Current status of outcome reporting in randomized controlled trials of traditional Chinese medicine for mammary gland hyperplasia: A systematic review

Objective:To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland(HMG)with traditional Chinese medicine(TCM).Methods:Eight online databases were searched from their inception to December 31,2022,to assess outcomes reported in randomized controlled trials(RCTs)of HMG treated with TCM.The quality of the included studies was assessed according to the Cochrane Risk of Bias Assessment Tool.All outcomes were extracted,classified,and described.Results:A total of 8249 articles were initially retrieved.Of these,70 articles were eligible and involved 10618 participants with HMG.A total of 17 outcome indicators with a frequency of 271 times were involved and were collected according to six outcome domains.Conclusions:The core outcomes of RCTs of HMG treated with TCM are large and divergent.There are problems in evaluation standards,primary and secondary outcomes,TCM characteristic indicators,long-term prognosis,and standardization of reporting.It is recommended to strengthen the trial design and actively construct the core outcome sets with TCM characteristics for HMG.

CLINICAL OBSERVATION ON THE ACUPOINT INTRADERMAL EMBEDDING OF RINGHEADED THUMBTACK-NEEDLE THERAPY FOR HYPERPLASIA OF MAMMARY GLANDS

In the present paper, the author used acupoint intradermal embedding of ringheaded thumbtack-needle therapy combined with herbal medicine therapy to treat 110 cases of hyperplasia of mammary glands, and compared its therapeutic effect with that of herbal therapy alone. The observed indexes of the treatment were pain relief degree, the size of hyperplasic glands and the time of occurrence of marked effect. Following 3 courses of treatment,the results showed the therapeutic effect of the ringheaded thumbtack-needle needle plus herbal medicine therapy was superior to that of herbal medicine therapy alone in the above-mentioned 3 indexes (P ＜ 0.01 ).

ACUPUNCTURE FOR TRERTING 120 CASES OF HYPERPLASIA OF MAMMARY GLANDS

Objective: To observe the therapeutic effect of acupuncture therapy for 120 cases of hyperplasia of mammary glands. Methods: These patients were classified into liver-qi-stagnation type (n=53), phlegm-coagulation type (n=30) and Thoroughfare-Conception vessel maladjustment type (n=37). Acupoints used were Qimen (期门 LR 14), Wuyi (屋翳 ST 15), Weishu (胃俞 BL 21), etc.. Acupuncture treatment was conducted once daily and 30 treatments constituted one therapeutic course. Results: After 3 courses of treatment, of the 53, 30 and 37 cases of the liver-qi-stagnation, phlegm-coagulation and Thoroughfare-Conception vessel maladjustment types, 43 (81.1%), 24 (80.0%) and 29 (78.4%) were cured, 7 (13.2%), 5 (16.7%)and 5 (13.5%) markedly improved, 3 (5.7%), 1 (3.3%) and 2 (5.4%) improved respectively, and 1 (2.7%) of Thoroughfare-Conception vessel maladjustment type failed. A two-years’ follow-up showed that 3 of the cured 92 cases had a relapse, and after 2 more courses of treatment, they were cured again. Conclusion: Acupuncture therapy is effective for the treatment of hyperplasia of mammary glands.

Effect of Lirukang Oral Liquid(利乳康口服液) on Neurotransmitters and Estrogen in Rats with Hyperplasia of Mammary Gland

Objective: To investigate the effects of Lirukang oral liquid (LRK, 利乳康口服液) on release of neurotransmitter in rats with hyperplasia of mammary glands (HMG) and to explore its mechanism. Methods: Sixty rats were divided into six groups, the normal control group, the model control group, the large dosage (3.6g/kg) and the small dosage (1.8g/kg ) LRK groups, the Ruzengning (乳增宁, RZN, 2.5g/kg) group and the tamoxifen (TAM, 5mg/kg) group, 10 in each group. Except those in the normal control group, all the animals were made into rat model of HMG by intraperitoneal injection of estradiol benzoate. Levels of dopamine (DA) and 5-hydroxytryptamine (5-HT) in hypothalamus and mammary gland in rats were detected by fluorescence luminosity assay, and level of prolactin (PRL) in serum was detected by radioimmunoassay. Results: In the model group, the level of DA reduced significantly ( P<0. 01), and 5-HT and PRL increased obviously ( P<0.01). Compared with the model group, the LRK groups of both dosages and the TAM group had their level of DA significantly increased (P<0. 01), and level of 5-HT significantly decreased ( P<0.01). The serum PRL in both LRK groups was significantly decreased ( P<0. 01). No obvious changes in DA, 5-HT and PRL were found in the RZN group. Conclusion: LRK and TAM have similar effects in regulating the release of neurotransmitter in hypothalamus and mammary gland and serum content of estrogen in the animal models of HMG.

