Chen 2014.
Study characteristics | ||
Methods | Study design: Randomized controlled trial Masking: Open label Number of arms: 2 |
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Participants |
Inclusion criteria: subjects diagnosed with mild dyslipidaemia and osteopenia before recruitment; and subjects not treated routinely with lipid‐lowering drugs in the last 3 months before recruitment Exclusion criteria: history of medications for diseases affecting bone metabolism; therapy for osteoporosis with diphosphonate and calcitriol within the last 6 months; other medications including diuretics, testosterones, thyroid hormones, glucocorticoids, or immunosuppressants within the last 1 year; relevant diseases: malignant tumours, severe hepatic or renal dysfunction, hyperthyroidism, and hyperparathyroidism. Baseline characteristics Lifestyle guidance
10 mg/day atorvastatin and lifestyle guidance
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Interventions | 10 mg/day atorvastatin and lifestyle guidance for 12 months lifestyle guidance for 12 months |
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Outcomes | Total testosterone (6‐12 months) | |
Statistical analysis and reporting | Statistical analyses were conducted using SPSS package for Windows, version 17.0. All data were expressed as means SEM. Comparison of baseline characteristics between atorvastatin and control groups was based on independent‐sample t‐test for continuous variables and chi‐square test for categorical variables. In follow‐up, comparison of parameters between groups was performed at 6 and 12 months using independent‐sample t‐test or ANOVA for repeated measurements with treatment group as the independent variables and changing of parameters from baseline as the dependent variables as a function of time. In addition, Mauchly’s test of sphericity was analyzed to evaluate the assumption of ANOVA for repeated measurements to adjust the degrees of freedom, according to Greenhouse–Geisser correction coefficient e, if necessary. Moreover, comparison of parameters within groups at different time points of follow‐up was performed using one‐way ANOVA followed by least significant differences test (LSD test). After obtaining the statistical significance of primary and secondary endpoints, Pearson correlation analysis of changed parameters was undertaken. All analyses were two‐tailed and P value of <0.05 was considered significant. | |
Number of participants lost to follow‐up | One subject went abroad to visit relatives and three participants were re‐treated due to other reasons | |
Source of funding | grants from National Nature Science Foundation of China (81370360) | |
Notes | Location: Ren‐Ji Hospital, Shanghai Jiao‐Tong University Medical School, China Ethical approval: Ethics Committee of Renji Hospital |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Conducted with complete randomization using SPSS package for Windows, version 17.0 |
Allocation concealment (selection bias) | Unclear risk | Method of concealment is not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Objective outcome like serum total testosterone is not likely to be influenced by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Testosterone was measured in a laboratory and the outcome measurement was not likely to be influenced by lack of blinding |
Blinding of outcome assessment (detection bias): WDAEs | High risk | No blinding of outcome assessment, and the outcome measurement was likely to be influenced by lack of blinding |
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 | Low risk | Government grants from China |
Incomplete outcome data (attrition bias): Total testosterone | Low risk | (2/32)*100 = 6.25% were not included in the testosterone measurement for the control group (2/32)*100 = 6.25% were not included in the testosterone measurement for the atorvastatin group missing outcome data balanced in numbers across intervention and control groups with similar reason for missing data across groups |