Choi 1999.
Study characteristics | ||
Methods | Study design: parallel randomized controlled clinical trial Randomization ratio: S. Korea (2:1); China (1:1); Singapore (1:1) (KRG: 40; placebo: 30) Dates when study was conducted: NR Setting/ countries: outpatient/ multi‐center (3)/ S. Korea, China, Singapore |
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Participants | Inclusion criteria: participants with penile rigidity under 70% on the audio visual sexual stimulation test under psychogenic ED, mild or moderate organic ED, ED from unknown cause Exclusion criteria: participants with definite organic ED and a need for surgical treatment Baseline characteristics of participants ‐ the number of participants randomized: 70 (Korea: 30; China: 20; Singapore: 20) (KRG: 40; Placebo: 30) ‐ the number of participants analyzed: 64 (KRG: 37; placebo: 27) ‐ age (mean): KRG: Korea ‐ 43.4, China ‐ 39.1, Singapore ‐ 50.2; placebo: Korea ‐ 45.2, China ‐ 42.9, Singapore ‐ 43.9 ‐ comorbidity: diabetes mellitus (KRG: Korea ‐ 4, China ‐ 0, Singapore ‐ 1; placebo: Korea ‐ 1, China ‐ 0, Singapore ‐ 2), hypertension (KRG: Korea ‐ 2, China ‐ 0, Singapore ‐ 3; placebo: Korea ‐ 1, China ‐ 0, Singapore ‐ 1), hypercholesterolemia (KRG: Korea ‐ 3, China ‐ 0, Singapore ‐ 2; placebo: Korea ‐ 0, China ‐ 1, Singapore ‐ 3) ‐ psychogenic ED (KRG: Korea ‐ 4, China ‐ 0, Singapore ‐ 1; placebo: Korea ‐ 2, China ‐ 0, Singapore ‐ 2), idiopathic (KRG: Korea ‐ 3, China ‐ 8, Singapore ‐ 0; placebo: Korea ‐ 3, China ‐ 7, Singapore ‐ 0) ‐ ED severity (mean):
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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 (same shape and appearance as KRG) Run‐in period: no Follow‐up period: 12 weeks |
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Outcomes | 1) Erectile function: How measured: questionnaire (not validated, items [libido, erection, ejaculation, sexual activity, satisfaction]) Time points measured: at baseline and 12 weeks Time points reported: at baseline and 12 week 2) AEs: How measured: NR Time points measured: NR Time points reported: likely cumulative |
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Funding sources | KT&G Corp. | |
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: "randomly divided to KRG and placebo" 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) | High risk | Quote: "... single blinded... The placebo group received the same shape and appearance with KRG group." Comment: the appearances of the treatments were the same in both groups but noted as single blind. |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Quote: "... single blinded...", " The placebo group received the same shape and appearance with KRG group." Comment: the appearances of the treatments were the same in both groups but noted as single blind. |
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: "6 patients were not assessed in the follow‐up assessment" Comment: 37/40 and 27/30 randomized participants in the KRG and placebo groups, respectively, were included in the analysis. |
Incomplete outcome data (attrition bias) Adverse events | Low risk | Quote: "6 patients were not assessed in the follow‐up assessment" Comment: 37/40 and 27/30 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: "6 patients were not assessed in the follow‐up assessment" Comment: 37/40 and 27/30 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: insufficient information available to permit a judgement and there was no published protocol. |
Other bias | Unclear risk | Comment: likely baseline imbalance in severity of sexual functions between the groups. |