A Randomized Multicenter Phase II Study of Docosahexaenoic Acid in Patients with a History of Breast Cancer, Premalignant Lesions, or Benign Breast Disease.

Obesity, a cause of subclinical inflammation, is a risk factor for the development of postmenopausal breast cancer and is associated with poorer cancer outcomes. Docosahexaenoic acid (DHA), an omega-3 fatty acid, possesses anti-inflammatory properties. We hypothesized that treatment with DHA would reduce the expression of proinflammatory genes and aromatase, the rate-limiting enzyme for estrogen biosynthesis, in benign breast tissue of overweight/obese women. A randomized, placebo-controlled, double-blind phase II study of DHA given for 12 weeks to overweight/obese women with a history of stage I-III breast cancer, DCIS/LCIS, Paget's disease, or proliferative benign breast disease was carried out. In this placebo controlled trial, the primary objective was to determine whether DHA (1,000 mg by mouth twice daily) reduced breast tissue levels of TNFα. Secondary objectives included evaluation of the effect of DHA on breast tissue levels of COX-2, IL1ß, aromatase, white adipose tissue inflammation, and gene expression by RNA-seq. Red blood cell fatty acid levels were measured to assess compliance. From July 2013 to November 2015, 64 participants were randomized and treated on trial (32 women per arm). Increased levels of omega-3 fatty acids in red blood cells were detected following treatment with DHA (P < 0.001) but not placebo. Treatment with DHA did not alter levels of TNFα (P = 0.71), or other biomarkers including the transcriptome in breast samples. Treatment with DHA was overall well-tolerated. Although compliance was confirmed, we did not observe changes in the levels of prespecified biomarkers in the breast after treatment with DHA when compared with placebo. Cancer Prev Res; 11(4); 203-14. ©2018 AACRSee related editorial by Fabian and Kimler, p. 187.

Metabolic Response to Omega-3 Fatty Acids and Vitamin E Co-Supplementation in Patients with Fibrocystic Breast Disease: A Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: There is scarce data on the effects of omega-3 fatty acids and vitamin E co-supplementation on metabolic status in patients with fibrocystic breast disease (FBD). The current study was carried out to determine the effects of omega-3 fatty acids and vitamin E co-supplementation on metabolic status in patients with FBD. METHODS: A randomized clinical trial was conducted on 56 patients with FBD. Participants were randomly divided into two groups to receive either 1000 mg omega-3 fatty acids plus 400 mg vitamin E (n = 28) or placebo (n = 28) for 12 weeks. Fasting blood samples were taken at the beginning of the study and after 12 weeks of intervention to determine inflammatory factors, biomarkers of oxidative stress, and metabolic profiles. RESULTS: After 12 weeks of intervention, changes in serum high-sensitivity C-reactive protein (-2171.4 ± 3189.1 vs. +696.9 ± 2774.8 ng/mL, P = 0.001) and plasma nitric oxide (+1.8 ± 4.0 vs. -0.1 ± 2.4 µmol/L, P = 0.04) in supplemented women were significantly different from those in the placebo group. In addition, compared to the placebo group, subjects who consumed omega-3 fatty acids plus vitamin E supplements had significantly decreased serum insulin concentrations (-3.2 ± 6.5 vs. -0.2 ± 1.7 µIU/mL, P = 0.01), the homeostasis model of assessment-estimated insulin resistance (-0.8 ± 1.7 vs. -0.02 ± 0.4, P = 0.03), serum triglycerides levels (-11.5 ± 47.3 vs. +10.6 ± 24.3 mg/dL, P = 0.03) and VLDL-cholesterol (-2.3 ± 9.5 vs. +2.1 ± 4.9 mg/dL, P = 0.03), as well as increased quantitative insulin sensitivity check index (+0.01 ± 0.01 vs. +0.001 ± 0.007, P = 0.001) and HDL-cholesterol (+3.4 ± 6.0 vs. -1.3 ± 4.3 mg/dL, P = 0.001). CONCLUSION: Overall, omega-3 fatty acids and vitamin E co-supplementation for 12 weeks had beneficial effects on inflammatory markers and metabolic profiles in patients with FBD.

