Haller applied the “Page 99 Test” to his new book, Shadow Medicine: The Placebo in Conventional and Alternative Therapies, and reported the following:
The book Shadow Medicine represents an effort to find common ground between evidence-based medicine (EBM) and complementary and alternative medicine (CAM) by exploring their respective epistemological foundations; how and why the double-blinded, placebo-controlled clinical trial came to be considered the gold standard in modern medicine; the challenges made by postmodern medicine as it encountered the positivism of EBM; and the politics of modern CAM and the rise of the National Center for Complementary and Alternative Medicine. The book conducts an in-depth case study of homeopathy, explaining why it emerged as a poster child for CAM, and assesses its popularity despite its poor performance in clinical trials. I conclude by expressing hope that new experimental protocols might tease out the evidentiary basis for the placebo effect in both EMB and CAM and thereby establish a degree of reconciliation between the two. While I maintain a healthy, scientific skepticism, I remain optimistic at finding promise in select CAM therapies and a more productive medical environment that includes both the objectivity of EMB and the subjectivity of CAM.Learn more about Shadow Medicine at the Columbia University Press website.
The quote from page 99 concerns a report by the “Quantitative Methods Working Group” established by NIH in 1995 and which concluded that while the randomized clinical trial remained at the top of the evidence-based pyramid, other designs were capable of producing valid and interpretable comparisons that should be admissible for addressing specific study questions. The quote is as follows:The issues challenging CAM research, explained the members of the working group, were not uncommon to research generally in that differences sometimes created difficult conceptual and measurement challenges. To offset these issues, acceptable options included large and small RCTs; nonrandomized trials with contemporaneous controls; nonrandomized trials with historical controls; cohort studies; case-control studies; cross-sectional studies; surveillance studies; consecutive case series; and single-case reports. In other words, established methodologies (i.e., experimental trials, observational epidemiology, and social survey research) and data procedures (i.e., analysis of variance, logistic regression, multivariate modeling techniques) were “quite satisfactory for addressing the majority of study questions related to alternative medicine—from research on therapeutic efficacy to basic science research on mechanisms of pathogenesis and recovery.”
Out of its deliberations, the working group concluded that if an unconventional therapy had an “identifiable, systematic, and consistent set of rules,” reliability could be ascertained even though its etiology was based on “unknown, mysterious, or novel mechanisms of action.” This meant that the unconventional nature of a given system would not, of itself, create an impediment to its validation through the use of appropriate research strategies. Accordingly, there was no justification for an unconventional therapy to refuse testing based on the argument that the particular technical challenges posed by characteristics inherent to CAM made it impossible to assess. The working group also refused to countenance the argument that the rules of biomedical reductionism could not be applied to CAM because it represented “an alternative paradigm with its own standards.” With both propositions, the working group “emphatically disagreed,” arguing that new methodologies using nonlinear modeling (i.e., chaos theory, neural net theory, fuzzy sets theory) were potential substitutes.