We live forwards, but we understand backwards. William James - PDF document

We live forwards, but we understand backwards. William James Alternative Medicine must be held to the same standards of evidence as conventional medicine. Various 1

Integrative Medicine must be held to the higher standards of evidence than either alternative or conventional medicine alone. Jonas Additional Quality Criteria for Integrated Medicine • Methods - “model validity” • Ethical - “your grandmother” • Strategies - “building a house” 2

Evaluation of Evidence Evaluation of Evidence Research Quality Research Quality • Internal Validity How likely is it that the effects reported are due to the independent variable (the treatment)? • External Validity How likely is it that the observed effects would occur outside the study and in different settings? • Model Validity How likely is it that the study accurately reflects the system under investigation? Evaluation of CAM Evaluation of CAM Internal Validity Internal Validity • Randomization (Was subject assignment to treatment groups done randomly and in a concealed manner?) • Baseline comparability (Where gender, age, and prognostic factors balanced?) Change of intervention (Was there loss to follow-up, contamination, poor compliance) • Blinding (Did the patients, practitioners, evaluators, analysts know who got the treatment?) • Outcomes (Was the objectivity, reliability, and sensitivity of the outcome assessed?) • Analysis (Was the number treated large? Where p. values significant? Was there multiple outcomes measured and analyzed?) 3

Evaluation of CAM Evaluation of CAM External Validity External Validity • Generalizability (Was there a range of patients as they would be seen in practice or where there multiple or narrow inclusions and exclusions? Was the study done at several sites with similar results?) • Reproducibility (Was what was done clear? Where Confidence Intervals reported? Was the treatment transferable to other practitioners?) • Clinical Significance (Was the effect size big enough to make a difference? Is the condition in need of this type of treatment? Were any preferences determined? Was adherence good?) • Therapeutic Interference (Was there flexibility in varying the treatment? Was feedback on the outcomes available? Is the treatment feasible in most (or your) practice settings?) • Outcomes (Were the outcomes clinically relevant? Were the outcomes checked for importance with the patients? Were any important outcomes missing?) “Rigorous”Evidence Hierarchy “Rigorous”Evidence Hierarchy Reviews Reviews Meta Meta- -analysis analysis Randomized Randomized Controlled Controlled Laboratory Laboratory Trials Trials Health Health Observational Observational Services Services Outcomes Outcomes Research Research Qualitative, Case Reports, Anecdotes Qualitative, Case Reports, Anecdotes 4

“Rigorous”Evidence for Acupuncture “Rigorous”Evidence for Acupuncture Effective Effective Ineffective Ineffective Post- Post -operative pain operative pain Obesity Obesity Nausea and vomiting Nausea and vomiting Smoking Cessation Smoking Cessation (Back Pain) (Back Pain) Stroke rehab., osteoarthritis Stroke rehab., osteoarthritis, drug addiction , drug addiction Depression, ADHD, Asthma Depression, ADHD, Asthma WHO list of 34 conditions for which acupuncture is safe and effe WHO list of 34 conditions for which acupuncture is safe and effective ctive Evaluation of CAM Evaluation of CAM Model Validity Model Validity • Representativeness/accuracy (Were the therapists well trained and experienced? Was the treatment strategy adequate? Was the treatment clearly described?) • Model congruity (Were the patients classified, was the treatment determined and were the outcomes assessed according to the system of the practice being assessed? ) • Context/Meaning (Did the patients/practitioners believe in the therapy? What was the impact of informed consent? How well was the intervention adapted to the culture, family, meaning of the patient?) • Methodology matching (Were the goals of the study clear and limited? Did the investigators select the correct research method to achieve the goals?)* 5

Evaluation of CAM Evaluation of CAM “ Model validity ” “ Model validity ” • Diagnostic taxonomy - “works” for X • Double classification - dual selection • Adequacy of treatment - standardization • Placebo and meaning effects - “proof” • Outcome selection - patient relevant? Diagnostic Taxonomy Osteoarthritis Depression TCM TCM Ayurveda Ayurveda Homeopathy Homeopathy Patient Patient Aurum Aurum Excess Spleen Excess Spleen Pitta Imbalance Pitta Imbalance “Stress” “Stress” Rhus. Rhus . Tox Tox. . Deficient Liver Deficient Liver etc. etc. Bad diet Bad diet Sepia Sepia etc. etc. Genes Genes etc. etc. Sadness Sadness, , Joint Pain and Stiffness Joint Pain and Stiffness, , Fatigue Fatigue, , Sleep Difficulty Sleep Difficulty, , Hair Combing Hair Combing 6

