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

Watson 1998.

Study characteristics
Methods Design: cross‐over
Duration: each cross‐over period lasted 5 weeks
Assessment: baseline and post‐cross‐over period
Country: Canada
Participants Pain condition: post‐herpetic neuralgia
Population: adults with post‐herpetic neuralgia
Minimum pain intensity: pain of at least moderate severity (disagreeable, unpleasant, uncomfortable) for at least one half of the day; no numerical values
Inclusion criteria
  • Post‐herpetic neuralgia of > 3 months' duration

  • Pain of at least moderate severity (disagreeable, unpleasant, uncomfortable) for at least one half of the day


Exclusion criteria
  • Cardiac disease, seizure disorder, severe depression with voiced suicidal intent requiring urgent management, presence of another significant pain problem, previous brain damage due to head injury, stroke or other causes, alcoholism


Total participants randomised: 33
Age in years (mean, SD): NR
Gender: NR
Pain duration in months (median): 13 months
Interventions Nortriptyline
  • TCA

  • Flexible dose: 10‐160 mg

  • Flexible titration: started on 10 mg/day if > 65 years old or 20 mg/day if < 65 years old. Depending on efficacy and tolerability, the dose was increased by 10 mg/day every 3‐5 days for the first 3 weeks.

  • Identical blue capsules


Amitriptyline
  • TCA

  • Flexible dose: 10‐160 mg

  • Flexible titration: started on 10 mg/day if > 65 years old or 20 mg/day if < 65 years old. Depending on efficacy and tolerability, the dose was increased by 10 mg/day every 3‐5 days for the first 3 weeks.

  • Identical blue capsules

Outcomes AEs
Withdrawal
Missing data methods Unclear
Funding source NR
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Individuals were randomised by telephone at another site by computer.
Allocation concealment (selection bias) Low risk The sequence was concealed in sequential, numbered, sealed envelopes.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, identical study drugs
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes by blinded participants
Incomplete outcome data (attrition bias)
All outcomes Low risk Missing data methods unclear, but only 1 participant withdrew
Attrition
Total: 2/33 (6.1%)
Amitriptyline 10‐160 mg: 1/33 (3.0%)
Nortriptyline 10‐150 mg: 1/33 (3.0%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified