Clinical factors of prolonged treatment duration in patients with non-puerperal mastitis

Introduction

Non-puerperal mastitis (NPM), also termed chronic mastitis, comprises a group of benign inflammatory breast disorders occurring in women outside the puerperal period. The disease is characterized by a prolonged clinical course, typically lasting 9–12 months, and a high recurrence rate. The principal pathological subtypes are periductal mastitis (PDM) and granulomatous lobular mastitis (GLM) (1). Both conditions commonly present with breast masses and abscess formation. PDM generally manifests as a periareolar mass, whereas GLM more often presents as a unilateral breast mass (2). Despite similarities in clinical presentation, the histopathological characteristics of these subtypes differ substantially. PDM is characterized by chronic inflammatory changes in breast tissue, ductal dilatation, plasma cell infiltration, and abscess formation. In contrast, GLM is defined by non-caseating granulomatous inflammation centered on the lobules, accompanied by infiltration of neutrophils, lymphocytes, plasma cells, and eosinophils (3-5).

According to the 2021 Clinical Practice Guidelines for the Diagnosis and Treatment of NPM issued by the Chinese Society of Breast Surgery (CSBrS), management of NPM remains challenging because of the limited availability of high-level evidence, and treatment strategies vary considerably according to disease stage and clinical presentation (1). Although the guidelines provide a general framework for diagnosis and management, they also acknowledge that the natural history of NPM remains poorly defined and that reliable predictors of treatment duration are lacking. This represents a clinically important gap, particularly given the prolonged course of this otherwise benign condition.

Multiple treatment approaches are currently used for NPM, including conservative management with antibiotics, corticosteroids, immunosuppressive agents, and both systemic and topical traditional Chinese medicine (TCM). Surgical procedures, including needle aspiration, incision and drainage of abscesses, and excision of affected tissue, are also commonly performed (6). Each treatment modality has distinct advantages and limitations, and treatment duration varies widely, ranging from 2 to 24 months, with most patients requiring more than 6 months of treatment (7,8). Previous studies have suggested that GLM may follow a self-limiting course, with spontaneous remission occurring within 6–12 months in up to 50% of patients (9). Nevertheless, a substantial proportion of patients experience a prolonged and debilitating disease course marked by recurrent abscesses, sinus tract formation, and persistent pain, often requiring surgical intervention or prolonged medical therapy.

This clinical heterogeneity raises an important practical question: which patients are suitable for conservative observation, and which may benefit from earlier aggressive intervention? The inability to estimate likely treatment duration limits individualized clinical decision-making and may result in either unnecessary intervention or avoidable disease progression. From a patient-centered perspective, uncertainty regarding recovery duration can contribute substantially to psychological distress, anxiety, and reduced quality of life (10). In addition, the prolonged and unpredictable nature of NPM may adversely affect treatment adherence, particularly in patients receiving TCM-based therapies that require sustained engagement over time (11). Identification of factors associated with time to clinical recovery may therefore facilitate more individualized treatment planning and help clinicians provide realistic expectations regarding disease course, potentially reducing anxiety and improving adherence.

Although several retrospective studies have reported clinical outcomes following different treatment modalities for NPM (7,8,12,13), most have focused primarily on recurrence rates or surgical outcomes rather than on clinical factors that may influence treatment duration. Furthermore, the available literature remains fragmented, with many studies evaluating surgical and conservative management separately and without comprehensive assessment of baseline clinical characteristics that may predict a prolonged disease course. Therefore, the present retrospective cohort study was conducted to evaluate clinical and pathological factors associated with treatment duration in patients with NPM, with the aim of providing evidence to support individualized and evidence-based treatment strategies. We present this article in accordance with the STROBE reporting checklist (available at https://gs.amegroups.com/article/view/10.21037/gs-2026-1-0034/rc).

Methods

Study design

This retrospective study included patients diagnosed with NPM who achieved clinical recovery following treatment at the Department of Traditional Chinese Medicine Surgery, authors’ hospital, between January 2017 and September 2022. Diagnosis was established based on comprehensive evaluation of clinical manifestations and histopathological findings.

Eligible participants were women aged 18–60 years with complete medical records, relevant demographic information, and full follow-up data available for analysis. Patients with hematopoietic disorders, endocrine disorders, other major comorbid conditions, or current pregnancy were excluded.

Treatment duration was defined as the interval from treatment initiation to documented clinical recovery. For descriptive and comparative analyses, patients were categorized into a short-duration group (≤6 months) and a prolonged-duration group (>6 months). This cutoff was selected empirically for analytical stratification and should not be interpreted as a clinically validated definition of prolonged disease course.

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Ethics Committee of China-Japan Friendship Hospital (No. 2022-KY-214). Written informed consent was obtained from all participants.

Treatment protocol

Treatment regimens were documented according to each patient’s clinical presentation. All participants received oral Chinese herbal decoctions in combination with adjunctive external therapies based on TCM principles. Specifically, Golden-yellow ointment and Hibiscus ointment, both prepared by authors’ hospital, were applied because of their reported effects in clearing heat, detoxification, promoting blood circulation, resolving blood stasis, and alleviating swelling and pain.

For patients with lesions involving more than two breast quadrants, a hospital-prepared TCM hot pack was applied locally. During the abscess stage or late ulcerative stage, interventions including fire needling therapy, incision and drainage, and needle aspiration were performed to facilitate pus drainage. In addition, a subset of patients received short-term courses of antibiotics and corticosteroids.

Data collection and observation

Demographic and clinical data were collected, including age, body mass index (BMI), prior treatment history, history of breast trauma, disease duration, and pathological classification. Initial clinical manifestations were documented, including the anatomical location of the breast mass; lesion stage (mass stage, abscess stage, or late ulcerative stage); extent of lesion involvement (confined to 1–2 quadrants vs. diffuse involvement affecting more than two quadrants); and the presence of breast abscess, ulceration or sinus tract formation, nipple discharge, and nipple inversion. Pain severity was evaluated using the numeric rating scale (NRS).

Details of treatments administered at the study hospital were also recorded, including surgical procedures, fire needling therapy, application of topical Chinese medicinal plasters, oral herbal decoctions, use of hot packs, and antibiotic therapy. Treatment duration was measured in months.

Study end point

The primary endpoint was clinical recovery, defined as resolution of clinical symptoms, regression of the breast mass, complete resolution of abscesses, and full healing of associated ulcers. Treatment duration served as the primary outcome measure.

Follow-up

Patients were followed for 1 year through WeChat communication, telephone interviews, and outpatient clinic visits.

Statistical analysis

All statistical analyses were performed using SPSS software, version 25.0. Continuous variables that were not normally distributed were expressed as medians and interquartile ranges (IQRs), and between-group comparisons were conducted using the Wilcoxon rank-sum test. Categorical variables were presented as frequencies and percentages and analyzed using Pearson’s chi-square test.

For multivariate logistic regression analysis, treatment duration (>6 vs. ≤6 months) was treated as a binary outcome variable. Potential predictors were initially evaluated using univariate logistic regression analysis. Variables with a P≤0.20, together with clinically relevant variables, were subsequently entered into the multivariate logistic regression model. These variables included age (years), BMI (kg/m²), disease duration before treatment, lesion area, pathological subtype, presence of nipple inversion, nipple discharge, maximum mass area (cm²), breast pain score, and lesion stage.

For multiple linear regression analysis, treatment duration (months) was treated as a continuous dependent variable. Univariate linear regression analysis was first performed to identify potential predictors. Variables with a P≤0.20, along with additional clinically relevant factors identified based on prior clinical experience, were included in the multivariate linear regression model. The final model was then constructed accordingly.

Results

A total of 121 patients diagnosed with NPM were included in the analysis. The mean age was 36.5±8.09 years. Patients were categorized into a short-duration group (≤6 months) and a prolonged-duration group (>6 months). The short-duration group comprised 74 patients with a median recovery time of 2.81 months, whereas the prolonged-duration group included 47 patients with a median recovery time of 4.87 months.

Analysis of treatment duration distribution showed that 32.2% of patients achieved recovery within 0–3 months (median: 1.6 months), 27.3% within 3–6 months (median: 3.9 months), 15.7% within 6–9 months (median: 6.8 months), and 11.6% within 9–12 months (median: 10 months). In addition, 13.2% of patients required more than 12 months to achieve complete recovery (median: 15.2 months). The overall median recovery time was 4.7 months, with the greatest proportion of patients recovering within 0–3 months (Figure 1).

Figure 1 Distribution of median recovery time within the study population.

No significant differences were observed between the prolonged- and short-duration groups with respect to age, BMI, marital status, number of pregnancies or deliveries, or duration of the most recent lactation (P>0.05). Likewise, pathological subtype and clinical diagnosis did not differ significantly between groups (P>0.05). However, several clinical characteristics differed significantly between the two groups. Compared with the short-duration group, the prolonged-duration group had a higher proportion of patients in the mass stage (P=0.01), with diffuse lesion involvement (P=0.002), breast pain scores >5 (P=0.004), and maximum breast mass area >50 cm² (P=0.001) (Table 1).

