Effect of Yiqi Yangyin Decoction(益气养阴方) on the Quality of Life of Patients with Unstable Angina Pectoris

<正>Objective:To observe the effect of Yiqi Yangyin Decoction(益气养阴方,YQYYD) on the quality of life(QOL) of patients with unstable angina pectoris(UAP).Methods:A total of 108 patients with UAP of qi-yin deficiency syndrome confirmed by coronary angiography were enrolled and assigned to the treated group(treated with YQYYD and conventional therapy of Western medicine) and the control group(treated with conventional therapy of Western medicine),by the use of the PROC PLAN of the SAS 6.12 software,in a prospective, randomized,controlled design.The clinical total effective rate,symptom score,QOL scale[Seattle Angina Questionnaire(SAQ)]and incidence of important clinical events were defined as the observation indices to evaluate the interventional effect of YQYYD on the QOL of patients with UAP of the qi-yin deficiency syndrome. Results:During the study,three cases dropped out in the treated group,one case dropped out in the control group,and 104 cases,including 51 cases in the treatment group and 53 cases in the control group,finished the trial.After four weeks of treatment,the total clinical effective rates in the treated group and the control group were 80.4%and 75.5%respectively,and there was no obvious difference between them(P0.05).However,the symptom score of the treated group(9.31±2.02) was significantly lesser than that of the control group(11.62±3.04,P0.05),and the total score of the QOL scale of the treated group(68.76±5.74) was significantly higher than that of the control group(61.06±3.31,P0.01).Among those in the treated group physical limitation, angina stability,angina frequency,and treatment satisfaction were significantly ameliorated when compared with the control group after treatment(P0.05,P0.01).The incidence of important clinical events in the treated group(3.9%) was lower than that in the control group(5.7%) during the 8-month follow-up period,but the difference was insignificant(P0.05).Conclusion:YQYYD could improve the clinical symptoms of patients with UAP of qi-yin deficiency syndrome and greatly improve their QOL.     

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.     

Dalitong Granule(达立通颗粒)Combined with Electroacupuncture in the Treatment of Functional Dyspepsia:A Randomized Controlled Trial

Objective:To explore clinical short and long-term effect of combining Dalitong Granule(达立通颗料,DG) and electroacupuncture group(EA) in the treatment of functional dyspepsia.Methods:Totally 640 patients with confirmed functional dyspepsia were randomly divided into 4 groups using a randomized digital table:the DG group,the EA group,the combined group and the control group,160 cases in each group.The DG group was treated with 6 g DG 3 times daily;the EA group was treated with puncture of points Zusanli(ST36),Zhongwan(CV12),Neiguan(PC6),Taichong(LR3) and Gongsun(SP4) twice daily;the combined group with above-mentioned DG and EA;and the control group with 5 mg mosapride 3 times,20 mg pantoprazole and25 mg amitriptylines twice daily.The treatment course was 4 weeks for all groups.The symptom score,quality of life score by Short Form 36 Health Survey Questionnaires(SF-36),plasma motilin by radioimmunoassay,electrogastrographic frequencies by electrogastrogram(EGG) and gastric emptying by B-sonography were examined,and adverse reactions were observed before,at the end of treatment and 60 weeks post-treatment.Results:In the DG group 1 case dropped out for not taking medicine strictly and 1 case was lost to follow-up,while 1 case in the EA group and 2 cases in the combined therapy group were lost to follow-up.Compared with pre-treatment,quality of life score,plasma motilin,electrogastrographic frequencies and gastric emptying were all increased significantly,while symptom score was decreased significantly at the end of treatment in each group(P0.01);in the combined group quality of life score,plasma motilin,electrogastrographic frequencies and gastric emptying were all significantly higher than those in the other groups,while symptom score was significantly lower than in the other groups(P0.05).Compared with at the end of treatment,these indices changed insignificantly in the combined group and the EA group 60 weeks post-treatment(P0.05),but the 4increased indices were all decreased significantly,and symptom score was increased significantly in the DG and the control groups(P0.05).The short and long-term total effective rates in the combined group were all significantly higher than those in the other treatment groups(P0.05 or P0.01).No serious adverse reaction occurred in the four groups.Conclusion:Combined treatment of DG and EA could increase both plasma motilin and electrogastrographic frequencies,promote gastric emptying,alleviate the symptom of dyspepsia so as to increase quality of life,with better safety and long-term effect.     

