Editorials: Point/Counterpoint Editorials

Counterpoint: Evidence-Based Medicine Lacks a Sound Scientific Base

Grading

A fundamental premise on which EBM is founded is the ability to grade the quality of research studies. The grading system (levels 1 to 5 evidence) was originally published in a CHEST Supplement (Table 2).² EBM grading views randomization as not just one important factor but more important than every other component of research methodology. The same concept is rephrased by Sackett et al³: “If the study wasn't randomized, we'd suggest that you stop reading it and go on to the next article.” EBM

Requirements for Reliable Research

Table 3lists eight examples of requirements for reliable research.¹⁰ It would be silly to rank these. If one is absent, the research is no longer reliable. Yet, EBM pregrades a study as level 1 evidence if researchers avoided assignment bias (through randomization) even if they ignored the other seven requirements.² A grading system premised on the belief that randomization can cancel every other methodologic error is contrary to the most elementary understanding of science.

Guidelines

Clinicians have been lured into accepting EBM-based, clinical-practice guidelines in the belief they place medicine on a more scientific basis.¹² An example familiar to CHEST readers is the grade A recommendation made by an EBM Task Force for implementation of weaning protocols.¹³ The task force refers specifically to the study by Ely et al¹⁴ as sound evidence. But this study has flawed internal validity: intermittent mandatory ventilation was used in 76% of patients in the control arm, whereas

Harm

You may think EBM does no harm. Not so. Clinical medicine requires thoughtful reflection about each individual patient, whereas graded guidelines encourage reflexive action. A double-blind RCT revealed that spironolactone decreased the mortality rate in patients with severe congestive heart failure (CHF) by 30%.¹⁵ The clinical practice guidelines of the American Heart Association subsequently recommended spironolactone for treatment of ventricular dysfunction.¹⁶ This was followed by a fourfold

EBM Proves That EBM Is Unsound

The fundamental assumption of EBM is that physicians who practice EBM provide superior care.⁴ But EBM founders have never undertaken an RCT of the effect of EBM on patient outcome.¹¹ So EBM does not satisfy its own basic requirements, which it demands of everyone else. (Hypocrisy or what?)

They say an RCT of EBM is unnecessary because “outcomes researchers consistently document that patients who receive proven efficacious therapies have better outcomes than those who do not.”²⁰ With this non

What Is the Alternative?

A major attraction of EBM is that it offers a means of coping with uncertainty. Given a physician's responsibility—to make life-and-death decisions about another human—the wish for certainty is understandable, as is the wish of wanting to act like the wisest physician when faced with a problematic patient. But these wishes are contrary to the reality of medicine.

A wise physician makes decisions on a background of scientific theory (universal principles) [Fig 1]. Clinical practice, however,