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

Kalso 1996.

Study characteristics
Methods Design: cross‐over
Duration: 4 weeks
Assessment: baseline, 2 weeks, post‐intervention
Country: Finland
Participants Pain condition: cancer‐related neuropathic pain
Population: women with chronic neuropathic pain following treatment for breast cancer
Minimum pain intensity: no
Inclusion criteria
  • Moderate‐severity neuropathic pain following treatment for breast cancer


Exclusion criteria: NR
Total participants randomised: 20
Age in years (median, range): 56 (39‐72)
Gender: 20/20 were female
Pain duration in years (mean, SD): NR
Interventions Placebo
  • Inert

  • Matched dosing to antidepressant


Amitriptyline 100 mg
  • TCA

  • Forced titration to maximum tolerated dose or 100 mg/day

Outcomes The article reported no useable data
Missing data methods Completer‐only analysis
Funding source Non‐pharmaceutical: The study was supported by the Academy of Finland (E.K., T.T.), the Paulo Foundation, Finland (E.K.) and the Centre for International Mobility (T.T.).
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 procedure not specified
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk States double‐blind and matched dosing but doesn't specify other blinding procedures
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Self‐reported outcomes from participants, but unsure of blinding procedures
Incomplete outcome data (attrition bias)
All outcomes High risk Completer‐only analysis. Withdrawal information doesn't specify in which period the participants withdrew
Attrition
Total: 5/20 (25.0%)
Attrition per arm NR
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified.