The Evidence Question
The increasing number of patients who use complementary, alternative, and integrative therapies raises new ethical challenges for physicians. These challenges arise in part because some of the therapies recommended in integrative medicine (IM) have not been assessed with the rigorous scientific testing recommended to validate conventional allopathic treatments. The dominant approach to medical research is the randomized double-blind clinical trial originally developed for evaluating the efficacy of new medications versus placebo. This pharmaceutical model is not well suited to integrative research for a number of reasons including: the requirement that identical, rather than individualized treatments be administered, a single modality focus that ignores the real-world multiple treatment approach used in clinical IM practice, and the lack of outcome measures which assess nondisease-specific (wellbeing), global, and multidimensional/multisystem changes that many IM practitioners report seeing in their patients .
To evaluate the utility of IM prior to the availability of broad, multidimensional health outcomes trials, a sliding scale of efficacy is used. The greater the potential for harm, the stricter the standards of evidence to which the treatment is held. Where no satisfactory conventional therapy has been shown to be effective, the IM physician considers appropriate alternatives and discusses the potential risks and benefits with the patient. A therapy that lacks substantial evidence for efficacy can be recommended in good conscience if the potential benefit is based on theoretical grounds or clinical experience and the risk to the patient is negligible. The physician explains the basis on which the recommendation is made to the patient in an honest, forthright, and supportive discussion.
Defining Integrative Medicine
Integrative medicine is defined as healing-oriented medicine that takes account of the whole person (body, mind, and spirit), including all aspects of lifestyle. It emphasizes the therapeutic relationship and makes use of all appropriate therapies, both conventional and alternative . In IM, the patient is a partner in his or her health care, with the physician taking the role of the informed, beneficent guide. The physician seeks to understand and respect the patient's beliefs and goals as well as his or her physical and psychological health and ailments. This is accomplished by asking a broader set of questions and listening carefully to the responses . The welfare of the patient is considered paramount, and the physician tailors her actions to result in the best possible outcome for the patient. Allopathic and integrative medicine share the same ethical framework; integrative medicine training reaffirms the importance of beneficence, nonmaleficence, respect for patients, and patient autonomy.
In the United States, up to 88 percent of patients with chronic illness use some form of complementary or alternative medicine (CAM) . The majority of patients do not share their use of CAM with their physicians often fearing the physician's scorn or skepticism . Communication is central to the therapeutic relationship. The ethical principle of nonmaleficence may be violated unintentionally if physicians fail to take a complete history and patients refuse to fully and honestly disclose health information. The most prominent example of this possibility is physicians' failure to ask patients about their use of dietary supplements, botanicals, and vitamins. Because of the widespread use of these compounds in the US, the potential for drug-herb interactions should be explored through a thorough history by the physician.
In addition, skepticism or negative statements on the part of the physician may diminish a patient's hope or damage his or her belief system. This represents a more subtle violation of the ethical principle of beneficence. The impact of reduced hope should not be underestimated. Research reveals that the strongest predictor of mortality is neither lab tests nor physician assessment but rather the patient's own self-rated health status .
The University of Arizona's Program in Integrative Medicine (PIM) has been offering fellowship training in IM since 1997 and has trained more than 100 physicians . The following cases are examples of specific ethical dilemmas that have arisen in the PIM training clinic. These cases serve to highlight the often challenging position of the physician seeking to balance allopathic and integrative medicine.
- A patient selects complementary and alternative medicine (CAM) when allopathic treatment offers better options and where delay in treatment presents risk. For example, a young man with testicular cancer prefers to try alternative approaches first despite the high success rate of conventional medicine for this potentially life-threatening cancer. This places the physician in the position of exploring and probably challenging the patient's belief system.
- A patient is offered a high-risk allopathic approach when a lower risk integrative approach is available. For example, a teenage boy with a 3-year history of headaches, neck pain, and a new onset tic disorder was treated with narcotics, antidepressants, betablockers, antipsychotic medications and epidural anesthesia. Osteopathic manipulation using the strain-counterstrain technique eliminated the pain in 2 visits. Physician ignorance of osteopathic (and other integrative) approaches is, of course, a significant problem and can lead to violation of the patient's right to full disclosure of all possible treatment options.
- A middle-aged, previously vibrant, professional man with a 6-month history of foot dystonia of unknown origin asks his physician when he will be able to use his treadmill again. The treating neurologist suggests that he give away the treadmill, stating he will never use it again. The negative prediction (a sort of "medical hexing") diminishes hope and counters the patient's belief that he will recover.
- A doctor practicing alternative medicine, with financial interests in the sale of his supplements, recommends multiple expensive dietary supplements to an elderly woman with hypertension. Despite her limited income she feels uncomfortable saying no. Selling products creates the potential for conflict of interest. If it is done at all, it is best separated from the therapeutic encounter. The physician's financial incentive must be made clear to the patient.
Patients' use of CAM and IM highlights existing, and presents some new, ethical challenges to physicians in training. Broadening the health history to understand a patient's belief system and motivation, as well as the full range of therapies he or she might be using is a first step to good care . Developing a clear awareness of how one's "own personal, cultural, ethnic, and spiritual beliefs may affect [his or her] choice of recommendations regarding patients' treatment decisions" is another . Greater self awareness is a stimulus of ethical behavior and can be developed through case discussions, reflection, and group process. Finally, broadening medical training to encompass the integrative paradigm provides a forum where ethics, science, and patient preferences are all considered in service to the best of medical care.
- Bell I, Caspi O, Schwartz G, et al. Integrative medicine and systemic outcomes research: issues in the emergence of a new model for primary health care. Arch Intern Med. 2002;162(2):133-140.
- The University of Arizona Program in Integrative Medicine. Available at: www.integrativemedicine.arizona.edu. Accessed August 30, 2004.
- Maizes V, Koffler K, Fleishman S. Revisiting the health history: an integrative medicine approach. Advances in Mind-Body Medicine. 2002;18(2):31-34.
- Matthees BJ, Anantachoti P, Kreitzer MJ, Savik K, Hertz MI, Gross CR. Use of complementary therapies, adherence, and quality of life in lung transplant recipients. Heart & Lung: Journal of Acute & Critical Care. 2001;30(4):258-268.
- Eisenberg D, Davis R, Ettner S, et al. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998;280(18):1569-1575.
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- Maizes V, Schneider C, Bell I, Weil A. Integrative medical education: development and implementation of a comprehensive curriculum at the University of Arizona. Acad Med. 2002;77(9):851-860.
- Maizes V, Koffler K, Fleishman S. Revisiting the health history: An integrative approach. Advances in Mind-Body Medicine. 2002;18(2):31-34.
- Kligler B, Maizes V, Schacter S, et al. Core competencies in integrative medicine for medical school curricula: A proposal. Acad Med. 2004;79(6):521-531.