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

Natelson 2015.

Study characteristics
Methods Design: parallel
Duration: 8 weeks
Assessment: baseline and post‐intervention
Country: USA
Participants Pain condition: fibromyalgia
Population: adults aged 18‐68 with fibromyalgia
Minimum pain intensity: no
Inclusion criteria
  • Fibromyalgia meeting the ACR criteria

  • > 10 of 18 tender points, points were considered tender if they were reported to be ≥ 2 on a pain intensity VAS from 0‐10 reported by patients


Exclusion criteria
  • Severe physical and mental health comorbidities


Total participants randomised: 34
Age in years (mean, SD): 46.8
Gender: 33/34 were female
Pain duration in years (mean, SD): NR
Interventions Placebo
  • n = 17

  • Inert

  • Identical appearance and matched dosing schedule


Milnacipran 100 mg
  • n = 17

  • SNRI

  • Forced titration to fixed dose

Outcomes Pain intensity
AEs
SAEs
Withdrawal
Missing data methods Completer‐only analysis
Funding source Part funded by pharmaceutical: "This work was supported by a Forest Laboratories Investigator‐initiated grant to B.H.N., and, in part, by National Institutes of Mental Health (NIMH) grant R01 MH100005 to D.C.S."
Conflicts of interest "J.D.C. has been a speaker for Pfizer, Forest, Bristol Myers Squibb, Glaxo Smith Kline, Eli Lilly, and Sunovion. He has received grants from Pfizer Pharmaceuticals, GSK, Corcept, and Neurocrine. There were no other conflicts of interest in doing this research. This work was supported by a Forest Laboratories Investigator‐initiated grant to B.H.N., and, in part, by National Institutes of Mental Health (NIMH) grant R01 MH100005 to D.C.S. The sources of funding had no involvement in any of the aspects of running this study, analyzing the data, or preparing this manuscript."
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) Low risk Mount Sinai Beth Israel Pharmacy dispensed the drug or placebo according to the randomisation list in sequential order.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, with identical study drugs and matched dosage schedule
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‐only analysis
Attrition
Total: 8/34 (23.5%)
Placebo: 4/17 (23.5%)
Milnacipran 100 mg: 4/17 (23.5%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified