Kvist 2004.

Methods	Randomised controlled trial.
Participants	88 women attending breastfeeding clinics in the South of Sweden with at least 2 of the following symptoms of breast inflammation: erythema, tension, resistance, pain or pyrexia. Half of the women were within 2 weeks of giving birth. Exclusion criteria (contraindications for acupuncture treatment): psychiatric illness, haemorrhagic disease, prosthetic heart valves, infections of the skin, hepatitis B or HIV.
Interventions	Group 1 (28 women): usual care, including oxytocin nasal spray at the discretion of attending midwives. Group 2 (35 women): acupuncture to points HT 3 (heart) and GB 21 (gall bladder). Group 3 (25 women): acupuncture to points HT 3, GB 21 and SP 6 (spleen). Acupuncture was carried out by midwives with acupuncture experience. All 3 groups received advice on interval and duration of breastfeeds, breast emptying and application of unrefined cotton wool.
Outcomes	Severity of symptoms on day 3 expressed as severity index (sum of scores for breast tension, erythema and pain); maternal satisfaction with breastfeeding; breast tissue resistance.
Notes	Published results were not reported in a way that we were able to use in data tables. Results state that there were no differences between groups at day 3, but no original data were presented. We contacted the author for further information; data from the study are no longer available.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"A total of 150 opaque envelopes, 50 for each group, were prepared with a paper denoting the intervention group and sealed. These were then randomly mixed and the envelopes numbered. The envelopes were identical in weight. For those wishing to take part, the midwife opened an envelope in correct numerical order, in the mothers’ presence."
Allocation concealment (selection bias)	Low risk	Described as sealed opaque envelopes opened by midwives in order.
Blinding (performance bias and detection bias) Women	High risk	Not feasible. "Blinding of participants was not attempted in this study because the practice of sham acupuncture has been questioned for its reliability."
Blinding (performance bias and detection bias) Clinical staff	High risk	Not feasible.
Blinding of outcome assessment (detection bias)	High risk	˝The treating midwife completed protocols for the mothers' initial visit to the clinic and for every follow‐up contact until the mother reported that symptoms had subsided.˝
Incomplete outcome data (attrition bias) All outcomes	High risk	Cannot be measured. 88 women randomised. Denominators for results not clear. No post‐intervention tables provided. Study was ended prematurely partly due to ˝the realization that the number of patients referred to the doctor for prescription of antibiotics was small".
Selective reporting (reporting bias)	High risk	Breast tissue resistance was not reported in the results even though a scale was devised to measure it. Non‐significant results are mentioned but not reported adequately.
Other bias	Unclear risk	Study report not very clear to allow identification of other potential sources of bias.