Jingbo Zhai

Liver Damage Associated with Polygonum multiflorum Thunb.: A Systematic Review of Case Reports and Case Series.

Objective. To summarize the characteristics and analysis of relevant factors and to give references for prevention and further study of liver damage associated with Polygonum multiflorum Thunb. (HSW), we provide a systematic review of case reports and case series about liver damage associated with HSW. Methods. An extensive search of 6 medical databases was performed up to June 2014. Case reports and case series involving liver damage associated with HSW were included. Results. This review covers a total of 450 cases in 76 articles. HSW types included raw and processed HSW decoction pieces and many Chinese patent medicines that contain HSW. Symptoms of liver damage occur mostly a month or so after taking the medicine, mainly including jaundice, fatigue, anorexia, and yellow or tawny urine. Of the 450 patients, two cases who received liver transplantation and seven who died, the remaining 441 cases recovered or had liver function improvement after discontinuing HSW products and conservative care. Conclusion. HSW causes liver toxicity and may cause liver damage in different degrees and even lead to death; most of them are much related to long-term and overdose of drugs. Liver damage associated with HSW is reversible, and, after active treatment, the majority can be cured. People should be alert to liver damage when taking HSW preparations.

Clinical assessment of Shenfu injection loading in the treatment of patients with exacerbation of chronic heart failure due to coronary heart disease: study protocol for a randomized controlled trial

BackgroundAcute exacerbation is a common cause of hospitalization in patients with chronic heart failure, and coronary heart disease is the most common cause. Shenfu injection, a Traditional Chinese Medicine injection, widely used in the adjuvant treatment of patients with acute exacerbation of chronic heart failure, shows some treatment effect in improving the symptoms and the quality of life, but it lacks the rigorous clinical evaluation of research reports. This paper describes the protocol for the clinical assessment of Shenfu injection loading in the treatment of patients with acute exacerbation of chronic heart failure.MethodsThis protocol adopts the design of a prospective, randomized, multicenter, blind imitation, placebo-controlled trial to assess the efficacy and safety of Shenfu injection loading in the treatment of patients with acute exacerbation of chronic heart failure due to coronary heart disease. The research will be carried out in 12 hospitals in China and is expected to enroll 160 inpatients with acute exacerbation of chronic heart failure due to coronary heart disease (yang and qi deficiency syndrome). On the basis of the conventional therapy of western medicine, patients will be randomized to either the treatment group (100 ml 5% glucose injection + 50 ml Shenfu injection) or the control group (150 ml 5% glucose injection) for 7 ± 1 days and follow-up for 28 ± 3 days. The primary outcomes are New York Heart Association cardiac function classification and Traditional Chinese Medicine syndromes. The secondary outcomes are left ventricular ejection fraction, brain natriuretic peptide level, Lee’s heart failure score, 6-minute walking distance, and the incidence and readmission rate of cardiovascular events (including the emergency rate due to acute exacerbation of chronic heart failure).DiscussionThis trial will assess the effect of loading Shenfu injection in the treatment of patients with acute exacerbation of chronic heart failure caused by coronary heart disease (yang-qi deficiency syndrome) on the symptoms and signs of heart failure, exercise tolerance, and other aspects, and observe its influence on the short-term prognosis with follow-up. The results of the study will provide clinical research evidence for application of Shenfu injection in the treatment.Trial registrationThis trial was registered on 26 December 2012 at the Chinese Clinical Trials Register (Identifier: ChiCTR-TRC-12002857).

A randomized, double-blind, placebo-controlled trial of Chinese herbal medicine granules for the treatment of menopausal symptoms by stages.

