Graff‐Radford 2000.
Study characteristics | ||
Methods | Design: parallel Duration: 8 weeks Assessment: baseline to post‐intervention Country: USA |
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Participants | Pain condition: post‐herpetic neuralgia Population: adults with post‐herpetic neuralgia Minimum pain intensity: no Inclusion criteria
Exclusion criteria: NR Total participants randomised: 50 Age in years (mean, SD): 72.9 (10.1) Gender: 22/50 were female Pain duration in months (mean, SD): 33.4 (29.5) |
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Interventions | Amitriptyline ≤ 200 mg
Amitriptyline ≤ 200 mg + fluphenazine ≤ 3 mg
Fluphenazine ≤ 3 mg
Placebo (glycopyrrolate)
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Outcomes | Pain intensity Mood Withdrawal |
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Missing data methods | Completer analysis only | |
Funding source | Non‐pharmaceutical: "This study was supported by a grant from the National Institute of Health/National Institute of Dental Research (1RO3DE10086‐01)" | |
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 | Double‐blind, identical appearing study drugs, double‐dummy design |
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 | Completer analysis but only 1 person withdrew Attrition Total: 1/50 (2.0%) Amitriptyline 12.5‐200 mg: 1/12 (8.3%) Amitriptyline 12.5‐200 mg + fluphenazine 1‐3 mg: 0/12 (0.0%) Fluphenazine 1‐3 mg: 0/13 (0.0%) Placebo: 0/13 (0.0%) |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias were identified. |