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Home Chiropractic Research Chiropractic: Efficacy, Safety and Satisfaction Adverse Events Associated With Pediatric Spinal Manipulation: A Systematic Review. What Does the Data Really Show?

Adverse Events Associated With Pediatric Spinal Manipulation: A Systematic Review. What Does the Data Really Show?

Abstract

Background: In a recent issue of the journal Pediatrics, Vohra and her colleagues 1 published the results of their systematic review of the literature on the adverse events associated with the use of spinal manipulative therapy (SMT) in children. Chiropractic, grounded on a holistic and vitalistic approach to patient care, remains a popular choice among parents for the conservative care of their children 2. Some 30 million visits were made by children to chiropractors in 1997 and indications are that these visits continued to increase with subsequent years 3. While Vohra et.al. 1 are to be commended for their efforts to fill the “virtually non-existent” database on this aspect of children’s care, a critical appraisal of their article brought forth issues germane to the practice of pediatric chiropractic 4 – the least of which are their findings that chiropractic care of children have resulted in misdiagnosis and/or inappropriate provision of chiropractic and adverse events may be associated with spinal manipulation therapy in children.

Methods: Vohra et.al. 1 searched the following electronic databases: Central [Second Quarter, 2004], Medline [1966-2004], PubMed [1966-2004], Embase [1988-2004], CINAHL [1982-2004], AltHealth [1990-2004], MANTIS [1900-2004] and  ICL [1985-2004]. Their initial search identified a total of 13,916 articles for consideration. An initial screening defined 164 articles for full review from the above pool with another 68 articles from a review of the reference lists and by contacting authors of included reports and experts in the field. Their predetermined study selection criteria consisted of (a) The study was a primary investigation/report (i.e., case report, case series, case control, randomized controlled trials and survey or surveillance studies) (b) Part or all of the study population was 18 years or younger and (c) Adverse events were reported were applied and identified 13 studies – 10 from the English language, 2 French and 1 German article. According to Vohra et.al. 1, 2 of the articles were RCTs, 4 case series, and 7 case reports. From this list, 14 cases of direct adverse events were identified.

Of the 14 cases reporting direct adverse events associated with pediatric spinal manipulation, 10 were attributed to chiropractic. It is these 10 events that are re-examined with the findings described using descriptive statistics. Furthermore, Vohra et.al. 1 identified 20 cases leading to a delayed diagnosis and/or inappropriate provision of chiropractic care that resulted in indirect adverse events. The literature base from which these cases were derived was also re-examined. The results are described using descriptive statistics.

Results: Of the 10 cases attributed to a direct adverse event attributed to chiropractic care, 9 were immediately retrievable for this study. The results of the re-analysis are provided in Table 1. What becomes obvious is that due to the lack of quantity and quality of the spontaneous reports re-examined and with due consideration of confounding variables (i.e., pre-existing morbidity and history of trauma), cause and effect inferences by Vohra and her colleagues were unsupported and lead to suspect their conclusion that adverse events may be associated with SMT as attributed to chiropractic care.

A re-examination of the 20 cases leading to a delayed diagnosis and/or inappropriate provision of chiropractic care that resulted in indirect adverse events is provided in Table 2. What becomes apparent after a thorough examination of the literature base from which these cases were derived indicates a violation of the selection criteria. Of the three references cited for these 20 cases, 2 were retrievable for examination and found to be Letters to the Editor while the referenced textbook with anti-chiropractic sentiments was not.

The authors further comment on risk factors associated with spinal manipulation of children were poorly supported with 4 cited references. These did not involve clinical trials or longitudinal studies, etc. that address risk, are not appropriate for the pediatric population and/or poorly translate to the cervical spine. Vohra et.al. comment throughout their article that SMT is some homogenous procedure demonstrating their naiveté on the myriad of techniques available on the use of SMT in children.

Conclusion: In the article by Vohra and colleagues, cases attributing direct adverse events associated with pediatric spinal manipulation as a result of chiropractic care were inappropriate and cases leading to a delayed diagnosis and/or inappropriate provision of chiropractic care were unsubstantiated.

Type of Adverse Event

Adverse Event

Gender and Age

Relevant Medical Diagnosis

Relevant Patient History Not Revealed in Vohra et.al.

