Current Status and Evaluation of Randomized Clinical Trials of Traditional Chinese Medicine in the Treatment of Cardiovascular Diseases

Traditional Chinese medicine has long been applied to various diseases in China for a few thousand years. In recent years, its market has gradually developed from Asian countries to Western countries. At present, due to the lack of evidence-based medicine research, the effect of traditional Chinese medicine on the prevention and treatment of cardiovascular disease remains unclear. In evaluating the efficacy and safety of drugs, randomized controlled clinical trials (RCTs) are recognized as the gold standard for testing the effectiveness and safety of treatments and could offer the best evidence for the formulation of clinical treatment guidelines. Although traditional Chinese medicine has long been used to treat cardiovascular diseases, the research on the application of RCT to test the combination of traditional Chinese and Western medicine therapy or single traditional Chinese medicine therapy started late, and the number is comparably small. In order to summarize and objectively evaluate the research results of integrated traditional Chinese and Western medicine in intervention of cardiovascular diseases, we reviewed the literature of RCTs in this field by searching some Chinese and English databases and put forward some suggestions for the future development and research of traditional Chinese medicine.

Five-Flavor Sophora flavescens Enteric-Coated Capsules for Ulcerative Colitis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Background. Ulcerative colitis (UC), a chronic inflammatory bowel disease, is characterized by abdominal pain, diarrhea, and mucopurulent bloody stool. In recent years, the incidence and prevalence of UC have been increasing consistently. Five-flavor Sophora falvescens enteric-coated capsule (FSEC), a licensed Chinese patent medicine, was specifically used to treat UC. This review was aimed to assess the effectiveness and safety of FSEC for the treatment of UC. Methods. Six electronic databases were searched from inception to March 2021. Randomized clinical trials (RCTs) comparing FSEC or FSEC plus conventional Western medicine with conventional Western medicine in participants with UC were included. Two authors screened all references, assessed the risk of bias, and extracted data independently. Binary data were presented as risk ratios (RRs) with 95% confidence intervals (CIs) and metric data as mean difference (MD) with 95% CI. The overall certainty of the evidence was assessed by GRADE. Results. We included 15 RCTs (1194 participants, 763 in the FSEC group and 431 in the control group). The treatment duration ranged from 42 to 64 days. Twelve trials compared FSEC with conventional Western medicine, and two trials compared FSEC plus conventional medicine with conventional medicine. Another trial compared FSEC plus mesalazine with compound glutamine enteric capsules plus mesalazine. FSEC showed a higher clinical effective rate (improved clinical symptoms, colonoscopy results, and stools) (RR 1.12, 95% CI 1.05 to 1.20; 729 participants; 8 trials; low-quality evidence) as well as the effective rate of traditional Chinese medicine (TCM) syndromes (RR 1.10, 95% CI 1.01 to 1.20; 452 participants; 5 trials; low-quality evidence) compared to mesalazine. There was no significant difference in the adverse events between FSEC and control groups. Conclusions. FSEC may show effectiveness in UC treatment compared to conventional medicine, and the use of FSEC may not increase the risk of adverse events. Due to the limited number of clinical trials and low methodological quality of the included trials, our findings must be interpreted with discretion.

Efficacy and Safety of “Bushen Huoxue Therapy”-Based Combined Chinese and Western Medicine Treatment for Diabetic Kidney Disease: an Updated Meta-Analysis of 2105 Patients

Background. Diabetic kidney disease (DKD) is the most important cause of the end-stage renal disease (ESRD) and the main cause of renal replacement therapy. Excessive inflammatory response and renal fibrosis are the keys to the development of this disease, and the conventional Western medical treatment is difficult to achieve and obtain long-term stable clinical results in all patients with DKD. Many studies have shown that Chinese medicine as a complementary and alternative medicine may be another therapeutic option to mitigate the progression of DKD to ESRD. In recent years, many doctors have used the Bushen Huoxue therapy to assist Western medicine in the treatment of the disease and have achieved certain clinical effects. However, most of the current studies are small sample studies, and there is no evidence-based confirmation. Objective. To systematically evaluate the efficacy and safety of the Bushen Huoxue therapy combined with conventional Western medicine in the treatment of DKD. Methods. A comprehensive search of literature databases such as CNKI, Wanfang, Pubmed, and Cochrane Library was conducted. The screening condition was that the control group was treated with conventional Western medicine and the experimental group was treated with Bushen Huoxue therapy’s RCT on top of the control group, and the RCTs were published from January 2011 to October 2021. The Cochrane risk bias assessment tool was used for literature quality evaluation, and RevMan 5.3 software was used for statistical analysis. Results. A total of 23 RCTs were finally included, with a total of 2,105 patients. Meta-analysis results show that the experimental group can effectively improve the clinical efficacy (RR = 1.28, 95% CI (1.22, 1.34), P < 0.01 ), significantly reduce Crea (SMD = −0.45, 95% CI (−0.57, −0.33), P < 0.01 ), 24 h UTP (SMD = −0.57, 95% CI (−0.69, −0.45), P < 0.01 ), BUN (SMD = −0.36, 95%CI (−0.48, −0.24), P < 0.01 ), UAER (SMD = −1.58, 95% CI (−1.78, −1.37), P < 0.01 ), and blood sugar, and have certain medication safety (RR = 0.00, 95% CI (−0.03, 0.03), P = 0.87 ). Conclusions. Chinese medicine based on the Bushen Huoxue therapy has a good clinical effect in the treatment of diabetic kidney disease and has certain safety. However, due to the limitation of the quality and quantity of the included literature, the above conclusion still needs more rational experiments to further verify.

Acupuncture Therapy on Patients with Flaccid Hemiplegia after Stroke: A Systematic Review and Meta-Analysis

Background. Acupuncture is a commonly used complementary treatment for flaccid hemiplegia caused by stroke, but evidences from previous randomized trials were inconclusive. The purpose of this study was to evaluate the efficacy and safety of acupuncture in a comprehensive synthesis. Methods. We searched literature from eight databases from their inception to December 2020. We included randomized controlled trials of acupuncture for the treatment of flaccid hemiplegia following stroke. The meta-analysis was carried out using Review Manager 5.3 and Stata 16.0. The main indicator was the Fugl-Meyer Assessment scale. The modified Barthel Index scale, Quality Of Life Assessment scale, Mini-Mental State Examination scale, Berg Balance Scale, Neurological Deficit Assessment scale, and the treatment effective rate were used to measure the secondary indicators. Adverse events from individual studies were used to determine safety. Results. Our search returned 7624 records, of which 27 studies involving a total of 1,293 patients fulfilled our inclusion criteria. To be noted, our results indicated that significant improvements in the scores of the primary indicator showed better clinical scores among the three groups with acupuncture than without acupuncture: acupuncture compared with rehabilitation, 13.53 (95% CI 11.65–14.41, P < 0.01 ); acupuncture plus rehabilitation compared with rehabilitation, 9.84 (95% CI 6.45–13.24, P < 0.01 , I2 = 98%); and acupuncture plus Western medicine therapy compared with Western medicine, 16.86 (95% CI 15.89–17.84, P < 0.01 , I2 = 38%), and the secondary indicators showed the same tendency. Conclusion. Acupuncture was effective and safe in the patients with flaccid hemiplegia after stroke, although there was high heterogeneity between studies.

Effects of Integrated Chinese Traditional Medicine and Conventional Western Medicine on the Quality of Life of Breast Cancer Patients: A Systematic Review and Meta-Analysis