With respect to pre-treatment interventions, 59.6% of patients in the prolonged-duration group had received antibiotics before initial presentation, compared with 39.2% in the short-duration group, representing a statistically significant difference (P=0.03). No significant between-group differences were identified in prior use of TCM, corticosteroids, incision and drainage, or needle aspiration (P>0.05) (Table 2).

Among patients in the prolonged-duration group, 53.2% received hyperthermia therapy and 68.1% underwent fire needling therapy. These interventions were used less frequently in the short-duration group (31.1% and 41.9%, respectively), and the differences were statistically significant (P=0.02 and P=0.005, respectively). No significant differences were observed between groups regarding oral TCM administration, antibiotic or corticosteroid therapy, or use of topical Chinese ointments (P>0.05) (Table 3).

No statistically significant differences were found between the two groups in the incidence of wound scar hyperplasia or disease recurrence (P>0.05) (Table 4).

Multivariate logistic regression analysis

Multivariate logistic regression analysis demonstrated a statistically significant association between larger breast mass area and prolonged treatment duration. Specifically, patients with a maximum mass area >50 cm² had a greater likelihood of prolonged treatment duration than those with a maximum mass area ≤50 cm² [odds ratio (OR) =2.70, 95% confidence interval (CI): 1.07–6.78, P=0.04]. No other variables included in the model were significantly associated with treatment duration (P>0.05) (Table 5).

Multiple linear regression analysis

The multiple linear regression model was statistically significant (F=4.360, P<0.001). Several variables were identified as significant predictors of prolonged treatment duration. Absence of nipple inversion was associated with shorter treatment duration (B=−1.644, 95% CI: −3.212 to −0.077; P=0.04). In contrast, maximum breast mass area >50 cm² was significantly associated with longer treatment duration (B=1.980, 95% CI: 0.301–3.659; P=0.02). A breast pain score ≥5 was likewise associated with prolonged treatment duration (B=1.996, 95% CI: 0.455–3.537; P=0.02). In addition, the presence of an abscess during the lesion stage was significantly associated with prolonged treatment duration (B=1.954, 95% CI: 0.235–3.674; P=0.03) (Table 6).

Distribution of median recovery time across subgroups

Subgroup analyses were performed to evaluate the distribution of median recovery time according to key clinical characteristics. The results are presented as box plots (Figure 2).

Figure 2 Distribution of median recovery time across clinical subgroups. Box plots illustrate differences in median recovery times according to key clinical variables: (A) presence or absence of nipple inversion; (B) maximum breast mass area (≤50 vs. >50 cm²); (C) breast pain score (<5 vs. ≥5); (D) lesion stage categorized by the presence or absence of abscess formation. ○: indicates outliers; *: indicates extreme values.

Patients with nipple inversion had a median recovery time of 4.933 months, compared with 3.90 months among those without nipple inversion. Patients with a maximum breast mass area ≤50 cm² had a median recovery time of 3.45 months, whereas those with a maximum breast mass area >50 cm² had a median recovery time of 6.83 months. Patients with a breast pain score <5 demonstrated a median recovery time of 3.40 months, compared with 6.083 months among those with a pain score ≥5.

Regarding lesion stage, patients without abscess formation had a median recovery time of 3.80 months, whereas those with abscess formation had a median recovery time of 6.83 months (Figure 2).

Discussion

Management of NPM remains clinically challenging because of its heterogeneous presentation and frequently prolonged disease course. Previous studies have reported that most patients achieve clinical recovery within
4–12 months, although treatment duration varies according to disease severity, clinical manifestations, treatment strategy, and individual patient characteristics. Surgical excision may shorten the treatment course; however, it is also associated with adverse outcomes, including breast deformity and impaired lactational function. Zhang et al. reported that treatment during the early acute stage lasted approximately 1 month, with postoperative remission achieved within 4–6 months (8). Liang et al. evaluated 84 patients with NPM, among whom 58 underwent local extended excision, resulting in a recovery rate of 93.1% within 0.2–0.7 months (mean: 0.4±0.1 months) (12). The remaining 26 patients, who presented with more extensive and difficult-to-manage lesions, underwent incision and drainage or wound expansion with dressing changes, yielding a lower recovery rate of 46.2% and a longer treatment duration of 4–12 months (mean: 8.1±2.4 months). Reports have also suggested that conservative TCM-based management generally results in recovery within approximately 4 months. Peng et al. compared fire needling therapy (n=63) with incision and drainage (n=32) in patients with NPM (13). The fire needling group achieved a recovery rate of 98.41%, with a mean treatment duration of 97.58±37.04 days, whereas the control group demonstrated a recovery rate of 93.75% and a longer treatment duration of 111.61±36.31 days.

In the present study, the comprehensive TCM-based treatment approach resulted in a mean recovery time of 5.89±4.58 months, which is generally consistent with previous reports. Although the observed recovery duration was longer than that reported for some surgical interventions, the conservative approach may reduce the risk of surgery-related adverse effects.

The primary objective of this study was to identify clinical factors associated with treatment duration. Univariate analyses demonstrated significant associations between treatment duration and lesion stage, lesion extent, breast pain score, maximum breast mass area, prior antibiotic use, hot pack application, and fire needling therapy. Multivariate logistic regression analysis identified maximum breast mass area as an independent factor associated with prolonged treatment duration. Furthermore, multiple linear regression analysis demonstrated that maximum breast mass area >50 cm², breast pain score ≥5, and presence of abscess formation were significantly associated with longer treatment duration. In contrast, absence of nipple inversion was associated with a shorter recovery period.

NPM can be clinically classified into three stages according to disease progression: mass stage, abscess stage, and late ulcerative stage (14). In the present study, lesion staging was determined according to the presence or absence of abscess formation at initial presentation, and treatment strategies were selected based on disease severity. Untreated early-stage lesions may progress to suppuration, ulceration, or sinus tract formation, thereby increasing treatment complexity and prolonging recovery. Patients with abscess formation demonstrated a significantly longer median recovery time than those without abscesses (6.83 vs. 3.80 months, P<0.05). In the multiple linear regression model, abscess formation remained independently associated with prolonged treatment duration (B=1.954, t=2.253, P=0.03; 95% CI: 0.235–3.674), suggesting that it may represent an important prognostic indicator. These findings emphasize the importance of early intervention to prevent disease progression.

The extent of lesion involvement, categorized as localized or diffuse, may also reflect underlying disease severity. Larger lesions generally indicate more extensive tissue involvement and may therefore increase treatment complexity and recovery duration. In the present study, maximum breast mass area emerged as an important prognostic factor. Patients with a maximum mass area >50 cm² had significantly longer treatment duration than those with smaller lesions (OR =2.695, 95% CI: 1.071–6.782; P=0.04).

In 1958, Patey and Thackray described ductal malformation and impaired ductal drainage as key contributors to the pathogenesis of PDM (15). They proposed that extension of squamous epithelium from the ductal orifice into the ductal lumen may lead to obstruction through keratin debris and lipid accumulation, thereby triggering ductal inflammation (16). Nipple inversion, a recognized contributor to ductal obstruction, has long been associated with PDM (17,18). The findings of the present study are consistent with these observations. Presence of nipple inversion was associated with longer treatment duration, whereas absence of nipple inversion predicted a shorter recovery course (B=−1.644, t=−2.080, P=0.04; 95% CI: −3.212 to −0.077). These findings support the importance of timely intervention for nipple inversion in patients with NPM.

Conservative approaches such as nipple traction therapy may be beneficial during treatment, while surgical correction may be considered when clinically appropriate and combined with other procedures (4,16,18). Previous studies have reported favorable outcomes with nipple traction therapy in patients with nipple inversion-related NPM (19). Although breast pain in NPM is typically less severe than in puerperal mastitis, pain intensity may increase substantially during acute inflammation or abscess formation. The present study demonstrated a significant association between higher breast pain scores and prolonged treatment duration (B=1.996, t=2.567, P=0.01; 95% CI: 0.455–3.537). Nevertheless, pain assessment using the NRS remains subject to interindividual variability. Future studies should consider more objective or validated methods for assessing pain severity and its relationship with disease progression in order to minimize potential measurement bias.

For patients with PDM complicated by abscess formation, simultaneous needle aspiration and drainage combined with antibiotic therapy has been reported to improve recovery outcomes (20). In contrast, management of GLM generally requires a combination of pharmacological therapies, including antibiotics, corticosteroids, and immunosuppressive agents, together with surgical intervention (9). Previous studies have reported a complete remission rate of approximately 71.8% with corticosteroid therapy for GLM (21). However, prolonged corticosteroid use may result in adverse effects, including central obesity and gastrointestinal ulceration (22,23). In addition, recurrence rates following corticosteroid discontinuation have been reported to range from 17% to 50% (24). Conservative management may better preserve breast appearance but is associated with a greater likelihood of residual lesions and recurrence. Conversely, surgical excision allows more definitive lesion removal (25), although postoperative recurrence has also been reported (26).

