FROM:
Chiropractic Journal of Australia 2016; 44 (3): 222–233 ~ FULL TEXT
Matthew F. Doyle MSc AP Paediatric Chiropractic,
BAppSc/BChiroSc, BSc (Neurobiology)
Private Practice of Chiropractic
6 Blue Gum Tce
Caboolture South QLD
Objective: Recent popular press commentary in Australia has raised concerns around the safety and evidence base for the chiropractic care of infants and children. This has led to statements such as “doctors speak out against chiropractors treating children” and “doctors at war with chiropractors over treatment of babies and children”. This selective review of the literature and commentary explores these issues.
Methods: Problems in assessing clinical interactions that involve a hands on approach with an objectivist quantitative methodology designed for a traditional western medical approaches (such as medication) versus a pragmatic constructivist methodology are discussed. Both PubMed and the Central Queensland University (CQU) Library database were searched using the terms “pediatric AND chiropractic”.
Results: The PubMed search returned 126 hits, and the CQU Library search returned 939 hits. A systematic review of the entire literature base is beyond the remit of this selective review and commentary, however, selected relevant literature is reviewed below.
Conclusion: The literature reviewed does not support the claim that the chiropractic care of children and infants has no evidence to support the practice, or the claim that chiropractic care of children and infants is dangerous.
Key words: Chiropractic; Pediatrics; Evidence-Based Clinical Practice
From the Full-Text Article:
INTRODUCTION
Chiropractic care of infants and children has been reported as part of the profession
since the early 1900s. [1] Material continues to be published in 2016 in mainstream
media which calls this practice into question, as reported by Arnold on the Australian
Broadcasting Commission (ABC) that “Doctors speak out against chiropractors
treating children” and Medew in the Sydney Morning Herald (SMH) that “Doctors at
war with chiropractors over treatment of babies and children.” [2, 3] This
confrontational approach is not new. In the USA, it took an antitrust lawsuit filed
against the American Medical Association in 1976 to reveal the magnitude and scope
of a decades long plan to contain and eliminate the chiropractic profession. This
lawsuit was finalised in 1987, when United States District Judge Susan Getzendanner
found the American Medical Association and its codefendants guilty of violating the
Sherman Antitrust Act. [4] In her decision, Getzendanner asserted that “the AMA
decided to contain and eliminate chiropractic as a profession” and that it was the
AMA’s intent to “destroy a competitor”. [5]
In Australia today multiple medical practitioners “speak out against chiropractors
treating children” and are claimed to be “at war with chiropractors over treatment of
babies and children”. [2, 3] The following is excerpt from the SMH April 28 2016:
"The head of paediatrics at Royal Darwin Hospital, Dr Paul Bauert, says he
wants the regulators to ban chiropractic treatment for children
altogether. 'AHPRA and the Chiropractic Board, should be banning any
treatment of children and adolescents under the age of 16, 17, until the
evidence is available that shows that there may be some effect,' Bauert
says. 'The only evidence that's available at the moment, looking at all the
published chiropractic literature, the conclusions of all of those studies say that
chiropractors may compete with physiotherapists in terms of treating some back
problems. But all their other claims are beyond belief, and can carry a range of
significant risks.' The Royal Australian College of General Practitioners has told
its members to not refer patients to chiropractors and is calling for the federal
government and private health insurers to stop paying them for questionable
treatments." [3]
The medical practitioners’ comments lead to specific questions regarding evidence of
effect and safety for the chiropractic care of infants and children. They also
highlight one of the fundamental problems in assessing clinical interactions that
involve a hands on approach with an objectivist quantitative methodology designed for
a traditional western medical approaches such as medication. A pragmatic
constructivist methodology would be more appropriate for this assessment. Lewith,
Jonas, and Walach in their second edition 2011 text on Clinical Research in
Complementary Therapies make several salient comments:
“we’ve seen substantial advances in how we think about complementary
medicine; research funders are beginning to understand that the range of
complementary and alternative medicines (CAM) on offer are not simply
‘alternative medications’ but in themselves complex whole systems of diagnosis
and treatment. The mixed qualitative and quantitative research methods
beginning to unravel this complex therapeutic interaction may not only allow us
to understand how complementary medicines themselves may be offering
benefit, but should also give us remarkable insights into the management (and
self-management) of a variety of different chronic problems. We have begun to
