balance. In other words: dry needling is a therapy that might best be avoided.
According to its authors, this study‘s objective was to demonstrate that acupuncture is beneficial for decreasing the risk of ischaemic stroke in patients with rheumatoid arthritis (RA).
The investigation was designed as a propensity score-matched cohort nationwide population-based study. Patients with RA diagnosed between 1 January 1997 and 31 December 2010, through the National Health Insurance Research Database in Taiwan. Patients who were administered acupuncture therapy from the initial date of RA diagnosis to 31 December 2010 were included in the acupuncture cohort. Patients who did not receive acupuncture treatment during the same time interval constituted the no-acupuncture cohort. A Cox regression model was used to adjust for age, sex, comorbidities, and types of drugs used. The researchers compared the subhazard ratios (SHRs) of ischaemic stroke between these two cohorts through competing-risks regression models.
After 1:1 propensity score matching, a total of 23 226 patients with newly diagnosed RA were equally subgrouped into acupuncture cohort or no-acupuncture cohort according to their use of acupuncture. The basic characteristics of these patients were similar. A lower cumulative incidence of ischaemic stroke was found in the acupuncture cohort (log-rank test, p<0.001; immortal time (period from initial diagnosis of RA to index date) 1065 days; mean number of acupuncture visits 9.83. In the end, 341 patients in the acupuncture cohort (5.95 per 1000 person-years) and 605 patients in the no-acupuncture cohort (12.4 per 1000 person-years) experienced ischaemic stroke (adjusted SHR 0.57, 95% CI 0.50 to 0.65). The advantage of lowering ischaemic stroke incidence through acupuncture therapy in RA patients was independent of sex, age, types of drugs used, and comorbidities.
The authors concluded that this study showed the beneficial effect of acupuncture in reducing the incidence of ischaemic stroke in patients with RA.
It seems obvious that the editors of ‘BMJ Open’, the peer reviewers of the study and the authors are unaware of the fact that the objective of such an investigeation is not to to demonstrate that acupuncture is beneficial but to test whether acupuncture is beneficial. Starting a study with the intention to to show that my pet therapy works is akin to saying: “I am intending to mislead you about the value of my intervention”.
One needs therefore not be surprised that the authors of the present study draw very definitive conclusions, such as “acupuncture therapy is beneficial for ischaemic stroke prevention”. But every 1st year medical or science student should know that correlation is not the same as causation. What the study does, in fact, show is an association between acupuncture and stroke. This association might be due to dozens of factors that the ‘propensity score matching’ could not control. To conclude that the results prove a cause effect relationship is naive bordering on scientific misconduct. I find it most disappointing that such a paper can pass all the hurdles to get published in what pretends to be a respectable journal.
Personally, I intend to use this study as a good example for drawing the wrong conclusions on seemingly rigorous research.
An article entitled “Homeopathy for worm infestations in children’s” caught my eye. Here is the un altered abstract:
Unusual sorts of worms can be there in a child’s stomach and may initiate several health complications such as pain, infection etc. To treat worm infections, one must identify about various categories of worms, and after understanding the kind of infection induced by the worm’s the treatment for the babies or children can planned. There are various Homeopathic medicines available which be used to treat worm infections without any side effects on the health of the children’s. In this paper we have discussed how the worm infection has been treated at our homeopathic research institute.
In the paper itself, the author, Dr. AK Dwivedi (Professor and H.O.D, Department of Physiology and Biochemistry, SKRP Guajarati Medical College, Indore, Madhya Pradesh, India), explains:
Homeopathic do not take care of just the disease, but is prescribed on the base of physical, emotional and genetic condition of a person. Homeopathic medicines act on both the mental and physical levels of individuals. Homeopathy is a natural and mild system of medicines that utilizes minute doses of well-researched remedies to improve the body’s natural curing procedure. Homeopathic medicines originate from substances that come’s from plants, minerals & animals.
The author’s conclusion is equally impressive:
On the basis of our research and after analysing the patients after medication we have found that homeopathy can completely cure the worm infection, If the dosages are properly prescribed and taken on that basis of investigation reports from time to time under guidance of experienced Homeopathic Physician worm infection can be treated with homeopathy effectively.
