Schizophrenia affects up to one in a hundred people at some point and can cause hallucinations, delusions, and loss of energy and motivation. Creative psychological interventions such as art therapy are widely used in combination with drugs. But the effectiveness of art therapy is unclear.

Professor Mike Crawford of Imperial College London, UK, and his team examined the benefits of group art therapy among 417 adults with a diagnosis of schizophrenia. The patients received group art therapy or non-art group activities each week for a year, or standard care.

The art therapy involved a range of art materials which the patients were encouraged to use “to express themselves freely.” Non-art group activities included board games, watching and discussing DVDs, and visiting local cafes.

This study differs from previous trials of art therapy by focusing on clinically important differences in outcomes. It also provides detailed information about attendance rates, and offers art therapy of a duration that is more like that in real-life clinical practice.

When patients were assessed after two years, overall functioning, social functioning, and mental health symptoms were similar between the groups. Levels of social functioning and satisfaction with care were also similar.

Patients offered a place in an art therapy group were more likely to attend sessions than those offered a place in an activity group. However, the levels of attendance at both types of group was low, with 39 percent of those referred to art therapy and 48 percent of those referred to activity groups not attending any sessions.

Writing in the British Medical Journal, the researchers state, “While we cannot rule out the possibility that group art therapy benefits a minority of people who are highly motivated to use this treatment, we did not find evidence that it leads to improved patient outcomes when offered to most people with schizophrenia.”

They conclude that art therapy, as delivered in this trial, “did not improve global functioning, mental health, or other health related outcomes.” They point out that “[T]hese findings challenge current national treatment guidelines that clinicians should consider referring all people with schizophrenia for arts therapies.” The authors suggest that art therapy should not be offered on a broad basis to all patients, but targeted at those most likely to make use of it, based on an assessment of the patient’s interest and motivation to attend sessions.

Currently, the UK’s National Institute for Health and Clinical Excellence recommends that doctors “consider offering arts therapies to all people with schizophrenia, particularly for the alleviation of negative symptoms.” This should be provided by a registered therapist who has experience working with people with schizophrenia.

The guidelines describe arts therapies as “complex interventions that combine psychotherapeutic techniques with activities aimed at promoting creative expression. The aesthetic form is used to ‘contain’ and give meaning to the service user’s experience, and the artistic medium is used as a bridge to verbal dialogue and insight-based psychological development.

“The aim is to enable the patient to experience him/herself differently and develop new ways of relating to others,” the guidelines add.

Professor Crawford and his team think that the lack of clinical improvement in their trial may be due to “the high degree to which people with established schizophrenia are impaired in their clinical and social functioning.” They explain that these impairments are known to increase over time, and the participants had been diagnosed for around 17 years.

It may be that to benefit from group art therapy, “patients need a greater capacity for reflective and flexible thinking,” so targeting interventions at an earlier stage of the illness may be more effective.

Commenting on the study, Dr. Tim Kendall of the UK’s National Collaborating Centre for Mental Health believes that, while art therapy is unlikely to be of clinical benefit for schizophrenia, it “still has great potential for success in the treatment of negative symptoms.”

In an online response to the study, psychiatric hospital art therapist Betsy A. Shapiro, of Alvarado Parkway Institute, La Mesa, California, says the once-weekly nature of the art therapy sessions in the study is a potential problem.

She writes, “I work with patients with schizophrenia and see them 3-5 times a week. Patients not only enjoy group art therapy, they excel in it. Working with a variety of materials keeps them focused, encourages their creativity and appears to increase self-esteem.”

She adds that patients can “show their auditory or visual hallucinations, and express feelings which are difficult for them to do verbally. It provides for safe release of strong emotions such as rage and has prevented them from hurting themselves, others or property.”

Overall, she concludes, “It would be a great disservice to patients if this study influenced a cut-back in art therapy services.”

References

http://www.bmj.com/content/344/bmj.e846

Group art therapy as an adjunctive treatment for people with schizophrenia: multi-centre pragmatic randomised trial. Crawford, M. J. et al. The British Medical Journal February 29, 2012 doi: 10.1136/bmj.e846

She covers a wide range of topics. Specific areas include how lab rats differ from wild rats, the effects of ‘work,’ their pleasure, their mental and physical health mental and physical, eating habits, grooming, sex, parenting, and how they deal with overpopulation. Sound familiar? It should. While Lambert is clearly — and admittedly — a rat-lover, she consistently makes sure each section is knitted with the life lessons that we can learn from their behaviors. She also carefully aligns the sections; it is not meant to be read in a disorganized fashion where you simply choose which segment sounds the most interesting. She builds on the information that is given to you in previous chapters.

Lambert’s informal style makes the heavy science easy to digest and helps the book appeal to a wide audience. Even if you have a neuroscience background, I’d imagine this would still be a fun read. She is a storyteller and a vigilant academic, so you get both a good read and a lot of information as she continually cites other scientists, their studies, and their books. For this reason, this book would be a great jumping-off point if you wanted to begin to learn more about the field. Additionally, the last section is a complete list of every study or book she’s mentioned.

Lambert states in the beginning that rats are the most successful and adaptive mammals on the planet and that they may hold the secret to our own success. Lambert’s gentle humor in no way impedes her boldness — she says she hopes this book will leave her readers wondering “What would the rodents do?” when they are caught in one of life’s sticky situations.

Her boldness, however, does not mean that she jumps into theories. Instead, the logical thought progression she builds makes you a believer one step at a time. The first chapter briefly introduces the reader to Lambert’s life as a researcher and vast knowledge of rats. In the second chapter she states that “as we examine common factors between humans and rodent mental capacities, it is important to avoid both overestimating (anthropomorphism) and underestimating (anthropodenial) commonalities.” Science, for Lambert, is king.

After a brief but thorough overview, Lambert delves into the idea of ‘trust-fund’ vs. worker rats, a consistent thread throughout the book. Trust-fund rats, as you may imagine, earned their name by being simply handed treats (Froot Loops), while worker rats had to dig and search to find their treats. The worker rats seemed to have “more clearly defined associations between their efforts and obtained rewards in life and had a perception of being better able to successfully complete the task — something psychologists typically refer to as self-efficacy.” The worker rats spent 60 percent more time on impossible tasks than the trust-fund rats.

