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Is There An Advantage of Using Dingkun Pill () alone or in Combination with Diane-35 for Management of Polycystic Ovary Syndrome? A Randomized Controlled Trial.
Deng, Y, Wang, YF, Zhu, SY, Ma, X, Xue, W, Ma, RL, Sun, AJ
Chinese journal of integrative medicine. 2020;(12):883-889
Abstract
OBJECTIVE To evaluate the effects of Chinese medicine Dingkun Pill () alone or in combination with Diane-35 on patients with polycystic ovary syndrome (PCOS). METHODS This is a prospective randomized controlled trial conducted at Peking Union Medical College Hospital Beijing, China, from December 2016 to September 2017. Totally 117 PCOS patients were randomly assigned to the Dingkun Pill group (38 cases), Diane-35 group (40 cases), or combined group (39 cases). Patients in the Dingkun Pill group or Diane-35 group took daily 7 g of oral Dingkun Pill or 1 tablet of oral Diane-35, respectively, for 21 consecutive days followed by 7 drug-free days. And the combined group received a combination of Dingkun Pill and Diane-35. The treatment course was 3 months. Fasting plasma glucose and insulin, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), free fatty acids (FFA) and sex hormones were analyzed, quantitative insulin sensitivity check index (QUICKI) was calculated, and menstruation and acne scores were recorded at baseline and after 3-month treatment. RESULTS Compared with before treatment, QUICKI decreased significantly in the Dingkun Pill and combined groups after 3-month treatment (P<0.05); TC, LDL-C and FFA decreased significantly in the Dingkun Pill group (P<0.01), LDL-C also decreased obviously in the Diane-35 group (P<0.01), while TC increased significantly in the combined group (P<0.01), TG increased significantly in all groups (P<0.01); total testosterone (TT) and menstruation regularity was improved significantly in the Diane-35 and combined groups (P<0.01); acne scores were improved in all groups (P<0.01). After treatment, TC and FFA in the Dingkun Pill group were significantly lower than the Diane-35 group (P<0.05 or P<0.01); TT was lower and regular menstruation rate was higher in the Diane-35 and combined groups than the Dingkun Pill group (P<0.01), and no differences were observed between Diane-35 group and combined group (P>0.05). CONCLUSIONS Dingkun Pill showed better effects than Diane-35 in improving insulin sensitivity, lowering TC and FFA. Diane-35 was more efficient in regulating menstruation and lowering androgen than Dingkun Pill. Combination of Dingkun Pill and Diane-35 may be a better choice to regulate menstruation, lower androgens while improve glucose metabolism in PCOS patients. (Registered on ClinicalTrials.gov, registration No. NCT03264638).
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Clinical Efficacy and Transcriptomic Analysis of Congrong Shujing Granules () in Patients with Parkinson's Disease and Syndrome of Shen (Kidney) Essence Deficiency.
Chen, SY, Xiao, SJ, Lin, YN, Li, XY, Xu, Q, Yang, SS, Huang, LH, Cai, J
Chinese journal of integrative medicine. 2020;(6):412-419
Abstract
OBJECTIVE To evaluate the clinical efficacy and safety of Congrong Shujing Granules ( , CSGs) in treating patients with Parkinson's disease (PD) and Chinese medicine (CM) syndrome of Shen (Kidney) essence deficiency, and to investigate the potential mechanism involving efficacy through a transcriptome sequencing approach. METHODS Eligible PD patients with syndrome of Shen essence defificiency were randomly assigned to a treatment group or a control group by a random number table, and were treated with CSGs combined with Western medicine (WM), or placebo combined with WM, respectively. Both courses of treatment lasted for 12 weeks. The Unifified Parkinson's Disease Rating Scale (UPDRS) score, the PD Question-39 (PDQ-39) score, CM Syndrome Scale score, and drug usage of all patients were evaluated before and after treatment. Safety was evaluated by clinical laboratory tests and electrocardiographs. Blood samples from 6 patients in each group were collected before and after the trial and used for transcriptomic analysis by gene ontology analysis and Kyoto Encyclopedia of Genes and Genomes pathway analysis. Differentially expressed genes were validated using reverse transcription-polymerase chain reaction. RESULTS A total of 86 PD patients were selected from the Third Affifiliated People's Hospital of Fujian University of Traditional Chinese Medicine between January 2017 and December 2017. Finally, 72 patients completed the trial, including 35 in the treatment group and 37 in the control group. When compared with the control group after treatment, patients in the treatment group showed signifificant decreases in UPDRS sub-II score, PDQ-39 score, CM syndrome score, and Levodopa equivalent dose (P<0.05). During the treatment course, no signifificant changes were observed in safety indicators between the two groups (P>0.05). A possible mechanism of clinical effificacy was proposed that involved regulating cell metabolism-related processes and ribosome-related pathways. Treatment with CSGs had shown to affect relevant gene loci for PD, including AIDA, ANKRD36BP2, BCL2A1, BCL2L11, FTH1P2, GCH1, HPRT1, NFE2L2, RMRP, RPS7, TGFBR1, WIPF2, and COX7B. CONCLUSIONS CSGs combined with WM can be used to treat PD patients with CM syndrome of Shen essence defificiency with a good safety. The possible mechanism of action and relevant gene loci were proposed. (Registration No. ChiCTR-IOR-16008394).
