Treatments for breast engorgement during lactation

Irena Zakarija-Grkovic; Fiona Stewart

doi:10.1002/14651858.CD006946.pub4

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Figure 1

Study flow diagram.

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Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1: Cabbage leaf treatments versus other treatments/placebo, Outcome 1: Breast pain (0‐10 VAS; higher score = more pain)

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Analysis 1.2

Comparison 1: Cabbage leaf treatments versus other treatments/placebo, Outcome 2: Breast hardness (higher score = more hardness)

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Analysis 1.3

Comparison 1: Cabbage leaf treatments versus other treatments/placebo, Outcome 3: Breast engorgement (measured with 6‐point engorgement scale)

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Analysis 1.4

Comparison 1: Cabbage leaf treatments versus other treatments/placebo, Outcome 4: Maternal opinion of treatment: women satisfied or very satisfied

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Analysis 1.5

Comparison 1: Cabbage leaf treatments versus other treatments/placebo, Outcome 5: Cessation of breastfeeding before six months

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Analysis 2.1

Comparison 2: Compress treatments versus other treatments/routine care, Outcome 1: Breast pain (higher score = more pain)

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Analysis 2.2

Comparison 2: Compress treatments versus other treatments/routine care, Outcome 2: Number of women with moderate or severe breast induration/hardness

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Analysis 2.3

Comparison 2: Compress treatments versus other treatments/routine care, Outcome 3: Breast engorgement (higher score = more pain)

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Analysis 2.4

Comparison 2: Compress treatments versus other treatments/routine care, Outcome 4: Cessation of breastfeeding

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Analysis 2.5

Comparison 2: Compress treatments versus other treatments/routine care, Outcome 5: Number of women with adverse effects

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Analysis 3.1

Comparison 3: Medical treatment versus placebo, Outcome 1: Breast swelling (no improvement)

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Analysis 3.2

Comparison 3: Medical treatment versus placebo, Outcome 2: Breast engorgement (symptoms not subsided after three days of treatment)

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Analysis 3.3

Comparison 3: Medical treatment versus placebo, Outcome 3: Breast pain (no improvement)

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Analysis 4.1

Comparison 4: Cold gel packs versus routine care, Outcome 1: Breast pain (higher score = more pain)

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Analysis 4.2

Comparison 4: Cold gel packs versus routine care, Outcome 2: Breast hardness (higher score = more hardness)

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Analysis 4.3

Comparison 4: Cold gel packs versus routine care, Outcome 3: Maternal opinion of treatment: women satisfied or very satisfied

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Analysis 4.4

Comparison 4: Cold gel packs versus routine care, Outcome 4: Cessation of breastfeeding before six months

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Analysis 5.1

Comparison 5: Massage‐based therapies versus other treatments/routine care, Outcome 1: Breast pain (higher score = more pain)

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Analysis 5.2

Comparison 5: Massage‐based therapies versus other treatments/routine care, Outcome 2: Number of women with moderate or severe breast induration/hardness

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Analysis 5.3

Comparison 5: Massage‐based therapies versus other treatments/routine care, Outcome 3: Cessation of breastfeeding

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Analysis 6.1

Comparison 6: Other treatments versus other treatments/advice/routine care, Outcome 1: Breast pain (0‐10 VAS; higher score = more pain)

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Analysis 6.2

Comparison 6: Other treatments versus other treatments/advice/routine care, Outcome 2: Breast engorgement (0‐10 VAS; higher score = more pain)

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Analysis 6.3

Comparison 6: Other treatments versus other treatments/advice/routine care, Outcome 3: Breast engorgement

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Analysis 6.4

Comparison 6: Other treatments versus other treatments/advice/routine care, Outcome 4: Cessation of breastfeeding within 6 weeks

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Analysis 6.5

Comparison 6: Other treatments versus other treatments/advice/routine care, Outcome 5: Pyrexia

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Analysis 6.6

Comparison 6: Other treatments versus other treatments/advice/routine care, Outcome 6: Breast abscess

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Analysis 7.1

Comparison 7: Ultrasound versus sham ultrasound, Outcome 1: Analgesic requirement

