Yasuda 2011.

Study characteristics
Methods	Design: parallel Duration: 12 weeks Assessment: baseline and post‐intervention Country: Japan
Participants	Pain condition: diabetic neuropathic pain Population: adults aged 20‐80 with diabetic neuropathic pain Minimum pain intensity: ≥ 4 on 0‐10 scale Inclusion criteria Sustained pain for ≥ 6 months as a result of distal symmetric polyneuropathy caused by type 1 or type 2 diabetes mellitus Pain intensity of ≥ 4 on 0‐10 scale Exclusion criteria Physical health comorbidities that could interact with neuropathic pain Psychiatric diseases, such as mania, bipolar disorder, depression, anxiety disorders and eating disorders, or patients with history of these diseases that needed any pharmacotherapy during the past year Total participants randomised: 339 Age in years (mean, SD): 60.8 (10.0) Gender: 82/339 were female Pain duration in years (mean, SD): 4.3 (4.1)
Interventions	Placebo n = 167 Inert Matched dosing Duloxetine 40 mg n = 86 SNRI Fixed dose, forced titration over 2 weeks Duloxetine 60 mg n = 86 SNRI Fixed dose, forced titration over 2 weeks
Outcomes	Pain intensity Mood Sleep Moderate pain relief Substantial pain relief PGIC AEs SAEs Withdrawal
Missing data methods	MMRM, LOCF
Funding source	Pharmaceutical: This study is financially supported by Shionogi & Co.Ltd., Eli Lilly Japan K.K., and Eli Lilly and Company.
Conflicts of interest	The study authors have no COI to declare.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Before randomisation, an assigning table was prepared using Create Key Code 3.3. Patients were randomly assigned to duloxetine 40 or 60 mg or placebo groups in a 1:1:2 ratio by stochastic minimisation allocation taking into account the following 4 factors: (i) weekly mean of 24‐h average pain score at baseline < or ‡6; (ii) duration of diabetic neuropathy < or ‡2 years; (iii) type 1 or type 2 diabetes mellitus; and (iv) each study center."
Allocation concealment (selection bias)	Unclear risk	Allocation procedure not specified
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Says double‐blind but procedures not specified. No information on drug or packaging concealment
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Self‐reported outcomes from participants but unsure of blinding procedures
Incomplete outcome data (attrition bias) All outcomes	Low risk	LOCF, MMRM. Low attrition Attrition Total: 44/339 (13.0%) Placebo: 17/167 (10.2%) Duloxetine 40 mg: 13/86 (15.1%) Duloxetine 60 mg: 14/86 (16.3%)
Selective reporting (reporting bias)	Unclear risk	Did not include depression outcome in publication, other than that, everything lines up with protocol
Other bias	Low risk	No other sources of bias were identified.