Differential Acupuncture Treatment of Hyperplasia of Mammary Glands

Hyperplasia of mammary glands is a common disease in the middle-aged women, and it is a precancerous lesion of mammary glands. For many years, the author has used Rugen (ST 18) of the Stomach Meridian of Foot-Yangming as the main point withcertain auxiliary points chosen on basis of the differentiation types to treat the disease and obtained satisfactory therapeutic effects. A report follows. ……

Core acupoints of acupuncture for hyperplasia of mammary gland: a network analysis

Backgroud:Clinical studies on acupuncture treatment of hyperplasia of mammary gland(HMG)have proved its effectiveness,but most studies have paid little attention to acupoints prescription and acupoint compatibility.The clinical prescription is not identical,the curative effect also has the difference.Therefore,through data mining and network analysis,this study explored the core acupoints and the compatibility law of acupoints in acupuncture treatment of HMG.Methods:To search and select qualified literature according to inclusion and exclusion criteria for relevant clinical research literature on acupuncture treatment of HMG in CNKI,VIP database,WanFang database and PubMed,etc.Then extract relevant information and establish a database.Using the method of statistical and complex network analysis,this paper studies the core acupoints and the law of acupoint compatibility.Results:A total of 104 Chinese literatures and 0 English literatures were included and 106 acupuncture prescriptions were extracted.The core acupoints in the treatment of HMG are Danzhong(CV 17),Wuyi(ST 15),Zusanli(ST 36),Jianjing(GB 21).Danzhong(CV 17)and Zusanli(ST 36),Danzhong(CV 17)and Wuyi(ST 15),Jianjing(GB 21)and Tianzong(SI 11),Jianjing(GB 21)and Wuyi(ST 15)have the highest correlation degree.The method of acupoint matching mainly consists of local-remote acupoints,upper-lower acupoints and front-rear acupoints.Conclusion:The results of a network analysis substantially accord with the general rules of acupuncture theories in traditional Chinese medicine,able to reflect the points-selection principles and features in acupuncture treatment of HMG and provide evidence for the acupoints selection in the treatment of HMG in acupuncture clinic.

ELECTROACUPUNCTURE TREATMENT OF 30 CASES OF HYPERPLASIA OF MAMMARY GLANDS

In the present paper,30 cases of hyperplasia of mammary glands were treated withelectroacupuncture in different times following menstruation,showing satisfactory results.The totaleffective rate was up to 96.67％.In addition,the symptom of mastalgla abated abviously after treat-ment.

300 CASES OF HYPERPLASIA OF MAMMARY GLANDS TREATED WITH RED-HOT NEEDLE PLUS FILIFORM NEEDLE

Clinical observations on 300 cases of hyperplasia of mammary glands (group A) treated by red hot needle plus filiform needle are reported in the present study. "Ashi" points were used as the main acupoints. For comparison, other 300 cases (group B) were treated with routine acupuncture method, and Rugen (ST 18) was used as the main acupoint. In addition, other auxiliary acupoints were supplemented in the light of the concrete syndromes in these two groups. The treatment was given once daily, with 10 sessions being a therapeutic course. Of the 300 cases in group A, 240 were clinically cured, amounting to 80%; 58 were effective, amounting to 19.3%; 2 were failed, with a total effective rate of 99.3%. Of the 300 cases in group B, 113 were clinically cured, 165 effective, 22 were failed, with a total effective rate of 92.7%. The therapeutic effect of group A is significantly superior to that of group B (P<0.05).

