Idiopathic granulomatous mastitis (IGM

Wiley

The Breast Journal

Volume 2025, Article ID 2997891, 10 pages https://doi.org/10.1155/tbj/2997891

Research Article

Management of Idiopathic Granulomatous Mastitis: Effectiveness of a Steroid-Free Regimen Using Tinospora cordifolia—A Single-Institution Experience

Ankita Das Sheth ,1 Shalaka Joshi ,1 Arul Kumar ,1 Nita Nair ,1 Tanuja Shet ,2 Ayushi Sahay ,2 Palak Thakkar ,3 Purvi Haria ,3 Aparna Katdare ,3 Vani Parmar ,1 Sangeeta Desai ,2 and Rajendra Badwe 1

1Department of Surgical Oncology, Breast Services, Tata Memorial Centre and Homi Bhabha National Institute, Mumbai, India 2Department of Pathology, Breast Services, Tata Memorial Centre and Homi Bhabha National Institute, Mumbai, India 3Department of Radiodiagnosis, Breast Services, Tata Memorial Centre and Homi Bhabha National Institute, Mumbai, India

Correspondence should be addressed to Shalaka Joshi; drjoshishalaka@gmail.com Received 21 June 2024; Accepted 2 December 2024

Academic Editor: Neslihan Cabioglu

Copyright © 2025 Ankita Das Sheth et al. Te Breast Journal published by John Wiley & Sons Ltd. Tis is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Introduction: Idiopathic granulomatous mastitis (IGM) is a benign, chronic infammatory disease with no efective treatment and high relapse rate. Te pathophysiology is poorly understood. Tinosporin, an immunomodulator obtained from Tinospora cordifolia, is known to be useful in treating immune-mediated diseases. We report our experience of using Tinosporin for IGM and the efectiveness of this “steroid-free” regimen.

Methods: We analysed the clinicopathological characteristics of patients diagnosed with IGM on histopathology during January 2018 and December 2022. Tinosporin tablet (500 mg Guduchi stem extract) was prescribed for 3–6 months; data were collected from electronic medical records and analysed in SPSS v-29.

Results: Of 315 patients, 132 had complete clinical records. Median age was 39years (25–77), and 107 (81.7%) were pre- menopausal. Seventy-eight (59.09%) had clinical suspicion of malignancy. On imaging, 84 (63.64%) were BIRADS 4/5 lesions. Empirical broad-spectrum antibiotics were prescribed to 101 patients. Tinosporin tablets were prescribed to 91 patients. Symptomatic response was seen in 72 (79.12%). Five patients did not achieve response, while 14 patients (15.38%) were lost to follow-up. At a median follow-up of 36 months (14–62 months), only 2 patients on Tinosporin had recurrence. None of the patients needed surgical intervention other than diagnostic biopsy or control of infection, and none received steroids. Conclusion: IGM is a benign, often self-limiting disorder. However, it mimics malignancy in 60% cases, and histology clinches the diagnosis. We report the efcacy of steroid-free management of IGM with immunomodulatory herbal origin phytopharma- ceutical drug Tinosporin. It is safe, inexpensive and efective. Large volume excisions or mastectomies can be reserved for severe and refractory cases.

Keywords: idiopathic granulomatous mastitis; immunomodulators; Tinosporin

1. Introduction

Granulomatous mastitis (GM) is a rare, benign, chronic infammatory lesion of the breast, frequently seen in pre- menopausal women, post-childbirth [1]. It was frst de- scribed in 1972 as a lesion clinically simulating breast

carcinoma [2]. It is a distressing condition which often masquerades as breast cancer, leading to diagnostic and therapeutic dilemmas for clinicians, and anxiety for patients. Patients with GM usually present with unilateral, discrete, palpable breast mass or multiple masses, often associated with skin changes, nipple retraction, sinus formation and

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axillary lymph node enlargement. Histologically referred to as granulomatous lobular mastitis, it is considered as sec- ondary GM when associated with trauma, hyper- prolactinaemia, infection (mycobacterial, bacterial or fungal) or sarcoidosis [3, 4]. In the absence of an identifable cause, it is referred to as primary or idiopathic GM (IGM) [3]. Te pathophysiology of IGM is poorly understood, and histologically, it is chronic infammation of ducts and lob- ules secondary to stasis of duct secretions. On imaging, over 50% of them resemble malignant lesions [1, 4]. Te con- siderable overlap of clinical features and radiological fnd- ings between IGM and malignancy makes the defnitive diagnosis difcult, often requiring multiple investigations and repeated biopsies to exclude cancer of the breast [5].

