Objective To systematically analyze the current status of outcomes reporting in clinical trials on treating stasis acute mastitis with Traditional Chinese Medicine breast massage.Methods We searched CNKI, Wanfang, VIP, SinoMed, PubMed, Web of Science, Embase, Cochrane library, JBI, CINAHL, PsycINFO, Clinical Trials Registry Platform portal, Clinical Trials Registry, Australian New Zealand Clinical Trials Registry, Center Watch Registry from inception to May 15, 2022 to find randomized controlled trials, non-randomized controlled trials, case series and cohort studies which reported the outcomes of stasis acute mastitis managed with Traditional Chinese Medicine breast massage, with search terms of mastitis, acute mastitis, lactation mastitis, puerperal mastitis, breast problem, breast engorgement, milk stasis, blocked ducked, breast pain, breast massage, and acupoint massage. Outcomes and the measurement schemes (measurement methods, timing of assessing outcome, frequency of assessing outcome, measurers) were extracted from the included studies. We used the Management of Otitis Media with Effusion in Children with Cleft Palate (MOMENT) to assess the quality of each study, then categorized outcomes derived from the included studies into different domains according to the Outcome Measures in Rheumatology Arthritis Clinic Trials (OMERACT) Filter 2.1 framework.Results We identified 85 clinical trials, in which 54 different outcomes were reported. A total of 81.2% (69/85) of studies were assessed as medium quality with a mean score of 2.6, and 18.8% (16/85) as low quality with a mean score of 0.9. These outcomes were organized in three core areas. Lump size (89.4%, 76/85) was the most frequently reported outcome, followed by breast pain (69.4%, 59/85) and milk excretion (68.2%, 58/85). Five methods were used to assess lump size and four methods to assess breast pain.Conclusions The outcomes reported in clinical trials regarding stasis acute mastitis treated by Traditional Chinese Medicine breast massage are heterogeneous. Developing a core outcome set to achieve consistent standards for reporting outcomes and modalities for validation of the outcomes is clearly warranted.
Child ; Female ; Humans ; Australia ; Massage ; Mastitis/therapy* ; Mastodynia ; Medicine, Chinese Traditional

Diagnosis, Differential ; Female ; Granulomatous Mastitis/drug therapy* ; Humans ; Mammography

INTRODUCTION: Idiopathic granulomatous mastitis (IGM) is a rare, benign, chronic breast condition that can cause repeated abscesses or mass formation in bilateral breasts. The condition can severely impact the quality of life of affected women. This study aims to evaluate effective treatment modalities, as well as understand the demographics and clinical presentation of patients with IGM. METHODS: An 11-year retrospective review was performed of patients diagnosed with IGM from 1 January 2008 to 31 December 2018 at a tertiary breast unit. RESULTS: A total of 77 patients were included in the study. The median age at presentation was 36 years old. IGM presented most commonly as a breast lump (98.1%). The median number of flares was 2 (1-12). Of the 77 patients, 68.8% (53) were treated with antibiotics, 50.6% (39) with steroids, and 44.2% (34) underwent surgery, in the course of their IGM treatment. Forty-five (59.2%) of the 76 patients with IGM required a multimodal treatment approach to achieve remission. There was no significant difference in the number of flares no matter the initial treatment ( CONCLUSION IGM is a clinical diagnosis. It is a rare, relapsing breast inflammatory condition that affects young females with no superior treatment modality. Smoking is associated with higher number of flares of IGM and should be discouraged in IGM patients.
Adult ; Anti-Bacterial Agents/therapeutic use* ; Female ; Granulomatous Mastitis/therapy* ; Humans ; Quality of Life ; Retrospective Studies ; Treatment Outcome

OBJECTIVETo evaluate the safety and the clinical value of external use of jiuyi Powder (JP) in treating plasma cell mastitis using partial least-squares discriminant analysis (PLSDA).

