Skip to main content
. 2021 Apr 19;2021(4):CD012654. doi: 10.1002/14651858.CD012654.pub2

Kim 1999.

Study characteristics
Methods Study design: parallel randomized controlled clinical trial
Randomization ratio: 1:1 (KRG: 13, placebo: 13)
Dates when study was conducted: January 1996 to January 1998
Setting/country: outpatient/ single center/ S. Korea
Participants Inclusion criteria: mild vasculogenic ED (rigidity 50‐70%, duration under 10 min on provocation test)
Exclusion criteria: neurogenic ED, endocrinologenic ED
Baseline characteristics of participants:
‐ the number of participants randomized: 26 (KRG: 13, placebo: 13)
‐ the number of participants analyzed: 21 (KRG: 11; placebo: 10)
‐ age (mean): KRG: 45.6; placebo: 44.8
‐ comorbidity: NR
‐ ED severity (mean):

  • Total sexual functioning score: KRG: 25.7; placebo: 26.3

  • Satisfaction: KRG: 4.1; placebo: 3.3

  • Frequency: KRG: 1.7; placebo: 1.7

  • Desire: KRG: 4.1; placebo: 4.0

  • Erection: KRG: 7.6; placebo: 8.6

  • Ejaculation: KRG: 4.9; placebo: 6.5

  • Orgasm: KRG: 3.3; placebo: 2
Interventions Details of intervention and control
‐ Experiment: KRG (2700 mg; 3 capsules of 300 mg 3 times daily)
‐ Control: placebo (same shape and smell)
Run‐in period: no
Follow‐up period: 12 weeks
Outcomes 1) Erectile function:
How measured: questionnaire (the modified Watts Sexual Function questionnaire)
TIme points measured: at baseline and 12 weeks
Time points reported: at baseline and 12 weeks
2) Sexual satisfaction
How measured: questionnaire (the modified Watts Sexual Function questionnaire)
TIme points measured: at baseline and 12 weeks
Time points reported: at baseline and 12 weeks
3) AEs: Not assessed
Funding sources KT&G
Declarations of interest NR
Notes Publication language: Korean
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "... in this randomized, double‐blinded, placebo‐controlled study"
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 which has the same shape and smell of red ginseng, ..." and "... in this randomized, double‐blinded, placebo‐controlled study"
Comment: placebo controlled study.
Blinding of outcome assessment (detection bias)
Subjective outcomes Low risk Comment: double‐blinded, placebo controlled study.
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 Unclear risk Quote: "Of the 26 subjects, 21 patients (group A: 11 patients, group B: 10 patients) completed the study and five patients were dropped out: There were 4 patients who complained of no efficacy of the test drugs, and 1 patient was lost to follow‐up. All of the 21 patients responded to the questionnaire before and after the treatment, ..."
Comment: 11/13 and 10/13 randomized participants in the KRG and placebo groups, respectively, were included in the analysis.
Incomplete outcome data (attrition bias)
Adverse events Unclear risk Comment: not measured.
Incomplete outcome data (attrition bias)
Ability to have intercourse reported by participants (or partner) Unclear risk Comment: not measured.
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 in the study groups.