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 .
Differential therapy of mild to moderate depressive episodes (ICD-10 F 32.0; F 32.1) with St. John's wort.
The purpose of this report was to evaluate specific depressive symptoms that are most suitable for a therapy with the Ze 117 St. John 's wort extract . We examined the antidepressant efficacy and drug safety of Ze 117 and fluoxetine in a multicentric prospect i ve r and omized double-blind parallel group comparison according to generally accepted guidelines such as the Declaration of Helsinki and GCP . We treated out patients ( n = 240 ; Ze 117 : 126 ; fluoxetine : 114 ) with mild to moderate depressive episodes ( ICD-10 : F 32.0 , F 32.1 ; HAMD range : 16 - 24 ) with either two tablets St John 's wort ( Ze 117 ; 500 mg extract/day ) or fluoxetine ( 20 mg/day ) for 6 weeks . Antidepressant efficacy was evaluated with the vali date d HAMD psychometric method . A vali date d analysis of HAMD subscores was made to verify the efficacy for certain depressive symptoms . The main results were : * The HAMD responder rate was 60 % in the Ze 117 group compared to 40 % in the fluoxetine group ( p = 0.005 ) . * Particularly , there was a marked decrease of depressive agitation ( pre-post comparison : 46 % ) and anxiety symptoms ( 44 % ) during the therapy with St. John 's wort . Depressive obstruction ( 44 % ) and sleep disorders ( 43 % ) were reduced during the treatment , too . There were no statistically significant differences between the treatment groups . * Adverse events occurred in 28 patients ( 25 % ) in the fluoxetine group and in 18 ( 14 % ) of the St. John 's wort group ( p < 0.07 ) . St. John 's wort extract is a clinical ly effective equivalent to fluoxetine regarding overall depressive symptoms and main symptoms of depressive episodes . An especially interesting overall observation is that Ze 117 is particularly effective in depressive patients suffering from anxiety symptoms . St. John 's wort revealed better safety and tolerability data than fluoxetine
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 .