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).     

RANITIDINE IN ACUTE DUODENAL ULCERDOUBLE BLIND CONTROLLED TRIAL

Ranitidine, a selective H2-blocker is assessed inacute duodenal ulcer by randomized double-blindplacebo controlled trial. 55 patients entered thestudy (27 ranitidine, 28 placebo). All had endo-scopically pro.ven duodenal ulcers and underwentfurther endoscopy after 4 and 8 weeks of treatment.The 4 week healing rate for ranitidine was 85(70 campared t0 2570 for placebo (p<0.01), and the 8 weekhealing rates were ranitidine 9070 and placeb0 23T。(p<0.01). Pain relief was obtained after l week in40.Wo of the ranitidine group versus 7.2U/o of theplacebo group. At 4th week, 66.7To of the ranitidinegroup were pain free versus 25To of the placebogroup. No significant adverse events were encountered. Therefore, ranitidine is significantly superiorto placebo in acute duodenal ulcer among Chinesepatients both in terms of healing and relieving pain.     

Effect of Essential Oil on Patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Pilot Randomized Controlled Trial

Objective: To evaluate the efficacy and safety of essential oil treatment for type Ⅲ chronic prostatitis/chronic pelvic pain syndrome(CP/CPPS). Methods: A randomized controlled trial was conducted from December 2014 to October 2015. Seventy type Ⅲ CP/CPPS patients were assigned to the essential oil group(35 cases) or almond placebo oil control group(35 cases) by a random number table. The oil was smeared by self-massage on the suprapubic and sacral region once a day for 4 weeks. The National Institutes of Health Chronic Prostatitis Syndrome Index(NIH-CPSI) and expressed prostatic secretions(EPS) were examined. The primary outcome was NIH-CPSI pain domain. The secondary outcomes included other NIH-CPSI domains and laboratory examinations of EPS. Adverse events were also observed. Results: Sixty-six subjects completed the full 4-week treatment. There was no significant difference between almond oil control and essential oil groups in terms of the total score of NIH-CPSI, pain, quality of life and urination domain scores of NIH-CPSI and EPS examinations(P0.05). In the essential oil group, pain between rectum and testicles(perineum) in the domain of pain or discomfort was significantly reduced at week 2 and week 4 compared with almond oil control group(P0.01). No serious adverse events occurred. Conclusion: The essential oil may reduce the pain or discomfort in the perineum region in patients with CP/CPPS.     

Clinical research on nourishing yin and unblocking meridians recipe combined with opioid analgesics in cancer pain management

Objective： To investigate the analgesic effects of Nourishing yin and Unblocking meridians Receipe （NUR） combined with opioid analgesics in managing cancer pain. Methods： All the patients enrolled were differentiated as of yin deficiency and meridian blocked syndrome type of TCM. Forty-one of them in the treated group were treated with NUR combined with opioid analgesics, while 43 of them in the control group were given opioid analgesics alone with successive 14 days as one treatment course for both groups. Results： The indexes of the treated group were superior to those in the control group as to the degree of pain-relieving, the therapeutic effect of analgesia, the occurrence frequency of cancer pain every day and its duration each time, the analgesic initial time, and the quality of life. Conclusion： NUR combined with opioid analgesics in cancer pain management was more effective than opioid analgesics alone. KEY WORDS     

瑞芬太尼静脉自控式分娩镇痛的临床研究

The study intended to evaluate the efficacy and safety of patient-controlled intravenous analgesia with remifentanil for labor. Three hundred and two parturients at 37 -42 week of gestation received remifentanil (0. 1μg · kg-1 ·min-1 ) as patient-controlled intravenous analgesia for labor (analgesia group) and their clinical results were compared with those of 221 parturients in labor without intravenous analgesia (control group). Maternal monitoring, including pain scores(VAS), delivery mode, side effects, laboring time was performed for both groups. There was a significant decrease (P ＜0. 01) of pain scores in analgesia group compared with those in control group. Parturients in analgesia group experienced a significantly shorter first stage, than those in the control group ( P ＜ 0. 01). There were no differences between two groups in the rate of cesarean section and instrumental delivery. And there were no significant differences for newborns with Apgar scores less than 7 at the point of one minute. Patient-controlled intravenous analgesia with remifentanil for labor is an effective and safe procedure, which can significantly relieve pain, shorten first stage of labor and has no effect on the delivery mode and Apgar scores of neonates.     

