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. 2020 Mar 12;2020(3):CD003965. doi: 10.1002/14651858.CD003965.pub3

Koitabashi 1996.

Methods

  • Study design: parallel, 4‐arm RCT

  • Time frame: November 2010 to June 2011

  • Duration of follow‐up: 4 months
Participants

  • Setting: multicentre (40 sites)

  • Country: Japan

  • Inclusion criteria: IgAN; aged < 15 years; no administration of steroids nor immunosuppressive drugs; no functionally disordered; diffuse proliferative GN

  • Number (analysed/randomised): 115/not reported

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Exclusion criteria: not reported
Interventions Treatment group 1

  • Chinese medicine (Saireito) in children with minor renal histology abnormalities or focal and segmental proliferative GN


Treatment group 2

  • No treatment in children with minor renal histology abnormalities or focal and segmental proliferative GN


Treatment group 3

  • Prednisolone + AZA + anticoagulants + dipyridamole in children with diffuse proliferative GN


Control group

  • Anticoagulants + dipyridamole in children with diffuse proliferative GN


Co‐intervention: not reported
Outcomes

  • Proteinuria

  • Haematuria

  • Kidney function

  • Renal histopathological findings
Notes

  • Conference abstract

  • Funding: not reported

  • Trials registration identification number: not applicable
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Blinding of outcome assessment not specifically reported. Key outcomes were objective laboratory measures and were unlikely to be affected by any knowledge of treatment allocation
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Selective reporting (reporting bias) High risk There was no pre‐specified protocol identified for this study. The study did not report extractable data for the key outcomes that would be expected for a study of this type (e.g., death (any cause), GFR loss, infection, malignancy)
Other bias Unclear risk Insufficient information to permit judgement