Research Progress on Classical Prescriptions in Treating Mammary Glands Hyperplasia

According to Zhongjing Zhang's academic thought,gynecological diseases mostly result from deficiency,accumulated cold,and qi stagnation,so the treatment of gynecological miscellaneous diseases should take qi and blood as the general principle,and focus on the liver.The pathogenesis of mammary glands hyperplasia(MGH)is liver and kidney deficiency,disharmony of the thoroughfare vessel and the conception vessel,the causes of which are emotional imbalance,liver qi depression,and failure of transportation due to spleen deficiency.The superficial causes include qi stagnation,phlegm coagulation,and blood stasis,which are mainly related to the liver,spleen,kidney,the thoroughfare vessel,and the conception vessel.In clinical treatment of MGH,Xiaochaihu Decoction or Sini Powder can be used for qi stagnation syndrome,Xiao Xianxiong Decoction for phlegm coagulation syndrome,Guizhi Fuling Pill or Dahuang Zhechong Pill for spleen deficiency syndrome,and Wenjing Decoction for the deficiency-cold syndrome.

Rupi Sanjie capsule plus surgical operation for the treatment of hyperplasia nodule of mammary gland:A meta-analysis and trial sequential analysis

Objective:To evaluate the efficacy and safety of Rupi Sanjie(RPSJ)capsule plus the conventional surgical operation for treatment of hyperplasia nodule of mammary gland.Methods:A meta-analysis was conducted on randomized controlled trials(RCT)related to RPSJ capsule plus surgical operation in the treatment of hyperplasia nodule of mammary gland.The methodological quality of eligible RCTs was assessed according to the criteria from the Cochrane Handbook for Systematic Reviews of Interventions.RevMan5.3 and Stata14.0 were used for data analyses.Trial sequential analysis was performed to estimate the sample size of systematic review base on TSA software v0.9.Results:Twenty-two RCTs were totally included in this study,involving 2135 patients.The result showed the clinical recurrence rate of RPSJ capsule plus surgical treatment group was significantly lower than surgical treatment alone group(RR:0.25,95%CI[0.17,0.37],P<0.01).The clinical cure rate and total effective rate were higher in RPSJ capsule plus surgical treatment group than the conventional surgical treatment group(RR:1.63,95%CI[1.46,1.82],P<0.01);(RR:1.29,95%CI[1.22,1.37],P<0.01).Application of RPSJ capsule decreased the occurrence of adverse events including nausea,vomiting,irregular menstruation,constipation,dizziness,and headache etc.(RR:0.90,95%CI[0.54,1.49],P=0.68).The results of trial sequential analysis demonstrated that the current available data did not reach the expected value.Conclusion:RPSJ capsule plus the conventional surgical treatment was more effective in reducing the clinical recurrence rate,and improving the total clinical effective rate and clinical cure rate,with a decrease in the occurrence of adverse events.

Network meta-analysis of acupuncture treatment for mammary gland hyperplasia

Objective: To evaluate the efficacy of acupuncture for the treatment of mammary gland hyperplasia. Methods: Randomized controlled trials before December 2017 in CNKI, China Biology Medicine disc, Chinese sci-tech periodical full-text database, Wanfang database, Cochrane Library, Pubmed, Embase and Web of Science were searched. The risks were evaluated by two investigators according to the Cochrane Handbook 5.1.0 criteria. Evaluation GeMTC was used for network-meta analysis. Results: A total of 43 articles were included, involving 5531 patients. Network meta-analysis results showed that there were differences in the comparison before and after treatment: acupuncture + Chinese herbal medicine vs acupuncture, acupuncture + Chinese herbal medicine vs Chinese herbal medicine, acupuncture + Chinese herbal medicine v s acupoint embedding, acupuncture + western medicine vs acupuncture, acupuncture + western medicine vs western medicine, acupuncture + western medicine vs Chinese herbal medicine, fire needle vs acupuncture, fire needle vs Chinese herbal medicine, moxibustion vs acupuncture, moxibustion vs Chinese herbal medicine, acupoint embedding line + Chinese herbal medicine vs Chinese herbal medicine, acupoint embedding line + Chinese herbal medicine vs western medicine, acupoint embedding line + Chinese herbal medicine vs acupuncture, acupoint embedding line + Chinese herbal medicine vs acupuncture + Chinese herbal medicine, acupoint embedding line + Chinese herbal medicine vs acupuncture + western medicine, acupoint embedding line + Chinese herbal medicine vs fire needle, acupoint embedding line + Chinese herbal medicine vs fire needle + Chinese herbal medicine, acupoint embedding line + Chinese herbal medicine vs electroacupuncture, acupoint embedding line + Chinese herbal medicine vs acupoint embedding line, Acupoint embedding line + Chinese herbal medicine vs ear acupuncture, acupoint embedding line + Chinese herbal medicine vs moxibustion, acupoint embedding line + Chinese herbal medicine vs moxibustion + Chinese herbal medicine. Conclusion: Acupoint embedding + traditional Chinese medicine, acupuncture + western medicine is the best treatment for mammary gland hyperplasia, but the exact conclusion still needs high-quality clinical research to further verify.

COMMENTS ON CLINICAL APPLICATION OF LOCAL MULTI-NEEDLE PUNCTURING

In the present paper, combining a few of typical cases, the author introduces his clinical experiences about the application of multiple acupuncture needles inserted into a certain local region for treatment of facial spasm, lumbago, hyperplasis of the mammary glands and herpes zoster and gives some brief comments.

乳腺增生症的中西医认识及治疗研究进展

乳腺增生症(hyperplasia of mammary gland,HMG)中医病名为乳癖,是一种乳腺组织增生的疾病,其中医基本病机为情志失常,病机以肝内气机郁滞为主,兼有脾肾不足等,由此导致气滞、血瘀、痰凝。气、血、痰、瘀于乳络互结。西医病因病理尚未完全明确。西药目前尚无特异性疗法,中药治疗具有良好效果。文章将对乳癖的中西医病因病机进行论述,并结合临床案例及经验总结中医药治法治则及常用药物,以临床为角度基础,提出治疗乳癖的方法,并为乳癖病因病机的研究与探讨提供新思路。

穴位埋线治疗中重度乳腺增生病临床研究

目的:观察穴位埋线治疗中重度乳腺增生病(MGH)的疗效。方法:选取72例中重度MGH患者,按随机数字表法分为对照组及观察组各36例。对照组采用小金丸口服,观察组采用聚对二氧环己酮(PPDO)对折旋转穴位埋线治疗。2组均连续治疗8周,随访3个月。比较2组临床疗效,比较2组治疗前后乳房疼痛评分、乳房肿块大小、情绪评分[汉密尔顿焦虑量表-14项(HAMA)、汉密尔顿抑郁量表-17项(HAMD)]的变化。结果:观察组总有效率为90.63%,对照组为63.64%,2组比较,差异有统计学意义(P<0.05)。2组不同时间点乳房疼痛评分在时间因素、时点交互因素方面比较,差异有统计学意义(P<0.05)。治疗后及随访期,2组乳房疼痛评分均较治疗前下降(P<0.05),观察组治疗后及随访期的乳房疼痛评分均低于同一时间段的对照组(P<0.05)。2组不同时间点乳房肿块大小在时间因素、组间因素、时点交互因素方面比较,差异有统计学意义(P<0.05)。治疗后及随访期,2组乳房肿块大小均较治疗前缩小(P<0.05),观察组治疗后及随访期乳房肿块均小于同一时间段的对照组(P<0.05)。2组不同时间点HAMA评分、HAMD评分在时间因素、组间因素、时点交互因素方面比较,差异有统计学意义(P<0.05)。治疗后及随访期,2组HAMA、HAMD评分均较治疗前下降(P<0.05);观察组治疗后及随访期HAMA评分、HAMD评分均低于同一时间段的对照组(P<0.05)。结论:穴位埋线治疗中重度MGH疗效较好,可减轻乳房疼痛程度,缩小肿块大小,改善患者情绪。

Efficacy of Lubeikangru formulation in mice with hyperplasia of the mammary glands induced by estrogen and progesterone

