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

Staud 2015.

Study characteristics
Methods Design: parallel
Duration: 6 weeks
Assessment: baseline and post‐intervention
Country: USA
Participants Pain condition: fibromyalgia
Population: adults with fibromyalgia
Minimum pain intensity: ≥ 4 on 0‐10 VAS
Inclusion criteria
  • Fulfill the 1990 ACR criteria for fibromyalgia including widespread pain


Exclusion criteria
  • Significant comorbidities: MDD, anxiety disorders and other chronic illnesses


Total participants randomised: 61
Age in years (mean, SD): NR
Gender: 56/61 were female
Pain duration in years (mean, SD): NR
Interventions Placebo
  • n = 30

  • Inert

  • Identical appearance and matched dosing


Milnacipran 100 mg
  • n = 31

  • SNRI

  • Fixed dose

Outcomes Pain intensity
Mood
Withdrawal
Missing data methods ITT with LOCF
Funding source Pharmaceutical: This study was supported by an investigator‐initiated grant from Forest Laboratories. All study drugs were provided by Forest Laboratories.
Conflicts of interest Funded by an investigator‐initiated grant from Forest Laboratories. All study drugs were provided by Forest Laboratories. The sponsors of this trial had no role in planning and implementing the study, and in the analysis of the data. They were not involved in the writing of this report. None of the authors have any financial or other relationships that might lead to a COI.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomised using Research Randomizer (http://www.randomizer.org/)
Allocation concealment (selection bias) Unclear risk Allocation procedure not specified
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 Similar attrition in both arms, report that they will use LOCF for missing data but then state that as "missing data did not result in different conclusions, we report only the results of uncorrected analyses", so completer analysis.
Attrition
Total: 26/62 (41.9%)
Placebo: 5/23 (21.7%)
Milnacipran 100 mg: 6/23 (26.1%)
15 participants (8 milnacipran, 7 placebo) withdrew post‐randomisation prior to receiving study medication, so were not included in the arm‐specific totals above. No reasons were given for the withdrawals of these 15 participants.
Selective reporting (reporting bias) High risk Protocol only lists mechanical and heat hyperalgesia and clinical pain as outcomes. Doesn't specify how these will be collected or the other measures used in the study.
Other bias High risk Create a second baseline essentially: a lot of participants withdrew after randomisation and so the authors ignore that in final analysis and only include those who came back for a second study visit.