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. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

Graff‐Radford 2000.

Study characteristics
Methods Design: parallel
Duration: 8 weeks
Assessment: baseline to post‐intervention
Country: USA
Participants Pain condition: post‐herpetic neuralgia
Population: adults with post‐herpetic neuralgia
Minimum pain intensity: no
Inclusion criteria
  • Post‐herpetic neuralgia for at least 6 months


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)
Interventions Amitriptyline ≤ 200 mg
  • n = 11

  • TCA

  • Flexible dose dependent upon tolerability

  • Double‐dummy design


Amitriptyline ≤ 200 mg + fluphenazine ≤ 3 mg
  • n = 12

  • Combined intervention: TCA + antipsychotic

  • Flexible doses dependent upon tolerability


Fluphenazine ≤ 3 mg
  • n = 13

  • Antipsychotic

  • Flexible dose dependent upon tolerability


Placebo (glycopyrrolate)
  • n = 13

  • Active placebo

  • Flexible dose dependent upon tolerability

  • Double‐dummy design

Outcomes Pain intensity
Mood
Withdrawal
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.