Various lines of management have been described in the literature. Recently, the international multidisciplinary consensus guideline article on GM has provided a com- prehensive review of the aetiopathogenesis and provided treatment recommendations and management pathways [6]. Te difculty in the treatment of IGM lies in its indolent course, diagnostic delays, slow response, lack of an efective treatment and high relapse rates. Te average treatment duration ranges from 3 to 6 months, sometimes lasting up to years. While some believe it to be a self-limiting condition requiring no treatment, the treatment ranges from antibi- otics to immunosuppressants such as steroids, methotrexate and even surgical excision with reconstruction. Some have also used vitamin D supplementation and ozone therapy for the treatment of IGM [7, 8]. Te abundant available liter- ature theorising the aetiopathogenesis and management of IGM refects lack of consensus and variability of practises.

Moreover, the data on the clinicopathological pre- sentation and treatment outcomes in Indian population are scarce. Tere is an overall practice of using steroids for rapid and acute control of symptoms. However, the relief with steroids is only temporary and recrudescence after stopping steroids is common. Recent studies focus on use of che- motherapeutic agents such as methotrexate [3]. Since IGM is thought to be an immune-mediated infammatory condition of the breast, hence immunomodulatory agents may be explored in its treatment. Tinospora cordifolia, also called as Giloy, Guduchi or Amrita, is a well-known Ayurvedic/herbal product used in ancient Indian Ayurvedic medicine to treat jaundice, rheumatism, skin diseases, diabetes, infammation and allergies. Te pharmacological action of the plant is to its chemical constituents such as diterpenoid lactones, glyco- sides, steroids, sesquiterpenoid, phenolics, aliphatic com- pounds, essential oils, a mixture of fatty acids and polysaccharides [9]. We routinely use this drug for the treatment of IGM and rarely use corticosteroids. We ret- rospectively evaluated the efcacy of Guduchi (in the form of a 250-mg tablet) in our cohort of patients with IGM.

2. Materials and Methods

We analysed retrospectively the clinicopathological char- acteristics of patients diagnosed with IGM on histopathology during January 2018 and December 2022. Data regarding disease presentation, clinical symptoms and signs,

radiological fndings, treatment patterns and response rates were obtained from electronic medical records of the hos- pital. All patients had a trucut or incision biopsy. After ruling our malignancy of the breast, the biopsies showing benign breast ducts with lobulocentric mixed infammation, fat necrosis, histiocytic aggregates forming ill-defned or well-defned noncaseating granulomas, with or without microabscesses were subjected to special stains (including acid fast stain for tuberculosis, Gram stain for bacterial infections and Grocott’s methenamine silver (GMS) for fungal infections). After excluding the specifc infective aetiologies, in conjunction with histological fndings, a di- agnosis of IGM was rendered (Figure 1). Whenever ap- propriate, blood investigation and chest X-ray was done, and physician opinion was sought to rule out extrapulmonary tuberculosis. In case of an acute chronic infammation, a course of amoxycillin and clavulanic acid was administered frst before beginning immunomodulatory treatment. After ruling out active infammation or tuberculosis and other causes of GM, patients were prescribed empirical broad- spectrum antibiotics such as ciprofoxacin/doxycycline or clindamycin for an initial period of 2weeks followed by immunomodulatory treatment comprising of Tinosporin capsule for a period of 3–6 months. Patients were followed up at a 3-monthly interval to assess response. Data were collected and analysed in SPSS v-25. Clinicopathological variables were reported as numbers, percentages, and ∗. And the chi-square test was applied for comparison of patients’ response rates when they received Tinosporin versus when they did not.

