Essentials of Complementary and Alternative Medicine (June 1999)

R
EFERRALS
Proper care for patients requires that complementary practitioners refer patients to the conventional system when conventional medicine offers effective treatment for 

the particular disease from which the patient suffers (e.g., bacterial pneumonia). These referrals may include a promise to continue to provide supportive or 
supplemental complementary healing in addition to conventional medical treatment. Except in cases in which a direct conflict exists between complementary and 
conventional therapies, neither side should require that the patient declare an exclusive allegiance to one school of treatment as a precondition of care.
P
ATIENT
 E
DUCATION
Some complementary systems rely on different definitions or measures of “benefit” from those employed by conventional medicine, and thus the patient should be 
educated as to these tenets of the complementary school of healing. This will allow the patient to make an informed choice of treatment modalities (
9
).
T
OLERANCE
We contend that a complementary practitioner should not deny the potential benefit of a medicine just because it is prepared in a pharmacological laboratory using 
synthetic compounds, as long as the patient would deem the response to the medication as positive and desirable. Because there may never be a full reconciliation 
between complementary and conventional paradigms, the patient's view of what is a harmful or beneficial reaction can serve as a framework for judgment.
S
PIRITUAL
 C
ONSIDERATIONS
Several complementary systems especially stress the spiritual aspects of healing; this dimension has been largely ignored by conventional medicine. To the extent 
that conventional medicine now accepts a scientific obligation to seek more holistic approaches to the care of the patient, complementary medicine can help 
conventional medicine to better understand the importance of the spiritual dimension. Moreover, complementary healing traditions may be particularly adept at 
avoiding the mind–body dualism that conventional medicine tends to propagate. Conventional medicine stands to benefit from this expertise developed in many of the 
complementary traditions.
Ethical Duties of Complementary Medicine: Legitimate Research of Its Methods
A profession that seeks the good of others and of society maintains high ethical standards when it is maximally accountable. One of the more exemplary features of 
conventional medicine has been its reliance on scientific research; it has been willing to discard remedies which, however well grounded in biological theory they may 
at first have appeared, have been shown by empirical trial to lack efficacy. However, some complementary schools of medicine employed sophisticated research 
techniques even before conventional medicine did; for example, homeopathy introduced blinding into its routine research design almost a century before conventional 
investigators did so (see 
Chapter 4
, “Evaluating Complementary and Alternative Medicine: The Balance of Rigor and Relevance”) (
10
).
It may seem that complementary medicine has little if any obligation in this direction, because it lacks the vast resources society has granted to conventional medicine 
for purposes of conducting research. However, the government and private foundations have shown interest in funding studies of complementary practices, and so 
the complementary medical community must begin to address its own research priorities and methods. There is a wide variation among complementary practices in 
the amount and type of research conducted to date.
We may distinguish healing practices based on faith and evidence. Some healing relies on faith, which, by definition, is only partly grounded in empirical evidence, 
and requires that one go beyond whatever can be proven or demonstrated rationally. It would be self-contradictory for advocates of faith-based healing to offer, or to 
demand, empirical proof of the efficacy of the healing practice. However, most complementary practices appear grounded in empirical systems of understanding the 
human body or the mind–body complex, regardless of how different these systems may be from the science of conventional medicine. In this case, it is not logically 
consistent for the complementary practice to deny the possibility of empirical proof or disproof of its claims. Moreover, practitioners who see practical possibilities for 
empirical investigations into the efficacy and mechanisms of their treatments but who do not avail themselves of these opportunities are lacking in accountability and 
thus occupy an ethically suspect position.
These comments must be understood within the context of what it means to conduct valid research on complementary practices. We reject the perspective that one 
can deny the value of complementary medicine simply because research conducted by the standards of conventional science fails to provide a basis for the 
complementary practice. It is not sufficient, in our view, for conventional medical scientists to conduct conventional-type research upon complementary practices, and 
then reject those practices because no conventional basis can be found for them without at least some critical scrutiny of whether the conventional research methods 
are truly appropriate for evaluating both the complementary approach and the setting in which it is practiced. The critical issue is about the types of research studies: 
can they be designed so that they are respectful of complementary practices, yet unbiased against those practices by the very nature of the research design? If so, 
and if resources exist for conducting such studies, then complementary practitioners  as a group are ethically deficient if they do not take advantage of the research 
opportunities and report the results openly. Not every practitioner can become a scientific investigator; professional or group responsibilities must be distinguished 
carefully from individual responsibilities.
Despite a century of heavy reliance on the scientific method, conventional medicine includes several diagnostic and therapeutic practices that are of undocumented 
efficacy. Some of these practices are, in fact, efficacious; and some practices simply do not work, despite both physicians and patients believing in them. To us, it is a 
sign of the ethical vitality of conventional medicine that its practitioners  care which treatments are proved or unproved,  and are willing to alter their habitual practices 
based on carefully conducted research showing the efficacy of a treatment. If complementary medicine seeks a secure place within society as a legitimate and 
ethically sound practice, then its practitioners should emulate this approach. Admittedly, the present willingness of some of the public to believe in complementary 
treatments (even those without scientific evidence) leaves practitioners with the power to ignore any proof-of-efficacy issues and still succeed economically and 
perhaps politically. But economic success, as conventional medicine knows, is not the same as the ethical high road.
Other Ethical Duties of Practitioners
Willingness to conduct properly designed research into its methods is only one of many obligations all medical practitioners owe to their patients. The scope of this 
chapter cannot accommodate a review of all ethical duties (e.g., informed consent) that apply equally to complementary and to conventional practitioners. However, a 
few issues merit specific comment.
It has been widely and generally stated that physicians are supposed to place fidelity to the patient's benefit above any interests of their own. This statement is good 
public relations, and physicians have made exceptional sacrifices to serve patients in need. But as a matter of day-to-day practice, physicians do not and should not 
act this way. According to this stringent ethical code, physicians should not take days off or vacations and should happily face bankruptcy rather than withhold 
services from any who cannot pay.
A much more realistic statement of medical ethics is that practitioners are constantly facing conflicts between their altruistic service goals and legitimate self-interest, 
and they must constantly work to find a reasonable balance. To deny the need for balance and to insist that practitioners should serve patients without regard for their 
own interest may have deleterious consequences. By setting an impossibly high standard, ethics become purely an idealistic exercise without practical value, 
because virtually all practitioners fail to live up to this standard.
All practitioners have some legitimate self-interests. Among complementary practitioners these include establishing individual economic well-being and promoting 
legitimacy and support for their type of practice. One can often promote these ends while simultaneously providing benefits and avoiding harm to individual patients. If 
some conflict exists, however, then patient benefit and professional accountability should take priority over self-interest.
The following case study provides an illustration of inappropriate balancing.

