Joharchi 2019.
Study characteristics | ||
Methods | Design: parallel Duration: 12 weeks Assessment: baseline, 4 weeks, 8 weeks, post‐intervention Country: Iran |
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Participants | Pain condition: diabetic peripheral neuropathy Population: type 2 diabetic adults aged ≥ 40 and ≤ 65 with diabetic peripheral neuropathic pain Minimum pain intensity: ≥ 40 on 0‐100 VAS Inclusion criteria
Exclusion criteria
Total participants randomised: 180 Age in years (mean): 54.48 Gender: 109/180 were female Pain duration in years (mean): 3.8 |
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Interventions | Duloxetine 30‐60 mg
Pregabalin 150‐300 mg
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Outcomes | Pain intensity AEs Withdrawal |
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Missing data methods | Completer analysis | |
Funding source | Non‐pharmaceutical: part of a PhD project ‐ financially supported by “Research Department of theSchool of Medicine Shahid Beheshti University of Medical Sciences(SBUMS)” (Grant No 13/587). | |
Conflicts of interest | The authors declare that they have no COI. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation methods not specified: Just states "randomly divided into 2 groups" |
Allocation concealment (selection bias) | Unclear risk | Allocation procedures not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Used "similar" capsules but participants in pregabalin arm took 2 capsules a day compared to 1 a day for duloxetine |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Self‐reported outcomes from blinded participants, unsure of blinding procedures |
Incomplete outcome data (attrition bias) All outcomes | High risk | Higher attirition in duloxetine group than pregabalin, completer analysis only Attrition Total: 36/180 (20.0%) Duloxetine 30‐60 mg: 24/90 (26.7%) Pregabalin 150‐300 mg: 12/90 (13.3%) |
Selective reporting (reporting bias) | Low risk | Protocol registered prospectively to study with outcome measures |
Other bias | Low risk | No other sources of bias were identified. |