Therapeutic Effect of Chang'an Ⅰ Recipe (肠安Ⅰ 号方) on Irritable Bowel Syndrome with Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial

Objective: To evaluate the efficacy and safety of Chinese medicine (CM) decoction Chang''an Ⅰ Recipe (肠安Ⅰ 号方) in the treatment of irritable bowel syndrome with diarrhea (IBS-D). Method: A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Based on the order of inclusion, the IBS-D patients were randomly assigned to the treatment group or the placebo control group, administrated with Chang''an Ⅰ Recipe or placebo, 150 mL/bag, 3 times daily, for 8 weeks. The primary indices of efficacy included the effective rates of IBS symptom severity score (IBS-SSS) and the differences in adequate relief(AR) responder; the secondary indexes of efficacy included the changes in scores of the IBS Quality of Life (IBS-QOL) and Hospital Anxiety and Depression (HAD) scales. The safety indices included adverse events and related laboratory tests. Results: A total of 216 patients were included, with 109 in the treatment group and 107 in the control group, and finally 206 were included in the full analysis set (FAS), 191 were included in the per protocol set (PPS). In FAS, the total effective rate was 67.6% and 40.2% for the treatment and control groups, respectively, with 95% confidence interval (CI) for difference in the effective rates between the two groups of 14.4%–40.2%; while in PPS, the total effective rate was 71.3% and 41.2% for the treatment and control groups, respectively (95% CI 16.6%–43.4%). The consistent conclusions of FAS and PPS showed a better efficacy in the treatment group. Both FAS and PPS showed higher AR responder in the treatment group (FAS: 59.6% vs. 35.5%; PPS: 62.8% vs. 38.1%). As for IBS-QOL, the total score and scores in various dimensions of IBS-QOL were not significantly different between the two groups (P>0.05). Both anxiety and depression scales of HAD were not significantly different between the two groups (P>0.05). No adverse events or laboratory abnormalities were found to be obviously related to the tested drugs or clinically significant. Conclusion: Chang''an Ⅰ Recipe was more effective than placebo in the treatment of IBS-D, with no obvious adverse reactions. (No.ChiCTR-TRC-09000328)     

Effect of Yangxinkang Tablets(养心康片)on Chronic Heart Failure:A Multi-Center Randomized Double-Blind Placebo-Controlled Trial

Objectives:To investigate the safety and efficacy of Yangxinkang Tablets(养心康片) in patients with chronic heart failure(CHF) and syndrome of qi and yin deficiency,blood stasis,and water retention.Methods:In a double-blinded,randomized,placebo-controlled,multicenter clinical trail,228 patients with CHF New York Heart Association(NYHA) class Ⅱ or Ⅲ in stage C were assigned by randomized block method to two groups in a 1:1 ratio to undergo either conventional Western treatment or conventional treatment plus Yangxinkang Tablets for 4 weeks.The outcome measure were effect of cardiac function,Chinese medicine(CM) syndromes,scores of symptoms,signs,and quality of life measured by Minnesota Living with heart failure questionnaire(MLHFQ) before and after the treatment.Results:Totally 112 patients were analyzed in the treatment group and 109 in the control group.They were comparable in NYHA functional class,basic parameters and primary diseases before treatment.Cardiac function and CM syndromes were greatly ameliorated in both groups after treatment.Total effective rates of cardiac function and CM syndrome in the treatment group were significantly higher than those in the control group(P0.05).Total symptom score and sign score in the treatment group decreased significantly after treatment(P0.01),which were significantly lower than those in the control group(P0.05).There were statistically significant differences in post-treatment scores of gasp,cough with phlegm,pulmonary rales and jugular vein engorgement between the two groups(P0.05 or P0.01).Three MLHFQ scores decreased significantly in both groups after treatment(P0.01).Post-treatment total scale score and physical subscale score in the treatment group and the reduction of them showed statistically significant differences(P0.05) as compared with the control group.There was no significant difference between the two groups in emotional subscale score and the reduction after treatment(P0.05).There was no obvious adverse reaction in either group noted during the study.Conclusions:Yangxinkang Tablets were safe and efficacious in improving cardiac function,CM syndromes,symptoms,signs,and quality of life in patients with CHF class Ⅱ orⅢ in stage C on the base of conventional treatment.     

