| Methods |
Double‐blind randomised cross‐over controlled trial |
| Participants |
10 adults with LEMS1 fulfilling diagnostic criteria of AAEM2 (2001). One withdrawal after the placebo phase |
| Interventions |
Intravenous immunoglobulin 1 g/kg body weight/day for 2 days or 0.3% albumin placebo infusions. 8 weeks later, participants who received IVIg infusions were given placebo infusions, and vice versa |
| Outcomes |
Myometric limb strength, respiratory and bulbar strength measures, and calcium channel antibody titres. Measurements made at 2‐weekly intervals for the 8 week period following treatment or placebo infusions |
| Notes |
Significant improvement in myometric limb strength after IVIg3 compared with placebo infusion |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
A random allocation table was used |
| Allocation concealment? |
Unclear risk |
No information is given in the text as to the method of concealment used, and therefore insufficient to permit judgement |
| Blinding?
All outcomes |
Low risk |
Though not outlined in the study text, discussions with the clinicians in this trial revealed an excellent standard of blinding both observers and participants |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
1 participant was withdrawn from the study due to side effects after the first infusion. A good explanation of this was given, and the omission is unlikely to have clinically relevant impact on observed effect size |
| Free of selective reporting? |
Low risk |
The study protocol is available and all of the study's pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way |
| Free of other bias? |
Low risk |
The study appears to be free of other sources of bias |
