MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

children

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Osteopathic manipulative treatment (OMT) is advocated not merely for spinal or musculoskeletal problems, as many consumers seem to think, osteopaths also claim it to be effective for (almost) every condition. Some osteopaths who believe in the gospel of Andrew Still, the founder of osteopathy, recommend it even to facilitate breastfeeding.

But is it effective? 

A double-blind randomised controlled trial to answer this question was conducted between July 2013 and March 2016. Breastfed term infants were eligible if one of the following criteria was met: suboptimal breastfeeding behaviour, maternal cracked nipples or maternal pain. The infants were randomly assigned to the intervention or the control group. The intervention consisted of two sessions of early OMT, while in the control group, the manipulations were performed on a doll behind a screen. The primary outcome was the exclusive breastfeeding rate at 1 month, which was assessed in an intention-to-treat analysis. Randomisation was computer generated and only accessible to the osteopath practitioner. The parents, research assistants and paediatricians were masked to group assignment.

One hundred twenty-eight mother-infant dyads were randomised, with 64 assigned to each group. In each group, five infants were lost to follow-up. In the intervention group, 31 of 59 (53%) of infants were still exclusively breastfed at 1 month vs 39 of 59 (66%) in the control group, (OR 0.55, 95% CI 0.26 to 1.17; p=0.12). After adjustment for suboptimal breastfeeding behaviour, caesarean section, use of supplements and breast shields, the adjusted OR was 0.44 (95% CI 0.17 to 1.11; p=0.08). No adverse effects were reported in either group.

The authors concluded succinctly that OMT did not improve exclusive breastfeeding at 1 month.

Surprised?

Suppose not!

The only question that I can think of is this: why did osteopaths ever think that OMT might facilitate breastfeeding?

Aromatherapy, the use of essential oils for medicinal purposes, exists in several guises. One of them is inhalation aromatherapy which is a complementary therapy used in different clinical settings. But is there any sound evidence about its effectiveness?

The aim of this review was to assess the effectiveness of inhalational aromatherapy in the care of hospitalized pediatric patients.

A systematic review of clinical trials and quasi-experimental studies was conducted, based on PRISMA recommendations, searching Medline, Web of ScienceScopus, SciELO, LILACS, CINAHLScience Direct, EBSCO, and updated databases. The Down and Black 2020, RoB 2020 CLARITY, and ROBINS-I 2020 scales were used through the Distiller SR software to verify the studies’ internal validity and risk of bias.

From 446 articles identified, 9 fulfilled the inclusion criteria. Seven were randomized controlled trials (RCTs), one pilot RCT, and one non-randomized quasi-experimental trial.

Different outcomes were analyzed, with pain being the most frequently measured variable. None of the 6 studies that evaluated pain showed significant effects with inhalation aromatherapy. Additionally, non-significant effects were found regarding nausea, vomiting, and behavioral/emotional variables.

The authors concluded that the findings are still inconclusive, and more evidence is required from future studies with high methodological quality, blinding, and adequate sample sizes.

Inconclusive?

Really?

Call me a skeptic, but I think the findings show quite clearly that there is no sound evidence to suggest that inhalation aromatherapy might be effective for kids.

Steiner (Waldorf) schools, like anthroposophical medicine, are the inventions of Rudolf Steiner. His followers have often been associated with rampant anti-vax sentiments. Yet, officially such beliefs are usually denied.

A few days ago, I came across this tweet:

Der Dachverband der anthroposophischen Medizin begrüßt Corona-Impfungen… & distanziert sich von Querdenken und Co. Steiner war selbst gegen Pocken geimpft und ließ impfen. 

As it is in German, allow me to translate it for you:

The umbrella organization of anthroposophical medicine welcomes corona vaccinations… & distances itself from lateral thinking and co. Steiner himself was vaccinated against smallpox and had it vaccinated.

Almost simultaneously, it was reported that, after the Corona outbreak at a Freiburg Steiner school with more than 100 people infected, it is now certain: the certificates presented to the school for exemption from wearing masks were invalid.

