| 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 |