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 .
Comparison of equivalence between the St. John's wort extract LoHyp-57 and fluoxetine.
In a r and omised double-blind comparative trial , the antidepressant efficacy of a daily dose of 800 mg of the St. John 's wort extract LoHyp-57 ( dry extract of St. John 's wort , drug extrakt ratio 5 - 7:1 , solvent , ethanol 60 % [ w/w ] ) was shown to be equivalent to that of 20 mg fluoxetine ( CAS 54910 - 89 - 3 ) in elderly patients with mild or moderate depressive episodes according to ICD 10 ( International Statistical Classification of Diseases and Related Health Problems ) . Treatment was given for six weeks . 149 out- patients ( 129 females and 20 males ) were included in the intention-to-treat analysis . 72 of these patients were assigned to the ICD 10 diagnostic criterion F32.0 ( mild depressive episode ) , while 77 patients were suffering from moderate depressive episodes , corresponding to F32.1 . The principal target criterion was the patient 's global score on the HAMILTON Depression Scale ( items 1 - 17 ) . During the six-week course of treatment with LoHyp-57 , the HAMILTON global score fell from 16.60 points at entry to 7.91 points , and in the fluoxetine sample it fell from 17.18 to 8.11 points . In the group of patients with mild depressive episodes , the score showed a mean fall from 14.21 to 6.21 points on LoHyp-57 , and from 15.21 to 7.46 points on fluoxetine . In patients with moderate depressive episodes , the score showed a mean fall from 18.73 to 9.43 points on LoHyp-57 and from 19.10 to 8.75 points on fluoxetine . The efficacy of both medications was found to be equivalent both in mild and moderate depressive episodes . Both treatment groups showed adverse drug reactions ( ADRs ) . Twelve ADRs with a possible relationship to the study medication were reported during treatment with LoHyp-57 . Six patients were prematurely withdrawn from treatment with the study medication for this reason . On fluoxetine 17 ADRs occurred with a possible relationship to the study medication . These led to ab and onment of treatment and therefore premature withdrawal from the study in 8 cases
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 .