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. Author manuscript; available in PMC: 2014 Sep 11.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Sep 8;(9):CD006946. doi: 10.1002/14651858.CD006946.pub2
Methods Quasi-randomised trial (breasts rather than women were the unit of analysis)
Participants 34 lactating women in postnatal wards in 2 Australian hospitals with breast engorgement (hard, warm, painful breasts, difficulty feeding)
Interventions Cabbage leaves were compared with chilled retaining gel packs. Each woman put cabbage leaves on 1 breast and a cold gel pack on the other
Outcomes Pre and post-test pain rating for each breast rated on a “pain ruler” (a VAS with numbers from 0-10, labelled with descriptions 0 = no pain, 5 = moderate pain, and 10 = excruciating pain)
Notes Analysis was at the breast level and results were at high risk of bias and difficult to interpret. We have not included data in the data tables
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? No Quasi randomisation (by hospital number) of right and left breasts
Allocation concealment? No
Blinding?
Women
No Not feasible. This is particularly a problem as women received both treatments (each breast having a different treatment)
Blinding?
Clinical staff
No
Blinding?
Outcome assessors
No
Incomplete outcome data addressed?
All outcomes
Yes None apparent.
Free of other bias? No The data were analysed at the breast level with no adjustment for the non-independence of breasts