Evidence-Based Practice

Research in CAM continues to increase, and studies have become more rigorous in the scientific methodology used. An evidence-based approach assumes the following:

Few CAM therapies claim to cure diseases; rather they propose to have therapeutic benefits related to the reduction or relief of symptoms (sleep disturbances, anxiety, irritability, depressed mood), and the promotion of well-being. Evidence-based outcomes provide more information about efficacy, tolerability, dosage, safety, and interactions with other treatments, allowing nurses to become more active in educating consumers about the evidence supporting these therapies. This chapter describes the most common evidence-based CAM therapies that have been used for some of the major psychiatric disorders.

Ethical Issues

Ethical concerns about CAM therapies include issues of safety and effectiveness, as well as the expertise and qualifications of the practitioner. Of equal importance is the communication between CAM and conventional health care providers. Nurses should always inquire about the use of CAM therapies in their assessments of patients.

Care must be taken to monitor medications being combined with herbal products for potential harmful interactions. For example, ginkgo biloba may interact with aspirin or warfarin to prolong bleeding times. The herbal product, Hypericum (St. John’s wort) lowers blood levels of protease inhibitors, thereby decreasing their effectiveness by an average of 57%. Herbal products that are metabolized by the same cytochrome enzyme system as psychotropic medications may increase or decrease the therapeutic drug levels of the psychotropic agents (Lake, 2007).

The possibility also exists that symptoms relieved by CAM therapies may mask signs of a more serious condition, thereby causing delays in seeking conventional, evidence-based treatment. There is still a general lack of quality control for herbal products and unfounded or exaggerated claims made about their safety and effectiveness. This is a concern because these products are accessible to many vulnerable populations, including elderly adults, youth, pregnant women, and individuals with psychiatric disorders who often may not consult or report use to a health care professional.

Many herbal products have not been tested in patients with severe psychiatric conditions, and prescribing such a product may be withholding evidence-based conventional therapy. Other concerns are related to effective symptom management, possible side effects, and the lack of regulation of herbal products for purity and potency.

Because of these concerns, the U.S. government has issued the “Final Rule” regulation for the manufacturers of dietary supplements. Under the new regulations, manufacturers are required to identify the purity, strength, composition, and associated adverse events of their dietary supplements.

Given these concerns, the nurse who refers a patient to a CAM practitioner needs to explore the evidenced-based options, as well as the health risk-benefit ratios. Local and state regulatory boards, other health regulatory agencies, and consumer affairs departments also can provide information about practitioner qualifications such as licensure, education, accreditations and complaints that may have been filed.

Box 30-1 provides patient guidelines for those considering a complementary or alternative therapy. In addition, the website www.consumerlab.com provides testing results of the authenticity of ingredients on product labels. The FDA website www.fda.gov provides consumer reports on dietary supplements.

Acupuncture

Acupuncture involves the insertion of needles into specific acupoints along body meridians in order to correct energy or Qi imbalances, which is thought to be the cause of many medical conditions. In Western cultures, the proposed mechanism of action is the activation of endogenous opioid receptors and possible involvement of the autonomic nervous system and central monoaminergic systems (Lin and Chen, 2011).

A meta-analysis of randomized controlled studies exploring the safety and effectiveness of acupuncture in depressive disorders found that acupuncture was more effective for post-stroke depression than major depressive disorder (MDD). The effectiveness of acupuncture in the MDD studies was comparable to antidepressants and there is some indication that acupuncture may accelerate the response to serotonin selective reuptake inhibitors (Zhang et al, 2010).

Another study showed acupuncture specific for depression decreased Hamilton Depression Rating Scale scores (63% reduction) significantly more that control acupuncture (37.5% reduction) or massage therapy (50% reduction) in pregnant women with a diagnosis of MDD (Manber et al, 2010). As many other studies have not been able to differentiate “real” from “sham” acupuncture effects, more research with well designed methodology is needed to conclude that acupuncture is a primary treatment for depression.

Meditation

In mindfulness meditation individuals focus on their “here and now” experiences. Patients are taught to be aware of sensations, thoughts, and feelings they are experiencing in the present moment. The goal is to allow oneself to observe these experiences in a purposeful, non-judgemental and accepting way in order to discover the deeper nature of these experiences (Tusaie and Edds, 2009).

There are two types of mindfulness practices: mindfulness-based stress reduction and mindfulness-based cognitive therapy. Mindfulness-based cognitive therapy integrates cognitive therapy into mindfulness practice. Maladaptive negative thoughts that are often associated with depression are recognized as transient mental events and not facts or reality. Consciously allowing oneself to be exposed to such experiences can lead to better emotional processing and thus, improved affect regulation and self management skills (Lau and Grabovac, 2009).

Meditation practices should be supervised in certain vulnerable psychiatric populations because of the potential to induce certain states of consciousness. Different meditation approaches may produce a stimulating effect, which could evoke mania in bipolar patients.

Yoga

About 6 percent of adults use yoga for health purposes (Barnes et al, 2008). Although there is limited evidence for yoga as a treatment for depression, yoga has been associated with antidepressant effects and stress reduction. Yoga is a physical and emotional conditioning of the body produced by engaging in a series of postures (asanas), stretching exercises, breath control (pranayama), and meditation (dhyana).

