Fundamental Criteria: Safety and Efficacy
The most fundamental criteria for any Integrative Medicine Services Program (IMSP) is to ensure that only services that are considered to be safe and effective are included in the program. The organization must determine first, based upon its patient population and its mission, the specific symptoms and conditions for which they will provide CAM services (as an option or adjunctive treatment) to patients. The organization must then determine which services are safe and effective for each symptom or condition. Figure 1 illustrates the relationship between CAM, safety and efficacy. A given therapy will fall somewhere along the spectrum of safety and efficacy. If a therapy is both safe and effective (upper right hand quadrant), in the absence of patient-specific contraindications, it should be offered as an alternative during the informed consent process. Therapies that are high efficacy-low safety and low efficacy-low safety (the left side of the box) should be eliminated from consideration. Therapies that are high safety-low efficacy (lower right hand quadrant) are the most difficult to address. And, because there are few evidence-based studies for many CAM therapies, often, healthcare providers find themselves wrestling with decision making for therapies in this quadrant – especially for therapies that patients specifically request.
A good example of patient demand for a high safety-low efficacy therapy was addressed in a recent New York Times article. To meet Hmong patients’ requests, a shaman traditional healer program was implemented at Mercy Medical Center in Merced, California. The shaman program was implemented to strengthen trust between doctors and the Hmong community. One goal of the policy was to expedite medical intervention by having a “healing ceremony” coincide with a hospital stay, rather than waiting days to admit a patient after he has had time to confer with family and clan leaders after a ceremony at home.11 Although the therapy has not been proven effective through research, it is safe and embraces the patient’s cultural beliefs and needs and may play a role in recovery and improved patient satisfaction.
Figure 1. Safety-Efficacy Criteria for CAM Therapies
CAM is still in need of much evidence-based research. However, in the past 20 years, significant research has been conducted. And, the National Center for Complementary and Alternative Health (NCCAM) is funding over $200 million of additional CAM research annually. Some CAM therapies, like Mindfulness-based Stress Reduction (MBSR) are extremely safe and can likely be used for any patients with appropriate symptoms or diagnoses. The American College of Physicians (ACP) has published a compendium of evidence-based research by symptom or condition, The ACP Evidence-Based Guide to Complementary and Alternative Medicine. Because new research is constantly being made available on CAM therapies, the guide is not complete. However, the ACP manual provides a good solid basis to begin the process of identifying appropriate therapies for a healthcare system’s patient population. Resources for evidence-based CAM research studies are provided in appendix C. The ACP methodology includes grades for every CAM therapy studied for a particular diagnosis. For effect, the grade is either none, small, moderate, or large. For safety, the grade is either double thumbs up, single thumbs up, unclear, single thumb down, or double thumbs down. And for recommendation, the grade is either strong recommendation in favor, weak recommendation in favor, no recommendation, weak recommendation against, or strong recommendation against. Like the box in figure 1, these grades help healthcare providers make decisions about the therapies they will offer in their own IMSP.
One condition for which the ACP analyzes the safety and effectiveness of CAM is anxiety. The ACP analyzes 11 different CAM therapies for anxiety. Relaxation training for anxiety is graded as strong in favor and meditation is graded as weak in favor. While both therapies are considered equally safe, the research studies on relaxation training are more robust
than those on meditation. So there is a need, for some level of subjective decision making by the healthcare provider to determine which safe therapies to offer or recommend to patients. Healthcare organizations can also use data available in the Centers for Disease Control and Prevention’s (CDC) National Health Statistics Reports to identify safe therapies and conditions and their appropriate CAM modalities. For example, the 2007 study showed that five of the top conditions for which Americans seek CAM therapies are back pain, neck pain, joint pain, arthritis, anxiety, and high cholesterol. The same study found that some of the most common CAM therapies used by patients includes deep breathing techniques, progressive relaxation, yoga, tai chi, qi gong, meditation, and massage. As information about safe and efficacious CAM therapies becomes more disseminated, physicians will likely have a duty to inform patients about these alternatives. Minimally, physicians should be able to answer basic questions about certain CAM therapies that their patients may ask.
Patient expenditures on CAM, which is estimated to be 12 percent of out-of-pocket spending can be used as another indicator of choice of CAM services, after validation of safety and efficacy. About 35 cents of each alternative therapy dollar is for visits to acupuncturists, chiropractors, massage therapists and other practitioners, mostly for pain relief. This represents nearly $12 billion, or about one-quarter of what Americans spend on visits to mainstream physicians. Acupuncture, as a CAM modality, is perceived to be effective by most patients who use it to treat a specific condition. And, acupuncture has been considered to be both highly effective and highly safe by the American College of Physicians for migraine headaches and postoperative nausea and vomiting. The ACP has rated acupuncture, based on current evidence-based research, to be highly safe and moderately effective for chemotherapy-induced nausea and vomiting, cancer pain, anxiety, pregnancy-induced nausea and vomiting, acute gastrointestinal pain, premenstrual syndrome (PMS), infertility, incontinence (female), low backpain (acute and chronic), neck pain (acute and chronic), and osteoarthritis of the knee.