Terapia neural como tratamiento contra el dolor en la displasia mamaria cíclica de grado II / Neural therapy as pain-relief treatment in grade III cyclic breast dysplasia

De enero a diciembre de 2004 se realizó un estudio experimental del tipo ensayo clínico de fase II, controlado y monocéntrico, cuyo objetivo fue evaluar la eficacia de la terapia neural en el tratamiento del dolor como manifestación de la displasia mamaria cíclica de grado II en comparación con la terapéutica convencional. Se estudiaron 240 pacientes, que fueron divididos en 4 grupos según el tipo de tratamiento: con terapia neural (grupo I), con vitamina E (grupo II), con progesterona (grupo III) y con antiinflamatorios no esteroideos (grupo IV). Se observó mejoría del dolor en más de 60 por ciento del grupo I y fue similar con el uso de la progesterona. Con los antiinflamatorios no esteroideos y la vitamina E hubo diferencias significativas. Se obtuvieron resultados satisfactorios con el empleo de la terapia neural con procaína al 1 por ciento, por lo que pudimos considerarla eficaz en la terapéutica de esta manifestación(AU)

A controlled monocentered experimental study of phase II clinical assay type was carried out from January to December, 2004 to evaluate the effectiveness of neural therapy in treating pain as manifestation of grade II cyclic breast dysplasia in comparison to the conventional therapy. Two hundred and forty patients were studied. They were divided into 4 groups according to the type of treatment: neural therapy (group I); vitamin E (group II); progesterone (group III); and non-steroidal anti-inflammatory drugs (group IV). Pain relief was observed in over 60 per cent of patients in group I, a result similar to that of group III (progesterone). There were significant differences in groups treated with non-steroidal anti-inflammatory drugs and Vitamin E. The use of neural therapy based on 1per cent procaine yielded satisfactory results, so we considered it as an effective therapy for pain relief in grade II breast dysplasia(AU)

Terapia neural como tratamiento contra el dolor en la displasia mamaria cíclica de grado II / Neural therapy as pain-relief treatment in grade III cyclic breast dysplasia

De enero a diciembre de 2004 se realizó un estudio experimental del tipo ensayo clínico de fase II, controlado y monocéntrico, cuyo objetivo fue evaluar la eficacia de la terapia neural en el tratamiento del dolor como manifestación de la displasia mamaria cíclica de grado II en comparación con la terapéutica convencional. Se estudiaron 240 pacientes, que fueron divididos en 4 grupos según el tipo de tratamiento: con terapia neural (grupo I), con vitamina E (grupo II), con progesterona (grupo III) y con antiinflamatorios no esteroideos (grupo IV). Se observó mejoría del dolor en más de 60 por ciento del grupo I y fue similar con el uso de la progesterona. Con los antiinflamatorios no esteroideos y la vitamina E hubo diferencias significativas. Se obtuvieron resultados satisfactorios con el empleo de la terapia neural con procaína al 1 por ciento, por lo que pudimos considerarla eficaz en la terapéutica de esta manifestación(AU)

A controlled monocentered experimental study of phase II clinical assay type was carried out from January to December, 2004 to evaluate the effectiveness of neural therapy in treating pain as manifestation of grade II cyclic breast dysplasia in comparison to the conventional therapy. Two hundred and forty patients were studied. They were divided into 4 groups according to the type of treatment: neural therapy (group I); vitamin E (group II); progesterone (group III); and non-steroidal anti-inflammatory drugs (group IV). Pain relief was observed in over 60 per cent of patients in group I, a result similar to that of group III (progesterone). There were significant differences in groups treated with non-steroidal anti-inflammatory drugs and Vitamin E. The use of neural therapy based on 1per cent procaine yielded satisfactory results, so we considered it as an effective therapy for pain relief in grade II breast dysplasia(AU)

[Clinical trial on mastoplasia treated by xiaozheng pills (qing xiang pills)].

OBJECTIVE: To assess the efficacy and safety of Xiaozheng pills in treating mastoplasia. METHOD: Clinical trials were carried out by five hospitals. In each hospital, patients were divided into two groups with one group 24 patients (trial group) and the other 24 patients (control group). Total 240 patients were included in the study. According to randomized, double-blinded and placebo-controlled clinical study, the trial groups were treated by Xiaozheng pills with Rujiekang mimetic (placebo) and the control groups were treated by Rujiekang with Xiaozheng pills mimetic (placebo). Symptoms, laboratory test results as well as ADR were evaluated after 1 period of treatment. RESULT: The overall response rates of trial group and control group were 93.8% and 88.6% respectively, no statistic difference between the two groups. No deleterious effect in both groups and the indexes of safety were normal. CONCLUSION: These results suggest that Xiaozheng pills are effective and safe in treating mastoplasia caused by qi stagnation, blood stasis or/and stagnation of phlegm.

