Smith 2013.

Study characteristics
Methods	Design: cross‐over Duration: cross‐over periods were 5 weeks Assessment: baseline and post‐cross‐over period Country: USA
Participants	Pain condition: neuropathic pain caused by chemotherapy Population: adults aged ≥ 25 with cancer and neuropathic pain after completing chemotherapy Minimum pain intensity: ≥ 4 on 0‐10 scale Inclusion criteria At least grade 1 sensory pain based on the National Cancer Institute Common Terminology Criteria for AEs version 3.0 grading scale, for at least 3 months after completing chemotherapy Average pain intensity ≥ 4 on 0‐10 scale Any cancer diagnosis Exclusion criteria Severe depression, suicidal ideation, bipolar disease, alcohol abuse, a major eating disorder Markedly abnormal renal or liver function tests Total participants randomised: 231 Age in years (mean, SD): 59 (10.5) Gender: 138/231 were female Pain duration in years (mean, SD): NR
Interventions	Placebo n = 116 Inert Sham dosing to match duloxetine arm Duloxetine 60 mg n = 115 SNRI Forced titration to fixed doses
Outcomes	Pain intensity Moderate pain relief Substantial pain relief Quality of life SAEs Withdrawal
Missing data methods	Completer analysis
Funding source	Non‐pharmaceutical: This study was supported by grant CA31946 from the NCI Division of Cancer Prevention, the Alliance Statistics and Data Center, and the Alliance Chairman
Conflicts of interest	"Disclosures: all authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Smith reported receiving support from CALGB/Alliance for travel to meetings. Dr Paskett reported institutional support from CALGB/Alliance for travel to meetings. Dr Ahles reported receiving support from CALBG/Alliance for travel to meetings. Dr Fadul reported pending institutional grants from Genentech. Dr Gilman reported institutional and direct grants pending from the NCI [National Cancer Institute]. No other financial disclosures were made."
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomisation, provided by the CALGB/Alliance Statistical Center, was stratified by neurotoxic drug class (taxanes vs platinums) and by pain risk (high risk vs no risk). A computer‐generated kit number was used to order the blinded study drug from a distribution center."
Allocation concealment (selection bias)	Low risk	"A computer‐generated kit number was used to order the blinded study drug from a distribution center. Drug labels were applied to the capsule bottles at the distribution center before being mailed to study sites; thus, all patients and personnel were blinded to the treatment assignment."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind, identical study drugs with matched dosing
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Self‐reported outcomes by blinded participants
Incomplete outcome data (attrition bias) All outcomes	High risk	Mention ITT and imputation, but only report completer analysis Attrition Total: 33/230 (14.3%) Placebo: 12/111 (10.8%) Duloxetine 60 mg: 21/109 (19.3%)
Selective reporting (reporting bias)	Low risk	Outcomes match those on prospective trial registration on clinicaltrials.gov
Other bias	Low risk	No other sources of bias were identified.