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) | Certainty/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) |
⊕⊕⊝⊝ lowa,b | 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) |
⊕⊕⊝⊝ lowa,c | 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. |
a Downgraded once due to unclear methods of randomisation and allocation. b Downgraded once due to imprecision: CIs around the relative effect are very wide as the trial has a low number of participants. c 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.