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 |
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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 |
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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) |
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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 |
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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 |
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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 |