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FCER Funds Multisite Clinical Trial in Australia to Assess Responsiveness of Asthmatics to Chiropractic Care

For Release: December 7, 2000
Contact: Robin R. Merrifield
1304 Perry Ave., Bremerton WA 98310
Phone: 360-471-7837/ Fax: 360-478-0834
E-mail: FCERedit@aol.com • Web: www.FCER.org

Des Moines, Iowa—The Board of Trustees for the Foundation for Chiropractic Education and Research (FCER) has approved funding for a multisite clinical trial to 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 in Sydney, Australia.

The aim of this undertaking is to mount a clinical investigation at 10 sites to 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 4 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 3 groups as follows: [i] those receiving chiropractic treatment at the clinics, [ii] those receiving no chiropractic treatment but visiting the clinic the same number of times as the treated group for monitoring, and [iii] those receiving no chiropractic treatment and being monitored at home. The fourth nonasthmatic group would undergo a regimen identical to Group iii above.

Two weeks will be allowed for a pre-trial baseline period, followed by one of the four techniques indicated above for a 6-week period, with chiropractic treatments (if indicated) administered 3 times per week. This in turn would be followed by 6 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 osmolality (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 which suggest that [i] a statistically significant pattern of spinal dysfunction is observed in young asthmatics, [ii] anxiety is associated with asthma, and [iii] cortisol levels may decrease in asthmatics following spinal manipulation. All biochemical markers will be measured from salivary samples that will be frozen after being taken from each subject at 8 am and 8 pm to coincide with the highest and lowest levels of cortisol that are routinely seen in people over the course of a 24-hour period.

This project transcends what was observed in an earlier, more limited clinical trial which 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 which 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.¹ Massage itself has since been demonstrated to produce significant improvements in asthma symptoms and lung function with depressed cortisol levels in children,² a favorable indication.

As in any research endeavor, sophistication grows with experience and data obtained—and the entire clinical research world now has come to the realization that so called sham or mimic procedures (contact procedures using lower forces than involved in the adjustment itself) involving physical methods of healthcare intervention need to be approached with extreme caution, as they may skew the ultimate findings. 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:

• Over 17,000,000 Americans suffer from asthmatic symptoms, the number more than doubling since 1988.³ 

• The disease is the leading cause of school absence in the United States, with the prevalence rates in children under 5 years of age increasing 160% from 1980-1994.³ 

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

REFERENCES:

¹Balon 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. New England Journal of Medicine 1998; 339(15): 1013-1020. Back

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

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

⁴Wickens K, Pearce N, Crane J, Beasley R. Antibiotic use in early childhood and the development of asthma. Clinical and Experimental Allergy 1999; 29: 766-771. Back

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