Savino 2002.

Methods	Randomised, double‐blind, placebo‐controlled trial
Participants	Sample size: 97 infants with colic. Of these 97 infants, 11 (5 from the treatment group and 6 from the control group) dropped out; 7 did not come to the second visit, 2 were excluded because of fever and 2 were excluded because of gastroenteritis. Setting: Children's Hospital Regina Margherita Sex: not reported Mean age: not reported (SD not reported); range 15 to 60 days Mean weight: not reported Mean duration of colic: not reported Mean crying: cimetropium bromide 17.3 (SD 12.6) minutes; placebo 47.5 (SD 28.5) minutes Feeding: exclusively breast fed Birth order: not reported Inclusion criteria: Healthy infants with regular growth 15 to 60 days old Diagnosis of infantile colic based on Wessel criteria Exclusion criteria: not reported
Interventions	Intervention (43 infants): cimetropium bromide 3 drops/kg (1.2 mg/kg) Control (43 infants): placebo; solution with the same colour, smell, taste and package but with no pharmacological properties Administration: Treatment should be administered at the onset of each crisis, defined as inconsolable full‐force crying with typical characteristics of infantile colic (legs flexed over the abdomen, fists closed, meteorism) and no response to common consolation procedures, such as pacifier use, rocking or dull continuous background noise. Duration of study: not reported
Outcomes	Therapy was considered efficacious if crying ended within 15 minutes of administration of the compounds. Responders were children who stopped crying within this time. Parents received a structured diary in which they recorded daily (1) time crying began, time medication was given and time crying ended; and (2) side effects observed (meteorism, vomiting, sleepiness, restlessness, inappetence, cutaneous reactions, constipation, diarrhoea, respiratory distress or apnoea).
Notes	Country: Italy Funding source: This study was not supported; the drug and placebo were provided by Pharma S.P. A., Carugate (Milan).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Sequentially to recruitment each infant was assigned randomly to one of the two groups". Insufficient information was reported.
Allocation concealment (selection bias)	Unclear risk	Comment: Method of concealment was not described.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: Placebo was a solution with the same colour, smell, taste and package but with no pharmacological properties. Quote: "Neither doctors nor parents knew which infants received treatment".
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Neither doctors nor parents knew which infants received treatment".
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: 11 infants (5 from the treatment group and 6 from the control group) dropped out. 7 did not come to the second visit, 2 were excluded because of fever and 2 were excluded because of gastroenteritis. Reasons for missing data could be related to treatment, but study authors did not report reasons for missing data by arm.
Selective reporting (reporting bias)	Low risk	Comment: Study authors reported results for all outcomes declared in the Methods section.
Other bias	Low risk	Comment: Before the study began, the average number of crises each day and average crying duration were similar in both groups.