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

Zanarini 2003.

Study characteristics
Methods 8‐week trial with 2 arms:

  1. ethyl‐eicosapentaenoic acid (E‐EPA)

  2. placebo: mineral oil


Duration: 8 weeks
Country: USA
Setting: outpatient
Participants Method of recruitment of participants: "Patients recruited through advertisements in Boston newspapers with the ads asking, “Are you extremely moody? Do you often feel out of control? Are your relationships painful and difficult?" (Zanarini 2003, p. 167)
Overall sample size: 30
Diagnosis of borderline personality disorder: DSM‐IV
Means of assessment: DIB‐R
Mean age: 26.3 years (SD 6.2; range = no information)
Sex: 100% women
Comorbidity: no information; however, exclusion criteria suggest comorbid mental disorders were not allowed
Inclusion criteria

  1. DSM‐IV criteria for borderline personality disorder

  2. Woman between the ages of 18 and 40 years


Exclusion criteria

  1. Major depressive episode

  2. Current or lifetime schizophrenia

  3. Schizoaffective disorder

  4. Bipolar I or bipolar II disorder
Interventions Experimental group
Treatment name: ethyl‐eicosapentaenoic acid (E‐EPA)
Number randomised to group: 20
Duration: 8 weeks
Control/comparison group
Comparison name: placebo: mineral oil
Number randomised to group: 10
Duration: 8 weeks
Both groups
Concomitant psychotherapy: no information
Concomitant pharmacotherapy: Patients were excluded if they were currently being prescribed any psychotropic medication or taking E‐EPA supplements; however, no further information was provided.
Proportions of participants taking standing medication during trial observation period: no information
Outcomes Primary outcomes : none
Secondary outcomes

  1. Impulsivity, measured by MOAS. Assessed at baseline and weeks 1, 2, 3, 4, 6, and 8 (EOT)

  2. Depression, measured by MADRS. Assessed at baseline and weeks 1, 2, 3, 4, 6, and 8 (EOT)

  3. Attrition

  4. Adverse effects, measured by structured questionnaire. Assessed at baseline and weeks 1, 2, 3, 4, 6, and 8 (EOT)
Notes Sample calculation: no information
Ethics approval: no information
Funding source: funded by grants from universities, authorities or research foundations
Conflicts of interest: Trial medication was provided by a pharmaceutical company.
Comments from trial authors (limitations): "The main limitations of this study are that only women were studied and all participants were moderately ill. Whether similar results would be found for male participants or participants with a more severe symptom picture is unknown." Zanarini 2003, p. 168)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: insufficient information on methods used to generate random sequence to permit a judgement of low or high risk of bias
Allocation concealment (selection bias) Unclear risk Comment: no information given 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 Comment: The trial was referred to as being double‐blind, however, insufficient information was given on how blinding of participants and personnel was carried out (packaging of trial medication etc.) and was maintained, to permit a judgement of low or high risk of bias.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comment: The trial was referred to as being double‐blind, however, insufficient information was given 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 Unclear risk Quote: "The three subjects who discontinued their participation (two taking E‐EPA and one taking placebo) did so because of life events unrelated to the study." (Zanarini 2003, p. 168)
Comments: Of the 30 patients enrolled, 27 completed treatment (18 in E‐EPA group, 9 in placebo group)
Reasons for early termination:
Life events unrelated to the trial: 2 in E‐EPA group, 1 in placebo group
Continuous outcomes were based on completers only.
Selective reporting (reporting bias) Unclear risk Comment: no protocol found
Vested Interest (funding and/or author affiliations) High risk Quotes: "Capsules were supplied by Laxdale Pharmaceuticals (Stirling,
U.K.)." (Zanarini 2003, p. 167), "Supported by an Independent Investigator Award from the National Alliance for Research on Schizophrenia and Depression to Dr. Zanarini." (Zanarini 2003, p. 169)
Other bias Low risk Comment: no apparent other sources of bias found