Yes, this level of incompetence could be quite funny! But sadly, it is also quite concerning. Most worm infestations are easily treated with effective conventional therapies. Untreated, they can have serious consequences. To advocate homeopathy – which is of course ineffective – is irresponsible, unethical and arguably criminal, in my view.
There are many variations of acupuncture. Electroacupuncture (EA) and Laseracupuncture (LA) are but two examples both of which are commonly used. However, it remains uncertain whether LA is as effective as EA. This study aimed to compare EA and LA head to head in dysmenorrhea.
A crossover, randomized clinical trial was conducted. EA or LA was applied to selected acupuncture points. Participants were randomized into two sequence treatment groups who received either EA or LA twice per week in luteal phase for 3 months followed by 2-month washout, then shifted to other groups (sequence 1: EA > LA; sequence 2: LA > EA). Outcome measures were heart rate variability (HRV), prostaglandins (PGs), pain, and quality-of-life (QoL) assessment (QoL-SF12). We also compared the effect of EA and LA in low and high LF/HF (low frequency/high frequency) status.
43 participants completed all treatments. Both EA and LA significantly improved HRV activity and were effective in reducing pain (Visual Analog Scale [VAS]; EA: p < 0.001 and LA: p = 0.010) and improving QoL (SF12: EA: p < 0.001, LA, p = 0.017); although without intergroup difference. EA reduced PGs significantly (p < 0.001; δ p = 0.068). In low LF/HF, EA had stronger effects than LA in increasing parasympathetic tone in respect of percentage of successive RR intervals that differ by more than 50 ms (pNN50; p = 0.053) and very low-frequency band (VLF; p = 0.035).
The authors concluded that there is no significant difference between EA and LA in improving autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea. EA is prominent in PGs changing and preserving vagus tone in low LF/HF; yet LA is noninvasive for those who have needle phobia. Whether LA is equivalent with EA and the mechanism warrants further study.
Looking at the affiliations of the authors, one might expect that they should be able to design a meaningful study:
- 1Division of Hemato-Oncology, Department of Internal Medicine, Branch of Zhong-Zhou, Taipei City Hospital, Taipei, Taiwan.
- 2Institute of Traditional Medicine, National Yang-Ming Chiao Tung University, Taipei, Taiwan.
- 3Department of Traditional Medicine, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.
- 4Department of Traditional Medicine, Branch of Kunming, Taipei City Hospital, Taipei, Taiwan.
- 5Department of Gynecology and Obstetrics, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.
Sadly, this assumption is evidently mistaken.
The trial certainly does not show what they claim and neither had it ever the chance to show anything relevent. A clinical trial is comparable to a mathematical equation. It can be solved, if it has one unkown; it cannot produce a result, if it has two unknowns.
The efficacy of EA and LA for dysmenorrhea are both unknown. A comparative study with two unknowns cannot produce a meaningful result. EA and LA did not both improve autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea but most likely they both had no effect. What caused the improvement was not the treatment per se but the ritual, the placebo effect, the TLC or other non-specific factors. The maginal differences in other parameters are meaningless; they are due to the fact that – as an equivalence trial – the study was woefully underpowered and thus open to coincidental differences.
Clinical trials should be about contributing to our knowledge and not about contributing to confusion.
Here is the abstract of a recent article that I find worrying:
In 2020, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) challenged the world with a global outbreak that led to millions of deaths worldwide. Coronavirus disease 2019 (COVID-19) is the symptomatic manifestation of this virus, which can range from flu-like symptoms to utter clinical complications and even death. Since there was no clear medicine that could tackle this infection or lower its complications with minimal adverse effects on the patients’ health, the world health organization (WHO) developed awareness programs to lower the infection rate and limit the fast spread of this virus. Although vaccines have been developed as preventative tools, people still prefer going back to traditional herbal medicine, which provides remarkable health benefits that can either prevent the viral infection or limit the progression of severe symptoms through different mechanistic pathways with relatively insignificant side effects. This comprehensive review provides scientific evidence elucidating the effect of 10 different plants against SARS-CoV-2, paving the way for further studies to reconsider plant-based extracts, rich in bioactive compounds, into more advanced clinical assessments in order to identify their impact on patients suffering from COVID-19.
