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

Yeephu 2013.

Study characteristics
Methods Design: parallel
Duration: 13 weeks
Assessment: baseline and post‐intervention
Country: Thailand
Participants Pain condition: fibromyalgia
Population: Thai adults with fibromyalgia
Minimum pain intensity: ≥ 40 on 0‐100 scale
Inclusion criteria
  • Adult outpatients, aged ≥ 18 years, descended from Thai parents, met fibromyalgia criteria as defined by the ACR criteria

  • Pain intensity of ≥ 40 on 0‐100 scale


Exclusion criteria
  • Physical health comorbidities

  • Severe or unstable physical or psychiatric conditions were excluded


Total participants randomised: 40
Age in years (mean, SD): 44.66 (10.77)
Gender: 40/40 were female
Pain duration in years (mean, SD): 3.44 (2.71)
Interventions Placebo
  • n = 13

  • Inert

  • Identical appearance to mirtazapine


Mirtazapine 15 mg
  • n = 13

  • NaSSA

  • Fixed dose, forced titration


Mirtazapine 30 mg
  • n = 14

  • NaSSA

  • Fixed dose, forced titration

Outcomes Moderate pain relief
PGIC
AEs
SAEs
Withdrawal
Missing data methods ITT with LOCF, BOCF
Funding source Non‐pharmaceutical: This study was supported by a scholarship from the Commission on Higher Education Staff Development Project for the Joint PhD Program in Biopharmaceutical Sciences, Thailand.
Conflicts of interest Study authors reported no conflicts of interest.
Notes Same study as Suttiruksa 2016 ‐ however different outcomes were reported in the two papers.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The patients were allocated using a block size of 3 in a ratio of 1:1:1 with parallel assignment to 1 of 3 groups using a pharmacy‐controlled randomisation process.
Allocation concealment (selection bias) Low risk Participants were allocated with sequentially numbered identical containers.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, identical study drugs
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias)
All outcomes Unclear risk State that they use LOCF and BOCF measures, but don't present the numbers of participants in each of these analyses. Low attrition rates across all arms.
Attrition
Total: 8/40 (20.0%)
Placebo: 3/13 (23.1%)
Mirtazapine 15 mg: 2/13 (15.4%)
Mirtazapine 30 mg: 3/14 (21.4%)
Selective reporting (reporting bias) Low risk All outcomes in protocol reported either in this article or Suttiruksa 2016
Other bias Low risk No other sources of bias were identified