Gokce 2012.
Study characteristics | ||
Methods | Study design: Randomized controlled trial Masking: single‐blind Number of arms: 2 |
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Participants |
Inclusion criteria: 30–70‐year‐old male patients, normal libido, IIEF< 17, no previous use of PDE5 Is and normal serum testosterone levels 300 ng/dL Exclusion criteria: history of any pelvic surgery, having any kind of medication for ED, having any neurological or mental problem, liver or hepatic insufficiency, use of nitrates, and use of antiandrogens Baseline characteristics Atorvastatin 10 mg/day
No treatment
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Interventions | 10 mg/day atorvastatin for 3 months no treatment for 3 months |
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Outcomes | Total testosterone (3 months) | |
Statistical analysis and reporting | Sample size estimation was performed by a conventional statistical program by taking into account an effect size of 50% improvement in symptoms, andminimum number of patients needed to reject the null hypothesis was 120. For randomisation, NCSS program was used, and patients were blinded for the treatment. The statistical analysis was performed by SPSS ver. 15.0. (SPSS Inc.,Chicago, Illinois). Data are expressed as numbers and percentages for discrete variables and as means ± SD for continuous variables. The chi‐square analysis or Fisher’s exact test was used to assess the significance of differences between dichotomous variables. Continuous variables were compared by Student’s t‐test or Mann–Whitney U‐test. | |
Number of participants lost to follow‐up | Atorvastatin group: one lost to follow up and three discontinued; Of the three that discontinued; one was due to nausea and two was due to lack of efficacy No treatment group: two lost to follow up and four discontinued; Of the four that discontinued; one was due to headache and three was due to lack of efficacy |
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Source of funding | not reported | |
Notes | Location: Department of Urology, Ankara University School of Medicine, Adnan Saygun Caddesi, Altındag˘, Ankara, Turkey Department of Cardiology, Ankara University School of Medicine, Adnan Saygun Caddesi, Altındag˘, Ankara, Turkey |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization, NCSS program was used |
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 | Unclear risk | No source of funding reported |
Incomplete outcome data (attrition bias): Total testosterone | Unclear risk | (4/45)*100 = 8.9% were not included in the testosterone measurement for the atorvastatin group (6/45)*100 = 13.3% were not included in the testosterone measurement for the control group |