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Treatments for breast engorgement during lactation. BACKGROUND: Engorgement is the overfilling of breasts with milk, often occurring in the early days postpartum. It results in swollen, hard, painful breasts and may lead to premature cessation of breastfeeding, decreased milk production, cracked nipples and mastitis. Various treatments have been studied but little consistent evidence has been found on effective interventions. OBJECTIVES: To determine the effectiveness and safety of different treatments for engorgement in breastfeeding women. SEARCH METHODS: On 2 October 2019, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), and reference lists of retrieved studies. SELECTION CRITERIA: All types of randomised controlled trials and all forms of treatment for breast engorgement were eligible. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for eligibility, extracted data, conducted 'Risk of bias' assessment and assessed the certainty of evidence using GRADE. MAIN RESULTS: For this udpate, we included 21 studies (2170 women randomised) conducted in a variety of settings. Six studies used individual breasts as the unit of analysis. Trials examined a range of interventions: cabbage leaves, various herbal compresses (ginger, cactus and aloe, hollyhock), massage (manual, electromechanical, Oketani), acupuncture, ultrasound, acupressure, scraping therapy, cold packs, and medical treatments (serrapeptase, protease, oxytocin). Due to heterogeneity, meta-analysis was not possible and data were reported from single trials. Certainty of evidence was downgraded for limitations in study design, imprecision and for inconsistency of effects. We report here findings from key comparisons. Cabbage leaf treatments compared to control For breast pain, cold cabbage leaves may be more effective than routine care (mean difference (MD) -1.03 points on 0-10 visual analogue scale (VAS), 95% confidence intervals (CI) -1.53 to -0.53; 152 women; very low-certainty evidence) or cold gel packs (-0.63 VAS points, 95% CI -1.09 to -0.17; 152 women; very low-certainty evidence), although the evidence is very uncertain. We are uncertain about cold cabbage leaves compared to room temperature cabbage leaves, room temperature cabbage leaves compared to hot water bag, and cabbage leaf extract cream compared to placebo cream because the CIs were wide and included no effect. For breast hardness, cold cabbage leaves may be more effective than routine care (MD -0.58 VAS points, 95% CI -0.82 to -0.34; 152 women; low-certainty evidence). We are uncertain about cold cabbage leaves compared to cold gel packs because the CIs were wide and included no effect. For breast engorgement, room temperature cabbage leaves may be more effective than a hot water bag (MD -1.16 points on 1-6 scale, 95% CI -1.36 to -0.96; 63 women; very low-certainty evidence). We are uncertain about cabbage leaf extract cream compared to placebo cream because the CIs were wide and included no effect. More women were satisfied with cold cabbage leaves than with routine care (risk ratio (RR) 1.42, 95% CI 1.22 to 1.64; 152 women; low certainty), or with cold gel packs (RR 1.23, 95% CI 1.10 to 1.38; 152 women; low-certainty evidence). We are uncertain if women breastfeed longer following treatment with cold cabbage leaves than routine care because CIs were wide and included no effect. Breast swelling and adverse events were not reported. Compress treatments compared to control For breast pain, herbal compress may be more effective than hot compress (MD -1.80 VAS points, 95% CI -2.07 to -1.53; 500 women; low-certainty evidence). Massage therapy plus cactus and aloe compress may be more effective than massage therapy alone (MD -1.27 VAS points, 95% CI -1.75 to -0.79; 100 women; low-certainty evidence). In a comparison of cactus and aloe compress to massage therapy, the CIs were wide and included no effect. For breast hardness, cactus and aloe cold compress may be more effective than massage (RR 0.66, 95% CI 0.51 to 0.87; 102 women; low-certainty evidence). Massage plus cactus and aloe cold compress may reduce the risk of breast hardness compared to massage alone (RR 0.38, 95% CI 0.25 to 0.58; 100 women; low-certainty evidence). We are uncertain about the effects of compress treatments on breast engorgement and cessation of breastfeeding because the certainty of evidence was very low. Among women receiving herbal compress treatment, 2/250 experienced skin irritation compared to 0/250 in the hot compress group (moderate-certainty evidence). Breast swelling and women's opinion of treatment were not reported. Medical treatments compared to placebo Protease may reduce breast pain (RR 0.17, 95% CI 0.04, 0.74; low-certainty evidence; 59 women) and breast swelling (RR 0.34, 95% CI 0.15 to 0.79; 59 women; low-certainty evidence), whereas serrapeptase may reduce the risk of engorgement compared to placebo (RR 0.36, 95% CI 0.14 to 0.88; 59 women; low-certainty evidence). We are uncertain if serrapeptase reduces breast pain or swelling, or if oxytocin reduces breast engorgement compared to placebo, because the CIs were wide and included no effect. No women experienced adverse events in any of the groups receiving serrapeptase, protease or placebo (low-certainty evidence). Breast induration/hardness, women's opinion of treatment and breastfeeding cessation were not reported. Cold gel packs compared to control For breast pain, we are uncertain about the effectiveness of cold gel packs compared to control treatments because the certainty of evidence was very low. For breast hardness, cold gel packs may be more effective than routine care (MD -0.34 points on 1-6 scale, 95% CI -0.60 to -0.08; 151 women; low-certainty evidence). It is uncertain if women breastfeed longer following cold gel pack treatment compared to routine care because the CIs were wide and included no effect. There may be little difference in women's satisfaction with cold gel packs compared to routine care (RR 1.17, 95% CI 0.97 to 1.40; 151 women; low-certainty evidence). Breast swelling, engorgement and adverse events were not reported. AUTHORS' CONCLUSIONS: Although some interventions may be promising for the treatment of breast engorgement, such as cabbage leaves, cold gel packs, herbal compresses, and massage, the certainty of evidence is low and we cannot draw robust conclusions about their true effects. Future trials should aim to include larger sample sizes, using women - not individual breasts - as units of analysis.

Treatments for breast engorgement during lactation. BACKGROUND: Breast engorgement is a painful condition affecting large numbers of women in the early postpartum period. It may lead to premature weaning, cracked nipples, mastitis and breast abscess. Various forms of treatment for engorgement have been studied but so far little evidence has been found on an effective intervention. OBJECTIVES: This is an update of a systematic review first published by Snowden et al. in 2001 and subsequently published in 2010. The objective of this update is to seek new information on the best forms of treatment for breast engorgement in lactating women. SEARCH METHODS: We identified studies for inclusion through the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2015) and searched reference lists of retrieved studies. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for eligibility, extracted data and conducted 'Risk of bias' assessments. Where insufficient data were presented in trial reports, we attempted to contact study authors and obtain necessary information. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: In total, we included 13 studies with 919 women. In 10 studies individual women were the unit of analysis and in three studies, individual breasts were the unit of analysis. Four out of 13 studies were funded by an agency with a commercial interest, two received charitable funding, and two were funded by government agencies.Trials examined interventions including non-medical treatments: cabbage leaves (three studies), acupuncture (two studies), ultrasound (one study), acupressure (one study), scraping therapy (Gua Sha) (one study), cold breast-packs and electromechanical massage (one study), and medical treatments: serrapeptase (one study), protease (one study) and subcutaneous oxytocin (one study). The studies were small and used different comparisons with only single studies contributing data to outcomes of this review. We were unable to pool results in meta-analysis and only seven studies provided outcome data that could be included in data and analysis. Non-medical No differences were observed in the one study comparing acupuncture with usual care (advice and oxytocin spray) (risk ratio (RR) 0.50, 95% confidence interval (CI) 0.13 to 1.92; one study; 140 women) in terms of cessation of breastfeeding. However, women in the acupuncture group were less likely to develop an abscess (RR 0.20, 95% CI 0.04 to 1.01; one study; 210 women), had less severe symptoms on day five (RR 0.84, 95% CI 0.70 to 0.99), and had a lower rate of pyrexia (RR 0.82, 95% CI 0.72 to 0.94) than women in the usual care group.In another study with 39 women comparing cabbage leaf extract with placebo, no differences were observed in breast pain (mean difference (MD) 0.40, 95% CI -0.67 to 1.47; low-quality evidence) or breast engorgement (MD 0.20, 95% CI -0.18 to 0.58; low-quality evidence). There was no difference between ultrasound and sham treatment in analgesic requirement (RR 0.98, 95% CI 0.63 to 1.51; one study; 45 women; low-quality evidence). A study comparing Gua-Sha therapy with hot packs and massage found a marked difference in breast engorgement (MD -2.42, 95% CI -2.98 to -1.86; one study; 54 women), breast pain (MD -2.01, 95% CI -2.60 to -1.42; one study; 54 women) and breast discomfort (MD -2.33, 95% CI -2.81 to -1.85; one study; 54 women) in favour of Gua-Sha therapy five minutes post-intervention, though both interventions significantly decreased breast temperature, engorgement, pain and discomfort at five and 30 minutes post-treatment.Results from individual trials that could not be included in data analysis suggested that there were no differences between room temperature and chilled cabbage leaves and between chilled cabbage leaves and gel packs, with all interventions producing some relief. Intermittent hot/cold packs applied for 20 minutes twice a day were found to be more effective than acupressure (P < 0.001). Acupuncture did not improve maternal satisfaction with breastfeeding. In another study, women who received breast-shaped cold packs were more likely to experience a reduction in pain intensity than women who received usual care; however, the differences between groups at baseline, and the failure to observe randomisation, make this study at high risk of bias. One study found a decrease in breast temperature (P = 0.03) following electromechanical massage and pumping in comparison to manual methods; however, the high level of attrition and alternating method of sequence generation place this study at high risk of bias. MedicalWomen treated with protease complex were less likely to have no improvement in pain (RR 0.17, 95% CI 0.04 to 0.74; one study; 59 women) and swelling (RR 0.34, 95% CI 0.15 to 0.79; one study; 59 women) on the fourth day of treatment and less likely to experience no overall change in their symptoms or worsening of symptoms (RR 0.26, 95% CI 0.12 to 0.56). It should be noted that it is more than 40 years since the study was carried out, and we are not aware that this preparation is used in current practice. Subcutaneous oxytocin provided no relief at all in symptoms at three days (RR 3.13, 95% CI 0.68 to 14.44; one study; 45 women).Serrapeptase was found to produce some relief in breast pain, induration and swelling, when compared to placebo, with a fewer number of women experiencing slight to no improvement in overallbreast engorgement, swelling and breast pain.Overall, the risk of bias of studies in the review is high. The overall quality as assessed using the GRADE approach was found to be low due to limitations in study design and the small number of women in the included studies, with only single studies providing data for analysis. AUTHORS' CONCLUSIONS: Although some interventions such as hot/cold packs, Gua-Sha (scraping therapy), acupuncture, cabbage leaves and proteolytic enzymes may be promising for the treatment of breast engorgement during lactation, there is insufficient evidence from published trials on any intervention to justify widespread implementation. More robust research is urgently needed on the treatment of breast engorgement.