During circus performances at the Steiner school in Freiburg, more than 100 people had become infected with the coronavirus in October: among them pupils, teachers, and contact persons. Therefore, the school inspectorate of the Freiburg Regional Council examined the certificates that freed people from the obligation to wear masks at school for health reasons. Heike Spannagel, a spokeswoman for the Freiburg Regional Council, called the results surprising. There were 55 certificates, 52 from pupils and three from teachers – and all of them were invalid. Heike Spannagel added that the school will no longer recognize any of the certificates. Those who cannot present new certificates that are more convincing will therefore have to wear the mask, Spannagel said.

It was noticeable that many certificates came from (far remote) private clinics in Bavaria or Berlin. In addition, a Freiburg doctor had exempted pupils from the obligation to wear a mask with identical justifications. According to the regional council, however, justifications must be individually tailored. In the meantime, the public prosecutor’s office in Freiburg has requested documents from the regional council in order to initiate an investigation.

So, what has been going on?

To me, it looks like the Steiner school was tolerating or even encouraging the use of dodgy certificates. This contrasts somewhat with the tweet cited above. And, in turn, this seems to indicate that proponents of anthroposophy say one thing about COVID and then do something entirely different. This suspicion was strengthened by a tweet that appeared a little while later as a response to the tweet cited above:

Alle Anhänger der Anthroposophie, die ich kenne, sind nicht geimpft. Es ist ja schön, wenn diese Verbände das öffentlich so verkünden. Die Praxis sieht leider anders aus.

Allow me to translate again:

All the followers of anthroposophy that I know are not vaccinated. It is nice when these associations proclaim this publicly. Unfortunately, the practice looks different.

Germany seems to have a significant problem with anti-vaxxers. Today, only 68% of the population has had a COVID vaccination. In the UK and France, these figures are 72% and 75% respectively.

How come?

This study investigated the willingness to vaccinate of parents of minors and people without children who are minors. The investigation was based on a random sample of Germans (telephone survey, n = 2,014, collected between 12 November and 10 December 2020). The evaluation is primarily based on the sub-sample of people with minors in the household (n = 461).

Parents of minors consistently show a lower willingness to be vaccinated with a COVID-19 vaccine than respondents without minors (54.1% vs 71.1%). Fathers show a stronger willingness to be vaccinated than mothers. Furthermore, men are more willing to get their own child vaccinated with a COVID-19 vaccine than are women.

The authors concluded that among parents and especially mothers, a considerable misrepresentation of vaccination risks and frequent beliefs in vaccination conspiracy theories can be observed. Clear and easily understandable information on the effects and side effects of vaccination with a COVID-19 vaccine by relevant institutions and physicians is recommended.

And what has this to do with so-called alternative medicine (SCAM) and homeopathy?

In the results section of the paper, the authors report interesting  additional findings (my translation):

In the total sample, a significantly higher willingness to vaccinate is associated with the rejection of “alternative healing methods”. There is also a significant correlation between the attitude towards homeopathy and one’s own willingness to vaccinate: if homeopathy is supported, the willingness to vaccinate is lower. This correlation between the attitude towards homeopathy and willingness to vaccinate is also evident in the sub-sample of parents. Among parents, it is again women who significantly more often have a positive attitude towards homeopathy than men, who more often do not think anything of it.

The authors also report that the parents were asked: “If a vaccine against the coronavirus is approved in Germany, would you get vaccinated?” CERTAINLY NOT was the answer of:

  • 41% of homeopathy fans
  • 10% of people who thought nothing at all about homeopathy
  • 15% of participants who were not fully convinced by homeopathy

Yes, Germany seems to have a problem with the anti-vaccination brigade but it seems that at the heart of it is a problem with a homeopathy cult.

 

We have covered urine therapy several times already (see for instance here, and here). Essentially it is ineffective but harmless …

except…

CTV reported that a mother in Canada has temporarily lost her right to unsupervised parenting over allegations she made her young son drink his own urine as part of a controversial so-called alternative medicine (SCAM). Specifically, she had fed the eight-year-old boy smoothies made with his own urine.

