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. 2022 Nov 14;2022(11):CD012956. doi: 10.1002/14651858.CD012956.pub2

Salzman 1995.

Study characteristics
Methods 12‐week trial with 2 arms:

  1. fluoxetine

  2. placebo


Duration of trial: 12 weeks
Country: USA
Setting: outpatient
Participants Method of recruitment of participants: Patients were recruited through newspaper advertisement.
Overall sample size: 22
Diagnosis of borderline personality disorder: DSM‐III‐R
Means of assessment: DIB‐R, SCID‐II and clinical interview
Mean age: 36.3 years (SD = no information; range = no information)
Sex: 63.64% women*
Comorbidity: Patients were excluded if they had current axis I disorders, as determined by clinical interview, or concurrent secondary axis II disorder. No further information
Inclusioncriteria: no information
Exclusion criteria

  1. Self‐mutilating behaviours during the past 4 years

  2. Recent suicidal behaviour

  3. Current suicidal or aggressive behaviour

  4. Current substance abuse or excessive daily alcohol use (> 2 drinks/day)

  5. History of psychiatric hospitalisation

  6. Concurrent secondary axis II disorder, major depression or other axis I disorder
Interventions Experimental group
Treatment name: fluoxetine
Number randomised to group: 13
Duration: 12 weeks with 1 week of placebo run‐in
Control/comparison group
Comparison name: placebo
Number randomised to group: 9
Duration: 13 weeks, including 1 week of placebo run‐in
Both groups
Concomitant psychotherapy: Two patients were receiving psychotherapy; however, they did not differ in demographic variables, in entry criteria, or in response to treatment from the remaining participants. 
Concomitant pharmacotherapy: Other psychotropic medication was an exclusion criterion.
Proportions of participants taking standing medication during trial observation period: Other psychotropic medication was an exclusion criterion. No further information provided
Outcomes Primary outcomes: mental health status (functioning), measured by GAS. Assessed at baseline and every week after for 13 weeks (EOT). Analyses for pre and post‐treatments only
Secondary outcomes

  1. Anger, measured by PDRS‐anger, POMS‐anger, and OAS‐M‐anger against objects. Assessed at baseline and every week after for 13 weeks (EOT). Analyses for pre and post‐treatments only

  2. Depression, measured by Ham‐D, PDRS‐depression and POMS‐depression. Assessed at baseline and every week after for 13 weeks (EOT). Analyses for pre and post‐treatments only
Notes Sample calculation: no information
Ethics approval: no information
Funding source: unclear funding
Conflicts of interest: No conflicts of interest were reported.
Comments from trial authors (limitations)

  1. "In order to place these findings in a meaningful clinical context, it is necessary to emphasize the small sample size and also the relative high functioning of the participants studied." (Salzman 1995, p. 27)

  2. "The findings reported here may not necessarily be generalized to other BPD patients who are more severely impaired, either functionally or affectively, or who show significant self‐abuse or suicidal or psychotic features." (Salzman 1995, p. 27)


Comments from review authors: *reported on completers only
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "random‐assignment comparison" (Salzman 1995, p. 24)
Comment: Trial was referred to as randomised, however, there was not sufficient information on how randomisation was carried out to permit a judgement of low or high risk of bias.
Allocation concealment (selection bias) Unclear risk Comment: Insufficient information provided on allocation concealment to permit a judgement of low or high risk of bias
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "All subjects began with a single, 20 mg capsule or identical placebo, and doses were titrated up to a maximum of 60 mg/day according to the needs of the patient and in accordance with package insert guidelines." (Salzman 1995, p. 24)
Comment: Participants appeared to have been blinded as medication and placebo were identical, however, there was no information about whether personnel were blind to allocation sequence.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "Subjects were evaluated by independent observers". (Salzman 1995, p. 24)
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Quote: "Thirty‐one subjects met criteria for this study; four decided not to enroll and were lost to follow‐up. Of 27 subjects who enrolled in the study, 22 completed the trial. One subject dropped out because she wanted assurance that she would be in the medication group; four others dropped out without explanation and were lost to follow‐up." (Salzman 1995, p. 24)
Comment: Of the 27 patients enrolled, 22 completed treatment. Reasons for early termination:
Wanted assurance to be in the active drug group: 1 (not specified, which group)
Dropped out without explanation: 4 (not specified, which group)
Continuous outcomes based on completer analysis
Selective reporting (reporting bias) Unclear risk Comment: no protocol found
Vested Interest (funding and/or author affiliations) Unclear risk Comment: no details provided
Other bias Low risk Comment: No apparent other sources of bias found