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LETTERS: Robert Peveler, Tony Kendrick THREAD Study Group Selective serotonin reuptake inhibitors: THREAD trial may show way forward BMJ 2005; 330: 420-b-421-b [Full text]

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THREAD study disappointing

Giselle Martinez   (11 March 2005)

THREAD looks at effectiveness, not efficacy

Tony Kendrick, THREAD Study Group   (15 March 2005)

THREAD study disappointing 11 March 2005
Giselle Martinez, consultant psychiatrist cardiff Send response to journal: Re: THREAD study disappointing	I was delighted when I first read this. At last, a sensible trial not sponsored by the pharmaceutical industry. Unfortunately when I looked up the details of this study I discovered it will not be placebo controlled, some people will have counselling, some CBT or any therapy at the whim of their GP and what is said to the patients aboout their illness is not standardised. I suppose if it fails to show a difference between drugs and "supportive treatment" alone (whatever that means) it could be seen as evidence that NICE is right. On the other hand, better outcomes for the fluoxetine treated group could be nothing more than the well known, good old placebo effect. Perhaps the authors can explain this deficiency? Competing interests: None declared
THREAD looks at effectiveness, not efficacy 15 March 2005
Tony Kendrick, Professor of Primary Medical Care University of Southampton SO16 5ST, THREAD Study Group Send response to journal: Re: THREAD looks at effectiveness, not efficacy	The unique contribution of the THREAD Study is to look at the effectiveness (rather than efficacy), of an SSRI plus supportive care versus supportive care alone. It is a ‘real-life’ pragmatic trial which is able to examine the effects of prescribing on the process and outcome of care, incorporating rather than controlling for the placebo effect. We are also able to examine cost-effectiveness, which you can't study with a placebo-controlled trial, as placebos aren't usually prescribed in practice and so the costs of the placebo arm are impossible to interpret for practice. Patients in either arm may be referred for counselling, CBT, or other psychotherapy, if this is part of usual care from the GP, but the large majority will not receive this within the 12 week treatment period. We have standardised the number of visits to the doctor for supportive care in both arms, to control for the amount of time spent with the patient. Rather than standardising what the doctor tells the patient about depression however, we are actually very interested in what the doctor talks about, and are measuring this through a patient questionnaire at the end of treatment, to see whether the patients in the non-antidepressant arm get more discussion of their life problems and possible solutions, because the doctor is refraining from prescribing and therefore doesn’t spend so long talking about the drug effects and side-effects. This is a possible benefit of not prescribing, which has not been examined before as far as we are aware. Competing interests: Chief Investigator of THREAD Study