Methods |
Double‐blind parallel‐group randomised controlled trial |
Participants |
38 participants with idiopathic polyneuritis diagnosed according to criteria of Osler 1960. People requiring artificial ventilation or with contraindications to steroids were excluded |
Interventions |
Active treatment for adults 100 units and children 2 units/kg aqueous ACTH intramuscularly daily for 10 days or equal volumes of diluent as placebo |
Outcomes |
Duration of hospitalisation, time to complete recovery. Excluding 1 participant who died in the ACTH group, the median time to recovery was 9.0 days in the placebo and 4.4 days in the ACTH group (P = 0.05) |
Funding |
"Supported in part by Special Traineeship Award" from National Institutes of Health, USA |
Conflicts of interest among primary investigators |
Not stated |
Notes |
Single centre
Conducted in USA |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Random groups were established using a table of random numbers |
Allocation concealment (selection bias) |
Low risk |
Random groups were established using a table of random numbers |
Blinding of participants and personnel (performance bias)
All outcomes except death |
Low risk |
Placebo was an equal volume of the diluent for ACTH |
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 |
Placebo was an equal volume of the diluent for ACTH |
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 |
Data for the outcomes required by this review not provided. However, 1 participant in the ACTH group who died was not included in the analysis of time to recovery, which was the main analysis considered by the authors |
Incomplete outcome data (attrition bias)
Death |
Low risk |
Deaths were reported |
Selective reporting (reporting bias) |
High risk |
Selective reporting not applicable as data for the outcomes required by this review are not provided. However, 1 participant in the ACTH group who died was not included in the analysis of time to recovery, which was the main analysis considered by the authors |
Other bias |
Low risk |
None detected |