| 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 | |