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. 2015 Jul 14;2015(7):CD010294. doi: 10.1002/14651858.CD010294.pub2

Higashihara 2008.

Methods

  • Study design: parallel, open‐label RCT

  • Duration of study: not reported

  • Follow‐up: 24 months

  • ADPKD assessment: CT scan
Participants

  • Country: Japan

  • Setting: multicentre

  • Patients aged 18 to 60 years; clinical and image diagnosis of ADPKD

  • Number: treatment group (21); control group (20)

  • Mean age ± SD (years): treatment group (47 ± 11); control group (47 ± 12)

  • Sex (M/F): treatment group (15/6); control group (14/6)

  • Exclusion criteria: ESKD; haemorrhagic lesions such as gastric ulcer; intracranial aneurysm and past history of central nervous vascular disease; any condition that could prevent completion of the planned follow‐up; pregnant or lactating women or fertile women without effective contraception
Interventions Treatment group

  • Eicosapentaenoic acid‐ethyl ester: 2.4 g/d


Control group

  • Standard therapy


Duration of intervention

  • 24 months
Outcomes

  • Kidney volumes

  • Fatty acid composition of the total phospholipid fraction of erythrocytes

  • Plasma cholesterol

  • Triglycerides

  • CrCl

  • UAE
Notes

  • Funding source: "This study was supported by a grant from the Ministry of Health, Labor and Welfare of Japan". "EPA ethyl ester capsules (Epadel‐S®) and research funds were provided by Mochida Pharmaceutical Co. Ltd (Tokyo, Japan) to each participating institute."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk "...using the dynamic balancing method to ensure equal distributions"
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement, presumably open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement, presumably open‐label study
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias High risk Sponsored by Mochida Pharmaceutical Co. Ltd