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

Watson 1992.

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
  • Pos‐therpetic 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: 35
Age in years (median, range): 71 (55‐85)
Gender: 17/35were female
Pain duration in months (median, range): 14 months (4 months‐7 years)
Interventions Amitriptyline
  • TCA

  • Flexible titration schedule: start with 12.5 mg/day if > 65 years old or 25 mg/day if < 65

  • Median dose at week 5: 100 mg/day (range: 37.5‐150 mg)

  • Double‐dummy design due to different colour/shape of amitriptyline and maprotiline


Maprotiline
  • TCA

  • Flexible titration schedule: start with 12.5 mg/day if > 65 years old or 25 mg/day if < 65

  • Median dose at week 5 was 100 mg/day (range: 50‐150 mg)

  • Double‐dummy design due to different colour/shape of amitriptyline and maprotiline

Outcomes Withdrawal
Missing data methods Unclear
Funding source Non‐pharmaceutical: The study was funded by Physicians’ Services Incorporated (PSI) Grant PSI: 88‐17.
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation methods NR
Allocation concealment (selection bias) Unclear risk Allocation procedures NR
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, double‐dummy design
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 Completer analysis but very low dropout
Attrition
Total: 3/35 (8.6%)
Amitriptyline 37.5‐150 mg: 2/35 (5.7%)
Maprotiline 50‐150 mg: 1/35 (2.9%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found. Lots of measures mentioned in the methods have no data given in results, just a sentence description
Other bias Low risk No other sources of bias were identified