瑞芬太尼静脉自控式分娩镇痛的临床研究

The study intended to evaluate the efficacy and safety of patient-controlled intravenous analgesia with remifentanil for labor. Three hundred and two parturients at 37 -42 week of gestation received remifentanil (0. 1μg · kg-1 ·min-1 ) as patient-controlled intravenous analgesia for labor (analgesia group) and their clinical results were compared with those of 221 parturients in labor without intravenous analgesia (control group). Maternal monitoring, including pain scores(VAS), delivery mode, side effects, laboring time was performed for both groups. There was a significant decrease (P ＜0. 01) of pain scores in analgesia group compared with those in control group. Parturients in analgesia group experienced a significantly shorter first stage, than those in the control group ( P ＜ 0. 01). There were no differences between two groups in the rate of cesarean section and instrumental delivery. And there were no significant differences for newborns with Apgar scores less than 7 at the point of one minute. Patient-controlled intravenous analgesia with remifentanil for labor is an effective and safe procedure, which can significantly relieve pain, shorten first stage of labor and has no effect on the delivery mode and Apgar scores of neonates.     

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.     

Clinical observation on treatment of depression by electro-acupuncture combined with Paroxetine

Objective:To observe the clinical efficacy and adverse reactions of Paroxetine combined with electro-acupuncture (EA) in treating depression.Methods:Forty-two patients with depression were randomly assigned to the observation group (22 patients) treated with EA combined with Paroxetine,and the control group (20 patients) treated with Paroxetine alone,and the therapeutic course for both groups was 6 weeks.The therapeutic efficacy and adverse reactions were evaluated with scores by Hamilton depression scale (HAMD) and treatment emergent symptoms scale (TESS), respectively.Results:HAMD scores determined at the end of the 1st,2nd,4th,and 6th week of the treatment course were significantly lower in the observation group than those in the control group (P<0.05).The significant improvement rate evaluated at the end of the 6-week treatment was remarkably higher in the observation group than that in the control group (72.7% vs 40.0%).No significant difference of TESS scores was found between the two groups.Conclusion:EA combined with Paroxetine has better clinical efficacy than that of Paroxetine alone,with milder adverse reaction and quicker initiation of effect.     

Effect of Zhubin (KI9) Acupuncture in Reducing Alcohol Craving in Patients with Alcohol Dependence: A Randomized Placebo-Controlled Trial

Objective:To examine the effect of acupuncture on Zhubin(KI9) in reducing alcohol craving in alcohol-dependent patients.Methods:Twenty male alcohol-dependent patients were randomly assigned to two groups,a treatment group(10 cases,age 43.0 ±6.8 years) and a placebo group(10 cases,age 44.5 ±7.9years).The treatment group was treated with real needle acupuncture on Zhubin(KI9) twice a week for 4 weeks,and the control group was treated with placebo needle acupuncture.Both groups were given acupuncture treatment using Park Sham Device(PSD).Alcohol craving was measured by the Visual Analogue Scale(VAS)before treatment to establish a baseline,and after 1,2,and 4 weeks of treatment.Repeated measures ANOVA was used to determine the main and interaction effects of time and on the outcome measure(VAS).Results:There was a significant effect of time on VAS score(df=3,F=13.3,P0.01).Main effect of group on VAS score was significant(df=1,F=10.9,P0.01) and the time x group interaction was also significant(df=3,F=4.7,P0.01).Conclusions:Real-needle acupuncture therapy on Zhubin(KI9) showed effectiveness in reducing alcohol craving.These results strongly suggest the usefulness of acupuncture therapy on Zhubin(KI9) in preventing a relapse in alcohol dependent patients.     