3. Results

3.1. Clinical Presentation. Tere were a total of 315 patients with histological diagnosis of IGM, of which 132 had complete clinical records and treatment details available. Te rest were mainly referred from outside centres for diagnostic purposes, and patients did not receive treatment at our centre and hence were excluded from this analysis. Te median age at presentation was 39 years (25–77), and 70% patients were under 45years of age. Hundred and seven patients (81.7%) were premenopausal. Of these 132 cases, 78 (59.1%) had clinical suspicion of breast cancer. Te most common presenting symptom was a breast lump; in 110 patients (83.33%), 23 (17.42%) of them with ulcerations of the overlying skin. Eleven patients (8.3%) presented with discharging sinuses with difuse lumps, eight (6%) presented with abscesses, while three (2.27%) presented with com- plaints of breast pain. Table 1 provides the details of clin- icopathological characteristics.

3.2. Imaging Findings. On radiological evaluation with mammography and ultrasound (n � 132), 84 (63.64%) presented as BIRADS 4 and 5 lesions, raising the suspicion of malignancies. Te diagnosis was established by trucut biopsy (blind or USG-guided) in all patients with 21 (15.9%) pa- tients needing an excision/incision biopsy for histological confrmation. On histopathology, 14 of the 132 patients

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Table 1: Clinicopathological profle of 132 cases of IGM.

immunosuppressant or chemotherapeutic drugs. Tinosporin tablet (500 mg Guduchi stem extract per day) was prescribed to 91 patients. For 13 patients, the data on Tinosporin prescription were missing as the patients did not follow up. Te treatment duration ranged from 1 to 7 months, with 75 (97.4%) patients requiring minimum 3 months of treatment. Symptomatic relief was seen in 72/77 patients (93.5%) who were prescribed Tinosporin. Only 5 patients did not achieve response, while data were missing for 13 patients. Two patients on Tinosporin had recurrence of symptoms. Only fve patients, those who did not respond to Tinosporin (6.5%), were treated by surgical curettage and excision. Of the 41 patients who were not prescribed Tinosporin, 13 patients had defaulted on the prescribed treatment. Of the 28 with follow-up, 8 were given anti-tuberculous treatment due to the suspicion of tuberculosis prior to visiting our centre, while the others were treated with antibiotics and/or ob- servation, and one was given steroids. Only 11 of the 28 patients (39.29%) responded to this form of treatment. Treatment details are summarised in Table 2, and response to treatment in Table 3. We summarise the clinical pre- sentations, radiological and histopathological fndings of three patients in the series in Figures 2, 3, and 4.

4. Discussion

We present a large dataset of 132 patients presenting with IGM treated with a steroid-free regimen without surgical resection. Te main contention behind diagnosis and work up of these patients had been to rule out malignancy since more than 60% had a clinicoradiological suspicion of breast cancer, as IGM also commonly presents as a painless breast mass. Azizi et al. reported a series of 474 patients in whom 70% patients presented with a palpable lump [10]. Another

(a)

(c)

(b)

(d)

Figure 1: (a) Lobulocentric infammation, (b) abscess formation, (c) dense mixed acute and chronic peri-ductal infammation with ductular destruction, and (d) ill-defned granulomas with multinucleate giant cells.

Demographic category

Age (median 39 [25–77]) < 45

> 45 Menstrual status

Premenopausal

Postmenopausal Clinical presentation

Benign

Malignant Radiological presentation

Benign

Suspicious Biopsy

Core biopsy

Incision biopsy

Diagnostic excision biopsy required

Cultures (n�61) Growth

No growth

N = 132 % 93 70.5

39 29.5

107 81.1 25 18.9

54 40.9 78 59.1

36.4 84 63.6

36 69 15

27.27 52.27 11.36

11 18.1 50 81.9

(10.6%) had a diagnosis and had signs of acute infammation superimposed on IGM in the form of microabscesses, while further 11 (16.9%) were identifed to be infective on mi- crobial culture—Staphylococcus aureus (4), Escherichia coli (3), Atypical mycobacteria (2), Enterococcus (1) and Candida (1) growth, while the others had no organisms.

