Published online June 1, 2007
PEDIATRICS Vol. 119 No. 6 June 2007, pp. 1261-1264 (doi:10.1542/10.1542/peds.2007-0124)

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LETTER TO THE EDITOR

Adverse Events in the Manipulation of Pediatric Patients: Flaws in a Systematic Review

Anthony Rosner, PhD, LLD
Foundation for Chiropractic Education and Research
Brookline, MA 02446

To the Editor.—

There is no question that the issue of safety in spinal manipulation, as with any medical intervention, needs to be thoroughly addressed if it is to be considered an effective and broadly used modality of health care. That said, numerous articles, often containing numerous methodologic flaws,^1–3 together with responses^4–6 have appeared in the literature addressing the issue of manipulation (usually cervical) in adults. The recent article by Vohra et al⁷ was one of the first to attempt to more comprehensively cull the observational studies as well as the randomized clinical trials to date in assessing the safety matter of manipulation as it pertains to children. It correctly stated that there is useful information to be gleaned from the case studies as well as the more rigorous clinical trials.

That said, however, there are flaws significant enough to invalidate 2 of the authors’ key objectives:

COMPLETENESS AND ACCURACY OF THE SYSTEMATIC REVIEW

The authors’ claim that they thoroughly searched the literature is threatened in their introduction, where they completely omitted any reference to the clear benefits of spinal manipulation in treating otitis media, as reported in 2 large cohort studies published in the indexed literature by Froehle⁸ and Fallon and Edelman.⁹ Of far more gravity, however, is the fact that they reported a series of 14 cases of direct adverse events and that "each case involved a chiropractor and was reported in the United States." From 1 of the references cited, however, the treating doctor was most decidedly not a chiropractor but, rather, a physical therapist,¹⁰ most likely practicing not in the United States but in Germany, where chiropractors are outnumbered by >150-fold by medical doctors legally performing >14 million treatments yearly in the spinal area, practicing what they call "chirotherapy."¹¹

Another citation of a "direct adverse event" involved a feasibility study for enrolling children affected by otitis media into a clinical trial involving spinal manipulation by chiropractors. The presumed seriousness of this "adversity" was reported as follows:

There were no serious side effects as a result of either the active or placebo chiropractic treatments. One parent in the active treatment group reported that their child had some mid-back soreness after one treatment that had resolved after a few days, and another child was reported by the parent as being irritable for a short time after treatment. One parent of a child in the placebo chiropractic group reported excessive crying by the child after treatment.¹²

Besides seeming to be a truly minor event that is almost misleading to classify as "adverse," the difference of these transient setbacks between active and placebo chiropractic treatment groups seems sufficiently narrow as to call into question data such as these. Simply speaking, are these presumably negative effects even valid enough to have been admitted into the Vohra et al study?

The most troubling reference in this study pertains to 3 cases of delayed treatment for the life-threatening conditions of meningitis and embryonal rhabdomyosarcoma in 1 of the articles included in the review. Besides not even being a direct consequence of spinal manipulation per se, the delayed diagnoses referred to by the authors are not even given any mention in 1 of the citations presented. Instead, this particular article focused solely on cerebrovascular incidents that follow chiropractic treatment.¹³ Oddly, the authors seemed to retract their own implication by stating as 1 of their study limitations that "our search strategy did not allow for systematic identification of indirect adverse events (eg, delayed or missed diagnoses)."⁷ If that was, in fact, the case, why was it discussed earlier in their article as indicated above?

These examples are sufficient to call into question whether the Vohra et al study even accomplished its minimal objective, which was to present an accurate and balanced assessment of the literature pertaining to the adverse events associated with spinal manipulation, presumably by chiropractors as set out by the authors in their introduction.

THE NEED TO QUANTIFY THE RISK ASSOCIATED WITH MANIPULATION

After discussing the supporting and dissenting viewpoints on spinal manipulation in children, the authors rightfully stated that "[t]here is an urgent need to quantify the risk associated with spinal manipulation in children." In addition to including events that could hardly be considered "adverse" by most accounts, the authors concluded that the reports sampled in their study did "not provide information on the incidence of adverse events because of the lack of data regarding the total number of manipulations provided (ie, denominator data)."⁷ Thus, the primary purpose of the Vohra et al study seems to remain unanswered. In addition, there are some lesser concerns.

Categories of Classification of Adverse Events
The authors’ categorization of the adverse events into 4 categories (adverse, severe, moderate, and minor) has not been validated. Furthermore, categorizing hospitalization as severe per se seems to ignore the fact that nonhospitalized occurrences could be more intense and disabling at times. Finally, the authors categorically assigned a fifth category (delayed diagnosis or treatment) as a "moderate to severe" adverse event. However, there seems to be no systematic or rational basis for this last classification.

Unreported Adverse Events
The authors rightfully reported that underreporting of adverse events in branches of medicine outside of chiropractic may be widespread, and cited a study that suggested that <10% of serious adverse events are reported as drug reactions.¹⁴ In reporting major incidents in hospitals, 1 Harvard School of Public Health professor indicated that many medical errors are barely investigated because of the lack of resources. In fact, only 20 states require the reporting of medical errors at all.¹⁵ Spinal manipulation, by comparison, would seem to involve far fewer numbers with overall less severity than what has occurred in the medical arena. Such is not to exonerate chiropractic from responsibility in safety matters but simply to make it clear that the authors have significantly weakened their case for this study, having made chiropractic safety a more pressing matter by stating that "[g]iven the large numbers of children who have received spinal manipulation during the decades assessed by our search strategy, adverse events resulting from spinal manipulation are either remarkably rare [italics mine] or underreported."⁷

Specification of Maneuvers
"Rapid and/or strong rotational maneuvers" were specified by the authors as having precipitated 2 of the 4 serious adverse events.⁷ Yet, 1 of the studies used a physical therapist and not a chiropractor as erroneously stated by the authors,¹⁰ as pointed out earlier. The other study they cited is dated almost 30 years ago,¹⁶ which leads one to suspect, or at least hope, that significant enlightenment and progress has been made since then.

