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. 2016 Jun 28;2016(6):CD006946. doi: 10.1002/14651858.CD006946.pub3

Roberts 1995a.

Methods Quasi‐randomised trial (breasts rather than women were the unit of analysis).
Participants 34 lactating women located on postnatal wards in 2 Australian hospitals.
Inclusion criteria: non‐Aboriginal, lactating, suffering from breast engorgement (hard, warm, painful breasts, with difficulty feeding), according to the professional judgement of the midwives caring for them.
Interventions Group 1 (even hospital registration numbers): chilled gel pack on the right breast and chilled cabbage leaves on the left breast.
Group 2 (odd hospital registration numbers): opposite to above.
Leaves from common green cabbages were prepared by stripping out the large vein, cutting a hole for the nipple, rinsing and chilling.
Breast‐shaped gel pack in small, medium, and large sizes were designed by the researcher to fit under the brassiere, covering the breast except for the nipple area.
Treatment left on breasts for up to 8 hours, with mothers renewing the cabbage leaves and gel packs ad lib, usually every 2 to 4 hours.
Outcomes Pre and post‐test pain rating for each breast rated on a "pain ruler" (a visual analogue scale with numbers from 0‐10, labelled with descriptions 0 = no pain, 5 = moderate pain, and 10 = excruciating pain). Descriptive data about engorgement were also collected.
Notes Analysis was at the breast level and results were at high risk of bias and difficult to interpret. We have not been able to included data in the data tables.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quasi‐randomisation (by hospital number).
Allocation concealment (selection bias) Unclear risk The authors did not mention allocation concealment.
Blinding (performance bias and detection bias) 
 Women High risk The nature of the study did not allow blinding of women.
Blinding (performance bias and detection bias) 
 Clinical staff High risk The nature of the study did not allow blinding of clinicians.
Blinding of outcome assessment (detection bias) High risk Participants rated outcomes in a self‐administered questionnaire. Given that visibly different interventions were placed on each breast blinding of participants/outcome assessors was not possible.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk The authors reported on all outcomes.
Selective reporting (reporting bias) Low risk No other identified bias.
Other bias High risk The data were analysed at the breast level with no adjustment for the non‐independence of breasts. As mentioned in McLachlan 1991, when the visual analogue scale was used, it was not always easy for women to make a clear distinction between the left and right breast.