Clinical trial: Asthmatics and chiropractic

Journal of the American Chiropractic Association, Feb 2001

Funded by the Foundation for Chiropractic Education and Research (FCER), a multi-site clinical trial will be conducted in Australia over the next 18 months. The investigation, entitled "A Multisite Trial: Chiropractic and Asthma with Physiological Markers," is directed by Ray Hayek, Bsc (Hons), MChiro, at Macquarie University, Sydney, Australia.

A clinical trial at 10 sites will assess the effects of chiropractic techniques (Activator, Gonstead, Diversified, and Sacral Occipital) on both the physiological and global symptoms of patients with asthma. A total of 420 subjects, 315 of whom suffer from asthma, will be divided into four groups of 105 each and tracked according to a parallel study design. The asthmatics who are already under medical management will then be divided into three groups-those receiving chiropractic treatment at the clinics; those receiving no chiropractic treatment but visiting the clinic the same number of times as the treated group for monitoring; and those receiving no chiropractic treatment and being monitored at home. The fourth non-asthmatic group will also receive no chiropractic treatment and be monitored at home. Two weeks will be allowed for a pretrial baseline period, followed by one of the four interventions indicated above for a six-week period, with chiropractic treatments administered three times a week. This, in turn, would be followed by six weeks of post-trial readings. The novel outcome measure in this trial is the assessment of stress by measurement of salivary cortisol and IgA against the internal standards of albumin, creatinine, and rate of salivary production. Respiratory status will be determined by spirometry to measure lung function. Functional status outcome variables include DASS (Depression and Anxiety Stress Scale), SF-36 (general health status), VAS (visual analogue scale), and a wellness inventory.

This research plan has been propelled by previous studies that suggest:

a statistically significant pattern of spinal dysfunction is observed in young asthmatics

anxiety is associated with asthma, and

cortisol levels may decrease in asthmatics following spinal manipulation.

All biochemical markers will be measured from salivary samples that are frozen after being taken from each subject at 8 am and 8 pm, the peak and nadir phases of the circadian rhythm in humans. This project transcends what was observed in an earlier, more limited clinical trial that had received funding from a variety of sources within the chiropractic community. The focus of this previous trial was to attempt to differentiate high-velocity thrusting from a sham procedure that involved significant contact with the patient. Although symptom improvement was observed in both treatment and control groups, the differences between the two did not appear to be statistically significant. In this previous investigation, the "control" group received soft-tissue massage, distraction, and palpation to multiple regions of the body. Massage itself has since been demonstrated to produce significant improvements in asthma symptoms and lung function with depressed cortisol levels in children.2

As in any research endeavor, our sophistication grows with experience and data obtained-and the entire clinical research world now realizes that so-called sham or mimic procedures involving physical methods of health care intervention should be approached with extreme caution. This is why the completion of this new Australian trial becomes an issue of highest priority.

Asthma has to be regarded as a major health concern in the United States because of the following:

Over 17,000,000 Americans suffer from asthmatic symptoms, a number that has more than doubled since 1988.3

Asthma is the leading cause of school absence in the United States, with the prevalence rates in children under 5 years of age increasing 160 percent from 19801994.3

Even more ominous is a recent report suggesting that in early childhood, the odds ratio for asthma occurrence increases up to fourfold with antibiotic use, the risk apparently being dose-dependent and especially pronounced if antibiotics are used within the first year of life.4

Further information id available at www.FCERorg. The Foundation for Chiropractic Education and Research is seeking support to help underwrite the quarter of a million dollars that it has underwritten for this important project. Contact DeAnna Beek at 704 East 4th Street, Des Monee, IA, 50309; 515/282-7118 or 800/622-6309.

References

1. Baton J, Aker PD, Crowther ER, Danielson C, Cox PG, O'Shaugnessy D, Walker C, Goldsmith CH, Duku E, Sears MR A comparison of active and,simulated chiropractic manipulation as adjunctive treatment for childhood asthma. NEJM, 1998; 339 (IS): 1013-1020.

2. FieD T, Henteleff T, Hernandez-Reif M, Martinez E, Mavunda K, Kuhn C, Schanberg S. Children with asthma have improved putmonary functions after massage therapy Journ of Pediatrico, 1998; 132(5): 854-858.

3. The Integrative Medicine Consult,1999; 1 (1): 120, 122.