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Efficacy of different forms of Guizhi Fuling Wan on reproduction and metabolism in women with polycystic ovary syndrome: A protocol for a meta-analysis of randomized controlled trials.
Liu, M, Zhu, H, Hu, X, Zhu, Y, Chen, H
Medicine. 2020;(44):e22954
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Abstract
BACKGROUND Polycystic ovary syndrome (PCOS), is a common endocrine disorder in women characterized by increased androgen levels, ovulatory dysfunction, and polycystic ovaries. Western medicine is widely used for the treatment of PCOS, but patient satisfaction is low, largely due to its associated gastrointestinal symptoms of nausea and diarrhea. Guizhi Fuling Wan (GFW) is a traditional Chinese medicine used to remove blood stasis and dissipate phlegm for treating gynecological diseases that was invented by Zhang Zhongjing in the Eastern Han dynasty. In recent years, GFW has been widely used to treat patients with PCOS. This study aims to assess the efficacy and safety of GFW in the treatment of PCOS through a systematic review and meta-analysis. METHODS All randomized controlled trials connected with GFW targeting PCOS will be searched in the following electronic bibliographic databases from their earliest recorded publications to December 2020 without any language restrictions: MEDLINE, Embase, PubMed, Web of Science, China National Knowledge Infrastructure, Chinese Biological Medicine Database, Wan-fang data, Chinese Technical Periodicals, and other databases. The primary outcomes include Sex hormone levels, ovulation rate, pregnancy rate, and total effective rate. The secondary outcomes were Total cholesterol, triglyceride, low-density lipoprotein, high-density lipoprotein, fasting glucose, fasting insulin, insulin sensitivity index, body mass index, hypertrichosis score, acne score, adverse reactions, etc. Two reviewers will independently conduct cations retrieval, de-duplication, filtering, quality assessment, and data analysis by Endnote X9.1 and Review Manager software (RevMan V.5.3). Meta-analysis and/or subgroup analysis will be performed on the included data. DISCUSSION This study will investigate the application of GFW in the treatment or prevention of PCOS, and provide a high-quality synthesis to judge whether GFW is an effective and safe intervention for PCOS. PROSPERO REGISTRATION NUMBER CRD42020192405.
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Effect of Daesiho-tang on obesity with non-alcoholic fatty liver disease: a study protocol for a randomised, double-blind, placebo-controlled pilot trial.
Han, K, Kwon, O, Park, HJ, Jung, SY, Yang, C, Son, CG
Trials. 2020;(1):128
Abstract
BACKGROUND The high prevalence of obesity and non-alcoholic fatty acid disease has become an important public health problem. Daesiho-tang (DST) is an herbal medicine widely used to treat obesity, metabolic syndrome and liver diseases. This pilot study will assess the feasibility of using DST in obese patients with a non-alcoholic fatty liver disease (NAFLD) prior to undertaking a full-scale clinical trial. METHODS/DESIGN This is a study protocol for a randomised, double-blind, parallel-group, stratified, placebo-controlled pilot trial. We will recruit a total of 60 participants with NAFLD who have a body mass index ≥ 25 kg/m2. They will take either DST or placebo (3 g, three times daily) for 12 weeks with a 4-week follow-up period. The effects of DST will be evaluated by the mean change in body weight as the primary measurement and other secondary parameters (body composition, anthropometric measurements, blood tests, hepatic fat quantification through transient elastography and a physical symptoms questionnaire). Faecal samples will be collected before and after the intervention for a gut microbial analysis. DISCUSSION In anticipation of conducting further large-scale trials, in this study we will explore the effect of DST on weight loss and obesity-related markers, along with NAFLD-related clinical parameters, in obese patients with NAFLD. Furthermore, it will provide insight into the DST pharmacological mechanism of action through a gut microbiome analysis. TRIAL REGISTRATION Korean Clinical Trial Registry, KCT0003554. Registered on 25 February 2019.
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[Effect of Qingshen Granules on inflammation/hepcidin axis and iron metabolism in patients with renal anemia: a single-center, randomized controlled trial].