No Additional Cholesterol-Lowering Effect Observed in the Combined Treatment of Red Yeast Rice and Lactobacillus Casei in Hyperlipidemic Patients:A Double-Blind Randomized Controlled Clinical Trial

Objective:To observe the effect of combining red yeast rice and Lactobacillus casei(L.casei)in lowering cholesterol in patients with primary hyperlipidemia,the later has also been shown to remove cholesterol in in vitro studies.Methods:A double-blind clinical trial was conducted to evaluate the cholesterol-lowering effect of the combination of red yeast rice and L.casei.Sixty patients with primary hyperlipidemia were recruited and randomized equal y to either the treatment group(red yeast rice+L.casei)or the control group(red yeast rice+placebo).One red yeast rice capsule and two L.casei capsules were taken twice a day.The treatment lasted for 8 weeks,with an extended follow-up period of 4 weeks.The primary endpoint was a difference of serum low-density lipoprotein cholesterol(LDL-C)level at week 8.Results:At week 8,the LDL-C serum level in both groups was lower than that at baseline,with a decrease of 33.85±26.66 mg/dL in the treatment group and 38.11±30.90 mg/dL in the control group;however,there was no statistical difference between the two groups(P0.05).The total cholesterol was also lower than the baseline in both groups,yet without a statistical difference between the two groups.The only statistical y significant difference between the two groups was the average diastolic pressure at week 12,which dropped by 2.67 mm Hg in the treatment group and increased by 4.43 mm Hg in the placebo group(P0.05).The antihypertensive activity may be associated with L.casei.Red yeast rice can significantly reduce LDL-C,total cholesterol and triglyceride.Conclusion:The combination of red yeast rice and L.casei did not have an additional effect on lipid profiles.     

Effect of stimulating acupoint Guanyuan(CV 4) on lower back pain by burning moxa heat for different time lengths: a randomized controlled clinical trial

OBJECTIVE: To investigate the effect of different heat-stimulating time lengths on lower back pain.METHODS: Forty participants were randomly assigned to four groups of various heating time lengths. The short heating time length group(SL),moderate heating time length group(ML), and long heating time length group(LL) respectively received 15, 30, and 60 min of moxibustion therapy stimulating the acupoint Guanyuan(CV 4). The conventional acupuncture group(CA) received needle acupuncture treatment as a control group. The participants were treated continuously over a 2-week treatment period for a total of 10 sessions, with five sessions given per week. Participants were assessed weekly by blinded assessors, using the visual analogue scale(VAS) and Roland Morris Questionnaire(RMQ).RESULTS: The VAS and RMQ scores reduced in all four groups during treatment. There were significant differences in VAS scores(P < 0.01) and RMQ scores(P < 0.01) between before treatment and after 2 weeks of treatment in the LL group. After treatment, the LL group reported significantly lower VAS scores compared with the CA group, ML group,and SL group(P < 0.05).CONCLUSION: The long and moderate lengths of heat-stimulating time of 30 and 60 min may be more effective for relieving lower back pain than that of short stimulating time lengths.     

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

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

Effect and Safety of Huannao Yicong Formula(还脑益聪方) in Patients with Mild-to-Moderate Alzheimer's Disease: A Randomized,Double-Blinded,Donepezil-Controlled Trial

Objective: To assess the effect and safety of Huannao Yicong Formula(还脑益聪方, HYF) in the treatment of patients with mild-to-moderate Alzheimer's disease(AD). Methods: Sixty patients with mild-tomoderate AD were evenly randomized into HYF group and donepezil group with the random number method. Patients in the HYF group took 5 g of HYF granules twice daily and 5 mg placebo of donepezil once daily. Patients in the donepezil group took 5 mg donepezil once daily and 5 g placebo of HYF granules twice daily. The intervention lasted for 6 months. Clinical researchers, participants and statisticians were blinded to the treatment assignment throughout the study. The primary outcomes were scores of Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-Cog) and Chinese Medicine Symptom Scale(CM-SS). The secondary outcomes were scores of Montreal Cognitive Assessment(MoCA) test and Mini-Mental State Exam(MMSE). The serum levels of acetylcholinesterase(AchE) and amyloid-β protein 42(Aβ42) were detected with enzymelinked immunosorbent assay kits. The scale assessments were conducted at baseline, the 3 rd and 6 th months of treatment, respectively. Biochemistry tests were conducted at baseline and the 6 th month of treatment. Results: A total of 52 patients completed the trial, 28 in HYF group and 24 in donepezil group. Compared with the baseline, HYF and donepezil significantly decreased the total scores of ADAS-Cog and CM-SS, and significantly increased the scores of MoCA and MMSE after 6-month treatment(all P0.01). Both treatments remarkably reduced the serum levels of AchE and Aβ42(both P0.05). The CM-SS total effective rate of HYF was significantly higher than donepezil [75.00%(21/28) vs. 54.17%(13/24), P0.05]. No severe adverse events were observed in both groups. Conclusion: HYF is effective and safe for improving the cognitive function in mildto-moderate AD patients. [Trial registration: Chinese Clinical Trial Registry(Reg No. ChiCTR-IOR-17011746)]     