understand that simple placebo-controlled randomised controlled clinical trials
offer us a very limited evidence base and that we need to expand our research
methodology and its interpretation, taking into account a whole variety of
different types of evidence so that we can begin to understand how best to
manage illness within the community.” [6]
This fundamental difference in ontological perception may lead to significant cognitive
dissonance. It commonly creates false perceptions with the resultant inaccurate
appreciations of the nature of reality related to what is being studied. Roblyer and
Doering effectively describe the key oppositional theories regarding ontology. [8]
Objectivist theories assert that knowledge is absolute and mirrors reality, whereas
constructivist theories postulate that knowledge is not absolute since an understanding
of reality changes in the light of new experiences. [8]
Issues appear to arise when objectivist quantitative measures are used to
understand processes that are more accurately reflected in a pragmatic constructivist
approach. This can be seen to be at odds with the general zeitgeist of the western
world placing of the scientific process, and particularly the objectivist approach, on a
pedestal. The scientific process is a tool of application for understanding the nature of
reality as it pertains to whatever the object being studied. However, this is commonly
confused as the end in itself - for example, something is given as true and accurate
and real if it has been demonstrated objectively in scientific studies. This concept has
been explored in depth by Sorell in his text on ‘Scientism – philosophy and the
infatuation with science’. [9] This is seen time and again in both the research literature
and the popular press. [10]
The articles presented by the ABC and the SMH are evidence of this, whereby the
quoted medical practitioners are decrying the lack of evidence as a general
statement. They do not have their argument presented in an accurate nature to what
they are commenting on - namely, objectivist research, preferably of a randomised
controlled trial (RCT) nature, or a systematic review of said RCTs. This, in and of
itself, is an issue as objectivist research does not capture the entirety of the clinical
interaction between practitioner and patient. [6]
RCT-style research is an effective
approach to understand efficacy and effectiveness of a drug on a particular
symptom/physiological marker within tightly controlled environments. This style of
research has a place in a clinical setting relating to the chiropractic care of infants and
children, but it falls far short of adequately describing the nature of the interaction
between practitioner and patient. A pragmatic approach combing both qualitative and
quantitative aspects leads to more accurate understandings of the interaction. This
has a capability of better capturing the ‘N of 1’ - the clinical presentation of the patient,
aspects of the patient and the practitioners sociodemographics that relate to their
worldview/ontology, the patient/caregivers reported outcomes, and experiences of the
interaction at each point along a continuum of care in a longitudinal sense.
The ABC and Sydney Morning Herald articles in Australia raised the questions of what
is the evidence for the chiropractic care of infants and children. This commentary and
selective review of the literature addresses the question of the evidence base and
safety for the chiropractic care of infants and children.
DISCUSSION
Contextualising Chiropractic in Australia
The chiropractic profession was established in 1895 in the USA. [4] The first
chiropractor in Australia, Barbara Brake, practiced in Melbourne in 1908. [11]
Chiropractic legislation was first enacted in Australia in 1964. Chiropractors have been
educated in the Australian university system for decades, and chiropractic is currently
taught at RMIT University, Murdoch University, Macquarie University, and Central
Queensland University (CQU). These all have government funding associated with
them. The World Federation of Chiropractic currently reports 47 chiropractic programs
around the globe. The World Health Organisation recognises the profession and
published its guidelines in 2005 on educational standards for the profession. [12] The
Australian Health Practitioner Regulation Agency (AHPRA) has 14 boards regulating
health care practitioners including medical practitioners, dentists, pharmacists, and
chiropractors. [13]
The Chiropractic Board of Australia (CBA) reports as of December
2015 there are 5,148 registered chiropractors in Australia. [14] The Chiropractic
Association of Australia (CAA) is the largest national association with a 2015
membership of 3,157. [15] [or 61.3%] The CAA has allocated significant funding to facilitate the
Australian Chiropractic Research Network project led by Professor Adams and
Professor Sibbritt. [16] These University of Technology Sydney professors have over
450 academic peer reviewed publications and over $24 million in competitive funding
grants between them. These factors contextualise the global nature of the profession
and its long term place in the health care framework of the Australian population.
