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).     

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.     

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)     

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)     

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)     

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.     

A Multicenter,Randomized,Double-blind Clinical Study on Wufuxinnaoqing Soft Capsule(五福心脑清胶囊) in Treatment of Chronic Stable Angina Patients with Blood Stasis Syndrome

Objective:To confirm the efficacy and safety of Wufuxinnaoqing Soft Capsule(五福心脑清胶囊,WSC)in the treatment of chronic stable angina(blood stasis syndrome).Methods:A multicenter,randomized,double-blind,placebo-controlled trial with superiority test was designed.A total of 240 patients with chronic stable angina(blood stasis syndrome)from multiple centers were randomly and equally assigned to the treatment group and the control group.Based on standard treatment of Westem medicine,the treatment group was given WSC,while the control group was given WSC mimetic,both for 12 weeks.Observed indicators included the efficacy in angina,the efficacy in Chinese medicine syndrome,the withdrawal or reduce rate of nitroglycerin and routine safety indices.Results:After 12-week treatment,the significant effective rate and total effective rate of the treatment group were significantly better than those of the control group(23.5%vs.9.2%,64.7%vs.30.8%),respectively,with statistically significant difference(P0.01).After 12-week treatment,the decreased points and the decreased rate of angina symptom score in the treatment group were better than in the control group(5.1±4.2 points vs.2.8±3.5 points,44.9%±37.2%vs.25.4%±30.7%)respectively,with significant difference(P0.01).After 12-week treatment,the significant effective rate and total effective rate of the treatment group were better than the control group(respectively,30.3%vs.15.0%,67.2%vs.45.0%,P0.01).After 8-or 12-week treatment,the decreased points and the decreased rate of Chinese medicine syndrome score in the treatment group were better than the control group(P0.05 or P0.01).After 12-week treatment,nitroglycerin withdrawal rate and the withdrawal or reduce rate in treatment group were better than the control group(P0.01).On safety evaluation,the incidence of adverse events(7.563%vs.7.500%)and the incidence of cardiovascular events(0.840%vs.0.000%)in the treatment group were similar with the control group,and the difference was not statistically significant(P0.05).Conclusion:In treatment of chronic stable angina(blood stasis syndrome),WSC can reduce angina attacks and consumption of nitroglycerin,decrease angina severity degree,effectively relieve the blood stasis syndromes,such as chest pain,chest tightness,palpitations,dark purple tongue and other symptoms.Besides,adverse events and cardiovascular adverse events in the treatment group and the control group showed no difference.All shows that the drug is safe and effective.[This study was registered in Chinese Clinical Trial Registry(ChiCTR),with registration number:ChiCTR-TRC-14005158.]     

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.     

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.     

Clinical Efficacy and Safety of Bathing with Chinese Medicine Taohong Siwu Decoction (桃红四物汤) for Treatment of Diffuse Cutaneous Systemic Sclerosis: A Randomized Placebo-Controlled Trial

Objective:To examine the efficacy and safety of bathing therapy with Taohong Siwu Decoction(桃红四物汤,TSD) in the treatment of early-stage,mild-moderate diffuse cutaneous systemic sclerosis(dc SSc).Methods:This randomized,placebo-controlled trial enrolled 148 men and women(18–60 years) with dc SSc(disease duration 12 months) and baseline modified Rodnan skin score(MRSS) 10.Patients were randomized into a TSD group(71 cases bathing with TSD plus oral prednisone) or control group(71 cases bathing with placebo plus oral prednisone).Bathing(40 ℃,30 min) of the upper and lower limbs was carried out once daily for 12 consecutive weeks.The primary outcome measure was MRSS;secondary outcomes were Raynaud's phenomenon(RP) score,quality of life(QOL),physician visual analogue scale(VAS),patient VAS,percent predicted diffusing capacity for carbon monoxide(DLCO),percent predicted forced vital capacity(FVC),erythrocyte sedimentation rate(ESR),C-reactive protein(CRP) level and overall treatment effect.Results:The final analysis included 135 patients(control group,68 cases;TSD group,67 cases).Primary and secondary outcome measures after 2 weeks of treatment showed no improvement(versus baseline) in both groups,with no differences between groups.At 12 weeks,QOL,physician VAS,patient VAS,ESR and CRP were improved in both groups,but MRSS and RP score were improved only in the TSD group(all P0.05).MRSS,RP score,QOL,physician VAS,patient VAS,ESR and CRP differed significantly between groups(all P0.05).Meanwhile,the overall treatment effect was significantly higher in the TSD group than in the control group(P0.05).Adverse events in the two groups were similar(P0.05).Conclusions:Bathing with TSD plus oral prednisone achieves better outcomes than oral prednisone alone in patients with dcS Sc and is not associated with serious adverse events.     

