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. 2021 Nov 24;2021(11):CD004692. doi: 10.1002/14651858.CD004692.pub5

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)
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
Outcomes Primary: HDRS (17‐item), CES‐D‐K measured at baseline, 4, 8, 12 weeks; Adverse events
Secondary: CGI, CGI‐IS, Trial non‐completion
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)
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)