Spaeth 1966.
Methods | Study design: Randomized, double‐masked, placebo‐controlled clinical trial. Exclusions after randomization: None. Losses to follow‐up: None. Intention‐to‐treat: All participants were analyzed in the group to which they had been randomly assigned. Sample size calculations: Not reported. |
|
Participants | Country: USA. Dates: 1963‐64. Number randomized: 85: 39 to estrogen, 46 to placebo. Age: Mean age: estrogen 16.2 years (range 2 to 62 years), placebo 18.9 years (range 0.5 to 65 years). Sex: 80% of estrogen group, 85% of placebo group were male. Race: 72% of estrogen group, 70% of placebo group were black; remaining participants were white. Sickle cell disease: Not reported. Participants appeared to be balanced with respect to baseline characteristics. Inclusion criteria: Traumatic hyphema. Exclusion criteria:
|
|
Interventions | Treatment: Conjugated estrogen, 5 mg intramuscularly for children < 5 years; 10 mg intramuscularly for children 5 years or older but < 10 years; and 20 mg intravenously for children 10 years or older and adults, for 5 days. Control: Placebo, for 5 days. Treatment for both groups included:
|
|
Outcomes | Primary outcome: Risk of secondary hemorrhage, assessed daily by "complete ocular examination" for 5 days. Documentation and definition not reported. Secondary outcomes:
|
|
Notes | Placebo and conjugated estrogen supplied by Ayerst Laboratories. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomized, but method of allocation not reported. |
Allocation concealment (selection bias) | Low risk | Allocation was concealed from investigators by use of coded bottles. |
Blinding (performance bias and detection bias) Participants | Low risk | Authors used coded bottles to mask participants. "Neither the person administering nor the patient receiving the medications knew whether estrogen or placebo was being given." |
Blinding (performance bias and detection bias) Personnel and outcome assessors | Low risk | Authors used coded bottles to mask healthcare providers and outcomes assessors. "Neither the person administering nor the patient receiving the medications knew whether estrogen or placebo was being given." |
Incomplete outcome data (attrition bias) Primary outcome | Low risk | There were no exclusions and no loss to follow‐up. All participants were analyzed in the group to which they had been randomly assigned. |
Incomplete outcome data (attrition bias) Secondary outcomes | Low risk | There were no exclusions and no loss to follow‐up. All participants were analyzed in the group to which they had been randomly assigned. |
Selective reporting (reporting bias) | Low risk | Reported results for primary and secondary outcomes |
Other bias | Low risk | No other sources of potential bias were identified. |