Non-pharmacological interventions for lactational mastitis: a systematic review and meta-analysis protocol

Background

Lactational mastitis is a common inflammatory condition that can adversely affect maternal well-being and is associated with early cessation of breastfeeding. Although antibiotics and analgesics are widely used in clinical practice, concerns regarding antimicrobial resistance and potential effects on the infant microbiome have prompted increasing interest in non-pharmacological approaches. A range of physical and biological interventions, including probiotics, therapeutic ultrasound, acupuncture and manual therapies, have been investigated; however, the comparative effectiveness and safety of these interventions remain unclear. This study aims to systematically evaluate the efficacy and safety of non-pharmacological interventions for lactational mastitis.

Methods and analysis

This protocol is reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. We will systematically search PubMed, Embase, Web of Science, the Cochrane Library, CNKI, Wanfang, VIP and SinoMed as well as relevant trial registries from database inception to March 2026.

We will include randomised controlled trials enrolling adult lactating women diagnosed with mastitis. Eligible studies will compare non-pharmacological interventions with usual care, placebo or pharmacological treatments. Interventions involving pharmacologically active agents will be excluded.

Two reviewers will independently perform study selection, data extraction and risk of bias assessment using the Cochrane RoB 2 tool. The primary outcome will be resolution of mastitis, defined as the return of body temperature to normal (<37°C) and resolution of localised breast symptoms (eg, pain, erythema and swelling). Secondary outcomes will include inflammatory markers (eg, C-reactive protein), pain intensity (measured using the Visual Analogue Scale or similar validated scales), incidence of adverse events, complete blood count parameters, time to symptom resolution or normalisation of body temperature, incidence of breast abscess and breastfeeding continuation rates.

Meta-analysis will be conducted, where appropriate, using random-effects models. Continuous outcomes will be summarised using mean differences or standardised mean differences, and dichotomous outcomes using risk ratios, all with 95% CIs. Statistical heterogeneity will be assessed using the I ² statistic. Subgroup and sensitivity analyses will be performed to explore potential sources of heterogeneity. Publication bias will be assessed using funnel plots and Egger’s test when sufficient studies are available. The certainty of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation（GRADE）approach.

Ethics and dissemination

Ethical approval is not required for this study as it is based on published data. The findings will be disseminated through peer-reviewed publications and conference presentations.

PROSPERO registration number

CRD420261347640.