Differences in treatment modalities and patient responses were observed in the present study, particularly regarding use of antibiotics, hot pack therapy, and fire needling during the post-treatment period. Selection of treatment during the abscess stage was primarily based on lesion extent. Fire needling therapy was preferentially used for smaller, localized microabscesses because of its limited tissue damage and favorable cosmetic outcomes. Zheng et al. reported that fire needling therapy was effective in NPM management without significantly affecting breast appearance or pain severity (27).

For abscesses >3 cm in diameter, the decision to perform incision and drainage or needle aspiration was made jointly with the patient after consideration of abscess characteristics and individual preferences. Current clinical guidelines recommend ultrasound-guided needle aspiration as first-line treatment for unilocular abscesses <3 cm, whereas surgical incision and drainage are generally indicated for larger or multiloculated abscesses (1). Given the observational nature of the present study, variation in treatment approaches represents a potential source of confounding that may influence interpretation of treatment efficacy. Consequently, comparative evaluation of specific therapeutic interventions was not the primary objective of this study. Future randomized controlled trials (RCTs) are warranted to compare treatment strategies, reduce potential bias, and support development of standardized treatment protocols.

From a clinical perspective, comprehensive assessment at initial presentation, including detailed medical history, physical examination, and lesion evaluation, may help estimate likely treatment duration and facilitate development of individualized treatment strategies. Providing patients with clear information regarding diagnosis and anticipated recovery course may also help reduce anxiety and improve treatment adherence. In addition, timely and appropriate intervention remains essential for preventing disease progression, shortening treatment duration, alleviating pain, and improving overall quality of life.

Several limitations of this study should be acknowledged. First, the relatively small sample size may limit statistical power and reduce generalizability of the findings. Larger multicenter studies are needed to improve the robustness and external validity of the results.

Second, in construction of the multiple linear regression model, variables with P≤0.20 in univariate analysis were included together with additional clinically relevant variables selected on the basis of clinical experience. Although these variables represent commonly encountered clinical features and were included to enhance clinical applicability, incorporation of 10 independent variables may have introduced model instability. The discrepancy between findings from the multivariate logistic regression and multiple linear regression analyses may partly reflect inclusion of a relatively large number of variables, some of which demonstrated weak statistical associations, thereby reducing interpretability. Future studies should aim to optimize model construction by increasing sample size, reducing the number of included variables, and minimizing potential bias to improve reliability of the findings.

Third, use of multiple linear regression may have been affected by violation of the normality assumption for the dependent variable, particularly given the limited sample size. Although the current model establishes preliminary associations between clinical variables and treatment duration, it does not permit reliable prediction intervals or robust estimation of predictive accuracy. Increasing the sample size in future studies may improve conformity with normality assumptions. Application of regularization approaches, such as least absolute shrinkage and selection operator regression, or use of Cox proportional hazards models may further help validate these preliminary findings and reduce the risk of model overfitting.

Fourth, heterogeneity in treatment strategies represents an inherent limitation of this study. NPM is characterized by diverse clinical presentations and a broad range of therapeutic approaches. In particular, TCM-based treatment is often stage-specific and individualized according to disease progression, resulting in variability in management strategies (28,29). Potential bias arising from these differences in treatment approaches cannot be completely excluded. Future studies are planned to identify and validate optimal treatment strategies and to stratify participants according to treatment regimen.

Conclusions

This study identified several clinical factors associated with prolonged treatment duration in patients with NPM. Larger breast mass area and higher breast pain scores were independently associated with longer recovery duration. In addition, nipple inversion and abscess formation emerged as potential contributors to prolonged treatment duration.

These findings have important clinical implications. Early recognition and appropriate management of these factors may assist clinicians in developing individualized treatment strategies, limiting disease progression, and reducing unnecessary delays in recovery. Future studies should seek to validate these associations through RCTs and further investigate the cellular and molecular mechanisms underlying disease progression. Such efforts may contribute to the development of more effective and standardized treatment approaches.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://gs.amegroups.com/article/view/10.21037/gs-2026-1-0034/rc

Data Sharing Statement: Available at https://gs.amegroups.com/article/view/10.21037/gs-2026-1-0034/dss

Peer Review File: Available at https://gs.amegroups.com/article/view/10.21037/gs-2026-1-0034/prf

Funding: This research was supported by Capital Health Development Research Project (No. First Issue 2022-2-4064): a randomized controlled clinical study on the treatment of non-lactation mastitis and abscess with traditional Chinese medicine Combined Therapy based on fire needle.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://gs.amegroups.com/article/view/10.21037/gs-2026-1-0034/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Ethics Committee of China-Japan Friendship Hospital (No. 2022-KY-214). Written informed consent was obtained from all participants.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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