Clinical Experience in Treatment of Alzheimer's Disease with Jiannao Yizhi Formula (健脑益智方) and Routine Western Medicine

Objective: To investigate the long-term therapeutic effects of the Chinese medicine Jiannao Yizhi Formula(健脑益智方, JYF) in the treatment of Alzheimer's disease(AD). Methods: Sixty mild-to-moderate AD participants were recruited and randomly allocated to the treatment(30 with JYF) and the control groups(30 with donepezil) for 6 months with the random numbers. The primary outcomes were scores of Alzheimer's Disease Rating Scale-Cognitive(ADAS-Cog) and Chinese Medicine Symptom Scale(CM-SS). The secondary outcomes were scores of Mini Mental State Examination(MMSE), Montreal Cognitive Assessment(MoCA), and Activities of Daily Living(ADL). Safety assessments were conducted at baseline and the 6 th month of treatment. Serum levels of acetylcholine(Ach), amyloid-β protein 42(Aβ_(42)), and the microtubule-associated protein tau(Tau) were also determined by enzyme-liked immunosorbent assay. Results: Fifty-one participants were included in the final analyses(JYF n=27; donepezil n=24). Compared with baseline, both JYF and donepezil increased the MoCA and MMSE scores and decreased the ADAS-Cog and CM-SS scores(P0.05 or P0.01). Both drugs increased the serum levels of Ach and decreased the serum levels of Aβ_(42) and Tau(all P0.05). There was no significant difference in these variables between the two groups, which showed that JYF was not inferior to donepezil. No obviously significant changes were observed in the ADL. No severe adverse events were observed in both groups. Conclusion: The effect and safety of JYF for the treatment of AD were not inferior to those of donepezil.     

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).     

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

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

Efficacy of Chinese Medicine Acupoint Application Combined with Montelukast on Children with Perennial Allergic Rhinitis: A Randomized Controlled Trial

Objective: To evaluate the efficacy of Chinese medicine acupoint application(CMAA) combined with Western medicine for perennial allergic rhinitis(PAR) in children. Methods: In this prospective, parallel, randomized, placebo-controlled and single-blind trial from August to September, 2017, 180 children with PAR were randomly assigned to an integrative group(CMAA and Montelukast), CMAA group(CMAA and placebo tablet), or Montelukast group(placebo CMAA and Montelukast). Participants were applied with CMAA for 6 sessions over 2 weeks, and/or Montelukast Chewable Tablet orally once daily for 12 weeks. The changes in severity of symptoms were measured by Visual Analog Scale(VAS) and rhinitis control assessment test(RCAT) at 0, 2, 4 and 12 weeks of treatment. Blood samples were collected for serum interleukin-4, interferon gamma γ and T helper type 1(Th1)/Th2 flow cytometric analysis at the time points of 0, 4 and 12 weeks. Results: Eight cases dropped out from the trial, 3 in the integrative group, 2 in the CMAA group and 3 in the Montelukast group. The VAS scores decreased significantly while the RCAT scores increased significantly in all three groups at 4 and 12 weeks compared with baseline(P0.01 or P0.05). The VAS scores were significantly lower while the RCAT scores were significantly higher in the integrative and CMAA groups than the Montelukast group at 2 and 4 weeks(P0.01 or P0.05). At 2, 4 and 12 weeks, the scores of nasal congestion, sneezing, sleep problem, and rhinitis symptom control in the integrative and CMAA groups increased significantly compared with baseline(P0.01 or P0.05). The least percentages of Th2 and the most alleviated Th2 shift(highest Th1/Th2) were observed in the integrative group at 12 weeks compared with the other two groups(P0.05). Conclusion: The combination of CMAA with Montelukast might be more effective and appropriate than either option alone for children with PAR.(Registered at Chinese Clinical Trial Register, registration No. Chi CTR-IOR-17012434)     

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)     

