Iwaki 2020.
Study characteristics | ||
Methods | Design: parallel Duration: 12 weeks Assessment: baseline and post‐intervention Country: Japan |
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Participants | Pain condition: pain in Parkinson's disease Population: adults with Parkinson's disease experiencing associated pain Minimum pain intensity: no Inclusion criteria
Exclusion criteria
Total participants randomised: 47 Age in years (mean): 68.0 Gender: 25/47 were female Pain duration in years (mean): 2.3 |
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Interventions | Placebo
Duloxetine 40 mg
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Outcomes | Pain intensity Mood SAEs Withdrawal |
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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 |