Kapoor 1998.
Methods | Method of
randomization: “Randomized” (method not
specified) Number randomized: 66 Exclusions after randomization: None Losses to follow up: 2 at last follow up (6 months) Method of allocation concealment: “Randomization was coordinated by the Hospitalpharmacy and the coding was not accessible to clinicians or patients taking part in thestudy until the data came to analysis” (Personal communication) Participant masking: YesProvider masking: YesOutcome assessor masking: Yes Intention to treat analysis: No |
|
Participants | Country and period
of study: United Kingdom (March 1991 to June
1994) Age: 18 to 50 Sex: Short lesions: Overall, 74% were female |
|
Interventions | Treatment:
Intravenous methylprednisolone (1 g/day given as a single
bolus) for 3 days Control: Intravenous saline for 3 days |
|
Outcomes | Visual
acuity Contrast sensitivity (measured using circular patches of luminance modulated vertical sinewave gratings) Visual field (Humphrey automatic perimetry using 30-2 protocol) |
|
Notes | Follow up at 4, 8 weeks and 6 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of sequence generation was not reported |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment was not reported |
Masking (performance bias and detection bias) | Unclear risk | “Patients in either subgroup were randomized double blind to receive IV saline or IVMP”; but specific details of masking was not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | “Sixty-four of 66
patients completed 6 months' clinical follow-up (33
treated, 31 placebo)” “The MRI was repeated after 6 months in 61 of 66 patients” “VEPs were repeated after 6 months in 43 of 66 cases” |
Selective reporting (reporting bias) | Low risk | Outcomes reported were described in the methods section, though we did not have access to the original study protocol |
Other bias | Unclear risk | “Because treatment did not appear to influence outcome, some of the results obtained in the treated and placebo groups were analyzed together” |