Survey and Practice of Reporting Quality of Randomized Controlled Clinical Trials on Traditional Chinese Medicine

Evidence obtained from randomized controlled trials （RCTs） has been generally accepted as the gold standard in the evaluation of clinical effectiveness. Readers need to understand the trial design, implementation, results, analysis and interpretation, so as to fully Jnderstand the results of RCTs. Thus, the investigators of RCTs have to report these items in a complete, accurate and clear manner. Since 1998, we have conducted several evaluations on the reporting quality of RCTs published in Chinese journals on traditional Chinese medicine （TCM） and results have shown that there is an urgent need for higher quality RCTs on TCM.

TAKING THE PATH OF COMBINING TRADITIONAL CHINESE MEDICINE WITH WESTERN MEDICINE IN CANCER RESEARCH AND CONTROL

Chinese oncologists have made great progress on the prevention and treatment of tumor with the combined traditional Chinese medicine (TCM) and Western Medicine (WM). Combining TCM with WM features the cancer research and control in China and has obtained world attention. Researches on cancer prevention with TCM. According to the theories of TCM, cancer is the result of the long-term action of carcinogenic factors under the condition of "Internal Insufficiency" of the body. Some chronic inflammatory changes could cause epithelial cell proliferation and malignant changes. Consequently, TCM treatment for precancerous lesions is very important. The interrup tion effect of Liuwei Dihuang decoction (六味地汤) in severe epithelial atypical hyperplasia of

QUALITY CONTROL OF TRADITIONAL CHINESE MEDICINES: INVESTIGATION ON CHEMICAL MARKERS

Traditional Chinese medicines(TCMs)have played an important role in the treatment of diseases for thousands of years.With the rise of the combination therapy for multi-gene diseases,TCMs attracted more attentions gradually.However,TCMs is a complex system which could contain tens,or even hundreds of compounds.Selection of chemical markers is thus a key to the

MHC-2D LC STRATEGY FOR THE HOLISTIC QUALITY CONTROL OF NOTOGINSENG-CONTAINING CHINESE PATENT MEDICINES

Current China Pharmacopoeia(ChP)standards employ diversified and case-dependent assay methods to evaluate the quality of different Chinese patent medicines(CPM)that contain Panax notoginseng as the monarch drug.These conventional HPLC-based approaches utilizing complex sample preparation procedure can easily result in low analytical efficiency and possible component loss.We thereby propose a'monomethodheterotrait matrix'(MHM)

Toward Evidence-Based Chinese Medicine：Status Quo,Opportunities and Challenges

How to test the treatments of Chinese medicine（CM） and make them more widely accepted by practitioners of Western medicine and the international healthcare community is a major concern for practitioners and researchers of CM.For centuries,various approaches have been used to identify and measure the efficacy and safety of CM.However,the high-quality evidence related to CM that produced in China is still rare.Over the recent years,evidence-based medicine（EBM） has been increasingly applied to CM,strengthening its theoretical basis.This paper reviews the past and present state of CM,analyzes the status quo,challenges and opportunities of basic research,clinical trials,systematic reviews,clinical practice guidelines and clinical pathways and evidence-based education developed or conducted in China,pointing out how EBM can help to make CM more widely used and recognized worldwide.

A Randomized Controlled Trial of Adjunctive Bunchang Naoxintong Capsule (步长脑心通胶囊) Versus Maintenance Dose Clopidogrel in Patients with CYP2C19*2 Polymorphism

Objective：To determine the impact of adjunctive Buchang Naoxintong Capsule（步心脑心通胶囊,NXT） on dual antiplatelet therapy in patients with cytochrome P450 2C19＊2（CYP2C19＊2） polymorphism undergoing percutaneous coronary intervention（PCI）.Methods：Ninety patients with CYP2C19＊2 polymorphism were enrolled,and their genotypes were confirmed by polymerase chain reaction（PCR）.The patients were randomly assigned to receive either adjunctive NXT（triple group,45 cases） or dual antiplatelet therapy（dual group,45 cases） using a computer-generated randomization sequence and sealed envelopes.Platelet function was assessed at baseline and 7 days after treatment with conventional aggregometry.Subsequent major adverse cardiovascular events（MACE,including sudden cardiac arrest and acute coronary syndrome） were recorded during a 12-month followup.Results：Baseline platelet function measurements were similar in both groups.After 7 days,percent inhibitions of maximum platelet aggregation and late platelet aggregation were significantly greater in the triple versus dual group（42.3%±16.0%vs.20.8%±15.2%,P〈0.01,and 54.7%±18.3%vs.21.5%±29.2%,P〈0.01,respectively）.During the 12-month follow-up,the rate of subsequent MACE（6/45） was significantly lower in the triple group compared with the dual group（14/45;P〈0.05）.Conclusion：Adjunctive NXT to maintenance dose clopidogrel（75 g） could enhance the antiplatelet effect and decrease subsequent MACE in patients with the CYP2C19＇2polymorphism undergoing PCI.

