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).     

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).     

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)     

Efficacy of Yangyin Yiqi Huoxue Granule (养阴益气活血颗粒) in Treatment of Ischemic Stroke Patients with Qi-Yin Deficiency and Blood Stasis Syndrome: A Randomized,Double-Blind,Multicenter, Phase-2 Clinical Trial*

目的:评价养阴益气活血颗粒(YYHG)治疗缺血性中风气阴两虚、瘀血阻络证的疗效和安全性,并探讨其有效剂量.方法:采用竞争性随机区组法,将288例患者随机分为YYHG高剂量,YYHG低剂量,阳性对照(消栓通颗粒,XSTG)或安慰剂对照组,每组72例,用药干预28天,随访180天.主要疗效指标是综合疗效评估,次要疗效指标是美国国立卫生研究院卒中量表评分(NIHSS),Barthel日常生活活动指数评分(ADL),生活质量指数评分(QLI)和中医证候评分(CMS),所有指标均采用意向性分析.本研究同时评估了YYHG的安全性.结果:2008年6月1日至2009年9月30日共招募288名参与者,其中287名患者接受了干预.四组间基线平衡;YYHG高剂量、低剂量,阳性对照组和安慰剂对照组的综合治愈率分别为63.38%,31.94%,36.11%和6.14%;两组之间有统计学差异(P<0.01),且YYHG高剂量组明显高于其他三组(P<0.01).YYHG高剂量和低剂量组的NIHSS、ADL、QLI和CMS评分的改善明显优于阳性对照组和安慰剂对照组(P<0.05).在改善NIHSS和ADL分级方面,YYHG高剂量组明显优于其他三组(P<0.05),而YYHG低剂量组优于安慰剂对照组(P<0.01).同时,YYHG高剂量组在NIHSS、ADL、CMS评分及改善NIHSS和ADL分级方面组均优于低剂量组(P<0.05).安全性方面,YYHG治疗后仅2例(3.78%)出现轻微不良反应,未见严重不良反应.结论:YYHG治疗缺血性中风气阴两虚、瘀血阻络证安全、有效.     

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.     

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.     

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)     

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.     

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     

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.     

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)     

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.     

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 and Safety of Qiaoshao Formula(翘芍方) on Patients with Lifelong Premature Ejaculation of Gan(Liver) Depression and Shen(Kidney) Deficiency Syndrome:A Randomized Controlled Trial

Objective: To observe the efficacy and safety of Qiaoshao Formula(翘芍方, QSF) on patients with lifelong premature ejaculation(LPE) of Gan(Liver) depression and Shen(Kidney) deficiency syndrome. Methods: A total of 60 LPE patients were randomly divided into treatment(QSF) and control(dapoxetine) groups. The treatment group received QSF twice a day and the control group received dapoxetine 1 to 2 h prior to planned sexual intercourse for 4 weeks. The outcomes included intra-vaginal ejaculation latency time(IELT), premature ejaculation diagnostic tool(PEDT), clinical global impression of change(CGIC), scores of Chinese medicine symptoms(CMSS), sex life satisfaction(SLS) and adverse events(AEs). Results: In the treatment group, the median IELT was 3 min vs. 1.5 min before and after treatment(P0.05). PEDT in the treatment group was reduced to 11.76±1.68 from 15.83±2.30 after treatment(P0.05). Besides, patient's SLS was improved from 1.30±0.05 to 6.30±0.04(P0.05), and spouse's SLS was increased from 1.30±0.08 to 6.10±0.06(P0.05); CMSS was decrease from 14.86±3.02 to 9.62±2.87(P0.05). In addition, no significant AE was observed in both groups. Conclusion: QSF may be effective and safe on LPE patients with Gan depression and Shen deficiency syndrome.     

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:Manypatientswithchronicanginaexperienceanginalepisodesdespitesuccessfulrecanalization,antianginalandantiischemicmedications.EmpiricalobservationssuggestedthatShenzhuGuanxinRecipeGranules(参术冠心方颗粒,SGR),aChineseherbalcompound,exertedpotentialimpactsonincreasedtreadmillexerciseperformanceandanginarelieve.However,therehasbeennosystematicstudytoclarifytheimpactofSGRonexercisetoleranceinpatientswithstableangina.TheSERIES(ShEnzhuguanxinRecipeforImprovingExercisetoleranceinpatientswithStableangina)trialisdesignedtodeterminetheeffectsofSGRonexerciseduration,electrocardiographic(ECG)evidenceofmyocardialischemia,andincidenceofmajoradversecardiacevents(MACE)instableanginalpatients.Methods:Atotalof184eligiblepatientswithstableanginawillberandomlyassignedtoreceiveplaceboorSGR(10g/dayfor12weeks)ina1:1ratio.Theprimaryoutcomewillbethechangefrombaselineintotalexercisetoleranceduration,timetoonsetofanginaandECGischemiaduringexercisetreadmilltestingperformedovera12-weekstudyperiod.ThesecondaryoutcomewillincludeECGmeasures,theoccurrenceandcompositeofMACEandtheSeattleAnginaQuestionnairescore.Moreover,thecoronarymicrocirculationwillbeevaluatedtoexplorethepossibleeffectsinresponsetotreatmentofSGR.Aftertheprocedure,allparticipantswillbefollowedupbyinterviewat3and6months,enquiringaboutanycardiacevents,hospitalizations,cardiacfunctionallevelandmedicationusage.Additionally,theoccurrenceofadverseeventswillbeevaluatedateachfollow-up.Discussion:ThisstudymayprovidenovelevidenceontheefficacyofSGRinimprovingexercisetoleranceandpotentiallyreducingclinicaladverseevents.(TrialregistrationNo.ChiCTR-TRC-14004504)     

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.]     

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...     

Efficacy of Ursodeoxycholic Acid Combined with Tongdan Decoction(通胆汤) on Immunological Indices and Histopathological Changes in Primary Biliary Cirrhosis Patients

<正>Objective:To observe the efficacy of ursodeoxycholic acid(UDCA) combined with Tongdan Decoction(通胆汤) on immunological indices and histopathological changes in patients with primary biliary cirrhosis(PBC) ofⅡorⅢhistological stage.Methods:Sixty PBC patients were assigned randomly and equally to the control group treated with UDCA alone and the treatment group treated with UDCA combined with Tongdan Decoction.The immunological indices and histopathological changes were detected before and after 24-week treatment,and the follow-up lasted for 1-3 years.Results:After 24-week treatment,CD4~+CD28~- in the peripheral blood was lowered and CD4~+CD25~+ was increased in both groups,and better effect was shown in the treatment group(P0.01).The levels of IgM,IgG,and IgA decreased markedly after 96-week treatment in the treatment group(P0.05,P0.01),while in the control group,only the latter two showed significant decrease after 148 week(all P0.05).At the end of the 3-year follow-up,the medians of histopathological inflammation grading and fibrosis staging declined to a lower rank,and the effect on inflammation was superior in the treatment group to the control group shown by non-parameters Wilcoxon paired symbols test(Z = 2.761, P=0.006).Conclusion:Combined therapy of Tongdan Decoction and UDCA showed a better therapeutic effect than UDCA monotherapy on PBC,especially in improving immunological indices and histopathological hepatic changes.