维持性血液透析述情障碍患者医学应对方式和生活质量的研究

Objective To discuss alexithymia in patients with maintenance hemodialysis and its impact on medical coping style and the ability of daily living. Methods The patients with end-stage renal disease treated by the maintenance hemodialysis (MHD) were divided into 2 groups, namely, alexithymia group (total score>60) and non-alexithymia group (total score <50) ,according to the Toronto Alexithymia Scale (TAS-20). The Medical response to the questionnaire (MCMQ) and the activities of daily living scale (ADL) were used to evaluate the patients. Results The TAS-20 score was (72.31±12.28) in 67 cases of patients with MHD. Among these, 31 cases for TAS-20 total score>60 points ,with an average score (82.37±15.84) and 26 cases for TAS-20 total score <50 points, with an average score (50.17±10.24). There was significant difference (t=8.90, P<0.01). The face factor score of MCMQ was significantly lower in alexithymia groups than that in non-alexithymia group,while the avoidance and subordination factor score was significantly higher than that in non-alexithymia group(P<0.01 or 0.05). The ADL scores and factor scores of the alexithymia group were significantly higher than that of non-alexithymia group,and there was a significant difference (t=3.53, P<0.01). Correlation analysis showed that TAS-20 score and the face factor score of MCMQ was significantly negatively correlated with MCMQ e-vasive and subordination factor,and factor scores and ADL score was significantly positively correlated (P<0.01 or 0.05). Conclusion MHD patients in the alexithymia group tend to use and yield response to avoid negative cop-ing style and less use of active coping style. The quality of life and activities of daily living of MHD patients in alex-ithymia group are worse than that of the non-alexithymia group.     

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.     

Tiaobu Xinshen Recipe (调补心肾方) Improved Mild Cognitive Impairment of Alzheimer's Disease Patients with Xin (Heart) and Shen (Kidney) Deficiency

Objective: To observe the intervention effects of Tiaobu Xinshen Recipe(调补心肾方, TXR) on patients with mild cognitive impairment caused by Alzheimer's disease(MCI-AD). Methods: Totally 88 MCI-AD patients with syndrome of Xin(Heart) and Shen(Kidney) deficiency were assigned to the experimental group(47 cases, treated with TXR) and the control group(41 cases, treated with donepezil hydrochloride) using a random number table. Final recruited qualified patients were 44 cases in the experimental group and 39 cases in the control group. The therapeutic course was 12 weeks. Neuropsychological scales [mini mental state examination(MMSE) and Montreal cognitive assessment(MoCA)], and Chinese medicine(CM) dementia syndromes scales were performed in all patients, and results were compared between groups or intra-group before and after treatment. Results: MMSE and Mo CA scores of the two groups were increased after treatment compared with those before treatment(P0.05). But there was no statistical difference in MMSE or MOCA scores after treatment between the two groups(P0.05). CM dementia syndrome score was significantly decreased after treatment in the experimental group compared with the control group(P0.01). Visual spatial and executive function scores and delayed recall scores of the two groups were increased compared with those before treatment(P0.01). Conclusion: TXR could effectively improve cognitive impairment of MCI-AD patients with syndrome of Xin and Shen deficiency.     

Psychological Distress,Social Support and Medication Adherence in Patients with Ischemic Stroke in the Mainland of China

