FCER AND ICPA RESPONDS TO PEDIATRICS ARTICLE
 
   

FCER and ICPA Respond to Pediatrics Article

This section is compiled by Frank M. Painter, D.C.
Send all comments or additions to:
   Frankp@chiro.org
 
   

FROM:   FCER's Website

Norwalk, Iowa—
It’s a battle that the chiropractic profession is familiar with—a “scientific” article appears in a medical journal decrying the risks of chiropractic cervical manipulation, and newspapers and television news programs spread the conclusions without either comparison to risks associated with common medical treatments or rebuttal from within chiropractic. The latest front in this battle is over the chiropractic treatment of the pediatric population. Published in the January 1, 2007 issue of Pediatrics, the Journal of the American Academy of Pediatrics, the article “Adverse Events Associated With Pediatric Spinal Manipulation: A Systematic Review,” (FULL TEXT) has quickly reached the airwaves of the popular media.

In response to this latest media cacophony, the Foundation for Chiropractic Education and Research’s (FCER) Director of Research, Anthony L. Rosner, PhD, drafted a response to the editors of the journal. To provide the practicing chiropractors with the rebuttals necessary to answer patient, medical colleague, and possibly local media questions, a version of that response has been drafted. That response follows:

Safety issues surrounding spinal manipulation have received much attention in recent years. However, there has been very little discussion of this topic as it applies to pediatric patients. A new review recently published in the journal Pediatrics addresses this very concern, in what has been labeled as a "systematic review." This is supposed to mean that all the published material in the medical journals has been retrieved, with specific articles having passed certain criteria for their more intensive review and analysis.

Because this approach has not been previously followed for pediatric populations who have experienced spinal manipulation, this study pursues an important goal in today's world of assessing risks and benefits of all medical interventions. It also avoids a common limitation in reviews of this type, in that it embraces case and cohort studies which occur in live doctors' offices as well as clinical trials.

Described in the 13 papers accepted for review are 14 cases of direct adverse events following spinal manipulation. These include 9 cases of serious events (subarachnoidal hemorrhage and paraplegia), 2 moderately adverse events requiring medical attention (severe headache), and 3 minor occurrences (mid-back soreness). Another 20 cases of indirect adverse events involved delayed diagnosis or the inappropriate provision of spinal manipulation for such serious medical conditions as meningitis or rhabdomyosarcoma.

It is both important and commendable that these events have been brought to light in Vohra's report. However, they must be viewed in the larger framework of three factors:

[1] the total number of treatments administered to children;

[2] the relative risks of medical procedures for the same conditions treated; and

[3] the benefits of spinal manipulation in children which have been amply described in the research literature. Lacking these considerations, this review presents a distorted and one-sided assessment of pediatric spinal manipulation.


Unfortunately, the review by Vohra falls short of its goals in its pursuits:

  • Important studies involving pediatric patients who have successfully undergone spinal manipulation in resolving their complaints of ear infections (otitis media) have gone unnoticed.

  • Another study in which the authors attribute adverse events to chiropractors in the United States instead involves physical therapists, most likely practicing in Germany.

  • Yet another citation of adverse events occurring in a clinical trial describes nothing more than a short period of mid-back soreness and irritability, difficult to distinguish from a period of extended crying in another subject who was not even manipulated but was instead assigned to the placebo group.

  • A final group of patients suffered from delayed diagnosis—which the authors erroneously attribute to one study that made no such mention of diagnoses at all but rather focused upon the direct consequences of manipulation per se.


So the question remains whether the authors have truly accomplished their minimal objective. Did they actually present an accurate and balanced assessment of the literature addressing the adverse events associated with spinal manipulation? The answer appears to be in the negative.

It is also not at all clear whether all the spinal manipulations described were in fact administered by qualified chiropractors, an important consideration when one considers the risks involved with individuals who have not received complete training in manipulating areas of the neck. Only when the following criteria are met will a truly "accurate and balanced" assessment of the scientific literature have been made:

  • The precise maneuvers applied to the patient;

  • The complete qualifications of those administering these treatments;

  • The several benefits of manipulations of the cervical area which in the literature have been shown to include the relief of headache, carpal tunnel syndrome, otitis media, colic, and enuresis (bed-wetting).


None of these standards have been met by Vohra's review, such that it can only be greeted with extreme skepticism.

For more information on FCER and its programs, which bolster the chiropractic profession through the support of quality research into the profession and its various modalities, please go to www.fcer.org. FCER is a proponent of evidence-based chiropractic practice and is establishing the Evidence-Based Chiropractic Resource Center. Visit FCER.org on a regular basis for more information on the resources available.


