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

Murakami 2015.

Study characteristics
Methods Design: parallel
Duration: 14 weeks
Assessment: baseline and post‐intervention
Country: Japan
Participants Pain condition: fibromyalgia
Population: adults aged 20‐75 with fibromyalgia
Minimum pain intensity: ≥ 4 on 0‐10 scale
Inclusion criteria
  • Outpatients aged between 20 and 75 years who met the ACR 1990 criteria for fibromyalgia

  • Pain intensity of ≥ 4 on 0‐10 scale


Exclusion criteria
  • Severe or unstable disease, psychiatric disorders other than major depressive disorder within the last year


Total participants randomised: 393
Age in years (mean, SD): 48.7 (11.9)
Gender: 321/393 were female
Pain duration in years (mean): 5.6
Interventions Placebo
  • n = 197

  • Inert

  • Identical appearance and matched dosing schedule


Duloxetine 60 mg
  • n = 196

  • SNRI

  • Forced titration to fixed dose

Outcomes Pain intensity
Mood
Sleep
Quality of life
Physical function
PGIC
AEs
SAEs
Withdrawal
Missing data methods ITT with LOCF, MMRM, and sensitivity analyses using BOCF and WOCF
Funding source Pharmaceutical: Shionogi & Co. Ltd., Eli Lilly Japan K.K., and Eli Lilly & Company provided funding for the study
Conflicts of interest HM and TO are employees of Shionogi & Co. Ltd. LA is an employee of Eli Lilly Japan K.K. MM, KO, and KN have provided consultancy services and MM and KO received compensation from Shionogi & Co. Ltd. for their participation in this study. MM, KO, and KN did not receive any compensation for their input into this study. The authors confirm that there are no non‐financial competing interests to declare in relation to this article.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients were assigned randomly to receive duloxetine or placebo in a 1:1 ratio, using a web‐based patient registration system (ACRONET Corp., Tokyo, Japan) with a stochastic minimisation procedure.
Allocation concealment (selection bias) Unclear risk Allocation procedure not specified
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, study drugs had identical appearance, packaging, and labelling, matched dosing schedule
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias)
All outcomes Low risk Although there was attrition, sensitivity analyses of the primary outcomes with LOCF, BOCF, and WOCF showed no signficiant differences.
Attrition
Total: 78/393 (19.9%)
Placebo: 48/198 (24.4%)
Duloxetine 60 mg: 30/196 (15.3%)
Selective reporting (reporting bias) Low risk All outcomes listed prospectively on clinicaltrials.gov
Other bias Low risk No other sources of bias were identified.