Research and Regulatory Issues for Integrative Oncology

Abstract

Many oncology patients are empowering themselves to self-treat with herbs, nutritional supplements, and mind-body techniques. Other practitioners, such as acupuncturists, are becoming involved in the supportive care of cancer patients. Government research agencies are supporting studies that evaluate complementary therapies. This educational article provides an overview of the challenges in designing appropriate studies of complementary and alternative therapies, evaluating the results, and regulating implementation of useful therapies. KEY WORDSIntegrative oncology, CAM, research, regulation, acupuncture, natural health products, herbs INTRODUCTIONPublic interest in, and research into, complementary and alternative medicine (generally called CAM) are both increasing. However, many medical practitioners would like to eliminate the term "alternative medicine." However, "alternative" is a useful anthropologic term for examining paradigms of practice such as Chinese medicine or Ayurveda.Complementary therapies are any therapies that are used with mainstream treatments (primarily surgery, drug treatments, chemotherapy, and radiotherapy). Complementary therapies are used in addition to mainstream treatments to improve outcomes. Complementary therapies can reduce side effects in patients and improve quality of life."Integrative medicine" is the current term for the evidence-based association of complementary therapies with mainstream medicine. There is great interest in conducting clinical trials to evaluate complementary therapies for use in a program of integrative medicine for cancer patients. Research and regulatory issues for integrative oncology S.M. Sagar MD* and R.K.W. Wong MB BS* PROBLEMS AND APPROACHES IN DESIGNING CLINICAL RESEARCH FOR CAM"Alternative therapies" are typically promoted as viable treatment options-that is, "alternatives" to socalled mainstream therapies such as chemotherapy, radiation, and surgery. Alternative therapies are unproven, seldom based on a credible scientific rationale, and potentially harmful-especially when patients are led away from effective, proven therapies by the lure of false promises and an emphasis on a lack of adverse side effects as compared with conventional therapies. In contrast, "complementary therapies" are to be distinguished from alternative therapies. In the context of cancer, complementary therapies are combined with conventional medicine into an "integrative oncology" program. Integrative oncology focuses on the roles of massage and other touch therapies, acupuncture, music therapy, botanicals, meditation and other mind-body approaches, nutrition, and fitness therapies, among others, in a research-orientated program. Treatment programs aim to reduce symptoms and to improve quality of life for cancer patients. Complementary therapies enhance the efficacy of conventional therapies and are evidence-based.Using modern research techniques, some so-called alternative therapies may be proved effective, at which point they will no longer be called "alternativ...

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