Skip to main content
. 2022 Nov 14;2022(11):CD012956. doi: 10.1002/14651858.CD012956.pub2

Shafti 2010.

Study characteristics
Methods 8‐week trial with 2 arms:
  1. olanzapine

  2. haloperidol


Duration of trial: 8 weeks
Country: Iran
Setting: inpatient
Participants Method of recruitment of participants: The participants were inpatients. Not otherwise specified
Overall sample size: 28
Diagnosis of borderline personality disorder: DSM‐IV
Means of assessment: no information
Mean age: 29.49 years (SD = no information; range = no information)
Sex: 100% women
Comorbidity: none
Inclusion criteria: female gender
Exclusion criteria: any prominent comorbid mental disorder
Interventions Experimental groupTreatment name: olanzapine
Number randomised to group: 14
Duration: 8 weeks
Control/comparison groupComparison name: haloperidol
Number randomised to group: 14
Duration: 8 weeks
Both groupsConcomitant psychotherapy: not allowed
Concomitant pharmacotherapy: not allowed
Proportions of participants taking standing medication during trial observation period: no other concurrent psychotropic medication during testing
Outcomes Primary outcomes: mental health status (functioning), measured by CGI‐S and BPRS. Assessed at baseline and at week 8 (EOT)
Secondary outcomes
  1. Anger, measured by Buss‐Durkee Hostility Inventory (BDHI). Assessed at baseline and at week 8 (EOT)

  2. Attrition

  3. Adverse effects, measured by use of laboratory values. Assessed at baseline and at week 8 (EOT) and spontaneous reporting

Notes Sample calculation: yes
Ethics approval: yes
Funding source: no funding received
Conflicts of interest: No conflicts of interest were reported.
Comments from trial authors (limitations): "Small size of the samples, short duration of the trial, and sex‐based sampling were among the weaknesses of this trial". (Shafti 2010, p. 46)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: No information on method for random sequence generation to permit a judgement of low or high risk of bias
Allocation concealment (selection bias) Unclear risk Comment: Insufficient information on concealment of random sequence allocation to permit a judgement of low or high risk of bias
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Comment: The article referred to the trial being double‐blind, however, there was insufficient information on how blinding of participants and personnel was carried out and maintained to permit a judgement of low or high risk of bias.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comment: The article referred to the trial being double‐blind, however, there was insufficient information on how blinding of outcome assessors was carried out and maintained to permit a judgement of low or high risk of bias.
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: No attrition
Selective reporting (reporting bias) Unclear risk Comment: No protocol found
Vested Interest (funding and/or author affiliations) Low risk Comment: No conflicts of interest reported
Other bias Low risk Comment: No other sources found