6

REASSESSMENT

Belief kills; belief heals. The beliefs held by persons in a society play a significant part in both disease causation and its remedy.

–Robert A. Hahn and Arthur Kleinman, “Belief as a Pathogen” (1983)

Given what has been presented in this study, several observations are worth noting. First and foremost is the fact that conventional biomedical research and practice fail to account for the full measure of human experience in health and disease. With approximately 80 percent of the world’s population, including half the US population, using some form of CAM, the scientific community can no longer view these therapies as simply a fringe interest among consumers. However, because CAM therapies diverge sharply from reductionist science, the nature of their evidence and the subjective manner of their production create substantive problems for evidence-based medical knowledge. This suggests a remarkable similarity between CAM therapies and numerous nonspecific theories and practices such as psychotherapy that, although difficult to explain in terms of their modus operandi, have proven beneficial to patients. The current tension between conventional therapies and unconventional therapies represents a collision of epistemologies. For the former, disease causation constitutes the ideal form of evidence; for the latter, outcomes are of equal or greater importance. In our postmodern world, multifactorial causation has become more accepted as doctors and medical researchers adopt a more integrative role for unconventional therapies—a road that neither is straight nor accompanied by clear markers.

As the usage of homeopathy, acupuncture, herbals, chiropractic, and other CAM modalities amply demonstrate, their poor performance in clinical trials have caused little or no diminution in their popularity. They remain robust in their claims and ever anxious to expand their therapeutic applications.¹ Even with increased consumer interest, however, only a small number of CAM therapies are expected to achieve legitimacy alongside conventional medicine. Unlike biomedicine, which is constantly justifying its existence through replication and evidence-based research, most CAM modalities have yet to prove their efficacy or replicability, standing firmly on a static set of principles and practices that appear to “work,” albeit only marginally better than the placebo. To date, only a few have been able to build a scientific explanation for their efficacy. And for those that have achieved this status, the outcome has not always been to their benefit. The fact that the management of chronic disease constitutes 78 percent of medical expenditures in the United States explains why conventional medicine has been so aggressive in fighting CAM and, where possible, co-opting its more effective therapies.²

To the extent that CAM therapies choose to seek third-party approval, they can be expected to institute some degree of standardized training and professionalization. This translates into a need to demonstrate not only a sense of stability, but one of replication—the ultimate test of their working truths. But the issues don’t end there. How is it, ask skeptics, that millions of Americans can still believe in meridians, crystals, auras, chakras, and water memory to cure disease? Worse still, how can those same individuals demand that the federal government spend taxpayer dollars to investigate modalities that defy the normative laws of science? Should there be a clear dividing line between biomedical and nonreductionist systems, or is this distinction determined by time, place, and attitude? How do CAM modalities use and abuse science? When is enough known to conclude that a practice is worthless? Do individuals have the right to demand that their health-care plans supply them with the therapy they desire? Should society be burdened with paying for treatments that are neither safe nor proven effective? Should druggists advise or caution purchasers concerning their choice of alternative medications? Is it really medicine if it has not been tested by the RCT? Will integration of EBM with alternative medicine enhance health care or simply appease patients or both? Should an evidence-based approval process be required for all CAM systems? Is there any substitute for science-based evaluation?

Overall, most CAM therapies have failed to meet the standards demanded of the evidence-based pyramid. Those few that have succeeded in achieving some degree of efficacy have done so with results that beg the question of whether they are equal to or more than what might be expected from the placebo effect alone. Most high-quality RCTs and meta-analyses of CAM therapies use such operative phrases as “safe but without clear evidence of benefit,” “not enough evidence,” “inadequate to allow any conclusion,” “insufficient evidence,” “the data do not allow firm conclusions,” “further studies are recommended,” “there is some evidence…but the results are not consistent,” “can make no definitive statement,” “currently no reliable evidence of benefit,” and “more trials are required.” In an environment where expense is no object, further research would perhaps be justified. In today’s world, that luxury is less of an option.

Given that poor evidence is often worse than no evidence at all, CAM continues to fight a perennial uphill battle due to weak methodologies, small trials, and the lack of predetermined criteria for evaluating claims. It counters criticism by claiming to be a holistic, consumer-driven phenomenon whose therapeutic benefits occur at levels not always quantitatively measurable, setting it directly opposite EBM with its quantifiable, reproducible outcomes. Nevertheless, only those CAM therapies that reach beyond their rhetorical defenses are likely to achieve the same degree of legitimacy as conventional practice. Aside from issues with the evidence-based pyramid, the challenge remains for systems such as homeopathy, naturopathy, therapeutic touch, anthroposophy, and other unconventional therapies to show that their outcomes for patients are more than the result of words, symbols, ritual, tradition, insight, or transference.³

As noted in earlier chapters, most CAM proponents question the suitability of the RCT, but they do not uniformly rule out other forms of qualitative analysis using observational studies, ethnography, phenomenology, and interviewing techniques to bring forth information worthy of survey research and other data manipulation.⁴ Some have suggested a biopsychosocial model rather than a strictly biomedical model of medicine to research the physical and psychical aspects of healing.⁵ Nevertheless, until more replicable evidence is demonstrated utilizing these forms of modeling, CAM therapies will continue to be criticized for lack of scientific rigor.⁶

All of this begs the question whether CAM therapies should be considered a form of psychotherapy, chaplaincy, or other faith-based (paranormal) system of healing. There is good reason to suggest that most fall under the umbrella of the placebo effect and that their strength lies in symptom management and in personalized strategies for health promotion. In the area of normative science, however, most CAM therapies have yet to be persuasive. To the extent that they are intent on seeking greater legitimacy, they must as a matter of good public policy submit to evaluation. There is an obligation to balance the patient’s right to medical pluralism with the public’s right to safe and efficacious therapies.