C
ASE
 E
XAMPLE
A patient who had developed cancer sued both his family physician and two complementary practitioners. The family physician had initially treated him for worrisome 
symptoms and had advised him to return soon for further evaluation. The patient instead went to the two other practitioners who did not advise returning to the family 
physician. As a result, the cancer went undiagnosed for many months, probably leading to a worse prognosis.
In depositions, the deans of two schools of complementary medicine where the practitioners had trained testified that there was no standard of practice in that 
particular field of complementary medicine. By definition, malpractice cannot be found unless the standard of practice is violated, so this testimony stated that no 
complementary practitioner in that school could ever be successfully sued for malpractice. The result was that the entire burden of the lawsuit was shifted to the 
family physician.
C
OMMENTS ON
 C
ASE
The course pursued by these complementary practitioners may have been an excellent legal ploy. By denying the basis for any tort action in law, the testimony of 
these leaders of the field neatly shifted the total burden to the physician (and to his “deep pockets” insurance company). In terms of economic self-interest, it was a 
brilliant strategy.
However, the ethics of this strategy are questionable in terms of public accountability. The two deans were saying, in effect, that they had never had grounds to flunk 
a student; presumably, anyone who enrolled and paid fees was guaranteed graduation and a diploma. The deans were saying to the public that membership in their 
particular school of complementary medicine did not entail any accountability, nor did it guarantee any standards of basic professional competence. “Let the buyer 
beware” would be the only prudent course a patient could adopt upon consulting anyone who practiced within that system or studied at that school. Of course, we 
presume that the deans did not intend to say these things and would assuredly not have said any of those things were they instead addressing, for example, the local 
Rotary Club luncheon. But the fact that they would say one thing about their discipline in the Rotary Club and something diametrically opposed in a court of law 
suggests that they were allowing economic interests to override any ethical concerns about public accountability.
The final negative consequence of this type of case is that it discourages conventional physicians from trusting in the goodwill of, or offering to collaborate with, 
complementary practitioners. Moreover, given the lack of education among conventional physicians about the various types of complementary medicine, these actions 
by one group of practitioners are likely to tar the entire complementary movement.
Ethical professionals naturally wish to receive credit when their treatments succeed, but that also implies that they should accept some measure of potential blame 
when their treatment fails. They wish to be paid reasonable fees for their healing practices, which means they should publicly promulgate and adhere to standards of 
practice. To take accountability for only the positive outcomes of their practice and to refuse any accountability for the negative outcomes is an unprofessional 
approach.
CONCLUSION
The cooperation between conventional and complementary systems of health care is in its infancy, and the current stage is critical. If patient autonomy is indeed an 
important ethical value, then the patient must assume more responsibility. Conventional medicine must yield some responsibility along with some of its exclusive 
claims to power. Conventional physicians may feel threatened by giving up some of their historical power and esteem, but they would benefit by a new social climate 
that does not make them the scapegoats for any negative health outcome. Patients must recognize that they cannot expect conventional physicians to be equally well 
versed in all other healing systems, so that if patients decide to use a particular method outside the physician's expertise, the physician cannot be held accountable 
for its failure or harm.
An ideal health care system is one in which power is shared equally among the patient, the conventional physician, and the complementary healer, with the patient 
