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

Bahar 2008.

Study characteristics
Methods Study design: double‐blinded, placebo‐controlled, randomised trial
Setting: private paediatric gastroenterology outpatient clinic in Encino, California, USA
Dates: 2002‐5
Participants Inclusion criteria:
Patients with IBS, based on Rome II criteria
Exclusion criteria:
Concurrent pharmacotherapy for depression, anxiety, or chronic pain syndromes
Sample size:
33 children (intervention: 16; control: 16)
Age (mean):
Intervention 14.2 years; Control: 15.3 years
Sex (M/F):
M: 9; F: 24
Number randomised:
Intervention: 18; Control: 17
Number analysed:
Intervention: 16; Control: 17
Post‐randomisation exclusion:
Intervention: 2
Control: 0
Interventions Intervention: AMI: 7‐week course of oral AMI (10 mg if 30 to 50 kg, 20 mg if 50 to 80 kg, 30 mg if > 80 kg), taken at night
Control: placebo
Outcomes Duration of study: 13 weeks

  1. Quality of life

  2. Pain intensity and frequency

  3. IBS symptom checklist ‐ validated in adults (Patrick 1997)

  4. Pain rating scale (Smith 1997, paediatrics)


Timing of outcome assessment: measured at 6, 10 and 13 weeks
Notes Funding source: This study was funded by a grant from James and Diane Brooks Medical Research Foundation and AstraZeneca
Conflict of interest: not mentioned
Power calculation: NS
Quality of life data:
AMI data ‐ baseline: 109.4; 10 weeks: 128; 13 weeks: 126,2
Placebo data ‐ baseline: 127.5; 10 weeks: 129.4; 13 weeks: 128.8
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described as randomised double‐blinded fashion, no more details given. No response from author.
Allocation concealment (selection bias) Unclear risk Method not reported, no response from author
Blinding (performance bias and detection bias)
All outcomes Unclear risk Described as double‐blinded, no further details. No clarification
Incomplete outcome data (attrition bias)
Efficacy outcomes Low risk No flow diagram, 2 participants dropped out after randomisation in the antidepressant group prior to medication
Selective reporting (reporting bias) Unclear risk No protocol presented, lack of clarity as to predefined outcomes. Suggestion of some additional outcomes reported after data collection
Other bias Unclear risk Imbalance in baseline characteristics (e.g. gender, 24 female vs 9 male total, difference in baseline between QOL scores (statistically significant P = 0.05)