The Placebo Effect in Alternative Medicine: Can the Performance of a Healing Ritual Have Clinical Significance?

Efficacious therapy, in one biomedical definition, is therapy that has positive effects greater than those of an indistinguishable dummy treatment in a randomized, controlled trial (RCT) (1-3). Such specific efficacy is actually a comparative measure: intervention contrasted with placebo. This relative effectiveness, which is estimated by statistical testing, is taken to indicate authenticity. The clinical significance, that is, the outcome measured by using the patient's original condition as a baseline, is usually a secondary consideration for determining legitimate medical interventions. Any clinical impact due to the placebo, which is deemed to lack truthfulness, is even less notable and is valued only as a comparison baseline for genuine effects (3). Specific effects are by definition superior to nonspecific effects. The clinical repercussions of the placebo are tolerated as necessary nuisance noise but are otherwise considered inconsequential or treated with contempt (4). Given the privileged status of specific effects, it is not surprising that the clinical impact of alternative medicine's placebo effects are routinely ignored (5). The only serious question has been whether alternative medicine has more than a placebo effect. Discarding all placebo effects in a single trash basket of untruthfulness, however, diminishes our knowledge of important dimensions of health care. This essay examines the neglected clinical significance of the placebo effect in alternative medicine and raises the possibility that some types of unconventional medicine may produce placebo outcomes that are dramatic and, from the patient's perspective, especially compelling. The term placebo effect is taken to mean not only the narrow effect of an imitation intervention but also the broad amalgam of nonspecific effects present in any patient-practitioner relationship, including attention; communication of concern; intense monitoring; diagnostic procedures; labeling of complaint; and alterations produced in a patient's expectancy, anxiety, and relationship to the illness. This essay asks whether alternative medicine can have an enhanced placebo effect. In some conditions, can any of alternative medicine's particular rituals have a greater impact than the rituals of conventional medicine or than a proven physiologically active treatment? After all, as many of the examples in this essay will demonstrate, two interventions may have different effects on patient outcome even though both [are] equivalent to placebo in clinical trials (6). Dismissing a treatment as just a placebo may not be enough. Alternative medicine may be an especially successful placebo-generating health care system. Rather than specific biological consequences, which epidemiologists designate as fastidious efficacy (7), alternative medicine may administer an especially large dose of what anthropologists call performative efficacy (8). Performative efficacy relies on the power of belief, imagination, symbols, meaning, expectation, persuasion, and self-relationship. This essay takes five components of the placebo dramapatient, practitioner, patient-practitioner interaction, nature of the illness, and treatment and settingand examines their placebogenic potentials in unconventional healing practices. Much of the evidence is derived from conventional research and is speculatively applied to alternative medicine. Also, it should be noted that most of the placebo research discussed in this essay does not represent an artifactual placebo effect explainable by natural history or regression to the mean. Rather, it usually involves comparative experiments with two different types of placebo or the same placebo delivered under different cognitive or emotional circumstances where two distinct placebo outcomes would not support the idea of placebo effect as only natural history. Finally, this essay argues mostly in generalities. Obviously, the placebo effect is likely to be at least as heterogeneous in alternative medicine as in conventional medicine, but it is hoped that raising these questions will encourage further discussion and research. Patient Characteristics Although the patient is the protagonist in the placebo drama, research has failed to find consistent placebo responders or to identify personality traits or other qualities of persons who frequently react to placebo (9-11). However, evidence shows that patient expectations influence outcomes of both placebo and active treatment. Asthmatic patients who believe that an inert substance is a bronchodilator or a bronchoconstrictor respond accordingly (12-14). In a small but classic crossover experiment, healthy volunteers received a placebo pill in which a magnet was embedded. In random order, at different times, they were told that they were receiving a relaxant, a stimulant, or a placebo. Subsequent gastric motility was significantly consistent with patients' expectations (15). Patient expectancies also significantly change or even reverse the actions of many potent pharmaceutical agents (16-19). Adherence to placebo may also be a surrogate marker for a patient's own contribution to the activation of the placebo response (20, 21). In RCTs, such placebo adherence effectsthe post hoc differences observed in the placebo arm between those who comply with taking placebo and those who do notare associated not only with symptom relief but also with concrete end points, including survival (22-24). Indeed, differences in adherence are associated with differences in outcomes that exceed the effects of many pharmaceutical agents (25). Patient preferences for one type of intervention, especially in participative interventions (for example, exercise or diet programs), may contribute significantly to outcomes, including increased placebo responses (26-28). In contrast to conventional medicine, with its measured objectivity, alternative medicine offers a charged constellation of expectations. Alternative medicine's romantic vision is inhabited by benevolent and intentional forces (for example, the innate intelligence of chiropractic or the qi of acupuncture) that are unrestrained by the laws of normative physics (29). An exaggerated notion of the possible readily elicits patients' magical anticipation. These unconventional concepts do not require absolute belief in the sense that their truth value is certified by logic or argument but rather requires moderate openness in the sense that they are taken into the imagination and lived with, if only for a time (30). Alternative medicine emphasizes personal responsibility, which can facilitate adherence. Indeed, the act of switching to another medical system and exhibiting preference by action demonstrates an openness to active participation and adherence and possibly enhances it. Paying out-of-pocket and other signs of commitment, such as following daily lifestyle regimens, undoubtedly marshal adherence effects. The reasons that patients choose alternative medicine may also potentiate a placebo response. Patients with chronic diseases often turn to unconventional healing after long-term negative conditioning with mainstream medicine (31). In this situation, patients' hope (based on no previous experience with alternative medicine) may provide an opportunity for deconditioning from previous unsuccessful medical experiences. Practitioner Characteristics The practitioner-healer must expertly play the role of heroic rescuer to facilitate a placebo effect (32). Numerous RCTs have compared optimistic or enthusiastic physician attitudes toward drug or placebo with neutral or doubtful physician attitudes. Practitioners have had significant impact on such clinical conditions as pain (33-36), psychiatric illness (37-41), hypertension (42, 43), obesity (44), and perimenopause symptoms (45). Although some studies have shown no effect of physicians' expectations on clinical end points (46-48), a systematic review of 85 studies found that although more research is needed, provider-induced expectancies are a mechanism for placebo effects, [which have] received support across a range of clinical areas in a variety of studies (49). A second review, which used more stringent entry criteria, found 25 RCTs that examined the impact of randomly assigning patients with physical illnesses to different levels of expectancy and emotional support. Although researchers found inconsistent effects and determined that further research was needed, they also found that enhancing patients' expectations through positive information about the treatment or illness, while providing support or reassurance, [seemed to] significantly influence health outcomes (50). Even in blinded RCTs, practitioner certitude seems to influence the magnitude of the placebo effect. In one RCT that simultaneously compared two double-blind RCTs, dental patients in one trial received placebo, narcotic analgesics, or narcotic antagonists and those in the other trial received only a placebo or a narcotic antagonist. Dentists knew the possible interventions in both trials but remained blinded to administration of medication. Pain in placebo recipients was significantly worse in the second trial, in which narcotic drugs were not an option, than in the first trial (51). An earlier RCT of the effect of physician expectations on hypertension drugs also found that practitioner belief can transform outcomes (52). Practitioners of unconventional medicine are less restrained by scientific objectivity than practitioners of conventional medicine. The sensibilities of alternative practitioners are therefore often more optimistic and positive than those of their mainstream counterparts (53). The characteristics thought to enhance the placebo effect (and any active intervention) seem to be fully operational in the offices of alternative medicine. Patient-Practitioner Interaction The placebo drama is probably more successful if the patient and practitioner find each o