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

Hallahan 2007.

Study characteristics
Methods 12‐week trial with 2 arms:
  1. omega‐3 fatty acid

  2. placebo


Duration of trial: 12 weeks
Country: Ireland
Setting: outpatient
Participants Methods of recruitment of patients: "All patients were recruited from the Accident and Emergency (A&E) Department of Beaumont Hospital, an academic teaching hospital in Dublin, Ireland." (Hallahan 2007, p. 118)
Overall sample size: 49
Diagnosis of borderline personality disorder: DSM‐IV
Means of assessment: SCID‐II
Mean age: 30.6 years (SD = no information; range = no information)
Sex: 65.31% women
Comorbidity: recurrent self‐harm
Inclusion criteria: no information
Exclusion criteria
  1. Current addiction

  2. Substance misuse

  3. Psychosis

  4. Eating disorder

  5. Dyslipidaemia

  6. Treatment, diet or illness known to interfere with trial drug

  7. Weight loss > 10% during previous 3 months

  8. Taking supplements containing omega‐3 fatty acids of consuming fish more than once per week

  9. Changes to or introduction of psychotropic medication during previous 6 weeks

  10. Pregnancy

Interventions Experimental groupTreatment name: omega‐3 fatty acid
Number randomised to group: 22
Duration: 12 weeks
Control/comparison groupComparison name: placebo
Number randomised to group: 27
Duration: 12 weeks
Both groupsConcomitant psychotherapy: "During the course of the study patients continued to receive standard psychiatric care and had changes to their psychotropic medication as prescribed." (Hallahan 2007, p. 118). Patients with changes to or introduction of psychotropic medication during the 6 weeks prior to screening were not eligible.
Concomitant pharmacotherapy: not allowed
Proportions of participants taking standing medication during trial observation period: 53.1% of participants continued to receive standard psychiatric care and had changes to their psychotropic medication as prescribed.
Outcomes Primary outcomes
  1. Suicidal behaviour, measured by OAS‐M suicidality subscale. Assessed at baseline and 12 weeks (EOT)

  2. Self‐harm: Number of patients with episodes of self‐harm during treatment


Secondary outcomes
  1. Anger, measured by OAS‐M irritability subscale. Assessed at baseline and 12 weeks (EOT)

  2. Impulsivity, measured by OAS‐M aggression subscale. Assessed at baseline and 12 weeks (EOT)

  3. Depression, measured by BDI and HRSD. Assessed at baseline and 12 weeks (EOT)

  4. Attrition in terms of non‐completers

Notes Sample calculation: yes
Ethics approval: yes
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): "Although 14 patients reported episodes of self‐harm during the study, it was known a priori that the study was insufficiently powered to detect significant differences between groups". (Hallahan 2007, p. 122)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "computer‐generated list" (Hallahan 2007, p. 119)
Allocation concealment (selection bias) Low risk Quote: "An independent colleague dispensed either active or placebo capsules according to a computer‐generated list. The code was only revealed to the researchers once data collection was complete". (Hallahan 2007, p. 119)
Comment: Participants and investigators enrolling participants could not foresee assignment because of central allocation.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "Participants were prescribed four identical capsules of either active agent or placebo [...] Placebo ensured a degree of equality in the incidence of 'fishy breath', the most frequent side‐effect of taking active treatment." (Hallahan 2007, p. 119)
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "identical capsules [...] Placebo ensured a degree of equality in the incidence of 'fishy breath' [...] An independent colleague dispensed [...] capsules according to a computer‐generated list. The code was only revealed to the researchers once data collection was complete." (Hallahan 2007, p. 119)
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Comments: LOCF used, reasons for early termination specified (Hallahan 2007 p. 120):
Left district: 1 in active group, 2 in placebo group
Lost to follow‐up: 2 in active group, 2 in placebo group
Admitted to psychiatric hospital: 0 in active group, 2 in placebo group
Refused to continue treatment: 0 in active group, 1 in placebo group
Dichotomous outcomes calculated on basis of the ITT sample
Of the 49 patients enrolled, 39 completed treatment (19 of the 22 allocated to active treatment, 20 of the 27 allocated to placebo).
Selective reporting (reporting bias) Unclear risk Comment: no protocol found
Vested Interest (funding and/or author affiliations) Low risk Quotes: "Pronova (now Epax) AS, Lysaker, Norway, provided the active preparation and placebo but were not otherwise involved in the study." (Hallahan 2007, p. 118)
"B.H. [i.e. first author] received salary support from the Department of Psychiatry, University of Illinois at Chicago, USA." (Hallahan 2007, p. 122)
Other bias Low risk Comment: No apparent other sources of bias found