3.3. Treatment Details. Antibiotics were prescribed to 101 patients. 13 patients did not follow up, and hence their compliance with respect to medication was not documented. Steroids were only prescribed to 1 patient for rapid control of symptoms. None of the patients were prescribed any other

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Category

Antibiotics Prescribed

Not prescribed Defaulted

Tinosporin Prescribed

Not prescribed Defaulted

Steroids

Surgical excision

Table 2: Treatment pattern.

N = 132 %

101 76.5 18 13.6 13 9.9

Te aetiology of IGM remains obscure. It may be pri- mary or autoimmune (idiopathic) or may be secondary to infection which is difcult to document. Te pathophysi- ology involves a hypertrophic state after pregnancy and lactation. Te ductal permeability increases, and retained milk due to stasis which is immunogenic enters the lobular mesenchyme, causing a cellular immune response and granuloma formation [18]. Poor breastfeeding and weaning habits are hence a risk factor [12, 19]. Autoimmunity, in- fections, smoking and α 1-antitrypsin defciency play a role in the pathogenesis [20]. Obesity, use of hormonal therapy, pregnancy and lactation have been aetiologically related in the afected patients [4]. Microbial infection with co- rynebacterium and Staphylococcus is also causatively asso- ciated with IGM, both often found in the cultures of surgical specimens and biopsies [21–24]. Atypical mycobacteria, seen less commonly, must be diferentiated from tuberculous mastitis. Pathologically, IGM manifests as lobulocentric granulomatous infammation with histiocytic aggregates forming ill-defned or well-defned noncaseating granulo- mas. Multinucleate giant cells, lymphocytes, plasma cells, eosinophils and fat necrosis may be seen, replete with neutrophils, which form microabscesses in case of super- imposed acute infammation. Lobulocentricity may be masked in cases with extensive infammation (Figure 1). Tis often requires a generous tissue sample and warrants a confrmatory incision or excision biopsy sample to ac- curately rule out malignancy and tuberculosis. A diagnostic algorithm based on a multidisciplinary panel of 66 experts from 509 articles, suggested ruling out hyperprolactinaemia, followed by simultaneous ultrasound-guided tissue biopsy and cultures of aspirates, for all patients with clinical sus- picion of IGM. Tey recommended the addition of anti- biotics for patients with positive cultures, in addition to the primary management, which included observation, steroids or surgery based on the severity of symptoms [6]. At our institution, biopsies showing features suggestive of IGM were subjected to special stains (including acid fast stain for tuberculosis, Gram stain for bacterial infections and GMS for fungal infections). After excluding the aforementioned specifc infective aetiologies, in conjunction with histological fndings, a diagnosis of IGM was rendered. In 91% patients tested, we found no growth on culture and hence no causative pathogen was identifable to guide specifc anti- biotic treatment.

IGM is a rare condition, with poor efcacy and durability of available treatment and a prolonged and recurrent course. It is often self-limiting, but remission is slow and re- crudescence is commonly seen during therapy. Only 50% patients achieve remission at 2–24months, taking on av- erage 5 months for relief [25, 26]. If an identifable cause is found such as infection or hyperprolactinaemia, treatment must be directed towards it. Bromocriptine and cessation of drugs causing hyperprolactinaemia (e.g., antipsychotics) are efective. IGM is commonly treated with antibiotics based on culture sensitivity tests. An empirical treatment with clin- damycin, levofoxacin or azithromycin can be used before sensitivity is available or if the culture report does not identify an organism [27, 28]. Some have found rifampicin

91 28 13

68.9 21.2 9.9

1 0.8 5 3.8

Table 3: Response to tinosporin.

