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By Alexandra Morris
Antipsychotic drugs are typically the first-line treatment for the roughly one percent of people who have schizophrenia — often in conjunction with psychotherapy. But for patients who are not helped by the drugs or cannot tolerate their side effects, what's left?
Last month, the Lancet published a study looking at the effects of cognitive therapy on patients with schizophrenia who refused to take medication – and prompted a heated debate within the mental health community.
Cognitive therapy involves one-on-one meetings between a patient and a therapist to discuss ways to change thinking and behavior in response to their symptoms.
Patients in the study were randomly assigned to receive either treatment as usual — ranging from no treatment at all to psychosocial support and other methods — or treatment as usual plus cognitive therapy. The researchers found that by the end of the study, the patients who received cognitive therapy had reduced psychiatric symptoms as compared to those who did not receive cognitive therapy.
Sounds reasonable, no? But initial media coverage included headlines claiming that cognitive therapy was an effective alternative to antipsychotic treatment. The Guardian posted “At last, a promising alternative to antipsychotics for schizophrenia,” and Science magazine wrote, “Schizophrenia: Time to flush the meds?” BBC News reportedly posted a headline “Schizophrenia: Talking therapies 'effective as drugs.'”
Shortly after the study hit the press, bloggers were off and running (from PLOS to The Mental Elf), highlighting the limitations in the study design, such as the small sample size of 74 patients and the fact that nearly a third of these patients dropped out of the study partway through. They urged readers not to generalize the effect of cognitive therapy on schizophrenia based on limited evidence.
In fact, cognitive therapy was never compared to antipsychotics in the study. Some patients were even prescribed antipsychotics during the trial as part of their routine treatment. Several of the media reports also failed to mention an important caveat – that the trial was conducted in a specific patient population: those with mild to moderate psychiatric symptoms, as compared to those with severe illness who require hospitalization. The findings therefore cannot be extrapolated to all patients suffering from schizophrenia.
Lead study author Dr. Tony Morrison of the University of Manchester attested to the high drop-out rate.
He said in an email, “The relatively high rates of attrition (planned and unplanned) clearly limit the confidence we can have in our findings and suggest the need for a larger definitive trial.” The Lancet also published a commentary -- Cognitive therapy: At last an alternative to antipsychotics? -- that reiterated the study’s limitations.
One of the major complaints about the study had to do with the abstract’s concluding statement: “Cognitive therapy signiﬁcantly reduced psychiatric symptoms and seems to be a safe and acceptable alternative for people with schizophrenia spectrum disorders who have chosen not to take antipsychotic drugs.”
Dr. David Henderson, psychiatrist and director of the Schizophrenia Clinical and Research Program at Massachusetts General Hospital, said that the abstract’s conclusion is “a bit of an overstatement, in that it’s suggestive that an effective treatment for patients who don’t want to take antipsychotic medication would be CT [cognitive therapy].”
And while he felt the authors presented a good and promising study, he said, “a statement generalizing [the results] to the whole population is very misleading and actually could be quite dangerous. People will want to say ‘Well, let me use CT and not medication,’ and it will be a disaster,” he said.
Dr. Henderson stressed the importance of adding qualifiers to explain that the patients studied do not represent the majority of patients with schizophrenia. The study patients who were “not very symptomatic” represented just 10 percent of his schizophrenia patient population, he said.
Although the abstract includes no qualifiers, the authors of the Lancet study do mention several of the study’s limitations in their discussion section. Dr. Morrison confirmed that “the results cannot be generalized to hospitalized patients, those requiring community treatment orders and those presenting significant risk to self or others” – in other words, patients with more severe forms of schizophrenia.
Could cognitive therapy have an impact on these patients with more severe symptoms? That was not tested in the trial. Henderson was skeptical that it would have the same level of effect, given the severity of illness and difficulty concentrating. “If you have somebody yelling in your head constantly, it’s difficult to focus and to pay attention and to work hard,” he said.
Another issue with the study: its subjects reported quite a few negative outcomes during the trial, including hospitalizations and two attempted overdoses – one in each group. This suggests that for those patients, treatment as usual even with cognitive therapy may not have been enough.
Antipsychotic drugs carry their own set of issues, including side effects such as drowsiness, weight gain, tremors, and reports that the drugs “mute” patients. Some researchers, such as Dr. Thomas Insel, the director of the National Institute of Mental Health, are also raising questions about the long-term impact of these treatments. In a blog entry published last year, Dr. Insel reports on a study in which antipsychotic medication proved beneficial in the early stages of psychosis, but over the long term, it appeared to worsen the prospects of recovery.
For schizophrenic patients suffering from severe illness, it’s a question of tradeoffs, said Dr. Henderson: “In this population, the risks of not being treated are far greater than the risks of the long-term effects of the medication.”
What does it mean to have schizophrenia? Imagine you are told that what you know to be real – the feel of someone’s fingers touching your skin, words you believe have meaning, or your internal voice that speaks to you, advises you, warns you of imminent danger – are just symptoms of a psychiatric disease. There are no fingers touching you, the words don’t exist, and the voice, or perhaps voices, guiding you each day are simply hallucinations. You’re trapped in your own version of reality.
Schizophrenia is a spectrum disorder, meaning there are varying levels of symptoms. Some patients have such severe symptoms that they require hospitalization, while others are highly functional – they can live independently, hold a steady job, engage in relationships. Given the range of illness types, it would make sense that there is no universal treatment.
For people with schizophrenia today, what is the answer? Antipsychotic treatment combined with psychotherapy? Drugs alone? Cognitive therapy alone? To help answer these questions, Tony Morrison and his colleagues are moving forward with a new trial that will conduct a head-to-head comparison of cognitive therapy versus antipsychotic treatment versus a combination of the two. The findings from that study could prove to be useful for patients trying to decide between treatment options. Stay tuned for results in the summer of 2017.
For now, even with the new findings, the guidelines for schizophrenia remain the same: treatment with a combination of drugs and therapy.
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