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

children

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This study sought to identify if an Neonatal Intensive Care Unit (NICU) integrating complementary medicine has low antibiotic prescribing.

The researchers conducted a retrospective analysis at the level-2 NICU of the Filderklinik, an integrative medicine hospital in Southern Germany, to compare antibiotic use locally and internationally; to compare neonates with suspected infection, managed with and without antibiotics; and to describe use and safety of complementary medicinal products.

Among 7778 live births, 1086 neonates were hospitalized between 2014 and 2017. Two hundred forty-six were diagnosed with suspected or confirmed infection, their median gestational age was 40.3 weeks (range 29-42), 3.25% had a birthweight <2500 g, 176 were treated with antibiotics for a median duration of 4 days, 6 had culture-proven infection (0.77 per 1000 live births), and 2.26% of live births were started on antibiotics. A total of 866 antibiotic treatment days corresponded to 111 antibiotic days per 1000 live births and 8.8 antibiotic days per 100 hospital days. Neonates managed with antibiotics more often had fever and abnormal laboratory parameters than those managed without. Complementary medicinal products comprising 71 different natural substances were used, no side effect or adverse event were described. A subanalysis using the inclusion criteria of a recent analysis of 13 networks in Europe, North America, and Australia confirmed this cohort to be among the lowest prescribing networks.

The authors concluded that antibiotic use was low in this NICU in both local and international comparison, while the disease burden was in the mid-range, confirming an association between integrative medicine practice and low antibiotic prescribing in newborns. Complementary medicinal products were widely used and well tolerated.

I have often suggested that somone does a study to assess the usage of meat products in a vegetarian restaurant. I am sure it would generate resuts that are at least as meaningful as the ones reported by the team of anthroposophic geniuses responsible for this paper. Here are their affiliations:

  • 1ARCIM Institute, Filderstadt, Germany.
  • 2Department of Pediatrics, Filderklinik, Filderstadt, Germany.
  • 3Department of Neonatology, University Hospital Tübingen, Tübingen, Germany.
  • 4Center for Integrative Pediatrics, Fribourg Cantonal Hospital, Fribourg, Switzerland.
  • 5Department of Community Health, Fribourg University, Fribourg, Switzerland.
  • 6Institute of Precision Medicine, University Furtwangen, Furtwangen, Germany.

Say no more!

Many fans of so-called alternative medicine have, as discussed ad nauseam on this blog, an irrational attitude towards vaccinations. They frequently claim that they do more harm than good. I wonder whether the data from a very large study might convince them other wise.

The WHO launched the ‘Expanded Programme on Immunization’ (EPI) in 1974 to make life-saving vaccines available to all globally. To mark the 50-year anniversary of EPI, this analysis sought to quantify the public health impact of vaccination globally since the programme’s inception.

his modelling study used a suite of mathematical and statistical models to estimate the global and regional public health impact of 50 years of vaccination against 14 pathogens in EPI. For the modelled pathogens, we considered coverage of all routine and supplementary vaccines delivered since 1974 and estimated the mortality and morbidity averted for each age cohort relative to a hypothetical scenario of no historical vaccination. These modelled outcomes were then used to estimate the contribution of vaccination to globally declining infant and child mortality rates over this period.

Since 1974, vaccination has averted 154 million deaths, including 146 million among children younger than 5 years of whom 101 million were infants younger than 1 year. For every death averted, 66 years of full health were gained on average, translating to 10·2 billion years of full health gained. Vaccination has thus accounted for 40% of the observed decline in global infant mortality, 52% in the African region. In 2024, a child younger than 10 years is 40% more likely to survive to their next birthday relative to a hypothetical scenario of no historical vaccination. Increased survival probability is observed even well into late adulthood.

The authors concluded that since 1974 substantial gains in childhood survival have occurred in every global region. We estimate that EPI has provided the single greatest contribution to improved infant survival over the past 50 years. In the context of strengthening primary health care, our results show that equitable universal access to immunisation remains crucial to sustain health gains and continue to save future lives from preventable infectious mortality.

>So, will this excellent and compelling analysis concince many irrational anti-vaxers? Somehow, I have my doubts.

