Weizman 1993.

Methods	Randomised, double‐blind, placebo‐controlled trial
Participants	Sample size: 72 infants (36 herbal tea, 36 placebo) were enrolled in the study. 4 infants were excluded during the study: 3 for acute illness (2 from tea arm, 1 from placebo arm), and 1 because of poor parental compliance. 68 were included in the analysis. Setting: primary community‐based paediatric clinics in the Beer‐Sheva area, in Israel Sex: boys (38% of 68) Mean age: herbal tea 21.1 (SD 9.3) days, placebo 24.6 (SD 7.6) days; range not reported Mean weight: herbal tea 3116 (SD 1060) grams, placebo 3201 (SD 1088) grams Mean duration of colic: not reported Mean crying: not reported Feeding: breast fed (herbal tea 72%, placebo 67%) Birth order: first child (herbal tea 59%, placebo 66%) Inclusion criteria: infants with colic according to Wessel definition Exclusion criteria: Prematurity Weight gain < 150 mg/week Acute or chronic illness and drug therapy
Interventions	Intervention (33 infants): herbal tea preparation (Calma Baby Bonomelli) containing fennel, chamomile, vervain, licorice, balm mint Control (35 infants): placebo. The placebo preparation consisted of an instant powder of glucose and natural flowers only, with no herbs. The smell and taste of the placebo and the tea were similar. Administration: Tea was offered to infants with every episode of colic, up to 150 mL/dose, but no more than 3 times a day. Tea powder was dissolved in water according to the manufacturer's instructions. Treatment was administered for 1 week. No significant differences were noted between 2 treatment arms.
Outcomes	Evaluation of the 2 groups was based on the following 3 measures: Number of night awakenings requiring parental response Elimination of colic based on the same definition adopted as inclusion criteria (crying < 3 hours/d or > 3 hours/d but for < 3 days/week) Colic improvement (5‐point score based on parental judgement: '‐ 1' worsening; '0' no change; '+ 1' mild improvement; '+ 2' moderate improvement; '+ 3' significant improvement) Families received a diary in which to record total daily hours of colic, numbers of night awakenings, a 5‐grade improvement score and adverse effects. Parental diaries covered 7 days with no therapy and 7 days with treatment.
Notes	Country: Israel Funding source: This study was supported by Materna Laboratories, Maabarot, Israel.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "infants were randomly assigned to receive either tea or placebo". Comment: Information was insufficient.
Allocation concealment (selection bias)	Low risk	Comment: During the entire study, the code determining group allocation was known only to the pharmacists.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "The smell and taste of the placebo and the tea were similar; both were packed in identical appearing cans; the code of group allocation was known only by the pharmacist".
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The code was known only by the pharmacist".
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: 4 infants were excluded during the study: 3 (2 tea and 1 placebo) because of acute illness, and 1 (tea) because of poor parental compliance. Study authors excluded these infants from the analyses because of exclusion criteria.
Selective reporting (reporting bias)	Low risk	Comment: Study authors reported study results for all outcomes.
Other bias	Low risk	Comment: Analysis of infant characteristics (gender, age, feeding method) and colic severity after 7 days of no‐treatment revealed no significant differences between the 2 groups.

CHC: child health centre.
 SD: standard deviation.