Background. Traditional Chinese medicine has been widely used, in conjunction with conventional Western medicine, in clinical practice around the world to treat breast cancer. The study systematically reviewed and summarized the quality of life of breast cancer patients treated with integrated treatment method vs. conventional Western medicine. Methods. Eight databases including PubMed, EMBASE, Web of Science, the Cochrane Library, Chinese National Knowledge Infrastructure, China Biology Medicine Disc, Chinese Scientific Journal Database, and Wanfang Data knowledge service platform were searched in this study. The retrieval period was set from January 1, 2005, to December 31, 2020. Results. Twenty-two high-quality publications were included in this study. The total sample size was 1689 patients including 844 in the intervention group receiving traditional Chinese medicine combined with conventional Western medicine and 845 patients in the control group receiving conventional Western medicine only. Compared with the single-used conventional Western medicine treatment, an integrated approach to treat breast cancer can increase quality of life measured by rating scales (SMD = 1.29, 95% CI (1.07, 1.52) and P = 0.01 ) and ranking scales (RR = 1.53, 95% CI (1.39 1.68) and P = 0.02 ) and also decrease adverse reactions measured by rating scales (Z = 10.89, P < 0.05 ; Group 1: I2 = 9.0%, P = 0.258 , SMD = 1.03; and Group 2: I2 = 31.6%, P = 0.199 , SMD = 1.56). For further analysis, chemotherapy with epirubicin exhibited higher quality of life than the chemotherapy without epirubicin among breast cancer patients [Z = 19.80, P < 0.05 ; Group 1: I2 = 62.4%, P = 0.070 , SMD = 1.61; and Group 2: I2 = 9.0%, P = 0.359 , SMD = 1.04]. Despite the heterogeneity, which was due to a portion of relative low-quality literature or other factors, the results were satisfactory. In terms of secondary results, the patients with lower tumor markers (CEA and CA153) had better efficiency in quality of life with a statistically significant difference (SMD = 1.39, 95% CI: 1.10,1.67) for rating scales. In addition, secondary results related to high incidence of gastrointestinal adverse reactions (RR = 1.33, 95% CI (1.20, 1.48)) and the traditional Chinese medicine syndrome (RR = 1.50, 95% CI (1.28, 1.80))showed lower quality of life in the intervention group than the control group for ranking scales. Conclusion. Traditional Chinese medicine, when used in conjunction with the conventional Western medicine, could be an effective way in improving the quality of life and alleviating incidence of associated adverse symptoms such as gastrointestinal adverse reactions, value of tumor markers, and the incidence of traditional Chinese medicine syndrome. Further investigation of larger and methodologically sound trials with longer follow-up periods and appropriate comparison groups is needed.

Polyphenol, Flavonoid Content and Antioxidant Activity of the Garlic (Allium sativum L.) Extract Obtained by Two Different Extraction Processes

Garlic is a globally used spice due to its pungent taste and a fishy deodorant and digestive stimulator. Owing to the widespread use of garlic in both Oriental and Western medicine, further investigations on garlic extracts might carry important implications in the industry. In this study, we conducted extraction of garlic extraction by two conventional methods and an ultrasonic assisted method. The processes were optimized with respect to various quality parameters including polyphenol, flavonoid content, and antioxidant activity. The results showed that extracting garlic under the ultrasonic support will show higher efficiency than the non-ultrasonic extraction. The optimal extraction parameters are: 70% ethanol solvent, 10/1 solvent / material ratio, 40 °C temperature and 40 minutes time. Keywords: Allium Sativum L., Garic, Polyphenol, Flavonoid, Antioxidant

Effect of Qingre Jiedu Huoxue Huayu Recipe on blood stasis and toxin syndrome in patients with non-ST segment elevation acute coronary syndrome, serum Lp-PLA2, TNF- α, and PIGF expression level

The pathological basis of non-ST-segment elevation acute coronary syndrome (NSTE-ACS) is severe coronary stenosis, unstable plaque erosion, and rupture, resulting in coronary blood flow reduction and myocardial ischemia, leading to acute thrombosis cardiovascular disease events. This subject intends to study the treatment of NSTE-ACS patients with blood stasis and toxin syndrome by Qingre Jiedu Huoxue Huayu Decoction, observe its clinical efficacy, and explore the effects of serum lipoprotein phospholipase A2 (Lp-PLA2) and tumor necrosis factor- α (TNF- α), the effect of placental growth factor (PIGF) expression. In this study, 100 patients with blood stasis and toxin syndrome of NSTE-ACS treated in the cardiovascular department of Enshi National Hospital from August 2020 to August 2021 were selected as the research object. They were randomly divided into traditional Chinese medicine comprehensive treatment groups and conventional western medicine control groups, with 50 cases. The conventional western medicine control group was treated with hydroclopidogrel tablets orally, and the comprehensive treatment group of traditional Chinese medicine combined with Qingre Jiedu Huoxue Huayu formula orally. The patients in both groups were treated for four weeks. The results showed that after treatment, the practical clinical rate of the comprehensive treatment group was significantly higher than that of the conventional western medicine control group. After treatment, the TCM syndrome score, angina pectoris attack duration, and angina pectoris attack frequency, myocardial zymogram index level, serum Lp-PLA2 and TNF of the two groups were measured- α. The levels of PIGF were significantly lower than those before treatment. The decline of the above indexes in the comprehensive treatment group of traditional Chinese medicine was significantly better than that in the control group of conventional Western Medicine (P<0.05). The incidence of MACE events in the TCM Comprehensive treatment group was significantly lower than that in the conventional western medicine control group (P <0.05).