Skip to main content
. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

Aragona 2005.

Study characteristics
Methods Design: parallel
Duration: 8 weeks
Assessment: baseline and post‐intervention
Country: Italy
Participants Pain condition: somatoform DSM‐IV‐TR pain disorder
Population: people with somatoform DSM‐IV‐TR pain disorder 
Minimum pain intensity: no
Inclusion criteria
  • People with DSM‐IV‐TR pain disorder as assessed by clinicians. Pain had to have no direct, organic explanation, and participants had to have presence of psychological factors that could have influenced consent/clinical course of pain.


Exclusion criteria
  • Pregnancy

  • Medical conditions of clinical importance

  • Diagnosis of another mental health condition


Total participants randomised: 35
Age in years (mean, SD): NR
Gender: 21/35 were female
Pain duration: NR
Interventions Citalopram
  • Fixed dose of 40 mg/day (2 x 20 mg doses)

  • Titrated over 4 days

  • SSRI


Reboxetine
  • Fixed dose of 8 mg/day (2 x 4 mg doses)

  • Titrated over 4 days

  • NaRI

Outcomes Pain intensity
Depression
AEs
SAEs
Withdrawal
Missing data methods LOCF
Funding source NR
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomly assigned using random tables
Allocation concealment (selection bias) Unclear risk No information given
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No information given regarding appearance of medications
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No information given regarding appearance of medications
Incomplete outcome data (attrition bias)
All outcomes High risk Used LOCF as imputation method, high attrition
Attrition:
Total: 6/35 (17.1%)
Citalopram 40 mg: 6/17 (35.3%)
Reboxetine 8 mg: 9/18 (50.0%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified