Majdinasab 2019.
Study characteristics | ||
Methods | Design: parallel Duration: 8 weeks Assessment: baseline and post‐intervention Country: Iran |
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Participants | Pain condition: painful diabetic peripheral polyneuropathy Population: adults with painful diabetic peripheral polyneuropathy Minimum pain intensity: ≥ 40 on 0‐100 VAS Inclusion criteria
Exclusion criteria
Total participants randomised: 104 Age in years (mean): 60.3 Gender: 50/104 were female Pain duration in years (mean): 3.75 |
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Interventions | Gabapentin 300‐900 mg
Duloxetine 30‐60 mg
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Outcomes | Pain intensity Sleep AEs Withdrawal |
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Missing data methods | NR | |
Funding source | Non‐pharmaceutical: "This study was funded by Ahvaz Jundishapur University of Medical Sciences (grant number IR.AJUMS.REC.1395.78)" | |
Conflicts of interest | Dr Nastaran Majdinasab, Dr Hossein Kaveyani, and Dr Mojgan Azizi have received research grants from Ahvaz Jundishapur University of Medical Sciences (grant number IR.AJUMS.REC.1395.78). The authors report no other conflicts of interest in this work. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised using the 4 block randomised method (equalised 4‐blocks). |
Allocation concealment (selection bias) | Low risk | "The medications of this study were first made similar to each other by a doctor who had no role in the collection and analysis of data and then sufficient amounts were packed into packets A and B and were given to the researcher." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Used identical drugs and placebos and packets but: "Before the commencement of the study, the side effects of the medications were explained to the patients " could then allow participants to know what they're experiencing and which medication it comes from. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Self‐reported outcomes from participants, but unsure of blinding |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Method of missing data not specified Attrition Total: 16/104 (15.4%) Gabapentin 300‐900 mg: 11/52 (21.2%) Duloxetine 30‐60 mg: 5/52 (9.6%) |
Selective reporting (reporting bias) | Unclear risk | Protocol registered retrospectively |
Other bias | Unclear risk | Errors in publication between tables |