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

Pakfetrat 2019.

Study characteristics
Methods Design: parallel
Duration: 11 weeks
Assessment: baseline, 3 weeks, 7 weeks, post‐intervention
Country: Iran
Participants Pain condition: burning mouth syndrome
Population: people with burning mouth syndrome
Minimum pain intensity: ≥ 5 on 0‐10 VAS
Inclusion criteria
  • Daily deep bilateral burning sensation in the mouth for at least 4‐6 months, persistent or increased burning intensity throughout the day

  • Pain intensity ≥ 5 on 0‐10 VAS


Exclusion criteria
  • Severe physical and mental health comorbidities


Total participants randomised: 47
Age in years (mean): 50.9
Gender: 32/47 were female
Pain duration in years (mean, SD): NR
Interventions Crocin (saffron) 30 mg
  • n = 26

  • Plant extract

  • Fixed dose

  • Identical appearance to citalopram


Citalopram 20 mg
  • n = 21

  • SSRI

  • Fixed dose

Outcomes Pain intensity
Mood
Withdrawal
Missing data methods No participants withdrew
Funding source Non‐pharmaceutical: "We are thankful to the Vice Chancellor of Mashhad University of Medical Sciences for providing financial support for this study".
Conflicts of interest "The authors declare that they have no conflict of interest in this research."
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) Unclear risk Allocation methods not specified
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Mention similar package and pill appearance but citalopram is being taken once daily and saffron twice daily so it's not completely identical in dosing schedule.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Blinding of participants who completed self reported measures is unclear
Incomplete outcome data (attrition bias)
All outcomes Low risk No participants withdrew
Selective reporting (reporting bias) Unclear risk Could not access trial registration
Other bias Low risk No other sources of bias were identified