Akbari 2016.
Study characteristics | ||
Methods | Study design: Randomized placebo controlled trial Masking: Double‐blind Number of arms: 2 |
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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
40 mg atorvastatin
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Interventions |
Intervention characteristics 40 mg/day for 6 weeks Placebo for 6 weeks |
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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. |
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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 |