Xinfeng Capsule(新风胶囊)for the Treatment of Rheumatoid Arthritis Patients with Decreased Pulmonary Function—A Randomized Controlled Clinical Trial

Objective:To determine the effectiveness and safety of Xinfeng Capsules(新风胶囊,XFC) for the treatment of rheumatoid arthritis(RA) patients with decreased pulmonary function.Methods:This was a randomized controlled clinical trial of 80 RA patients.Participants were assigned to the trial group(40 cases) and the control group(40 cases) by block randomization.The trial group was treated with XFC,three pills each time three times daily for 2 months.The control group was treated with tripterygium glycoside(TPT),two pills each time three times daily for 2 months.Both groups were followed up after 2 months.The clinical effects,changes in joint and pulmonary function,and quality of life before and after treatment were observed;safety indices were also evaluated.Results:Pain,swelling,tenderness,and duration of morning stiffness of joints were obviously decreased after treatment in both the trial and the control groups compared with baseline(P0.01).Compared with before treatment,hand grip strength increased significantly after treatment in the trial group(P=0.0000);pulmonary function parameters such as forced expiratory volume in the first second of expiration/forced vital capacity(FEV_1/FVC),50%of the expiratory flow of forced vital capacity(FEF_(50)),carbon monoxide diffusing capacity(DLco) were increased(P0.01 or P0.05);measures of quality of life such as role-physical,body pain,vitality and mental health were also improved after treatment in the trial group(all P0.05).Joint swelling in the trial group decreased compared with the control group(P=0.0043),while hand grip strength was increased after treatment(P=0.0000).The increase in FEF_(50),DLco,and the dimensions of quality of life such as vitality and mental health were all significantly greater in the trial group than the control group(P0.05 or P0.01).Conclusions:XFC not only relieved joint pain in RA patients,but also significantly improved the ventilation and diffusion function of the lungs.Therefore,XFC could improve the whole body function and enhance the quality of life of RA patients.     

Effect of Longbishu Capsule (癃闭舒胶囊) plus Doxazosin on Benign Prostatic Hyperplasia: A Randomized Controlled Trial

Objective:To investigate the effect of Longbishu Capsule(癃闭舒胶囊,LBS),doxazosin,and combination therapy on benign prostatic hyperplasia(BPH).Methods:A randomized,double-blind,multi-center parallel trial was conducted involving 360 patients in hospitals in Beijing(108 cases),Heilongjiang(90 cases),Sichuan(90 cases),Shanghai(72 cases),China.They were randomly assigned with central randomization method to group A(LBS placebo plus doxazosin),group B(LBS plus doxazosin)or group C(LBS plus doxazosin placebo),120 cases for each group.The international prostate symptom score,maximum urinary flow rate,postvoid residual urine volume and prostate volume were measured for evaluating the efficacy of the three treatments.Results:At baseline,there was no significant difference in the measured variables among the three groups.After 12-month treatment,the three groups showed significant improvements in IPSS and maximum urinary flow rate from baseline(P0.01).Although postvoid residual urine volume was not significantly different from the baseline in group A(P0.05),it significantly decreased in group B and C(P0.05).The incidence of adverse events were similar among the three groups.Conclusions:The treatment of LBS alone or LBS plus doxazosin was able to significantly improve IPSS in patients with BPH.The treatments may reduce the increase in prostate volume and postvoid residual urine volume as well.     

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(P0.05).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(P0.05).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.     

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.     

