Therapeutic Effects of a Traditional Chinese Medicine Formula Plus Tamoxifen vs. Tamoxifen for the Treatment of Mammary Gland Hyperplasia: A Meta-Analysis of Randomized Trials.

As a common disorder that accounts for over 70% of all breast disease cases, mammary gland hyperplasia (MGH) causes a severe problem for the quality of patients' life, and confers an increased risk of breast carcinoma. However, the etiology and pathogenesis of MGH remain unclear, and the safety and efficacy of current western drug therapy for MGH still need to be improved. Therefore, a meta-analysis was conducted by our team to determine whether a TCM formula named Ru-Pi-Xiao in combination with tamoxifen or Ru-Pi-Xiao treated alone can show more prominent therapeutic effects against MGH with fewer adverse reactions than that of tamoxifen. Studies published before June 2017 were searched based on standardized searching rules in several mainstream medical databases. A total of 27 articles with 4,368 patients were enrolled in this meta-analysis. The results showed that the combination of Ru-Pi-Xiao and tamoxifen could exhibit better therapeutic effects against MGH than that of tamoxifen (OR: 3.79; 95% CI: 3.09-4.65; P < 0.00001) with a lower incidence of adverse reactions (OR: 0.35; 95% CI: 0.28-0.43; P < 0.00001). The results also suggested that this combination could improve the level of progesterone (MD: 2.22; 95% CI: 1.72-2.71; P < 0.00001) and decrease the size of breast lump (MD: -0.67; 95% CI: -0.86 to -0.49; P < 0.00001) to a greater extent, which might provide a possible explanation for the pharmacodynamic mechanism of Ru-Pi-Xiao plus tamoxifen. In conclusion, Ru-Pi-Xiao and related preparations could be recommended as auxiliary therapy combined tamoxifen for the treatment of MGH.

Effects of Kaixin Powder on melatonin receptor expression and (125)I-Mel binding affinity in a rat model of depression.

OBJECTIVE: To explore the effects of Kaixin Powder (, KXP) on melatonin receptor (MR) expression and (125)I-Mel binding affinity in a depression rat model. METHODS: Seventy-two male Wistar rats were divided into six groups: a blank control group, model group, ramelteon group, KXP high-dosage group (HKXP), medium-dosage group (MKXP) and low-dosage group (LKXP). To establish the depression model, all groups except the blank control group were singly housed and exposed to chronic unpredictable mild stress. Weight gain, sucrose consumption and the open-field test were used to evaluate induction of depression. KXP at 260, 130 and 65 mg/(kg•d) was also respectively administered to the rats in the HKXP, MKXP and LKXP groups for 21 days. Ramelteon [0.83 mg/(kg•d)] was given to the positive drug control group. An equivalent volume of physiological saline was given to the blank and model groups. The liquid chip method was used to measure the concentration of plasma melatonin (MT). Mel1a (MT1) and Mel1b (MT2) expression levels were determined by Western blotting. In addition, a radioactive ligand-binding assay was used to analyze the specific binding properties and dynamic characteristics between MR and (125)I-Mel. RESULTS: The results of weight gain, sucrose consumption and the open-field test showed that our model successfully produced depressive symptoms and depressive-like behavior. The concentration of plasma MT in the model group decreased significantly at night but increased in the MKXP group (P<0.05). The HKXP group showed significantly increased expression of MT1 (P<0.05); however, the expression of MT2 in all groups exhibited no significant differences (P>0.05). The maximum binding capacity (B(max)) for specific binding between MR and 125I-Mel in the MKXP group was significantly higher than that in the model group (P<0.05), but no significant differences were found in the equilibrium dissociation constant (K(d)) of each group (P>0.05). CONCLUSIONS: KXP may have a similar effect as ramelteon. KXP improved depressive-like behavior by increasing the concentration of plasma MT and MT1 expression, thereby increasing three B(max) of MR to achieve the desired antidepressant effect.

A randomized trial of Chinese medicine Lirukang Granule combined with psychological intervention for cyclomastopathy and menoxenia.

