Kim 2009.
Study characteristics | ||
Methods | Study design: parallel randomized controlled clinical trial Randomization ratio: 1:1 (MG: 75, placebo: 68) Dates when study was conducted: NR Setting/country: outpatient/ single center/ S. Korea |
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Participants | Inclusion criteria: total IIEF score under 51, no allergy to ginseng and no acute illness Exclusion criteria: participants with severe neurological disorders such as spinal cord injury and multiple sclerosis, or with a history of radical prostatectomy, genital anomaly or drug abuse Baseline characteristics of participants: ‐ the number of participants randomized: 143 (MG: 75, placebo: 68) ‐ the number of participants analyzed: 86 (MG: 65, placebo: 21) ‐ age (mean): 58.1 (MG: 57.5; placebo: 60.2) ‐ comorbidity: yes (diabetes mellitus (19); hypertension (15); hyperlipidaemia (16); BPH (21)) ‐ ED severity:
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Interventions | Details of intervention and control ‐ Experiment: MG (2000 mg: 1000 mg 2 times daily) ‐ Control: placebo (NR in detail) Number of study centres: 1 Run‐in period: no Follow‐up period: 8 weeks |
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Outcomes | 1) Erectile function: How measured: questionnaire (IIEF‐5, and IIEF‐15) TIme points measured: at baseline and 8 weeks Time points reported: at baseline and 8 weeks 2) AEs: not assessed. |
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Funding sources | Kyung Hee University Research Fund in 2007 (KHU‐20071507) | |
Declarations of interest | NR | |
Notes | Publication language: English Two of seven authors were affiliated with the MG production institute. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The 143 patients selected were randomly divided into two group." Comment: no explicit explanation of the sequence generation. |
Allocation concealment (selection bias) | Unclear risk | Not reported Comment: no detailed information about allocation concealment. |
Blinding of participants and personnel (performance bias) | Low risk | Quote: "Thus, medications were distributed for 8 weeks using a double‐blind method." Comment: placebo controlled study. |
Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Comment: double‐blind 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 | High risk | Quote: "Three patients stopped taking the medication because of minor headaches; these patients were included among the 10 treated patients who dropped out. Of the 68 patients in the placebo group, only 21 completed the study. Most patients who dropped out of the study saw no improvement in their erectile function or sexual satisfaction. One reason for the high drop‐out rate in the placebo group might be that many patients in this group wanted to experience a faster response to the drug; however, we could not confirm that this was a major factor..." Comment: 65/75 and 21/68 randomized participants in the MG 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 | Low risk | Comment: not detected. |
AE: adverse events; GAQ: Global Assessment Questionnaire; ED: erectile dysfunction; IIEF: International Index of Erectile Function; KRG: Korean red ginseng; MG: tissue‐cultured mountain ginseng; NR: not reported; PE: premature ejaculation.