Montaseri 2013.

Methods	Randomised, double‐blind, multi‐centre, placebo‐controlled trial
Participants	Sample size: 60 infants. 17% of infants were withdrawn from the study for non‐attendance at clinic or an incomplete booklet. Setting: 6 clinics affiliated with Shiraz University of Medical Sciences Sex: boys (50%) Mean age: not reported (SD not reported); range 1 to 4 months. The largest age group consisted of 2‐month‐old infants in both treatment and control groups. Mean weight: not reported Mean duration of colic: not reported Mean crying: not reported Feeding: not reported Birth order: first born (intervention 50%, control 58%) Inclusion criteria: infants with colic pain (selected and examined by a physician) Exclusion criteria: infants with other problems/disorders
Interventions	Intervention (26 infants):Fumaria extract 2.5 cc was prescribed to be taken 3 times a day for a week. Control (24 infants): placebo Mothers were required to refrain from using any other type of medicine or treatment during this period. Fumaria extract and placebo were prepared and encoded according to the table of random numbers. These codes were kept secret until data collection by a pharmacist was complete, and they were revealed after analysis was performed and labels on reports were prepared. Administration: 2.5 cc of Fumaria extract was prescribed to be taken by infants 3 times a day for a week. Duration of study: 1 week
Outcomes	Treatment efficacy was measured by mothers via a booklet diary. Parents were asked to come to the clinic after the treatment period to hand in the booklet and, at the same time, evaluate colic pain in their infant. Information recorded by mothers included frequency and length of crying and frequency of waking up owing to colic pain per day.
Notes	Country: Iran Funding source: This study was supported by the Vice Chancellor of Shiraz University of Medical Sciences.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment:Fumaria extract and placebo were prepared and encoded according to the table of random numbers. After written informed consent was obtained from the mothers of the infants, control and treatment groups were established on the basis of labels.
Allocation concealment (selection bias)	Low risk	Comment:Fumaria extract and placebo were prepared and encoded according to the table of random numbers. These codes were kept secret until data collection by a pharmacist was complete, and they were revealed after analysis was performed and labels on reports were prepared. After written informed consent was obtained from the mothers of the infants, control and treatment groups were established on the basis of these labels.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: Information was insufficient to permit a judgement.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: Information was insufficient to permit a judgement.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: 17% of infants were withdrawn from the study for non‐attendance at clinic or an incomplete booklet. The number of infants randomised to each group was not reported, nor was the number of dropouts in each group.
Selective reporting (reporting bias)	Low risk	Comment: Study authors reported results for outcomes declared in the Methods section.
Other bias	Low risk	Comment: At baseline, no significant differences in demographic characteristics and colic criteria were evident between the 2 groups.