Clinical Problem Solving Strategies

1. Clinical Problem Solving Strategies

2. Chiropractic care for asthma • A Comparison of Active and Simulated Chiropractic Manipulation as Adjunctive Treatment for Childhood Asthma • Balon, M.D., et al • Aker, D.C., Rowther, D.C. • The New England Journal of Medicine • October 8, 1998 • Volume 339, Number 15 Evidence-based Chiropractic

3. Why this study was done • There have been reports that chiropractic spinal manipulation is beneficial for non-musculoskeletal conditions, including asthma (by DCs and DOs) • 45 percent of families with a family member with asthma had consulted a practitioner of alternative medicine, most often a chiropractor, for management of the disease (in Brisbane, Australia) Evidence-based Chiropractic

4. Why this study was done cont. • “Chiropractic theory states that the correction of subluxation by manipulation, with restoration of normal mechanical and nerve function, should improve airway function and aid in the resolution of asthma.” Dhami MSI, DeBoer KF. Systemic effects of spinal lesions. In: Haldeman S, ed. Principles and practice of chiropractic. 2nd ed. Norwalk, Conn.:Appleton & Lange, 1992:115-35. Evidence-based Chiropractic

5. Why this study was done cont. • The long-term use of b-agonists and inhaled corticosteroids, is controversial because of adverse effects • Consequently an alternative approach that reduces the need for medication would be valuable Evidence-based Chiropractic

6. What was done • “We assessed objective and subjective outcomes in children with asthma who were treated with active or simulated chiropractic manipulation in a randomized, controlled trial.” Evidence-based Chiropractic

7. Methods • Subjects • [inclusion criteria] • Children 7 to 16 years of age with asthma (diagnosed by a physician) for more than one year • Had symptoms requiring the use of a bronchodilator at least three times weekly • Recruited through advertising Evidence-based Chiropractic

8. Subjects cont. • Responsiveness to bronchodilators was required to confirm the presence of asthma • Defined as: • A rise in the forced expiratory volume (FEV) after the use of an inhaled bronchodilator • Or airway hyperresponsiveness to methacholine (a decrease of FEV after administration) Evidence-based Chiropractic

9. Subjects cont. • There had to be evidence of vertebral subluxation on palpation, as determined by a single chiropractor on screening • Excluded if they had other lung diseases, contraindications to spinal manipulation, previously received chiropractic care, had unstable asthma, or if they were noncompliant with their prescribed medical regimen (exclusion criteria) Evidence-based Chiropractic

10. Assessments • Baseline • Questionnaires covering respiratory and musculoskeletal history (qualitative methods) • Spirometry before and after the inhalation of 200 µg of salbutamol (quantitative) • Subjects were instructed to use a flowmeter at home, and to complete a study-specific symptom diary Evidence-based Chiropractic

11. Assessments cont. • Subjects kept track of episodes of nocturnal wheezing and cough, daytime wheezing, cough, chest tightness or breathlessness, production of sputum, and episodes of limitation of activity • After one week, another methacholine challenge was performed • And the Pediatric Asthma Quality of Life Questionnaire was administered Evidence-based Chiropractic

12. Assessments cont. • After another two-week period of evaluation, eligibility was confirmed by a pulmonologist • Then the subjects were randomly assigned to active or simulated treatment Evidence-based Chiropractic

13. Blinding • Except for the treating chiropractor and one investigator, all the participants were blinded to treatment assignment throughout the study • There were 11 experienced chiropractors participating Evidence-based Chiropractic

14. Visit frequency • Subjects visited the chiropractor three times weekly for four weeks, twice weekly for four weeks, then weekly for eight weeks • 20 to 36 visits Evidence-based Chiropractic

15. Intervention • Active chiropractic treatment consisted of manipulation with the subject prone, lying on one side, and supine, in conjunction with the administration of gentle soft-tissue therapy • Vertebral segments were treated as determined by the treating chiropractor • All chiropractors used diversified technique Evidence-based Chiropractic

16. Simulated treatment • Soft-tissue massage and gentle palpation were applied to the spine, paraspinal muscles, and shoulders • A distraction maneuver was performed by turning the subject’s head from one side to the other while alternately palpating the ankles and feet Evidence-based Chiropractic

17. Simulated treatment cont. • A nondirectional push (impulse) was applied to the gluteal region with the subject positioned on each side • In the prone position, a similar impulse was applied bilaterally to the scapulae Evidence-based Chiropractic

18. Simulated treatment cont. • The subject was then placed supine, with the head rotated slightly to each side, and an impulse applied to the external occipital protuberance • Low-amplitude, low-velocity impulses were applied in all these nontherapeutic contacts, with adequate joint slack so that no joint opening or cavitation occurred Evidence-based Chiropractic

19. Comparison • The comparison of treatments was between • Active spinal manipulation as routinely performed by chiropractors • And hands-on procedures without adjustments or manipulation • All medical treatment the subjects were receiving before the study was maintained during the study Evidence-based Chiropractic

20. Comparable groups? • Subjects were asked 12 questions at the end of the study, regarding the attention the subjects received from the chiropractor, the explanations of procedures, communication, feeling at ease, the skill and ability of the chiropractor, and overall quality of care Evidence-based Chiropractic

21. Outcomes • The primary outcome was the change from base line in the morning peak expiratory flow measured before the use of a bronchodilator at two and four months • Secondary outcomes were the changes in airway responsiveness, FEV 1, symptoms of asthma, the need for inhaled b-agonists, the use of oral corticosteroids, quality of life, and overall satisfaction with treatment Evidence-based Chiropractic

22. Results • All subjects were accounted for • 199 were assessed • 108 were ineligible and reasons were given • 91 were eligible and were randomly assigned • 45 to active treatment (6 dropped out) • 46 to simulated treatment (4 dropped out) Evidence-based Chiropractic

23. Evidence-based Chiropractic

24. Results cont. • There were small increases (7 to 12 liters per minute) in morning and evening peak expiratory flow in both treatment groups • With no significant differences in the change from base-line values between the groups • See Fig. 1 Evidence-based Chiropractic

25. Figure 1 • Differences in Percent Change in the Mean Morning Peak Expiratory Flow from Base Line to Two Months and Four Months. • Values shown are the changes in the active-treatment group minus those in the simulated-treatment group. The I bars indicate means and 95 percent confidence intervals. Evidence-based Chiropractic

26. Evidence-based Chiropractic

27. Results cont. • Symptoms and use of b-agonists declined in both groups, but no significant difference between the groups • Increases in quality of life were greater than the minimally important differences in both groups at two and four months, but no significant differences between the groups overall Evidence-based Chiropractic

28. Results cont. • There were no significant changes in spirometric measurements or airway responsiveness Evidence-based Chiropractic

29. Evidence-based Chiropractic

30. Results cont. • Mean satisfaction scores were similar — 6.22 for the active-treatment group and 6.46 for the simulated treatment group (maximal score, 7.0) • The majority of the subjects (63 percent) were uncertain whether they had received active or simulated treatment • No adverse events occurred during the study Evidence-based Chiropractic

31. Discussion • There was a substantial improvement in symptoms and quality of life and a reduction in b-agonist use • However, these changes did not differ significantly between the active-treatment and simulated-treatment groups • There were no significant changes in objective measurements of airway function Evidence-based Chiropractic

32. Discussion cont. • Hence, the addition of chiropractic spinal manipulation to usual medical care for four months had no effect on the control of childhood asthma Evidence-based Chiropractic

33. Discussion cont. • The authors were critical of previous trials that showed evidence of benefit of chiropractic treatment of asthma because they were methodologically deficient • They were not matched for age or respiratory status • Or there was no control group Evidence-based Chiropractic

34. Discussion cont. • The possibility of spontaneous or placebo-driven improvement in chronic illness dictates that studies of the efficacy of treatment regimens be adequately controlled, randomized, and blinded • Although it was impossible for the treating chiropractors and the investigator undertaking treatment checks to remain unaware of the treatment assignments Evidence-based Chiropractic

35. Discussion cont. • The successes of previous trials were denigrated because airway responsiveness did not change along with subjective symptoms • This suggests that the effect was more likely to have been a placebo effect or study effect (Hawthorne effect) Evidence-based Chiropractic

36. Conclusions • In children with mild or moderate asthma, the addition of chiropractic spinal manipulation to usual medical care provided no benefit Evidence-based Chiropractic

37. Evidence-based Chiropractic

38. Critique • Are there any methodological flaws? • What conclusions can we draw from the study? • What conclusions can’t we draw from the study? • Why do you think it’s necessary to know how to critique these articles? Evidence-based Chiropractic

39. Anthony Rosner,PhD • “. . . the same authors had already concluded 17 months earlier that with nighttime symptoms there was a significant difference between the same two patient groups at the highly robust null probability level of p<0.001. This discrepancy was not mentioned by the authors in their NEJM paper.” • A randomized controlled trial of chiropractic spinal manipulation in children with chronic asthma. American Thoracic Society Convention, San Francisco, CA, May 21, 1997. Evidence-based Chiropractic

40. Sham chiropractic • Placebo or sham chiropractic manipulations are either • So invasive that they introduce possibly therapeutic forces into the tissues or • So dissimilar from chiropractic manipulation that blinding is not possible • Patients may not receive a placebo effect Evidence-based Chiropractic

41. Eric L. Hurwitz, et al. Frequency and Clinical Predictors of Adverse Reactions to Chiropractic Care in the UCLA Neck Pain Study Given the possible higher risk of adverse reactions and lack of demonstrated effectiveness of manipulation over mobilization, chiropractors should consider a conservative approach for applying manipulation to their patients, especially those with severe neck pain. Evidence-based Chiropractic

42. Is Chiropractic Evidence Based? Adrian B. Wenban, BAppSc, MMedSc Private Practice JMPT 2003;26:1E-9E.

43. Introduction • Editorials in a number of major medical journals have considered chiropractic to be part of complementary and alternative medicine (CAM) • They also contend that CAMs, and therefore chiropractic, by definition, are not evidence based Evidence-based Chiropractic

44. Introduction cont. • On the other hand, a recently published review article concluded that there was an increase in the number of CAM clinical trials published in mainstream medical journals over the last 30 years • Indicates an increasing level of original CAM research activity (and chiropractic) and a trend toward an evidence-based approach Evidence-based Chiropractic

45. Quotes suggesting that CAM is not evidence based • Applying evidence-based medicine to CM, which includes such therapies as acupuncture, chiropractic, hypnosis and herbal medicines, seems contradictory. CM is often defined as techniques for which no evidence of benefit exists • What most sets alternative medicine apart..., is that it has not been scientifically tested Evidence-based Chiropractic

46. Quotes cont. • One might still ask why so many people pay for unproved CM when they can have scientifically backed medicine at no extra expense • Most alternative medicine has not been tested scientifically Evidence-based Chiropractic

47. Quotes cont. • Opponents of alternative medicine argue that the field is filled with crackpots who deceive and defraud patients and wreak havoc by resorting to unscientific treatments • Most unconventional therapies are not evidence based • The efficacy and safety of CM are grossly under researched Evidence-based Chiropractic

48. Introduction cont. • The author of this current article pointed out that the extent to which the day-to-day care delivered in chiropractic practice is based on evidence has not been quantified Evidence-based Chiropractic

49. Study Objectives • To determine: • The proportion of care delivered in achiropractic practice that is based on evidence from good-quality RCTs • Whether chiropractic practice can be evaluated with methods as rigorous as those used to evaluate medical specialties • How the proportion of care delivered, and supported by good-quality RCTs, compares between chiropractic and medicine Evidence-based Chiropractic

50. Methods • A retrospective survey of patient files from a single chiropractic office was carried out • The author reviewed the case notes of 180 consecutive patients seen over the course of 5 working days • The chiropractor had 6 years of clinical experience and only a very basic understanding of evidence-based practice Evidence-based Chiropractic