Of course, I am always reluctant to contradict anyone’s grandmother except when the advice might be dangerous. Cortlandt Forum 1997 February p.122 The Audience and the Evidence The Audience and the Evidence • Public • Stories • Practitioners • Probabilities • Clinical Investigators • Comparative Effects • Basic scientists • Mechanisms • Policy and payment • Certainty, “proof” 7

Evidence Hierarchy Evidence Hierarchy POLICY SCIENCE Reviews Reviews Meta- -analysis analysis Meta Randomized Randomized PRACTICE Controlled Controlled Laboratory Laboratory Trials Trials Health Health Observational Observational Services Services Outcomes Outcomes Research Research Qualitative, Case Reports, Anecdotes Qualitative, Case Reports, Anecdotes PATIENTS Decision Points in Medicine Decision Points in Medicine • Patient • Practitioner • Scientist • Payer/Policy Jonas, WB. And Levin, JS. Essentials of Complementary andAlternative Medicine. Littincott Williams & Wilkins. 1999; p. 34. 8

Treatment of Allergies with Treatment of Allergies with Homeopathy Homeopathy A patient with seasonal allergies says that her daughter recommended a homeopathic remedy from a health food store for allergies. Her daughter said it worked great for her and had no side effects. Your patient says she would like to stop her conventional drugs, which make her sleepy. She wants to know if this is alright? Is she harming herself or wasting her money? Evidence Hierarchy Evidence Hierarchy Reviews Reviews Meta- Meta -analysis analysis Randomized Randomized Controlled Controlled Laboratory Laboratory Trials Trials Health Health Observational Observational Services Services Outcomes Outcomes Research Research Qualitative, Case Reports, Anecdotes Qualitative, Case Reports, Anecdotes PATIENTS 9

Homeopathic Galphimia glauca in Pollinosis Estimated Success Rates and 95% confidence Intervals 1 1 0.9 0.9 0.8 0.8 Relative Chance Relative Chance 0.7 0.7 0.6 0.6 0.5 0.5 0.4 0.4 0.3 ë80 ë81a ë81b ë82 ë83 ë84 ë85 ë86 ë87 ë88 ë89 common ë80 ë81a ë81b ë82 ë83 ë84 ë85 ë86 ë87 ë88 ë89 common Year of study Performance Year of study Performance Wiesenauer, Forsch. Kompl. 3:230 (1996) Evidence Hierarchy Evidence Hierarchy Reviews Reviews Meta Meta- -analysis analysis Randomized Randomized PRACTICE Controlled Controlled Laboratory Laboratory Trials Trials Health Health Observational Observational Services Services Outcomes Outcomes Research Research Qualitative, Case Reports, Anecdotes Qualitative, Case Reports, Anecdotes PATIENTS 10

Homeopathic Galphimia glauca in Pollinosis Estimated Success Rates and 95% confidence Intervals 2.8 2.8 2.4 2.4 2 2 Relative Chance Relative Chance 1.6 1.6 1.2 1.2 0.8 0.8 0.4 0.4 ë80 ë80 ë81a ë81a ë81b ë81b ë82 ë82 ë83 ë83 ë84 ë84 ë85 ë85 ë86 ë86 ë87 ë87 ë88 ë88 ë89 ë89 common common Year of study Performance Year of study Performance Wiesenauer, Forsch. Kompl. 3:230 (1996) Evidence Hierarchy Evidence Hierarchy POLICY SCIENCE Reviews Reviews Meta Meta- -analysis analysis Randomized Randomized PRACTICE Controlled Controlled Laboratory Laboratory Trials Trials Health Health Observational Observational Services Services Outcomes Outcomes Research Research Qualitative, Case Reports, Anecdotes Qualitative, Case Reports, Anecdotes PATIENTS 11