for the main comparison.

Lacosamide 400 mg compared with placebo for painful diabetic neuropathy
Patient or population: painful diabetic neuropathy Settings: community Intervention: oral lacosamide 400 mg daily Comparison: oral placebo
Outcome	Probable outcome with intervention	Probable outcome with comparator	NNTB or NNTH and/or relative effect	No of participants and events	Quality of the evidence (GRADE)	Comments
"Substantial" benefit At least 50% reduction in pain or equivalent	350 in 1000	250 in 1000	10 (5.2 to 120) 1.4 (1.01 to 1.9)	412 participants 142 events	Low quality	LOCF imputation makes this likely to be an overestimate
"Moderate" benefit At least 30% reduction in pain	540 in 1000	440 in 1000	9.8 (5.7 to 36) 1.3 (1.1 to 1.5)	715 participants 359 events	Low quality	LOCF imputation makes this likely to be an overestimate
Proportion below 30/100 mm on VAS	No data
Patient global impression much or very much improved	330 in 1000	240 in 1000	12 (6.6 to 52) 1.5 (1.2 to 1.9)	715 participants 209 events	Moderate quality	Low number of events, but not LOCF imputation
Quality of life measure	No data
Adverse event withdrawals	180 in 1000	91 in 1000	11 (7.5 to 22) 2.01 (1.4 to 2.9)	874 participants 125 events	Moderate quality	Low number of events
Serious adverse events	66 in 1000	63 in 1000	Not calculated 1.0 (0.7 to 1.6)	1304 participants 85 events	Moderate quality	Low number of events
Death	There were no deaths with lacosamide 400 mg or placebo
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.

NNTB: number needed to treat to benefit; NNTH: number needed to treat for an additional harmful outcome; VAS: visual analogue scale; LOCF: last observation carried forward.