Clinical Problem Solving Strategies

1. Clinical Problem Solving Strategies

2. Placebo effects • Placebo is Latin for “I will please” • Refers to any type of treatment that is inert • Used in research trials to objectively test the efficacy of new treatments • One group is given the treatment, while another group (the control group) receives a placebo • Comparing the results from both groups should reveal the effects of the treatment

3. Intervention

4. Placebo American Heritage Dictionary • A substance containing no medication and prescribed or given to reinforce a patient's expectation to get well • An inactive substance or preparation used as a control in an experiment or test to determine the effectiveness of a medicinal drug • Something of no intrinsic remedial value that is used to appease or reassure another

5. Placebo effects cont. • Interestingly, some people get better in the placebo group • This phenomenon is known as “the placebo effect” • The placebo effect is substantial • About one third of people taking placebos for a number of complaints will experience relief • The underlying mechanisms remain a mystery

6. Sham • The term “sham treatment” is often used instead of placebo • Definition: • Something false or empty that is purported to be genuine; a spurious imitation

7. Placebo effects cont. • The placebo effect is triggered by the patient's belief in the treatment and their expectation of feeling better • If symptoms are relieved by taking an inert substance or undergoing a dummy procedure, was the original illness imaginary? • No

8. Factors that influence the placebo effect • Characteristics of the placebo • If the pill (or treatment) looks genuine, the person taking it is more likely to believe that it contains active ingredients • Larger sized pills suggest a stronger dose than smaller pills, and taking two pills appears more potent than just one • Injections have a more powerful effect than pills

9. Factors that influence cont. • Attitude of the patient • If the person expects the treatment to work, the chances of a placebo effect are higher • However, the placebo effect may still take place even if the person is skeptical of success • The power of suggestion is probably at work here

10. Factors that influence cont. • Doctor-patient relationship • If the person trusts their health care practitioner, they are more likely to believe that the placebo will work • Chiropractors typically instill more trust in their patients, consequently critics have pointed to this as a likely explanation of our successes

11. Placebo effects cont. • Types of placebos • Pills are well-known for their placebo effect • However, a placebo can be any inert or “dummy” treatment • Special diets, exercise, physical therapy or surgery • Even chiropractic manipulation

12. Psychic surgery - Is actually produced by sleight of hand. Animal tissue and blood are used to give a realistic appearance, while a patient's fleshy midriff helps create the illusion that the surgeon's fingers have actually penetrated the body. Still practiced today in Brazil and the Philippines.

13. How placebos work • Self-limiting disorders • Many conditions are self-limiting (e.g., common cold, some back or neck pain) • They will resolve on their own with or without treatment • Symptoms resolving is merely coincidence

14. How placebos work cont. • Remission • The symptoms of some disorders, such as multiple sclerosis and lupus, may wax and wane • A remission during a course of placebos may be coincidence, and not due to the placebos at all

15. How placebos work cont. • Changes in behavior • The placebo may increase a person’s motivation to take better care of themselves, which may be responsible for the easing of their symptoms • Altered perception • The person’s interpretation of their symptoms may change with the expectation of feeling better. (e.g., a sharp pain being reinterpreted as an uncomfortable tingling)

16. How placebos work cont. • Reduced anxiety • Taking the placebo and expecting to feel better may soothe the autonomic nervous system reducing levels of stress chemicals • Brain chemicals • Placebos may trigger the brain to release endorphins, the body's own natural painkillers

17. How placebos work cont. • Altered brain state • Research has shown that the brain responds to an imagined scene in much the same way it responds to an actual visualized scene. Placebos may help the brain to remember a time before the onset of symptoms, and then bring about physiological change • The so-called “remembered wellness” theory

18. Placebo examples • A meta-analysis of studies of depressed individuals taking antidepressant medications suggests that approximately: • One quarter of the drug response is due to the administration of an active medication • One half is a placebo effect • The remaining quarter is due to other nonspecific factors • Listening to Prozac but Hearing Placebo: A Meta-Analysis of Antidepressant Medication. Prevention & Treatment, Volume 1, Article 0002a, June 26, 1998

19. Placebo examples cont. • In a survey of surgery for lumbar disc disease, although no disc herniation was present in 346 patients (negative surgical exploration), complete relief of sciatica occurred in 37 percent and from back pain in 43 percent

20. Placebo examples cont. • Moseley et al did a double-blinded, randomized, placebo-controlled trial to compare arthroscopic lavage and debridement vs. a sham procedure • They found that all three treatment groups fared equally: subjective symptomatic relief was reported, but no objective improvement in function in any of the groups

21. Placebo examples cont. • Forty years ago, a young Seattle cardiologist named Leonard Cobb conducted a unique trial of a procedure then commonly used for angina, in which doctors made small incisions in the chest and tied knots in two arteries to try to increase blood flow to the heart. It was a popular technique and 90 percent of patients reported that it helped, but when Cobb compared it with placebo surgery in which he made incisions but did not tie off the arteries, the sham operations proved just as successful. The procedure, known as internal mammary ligation, was soon abandoned • "The Placebo Prescription" by Margaret Talbot, New York Times Magazine, January 9, 2000

22. Sham v. Pill • Kaptchuk et al. Sham device v inert pill: randomised controlled trial of two placebo treatments. BMJ  2006;332:391-397. • Fake acupuncture and sugar pills were tested for their effect on relieving arm pain • Both groups noticed improvements, but fake acupuncture was significantly better • 25% of acupuncture group noticed side effects and 3 of the sugar pill group actually withdrew because of them

24. Placebo Death?

25. Natural history of a disease vs. placebo effect • The body has a natural ability to heal itself and people heal spontaneously, occasionally even when the illnesses is serious • Hard to differentiate from placebo effect • Cases of spontaneous remission sometimes end up being regarded as miracles

26. Why is this important? • Placebo effects, disease natural history, and regression to the mean can result in high rates of good outcomes, which may be falsely ascribed to specific treatment effects • The true causes of improvements in pain after treatment remain unknown in the absence of independently evaluated randomized controlled trials

27. 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

28. 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)

29. 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.

30. 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

31. 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.”

32. 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

33. 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)

34. 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)

35. 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

36. 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

37. 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

38. 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

39. 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

40. 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

41. 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

42. 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

43. 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

44. 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

45. 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

46. 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

47. 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)

49. 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

50. 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.