Objective:The study aims to evaluate the effectiveness and safety of Chinese herbal medicine granules Danzhi Qing’e formula (DZQE), Erzhi formula (EZ), and their combination (Combined formula) in the treatment of menopausal symptoms at different stages of menopause. Methods:Women between the ages of 40 to 60 years, who met menopausal symptoms diagnostic criteria and experienced hot flushes at least 14 times/week in the last 4 weeks, were recruited to participate in a stratified randomized, double-blind, placebo-controlled clinical trial (n = 389). They received a treatment period of 8 weeks and were followed up for 4 weeks. Participants were categorized into two subgroups: 197 in the perimenopausal subgroup (menstrual disorder to 1 y after amenorrhea) and 192 in the early postmenopausal subgroup (1-5 y after amenorrhea). Participants were randomly assigned to placebo or one of the three herbal formula treatments. The primary outcome instrument was the Menopause-Specific Quality of Life (MENQOL) questionnaire. Results:When analyzing the two subgroups together, DZQE markedly decreased the MENQOL total score at the end of 12th week with statistical significance (P = 0.02) and improved vasomotor symptoms after 8 weeks treatment and 4 weeks follow-up (P < 0.05). What is more, the combined formula also greatly improved the participants’ vasomotor symptoms compared with placebo after the 4 weeks follow-up. No statistically meaningful difference was observed in any other outcomes among the groups. The results of subgroup analysis showed that DZQE and Combined formula were more effective than placebo in improving MENQOL total score for perimenopausal women at the end of week 12. For typical menopausal symptoms such as hot flushes and night sweats, DZQE displayed more favorable effects on early postmenopausal participants. Compared to placebo, the DZQE both showed statistically significant differences after 8 weeks treatment and 4 weeks follow-up. Although at the end of 12th week, DZQE also had better effects than placebo in the perimenopausal subgroup on vasomotor symptoms. Participants in the EZ group did not show a significant difference of any domains in MENQOL compared with participants in the placebo group. Conclusions:The DZQE formula improves the quality of life for menopausal women, especially for those with vasomotor symptoms during the whole menopausal period. The DZQE and EZ combination formula is effective only on perimenopausal symptoms.

Potential effectiveness of traditional Chinese medicine for cardiac syndrome X (CSX): a systematic review and meta-analysis

BackgroundTreatment of cardiac syndrome X with unknown pathological mechanism remains a big challenge for clinicians. Complementary and alternative medicine may bring a new choice for its management. The aim of this study is to evaluate the clinical effects of traditional Chinese medicine on cardiac syndrome X patients.MethodsWe systematically searched databases such as Cochrane CENTRAL, PubMed, EMBASE, CBM, Chinese National Knowledge Infrastructure (CNKI), WanFang and VIP, and handsearched relevant journals to identify randomized controlled trials. Following the steps of systematic review recommended by the Cochrane group, we assessed the quality of included studies, extracted valid data and undertook meta-analysis.ResultsTwenty one moderate-to low-quality randomized controlled trials involving 1143 patients were included. The results showed that traditional Chinese medicine could improve angina [OR=1.34, 95% CI: 1.2 to 1.50], electrocardiogram (ECG), endothelin-1 (ET-1) levels, prolong exercise duration in treadmill tests, and reduce angina frequency per week compared with routine treatment. No other side effect was reported except two cases of stomach pain.ConclusionCompared with conventional treatment, traditional Chinese medicine shows the potential of optimizing symptomatic outcomes and improving ECG and exercise duration. The efficacy of TCM may find explanation in its pharmacological activity of adjusting the endothelial function. TCM, as a kind of alternative and complementary medicine, may provide another choice for CSX patients.

Probiotics, prebiotics and synbiotics for chronic kidney disease: protocol for a systematic review and meta-analysis

Introduction There is a growing interest in probiotic, prebiotic and synbiotic supplements for patients with chronic kidney disease (CKD). However, a systematic review and evaluation is lacking. The purpose of the present study is to assess the efficacy and safety of probiotics, prebiotics and synbiotics for non-dialysis or non-renal transplant patients with CKD. Methods and analysis An extensive literature search will be undertaken to identify potentially eligible studies from electronic databases including PubMed (1946 to present), EMBASE (1974 to present), Web of Science (1900 to present) and the Cochrane Central Register of Controlled Trials (CENTRAL, all years). No language restriction will be applied to the search. Both parallel and crossover randomised controlled trials will be included. The risk of bias of each included study will be assessed using the Cochrane Risk of Bias Tool. The primary outcome measures are uraemic toxins. Secondary outcomes include kidney function, adverse cardiovascular events, all-cause mortality, cause-specific death, progression to end-stage kidney disease, quality of life, gastrointestinal function and adverse events. Data will be synthesised using appropriate statistical methods. The quality of evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. Ethics and dissemination No ethical approval is required as no primary data will be collected. We will publish findings from this systematic review in a peer-reviewed scientific journal, and the data set will be made freely available. PROSPERO registration number CRD42017079177.

