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Non-pharmacological interventions for lactational mastitis: a systematic review and meta-analysis protocol
Siyuan Zhang1, Yuehan Ren2, Qiong Zhang1
1Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
BMJ Open
|July 31, 2026
Summary
This systematic review evaluates non-pharmacological treatments for lactational mastitis, a common condition affecting breastfeeding mothers. It aims to clarify the effectiveness and safety of these interventions compared to standard care.
Area of Science:
- Lactational mastitis research
- Evidence-based complementary medicine
- Maternal health and breastfeeding support
Background:
- Lactational mastitis is a prevalent inflammatory condition impacting maternal well-being and breastfeeding duration.
- Concerns about antibiotic resistance and infant microbiome effects drive interest in non-pharmacological mastitis treatments.
- Existing evidence on the comparative effectiveness and safety of interventions like probiotics, ultrasound, and acupuncture is limited.
Purpose of the Study:
- To systematically evaluate the efficacy and safety of non-pharmacological interventions for lactational mastitis.
- To compare non-pharmacological treatments against usual care, placebo, or pharmacological therapies.
- To provide evidence to guide clinical practice and support breastfeeding mothers.
Main Methods:
- Systematic literature search across multiple databases (PubMed, Embase, Web of Science, Cochrane Library, etc.) and trial registries until March 2026.
- Inclusion of randomized controlled trials (RCTs) comparing non-pharmacological interventions with control groups; exclusion of pharmacologically active agents.
- Independent data extraction, risk of bias assessment (Cochrane RoB 2), and meta-analysis (random-effects models) of primary (mastitis resolution) and secondary outcomes.
Main Results:
- Primary outcome: resolution of mastitis (normal body temperature and breast symptoms).
- Secondary outcomes: inflammatory markers, pain intensity, adverse events, breastfeeding continuation, etc.
- Meta-analysis will quantify treatment effects using mean differences or risk ratios with 95% CIs.
Conclusions:
- This systematic review will synthesize evidence on non-pharmacological interventions for lactational mastitis.
- Findings will inform clinical decision-making regarding safe and effective non-pharmacological mastitis management.
- Dissemination through peer-reviewed publications and conference presentations is planned.
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