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Responding to Violence, Suicide, Psychosis and Trauma

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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Prozac, used by 40m people, does not work say scientists

I am posting this because on a recent course on responding to suicidal behaviour, I suggested that fluoxetine (Prozac), paroxetine (Seroxat), venlafaxine (Effexor) and nefazodone (Serzone) were far less effective than previously thought. One participant asked about the evidence, so here it is. happy reading! Iain Bourne

Analysis of unseen trials and other data concludes it is no better than placebo

Prozac, the bestselling antidepressant taken by 40 million people worldwide, does not work and nor do similar drugs in the same class, according to a major review released today.

The study examined all available data on the drugs, including results from clinical trials that the manufacturers chose not to publish at the time. The trials compared the effect on patients taking the drugs with those given a placebo or sugar pill.

When all the data was pulled together, it appeared that patients had improved – but those on placebo improved just as much as those on the drugs.

The only exception is in the most severely depressed patients, according to the authors – Prof Irving Kirsch from the department of psychology at Hull University and colleagues in the US and Canada. But that is probably because the placebo stopped working so well, they say, rather than the drugs having worked better.

“Given these results, there seems little reason to prescribe antidepressant medication to any but the most severely depressed patients, unless alternative treatments have failed,” says Kirsch. “This study raises serious issues that need to be addressed surrounding drug licensing and how drug trial data is reported.”

The paper, published today in the journal PLoS (Public Library of Science) Medicine, is likely to have a significant impact on the prescribing of the drugs. The National Institute for Health and Clinical Excellence (Nice) already recommends that counselling should be tried before doctors prescribe antidepressants. Kirsch, who was one of the consultants for the guidelines, says the new analysis “would suggest that the prescription of antidepressant medications might be restricted even more”.

The review breaks new ground because Kirsch and his colleagues have obtained for the first time what they believe is a full set of trial data for four antidepressants.

They requested the full data under freedom of information rules from the Food and Drug Administration, which licenses medicines in the US and requires all data when it makes a decision.

The pattern they saw from the trial results of fluoxetine (Prozac), paroxetine (Seroxat), venlafaxine (Effexor) and nefazodone (Serzone) was consistent. “Using complete data sets (including unpublished data) and a substantially larger data set of this type than has been previously reported, we find the overall effect of new-generation antidepressant medication is below recommended criteria for clinical significance,” they write.

Two more frequently prescribed antidepressants were omitted from the study because scientists were unable to obtain all the data.

Concerns have been raised in recent years about the side-effects of this class of antidepressant. Evidence that they could prompt some young people to consider suicide led to a warning to doctors not to prescribe them for the under-18s – with the exception of Prozac, which was considered more effective than the rest.

In adults, however, the depression-beating benefits were thought to outweigh the risks. Since its launch in the US in 1988, some 40 million people have taken Prozac, earning tens of billions of dollars for the manufacturer, Eli Lilly. Although the patent lapsed in 2001, fluoxetine continues to make the company money – it is now the active ingredient in Sarafem, a pill sold by Lilly for premenstrual syndrome.

Eli Lilly was defiant last night. “Extensive scientific and medical experience has demonstrated that fluoxetine is an effective antidepressant,” it said in a statement. “Since its discovery in 1972, fluoxetine has become one of the world’s most-studied medicines. Lilly is proud of the difference fluoxetine has made to millions of people living with depression.”

A spokesman for GlaxoSmithKline, which makes Seroxat, said the authors had failed to acknowledge the “very positive” benefits of the treatment and their conclusions were “at odds with what has been seen in actual clinical practice”.

He added: “This analysis has only examined a small subset of the total data available while regulatory bodies around the world have conducted extensive reviews and evaluations of all the data available, and this one study should not be used to cause unnecessary alarm and concern for patients.”

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