Effect of Kuanxiong Aerosol(宽胸气雾剂)on Patients with Angina Pectoris:A Non-inferiority Multi-center Randomized Controlled Trial

Objective: To evaluate the effect and safety of Kuanxiong Aerosol(宽胸气雾剂, KA) on patients with angina pectoris. Methods: Block randomization was performed to randomly allocate 750 patients into KA(376 cases) and control groups(374 cases). During an angina attack, the KA group received 3 consecutive sublingual sprays of KA(0.6 m L per spray). The control group received 1 sublingual nitroglycerin tablet(NT, 0.5 mg/tablet). Log-rank tests and Kaplan-Meier estimations were used to estimate the angina remission rates at 6 time-points after treatment(1, 2, 3, 4, 5, and 5 min). Logistic regression analysis was performed to observe the factors influencing the rate of effective angina remission, and the remission rates and incidences of adverse reactions were compared for different Canadian Cardiovascular Society(CCS) classes of angina. Results: The 5-min remission rates in the KA and control groups were not significantly different(94.41% vs. 90.64%, P0.05). The angina CCS class significantly influenced the rate of remission (95% confidence interval = 0.483–0.740, P0.01). In the CCS subgroup analysis, the 3-and 5-min remission rates for KA and NT were similar in the CCSⅠ and Ⅳ subgroups(P0.05), while they were significantly better for KA in the CCSⅡ and Ⅲ subgroups(P0.05 or P0.01). Furthermore, the incidence of adverse reactions was significantly lower in the KA group than in the control group for the CCSⅡ and Ⅲ subgroups(9.29% vs. 26.22%, 10.13% vs. 20.88%, P0.05 or P0.01). Conclusions: KA is not inferior to NT in the remission of angina. Furthermore, in CCSⅡ and Ⅲ patients, KA is superior to NT, with a lower incidence of adverse reactions.     

Effects of Qianlie''''an(前列安)Suppository in Patients with Chronic prostatitis Syndrome:A Randomized Open-Labelled Prospective and Controlled Trial

Objective:To evaluate the clinical efficacy of Qianllie’an(前列安,QLA)suppository via a-nal route administration in treating chronic prostatitis syndrome.Methods:A randomized open-labelledprospective controlled trial was carried out.The total of 120 patients with chronic prostatitis syndromewere randomly divided into 2 groups:60 patients in the treated group who were treated with QLA supposi-tory combined with ofloxacin,and the other 60 patients in the control group who were given ofloxacin a-lone.The efficacy was evaluated by WBC Count in the expressed prostatic secretion(EPS)and the ChronicProstatitis Symptom Index(CPSI)made by the National Institute of Health(NIH).The clinical effectsWere also observed in a 4-week follow-up.Results:All but six cases completed the trial and the follow-up.It showed that in the treated group recovery rate was 17.2％,markedly effective rate 34.5％,effectiverate 32.8％,total markedly effective rate 51.7％,and total effective rate 84.5％,all of which were supe-rior to th     

Dalitong Granule(达立通颗粒)Combined with Electroacupuncture in the Treatment of Functional Dyspepsia:A Randomized Controlled Trial

Objective:To explore clinical short and long-term effect of combining Dalitong Granule(达立通颗料,DG) and electroacupuncture group(EA) in the treatment of functional dyspepsia.Methods:Totally 640 patients with confirmed functional dyspepsia were randomly divided into 4 groups using a randomized digital table:the DG group,the EA group,the combined group and the control group,160 cases in each group.The DG group was treated with 6 g DG 3 times daily;the EA group was treated with puncture of points Zusanli(ST36),Zhongwan(CV12),Neiguan(PC6),Taichong(LR3) and Gongsun(SP4) twice daily;the combined group with above-mentioned DG and EA;and the control group with 5 mg mosapride 3 times,20 mg pantoprazole and25 mg amitriptylines twice daily.The treatment course was 4 weeks for all groups.The symptom score,quality of life score by Short Form 36 Health Survey Questionnaires(SF-36),plasma motilin by radioimmunoassay,electrogastrographic frequencies by electrogastrogram(EGG) and gastric emptying by B-sonography were examined,and adverse reactions were observed before,at the end of treatment and 60 weeks post-treatment.Results:In the DG group 1 case dropped out for not taking medicine strictly and 1 case was lost to follow-up,while 1 case in the EA group and 2 cases in the combined therapy group were lost to follow-up.Compared with pre-treatment,quality of life score,plasma motilin,electrogastrographic frequencies and gastric emptying were all increased significantly,while symptom score was decreased significantly at the end of treatment in each group(P0.01);in the combined group quality of life score,plasma motilin,electrogastrographic frequencies and gastric emptying were all significantly higher than those in the other groups,while symptom score was significantly lower than in the other groups(P0.05).Compared with at the end of treatment,these indices changed insignificantly in the combined group and the EA group 60 weeks post-treatment(P0.05),but the 4increased indices were all decreased significantly,and symptom score was increased significantly in the DG and the control groups(P0.05).The short and long-term total effective rates in the combined group were all significantly higher than those in the other treatment groups(P0.05 or P0.01).No serious adverse reaction occurred in the four groups.Conclusion:Combined treatment of DG and EA could increase both plasma motilin and electrogastrographic frequencies,promote gastric emptying,alleviate the symptom of dyspepsia so as to increase quality of life,with better safety and long-term effect.     