In the previous 3 parts of this series (see here, here and here), we have discussed 9 fake diagnoses of so-called alternative medicine (SCAM):

  • adrenal fatigue,
  • candidiasis hypersensitivity,
  • chronic intoxications,
  • chronic Lyme disease,
  • electromagnetic hypersensitivity,
  • homosexuality,
  • leaky gut syndrome,
  • multiple chemical sensitivity,
  • neurasthenia.

Today I will briefly discuss three further fake diagnoses and list the treatments that SCAM practitioners might recommend for them.

Vaccine overload

Vaccine overload is a term for the notion that giving many vaccines at once may overwhelm or weaken a patient’s immune system which, in turn, is alleged to lead to adverse effects. Because children have an immature immune system, they are claimed to be afflicted most frequently.

There is no evidence that vaccine overload exists nor that it can lead to illness. This does not stop SCAM practitioners to apply or recommend all sorts of SCAMs for the imagined condition. Particular favourites are all sorts of detox diets, homeopathy and a wide range of dietary supplements. Such diets and supplements can be tricky for younger children. In this case, SCAM practitioners recommend, amongst many other things, smoothies or adding turmeric, ginger, and small amounts of Shillington’s adult supplements to the child’s food.

None of these recommendations are supported by anything resembling sound evidence, of course.

Vertebral subluxation

On this blog, we have discussed vertebral subluxations more often than I care to remember. Chiropractors claim that these figments of their imagination impair the flow of innate which, in turn, makes us ill. Straight chiros, those who adhere to the gospel of their guru DD Palmer, diagnose subluxations in 100% of their patients. They are undeterred by the fact that vertebral subluxations do not exist.

I can understand why! If they did aknowledge that the diagnosis is fake, they would have no reason to treat patients with spinal manipulations, and they would quickly go out of business.

Yin/Yang imbalance

According to the assumptions of practitioners of Traditional Chinese Medicine (TCM), all health problems arise from an imbalaance of the two life forces , yin and yang. To restore the balance, they employ a range of therapies such as acupuncture, herbal mixtures, massages, etc.

But these life forces do not exist. Thus they cannot be out of balance, and consequently the imbalance cannot cause illness. TCM practitioners don’t want to hear any of this. Why not? You guessed it: if they aknowledged these facts, they would need to stop practising.

____________________

Fake diagnoses are the life-line of many SCAM practitioners:

  • they tell you that something is wrong with you (despite the fact that you are entirely healthy);
  • they make sure that this is a reason for serious concern;
  • they claim they can put the alleged abnormality right again;
  • they administer a lengthy series of treatments and/or sell you plenty of remedies;
  • when they have earned enough money treating you, they give you the good news: you are back to narmal;
  • gullible consumers are impressed by the unfailing competence of the SCAM practitioners.

My conclusion:

there is nothing easier and more profitably to heal that a condition that did not exist  in the first place.

 

Acute tonsillitis, which includes tonsillopharyngitis, is a common condition, particularly in childhood. It is mostly caused by a viral infection. Symptomatic treatment is of high importance. But which treatment is effective and which isn’t?

For this expert consensus, 53 physicians from Germany, Spain, Netherlands, Switzerland, Austria, and Hungary with at least one year of experience in anthroposophic paediatric medicine were invited to participate in an online Delphi process. The process comprised 5 survey rounds starting with open-ended questions and ending with final statements, which need 75% agreement of experts to reach consensus. Expert answers were evaluated by two independent reviewers using MAXQDA and Excel.

Response rate was between 28% and 45%. The developed recommendation included 15 subtopics. These covered clinical, diagnostic, therapeutic and psychosocial aspects of acute tonsillitis. Six subtopics achieved a high consensus (>90%) and nine subtopics achieved consensus (75-90%). The panel felt that AM was an adequate therapy for acute tonsillitis.

The authors of this paper concluded that the clinical recommendation for acute tonsillitis in children aims to simplify everyday patient care and provide decision-making support when considering and prescribing anthroposophic therapies. Moreover, the recommendation makes AM more transparent for physicians, parents, and maybe political stakeholders as well.

I found it hard to decide whether to cry or to laugh while reading this paper.

Experience in anthroposophic paediatric medicine does not make anyone an expert in anything other than BS.