Spontaneity of Events
By citing a study that suggests that >1 in 3 spontaneous case reports of rare or uncommon adverse events is unlikely to be coincidental,¹⁷ the authors create the impression that the same holds true for spinal manipulations. Recently, by far the majority of serious adverse events associated with spinal manipulation have been linked to the chiropractic treatment of the cervical region leading to vertebral artery dissections.^1–3 However, it has been pointed out that the rate of spontaneous arterial dissections ranges from 1 to 3 per 100000,^18,19 which may be as much as 10 times the rates of arterial dissections that have been attributed (and not even linked causally) to spinal manipulation.^4,5 Therefore, the Vohra et al study may have created a misleading impression that spinal manipulation is a more serious problem than has been currently regarded. In reality, the responses to the topic of cervical manipulation of the mass media in particular have sometimes approached hysterical dimensions in reaction to the flawed investigations cited involving adult patients.⁶

CONCLUDING REMARKS

From several vantage points, the Vohra et al study fell short of the mark of having achieved its objectives or even maintaining its credibility as a systematic review of the literature pertaining to cervical manipulation. For these reasons and its inexplicable inaccuracies within a framework of peer review that is designed to eliminate such fallacies, the Vohra et al study can be greeted only with the most extreme skepticism.

REFERENCES

1. Smith WS, Johnston SC, Skalabrin EJ, et al. Spinal manipulative therapy is an independent risk factor for vertebral artery dissection. Neurology. 2003;60 :1424 –1428[Abstract/Free Full Text]
2. Lee KP, Carlini WG, McCormick GF, Walters GW. Neurologic complications following chiropractic manipulation: a survey of California neurologists. Neurology. 1995;45 :1213 –1215[Abstract]
3. Rothwell DM, Bondy SJ, Williams JI. Chiropractic manipulation and stroke: a population-based case-control study. Stroke. 2001;32 :1054 –1060[Abstract/Free Full Text]
4. Rosner AL. Spontaneous cervical artery dissections and implications for homocysteine. J Manipulative Physiol Ther. 2004;27 :124 –132[CrossRef][Web of Science][Medline]
5. Rome PL. Perspective: an overview of comparative considerations of cerebrovascular accidents. Chiropr J Austr. 1999;29 :87 –102
6. Rosner A. CVA risks in perspective. Manuelle Medizin. 2003;41 :215 –223[CrossRef]
7. Vohra S, Johnston BC, Cramer K, Humphreys K. Adverse events associated with pediatric spinal manipulation: a systematic review [published correction appears in Pediatrics. 2007;119:867]. Pediatrics. 2007;119(1). Available at: www.pediatrics.org/cgi/content/full/119/1/e275
8. Froehle RM. Ear infection: a retrospective study examining improvement from chiropractic care and analyzing for influencing factors. J Manipulative Physiol Ther. 1996;19 :169 –177[Medline]
9. Fallon J, Edelman MJ. Chiropractic care of 401 children with otitis media: a pilot study [abstract]. Altern Ther Health Med. 1998;4 :93
10. Jocobi G, Riepert TH, Kieslich M, Bohl J. Case of death during physical therapy according to Vojta [in German]. Z Physiother. 2001;53 :573 –576
11. Graf-Baumann T, Mohrle A, Weisbauer W. Investigation and Treatment [in German]. Ebelsbach, Germany: DIOmed Verlags; 2003:2
12. Sawyer CE, Evans RL, Boline PD, Brantson R, Spicer A. A feasibility study of chiropractic spinal manipulation versus sham manipulation for chronic otitis media with effusion in children. J Manipulative Physiol Ther. 1999;22 :292 –298[CrossRef][Web of Science][Medline]
13. Klougart N, Lebouef-Yde C, Rasmussen LR. Safety in chiropractic practice, part II: treatment to the upper neck and the rate of cerebrovascular incidents. J Manipulative Physiol Ther. 1996;19 :563 –569[Medline]
14. Nissen SE. ADHD drugs and cardiovascular risk. N Engl J Med. 2006;354 :1445 –1447[Free Full Text]
15. Most D. The silent treatment. Boston Magazine. February 2003:104–138. Available at: www.bostonmagazine.com/articles/the_silent_treatment. Accessed April 10, 2007
16. Zimmerman AW, Kumar AJ, Gadoth N, Hodges FJ 3rd. Traumatic verteobrobasilar artery occlusive disease in childhood. Neurology. 1978;28 :185 –188[Abstract/Free Full Text]
17. Chou R, Helfand M. Challenges in systematic reviews that assess treatment harms. Ann Intern Med. 2005;142 :1090 –1099[Abstract/Free Full Text]
18. Shievink WT, Mokri B, O’Fallon WM. Recurrent spontaneous cervical-artery dissection. N Engl J Med. 1994;330 :393 –397[Abstract/Free Full Text]
19. Shievink WT, Mokri B, Whisnant JP. Internal carotid artery dissection in a community. Rochester, Minnesota, 1987–1992. Stroke. 1993;24 :1678 –1680[Abstract/Free Full Text]

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PEDIATRICS (ISSN 1098-4275). ©2007 by the American Academy of Pediatrics

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This Article Extract Full Text (PDF) Submit a response Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services E-mail this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Alert me to new issues of the journal Add to My File Cabinet Download to citation manager Request Permissions Citing Articles Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Rosner, A. Search for Related Content PubMed Articles by Rosner, A. Related Collections Musculoskeletal System Social Bookmarking                         What's this?