Effect of Xuefu Zhuyu Capsule (血府逐瘀胶囊) on the Symptoms and Signs and Health-related Quality of Life in the Unstable Angina Patients with Blood-stasis Syndrome after Percutaneous Coronary Intervention: A Randomized Controlled Trial

Objective: Compared with Shengmai Capsule (生脉胶囊, SM), the study was conducted to evaluate the efficacy and safety of Xuefu Zhuyu Capsule (血府逐瘀胶囊, XFZY) on the symptoms and signs and health-related quality of life (HR-QOL) in the unstable angina (UA) patients with blood-stasis syndrome (BSS) after percutaneous coronary intervention (PCI). Methods: A randomized, double-blinded, doubledummy, and placebo-controlled trial was applied. Ninety patients, diagnosed as UA and BSS after successful PCI, were enrolled and equally randomized into three groups, XFZY group, SM group, and placebo group, and administered with the corresponding medications respectively for four weeks. The clinical symptoms and signs (CSS), electrocardiography (ECG), and BSS scores were recorded and compared among groups during and after the treatment. Short-form 36 (SF-36) and Seattle Angina Questionnaire (SAQ) were applied to assess the HR-QOL in each group before and after the treatment. Safety indexes (blood routine and liver and kidney function tests) were also examined at the beginning and after the treatment. Results: Eighty-six patients completed the whole study. After the treatment, the total effective rates of the XFZY group in ameliorating CSS and ECG were 76.7% and 60.0%, respectively, which were obviously higher than those in SM (CSS: 53.3%; ECG: 36.7%) and the placebo (CSS: 43.3%; ECG: 30.0%) groups. After one week's treatment, BSS scores slightly decreased in each group, but no significant differences were found among three groups (P0.05). After four weeks' treatment, BSS scores in the XFZY group decreased to a lower level compared with SM (P0.05) and the placebo (P0.01) groups. After the treatment, the efficacy of XFZY group in improving body pain (BP), general health (GH), vitality (VT), society functioning (SF), role emotional (RE), angina stability (AS), angina frequency (AF), and treatment satisfaction (TS) were better than those in the placebo group (P0.05, P0.01). Meanwhile, the dimensions of BP, GH, SF, AS, AF, and TS were better improved than those in the SM group (P0.05). No obvious adverse reaction was found during and after the treatment except one case in the XFZY group reporting of stomach discomfort. Conclusions: Compared with SM Capsule treatment, a short-term treatment with XFZY Capsule exhibits better efficacy on CSS and BSS scores, and HR-QOL in UA patients with BSS after PCI. However, its long-term efficacy and safety still needs further investigation.     

Clinical Study on Kangquan Recipe (康泉方) for Benign Prostatic Hyperplasia Patients: A Randomized Controlled Trial

