Sethi 1988.

Methods	Double‐blind, randomised, placebo‐controlled, cross‐over trial
Participants	Sample size: 26 children; no dropouts/withdrawals Setting: not reported Sex: boys (40%) Mean age: not reported (SD not reported); range 1 week to 3 months Mean weight (SD): not reported Mean duration of colic: not reported (SD not reported); states simply that no differences in frequency of symptoms at the beginning of treatment were noted between groups Mean crying: not reported Feeding: not reported Birth order: not reported Inclusion criteria: infants with diagnosis of colic Exclusion criteria: not specified
Interventions	Intervention (n = 26): simethicone; 25 participants received 1 dropper load of medication (20 mg) and 11 received 2 droppers (dose not reported) before evening feeds, since symptoms were nocturnal Control (n = 26): placebo Administration: Therapy was administered as a suspension containing 40 mg/mL simethicone and as a matching placebo suspension. Parents were issued a coded trial medication, and after 1 week, the trial medication was returned; parents then were issued the alternative trial medication for the coming week. Duration of study: 2 weeks Washout period: none
Outcomes	Parents were asked to record (1) daily frequency of crying and (2) amplitude for crying attacks, using a 4‐point rating scale. Parents were also asked to record (3) the number, nature and consistency of infant stools and (4) any perceived adverse effects.
Notes	Country: England Funding source: Study authors did not report whether the study received support.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: Information was insufficient to permit a judgement.
Allocation concealment (selection bias)	Unclear risk	Comment: Method of concealment was not described.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "Parents were issued with a coded trial medication".
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "Parents were issued with a coded trial medication".
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: All infants completed the study.
Selective reporting (reporting bias)	High risk	Comment: Study authors did not clearly report results for all outcomes and did not report results of each treatment by study period.
Other bias	High risk	Comment: No washout period was planned.