Summary of findings 4.
Ephedrine versus placebo
| Ephedrine 15 mg compared with placebo for stuttering priapism | ||||||
|
Patient or population: men and boys with SCD and stuttering priapism Settings: outpatients Intervention: ephedrine 15 mg/30 mg once daily Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Ephedrine | |||||
| 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 | 24 (1) |
⊕⊝⊝⊝ very low1,2 | No significant difference was found between ephedrine 15mg and placebo or ephedrine 30mg and placebo but there were concerns over the reliability of the published results. |
| Immediate side effects of treatment with 30 mg ephedrine (palpitations) Follow‐up: 6 months |
333 per 1000 |
333 per 1000 (107 to 1000) |
RR 1.00 (95% CI 0.32 to 3.10) |
24 (1) |
⊕⊝⊝⊝ very low1,2 | No significant difference was seen between ephedrine 15mg or 30mg and placebo for any of the other immediate side effects measured (lack of sleep, hand shaking, anxiety, dry mouth). |
| Immediate side effects of treatment with 30 mg ephedrine (tachycardia) Follow‐up: 6 months |
250 per 1000 |
168 per 1000 (33 to 825) |
RR 0.67 (95% CI 0.13 to 3.30) |
24 (1) |
⊕⊝⊝⊝ very low1,2 | No significant difference was seen between ephedrine 15mg or 30mg 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. | ||||||
1. Downgraded twice due to high risk of bias from incomplete outcome data and unclear risk of bias from randomisation and allocation concealment. 2. Downgraded once due to imprecision: confidence intervals around the relative effect are very wide as the trial has a low number of participants.