Acers 1964.
Methods | Participants allocated by a "random listing" It was not clear whether 1 or both eyes were included |
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Participants | Participants (n = 20) residing in Baltimore, USA with active retinitis, positive toxoplasma skin test and antibody test (dye test), and no other cause of retinitis. Mean age 32.9 years (treatment), 30.9 years (controls) (age range 18 to 49 years) | |
Interventions | Pyrimethamine (200 mg/day 1, 100 mg/day 2, 50 mg/day on days 3 to 15, 25 mg/day on days 16 to 56); trisulfapyrimidine 2 g/day for 8 weeks; prednisolone (40 mg/day on days 1 to 7, 20 mg/day on days 8 to 56) versus lactose capsules and prednisolone as above | |
Outcomes |
Outcomes assessed masked to treatment allocation at 8 weeks but not thereafter. Follow‐up complete at 8 weeks but not stated for the 2 years of the study |
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Notes | Date study conducted: Not reported Funding source: Training Grant No. 2B‐5217, from the National Institute of Neurological Diseases and Blindness, US Public Health Service Declaration of interest: not reported Trial registration: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random listing |
Allocation concealment (selection bias) | Unclear risk | No relevant statement |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | A lactose capsule was used as a placebo: “placed in identical bottles.” Masking of ocular outcomes from clinical data on side effects |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Separate, independent assessors were used for clinical signs and for ophthalmic examination. The ophthalmic assessor “did not inquire about, or obtain, any subjective information or laboratory data.” |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Complete follow‐up for 8 weeks, but this would not be adequate for detecting recurrence. Completeness of follow‐up over the entire 2‐year study period unclear |
Selective reporting (reporting bias) | Low risk | Recurrence was a secondary outcome, although no details are given about the completeness of follow‐up for this outcome |