Chair’s Column December 2012

Unresolved Efficacy and Safety Issues Limit Current Mental Health Care

J. Lake

The appropriate prescribing of conventional psychopharmacologic drugs based on sound research evidence and clearly defined clinical treatment indications is an important component of conventional mental health care. However prescribing potent psychotropic medications based on ambiguous diagnostic findings or prescribing multiple drugs (ie, “polypharmacy”) can be problematic and is often associated with safety problems. In spite of decades of research and billions of dollars of industry funding, the evidence supporting pharmacologic treatments of major psychiatric disorders is still not compelling ( Fournier et al 2010; Hermann et al 2011; Thase 2007; Velligan et al 2009). For example, one meta-analysis found almost no benefit from anti-depressants (Kirsh et al 2008) and another meta-analysis found no effect even after correction for the use of the wrong type of placebo in randomized controlled trials examined (Moncrieff, Wesseley & Hardy 2004). In addition to growing concerns about lack of efficacy, many widely used psychopharmacologic drugs are associated with potentially serious adverse effects, including weight gain, increased risk of diabetes and heart disease, neurologic disorders, sudden cardiac death, and increased suicide risk. Further, adverse drug effects may lead to additional medical disorders, which in turn increase the patient’s psychological burden. Metabolic syndrome, a well-documented adverse effect of antipsychotics and other psychotropic agents, is associated with weight gain and increased risk of diabetes and coronary heart disease (Henderson, 2008). Even when recommended treatment protocols are rigorously followed in clinical practice prescription drugs often yield disappointing outcomes. The limitations of conventional medications when treating serious symptoms of depressed mood, anxiety, psychosis and other psychiatric disorders often translates into impaired occupational functioning and losses in productivity. In addition to these issues there are growing concerns over limitations of the mainstream model of care, including inequalities in the delivery of mental health services, lack of integration of mental health services into primary care and other medical specialties, and conflicts of interest in relationships between the research community and the pharmaceutical industry that have been shown to influence physician prescribing practices, especially of highly profitable more recently introduced drugs.

The shortcomings of conventional treatments and established models of mental healthcare invite urgent open-minded dialog on the range of promising non-conventional treatments, as well as innovative concepts in care delivery. Rapidly accumulating research evidence is demonstrating the efficacy of novel pharmacologic therapies as well as non-pharmacologic treatments that will be used in the coming years to treat the broad range of mental health problems. These include new forms of psychotherapy, standardized pharmaceutical-grade natural products from diverse healing traditions including Traditional Chinese Medicine (TCM), Ayurveda and Tibetan medicine, and mind-body approaches. Examples of non-conventional therapies for which there is consistent evidence of efficacy in mental health include St John’s wort and S-adenosyl methionine (SAMe) for depression; adjunctive uses of nutrients in combination with conventional drugs including omega-3 fatty acids, folic acid, l-tryptophan, n-acetyl cysteine, and SAMe in the treatment of mood disorders; acupuncture for acute anxiety and depressed mood; and mindfulness training for negative symptoms of schizophrenia, anxiety and mood disorders (Lake 2007). In addition to these complementary and alternative (CAM) therapies, lifestyle modifications such as regular moderate exercise, a healthy diet, and reduced use of alcohol and nicotine, also offer encouraging evidence for improving overall mental health and reducing relapse risk (Sarris, 2011).

While conventional pharmacologic treatments alone are appropriate and efficacious treatments for some mental health problems, we feel strongly that the time has come to move beyond a limited allopathic approach to understanding, treating and preventing mental health problems. Integrative mental health care offers a more inclusive model in which the evidence for social, psychological and biological therapies is impartially evaluated to achieve the most appropriate integrative approach taking into account each patient’s unique needs, values, preferences and financial constraints. The integrative model we espouse starts from the principle of “wellness,” and can be used as the basis for developing effective strategies for both prevention and treatment of common mental health problems.