Methods | Quasi-randomised trial. Women allocated to different groups on alternate days. Treatment group on even number days and placebo on odd number days | |
Participants | 59 women presenting with breast engorgement on 3rd and 5th day post- delivery with pain and tenderness | |
Interventions | Women in treatment group were given 2 tablets of protease complex 4 times on day 1 after each meal and before bed time and on second and third day they were given 1 tablet 4 times a day and the placebo group were given placebo | |
Outcomes | Swelling; pain; maternal opinion of treatment. | |
Notes | It was not clear that all women were breastfeeding. | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | No | Quasi randomisation, allocation by day of the week. |
Allocation concealment? | No | Group allocation could be anticipated in advance. |
Blinding? Women |
Yes | Placebo controlled trial. |
Blinding? Clinical staff |
Yes | Placebo controlled trial. |
Blinding? Outcome assessors |
Yes | 2 outcome assessors were recording the change of swelling and pain and were not informed as to which participant belonged to which group |
Free of other bias? | Yes |