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 Treatment of Mammary Gland Hyperplasia by Acupoint Injection Combined with Ion-Introduction of Chinese Herbal Medicine

Objective: To observe the effect of combined therapy of acupoint Injection and Chinese herbal medicine ion-introduction in treating mammary gland hyperplasia (MGH). Methods: Eighty-six patients of MGH were treated with the combined therapy and compared with a control group treated with other Chinese or western drugs. Results: Therapeutic effect evaluated after 3 courses of treatment showed that the effect of combined therapy was superior to that of the control groups treated by Xiaoyao Pill, Rupixiao tablet, Asparagine tablet and combined therapy of vitamin E + oryzanol + vitamin B6. Conclusion: Combined treatment of acupoint injection and ion-introduction of Chinese herbal medicine is an effective treatment for mammary gland hypertrophy.

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.

Clinical Observation on Treatment of Hyperplasia of Mammary Gland by Lirukang Granule (利乳康颗粒)

Objective： To explore the efficacy and mechanism of Lirukang Granule （利乳康颗粒, LRKG） in treating hyperplasia of mammary gland （HMG）. Methods： One hundred patients with HMG were randomly assigned to two groups, 50 in each group. The patients in the treated group were orally administered with LRKG thrice a day, one package each time, and those in the control group were given orally Rukuaixiao Tablet （乳块消, RKX） thrice a day, 4 tablets each time. The therapeutic course for both groups was 4 months. The clinical efficacy, pain alleviating rate, as well as changes of local sign and symptom scores were observed before and after treatment. The changes of serum estradiol （E2）, progesterone （P）, testosterone （T）, follicle stimulating hormone （FSH）, luteinizing hormone （LH） and prolactin （PRL） in some randomly selected patients （24 patients in the treated group and 24 in the control group） before and after treatment were measured with radioimmunoassay. Results： The total clinical efficacy in the treated group was superior to that in the control group, significant difference was shown between the two groups （P〈 0.01）. The cure-effective rate and total effective rate in the treated group were 70.0%and 88.0% respectively, significantly higher than those in the control group （38.0% and 64.0%） respectively （P〈 0.01）, and the pain alleviating rate in the treated group was also significantly higher in the former than that in the latter （88.0% vs 64.0%, P 〈 0.05）. Moreover, the treated group showed obvious superiority in improving the patients＇ symptom and sign scores （P 〈 0.01）, and abnormalities of gonadal hormone as compared with the respective items in the control group （P〈0.01）. Conclusion： LRKG has good efficacy in the treatment of HMG, and its mechanism may be related to the regulation on endocrine and immune function.