Methods
Selected research review - evidence and safety.
The next question pertains to research. The Head of Paediatrics at Darwin Hospital,
Dr Bauert, was reported as stating ‘the only evidence that's available at the moment,
looking at all the published chiropractic literature, the conclusions of all of those
studies say that chiropractors may compete with physiotherapists in terms of treating
some back problems. But all their other claims are beyond belief, and can carry a
range of significant risks.'. [2]
Posing this question in a simple PubMed search of “pediatric AND chiropractic” returns
126 hits, and a search of the CQU Library database for “paediatric AND chiropractic”
returns 939 hits. A systematic review of the entire literature base is beyond the remit of
this selective review and commentary; however, selected relevant literature is
reviewed below.
Results
Two textbooks on the subject are currently in their second edition.
Chiropractic Pediatrics, by Neil Davies, was published by Churchill Livingstone with the first edition
in 2000 and the second edition from 2010. [17] This 414-page hardback text describes
the thorough process of clinical chiropractic care of children, from intake, examination,
recognising the seriously ill child, neurology, orthopaedics, relevant age related
conditions, developmental disorders, nutrition, pain assessment, and specific
chiropractic approaches to the paediatric patient.
Pediatric Chiropractic, by Anrig and Plaugher, is likewise in its second edition from 2012. [18] It is a comprehensive resource that covers a wide range of information on pediatric chiropractic care. An
international panel of 42 experts contributed to this book. Among the many topics
covered are: care during pregnancy and the perinatal period, subluxation, clinical and
radiological examination, child abuse, adolescent health, spinal trauma, scoliosis,
pediatric nutrition, vaccination issues, and full spine and cranial adjustments. This
reference carefully illustrates that the chiropractor is an appropriate provider of health
care for children.
Core competencies of the certified pediatric doctor of chiropractic from a Delphi consensus process were published in 2016 in the Journal of Evidenced Based Complementary and Alternative Medicine. [19] The Delphi panel consisted of 23
specialists in chiropractic pediatrics from across the broad spectrum the chiropractic
profession. Sixty-one percent of panelists had postgraduate paediatric certifications or
degrees, 39% had additional graduate degrees, and 74% were faculty at a chiropractic
institution and/or in a postgraduate paediatric program. The introduction to the
competencies state that all doctors of chiropractic are adequately trained in basic
paediatric skill and are licensed to examine, treat, and managed paediatric patients.
Hawk et al and Miller give a broad overview of current chiropractic the chiropractic
care of infants and children. [20, 21] Hawk quotes “according to Sackett, the “father” of
evidence-based medicine, evidence based medicine is not restricted to randomised
trials and meta-analysis. It involves tracking down the best external evidence
with which to answer our clinical questions.” [19] They note that that chiropractic care,
as a package of conservative approaches including manipulation, for pain
management and/or promoting optimal function, has accumulated a substantial
evidence base, primarily for musculoskeletal complaints. Best practices for the
chiropractic care of children, first published in the Journal of Manipulative and
Physiologic Therapeutics in 2009, was updated by Hawk et al in 2016. [20, 22] Below
is documented some of the significant evidence base supporting the
chiropractic approach to care, from birth onwards.
