Anthony Rosner, Ph.D.'s Response
to the Balon Asthma Study

NEJM 1998 (Oct 8); 339 (15): 1013-1020

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

Foundation for Chiropractic Education and Research

   PO Box 4689 Des Moines IA 50306-4689

For Immediate Release: October 14, 1998
Contact: Robin R. Merrifield

P.O. Box 9656
Seattle WA 98109
Phone/Fax: 800-343-0549

New England Journal of Medicine Publishes Study on
Chiropractic and Asthma:
FCER's Director of Research Responds

Des Moines, Iowa The publication of "A Comparison of Active and Simulated Chiropractic Manipulation as Adjunctive Treatment for Childhood Asthma" in The New England Journal of Medicine, prompted the following response from Anthony L. Rosner, Ph.D., the Director of Research for the Foundation for Chiropractic Education and Research (FCER).

A casual reading of the Balon and Aker study, published in the October 8, 1998 issue of The New England Journal of Medicine suggests that chiropractic spinal manipulation provides no benefit to patients. What is overlooked are the facts that the design of the study is such that the outcome is all but guaranteed in advance and the benefits of chiropractic manipulation in the management of asthma (suggested in several previously published case studies and clinical trials) are obscured and therefore judged to be nonexistent. At a time when public interest in the application of alternative medicine is rising, it is regrettable that a study with such deep flaws should have found its way to the lead position in such a prominent journal. Major deficiencies of the study are summarized as follows:

• Lack of validity of the sham procedure

With over 20 commonly used techniques and over 100 procedures overall described for chiropractic, there is a great deal of controversy as to what constitutes a proper sham or mimic treatment. Furthermore, with applications to no less than three regions of the patient (gluteal, scapular, and cranial), there is high probability that the sham procedure is invasive and overlaps to a large extent with the maneuvers chosen for the actual manipulation. The problem is compounded by the fact that nearly a dozen chiropractors had to be trained to perform such a procedure with no indication of standardization. The effect of all of this is to minimize or obscure the therapeutic effect that might be observed in an actual adjustment.

• Masking of possible effects by medication

The fact that all patients have been medicated may be necessary from an ethical point of view, but it would be expected to mask the beneficial effects that might have been observed from spinal manipulation. The reader must be cognizant of the fact that the trial reports no benefits in addition to standard medication.

• Vagueness of interaction with the patient

The nature of personal interaction with the patient is ill-defined at best, dubious at worst. No indication is given as to how the practitioner (such as might be seen in the clinic) interacts with the patient except to administer a satisfaction questionnaire. This leads to additional intrigues as it is by no means clear how eligible patients as young as 7 years of age are to answer questions pertaining to "feeling at ease, the skill and the ability of the chiropractor, and overall quality of care."

• Improvements over baseline values in both treatments

The fact that there were significant improvements by intervening with the patients is demonstrated by the declines at 2 months and 4 months of both daytime symptom scores and the number of puffs per day of a beta-antagonist, in addition to small increases in peak expiratory flow rates and pediatric quality of life scores in both groups. Such is to suggest that even in this trial there was significant improvement in the patients enrolled. What is not clear is which form(s) of intervention (global and/or manual) elicited responses and not that contact with the patient in the chiropractor s office under customary clinical conditions fails to provide additional benefits in addition to medication in the management of childhood asthma. It is simply an outmoded concept to assume that simply the presence or absence of cavitation constitutes the difference between chiropractic and no treatment.

• Lack of complete representation of global symptoms

Given the fact that the human diurnal cycle lasts for 24 hours, I am surprised by the lack of data representing nighttime symptoms. In effect, we have been shown only half the picture in this study.

This presentation reflects the challenges and problems of properly designing a clinical trial that involves more than simply ingesting medications that can fully mask the other forms of treatment. Practitioners cannot be blinded in the application of manual therapies, with the result that the authors have relied upon the patients incorrect answers to validate their ignorance of the type of treatment applied despite the fact that nuances of emotion or expectations of the therapist would be expected to be conveyed to the patient.

What is needed is far more sensitivity to the actual nature of asthma. Since it is exacerbated by stress by a plausible mechanism, one would hope in the future to measure suitable indicators of stress (such as cortisol levels) in assessing the outcomes of asthma treatments. The chiropractor remains an ideal candidate for the evaluation of such procedures, and it is hoped that the current trial appearing in The New England Journal of Medicine will not be in any way a deterrent to much-needed future research.

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