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Dear All,
One of our psychiatric colleagues has approached me with the following 
query.

What works best in patients with Somatisation disorder?
Is it Psychotherapy?/ Medication with SSRI?/ or a combination of both. 
We tried to find some evidence for this without any success? Is any 
one out there aware of evidence regarding the the management of this 
condition?

The reason they are looking for this information is that they are 
planning for a trial with three arms; psychotherapy, SSRI and the 
combination of the above as the interventions in patients with SSRI. 
The problem is they don't expect more than 20 patients to be recruited 
in each arm in the 1 year life span of the study.
Here are a few points which they struggling with. Can any one help?

1) Is it appropriate to use Sheehan social disability scale as the 
primary out come for this proposed trial or are there any other better
outcome they should be using?
2) If this is appropriate what should be the clinically significant 
upward shift in score they should propose to detect?
3) The ethical committee is objecting that 20 patients are too small 
for each arm. Is the total of 60 with 20 in each arm good enough to do 
this trial at all.

I will be grateful for any thoughts on the above above especially 
from psychiatric colleagues practicing EBM.

As the query is specialised I will be happy to send the responses I 
receive to any one who asks for it and not to the entire list. If 
there are suggestions that I should post it to the entire list then I 
will promptly do so.

Thanking you all in anticipation,

Badri 


Dr.P.Badrinath M.D.,M.Phil.,(Epid) PhD(Cantab) 
Assistant Professor and Epidemiologist, 
Department of Community Medicine, 
UAE University, PO Box 17666, Al Ain, 
United Arab Emirates. 
Tel: 00 971 3 5039 652 
Fax: 00 971 3 672022. 
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