OBJECTIVE: To observe the influence of therapy with Chinese medicine Lirukang Granule (, LRKG) combined with psychological intervention on anxiety states and sex hormones in patients with cyclomastopathy and menoxenia. METHODS: A total of 470 subjects were randomly assigned to three groups by the net-central randomization system, the treatment group (161 patients, treated with LRKG and psychological intervention), the Chinese medicine group (157 patients, treated with LRKG), and the psychological intervention group (152 patients, treated with psychological intervention). The dose of LRKG was 12 g three times per day; psychological intervention included establishing relations, cognitive intervention and psychological persuasion, 30-40 min per session, once a week. The therapy duration for all groups was three months. The efficacy was compared and anxiety state/State-Trait Anxiety Invertory (STAI) scoring was measured before and after treatment. The serum estradiol (E2), progesterone (P), prolactin (PRL) and follicle stimulating hormone (FSH) levels of 60 patients selected randomly from each group during the luteal phase were measured before and after treatment, and a group of 20 healthy women were evaluated for comparison. A follow-up was arranged for one year after treatment. RESULTS: Thirty subjects were lost to follow-up. (1) Comparison of efficacy: the markedly effective rate and the total effective rate of the treatment group were 86.67% (131/150) and 98.00% (147/150), respectively; of the Chinese medicine group, 64.58% (93/144) and 90.27% (130/144), respectively; and of the psychological intervention group, 0% (0/146) and 3.42% (5/146), respectively. The markedly effective rate and the total effective rate in the treatment group were significantly higher than those in the Chinese medicine and psychological intervention groups (P < 0.05). (2) Comparison of STAI scoring: STAI scoring was decreased dramatically in the treatment group after treatment compared with that of the Chinese medicine group (P < 0.01), but there was no significant difference compared with the psychological intervention group. (3) Comparison of levels of sex hormones: E2, P, PRL and FSH of the three patient groups were disordered before treatment, and significantly different from healthy women (P < 0.01). After treatment, the levels of P and FSH of the treatment group were significantly increased (P < 0.01), E2 and PRL were significantly reduced, which were also significantly decreased compared with the psychological intervention groups (P < 0.01). (4) FOLLOW-UP: the markedly effective rate and the total effective rate of the treatment group remained higher than those of the other two groups after one year of treatment (P < 0.05). (5) Adverse reactions: no obvious adverse reactions were found among the three groups. CONCLUSIONS: Therapy with Chinese medicine combined with psychological intervention was effective for short-term and long-term treatment of cyclomastopathy and menoxenia. The mechanism might be related to the regulation of sex hormones.

Assessment of the clinical effect of Chinese medicine therapy combined with psychological intervention for treatment of patients of peri-menopausal syndrome complicated with hyperlipidemia.

OBJECTIVE: To observe the effect of Chinese medicine therapy combined with psychological intervention (combined therapy) on the clinical symptoms and levels of blood lipids and sex hormones of patients of peri-menopausal syndrome complicated with hyperlipidemia. METHODS: With the use of a randomizing digital table method, 185 patients that fit the registration standard were randomly assigned to three groups. The 59 cases in Group A were treated with two Chinese patents, Kunbao Pill and Modified Xiaoyao Pill; the 63 in Group B received psychological intervention alone; and the 63 in Group C were treated with both (the combined therapy), with the treatment course for all six months. The items of observation included: (1) scoring by SCL-90 on eight factors and seven symptoms; (2) scoring on Chinese medicine symptoms by Kupermann scale, including anxiety and bad temper, scorching sense action with sweating, dizziness, tinnitus, soreness and weakness of the loin and knees, palpitation, insomnia, lassitude, weakness, and hyposexuality; (3) blood contents of total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), apoprotein AI (ApoAI) and B (ApoB); (4) levels of sex hormones, including estradiol (E(2)), progesterone (P), pituitary prolactin (PRL), follicular stimulating hormone (FSH), and), luteinzing hormone (LH) in some randomly selected patients; (5) adverse reaction; and (6) one-year follow-up study on long-term effect. RESULTS: A total of 21 patients (6, 8, and 7 cases in Groups A, B, and C, respectively) dropped out; the drop-out rate was insignificant among groups. (1) The markedly effective rates in Group A, B, and C were 26.42% (14/53), 18.18% (10/55), and 53.57% (30/56), respectively, and the total effective rates in them were 64.15% (34/53), 50.91% (28/55), and 87.50% (49/56), respectively, suggesting the therapeutic efficacy in Group C was significantly better than that in Groups A and B (P<0.01). (2) SCL-90 scoring showed that the total scores decreased significantly after treatment in Group C (P<0.01), but remained unchanged in Groups A and B (P>0.05). (3) Scoring on Chinese medicine symptoms showed the same results as shown by SCL-90 scoring in terms of total scores and individual symptoms, except that menstrual disorder and amenorrhea were unchanged in all three groups (P>0.05). (4) Levels of HDL-C, ApoAI, and E(2) increased and those of TG, TC, LDL-C, ApoB, FSH, and LH decreased after treatment in Group C, reaching near normal levels; similar trends of blood lipids were shown in Group A, but the level of sex hormones was unchanged. In Group B all the above-mentioned indices were unchanged (P>0.05). (5) A one-year follow-up study showed the markedly effective rate and the total effective rate in Group C were higher than those in the other two groups respectively (P<0.01). (6) No adverse reaction was found. CONCLUSION: Chinese medicine therapy combined with psychological intervention could not only improve the nervous symptoms, but also regulate the blood levels of lipids and sex hormones in patients of peri-menopausal syndrome complicated with hyperlipidemia.

Clinical observation on treatment of hyperplasia of mammary gland by Lirukang Granule.

OBJECTIVE: To explore the efficacy and mechanism of Lirukang Granule 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 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 (E(2)), 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.