Paediatr Child Health. 2005 (Mar); 10 (3): 157–161 ~ FULL TEXT
Allan Gotlib, BSc DC and Ron Rupert, MS DC
Canadian Chiropractic Association,
OBJECTIVE: To review the biomedical literature up to and including 2003, and determine the extent of the evidence related to the therapeutic application of chiropractic manipulation for paediatric health conditions. No critical appraisal of the evidence is undertaken.
DATA SOURCES: The indexed manual therapy sector including medical, chiropractic, physiotherapy, naturopathic and osteopathic literature was searched. This included PubMed; the Manual, Alternative, and Natural Therapy Index System; the Cumulative Index to Nursing and Allied Health Literature; the Index to Chiropractic Literature; the Paediatric Economic Database Evaluation Project; the Cochrane Library; the Canadian Coordinating Office for Health Technology Assessment database; and the Agency for Healthcare Research and Quality database. Other resources included research conference and symposium proceedings, and the references of identified studies.
RESULT: The search identified 1731 articles, of which 166 met the eligibility criteria. Two reviewers determined by consensus each citation's appropriate level on the strength of evidence scale. There was one systematic review, nine randomized controlled trials, one observational study, 141 descriptive case studies and 14 conference abstracts.
SUMMARY: Health claims made by practitioners regarding the application of chiropractic manipulation as a health care intervention for paediatric health conditions are, for the most part, supported by low levels of scientific evidence. Chiropractors, in particular, employ manipulation for the treatment of a wide variety of paediatric health conditions. The evidence rests primarily with clinical experience, descriptive case studies and a few randomized controlled trials. There is a need for more rigorous scientific inquiry to examine the value of manipulative therapy in the treatment of paediatric conditions. To advance the health interests of paediatric patients, health care decisions made on the basis of expert opinion or clinical experience must integrate the best research evidence available from high-quality, scientific studies.
KEYWORDS: Adolescent; Child; Chiropractic manipulation; Evidence-based medicine; Infant; Newborn; Paediatrics
From the FULL TEXT Article:
Literature reviews undertaken in the past have described the evidence related to the use of chiropractic manipulation in a wide variety of paediatric conditions. In 1992  and 1997 , Rupert addressed the quantitative aspects of chiropractic manipulation, and in 1995 , Gotlib and Beingessner primarily addressed the qualitative aspects of chiropractic manipulation in the paediatric population. Others have undertaken narrative reviews of particular paediatric conditions [4–9] The present paper seeks to update the previous reviews and to assess the evidence for the health intervention claims made by practitioners (chiropractors, physicians, physiotherapists, naturopaths and osteopaths) with respect to paediatric patients and manipulation.
In the absence of high-quality randomized controlled trials (RCTs) and systematic reviews, health care providers who use manipulation have relied on clinical observations coupled with varying measures of successful outcomes as the basis for their continued claims of efficacy and safety for a particular health care intervention. This is at variance with scientific, evidence-based decision-making.
The providers, consumers and payers of health interventions require reliable information to determine patient-centred risks, benefits, effectiveness and safety, and are shifting their reliance from expert opinion or clinical experience alone to more scientific, evidence-based research. Narrowing the gap between the clinical and scientific communities advances the health interests of paediatric patients.
The objective of this project was to summarize the indexed biomedical literature up to and including 2003, and to determine the extent of the evidence related to the therapeutic application of manipulation for paediatric health conditions. No critical appraisal of the evidence was undertaken.
Paediatric data sources
The list of data sources set out in Table 1 captures the peer-reviewed biomedical literature related to the manual therapy sector, and includes osteopathic, naturopathic, physiotherapy, medical and chiropractic literature. The Cochrane Library, the Canadian Coordinating Office for Health Technology Assessment database and the Agency for Healthcare Research and Quality database were searched to retrieve relevant systematic reviews and clinical trials. The references of identified articles were also searched for additional studies.
The recent conference proceedings of the World Federation of Chiropractic Congress (1999, 2001 and 2003), the Symposium of the Consortium of Canadian Chiropractic Research Centers (1998, 2000 and 2002), the Research Agenda Conference (1999–2003), and the Association of Chiropractic Colleges (2001–2003) were searched. The Manual, Alternative, and Natural Therapy Index System database contains the proceedings of the International Conference on Chiropractic and Pediatrics and the International Conference on Spinal Manipulation. The Paediatric Economic Database Evaluation Project produced no citations for spinal manipulation . At the conclusion of these searches, all references were screened to preclude duplication.
The paediatric age range was defined as birth to 18 years of age inclusive. Manipulation was defined as the application of a high velocity short amplitude thrust to a spinal or peripheral joint. Treatment was defined as the application of manipulation in a therapeutic clinical context.
Levels of evidence
The scale of evidence employed by the two reviewers in hierarchical order was systematic reviews, experimental studies (RCT), observational studies (quasi-experimental studies that are controlled but not randomized, such as case control studies or cohort studies), descriptive studies (non-controlled, nonrandomized studies such as case series, case reports, surveys, literature reviews and expert opinions) and, finally, abstracts from conferences.