Apparently, the mother began pursuing a fringe “natural and holistic” lifestyle about three years ago. “It has created significant distrust by the (father) as to the respondent’s judgment in ensuring that the child is safe in her care, which came to a head when the allegation that she was imposing urine therapy on the child arose,” the judge wrote.

The mom’s interest in alternative medicine previously resulted in her seeking unsupported remedies such as homeopathy to treat her breast cancer – all of which failed, ultimately leaving her with no choice but to undergo surgery. Eventually, that inclination also brought her to urine therapy, described in the decision as “a centuries-old practice of drinking one’s own urine and massaging it into one’s skin.”

The mother admitted in court that she started drinking her own urine last January, and even that she appeared on an obscure podcast called “Healing Powers of Urine Therapy,” but denied forcing her son to take part in the practice. The father recounted an after-school incident in which the child approached him looking confused and guilty and said, “I have a secret, you have to promise me not to tell mom. Mom made me pee in a jar, then she put the pee into my fruit smoothie.” The boy later repeated the allegations during an appointment alone with their family doctor. The child said he “didn’t want to do it, told his mom he didn’t want to but she encouraged him to.”

There were also concerns raised about the mother’s fasting, which the father said went on for days on end and left her physically incapable of caring for their son. The judge wasn’t convinced that foregoing food left the mom unable to parent, but ultimately said she agreed with the father’s assessment that, while his former partner loves their son, her “judgment and health are questionable at this time.” The judge ruled that the mother can have parenting time from Sunday mornings to Wednesday evenings, but only with supervision from a professional or a third party agreed upon by both parents.

_________________

The case shows that, once a gullible consumer falls under the influence of the SCAM cult and goes ‘off the rails’, there are no limits. This woman started by treating her cancer with homeopathy and, even though this was not successful, she continued to slide down the slippery SCAM slope until, finally, she experimented with urine therapy on her own son. This indicates to me that we might have to add another risk to the many dangers of homeopathy: it can serve as a gateway drug for all sorts of other SCAMs.

I was alerted the these Chiropractic Paediatric Courses. After studying the material, I was truly stunned. Now that I have recovered, I feel I should share it with you:

Chiropaeds Australia is an approved and accredited provider of the Diplomate of Australian College of Chiropractic Paediatrics program.

Diplomate of Australian College of Chiropractic Paediatrics Offered for the first time in 2013, the Diplomate program is a two-year chiropractic paediatric course. This course is ideal for the family chiropractor wanting to improve his or her knowledge in chiropractic paediatrics. The emphasis is on conditions and management issues which are commonly seen by the family chiropractor.

The course is structured around 20 four-week modules over two years. Each module consists of required reading, exercises and at the end of each four-week module there is a six-hour seminar. Each six-hour seminar will reinforce the reading and develop the practical and management skills needed to feel confident in providing optimal chiropractic care for children…

Registration post 31 December – $AUD 6050 (includes GST) This covers the cost of all materials and seminars but does not include any books or texts you may decide to purchase.

To provide you with an impression of the content of the modules, I have chosen three of them. Here they are:

Module 7

Neurological assessment of the infant
1. Neurological examination of the infant (Infanib)
2. Motor issues: diagnosis and chiropractic management
a. Gross motor developmental delay
b. Hyper/ hypotonia
c. Cerebral palsy
It is only by knowing how to assess the infant’s neurological system that you can start to fully appreciate and understand the immense impact of the subluxation. The information covered in this module allows you to demonstrate to your parents the impact the subluxation has on their infant’s nervous system. As a result your subluxation diagnosis, treatment and management with infants will be enhanced. We look at muscle function issues which occur in this age group with particular emphasis on gross motor developmental delay and hyper/hypotonia.