The conclusions of this paper read as follows:
…since these 10 herbs hold distinct bioactive compounds with significant properties in vitro and with remarkable benefits to human health, it is possible to prevent SARS-CoV-2 infection and reduce its symptomatic manifestations by consuming any of these 10 plants according to the recommended dose. The diversity in bioactive molecules between the different plants exerts various effects through different mechanisms at once, which makes it more potent than conventional synthetic drugs. Nonetheless, more studies are needed to highlight the clinical efficacy of these extracts and spot their possible side effects on patients, especially those with comorbidities who take multiple conventional drugs.
I should point out that the authors fail to offer a single reliable trial that would prove or even imply that any of the 10 herbal remedies can effectively treat or prevent COVID infections (to the best of my knowledge, no such studies exist). Laguage like “it is possible to prevent SARS-CoV-2 infection and reduce its symptomatic manifestations” is therefore not just misleading but highly dangerous and deeply unethical. Sadly, such evidence-free claims abound in herbal medicine.
I think the journal editor, the peer-reviewer, the authors and their universities ( University of Tripoli in Lebanon, American University of the Middle East, Egaila in Kuwait, University of Balamand, Kalhat, Tripoli in Lebanon, Lebanese University, Tripoli in Lebanon, Aix-Marseille Université in France) should be ashamed to produce such dangerous rubbish.
Traditional herbal medicine (THM) is frequently used in pediatric populations. This is perticularly true in many low-income countries. Yet THM has been associated with a range of adverse events, including liver toxicity, renal failure, and allergic reactions. Despite these concerns, its impact on multi-organ dysfunction syndrome (MODS) risk has so far not been thoroughly investigated.
This study aimed to investigate the incidence and predictors of MODS in a pediatric intensive care unit (PICU) in Ethiopia, with a focus on the association between THM use and the risk of MODS. It was designed as a single-center prospective cohort study conducted at a PICU in the university of Gondar Comprehensive Specialized hospital, Northwest Ethiopia. The researchers enrolled eligible patients aged one month to 18 years admitted to the PICU during the study period. Data on demographic characteristics, medical history, clinical and laboratory data, and outcome measures using standard case record forms, physical examination, and patient document reviews. The predictors of MODS were assessed using Cox proportional hazards models, with a focus on the association between traditional herbal medicine use and the risk of MODS.
A total of 310 patients were included in the final analysis, with a median age of 48 months and a male-to-female ratio of 1.5:1. The proportion and incidence of MODS were 30.96% (95% CI:25.8, 36.6) and 7.71(95% CI: 6.10, 9.40) per 100-person-day observation respectively. Renal failure (17.74%), neurologic failure (15.16%), and heart failure (14.52%) were the leading organ failures identified. Nearly one-third of patients (32.9%) died in the PICU, of which 59.8% had MODS. The rate of mortality was higher in patients with MODS than in those without. The Cox proportional hazards model identified renal disease (AHR = 6.32 (95%CI: 3.17,12.61)), intake of traditional herbal medication (AHR = 2.45, 95% CI:1.29,4.65), modified Pediatric Index of Mortality 2 (mPIM 2) score (AHR = 1.54 (95% CI: 1.38,1.71), and critical illness diagnoses (AHR = 2.68 (95% CI: 1.77,4.07)) as predictors of MODS.
The authors concluded that the incidence of MODS was high. Renal disease, THM use, mPIM 2 scores, and critical illness diagnoses were independent predictors of MODS. A more than twofold increase in the risk of MODS was seen in patients who used TMH. Healthcare providers should be aware of risks associated with THM, and educate caregivers about the potential harms of these products. Future studies with larger sample sizes and more comprehensive outcome measures are needed.
I do fully agree with the authors about the high usage of herbal and other so-called alternative medicines by children. We have shown that, in the UK the average one-year prevalence rate was 34% and the average lifetime prevalence was 42%. We have furthermore shown that the evidence base for these treatments in children is weak, even more so than for general populations. Finally, we can confirm that adverse effects are far from rare and often serious.
It is therefore high time, I think, that national regulators do more to protect children from SCAM practitioners who are at best uncritical about their treatments and at worse outright dangerous.
