Park 2015.
Study characteristics | ||
Methods | Randomised controlled parallel‐arm trial, 12 weeks | |
Participants |
Participants: 35 participants, mean age only reported by group (Intervention 43.5 (SD 3.72) years; comparator 39.41 (SD 3.58) years); 27 women, 8 men. Participants recruited from Hanyang University Hospital, Korea, from 2010 to 2013 Comorbidities: None reported, possible psychiatric comorbidities Adjunctive therapy: Yes, usual care and antidepressant medications in all participants Inclusion criteria: CES‐D‐K (Cho 1998) score > 24, confirmed by psychiatrist according to DMS‐IV Exclusion criteria: pregnant, lactating, < 18 / > 65 years old, taking supplements containing n‐3PUFAs, medical comorbidity (CV disease, dementia), chronic depression lasting > 2 years or treatment‐resistant depression, other primary psychiatric disorders (bipolar or schizophrenia) |
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Interventions |
Intervention: E‐EPA/DHA combination (EPA 3420 mg/d, DHA 1800 mg/d), 3 capsules daily Comparator: safflower oil and oleic acid (3g), 3 capsules daily Treatment for 12 weeks |
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Outcomes |
Primary: HDRS (17‐item), CES‐D‐K measured at baseline, 4, 8, 12 weeks; Adverse events Secondary: CGI, CGI‐IS, Trial non‐completion |
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Notes |
Funded by the Korean Research Foundation Supplements provided by DSM Nutritional Products, Switzerland Conflicts of Interest: None declared, however Dr Y Park is a founder of Omega Quant Asia (a laboratory specialising in fatty acid analysis) Compliance: Plasma n‐3PUFA levels measured Depressed mood (continuous): Analysis conducted on HDRS (17‐item) scores at 12 weeks, data using modified ITT (at least 1 post‐baseline visit) provided by authors Adverse events: Adverse events were reported in 4 individuals: Intervention group 3 (3 fishy eructation), comparator group 1 (1 fishy eructation) Quality of life: Analysis conducted on CGI (scale) Trial non‐completion: Intervention group = 6 (1 rejected blood sampling, 5 participant decision), comparator group = 5 (1 rejected blood sampling, 4 participant decision) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Independent statistician, _ computer‐generated randomisation scheme allowing for randomisation blocks" (P. 143) |
Allocation concealment (selection bias) | Low risk | "Sequentially‐numbered containers with either n‐3PUFAs or placebo were randomly assigned to participants. Identity codes were concealed in sequentially‐numbered opaque envelopes managed by the study investigators" (P. 143) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No attempt to mask flavour or check blinding (P. 142) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | HDRS scores were "measured by psychiatrist who was blinded to treatment groups" (P. 142) |
Blinding of outcome assessment (Adverse Events) | High risk | AEs ‐ participant‐rated (participants not blinded effectively) |
Incomplete outcome data (attrition bias) All outcomes | High risk | HDRS ‐ > 10% missing in the overall sample and not ITT analysis |
Incomplete outcome data (Adverse Events) | High risk | All AEs reported, P 144, but > 10% withdrawals. |
Selective reporting (reporting bias) | Low risk | All outcomes reported (correspondence from authors) |
Other bias | High risk | Significant baseline imbalance for mood disorders (P. 144) |