Expert consensus and clinical guidelines are not conducted by assembling a few people who all are in favour of a certain therapy while ignoring the scientific evidence.

AM for acute tonsillitis in children is nonsense, whatever these pseudo-experts claim.

Imagine we run a Delphi process with a few long-standing members of ‘the flat earth society’ and ask them to tell us about the shape of the earth …

…I rest my case.

Some abstracts of medical papers are so bizarre that they must not be tempered with, I find. This is one of them:

Rationale:

This case report aims to provide clinical evidence on the effectiveness of integrating chiropractic and moxibustion techniques for treating pseudomyopia accompanied by elevated intraocular pressure resulting from cervical spine issues because the application of complementary medicine modalities for managing such vision disorders currently lacks adequate investigations.

Patient concerns:

A 6-year-old patient presented with blurred vision, intermittent ocular discomfort, and upper cervical discomfort.

Diagnoses:

Spine-related increased intraocular pressure and pseudomyopia.

Interventions:

The patient received integrative treatment of chiropractic and walnut-shell moxibustion 3 times a week for a total of 10 treatment sessions.

Outcomes:

The patient exhibited progressive improvements in visual acuity and reductions in intraocular pressure over the treatment period, with unaided vision exceeding 2 lines of improvement in visual acuity charts and normalized intraocular pressure after 10 treatment sessions. These therapeutic effects were sustained at 3-month follow-up.

Lessons:

The integrative use of chiropractic and walnut-shell moxibustion demonstrates considerable potential in alleviating symptoms of pseudomyopia, reducing intraocular pressure, and restoring visual function in spine-related pseudomyopia cases.

Pseudomyopia is a spasm of the ciliary muscle that prevents the eye from focusing in the distance. It differs from myopia which is caused by the eye’s shape or other basic anatomy. Pseudomyopia may be either organic, through stimulation of the parasympathetic nervous system, or functional in origin, through eye strain or fatigue of ocular systems. It is common in young adults after a change in visual requirements, such as students preparing for an exam, or a change in occupation. The condition is often transitory and it is necessary to request psychiatric consultation in each case of pseudomyopia. Comorbidity of anxiety and depressive disorders is more common in pseudomyopia cases. In addition, as the severity of psychiatric symptoms increases, the amount of accommodation also appears to increase.

A few question, if I may:

  • Walnut-shell moxibustion? Yes, it exists! Moxibustion with walnut shell spectacles is a characteristic therapy of Guang’anmen Hospital, developed on the basis of walnut shell moxibustion, and mainly composed of an eye moxibustion frame, a walnut shell soaked with wolfberry and chrysanthemum liquid, and moxibustion strips. Moxibustion with a walnut shell was first recorded by Shicheng Gu for treating surgical ulcers in the Qing dynasty. Then, moxibustion with walnut shell spectacles was reformed by us, combining Shicheng Gu’s experience with our clinical practice, and is mainly used for the treatment of optic nerve atrophy and myopia.
  • The authors state that, “based on traditional Chinese medicine principles, moxibustion is known to warm meridians, dredge collaterals, relax tendons, and enhance blood circulation”. Is this true? Well, based on TCM, anything goes, but it does not make it true.
  • How can we know whether chiropractic or walnut-shell moxibustion or both caused the outcome? We can’t!
  • Can we be sure what caused the child’s problem? No!
  • Do we know whether the outcome was not a spontaneous recovery? No!
  • The authors claim that “cervical spine imbalance leads to visual impairment”. Is that correct? Not as far as I know.
  • The authors state that “the patient in this case, presenting with pseudomyopia, elevated intraocular pressure, and neck pain, likely had a cervical spine-derived condition. Currently, such spine-derived vision disorders lack sufficient clinical recognition.” Is this true? No, I’d say such spine-derived vision disorders might not even exist.
  • Why would anyone publish a paper about the case? Search me!

 

The aim of this study was to establish an international consensus regarding the use of spinal manipulation and mobilisation among infants, children, and adolescents among expert international physiotherapists. Twenty-six international expert physiotherapists in manual therapy and paediatrics voluntarily participated in a 3-Round Delphi survey to reach a consensus via direct electronic mail solicitation using Qualtrics®. Consensus was defined a-priori as ≥75% agreement on all items with the same ranking of agreement or disagreement. Round 1 identified impairments and conditions where spinal mobilisation and manipulation might be utilised. In Rounds 2 and 3, panelists agreed or disagreed using a 4-point Likert scale.

