Background <p>Breast engorgement is a common postpartum condition affecting many lactating women and represents a significant maternal health concern, often leading to pain, breast hardness, impaired infant latch, and early discontinuation of breastfeeding. Therapeutic ultrasound, a non-pharmacological physiotherapy intervention, has been proposed for its management; however, its clinical effectiveness remains uncertain. This study aimed to evaluate the effectiveness and safety of therapeutic ultrasound in reducing pain and engorgement severity among women with postpartum breast engorgement.</p> Methods <p>This systematic review and meta-analysis was prospectively registered in PROSPERO (CRD42024520826). A systematic search of PubMed, Web of Science, Scopus, and Google Scholar was conducted from database inception to January 2026. Only randomised controlled trials (RCTs) were included in the quantitative meta-analysis, while non-randomised studies were included exclusively in the qualitative narrative synthesis. Outcomes were pain (VAS) and engorgement severity (SPES). Risk of bias was assessed using the Cochrane RoB II tool. Meta-analysis was performed using a random-effects model, and mean differences (MD) with 95% confidence intervals (CIs) were calculated.</p> Results <p>Nine studies (<i>n</i> = 466) were included, of which four RCTs (<i>n</i> = 101) contributed to the pain meta-analysis and three RCTs (<i>n</i> = 75) to the engorgement severity analysis. For pain, the pooled estimate under the random-effects model was not statistically significant (MD − 0.84; 95% CI: −1.88 to 0.20), with substantial heterogeneity (I² = 95.8%), indicating considerable variability across studies. For engorgement severity, a statistically significant reduction was observed (MD − 0.25; 95% CI: −0.36 to − 0.13) with no observed heterogeneity (I² = 0%). The certainty of evidence was rated as very low for pain and moderate for engorgement severity using the GRADE approach. No treatment-related adverse events were reported.</p> Conclusion <p>Therapeutic ultrasound may contribute to a reduction in breast engorgement severity when used as an adjunct to conventional therapy; however, the effect is modest and should be interpreted with caution. Evidence for pain reduction remains inconclusive due to heterogeneity and imprecision. While ultrasound appears to be safe, current evidence in maternal health remains limited. Larger, rigorously designed, double-blind, sham-controlled RCTs with standardised protocols are required to establish its clinical effectiveness.</p>

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Clinical Effectiveness and Safety of Therapeutic Ultrasound for Breast Engorgement in Lactating Women: A Systematic Review and Meta-Analysis

  • Jeevarathinam Thirumalai,
  • Logeshwari Venkatesan,
  • Vinodhkumar Ramalingam,
  • Indra Sivakumar,
  • Jeslin GN,
  • Saravanan Sekaran

摘要

Background

Breast engorgement is a common postpartum condition affecting many lactating women and represents a significant maternal health concern, often leading to pain, breast hardness, impaired infant latch, and early discontinuation of breastfeeding. Therapeutic ultrasound, a non-pharmacological physiotherapy intervention, has been proposed for its management; however, its clinical effectiveness remains uncertain. This study aimed to evaluate the effectiveness and safety of therapeutic ultrasound in reducing pain and engorgement severity among women with postpartum breast engorgement.

Methods

This systematic review and meta-analysis was prospectively registered in PROSPERO (CRD42024520826). A systematic search of PubMed, Web of Science, Scopus, and Google Scholar was conducted from database inception to January 2026. Only randomised controlled trials (RCTs) were included in the quantitative meta-analysis, while non-randomised studies were included exclusively in the qualitative narrative synthesis. Outcomes were pain (VAS) and engorgement severity (SPES). Risk of bias was assessed using the Cochrane RoB II tool. Meta-analysis was performed using a random-effects model, and mean differences (MD) with 95% confidence intervals (CIs) were calculated.

Results

Nine studies (n = 466) were included, of which four RCTs (n = 101) contributed to the pain meta-analysis and three RCTs (n = 75) to the engorgement severity analysis. For pain, the pooled estimate under the random-effects model was not statistically significant (MD − 0.84; 95% CI: −1.88 to 0.20), with substantial heterogeneity (I² = 95.8%), indicating considerable variability across studies. For engorgement severity, a statistically significant reduction was observed (MD − 0.25; 95% CI: −0.36 to − 0.13) with no observed heterogeneity (I² = 0%). The certainty of evidence was rated as very low for pain and moderate for engorgement severity using the GRADE approach. No treatment-related adverse events were reported.

Conclusion

Therapeutic ultrasound may contribute to a reduction in breast engorgement severity when used as an adjunct to conventional therapy; however, the effect is modest and should be interpreted with caution. Evidence for pain reduction remains inconclusive due to heterogeneity and imprecision. While ultrasound appears to be safe, current evidence in maternal health remains limited. Larger, rigorously designed, double-blind, sham-controlled RCTs with standardised protocols are required to establish its clinical effectiveness.