Campbell 1989.
| Methods | Single‐centre, double‐blind, randomised controlled trial with 2 treatment groups | |
| Participants |
Sample size: 19 infants diagnosed with colic (0 dropped out) Setting: recruited in a single town (Livingston, West Lothian in Scotland, UK) Sex: 11 boys (58%), 8 girls (42%) Mean age: 7 weeks (SD not reported, range 3 to 14) Mean weight: not reported Mean duration of colic (baseline): not reported Mean crying (baseline): not reported Feeding: formula fed (100%) Birth order: 4 first born, 7 second born, 8 third to sixth born Inclusion criteria: formula‐fed infants with a clinical diagnosis were included in the study if they met the Wessel 1954 criteria Exclusion criteria: spontaneous remission in the observation week, colic not severe or already improving during baseline week. Does not specify that babies were 'otherwise well'; however, referral was via GP or HV who considered the baby to have infant colic |
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| Interventions |
Intervention (n = 10): soy formula Control (n = 9): standard formula Duration: 1 week |
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| Outcomes | Mothers asked to complete a record sheet noting the amount of time of baby's colic symptoms each day. Record sheets scored by totaling all the periods of colic, to the nearest half hour, for 6 days of the week, omitting the first day of the week to allow for transition from previous milk | |
| Notes |
Study start and end dates: not recorded; however it was a 2‐year study period and published in 1989 COIs: none stated Funding source: formula provided by Cow & Gate. Author was a GP, doing a research fellowship funded by the Health Service Research Committee of Scottish Home and Health Department Adverse effects: not reported Comments: none |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote: "on the basis of random assignment" Comment: no further details given. Wrote to study author but received no response |
| Allocation concealment (selection bias) | High risk | Comment: no details given. Wrote to study author but received no response |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "control and intervention were packaged in identical coded tins" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "and the code of each pair of milks was not broken until the end of the ... period so that the observations would be double blind" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all data recorded. Accounted for all patients |
| Selective reporting (reporting bias) | High risk | Comment: no specific mention or reporting of adverse effects |
| Other bias | Low risk | Comment: not apparent |