Hill 2005.
| Methods | Randomised controlled trial with 2 treatment groups | |
| Participants |
Sample size: 107 infants (17 dropped out – intervention = 6, control = 11) Setting: metropolitan, community‐based, well‐infant centres, Melbourne, Australia Sex: 54 boys (50%) 53 girls (50%) Mean age: 5.7 weeks (SD 1.1, range 2.9 to 8.6) Mean weight: not reported Mean duration of colic (baseline): Mean distress duration at start of diet, in weeks intervention = 3.2 (range = 1 to 7), control = 3.4 (range = 1 to 6.0) Mean crying (baseline): not reported Feeding: breastfed (100%) Birth order: not reported Inclusion criteria: < 6 weeks of age, breastfed, well‐term infants (gestational age of > 37 weeks), normal singleton pregnancy, otherwise uneventful perinatal history and no perinatal morbidity other than distress, and presence of 'rule of three' crying in the week before presentation Exclusion criteria: mothers who were vegan, babies who were formula fed, spontaneous improvement |
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| Interventions | Intervention (n = 47): low‐allergen diet without milk, soy, nuts, eggs, wheat and soy, but including a rice drink every day and rice bread Control (n = 43): diet must have included milk, peanuts, egg, wheat, fish, tree nuts and soy every day Duration: 1 week | |
| Outcomes | Detailed food diary by mothers, and recording of infant crying or fussing behaviour on a pre‐validated chart, for 48 h on days 1, 2, 8 and 9 | |
| Notes |
Study start and end dates: 2000 (start) to 2002 (end) COIs: not reported but see funding source directly below Funding source: financed by the Rice Growers' Co‐operative, Australia. Intervention was rice milk and rice bread Adverse effects: none reported Comments: none |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote: "referred to the Department of Allergy for diet randomisation" Quote: "assigned to one of the diets by the research dietician on the basis of a randomisation schedule provided by the statistician" Comment: no further details. Wrote to study author but received no response |
| Allocation concealment (selection bias) | High risk | Comment: no details. Wrote to study author but received no response |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: not possible to blind participant mothers as diets were different |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: not possible to blind participant mothers as diets were different |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: participant enrolment/study progress diagram included in paper. Accounted for all participants |
| Selective reporting (reporting bias) | High risk | Comment: no specific mention or reporting of adverse effects. No response received from study author |
| Other bias | High risk | Comment: funded by Rice Grower's Co‐operative, and intervention includes a rice drink and rice bread daily. No further details of involvement and no response received from study author |