As an example of how quickly Lambert rolls into the implications for humans, she then explains how this idea led her to think about emotional resilience in humans. Thinking that “ if effort-driven reward therapy enhances resilience in rats,” it could do the same for humans “without the use of psychoactive drugs such as anti-depressants?” Work, therefore, may lead to healthier brains and resilience to stress.

She does this in each chapter, mixing a careful combination of story, facts, and connections between humans and rats. For example, she looks to the rat for answers in the health care system (are we too dependent and unable to look out for our own well-being?), as well as to the benefits of grooming (it can help heal and shows that an animal is in good health which, to Lambert, is a small sign of why we detest bad hair days).

Lambert even goes on to look at how rats respond to sex, finding in her studies that sex is shown to “build more complex brains.” She also examines how female rats choose mates in order to diversify their gene pool and give their offspring a better chance of fighting disease (yes, she even writes a potential rat singles ad). She then discusses the after-effects of sex: parenting. Again, the rats in the study can be quickly aligned with human counterparts. She focuses particularly on single rat moms that live below poverty level: the rats groom themselves less, have increased stress, and the children are compromised in development.

Personally, I’m a believer. Rats are survivors, as Lambert consistently points out, and “can respond to changes in the environment faster than other mammals.” With the constant mounting stress in the world and our daily lives, I’m happy to embrace anything that might reduce that pressure. Also, there has to be a reason why 85 percent of testing is done on rats and mice — they can’t be that different than us!

I enjoyed all the research Lambert collected and analyzed, but also that it is said in plain language, so it made for a fun read. Like psychology itself, this book is a wonderful combination of science and human understanding.

The Lab Rat Chronicles: A Neuroscientist Reveals Life Lessons from the Planet’s Most Successful Mammals
By Kelly Lambert, PhD
Perigee Trade: June 7, 2011
Paperback, 320 pages
$15

Brain damage can affect movement and language abilities, having a significant impact on quality of life. Patients may have had trauma to the head, damage following brain surgery, or a stroke. An estimated 1.5 million people in the U.S. sustain a traumatic brain injury each year, of whom 80,000 to 90,000 will be left with long-term disability.

Dr. Joke Bradt of the Arts and Quality of Life Research Center at Temple University in Philadelphia, Pa., carried out a Cochrane Systematic Review of music in recovery from brain injury. She explains that the restoration of motor function is a primary concern, because improvements “directly affect the level of independence of the patient related to activities of daily living.”

Music therapists use techniques that aim to stimulate brain function controlling movement, cognition, speech, emotions and the senses. It is hoped that such therapies may also prevent depression. Methods range from rhythmic auditory stimulation (RAS), which connects rhythm and movement, to singing, and the use of music listening, music improvisation, and composition.

Listening to music is often encouraged in rehabilitation settings, but Dr. Bradt says it is important to distinguish this from music therapy interventions, as music therapists have specific clinical training and the approach is “underpinned by music therapy theory.”

Her research team reviewed seven studies involving 184 patients. All were controlled studies, meaning they compared music therapy against standard care. Four studies used stroke patients only; the remainder included other brain-injured patients. Many studies were too small to lead to statistically significant results, and were designed too differently to compare.

RAS therapy, used in three of the stroke-only studies, improved walking speed by an average of 14 meters per minute, compared to standard movement therapy. It also helped patients to take longer steps and improved arm movements, such as elbow extension.

The review states, “RAS may be beneficial for improving gait parameters in stroke patients, including gait velocity, cadence, stride length and gait symmetry. These results are encouraging, but more trials are needed before recommendations can be made.” It adds that the results agree with findings from non-controlled trials that there may be a beneficial effect of RAS.

Dr. Bradt said, “This review shows encouraging results for the effects of music therapy in stroke patients. As most of the studies we looked at used rhythm-based methods, we suggest that rhythm may be a primary factor in music therapy approaches to treating stroke.”

But the evidence is “limited” for other music therapy techniques. Listening to live and recorded music was used with the aim of improving speech, behavior and pain in brain injured patients, but several of these trials had fewer than 20 participants.

At present, “recommendations linking specific interventions to specific neurological damage cannot be made,” the review states. But “as most of the included studies successfully improved motor outcomes with rhythm-based methods, we suggest that rhythm may be a primary factor in music therapy methods facilitating functional gains with this population.”

It concludes, “Research efforts need to focus on conducting music therapy trials with high quality designs, as well as including the effects on mood and emotions, social skills and interactions, and activities of daily living.”

Other studies looking at the effects of music therapy have concluded it “may” be useful for cancer patients, those who need mechanical ventilation, people with coronary heart disease, and patients in end-of-life care.

Dr. Bradt says, “I think it’s definitely worth offering to patients to see if it works for them.” In contrast to anxiety-reducing medications, she says, music therapy comes with almost no risk of adverse side effects and is cheaper.

Commenting on her study of cancer patients, Dr. Bradt pointed out that music may distract people from pain or anxiety about cancer treatment side effects, and the right piece of music can relax patients. It can also help patients communicate with their families. “In a music therapy session, you may be able to select a song you feel would express perfectly what you’re trying to say,” she said.

Engaging in music making can also be empowering. “This is important as patients may feel victimized by their cancer,” she added.

References

Bradt, J. et al. Music therapy for acquired brain injury. Cochrane Database of Systematic Reviews 2010 Jul 7;(7):CD006787.

http://www.temple.edu/boyer/ResearchCenter/documents/MTforABI_publishedreview.pdf

Bradt, J. et al. Music interventions for improving psychological and physical outcomes in cancer patients. Cochrane Database of Systematic Reviews 2011 Aug 10;(8):CD006911.

His team looked at rates of mental disorder among 7,403 adults living in the UK, whose details were obtained from the Adult Psychiatric Morbidity Survey 2007. Rates of depression, anxiety, obsessive compulsive disorder, phobia, self-harm, suicidal thoughts, and alcohol and drug dependence were significantly higher in homosexual respondents.

