Methods |
Double‐blind randomised parallel‐group controlled trial |
Participants |
16 participants with GBS fulfilling diagnostic criteria of Asbury 1990
|
Interventions |
Prednisolone 60 mg daily in divided doses for 1 week, 40 mg daily for 1 week, 30 mg daily for 2 weeks, and thereafter at the discretion of the physician or identical appearing placebo tablets |
Outcomes |
Changes in the disability grade of Hughes 1978 after 1, 4, and 6 weeks. After 4 weeks, 5 of 8 corticosteroid and 3 of 6 placebo participants had improved ≥ 1 grades. 2 placebo participants dropped out |
Funding |
Not stated |
Conflicts of interest among primary investigators |
Not stated |
Notes |
Single centre
Conducted in India |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"Patients were randomised: packets of drugs had been prepared and numbered randomly well in advance" |
Allocation concealment (selection bias) |
Unclear risk |
See above |
Blinding of participants and personnel (performance bias)
All outcomes except death |
Low risk |
"Placebo tablets of the same size, shape and colour were given in the equivalent number and duration" |
Blinding of participants and personnel (performance bias)
Death |
Low risk |
Reporting of death unlikely to be affected by blinding |
Blinding of outcome assessment (detection bias)
All outcomes except death |
Low risk |
"Assessments were made...by a doctor who had no knowledge of the treatment schedule" |
Blinding of outcome assessment (detection bias)
Death |
Low risk |
Reporting of death unlikely to be affected by blinding |
Incomplete outcome data (attrition bias)
All outcomes except death |
High risk |
3 of 8 corticosteroid and 1 of 8 control participants were omitted at 4‐week follow‐up, including 1 from each group who died |
Incomplete outcome data (attrition bias)
Death |
Low risk |
Deaths were reported |
Selective reporting (reporting bias) |
Low risk |
None identified |
Other bias |
Unclear risk |
Insufficient information to judge |