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

Akbari 2016.

Study characteristics
Methods Study design: Randomized placebo controlled trial
Masking: Double‐blind
Number of arms: 2
Participants Inclusion criteria: women with a diagnosis of PCOD based upon existence of 2 of the 3 criteria specified by Rotterdam, BMI > 25.2, LDL > 100, not pregnant, no other reasons for obesity and metabolic and hormone and glands and metabolism issues, no use of metformin and other medicines that create sensitivity to insulin and no use of OCP over the last three months and no consumption of medicines that reduce androgen, not sensitive to atorvastatin, and participants are 18 to 35 years old
Exclusion criteria: pregnancy, using metformin or any other medicines that cause sensitivity to insulin and OCP over the last 3 months before the research and androgen reducer (using progesterone for withdrawal or keeping mensuration was ok), LDL < 100, BMI < 25, any hormonal or metabolic disorders not related to PCOS, any sensitivity to atorvastatin exhibited by the rise of liver enzymes more than three times the normal level and severe muscle cramps
Baseline Characteristics
Placebo
  • n: 20

  • sex: female

  • BMI: 26.3

  • Age:27.7

  • Total cholesterol: 224.5 mg/dL (5.81 mmol/L)

  • LDL cholesterol: 138.3 mg/dl (3.58 mmol/L)

  • HDL cholesterol: 50.2 mg/dL (1.30 mmol/L)

  • Triglycerides: 182.4 mg/dL (2.06 mmol/L)

  • Total testosterone: 0.69 nmol/L (19.90 ng/dL)

  • Androstenedione: 2.3

  • DHEAS: 232.6

  • Left ovary size: 13.1

  • Right ovary size: 13.6


40 mg atorvastatin
  • n: 20

  • sex: female

  • BMI: 26.7

  • Age:30.9

  • Total cholesterol: 223.4 mg/dL (5.78 mmol/L)

  • LDL cholesterol: 146.1 mg/dL (3.78 mmol/L)

  • HDL cholesterol: 50.0 mg/dL (1.29 mmol/L)

  • Triglycerides: 134.9 mg/dL (1.52 mmol/L)

  • Total testosterone: 0.72 nmol/L (20.77 ng/dL)

  • Androstenedione: 2.5

  • DHEAS: 225.3

  • Left ovary size: 14.9

  • Right ovary size: 15.1

Interventions Intervention characteristics
40 mg/day for 6 weeks
Placebo for 6 weeks
Outcomes Total testosterone, DHEAS and androstenedione
Statistical analysis and reporting Sequential nonrandom sampling method was used in both groups. The resulting information was analyzed using SPSS 16. As for qualitative variables, indicators such as frequency, mode, mean, and average were calculated. The frequency of qualitative variables was also measured. Independent t test was used to study qualitative variables, while repeated measures test was used to calculate the changes observed in two groups before and after intervention. Forward linear regression was used to study the confounding effect.
Number of participants lost to follow‐up None
Source of funding not reported
Notes Location: clinic of Firouzgar Hospital, Tehran, Iran
Ethical approval: The ethics committee of Iran University of Medical Sciences studied the ethical aspects of this research and approved it under the code 93/D/105/4431. The ethical principles specified in the Treaty of Helsinki were observed.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Used block randomization, but the process for selecting the blocks was not specified "People qualified for the research were randomly divided into randomised blocks containing 4 people in each one."
Allocation concealment (selection bias) Unclear risk Method of concealment is not described
Blinding of participants and personnel (performance bias)
All outcomes Low risk Objective outcomes like serum total testosterone, DHEAS and androstenedione are not likely to be influences by lack of blinding
Blinding of outcome assessment (detection bias)
All outcomes Low risk Androgen parameters 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 Blinding method was not described
Selective reporting (reporting bias) Unclear risk No protocol was found, and there is insufficient information to judge if it is low or high risk of bias
Selective reporting (reporting bias) WDAEs Low risk WDAE outcome reported
Source of funding, sponsorship and conflict of interest Unclear risk Source of funding not reported
Incomplete outcome data (attrition bias): Total testosterone Low risk All participants were included in the efficacy analysis
Incomplete outcome data (attrition bias): Androstenedione Low risk All participants were included in the efficacy analysis
Incomplete outcome data (attrition bias): DHEAS Low risk All participants were included in the efficacy analysis