Response from the ICPA

A recent article recently published in the January 1, 2007 issue of the journal Pediatrics (a journal of the American Academy of Pediatrics) addressed the issue of pediatric safety as they pertain to spinal manipulative therapy. The study by Vohra et. al. entitled, “Adverse Event Associated with Pediatric Spinal Manipulation” has incited questions and undue concern from the general public from news headlines that have misinterpreted this article. Our Research Director, Dr Joel Alcantara, has critically appraised the study by Vohra et. al. and the immediately retrievable supporting articles. His findings thus far are very revealing about the true nature of this publication, which he will address in a Letter to the Editor to the journal Pediatrics and in articles to be published within our own profession. We will keep you updated.

As the largest pediatric chiropractic organization in the world, the ICPA is making these comments immediately to the profession (particularly to practicing chiropractors) to assure them that the chiropractic care of children is safe. The ICPA is making these comments:

“In a review of the scientific literature spanning a period of 104 years, Vohra et. al. ultimately could only identify 14 cases involving adverse events associated with spinal manipulation. Of these, 10 were associated with chiropractic care. Of the 10 cases, 5 patients experienced only minor adverse events (i.e., sore and stiff neck, sore back) that were self-limiting, did not require medical attention and cared for successfully by the treating chiropractor. Incidentally, 2 of the 5 cases were incorrectly sub-typed by Vohra et. al. Of the articles documenting the 5 cases associated with severe adverse events (i.e., required medical care) from chiropractic care, 4 were immediately retrievable. What does the date really show?

What becomes apparent after reading these articles are the following. The patients had a pre-existing condition that are associated with the patient’s adverse events and/or had a history of significant trauma (i.e., gymnastic somersaults and falling on their head and neck) prior to presenting to the chiropractor. To make cause and effect inferences (i.e., chiropractic care directly caused the adverse events) from these case reports are inappropriate. Furthermore, Vohra et.al’s cited cases involving delayed diagnosis and/or inappropriate provision of chiropractic care was based on testimonials and anecdotal evidence. Vohra et. al.’s conclusion that “serious events may be associated with pediatric spinal manipulation” are unsubstantiated by the scientific literature and reflect a suspicious agenda against chiropractic by those who interpret it otherwise.”

The ICPA recognizes the need and is committed to performing research on the safety and effectiveness of the chiropractic care for children. Based on our Research Department review, we have prepared: a statement for your concerned patients, a press release for your local papers and a new alert for your office newsletters. Next week, you will have on-line access to these articles. Stay on the look out for next PedEx.


ICPA Research Director's Letter to the Editor of Pediatrics


To the Editor

In a recent issue of the journal Pediatrics, Vohra et.al. [1] performed a systematic review of the literature for articles that document adverse events associated with spinal manipulation of pediatric patients. It is the responsibility of every healthcare profession to address adverse events associated with their types of care for the safety and effective delivery of such a care. Vohra et.al. [1] are to be commended at their attempt to fill the “virtually non-existent” database on this aspect of children’s care. However, upon further examination of their article, issues brought forth as well as issues germane to the use of spinal manipulative therapy (SMT) in children require further comment.

Vohra et.al. [1] discovered 14 cases of “direct adverse events” associated with SMT in children. Ten of these cases involved a chiropractor. It is these 10 cases I would first like to address. Upon further examination of the cited references involving chiropractic and adverse events, what becomes apparent are the following. Vohra et.al. incorrectly applied their own adverse event classification scheme. The two cases (i.e., severe headache/stiff neck and acute lumbar pain) cited as a moderate adverse events in Le Boeuf et.al. [2] were in fact minor adverse events as they were self-limiting and did not require further medical care.

