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

Branco 2010.

Study characteristics
Methods Design: parallel
Duration: 17 weeks
Assessment: baseline and post‐intervention
Country: Czech Republic, Denmark, Finland, France, Germany, Italy, Norway, Poland, Portugal, Romania, Spain, Sweden, UK
Participants Pain condition: fibromyalgia
Population: adults with fibromyalgia
Minimum pain intensity: baseline VAS pain intensity rating between 40 and 90 (0‐100 scale)
Inclusion criteria
  • Aged 18‐70

  • Diagnosed with fibromyalgia as per the ACR criteria

  • Raw score ≥ 3 on physical function component of the FIQ

  • Baseline VAS pain intensity rating between 40 and 90 (0‐100 scale)


Exclusion criteria
  • Severe mental health conditions

  • Comorbid physical health conditions


Total participants randomised: 884
Age in years (mean): 48.4
Gender: 826 were female
Pain duration in years (mean): 9.5
Interventions Placebo
  • n = 449

  • Matched dosing and identical appearance

  • Inert


Milnacipran 200 mg
  • n = 435

  • SNRI

  • Forced titration to fixed dose

Outcomes Pain intensity
Quality of life
Physical function
Mood
PGIC
AEs
SAEs
Withdrawal
Missing data methods ITT with LOCF, and BOCF sensitivity analyses
Funding source Pharmaceutical ‐ Pierre Fabre Medicament, France
Conflicts of interest Dr Branco has received grant support as an investigator and consultant for Pierre Fabre Medicament. Drs Zachrisson and Perrot have served as speakers and consultants for Pierre Fabre Medicament. Dr Mainguy is an employee and shareholder of Pierre Fabre Medicament. Medical writing assistance provided by Prescott Medical Communications Group was supported by Pierre Fabre Medicament.
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 Matched dosing but no information regarding appearance of drugs
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 ITT with LOCF and BOCF as sensitivity analysis. More dropouts in antidepressant arm related to side‐effects
Attrition
Total: 206/882 (23.3%)
Placebo: 79/449 (17.6%)
Milnacipran 200 mg: 127/435 (29.2%)
Selective reporting (reporting bias) Unclear risk Primary outcome matches trial registry, but secondary outcomes not listed
Other bias Low risk No other sources of bias were identified.