There was also some weak evidence to suggest that patients taking milnacipran experienced fewer adverse events of sleepiness/ drowsiness , dry mouth or constipation compared with TCAs .
AUTHORS ' CONCLUSIONS Currently , there is inadequate evidence to conclude whether milnacipran is superior , inferior or the same as other antidepressive agents in terms of efficacy , acceptability and tolerability in the acute phase treatment of major depression .
However , there is some evidence in favour of milnacipran over TCAs in terms of dropouts due to adverse events ( acceptability ) and the rates of experiencing adverse events ( tolerability ) .
Further study is needed to answer whether milnacipran would be the better choice of antidepressant for acute major depression
BACKGROUND Although pharmacological and psychological interventions are both effective for major depression , antidepressant drugs are frequently used as first-line treatment in primary and secondary care setting s. Milnacipran , a dual serotonin-norepinephrine reuptake inhibitor ( SNRI ) , is one of the antidepressant drugs that clinicians use for routine depression care .
OBJECTIVES To assess the evidence for the efficacy , acceptability and tolerability of milnacipran in comparison with tricyclic antidepressants ( TCAs ) , heterocyclics , SSRIs and other newer antidepressive agents in the acute-phase treatment of major depression .
Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.
CONTEXT Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected , but direct evidence of such bias is currently limited to case reports . OBJECTIVE To study empirically the extent and nature of outcome reporting bias in a cohort of r and omized trials . DESIGN Cohort study using protocol s and published reports of r and omized trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg , Denmark , in 1994 - 1995 . The number and characteristics of reported and unreported trial outcomes were recorded from protocol s , journal articles , and a survey of trialists . An outcome was considered incompletely reported if insufficient data were presented in the published articles for meta- analysis . Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial and then pooled to provide an overall estimate of bias . Protocol s and published articles were also compared to identify discrepancies in primary outcomes . MAIN OUTCOME MEASURES Completeness of reporting of efficacy and harm outcomes and of statistically significant vs nonsignificant outcomes ; consistency between primary outcomes defined in the most recent protocol s and those defined in published articles . RESULTS One hundred two trials with 122 published journal articles and 3736 outcomes were identified . Overall , 50 % of efficacy and 65 % of harm outcomes per trial were incompletely reported . Statistically significant outcomes had a higher odds of being fully reported compared with nonsignificant outcomes for both efficacy ( pooled odds ratio , 2.4 ; 95 % confidence interval [ CI ] , 1.4 - 4.0 ) and harm ( pooled odds ratio , 4.7 ; 95 % CI , 1.8 - 12.0 ) data . In comparing published articles with protocol s , 62 % of trials had at least 1 primary outcome that was changed , introduced , or omitted . Eighty-six percent of survey responders ( 42/49 ) denied the existence of unreported outcomes despite clear evidence to the contrary . CONCLUSIONS The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocol s. Published articles , as well as review s that incorporate them , may therefore be unreliable and overestimate the benefits of an intervention . To ensure transparency , planned trials should be registered and protocol s should be made publicly available prior to trial completion
There was also some weak evidence to suggest that patients taking milnacipran experienced fewer adverse events of sleepiness/ drowsiness , dry mouth or constipation compared with TCAs .
AUTHORS ' CONCLUSIONS Currently , there is inadequate evidence to conclude whether milnacipran is superior , inferior or the same as other antidepressive agents in terms of efficacy , acceptability and tolerability in the acute phase treatment of major depression .
However , there is some evidence in favour of milnacipran over TCAs in terms of dropouts due to adverse events ( acceptability ) and the rates of experiencing adverse events ( tolerability ) .
Further study is needed to answer whether milnacipran would be the better choice of antidepressant for acute major depression
BACKGROUND Although pharmacological and psychological interventions are both effective for major depression , antidepressant drugs are frequently used as first-line treatment in primary and secondary care setting s. Milnacipran , a dual serotonin-norepinephrine reuptake inhibitor ( SNRI ) , is one of the antidepressant drugs that clinicians use for routine depression care .
OBJECTIVES To assess the evidence for the efficacy , acceptability and tolerability of milnacipran in comparison with tricyclic antidepressants ( TCAs ) , heterocyclics , SSRIs and other newer antidepressive agents in the acute-phase treatment of major depression .