Gao 2010.
Study characteristics | ||
Methods | Design: parallel Duration: 12 weeks Assessment: baseline and post‐intervention Country: China |
|
Participants | Pain condition: diabetic peripheral neuropathy Population: adults with diabetic peripheral neuropathy Minimum pain intensity: ≥ 4 on 0‐10 VAS Inclusion criteria
Exclusion criteria
Total participants randomised: 215 Age in years (mean): 59.3 Gender: 14/215 were female Pain duration in years (mean): 3.2 |
|
Interventions | Placebo
Duloxetine 60 to 120 mg
|
|
Outcomes | Pain intensity Sleep Mood Quality of life Moderate pain relief Substantial pain relief PGIC AEs SAEs Withdrawal |
|
Missing data methods | ITT with LOCF | |
Funding source | Pharmaceutical: Eli Lilly and Boehringer Ingelheim Pharmaceuticals | |
Conflicts of interest | Drs Vladimir Skljarevski, Durisala Desaiah, Zhang Shu‐yu, and Zhang Qi are employees and stockholders of Eli Lilly and Company. All other authors from China were the investigators and received funding from Eli Lilly and Company for conducting this study. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation methods not specified |
Allocation concealment (selection bias) | Unclear risk | Allocation procedures not specified |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind with identical placebo and matched dosing schedule |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes from blinded participants |
Incomplete outcome data (attrition bias) All outcomes | High risk | ITT with LOCF Attrition Total: 36/215 (16.7%) Placebo: 17/109 (15.6%) Duloxetine 60‐120 mg: 19/106 (17.9%) |
Selective reporting (reporting bias) | Low risk | All outcomes registered prospectively on clinicaltrials.gov |
Other bias | Low risk | No other sources of bias identified |