Clinical Problem Solving Strategies

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Clinical Problem Solving Strategies
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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

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Intervention
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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

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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

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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

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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

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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

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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

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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

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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

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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.
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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

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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

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How placebos work cont.

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

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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

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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

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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
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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

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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

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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

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Sham v. Pill

• Kaptchuk et al. Sham device v inert pill
  randomised controlled trial of two placebo
  treatments. BMJ  2006332391-397.
• 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

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Placebo Death?
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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

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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

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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

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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)

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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, 1992115-35.

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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

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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.

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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

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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)

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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)

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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

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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

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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

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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

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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

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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

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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 subjects head from one side to the other
  while alternately palpating the ankles and feet

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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

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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

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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

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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

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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

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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)

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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

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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.

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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

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Results cont.

• There were no significant changes in spirometric
  measurements or airway responsiveness

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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

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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

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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

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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

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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

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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)

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Conclusions

• In children with mild or moderate asthma, the
  addition of chiropractic spinal manipulation to
  usual medical care provided no benefit

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Critique

• Are there any methodological flaws?
• What conclusions can we draw from the study?
• What conclusions cant we draw from the study?
• Why do you think its necessary to know how to
  critique these articles?

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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 plt0.001. 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.

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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

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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.
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Is Chiropractic Evidence Based?

• Adrian B. Wenban, BAppSc, MMedSc
• Private Practice
• JMPT 2003261E-9E.

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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

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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

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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

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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

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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

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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

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Study Objectives

• To determine
• The proportion of care delivered in a
  chiropractic 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

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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

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Methods cont.

• The chiropractor was not aware that her case
  notes would be reviewed at the time they were
  recorded
• She was blinded to the intent of the study, thus
  removing practitioner bias
• The chief complaints and the primary
  interventions were decided through discussions
  between the author and chiropractor

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Methods cont.

• Literature searches were carried out to determine
  the extent of evidence supporting the primary
  interventions associated with the chief
  complaints
• The goal was to locate at least 1 relevant RCT
  published in a peer-reviewed journal that
  supported the care delivered
• RCTs were critically appraised and rated

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Results

• 5 of the 19 supportive RCTs were not of good
  methodologic quality and were not included in the
  evidence base
• 68.3 of patients received primary interventions
  for chief complaints that were supported by
  good-quality clinical trials
• 31.7 were deemed to be based on poor-quality or
  no RCT evidence

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Comparison of interventions from different
disciplines
Interventions supported byDiscipline
clinical trials () Pediatric general
surgery 11 Inpatient general surgery 24
General practice 31 38 Inpatient
general medicine 53 Acute general psychiatry
65 Chiropractic practice 68.3
Pediatric practice 39.9 Internal
medicine 64.8
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Discussion

• This study was based on a very simplified model
  of clinical practice
• In reality, clinical practice is more complex
  with patients presenting with more than 1
  complaint
• Also, chiropractors often use more than 1
  intervention with the same patient

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Discussion cont.

• These results were limited to patients under the
  care of 1 chiropractor
• Generalization of these findings to other
  chiropractic practices must await confirmatory
  findings from larger similar surveys

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Discussion cont.

• Since the literature review for this study was
  performed, several RCTs have been published
  supporting interventions that formed part of this
  study and may result in a greater proportion of
  chiropractic practice being deemed evidence based

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Conclusion

• The results, suggest that chiropractic practice
  can readily be examined with methodologies as
  rigorous as those used to evaluate specialties of
  medicine
• And that 68.3 of the care delivered to patients
  presenting to a chiropractic practice was
  supported by evidence from good-quality,
  randomized clinical trials

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Conclusion

• This proportion compares favorably to a number of
  specialties of medicine

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SA, spinal adjustment EX, exercise ED, education
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