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 m L/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(P0.05). Both anxiety and depression scales of HAD were not significantly different between the two groups(P0.05). 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.ChiC TR-TRC-09000328)     

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)     

Treatment of Irritable Bowel Syndrome by Oral Administration of Chinese Medicines and Retention-Enema——A Report of 50 Cases

Irritable bowel syndrome (IBS),a commondisease of intestinal dysfunction,is also calledemotional enteritis,mucous enteritis,irritable colonand so on.It is often lingering with a long diseasecourse and is easy to recur.The author has in recentyears treated 50 cases of the disease by oraladministration of Chinese medicines and retention-enema,with satisfactory results reported as follows.General DataAll the patients under observation came fromthe outpatient department of my hospital.Routine     

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.     

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)     

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     

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.     

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).     

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.     

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.     

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.     

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)     

Treatment of HBV Cirrhosis with Fuzheng Huayu Tablet (扶正化瘀片) and Entecavir: Design of a Randomized, Double-Blind, Parallel and Multicenter Clinical Trial

Background: Antiviral therapy can lead to regression of fibrosis in chronic hepatitis B (CHB), but it has a limited effect on cirrhosis. Chinese medicines (CMs), particularly Fuzheng Huayu Tablet (扶正化瘀片, FZHY), have an antifibrotic effect in patients with CHB. Objective: To observe the safety and efficacy of adjunctive FZHY in patients with hepatitis B virus (HBV) cirrhosis, this study was designed as a randomized, placebo-controlled, double-blind, parallel assignment, multicenter trial at 20 centers in China. The total 700 naive patients will be enrolled with compensate cirrhosis due to HBV, and randomly assigned into 2 groups, receiving entecavir (0.5 mg, daily) and FZHY placebo (1.6 g, 3 times a day), or entecavir (0.5 mg, daily ) and FZHY (1.6 g, 3 times a day) , respectively. The primary endpoint was histological improvement at week 48. The secondary outcome is the decline values of liver fibrosis using the noninvasive methods from baseline to week 48 in each arm of the study. Adverse events such as stomach upset, headache, fatigue, dizziness, nausea will be strictly recorded. Discussion: Through this study, we hope to generate a solid evidence for the therapeutic strategy of HBV cirrhosis with a combination of anti-viral such as ETV and anti-fibrotic herbal product such as FZHY. Protocol version: Version 1.3, Date: 2014.12.4. Trial registration number: NCT02241590.     

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.     

Efficacy of Modified Wuzhuyu Decoction Granule(加减吴茱萸汤颗粒剂)for Migraine Patients with Cold and Stasis Obstructing Meridian Syndrome:A Randomized,Double-Blind,Placebo-Controlled Trial

Objective: To study the efficacy of modified Wuzhuyu Decoction Granule(加减吴茱萸汤颗粒, MWDG) in the treatment of migraine patients with cold and stasis obstructing meridian syndrome. Methods: This study was a randomized, double-blind, placebo-controlled trial. A total of 78 migraine patients with cold and stasis obstructing meridian syndrome were recruited and randomly assigned by a ratio of 2:1 into a treatment group(51 cases) and a placebo group(27 cases). Patients in the treatment group were treated with MWDG while placebo granules were applied in the control group. The treatment course lasted for 12 weeks with a follow-up of 4 weeks. The primary outcome measures included frequency and days of migraine attacks and the secondary outcome measures were analgesics consumption and visual analogue scale(VAS) scores. All outcome assessments were conducted respectively at baseline, the 4 th, 8 th and 12 th week, and the end of follow-up. Results: In the treatment group, significant decrease in frequency of migraine attacks were observed since the 4 th week and that of analgesics consumption since the 8 th week(both P0.05). While, in the placebo group, significant decrease in frequency of migraine attacks were observed since the 8 th week and that of analgesics consumption since the 12 th week(both P0.05). No significant decrease in days of migraine attacks and VAS scores of migraine pain were observed in both groups. Between the two groups, there were significant differences in VAS scores and intensity of pain appeared in the 8 th week(P0.05). However, no significant differences were found in days and frequency of migraine attacks and analgesics consumption(P0.05). Conclusions: MWDG was probably effective in the treatment of migraine especially for alleviating pain intensity. Furthermore, MWDG could reduce the frequency of migraine attacks and analgesics consumption sooner than the placebo.     

