Summary of findings 2.
Sildenafil versus placebo
| Sildenafil 50 mg compared with placebo for stuttering priapism | ||||||
|
Patient or population: men and boys with SCD and stuttering priapism Settings: outpatients Intervention: sildenafil 50 mg 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 | Sildenafil 50 mg daily | |||||
| 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: 8 weeks |
286 per 1000 |
166 per 1000 (20 to 1000) |
RR 0.58 (95% CI 0.07 to 4.95) |
13 (1) |
⊕⊕⊝⊝ low1,2 | There was also no significant difference between treatments for the reduction in episodes of priapism by score tier: RR 1.17 (95% CI 0.36 to 3.76). |
| Immediate side effects of treatment Follow‐up: 16 weeks |
See comment | See comment | N/A | 13 (1) |
⊕⊕⊝⊝ low1,3 | Side effects of treatment were reported for the whole treatment phase including the open label phase. No significant differences were found between sildenafil and placebo. |
| 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 once due to unclear methods of randomisation and allocation. 2. Downgraded once due to imprecision. Confidence intervals around the relative effect are very wide as the trial has a low number of participants. 3. Downgraded once due to indirectness as we are only interested in the treatment phase but they have included the open label phase for reporting of adverse effects.