Danielsson 1985.

Methods	Double‐blind, placebo‐controlled, cross‐over trial
Participants	Sample size: Study included 32 infants with colic: 5 infants dropped out after 2 to 7 days owing to parents' decisions (2 taking simethicone, and 3 placebo). Data from this study were derived from 27 infants. Setting: baby clinics near Gothenburg Sex: boys (44%) Mean age: 4.8 (SD not reported) weeks; range 2 to 8 weeks Mean weight: not reported Mean duration of colic: not reported Mean crying: not reported Feeding: breast fed (all mothers, except 1, were breast feeding); received bottle supplements (3 mothers gave their infants occasional bottle supplements) Birth order: not reported Inclusion criteria: Crying was diagnosed as infantile colic if it lasted longer than 3 hours a day and occurred more than 3 days a week. Exclusion criteria: not specified
Interventions	Intervention (27 infants): simethicone: 0.3 mL (10 drops) of simethicone solution (94 mg/mL) administered to each infant before each meal Control (27 infants): placebo; designed to have the same taste, smell, colour and texture as the active solution Administration: The same assistant visited each family twice. The first treatment was administered from day 1 to day 7; this was followed by a 3‐day washout period. The second treatment was administered from day 11 to day 17. Duration of study: 7 days of treatment, 3 days of washout and 7 days of another treatment Washout period: 3 days
Outcomes	Parents were interviewed before and after treatment to obtain background data and to evaluate treatment efficacy. Parents kept 24‐hour records about how long their infants had been crying or fussing, and how often their infants had eaten and passed stools.
Notes	Country: Sweden Funding source: This research was supported by a grant from the First of May Flower Annual Campaign for Children's Health (Sweden).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Comment: It is not clearly reported whether treatment order was assigned by randomisation.
Allocation concealment (selection bias)	Unclear risk	Comment: Information was insufficient to permit a judgement.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: Medicine bottles were coded by the manufacturer; placebo and tested drug had the same smell, taste, colour and texture.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: Medicine bottles were coded by the manufacturer; placebo and tested drug had the same smell, taste, colour and texture.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: Five infants dropped out owing to parents' decisions (2 taking simethicone, and 3 placebo). 15% were lost. Balanced reasons for dropout were reported.
Selective reporting (reporting bias)	High risk	Comment: Outcomes were not clearly reported in the Methods section, and results were not reported by study period.
Other bias	Low risk	Comment: Three‐day washout period was planned.