OBJECTIVE: To evaluate the protective effects of Lubeikangru formula(LF) on hyperplasia of the mammary glands(HMG) induced by estrogen and progesterone in mice.METHODS: Female mice were divided randomly into five groups: normal, model, tamoxifen(3 mg/kg),Rupixiao(900 mg/kg) and LF(900 mg/kg). All mice except those in the normal group were treated sequentially with estradiol and progesterone to induce HMG. From the tenth day of induction, mice in normal and model groups received distilled water and mice in the other groups were given the corresponding drugs by gavage, once a day, for 30 d.At the end of treatment, the mammary glands, ovaries, hypothalamus, and serum was collected for whole-mount and hematoxylin and eosin(HE)staining, enzyme-linked immunosorbent assays(ELISAs), or western blotting.RESULTS: Whole-mount and HE staining of mammary glands showed that LF rescued(at least in part) the hyperplasic morphology of the mammary glands, and the number of branch points decreased after LF treatment(P < 0.05). ELISAs revealed that levels of estrogen and progesterone were decreased following LF treatment, whereas levels of gonadotropin-releasing hormone, follicle-stimulating hormone, and luteinizing hormone were increased in serum and tissues. Western blotting confirmed that LF treatment led to a reduction in expression of phosphorylated(p)-Erk, p-p38 and p-c-Jun N-terminal kinase. LF was also confirmed to be safe by acute-toxicity tests.CONCLUSION: LF can protect the mammary glands of mice from estrogen-and progesterone-induced hyperplasia by adjusting hormone levels and regulating the mitogen-activated protein kinase pathway.

蒲公英对乳腺疾病治疗作用机制的研究进展

乳腺疾病是我国常见的危害女性心理及健康的最主要因素,蒲公英在治疗乳腺疾病方面疗效确切,深入研究其药理作用及临床应用尤为必要。基于此,就近年来关于蒲公英对乳腺疾病的药理作用和临床应用的相关文献进行归纳分析,发现可通过含蒲公英的复方治疗乳腺增生病;其主要有效成分可通过调控核因子κB(nuclear factor-kappa B,NF-κB)信号通路和微生物相关分子模式(microbe-associated molecular patterns,MAMPs)信号通路,下调肿瘤坏死因子-α(tumor necrosis factor-α,TNF-α)、白细胞介素-1β(interleukin-1β,IL-1β)和白细胞介素-6(interlukin-6,IL-6)等炎性因子的表达治疗哺乳期乳腺炎;通过中药复方合理配伍治疗非哺乳期乳腺炎;通过调控细胞周期以抑制增殖、促进凋亡、抗侵袭转移、调节自噬、影响雌激素、提高免疫力、抑制相关代谢途径等抗乳腺癌。总结梳理的关于蒲公英作用于乳腺疾病的药理作用及临床应用,可为进一步研究蒲公英在乳腺疾病的治疗提供新的思路和科学依据。

基于数据挖掘探讨针刺治疗乳腺增生症选穴规律

目的 采用数据挖掘技术探讨针刺治疗乳腺增生症(MGH)选穴规律,为规范临床针刺治疗MGH选穴提供理论依据。方法 检索中国知识资源总库(CNKI)、中国学术期刊数据库(万方数据)、中文科技期刊数据库(VIP)、PubMed 2013年8月27日-2023年8月27日收录的针刺治疗MGH临床研究文献,提取针刺处方并录入Excel2019建立数据库,运用SPSS25.0、SPSS Modeler 18.0、R studio4.2.2对数据进行描述性分析、聚类分析和关联规则分析并绘制关联网络图,运用Cytoscape3.9.1软件将网络图可视化。结果 共纳入95篇文献,提取针刺处方95条,涉及腧穴65个,总使用频次为658。高频腧穴有膻中、足三里、乳根等,常用经脉为足阳明胃经、任脉和足厥阴肝经,腧穴分布部位以胸腹胁部和下肢部为主,高频特定穴为募穴、五输穴、八会穴。聚类分析得到2个有效聚类群,关联规则分析得到膻中-足三里、膻中-乳根、膻中-三阴交3个核心组合。结论 针刺治疗MGH选穴集中在胸腹胁部,以肝经、任脉、胃经腧穴为主,重视特定穴使用,遵循“远近配穴”原则,重视从肝、脾、胃论治。

