Taubman 1988.

Methods	Study design: randomised controlled trial of parent counselling vs elimination of cows' milk or soy milk protein for infantile colic Location: USA Setting: outpatient paediatric appointments
Participants	Sample size: 21 infants Number of dropouts/withdrawals: 1 infant Mean age: The mean age of intervention group infants was 5.4 ± 2.2 weeks, and the mean age of control group infants was 6.5 ± 1.8 weeks. Inclusion criteria: crying more than 2 hours per day younger than 3 months of age normal growth and development normal physiological findings no history of diarrhoea or vomiting receiving enough breast milk Exclusion criteria: infants receiving hydrolyzed casein formula (Nutramigen) mothers who received milk‐free diets
Interventions	Intervention group (n = 10): parents received counselling with written instructions to seek why the infant was crying and a request to respond to this. Control group (n = 10): infants received a hydrolysed casein formula and mothers were informed to exclude milk from their infants' diets. After 9 days, parents received counselling and were informed to return to the original diets and original formulas. Duration of intervention: 9 days
Outcomes	Primary outcome: crying time Group 1: mean crying time at baseline = 3.21 hours per day (SD = 1.10); mean crying time at 1 to 3 days = 1.50 hours per day (SD = 1.03); mean crying time at 4 to 6 days = 1.43 hours per day (SD = 0.72); mean crying time at 7 to 9 days = 1.08 hours per day (SD = 0.70). The reduction in mean crying time from baseline to 7 to 9 days was seen as significant (P = 0.001). Group 2: mean crying time at baseline = 3.19 hours per day (SD = 0.69); mean crying time at 1 to 3 days = 2.6 hours per day (SD = 0.99); mean crying time at 4 to 6 days = 2.13 hours per day (SD = 0.86); mean crying time at 7 to 9 days = 2.03 hours per day (SD = 1.03). The reduction in mean crying time from baseline to 7 to 9 days was seen as significant (P = 0.01).
Notes	Study start date: not reported Study end date: not reported Declared DOI: not reported Perceived DOI: none perceived Funding source: Mead Johnson Nutrition group Other comments: none
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: infants assigned by random numbers generator
Allocation concealment (selection bias)	Low risk	Comment: states participants assigned by a gastroenterology office co‐ordinator
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: investigator and participants aware of intervention
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: parents of participants recorded crying times
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: 1 infant dropped out and was not included in analysis
Selective reporting (reporting bias)	Low risk	Comment: all outcomes reported
Other bias	Unclear risk	Comment: funded by Mead Johnson Nutrition group