REASSESSMENT OF DEFIBRASE IN TREATMENT OF ACUTE CEREBRAL INFARCTION： A MULTICENTER, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED TRIAL

Objoctive To evaluate the efficacy and safety of defibrase in patients with acute cerebral infarction by a large sample, multicenter, randomized, double-blind, placebo-controlled clinical trial. Mothods Patients with acute cerebral infarction within 12 hours of stroke onset were randomly assigned to receive either an initial intravenous infusion of defibrase 15 U plus normal saline 250 mL or 250 mL of normal saline only. Subsequent infusions of defibrase 5 U or placebo （normal saline） were given on the 3rd, 5th, 7th, and 9th day, respectively. Both groups received standard care of acute cerebral infarction. The primary efficacy outcome was functional status （Barthel Index） at 3 months after treatment. Safety outcome were bleeding events and mortality rate. Secondary outcome included Chinese Stroke Scale （CSS） score at 14 days and recurrence rate of stroke at 1 year. A total of 1053 patients were enrolled at 46 centers from September 2001 to July 2003, and 527 patients were randomly assigned to receive defibrase and 526 to receive placebo. A similar proportion of patients in both groups completed a full course of treatment. There was a significantly greater proportion of favorable functional status （Barthel Index 1≥95） in defibrase group than in placebo group at 3 months （52.2% vs. 42.8%, P 〈 0.01）, and the proportion of dependent functional status （Barthel Index ≤60） was a little lower in defibrase group compared with placebo group （27.7% vs. 32.4%）. These differences were more obvious among patients who were treated within 6 hours of stroke onset. Patients in defibrase group had better improvement with respect to CSS score than those in placebo group at 14 days （P 〈 0.05）. Recurrence rate of stroke at 1 year was lower in the defibrase group compared with placebo group （6.2% vs. 10.1%, P = 0.053）. Patients in defibrase group had higher risk of extracranial bleeding events （4.7% vs. 1.5%, P 〈 0.01 ） and a tendency of higher risk of symptomatic intracranial hemorrhage. The hemorrhage incidence was higher in patients with fibrinogen level 〈 130 mg/dL than ≥ 130 mg/dL （10.6% vs. 3.8%, P 〈 0.05）. Mortality rate at 3 months were slightly higher in defibrase group than placebo group （5.9% vs. 4.2%）. Conclusions The defibrase is effective to improve neurological function and function of daily living for patients with acute cerebral infarction within 12 hours of symptom onset. The efficacy was even better for acute cerebral infarction within 6 hours of onset. The increased risks of intra- and extracranial hemorrhage during defibrase administration were related to the plasma fibrinogen level.     

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 Bushen Huoxue Decoction on Nitric Oxide （NO） in Serum, Articular Cartilage and Synovium in Rabbits of Knee Osteoarthritis

Forty-eight New Zealand rabbits were divided into normal group(n=18),control group(n=18)andChinese herbs treatment group(n=12)randomly.The rabbits in the normal group receivedsham-operation,and the OA model was established by Hulth's method.All the rabbits in the treatmentgroup were given Bushen Huoxue Decoction(补肾活血汤)from the 6th week after the operation.At 6th,8th and 12th week after the operation,the NO concentrations of the serum,joint cartilage and synoviumwere examined.Results:Indicated that the NO concentrations of the serum,joint cartilage and synoviumin the control group were all significantly higher than those in the normal group,with the joint cartilagemore obvious(P<0.05).In the Chinese herbs treatment group the NO concentrations in all the partsobviously decreased as compared with the control group(P<0.05).It is suggested that Bushen HuoxueDecoction decrease the levels of NO in the serum,synovium and joint cartilage in the OA rabbit.     

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.]     