Four percent had a depressive episode in the last week, compared to two percent of heterosexual people. The rate of alcohol dependence was ten percent versus five percent, and for self-harming it was nine percent versus five percent.

The proportion of homosexual people who described themselves as being fairly or very happy was 30 percent, versus 40 percent for heterosexual people.

Dr. Chakraborty believes the findings are “very worrying.” He said, “This study is the first time the mental health and well-being of gay, lesbian and bisexual people has been examined in a random sample of the population.

“Our study confirms earlier work carried out in the UK, USA and Holland which suggests that non-heterosexual people are at higher risk of mental disorder, suicidal ideation, substance misuse and self-harm than heterosexual people.”

He stated that, although the level of discrimination was low, it was still significantly higher than against heterosexual people. This “lends support to the idea that people who feel discriminated against experience social stressors, which in turn increases their risk of experiencing mental health problems,” he says.

These higher levels of psychiatric problems in homosexual people call for greater efforts at preventing the issues arising, Dr. Chakraborty adds.

In the Adult Psychiatric Morbidity Survey, participants chosen to be representative of the UK population gave information on neurotic symptoms, common mental disorders, probable psychosis, suicidal thoughts, and alcohol and drug use, as well as aspects of sexual identity and perceived discrimination.

The study is published in the British Journal of Psychiatry. Dr. Chakraborty and his team write, “Discrimination on the grounds of sexual orientation predicted certain neurotic disorder outcomes, even after adjustment for potentially confounding variables.”

Commenting on the study on the journal’s website, psychiatrist Dr. Mohinder Kapoor of the South West Yorkshire Foundation NHS Trust, UK, highlights the limited evidence in this area. He says “credit should be given to the authors in conducting this study.”

But he pointed out that a cross-sectional study like this can only raise the question of an association, rather than test a hypothesis. The authors “appear over-ambitious,” he writes, because “one cannot test whether psychiatric problems are associated with discrimination on grounds of sexuality.”

To study the true impact of sexuality-based discrimination on mental health problems, a longer-term approach is needed, he states.

Whether or not discrimination is the cause, mental health problems have previously been found to be higher among homosexual people. In 2008, Professor Michael King and his team at University College London, UK, carried out a review of 28 papers on the subject. All were published between 1966 and 2005, and included a total of 214,344 heterosexual and 11,971 homosexual people.

Their analysis revealed twice the rate of suicide attempts among lesbian, gay and bisexual people. The risks of depression and anxiety disorders were at least one and a half times higher, as was alcohol and other substance abuse.

Most of the results were similar in both sexes, but women were particularly at risk of alcohol and drug dependence and men at a higher risk of suicide attempts.

The researchers say, “There are a number of reasons why gay people may be more likely to report psychological difficulties, which include difficulties growing up in a world orientated to heterosexual norms and values and the negative influence of social stigma against homosexuality.

“In addition, the gay commercial world in which some men and women may participate to find partners and friends may make misuse of alcohol and cigarettes more likely. The former in particular can have adverse effects on mental well-being.

“Finally, our results add to evidence that sexual experiences in childhood in men classified as gay or bisexual may play a role in adult psychological adjustment,” they conclude.

References

Chakraborty, A. et al. Mental health of the non-heterosexual population of England. British Journal of Psychiatry, Vol. 198, February 2011, pp. 143-48.

King, M. et al. A systematic review of mental disorder, suicide, and deliberate self-harm in lesbian, gay and bisexual people. BMC Psychiatry, Vol. 18, August 2008, 8:70.

King, M. and Nazareth, I. The health of people classified as lesbian, gay and bisexual attending family practitioners in London: a controlled study. BMC Public Health, Vol. 6, May 2006, 6:127.

For decades, the dominant hypothesis of depression has been that low levels of monoamines in the brain cause this debilitating disorder.

In the ‘80s, the selective serotonin reuptake inhibitor (SSRI) fluoxetine (brand name: Prozac) heralded a new era of safer drugs which also target the monoamine system. Since then, various SSRIs and serotonin-norepinephrine reuptake inhibitors (or SNRIs) have been developed as new antidepressants. While these drugs aren’t more effective than older antidepressants, they are less toxic.

But SSRIs and SNRIs don’t work for everyone, so MAOIs and TCAs still are prescribed.

Two out of three patients with depression do not fully recover on an antidepressant medication according to findings from STAR*D, the largest clinical trial study of treatments for major depressive disorder, funded by the National Institute of Mental Health. (One-third of patients do have a remission of their depression symptoms.)

These results “are important because previously it was unclear just how effective (or ineffective) antidepressant medications are in patients seeking treatment in real-world settings,” said James Murrough, M.D., board-certified psychiatrist and a research fellow at the Mount Sinai School of Medicine Mood and Anxiety Disorders Program.

As Murrough explained, depression treatment can be thought of in thirds: “for one third of patients, symptoms remit; another third don’t have as good of an outcome, experiencing residual symptoms and waxing and waning course or chronic course and are at risk for relapse whether they’re on or off medication; and then a third don’t get much benefit at all.”

He added that around “10 to 20 percent have persistent clinically significant symptoms that aren’t decreased by current treatment — these are the patients that we are the most worried about.”

So there’s a real need to find treatments that work for these patients. Since the 1950s and 1980s breakthroughs, researchers haven’t discovered drugs that target chemical systems in the brain other than the monoamine system.

“We haven’t been able to find any new systems, because we don’t understand the underlying biology of depression,” Murrough said.

But researchers are studying other mechanisms of depression and various drugs have recently been approved to treat depression. Below, you’ll learn about these drugs along with several chemical systems research is exploring.

Recently Approved Drugs for Depression

Recently approved drugs for depression are generally “me-too” drugs. A “me-too drug is a drug whose mechanism of action (what it does at the molecular level in the brain) is not meaningfully different than its predecessor,” Dr. Murrough said.