Therapeutic Effect of Jinlongshe Granule (金龙蛇颗粒) on Quality of Life of Stage Ⅳ Gastric Cancer Patients Using EORTC QLQ-C30: A Double-Blind Placebo-Controlled Clinical Trial

Objective: To evaluate the impact of Jinlongshe Granule (金龙蛇颗粒, JLSG) on quality of life (QOL) of stage Ⅳ gastric cancer patients. Methods: This randomized, double-blind and placebo-controlled clinical trial included 50 patients with advanced gastric cancer. They were equally randomized into a JLSG group and a placebo group. Patients in both groups received routine Chinese herbal decoctions according to Chinese medicine (CM) treatment based on syndrome differentiation. Patients in JLSG group received additional JLSG, and those in the placebo group received an additional placebo. In the JLSG group, 19 patients who completed the study were used for analysis. In the placebo group, finally the data of 20 patients who completed the study were used for analysis. The treatment course was at least 3 months, and the follow-up duration was at least 6 months in 5 interviews. Repeated measurements of the subscale items and individual items in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QLQ-C30) obtained at the 5 interviews were compared using different patient groups, changes over time and changes within one group over time independently to observe the tendency of changes in the scores. Results: Using time as the variant, there was significant difference in 4 functional scales (physical, role, emotional and social, P<0.05), 3 symptom scales (fatigue, nausea and vomiting and pain, P<0.05) and a global health status/QOL scale (P<0.05) and 6 single symptoms dyspnoea (P>0.05), insomnia (P<0.05), appetite loss (P<0.05), constipation (P<0.05), diarrhea (P>0.05) and financial difficulties (P<0.05). There was also significant difference in these items between the two groups when the placebo group and group over time were used as variants (P<0.05 or P<0.01). Conclusion: Additional use of JLSG on the basis of routine CM treatment could improve the somatic function, role function, emotional function, social function, cognitive function and general QOL of patients with advanced gastric cancer, and relieve the symptoms of fatigue, nausea and vomiting, pain, loss of appetite and constipation.     

Shenzhu Guanxin Recipe Granules (参术冠心方颗粒) for Improving Exercise Tolerance in Patients with Stable Angina (SERIES Trial):A Protocol of Multicenter,Randomized,Double-Blind,Placebo Parallel Controlled Clinical Trial

Background: Many patients with chronic angina experience anginal episodes despite successful recanalization, antianginal and antiischemic medications. Empirical observations suggested that Shenzhu Guanxin Recipe Granules(参术冠心方颗粒, SGR), a Chinese herbal compound, exerted potential impacts on increased treadmill exercise performance and angina relieve. However, there has been no systematic study to clarify the impact of SGR on exercise tolerance in patients with stable angina. The SERIES(ShEnzhu guanxin Recipe for Improving Exercise tolerance in patients with Stable angina) trial is designed to determine the effects of SGR on exercise duration, electrocardiographic(ECG) evidence of myocardial ischemia, and incidence of major adverse cardiac events(MACE) in stable anginal patients. Methods: A total of 184 eligible patients with stable angina will be randomly assigned to receive placebo or SGR(10 g/day for 12 weeks) in a 1:1 ratio. The primary outcome will be the change from baseline in total exercise tolerance duration, time to onset of angina and ECG ischemia during exercise treadmill testing performed over a 12-week study period. The secondary outcome will include ECG measures, the occurrence and composite of MACE and the Seattle Angina Questionnaire score. Moreover, the coronary microcirculation will be evaluated to explore the possible effects in response to treatment of SGR. After the procedure, all participants will be followed up by interview at 3 and 6 months, enquiring about any cardiac events, hospitalizations, cardiac functional level and medication usage. Additionally, the occurrence of adverse events will be evaluated at each follow-up. Discussion: This study may provide novel evidence on the efficacy of SGR in improving exercise tolerance and potentially reducing clinical adverse events.     

