Rowbotham 2004.
Study characteristics | ||
Methods | Design: parallel Duration: 6 weeks Assessment: baseline and post‐intervention Country: USA |
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Participants | Pain condition: diabetic peripheral neuropathy Population: type 1 or 2 diabetic adults with diabetic peripheral neuropathy Minimum pain intensity: ≥ 40 on 0‐10 scale Inclusion criteria
Exclusion criteria
Total participants randomised: 245 Age in years (mean): 59 Gender: 99/245 were female Pain duration in weeks (mean): 252.6 |
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Interventions | Placebo
Venlafaxine 75 mg
Venlafaxine 150/225 mg
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Outcomes | Substantial pain relief AEs SAEs Withdrawal |
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Missing data methods | ITT with LOCF | |
Funding source | Pharmaceutical: support for this study was provided by Wyeth Research, Collegeville, Pennsylvania. | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation methods not specified |
Allocation concealment (selection bias) | Unclear risk | Allocation procedures not specified |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinded bottles and capsules, identical dosing schedules between groups |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes from blinded participants |
Incomplete outcome data (attrition bias) All outcomes | High risk | ITT with LOCF Attrition Total: 43/245 (17.6%) Placebo: 12/81 (14.8%) Venlafaxine 75 mg: 13/82 (15.9%) Venlafaxine 150‐225 mg: 18/82 (22.0%) |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias were identified. |