Stroke research and rehabilitation have traditionally focused on the physical and functional impact of a stroke. Less attention has been given to the psychosocial factors associated with this chronic condition. By the few studies that have specifically focused on psychosocial factors in the context of stroke, poststroke depression is demonstrated to significantly influence stroke outcomes. Associations of stroke with psychological symptoms other than depression have rarely been evaluated. This study was aimed to investigate the changes of psychological stress, social support and medication adherence in patients with ischemic stroke in the mainland of China. In this study, 90 patients with hemiplegia one year after first-ever middle cerebral artery infarction(stroke group) in the Zhongnan Hospital of Wuhan University from June 2008 to June 2011 were recruited for interview. Ninety age- and sex-matched normal volunteers(control group) were also examined at the same period. The psychological distress was assessed by the Symptom Checklist 90(SCL-90), the social support by the Social Support Rating Scale(SSRS), and medication adherence by Morisky’s self-reported inventory, respectively. Group differences were analyzed using unpaired-t test and chi-squared test. The results showed that total mean scores of the SCL-90 in the stroke group were higher than those in the control group(P<0.01). Except two dimensions, paranoid ideation and psychoticism, mean scores of the rest dimensions(including somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, hostility, and phobic anxiety) of SCL-90 were significantly higher in the stroke group than those in the control group(P<0.05, or P<0.01). The objective support, subjective support, support availability and total social support scores in the stroke group were significantly higher than those in the control group(P<0.05, or P<0.01). Those in the “SCL-90 total scores >150 group” were significantly higher than in the “SCL-90 total scores <100 group” and the “SCL-90 total scores between 100 to 150 group”(P<0.05, or P<0.01). Those in the “SCL-90 total scores between 100 to 150 group” were significantly higher than in the “SCL-90 total scores <100 group”(P<0.05). In 90 patients with ischemic stroke, 26(28.89%) patients obtained high medication adherence, 47(52.22%) patients medium medication adherence, and 17(18.89%) patients low medication adherence, respectively. Among these stroke patients, there were 17(50.00%) patients with high medication adherence in the “SCL-90 total scores >150 group”, 28(75.67%) patients with medium medication adherence in the “SCL-90 total scores between 100 to 150 group”, and 12(61.16%) patients with low medication adherence in the “SCL-90 total scores <100 group”, respectively. There was significant difference in the medication adherence rate among the different SCL-90 scores groups in these stroke patients(P<0.05 or P<0.01). It was led to conclude that ischemic stroke patients one year after hemiplegia have psychological distress, low level of social support and poor medication adherence in the mainland of China. Therefore, it is necessary to mobilize the government, medical institutions and various social support groups to offer psychological interventions to relieve the stress of patients with ischemic stroke, and improve their medication adherence.     

Chinese Medicine Improves Postoperative Quality of Life in Endometriosis Patients: A Randomized Controlled Trial

Objective:To investigate the effect of Chinese medicine(CM) and Western medicine(WM) on quality of life(QOL) after conservative surgery for endometriosis.Methods:A total of 320 patients with endometriosis were randomized into two groups by using random block design,CM group(160 cases,activating blood circulation and removing blood stasis treatment based on syndrome differentiation) and WM group(160 cases,gonadotropin-releasing hormone agonist or gestrinone treatment) after conservative surgery.Treatment was given for 3-6 months(according to the revised American Fertility Society scoring system stage),and the World Health Organization QOL-BREF(WHOQOL-BREF) was applied to patients before and after treatment to assess QOL.Results:There were 136 cases in the CM group and 141 cases in the WM group completing therapy.In the CM group,the use of the WHOQOL-BREF showed that the physical,psychological and environmental scores post- treatment were significantly higher than those at pre-treatment(P<0.05),and for 12 items(pain and discomfort, energy and fatigue,sleep and rest,mobility,activities of daily living,work capacity,negative feelings,health and social care:accessibility and quality,participation in and opportunities for recreation/leisure activities,appetite, QOL score,overall health status and QOL),the difference in scores was significant(P<0.05).In the WM group,4 items(pain and discomfort,opportunities for acquiring new information and skills,QOL score,overall health status and QOL) had significantly different scores post-treatment compared with those at pre-treatment(P<0.05).Before treatment,the QOL in the two groups of patients showed no significant difference(P>0.05).After treatment,the scores for physical health in the CM group were significantly higher than those of the WM group(P<0.05) and the scores of 4 items(mobility,activities of daily living,sexual activity,QOL score) in the CM group were significantly higher than those in the WM group(P<0.05).Conclusions:CM and WM treatment could improve the QOL of patients with endometriosis after conservative surgery.CM treatment is more effective than WM.     

Clinical curative effect of electroacupuncture combined with Zhizhukuanzhong Capsules for treating gastroesophageal reflux disease

