Obstetrics & Gynecology · Medical Literature
Non-pharmacological interventions for lactational mastitis: a systematic review and meta-analysis protocol
Abstract
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 ( 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 I² statistic. Subgroup and sen
Clinical relevance
Lactational mastitis affects a substantial proportion of breastfeeding women — with reported incidence as high as 33% — and is a leading driver of premature breastfeeding cessation, with significant implications for maternal and infant health. Current standard-of-care reliance on antibiotics raises concerns about antimicrobial resistance and disruption of the neonatal microbiome, creating an urgent need for rigorous evidence on alternative approaches. This protocol addresses a critical evidence gap: no existing systematic review has comprehensively and quantitatively compared the efficacy and safety of the full range of non-pharmacological interventions (probiotics, therapeutic ultrasound, acupuncture, manual therapies) for treating established lactational mastitis.
Key findings
NOTE: This article is a systematic review and meta-analysis PROTOCOL (not a completed review); therefore, no outcome data, effect sizes, confidence intervals, p-values, or NNT/NNH are yet available. The following represent the pre-specified methodological parameters as reported in the protocol abstract: 1. Study design: Only randomised controlled trials (RCTs) enrolling adult lactating women with a confirmed diagnosis of mastitis will be eligible for inclusion. 2. Comparators: Eligible studies must compare non-pharmacological interventions (e.g., probiotics, therapeutic ultrasound, acupuncture, manual therapies) against usual care, placebo, or pharmacological treatments; studies involving pharmacologically active agents as the experimental intervention will be excluded. 3. Primary outcome: Resolution of mastitis, defined as return of body temperature to normal (specific threshold truncated in abstract), to be analysed as a dichotomous outcome using risk ratios with 95% CIs. 4. Statistical approach: Meta-analysis will employ random-effects models; continuous outcomes will be expressed as mean differences (MD) or standardised mean differences (SMD), and heterogeneity will be quantified using the I² statistic. 5. Risk of bias: Independent dual-reviewer assessment using the Cochrane RoB 2 tool, with planned subgroup and sensitivity analyses (full criteria truncated in abstract). 6. Database coverage: Eight international databases (PubMed, Embase, Web of Science, Cochrane Library, CNKI, Wanfang, VIP, SinoMed) plus trial registries will be searched from inception to March 2026, ensuring comprehensive capture of both English- and Chinese-language RCT evidence.
Practice implications
As this is a published protocol rather than a completed systematic review, no evidence-based practice changes can be recommended at this time; clinicians should await the full review results before modifying management pathways. In the interim, practitioners should be aware that existing guidance on non-pharmacological strategies (e.g., optimised feeding technique, breast emptying, lymphatic drainage) is based on low-quality evidence, and that routine use of aggressive heat, massage, or probiotic supplementation remains unsupported by high-certainty data. The forthcoming meta-analysis — with its focus on patient-centred outcomes including mastitis resolution, breastfeeding continuation, recurrence, and safety — is expected to provide actionable, quantitative guidance on which non-pharmacological interventions, if any, should be integrated into first-line or adjunctive management protocols for lactating women with mastitis.