Summary of findings 3. Etilefrine versus placebo.
| Etilefrine 50 mg compared with placebo for stuttering priapism | ||||||
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Patient or population: men and boys with SCD and stuttering priapism Settings: outpatient Intervention: etilefrine 50mg once daily Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of Participants (studies) | Certainty/quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Etilefrine 50 mg | |||||
| Detumescence Follow‐up: N/A |
See comment | See comment | N/A | N/A | N/A | This outcome was not measured. |
| Reduction in frequency of priapism Follow‐up: 6 months |
See comment | See comment | N/A | 23 (1) |
⊕⊝⊝⊝ very lowa,b | No significant difference was found between etilefrine and placebo but there were concerns over the reliability of the published results. |
| Immediate side effects of treatment (palpitations) Follow‐up: 6 months |
333 per 1000 |
546 per 1000 (206 to 1000) |
RR 1.64 (95% CI 0.62 to 4.30) |
23 (1) |
⊕⊝⊝⊝ very lowa,b | No significant difference was seen between etilefrine and placebo for any of the other immediate side effects measured (lack of sleep, hand shaking, anxiety, dry mouth). |
| Immediate side effects of treatment (tachycardia) Follow‐up: 6 months |
250 per 1000 |
545 per 1000 (178 to 1000) |
RR 2.18 (95% CI 0.71 to 6.68) | 23 (1) |
⊕⊝⊝⊝ very lowa,b | No significant difference was seen between etilefrine and placebo for any of the other immediate side effects measured (lack of sleep, hand shaking, anxiety, dry mouth). |
| Effect on later sexual function Follow‐up: N/A |
See comment | See comment | N/A | N/A | N/A | This outcome was not measured. |
| Other untoward side effects of treatment Follow‐up: N/A |
See comment | See comment | N/A | N/A | N/A | This outcome was not measured. |
| Efficacy of a prevention strategy Follow‐up: N/A |
See comment | See comment | N/A | N/A | N/A | This outcome was not measured. |
| *The basis for the assumed risk (e.g. the median control group risk across trials) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; N/A: not applicable; RR: risk ratio. | ||||||
| GRADE Working Group grades of evidence High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate. | ||||||
a Downgraded twice due to high risk of bias from incomplete outcome data and unclear risk of bias from randomisation and allocation concealment. b Downgraded once due to imprecision: CIs around the relative effect are very wide as the trial has a low number of participants.