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

Matthey 2013.

Study characteristics
Methods Design: parallel
Duration: 7 weeks
Assessment: baseline and post‐intervention
Country: Switzerland
Participants Pain condition: fibromyalgia
Population: adult women with fibromyalgia
Minimum pain intensity: ≥ 40 on 0‐100 VAS
Inclusion criteria
  • Women who met the ACR fibromyalgia criteria

  • Pain intensity of ≥ 40 on 0‐100 VAS at baseline


Exclusion criteria
  • Physical and mental health comorbidities


Total participants randomised: 80
Age in years (mean): 49.7
Gender: 80/80 were female
Pain duration in years (mean, SD): NR
Interventions Placebo
  • n = 39

  • Inert


Milnacipran 100‐200 mg
  • n = 40

  • SNRI

  • Flexible dosing to 100 mg, 150 mg, or 200 mg per day based on tolerability

Outcomes Pain intensity
Quality of life
Physical function
Mood
Sleep
Withdrawal
Missing data methods ITT wit h LOCF
Funding source Pharmaceutical: This trial was supported by a grant from Pierre Fabre Médicament.
Conflicts of interest "Each author certifies that he or she, or a member of his or her immediate family, has no commercial association, (i.e., consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might post a COI in connection with the submitted manuscript."
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A randomisation list was computer‐generated.
Allocation concealment (selection bias) Low risk Allocation of treatments was done by the investigator according to the chronological order of the occurring visit 2
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk State double‐blind but not enough information about study drug appearance and dosing
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, high attrition
Attrition
Total: 37/80 (46.3%)
Placebo: 16/40 (40.0%)
Milnacipran 100‐200 mg: 21/40 (52.5%)
Selective reporting (reporting bias) Unclear risk No changes to protocol, but it's registered 2 years after trial start
Other bias Low risk No other sources of bias were identified.