Kvist 2007.

Methods	Randomised, non‐blinded 3‐arm controlled trial.
Participants	Women attending a hospital breastfeeding clinic in the South of Sweden. 210 cases randomised. Inclusion criteria: at least 2 of the following symptoms: breast erythema, tension, resistance, pain or pyrexia. Exclusion criteria (contraindications for acupuncture treatment): psychiatric illness, haemorrhagic disease, prosthetic heart valves, infections of the skin, hepatitis B or HIV.
Interventions	Essential care to everyone: advice on duration and frequency of breastfeeds, advice on breast emptying (manual expression, pumping or warm shower) and application of unrefined cotton wool. Group 1 (70 women): essential care and oxytocin nasal spray, at the discretion of the clinical staff. Group 2 (70 women): essential care and acupuncture, avoiding the SP6 site which stimulates oxytocin. Group 3 (70 women): essential care and acupuncture, including the SP6 site. The acupuncture was performed by midwives who had completed a course in obstetrical acupuncture and had at least 5 years experience in its use.
Outcomes	Severity index (sum of scores for breast tension, erythema and pain) on days 3, 4 and 5; number of contact days till recovery; maternal satisfaction with breastfeeding on days 3, 4 and 5; need for antipyretics, number of contact days till recovery; residual symptoms after 6 weeks, occurrence of breast abscess, need for antibiotics.
Notes	The authors included 5 women, who were randomised twice because they developed residual symptoms after 6 weeks, to the original 205 participants to give 210 episodes of inflammatory symptoms.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Envelopes prepared in advance. These were then randomly mixed and the envelopes numbered.
Allocation concealment (selection bias)	Low risk	Opaque envelopes were used to allocate women into the 3 groups. "The sequence of group allocation was not known to anyone.˝
Blinding (performance bias and detection bias) Women	High risk	The nature of the trial did not allow blinding. Women who were getting acupuncture would know their intervention.
Blinding (performance bias and detection bias) Clinical staff	High risk	The authors do not mention blinding of clinical staff but the nature of the study would not allow blinding of clinical staff.
Blinding of outcome assessment (detection bias)	Unclear risk	The authors do not mention blinding of outcome assessors.
Incomplete outcome data (attrition bias) All outcomes	Low risk	The authors report about drop outs and they report that they did ITT analysis.
Selective reporting (reporting bias)	Low risk	The authors reported on all pre‐specified outcomes.
Other bias	Low risk	No other bias identified.