Inclusion and exclusion criteria
The inclusion and exclusion criteria for documents are described in Table 2. Two reviewers determined in consensus the eligible articles retrieved from the data sources set out in Table 1. They adopted by default the PubMed classification for the papers retrieved from PubMed, including all of the nine RCTs. For the papers from other data sources, the reviewers determined in consensus the eligibility and placement of each paper on the evidence scale. Where the two reviewers disagreed, a third reviewer’s opinion was sought. This occurred with only one paper, an observational study  The papers that did not meet the inclusion criteria were deleted.
One thousand seven hundred thirty-one articles were identified. Of these, 166 discrete documents met the eligibility criteria for the present study (Table 3). The bibliography is available to readers on request.
One systematic review on infantile colic was completed by the Canadian Coordinating Office for Health Technology Assessment in December 2003 . Four reports met that review’s inclusion criteria. These reports described four RCTs (two published in peer-reviewed journals, one conference abstract and one unpublished manuscript) with spinal manipulation performed by chiropractors. The quality scores were measured by the Jadad scale. The systematic review concluded that there is no convincing evidence that spinal manipulation alone can affect the duration of infantile colic symptoms; the effect of spinal manipulation on sleep time, parental anxiety, quality of life and the number of infants meeting diagnostic criteria for colic could not be determined with the available evidence; and the potential harm from the spinal manipulation of infants with colic could not be determined with the available evidence from the RCTs.
The nine RCTs involved a total of 590 children [13–21]. Two trials on asthma involved 80  and 36 children . Spinal manipulations were performed by chiropractors in all the studies. The first trial  concluded that in children with mild or moderate asthma, the addition of chiropractic spinal manipulation to usual medical care provided no benefit. In the second trial , after three months of combining chiropractic spinal manipulation with optimal medical management for paediatric asthma, the children rated their quality of life substantially higher and their asthma severity substantially lower.
Two trials on enuresis involved 171  and 46 children . All spinal manipulations were performed by chiropractors. The first trial  concluded the study results do not support the claim that chiropractic care in enuretic children is an effective therapy for this condition. The second trial  concluded that the study results strongly suggest that chiropractic treatment for primary nocturnal enuresis is effective.
Two trials on infantile colic involved 50  and 86 children , respectively. All spinal manipulations were performed by a chiropractor. In the first trial  the study concluded that spinal manipulation is effective in relieving infantile colic. In the second trial  the study concluded that chiropractic manipulation is no more effective than placebo in the treatment of infantile colic.
One trial  on chronic otitis media was a feasibility study involving 22 children with spinal manipulation performed by a chiropractor. It concluded that recruitment for a RCT is feasible and could be enhanced by medical collaboration.
One trial  on jet lag involved 15 children with spinal manipulation performed by a chiropractor. It concluded that chiropractic care did not reduce the effects of jet lag.
One trial  on radial head subluxation involved 84 children. Manipulation of the radial head was performed by a physician. The study concluded that in the reduction of radial head subluxations, the hyperpronation technique required fewer attempts and was successful more often than supination. It also noted that the hyperpronation technique was often successful when supination failed.
There was one observational study  involving 24 children with manipulation performed by chiropractors. It concluded that chiropractic treatment was effective for the wide range of symptoms associated with “learning and behavioural impairments resulting from brain damage and/or neurological dysfunction accompanied by impairing emotional overlay”.
The 141 descriptive studies involved a total of 2245 children. The literature retrieved revealed a host of conditions reported by a number of practitioners, primarily chiropractors, who claimed to successfully treat a variety of paediatric health conditions with manipulation. The conditions included, but were not limited to the following: scoliosis, congenital torticollis, juvenile arthritis, strabismus, foot inversion, neurological performance (eg, learning, behaviour and attention), enuresis, Erb’s palsy, infantile colic, asthma, esophoria, fever, shoulder impingement, encopresis, neurogenic bladder, bronchitis, atelectasis, birth trauma, back pain, neck pain, headache, otitis media, seizure, tetraparesis, Bell’s palsy, constipation, disk herniation, lumbar fracture, hemiparesis, Osgood-Schlatter disease, radial head subluxation and developmental delay.
Abstracts at conference proceedings
Fourteen conference proceeding abstracts involving a total of 173 children were identified. Five RCTs involved asthma, autism, infantile colic (n=2), and otitis media, with chiropractors performing all spinal manipulations. The trial on asthma  was a feasibility study with six children. The trial on autism  involved 14 children and concluded that the clinical improvement of autistic children under full spine chiropractic adjustment can be enhanced fourfold and may reach to complete cure if the technique of adjustment is shifted to the upper cervical spine. The first trial on infantile colic  involved 30 children and concluded that chiropractic spinal manipulation is more effective than placebo in the treatment of the symptomatology of infantile colic. The second trial on infantile colic  involved 45 children and concluded that chiropractic spinal manipulation is effective and safe in the treatment of infantile colic. The trial on chronic otitis media  involved 30 children and concluded that there is a significant decrease in the number of days it takes to resolve chronic otitis media using chiropractic care compared with antimicrobial therapy.