Objective：To observe the effectiveness and safety of Kangquan Recipe（康泉方,KQR） for benign prostatic hyperplasia（BPH） patients.Methods：One hundred and six BPH patients were randomly assigned to the treatment group（53 cases） and the control group（53 cases） according to a random number table.The treatment group was given KQR orally;the control group was given cemilton orally.After 24-week treatment,the clinical effect and safety were evaluated using the International Prostatic Symptom Score（l-PSS）,quality of life（QOL）,maximum flow rate（Qmax）,average flow rate（Qave）,residual urine volume（RUV）,total prostatic volume（TPV）,etc.Results：After treatment,the score of l-PSS was decreased from 16.9 ±5.6 to 12.5 ±4.6in the treatment group,significantly lower compared with the control group;the levels of Qmax and Qave were from 10.9 ±3.5 to 15.6 ±4.5 and 5.4 ±2.1 to 7.3 ±2.5（mL/s） in the treatment group,significantly higher compared with the control group;the levels of RUV and TPV were from 70.8 ±28.2 to 35.2 ±21.8 and37.2 ± 16.9 to 30.1 ± 10.8（mL） in the treatment group,significantly lower compared with the control group（all P〈0.05）.The incidence rate of adverse reaction was similar between the two groups（P〉0.05）.Conclusion：KQR is effective and safe for the treatment of BPH.     

A Multi-center,Randomized,Controlled and Open Clinical Trial of Heyan Kuntai Capsule (和颜坤泰胶囊) and Hormone Therapy in Perimenopausal Women

Objective: To evaluate the efficacy and safety of Heyan Kuntai Capsule(和颜坤泰胶囊, HYKT) and hormone therapy(HT) on perimenopausal syndromes(PMSs). Methods: From 2005 to 2008, 390 women with PMSs were recruited from 4 clinic centers. The inclusion criteria included ages 40 to 60 years, estradiol(E2) below 30 ng/L, and follicle stimulating hormone(FSH) above 40 IU/L, etc. The patients were randomly assigned to HYKT group or HT group by random number table method, administrated HYKT or conjugated estrogen with/without medroxyprogesterone acetate tablets for 12 months. During treatment, the patients were interviewed quarterly, Kupperman Menopausal Index(KMI) scores, hot flush scores, insomnia scores, Menopause-Specific Quality of Life(MENQOL) scores and adverse effects were used for evaluating drug efficacy and safety respectively. The last interview was made at the end of 12-month treatment. Results: After treatment, KMI scores of HYKT group and HT group were both significantly decreased compared with baseline(P0.01) and there was no significant difference between groups(P0.05), except that KMI of HYKT group was higher after 3-month treatment(P0.05). After treatment, hot flush and insomnia scores were both improved significantly in two groups(P0.01); and HT had a better performance than HYKT in improving hot flush(P0.05). MENQOL were significantly improved in both groups after treatment(P0.01); but there was no significant difference between two groups(P0.05). The incidence of adverse event in the HYKT group was much lower than that in the HT group(P0.01). Conclusions: HYKT could effectively relieve PMSs and improve patient quality of life without severe adverse reactions. Although HYKT exerted curative effects more slowly than hormone, it possessed better safety profile than hormone.     

Wendan Decoction(温胆汤) for Treatment of Schizophrenia: A Systematic Review of Randomized Controlled Trials

Objective: To assess the beneficial and adverse effects of Wendan Decoction(温胆汤, WDD) for the treatment of schizophrenia. Methods: Five electronic databases were searched until May 2014, including the Chinese National Knowledge Infrastructure, the Chinese Biomedical Literature Database, the Chinese Scientist Journal Database, Pub Med, and the Cochrane Central Register of Controlled Trials in the Cochrane Library. The randomized controlled trials(RCTs) testing WDD against placebo, antipsychotic drugs, or WDD combined with antipsychotic drugs against antipsychotic drugs alone were included. Study selection, data extraction, quality assessment, and data analyses were conducted according to the Cochrane standards. Results: Thirteen RCTs(involving 1,174 patients) were included and the methodological quality was evaluated as generally low. The pooled results showed that WDD combined with antipsychotic drugs were more effective in clinical comprehensive effect, Positive and Negative Syndrome Scale(PANSS) scores and Brief Psychiatric Rating Scale scores compared with antipsychotic drugs alone. However, WDD had less effectiveness compared with antipsychotics in clinical comprehensive effect; and WDD was not different from antipsychotic drugs for PANSS scores. The side effects were significantly reduced in the intervention group compared with the control group. Conclusions: WDD appears to be effective on improving symptoms in patients with schizophrenia. However, due to poor methodological quality in the majority of the included trials, the potential benefit from WDD needs to be confirmed in rigorous trials and the design and reporting of trials should follow the international standards.     

