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. 2021 Feb 9;2021(2):CD008013. doi: 10.1002/14651858.CD008013.pub3

Roohafza 2014.

Study characteristics
Methods Study design: double‐blinded, placebo‐controlled, randomised trial
Setting: outpatient tertiary clinic of paediatric gastroenterology in Isfahan, Iran
Dates: February ‐ December 2013
Participants Inclusion criteria:
Patients with FAP based on Rome III criteria
Exclusion criteria:
Other concomitant gastrointestinal disorders and those with a history of receiving psychotropic drugs, antibiotics, or probiotics in the preceding 2 months
Sample size:
115 children (intervention: 59; control: 56)
Age (mean):
Intervention: 10.4 ± 1.9 years; control: 8.5 ± 2.2 years
Sex (M/F):
Intervention: 11/32
Control: 19/24
Number randomised:
Intervention: 59; Control: 56
Number analysed:
Intervention: 59; Control: 56
Post‐randomisation exclusion:
Intervention: 16
Control: 13
Interventions Intervention: Citalopram for 4 weeks (10 mg/day for the first week; 20 mg/day for the remaining 3 weeks)
Control: placebo (in same order as citalopram group)
Outcomes Duration of study: 12 weeks
1: Change in participant's pain score in 12 weeks measured with the Wong‐Baker Pain Rating Scale (6 faces that show pain effect from 0‐ no hurt to 5‐ hurts worse)
2: Change in Clinical Global Impression Scale Improvement (CGI‐I) in 4 and 12 weeks measured by physician‐rated global improvement that is scored 1 (very much improved) to 7 (very much worse.
3. Changes in the severity of depression assessed by Children Depression Inventory
4. Changes in the severity of anxiety assessed by Revised Children's Manifest Anxiety Scales
5. Changes in somatization by using the Children's Somatisation Inventory‐Revised Form
Notes Funding source: this study was funded by a grant from the Isfahan University of Medical Sciences
Conflict of interest: no competing interests declared
Power calculation: power calculation performed
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block randomisation by allocation software
Allocation concealment (selection bias) Low risk Allocation was concealed and completed by a pharmacist not involved in the rest of the trial
Blinding (performance bias and detection bias)
All outcomes Low risk Opaque bottles with placebo or citalopram
Incomplete outcome data (attrition bias)
Efficacy outcomes Low risk Flow is well described for all participants with reasons given (high general dropout rate of 25%, balanced)
Selective reporting (reporting bias) Unclear risk Reporting of all reported outcomes. Protocol is given; there are some methodological discrepancies that are not explained
Other bias Low risk No other biases reported