Effect of Qingfei Mixture (清肺合剂) on Pediatric Mycoplasma Pneumoniae Pneumonia with Phlegm Heat Obstructing Fei (Lung) Syndrome

Objective: To explore the effect and mechanism of Qingfei Mixture(清肺合剂), a Chinese medicine, in treating mycoplasma pneumonia(MP) in MP patients and rat model. Methods: A total of 46 MP children with phlegm heat obstructing Fei(Lung) syndrome were randomly assigned to two groups by the method of random number table, with 23 children in each group. The control group was treated with intravenous infusion of azithromycin; the treatment group received intravenous infusion of azithromycin and oral administration of Qingfei Mixture. The treatment course was 7 days. Major symptoms and minor symptoms were observed and scored before and after treatments. A rat model of MP was also established. A total of 120 wistar rats were randomly divided into 5 groups: a normal group, infection group, Qingfei Mixture treatment group, azithromycin treatment group, and Qingfei Mixture + azithromycin treatment group. Each group contained 24 rats, from which every 6 were euthanatized 1, 3, 7 and 14 days after infection. MP DNA in pulmonary tissue homogenates was detected using real-time fluorescence quantitative polymerase chain reaction. Pathology was assessed after hematoxylin(HE) staining and lung tissue pathology scores were determined in pulmonary tissue. Transmission electron microscopic detection and electronic image analysis were performed on lung tissue 3 days after infection. Interleukin(IL)-17 was detected in serum using enzymelinked immunosorbent assay(ELISA) 7 days after infection. Results: In the clinical study, both control and the treatment group showed improved results on removing symptoms of phlegm heat syndrome compared to the control group(P0.05). In animal experiments, On the 7th day after MP infection, as detected by electron microscopy, the pulmonary capillary basement membranes of the azithromycin + Qingfei Mixture treatment group were much thinner than those of the azithromycin or Qingfei mixture treatment groups(P0.05). The level of serum IL-17 in the azithromycin + Qingfei Mixture treatment group was lower than that in the azithromycin or Qingfei Mixture groups(P0.01). Conclusion: Both Qingfei Mixture and azithromycin have therapeutic effects on mycoplasma pneumoniae pneumonia, but the combination of both agents had the greatest effect.     

A randomized double-blinded sham-controlled trial of α electroencephalogram-guided transcranial magnetic stimulation for obsessive-compulsive disorder

Background Obsessive-compulsive disorder （OCD） is a highly prevalent and devastating psychiatric condition.Repetitive transcranial magnetic stimulation （rTMS） is a potential and non-invasive treatment for OCD.Diverse efficacies of rTMS have been reported in different locations or frequencies of the stimulation.The main objective of this study was to assess the treatment effect for OCD with alpha electroencephalogram （αEEG）-guided TMS over dorsal Iateral prefrontal cortex bilaterally.Methods There were 25 OCD patients in the αTMS treatment group and 21 OCD patients in the sham control group.Each subject received 10 daily treatment sessions （5 days a week）.The αTMS group had significant reduction in scores of Yale-Brown Obsessive Compulsive Scale and Hamilton Rating Scale for Anxiety （HAMA） compared with the control group at the end of 2-week treatment and 1-week follow-up.Analysis of variance with repeated measures was used to test the effects between the two groups.Results Significant difference in scores of obsession and HAMA were found between the two groups after treatment.No significant difference in scores of Hamilton Rating Scale for Depression was found between the two groups after the treatment,but statistical significance was shown at the end of 1-week follow-up.Conclusions αEEG-guided TMS may be an effective treatment for OCD and related anxiety.Delayed response to αTMS in depression suggests that it might be secondary to the improvement of primary response in OCD and anxiety.     

Effects of Acupressure and Ibuprofen on the Severity of Primary Dysmenorrhea

The present study aims at comparing the effects of acupressure using new combination of acupoints,and Ibuprofen on the severity of primary dysmenorrhea(PD).216 female high school students,agedbetween 14 to 18 years,were randomly selected and divided into three groups.Each group underwentdifferent treatment techniques:acupressure,Ibuprofen and sham acupressure as a placebo.Theresults indicated that the three therapeutic techniques were significantly effective in reducing the pain.However the therapeutic efficacies of acupressure and Ibuprofen were similar with no significantdifference,and were significantly better than the placebo.Thus acupressure,with no complications,isrecommended as an alternative and also a better choice in the decrease of the severity of PD.