Module 8
Neurological assessment of the pre-schooler and the school aged child
1. Gross motor function
2. Fine motor function
3. Cerebellar function
4. Assessment of higher cognitive functions
5. Visual processing
6. Auditory processing
7. Language development
Syndrome management
1. Auditory processing syndromes
2. Visual processing syndromes
Chiropractic has a major role to play in treating and managing children with learning difficulties. Crucial to optimal outcomes is an ability to fully assess and determine the particular issues and neurological problems your patient experiences. This module is very practical: you will learn how to accurately test cortical and cerebellar function in preschool and school aged children to a very advanced level. Being able to perform extensive testing of learning ability in children will assist you to accurately find and monitor their learning difficulties. The interplay of higher cortical function, cerebellar function and the subluxation is explored and the impact of your consultation assessment routine on the subluxation is addressed. Management of learning difficulties is emphasised.

Module 11
The child’s ear, nose and throat
1. Acute otitis media
2. Chronic otitis media
3. Serous otitis media
4. Nose and throat issues with children
5. Tonsillitis, epiglottitis, coup and neck abscesses
Chiropractors have a key role to play in the treatment and management of otitis media along with other conditions associated with recurrent viral infection as well as decreased or imbalanced immune system function. We cover the diagnosis of each condition along with chiropractic treatment and management, including the interaction of the subluxation and the immune system. Nutritional management is also covered. Key management issues are explored and literature based knowledge is provided to allow you to educate you patient’s parents. This fosters improved compliance with your care and permits you to expand the boundaries of your chiropractic care of children.

____________________________________

I wonder whether some chiropractor feels like defending this outright charlatanry.

I know of no evidence to assume that chiropractors can provide effective care for children. I see, however, many reasons to fear that they may cause considerable harm. I also see no reason to take a profession seriously that tolerates or even supports such extreme quackery.

I have expressed these concerns often enough, e.g.:

In my view, it is high time to stop this dangerous nonsense.

Prof Harald Walach has had a few rough weeks. First, he published his paper suggesting that Covid vaccinations do more harm than good which was subsequently retracted as flawed, if not fraudulent. Next, he published a paper showing that children are put in danger when wearing face masks suggesting that “decision-makers weigh the hard evidence produced by these experimental measurements accordingly, which suggest that children should not be forced to wear face masks.” Now, the journal put out the following announcement about it:

The Research Letter, “Experimental Assessment of Carbon Dioxide Content in Inhaled Air With or Without Face Masks in Healthy Children: A Randomized Clinical Trial,” by Harald Walach, PhD, and colleagues published online in JAMA Pediatrics on June 30, 2021,1 is hereby retracted.

Following publication, numerous scientific issues were raised regarding the study methodology, including concerns about the applicability of the device used for assessment of carbon dioxide levels in this study setting, and whether the measurements obtained accurately represented carbon dioxide content in inhaled air, as well as issues related to the validity of the study conclusions. In their invited responses to these and other concerns, the authors did not provide sufficiently convincing evidence to resolve these issues, as determined by editorial evaluation and additional scientific review. Given fundamental concerns about the study methodology, uncertainty regarding the validity of the findings and conclusions, and the potential public health implications, the editors have retracted this Research Letter.

To make things even worse, Walach’s University fired him because of his fraudulent anti-vax research. Poznan University of Medical Sciences tweeted on 6 July:

We wish to emphasize that the claims included in dr Harald Walach’s recent article in @Vaccines_MDPI do not represent the position of @PUMS_tweets . We find that the article lacked scientific diligence and proper methodology. Dr. Walach’s affiliation with PUMS was now terminated. Throughout the pandemic PUMS has actively promoted vaccination programs, offering scientific expertise in the media, broadcasting seminars, and reported on progress of the vaccination program. We consider vaccinations as the paramount tool in the global fight against the pandemic. We consider vaccinations as the paramount tool in the global fight against the #pandemic. Over 85% of our own academic community has already been vaccinated with support and encouragement from the University.

As I said, this is truly unlucky …

.. or perhaps not?