By contrast, EBM continues to provide the most credible information for justifying a clinical practice. Nevertheless, its ultimate value remains uncertain because so much of what happens in a clinical trial fails to capture the various independent and related variables that intrude into the encounter. Beyond the shadow it casts from atop the evidence-based pyramid, the RCT remains an imperfect tool, lacking a touchstone on which its intentionality ultimately rests. Representative of so many possible variables, it lacks a core to give it solid identification. Calibrating the outcome of a medical procedure, including the efficacy of a pharmacologic treatment, defies prediction or certitude insofar as the organic side of the medicine tends to be infused with so many psychotherapeutic interventions, some of which are intended and others are hidden. This suggests that there has been an overestimation of the value of the RCT in resolving the challenges presented in clinical medicine. For this reason, more creative efforts are needed that compare “whole treatments” rather than just individualized components with which conventional medicine is most acquainted.

Given the complexity of the human organism, the question naturally arises whether evidence from the RCT can or should be the sole judge of the safety or efficacy of an intervention when other factors might intrude.⁷ In other words, issues of clinical effectiveness and inference, causation and correlation, clinical judgment, and collective knowledge continue to challenge the RCT’s claims. Outside the range of acceptable data-based evidence are numerous subjective factors (e.g., beliefs, ethics, language, education, training, politics, cultural biases, etc.) that demand sensitivity to a particular contextual environment operating parallel to the empirical model. The neglect of this environment undermines the logical deductions extracted from the data.⁸ As Ted Kaptchuk explained, “Human subjectivity can undermine objectivity even under double-blind conditions.”⁹

CAM’s general failure to conform to the biomedical model does not necessitate its retreat from the field. The mind–body dualism has long overstayed its visit. Western science needs to advance beyond the current reductionist model to some blending of the subjective and social aspects of healing that includes the placebo. This will require conventional medicine to end its either–or reliance on the RCT. Equally important, both CAM and conventional medicine must spend less time generating arguments of mutual disparagement and look for new and different tools with which to understand the causal links to explain and treat disease and illness. Such a task is not easy, and getting there will probably be fraught with considerable error before it can provide a better approach for medical research.

In the interest of both reductionist science and CAM, the next decade must include the challenge of bringing together the polar entities of objectivity and subjectivity in some viable, observable, and replicable evidence-based system that will separate those belief systems that remain wedded to a priori laws and principles from those that can stand with biomedicine as partners in the nation’s health-care system. The clinical encounter represents the nexus of biology, medicine, and meaning. Integral to this encounter will be the placebo in all its current and future guises. Franklin Miller and Ted Kaptchuk said it best in referring to the need to reconceptualize the placebo effect as “contextual healing,” a phrase that emphasizes the connection between the clinical encounter and improvement in the patient’s condition. “That aspect of healing that is produced, activated or enhanced by the context of the clinical encounter, as distinct from the specific efficacy of treatment interventions,” they wrote, “is contextual healing.”¹⁰

Making this argument for the integration of subjectivity and objectivity into the evidence-based pyramid does not negate past findings, nor does it rule out the role and purpose of the RCT and meta-analysis in the absence of a viable alternative. Until such integration is successfully accomplished, it remains in the skeptic’s purview to question. Skepticism represents an ingrained agnosticism within the biomedical world. If the statistical outcome of an RCT demonstrates the efficacy of a CAM intervention, or if the difference between the intervention and the placebo shows little statistical variation, the skeptic sees the opportunity for making a reasoned judgment. Yet even with this information the skeptic understands the risk of the influence of expectation on findings, which can in turn lead to biased results. Blinding (concealment) is intended to eliminate bias, but its relevance varies with the circumstances, and it is not always possible because of different styles of patient management or the nature of the alternative therapies. If blinding is inadequate, results fail to be credible. Until now, reductionist medicine has remained the most trustworthy form of therapy due to its willingness to be subjected to the constant challenge of verifiability and replicability—an intense process of error detection in pursuit of some unifying (even if temporary) “truth” or “meaning.” For sociologist Robert King Merton, author of the classic paper “Science and Technology in a Democratic Order” (1942), replication is the “norm of universality.”¹¹ The authority behind reductionist medicine is in its persistent search for evidence of what is being asserted over periods of time. Nevertheless, biomedicine remains an uncertain science; for all its benefits, it carries a degree of unpredictability. Nietzsche once commented, “But science, spurred by its powerful illusion, speeds irresistibly towards its limits where its optimism, concealed in the essence of logic, suffers shipwreck.”¹² Certainty remains illusive, and so practices, systems, assumptions, and research methods require continued verification and explanation.

Biomedicine, which is both theoretically and empirically based, justifies its legitimacy on the most current science and the healing effects of its therapies. It applies the methodological rigor of evidence-based testing as the basis of its admission into the world of reductionist science. This, its proponents argue, is what distinguishes science from nonscience. But science remains conceptually unsettled—and always will be. CAM therapies, in contrast, rely on their healing effects alone under the belief that, in the fullness of time, future science will ultimately explain what is now inexplicable. How different is this from religion, which explains the contradictions of life as issues answerable only in the afterlife? Both CAM therapies and religion have used this ratiocination to define their role as well as to close off debate. CAM’s strength lies exactly where the torch of science fades, and that remains the conundrum facing the scientific world.

From the many contributors to this discussion, one learns to appreciate—as did William James, from whom we still have much to learn—that epistemologies that seem illogical and irreconcilable with normative science may nonetheless work. The question at hand is not only whether conventional and unconventional therapies can stand on their own self-authenticating authority, but whether it is possible to modify the context of these two opposing camps into something both can benefit from sharing. To date, there is no hard-wired connection, but the bridge between them is nowhere as long nor the chasm beneath them as deep as they once appeared.