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Summary of findings 1. Cabbage leaf treatments versus other treatments/placebo for breast engorgement during lactation

Outcomes	Impact	№ of participants (studies)	Certainty of the evidence (GRADE)
Cabbage leaf treatments versus other treatments/placebo for breast engorgement during lactation
Patient or population: women with breast engorgement during lactation Setting: obstetric outpatient clinic Intervention: cabbage leaf treatments Comparison: control treatments
Breast pain assessed with: 0‐10 visual analogue scale (higher score = greater pain), follow‐up: range from 2 hours to 36 hours	One study found cold cabbage leaves to be more effective than routine care (MD ‐1.03, 95% CI ‐1.53 to ‐0.53; 1 study; 152 women) or cold gel packs (‐0.63, 95% CI ‐1.09 to ‐0.17; 1 study; 151 women). Another study found cold cabbage leaves to be slightly more effective than room temperature cabbage leaves but the data were reported in a way that was unsuitable for analysis (1 study, 28 women). One study found room temperature cabbage leaves to be slightly more effective than hot water bag but with wide confidence intervals that included no effect (MD ‐0.16, 95% CI ‐0.39 to 0.07; 1 study; 63 women). One study found cabbage leaf extract cream to be slightly less effective than placebo cream but with wide confidence intervals that included no effect (MD 0.40, 95% CI ‐0.67 to 1.47; 1 study; 39 women).	393 (4 RCTs) data not pooled	⊕⊝⊝⊝ VERY LOW ^{1 2 3}
Breast induration/hardness assessed with: 1‐6 breast engorgement assessment scale (higher score = greater hardness), follow‐up: 4 hours	One study found cold cabbage leaves to be more effective than routine care (MD ‐0.58, 95% CI ‐0.82 to ‐0.34; 1 study 152 women). The same study found cold cabbage leaves to be slightly more effective than cold gel packs but with wide confidence intervals that included no effect (MD ‐0.24, 95% CI ‐0.48 to ‐0.00; 1 study; 151 women).	227 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 3}
Breast swelling	Not reported
Breast engorgement assessed with: 1‐6 breast engorgement assessment scale (higher score = greater engorgement), follow‐up: range from 2 hours to 36 hours	One study found room temperature cabbage leaves to be more effective than hot water bag (MD‐1.16, 95% CI ‐1.36 to ‐0.96; 1 study; 63 women). One study found cabbage leaf extract cream to be slightly less effective than placebo cream but with wide confidence intervals that included no effect (MD 0.20, 95% CI ‐0.18 to 0.58; 1 study; 39 women).	102 (2 RCTs) data not pooled	⊕⊝⊝⊝ VERY LOW ^{1 2 3}
Maternal opinion of treatment follow‐up: 4 hours	In one study, 29% more women were satisfied or very satisfied with cold cabbage leaves than with routine care (RR 1.42, 95% CI 1.22 to 1.63; 152 women). In the same study, 19% more women were satisfied or very satisfied with cold cabbage leaves than with cold gel packs (RR 1.23, 95% CI 1.10 to 1.38; 152 women).	228 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 3}
Cessation of breastfeeding follow‐up: 6 months	In one study, slightly more women in the cold cabbage leaf group stopped breastfeeding within 6 months than in the routine care group (RR 1.75, 95% CI 0.93 to 3.30; 108 women) or the cold gel pack group (RR 1.70, 95% CI 0.92 to 3.13; 111 women) but the confidence intervals were wide and included no effect.	111 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 3}
Number of women with adverse events	Not reported
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Downgraded one level due to risk of detection bias and performance bias in most studies ² Downgraded one level for inconsistency due to large variation in the extent to which the intervention had an effect ³ Downgraded one level for imprecision due to small number of participants

Summary of findings 1. Cabbage leaf treatments versus other treatments/placebo for breast engorgement during lactation

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Summary of findings 2. Compress treatments versus other treatments/routine care for breast engorgement during lactation

