Razazian 2014.
Study characteristics | ||
Methods | Design: parallel Duration: 4 weeks Assessment: baseline, 2 days, 7 days, 14 days, 1 week post‐intervention Country: Iran |
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Participants | Pain condition: diabetic polyneuropathy Population: adults with diabetic polyneuropathy referred to diabetic clinic Minimum pain intensity: ≥ 40 on 0‐100 scale Inclusion criteria
Exclusion criteria
Total participants randomised: 257 Age in years (mean, SD): 56.3 (10.4) Gender: 156/257 were female Pain duration in months (mean, SD): 23.5 (2.5) |
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Interventions | Carbamazepine 400 mg
Pregabalin 150 mg
Venlafaxine 150 mg
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Outcomes | Moderate pain relief Substantial pain relief Sleep Mood AEs SAEs Withdrawal |
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Missing data methods | NR | |
Funding source | Non‐pharmaceutical: Kermanshah Univesity Of Medical Science | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised via a computer‐generated randomisation schedule |
Allocation concealment (selection bias) | Low risk | Investigators and participants were blinded to the treatments by preprinted medication code labels. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | States double‐blind but drugs not identical and dosage schedule differs between participants: venlafaxine taken as tablet twice daily, pregabalin as capsule once daily and carbamazepine twice daily as tablet |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Self‐reported outcomes from participants, but not strict blinding procedures |
Incomplete outcome data (attrition bias) All outcomes | High risk | No methods for dealing with missing data specified, think they present completer analysis. Attrition Total: 33/257 (12.8%) Carbamazepine 400 mg: 7/85 (8.2%) Pregabalin 150 mg: 9/86 (10.5%) Venlafaxine 150 mg: 17/86 (19.8%) |
Selective reporting (reporting bias) | High risk | Protocol not very clear, mention reporting 30th day as outcome time point but in article it's the 35th day. Did not mention work interference as outcome but have included it in paper, mention primary outcome will be measured with "PPI" and VAS but seems that PPI NR in article. Protocol registered on IRCT while recruiting participants, only 2 outcomes specified. |
Other bias | High risk | Significant difference in VAS pain between groups at baseline |