Markovitz 1995a.
Study characteristics | ||
Methods | A 14‐week trial with 2 arms:
Duration of trial: 14 weeks Country: USA Setting: inpatient |
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Participants |
Methods of recruitment of patients: no information Overall sample size: 17 Diagnosis of borderline personality disorder: DSM‐III‐R Means of assessment: SCID‐II and Gunderson's DIB20 Mean age: no information Sex: no information Comorbidity: Axis I: Each patient had on average 3.0 current Axis I diagnoses and 4.7 lifetime diagnoses at the time of the study. Axis II: 100% borderline, 82% self‐defeating, 82% paranoid, 71% compulsive, 65% avoidant, 65% dependent, 59% histrionic, 59% passive‐aggressive, 53% schizotypal, 35% narcissistic, 35% antisocial. Axis III: 92% premenstrual syndrome, 47% headaches/migraines, 41% IBS, 35% fibrocytis, 29% neurodermatitis, 29% sleep apnoea Inclusion criteria: no information Exclusion criteria: no information |
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Interventions |
Experimental group
Treatment name: fluoxetine
Number randomised to group: 9
Duration: 14 weeks Control/comparison group Comparison name: placebo Number randomised to group: 8 Duration: 14 weeks Both groups Concomitant psychotherapy: no information Concomitant pharmacotherapy: no information Proportions of participants taking standing medication during trial observation period: no information |
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Outcomes |
Primary
Secondary
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Notes |
Sample calculation: no information Ethics approval: no information Funding source: no information Conflicts of interest: no information Comments from trial authors (limitations): "All of the rating instruments were continuing to show increasing improvement at 14 weeks in patients on fluoxetine, suggesting the trial may not have been long enough". (Markovitz 1995a, p. 271) Comment from review authors: This trial was not included in quantitative analyses due to data unavailability for effect size calculations. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: The study was referred to as randomised; however, the method used to generate the allocation sequence was not described in sufficient detail to allow an assessment of whether it produced comparable groups. |
Allocation concealment (selection bias) | Unclear risk | Comment: Allocation concealment and the method used to conceal the allocation sequence was not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: The study was referred to as being double‐blind but there was no information on method or if the blinding was successful. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: The study was referred to as being double‐blind but there was no information on method or if the blinding was successful. |
Incomplete outcome data (attrition bias) All outcomes | High risk |
Quote: “Dropout after 3 weeks but prior to 14 weeks and their final rating scores carried through for each subsequent time point. Seven of nine patients on fluoxetine completed the entire study, and seven of eight patients on placebo completed all 14 weeks of the trial”. (Markovitz 1995a, p. 271) Comment: last‐observation‐carried‐forward |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol available. Insufficient information to permit judgement of high or low risk of bias |
Vested Interest (funding and/or author affiliations) | Unclear risk | Comment: insufficient information on funding and conflict of interest to permit judgement of high or low risk of bias |
Other bias | Low risk | Comment: The study appeared to be free of other sources of bias. |