OBJECTIVE:To study the clinical curative effect,safety and mechanism of action of electroacupuncture combined with Zhizhukuanzhong capsules(ZZKZC) in treating gastroesophageal reflux disease(GERD).METHODS:A total of 480 patients with confirmed GERD were randomly divided into four groups:the electroacupuncture group,the ZZKZC group,the combined therapy group,and the control group,with 120 cases in each group.Each case in the electroacupuncture group was treated with electroacupuncture on Zusanli(ST36),Zhongwan(CV12),Neiguan(PC6),Taichong(LR3)and Gongsun(SP 4)once daily for 6 weeks.Each case in the ZZKZC group was treated with oral administration of 1.29 g ZZKZC three times daily.The combined therapy group had electroacupuncture and ZZKZC.The control group was given oral administration of 5 mg mosapride three times and 20 mg pantoprazole twice daily.The 24-hour intraesophageal total number of reflux episodes with pH <4(or bilirubin absorbance ≥ 0.14),the number of long-term(≥5 min) reflux episodes,the percentage of upright time,the percentage of supine time,the percentage of total time of pH <4(or bilirubin absorbance ≥0.14),endoscopic grading score,symptom score,quality of life score,and adverse reactions were observed before treatment,at the end of treatment and 54 weeks after treatment in the four groups.RESULTS:The 24-hour intraesophageal pH and bile reflux,endoscopic grading score and symptom score were all significantly decreased at the end of treatment in every group,while the scores of 8 dimensions of quality of life were all increased compared with those before treatment(P<0.01).All of these indices were better in the combined therapy group than those in the other groups(P<0.05).These indices did not significantly deteriorate in the combined therapy group and electroacupuncture group 54 weeks after treatment compared with the end of treatment(P>0.05);however,these indices all significantly deteriorated in the ZZKZC and control groups(P>0.05).The short and long-term total efficacy rates in the combined therapy group showed significant superiority to those in the other groups(P<0.05 or P<0.01).No serious adverse reactions were found in the four groups.CONCLUSION:Electroacupuncture and ZZKZC play an important role in inhibiting intraesophageal acid and bile reflux,decreasing the endoscopic grading score,and alleviating the symptoms of gastroesophageal reflux to improve the quality of life.However,the effect of combined treatment is more effective,with better security and long-term efficacy,and therefore,this combination treatment is appropriate for clinicaluse.     

Effect of Longbishu Capsule (癃闭舒胶囊) plus Doxazosin on Benign Prostatic Hyperplasia: A Randomized Controlled Trial

Objective:To investigate the effect of Longbishu Capsule(癃闭舒胶囊,LBS),doxazosin,and combination therapy on benign prostatic hyperplasia(BPH).Methods:A randomized,double-blind,multi-center parallel trial was conducted involving 360 patients in hospitals in Beijing(108 cases),Heilongjiang(90 cases),Sichuan(90 cases),Shanghai(72 cases),China.They were randomly assigned with central randomization method to group A(LBS placebo plus doxazosin),group B(LBS plus doxazosin)or group C(LBS plus doxazosin placebo),120 cases for each group.The international prostate symptom score,maximum urinary flow rate,postvoid residual urine volume and prostate volume were measured for evaluating the efficacy of the three treatments.Results:At baseline,there was no significant difference in the measured variables among the three groups.After 12-month treatment,the three groups showed significant improvements in IPSS and maximum urinary flow rate from baseline(P0.01).Although postvoid residual urine volume was not significantly different from the baseline in group A(P0.05),it significantly decreased in group B and C(P0.05).The incidence of adverse events were similar among the three groups.Conclusions:The treatment of LBS alone or LBS plus doxazosin was able to significantly improve IPSS in patients with BPH.The treatments may reduce the increase in prostate volume and postvoid residual urine volume as well.     

The effects of Chinese Yam-Epimedium mixture on respiratory function and quality of life in patients with chronic obstructive pulmonary disease

OBJECTIVE:To examine the clinical effects of a mixture of Chinese Yam and Epimedium in patients with stable moderate or severe chronic obstructive pulmonary disease(COPD).METHODS:Forty-nine patients with COPD were randomly allocated to a group whose usual treatment was supplemented with oral Chinese Yam-Epimedium mixture,or a control group given placebo.For each patient,body mass index,airflow obstruction,dyspnea,and exercise capacity were measured and converted into the BODE index before treatment and at one and three months after initiation of treatment.Participants also completed the St George’s Respiratory Questionnaire(SGRQ) at the same intervals.RESULTS:After one month,improvements were seen in the BODE index and SGRQ of participants taking Chinese Yam-Epimedium mixture compared to controls.There were statistically significant differences in the SGRQ:three of its components and the total SGRQ scores were significantly decreased(P<0.05),respiratory symptom scores had improved(P<0.01),and the dyspnea component of the BODE index had significantly decreased(P<0.05).Similar improvements were observed after three months of treatment,but exercise tolerance had also improved:the six-minute walking distance had significantly increased(P<0.05) in the treatment group when compared with controls.CONCLUSION:Chinese Yam-Epimedium mixture can significantly improve dyspnea,exercise capacity,and the quality of life of patients with stable moderate or severe COPD.     