Zhang, L, Wang, Y, Jin, H, Wang, D, Wei, L, Ren, K, Mao, Y
Nan fang yi ke da xue xue bao = Journal of Southern Medical University. 2019;(10):1155-1159
Abstract
OBJECTIVE To evaluate the therapeutic effect of Qingshen Granules on renal anemia in patients with damp-heat syndrome and explore the mechanisms in light of inflammation/hepcidin axis and iron metabolism. METHODS Sixty patients with renal anemia and dampness-heat syndrome were randomized into control group (n=30) and treatment group (n=30). All the patients were given routine treatment, and the patients in the treatment group received additional treatment with Qingshen Granules (3 times a day). After 12 weeks of treatments, the patients were examined for changes in the integral value of TCM syndrome, serum creatinine (Scr), glomerular filtration rate (eGFR), hemoglobin (HGB), hematocrit (HCT), red blood cell (RBC) count, interleukin-6 (IL-6), hypersensitive C-reactive protein (hs-CRP), ferritin, growth differentiation factor-15 (GDF-15), serum iron (SI), total iron binding capacity (TIBC), transferrin saturation (TAST), soluble transferrin receptor (sTfR) and ferritin levels. RESULTS After the treatment, the scores of TCM syndrome were significantly improved in the treatment group and were better than those in the control group (P=0.000). Scr and eGFR were improved in both groups after the treatment. The levels of HGB, HCT and RBC were all improved in the two groups after treatment, and the improvements were more obvious in the treatment group (P=0.002, 0.002, and 0.017, respectively). The levels of IL-6, hs-CRP, hepcidine and GDF-15 were all lowered in the two groups after the treatment, and they were all significantly lower in the treatment group than in the control group (all P=0.000). The treatments increased the levels of SI and TAST in both of the groups, and compared with those in control group, the levels of TIBC, sTfR and ferritin were significantly lowered in the treatment group after the 12-week treatment (P=0.000). CONCLUSIONS Qingshen granules can effectively improve renal anemia in patients with damp-heat syndrome possibly by improving iron metabolism through alleviation of inflammation and reduction of hepcidine level.
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[Effect of Ronghuang Granule on serum FGF23, FGFRs and Klotho in non-dialysis patients with CKD-MBD and kidney deficiency and damp-heat syndrome].
Hu, S, Wang, D, Zhang, R, Cao, Y, Jin, H, Mao, Y, Wei, L, Ren, K, Zhang, X, Wang, Y
Nan fang yi ke da xue xue bao = Journal of Southern Medical University. 2018;(12):1427-1432
Abstract
OBJECTIVE To observe the effect of Ronghuang granule on serum fibroblast growth factor 23 (FGF23), fibroblast growth factor receptor (FGFRs) and Klotho protein levels in non-dialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD) and kidney deficiency and damp heat syndrome. METHODS Seventy non-dialysis CKD-MBD patients with kidney deficiency and dampness-heat syndrome were randomized into control group (n=35) and treatment group (n=35). All the patients were given routine treatment combined with traditional Chinese medicine retention enema, and the patients in the treatment group received additional Ronghuang granule treatment (3 times a day). After the 12-week treatments, the patients were examined for changes of TCM syndromes. Serum levels of Ca, P, parathyroid hormone (iPTH), FGF23, FGFRs and Klotho proteins were detected before and after treatment. These parameters were also examined in 20 healthy volunteers. RESULTS Sixty-five patients completed the study, including 33 in the control group and 32 in the treatment group. The patients in the treatment group showed significantly better treatment responses than those in the control group (P < 0.05 or 0.01). At 4, 8, and 12 weeks of treatment, the patients in the treatment group had significantly lowered scores of TCM syndromes compared with the score before treatment (P < 0.05 or 0.01), while in the control group, significant reduction of the scores occurred only at 12 weeks (P < 0.05); at each of the time points, the treatment group had significantly greater reductions in the score than the control group (P < 0.01). Significant improvements in serum Ca, P and iPTH levels were observed at 4, 8, and 12 weeks in the treatment group (P < 0.05) but only at 12 weeks in the control group (P < 0.05). The patients in the control and treatment groups all showed elevated serum levels of FGF23, FGFRs and Klotho protein compared with the normal subjects (P < 0.01); FGF23, FGFRs and Klotho levels were significantly reduced in the treatment group (P < 0.05) but remained unchanged in the control group (P>0.05), showing significant differences between the two groups. CONCLUSIONS Ronghuang granule improves the clinical symptoms of non-dialysis CKD-MBD patients with kidney deficiency and dampness heat syndrome by reducing serum levels of FGF23, FGFRs and Klotho, improving calcium and phosphorus metabolism disorder, and inhibiting secondary hyperparathyroidism.