Sellebjerg 1999.
| Methods | Method of
randomization: Random number table; randomized in blocks of
10 using random numbers table and stratified as visual
acuity < 0.1 and visual acuity of at least
0.1 Number randomized: 60, 30 to treatment; 30 to control Exclusions after randomization: No exclusions Losses to follow up: 5 in treatment group (1 patient after eight weeks and 4 after one year); 4 in control group at one year Method of allocation concealment: Numbered sealed envelopes, unopened by investigators until all patients completed the trial Participant masking: Yes Provider masking: Yes Outcome assessor masking: Yes Intention to treat analysis: No |
|
| Participants | Country and period
of study: Denmark (August 1993 to January 1997) Age: 18 to 55 (median 32 years) Sex: 60% were female in treatment group and 63% were female in control group |
|
| Interventions | Treatment:
Methylprednisolone tablets 500 mg once daily for 5 days,
followed by 400, 300, 200, 100, 64, 48, 32, 16, 8 and 8 mg
on each of the 10 following days Control: Identical looking tablets for 15 days (not explicitly stated) |
|
| Outcomes | Visual acuity
(Snellen) Visual field not measured systematically (personal communication) Contrast sensitivity (Arden gratings. Normal defined as 80 points or less) |
|
| Notes | Dr. Sellebjerg
provided 12 month data in personal communication We used 3 week data for 1 month outcome because data not collected at 1 month Follow up at weeks 1, 3, 8 and 12 months |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | “Individual randomization in blocks of 10 was performed by the producer using a random numbers table. Consecutive patients were allocated to consecutive randomization numbers in each stratum” |
| Allocation concealment (selection bias) | Low risk | “The treatment assignment of each patient was concealed in a numbered, sealed envelope at the department of neurology and was not opened by the investigators before all patients had completed the trial” |
| Masking (performance bias and detection bias) | Unclear risk | “Visual function was tested by a technician unaware of the clinical status of the patient” |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | “Five patients in the
methylprednisolone group and four placebo-treated patients
did not participate in the 1-year follow-up study. Follow-up
data on one patient from each treatment arm was censored
because interferon treatment was initiated within 1
year” “One patient in the methylprednisolone group discontinued treatment after 4 days due to nausea, migraine, and diarrhea. Another methylprednisolone-treated patient discontinued treatment after 10 days due to heartburn, abdominal discomfort, palpitations, dysphoria, and insomnia. One patient in the placebo group discontinued treatment after 2 days due to vertigo, vomiting, and headache, presumably caused by a demyelinating lesion in the brainstem” Study reported ITT analysis in the methods |
| Selective reporting (reporting bias) | Low risk | “The four primary
efficacy measures were the spatial vision and VAS scores at
the 1-week and 3-week
visits” “Secondary outcome measures were changes in spatial vision, color vision, and VAS scores; normalization of the visual acuity, color vision, and contrast sensitivity scores at the individual visits; and an increase of one point in the visual functional system of Kurtzke's Expanded Disability Status Scale (EDSS)” “The primary efficacy measures were chosen before unblinding. In patients with bilateral symptoms only, the results obtained in the eye with the worse baseline visual acuity were analyzed” |
| Other bias | Unclear risk | Funded by pharmaceutical industry |