piloting the ship. Currently we are far from that system, and approaching it will be a challenging transition. Among other factors, this transition requires a change in 
thinking about health outcomes instead of focusing strictly on disease and diagnosis. A practice that focuses only on curing disease shifts power inevitably toward the 
practitioner, whereas a practice aimed at optimizing health tends to stress shared responsibility and the power of the individual. Moreover, the treatment's 
effectiveness is much more important to a patient than the healing paradigm that explains it. Whether the benefit is a placebo effect is of little concern to the patient 
who feels better. Conventional and complementary medicine coexist best when both recognize that a placebo response is as favorable and important as a specific 
therapeutic response because the ultimate goal is the health and well-being of the patient (
11
). Placebo effects may have been stigmatized in the past because they 
were associated with deception (i.e., “dummy” pills). Today, scientifically informed practitioners of both conventional and complementary medicine can agree that all 
treatments, in addition to their powers to alter the body directly, exert psychological and spiritual effects that may themselves add to healing.
In the late 1970s, when textbooks of medical ethics in the modern era first began to be published, it was typical for each text to be liberally illustrated with case 
examples. Some monographs on medical ethics consisted entirely of cases and commentaries. By highlighting real dilemmas and indicating some of the ethically 
problematic features of actual practice, this case focus was helpful for the developing field of medical ethics. Unfortunately, these case studies were only rarely 
accompanied by any true epidemiology of ethics, in which one sought to find out exactly how common or how rare specific sorts of cases and dilemmas were in 
practice overall.
Ethics of complementary medicine today is in much the same state as the ethics of conventional medicine in the 1970s. Collections of case studies, with quantitative 
assessments of the most common, most vexing, and most clinically relevant ethical problems for complementary healers, would help focus attention on the matters of 
greatest concern to the front-line practitioners and help guide future research and education.
Some conventional physicians in the 1970s attacked or ignored this new field of ethical inquiry because it was a threat to their historical prerogatives or because they 
felt that nonphysicians could say nothing useful to them about their practices. But many other physicians embraced this line of inquiry as a way of improving the 
quality of practice and making practice more emotionally satisfying. We anticipate both types of reactions among today's complementary practitioners who have even 
more reason to be skeptical of anything emanating from conventional medicine. We hope that the latter reaction will ultimately dominate.
C
HAPTER
 R
EFERENCES
1.
Pellegrino ED, Thomasma DC. A philosophical basis of medical practice. New York: Oxford University Press, 1981.
2.
Brody H. The healer's power. New Haven: Yale University Press, 1992.
3.
Starr P. The social transformation of American medicine. New York: Basic Books, 1982.
4.
Beauchamp TL, Childress JF. Principles of biomedical ethics, 4th ed. New York: Oxford University Press, 1994.
5.
Miller FG, Brody H. Professional integrity and physician-assisted death. Hastings Center Report 1995;25(3):8–17.
6.
Eisenberg DM, Kessler RC, Foster C, et al. Unconventional medicine in the United States: prevalence, costs, and patterns of use. N Engl J Med 1993;328:246–252.
7.
Engel GL. The need for a new medical model: a challenge for biomedicine. Science 1977;196: 129–136.
8.
Leopold N, Cooper J, Clancy C. Sustained partnership in primary care. J Fam Pract 1996;42: 129–137.
9.
Clouser KD, Hufford DJ, O'Connor BB. Informed consent and alternative medicine. Altern Ther 1996;2:76–78.
10.
Kaptchuk TJ. When does unbiased become biased? The dilemma of homeopathic provings and modern research methods. Br Homeop J 1996;85: 237–247.
11.
Lynoe N. Ethical and professional aspects of the practice of alternative medicine. Scand J Soc Med 1992;4:217–225.