Therapeutic Effect of Jinlongshe Granule(金龙蛇颗粒) on Quality of Life of Stage IV Gastric Cancer Patients Using EORTC QLQ-C30:A Double-Blind Placebo-Controlled Clinical Trial

Objective:To evaluate the impact of Jinlongshe Granule(金龙蛇颗粒,JLSG)on quality of life(QOL)of stageⅣgastric cancer patients.Methods:This randomized,double-blind and placebo-controlled clinical trial included 50 patients with advanced gastric cancer.They were equally randomized into a JLSG group and a placebo group.Patients in both groups received routine Chinese herbal decoctions according to Chinese medicine(CM)treatment based on syndrome differentiation.Patients in JLSG group received additional JLSG,and those in the placebo group received an additional placebo.In the JLSG group,19 patients who completed the study were used for analysis.In the placebo group,finally the data of 20 patients who completed the study were used for analysis.The treatment course was at least 3 months,and the follow-up duration was at least 6 months in5 interviews.Repeated measurements of the subscale items and individual items in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30(EORTC QLQ-C30)obtained at the 5interviews were compared using different patient groups,changes over time and changes within one group over time independently to observe the tendency of changes in the scores,Results:Using time as the variant,there was significant difference in 4 functional scales(physical,role,ernotionai and social,P0.05),3 symptom scales(fatigue,nausea and vomiting and pain,P0.05)and a global health status/QOL scale(P0.05)and 6 single symptoms dyspnoea(P0.05),insomnia(P0.05),appetite loss(P0.05),constipation(P0.05),diarrhea(P0.05)and financial difficulties(P0.05).There was also significant difference in these items between the two groups when the placebo group and group over time were used as variants(P0.05 or P0.01).Conclusion:Additional use of JLSG on the basis of routine CM treatment could improve the somatic function,role function,emotional function,social function,cognitive function and general QOL of patients with advanced gastric cancer,and relieve the symptoms of fatigue,nausea and vomiting,pain,loss of appetite and constipation.     

Efficacy of Modified Qufeng Runmian Powder (加减祛风润面散) on Acne Vulgaris with Syndromes of Dampness and Blood Stasis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Objective: To evaluate the efficacy and safety of a Chinese medicine(CM) Modified Qufeng Runmian Powder(加减祛风润面散, MQFRMP) for the treatment of acne vulgaris with CM syndromes of dampness and blood stasis. Methods: In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 220 acne vulgaris patients with CM syndrome of dampness and blood stasis were included and randomly assigned using a central area group random design to receive either MQFRMP or the placebo, with 110 cases in each group. MQFRMP or a placebo at 145 g/bag were administered once daily for 4 weeks, respectively. The primary index of efficacy was the effective rate according to the acne severity score(ASS). The secondary indices of efficacy included the changes in the dermatology life quality index(DLQI) score, VISIA scores(spots, pores, brown spots, porphyrins and red areas) and skin assessment(skin p H, sebum amount and hydration) according to a SOFT skin multianalyzer. Results:(1) Follow-up: a total of 204 patients completed the follow-up, with 103 in the treatment group and 101 in the control group.(2) Effective rate: the total effective rate of the treatment group was significantly higher than the control group [83.5%(86/103) vs. 31.7%(32/101), P0.01)] with 95% confidence interval of 39.3%–66.4%.(3) DLQI: DLQI scores were significantly decreased the treatment and control groups(both P0.01), but the treatment group was more obvious than the placebo group(P0.01).(4) VISIA scores: the scores of spots, brown spots and red areas in the treatment group decreased compared with baseline(P0.05). In the control group, the scores of brown spots and pores decreased compared with baseline(P0.05). The improvement was more obvious in the treatment group than in the control group for all items(P0.05).(5) Skin assessment : the p H and sebum score in the both groups decreased drastically compared with the baseline(all P0.01), however, the improvement was more obvious in the treatment group than in the control group(P0.01). The hydration amount in the two groups showed no statistically significant difference compared with the baseline(both P0.05).(6) Safety: two cases of mild drug allergy were observed in the treatment group. Conclusion: MQFRMP was effective and safe for the treatment of acne vulgaris with syndromes of dampness and blood stasis.(No. ChiCTR1900020479).     

