Alexandrovich 2003.

Methods	Randomised, double‐blind, placebo‐controlled trial with 2 treatments groups
Participants	Sample size: 125 infants diagnosed with colic. Infants enrolled into the study were not tested for milk allergy, and continued their diets. 4 participants dropped out Setting: recruited at 2 large multi‐specialty clinics of Kalinin district of St Petersburg Sex: boys (45.5%) Mean age: 30 (SD 7) days. Range 2 to 12 weeks Mean weight: 3868 (SD 295) grams Mean duration of colic: not reported Mean crying: 13.2 (SD 1.7) hours per week Feeding: breast fed (45.5%) Birth order: not reported Inclusion criteria: infants were included in the study if they met the criteria offered by Wessel et al Exclusion criteria: Premature infants Infants with chronic or acute illness Infants gaining < 30 grams a day over a period of 1 week before the study Infants who received any medication Infants with an estimated cumulative crying time < 9 hours per week
Interventions	Intervention (65 infants): fennel seed oil emulsion (water emulsion of 0.1% fennel seed oil and 0.4% polysorbate‐80) Placebo (60 infants): 0.4% polysorbate in water Administration: A pharmacist dispensed both the fennel preparation and the placebo into quantities sufficient to last 1 week. Parents were instructed to administer a minimum of 5 mL and a maximum of 20 mL of fennel seed oil emulsion or placebo up to 4 times a day, orally before meals, and at the onset of colic episodes. In addition, parents were instructed to limit consumption to about 12 mL/kg/d, which would provide about 12 mg/kg/d of fennel seed oil. Duration of the study: 7 days (+ 7 days follow‐up)
Outcomes	Calculated cumulative crying for a week. Relief of colic symptoms, which was defined as decrease in cumulative crying to < 9 hours per week Each family received a diary with instructions to enter data on a daily basis. Diaries were completed for 21 days: 7 days before the trial, during the 7‐day trial, and 7 days after the trial
Notes	Country: Russia Funding source: This study was supported by institutional funds. The fennel seed oil emulsion and placebo were provided by Lev Laboratories (Glencoe, IL)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: Randomisation was achieved by a computer‐generated number with the use of Microsoft Excel (Microsoft, Redmond, WA, USA).
Allocation concealment (selection bias)	Low risk	Comment: A pharmacist dispensed both the fennel preparation and placebo in quantities sufficient to last 1 week. The pharmacist was unaware of which parents received the preparation.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: The fennel preparation and the placebo appeared identical on visual examination and were bottled in plastic 6 oz (180 mL) nursing bottles by a laboratory technician. Neither the observing paediatrician nor parents were aware of the content of the bottles.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: Neither the observing paediatrician nor the parents were aware of the content of the bottles.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: A total of 121 infants completed the study (97%). 1 infant in the treatment group was withdrawn from the study because his parents failed to complete the diary. Because of a relocation, 2 infants (twins) in the treatment group were lost to follow‐up. 1 infant in the control group was withdrawn from the study because of a severe cold. Percentage of drop‐outs < 10%.
Selective reporting (reporting bias)	Unclear risk	Comment: Outcomes were not clearly specified in the Methods section.
Other bias	Low risk	Comment: Intervention and control groups did not differ significantly in baseline infant characteristics. No significant difference in cumulative crying was noted between the 2 groups before the start of treatment.