Prime examples of me-too drugs are desvenlafaxine (Pristiq), an SNRI, and escitalopram (Lexapro), an SSRI, he said. Pristiq is simply Effexor’s main metabolite. Lexapro is essentially a close relative derivative of citalopram (Celexa). Interestingly, sales still skyrocketed when Lexapro came out.

As Murrough said, there is value in some me-too drugs. Generally, all drugs within the classes SSRIs and SNRIs are me-too drugs. But the side effect profiles for each drug have slight differences, which can help patients.

For instance, Prozac tends to be more activating, so a doctor may prescribe it for patients with low energy, Murrough said. In contrast, paroxetine (Paxil) makes people more tired, so it’s prescribed to patients who have trouble sleeping, he said.

The drug Oleptro was approved this year for depression. It doesn’t target new mechanisms, and it isn’t even a me-too drug, Murrough said. It’s a reformulation of trazodone, an atypical antidepressant that’s been used as a sleeping aid by psychiatrists and other doctors. Because it’s so sedating, its earlier form would just put patients to sleep. “It is unclear if the new formulation will offer any benefit for patients over the original,” Murrough said.

These recently approved medicines “characterize the state of drugs in psychiatry,” Murrough said, and speak to “what’s wrong with antidepressant drug development today.” Novel treatments just aren’t on the market.

Augmentation of Depression Drugs

Recently, the biggest development in depression treatment has been the use of augmenting agents, said David Marks, M.D., assistant professor at the Department of Psychiatry & Behavioral Sciences at the Duke University Medical Center.

Specifically, some research has found that adding atypical antipsychotic drugs, like aripiprazole (Abilify) and quetiapine (Seroquel), to an antidepressant can boost its effectiveness.

Atypical antipsychotics are used to treat schizophrenia and bipolar disorder. “Abilify has three strong studies that show how well it works in patients that have partially responded to antidepressants,” Marks said. According to Murrough, augmentation has become a common strategy in depression treatment.

The Glutamate System and Depression

Researchers have looked at the role of the glutamate system in depression. Glutamate is abundant in the brain and is one of the most common neurotransmitters. It’s involved in memory, learning and cognition.

Some research has implicated the dysfunction of the glutamate system in medical conditions, such as Huntington’s chorea and epilepsy, and psychological disorders, such as schizophrenia and anxiety disorders.

Recent research suggests that drugs targeting a specific type of glutamate receptor in the brain — called the NMDA receptor — may have antidepressant effects.

Studies have explored ketamine, an NMDA antagonist, in treating treatment-resistant depression and acute suicidal ideation. Ketamine has a long history in analgesia and anesthesiology.

Currently, when a person is at imminent risk for attempting suicide or has attempted suicide, they’re admitted to a psychiatric hospital and closely monitored. But, as Murrough explained, medically, there’s nothing doctors can do to help with suicidal ideation or intense depressed mood. Antidepressants typically four to six weeks to work.

Ketamine appears to have fast antidepressant effects — within hours or a day. Thus, it may help protect patients from suicidal thinking or acute dysphoria when they’re in the hospital. Unfortunately, its effects only last seven to 10 days.

This research is “highly experimental, and probably less than 100 patients in the country have participated in controlled depression studies of ketamine,” Murrough said. The patients in these studies typically have treatment-resistant depression: They haven’t responded to several antidepressants and have moderate to severe symptoms of depression.

They’re admitted to the hospital and receive ketamine intravenously from an anesthesiologist, while their vital signs are closely monitored.

Ketamine is a drug of abuse, known by such street names as “Special K.” It induces trance-like or hallucination states. It also produces mild to moderate cognitive side effects, like other anesthetics. People report feeling “out of it,” intoxicated and disconnected in general.

These side effects actually “introduce a potential bias to the study design” because participants know they’re getting the treatment (when saline is given in the placebo condition), Murrough said.

To eliminate this bias, Murrough and his team are conducting the first-ever study to compare ketamine to a different anesthetic — the benzodiazepine midazolam (Versed) — which has similar transient effects as ketamine, he said. The study is currently recruiting participants.

Murrough cautioned that ketamine isn’t meant to be a treatment administrated at your doctor’s office. In a recent article in the journal Nature Medicine, he said ketamine treatment may be “akin to electroconvulsive shock treatment.”

Studying ketamine may reveal mechanisms underlying depression and help to find drugs that can be prescribed as antidepressants to a wider patient population.

Pharmaceutical companies have started exploring other NMDA receptor antagonists for treatment-resistant depression. For instance, in July 2010, the pharmaceutical company Evotec Neurosciences began testing a compound in a Phase II study, which evaluates the safety and efficacy of a drug.

Depressive symptoms also are thought to increase the risk of further heart problems and mortality.

Dr. Michael Rapp from St. Hedwig’s Hospital, Berlin, and his team enrolled 22 patients three months after hospitalization for acute coronary syndrome. The patients had brain scans to highlight any cerebral deep white matter changes or structural abnormalities in areas called the anterior cingulate cortex and the dorsolateral prefrontal cortex. They also completed the Beck Depression Inventory.

Results showed that, after three months, patients with persistent depressive symptoms had “more advanced deep white matter changes” than patients who were not depressed.

Details are published in the journal Psychotherapy and Psychosomatics. The authors believe, “this study provides the first evidence that persistent depressive symptoms after acute coronary syndrome are associated with brain changes.”

They call for long-term studies to see whether depression develops in advance of these brain changes or afterward and which aspects of depression are worthy of further investigation.

Dr. Rapp writes, “Elevated depressive symptoms appear to be a robust risk and prognostic marker of cardiovascular disease. This has led to conjectures that depression is a causal risk factor, and that depression treatment may alter the course of cardiovascular disease.”

In February this year, researchers from the Royal College of Surgeons in Ireland again found that depression predicts the onset and recurrence of heart disease. They looked at which depressive symptoms in particular were linked to poorer outcomes, and found that “fatigue/sadness,” but not other symptoms, were associated with increased risk of having a major cardiac event.

They write that in the context of heart disease, “Depression should be considered as a multidimensional, rather than a unidimensional, entity.”