CUPID: a protocol of a randomised controlled trial to identify characteristics of similar Chinese patent medicines

Introduction Traditional Chinese medicine (TCM) has accumulated some experience in curing stable angina pectoris (SAP) and efficacy has been demonstrated. Chinese patent medicines, known as modern dosage forms of TCM, can attain the desired effect in clinical application only with the guidance of TCM syndrome theory. However, due to their use by a large number of persons with little knowledge of TCM theories and practices, their efficacy and reputation have been seriously affected. Method and analysis Two common syndrome types of SAP in TCM, ‘qi deficiency and blood stasis’ and ‘qi stagnation and blood stasis’, will be studied in 144 subjects from four TCM hospitals in Tianjin in China using a partial crossover design. The two syndromes will be broken down into six symptom combinations; patients will select a combination of the most distressing to them, and then will be randomised into two groups. Each group, on the basis of routine medication, will be administered one kind of Chinese patent drug: Qishenyiqi Dripping Pills or Compound Danshen Dripping Pills. The treatment characteristics of the two medicines will be evaluated with the COME-PIO method developed by our research team. Ethics and dissemination This protocol has been approved by the medical ethics committee of Tianjin University of TCM (registration number TJUTCM-EC20130005). The study is safe and reliable. Trial registration number Chinese clinical trials register ChiCTR-TTRCC-14004406.

Traditional Chinese Medicine Injections in the Treatment of Diabetic Foot: A Systematic Review and Meta-Analysis

Context The role of traditional Chinese medicine injections (TCMIs) in diabetic foot (DF) has not been well estimated. Objective To evaluate the clinical effective rate, safety, and the financial cost of TCMIs in treating DF and ulcer wound healing. Methods We searched PubMed, Embase, CENTRAL, China National Knowledge Infrastructure (CNKI), VIP database, and Wanfang database from inception to May 2018 to find all randomized control trials (RCTs) related to TCMIs in DF treatment. The search items were “Traditional Chinese Medicine Injection” AND “Diabetic foot or Diabetic foot ulcer” AND “random”. Study Selection and Synthesis Only RCTs of TCMIs combined conventional therapies versus conventional therapies and that can be quantitatively synthesized were included. Finally, 17 studies and 1294 participants were included after extraction. Two investigators independently extracted and analyzed the data using RevMan5.3 software. Results The overall clinical effective rate of TCMI groups is higher than that of control groups [RR=1.27, 95CI % (1.20, 1.34), P<0.00001] based on fixed effect model analysis. Regarding motor nerve conduction velocity of median nerve and peroneal nerve, TCMI group showed a significant improvement (MD=3.84[2.28, 5.41], P<0.00001; MD=2.89[0.63, 5.15], P=0.01). Regarding plasma viscosity TCMI group showed a statistically difference (MD=0.27[0.04, 0.49], P=0.02). In terms of blood viscosity at high shear rate, there was an improvement of TCMI group (MD=0.36[0.05, 0.67], P=0.02). However, sensory nerve conduction velocity of peroneal nerve and median nerve showed a contradiction to motor nerve conduction velocity, respectively (MD=2.59[-1.69, 6.87], p=0.24; MD=2.73[-0.96, 6.43], P=0.15). Conclusion The data of this study shows that TCMIs can bring benefits to patients with diabetic foot. However, due to low methodological quality of included RCTs, more rigorous designed RCTs with large sample size are recommended to provide more high-quality evidence.

