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

Otto 2008.

Study characteristics
Methods Design: cross‐over
Duration: 5 weeks
Assessment: baseline and post‐intervention
Country: Denmark
Participants Pain condition: polyneuropathy
Population: adults aged 20‐80 with chronic polyneuropathy
Minimum pain intensity: ≥ 4 on 0‐10 scale
Inclusion criteria
  • Symptoms of polyneuropathy within at least 6 months, diagnosis confirmed by physical examination

  • Pain intensity ≥ 4 on 0‐10 scale


Exclusion criteria
  • Other pain conditions and severe physical comorbidities


Total participants randomised: 48
Age in years (median, range): 62 (37–74)
Gender: 12/48 were female
Pain duration in months (median, range): 48 (8–180)
Interventions Placebo
  • Inert

  • Identical appearance and matched dosing


Escitalopram 20 mg
  • SSRI

  • Fixed dose

Outcomes Pain intensity
Sleep
Mood
AEs
Withdrawal
Missing data methods ITT with LOCF
Funding source Partly pharmaceutical: Odense University Hospital The work behind this study was supported by unrestricted grants from H. Lundbeck A/S and Gruenenthal GmbH and a grant from the Danish Clinical Intervention Research Academy.
Conflicts of interest This was an investigator‐initiated study and neither company was responsible for the creation of the study protocol, the data analysis, data interpretation, or writing of the manuscript.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Assignment to treatment sequence was random via a computer‐generated randomisation code with a block size of 4.
Allocation concealment (selection bias) Low risk The randomisation plan was generated by a person in the hospital pharmacy at Odense University Hospital who was not involved in the conduct of the trial. The study drugs were packed in boxes marked with randomisation number and treatment period by the hospital pharmacy. Patients were enrolled by the investigators and, after the baseline period, numbered consecutively by the investigators and treated with the study drugs with the corresponding randomisation number. Sealed opaque envelopes with the treatment sequence for each patient for emergency situations were present at the study sites.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, identical study drugs with matched dosing
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias)
All outcomes High risk ITT with LOCF
Attrition
Total: 10/41 (24.4%)
Placebo: 4/41 (9.8%)
Escitalopram 20 mg: 6/41 (14.6%)
Selective reporting (reporting bias) High risk Some outcomes mentioned prospectively on clinicaltrials.gov NR e.g. different subtypes of pain and quality of life
Other bias Low risk No other sources of bias were identified