Whether you are a general practitioner, psychiatrist, neurologist, internist, or other medical specialist, a psychologist, nurse, social worker, counselor, physician’s assistant, chiropractor, physical therapist, acupuncturist, mind–body therapist, nutritionist, homeopathic practitioner, dentist, or other health care provider, you already know the basic principles of good clinical practice in your field. We offer a few suggestions regarding how to apply what you know to improve your practice of complementary and alternative medicine (CAM) and to seamlessly integrate it into your work.
A study of information-seeking behavior among the health sciences faculty at the University of California, San Francisco concluded that the majority of health professionals are unable to locate the CAM information they need for research, teaching, and practice (Owen & Fang, 2003). While 41% of respondents got useful information from the Web and 40% from journals, 46% relied on their colleagues for advice. Reliable information is the foundation of clinical work. In Appendix B you will find useful resources for CAM information. In each chapter you will find treatments that we have found beneficial in clinical practice and in Appendix A information on where to obtain products of good quality.
The quality and quantity of scientific information on CAM treatments varies greatly. This can add to the clinician’s uncertainty about using such treatments. In addition to indicating the extent and validity of the scientific research for each treatment, we will put this information in the context of clinical decision making. Keep in mind that a lack of research often has little to do with the potential benefits of an herb and more to do with whether a company would profit enough from sales to offset the costs of doing a double-blind, placebo-controlled study (approximately $500,000 to $2,000,000). Unlike synthetic drugs, patents usually cannot protect the sale of natural herbs, so no single company would profit enough from exclusive sales to pay the cost of research. Many companies obtain patents for herbal combinations with “proprietary blends.” While we prefer to see large-scale controlled studies, these are available for only a few CAM treatments. In most cases, there is preliminary or pilot data. Each clinician must decide how long to wait for positive preliminary results to be validated by further studies before using these treatments.
While most health care professionals agree that double-blind randomized placebo-controlled trials are the gold standard of research, in many cases such studies are no guarantee of efficacy or safety. Numerous drugs have been pulled from the market due to serious adverse effects or lack of efficacy after initial positive results in such studies. This may be due to the fact that most studies use carefully selected subjects without comorbid conditions who do not represent the range of patients in clinical practice. Furthermore, few studies run for more than six weeks and therefore yield little information on long-term effects.
We have a lower threshold for trying CAM treatments based on preliminary data than for synthetic drugs for several reasons. First, synthetic pharmaceuticals are new to biological systems. Because most CAM treatments have been used by large groups of people of all ages and stages of health for hundreds if not thousands of years, we have much more information about their safety and potential side effects than we could possibly have for drugs that are often tested for six weeks in a carefully selected group of physically healthy subjects. Second, in general, CAM treatments have far fewer and far milder side effects than prescription medications or surgery. The relatively high safety profile of most CAM treatments weighs in favor of trying them even if the scientific research is limited.
The context and options are also important in deciding whether to offer complementary treatments. If a patient is suffering and has not responded to standard treatments or cannot tolerate side effects, then it makes sense to offer low-risk alternatives with few adverse effects. The level of evidence for medical treatments is an assessment of the amount and the quality of research available to support the use of each treatment. For example, if there are six well-documented double-blind randomized placebo-controlled studies of a substantial number of patients that all report significant positive benefits, the level of evidence is rated as high. In contrast, if there is only one study or if there are only a few small open, uncontrolled studies, then the level is lower. Rather than dismissing all but those treatments with the highest levels of evidence, we suggest that different clinical situations warrant different levels of evidence for treatment. Here are several scenarios in which the clinician might accept a lower level of evidence in recommending CAM treatments:
1.The patient has tried and failed to respond to standard treatments.
2. The patient is unable to tolerate side effects of standard treatments.
3. The patient has a condition for which there is no effective standard treatment.
4. Standard treatments and augmentation strategies partially relieve symptoms, but the patient is still symptomatic.
5. The patient is taking necessary medications and those medications are causing side effects that could be alleviated by CAM treatments.
6. The patient wants to reduce or mitigate the effects of risk factors, for example, a family history of Alzheimer’s disease, a personal history of cigarette smoking, or head trauma.
7. The patient wants to explore the full range of preventive, antiaging, or function-enhancing (e.g., cognitive or sexual) options.
8. The patient is in a situation in which there is no access to standard treatments, for example, a mass disaster or war zone.
9. The patient is uncomfortable with traditional pharmaceuticals and is more comfortable starting with CAM.
10. The patient cannot afford traditional pharmaceuticals and wants to start with lower cost alternatives.
It is best to start by focusing on a small number of CAM treatments to develop in-depth knowledge as you gain experience. Clinicians add to their repertoire of CAM treatments over time. As is true in all areas of health care, it is important to know one’s limits and when to refer to other providers in order to do no harm. The same principles of good clinical judgment used in standard practice apply to CAM, including objectively weighing risks versus benefits, evaluating the evidence base for each treatment, flexibility in adapting treatments to the individual patient’s needs, and risk reduction. Along the way you will discover through clinical work which experts provide information that really helps your patients do well. Once you identify such experts, you can attend their lectures or contact them for advice or supervision if needed. Reading their articles can offer an opportunity to dig for diamonds in their reference lists.
It is essential to learn how each CAM treatment works. Simplistic tables that say use herb X for symptom Y are of limited use. Knowledge of the underlying mechanisms of action for each treatment allows better understanding of all the ways it may affect the patient, including interactions with medications. Look for CAM lectures and courses sponsored by reputable organizations such as professional societies and academic institutions.
The quality of products used in CAM varies greatly. Not knowing which brands are of high quality is a major obstacle for practitioners. Stable supplements that are easy to produce, such as vitamin C, can be purchased from any large reliable company. However, the purity and potency of herbal preparations may depend on where they were grown, when they were harvested, and the specific extraction techniques. Certain nutrients, such as S-adenosylmethionine, are highly unstable and require great care not only in production, but also in the manufacturing and packaging of the tablet. For those supplements that require special attention for processing and manufacturing, we provide a list of products believed to be of good quality in the tables in Appendix A. The intention is to help practitioners identify reliable products that they can begin to use while gaining experience. These lists do not cover all available products. Exclusion from a list does not mean that we have assessed other products to be inferior. In developing the list of quality herbal products, we took into consideration the following sources of information:
1. Some companies were asked to supply detailed information about the source of their materials, the methods of extraction and manufacture, documents such as high-pressure liquid chromatography as proof of purity, reports of all tests and clinical studies done on their products, and evidence of testing for shelf life (how long the product retains full potency while sitting on the shelf). If a company was unable or unwilling to supply adequate documentation, they were not included on our list.
2. Specific products that demonstrated efficacy in controlled studies published in peer-reviewed journals were considered of high quality.
3. Information gathered from independent testers such as ConsumerLab and SupplementWatch was also used.
4. Observations over many years of clinical practice provided us with valuable information about the efficacy and tolerability of products.
The information about quality products is not intended to promote any company. We have attempted to provide several options in each category. Some companies specialize in combination products tailored to specific clinical problems. In such cases, the choices may be limited to one or two product lines.
We recommend avoiding the temptation to profit from the sale of CAM products. Practitioners are often approached by herbal companies offering financial incentives to prescribe or sell their products. One can promote ethical practices by just saying no. Even if you believe that a product is of good quality, as soon as you start to sell it in your office, you are on the slippery slope of allowing money to influence clinical judgment. Although many CAM experts believe in the quality of their name brand products, they have opened the door for conflict of interest to erode trust. However, there are exceptions. For example, some CAM products and medications used in other countries can only be purchased by a licensed physician. In such cases, the physician may have to purchase and resell the product to patients. To prevent any compromise of ethics, we advise selling such products at cost without profit. This may seem a bit austere, but the unconscious is a greedy beast that can subvert clinical judgment. Even when the practitioner’s decision to prescribe a CAM product is not influenced by profit, if the practitioner benefits financially from the sale of that product, the patient’s trust may be undermined by the appearance of a conflict of interest. Accepting customary lecture fees is also within the bounds of ethical practice. It is best to apply the same ethical standards to CAM that you would use with prescription medications.
Fear of malpractice liability prevents many practitioners from integrating CAM into their work. Many are uncertain about how to handle liability issues. In discussing legal and regulatory issues, malpractice experts Michael Cohen and Ronald Schouten (2007) suggest that the following categories of malpractice could be applied to CAM: misdiagnosis, failure to treat, failure of informed consent, fraud and misrepresentation, abandonment, vicarious liability, and breach of privacy and confidentiality. Obviously, patients who request CAM treatments are entitled to the same level of diagnostic evaluation as those who seek conventional treatments.
While, in general, the same approach used to address liability issues in standard practice is applicable to all categories of liability in integrative mental health care, in using CAM treatments, the issue of failure to treat raises several potential scenarios worth noting:
1. If scientific evidence supports the safety and efficacy of a CAM treatment, then it is not likely to lead to a liability. There could be cases in which a patient who is unable to tolerate or respond to conventional treatments could be treated with a reasonably safe and effective CAM therapy. In such cases, one could argue that it would be negligent not to inform the patient of the CAM treatment and offer the option to try it.
2. If scientific evidence indicates that a particular CAM treatment is ineffective or is likely to cause harm, then the practitioner should try to dissuade the patient.
3. If the evidence for the safety or efficacy of a CAM treatment is equivocal, then the practitioner should discuss with the patient all of the known potential risks as well as the quality of the evidence both in favor of and against the treatment. If the patient decides to try the treatment after this discussion (which has been documented in the chart), then the practitioner should monitor the patient during the trial and intervene if any adverse reactions occur.
4. If the patient has a condition that can be easily or rapidly cured by standard treatment, and if the use of CAM delays effective treatment such that the patient suffers harm or the illness progresses, this could be considered malpractice, negligence, or substandard care.
The same principles that govern informed consent in conventional treatments can be applied to CAM. Practitioners should consult their individual state regulations governing the practice of CAM. The Federation of State Medical Boards (FSMB; 2002) of the United States approved model guidelines for the use of CAM therapies in medical practice (http://www.fsmb.org/pdf/2002_grpol_complementary_alternative_therapies.pdf). They recommend that before offering any recommendation for treatment, the physician should conduct an appropriate medical history and physical examination of the patient as well as a review of the patient’s medical records. The FSMB (2002) guidelines note:
The evaluation shall include, but not be limited to, conventional methods of diagnosis and may include other methods of diagnosis as long as the methodology utilized for diagnosis is based upon the same standards of safety and reliability as conventional methods, and shall be documented in the patient’s medical record. The medical record shall also document:
• what medical options have been discussed, offered or tried, and if so, to what effect, or a statement as to whether or not certain options have been refused by the patient or guardian; that proper referral has been offered for appropriate treatment;
• that the risks and benefits of the use of the recommended treatment to the extent known have been appropriately discussed with the patient or guardian;
• that the physician has determined the extent to which the treatment could interfere with any other recommended or ongoing treatment.
Sidebar 1.1 shows an example of how to write a note to document the decision to treat a depressed patient with S-adenosylmethionine, an alternative antidepressant described in Chapter 2. Including a direct quote from the patient adds credibility to the record.
Written informed consent forms for CAM can be created by adapting language found on conventional forms and including space to fill in the potential risks, drug interactions, and benefits. However, clinicians will find that it is cumbersome and time consuming to ask the patient to sign a form every time a treatment is initiated. Moreover, this does not obviate the need for full documentation of the decision-making process and discussion in the patient record.
In general, referral to a CAM therapist should not engender liability for the referring conventional practitioner. However, the practitioner may be considered liable if the referral delays medical care and leads to harm for the patient, if the conventional practitioner knows or should know that the CAM therapist is incompetent, or if there is a joint treatment (Cohen & Schouten, 2007).
Practitioners of conventional medicine, CAM, and integrative medicine can minimize liability risks by becoming well-informed about the treatments they recommend, completing a thorough diagnostic workup, fully informing the patient of treatment options (both conventional and CAM), clearly documenting treatment discussions in the medical record, monitoring the patient for progress as well as adverse reactions, engaging the patient in treatment decisions, and communicating clearly with the patient about treatment issues. Ultimately, the single most effective way to prevent liability problems is to maintain a caring and responsive professional relationship with the patient.