A 2006 study again highlighted the complexity of the link between depression and heart problems. It found that the Hospital Anxiety and Depression Scale depression subscale, but not the Beck Depression Inventory-Fast Scale, is able to identify heart patients with a raised risk of mortality in the following year.

Previous studies also have found that depression is a strong predictor of future heart disease in healthy people. A 2004 review summed up the evidence. It concluded that depression can double the risk of developing cardiovascular disease, due to a number of plausible reasons such as lifestyle risk factors and differences in the nervous system.

The team also looked at the effects of treating depression in heart patients. They write, “There are currently several empirically validated treatments for depression. However, to our knowledge, there have been only two completed clinical trials treating depression in cardiac patients.”

One of these trials took heart attack patients with depression and gave them either usual care or a psychosocial intervention consisting of at least six sessions of individual cognitive behavior therapy, group therapy, and antidepressants. But the intervention was not effective at reducing rates of mortality or recurrent cardiac events.

The second trial compared the effects of sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI) antidepressant and placebo for patients with depression alongside heart problems. In this case, there was a tendency for the patients treated with sertraline to have fewer serious adverse events (death or rehospitalization for heart problems) than those on placebo. This may be because, in addition to reducing symptoms of depression, SSRIs act as an anticoagulant or blood thinner.

The researchers conclude that the effectiveness of depression treatment to improve outcomes for depressed cardiovascular disease patients is still unclear.

Nevertheless, Dr. Hannah McGee of the Royal College of Surgeons in Dublin, Ireland, believes that depression symptoms in heart patients should be measured by health practitioners. Her research leads her to believe, “Routine assessment would identify those at increased risk of poorer outcomes. Short-form depression questionnaires are an acceptable substitute for clinical interviews in a setting where depression would not be routinely assessed.

“Identification of depressed patients is advisable for both service providers and patients. The prevalence of depression and the poorer outcomes seen in this group provide support for the treatment of depression to enhance patients’ quality of life, and to reduce the negative outcomes associated with depression.”

References

Rapp, M. A. et al. Persistent Depressive Symptoms after Acute Coronary Syndrome Are Associated with Compromised White Matter Integrity in the Anterior Cingulate: A Pilot Study. Psychotherapy and Psychosomatics, Vol. 79, April 2010, pp. 149-55.

Davidson, K. W., Rieckmann, N. and Rapp, M. A. Definitions and Distinctions Among Depressive Syndromes and Symptoms: Implications for a Better Understanding of the Depression-Cardiovascular Disease Association. Psychosomatic Medicine, Vol. 67, May/June 2005, S6-S9.

Doyle, F. et al. Depressive symptoms in persons with acute coronary syndrome: specific symptom scales and prognosis. The Journal of Psychosomatic Research, Vol. 68, February 2010, pp. 121-30.

Lett, H. S. et al. Depression as a risk factor for coronary artery disease: evidence, mechanisms, and treatment. Psychosomatic Medicine, Vol. 66, May-June 2004, pp. 305-15.

Doyle, F. et al. The Hospital Anxiety and Depression Scale depression subscale, but not the Beck Depression Inventory-Fast Scale, identifies patients with acute coronary syndrome at elevated risk of 1-year mortality. Journal of Psychosomatic Research, Vol. 60, May 2006, pp. 461-67.

McGee, H. M. et al. Impact of briefly-assessed depression on secondary prevention outcomes after acute coronary syndrome: a one-year longitudinal survey. BMC Health Services Research, Vol. 6, Feb 2006, article 9.

Hahnemann suggested two key principles. First, he asserted that “like cures like.” In other words, a substance that produces certain symptoms in a healthy person can be used to cure similar symptoms in a sick person. Second, he claimed that very small doses of a remedy would be effective. Hahnemann diluted the remedies in a process he named potentization. He would take an original natural substance and dilute it numerous times. Between each dilution, he would shake the remedy. Shaking supposedly released the cure’s healing energy.

A 1991 study in the British Medical Journal investigated 107 controlled trials of homeopathy. The researchers concluded: “At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well-performed trials.”

A 1990 study published in Revue d’Epidemiologie et de Sante Publique investigated 40 randomized trials involving homeopathy. The researchers concluded that the evidence did not show homeopathy to be effective. In 1994 the National Council Against Health Fraud, a U.S.-based organization, advised consumers not to buy homeopathic products or to patronize homeopathic practitioners. In addition, they stated, “Basic scientists are urged to be proactive in opposing the marketing of homeopathic remedies because of conflicts with known physical laws. Those who study homeopathic remedies are warned to beware of deceptive practices in addition to applying sound research methodologies.”

A 2005 study published in Lancet analyzed 110 homeopathy trials and 110 conventional medicine trials. The researchers concluded “there was weak evidence for a specific effect of homoeopathic remedies, but strong evidence for specific effects of conventional interventions. This finding is compatible with the notion that the clinical effects of homoeopathy are placebo effects.”

Brien and colleagues (2010) conducted a study to assess whether benefits from adjunctive homeopathic intervention in patients with rheumatoid arthritis (RA) are due to the homeopathic consultation, homeopathic remedies or both. The researchers found that homeopathic consultations were associated with clinically relevant benefits for patients with active but relatively stable RA. Homeopathic remedies were not associated with benefits.

Very few studies validating homeopathy’s efficacy have appeared in major medical journals. Most positive studies have appeared in nonscientific journals, and have been subject to bias, or have had a poor research design. The overwhelming majority of data appearing in scientific journals shows that homeopathy is an ineffective treatment for any clinical condition.

Why Homeopathy?

Why do people turn to homeopathic treatment? In many cases they do not trust physicians or the expensive drugs that are often prescribed. Some people feel like physicians are not really interested in them personally, especially if they can’t find anything wrong with the patient, or if the diagnosis doesn’t match with what they think it should. Not hearing what the patient knows is right may be taken offensively. Physicians, generally, do not spend much time talking with the patient, which further supports the patient feeling the doctor’s lack of interest. If the physician doesn’t find anything wrong this may further offend the patient.