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.     

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.     

Shenzhu Guanxin Recipe Granules (参术冠心方颗粒) for Improving Exercise Tolerance in Patients with Stable angina (SERIES Trial): A Protocol of Multicenter, Randomized, Double-Blind, Placebo Parallel Controlled Clinical Triallimited

Background: Many patients with chronic angina experience anginal episodes despite successful recanalization, antianginal and antiischemic medications. Empirical observations suggested that Shenzhu Guanxin Recipe Granules (参术冠心方颗粒, SGR), a Chinese herbal compound, exerted potential impacts on increased treadmill exercise performance and angina relieve. However, there has been no systematic study to clarify the impact of SGR on exercise tolerance in patients with stable angina. The SERIES (ShEnzhu guanxin Recipe for Improving Exercise tolerance in patients with Stable angina) trial is designed to determine the effects of SGR on exercise duration, electrocardiographic (ECG) evidence of myocardial ischemia, and incidence of major adverse cardiac events (MACE) in stable anginal patients. Methods: A total of 184 eligible patients with stable angina will be randomly assigned to receive placebo or SGR (10 g/day for 12 weeks) in a 1:1 ratio. The primary outcome will be the change from baseline in total exercise tolerance duration, time to onset of angina and ECG ischemia during exercise treadmill testing performed over a 12-week study period. The secondary outcome will include ECG measures, the occurrence and composite of MACE and the Seattle Angina Questionnaire score. Moreover, the coronary microcirculation will be evaluated to explore the possible effects in response to treatment of SGR. After the procedure, all participants will be followed up by interview at 3 and 6 months, enquiring about any cardiac events, hospitalizations, cardiac functional level and medication usage. Additionally, the occurrence of adverse events will be evaluated at each follow-up. Discussion: This study may provide novel evidence on the efficacy of SGR in improving exercise tolerance and potentially reducing clinical adverse events. (Trial registration No. ChiCTR-TRC-14004504)     

Effect and Safety of Hydroxysafflor Yellow A for Injection in Patients with Acute Ischemic Stroke of Blood Stasis Syndrome: A Phase Ⅱ , Multicenter, Randomized, Double-Blind, Multiple-Dose, Active-Controlled Clinical Trial

Objective: To assess the effect and safety of Hydroxysafflor Yellow A for Injection(HSYAI) in treating patients with acute ischemic stroke(AIS) and blood stasis syndrome(BSS). Methods: A multicenter, randomized, double-blind, multiple-dose, active-controlled phase Ⅱ trial was conducted at 9 centers in China from July 2013 to September 2015. Patients with moderate or severe AIS and BSS were randomly assigned to low-, medium-, high-dose HSYAI groups(25, 50 and 70 mg/d HSYAI by intravenous infusion, respectively), and a control group(Dengzhan Xixin Injection(灯盏细辛注射液, DZXXI) 30 mL/d by intravenous infusion), for 14 consecutive days. The primary outcome was the Modified Rankin Scale(mRS) score 1 at days 90 after treatment. The secondary outcomes included the National Institute of Health Stroke Scale(NIHSS) score 1, Barthel Index(BI) score 95, and BSS score reduced 30% from baseline at days 14, 30, 60, and 90 after treatment. The safety outcomes included any adverse events during 90 days after treatment. Results: Of the 266 patients included in the effectiveness analysis, 66, 67, 65 and 68 cases were in the low-, medium-, and high-dose HSYAI and control groups, respectively. The proportions of patients in the medium-and high-dose HSYAI groups with m RS score 1 at days 90 after treatment were significantly larger than the control group(P0.05). The incidences of favorable outcomes of NIHSS and BI at days 90 after treatment as well as satisfactory improvement of BSS at days 30 and 60 after treatment in the medium-and high-dose HSYAI groups were all significantly higher than the control group(P0.05). No significant difference was reported among the 4 groups in any specific adverse events(P0.05). Conclusions: HSYAI was safe and well-tolerated at all doses for treating AIS patients with BSS. The medium(50 mg/d) or high dose(75 mg/d) might be the optimal dose for a phase Ⅲ trial.(Registration No. ChiCTR-2000029608)     