Whether Syndrome Differentiation Affects Treatment Result: Study Protocol of MaZiRenWan (麻子仁丸) for Functional Constipation in A Randomized Controlled Trial

BackgroundSyndrome is one of the most important concepts in Chinese medicine (CM) theory. However, it was not well accounted in most of randomized controlled trials (RCTs).ObjectivesTo determine whether CM syndrome differentiation affects the treatment results, functional constipation (FC) was selected as a target disease, and MaZiRenWan (麻子仁丸, MZRW), a classic CM formula commonly used for constipation with excessive heat syndrome, was selected for study.MethodsIt is an 18-week prospective double-blinded, doubledummy RCT, including 2-week run-in, 8-week treatment and 8-week post treatment follow-up. A total of 120 FC patients diagnosed as excessive heat syndrome will be recruited from the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine and the Baokang Affiliated Hospital of Tianjin University of Traditional Chinese Medicine. Patients will be randomly allocated into fixed MZRW (f_MZRW) granule group, modified MZRW (m_MZRW) granule group or bisacodyl group. For m_MZRW group, no more than two herbal granules can be added according to the syndrome differentiation for individual participants. The primary end point is the mean of complete spontaneous bowel movements (CSBMs) per week during the treatment period. Secondary end points include mean of CSBMs per week during follow-up, stool form, global symptom improvement, constipation and constipation-related symptoms assessment, CM syndrome change, and reported adverse events.DiscussionThis trial is designed to evaluate the effectiveness of these three interventions for FC patients with the CM syndrome of excessive heat, and to determine the change of CM syndrome and the progress of disease during the treatment course. The results are important to explore whether syndrome differentiation is important for the therapeutic effect of a formula on a disease. [Trial registration: Chinese Clinical Trial Registry (Reg No. ChiCTR-TRC-13003742); protocol version: MZRW/NSFC-81173363 (2015.05.04)]

Acupuncture for constipation in patients with stroke: protocol of a systematic review and meta-analysis

Introduction Constipation is one of the most common complications in patients with stroke. Acupuncture has gained increased popularity for the management of constipation. However, there is a lack of supportive evidence on the efficacy of acupuncture for poststroke constipation. This systematic review aims to collect and critically appraise all the available evidence about the efficacy and safety of the acupuncture for constipation in poststroke patients. Methods and analysis A comprehensive search of Pubmed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, four Chinese databases (National Knowledge Infrastructure (CNKI), Chinese Biomedical Literatures database (CBM), Wanfang Digital Periodicals (WANFANG) and Chinese Science and Technology Periodicals (VIP) database), one Japanese medical database (National Institute of Informatics, CiNii) and one Korean medical database (Oriental Medicine Advanced Searching Integrated System, OASIS) will be conducted to identify randomised controlled trials of acupuncture for constipation in poststroke patients. There is no restriction on language or publication status. The primary outcome measure will be frequency of bowel movement. The risk of bias will be assessed using the approach recommended by Cochrane Handbook for Systematic Reviews of Interventions. We will conduct the meta-analysis to synthesise the evidence for each outcome, if possible. The heterogeneity will be statistically assessed using a χ2 test and I2 statistic. This protocol is developed following the guideline of Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols 2015. Ethics and dissemination The ethical approval is not required because no primary data are collected. The findings will be presented at scientific conferences or a peer-reviewed scientific journal. PROSPERO registration number CRD42017076880.

JinqiJiangtang tablets for pre-diabetes: A randomized, double-blind and placebo-controlled clinical trial

This study observed the efficacy and safety of JinqiJiangtang tablets (JQJT tablets, a traditional Chinese patent medicine) for pre-diabetes. Four hundred patients with pre-diabetes at five centres were treated for 12months and followed for an additional 12months to investigate the preventative effects of JQJT tablets (Registration ID: ChiCTR-PRC-09000401). The incidence rate of diabetes mellitus was the primary endpoint. The risk of converting from pre-diabetes to diabetes was 0.58-fold less in the JQJT tablets group than in the placebo group [HR (95% CI): 0.58 (0.384, 0.876), P = 0.010]. Furthermore, the probability of achieving normalized blood glucose was 1.41-fold greater in the JQJT tablets group than in the placebo group [HR (95% CI): 1.41 (1.002, 1.996), P = 0.0049]. ITT analysis revealed that the incidence of diabetes upon treatment completion was 16.5% in the JQJT tablets group compared with 28.9% in the control group. The percentage of patients with normalized blood glucose upon 12-month intervention was 41.8% in the JQJT tablets group compared with 27.8% in the control group. JQJT tablets could be an effective intervention for preventative treatment of Type 2 diabetes mellitus.