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

Hameroff 1984.

Study characteristics
Methods Design: parallel
Duration: 6 weeks
Assessment: baseline and post‐intervention
Country: USA
Participants Pain condition: chronic cervical and/or lumbar spine pain
Population: adults with chronic cervical and/or lumbar spine pain and depression
Minimum pain intensity: no
Inclusion criteria
  • Patients with chronic cervical and/or lumbar spine pain and co‐existing clinical depression

  • Pain for at least 2 months


Exclusion criteria: NR
Total participants randomised: 60
Age in years (mean): 48.7
Gender: 28/60 were female
Pain duration in years (mean, SD): NR
Interventions Placebo
  • n = 30

  • Inert


Doxepin ≤ 300 mg
  • n = 30

  • TCA

  • Flexible dose dependent upon tolerability and effficacy

Outcomes Withdrawal
Missing data methods NR
Funding source NR
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information, just says "patients were randomly assigned to one of two treatment groups"
Allocation concealment (selection bias) Unclear risk Allocation procedures not specified
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Says double‐blind but no information regarding 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 Only report completer analysis. 50% more dropout in placebo arm than intervention
Attrition
Total: 9/60 (15.0%)
Placebo: 6/30 (20.0%)
Doxepin ≤ 300 mg: 3/30 (10.0%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified