Methods |
Open parallel‐group controlled trial with alternate allocation |
Participants |
20 people with GBS defined according to criteria similar to those of Asbury 1990
|
Interventions |
Prednisolone 15 mg 4 times daily for 4 days, 10 mg 4 times daily for 3 days, 10 mg 3 times daily for 10 days, and then tapered or no treatment |
Outcomes |
Multiple outcomes including changes in the disability grade of Hughes 1978 after 1, 2, 3, and 4 weeks and 3 months; disease duration; residual disability; death; relapse |
Funding |
Not stated |
Conflicts of interest among primary investigators |
Not stated |
Notes |
Single centre
Conducted in India
Mean (SD) age 54.5 (15.1) years in steroid group and 39.6 (14.4) years in control group. Unusually large improvements after 4 weeks in both groups, mean 2.4 grades in steroid group and 4.0 grades in control group |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
High risk |
"Patients were randomised alternatively into two groups" |
Allocation concealment (selection bias) |
High risk |
"Patients were randomised alternatively into two groups" |
Blinding of participants and personnel (performance bias)
All outcomes except death |
High risk |
Control group received no treatment |
Blinding of participants and personnel (performance bias)
Death |
Low risk |
Blinding was unlikely to affect reporting of death |
Blinding of outcome assessment (detection bias)
All outcomes except death |
High risk |
Control group received no treatment |
Blinding of outcome assessment (detection bias)
Death |
Low risk |
Blinding was unlikely to affect reporting of death |
Incomplete outcome data (attrition bias)
All outcomes except death |
Low risk |
Follow‐up for 12 weeks was complete |
Incomplete outcome data (attrition bias)
Death |
Low risk |
Follow‐up for 12 weeks was complete |
Selective reporting (reporting bias) |
Low risk |
Only disability grade was specified in methods and was reported in full. Disease duration, residual disability, death, and relapse were also reported |
Other bias |
Unclear risk |
Insufficient information to judge |