METHODSTotally 50 patients with plasma cell mastitis treated by external use of JP were observed and biochemical examinations of blood and urine detected before application, at day 4 after application, at day 1 and 14 after discontinuation. Blood mercury and urinary mercury were detected before application, at day 1, 4, and 7 after application, at day 1 and 14 after discontinuation. Urinary mercury was also detected at 28 after discontinuation and 3 months after discontinuation. The information of wound, days of external application and the total dosage of external application were recorded before application, at day 1, 4, and 7 after application, as well as at day 1 after discontinuation. Then a discriminant model covering potential safety factors was set up by PLSDA after screening safety indices with important effects. The applicability of the model was assessed using area under ROC curve. Potential safety factors were assessed using variable importance in the projection (VIP).

RESULTSUrinary β2-microglobulin (β2-MG), urinary N-acetyl-β-D-glucosaminidase (NAG), 24 h urinary protein, and urinary α1-microglobulin (α1-MG) were greatly affected by external use of JP in treating plasma cell mastitis. The accuracy rate of PLSDA discriminate model was 74. 00%. The sensitivity, specificity, and the area under ROC curve was 0. 7826, 0. 7037, and 0. 8084, respectively. Three factors with greater effect on the potential safety were screened as follows: pre-application volume of the sore cavity, days of external application, and the total dosage of external application.

CONCLUSIONSPLSDA method could be used in analyzing bioinformation of clinical Chinese medicine. Urinary β2-MG and urinary NAG were two main safety monitoring indices. Days of external application and the total dosage of external application were main factors influencing blood mercury and urine mercury. A safety classification simulation model of treating plasma cell mastitis by external therapy of JP was established by the two factors, which could be used to assess the safety of external application of JP to some extent.

Acetylglucosaminidase ; Alpha-Globulins ; Discriminant Analysis ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Least-Squares Analysis ; Mastitis ; drug therapy ; Plasma Cells ; ROC Curve ; Safety

Acupuncture Therapy ; instrumentation ; Adult ; Female ; Humans ; Lactation ; Mastitis ; physiopathology ; therapy ; Young Adult

Acupuncture Therapy ; Acute Disease ; therapy ; Administration, Cutaneous ; Adult ; Combined Modality Therapy ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Humans ; Lactation ; Massage ; Mastitis ; drug therapy ; physiopathology ; therapy ; Young Adult

OBJECTIVETo study the clinicopathologic features of granulomatous lobular mastitis and mammary duct ectasia.

METHODSThe clinicopathologic data from August 2005 to May 2013 of 32 cases of granulomatous lobular mastitis and mammary duct ectasia were retrospectively reviewed.

RESULTSThe age of patients ranged from 26 to 45 years. Two patients had no history of delivery. Fourteen patients had no history of lactation or lactational disorder in the lesional side. Most of the remaining patients had history of breast feeding. Gross examination showed that the lesions were poorly circumscribed and varied from 3 to 12 cm in greatest dimension. Tiny abscess cavities, ranging from 0.1 to 0.5 cm in diameter and containing light yellowish to greyish secretion, were demonstrated. Histologic examination showed granuloma formation and ductal dilatation. Eleven patients had received antibiotic treatment. Twelve cases were complicated by sinus formation related to skin incision and drainage. The duration of follow-up ranged from 5 to 90 months. Three cases showed ipsilateral recurrence and 3 cases had similar pathology in the contralateral breast. Four patients defaulted follow-up.

CONCLUSIONSGranulomatous lobular mastitis is associated with mammary duct ectasia. Accurate pathologic diagnosis is prudent for clinical management and control of local recurrence.

Adult ; Anti-Bacterial Agents ; therapeutic use ; Breast Diseases ; complications ; drug therapy ; pathology ; surgery ; Breast Feeding ; Dilatation, Pathologic ; complications ; drug therapy ; pathology ; surgery ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Follow-Up Studies ; Granulomatous Mastitis ; complications ; drug therapy ; pathology ; surgery ; Humans ; Mammary Glands, Human ; pathology ; surgery ; Middle Aged ; Recurrence ; Retrospective Studies

OBJECTIVETo observe the clinical effect of Guoshu acupoint pressure therapy on acute mastitis during lactation.