Response No response Lost to follow-up

Tinosporin (91) 72 5 14 No tinosporin (41) 11 17 13

series of 206 patients from Iran had 81% patients presenting with a suspicious breast mass [11]. Tere can be subsequent rapid progression of infammation, usually from periphery to areola due to the involvement of lobules in its patho- genesis. Subcutaneous abscesses form which lead to fstulae and sinuses in severe cases. In our cohort, 110 patients (83.33%) presented with a suspicious lump, amongst which 38 (28.8%) had features of locally advanced breast cancers. Rarely, associated systemic manifestations such as fever and erythema nodosum or polyarthritis are seen [10, 12–15].

Te diagnostic dilemma of IGM extends to radiology as well. Sixty-three percent of our patients had radiologically suspicious fndings suggestive of malignancy, of which 5.3% had BIRADS 5 lesions. Mammography is often difcult due to acute infammation, abscesses and discharging sinuses, commonly has vague fndings such as focal or global asymmetric density, blurred edges, skin thickening and parenchymal distortion [16]. 81.1% of our patients were premenopausal, consistent with the literature [1], mam- mography may not be helpful in this population as they have dense breast parenchyma. Te most common fnding was a hyperdense mass (35, 43.75%), while over half the patients had only subtle architectural distortion (15, 18.75%) and asymmetric densities (15, 18.75%). Four (5%) patients had only benign appearing calcifcations. Te literature suggests MRI may often not add value to the diagnosis [17]. Ultra- sound is the frst line investigation as it can detect abscesses and sinuses, guide biopsies and is efective for follow-up response. Te most common fnding was an irregular hypoechoic mass (44.1%). Eighteen patients (15.3%) had only an area of architectural distortion, and 18 (15.3%) only ill-defned hypoechoic areas with surrounding hyper- echogenic regions. Hence, over 50% patients had vague fndings even on imaging, while 13% had completely normal mammography and ultrasound, emphasising that IGM may be completely occult, needing a high index of suspicion and requiring a multidisciplinary discussion for conclusive diagnosis.

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(a) (c)

(b) (d)

(e)

(f)

Figure 2: Clinical Scenario 1: 53-year-old perimenopausal lady, diabetic, presented with (a) right breast 12×12cm difuse lump with overlying peau d’orange and (b) ulcerated skin in the inner central region. Ultrasound showed (c) multiple difuse masses, hard on elastography, and (d) suspicious lymph nodes, BIRADS 4C. Biopsy showed granulomatous mastitis with histiocytes, negative special stains (ZN, PAS, and GMS). (e) Sheets of multinucleate giant cells with abundant mixed infammation, granulation tissue, and surrounding fbrosis (H&E, x100). (f) Te infammatory infltrate comprises of neutrophils, lymphocytes, and plasma cells (H&E, x200).

300 mg twice daily for 6–9 months efective with low re- currence; however, the side efects of rifampicin can cause morbidity [13]. In our series, 101 patients were prescribed antibiotics, namely, ciprofoxacin, clindamycin or doxycy- cline, and only 11 (39.29%) responded to antibiotics and observation alone. Overall, the efcacy of antibiotics alone in the management of IGM is poor, ranging from 3% to 50% response and with 23% relapse rate [4, 11].

Te most commonly reported frst-line treatment is oral corticosteroids, with a response rate of 64%–80% [11, 29], but requiring a mean treatment duration of 4–6months (range, 1–12 months) [30] and a high relapse rate of 30%– 40% [30, 31]. Tere is no consensus on the ideal duration of steroids, commonly leading to months of use up until complete clinical response due to the slow response rate [19]. Prolonged use of corticosteroids is associated with weight gain, osteoporosis and infections among other side efects. High-dose steroid regimens, intralesional and topical ste- roids have been explored to circumvent the systemic tox- icities, some have found a lower recurrence in the local treatment group compared with oral corticosteroids (8 versus 46%) [32, 33]. One study compared steroid use with conservative management and found that steroid use did not signifcantly reduce the mean recovery period [1]. For those resistant to steroids, having contraindications, or sufering from their side efects, other immunosuppressive agents have been described. Methotrexate is commonly used, sometimes in combination with corticosteroids to reduce the dose [3, 34, 35]. Te treatment duration remains 6–24 months with a dosage of 5–15 mg per week [36]. Methotrexate also has side efects and must be advised with precaution in these women of child-bearing age. Yuan et al.

