Methods |
Prospective randomised double‐blind cross‐over trial |
Participants |
8 participants with LEMS fulfilling diagnostic criteria of AAEM (2001). Three participants had small cell lung cancer. 1 participant was in complete stable remission and was used as control subject |
Interventions |
Oral 3,4‐DAP was given to 7 participants. Trial length and doses varied. Three participants received 15 mg on day one increasing to 80 mg by day 8. Four participants received 30 mg increasing to 75mg over 3 days |
Outcomes |
Several outcomes including subjective symptom score, LEMS classification, muscle strength score, QMG5 Score and CMAP6 amplitude were assessed over the study period |
Notes |
Significant improvement in subjective symptom score, LEMS classification, muscle strength score, QMG score, and CMAP amplitude versus placebo and baseline |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Low risk |
A random number table was used |
Allocation concealment? |
Low risk |
Pharmacy controlled central allocation of assignment into groups, resulting in effective blinding to both investigators and participants |
Blinding?
All outcomes |
Low risk |
Blinding of participants and key study personnel was ensured |
Incomplete outcome data addressed?
All outcomes |
Low risk |
1 participant withdrew from study, with appropriate reasons explained |
Free of selective reporting? |
Low risk |
The study protocol is available and all of the study's pre‐specified (primary and secondary) outcomes have been reported in the pre‐specified way |
Free of other bias? |
Low risk |
The study appears free from other sources of bias |