| Methods |
Randomised
Multicentre
Parallel group |
| Participants |
Adults who had contraindications to PE
N = 39 |
| Interventions |
IVIg (LFB) 0.4 g/kg/day for 3 days versus 6 days |
| Outcomes |
Time to regain ability to walk 5 metres with aid |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Randomisation was performed in a centralised manner using a permuted block algorithm with stratification by study centre" |
| Allocation concealment (selection bias) |
Low risk |
"Randomisation codes were given to the investigators by telephone" |
| Blinding (performance bias and detection bias)
All outcomes except death |
Low risk |
"The patients, investigators, and caregivers were blinded to treatment assignment until completion of the final analyses. IVIg was given at a dose of 0.4 g/kg body weight/day as a 12 hour infusion for 3 or 6 consecutive days. Double blinding was ensured by giving intravenous infusions of a placebo (3.8% albumin) from the 4th to the 6th day to the patients assigned to 3 days of IVIg therapy" |
| Blinding (performance bias and detection bias)
Death |
Low risk |
"The patients, investigators, and caregivers were blinded to treatment assignment until completion of the final analyses. IVIg was given at a dose of 0.4 g/kg body weight/day as a 12 hour infusion for 3 or 6 consecutive days. Double blinding was ensured by giving intravenous infusions of a placebo (3.8% albumin) from the 4th to the 6th day to the patients assigned to 3 days of IVIg therapy" |
| Incomplete outcome data (attrition bias)
All outcomes except death |
Low risk |
2 of 21 in the 3‐day group and 0 of 18 in the 6‐day group did not provide data |
| Incomplete outcome data (attrition bias)
Death |
Low risk |
2 of 21 in the 3‐day group and 0 of 18 in the 6‐day group did not provide data |
| Selective reporting (reporting bias) |
Low risk |
All specified outcomes reported |
| Other bias |
Low risk |
None detected |
| Diagnostic criteria |
Low risk |
Asbury 1990 criteria |
| Baseline differences |
Low risk |
Baseline characteristics were similar in the two groups except that the proportion of ventilated participants was slightly higher in the 3‐day group |