SIDEBAR 1.1 SAMPLE NOTE FOR DOCUMENTATION OF CAM
Impressions and Recommendations:
1. The patient has major depression, recurrent moderate causing significant difficulties functioning at work and at home. Previous trials of 8 prescription antidepressants, including 2 TCAs, 3 SSRIs, venlafaxine, bupropion, mirtazepine, and 2 mood stabilizers have been unsuccessful because of intolerable side effects (sedation, weight gain, cognitive impairment, elevated liver enzymes, and sexual dysfunction).
2. The patient has been informed of the risks and benefits of further medication trials including MAOIs and mood stabilizers. I also discussed the potential risks and benfits of an alternative antidepressant, S-adenosylmethionine (SAMe), including nausea, diarrhea, headache, palpitations, insomnia, anxiety, agitation, and mania in bipolar patients. I informed the patient that SAMe has been approved by the FDA for over-the-counter sale in the United States as a nutraceutical.
3. I recommended SAMe because it does not cause any sedation, weight gain, cognitive impairment, liver enzyme elevations, or sexual dysfunction. SAMe has no adverse interactions with any of the medications the patient is taking.
4. The patient chose to begin a trial of SAMe because she prefers to avoid medication side effects if possible. The patient states, “I’ve suffered enough from the prescriptions I’ve already tried. I want to try some alternative treatments.”
The differential diagnosis is a working list of the possible diagnoses that could account for the patient’s symptoms. Sometimes the diagnosis is evident in the first encounter, but usually it unfolds over time. Diagnosis and treatment can be like a game of chess in that as it evolves, only certain moves are possible at each moment in time. Every therapy opens with the building of trust based on understanding and compassion. As you elicit the clinical history, inquire respectfully about the patient’s attitudes toward and experiences with CAM as well as standard treatments. Has the patient benefited from complementary approaches? What products is the patient using? Does the patient engage in mind–body practices? Often patients will tell you that years ago they did yoga or meditation or Tai Chi, but that they had forgotten how good it made them feel. Others will say that they tried meditation but never could do it because they were thinking too much. In Chapter 3 we show how useful these nuggets of information can be as you formulate a treatment plan.
If you drink too much from a bottle marked “poison,” it is almost certain to disagree with you, sooner or later.
—Alice’s Adventures in Wonderland by Lewis Carroll
Alice remembered to read the label before following the directions “Drink Me” on the bottle she found on a glass table. Clinicians also need to read the labels on bottles of herbs while keeping in mind that labels do not tell all that you might wish to know. As Alice discovered, the absence of a “poison” label is no assurance of safety. We ask patients to bring to the office all of the vitamins and supplements they are taking and we keep a magnifying glass handy for reading the fine print. Obtaining previous treatment records and knowing what substances your patient has been ingesting are essential in working through the differential diagnosis.
The patient’s level of interest in or resistance to CAM is an important consideration in the treatment plan. Take time to explain the pros and cons of standard and alternative treatments pertinent to the symptoms. When the client absolutely favors prescription medication and maintains a completely negative attitude toward CAM, it makes sense to start with prescription drugs if they are appropriate. If the response to medication is robust with few side effects, then CAM may not be necessary. However, if after doing appropriate medication trials the patient is only 50% or 75% improved or if there are troublesome side effects, it may be time to reopen the CAM discussion. By this time, the patient has learned from experience the limitations of prescription medication and is probably more willing to try alternative approaches. You can share what you know with the patient by discussing CAM options, explaining how each one works and the potential benefits and risks. When you record this discussion in the chart along with your reasons for recommending CAM, you will also be reducing the liability risks.
Conversely, if patients come to you strongly favoring CAM, then you first need to understand the reasons for their interest and make certain that you fully inform them of both standard and alternative treatment options. The history may show that the patient has already run the gamut of medication trials without satisfactory results. Again, be sure to document in the chart that you have fully informed the patient about standard and CAM treatments.
CAM is not a panacea, but it can contribute to recovery and well-being. Enabling the patient to participate in the decision-making process strengthens the therapeutic relationship. Many come from backgrounds in which they had no choice but to obey what others imposed upon them. Approaching the integration of CAM as an exploratory collaboration supports the therapeutic process.
