Many CAM modalities include patients’ hopes, expectations, emotional states, energies, and other self-healing processes as part of their core “mechanisms of action.” Studies of effectiveness of these modalities and therapies cannot consider these factors to be extraneous confounders that are separate from the mechanism(s) of action being tested, as would typically be the case in effectiveness research in conventional medicine.

If the core research question in a CAM effectiveness study involves the identification of a mechanism of action apart from or in addition to nonspecific placebo or expectation effects, then a traditional two-arm study comparing a particular treatment to placebo control would be appropriate. Studies of herbal remedies with inert substances in the control condition or studies of acupuncture with sham-treated controls (Biella et al., 2001) would be examples of this kind of study design. The only CAM therapies or modalities for which this design would not be appropriate would be those that do not claim any mechanism of action other than the patients’ own expectations or self-healing processes.

It is also possible to design studies that specifically manipulate the nonspecific placebo or expectation effects to determine whether variation of the “dose” of this variable can influence outcomes. For example, Pollo et al. (2001) conducted a study of how different expectations can produce different analgesic effects. Three groups of patients were treated with buprenorphine, given on request for 3 consecutive days, plus a basal intravenous infusion of saline solution; however each group was given different information about the basal infusions. Group A was told nothing; Group B was told that the infusion was either a powerful painkiller or a placebo; and Group C was told that it was a powerful painkiller. The results are shown in Table 4-1.

The investigators concluded that “different verbal instructions about certain and uncertain expectations of analgesia produce different placebo analgesic effects, which in turn, trigger a dramatic change of behavior leading to a significant reduction of opioid intake” (Pollo et al., 2001).

Given that expectation or placebo effects are generally presumed to

Front Matter (R1-R22)

Executive Summary (1-12)

1 Introduction (13-33)

2 Prevalence, Cost, and Patterns of CAM Use (34-73)

3 Contemporary Approaches to Evidence of Treatment Effectiveness: A Context for CAM Research (74-107)

4 Need for Innovative Designs in Research on CAM and Conventional Medicine (108-128)

5 State of Emerging Evidence on CAM (129-167)

6 An Ethical Framework for CAM Research, Practice, and Policy (168-195)

7 Integration of CAM and Conventional Medicine (196-225)

8 Educational Programs in CAM (226-252)

9 Dietary Supplements (253-277)

10 Conclusion (278-282)

Appendix A: CAM Therapies, Practices, and Systems (283-292)

Appendix B: Consortium of Academic Health Centers for Integrative Medicine (293-294)

Appendix C: Table 1-1 List of Abbreviations (295-295)

Appendix D: Liaison Panel Organizations (296-297)

Appendix E: Model Guidelines for the Use of Complementary and Alternative Therapies in Medical Practice (298-306)

Appendix F: National Center for Complementary and Alternative Medicine Research Centers (307-309)

Appendix G: Public Meetings (310-318)

Appendix H: Committee Biosketches (319-326)

Index (327-338)