A Multi-center,Randomized,Controlled and Open Clinical Trial of Heyan Kuntai Capsule (和颜坤泰胶囊) and Hormone Therapy in Perimenopausal Women

Objective: To evaluate the efficacy and safety of Heyan Kuntai Capsule(和颜坤泰胶囊, HYKT) and hormone therapy(HT) on perimenopausal syndromes(PMSs). Methods: From 2005 to 2008, 390 women with PMSs were recruited from 4 clinic centers. The inclusion criteria included ages 40 to 60 years, estradiol(E2) below 30 ng/L, and follicle stimulating hormone(FSH) above 40 IU/L, etc. The patients were randomly assigned to HYKT group or HT group by random number table method, administrated HYKT or conjugated estrogen with/without medroxyprogesterone acetate tablets for 12 months. During treatment, the patients were interviewed quarterly, Kupperman Menopausal Index(KMI) scores, hot flush scores, insomnia scores, Menopause-Specific Quality of Life(MENQOL) scores and adverse effects were used for evaluating drug efficacy and safety respectively. The last interview was made at the end of 12-month treatment. Results: After treatment, KMI scores of HYKT group and HT group were both significantly decreased compared with baseline(P0.01) and there was no significant difference between groups(P0.05), except that KMI of HYKT group was higher after 3-month treatment(P0.05). After treatment, hot flush and insomnia scores were both improved significantly in two groups(P0.01); and HT had a better performance than HYKT in improving hot flush(P0.05). MENQOL were significantly improved in both groups after treatment(P0.01); but there was no significant difference between two groups(P0.05). The incidence of adverse event in the HYKT group was much lower than that in the HT group(P0.01). Conclusions: HYKT could effectively relieve PMSs and improve patient quality of life without severe adverse reactions. Although HYKT exerted curative effects more slowly than hormone, it possessed better safety profile than hormone.     

Evaluation of the efficacy and safety of tiotropium bromide (5 ug) inhaled via Respimat in Chinese patients with chronic obstructive pulmonary disease

Background A pharmacokinetic study in an Asian population showed that tiotropium 5 μg via Respimat leads to the same plasma levels compared to 18 μg via HandiHaler.The objective of the trial was to compare the efficacy and safety of longterm treatment （1 year） with tiotropium bromide （5 μg） via Respimat（R） with placebo in patients with chronic obstructive pulmonary disease （COPD）.Methods A total of 3991 patients were randomized in this double-blind,placebo controlled,parallel group study,while in China 338 patients （309 males,29 females） received either tiotropium bromide （n=167） or placebo （n=171）.Tiotropium bromide solution or matching placebo was delivered via Respimat（R） at a dosage of 5 μg （2 x 2.5 μg/puff） once daily for 48 weeks.Co-primary endpoints were trough forced expiratory volume in one second （FEV1） and the time to first exacerbation.Results Statistically significant improvements in trough FEV1 and trough forced vital capacity （FVC） in the tiotropium group were achieved at weeks 4,24,and 48 compared with those in the placebo group.A statistically significant difference （P=0.0027） in favour of tiotropium was also observed for the time to first exacerbation.The total numbers of exacerbations during treatment were 90 and 128 in the tiotropium and placebo groups,respectively,with a rate ratio of 0.69 （P=0.0164）.The difference between the treatment groups in the adjusted mean changes from baseline of St.George Respiratory Questionnaire （SGRQ） total score was-3.9 （95% Cl：-7.5,-0.2） and was of statistical significance （P=0.0367）.The incidences of serious adverse events （SAEs） in the tiotropium and placebo groups were 16.2% and 17.0%,respectively.Seven deaths occurred whilst patients were on treatment,four in the tiotropium group and three in the placebo group,all of which were assessed as non-related study drugs by the investigators.Conclusions Tiotropium significantly improved lung function and quality of life,delayed the time to first exacerbation,reduced the number of exacerbations.Overall,tiotropium was well tolerated.     

