Methods | Double‐blind, placebo‐controlled cross‐over trial, with two 14‐day treatment periods. Allocation concealment and method of randomisation was unclear. | |
Participants | 11 males with stuttering priapism and homozygous sickle cell (SS) disease were randomised. 9 completed the trial, 1 participant defaulted after baseline and 1 participant had a painful crisis which aborted the priapism before any tablets were taken. Participants came from the sickle cell clinic of the University Hospital of the West Indies, Kingston, Jamaica. | |
Interventions | Stilboestrol 5 mg daily versus placebo. | |
Outcomes | Reduction in frequency of stuttering priapism. Return of priapism. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Described as double blind. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described if outcome assessors were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 1 participant defaulted, and in two participants the attacks of stuttering priapism ceased spontaneously during the baseline observation period. There was a fourth participant who initially did not take the placebo because a painful crisis aborted the stuttering priapism prior to taking the assigned tablet. In this participant (identified as patient 9) attacks of priapism recurred 2 weeks later and data on a second baseline period were collected. The paper did not discuss an ITT analysis. |
Selective reporting (reporting bias) | Low risk | No protocol available therefore outcomes reported in the results section against the methods section of the paper; no discrepancies found. |
Other bias | Low risk | None identified. |
BP: blood pressure ITT: intention‐to‐treat SCD: sickle cell disease