Clinical Assessment on Treatment of Hyperlipidemia with Pushen Capsule (蒲参胶囊)

Objective: To explore the therapeutic effect of Pushen capsule (PSC, 蒲参胶囊) in treating primary hyperlipidemia. Methods: Two hundred and forty patients with primary hyperlipidemia were randomly divided into two groups, the 120 patients in the treated group treated with PSC (4 capsules, tid) and the 120 patients in the control group treated with Zhibituo tablet (脂必妥, 3 tablets, tid), and they were administered at the same time with Zhibituo placebo. The therapeutic course for both groups was 4 weeks. The therapeutic effect and the effects on blood lipids and viscosity were observed. Results: The effective rate in thetreated group was 76. 3%, which was significantly higher than that in the control group (48. 7% , P< 0. 01). PSC showed a significant lowering effect on TC, TG and LDL-C and raising effect on HDL-C, and the effect in lowering TG was significantly better than that of Zhibituo (P<0.01). PSC also showed a certain effect in decreasing whole blood viscosity of both high-sheared and low-shear     

Randomized Double-blinded and Controlled Clinical Trial on Treatment of HIV/AIDS by Zhongyan-4 (中研-4号)

Now,the clinical trial and efficacy eval-uation of theresearches ontreat ment of AIDSby traditional Chinese medicine (TCM) hasturned out to be one of the key points at homeand abroad. With randomized double-blindedplacebo-controlled method adopted, clinicalobservation on 72 HIV/AIDS patientsinfectedfrom paid blood supplyin Henan Province andtreated with Zhongyan-4 (中研-4号, ZY-4)had been conducted by the authors fromJune2002 to July 2003 .Theresults are nowrepor-ted as follows .METH…     

Effect of Shenzhu Guanxin Recipe (参术冠心方)on Patients with Angina Pectoris after Percutaneous Coronary Intervention:A Prospective,Randomized Controlled Trial

Objective:To evaluate the efficacy and safety of a combination therapy using Chinese medicine(CM) Shenzhu Guanxin Recipe(参术冠心方 SGR) and standard Western medicine treatment(SWMT) in patients with angina pectoris after percutaneous coronary intervention(PCI).Methods:Double-blind randomized controlled trial was used in this experimental procedure.One hundred and eighty-seven patients with coronary heart disease receiving SWMT after PCI were randomly assigned to the treatment(SGR) and control(placebo) groups.Outcome measures including angina pectoris score(APS),CM symptom score,and Seattle Angina Questionnaire(SAQ)score were evaluated in 1,2,3 and 12 months,and the death rate,restenosis and other emergency treatments were observed.The mixed-effects models were employed for the data analysis.Results:In the treatment group,a larger within-treatment effect size(d=1.74) was found,with a 76.7%reduction in APS from pretreatment to12-month follow-up assessment compared with the control group(d=0.83,53.8%symptom reduction);betweentreatment(BT) effect size was d=0.66.CM symptom scores included an 18.3%reduction in the treatment group(d=0.46),and a 16.1%decrease in the control group(d=0.31);d=0.62 for BT effect size.In regard to scores of SAQ,the BT effect size of cognition level of disease was larger in the treatment group(d=0.63),followed by the level of body limitation of activity(d=0.62),condition of angina pectoris attacks(d=0.55),satisfaction level of treatments(d=0.31),and steady state of angina pectoris(d=0.30).Two cardiovascular related deaths and one incidental death were recorded in the control and treatment groups,respectively.No significant difference in any cardiovascular event(including death toll,frequency of cardiovascular hospitalization or emergency room visits)was found between the two groups.Conclusion:The combination therapy of SGR and SWMT is effective and safe in patients with angina pectoris after PCI when compared with SWMT alone.     