The breathing techniques associated with yoga may be associated with vagus nerve stimulation and balancing of the autonomic nervous system. The activity (asanas and stretching) associated with yoga may reduce the agitation and inactivity that some depressed patients experience when practicing dhyana alone.

Other yoga-related mechanisms of action include hypothalamic-pituitary-adrenal (HPA) axis down-regulation with resulting decrease in stress, regulating neurotransmitter systems, improving sleep efficacy, and promoting behavioral activation and adaptive thinking (Uebelacker et al, 2010).

Herbal Products

One of the most widely researched herbal products is Hypericum (St. John’s wort). It is currently used throughout Europe and the United States to treat mild to moderate depression, anxiety, seasonal affective disorder, and sleep disorders.

The herb’s mechanism of action may involve serotonin, dopamine, gamma-aminobutyric acid (GABA), and norepinephrine reuptake inhibition. Other reported effects of Hypericum include antiinflammatory, antiviral, antimicrobial, antiulcerogenic, and astringent activity.

The herb is available in tea, capsule, or tincture form, usually standardized to contain 0.3% hypericin. The higher 5% hyperforin extract may have more antidepressant effects than the 0.5% hyperforin constituent (Sarris and Kavanagh, 2009). The standard dose is 900 mg per day, taken in divided doses. Side effects include dry mouth, headache, dizziness, gastrointestinal symptoms, photosensitivity and acute mania.

Meta-analyses studies have found Hypericum to be superior to placebo and of comparable efficacy to conventional antidepressants, including selective serotonin reuptake inhibitors (SSRIs), in patients with major depression. Adverse events and discontinuation rates were lower in patients treated with Hypericum versus antidepressants (Linde et al, 2008; Rahimi et al, 2009).

However Hypericum has significant and potentially dangerous drug interactions. It interferes with the metabolism of many medications and should not be taken with medications that use the CYP450-3A4 pathway for metabolism, including posttransplant antirejection drugs, oral contraceptives, statin anticholesterol drugs, protease inhibitors, antineoplastics, antiretrovirals, anticonvulsants, digoxin, theophylline, triptans, SSRIs, and anticoagulants (Mischoulon, 2007).

Hypericum extracts with the higher concentrations of hyperforin are more likely to cause CYP3A induction. Since serotonin syndrome is a potential problem when Hypericum is administered with SSRIs, a 2-week washout period is recommended before initiating SSRI antidepressants following Hypericum discontinuation or vice versa (Kasper et al, 2010).

Melatonin, a hormone secreted by the pineal gland, works by synchronizing circadian rhythms. In doses of 0.3 to 3 mg, melatonin has been shown to shorten sleep latency and improve duration and quality of sleep (Brzezinski et al, 2005). Melatonin may be used as an adjunct to medications such as antidepressants and benzodiazepines and can potentially decrease the therapeutic dosages needed for these medications.

In addition, melatonin may be used to facilitate tapering off benzodiazepines. Several studies found melatonin to be effective for improving sleep in elderly depressed patients. This population is at a higher risk for adverse effects associated with use of benzodiazepines, such as cognitive impairment and increased risk for falls.

S-Adenosylmethionine (SAMe), a dietary supplement, has been used for the treatment of mild to moderate depression. SAMe is a naturally occurring substance found in living cells and is involved in many biochemical reactions. Transmethylation, one reaction that affects neurotransmitter—namely, serotonin, dopamine, and norepinephrine—levels, is most likely responsible for the antidepressant action. Vitamin B₁₂ and folate, which are believed to be deficient in depressed patients, are required for the synthesis of SAMe.

Only a few randomized, double-blind, placebo-controlled studies have explored the effectiveness of SAMe. They concluded that it was more effective than placebo and comparable to several standard antidepressants for the treatment of depression (Freeman et al, 2010). SAMe may be indicated as an adjunct to standard antidepressant therapy to enhance responsiveness and may possibly increase the onset of standard antidepressant effects (Saeed et al, 2009).

The usual oral dose of SAMe for the treatment of depressive symptoms is 800 to 1600 mg per day. Side effects are generally mild and include mostly gastrointestinal symptoms, sweating, dizziness, and nervousness. SAMe should not be combined with other psychotropic medications unless medically supervised and should not be taken by patients with bipolar or manic disorders.

Omega-3 essential fatty acids, a supplement found mostly in fish oils and plants, may have some efficacy in patients with affective disorders. Although little evidence exists regarding essential fatty acids as a single therapy, several studies show that omega-3 fatty acids—namely, eicosapentaenoic acid (EPA) and EPA combined with docosahexaenoic acid (DHA)—used with conventional antidepressants and mood stabilizers, improve treatment response.

There is some evidence that the EPA or the combination of EPA and DHA are more effective than the DHA alone. One recent study compared EPA 1 gram daily to fluoxetine 20 mg and to a combination of the two. The EPA and fluoxetine groups had comparable response rates as measured by the Hamilton Depression Scale but the combination group had the highest response rates (Saeed et al, 2009).

Some evidence indicates that mood disorders are associated with low plasma omega-3 fatty acid levels (Lake, 2007). As such, the dose range for treatment response may depend on plasma levels, and there appears to be a ceiling effect on the dosage. The dose range of EPA augmentation is between 1 and 2 g per day.

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