1. Summary of study characteristics.
| Study | N°infants enrolled | N° infants analysed | Mean age (SD) in weeks at study entry | Male (%) | Intervention/control | Loss to follow‐up (%) (intervention/control) | Study treatment duration (in days) | Study design | Outcomes |
| Akçam 2006 | 30 | 25 | 9.1 (5.9) | 40 | Glucose (30%)/placebo | 16.7 | 4 | Randomised, cross‐over | Responders Adverse effects |
| Alexandrovich 2003 | 125 | 121 | 4.3 (1.1) | 45.5 | Fennel seed oil emulsion/placebo | 4.6/1.7 | 7 | Randomised, parallel‐arm | Responders (as relief of colic symptoms) Cumulative crying time (hours/week) Number of doses/d Consumed mL/d Adverse effects |
| Alves 2012 | 30 | 30 | 4.7 (1.6) | 45.5 | Simethicone/herbal agents (Mentha piperita) | 0 | 7 | Randomised, cross‐over | Responders (as improvement in symptoms) Frequency of colic episodes (daily) Daily colic duration (minutes) Duration of colic Adverse effects |
| Arikan 2008 | 175 | 105* | 8.24 (2.88) | 55.5 | Herbal tea or sucrose/no treatment | 0 | 7 | Randomised, parallel‐arm | Crying time (hours/d) |
| Blomquist 1983 | 18 | 18 | Range 2 to 14 | 44.4 | Dicyclomine plus sugar/placebo | 0 | 7 | Randomised, cross‐over | Responders (as improvement in colic severity) Frequency of crying episodes |
| Danielsson 1985 | 27 | 27 | 4.8 (range 2 to 8) | 44.4 | Simethicone/placebo | 0 | 7 | Quasi‐randomised, cross‐over | Responders Crying time (hours/d) Time sleeping (hours/d) Number of feedings Number of stools |
| Gomirato 1989 | 40 | 40 | 4.4 | 40 | Cimetropium bromide (1.2 mg/kg)/cimetropium bromide (2.0 mg/kg) | 0 | 14 | Randomised, parallel‐arm | Responders (as improvement in symptoms) Number of crying episodes/d Duration of longest episodes (minutes) Adverse effects |
| Grunseit 1977 | 25 | 22 | 5.4 (range 3 to 12) | 40.9 | Dicyclomine/placebo | 12.0 | 7 | Randomised, cross‐over | Score of symptoms (as continuous measure) |
| Hwang 1985 | 30 | 30 | 4 to 5 | Not reported | Dicyclomine/placebo | 0 | 7 | Quasi‐randomised, cross‐over | Responders (as improvement in symptoms) Crying time (hours/d) Sleeping time (hours/d) Adverse effects |
| Illingworth 1959 | 16 | 16 | < 8 | Not reported | Dicyclomine/placebo | 0 | 7 | Randomised, cross‐over | Score of symptoms Responders (as improvement in symptoms) |
| Markestad 1997 | 19 | 19 | 7.3 (3.4) | 68.4 | Sucrose (12%)/placebo | 0 | 8 to 12 | Randomised, cross‐over | Responders (as improvement in symptoms) Parental satisfaction |
| Metcalf 1994 | 83 | 83 | Not reported | 49.4 | Simethicone/placebo | 0 | 7 (3 to 10) | Randomised, cross‐over | Responders (as improvement in symptoms) |
| Montaseri 2013 | 60 | 50 | 8 (4 to 16) | 50 | Fumaria extract/placebo | 17.0 | 7 | Quasi‐randomised | Frequency of crying attack Crying duration Frequency of waking up (all as categorical variables) |
| Savino 2002 | 97 | 86 | Range 2 to 8 | Not reported | Cimetropium bromide/placebo | 9.8/13.0 | 3 | Randomised, parallel‐arm | Responders Adverse effects |
| Savino 2005 | 93 | 88 | 4.3 (1.5) | 46.6 | Herbal tea/placebo | 4.7/6.0 | 7 | Randomised, parallel‐arm | Responders Crying time (minutes/d) Adverse effects |
| Sethi 1988 | 26 | 26 | Range 1 to 12 | 40 | Simethicone/placebo | 0 | 7 | Randomised, cross‐over | Frequency of crying (daily) Amplitude of crying attack |
| Weissbluth 1984 | 48 | 48 | 5 | 58 | Dicyclomine/placebo | 0 | 14 | Randomised, parallel‐arm | Responders Adverse effects |
| Weizman 1993 | 72 | 68 | 3.3 (1.2) | 38.6 | Herbal tea/placebo | 8.3/2.8 | 7 | Randomised, parallel‐arm | Responders (as colic eliminated) Frequency of nocturnal awakenings Colic improvement score |
*105 infants analysed for the three groups included in this review.
SD: standard deviation.