Guidelines on Evidence and Ways of Knowing

"Keep an open mind – but not so open that your brain falls out."  
           - attributed to Richard Feynman, Carl Sagan, and others

Using Evidence in Clinical Practice:

Steps of evidence based practice:
  1. Cultivate the spirit of inquiry
  2. Ask the clinical question
  3. Search for and collect the most relevant information (best evidence)
  4. Appraise the info for validity, reliability and applicability.
  5. Integrate the best information with one's clinical expertise, patient preferences and values in making a practice change.
  6. Evaluate outcomes of the practice change.
  7. Disseminate the outcomes of the change.
Source: Source: Melnyk BM, Fienout-Overholdt E. Evidence-Based Practice in Nursing & Healthcare: A Guide to Best Practice, 2nd ed. Philadelphia: Lippincott, Williams & Wilkins; 2010.
“Evidence” as currently defined by biomedicine involves modern scientific research, and this is often problematic for the interventions used in integrative medicine:
  1. Research is often not funded for interventions for which there is no profit to be made, and therefore many effective interventions may never have been studied in large clinical trials, though some of these healing modalities have been used successfully for thousands of years.
  2. The double-blind placebo-controlled trial is not ideal for studying interventions which individualize care, such as homeopathy and acupuncture.
  3. The healing interaction may be dismissed by many researchers as “placebo” effect, whereas we acknowledge this is often more important than any other treatments we apply.
  4. Meta-analysis, considered the gold standard in some circles, often pools reasonable studies with poorly-designed studies which may have used an inferior botanical extract, used inadequate dosing or had other serious methodological flaws, so that a truly effective intervention may be discounted based on such pooling of good and bad studies.

Despite these concerns, we still want to help our patients with limited resources navigate to the most safe and effective treatments.   We at IM4US appreciate the grading of levels of evidence and risk as recommended by Rakel’s textbook(Integrative Medicine , David Rakel.  )  In this system, interventions with lower levels of scientific “evidence” for support but with very low levels of risk might be considered before well-studied interventions with significant risk, for instance implementation of high dose fish oil for Crohn’s disease might be considered more favorably when the alternatives are chemotherapy agents or biological medications with significant risk of life-threatening infections.  
To this system, we would introduce a 3rd criterion, that of accessibility, with the intent of helping to evaluate which interventions are practical in underserved settings.  By accessibility we refer to issues such as cost, language, cultural sensitivity, and ease of adoption in underserved settings.   We do this with all humility, however, as what is accessible and well-accepted by one underserved population may have significant cultural barriers to acceptance among other groups.

Levels of Evidence in the conventional medical literature:

Grade A Based on consistent, good-quality, patient-oriented evidence (e.g., systematic review or meta-analysis showing benefit, Cochrane Review with clear recommendation, high-quality patient-oriented randomized controlled trial). Example: Acupuncture for nausea and vomiting.
Grade B Based on inconsistent or limited-quality patient-oriented evidence. Example: Ginger for osteoarthritis.
Grade C Based on consensus, usual practice, opinion, disease-oriented evidence (e.g., study showing a reduction in blood sugar but no studies in humans to show a benefit to those with diabetes).

Grading Potential Harm

Grade 3 (most harm) This therapy has the potential to result in death or permanent disability. Example: Major surgery under general anesthesia or carcinogenic effects of the botanical Aristolochia (birthwort).
Grade 2(moderate harm) Grade 2 (moderate harm)    This therapy has the potential to cause reversible side effects or interact in a negative way with other therapies. Example: Pharmaceutical or nutraceutical side effects.
Grade 1(least harm) This therapy poses little, if any, risk of harm. Examples: Eating more vegetables, increasing exercise, elimination diets, encouraging social connection.

Putting these together

Strengths of evidence vs. harm grading:
o    Gives more credibility to therapies that have little potential harm.
                           e.g. social support, reducing stress, and enhancing spiritual connection
o    Helps us honor our primary goal, which is to “first, do no harm.”

Grading Accessibility

$$$ (Most expense, difficulty in applying to underserved populations) Requires expensive modalities not covered by Medicaid or other insurers or inclusion of alternative practitioners with significant political barriers to involvement in standard medical settings.   Example: IV nutrients or chelation, integration of non-licensed health care providers in inpatient settings, or application of therapies not culturally acceptable to patients, such as yoga therapy for fundamentalist Christian patients or Acupuncture for Russian patients
$$ (Moderate expense/barriers to care) This therapy involves modalities with moderate expense or infrastructure requirements, such as availability of a teaching kitchen for dietary interventions, dietary supplements costing more than $15 per month
$ (Least expense/barriers to care) This therapy involves inexpensive/widely accessible substances which are acceptable to most patients, or which can be implemented by primary care providers with minimal additional training e.g. nasal saline for chronic sinusitis, strain-counterstrain for musculoskeletal complaints, low-cost dietary supplements such as magnesium or vitamin D for musculoskeletal pain, or homeopathic remedies for PTSD.