消乳散结胶囊治疗乳腺增生临床观察

目的:观察消乳散结胶囊治疗乳腺增生的疗效。方法:80例按随机数字表法分为两组,对照组用三苯氧胺治疗,观察组用消乳散结胶囊治疗。结果:总有效率观察组较对照组高(P<0.05)。治疗后两组乳房肿块大小与乳房疼痛评分均下降(P<0.05),且观察组下降更明显(P<0.05)。随访6个月复发率观察组低于对照组(P<0.05)。观察组不良反应率低于对照组(P<0.05)。结论:消乳散结胶囊治疗乳腺增生效果较好,并可减少复发。

基于定量蛋白质组学探讨西黄丸抗乳腺增生的作用机制

目的基于定量蛋白质组学技术明确西黄丸抗乳腺增生(hyperplasia of mammary glands,HMG)中乳腺组织的差异蛋白并验证,探讨其作用机制。方法将SD大鼠随机分为空白组、模型组和西黄丸组,每组10只。除空白组外,肌注雌孕激素建立HMG大鼠模型,为期30 d。给药西黄丸14 d后,观察各组大鼠表观形态变化,HE染色观察乳腺组织病理改变,定量蛋白质组学技术筛选各组差异表达蛋白(differentially expressed proteins,DEPs),并进行生物信息学分析和Western blot验证。结果与模型组比较,西黄丸组表观病理形态明显改善,大鼠乳头高度直径明显降低(P<0.01),组织病理程度明显缓解。定量蛋白质组学鉴定出乳腺组织4299个DEPs,对西黄丸组与空白组相对模型组变化一致的14个DEPs进行生物信息学分析,发现与肌肉系统过程的调节、肌肉收缩调节、DNA复制和DNA复制启动前过程有关。Western blot结果表明,与模型组比较,西黄丸组大鼠乳腺组织ACLY与ALDOC蛋白表达水平明显降低,BIN1蛋白表达水平明显增加(P<0.01)。结论西黄丸可能通过调控BIN1、ACLY及ALDOC蛋白水平,调控DNA复制、DNA复制启动前和肌肉系统过程的调节、肌肉收缩调节等途径发挥抗HMG作用。

基于网络药理学和分子对接探究白术治疗乳腺增生的作用机制

目的:利用网络药理学、分子对接和实验验证的方法来研究白术对乳腺增生的治疗机制。方法:采用TCMSP、Swiss Target Prediction、GeneCards和OMIM等数据库来预测白术的活性成分和乳腺增生症相关疾病靶点,取交集后构建蛋白互作网络,使用Cytoscape3.7.1分析平台绘制“药物-有效成分-潜在靶点”PPI网络图。使用David数据库来进行GO和KEGG通路的集成分析,并借助Pymol和AutoDock软件来预测分子的结合能力。在HMG实验的大鼠模型里,使用苯甲酸雌二醇与黄体酮联合进行诱导,同时利用HE染色法研究了大鼠乳腺的病理改变,对大鼠的血清E 2和PRL含量进行了测定。结果:筛选得到白术活性成分7个,潜在靶点89个,“药物-有效成分-潜在靶点”网络提示3β-乙酞氧基苍术酮、白术内酯III等为白术治疗HMG的主要成分,蛋白质互作网络提示PTGS2、ESR1、MAPK14等靶点为关键靶点;得到GO富集条目178条(P<0.05),KEGG富集条目24条(P<0.05);主要涉及VEGF信号通路、钙离子信号通路和催乳素信号通路,通过对白术的主要活性成分及其目标的分子对接分析发现,它们之间存在良好的亲合能力。体内药理实验结果表明,白术可显著降低HMG大鼠乳头直径,缓解乳腺组织的损害情况,同时使血清中E_(2)和PRL水平显著下降(P<0.05)。结论:大鼠乳腺增生症的改善可以通过白术的有效应用,这种应用可能与调整性激素的水平存在一定关联。