de Andrade 2007.
| Study characteristics | ||
| Methods | Study design: parallel randomized controlled clinical trial Randomization ratio: 1:1 (KRG: 30, placebo: 30) Dates when study was conducted: July 2004 to September 2004 Setting/country: outpatient/ single center/ Brazil |
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| Participants | Inclusion criteria: participants with IIEF‐5 scores between 13 and 21 (mild or mild to moderate ED) Exclusion criteria: history of radical prostatectomy, spinal cord injury, neurological impairments, Peyronie's disease, drug abuse and specific previous treatment Baseline characteristics of participants ‐ the number of participants randomized: 60 (KRG: 30, placebo: 30) ‐ the number of participants analyzed: 60 (KRG: 30, placebo: 30) ‐ age (mean): KRG: 52.6; placebo: 54.3 ‐ comorbidity: yes (diabetes: KRG (4), placebo (6); hypertension: KRG (9), placebo (13); cardiovascular disease: KRG (2), placebo (3)) ‐ ED severity (mean):
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| Interventions | Details of intervention and control ‐ Experiment: KRG (3000 mg; 1000 mg 3 times daily) ‐ Control: placebo (capsule containing starch with KRG flavour) Run‐in period: no Follow‐up period: 12 weeks |
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| Outcomes | 1) Erectile function: How measured: questionnaire (IIEF‐5) TIme points measured: at baseline and 12 weeks Time points reported: at baseline and 12 weeks 2) AEs: How measured: NR TIme points measured: NR Time points reported: likely cumulative 3) Participant's ability to have intercourse reported by participant (or partner): How measured: number of participants with improvement in the total score of IIEF‐5 compared with baseline TIme points measured: at 12 weeks Time points reported: at 12 weeks |
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| Funding sources | NR | |
| 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... randomized..." 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: "A total of 60 patients ... were enrolled in a double‐blind, placebo‐controlled study...." 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 | Low risk | Quote: "Every patient returned for reevaluation through IIEF‐5 every month over a 3‐month period." Comment: 30/30 and 30/30 randomized participants in the KRG and placebo groups, respectively, were included in the analysis. |
| Incomplete outcome data (attrition bias) Adverse events | Low risk | Quote: "Every patient returned for reevaluation through IIEF‐5 every month over a 3‐month period." Comment: 30/30 and 30/30 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: "Every patient returned for reevaluation through IIEF‐5 every month over a 3‐month period." Comment: 30/30 and 30/30 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: the outcomes were described well but the protocol was not published. |
| Other bias | Low risk | Comment: not detected. |