Ham 2009.
| Study characteristics | ||
| Methods | Study design: parallel randomized controlled clinical trial Randomization ratio: 1:1 (KRG: 37, placebo: 36) Dates when study was conducted: June 2007 to October 2007 Setting/country: outpatient/ two centers/ S. Korea |
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| Participants | Inclusion criteria: participants suffered from ED (more than 3 months), mild or moderate ED (IIEF score over 11) Exclusion criteria: severe ED (IIEF score 0‐10), cerebral infarction, myocardial infarction, unstable angina diagnosed in 6 months, use of PDE‐5 inhibitor or penile injection therapy Baseline characteristics of participants ‐ the number of participants randomized: 73 (KRG: 37, placebo: 36) ‐ the number of participants analyzed: 69 (KRG: 35, placebo: 34) ‐ age (mean): KRG: 53.2; placebo: 50.8 ‐ comorbidity: yes (diabetes mellitus: KRG (10), placebo (5); hypertension (KRG (8), placebo (9)) ‐ ED severity (mean):
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| Interventions | Details of intervention and control ‐ Experiment: KRG plus ginsenoside (800 mg; 2 capsules of 200 mg 2 times daily) ‐ Control: placebo (capsule, microcrystalline cellulose 200 mg) 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 | BT Gin Inc (4‐2004‐0018); Korea Healthcare Technology R&D Project, Ministry of Health, Welfare & Family Affairs, Republic of Korea (A084120) | |
| Declarations of interest | NR | |
| Notes | Publication language: English Supported by commercial company (BT Gin Inc) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | 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 has the same smell and flavour with KRG". "... multicenter, randomized, double‐blind, placebo controlled study" in the title. Comment: placebo controlled study. |
| 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 | Comment: 35/37 and 34/36 randomized participants in the KRG and placebo groups, respectively, were included in the analysis. |
| Incomplete outcome data (attrition bias) Adverse events | Low risk | Comment: 35/37 and 34/36 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) | 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 | Low risk | Comment: not detected. |