Bronfort et al completed an effectiveness report of manual therapies with strict
inclusion criteria of research to September 2009. [23] They identified 13
musculoskeletal conditions, 4 types of chronic headaches, and 9 non-musculoskeletal
conditions. They identified 49 relevant systematic reviews, 16 evidence based
guidelines and included an additional 46 RCTs not yet included in systematic reviews
and guidelines. In children, the evidence was inconclusive regarding spinal
manipulation for the effectiveness for otitis media, enuresis, and was not effective
for infantile colic and asthma when compared to sham manipulation. Massage was
found to have inconclusive evidence for children with asthma or infantile colic. In 2014
Clar et al completed an updated extension of Bronfort et al effectiveness report. [24]
They found 178 new and additional studies to March 2013 (3.5 years after the cutoff
date of Bronfort et al) of which 72 were systematic reviews, 96 were randomised
controlled trial, and 10 were non-randomised primary studies. Evidence was identified
for a large number of non-musculoskeletal conditions not previously considered. Of
interest is the amending of the reporting for infantile colic from 2010 as moderate
negative to 2014 of inconclusive favourable. A rapid growth in the body of evidence
surrounding manual therapy over a 3.5-year time frame stand is apparent. This
indicates further interest, investment and growth in developing the evidence base. It is
noteworthy that these studies only accepted what the authors selected guidelines
allowed - namely high quality randomised controlled trials and non-randomised
primary studies. Clinical practice would grind to a halt if evidence-based practice
was inaccurately applied as evidence-only practice - i.e. presentations may only be
treated with interventions with RCT level evidence associating positive effect. This is
not the reality of day-to-day clinical practice, and Sackett approached evidence based
practice as tracking down the best external evidence with which to answer the clinical
questions.
The updated “Best practices for chiropractic care of children” consensus paper by
Hawk et al notes that the scientific evidence for the effectiveness and efficacy of
chiropractic care and spinal manipulation for treatment of children is not plentiful
or definitive. [22] Gotlib and Rupert completed systematic reviews
of chiropractic manipulation in paediatric health conditions in 2005 and 2008. [25, 26]
The additional evidence found in the 2008 review showed the body of knowledge to
entail 2 systematic reviews, 10 RCTs, 3 observational studies, 177 descriptive studies,
and 31 conference abstracts. Two years later, Ferrance and Miller discuss the
chiropractic diagnosis and management of non-musculoskeletal conditions in children
and adolescents. [27] Their commentary explores the presence of evidence for many
of childhood conditions, but laments at its low level of quality and strength. They
suggest chiropractors be bold in what they hypothesize but cautious and humble in
what they claim, and that the conscientious and educated chiropractor, while working
within their scope of practice, can potentially be a valuable member of the paediatric
health care team. Gleberzon et al completed a systematic review of the
literature surrounding the use of spinal manipulative therapy for paediatric health
conditions. [28]
This served as an update to 2 previous systematic reviews in 2005
and 2008 by Gotlib and Rupert. They note 16 clinical trials that met their inclusion
criteria, with 6 investigating the effectiveness of spinal manipulative therapy (SMT) on
colic, 2 each on asthma and enuresis, and 1 each on hip extension, otitis media,
suboptimal breastfeeding, autism, idiopathic scoliosis, and jet lag. None investigated
the effectiveness of SMT on spinal pain.They reported that the studies that monitored
both subjective and objective outcome measures of relevance to both patients and
parents tended to report the most favourable response to SMT, especially among
children with asthma. However, many studies suffered from severe methodological
limitations, and they clearly suggest more research in the area. What is noteworthy
here is the number of quality research articles that acknowledges the chiropractic care
of infants and children as an aspect of chiropractic practice. They demonstrate an
evidence base to the practice of chiropractic for infants and children, and a rationale
for application of chiropractic care to this population. Hawk et al state that chiropractic
undergraduate education includes the study of the unique anatomy and physiology of
the paediatric patient as well as the modification of evaluation and therapeutic
procedures as it applies to this special population when addressing musculoskeletal
problems and their effect on the overall health and well-being of the child. [22]
As
further context to the normality of conservative manual care for the newborn, the
results of a US registered clinical trial were published in the Journal of the American
Osteopathic Association in 2015 by Waddington et al. [29] Osteopaths in the USA
hold licenses as general medical practitioners who also integrate a hands on
musculoskeletal approach to patient care.They quote recent evidence suggesting
osteopathic manipulative treatment may decrease complications and hospital length of
stay; that such dysfunction may result from the external forces related to the birth
process; but that its incidence is unknown. They summarised findings of 100 newborns
aged between 6 and 72 hours and totaled a score of dysfunction relating to cranial
motion, condylar motion, cervical motion, lumbar motion, and sacral motion. [29]
Dysfunction in each of these areas was found in 80-99% of newborns. This score was
positively associated with the duration of labour. This reinforces the appropriateness of
trained practitioners in manual approaches to the neuro-musculoskeletal system
assessing newborns.