Efficacy of Getong Tongluo Capsule(葛酮通络胶嚢)for Convalescent-Phase of Ischemic Stroke and Primary Hypertension:A Multicenter,Randomized,Double-Blind,Controlled Trial

Objective:To evaluate whether the efficacy of Getong Tongluo Capsule(葛酮通络胶囊,GTC,consisted of total flavone of Radix Puerariae)on improving patients'quality of life and lowering blood pressure are superior to the extract of Ginkgo biloba(EGB)for patients with convalescent-phase ischemic stroke and primary hypertension.Methods:This randomized,positive-drug-and placebo-controlled,double-blind trial was conducted from September 2015 to October 2017.Totally 477 eligible patients from 18 hospitals in China were randomly assigned in a 2:1:1 ratio to the following interventions,twice a day for 12 weeks:(1)GTC 250 mg plus EGB-matching placebo 40 mg(237 cases,GTC group),(2)EGB 40 mg plus GTC-matching placebo 250 mg(120 cases,EGB group)or(3)GTC-matching placebo 250 mg plus EGB-matching placebo 40 mg(120 cases,placebo group).Moreover,all patients were orally administered aspirin enteric-coated tablets 100 mg,once a day fo r 12 weeks.The primary outcome was the Barthel Index(Bl).The secondary outcomes included the control rate of blood pressure and National Institutes of Health Stroke Scale(NIHSS)scores.The incidence and severity of adverse events(AEs)were calculated and assessed.Results:The Bl relative independence rates,the clinical recovery rates of NIHSS,and the total effective rates of NIHSS in the GTC and EGB groups were significantly higher than the placebo group at 12 weeks after treatment(P<0.05),and no statistical significance was found between the GTC and EGB groups(P>0.05).The control rate of blood pressure in the GTC group was significantly higher than the EGB and placebo groups at 12,18 and 24 weeks after treatment(P<0.01).There were no statistically significant differences in the incidences of AEs,adverse drug reactions,or serious AEs among the 3 groups(P>0.05).Conclusion:GTC exhibited significant efficacy in improving patients'quality of life as well as neurological function and controlling hypertension.     

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...     

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

Background: Syndrome 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). Objective: To 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. Methods: It 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. Discussion: This 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.     

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.     

A Randomized Trial of Chinese Medicine Lirukang Granule (利乳康颗粒) Combined with Psychological Intervention for Cyclomastopathy and Menoxenia

Objective:To observe the influence of therapy with Chinese medicine Lirukang Granule（利乳康颗粒）,LRKG) combined with psychological intervention on anxiety states and sex hormones in patients with cyclomastopathy and menoxenia.Methods:A total of 470 subjects were randomly assigned to three groups by the net-central randomization system,the treatment group（161 patients,treated with LRKG and psychological intervention）,the Chinese medicine group（157 patients,treated with LRKG）,and the psychological intervention group（152 patients,treated with psychological intervention）.The dose of LRKG was 12 g three times per day; psychological intervention included establishing relations,cognitive intervention and psychological persuasion, 30-40 min per session,once a week.The therapy duration for all groups was three months.The efficacy was compared and anxiety state/State-Trait Anxiety Invertory（STAI） scoring was measured before and after treatment.The serum estradiol（E₂）,progesterone（P）,prolactin（PRL） and follicle stimulating hormone（FSH） levels of 60 patients selected randomly from each group during the luteal phase were measured before and after treatment,and a group of 20 healthy women were evaluated for comparison.A follow-up was arranged for one year after treatment.Results:Thirty subjects were lost to follow-up.（1） Comparison of efficacy:the markedly effective rate and the total effective rate of the treatment group were 86.67%（131/150） and 98.00%（147/150）, respectively;of the Chinese medicine group,64.58%（93/144） and 90.27%（130/144）,respectively;and of the psychological intervention group,0%（0/146） and 3.42%（5/146）,respectively.The markedly effective rate and the total effective rate in the treatment group were significantly higher than those in the Chinese medicine and psychological intervention groups（P<0.05）.（2） Comparison of STAI scoring:STAI scoring was decreased dramatically in the treatment group after treatment compared with that of the Chinese medicine group（P<0.01）, but there was no significant difference compared with the psychological intervention group.（3） Comparison of levels of sex hormones:E₂,P,PRL and FSH of the three patient groups were disordered before treatment,and significantly different from healthy women（P<0.01）.After treatment,the levels of P and FSH of the treatment group were significantly increased（P<0.01）,E₂ and PRL were significantly reduced,which were also significantly decreased compared with the psychological intervention groups（P<0.01）.（4） Follow-up:the markedly effective rate and the total effective rate of the treatment group remained higher than those of the other two groups after one year of treatment（P<0.05）.（5） Adverse reactions:no obvious adverse reactions were found among the three groups.Conclusions:Therapy with Chinese medicine combined with psychological intervention was effective for short-term and long-term treatment of cyclomastopathy and menoxenia.The mechanism might be related to the regulation of sex hormones.