Methods |
Double blind, placebo‐controlled trial. |
Participants |
730 patients, with a diagnosis of ALS according to the El Escorial criteria. |
Interventions |
Subcutaneous injections of 30 or 15 microg/kg, three times a week for 9 months. |
Outcomes |
Primary: muscle strength. Secondary: pulmonary function (FVC), walking speed, Purdue Pegboard test, oral‐labial‐lingual dexterity, ALSFRS, S&E, GCIC. |
Notes |
Multicentre study. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomization is reported without specification of randomization method |
Allocation concealment (selection bias) |
Unclear risk |
No data are presented on this matter |
Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
The trial is presented as a double‐blind trial, no further data are given |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
The authors provide an account of all patients lost to follow‐up in each group (death or other reasons) |
Selective reporting (reporting bias) |
Unclear risk |
No protocol was available or referenced |
Other bias |
Low risk |
The study appears to be free of other sources of bias |