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

Hadianfard 2012.

Study characteristics
Methods Design: parallel
Duration: 8 weeks
Assessment: baseline, 2 weeks, 4 weeks, post‐intervention, follow‐up (10 months post‐intervention)
Country: Iran
Participants Pain condition: fibromyalgia
Population: women ≤ 65 with fibromyalgia
Minimum pain intensity: ≥ 4 on 0‐10 VAS
Inclusion criteria
  • Women aged 20‐65

  • Diagnosed with fibromyalgia as per ACR criteria

  • ≥ 4 on 0‐10 pain intensity scale


Exclusion criteria
  • Significant physical and mental health comorbidities


Total participants randomised: 30
Age in years (mean): 44
Gender: 30/30 were female
Pain duration in months (mean): 81.2
Interventions Acupuncture
  • n = 15

  • 2 weeks of 3 sessions (weekly) lasting for 30 min in each session


Fluoxetine 20 mg
  • n = 15

  • SSRI

  • Fixed dose

Outcomes Pain intensity
Quality of life
Mood
Physical function
Missing data methods ITT but methods not specified
Funding source Non‐pharmaceutical: Shiraz University of Medical Sciences research project No. 88‐5035
Conflicts of interest "We declare no conflict of interest. This article is from Shiraz University of Medical Sciences research project No. 88‐5035"
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was performed using a computer‐generated random sequence of the numbers
Allocation concealment (selection bias) Unclear risk Allocation procedures not specified
Blinding of participants and personnel (performance bias)
All outcomes High risk Not blinded. Lead author was the acupuncturist
Blinding of outcome assessment (detection bias)
All outcomes High risk Self‐reported outcomes from unblinded participants
Incomplete outcome data (attrition bias)
All outcomes Unclear risk States ITT but no imputation methods reported
Attrition
NR
Selective reporting (reporting bias) Unclear risk Protocol registered retrospectively
Other bias Low risk No other sources of bias were identified.