Eleven physiotherapists from seven countries representing five continents completed all three Delphi rounds. Consensus regarding spinal mobilisation or manipulation included:

● Manipulation is not recommended: (1) for infants across all conditions, impairments, and
spinal levels; and (2) for children and adolescents across most conditions and spinal levels.
● Manipulation may be recommended for adolescents to treat spinal region-specific joint
hypomobility (thoracic, lumbar), and pain (thoracic).
● Mobilisation may be recommended for children and adolescents with hypomobility, joint
pain, muscle/myofascial pain, or stiffness at all spinal levels.

The authors of this paper concluded that consensus revealed spinal manipulation should not be performed on infants regardless of condition, impairment, or spinal level. Additionally, the panel agreed that manipulation may be recommended only for adolescents to treat joint pain and joint hypomobility (limited to thoracic and/or lumbar levels). Spinal mobilisation may be recommended for joint hypomobility, joint pain, muscle/myofascial pain, and muscle/myofascial stiffness at all spinal levels among children and adolescents.

Various forms of spinal manipulations are the hallmark therapy of chiropractors. Almost 100% of their patients recieve these interventions. So, what will our friends, the chiros, say about the consensus? Might it be this:

  • Physiotherapists are not the experts on spinal manipulation.
  • Only chiropractors can do them properly.
  • And when WE do them, they are very good*!

 

 

 

(* for our income)

This study aims to assess the feasibility of a pragmatic prospective study aiming to report the immediate and delayed (48-hours post-treatment) AEs associated with manual therapies in children aged 5 or younger and to report preliminary data on AEs frequency.

Between July 2021 and March 2022, chiropractors were recruited through purposive sampling and via a dedicated Facebook group for Quebec chiropractors interested in pediatrics. Legal guardians of patients aged 5 or younger were invited to fill out an online information and consent form. AEs were collected using the SafetyNET reporting system, which had been previously translated by the research team. Immediate AEs were collected through a questionnaire filled out by the legal guardian immediately after the treatment, while delayed AEs were collected through a questionnaire sent by email to the legal guardian 48 h after the treatment. Feasibility was assessed qualitatively through feedback from chiropractors and quantitatively through recruitment data.

Overall, a total of 28 chiropractors expressed interest following the Facebook publication, and 5 participated. An additional two chiropractors were enrolled through purposive sampling. In total, 80 legal guardians consented to their child’s participation, and data from 73 children were included for the analysis of AEs. At least one AE was reported in 30% of children (22/73), and AEs were mainly observed immediately following the treatment (16/22). The most common AEs were irritability/crying (11 children) or fatigue/tiredness (11 children). Feasibility analysis demonstrated that regular communication between the research team and clinicians, as well as targeting clinicians who showed great interest in pediatrics, were key factors for successful research.

The authors concluded that their results suggest that it is feasible to conduct a prospective pragmatic study evaluating AEs associated with manual therapies in private practices. Direct communication with the clinicians, a strategic clinicians’ recruitment plan, and the resulting administrative burden should be considered in future studies. A larger study is required to confirm the frequency of AEs reported in the current study.

It is hardly surprising that such a study is ‘feasible’. I could have told the authors that and saved them the trouble of doing the study. What is surprising, in my view, that chiropractors, after ~120 years of existence of the profession, ask whether it is feasible.

I suggest to do the definitive study on a much larger sample, extend the observation period, and recruit a representative rather than self-selected sample of chiros … or – much better – forget about the study and establich a functioning post-marketing surveillance system.

These days, it has become a rare event – I am speaking of me publishing a paper in the peer-reviewed medical literature. But it has just happened: Spanish researchers and I published a meta-analysis on the effectiveness of craniosacral therapy. Here is its abstract:

The aim of this study was to evaluate the clinical effectiveness of craniosacral therapy (CST) in the management of any conditions. Two independent reviewers searched the PubMed, Physiotherapy Evidence Database, Cochrane Library, Web of Science, and Osteopathic Medicine Digital Library databases in August 2023, and extracted data from randomized controlled trials (RCT) evaluating the clinical effectiveness of CST. The PEDro scale and Cochrane Risk of Bias 2 tool were used to assess the potential risk of bias in the included studies. The certainty of the evidence of each outcome variable was determined using GRADEpro. Quantitative synthesis was carried out with RevMan 5.4 software using random effect models.

Fifteen RCTs were included in the qualitative and seven in the quantitative synthesis. For musculoskeletal disorders, the qualitative and quantitative synthesis suggested that CST produces no statistically significant or clinically relevant changes in pain and/or disability/impact in patients with headache disorders, neck pain, low back pain, pelvic girdle pain, or fibromyalgia. For non-musculoskeletal disorders, the qualitative and quantitative synthesis showed that CST was not effective for managing infant colic, preterm infants, cerebral palsy, or visual function deficits.

We concluded that the qualitative and quantitative synthesis of the evidence suggest that CST produces no benefits in any of the musculoskeletal or non-musculoskeletal conditions assessed. Two RCTs suggested statistically significant benefits of CST in children. However, both studies are seriously flawed, and their findings are thus likely to be false positive.

So, CST is not really an effective option for any condition.

Not a big surprise! After all, the assumptions on which CST is based fly in the face of science.

Since CST is nonetheless being used by many healthcare professionals, it is, I feel, important to state and re-state that CST is an implausible intervention that is not supported by clinical evidence. Hopefully then, one day, these practitioners will remember that their ethical obligation is to treat their patients not according to their beliefs but according to the best available evidence. And, hopefully, our modest paper will have helped rendering healthcare a little less irrational and somewhat more effective.

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.

 

Acute Otitis Media (AOM) is one of the most common acute infections in children and often injudiciously treated by antibiotics. Homeopathy has been claimed to work but is it really effective?

This open label, randomized, controlled, parallel arm trial was conducted on children (aged 0–12 years), suffering from AOM. The primary outcome was changes in Tympanic Membrane Examination scale (TMES) and Acute Otitis Media-Severity of Symptoms (AOM-SOS) scale, time to improvement in pain through Facial Pain Scale-Revised (FPS-R) over 10 days. The need for antibiotics in both groups and the recurrence of subsequent episodes of AOM over 12 months were also compared.

Intention-to-treat analysis was performed on 222 children; Homeopathy (n = 117) (H-group), Allopathy (A-group) (n = 105). There was a statistically significant reduction of scores in H-group compared with A-group at each time point: at day 3 (mean diff. ± sd: 1.71 ± 0.19; 95% CI: 1.34 to 2.07; p = 0.0001), at day 7 (mean diff. ± sd: 1.29 ± 0.24; 95% CI: 0.82 to 1.76; p = 0.0001) and at day 10 (mean diff. ± sd: 1.23 ± 0.25; 95% CI = 0.74 to 1.71; p = 0.0001) favoring homeopathy. Clinical failure by the third day of treatment was observed in 11% and 24% of children in H-group vs A-group (OR: 0.03; 95% CI: 0.001 to 0.52; p = 0.03). None of the children in the H-group required antibiotics, whereas 14 children in the A-group did.

The authors concluded that both therapies seemed to produce comparable effects and appeared safe. The study consolidated the findings observed during a pilot study, i.e., homeopathy is non-inferior to allopathy in managing AOM in children and antibiotics in children can be avoided.

This study was published in the journal ‘Homeopathy’ and originates from the Central Council for Research in Homeopathy, New Delhi, India. Sadly, I do not have the full text of the paper and cannot therefore scrutinize it adequately.

Let me just mention these three facts:

  1.  The journal ‘Homeopathy’ never publishes negative results.
  2. Indian researchers of homeopathy publish as good as no negative results.
  3. As far as I can see, the Central Council for Research in Homeopathy, New Delhi, has never published a negative result.

These points do, of course, not necessarily mean that the study is false-positive, but they do not inspire me with confidence. In any case, it seems wise to insist on better evidence. To render it credible, we would need:

  1. Several rigorous RCTs that test homeopathy for AOM against placebo.
  2. If (and only then) they show that homeopathy is better than placebo, at least one independent replication of the present study.

As the biological plausibility of all this is close to zero, the chances that this will happen are also zero.

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