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

Saps 2009.

Study characteristics
Methods Study design: multicentre, double‐blinded, placebo‐controlled, parallel‐group, randomised trial
Setting: 6 paediatric gastroenterology clinics of 6 tertiary care centres geographically dispersed in the USA
Dates: January 2003 ‐ August 2006
Participants Inclusion criteria:
Patients with IBS, FAP or FD based on Rome II criteria
Exclusion criteria:
Diagnosis with an organic disease, plotted below the 5th percentile for weight or height, abnormal testing (EKG, complete blood count, erythrocyte sedimentation rate, albumin, pancreatic and liver enzymes, urine analysis, stool examination for occult blood and ova and parasites, tissue transglutaminase), positive lactose breath test or history of symptoms resolving after 2 weeks of a lactose‐free diet
Sample size:
90 children (intervention: 46; control: 44)
Age (mean / SD):
Intervention: 12.5 ± 2.9 years; control: 13.0 ± 2.7 years
Sex (M/F):
Intervention: 35/11
Control: 31/13
Disease type:
Intervention: FD = 13%, FAP = 53%, IBS = 40%
Control: FD = 8%; FAP = 31%; IBS = 62%
Number randomised:
Intervention: 46; Control: 44
Number analysed:
Intervention: 43; Control: 40
Post‐randomisation exclusion:
Intervention: 3
Control: 4
Interventions Intervention: amitriptyline for 4 weeks (10 mg/day < 35 kg; 20 mg/day > 35 kg)
Control: placebo
Outcomes Duration of study: 5 weeks

  1. 1. Participant's satisfactory relief and satisfaction with treatment assessed by the questions:

    1. "Overall how do you feel your problem is?" (Better/Same/Worse)

    2. "How did the medication relieve your pain?" (Excellent/Good/Fair/Poor/Failed)

  2. Effect on psychosocial traits and ability to perform daily activities, measured by the

    1. Pain Response Inventory

  3. Children's Depression Inventory (CDI)

  4. State‐Trait Anxiety Inventory for Children (STAIC)

  5. Children Somatisation Inventory Questionnaire

  6. Paediatric Functional Disability Inventory (PFDI)

  7. Visual analogue scale for pain intensity
Notes Funding source: this study was supported in part by the 2003 Clinical Research Award of the American College of Gastroenterology, the CHP 19596 RA501 grant and the grants M01 RR‐00048, M01 RR00084 and M01 RR‐02172 from the National Center for Research Resources, National Institute of Health
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 Method not reported in the study
Author response: it was computer‐randomised 1:1 (drug vs placebo)
Allocation concealment (selection bias) Low risk Method not reported in the study
Author response: double‐blinded, randomisation and dispensation of drug/placebo was done by central pharmacy after the participant left the clinic
Blinding (performance bias and detection bias)
All outcomes Low risk Identical capsules as medical intervention, data were analysed independently of the investigators at a central co‐ordinating site, which did not have access to the code until analysis was completed
Incomplete outcome data (attrition bias)
Efficacy outcomes Low risk 7 dropouts with detailed explanation. For those lost to follow‐up the specific group was not defined, but these were not study‐relevant dropouts
Selective reporting (reporting bias) Low risk Primary and secondary outcomes are reported. No protocol is given but outcomes were as expected
Other bias Low risk The study appears to be free of other sources of bias

EKG: electrocardiogram; FAP: functional abdominal pain; FD: functional disorder; IBS: irritable bowel syndrome