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. 2021 Jan 22;2021(1):CD013211. doi: 10.1002/14651858.CD013211.pub2

Raja‐Khan 2011.

Study characteristics
Methods Study design: randomized, double‐blind, placebo controlled
Masking: double‐blind
Number of arms: 2
Participants Inclusion criteria: Women with PCOS and LDL‐cholesterol > 100 mg/dL were eligible to participate in the study.
Exclusion criteria: not reported
Baseline characteristics
Placebo
  • n: 11

  • sex: female

  • age: 29.4

  • BMI: 36.0

  • Total cholesterol: 202.8 mg/dL (5.24 mmol/L)

  • LDL cholesterol: 131.3 mg/dL (3.40 mmol/L)

  • HDL cholesterol: 46.5 mg/dL (1.20 mmol/L)

  • Triglycerides: 125.5 mg/dL (1.42 mmol/L)

  • Total testosterone: 92.3 ng/dL (3.20 nmol/L)

  • Free testosterone: 20.2 ng/dL (0.70 nmol/L)

  • DHEAS: 170.2 μg/dL (4.62 μmol/L)

  • Androstenedione: 380 ng/dL (13.27 nmol/L)


40 mg/day atorvastatin
  • n: 9

  • sex: female

  • age: 33.8

  • BMI: 40.1

  • Total cholesterol: 215.8 mg/dL (5.58 mmol/L)

  • LDL cholesterol: 140.7 mg/dL (3.64 mmol/L)

  • HDL cholesterol: 44.4 mg/dL (1.15 mmol/L)

  • Triglycerides: 153.3 mg/dL (1.73 mmol/L)

  • Total testosterone: 61.3 ng/dL (2.13 nmol/L)

  • Free testosterone: 18.1 ng/dL (0.63 nmol/L)

  • DHEAS: 162.9 μg/dL (4.42 μmol/L)

  • Androstenedione: 340 ng/dL (11.87 nmol/L)

Interventions Placebo for 6 weeks
Atorvastatin 40 mg/day for 6 weeks
Outcomes Total testosterone, Free testosterone, Androstenedione and DHEAS
Statistical analysis and reporting Linear mixed‐effects models, extensions of regression that account for within‐subject correlation inherent in pre‐post designs, were fit to continuous outcomes to assess the change from baseline to 6weeks within and between treatment groups. All hypotheses tests were two‐sided. All analyses were performed by intention‐to‐treat using SAS software, version 9.1 (SAS Institute Inc., Cary, NC)
Number of participants lost to follow‐up 2
Source of funding National Institutes of Health (NIH) grant number K12HD055882, GCRC grant M01 RR10732 and construction grant C06 RR016499 to Pennsylvania State University and a research grant from Pfizer
Notes Location: Department of Medicine, Pennsylvania State University College of Medicine, Hershey, Pennsylvania
Ethical approval: The institutional review board of Pennsylvania State University approved the study. Written informed consent was obtained from all participants.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "The biostatistician generated a permuted block randomisation scheme"
Allocation concealment (selection bias) Low risk "The biostatistician generated a permuted block randomisation scheme for the allocation sequence and provided it to the pharmacist"
Blinding of participants and personnel (performance bias)
All outcomes Low risk The atorvastatin and placebo were over encapsulated by the pharmacist so that the participants, research coordinator who administered the intervention, and investigators who assessed the outcomes were blinded to group assignment and objective outcome like serum androgens are not likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias)
All outcomes Low risk Androgens were measured in a laboratory and the outcome measurements were not likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias): WDAEs Unclear risk Not reported
Selective reporting (reporting bias) Low risk Study protocol is available (NCT00529542) and all the study's prespecified outcomes were reported
Selective reporting (reporting bias) WDAEs High risk Not reported
Source of funding, sponsorship and conflict of interest High risk National Institutes of Health (NIH) grant number K12HD055882, GCRC grant M01 RR10732 and construction grant C06 RR016499 to Pennsylvania State University and a research grant from Pfizer
N.R‐K. has nothing to disclose. A.R.K. reports ownership of Merck stock. C.S.H. has nothing to disclose. C.M.S. has nothing to disclose.
L.M.D. has nothing to disclose. R.S.L. has received speaker honorarium from Merck‐Serono and study support from Solvay
Incomplete outcome data (attrition bias): Total testosterone Unclear risk (20‐18)*100/20 = 10% did not complete the trial but the authors included all the data of all participants in the analysis
Incomplete outcome data (attrition bias): Free testosterone High risk Only baseline free testosterone was reported in each group
Incomplete outcome data (attrition bias): Androstenedione Unclear risk (20‐18)*100/20 = 10% did not complete the trial but the authors included all the data of all participants in the analysis
Incomplete outcome data (attrition bias): DHEAS Unclear risk (20‐18)*100/20 = 10% did not complete the trial but the authors included all the data of all participants in the analysis