Effectiveness and Safety Evaluation of Qixiong Zhongzi Decoction (芪芎种子汤) in Idiopathic Asthenozoospermia Treatment: A Randomized Controlled Trial

Objective: To evaluate the clinical effectiveness and safety of the Chinese medicine(CM) Qixiong Zhongzi Decoction(芪芎种子汤, QZD) in the treatment of patients with idiopathic asthenozoospermia. Methods: A total number of 66 patients with idiopathic asthenozoospermia were included and randomly divided into treatment and control groups by SAS-generated code from January 2015 to August 2016, 33 patients in each group. Patients in the treatment group were administered with 150 m L of QZD twice a day, whereas those in the control group were given 1 g of levocarnitine oral liquid twice a day. The two groups received the indicated medication for 12 weeks and were then followed up for 4 weeks. The primary outcome was sperm motility, and the secondary therapeutic indices were sperm volume, density, pregnancy probability, and CM syndrome score. The comparison between groups was carried out at 4, 8 and 12 weeks, respectively. The safety was determined before and after treatment. Results:(1) Drop-off: 5 cases(7.58%) were lost after treatment(2 from the treatment group and 3 from the control group).(2) Primary outcomes: after 8-and 12-week treatment, the progressive sperms in the two groups were significantly higher than the baseline(all P0.05); however, the treatment group showed greater improvement compared with the control group at 12-week treatment(22.7%±9.0% vs. 14.1%±8.8%, P0.05). The increasement of non-progressive grade sperms at both groups was observed at 8-and 12-week treatment with statistical difference(all P0.05), however, the treatment group showed remarkable improvement compared with the control group at 12-week treatment(38.7%±14.1% vs. 26.2%±15.4%, P0.05).(3) Secondary outcomes: no significant statistical differences were found in semen volume and density(4, 8, and 12-week treatment) and pregnancy probability of patients' wives(12-week treatment) between two groups(all P0.05), however, the CM syndrome score of the treatment group significantly declined compared with baseline level at each time points(all P0.05).(4) Safety: no obvious side reactions were found during the treatment in both groups. Conclusions: QZD could improve the progressive and non-progressive grade sperm in the treatment of idiopathic asthenozoospermia. It is safe with no obvious side effects.     

Treatment of Non-alcoholic Fatty Liver Disease by Qianggan Capsule(强肝胶囊)

<正>Objective:To observe the therapeutic effect and safety of Qianggan Capsule(强肝胶囊,QGC) in treating non-alcoholic fatty liver disease(NAFLD),using polyene phosphatidylcholine capsule(PPC) as a reference.Methods:Eighty-eight patients with NAFLD were randomly assigned to two groups,45 in the treatment group treated with QGC and 43 in the control group treated with PPC.The course of treatment lasted for 6 months.Changes in liver function,blood lipids,and iconographic indexes before and after treatment were observed,and clinical efficacy was evaluated.Results:In the treatment group,alanine aminotransferase(ALT) was lowered significantly from 56.02±32.59 IU/L before treatment to 38.27±22.68 IU/L after treatment,and CT liver/spleen ratio significantly increased from 0.69±0.18 to 0.91±0.25,showing statistical significance(P0.05);in contrast,the corresponding changes of the two indexes in the control group were 56.56±26.33 IU/L to 49.67±26.22 IU/L, and 0.66±0.20 to 0.75±0.24,respectively,the pre-post treatment difference showing insignificant difference(P0.05). No severe adverse reactions occurred during the whole treatment course.Conclusion:QGC is an effective and safe remedy for the treatment of NAFLD.     