Effectiveness and Safety of Umbilicus Treatment with Modified Dinggui Powder(加味丁桂散)in Patients with Chronic Nonbacterial Prostatitis:A Randomized,Double-Blind,Placebo-Controlled Clinical Trial

Objective:To evaluate the effectiveness and safety of Chinese herbal external umbilicus treatment with Modified Dinggui Powder(加味丁桂散,MDGP)in patients with chronic nonbacterial prostatitis(CNP).Methods:A randomized,double-blind,placebo-controlled clinical trial was conducted among 72 patients with CNP.Participants were randomly allocated to a treatment group and a placebo group using computer software in a 1:1 ratio,and received either MDGP external umbilicus treatment(MDGP group,36 cases)or placebo(control group,36 cases)at acupoints Shenque(CV 8),twice a week for 4 weeks.In addtion,patients all received herbal medicine treatment twice a day for 4 weeks.The primary outcome was the US National Institutes of Health Chronic Prostatitis Symptom Scores Index(NIH-CPSI)with a questionnaire at weeks 2 and 4.The secondary outcomes including prostatic fluid examination(white blood cells and lecithin bodies),the clinical efficacy evaluation,and the adverse events were also assessed during the entire trial.Results:The NIH-CPSI scores regarding pain or discomfort scores showed greater improvement in the MDGP group than placebo control group at weeks 2(P=0.001)and week 4(P=0.004),respectively.NIH-CPSI scores of symptom severity,total scores and leukocytes number in the prostatic fluid in the MDGP group were significantly improved(P<0.05).There was no statistical difference in the urinary symptoms,quality of life,lecithin and other scores between two groups(P>0.05).The clinical effective rate was 73.53%(25/34)in the MDGP group,which was significally higher than the placebo control group with 48.39%(25/31,P<0.05).Patients were blinded successfully,and no serious adverse effects were found during the trial.Conclusion:A 4-week course of umbilicus treatment with modified Dinggui Powder seems to relieve pain and symptom severity effectively and increase the amount of leukocytes number in patients with CNP(Trial registration No.ChiCTRI 800014687).     

Post-marketing Re-evaluation of Tongxiening Granules (痛泻宁颗粒) in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome:A Multi-center,Randomized,Double-Blind,Double-Dummy and Positive Control Trial

Objective: To evaluate the efficacy and safety of Tongxiening Granules(痛泻宁颗粒, TXNG) in the treatment of irritable bowel syndrome with predominant diarrhea(IBS-D). Methods: A randomized, double-blind, double-dummy, and positive paral el control ed clinical trial was conducted from October 2014 to March 2016. Total y 342 patients from 13 clinical centers were enrolled and randomly assigned(at the ratio of 1:1) to a treatment group(171 cases) and a control group(171 cases) by a random coding table. The patients in the treatment group were administered oral y with TXNG(5 g per time) combined with pinaverium bromide Tablet simulator(50 mg per time), 3 times per day. The patients in the control group were given TXNG simulator(5 g per time) combined with pinaverium bromide Tablets(50 mg per time), 3 times per day. The treatment course lasted for 6 weeks. The improvement of Irritable Bowel Syndrome Symptom Severity Score(IBS-SSS) was used to evaluate the primary outcome. Secondary outcomes included adequate relief(AR) rate, Irritable Bowel Syndrome-Quality of Life Questionnaire(IBS-QOL), Hamilton Anxiety Scale(HAMA), Hamilton Depression Scale(HAMD), and the recurrence rate at fol ow-ups. Safety indices including the adverse events(AEs) and related laboratory tests were evaluated. Results: Primary outcome: IBS-SSS at baseline, weeks 2, 4, 6 showed no statistical significance in both full analysis set(FAS) and per protocol set(PPS, P0.05). After 6 weeks of treatment, the total effective rate of IBS-SSS scores in the treatment group(147/171, 86.0%) was higher than the control group(143/171, 83.6%) by FAS(P0.05). In regard to secondary outcomes, after 6-week treatment, there was no significant difference in AR rate, total score of IBS-QOL, improvement of HAMD and HAMA total scores between the two groups(P0.05). The recurrence rate at 8-week fol ow-up was 12.35%(10/18) in treatment group and 15.79%(12/76) in control group, respectivery(P0.05). A total of 21 AEs occurred in 15 cases, of which 11 occurred in 8 cases in the treatment group and 10 AEs in 7 cases in the control group. The incidence of AEs had no statistical significance between the two goups(P0.05). Conclusion: Tongxiening Granules could relieve the symptoms of patients with IBS-D and the treatment effect was comparable to pinaverium bromide.(No. ChiCTR-IPR-15006415)     

