Choi 1995.
Study characteristics | ||
Methods | Study design: parallel randomized controlled clinical trial Randomization ratio: 1:1:1 (KRG: 30; placebo: 30; trazodon: 30) Dates when study was conducted: April 1994 to September 1994 Setting/country: outpatient/ single center/ S. Korea |
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Participants | Inclusion criteria: participants with ED classified as type I and type IIb by radioisotope audio‐visual stimulation (AVS)‐penogram Exclusion criteria: organic dysfunction Baseline characteristics of participants ‐ the number of participants randomized: 90 (KRG: 30; placebo: 30; trazodon: 30) ‐ the number of participants analyzed: 90 (KRG: 30; placebo: 30; trazodon: 30) ‐ age (mean): KRG: 42.8; placebo: 45.2; trazodon: 43.2 ‐ comorbidity: NR ‐ ED severity: NR ‐ Psychogenic ED: 81 (90%); mild vasculogenic: 9 (10%, 3 participants per group) |
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Interventions | Details of intervention and control ‐ Experiment: Korean red ginseng (1800 mg/day [6 tablets of 300 mg, the frequency NR]) (commercial product from KT&G) ‐ Control: placebo; trazodon (25 mg daily at bedtime) Number of study centres: 1 Run‐in period: no Follow‐up period: 12 weeks |
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Outcomes | 1) Erectile function
How measured: questioning participants and their partners Time points measured: at baseline, 4 weeks, 8 weeks and 12 weeks Time points reported: at baseline and 12 weeks 2) Complications How measured: NR Time points measured: at baseline, 4 weeks, 8 weeks and 12 weeks Time points reported: likely cumulative |
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Funding sources | KT&G Corp. This was noted in the Korean version of the paper. | |
Declarations of interest | NR | |
Notes | Publication language: English | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The patients... were randomly assigned into three 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) | Unclear risk | Comment: not described. |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Comment: not described. |
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: "All patients received drugs for three months. A total of 90 patients with 30 patients in each group were closely followed." Comment: all participants who were randomized were included in analysis. |
Incomplete outcome data (attrition bias) Adverse events | Low risk | Quote: "All patients received drugs for three months. A total of 90 patients with 30 patients in each group were closely followed." Comment: all participants who were randomized were included in analysis. |
Incomplete outcome data (attrition bias) Ability to have intercourse reported by participants (or partner) | Low risk | Quote: "All patients received drugs for three months. A total of 90 patients with 30 patients in each group were closely followed." Comment: all participants who were randomized were included in analysis. |
Incomplete outcome data (attrition bias) QoL | Unclear risk | Comment: not measured. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information available to permit a judgement and there was no published protocol. |
Other bias | Unclear risk | Comment: the severity of erectile dysfunction at baseline was not reported between the study groups. |