Skip to main content
. 2021 Feb 15;2021(2):CD013109. doi: 10.1002/14651858.CD013109.pub2

Lin 2016a.

Study characteristics
Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Follow‐up period: 2 years

Participants
  • Setting: multicentre (3 sites)

  • Country: China

  • Relevant health status: CKD‐5D on HD/PD

  • Number: treatment group (125); control group (128)

  • Mean age ± SD (years): treatment group (70.3 ± 10.9); control group (70.6 ± 8.4)

  • Sex (M): treatment group (58.4%); control group (62.5%)

  • Exclusion criteria: hypotension, hepatic failure, and any life‐threatening disease other than ESKD; congestive heart failure (EF ≤ 50%) in recent 6 months; occurrence of an acute MI or stroke within 6 months after the study initiation; prior use of spironolactone or potassium level > 6.0 mmol/L

Interventions Treatment group
  • Spironolactone: 25 mg/day for 2 years


Control group
  • Standard care for 2 years

Outcomes
  • Death (any cause)

  • Death (cardiovascular)

  • LVM index: men, women

  • EF

  • Serum potassium

  • Gynaecomastia

Identification
  • Authors name: Chong Ting Lin, MD

  • Institution: Department of Hemodialysis Room, Yantaishan Hospital Taishan Medical College

  • Email: lingchongting0535@126.com

Notes
  • Funding source: not reported

  • Complete follow‐up: treatment group (100/125, 80.0); control group (98/128, 76.6)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The allocation sequence was generated independently by a nurse and concealed in opaque envelopes."
Allocation concealment (selection bias) Low risk Quote: "Both investigators and participants were not aware of the allocations."
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "placebo‐controlled"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "placebo‐controlled"
Incomplete outcome data (attrition bias)
All outcomes High risk Imbalance in numbers for missing data across intervention groups
Selective reporting (reporting bias) Unclear risk Protocol: not reported
Other bias Unclear risk Funding: not reported