Pakfetrat 2019.
Study characteristics | ||
Methods | Design: parallel Duration: 11 weeks Assessment: baseline, 3 weeks, 7 weeks, post‐intervention Country: Iran |
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Participants | Pain condition: burning mouth syndrome Population: people with burning mouth syndrome Minimum pain intensity: ≥ 5 on 0‐10 VAS Inclusion criteria
Exclusion criteria
Total participants randomised: 47 Age in years (mean): 50.9 Gender: 32/47 were female Pain duration in years (mean, SD): NR |
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Interventions | Crocin (saffron) 30 mg
Citalopram 20 mg
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Outcomes | Pain intensity Mood Withdrawal |
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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 |