Choi 2001.
| Study characteristics | ||
| Methods | Study design: parallel randomized controlled clinical trial Randomization ratio: 1:1 (KRG: 25, placebo: 25, total 50) Dates when study was conducted: NR Setting/country: outpatient/ single center/ S. Korea |
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| 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: 50 (KRG: 25, placebo: 25) ‐ the number of participants analyzed: 47 (KRG: 24, placebo: 23) ‐ age (mean): KRG: 46.1; placebo: 45.4 ‐ comorbidity: no ‐ ED severity (mean):
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| Interventions | Details of intervention and control ‐ Experimental: KRG (1800 mg; 2 tablets of 300 mg 3 times daily) (commercial product from KT&G) ‐ Control: placebo (same shape as experiment) Run‐in period: no Follow‐up period: 8 weeks |
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| Outcomes | 1) Erectile function: How measured: questionnaire (IIEF ‐15) Time points measured: at baseline and 8 weeks Time points reported: at baseline and 8 weeks 2) AEs How measured: NR TIme points measured: NR Time points reported: likely cumulative |
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| Funding sources | NR | |
| Declarations of interest | NR | |
| Notes | Publication language: Korean Ginseng seemed to be supported by KT&G but not described. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "...randomly divided into two groups" 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 | Quote: "...placebo group used the same shape with KRG capsule" Comment: the appearance of each treatment was the same and adequately used. |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Quote: "...placebo group used the same shape with KRG capsule" 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: "3 patients were not assessed in the follow‐up assessment" Comment: 24/25 and 23/25 randomized participants in the KRG and placebo groups, respectively, were included in the analysis. |
| Incomplete outcome data (attrition bias) Adverse events | Low risk | Quote: "3 patients were not assessed in the follow‐up assessment" Comment: 24/25 and 23/25 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: "3 patients were not assessed in the follow‐up assessment" Comment: 24/25 and 23/25 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 not described well and the protocol was not published. |
| Other bias | Unclear risk | Comment: the severity of erectile dysfunction at baseline was not reported for the study groups. |