Wang 2017.
Study characteristics | ||
Methods | Design: parallel Duration: 13 weeks Assessment: baseline and post‐intervention Country: China |
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Participants | Pain condition: knee or hip OA Population: adults aged ≥ 40 with knee or hip OA Minimum pain intensity: ≥ 4 on 0‐10 scale Inclusion criteria
Exclusion criteria
Total participants randomised: 407 Age in years (mean): 60.5 Gender: 311/407 were female Pain duration in years (mean): 7.99 |
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Interventions | Placebo
Duloxetine 60 mg
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Outcomes | Pain intensity Physical function Mood Sleep Moderate pain relief Substantial pain relief PGIC AEs SAEs Withdrawal |
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Missing data methods | MRMM, ITT with LOCF | |
Funding source | Pharmaceutical: Eli Lilly and Company | |
Conflicts of interest | Drs Guochun Wang, LiQi Bi, Xiangpei Li, Zhijun Li, Dongbao Zhao, Jinwei Chen, and Dongyi He had no conflicts of interest to report. Drs Hector Due nas, Li Yue, Chia‐Ning Wang, and Vladimir Skljarevski, are employees and minor shareholders of Eli Lilly and Company. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Assignment to treatment groups was determined by a computer‐generated random sequence using an interactive web‐response system (IWRS)." |
Allocation concealment (selection bias) | Low risk | "The IWRS was used to assign investigational product packages to each patient throughout this study." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, identical study drugs, matched dosing |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes from blinded participants |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low levels of attrition. Used ITT with both MMRM and LOCF Attrition Total: 65/407 (16.0%) Placebo: 26/202 (12.9%) Duloxetine 60 mg: 39/205 (19.0%) |
Selective reporting (reporting bias) | Low risk | All outcomes match those registered prospectively on clinicaltrials.gov. |
Other bias | Low risk | No other sources of bias were identified. |