Efficacy and Safety of Guilingji Capsules (龟龄集胶囊) for Treating Mild-to-Moderate Cognitive Impairment: Study Protocol for A Randomized, Double-Blind, Positive-Controlled, Multicenter and Noninferiority Trial

Background: The incidence of cognitive impairment(CI) is gradually increasing, which has attracted more attention from medical researchers worldwide. Definitive mechanisms of pathogenesis remain elusive, and there are few medications that have been proven effective for CI. The utilization of Chinese herbal medicine has shown positive therapeutic effects for a broad spectrum of diseases, including CI. Objective: The purpose of this study is to evaluate the safety and efficacy of Guilingji Capsules(GLJC,龟龄集胶囊) in treating mild-to-moderate CI with Shen(Kidney) and marrow deficiency syndrome. Methods: This is a randomized, double-blind, positive-controlled, multicenter clinical trial with a noninferiority design that included 348 participants randomly divided into an experimental arm and an active comparator arm. Individuals in the experimental arm(174 cases) took 0.6 g of GLJC once a day and 19.2 mg of Gingko biloba extract mimetic 3 times a day. Individuals in the active comparator arm(174 cases) took 0.6 g of GLJC mimetic once a day and 19.2 mg of Gingko biloba extract in tablet form 3 times a day. The intervention period included two sessions over 24 weeks. The primary outcome be the effectiveness of GLJC on cognitive improvement after 24 weeks of treatment, which was defined as an increase in the Mini Mental State Examination(MMSE) and Montreal Cognitive Assessment(MoCA) Scale. The secondary outcomes were improvement in independence, daily living ability, and Chinese medicine(CM) syndrome, which were measured with the Alzheimer's disease Rating Scale-Cognitive Project(ADAS-Cog), Clinical Dementia Rating(CDR) Total Score, Activities of Daily Living(ADL) Total Score and the Chinese Medicine Symptom Scale(CM-SS), respectively. Serum acetylcholine, acetylcholinesterase, bax and bcl-2 were monitored to explore the mechanism of GLJC on CI. In addition, safety measures, including vital signs, electrocardiography, laboratory indicators(full blood count, kidney and liver function tests, routine urine test and routine stool test) and adverse events, were also recorded. Discussion: The purpose of this trial is to evaluate the efficacy and safety of GLJC in patients with mild-to-moderate CI with kidney and marrow deficiency syndrome. If successful, the results would provide a viable treatment for patients with mild-to-moderate CI.(Clinical Trials.gov. ID: NCT03647384. Registered on 23 August 2018)     

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)     

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.     

A Clinical Study on the Treatment of Chronic Pelvic Inflammation of Qi-stagnation with Blood Stasis Syndrome by Penyanqing Capsule (盆炎清胶囊)

Objective: To observe the clinical efficacy of Penyanqing Capsule (盆炎清胶囊, PYQC) in treating pelvic inflammation of Qi-stagnation with blood stasis syndrome. Methods: The randomized, single blinded, parallel positive drug controlled method was adopted, with 82 patients assigned into two groups by envelop method. The 42 patients in the treated group received PYQC 3 times a day, 4 capsules each time taken orally; the 40 patients in the control group were given orally Fuyankang tablets (妇炎康片, FYKT) 3 times a day, 6 tablets each time. The therapeutic course for both groups was 2 months, and 2 courses of treatment were given successively to observe the comprehensive effect, changes of symptoms and signs before and after treatment. The effects of PYQC on hemorrheological character in part of the patients and on the pathogenetic chlamydia and mycoplasma were also observed. Results: The total effective rate in the treated group was 83.3 %, which was insignificantly different from that in the control group ( 77.5 %, P ＞ 0.05 ).However, PYQC could significantly lower the hemorrheologic indexes in patients and showed definite influence on the pathogenetic chlamydia and mycoplasma. Conclusion: PYQC has good therapeutic effect in treating chronic pelvic inflammation of Qi-stagnation with blood stasis syndrome, and showed definite effect on chlamydia and mycoplasma.     

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.     

Effect of Chinese Herbs for Activating Blood Circulation,Removing Stasis and Supplementing Qi on the Circulating Endothelial Cells in Patients with Unstable Angina Pectoris

Objective: To observe the effect and clinical significance of circulating endothelial cells (CEC) in the pathogenesis of coronary heart disease with unstable angina pectoris (CHD-UAP), and to explore the protective effect of Chinese herbs for activating blood circulation, removing stasis and supplementing Qi (CH) on CHD-UAP patient's CEC. Methods: Sixty patients with diagnosis of CHD-UAP confirmed and differentiated to be Qi-deficiency and blood stasis by TCM were randomly divided into two groups and treated, on the basis of Western drug-therapy, with Tongxinluo capsule (通心络胶囊, TXL) and Huoxue Tongmai capsule (活血通脉胶囊, HXTM) respectively by way of oral taking three times a day, 3 capsules every time, with 1 month as one therapeutic course. The number of CEC in patients' blood circulation was counted before and after treatment. Besides, the number of CEC in 30 healthy persons was also counted for control. Results: The number of CEC in CHD-UAP patients was significantly higher than that in the he     

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.