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.     

Effect and Safety of Guanxinning Tablet(冠心宁片) for Stable Angina Pectoris Patients with Xin(Heart)-Blood Stagnation Syndrome:A Randomized,Multicenter,Placebo-Controlled Trial

Objective: To investigate the effect and safety of Guanxinning Tablet(冠心宁片, GXN) for the treatment of stable angina pectoris patients with Xin(Heart)-blood stagnation syndrome(XBSS). Methods: One hundred and sixty stable angina pectoris patients with XBSS were randomly assigned to receive GXN(80 cases) or placebo(80 cases, Guanxinning simulation tablets, mainly composed of lactose), 4 tablets(0.38 g/tablet), thrice daily for 12 weeks. After treatment, an exercise stress test(treadmill protocol), Chinese medicine(CM) syndrome score, electrocardiogram(ECG), and nitroglycerin withdrawal rate were evaluated and compared in the patients between the two groups. Meanwhile, adverse events(AEs) were evaluated during the whole clinical trial. Results: Compared with the control group, the time extension of exercise duration in the GXN group increased 29.28±17.67 s after treatment(P0.05); moreover, the change of exercise duration in the GXN group increased 63.10±96.96 s in subgroup analysis(P0.05). The effective rates of angina pectoris, CM syndrome and ECG as well as nitroglycerin withdrawal rate were 81.33%, 90.67%, 45.76%, and 70.73%, respectively in the GXN group, which were all significantly higher than those in the control group(40.58%, 75.36%, 26.92%, 28.21%, respectively, P0.05). Conclusion: GXN was a safe and effective treatment for stable angina pectoris patients with XBSS at a dose of 4 tablets, thrice daily.     

Randomized Double-Blind Clinical Trial of Moluodan(摩罗丹) for the Treatment of Chronic Atrophic Gastritis with Dysplasia

Objective:To assess the efficacy and safety of Moluodan(摩罗丹) in treating dysplasia in chronic atrophic gastritis(CAG) patients.Methods:This was a multi-centered,double-blind,randomized controlled trial.The total of 196 subjects were assigned to receive either Moluodan or folic acid in a 2:1ratio by blocked randomization.Mucosa marking targeting biopsy(MTB) was used to insure the accuracy and consistency between baseline and after 6-month treatment.Primary outcomes were histological score,response rate of pathological lesions and dysplasia disappearance rate.Secondary endpoints included gastroscopic findings,clinical symptom and patient reported outcome(PRO) instrument.Results:Dysplasia score decreased in Moluodan group(P=0.002),significance was found between groups(P=0.045).Dysplasia disappearance rates were 24.6%and 15.2%in Moluodan and folic acid groups respectively,no significant differences were found(P=0.127).The response rate of atrophy and intestinal metaplasia were 34.6%and23.0%in Moluodan group,24.3%and 13.6%in folic acid group.Moluodan could improve erythema(P=0.044),and bile reflux(P=0.059),no significance between groups.Moluodan was better than folic acid in improving epigastric pain,epigastric suffocation,belching and decreased appetite(P0.05),with symptom disappearance rates of 37%to 83%.Conclusions:Moluodan improved dysplasia score in histopathology,and erythema and bile reflux score in endoscopy,and superior to folic acid in improving epigastric pain,epigastric suffocation,belching and decreased appetite.     