Trifolium pratense for breast disease: a case series.

A series of cases in which Trifolium pratense was used in breast disease with hyperoestrogenic symptoms is reported. Several patients with cystic mastosis and breast cancer appeared to do well. The 'picture' of Trifolium is discussed.

Aplicación de la medicina tradicional a un grupo de mujeres con displasia mamaria / Application of traditional herb medicine to a group of women with breast dysplasia

Se hizo un estudio de 100 pacientes de la consulta de mastología en el año 1999, con el diagnóstico de displasia mamaria demostrado por la clínica y la citología aspirativa con aguja fina. El objetivo principal fue hacer un enfoque sistémico, dinámico y abierto del que está dotada la medicina tradicional, así como la repercusión social y el beneficio económico de este tratamiento. Se sustituyeron métodos con efectos secundarios que al cesar puede recidivar la enfermedad, por métodos inocuos con fines curativos y con efectos permanentes, de fácil aplicación. El más duradero y mejor tolerado fue la auriculoterapia, predominaron las mujeres de 21 a 30 años, obesas, ansiosas, fumadoras, tomadoras de café, té y píldoras anticonceptivas(AU)

Aplicación de la medicina tradicional a un grupo de mujeres con displasia mamaria / Application of traditional herb medicine to a group of women with breast dysplasia

Se hizo un estudio de 100 pacientes de la consulta de mastología en el año 1999, con el diagnóstico de displasia mamaria demostrado por la clínica y la citología aspirativa con aguja fina. El objetivo principal fue hacer un enfoque sistémico, dinámico y abierto del que está dotada la medicina tradicional, así como la repercusión social y el beneficio económico de este tratamiento. Se sustituyeron métodos con efectos secundarios que al cesar puede recidivar la enfermedad, por métodos inocuos con fines curativos y con efectos permanentes, de fácil aplicación. El más duradero y mejor tolerado fue la auriculoterapia, predominaron las mujeres de 21 a 30 años, obesas, ansiosas, fumadoras, tomadoras de café, té y píldoras anticonceptivas

Effect of bioactive additive mammoleptin on development of transplanted tumors in mice.

Bioactive additive mammoleptin used for the treatment of fibrocystic breast disease did not stimulate the growth of primary tumors and metastases in mice with transplanted tumors. Mammoleptin in high doses inhibited the growth of Ehrlich adenocarcinoma and metastatic spreading of solid tumors.

[Effect of running granule on repairing capacity of neuro-endocrine-immunity and DNA in treating mastoplasia].

OBJECTIVE: To explore the clinical effect and therapeutic mechanism of Runing Granule (RNG) in treating mastoplasia to elucidate its pathogenesis. METHODS: One hundred and eighty-seven patients suffering from mastoplasia were randomly divided into the RNG treated group (treated group, 147 cases), and the tabellae tamoxifen control group (control group, 40 cases). The follow-up underwent for 3 months. Before and after treatment, changes of levels of plasma neurotransmitters, serum endocrine hormone, peripheral lymphocyte unscheduled DNA synthesis, the count of T lymphocyte subsets in the luteal phase during the menstrual cycle of 104 cases were measured, their clinical effects were also observed. RESULTS: Before treatment, these cases showed disturbances in the secretion of 5-hydroxytryptamine (5-HT), epinephrine (E), estradiol (E2), follicle stimulating hormone (FSH), luteinizing hormone (LH), and the levels of norepinephrine (NE), prolactin (PRL), inducer-helper T lymphocytes (OKT4+), suppressor T lymphocytes (OKT3+), were significantly increased, progesterone (P), testosterone (T), total T cells (OKT3+), OKT4+/OKT8+ ratio, unscheduled DNA synthesis (UDS) were obviously reduced (P < 0.05, P < 0.01) in mastoplasia patients. After treatment, RNG showed regulation on disturbances of these parameters, the curative rate of the treated group was higher than that of the control group; the metabolic disturbances of 5-HT/NE, E2/P, T, OKT3+ in the treated group were improved more significantly than those in the control group (P < 0.05). During the period of clinical observation, no obvious side effect and toxicity of RNG were found. CONCLUSIONS: Mastoplasia is caused by the interactions among multi-factors in which the neuro-endocrine-immune network plays a key role in the pathogenesis of mastoplasia. RGN was effective in treating mastoplasia, the mechanism probably lays on the regulation of comprehensive coordination from the multi-layers, multi-links and multiple pathways in the neuro-endocrine-immunity network and elevation of internal environment-stabilizing capacity of the body.