Outcomes	Impact	№ of participants (studies)	Certainty of the evidence (GRADE)
Compress treatments versus other treatments/routine care for breast engorgement during lactation
Patient or population: women with breast engorgement during lactation Setting: obstetric outpatient clinic Intervention: compress treatments Comparison: control treatments
Breast pain assessed with: 0‐10 visual analogue scale (higher score = greater pain), follow‐up: range from 20 minutes to 7 days	One study found herbal compress to be more effective than hot compress (MD ‐1.80, 95% CI ‐2.07 to ‐1.53; participants = 500; studies = 1). Another study found cactus and aloe compress to be slightly less effective than massage therapy but with wide confidence intervals that included no effect (MD 0.17, 95% CI ‐0.55 to 0.89; participants = 102; studies = 1). One study found massage therapy plus cactus and aloe compress to be more effective than massage therapy alone (MD ‐1.27, 95% CI ‐1.75 to ‐0.79; participants = 100; studies = 1).	602 (2 RCTs) data not pooled	⊕⊕⊝⊝ LOW ¹
Breast induration/hardness assessed with: presence of moderate or severe breast induration, follow‐up: 7 days	One study found 28.6% fewer women had breast hardness with cactus and aloe cold compress compared to massage therapy (RR 0.66, 95% CI 0.51 to 0.87; participants = 102; studies = 1). The same study found 52.1% fewer women had breast hardness with massage plus cactus and aloe compress alone compared to massage alone (RR 0.38, 95% CI 0.25 to 0.58; participants = 100; studies = 1).	152 (1 RCT)	⊕⊕⊝⊝ LOW ¹
Breast swelling	Not reported
Breast engorgement assessed with: 0‐19 breast engorgement assessment scale (higher score = greater pain), follow‐up: range from 2 days to 7 days	One study found herbal compress with hollyhock leaf to be more effective than warm compress (MD ‐2.82, 95% CI ‐4.60 to ‐1.04; participants = 40; studies = 1). One study found lower engorgement scores in the ginger compress group compared to the routine care group but since the data were reported according to left and right breast it is unclear what the true effect is.	116 (2 RCTs) data not pooled	⊕⊝⊝⊝ VERY LOW ^{1 2 3}
Maternal opinion of treatment	Not reported
Cessation of breastfeeding, follow‐up: 7 days	In one study, 9/52 women in the cactus and aloe cold compress group stopped breastfeeding compared to 8/50 women in the massage group. In the same study, 2/50 women in the cactus and aloe cold compress plus massage therapy group stopped breastfeeding compared to 8/50 women in the massage group.	102 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 3}
Number of women with adverse events, follow‐up: 24 hours	One study found more women in the herbal compress group had adverse events (skin irritation) compared to the hot compress group (2/250 and 0/250, respectively) (RR 5.00, 95% CI 0.24 to 103.62; 1 study; 500 women)	500 (1 RCT)	⊕⊕⊕⊝ MODERATE ⁴
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Downgraded two levels due to risk of selection, detection and performance bias ² Downgraded one level due to indirectness: some data reported per breast ³ Downgraded one level for imprecision due to small number of participants ⁴ Downgraded one level for imprecision: few events and wide confidence interval including no effect

Summary of findings 2. Compress treatments versus other treatments/routine care for breast engorgement during lactation

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Summary of findings 3. Medical treatments versus placebo for breast engorgement

Outcomes	Impact	№ of participants (studies)	Certainty of the evidence (GRADE)
Medical treatments versus placebo for breast engorgement
Patient or population: women with breast engorgement Setting: obstetric outpatient clinic Intervention: medical treatments (oxytocin, serrapeptase or protease) Comparison: placebo
Breast pain assessed with: presence of moderate or severe pain, follow‐up: range from 3 to 4 days	One study found 27.7% fewer women experienced breast pain with protease than with placebo (RR 0.17, 95% CI 0.04 to 0.74; participants = 59; studies = 1). Another study found fewer women experienced breast pain with serrapeptase than with placebo but with wide confidence intervals that included no effect (RR 0.56, 95% CI 0.21 to 1.49; participants = 70; studies = 1).	70 (2 RCTs) data not pooled	⊕⊕⊝⊝ LOW ^{1 2}
Breast induration/hardness	Not reported
Breast swelling assessed with: no improvement in breast swelling, follow‐up: 4 days	In one study, 33.0% fewer women had breast swelling with protease compared to placebo (RR 0.34, 95% CI 0.15 to 0.79; participants = 59; studies = 1) and one study found a slightly lower risk with serrapeptase compared to placebo but with wide confidence intervals that included no effect (RR 0.75, 95% CI 0.36 to 1.55; participants = 70; studies = 1).	129 (2 RCTs) data not pooled	⊕⊕⊝⊝ LOW ^{1 2}
Breast engorgement, follow‐up: range from 3 to 7 days	In one study, 25.6% fewer women had breast engorgement with serrapeptase than with placebo (RR 0.36, 95% CI 0.14 to 0.88; participants = 70; studies = 1). One study found a greater risk of symptoms persisting after 3 days of treatment with oxytocin than with placebo but with wide confidence intervals that included no effect (RR 3.13, 95% CI 0.68 to 14.44; participants = 45; studies = 1).	115 (2 RCTs) data not pooled	⊕⊕⊝⊝ LOW ^{1 2}
Maternal opinion of treatment	Not reported
Cessation of breastfeeding	Not reported
Number of women with adverse events, follow‐up: range from 3 to 4 days	In one study, there were no adverse events in either the serrapeptase group or the placebo group. In another study, there were no adverse events in either the protease group or the placebo group.	129 (2 RCTs) data not pooled	⊕⊕⊝⊝ LOW ^{2 3}
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Downgraded one level due to serious risk of allocation bias ² Downgraded one level due to serious imprecision: very few events ³ Downgraded two levels due to risk of allocation bias and bias arising from industry funding

Summary of findings 3. Medical treatments versus placebo for breast engorgement

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Summary of findings 4. Cold gel packs versus routine care for breast engorgement during lactation

Outcomes	Impact	№ of participants (studies)	Certainty of the evidence (GRADE)
Cold gel packs versus routine care for breast engorgement during lactation
Patient or population: women with breast engorgement during lactation Setting: obstetric outpatient clinic Intervention: cold gel packs Comparison: routine care
Breast pain assessed with: 0‐10 visual analogue scale (higher score = more pain), follow‐up: range from 2 hours to 8 hours	One study found slightly lower pain scores in the cold gel pack group than in the routine care group but with wide confidence intervals that included no effect (MD ‐0.40, 95% CI ‐0.91, 0.11; 1 study; 151 women). One study found slightly lower pain scores in the cold gel pack group than in the cold cabbage leaf group but since data were reported per breast it is unclear what the true effect is. One study found lower pain scores in the cold pack group than in the control group but the data were not reported in full.	200 (3 RCTs) data not pooled	⊕⊝⊝⊝ VERY LOW ^{1 2}
Breast induration/hardness assessed with: 1‐6 breast engorgement assessment scale (higher score = greater hardness), follow‐up: 4 hours	One study found cold gel packs to be more effective than routine care (MD ‐0.34, 955 CI ‐0.60 to ‐0.08; 1 study; 151 women).	151 (1 RCT)	⊕⊕⊝⊝ LOW ^{3 4}
Breast swelling	Not reported
Breast engorgement	Not reported
Maternal opinion of treatment, follow‐up: range from 2 to 4 hours	In one study, slightly more women in the cold gel pack group were satisfied or very satisfied than in the routine care group but the confidence intervals were wide and included no effect (RR 1.17, 95% CI 0.97 to 1.40; 1 study; 151 women). Another study found two‐thirds of 34 women preferred cold cabbage leaves to cold gel packs.	151 (1 RCT)	⊕⊕⊝⊝ LOW ^{3 4}
Cessation of breastfeeding, follow‐up: 6 months	In one study, slightly more women in the cold gel pack group stopped breastfeeding than in the routine care group but the confidence intervals were wide and included no effect (RR 1.03, 955 CI 0.50 to 2.14; 1 study, 109 women).	109 (1 RCT)	⊕⊕⊝⊝ LOW ^{3 4}
Number of women with adverse events	Not reported
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Downgraded two levels due to risk of bias: unclear randomisation procedures, risk of detection and performance bias ² Downgraded one level due to indirectness: some data reported per breast ³ Downgraded one level due to risk of detection bias and performance bias ⁴ Downgraded one level for imprecision due to small number of participants

Summary of findings 4. Cold gel packs versus routine care for breast engorgement during lactation

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Summary of findings 5. Massage‐based therapies versus other treatments/routine care for women with breast engorgement during lactation

Outcomes	Impact	№ of participants (studies)	Certainty of the evidence (GRADE)
Massage‐based therapies versus other treatments/routine care for women with breast engorgement during lactation
Patient or population: women with breast engorgement during lactation Setting: obstetric clinic Intervention: massage‐based therapies Comparison: control treatments
Breast pain assessed with: 0‐10 visual analogue scale (higher score = greater pain), follow‐up: 7 days	One study found massage plus cactus and aloe cold compress was more effective than cactus and aloe cold compress alone (MD ‐1.44, 95% CI ‐2.14 to ‐0.74; 1 study; 102 women).	102 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 2}
Breast induration/hardness assessed with: presence of moderate or severe breast induration, follow‐up: 7 days	One study found 24% fewer women had breast induration with massage plus cactus and aloe cold compress compared to cactus and aloe cold compress alone (RR 0.57, 955 CI 0.36 to 0.92; 1 study; 102 women).	102 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 2}
Breast swelling	Not reported
Breast engorgement assessed with: 0‐19 breast engorgement assessment scale or 0‐10 visual analogue scale (higher score = greater pain), follow‐up: 2 days	One study found lower breast engorgement scores in women who had Oketani massage than those who had routine care but the data were reported per breast so the true effect is unclear.	100 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 3}
Maternal opinion of treatment	Not reported
Cessation of breastfeeding, follow‐up: 7 days	In one study, slightly fewer women in the massage plus cactus and aloe cold compress group stopped breastfeeding than in the cactus and aloe cold compress only group but the confidence intervals were wide and included no effect (RR 0.23, 95% CI 0.05 to 1.02; 1 study; 152 women).	152 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 2}
Number of women with adverse events	Not reported
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Downgraded one level due to risk of selection, detection and performance bias ² Downgraded one level for imprecision due to small number of participants ³ Downgraded one level due to indirectness: data reported per breast instead of per woman

Summary of findings 5. Massage‐based therapies versus other treatments/routine care for women with breast engorgement during lactation

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Summary of findings 6. Other treatments versus other treatments/advice/routine care for women with breast engorgement during lactation

Outcomes	Impact	№ of participants (studies)	Certainty of the evidence (GRADE)
Other treatments versus other treatments/advice/routine care for women with breast engorgement during lactation
Patient or population: women with breast engorgement during lactation Setting: obstetric outpatient clinic Intervention: other therapies Comparison: control treatments
Breast pain assessed with: 0‐10 visual analogue scale (higher score = greater pain), follow‐up: 30 minutes	One study found Gua‐Sha therapy was more effective than hot packs with massage (MD ‐2.01, 95% CI ‐2.60 to ‐1.42; 1 study; 54 women).	54 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 2}
Breast induration/hardness	Not reported
Breast swelling	Not reported
Breast engorgement assessed with: 0‐19 breast engorgement assessment scale or 0‐10 visual analogue scale (higher score = greater pain), follow‐up: range from 30 minutes to 6 weeks	One study found Gua‐Sha therapy was more effective than hot packs with massage (MD ‐2.42, 95% CI ‐2.98 to ‐1.86; 1 study; 54 women). One study found fewer women had breast engorgement symptoms with acupuncture than with usual care but the confidence intervals were wide and included no effect (RR 0.72, 95% CI 0.47 to 1.10; 1 study; 210 women). One study found lower breast engorgement scores in women who had acupressure than those who had routine care but the data were reported per breast so the true effect is unclear.	328 (3 RCTs) data not pooled	⊕⊝⊝⊝ VERY LOW ^{1 3 4}
Maternal opinion of treatment	Not reported
Cessation of breastfeeding, follow‐up: 6 weeks	In one study, slightly fewer women stopped breastfeeding in the acupuncture group than in the usual care group but the confidence intervals were wide and included no effect (RR 0.72, 95% CI 0.17 to 1.49; 1 study; 210 women).	210 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 5}
Number of women with adverse events	Not reported
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Downgraded one level due to risk of selection and performance bias ² Downgraded one level for imprecision due to small number of participants ³ Downgraded one level for inconsistency: heterogeneity in effect size ⁴ Downgraded one level due to indirectness: some data reported per breast instead of per woman ⁵ Downgraded one level due to imprecision: wide 95% confidence interval consistent with both appreciable harm and benefit

Summary of findings 6. Other treatments versus other treatments/advice/routine care for women with breast engorgement during lactation

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Comparison 1. Cabbage leaf treatments versus other treatments/placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Breast pain (0‐10 VAS; higher score = more pain) Show forest plot	3		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.1.1 Room temperature cabbage leaves versus hot water bag	1	63	Mean Difference (IV, Fixed, 95% CI)	‐0.16 [‐0.39, 0.07]
1.1.2 Cold cabbage leaves versus routine care	1	152	Mean Difference (IV, Fixed, 95% CI)	‐1.03 [‐1.53, ‐0.53]
1.1.3 Cold cabbage leaves versus cold gel packs	1	151	Mean Difference (IV, Fixed, 95% CI)	‐0.63 [‐1.09, ‐0.17]
1.1.4 Cabbage leaf extract versus placebo cream	1	39	Mean Difference (IV, Fixed, 95% CI)	0.40 [‐0.67, 1.47]
1.2 Breast hardness (higher score = more hardness) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.2.1 Cold cabbage leaves versus routine care	1	152	Mean Difference (IV, Fixed, 95% CI)	‐0.58 [‐0.82, ‐0.34]
1.2.2 Cold cabbage leaves versus cold gel packs	1	151	Mean Difference (IV, Fixed, 95% CI)	‐0.24 [‐0.48, ‐0.00]
1.3 Breast engorgement (measured with 6‐point engorgement scale) Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.3.1 Room temperature cabbage leaves versus hot water bag	1	63	Mean Difference (IV, Fixed, 95% CI)	‐1.16 [‐1.36, ‐0.96]
1.3.2 Cabbage leaf extract versus placebo cream	1	39	Mean Difference (IV, Fixed, 95% CI)	0.20 [‐0.18, 0.58]
1.4 Maternal opinion of treatment: women satisfied or very satisfied Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

1.4.1 Cold cabbage leaves versus routine care	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
1.4.2 Cold cabbage leaves versus cold gel packs	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
1.5 Cessation of breastfeeding before six months Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

1.5.1 Cold cabbage leaves versus routine care	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
1.5.2 Cold cabbage leaves versus cold gel packs	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 1. Cabbage leaf treatments versus other treatments/placebo

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Comparison 2. Compress treatments versus other treatments/routine care

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Breast pain (higher score = more pain) Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1.1 Herbal compress versus hot compress	1	500	Mean Difference (IV, Fixed, 95% CI)	‐1.80 [‐2.07, ‐1.53]
2.1.2 Cactus & aloe cold compress versus massage therapy	1	102	Mean Difference (IV, Fixed, 95% CI)	0.17 [‐0.55, 0.89]
2.1.3 Cactus & aloe cold compress plus massage versus massage alone	1	100	Mean Difference (IV, Fixed, 95% CI)	‐1.27 [‐1.75, ‐0.79]
2.2 Number of women with moderate or severe breast induration/hardness Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.2.1 Cactus & aloe cold compress versus massage therapy	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.51, 0.87]
2.2.2 Cactus & aloe cold compress plus massage versus massage alone	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.38 [0.25, 0.58]
2.3 Breast engorgement (higher score = more pain) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.3.1 Hollyhock leaf compress versus warm compress	1	40	Mean Difference (IV, Fixed, 95% CI)	‐2.82 [‐4.60, ‐1.04]
2.4 Cessation of breastfeeding Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.4.1 Cactus & aloe cold compress versus massage therapy	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.45, 2.58]
2.4.2 Cactus & aloe cold compress plus massage versus massage alone	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.25 [0.06, 1.12]
2.5 Number of women with adverse effects Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.5.1 Herbal compress versus hot compress	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 2. Compress treatments versus other treatments/routine care

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Comparison 3. Medical treatment versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Breast swelling (no improvement) Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1.1 Protease complex versus placebo	1	59	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.15, 0.79]
3.1.2 Serrapeptase versus placebo	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.36, 1.55]
3.2 Breast engorgement (symptoms not subsided after three days of treatment) Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.2.1 Oxytocin versus placebo	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	3.12 [0.68, 14.44]
3.2.2 Serrapeptase versus placebo	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	0.36 [0.14, 0.88]
3.3 Breast pain (no improvement) Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.3.1 Protease complex versus placebo	1	59	Risk Ratio (M‐H, Fixed, 95% CI)	0.17 [0.04, 0.74]
3.3.2 Serrapeptase versus placebo	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.21, 1.49]

Comparison 3. Medical treatment versus placebo

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Comparison 4. Cold gel packs versus routine care

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Breast pain (higher score = more pain) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

4.2 Breast hardness (higher score = more hardness) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

4.3 Maternal opinion of treatment: women satisfied or very satisfied Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.4 Cessation of breastfeeding before six months Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 4. Cold gel packs versus routine care

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Comparison 5. Massage‐based therapies versus other treatments/routine care

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 Breast pain (higher score = more pain) Show forest plot	1	102	Mean Difference (IV, Fixed, 95% CI)	‐1.44 [‐2.14, ‐0.74]

5.2 Number of women with moderate or severe breast induration/hardness Show forest plot	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	0.57 [0.36, 0.92]

5.3 Cessation of breastfeeding Show forest plot	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	0.23 [0.05, 1.02]

Comparison 5. Massage‐based therapies versus other treatments/routine care

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Comparison 6. Other treatments versus other treatments/advice/routine care

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
6.1 Breast pain (0‐10 VAS; higher score = more pain) Show forest plot	1	54	Mean Difference (IV, Fixed, 95% CI)	‐2.01 [‐2.60, ‐1.42]

6.1.1 Gua‐Sha therapy versus hot packs and massage	1	54	Mean Difference (IV, Fixed, 95% CI)	‐2.01 [‐2.60, ‐1.42]
6.2 Breast engorgement (0‐10 VAS; higher score = more pain) Show forest plot	1	54	Mean Difference (IV, Random, 95% CI)	‐2.42 [‐2.98, ‐1.86]

6.2.1 Gua‐Sha therapy versus hot packs and massage	1	54	Mean Difference (IV, Random, 95% CI)	‐2.42 [‐2.98, ‐1.86]
6.3 Breast engorgement Show forest plot	1	210	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.47, 1.10]

6.3.1 Acupuncture versus routine care	1	210	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.47, 1.10]
6.4 Cessation of breastfeeding within 6 weeks Show forest plot	1	210	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.17, 1.49]

6.4.1 Acupuncture versus routine care	1	210	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.17, 1.49]
6.5 Pyrexia Show forest plot	1	210	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.72, 0.94]

6.5.1 Acupuncture versus routine care	1	210	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.72, 0.94]
6.6 Breast abscess Show forest plot	1	210	Risk Ratio (M‐H, Fixed, 95% CI)	0.20 [0.04, 1.01]

6.6.1 Acupuncture versus routine care	1	210	Risk Ratio (M‐H, Fixed, 95% CI)	0.20 [0.04, 1.01]

Comparison 6. Other treatments versus other treatments/advice/routine care

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Comparison 7. Ultrasound versus sham ultrasound

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
7.1 Analgesic requirement Show forest plot	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.63, 1.51]

Comparison 7. Ultrasound versus sham ultrasound

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