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. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

Uchio 2018.

Study characteristics
Methods Design: parallel
Duration: 14 weeks
Assessment: baseline and post‐intervention
Country: Japan
Participants Pain condition: knee OA
Population: adults aged 40‐80 with chronic knee pain due to OA
Minimum pain intensity: ≥ 4 on 0‐10 scale
Inclusion criteria
  • Outpatients aged 40 to < 80 years were eligible if they had experienced pain for ≥ 14 days/month during the 3‐month period before Visit 1

  • BPI‐Severity average pain score of ≥ 4

  • Patients needed to satisfy the ACR criteria for idiopathic knee OA


Exclusion criteria
  • Physical and mental health comorbidities


Total participants randomised: 354
Age in years (mean): 65.9
Gender: 274/354 were female
Pain duration in years (mean, SD): NR
Interventions Placebo
  • n = 176

  • Inert

  • Identical appearance to duloxetine


Duloxetine 60 mg
  • n = 177

  • SNRI

  • Fixed dose, forced titration

Outcomes Pain intensity
Sleep
Quality of life
Mood
Physical function
Moderate pain relief
Substantial pain relief
PGIC
AEs
SAEs
Withdrawal
Missing data methods ITT with LOCF and BOCF
Funding source Pharmaceutical: Eli Lilly and Company and Shionogi
Conflicts of interest TT is an employee of and owns stock in Shionogi Co. Ltd. HE, SF, NS, and HT are employees of Eli Lilly Japan K.K. SF and HE own stock in Eli Lilly and Company. YU has been a member of a Board of Directors and Speakers' Bureau and had a consulting role with Eli Lilly Japan K.K.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised participants an Interactive Web Response System and stochastic minimisation method
Allocation concealment (selection bias) Low risk Participants were allocated using an Interactive Web Response System
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, identical capsules for study drugs, matched doses
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes by blinded participants
Incomplete outcome data (attrition bias)
All outcomes Low risk Low attrition. Missing data were imputed using the LOCF, BOCF, or the modified BOCF. These findings were consistent for all missing data imputation methods.
Attrition
Total: 31/354 (8.8%)
Placebo: 14/176 (8.0%)
Duloxetine 60 mg: 17/178 (10.0%)
Selective reporting (reporting bias) Low risk Some results for outcomes (BDI, Patient Global Assessment of Illness) reported on clinicaltrials.gov but not in the paper
Other bias Low risk No other sources of bias were identified.