Skip to main content
. 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 Randomised, non-blinded 3-arm controlled trial. The opaque randomisation envelopes were randomly mixed
Participants 205 mothers with 210 episodes of inflammatory symptoms of breast during lactation
Interventions Essential care to everyone: breastfeeding advice, manual expression and warm shower. Group 1 was given essential care and oxytocin nasal spray at the discretion of the clinical staff, group 2 was given essential care and acupuncture avoiding the SP6 site which stimulates oxytocin, group 3 was given essential care and acupuncture including the SP6 site. The acupuncture treatment was given by experienced midwives
Outcomes Pain score, maternal satisfaction with breastfeeding, needs for antipyretics, breast abscess, need for antibiotics
Notes In the data tables the 2 acupuncture groups have been combined into a single treatment group (140) and compared with the group receiving usual care
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes Envelopes prepared in advance. “The sequence of group allocation was not known to anyone.”
Allocation concealment? Yes Opaque envelopes were used to allocate women into the 3 groups
Blinding?
Women
No Blinding was not possible as women who had no acupuncture would know which group they were in
Blinding?
Clinical staff
No
Blinding?
Outcome assessors
No
Incomplete outcome data addressed?
All outcomes
Yes 205 women (210 episodes). 2 women withdrew but were included in the analysis
Free of other bias? Yes