CHAPTER 4. E
VALUATING
 C
OMPLEMENTARY AND
 A
LTERNATIVE
 M
EDICINE:
 T
HE
 B
ALANCE OF
 R
IGOR AND
 R
ELEVANCE
Essentials of Complementary and Alternative Medicine
CHAPTER 4. E
VALUATING
 C
OMPLEMENTARY AND
 A
LTERNATIVE
 M
EDICINE:
 T
HE
 B
ALANCE OF
 R
IGOR AND
 R
ELEVANCE
Klaus Linde and Wayne B. Jonas
Introduction
 
The Scientific Approach to Medicine
 
Evaluating and Researching CAM Treatments
Effective Treatment
Evaluation of Specific CAM Practices
 
Phytotherapy
 
Acupuncture
 
Homeopathy
 
Complex Naturopathic Interventions
Developing Decision Rules for a Strategic Science in CAM
 
Balancing Relevance, Rigor, and Realism in Practice
 
Choosing Research Strategies in CAM
CAM and The Evolution of Scientific Medicine
Chapter References
INTRODUCTION
THE SCIENTIFIC APPROACH TO MEDICINE
Applying scientific methods to medicine is a relatively recent phenomenon. Technologies for examining basic life processes, such as cellular functioning, genetic 
regulation of life, and mechanisms of infectious agents and environmental stressors to disease, have developed only in the last 100 years. The randomized controlled 
clinical trial is only 50 years old and has been an established standard for accepting new drugs for only about half that time. Statistical principles and approaches for 
analyzing large data sets have also only recently evolved. The use of scientific methods has taken much of the guesswork and unverifiable theory out of medicine by 
providing more precision and control over the body and the public's health than ever before. The continued development and refinement of science and technology 
promise even greater benefits to medicine in the future.
Despite the rather recent development of science-based approaches to biology and medicine, a wide array of research methods now exists for acquiring information 
useful for treating disease and illness. We discuss methods of investigation frequently used in medical research and the general type of information that these 
approaches provide. 
Figure 4.1
 illustrates how these methods of investigation are put together into strategies of medical research.
F
IGURE
 4.1. Research strategy chart.
Qualitative research, such as detailed case studies and patient interviews, describe diagnostic and treatment approaches and investigate patient preferences 
and the relevance of those approaches. Qualitative approaches have been extensively developed in the nursing profession and are becoming increasingly 
common in primary care.
Laboratory and basic science approaches investigate the basic mechanisms and biological plausibility of practices. In vitro (e.g., cell culture, intracellular with 
probe technology), in vivo (e.g., testing in normal, disease prone or genetically altered animals), and mixed approaches are now extensively used.
Observational studies, such as practice audit, outcomes research, and other types of observational research, describe associations between interventions and 
outcomes. Practice audit involves monitoring outcomes on all or a selected sample of patients who receive treatment with evaluation before and after an 
intervention to measure effects. These studies may not have a comparison group; or, comparison groups may be developed by sampling patients not treated 
with the intervention from other practices or in the same practice previous to the intervention.
Randomized controlled trials (RCTs) which attempt to isolate or compare the specific contribution of different interventions on outcomes. These studies 
usually involve assigning patients to one treatment group or another using a method that assures the groups are comparable on all factors that might influence 
outcomes, except for the treatment. Various methods, such as randomly selected numbers or computer-generated assignment, are used. The treatment may be 
evaluated without knowledge of this assignment; these trials are best done by concealing knowledge of which patients will get which treatment at the time of 
assignment.
Meta-analysis, systematic reviews, and expert review and evaluation assess the accuracy of the previously mentioned methods. Methods for expert review 
and summary of research have evolved over the last several years. Systematic, protocol-driven methods, such as meta-analysis, are used increasingly to try 
and prove that the effects found in clinical research are accurate and applicable across populations.
Health services research examines the actual use and impact of interventions in context of social factors, such as access, feasibility, cost, practitioner 
competence, patient compliance, and so on. This type of research often involves surveys or sampling from groups already receiving an intervention; the 
research looks at the quality and costs of the intervention, as well as other factors. Random sampling may or may not be used.
Although certain groups may preferentially seek out one or more of these methods and the type of information they provide (e.g., basic scientists may have more 
interest in laboratory research results), information from all of these methods may be needed for making clinical decisions.
Tension often exists between research that tries to isolate specific mechanisms and effects (e.g., laboratory, RCTs, meta-analyses) and research that tries to identify 
the pragmatic use and patient-specific relevance of a practice in the real world (e.g., qualitative, observational, health services). Because addressing more than one 
question in a single research project is rare, designing research strategies that attempt to address both specific and pragmatic questions simultaneously is often 
difficult. To address both specificity and pragmatism, strategies for applying and interpreting multiple research methods are needed. Without such strategies, research 
methods and their interpretation are inconsistently applied in both conventional and complementary medicine. A consistent set of decision rules for the strategic 
application of research methods in medicine is a needed step in the continued development of science-based medicine (
1
). 
Figure 4.1
 illustrates a framework for 
developing such strategies.