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Antidepressant Studies Exclude Many by Peggy Peck PROVIDENCE, R.I., Feb 28, 2002 (United Press International via COMTEX) -- Most people who seek treatment for depression would not meet the entry criteria for a study of antidepressant drugs yet these same patients often get prescriptions for the very same medications, researchers said Thursday. The study has some psychiatrists raising questions about possible overuse of antidepressants. Dr. Mark Zimmerman, of Brown University School of Medicine in Providence, said in general, study criteria would exclude 86 percent of depressed patients treated in a typical clinical practice. Zimmerman told United Press International because drugs like Prozac and Wellbutrin were only tested in a highly select group of patients, there are no data to prove they actually benefit most depressed patients. His study is published in the March issue of the American Journal of Psychiatry. "This is analogous to an infectious disease study that tested an antibiotic but only included people whose body temperature was above 103 degrees. The drug may work in people with very high temperatures, but studies are never done in people with temperatures of 102 degrees," he said. People with lower temperatures also may recover after they are given the antibiotic, but "those lower temperatures may indicate a viral infection, not a bacterial infection. Those people will recover irrespective of the drug," he added. Zimmerman said he suspects the same is true in psychiatry. Many depressed people will recover with or without drug therapy but the drugs routinely are given because published studies report the drugs work. In the study, Zimmerman and his colleagues reviewed records from 803 people ages 16 to 65 who sought care at a general psychiatric clinic. It found 346 of the patients were diagnosed with a current major depressive episode. The authors then compared the clinical characteristics of these patients to the inclusion and exclusion criteria from 31 published studies of the efficacy of various antidepressants. In general, patients included in the drug studies were more severely depressed than patients seen in practice. Moreover, the patients in the studies had "pure" depression -- meaning it was not complicated by other psychiatric or medical illnesses and the patients did not have a history of suicide or substance abuse. Zimmerman said, however, in the real world of clinical practice, depressed patients rarely present with depression alone. Dr. Ward Smith of Summit Research Network Inc. in Portland, Ore., said clinical studies of antidepressants represent a "damned if you do, damned if you don't" scenario for researchers. To demonstrate a clear benefit, a trial must be designed so "confounding variables are eliminated," Smith said. In the world of psychiatry, confounding variables are other psychiatric and medical conditions, he added. Zimmerman said he worries both psychiatrists and patients are relying too heavily on "miracle pills to cure depression," which actually can be as easily treated with psychiatric talk therapy or resolved without any treatment. Moreover, he said, using powerful antidepressants in patients might expose them to unwanted side effects. He said many antidepressants impair sexual function. "Why should a patient put their sexual relations at risk because they are feeling depressed?" he asked. Yet positive findings increase demand for antidepressants and persuade psychiatrists to turn to drug therapy, Zimmerman said. "I'm worried that psychiatrists are being turned into prescription machines," he said. Smith, who has been a clinical investigator in drug studies for more than 29 years, said he agreed not all patients require drug therapy. "That's where clinical judgment comes into play," he said. At their best, antidepressants should be a tool to help the patient "get out of the hole quicker" but he said many times patients only require counseling to help them "make some changes in their lives." Smith said in his own practice "sometimes I see a patient and I know that this patient just needs someone to talk to. Other patients may need pharmacotherapy to help them stop staring at the floor." Finally, Smith challenged the notion that antidepressants may be harmful to people who do not exactly mirror patients in drug studies. He said it is difficult to find a drug that demonstrates a clear benefit over a placebo and when one does, "those are generally pretty good drugs that actually help people." Source: PsycPort.Com This "Mental Health E-News" posting is a service of the New York Ass'n of Psychiatric Rehabilitation Services, a statewide coalition of people who use and/or provide community mental health services dedicated to improving services and social conditions for people with psychiatric disabilities by promoting their recovery, rehabilitation and rights. To join our list, e-mail us your request and, where appropriate, the name of your organization to NYAPRS@aol.com. |
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