Many of the case examples used in this book involve assessing, augmenting, or changing prescription medications. Practitioners and students who are not licensed to prescribe medication will find a guide to medications in Appendix C. Even if you cannot write prescriptions, you may still contribute to an integrative treatment plan through team discussions and by providing clients and other practitioners with current information on CAM treatments. Those who offer CAM treatments need to be aware that patients who have medical conditions and those taking prescription medications should be advised to consult their physician before adding or substituting herbs or supplements.
Focus on Stress
The most useful concept in complementary medicine is stress—psychological, environmental, and physical. Directly and indirectly, CAM works by reducing stress, enhancing stress resistance, or ameliorating the adverse effects of stress.
We can consider stress to be any condition in which the demands for activity exceed the supply of energy. This applies at the cellular level as well as to the organism as a whole. Energy is generated in mitochondria and stored in energy molecules such as adenosine triphosphate and creatine phosphate. This energy fuels all functions of life including cellular repair. Cells are subject to constant damage from free radicals, radiation, inflammation, infections, toxins, and aging. Oxygen, nutrients, and energy are required to continuously repair the damage inflicted on cell membranes, mitochondria, DNA, and other cellular components.
Prescription antidepressants target specific neurotransmitters involved in mood regulation. Alternative approaches support the optimal functioning of all neurons by ensuring a rich supply of vitamins and nutrients known to support cellular energy production and metabolic pathways, prevent damage to cellular components, reduce excess inflammation and lipid peroxidation, and enhance cellular repair. Furthermore, through mind–body practices it is possible to increase oxygenation and to shift the chemical and electrical activity of the nervous system toward more integrated, synchronous, and effective functioning with a reduction in energy expenditure.
Under conditions of emotional or physical stress, cells burn energy at a higher rate while generating more free radicals as by-products. The main components of the stress response system are the sympathetic nervous system (SNS) and the hypothalamic-pituitary-adrenal axis (HPA). When we perceive danger, the SNS prepares the body for fight or flight by releasing neurotransmitters that accelerate the heart rate and respiration, increase blood flow to muscles, and reduce blood flow to the digestive tract. The HPA contributes hormones such as adrenaline to stimulate the heart and nervous system. Cortisol is released to mobilize glucose stores. The human stress response system is designed for short periods of intense activity to be followed by long periods of rest and recovery. Once the immediate danger has passed, the parasympathetic nervous system (PNS) is supposed to become more active to slow the heart and respiration, relax the gastrointestinal tract, restore energy reserves, and enhance cellular repair. Failure of the PNS to counterbalance the SNS is critical in the pathogenesis of anxiety, depression, and stress-related conditions including heart disease, diabetes, irritable bowel disease, cancer, and diseases of aging.
Stress is a major factor in most illnesses of the mind, body, and spirit. It is well known that prolonged emotional stress can lead to chronic overactivation of the SNS. Common symptoms of elevated SNS activity include anxiety, agitation, insomnia, excess worry, overreactivity, rapid or irregular heartbeat, elevated blood pressure, abdominal pain (e.g., a knot in the stomach), and weight gain. In more extreme cases, all of the symptoms of panic, post-traumatic stress disorder, or chronic fatigue syndrome can appear. Pharmacological interventions for stress symptoms have targeted the SNS. Anxiolytics and many antidepressants dampen SNS responses. However, more recent studies are showing that underactivity of the PNS is an important feature of anxiety disorders and many other conditions including panic, PTSD, depression, ADHD, aggression, sociopathy, and autism. Medications have not been shown to boost the activity of the PNS even though it is critical for restoring balance within the stress response system (Glassman, Bigger, Gaffney, & Van Zyl, 2007). Adaptogenic herbs such as Rhodiola rosea may boost PNS activity (Baranov, 1994). The importance of autonomic nervous system function and methods to enhance PNS activity using certain mind–body techniques are discussed in Chapter 3.
Go for the Gold: Optimal Health
The goal of treatment is remission, the complete relief of symptoms and resumption of full functioning in all areas of life. While 100% remission is not possible in all cases, it is well worth exploring complementary treatments to increase the patient’s progress toward this goal. Integrative mental health care broadens the focus from reducing the burden of disease to attaining optimal health. Clients who have struggled with mental health issues for many years may not know what level of function they might attain. While a past history of limited treatment response is important, the clinician should leave no stone unturned in questioning previous diagnoses and treatments while searching for opportunities to help the patient go for the gold.