Severe

Quadriplegia secondary to spinal cord astrocytoma and SM; regressed to paraplegia (18 mo postoperatively)

Male/ 4 month old

Congenital torticollis; spinal cord astrocytoma

Tumor infiltration described mostly as necrotic tissue in the cervical and thoracic spine

 

Progressive neuromuscular deficits in legs, clonus at rest, urinary urgency and frequency, paraplegia

Female/ 12-yr-old

Osteogenesis imperfecta, head, neck, and low-back pain

History of multiple fractures of the limbs and recently fell resulting in a “sagging chin”

 

Severe occipital and bifrontal headache, vomiting, left facial weakness, diplopia, ataxia

Male/ 7-yr-old

Intermittent headaches

Prior to DC care, suffered from headaches OFTEN following gymnastics exercises in which he attempted mid-air summersaults, landing on the occiput and cervical spine.

 

Neck pain and progression to unsteady gait, poor coordination, drowsiness, and hospitalization; delayed diagnosis of congenital occipitalization

Female/12-yr-old

Neck pain resulting from congenital torticollis

Fell from the upper bunk-bed on her head, accidentally crushed in a collision with playmates and falling backwards prior to chiropractic care. Following initiation of DC care, the patient fell from her bicycle and fell on her head.

Moderate

Severe headache and stiff neck

?/4-15-yr-old

Nocturnal enuresis

From a prospective study examining chiropractic care and nocturnal enuresis. Self-liming and did not require MD care

Moderate

Acute Lumbar Pain

?/4-15-yr-old

Nocturnal enuresis

Same as above

Minor

Irritability

?/6 month-6-yrs

Nocturnal enuresis

From feasibility study of chiropractic care versus sham spinal manipulation for chronic otitis media with effusion in children

Minor

Mid-Back Soreness

?/6 month-6-yrs

Nocturnal enuresis

Same as above

Minor

Loss of consciousness

Female/ 10-yr-old

Headache and Nausea

Retrospective findings from patient file examining the safety of the chiropractic care of cervical spine and the rate of cerebrovascular accidents.

Table 1. Cases Associated with Direct Adverse Event Attributed to Chiropractic

 

Adverse Event

Reference Type

Rating

Delayed treatment for choriocarcinoma

Letter to Editor

Poor Evidence

Delayed treatment for aggressive osteosarcoma

Letter to Editor

Poor Evidence

Delayed treatment for posterior fossa ependymoma

Letter to Editor

Poor Evidence

Delayed treatment for acute lymphocytic leukemia

Letter to Editor

Poor Evidence

Delayed treatment for testicular carcinoma

Letter to Editor

Poor Evidence

Delayed treatment for metastatic neuroblastoma

Letter to Editor

Poor Evidence

Delayed treatment for metastatic neuroblastoma

Letter to Editor

Poor Evidence

Delayed treatment for reactive cervical adenitis

Letter to Editor

Poor Evidence

Delayed treatment for encopresis with learning disability

Letter to Editor

Poor Evidence

Delayed treatment for otitis media

Letter to Editor

Poor Evidence

Delayed treatment for Crohn disease

Letter to Editor

Poor Evidence

Delayed treatment for complex partial seizures

Letter to Editor

Poor Evidence

Delayed treatment for hypertension with unilateral kidney disease

Letter to Editor

Poor Evidence

Delayed treatment for iron-deficiency anemia

Letter to Editor

Poor Evidence

Delayed treatment for severe rheumatoid arthritis

Letter to Editor

Poor Evidence

Delayed treatment for slipped femoral epiphysis

Letter to Editor

Poor Evidence

SAE involving delayed medical treatment for meningitis and death after 4 mo of care

Medico-legal text

Poor Evidence

SAE involving delayed medical treatment for embryonal rhabdomyosarcoma and death after 5 mo of care

Medico-legal text

Poor Evidence

SAE involving delayed medical treatment for meningitis and death

Medico-legal text

Poor Evidence

Table 2. Case involving misdiagnosis and/or provision of inappropriate chiropractic care.

 

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):e275-83. Epub 2006 Dec 18
  2. Spigelblatt L, Liane-Ammara G, Pless B, Guyver A. The use of alternative medicine by children. Pediatrics. 1994;94:811–814
  3. Lee AC, Li DH, Kemper KJ. Chiropractic care for children. Arch Pediatr Adolesc Med 2000 Apr;154(4):401-7
  4. Alcantara J, Plaugher G and Anrig C. Pediatric chiropractic. In: Redwood D and Cleveland C. Fundamentals of Chiropractic. Mosby Inc. 2003

Joel Alcantara, BSc, DC 1

  1. Research Director, International Chiropractic Pediatric Association, Media, PA, USA and Private Practice of Chiropractic, San Jose, CA, USA

Presented at WFC Annual Conference. Portugal, May 2007.