Wernicke 2006.

Study characteristics
Methods	Design: parallel Duration: 12 weeks Assessment: baseline and post‐intervention Country: USA
Participants	Pain condition: diabetic peripheral neuropathic pain Population: type 1 and 2 diabetic adults with diabetic peripheral neuropathic pain Minimum pain intensity: ≥ 4 on 0‐10 scale Inclusion criteria diabetic peripheral neuropathic pain caused by type 1 or type 2 diabetes mellitus. The pain had to begin in the feet and with relatively symmetrical onset. Daily pain must have been present for at least 6 months, and the diagnosis was to be confirmed by a score of at least 3 on the MNSI Pain intensity of ≥ 4 on BPI pain severity item Exclusion criteria Physical health comorbidities Any DSM‐IV diagnosis of MDD, dysthymia, GAD, alcohol or eating disorders Total participants randomised: 334 Age in years (mean, SD): 60.7 (10.6) Gender: 130/334 were female Pain duration in years (mean, SD): 3.8 (4.4)
Interventions	Placebo n = 108 Inert Duloxetine 60 mg n = 114 SNRI Fixed dose, no titration Duloxetine 120 mg n = 112 SNRI Fixed dose, forced titration over 3 days
Outcomes	Pain intensity Mood Quality of life Physical function Moderate pain relief Substantial pain relief PGIC AEs SAEs Withdrawal
Missing data methods	ITT with LOCF
Funding source	Pharmaceutical: research for this study was funded by Eli Lilly and Company
Conflicts of interest	"Authors (J.F.W., D.N.D., A.W., S.I., J.R.) are employees and stockholders of Eli Lilly and Company. P.T. and Y.L.P. are former employees of Eli Lilly and Company. J.F.W., Y.L.P., P.T., and J.R. hold equity in Eli Lilly and Company in excess of USD 10,000."
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Assignment to a treatment group was determined by a computer‐generated random sequence.
Allocation concealment (selection bias)	Low risk	Participants were allocated using an interactive voice response system (IVRS).
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information on blinding procedures for study drugs, appearance, dosing etc
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Self‐reported outcomes from participants, uncertain of blinding procedures
Incomplete outcome data (attrition bias) All outcomes	High risk	ITT with LOCF Attrition Total: 86/334 (25.8%) Placebo: 23/108 (21.3%) Duloxetine 60 mg: 29/114 (25.4%) Duloxetine 120 mg: 34/112 (30.4%)
Selective reporting (reporting bias)	Unclear risk	No protocol or trial registration found
Other bias	Low risk	No other sources of bias were identified