Hallahan 2007.
Study characteristics | ||
Methods | 12‐week trial with 2 arms:
Duration of trial: 12 weeks Country: Ireland Setting: outpatient |
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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
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Interventions |
Experimental group
Treatment name: omega‐3 fatty acid
Number randomised to group: 22
Duration: 12 weeks Control/comparison group Comparison name: placebo Number randomised to group: 27 Duration: 12 weeks Both groups Concomitant 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. |
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Outcomes |
Primary outcomes
Secondary outcomes
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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) |
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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 |