Liu 2002.
Methods | Study design: Randomized 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. |
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Participants | Country: China. Dates: December 1997 to December 2000. Number randomized: 92: 60 to aminomethylbenzoic acid, 32 to control. Age: Mean age: aminomethylbenzoic acid 32.7 ± 11.25 years, control 33.4 ± 10.75 years. Sex: 75% male. Race: Not reported. Sickle cell disease: Not reported. Participants appeared to be balanced with respect to baseline characteristics. Inclusion criteria: Traumatic hyphema. Exclusion criteria:
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Interventions | Treatment: Oral aminomethylbenzoic acid 0.5 g plus oral vitamin B1 20 mg 3 times/day, for 6 days. For children, the dosage of aminomethylbenzoic acid was modified to "follow age‐recommended dose"; the vitamin B1 dosage remained the same. Control: Oral vitamin B1 20 mg 3 times/day, for 6 days. Treatment for both groups included 0.3% ofloxacin eyedrops 4 times/day, for 6 days. |
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Outcomes | Primary outcome: Risk of secondary hemorrhage, details not reported. Secondary outcomes: Risk of complications and adverse events. |
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Notes | Poor description of study methods in publication | |
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) | Unclear risk | Method of allocation concealment not reported. |
Blinding (performance bias and detection bias) Participants | Unclear risk | The authors do not state whether masking was used. |
Blinding (performance bias and detection bias) Personnel and outcome assessors | Unclear risk | The authors do not state whether masking was used. |
Incomplete outcome data (attrition bias) Primary outcome | Low risk | No exclusions or 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 | No exclusions or loss to follow‐up. All participants were analyzed in the group to which they had been randomly assigned. |
Selective reporting (reporting bias) | Unclear risk | Study outcomes of interest not clearly stated. |
Other bias | Low risk | No other sources of potential bias were identified. |