A visit to a homeopathy practitioner may take 45 minutes to an hour. The homeopathy practitioner asks numerous questions and appears to be genuinely concerned with the patient’s personal life. The homeopathy practitioner designs the remedy to suit the unique individual, which furthers the patient’s confidence in the remedy. Homeopathy is alluring to both the patient and practitioner. They become partners in fighting this terrible condition. The benefits of homeopathy are not the remedies, but the consultations (increasing placebo effects) associated with homeopathy (see Brien et al. above).

References

Brien, S., Lachance, L., Prescott, P., McDermott, C., & Lewith, G. (2010). Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: a randomized controlled clinical trial. Rheumatology (Oxford) Nov.13.

Hill, C. and F. Doyon. 1990. Review of randomized trials of homeopathy. Revue d’Epidemiologie et de Sante Publique 38 (2): 139–47.

Kleijnen, J. et al. 1991. Clinical trials of homeopathy. BMJ 302 (6772): 316–23.

National Council Against Health Fraud, Inc. NCAH F position paper on homeopathy. http://www.ncahf.org/pp/homeop.html (accessed November 25, 2010).

Shang, A. et al. 2005. Are the clinical effects of homeopathy placebo effects? Comparative study of placebo-controlled trials of homeopathy and allopathy. Lancet 366 (9487): 726–32.

Wagner, M. W. 2002. Is homeopathy “new science” or “new age”? Homeowatch. http://www.homeowatch.org/articles/wagner.html (accessed November 25, 2010).

Drugs for high blood pressure and heart disease have been linked to protection from Alzheimer’s disease and dementia. A team led by Professor Benjamin Wolozin of Boston University looked at the possible effects of angiotensin receptor blockers on the risk of these conditions.

They write in the British Medical Journal that dementia, including Alzheimer’s disease, is one of the major threats to public health. Evidence increasingly points to three main risk factors: age, the buildup of amyloid plaque in the brain, and the deterioration of the cardiovascular system.

Drugs used to treat cardiovascular risk factors may also reduce the risk of dementia, according to the article.

Angiotensin receptor blockers reduce blood pressure and protect against cardiovascular outcomes. The also drugs help to preserve cognitive function through a separate mechanism, say the experts.

They looked at figures on 819,491 individuals in the U.S. Veteran Affairs database. All were age 65 or older and had cardiovascular disease. All but two percent were male.

Over four years, dementia rates for participants taking angiotensin receptor blockers were 19 percent lower than for those taking the blood pressure-lowering drug lisinopril, and 24 percent lower than for those on other cardiovascular drugs.

Among patients already diagnosed with Alzheimer’s disease or dementia, those on angiotensin receptor blockers had a 49 percent lower risk of admission to a nursing home than those on other cardiovascular drugs. Their mortality risk was 17 percent lower, on average.

The drug’s benefits increased on larger doses, and had an additive effect when taken with another type of high blood pressure drug, ACE inhibitors.

The team concluded, “Angiotensin receptor blockers are associated with a significant reduction in the incidence and progression of Alzheimer’s disease and dementia compared with other cardiovascular drugs.”

They added that the lower rate of admission to a nursing home “is a particularly important observation that could have a major impact on public health if validated by future studies.”

Dr. Colleen Maxwell and Dr. David Hogan of the University of Calgary, Canada, write in an accompanying editorial that the drugs may cause “improved cerebral blood flow and an enhanced neuroprotective effect.” But two randomized controlled trials have found “no significant benefit in either the rate of cognitive decline or incident dementia.”

They warn that important factors such as a family history of dementia, education, and severity of disease were not considered, and the “non-random allocation of treatment” is also a serious problem. Racial and ethnic variation in the use of drugs such as these has been shown among American veterans, and the ethnic origin of most participants was not reported. Furthermore, the results may not be generalizable to women, because women comprised only two percent of participants.

“As with all studies of this nature, association does not prove causation. Further work is needed to verify the usefulness of antihypertensives in general and angiotensin receptor blockers in particular,” they conclude.

A previous study by Professor Wolozin’s team reported that simvastatin, a cholesterol-lowering drug, is linked to a reduction in the risk of dementia and Parkinson’s disease. The study also used figures on more than 70,000 people from the database of the U.S. Veteran Affairs.

However, a more recent review, from 2010, states, “There is good evidence from randomized controlled trials that statins given in late life to individuals at risk of vascular disease have no effect in preventing Alzheimer’s disease or dementia.

“Biologically it seems feasible that statins could prevent dementia due to their role in cholesterol reduction and initial evidence from observational studies was very promising. [But] the evidence from subsequent randomized controlled trials has been negative.”

So far, say the authors of this Cochrane review, there is insufficient evidence to recommend statins for the prevention treatment of dementia.

Dr. Mary N. Haan of the University of California, San Francisco points out that there have not been any randomized clinical trials of initially healthy individuals that were expressly designed to test whether statins can prevent dementia.

“It is now recognized that dementia begins to develop decades before it is symptomatic,” she writes in the journal Evidence Based Mental Health. “Thus to design an adequate prevention trial for dementia requires a relatively young study sample, a large sample and substantial follow-up time.”

She believes that, “At this juncture, it is not possible to conclude that statins could or could not prevent dementia.”

References

Li, N-C. et al. Use of angiotensin receptor blockers and risk of dementia in a predominantly male population: prospective cohort analysis. The British Medical Journal, 2010;340:b5465.
www.bmj.com/cgi/doi/10.1136/bmj.b5465

Maxwell, C. J. and Hogan, D. B. Antihypertensive agents and prevention of dementia. The British Medical Journal, 2010;340:b5409.
www.bmj.com/cgi/doi/10.1136/bmj.b5409

Wolozin, B. et al. Simvastatin is associated with a reduced incidence of dementia and Parkinson’s disease. BMC Medicine, published online July 19, 2007.

McGuinness, B. et al. Statins for the treatment of dementia. Cochrane Database of Systematic Reviews, August 4, 2010.

McGuinness, B. et al. Statins for the prevention of dementia. Cochrane Database of Systematic Reviews, April 15, 2009.