The nine descriptive studies involved 48 children with chiropractors performing manipulation for the following conditions: autism, headache, acute otitis media, seizure, difficult breast feeding and torticollis.
There are several limitations in the present review. The authors relied on the databases to capture the full breadth of the available evidence, and while it may be comprehensive, it may not be exhaustive. Some evidence may be currently in the publication process. The inclusion criteria allowed for observational and descriptive studies in addition to RCTs; therefore, the capture rate was high, which some may argue is selection bias. The conference proceedings reported in abstract form usually lacked sufficient detail to scrutinize methodology and/or data analysis, and generally had not been subjected to the same peer-review process as studies published by scholarly journals. The authors did not address the issue of publication bias in child health , and a critical appraisal of the evidence was not performed because there is insufficient high-quality evidence to warrant treating the evidence to explicit statistical methodologies. The present review is further limited by the small sample sizes in some of the RCTs, which should be more properly considered as pilot or feasibility studies.
The risk of potential harm in applying a health intervention must be balanced against the potential benefits, and where the benefits are not yet convincingly grounded in science, the risks cannot be dismissed.
In the absence of systematic reviews and RCTs, simply defaulting to lower levels of evidence as the basis for applying a health procedure may itself be a risk. In the present review, most of the evidence is clinically rated at low levels on the scale of evidence. Practitioners have realized successful outcomes on a single case basis, but the conclusions arrived at may be premature. Yet, some practitioners are quick to generalize such premature conclusions to larger patient populations – a position that is not well grounded in science.
For example, in 1999, Budgell  undertook an extensive literature review and concluded that little original data exist to support the use of spinal manipulation in the treatment of visceral disorders. The review included papers describing 39 disorders or syndromes from the nervous, cardiovascular, respiratory, gastrointestinal and urogenital systems. In 27 of the 39 instances, the use of manipulation to treat a particular visceral disorder was supported by a single paper. Fifteen of the 27 papers referred to a single patient.
Ohlsson and Clark  explained that health care professionals and consumers of health care are overwhelmed by exponentially increasing amounts of information and are challenged on how to critically assess and implement the best available evidence to improve clinical outcomes, reduce costs and increase satisfaction for patients. Klassen et al  expressed similar views with respect to paediatricians in particular. Systematic reviews clearly provide the basis to establish conclusive findings and thereby generalize these scientific findings across populations in a manner that protects and advances the health interests of patients
As a general proposition, health claims made by practitioners with respect to the application of manipulation as a health care intervention for paediatric health conditions, are, for the most part, supported by low levels of scientific evidence. Chiropractors, in particular, employ manipulation for the treatment of a wide variety of paediatric health conditions. The evidence is primarily based on clinical experience, many descriptive case studies and a few RCTs. Interestingly, no RCTs have been published on the treatment of back pain with manipulation in a paediatric population.
There is a need for more rigorous scientific inquiry to examine the value of manipulative therapy for the treatment of paediatric conditions. Clinician and scientists should expeditiously narrow the gap between the clinical and scientific environments to advance the health interests of paediatric patients. The clinical encounter needs to be better grounded on scientific evidence of much higher quality than currently exists. The chiropractic profession should collaborate with paediatricians, family physicians and medical researchers, and undertake multidisciplinary paediatric research to further explore the potential benefits of manipulation.
Physicians are confronted on a regular basis with families who have questions about the use of chiropractic treatments for their children. To give credible advice, doctors need accurate information. However, studies on chiropractic use in children are rarely published in conventional medical journals. To enable physicians to evaluate the literature supporting chiropractic claims, Drs Gotlib and Rupert undertook the challenging task of documenting and classifying the literature on manipulation used almost exclusively by chiropractors to treat a large number of paediatric conditions. They concluded that there are very few randomized, double-blind, clinical trials on the subject and that the overall quality of these and other types of studies is poor. Also, published research into the chiropractic treatment of musculoskeletal disorders such as low back pain in the paediatric age group is almost nonexistent.
It is difficult to disagree with the authors’ conclusion that the needs of children are best served when those who treat them base their decisions on sound scientific evidence from well-designed trials. The following article helps reaffirm the Canadian Paediatric Society statement entitled “Chiropractic care for children: Controversies and issues” (Paediatr Child Health 2002;7:85–9), which encouraged dialogue with parents and chiropractic practitioners without endorsing chiropractic treatment.
Dr Linda Spigelblatt, Hôpital Maisonneuve-Rosemont, Montreal, Quebec, Principal author of “Chiropractic care for children: Controversies and issues”, Community Paediatrics Committee, Canadian Paediatric Society
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