Conclusions : International differences in prescriber behaviour may influence , and in turn be influenced by , the conduct of clinical trials .
Objective : International differences are thought to exist in dosages used by clinicians treating mood disorders .
This study examined international dosage differences in antidepressant clinical trials , using a data base formed and maintained as a component of a Cochrane review of comparative clinical trials of fluoxetine .
A double-blind comparative study of fluoxetine and dothiepin in the treatment of depression in general practice.
Fluoxetine , a selective inhibitor of 5-HT uptake , was compared to dothiepin in a double-blind study of 6 weeks duration in 100 depressed patients ( male and female ) drawn from 8 general practice s. Only those who scored at least 17 on the first 17 questions of the Hamilton Psychiatric Rating Scale for Depression ( HAM-D ) were selected . Both groups improved throughout the trial , though the dothiepin treated patients tended to improve quicker . However , by the end of the trial there was no statistically significant difference between the 2 groups . Subset analyses of HAM-D scores associated with anxiety and sleep revealed no statistically significant differences between the 2 treatments though improvement in anxiety scores was marginally greater for those receiving fluoxetine by the end of the trial . Other global assessment s by patients and doctors confirmed the changes in HAM-D scores . Statistically significant weight changes occurred between visits 1 and 5 . Whereas fluoxetine-treated patients lost weight ( p less than 0.05 ) , dothiepin-treated patients gained weight ( p = 0.05 ) over this period . Adverse effects were reported in 27 patients given fluoxetine and 20 dothiepin . Of these , 14 fluoxetine and 7 dothiepin-treated patients withdrew before the end of the trial . The most common adverse effects were nausea , vomiting and diarrhoea in the fluoxetine group and tiredness , drowsiness and diarrhoea in the dothiepin group . There were no haematological or clinical chemistry changes
Conclusions : International differences in prescriber behaviour may influence , and in turn be influenced by , the conduct of clinical trials .
Objective : International differences are thought to exist in dosages used by clinicians treating mood disorders .
This study examined international dosage differences in antidepressant clinical trials , using a data base formed and maintained as a component of a Cochrane review of comparative clinical trials of fluoxetine .