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How effective are Anti-depressants?

One of the problems in assessing the efficacy of drugs is that the assumption that patients don’t know in a double-blind study if they are taking the active medicine or a placebo. However, all medicines have side-effects and placebos have none, so in fact most trialists know if they are taking sugar pills because they don’t notice any physical changes. Consequently when trials show, for example, fluoxetine to be better than placebos, they may show nothing of the kind.

In this light, the study below is even more surprising in that it suggests that anti-depressants, placebo and a talk therapy are all equally (in)effective! It would be even more alarming if they had chosen fluoxetine as the antidepressant (although recent studies have suggested that even this is only more effective than placebos for the most severe forms of depression) and CBT in place of supportive-expressive therapy.

Antidepressant, Talk Therapy Fail to Beat Placebo

By Amy Norton

NEW YORK (Reuters Health) Dec 22 – Neither antidepressants nor “talk therapy” were able to outperform placebo pills in a new clinical trial on depression treatment — although there were hints that the effects varied by gender and race, researchers report.

The findings, published November 29 in the Journal of Clinical Psychiatry, add to evidence that people receiving “real” depression treatment in studies — from antidepressants to St. John’s wort — often do no better than people given a placebo.

A recent review found that a minority of antidepressant users even fared worse than placebo users.

In this latest study, researchers randomly assigned 156 patients with major depression to either take sertraline daily for 16 weeks; take a placebo for the same period, or undergo supportive-expressive therapy twice a week for four weeks and then weekly for 12 weeks.

The three groups did similarly overall.

In the antidepressant group, 31% responded (as judged by improvements on the Hamilton Rating Scale for Depression). The same was true of about 28% of patients in the talk-therapy group, and 24% in the placebo group.

“I was surprised by the results. They weren’t what I’d expected,” said lead researcher Dr. Jacques P. Barber, dean of the Institute of Advanced Psychological Studies at Adelphi University in Garden City, New York.

Still, he stressed in an interview, the lack of benefit over placebo does not mean that depression therapies are pointless.

For one, Dr. Barber said, receiving a placebo in a clinical trial “is not the same as getting no treatment.”

Study participants in placebo groups have contact with health professionals who are asking about their symptoms and well-being, he said. And for some people, that attention can make a difference — and may help explain the placebo response seen in studies.

In addition, at least some people in placebo groups believe they are getting the real treatment – and people’s beliefs about their therapy can play a key role in whether they get better.

But apart from that, different people may respond differently to a given type of depression therapy. Dr. Barber’s team found some evidence of that.

The study had an unusually large minority population for a clinical trial on depression: Forty-five percent of the patients were African American.

The researchers found that African-American men tended to improve more quickly with talk therapy than with medication or placebo. In contrast, white men fared best on placebo, while black women showed no differences in their responses to the three treatments.

Only white women, Dr. Barber said, showed the expected pattern: a quicker response to both medication and talk therapy than to the placebo.

But all of that is based on fairly small numbers of people, and more research is needed to see if the gender and racial differences are real, according to Dr. Barber.

A psychiatrist not involved in the study agreed. “Those findings are interesting, but need to be interpreted with a grain of salt,” said Dr. David Mischoulon from Harvard Medical School.

As for the overall lack of benefit from the real treatments over placebo — in this and other studies – Dr. Mischoulon cautioned against reading that as “nothing works for depression.”

“I think it’s the opposite,” he told Reuters Health, “It’s more that, everything seems to work to some degree.”

Like Dr. Barber, Dr. Mischoulon said that the placebo condition in clinical trials is not really “no treatment.”

Instead, he said, “I try to offer as broad a menu of options as possible, because all may potentially help.” Dr. Mischoulon has also studied alternative depression remedies, like fish oil and acupuncture.

Another caveat from the current study, he noted, is that it looked only at two types of medication. (Some patients were switched to venlafaxine if they did not respond to sertraline after eight weeks). And it tested just one type of talk therapy.

Supportive-expressive therapy is a short-term form of psychoanalysis that aims to help people understand how their personal relationships are related to their symptoms.

It’s different from cognitive behavioral therapy, the best-studied form of talk therapy for depression. Both Dr. Barber and Dr. Mischoulon said it’s not clear if the current findings would extend to psychotherapies other than supportive-expressive therapy.

“This is one type of psychotherapy, and it’s two antidepressants,” Dr. Mischoulon said. “It would be wrong to conclude that psychotherapy doesn’t work, and antidepressants don’t work.”

The study was funded by the National Institutes of Health. Some of Dr. Barber’s co-researchers have received funding from the pharmaceutical industry.

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