A health practitioner in Australia is held to an approach to “do no harm,” where the
balance of the positively potential outweighs the negative. Opinions expressed in the
ABC and SMH articles would indicate that a significant level of harm or potential harm
is associated with paediatric chiropractic; however, no evidence to support that opinion
is given. This opinion is not supported by the evidence in the peer-reviewed
literature, which is readily available and reviewed herein.
The most comprehensive review of the literature on adverse events due to chiropractic and other manual therapies for infants and children was published late 2014 by Todd
et al. [30] This thorough review found 31 articles which met the inclusion criteria, with
12 articles reporting 15 serious adverse events - in the history of published peer
reviewed literature relating to paediatric manual therapies. Three deaths occurred
under the care of various providers (a physical therapist, an unknown provider, and a
craniosacral therapist) and 12 serious injuries were reported. Their conclusion was the
published cases of serious adverse events in this cohort are rare. The 3 deaths
reported were associated with manual therapists; however, no deaths associated with
chiropractic care were found in the literature to date. [30]
They note that underlying
preexisting pathology was associated with the majority of reported cases, that
performing a thorough history and examination to exclude anatomical
or neuralgic anomalies before applying any manual therapy may further reduce
adverse events across all manual therapy professions. This point is reiterated in both
Hawk et al’s 2009 consensus article [20] on the chiropractic care of infants and
children, and Hewitt et al’s 2016 updated core competencies of the paediatric
chiropractor. [19] The reviewed published chiropractic literature by Doyle in 2011
suggest a rate of .53% to 1% mild adverse events (AE) associated with
chiropractic paediatric SMT. [31] A mild AE is irritability or soreness lasting less than
24 hours and resolving without the need for additional care beyond initial chiropractic
recommendations. Put in terms of individual patients, between 1 in 100 to
200 patients presenting for chiropractic care, or in terms of patient visits, between 1
mild AE per 1310 visits to 1 per 1812 visits. For comparison, osteopathic paediatric
SMT have reported a rate of 9%, and medical practitioners utilising paediatric SMT
under the auspices of ‘chiropractic therapy’ have reported a rate of 6%. In 2013 the
chiropractic profession published research that highlighted the importance of modifying
force in infants compared to adult cases. [32]
If the concerns around safety of chiropractic care, and the chiropractic care of infants
and children, are turned to usual medical care, and paediatric medical care, a number
of concerning published findings arise. In the Journal of the American Medical
Association, 2009, Kilo and Larson comment on the harmful effects of healthcare in
the USA. [33] They state that “on balance, the data remains imprecise, and the
benefits that US health care currently delivers may not outweigh the aggregate health
harm it imparts. Health care contributes only about 10% toward reducing premature
death; even a perfectly designed delivery system would prevent only a modest
proportion of premature death."