Come to think of it, it is lucky when pseudo-science and fraud are called out. It means that the self-cleaning mechanisms of science are working and we are protected from the harm done by charlatans.

Mind-body interventions (MBIs) are one of the top ten so-called alternative medicine (SCAM) approaches utilized in pediatrics, but there is limited knowledge on associated adverse events (AE). The objective of this review was to systematically review AEs reported in association with MBIs in children.

Electronic databases MEDLINE, Embase, CINAHL, CDSR, and CCRCT were searched from inception to August 2018. The authors included primary studies on participants ≤ 21 years of age that used an MBI. Experimental studies were assessed for whether AEs were reported on or not, and all other study designs were included only if they reported an AE.

A total of 441 were included as primary pediatric MBI studies. Of these, 377 (85.5%) did not explicitly report the presence/absence of AEs or a safety assessment. In total, there were 64 included studies: 43 experimental studies reported that no AE occurred, and 21 studies reported AEs. A total of 37 AEs were found, of which the most serious were grade 3. Most of the studies reporting AEs did not report on severity (81.0%) or duration of AEs (52.4%).

The authors concluded that MBIs are popularly used in children; however associated harms are often not reported and lack important information for meaningful assessment.

SCAM is far too often considered to be risk-free. This phenomenon is particularly stark if the SCAM in question does not involve physical or pharmacological treatments. Thus MBIs are seen and often waved through as especially safe. Consequently, many researchers do not even bother to monitor AEs in their clinical trials. This might be understandable, but it is nevertheless a violation of research ethics.

This new review is important in that it highlights these issues. It is high time that we stop giving researchers in SCAM the benefit of the doubt. They may or may not make honest mistakes when not reporting AEs. In any case, it is clear that they are not properly trained and supervised. All too often, we still see clinical trials run by amateurs who have little idea of methodology and even less of ethics. The harm this phenomenon does is difficult to quantify, but I fear it is huge.

The usage of so-called alternative medicine (SCAM) in pediatric settings has been high for some time. However, the risks of pediatric SCAM use remain under-investigated. Almost 20 years ago, I published this systematic review:

Unconventional therapies have become popular in paediatric and adolescent populations. It is therefore important to define their risks. The aim of this systematic review was to summarise the recent evidence. Computerised literature searches were carried out in five databases to identify all recent reports of adverse events associated with unconventional therapies in children. The reports were summarised in narrative and tabular form. The results show that numerous case reports and several case series have been published since 1990. Investigations of a more systematic nature are, however, rare. Most of the adverse events were associated with herbal medications. Inadequately regulated herbal medicines may contain toxic plant material, be contaminated with heavy metals, or be adulterated with synthetic drugs. The adverse events included bradycardia, brain damage, cardiogenic shock, diabetic coma, encephalopathy, heart rupture, intravascular haemolysis, liver failure, respiratory failure, toxic hepatitis and death. A high degree of uncertainty regarding a causal relationship between therapy and adverse event was frequently noted. The size of the problem and its importance relative to the well-documented risks of conventional treatments are presently unknown. Several unconventional therapies may constitute a risk to the health of children and adolescents. At present, it is impossible to provide reliable incidence figures. It seems important to be vigilant and investigate this area more systematically.

Nothing much has happened since in terms of systematic investigation. But now, a 3-year survey was carried out at the Dutch Pediatric Surveillance Unit. Pediatricians were asked to register cases of adverse events associated with pediatric SCAM usage.

In 3 years, 32 unique adverse events were registered. Twenty-two of these adverse events were indirect and not related to the specific SCAM therapy but due to delaying, changing, or stopping of regular treatment, a deficient or very restrictive diet, or an incorrect diagnosis by a SCAM therapist. These events were associated with many different SCAM therapies.

Nine events were deemed direct adverse events like bodily harm or toxicity and one-third of them occurred in infants. Only supplements, manual therapies, and (Chinese) herbs were involved in these nine events. In one case, there was a risk of a serious adverse event but the harm had not yet occurred.

