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

Gokce 2012.

Study characteristics
Methods Study design: Randomized controlled trial
Masking: single‐blind
Number of arms: 2
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
  • n:45 were randomized and 41 were measured

  • sex: male

  • age: 57.1

  • Total cholesterol: 195.1 mg/dL (5.04 mmol/L)

  • LDL cholesterol: 127.3 mg/dL (3.29 mmol/L)

  • HDL cholesterol: 42.2 mg/dL (1.09 mmol/L)

  • Triglycerides: 155.6 mg/dL (1.76 mmol/L)

  • Total testosterone: 323.4 ng/dL (11.21 nmol/L)


No treatment
  • n:45 were randomized and 39 were measured

  • sex: male

  • age: 55.8

  • Total cholesterol: 189.4 mg/dL (4.90 mmol/L)

  • LDL cholesterol: 128.4 mg/dL (3.32 mmol/L)

  • HDL cholesterol: 40.9 mg/dL (1.06 mmol/L)

  • Triglycerides: 149.0 mg/dL (1.68 mmol/L)

  • Total testosterone: 330.7 ng/dL (11.47 nmol/L)

Interventions 10 mg/day atorvastatin for 3 months
no treatment for 3 months
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
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
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