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

Iwaki 2020.

Study characteristics
Methods Design: parallel
Duration: 12 weeks
Assessment: baseline and post‐intervention
Country: Japan
Participants Pain condition: pain in Parkinson's disease
Population: adults with Parkinson's disease experiencing associated pain
Minimum pain intensity: no
Inclusion criteria
  • Aged ≥ 20 with diagnosed Parkinson's disease

  • Pain associated with Parkinson's disease


Exclusion criteria
  • Evidence of clinically significant disease

  • Suicidal risk


Total participants randomised: 47
Age in years (mean): 68.0
Gender: 25/47 were female
Pain duration in years (mean): 2.3
Interventions Placebo
  • n = 23

  • Inert

  • Matched dosing


Duloxetine 40 mg
  • n = 23

  • SNRI

  • Fixed dose

Outcomes Pain intensity
Mood
SAEs
Withdrawal
Missing data methods Not specified
Funding source Pharmaceutical: funding was provided by Ehime University under a contract with Shionogi & Co. Ltd (pharmaceutical company).
Conflicts of interest The authors have no COI to report
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation methods NR
Allocation concealment (selection bias) Unclear risk Allocation procedures not specified
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk States double‐blinded but no information on appearance of study drugs
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Self‐reported outcomes from participants, but uncertain of blinding procedures
Incomplete outcome data (attrition bias)
All outcomes High risk Much higher attrition in antidepressant arm than placebo. Unsure of imputation methods used
Attrition
Total: 9/46 (19.6%)
Placebo: 2/23 (8.7%)
Duloxetine 40 mg: 7/23 (30.4%)
Selective reporting (reporting bias) Low risk Outcomes match those in protocol
Other bias Low risk No other sources of bias were identified