| Methods |
Double‐blind randomised cross‐over controlled trial |
| Participants |
12 adults with LEMS fulfilling diagnostic criteria of AAEM (2001) |
| Interventions |
Oral 3,4‐DAP up to 20 mg four times a day for 3 days or placebo tablets for 3 days. Participants received 3,4‐DAP first then received placebo for 3 days, and vice versa |
| Outcomes |
Improvement in a neurological disability score comprising muscle strength and reflexes; isometric myometry limb strength measures; compound muscle action potential amplitude change; autonomic function testing change. Measurements made at days 1, 3, 5, 9, 12 and 15 |
| Notes |
Significant improvement in neurological disability score and resting compound muscle action potential 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 number table was used |
| Allocation concealment? |
Unclear risk |
Not enough information included to permit judgement |
| Blinding?
All outcomes |
Low risk |
Blinding of participants and study personnel was adequate, however it was not clear whether placebo capsules were aesthetically similar to 3,4‐DAP4 capsules |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
2 participants failed to tolerate a full dose of 3,4‐DAP due to side effects. It is unlikely that these missing outcomes have a clinically relevant impact on observed effect size |
| Free of selective reporting? |
Low risk |
The study protocol is available and all of the pre‐specified outcomes were included |
| Free of other bias? |
Low risk |
The study appears to be free of other sources of bias |
