Table 2

Summary of studies characteristics
Study
 Number of Studies Patients on Flx
 Comparator(s)
 Disease and Patient Population
 Methodology
Addis 2000 [36]
 4 studies 367 pts
 TCAs
 Pregnant in the first trimester
 Medline and Embase search up to August 1996. REPROTOX and Current content up to November 1996. Manual retrieve from conferences acts.
Only cohort studies eligible for the analysis. Weighted average of fetal risk for major malformations.
Mantel-Haenszel odds ratio and overall 95% confidence interval.
Bacaltchuk 2003 [37]
 16 studies 449 pts
 Placebo TCAs MAOIs
 Bulimia nervosa
 MEDLINE (1966 to December 2000), EMBASE (1980-December 2000), PsycLIT (to December 2000), LILACS & SCISEARCH (to 1997) search.
Randomized, placebo-controlled trials in which antidepressant medications were compared to placebo to reduce the symptoms of bulimia nervosa in patients of any age or gender.
The main objective was the evaluation of antidepressant medications as clinically effective for the treatment of bulimia nervosa.
Beasley 2000 (1) [38]
 25 studies 1258 pts
 Placebo TCAs
 Major Depressive Disorder
 Data from US IND double-blind, randomized controlled clinical trials.
Spontaneously reported treatment emergent adverse events (regardless of cause), reasons for discontinuation, and events leading to discontinuation were compared between groups.
Mantel-Haenszel incidence difference after Cochran test; Der-Simonian-Laird test, when appropriate.
Beasley 2000 (2) [39]
 3 studies 233 pts
 Placebo
 Major Depression
 Data from US IND double-blind, randomized controlled clinical trials using fluoxetine fixed dose 20 mg/die on adult patients.
Only efficacy data (response rate, depression improvement) included in this review because safety data are included in the Beasley 2000 article [28].
Whitehead and Whitehead method. Mantel-Haenszel incidence difference stratified by study. Der-Simonian-Laird test, when appropriate
Beasley 1992 [40]
 17 studies 1765 pts
 TCAs Placebo
 Depression Suicidal acts
 Data from US IND double-blind, randomized controlled clinical trials up to December 1989.
Incidence of suicides. Suicide ideation acts and worsening in suicidal ideation.
Binomial unconditional Mantel-Haenszel estimate. Mantel-Haenszel adjusted incidence difference. Pearson's chi-square test.
Bech 2000 [41]
 30 studies 4120 pts
 TCAs Placebo
 Major Depression Short term effect
 Data from US IND double-blind, randomized controlled clinical trials up to December 1992.
Efficacy and discontinuations rate for acute treatment. Log odds ratio for binary data. Effect size analysis. Whitehead and Whitehead method.
Cox 1993 [42]
 25 studies
 Clomipramine Behavior therapy
 OCD
 MEDLINE (1975 to 1991), PsycLIT (1975 to 1991) search. Studies excluded if case studies, review paper, contained previously published data or did not contain the dependent variables of interest (severity of OCD symptoms, anxious and depressed mood assessed by a commonly used numeric scale). Effect size and Z-Score.
Hoog 1999 [43]
 6 studies 746 pts
 Placebo
 Depression Pts over 55
 Data from US IND double blind, randomized controlled clinical trials up to December 1998.
Changes in HAMD-17 total score, anxiety, agitation, and insomnia during treatment of depression. Treatment emergent adverse events and reasons for discontinuation. Mantel-Haenszel incidence difference with Sato's correction after Cochran test. Der-Simonian-Laird test, when appropriate.
Tollefson 1994 [44]
 6 studies 962 pts
 Placebo
 Major Depression
 Data from US IND double blind, randomized controlled clinical trials.
Time of onset of antidepressant action and patient's discontinuation rates.
Least squares means and standard error for the description of response variables.
Cochran-Mantel-Haenszel statistic stratified by study. Kaplan.Meier estimate of the time to response and remission. Wilcoxon test and log rank test to evaluate the difference between the two distributions.

Rossi et al. Annals of General Hospital Psychiatry 2004 3:2   doi:10.1186/1475-2832-3-2