Effect of Tongguan Capsules(通冠胶囊)on Restenosis after Coronary Stent Implantation:Study Protocol for A Randomized Controlled Trial

Background:Although percutaneous coronary intervention(PCI)had become widely employed therapeutic procedure for coronary artery disease,stent restenosis limited the benefits of this revascularization and the question how to prevent such events remained unresolved.While numerous empirical observations suggested Tongguan Capsules(通冠胶囊),a patented Chinese Medicine,could decrease frequency and duration of angina pectoris attacks,evidence supporting its efficacy on restenosis remained inadequate.Objective:This trial was designed to determine whether Tongguan Capsules would reduce restenosis rate in patients after successful stent implantation.Methods:Approximately 400 patients undergoing percutaneous coronary stent deployment were enrolled and randomized to control group or Tongguan Capsules(4.5 g/d)for 3 months.All patients received standard anti-platelet,anti-coagulation and lipid-decreasing treatments,concurrently.The primary clinical endpoint was the 12-month incidence of the major adverse cardiovascular events(defined as cardiac death,myocardial infarction,and recurrence of symptoms requiring additional revascularization).The angiographic end point was restenosis rate at 6 months.Conclusion:This study would provide important evidence for the use of Tongguan Capsules in patients after stent implantation in combination with routine therapies,which may significantly reduce incidence of the restenosis so as to potentially improve the clinical outcomes.(registration number:ChiCTR-TRC-ChiCTR-IIR-17011407)     

Effect of Zhizhu Kuanzhong Capsules(枳术宽中胶囊) on Treatment of Functional Dyspepsia: A Meta-Analysis of Randomized Controlled Trials

Objective: To evaluate the effect of Zhizhu Kuanzhong Capsules(枳术宽中胶囊, ZKC) for functional dyspepsia(FD) through meta-analysis. Methods: Online databases, including PubMed, EM base, China National Knowledge Infrastructure, Wanfang Data, VIP database and Cochrane Library, were searched for randomized controlled trials(RCTs) of ZKC for FD from the inception to April, 2016. Trials were selected according to inclusion criteria and were evaluated with quality assessment standards in the Cochrane Handbook for Systematic Reviews of Interventions and Jadad scale. RevMan 5.3 and GRADEprofiler 3.6 were used for statistical analysis and evidence quality assessment. Results: Twenty-three trials with 2,496 patients were included and most of them were of poor methodological quality. ZKC alone or ZKC combined with routine Western medicine(WM) showed a better clinical effect rate compared with the control group of WM [odds ratio(OR)=3.32, 95% confidence interval(2.66, 4.15), P0.00001]. No serious adverse reactions were reported. Conclusions: ZKC alone or ZKC combined with routine WM could significantly improve the clinical effective rate in the treatment of FD. The quality of the evidence is low, so it is necessary to design multicenter, strictly randomized and double-blind controlled trials with large samples to validate the conclusions.     

Clinical Study on Yishen Qufeng Shengshi Recipe (益肾祛风胜湿方) for Glomerular Proteinuria Patients: A Randomized Controlled Trial

Objective: To explore the therapeutic effect of Yishen Qufeng Shengshi Recipe(益肾祛风胜湿方,YQSR) in patients with glomerular proteinuria. Methods: A total of 145 patients with glomerular proteinuria were selected and randomly assigned to the treatment group(108 cases) and the control group(37 cases) according to a random number table in a ratio of 3:1. All patients received conventional and symptomatic treatment. In addition, patients in the treatment and control groups were given YQSR(200 m L, twice per day, orally) and losartan(50 mg/d orally), respectively for 6 months. The 24-h urine protein quantity, blood urea nitrogen, and serum creatinine in the two groups were measured at multiple time points before and after treatment. Results: At the end of the study, 5 cases were lost to follow-up in the treatment group and 1 in the control group. Finally, the statistical data included 103 cases in the treatment group and 36 cases in the control group. The total effectiveness after 2, 4, and 6 months was 81.6%(84/103), 87.4%(90/103), and 92.2%(95/103), respectively, in the treatment group and 47.2%(17/36), 55.6%(20/36), and 61.1%(22/36), respectively, in the control group, with significant difference between the two groups(P0.01 at all observation points). In the treatment group, the curative effect after 6 months was better than that after 2 months(P0.05). The 24-h urine protein quantity was significantly lower in the treatment group at 3, 4, 5, and 6 months than that in the control group(P0.05 or P0.01, respectively). Conclusion: YQSR could significantly reduce the amount of glomerular proteinuria in the early stage.