described repeated aspirations and saline washes with in- jection of 40 mg triamcinolone acetate 6-7 times and showed 78% efcacy [6, 37]. Surgical wide excision may be required in those with complicated local sinuses, fstulae and ab- scesses for those not responding to treatment. A recent meta-analysis found surgery to have a high cure rate and low recurrence rate at par with that of steroid use [19]. However, a prospective study from Kolkata found high rate of relapse with surgical excision alone [38]. Surgery is contraindicated in acute infammation and extensive involvement of the breast skin. Recurrences are common in IGM, 15.4%–24.8%, and are diagnosed clinically [39–42]. Te clinical pre- sentation remains the same and often worsens in relapses. Young age, corynebacterium on culture and pregnancy are at higher risk of recurrence and need longer treatment durations [39].

None of the above commonly practiced treatments result in an efective and durable remission. Immunological dys- function plays a major role in the pathogenesis of IGM. Alterations in intracellular cytokine expression patterns in T-lymphocyte subsets after ozone therapy in refractory IGM have been found [8]. Deng et al. found predominant presence of CD3, CD4, CD8, CD79a, IgG and IgM, high- lighting the role of cell-mediated immunity [43]. A Turkish study evaluated molecular changes at the proteome level, extracts from IGM patients had a signifcant overlap with immune related proteins, and those involved in cancer metabolism [44]. Tis called for exploration of new avenues in the treatment, with a scientifc approach based on the immunological pathogenesis, while avoiding drugs that cause signifcant side efects with a variable and often negligible impact to the course of the disease. Te response

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(a)

(b)

(e)

(f)

Figure 3: Clinical Scenario 2: 31 year old, premenopausal, presented with (a) right breast 4 × 4 cm difuse lump with fuctuation in the right upper outer quadrant and (b) skin changes extending upto the lower inner quadrant. Ultrasound showed (c) multiple ill-defned confuent hypoechoic areas, peripheral vascularity, and mobile echoes within, and mammography had (d) global asymmetry and high density lesion in the right upper outer quadrant. BIRADS 4A. Biopsy: granulomatous mastitis. (e) Numerous multinucleate giant cells with surrounding abundant infammation and fbrosis (H&E, x100). (f ) Te infammatory infltrate comprises of admixed neutrophils, histiocytes, giant cells, lymphocytes, and plasma cells (H&E, x400). She was given a course of doxycycline 100 mg BD for 2 weeks, followed by T Guduchi.

to steroids and immunosuppressants supports this theory [43].

Tinospora cordifolia, commonly named “Guduchi” in Sanskrit, belonging to the family Menispermaceae is a ge- netically diverse, large, deciduous climbing shrub found at a higher altitude, with green-yellow fowers [45–47]. Te active components include alkaloids, steroids, diterpenoid lactones, aliphatics and glycosides, 11-hydroxymustakone, cordifolioside A, magnoforine, N-methyl-2-pyrrolidone, N- formylannonain tinocordiside and syringin [48–50], from diferent parts of the plant body, including the root and stem. It has recently been reported antidiabetic, antispasmodic, anti-infammatory, antiarthritic, antioxidant, antiallergic, antileprotic, antimalarial, hepatoprotective and antineo- plastic too. Tinosporin, extracted from the stem root, is the active ingredient efective against IGM. Tere are multiple documented mechanisms of action of Tinosporin. As per an

