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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. 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