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.     

Observation of the Clinical Therapeutic Effect of Gandou Tabl et Ⅰ(肝豆片Ⅰ号) on Hepatolenticular Degeneration

Objective: To investigate the therapeutic efficacy of Gandou Tablet Ⅰ (肝豆片Ⅰ号) in tre ating hepatolenticular degeneration (HLD) and its effect on urinary trace element in 24 hours. Methods: Thirty-four patients with HLD took Gandou Tablet Ⅰ for 4 weeks, their changes of symptoms, signs and d aily life pattern were observed closely, and the levels of urinary trace element in 24 hours before the therapy an d every week after initiation of treatment were measured. Result s: The total effective rate reac hed 70.59%, with markedly effective rate being 8.82%.The therapeutic effect was much better in the child and mild patients. After treatment, the daily urina ry coppe r output was obviously increased every week compared with that before (P< 0. 01 ). Although i t was highly negative linear correlated with the duration of treatment (γ=-0.96 , P < 0.05 ), it has insignificant difference between any two weekly excretion of urin ary copper per 24 hours after treatment (P>0.05). So its effect on urinary copp er excretion was not decreased. Conclusion: Gandou Tablet Ⅰ could increase the output of urinary copper, hence it was effective in treating HLD wi thout apparent toxic or side reaction.     

Effect of Modified Sinisan (四逆散) on Anorectal Manometry of the Constipation Predominant Type of Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) of theconstipation predominant type is a functionalintestinal disease characterized by abdominaldistress or pain, changed habit of defecationand abnormal defecation. Its pathogenesishas not been totally clarified yet. This re search is to explore the mechanism of pa tients with IBS of the constipation predomi nant type through the determination of ano rectal pressure via anus and better efficacyhas been obtained in the study by modify…     

Effect of Shenfu Injection(参附注射液)on Lactate and Lactate Clearance in Patients with Post-cardiac Arrest Syndrome:A Post Hoc Analysis of a Multicenter Randomized Controlled Trial

Objective: To assess the effects of Shenfu Injection(参附注射液, SFI) on blood lactate, and secondarily its effect on the lactate clearance(LC) in patients with post cardiac arrest syndrome(PCAS). Methods: The present study is a post hoc study of a randomized, assessor-blinded, controlled trial. Patients experienced in-hospital cardiac arrest between 2012 and 2015 were included in the predefined post hoc analyses. Of 1,022 patients enrolled, a total of 978 patients were allocated to the control group...     

The Therapeutic Effect of Xiaopi-Ⅰ(消痞Ⅰ号) on Functional Dyspepsia

Objective: To observe the therapeutic efficacy of Xiaopi-Ⅰ(消痞Ⅰ号) on functional dyspepsia and its effects on gastric emptying. Methods: A total of 134 patients with functional dyspepsia were randomly assigned to 2 groups. The patients in the Xiaopi-Ⅰ group (66 cases) and the Domperidone group (68 cases) were given Xiaopi-Ⅰ granules and Domperidone 10 mg, 3 times a day, respectively. Another 20 healthy volunteers were chosen as the negative control group. The severity scores of the symptoms, as well as the gastric emptying, were detected before and after 4-week treatment by barium strip-trial meal. Results: During therapy, 6 cases from the Xiaopi-Ⅰ group and 8 cases from the Domperidone group were lost to follow, and 120 cases finally finished the study. Statistical differences were observed from both groups in terms of the symptoms of postprandial fullness early satiety, epigastric pain, and epigastric burning after 4-week treatment (P<0.01). The symptomatic severity scores of the Xiaopi-Ⅰ group before and after the treatment were 7.48±1.64 and 2.16±1.26, respectively (P<0.01). Gastric emptying rates were also improved in the patients with delayed gastric emptying, and the effective rates were 91.3% and 75.8% in the Xiaopi-Ⅰ and Domperidone groups, respectively. No obvious adverse effects were found from both groups. Conclusion: Xiaopi-Ⅰ was an effective and safe agent in the treatment of functional dyspepsia and was worth of further development in clinical.