analysis of 175 articles, active compounds [49, 50] have potential immunomodulatory and cytotoxic efects [51–54]. Tey boost the phagocytic activity of macrophages, pro- duction of reactive oxygen species in neutrophils [55], and enhance nitric oxide [56]. In mice, extracts cause upregu- lation of IL-6 cytokine, activation of cytotoxic T-cells and B- cell diferentiation [57]. Te (1,4)-alpha-d-glucan in Tino- spora cordifolia activates human lymphocytes with down- stream synthesis of pro- and anti-infammatory cytokines in vitro [58]. It scavenges free radicals, lowers thiobarbituric acid reactive substances levels and increases antioxidants glutathione, superoxide dismutase, ascorbic acid and glu- tathione S-transferase in kidney, preventing nephropathy [59]. Oral administration of plant extracts prevented the occurrence of liver damage in mice models. Decreased SOD was observed in mice sufering from lead toxicity [60]. Te methanol extracts have potential antimicrobial action [59]

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(a)

(b)

(c)

(d)

(e)

(f)

Figure 4: Clinical Scenario 3: 47 year old lady presented with a lump in the right breast since 1 month, (a) skin ulceration and pus discharge with (b) underlying 5 × 5 cm lump in the outer central region of the right breast. On mammography, she had (c) global asymmetry in the right breast with (d) irregular architectural distortion on ultrasound, over an area of 3.9 × 3.8 cm with internal vascularity and surrounding non-mass enhancement on CEM upto 8 cm, BIRADS 4B. A biopsy showed (e) benign breast parenchyma with dense mixed infammation with fat necrosis and fbrosis (H&E, x100). (f ) Te mixed infammation comprises of multinucleate giant cells, neutrophilic microabscesses and lymphocytes (H&E, x200).

against E. coli, S. aureus and other Gram-positive bacteria. Intramammary infusion of hydromethanolic extracts of Tinospora showed enhanced phagocytic activity of poly- morphonuclear cells in bovine subclinical mastitis [61, 62].

We have been treating IGM primarily with immuno- modulators. Usually following a course of empirical or

culture-based antibiotics for 7–14 days in those with signs of infammation, our patients are prescribed oral Tinosporin tablet 500 mg for three months. At 3 months, the patients are asked to visit for a clinical follow-up, wherein the response is assessed based on symptoms, clinical features and size of the lump. In case of good response, treatment with Guduchi is

Te Breast Journal

continued for another 3 months. In case of persistence of symptoms or progression, the tablets are continued longer as per clinicians’ discretion. Steroids are seldom used.

In our audit, 97.4% patients responded to a maximum of 3 months of treatment with Tinosporin, with a 93.5% (72/77 patients) response rate. Only fve patients (6.5%) did not respond to the treatment and were treated with cavity cu- rettage, and two patients had a relapse, with a median follow- up of 36 months. Only 11 of the 28 patients (39.29%) who were treated without Tinosporin but with antibiotics and observation alone, experienced relief of symptoms. None of the patients sufered from any side efects of the medication or required discontinuation or dose adjustment, or required steroids. None of our patients were prescribed methotrexate or any other immunosuppressants.

Te strength of our study is that we provide a safe, steroid- sparing, inexpensive, well-tolerated and efective treatment regimen for IGM without the side efects which are often seen with steroids and without surgical resections amounting to partial or total mastectomy. Te limitations of the study are its retrospective nature and lack of comparison with diferent treatment strategies. Te loss to follow-up of patients inherent to a retrospective design weakens the data. Future studies are needed to further understand the aetiopathogenesis of this disease entity and determine the factors causing it.

5. Conclusion

IGM is a benign infammatory disorder of the breast. We provide an efective treatment strategy for IGM with a natural plant product Tinosporin without steroids and surgical resections.

Data Availability Statement

Te data that support the fndings of this study are available from the corresponding author upon request.

Ethics Statement

Tis research was retrospective in nature, patients had al- ready received the treatment and only charts were reviewed. Te study was conducted with the unit chief’s approval, and ethics committee’s approval was not necessary. Raw data were generated at our institution. Derived data supporting the fndings of this study are available from the corre- sponding author on request.

Conflicts of Interest

Te authors declare no conficts of interest.

Funding

Tis project has not received any funding.

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