Of the 5 cases classified as severe adverse events involving chiropractic, 4 were immediately retrievable by this author for further examination. The article by L’Ecuyer [3] involved a 12-yr-old girl with a history of a fall “from her upper-bunk bed hitting her head” resulting in one to two frontal headaches per week. Furthermore, she was “accidentally crushed in a collision of several playmates from which she fell backward to the ground.” In between chiropractic care, she ‘fell from her bicycle hitting her head.”  The case cited by Zimmerman et.al. [4] involved a  7-yr-old boy with recurrent headaches. What was not apparent in the paper by Vohra et.al. was that prior to attending chiropractic care, the patient suffered from “headaches without prodrome, on either side, once or twice a week , often following gymnastic exercises in which he attempted mid-air sommersaults, landing on the occiput and cervical spine.” The article by Ziv et.al. [5] described a 12-yr-old female with osteogenesis imperfecta, a history of multiple fractures of the limbs and a sagging chin following a fall prior to chiropractic. Again, this information was not apparent in the paper by Vohra et.al. [1]. The article by Shafir and Kaufman [6] attribute the patient’s demise to chiropractic due to a close temporal association between the patient’s visits to the chiropractor and neurological deterioration. We are also led to believe the same from Vohra et.al. [1]. However, a closer examination of the paper by Shafir and Kaufman [6] indicate that the 4-month-old patient had an intraspinal mass prior to chiropractic SMT that may have compromised the blood supply to the tumor and his spinal cord. Furthermore, a pathologic examination of the lower cervical and thoracic portions of the tumor revealed mostly necrotic tissue. As one can plainly see from an examination of the cases cited by Vohra et.al. [1], attributing “direct adverse events”  to chiropractic care is questionable given the pre-existing morbidities and/or histories of trauma. Furthermore, it would seem that Vohra et.al. [1] did not heed to their own comments that, “serious concerns regarding both the quantity and quality of these spontaneous reports limit assessment of causation.” Hence, I take issue with their conclusion that “serious adverse events may be associated with pediatric spinal manipulation.”

Of the 20 cases cited by Vohra et.al. [1] resulting in delayed diagnosis or inappropriate provision of chiropractic care; upon further examination of the references cited, they too require further comment. Vohra et.al. [1] violated their own study selection criteria of primary investigations/reports. The references cited by Vohra et.al. were Letters to the Editor or a textbook citing a medico-legal case that could hardly count as primary investigations/reports. Again, to make such bold remarks attributing delayed diagnosis or inappropriate provision of chiropractic care in these testimonials reflects a lack of appreciation for making cause and effect inferences, of which they seem to comment upon only when it suits their needs.  To further postulate that this is due to a lack of sufficient training for CAM providers is unwarranted and egocentric.

Vohra et.al. [1] commented on the need for randomized clinical trials (RCT) and population-based samplings for providing or refuting causation between pediatric SMT and serious adverse events as well as developing risk estimates. Yet, they boldly comment on the risk factors that may predispose a child to an adverse event including [1] immaturity of the spine [2] rotational manipulation and [3] high-velocity spinal manipulation. Their 4 supporting articles for these comments are inappropriate in that they do not involve an RCT or a population-based longitudinal study, have questionable appropriateness in translating to the pediatric population or the cervical spine and is not as a result of an exhaustive review of the literature on risk indicators/factors on the use of SMT in children. An appreciation for the unique biomechanical features of the pediatric spine alone as well as the many available SMT techniques would lead one to suspect their naiveté on the use of SMT in children.

In closing, I would like to make one final point. Given that the literature search by Vohra et.al. [1] involved a 104 year time span and found only 10 cases involving chiropractic care of questionable circumstances as well as indications that millions of visits are made by children to chiropractors – ceteris paribus – “all other things being equal” – it would seem more appropriate to conclude what we in the chiropractic profession have always advocated – that there lacks sufficient evidence to indicate that the use of SMT in children is harmful.

Joel Alcantara, DC
Private Practice of Chiropractic

Research Director
International Chiropractic Pediatric Association


References:

  1. Vohra S, Johnston BC, Cramer K, Humphreys K.
    Adverse Events Associated With Pediatric Spinal Manipulation: A Systematic Review
    Pediatrics 2007 (Jan);   119 (1):   e275–283     Epub Dec 18, 2006

  2. Le Boeuf C, Broen P, Herman A, et.al.
    Chiropractic Care of Children with Nocturnal Enuresis; A Prospective Outcome Study
    J Manipulative Physiol Ther 1991 (Feb);   14 (2):   110–115

  3. L’Ecuyer JL.
    Congenital Occipitalization of the Atlas with Chiropractic Manipulations: A Case Report
    Nebr State Med J 1959 (Nov);   44:   546–550

  4. Zimmnerman AW, Kumar AJ, Gadoth N, and Hodges FJ.
    Traumatic Vertebrobasilar Occlusive Disease in Childhood
    Neurology 1978 (Feb);   28 (2):   185–188

  5. Ziv I, Rang M, Hoffman HJ.
    Paraplegia in Osteogenesis Imperfecta
    J Bone Joint Surg Br. 1983 (Mar);   65 (2): 184–185

  6. Shafir Y and Kaufman BA.
    Quadraplegia After Chiropractic Manipulation in an Infant with Congenital Torticollis Caused by a Spinal Cord Astrocytoma
    J Pediatr 1992 (Feb);   120 (2 Pt 1):   266–269





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