Haan, M. N. et al. Review: statins do not protect against development of dementia. Evidence Based Mental Health, Vol. 12, November 2009, p. 114.

Types of Research

The basis of a scientific research study follows a common pattern:

1. Define the question
2. Gather information and resources
3. Form hypotheses
4. Perform an experiment and collect data
5. Analyze the data
6. Interpret the data and draw conclusions
7. Publish results in a peer-reviewed journal

While there are dozens of types of research, most research done falls into one of five categories: clinical case studies; small, non-randomized studies or surveys; large, randomized clinical studies; literature reviews; and meta-analytic studies. Studies can also occur in widely varying fields, from psychology, pharmacology and sociology (what I’ll call “behavioral and treatment studies”), to genetics and brain scans (what I’ll call “organic studies”) to animal studies. Some fields contribute results that are more instantly relevant, while others’ results may help researchers develop new tests or treatments decades from now.

Clinical Case Studies

A clinical case study involves reporting on a single case (or series of cases) that the researcher or clinician has tracked over a period of some significant time (usually months or even years). Many times, such case studies emphasize a narrative or more subjective approach, but may also include objective measures. For instance, a researcher might publish a case study about the positive effects of cognitive-behavioral psychotherapy for a person with depression. The researcher measured the client’s level of depression with an objective measure such as the Beck Depression Inventory, but also describes in detail the client’s progress with specific cognitive-behavioral techniques, such as doing regular “homework” or keeping a journal of one’s thoughts.

The clinical case study is a very good research design for generating and testing hypotheses that may be used in larger studies. It is also a very good manner for disseminating the effectiveness of specific or novel techniques for individuals, or for those that may have a fairly uncommon set of diagnoses. However, generally a clinical case study’s results are not able to be generalized to a broader population. A case study is therefore of limited value to the general population.

Small Studies and Survey Research

There’s no specific criteria that differentiates a “small study” from a “large study,” but I place any non-randomized study in this category, as well as pretty much all survey research. Small studies are generally conducted on student populations (because students are often required to be a research subject for their university psychology classes), involve less than 80 to 100 participants or subjects, and often lack at least one of the core, important research components most often found in larger studies. This component can be the lack of true randomization of subjects, a lack of heterogeneity (e.g., no diversity in the population being studied), or a lack of a control group (or a relevant control group, e.g. a placebo control).

Most survey research also falls into this category, because it also lacks one of these core research components. For instance, a lot of survey research asks participants to identify themselves as having a particular problem, and if they do, then they fill out the survey. While this will almost guarantee the researchers interesting results, it’s also not very generalizable.

The upshot is that while these studies often provide interesting insights and information that can be used for future research, people shouldn’t read too much into these research findings. They are important data points in our overall understanding of the subject. When you take 10 or 20 of these data points and string them together, they should provide a fairly clear and consistent picture about the topic. If the results don’t provide such a clear picture, then there is likely more work to be done in the subject area before meaningful conclusions can be made. Literature reviews and meta-analyses (discussed below) help professionals and individuals better understand such findings over time.

Other good health habits, combined with good medication compliance, can help treatment success. According to Dr. Betty Chewning of the University of Wisconsin-Madison, “it is quite possible that people who adhere to healthy lifestyles also tend to take care of themselves by greater adherence to prescribed treatments.”

Recent evidence to support the healthy adherer concept comes from a large study at the University of Alberta, Canada. Dr. Scot Simpson and colleagues performed a meta-analysis of data from 21 studies with almost 47,000 participants. They found that when patients diligently took pills, their mortality rates dropped by almost half compared with those patients who were less diligent. The lower mortality rates were similar whether the pills were real medication or inactive placebos.

The authors theorize that those who do not always take their medication may be depressed or have other conditions which affect adherence. About one in four patients do not keep to prescribed drug therapy.

Another study of the healthy adherer concept focused on chronic heart failure patients. Dr. Bradi Granger and colleagues at Duke University, North Carolina, categorized nearly 7,600 patients on the drug candesartan (Atacand) as either good or bad adherers. (The good adherers took more than 80 percent of their study medication.) After three years, good adherence was linked to lower all-cause mortality in all patients, even those on placebo.

Previous studies have found a great deal of evidence to support the healthy adherer effect. One review looked at 12 studies on the outcomes of drug adherence on patients with coronary artery disease and congestive heart failure. Adherence to placebo was linked to improved outcomes in three of the studies, suggesting that such behavior may be a useful marker of better outcome.

A more recent review of three decades of research on adherence and treatment outcomes showed that the risk of a poor health outcome is 26 percent lower in participants with good adherence.

“Traditionally, the healer’s greatest tool has been to listen and build on the patient’s story and its meaning,” Dr. Chewning said. “Coupled with other patient-centered approaches, practice based on these hypotheses could yield extra value in treatment regimens that patients agree to, believe in, and will sustain over time.”

Further research is needed to find out whether adherence can be effectively taught or encouraged, but Dr. Chewning would like to see structured patient interviewing — for example, asking a patient “what would make it worth while for you to take this medication in the next month?” could bring out the patient’s fears, values and social pressures. Physicians could use that information to inform treatment and prescribing decisions.

References

Simpson, S. H. et al. A meta-analysis of the association between adherence to drug therapy and mortality. British Medical Journal, Vol. 333, July 1, 2006, pp. 15-18.

Chewning, B. Commentary: The healthy adherer and the placebo effect. British Medical Journal, Vol. 333, July 1, 2006, pp. 18-19.

Granger, B. B. et al. Adherence to candesartan and placebo and outcomes in chronic heart failure in the CHARM programme: double-blind, randomised, controlled clinical trial. The Lancet, Vol. 366, 10 December 2005, pp. 2005-11.

McDermott, M. M. et al. Impact of medication nonadherence on coronary heart disease outcomes. A critical review. Archives of Internal Medicine, Vol. 157, September 22, 1997, pp.1921-29.

DiMatteo, M. R. et al. Patient adherence and medical treatment outcomes: a meta-analysis. Medical Care, Vol. 40, September 2002, pp. 794-811.