Phonopheresis Associated with Nanoparticle Gel from Phyllanthus amarus Relieves Pain by Reducing Oxidative Stress and Proinflammatory Markers in Adults with Knee Osteoarthritis

Objective: To determine the changes in serum levels of inflammatory biomarkers and antioxidant levels among the knee osteoarthritis(OA) patients after treatment with Phyllanthus amarus(PP) by nanoparticle gel phonophoresis. Methods: This study was a randomized, double-blind, placebo-control, parallel-group, clinical trial involving 30 subjects with mild-to-moderate degree of knee OA. The patients were allocated to two groups using a computer-generated random numbers, and received conventional ultrasound therapy(control group, 15 cases) and PP(treatment group, 15 cases) once daily for 10 sessions. The pain was evaluated by visual analogue scale(VAS). Serum levels of tumor necrosis factor-α(TNF-α) were determined by enzyme-linked immunosorbnent assay(ELISA). Nitric oxide(NO) was determined by modified Griess reagent. The antioxidant effects, including superoxide dismutase(SOD) and total antioxidant capacity(TAC), were also measured by ELISA assay. Results: The VAS score was significantly decreased in the treatment group compared with the control group after treatment(P0.01). The serum concentrations of TNF-α and NO were significantly reduced in the treatment group compared with the control group(P0.01) after treatment. However, the serum concentrations of SOD and TAC in the treatment group were significantly higher after treatment compared with the control group(P0.01). Conclusion: PP could alleviate knee pain and significantly reduce systemic antiinflammatory effects in knee OA patients.     

Jian Nao Ning for Treatment of Memory Impairment in Patients with Mild or Moderate Multi-infarct Dementia

Forty patients with multi-infarct dementia(MID) were randomly assigned to the treatment group(25cases)treated with Jian Nao Ning(健脑宁 JNN)and the duxii control group(15 cases).Memoryfunction were assessed at baseline and endpoint using memory subscales of a battery of NewPsychometric Tests(Chinese version)including mini-mental state examination (MMSE),verbalmemory,and non-verbal memory,etc.After treatment,the mean scores of verbal memory in theHopkins Verbal Learning Test(P<0.05)and total memory scores of memory items(P<0.001)in JNNgroup increased significantly;and improvement in episodic memory function including story recall(immediate and delayed),delayed word recall,verbal learning and verbal recognition and visualrecognition in the JNN group was better than that in the duxil control group,suggesting that JNN canobviously improve memory function for the patients with mild or moderate multi-infarct dementia.     

Relationship of anxiety state with lymphocyte subsets and the effect of chinese medical treatment on anxiety in patients with chronic hepatitis B

Objective:To analyze the relationship of anxiety state with CD4~+ level and CD4~+/CD8~+ ratio and to observe the effect of Chinese medicine(CM) treatment on anxiety in chronic hepatitis B(CHB) patients. Methods:The anxiety state of 120 CHB patients was evaluated based on Hamilton Anxiety Scale(HAMA) scoring.According to the scores,63 patients with scores≥14 were classified to anxiety and 57 patients with scores<14 to non-anxiety.The differences in CD4~+ cells and CD4~+/CD8~+ ratio between patients with anxiety and non-anxiety were analyzed.Moreover,63 patients with anxiety were randomized into two groups:31 in the control group were treated with lamivudine(100 mg per day) alone and 32 in the observation group were given equal dosage lamivudine combined with CM treatment depending on syndrome differentiation,all for 12 weeks. The effects of treatment on anxiety state and T-lymphocyte subsets as well as its impact on some CHB-related indices were observed and compared.Results:The anxiety state of CHB patients was negatively correlated with CD4~+ and CD4~+/CD8~+;the level of CD4~+ in patients with anxiety was significantly lower than that in non-anxiety patients(P<0.01 or P<0.05).After treatment,anxiety state in the observation group was significantly improved, with their HAMA scores significantly lowered(P<0.01),and the levels of CD4~+ and CD4~+/CD8~+ were significantly higher than those in the control group(P<0.05 or P<0.01).Moreover,the alanine transaminase recovery rate and the HBV-DNA-negative conversion rate in the observation group were significantly higher than those in the control group,respectively(P<0.05).Conclusions:The anxiety state of CHB patients was related to CD4~+ and CD4~+/CD8~+ levels.CM treatment could improve the anxiety state and showed certain regulatory effect on the patients’ immune system.