METHODSFifteen cases suffered from acute lactation mastitis were treated with Guoshu acupoint pressure therapy, that is, firstly with lifting and flicking reduction at "Taiji" and "Xuepen" point, whose intensity was varied from patient's physical fitness. Subsequently, the patients were treated with flame therapy induced by distillate spirit, once each day.

RESULTSAfter the treatment, all the patients were cured completely in from 1 to 5 days, with an average of 2.5 days.

CONCLUSIONGuoshu acupoint pressure therapy is effective on acute mastitis during lactation.

Acupressure ; Acupuncture Points ; Adult ; Female ; Humans ; Lactation ; Mastitis ; therapy

OBJECTIVESTo study the etiology, clinical and pathologic characteristics of periductal mastitis with fistula and estimate the effect of anti-mycobacterial agents for periductal mastitis with fistula.

METHODSTotally 27 patients of periductal mastitis with fistula received anti-mycobacteria drugs therapy from December 2008 to September 2011 were analyzed retrospectively. All of the patients were female. The mean age at onset was 28 years (range 15 to 40 years old). The main clinical manifestation of the 27 patients was breast fistula, including 21 patients with single fistula and 6 patients with multiple fistula. Three patients manifested with pure fistula, 14 patients with both fistula and lump, 10 patients with fistula, lump and abscess. The samples including pus or tissues of all patients were underwent bacteria culture and all patients core needle biopsy. All patients were given primary anti-mycobacteria drugs therapy, parts of patients received surgery based on the evaluation of medical treatment.

RESULTSThe common bacteria culture of all patients failed to demonstrate any causative microorganism. Four cases were selected randomly to undergo PCR of mycobacteria, only one case was identified as Massiliense in bacteria culture of mycobacteria. Twenty-seven patients with periductal mastitis with fistula were treated with anti-mycobacterial agents (isoniazid, rifampicin and ethambutol or pyrazinamide of triple oral drugs) for 1 to 3 months, the fistula of all 27 patients were closed well. Sixteen patients were treated with the agents only and cured. Eleven patients received surgical treatment after treated with the medical agents. None of the patients were given mastectomy. All patients had no reccurence until now.

CONCLUSIONSThe periductal mastitis with fistula has a closely relationship with the infection of nontuberculosis mycobacteria. Those patients could be treated with triple anti-mycobacterial agents and could also avoided mastectomy.

Adolescent ; Adult ; Anti-Bacterial Agents ; therapeutic use ; Drug Therapy, Combination ; Ethambutol ; therapeutic use ; Female ; Fistula ; drug therapy ; microbiology ; Humans ; Isoniazid ; therapeutic use ; Mastitis ; drug therapy ; pathology ; Nontuberculous Mycobacteria ; isolation & purification ; Pyrazinamide ; therapeutic use ; Retrospective Studies ; Rifampin ; therapeutic use ; Young Adult

Idiopathic granulomatous mastitis (IGM) is a rare and chronic benign disease of the breast. Histologically, the disease presents as an intense inflammatory reaction with non-caseated granulomas that are the characteristic symptom of the disease. No consensus exists on the best treatment modality for this disease. In this report, we present a patient with granulomatous mastitis who was treated successfully with low-dose oral and topical steroids. Our aim here is to discuss various approaches for IGM in view of the literature and present treatment with topical steroids, which has not been reported.
Administration, Cutaneous ; Administration, Oral ; Adult ; Biopsy ; Female ; Granulomatous Mastitis/diagnosis/*drug therapy ; Humans ; Magnetic Resonance Imaging ; Steroids/*administration & dosage ; Treatment Outcome