Efficacy and Safety of Quxie Capsule(祛邪胶囊) in Metastatic Colorectal Cancer:A Double-Blind Randomized Placebo Controlled Trial

Objective：To verify the efficacy and safety of Quxie Capsule（祛邪胶囊） in patients with metastatic colorectal cancer（mC RC）.Methods：The present study was a randomized,double-blind,placebo-controlled trial.Sixty patients with mC RC were randomized into two groups at a 1：1 ratio by sealed envelope.The treatment group received conventional therapy combined with Quxie Capsule for 3 months.The control group was treated with conventional therapy combined with placebo for 3 months.Main outcome measures were overall survival（OS） and progression-free survival（PFS）.Subgroup analysis was performed according to age,right or left-sided disease,and second-line therapy to determine the differences in PFS and OS between the two groups.Patients were followed up every 3 months until Dec 31 st 2016.Results：The median OS was 23 months in the treatment group [95% confidence interval（CI）：15–not calculated] vs.14 months in the control group（95% CI：11–22,P=0.060）.The OS of the treatment group tended to be longer than that of the control group（P〉0.05）.In the subgroups of patients 〈65 years old,left-sided colon,and 2 nd-line therapy,the treatment group showed a significant survival benefit compared with the control group（P=0.006,0.038,0.013,respectively）.There were no significant differences between the two groups in PFS（P〉0.05）.Safety analysis showed no severe hematological toxicity or liver and renal function injury in the treatment group.Conclusions：Quxie Capsule showed good safety and efficacy,and could prolong the OS of patients with mC RC.

Sodium Tanshinone Ⅱ A Sulfonate Injection as Adjuvant Treatment for Unstable Angina Pectoris: A Meta-Analysis of 17 Randomized Controlled Trials

Objective： To systematically evaluate the effectiveness and safety of Sodium Tanshinone ⅡA Sulfonate Injection（STS） as one adjuvant therapy for treating unstable angina pectoris（UAP）. Methods： Randomized controlled trials（RCTs） of UAP treated by STS were searched in the China National Knowledge Infrastructure Database（CNKI）, VIP Database for Chinese Technical Periodicals（VIP）, Wanfang Database, the Chinese Biomedical Literature Database（CBM）, Web of Science, the Cochrane Library, Embase, and Pub Med, which from inception to January, 2016. The Cochrane Risk Assessment Tool was used to evaluate the methodological quality of the RCTs. The Review Manager 5.3 software was used to conduct the metaanalysis. Results： The results showed that 17 RCTs involving 1,372 patients were included. The meta-analysis indicated that the combined use of STS and Western medicine（WM） in the treatment of UAP can obviously improve the total effective rate [risk ratio（RR）=1.31, 95% confidence interval（CI）（1.24,1.39）, P〈0.0001], and the total effective rate of electrocardiogram [RR=1.43, 95% CI（1.30,1.56）, P〈0.0001], decrease the level of CRP [mean difference（MD）=–3.06, 95%CI（–3.85, –2.27）, P〈0.00001], fibrinogen [MD=–1.03, 95% CI（–1.16, –0.89）, P〈0.00001], and whole blood high shear viscosity [MD=–0.70, 95% CI（–0.92, –0.49）, P〈0.00001]. Additionally, the occurrence of adverse drug reaction of the experimental group was significantly higher than that of the control group [RR=3.57, 95% CI（1.28, 9.94）, P〈0.05]. Conclusions： Compared with WM, the combined use of STS was more effective.

Traditional Chinese Medicine for Diminished Ovarian Reserve: A Systematic Review and Meta-analysis

Objective To assess the effectiveness and safety of traditional Chinese medicine（TCM）for women with diminished ovarian reserve（DOR）.Methods A literature search was conducted in eight electronic databases for randomized controlled trials.Results Seventeen randomized controlled trials involving 1174 patients were included.Meta-analysis indicated that TCM was superior to Western medicine（WM）in reducing basal serum FSH level[MD=-1.70,95%CI（-2.63,-0.77）;P=0.0004]and FSH/LH（MD=-0.43,95%CI[-0.56,-0.30];P=0.0001）,and the effect was more obvious two months after the last treatment（MD=-4.60,95%CI[-6.26,-2.90],P〈0.000 01 and MD=-0.56,95%CI[-0.85,-0.28],P=0.0001）,and increasing antral follicle count（AFC）（MD=0.44,95%CI[0.04-0.83];P=0.03）.The review also revealed the positive role of CMM as an adjuvant to IVF-ET in improving pregnancy rate（PR=1.75,95%CI[1.25,2.46];P=0.001）.Conclusion TCM,with its unique way of replenishing the kidney,may provide an effective and safe alternative therapy to patients with DOR.

Treatment of constipation-predominant irritable bowel syndrome by focusing on the liver in terms of Traditional Chinese Medicine:a meta-analysis

OBJECTIVE:To assess the efficacy of Traditional Chinese Medicine(TCM)on constipation-predominant irritable bowel syndrome by focusing on the liver.METHODS:Databases(domestic and foreign)were searched with the key words"irritable bowel syndrome","constipation",and"Chinese medicine";the relevant articles were retrieved and evaluated.Cure rate,"remarkable efficacy",recurrence rate and the incidence of adverse reactions were the outcome indicators.Review Manager ver 5.1 was used for this meta-analysis,and funnel plots used to detect publication bias.RESULTS:Nineteen randomized controlled trials were included and 1510 patients involved.The treatment guided byTCM based on the liver was superior to Western Medicine[odds ratio(OR)=2.46,95%confidence interval(CI)1.80,3.35)],cure rate[OR=2.61,95%CI(1.93,3.52)],remarkable efficacy[OR=2.68,95%CI(1.82,3.95)],recurrence rate[OR=0.19,95%CI(0.12,0.29)]and the incidence of adverse reactions[OR=0.24,95%CI(0.09,0.65)].However,funnel plots showed publication bias.CONCLUSION:Compared with Western Medicine,the treatment of IBS-C based on the liver is significantly better but the results must be treated with caution because publication bias was recorded.