Arikan 2008.

Methods	Randomised, controlled trial with 4 treatment groups
Participants	Sample size: 175 infants. No withdrawals from the study Setting: recruited at public healthcare clinics and Department of Pediatrics at the Yakutiye Research Hospital, Atatürk University Sex: boys (55%) Mean age: 2.15 (SD 0.7) months. Range not reported Mean weight: 5250 (SD 1039) grams Mean duration of colic: not reported Mean crying: 5.14 (SD 1.59) hours/d Feeding: breast fed (80%) Birth order: not reported Inclusion criteria: Typical infantile colic as defined by Wessel et al Infant from 4 to 12 weeks of age Born at term or preterm (gestational age 37 to 42 weeks), with birth weight between 2.5 kg and 4 kg Appropriate gain in weight, length and head circumference, and normal psychomotor development on paediatric physical examination Exclusion criteria: Previous colic treatment Clinical evidence of gastroenterological disease Mother defined as having anxiety (by means of observation) Infant previously treated with medication that affects abdominal symptoms, such as antibiotic or probiotic medication
Interventions	Intervention 1 (35 infants): massage (chiropractic spinal manipulation). Parents were advised to administer massage twice a day for 25 minutes during symptoms of colic. This time period and method were used successfully in a previous study (Huhtala et al. 2000). Intervention 2 (35 infants): sucrose solution (12%). Sucrose administered at a dose of 2 mL of 12% solution twice a day at 5 PM and 8 PM. This concentration and volume were chosen because they had been used successfully in a previous study on pain in newborn infants (Haourai et al. 1995). Intervention 3 (35 infants): herbal tea (fennel tea). Herbal tea administered at a dose of 35 mL (maximum dose of 150 mL), 3 times a day (Weizman et al. 1993). Intervention 4 (35 infants): hydrolysed formula. In the group receiving breast feeding, it was thought that it would be wrong to discontinue breast feeding. Therefore, only infants fed standard formula were assigned to the group to receive hydrolysed formula. Control (35 infants): no intervention. No nursing intervention was administered to the control group. Administration: The same paediatrician and nurse were in contact with all study parents, each of whom was visited and trained in the scoring system. Parents were educated by researchers about their assigned regimen. Mothers were trained in massage technique and were given brochures with written illustrated instructions. Duration of the study: 7 days
Outcomes	Crying time: Before starting the study, parents were given a structured questionnaire about their infants’ behaviour, temperament, sleeping and eating habits and history of colic symptoms. Parent participants were then given a 1‐week diary in which to record crying times and durations (onset of crying time, when the intervention was administered, end of crying time, side effects observed during week of therapy). Crying was quantified by length of crying in hours per day for 1 week before and 1 week during the intervention.
Notes	Country: Turkey Funding source: Study authors received no financial support for this study.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Comment: Information reported on the group receiving breast feeding was insufficient; it was thought that it would be wrong to discontinue breast feeding. Therefore, only infants fed with standard formula were assigned to the group to receive hydrolysed formula.
Allocation concealment (selection bias)	Unclear risk	Comment: No information was reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Because of the design of the study, blinding was not applied.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: No blinding was applied.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: Study authors reported study results for all randomised infants.
Selective reporting (reporting bias)	High risk	Comment: Parents wrote a diary to record crying duration and side effects observed during therapy. Side effects results were not reported.
Other bias	High risk	Comment: Intervention groups and control group did not differ significantly in baseline infant characteristics, except for crying duration.