| Methods |
Double‐blind randomised parallel group controlled trial |
| Participants |
26 adults with LEMS fulfilling diagnostic criteria of AAEM (2001) |
| Interventions |
Oral 3,4‐DAP 20 mg three times daily for 6 days. Control participants received identical appearing lactose placebo tablets for 6 days |
| Outcomes |
Primary: change from baseline QMG score.
Secondary: changes in the amplitudes of compound muscle action potentials in abductor digiti minimi, abductor pollicis brevis, and extensor digitorum brevis |
| Notes |
Significant improvement in QMG score and resting CMAP amplitude following 3,4‐DAP treatment compared with placebo |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
A random allocation table was used |
| Allocation concealment? |
Unclear risk |
The random allocation table was maintained by the pharmacy involved in the study, but little further information is given to directly determine the degree of allocation concealment |
| Blinding?
All outcomes |
Low risk |
Attempts to ensure participant blinding were good (ensuring that the placebo was aesthetically similar to the active drug). The only exception was that 4 of 14 participants on 3,4‐DAP experienced limb tingling giving a possible means of identification, though this would not have affected objective neurophysiology |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
No missing outcome data |
| Free of selective reporting? |
Low risk |
All of the study's pre‐specified (primary and secondary) outcomes were reported in the pre‐specified way in keeping with their methods |
| Free of other bias? |
Low risk |
The study appears to be free of other sources of bias |