The authors concluded that relatively few cases of adverse events associated with pediatric SCAM usage were found, mostly due to delaying or stopping conventional treatment. Nevertheless, parents, pediatricians, and SCAM providers should be vigilant for both direct and indirect adverse events in children using SCAM, especially in infants.

The number of cases seems small indeed, but there may be many further adverse events that went unreported. Here are 4 of the documented cases of severe and life-threatening consequences:

  • An 8-year-old child with autoimmune hypothyroidism had his prescribed replaced with an ineffective herbal remedy.
  • A 14-year-old child developed septic shock with multiple organ failure after receiving homeopathy for acute appendicitis.
  • A 14-year-old child needed colectomy after ineffective naturopathic treatments for colitis.
  • A 5-year-old developed secondary adrenal insufficiency after his eczema was treated with Chinese herbal remedies adulterated with large doses of corticosteroids.

In view of the risks – even if small – I suggest that, in pediatric settings, we employ only those SCAMs that are supported by solid evidence. And those are very few indeed.

The General Chiropractic Council’s (GCC) Registrant Survey 2020 was conducted in September and October 2020. Its aim was to gain valuable insights into the chiropractic profession to improve the GCC’s understanding of chiropractic professionals’ work and settings, qualifications, job satisfaction, responsibilities, clinical practice, future plans, the impact of the COVID-19 pandemic on practice, and optimism and pessimism about the future of the profession.

The survey involved a census of chiropractors registered with the GCC. It was administered online, with an invitation email was sent to every GCC registrant, followed by three reminders for those that had not responded to the survey. An open-access online survey was also available for registrants to complete if they did not respond to the mailings. This was promoted using the GCC website and social media channels. In total, 3,384 GCC registrants were eligible to take part in the survey. A fairly miserable response rate of 28.6% was achieved.

Here are 6 results that I found noteworthy:

  • Registrants who worked in clinical practice were asked if performance was monitored at any of the clinical practices they worked at. Just over half (55%) said that it was and a third (33%) said it was not. A further 6% said they did not know and 6% preferred not to say. Of those who had their performance monitored, only 37% said that audits of clinical care were conducted.
  • Registrants working in clinical practice were asked if any of their workplaces used a patient safety incident reporting system. Just under six in ten (58%) said at least one of them did, whilst 23% said none of their workplaces did. A further 12% did not know and 7% preferred not to say.
  • Of the 13% who said they had a membership of a Specialist Faculty, a third (33%) said it was in paediatric chiropractic, 25% in sports chiropractic, and 16% in animal chiropractic. A further 13% said it was in pain and the same proportion (13%) in orthopaedics.
  • Registrants who did not work in chiropractic research were asked if they intended to work in that setting in the next three years. Seven in ten (70%) said they did not intend to work in chiropractic research in the next three years, whilst 25% did not know or were undecided. Only 5% said they did intend to work in chiropractic research.
  • Registrants were also asked how easy it is to keep up to date with recommendations and advances in clinical practice. Overall, two-thirds (67%) felt it was easy and 30% felt it was not.
  • Registrants were asked in the survey whether they felt optimistic or pessimistic about the future of the profession over the next three years. Overall, half (50%) said they were optimistic and 23% were pessimistic. A further 27% said they were neither optimistic nor pessimistic.

Perhaps even more noteworthy are those survey questions and subject areas that might have provided interesting information but were not included in the survey. Here are some questions that spring into my mind:

  • Do you believe in the concept of subluxation?
  • Do you treat conditions other than spinal problems?
  • How frequently do you use spinal manipulations?
  • How often do you see adverse effects of spinal manipulation?
  • Do you obtain informed consent from all patients?
  • How often do you refer patients to medical doctors?
  • Do you advise in favour of vaccinations?
  • Do you follow the rules of evidence-based medicine?
  • Do you offer advice about prescribed medications?
  • Which supplements do you recommend?
  • Do you recommend maintenance treatment?

I wonder why they were not included.

 

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