[Clinical and experimental study of jianruling in treating hyperplasia of mammary gland].

OBJECTIVE: To observe the therapeutic effect of Jianruling (JRL) on hyperplasia of mammary gland (HMG) and to explore its mechanism in regulating sex hormones. METHODS: Clinical changes of HMG were observed and serum sex hormones measured before and after JRL treatment. In experimental study, the effect of JRL was estimated by using electron microscope, pathologic and radioimmunoassay. RESULTS: JRL could not only cure HMG, but also regulate the sex hormone secretion both in HMG patients and in rats. Clinical study showed that the clinical cure rate was 72.5%, and the total effective rate was 90.8%, it demonstrated a significant difference in comparing with the control group, P < 0.01. The estradiol and prolactin levels of patients lowered significantly after JRL treatment, P < 0.05, while progestogen and testosterone increased significantly, P < 0.05, but no significantly change of follicle-stimulating hormone and luteinizing hormone was found. JRL showed marked effect in treating and preventing experimental HMG in rats, it could modulate the secretive function of sex hormone, and improve the construction of mammary gland. CONCLUSION: JRL has significant effect in treating HMG, it can adjust the endogenous sex hormone level, delay the development of chronic cystic hyperplasia of mammary gland.

280 cases of hyperplasia of mammary gland treated by ru he chong ji.

280 patients with hyperplasia of mammary gland were treated by Ru He Chong Ji, a breast nodule granular dissolvable agent. Thirty-one were cured, 117 markedly improved, 119 improved, and 13 showed no change. The rate of cure and marked effectiveness was 52.86%, with a total effective rate of 95.36%. The agent is also effective for treatment of depression of liver-energy and menoxenia.

Doppler measurement of breast vascularity in women under pharmacologic treatment of benign breast disease.

Breast vascularization was measured with an 8-MHz continuous wave Doppler pencil probe. Flow values were low in asymptomatic women and high in patients with severe pain or dysplastic changes. Mild treatment with a plant extract produced only a small decrease in breast vascularization. Treatment with norethisterone acetate showed a dose-dependent decrease in blood flow. A good response was seen with a dosage of 5 mg/d, and a dramatic decrease was seen when 10 mg/d was taken. These results showed a good correlation with the patients' symptoms.

Plasma fatty acid profiles in benign breast disorders.

Breast pain (mastalgia) and macroscopic breast cysts present commonly. Mastalgia may be improved by dietary manipulation to reduce saturated fat or supplement essential fatty acid intake. Fatty acid profiles were measured in women with mastalgia and breast cysts, before and during treatment with evening primrose oil, a rich source of essential fatty acids. The fatty acid profiles of both groups of patients were abnormal, with increased proportions of saturated fatty acids and reduced proportions of essential fatty acids. Treatment with evening primrose oil improved the fatty acid profiles towards normal, but this was not necessarily associated with a clinical response.

[Treatment of breast proliferation disease with modified xiao yao san and er chen decoction].

The authors report the 3 months' treatment of 51 cases of breast proliferation disease with modified Xiao Yao San and Er Chen decoction, an effective rate being 96.1%. In each patient before and after treatment, saliva estradiol (SE2), saliva progesterone (SP), saliva testosterone (ST) and plasma prolactin (PRL) concentrations were monitored and breast molybdenum-target X-ray films were taken. The results showed that after treatment, SE2 concentrations declined very significantly (P less than 0.001); SP concentrations declined significantly (P less than 0.05); PRL concentrations declined very significantly (P less than 0.005), but ST concentrations did not change significantly. Breast molybdenum-target X-ray films showed absorption of proliferation masses in 21 cases. These indicated that the medicine could regulate endocrine system, perhaps through suppressing secretion of PRL, decreasing prolactin antagonist action to follicular stimulating hormone so as to restore follicle function, and could regulate pituitary-follicle axis and make the axis normal.