A study published in 2015 by Marquet et al identified all patients with an unplanned
need for a higher level of care during a 6-month period through 6 Belgium
hospitals. [34] Adverse events were found in 56% of reviewed patient hospital records,
of which 46% were highly preventable. This means 1 in 4 unplanned transfers to a
higher level of care were related to a highly preventable adverse event. The adverse
events were mainly associated with drug therapy (25.6%), surgery (23.7%), diagnosis
(12.4%), and systems issues (12.4%). The level of harm varied from temporary harm
(55.7%) to long term or permanent impairment (19.1%) and death (25.2%). This
means one quarter of these highly preventable adverse events resulted in death. A
Canadian study by Matlow et al in 2012 reviewed the 3669 records of children
admitted to 22 hospitals during the 12-month period. [35]
The weighted rate of
adverse events was 9.2%. The most responsible services for this were surgery
(35.1%), and medicine (29.8%). Permanent disability occurred in 13 cases and death
occurred in 4 patients, which equates to 1 death per 917 patients admitted.
It has been estimate by Wood et al in 2005 that adverse events occur in about 1% of
children treated in hospital, and on average 60% of these events are preventable. [36] It is notable above that medications account for a significant component of
adverse events. Szasz noted in 2001 that “in a pharmacracy, people are obsessed
with medicine and perceive all manner of human problems as medical in nature
and therefore amenable to medical remedies”. [37]
Radlely et al noted 73% of off-label
drug uses lacked evidence of clinical efficacy. [38] The greatest disparity between
supported and unsupported off-label uses was found among prescriptions for
psychiatric use (4% strong support vs 96% limited or no support) and allergies (11%
strong support vs 89% limited or no support). Three fourths of the prescription drugs
on the market do not have labelling indications for children, leaving their use in
children to physicians discretion. [39] A systematic review of studies concerning the
reasons for paediatric hospitalisation (children under the age of 19), which captured
data from the USA, the UK, and Spain, showed the rate of paediatric hospitalisations
due to adverse drug reactions was 2.09%. [40] 39.3% of these were life threatening.
A 11-year national analysis of paediatric adverse drug events (ADE) in the outpatient
setting in the USA revealed a mean annual number of ADE-related visits of 585,922. [41] Children 0-4 years of age accounted for 43.2% of these visits. The most common
symptom manifestation was dermatologic conditions (45.4%) and gastrointestinal
symptoms (16.5%). The medication classes most frequently implicated in an
ADE were antimicrobial agents (27.5%), central nervous system agents (6.5%), and
hormones (6.1%). Miller and Zahn provided a national picture in 2000
of paediatric patient safety in hospitals, published in Pediatrics 2004, where they
reviewed 5.7 million discharge records from 27 states in the USA of children under 19. [42] They reported 4,483 deaths due to patient safety events. This equates to 1 death per 1,300 visits. As noted previously, a child visiting a chiropractor has a one per 1,300
visit risk of irritability or soreness lasting less than 24 hours [31], and no deaths associated with chiropractic care have been published in the literature to date. [29]
CONCLUSION
This selective review of the literature was conducted to examine the accuracy of
claims reported in Australia in the popular press relating to chiropractic care of infants
and children. These were specifically that there is no evidence to support the practice,
and that it is dangerous. The reviewed literature reveals several important points.
Aspects of medical care were reviewed to contextualize the relative risk of normal
medical care relating to hospitalisation and medications, and particularly with respect
to the paediatric age group. Adverse events were commonly reported related to this.
The adverse event literature relating to the chiropractic care of infants and children
reports the practice as a low-risk intervention. It highlights the importance of a
thorough history and examination, an ability to refer when appropriate to minimize
delayed diagnosis of medically treatable conditions, and age appropriate modification
of technique.
The review has documented a range of literature to underpin the
evidence base for the chiropractic care of children and infants. This base is small, and
it is noted that it has grown substantially over the past decade. Australian chiropractors
are university educated and regulated under the Australian Health Practitioners
Regulatory Authority along with 13 other health professions including medicine,
nursing and midwifery, dentistry, and physiotherapy. [43] The literature reviewed does
not support the claims that the chiropractic care of children and infants has no
evidence to support the practice, and that it is dangerous.
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