But how do you know if you want to take part? What questions should you ask? The researcher should answer these basic questions clearly for you. Others undoubtedly will arise during the discussion.

• Why do you want me in your study?
• What is the research about? How will this research help in treating or understanding my disorder?
• What do I need to do and how much time will this take?
• How might this study help me, my relatives, or other people with my disorder?
• What possible risks are there to me or my relatives if I take part?
• How will this be different from the care I am getting now, and do I have other options or choices?
• Could my illness become worse during the study? What will happen if it does?
• What will happen to me at the end of the study?
• What should I do if I want to drop out of the study?
• May I get back to you after I discuss this with my family/friend/case manager/doctor?

Remember to ask again if you do not understand the explanation to any question you have. And, if you forget the answers to these questions during the study, just ask them again.

Be sure to ask the director of research when you can expect to hear about the results. Ask how you will get this information. Will the researcher write an article describing the study, or will those who took part be invited to a meeting with the study director when all the results are in? If you have questions about the results when you receive them, ask the researcher who can help you to understand what they mean.

A frustrating thing about research is that it often takes years before the results of a study are available. This is because of the time it takes to conduct the study, including getting enough people in the study to make the results meaningful. Be patient, but remember to ask for the results if you have not received them when you expected them.

Often, the company developing a new drug may try to see that you can continue to get it, even before the FDA has approved it for sale. You may be able to do this under what is termed a compassionate plea basis. This means that because the new drug has been so helpful, the manufacturer can give it to a physician, who may then prescribe it for you.

While companies often make such a new drug available, there may also be good reasons why a company cannot. Perhaps only a very small amount of a drug was prepared for the research project, and no more is available for use afterwards. Then again, a manufacturer may want to further test the drug under certain conditions, or to examine the results of a research study more fully before releasing it for compassionate plea use. A company would be especially careful if a new medication required that the doctor who prescribed it have some special knowledge or skill to monitor its safe use.

You and any family members interested in your well-being should discuss with the director of the research your questions about compassionate plea use. Each case is different, so the agreement has to be between the drug manufacturer and your own doctor.

If you decide to take part in a research study and, especially one that takes place in a hospital you may find that you will have to stop, or interrupt, the care you now are getting for a mental disorder. Doing that, even temporarily, may result in your losing access to a program of personal care that had been expensive and hard to come by. The director of research on your study often will help you to get back into a program of care when the study is finished. The investigator’s institution may assist in arranging for follow-up care.

Many family members welcome the chance to make sure, along with the research team, that no one will take advantage of you during the study. This role is clear if a family member is a patient’s formal legally authorized representative; but even lacking such legal status, families usually do all they can to protect a family member who is ill.

Remember that Federal regulations protect your right to privacy in the handling of your records throughout (and following) a study. You must give clear permission if you wish the researcher to share personal information about you with family members. Still, you should be aware that, with your consent, your family members or other friends may have several opportunities to provide information during the study.

A researcher must ask you to sign a written informed consent form in which you agree to take part in a certain study. The form contains a description of the study, possible risks, and benefits of the research. The director of the research must prepare the form and an IRB must approve it. The researcher must then go over this form with you and get your permission to enter you into the study.

Having a mental disorder does not necessarily mean that a person cannot understand and see the value and risks of taking part in research. Most people, therefore, who enter research studies on mental disorders can provide informed consent. Additional guidelines and safeguards exist for patients who are not able to give their permission with full understanding. In those cases consent is obtained both from the participant and the legally authorized representative.

Informed consent is not a one-time event, but a continuing process. Throughout a study, the research team must continue to provide information about participating in the study. They must respond to any questions you have about the research and inform you if any new risks are identified. You may, at any time, reappraise your decision to take part in the project and withdraw your consent. It is advisable to discuss any concerns with the director of the study.

Every informed consent form developed by an investigator and submitted to an IRB for approval must include eight basic parts. These parts are:

• A statement that the study involves research and that tells what its goals are, how long the research will last, and what methods will be used.
• A description of any reasonably foreseeable risks or discomforts you could experience as a result of the research.
• A description of any benefits that the research may be reasonably expected to yield to you or to others.
• A description of alternative courses of treatment, or therapies, if any, which might help you.
• A statement describing how the researcher will protect the confidentiality, or privacy, of your medical records.
• For research in which risk is somewhat more likely than you would expect in routine health care, an explanation and description of the availability of compensation or medical treatments if injury occurs.
• The name and phone number of the person to contact about the research and your rights, and whom to contact in case the research causes an injury.
• A statement that your taking part in the research is voluntary, and that if you change your mind, or quit later on, you will not be penalized in any way, or lose any benefits you have coming to you.

The informed consent process must include the following items when they apply to you:

• A statement that the particular treatment or method used may not work as planned and may be risky for you.
• The reasons why the investigator might have to drop you from the study without asking you first.
• A list of any extra charges you may have to pay to take part in the research.
• A description of what would happen if you decide to drop out of the study, and what the researcher will do to make sure you keep receiving appropriate treatment if you do drop out.
• A statement that you will be told of any important results of the research which may help you to decide whether to continue taking part in the study.
• Approximately how many subjects are in the study.

Clinical researchers try to write informed consent forms that are brief and understandable by people without scientific or medical training. Even so, some informed consent forms appear long and complicated. Thus, it is important that you are given the opportunity to read the form thoroughly, perhaps discuss it with a family member or a trusted friend, and raise any questions you have with the investigator. We hope you will feel comfortable talking to the investigator or other members of the research team and asking questions until you are satisfied that you understand the informed consent form.

Some investigators prepare additional material to help research subjects understand the contents of an informed consent form. These might include, for example, a videotape that describes the illness under study, the research project, and the methods it will use. There may be a short quiz you can take to help identify issues you wish to discuss further with the researcher. You may be able to complete such a quiz at home at your convenience. If these ideas sound useful, ask the director of the research if these or similar items are available. You can ask for a copy of the protocol to take home to discuss with family members, your physicians and others.