Choi 2003.
Study characteristics | ||
Methods | Study design: parallel randomized controlled clinical trial Randomization ratio: 2:1 (KRG: 20, placebo: 10) Dates when study was conducted: NR Setting/country: outpatient/ single center/ S. Korea |
|
Participants | Inclusion criteria: participants with clinical ED, without definite organic cause Exclusion criteria: 1) anatomic penile disorder 2) decreased libido without ED 3) elevated prolactin (over three times the upper limit) or decreased free testosterone (less than 80% of the lower limit) 4) psychologic disorder (major depression or schizophrenia) 5) ED from spinal cord injury 6) history of alcohol abuse or drug abuse 7) history of hematologic disease, renal disease, hepatic disease 8) refractory diabetes mellitus Baseline characteristics of participants ‐ the number of participants randomized: 30 (KRG: 20, placebo: 10) ‐ the number of participants analyzed: 28 (KRG: 19, placebo: 9) ‐ age (mean): KRG: 45.1; placebo: 44.4 ‐ comorbidity: unclear ‐ ED severity: NR |
|
Interventions | Details of intervention and control ‐ Experiment: KRG (1800 mg; 2 tablets of 300 mg 3 times daily) (commercial product from KT&G) ‐ Control: placebo (NR in detail) Run‐in period: no Follow‐up period: 4 weeks |
|
Outcomes | 1) AEs: How measured: NR TIme points measured: NR Time points reported: likely cumulative 2) Participant's ability to have intercourse reported by participant (or partner): How measured: number of participants with improvement in the total score of IIEF‐15 compared with baseline TIme points measured: at 4 weeks Time points reported: at 4 weeks |
|
Funding sources | KT&G | |
Declarations of interest | NR | |
Notes | Publication language: Korean The authors did not reported the score for each domain of the IIEF |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "... randomly assigned..." Comment: no explicit explanation of the sequence generation. |
Allocation concealment (selection bias) | Unclear risk | Comment: no detailed information about allocation concealment. |
Blinding of participants and personnel (performance bias) | Low risk | Comment: the appearance of each treatment was the same and adequately used. |
Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Comment: placebo controlled trial. |
Blinding of outcome assessment (detection bias) Objective outcome: adverse events | Low risk | Comment: objective outcome was not likely affected by lack of blinding. |
Incomplete outcome data (attrition bias) Erectile function and sexual satisfaction | Low risk | Quote: "2 patients were not assessed in the follow‐up assessment" Comment: 19/20 and 9/10 randomized participants in the KRG and placebo groups, respectively, were included in the analysis. |
Incomplete outcome data (attrition bias) Adverse events | Low risk | Quote: "2 patients were not assessed in the follow‐up assessment" Comment: 19/20 and 9/10 randomized participants in the KRG and placebo groups, respectively, were included in the analysis. |
Incomplete outcome data (attrition bias) Ability to have intercourse reported by participants (or partner) | Low risk | Quote: "2 patients were not assessed in the follow‐up assessment" Comment: 19/20 and 9/10 randomized participants in the KRG and placebo groups, respectively, were included in the analysis. |
Incomplete outcome data (attrition bias) QoL | Unclear risk | Comment: not measured. |
Selective reporting (reporting bias) | Unclear risk | Comment: the outcomes were described well but the protocol was not published. |
Other bias | Unclear risk | Comment: the severity of erectile dysfunction at baseline was not reported for the study groups. |