Shakiba 2018.

Study characteristics
Methods	Design: parallel Duration: 8 weeks Assessment: baseline, 4 weeks, post‐intervention Country: Iran
Participants	Pain condition: fibromyalgia Population: adults aged 18‐60 with fibromyalgia Minimum pain intensity: ≥ 40 on 0‐100 scale Inclusion criteria Aged 18‐60 years who were diagnosed with fibromyalgia based on ACR criteria Exclusion criteria Psychiatric disorders other than depressive disorders, serious medical conditions, other pain/inflammatory conditions Total participants randomised: 54 Age in years (mean): 41.98 Gender: 34/54 were female Pain duration in years (mean, SD): NR
Interventions	Saffron 15 mg n = 27 Plant extract Identical appearance to duloxetine Duloxetine 30 mg n = 27 SNRI Fixed dose
Outcomes	Pain intensity Mood Quality of life Withdrawal
Missing data methods	ITT with LOCF
Funding source	Non‐pharmaceutical: "This study was supported by Tehran University of Medical Sciences (TUMS) through a grant to Prof. Shahin Akhondzadeh (Grant number 31842)."
Conflicts of interest	"The authors of this manuscript declare that they have no COI. TUMS had no role in the design, conduct, data collection, analysis, data interpretation, manuscript preparation, review, final approval, or decision to submit this paper for publication."
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation to either saffron or the duloxetine arm, was carried out in a 1:1 ratio through computerised random number generation by an independent person.
Allocation concealment (selection bias)	Low risk	Treatment allocation concealment was achieved using sequentially numbered sealed opaque envelopes.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Saffron capsules were identical to duloxetine in shape, size, texture, odour, and colour. Medications were distributed by an independent investigational drug pharmacist.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias) All outcomes	High risk	State that they use ITT with LOCF, but then the n in tables is completers Attrition Total: 8/54 (14.8%) Saffron 15 mg: 4/27 (14.8%) Duloxetine 30 mg: 4/27 (14.8%)
Selective reporting (reporting bias)	Low risk	Outcomes listed prospectively: https://en.irct.ir/trial/940
Other bias	Low risk	No other sources of bias were identified