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

Pickering 2018.

Study characteristics
Methods Design: parallel
Duration: 4 weeks
Assessment: baseline and post‐interventions
Country: France
Participants Pain condition: fibromyalgia
Population: adult women with fibromyalgia
Minimum pain intensity: no
Inclusion criteria
  • Fibromyalgia meeting ACR criteria


Exclusion criteria
  • Physical or mental health comorbidities


Total participants randomised: 54
Age in years (mean, SD): 46.7 (10.6)
Gender: 54/54 were female
Pain duration in months (mean): 71.9
Interventions Placebo
  • n = 25

  • Inert

  • Matched dosing


Milnacipran 100 mg
  • n = 29

  • SNRI

  • Fixed dose

Outcomes Pain intensity
Moderate pain relief
AEs
SAEs
Withdrawal
Missing data methods Completer analysis only
Funding source Non‐pharmaceutical: "We thank the Apicil foundation for their financial support"
Conflicts of interest The study authors report no conflicts of interest in this work.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The randomisation sequence was generated using random blocks.
Allocation concealment (selection bias) Low risk Treatment allocation followed a predefined randomisation plan and was conducted by a person independent from the protocol.
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 Completer analysis only
Attrition:
Total: 6/54 (11.1%)
Placebo: 1/29 (3.5%)
Milnacipran 100 mg: 5/25 (20.0%)
Selective reporting (reporting bias) Low risk Study protocol published: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4393595/
All outcomes matched those published
Other bias Low risk No other sources of bias were identified.