A Multicentral Randomized Control Study on Clinical Acupuncture Treatment of Bell's Palsy

To confirm the clinical therapeutic effects of acupuncture and moxibustion on Bell's palsy.Methods:480 cases from 4 hospitals were enrolled for this study,among whom 439 cases completed thewhole course of the study.The patients were randomly divided into the following 3 groups,a controlgroup(treated with prednisone,vitamin Bl,vitamin B_(12)and dibazol),an acu-moxibustion group(treatedwith filiform needle plus moxibustion),and a basic treatment plus acu-moxibustion group(treated withoral medicine like those in the control group plus acupuncture,and with moxibustion like in theacu-moxibustion group).The whole treatment course lasted 4 weeks.The therapeutic effects wereevaluated according to the symptoms and signs,House-Brackmann grading scale and facial disabilityindexes(FDI).Results:All the 4 centers(hospitals)completed this study well,with no statisticallysignificant difference found among the 4 centers in therapeutic effects.The patients with differentconditions were well distributed in the 3 groups,thus the basic general,data were comparable(P>0.05).The therapeutic effects of the two treatment groups were better than the control group(respectivelyP<0.05 and P<0.01),and it was the best in the acu-moxibustion group(P<0.01).Conclusion:Acupuncture and moxibustion may exert definite therapeutic effects on Bell's palsy,better than that ofthe basic treatment group or the basic treatment plus acu-moxibustion group.     

Frequent Ventricular Extrasystole Treated by Needling Neiguan （PC 6） plus Oral Administration of Mexiletine——A Report of 30 Cases

Purpose:To observe the therapeutic effect of needling at Neiguan(PC 6)plus oral administration ofmexiletine.Methods:60 cases of frequent ventricular extrasystole were randomly divided into two groups:a treatment group,and a control group.In the control group,mexiletine was orally administered,and in thetreatment group needling at bilateral Neiguan(PC 6)plus oral administration of mexiletine were given.2weeks of treatments constituted a therapeutic course.Results:Of the 30 cases in the treatment group,23cases were markedly effective,5 cases improved,and 2 cases failed;while in the control group 16 caseswere markedly effective,8 cases improved,4 cases failed,and 2 cases aggravated.The total effective ratesof 90.3% and 80.0%,respectively in the treatment and control groups showed a very significant differencebetween the two groups(P<0.01).Conclusion:Needling at bilateral Neiguan(PC 6)may enhance thetherapeutic effect for frequent ventricular extrasystole.     

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.     

A Controlled Study on Treatment of Mental Depression by Acupuncture plus TCM Medication

Objective: To evaluate the therapeutic effect and safety of acupuncture plus TCM medication for treatment of mental depression. Method: 61 cases of mental depression were randomly divided into a treatment group of 30 cases and a control group of 31 cases. The former group was treated by acupuncture plus TCM medication, and the latter with TCM medication alone. The Hamilton Mental Depression (HAMD) scoring system was adopted to evaluate the therapeutic effects, and the Treatment Emergent Symptom Scale (TESS) was used to evaluate the adverse reactions. Results: The treatment group was superior to the control group in the total effective effect (P<0.05), with a significant difference in the HAMD score before and after treatment between the 2 groups (P<0.01). There were marked differences in the reducing rate of HAMD score at the end of the second and sixth week of the treatment between the 2 groups (P<0.05) and the difference was very obvious at the end of the fourth week (P<0.01). No remarkable difference was found in adverse reactions between the 2 groups (P>0.05). Conclusion: Acupuncture plus TCM medication may show satisfactory results for mental depression, indicating that a synergic action may exist between acupuncture and TCM medication.     

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.     

Effect of Feitai Capsule(肺泰胶囊) on Quality of Life and Progression-Free Survival of Patients with Unresectable Non-Small Cell Lung Cancer

<正>Objective:To examine the effect of a Chinese medicinal herbal formula(Feitai Capsule,肺泰胶囊) on the quality of life(QOL) and progression-free survival(PFS) of patients with unresectable non-small cell lung cancer(NSCLC).Methods:Sixty-two patients were randomly divided into the treatment group(31 cases) and the control group(31 cases).For the treatment group,4 capsules(1.2 g/capsule) of Feitai Capsule were administered 3 times a day after meals for 3 weeks;then no drug was administered for 1 week.This schedule was continued for at least 3 more cycles(12 weeks totally).If there were no obvious toxic reactions,the treatment was extended.The patients were evaluated at least once every 8 weeks until progressive disease(PD). For the control group,the regular follow-up and evaluation were performed at least once every 8 weeks until PD.Clinical symptoms,objective response,physical constitution and energy,QOL,and PFS were evaluated regularly.Analysis of variance(ANOVA),a non-parametric test,and analysis of covariance were used to compare clinical features,amelioration of clinical symptoms,physical constitution and energy,and QOL.Kaplan-Meier analysis was used to compare the two-group PFS.Results:Sixty patients finished the final evaluation, with 30 patients in each group.Baseline characters between groups were not significantly different(P0.05). The control group had a 36.7%improvement in clinical symptoms,while the treatment group had a 73.3% improvement.This difference was statistically significant(Z=-2.632,P=0.008).The control group had a 26.7% improvement in the Karnofsky performance status(KPS),while the treatment group had a 53.4%improvement. This was also significantly different(Z=-2.182,P=0.029).A comparative analysis indicated a positive correlation (r=0.917,P0.001).Compared with the control group,QOL in the treatment group was significantly improved, except in the social/family condition and doctor-patient relationship indicators.The PFS of the treatment group and control group were 6.23 months and 4.67 months,respectively(P=0.048).Conclusion:Feitai Capsule,a Chinese medicinal herbal treatment could improve the QOL and extend the PFS of the unresectable NSCLC patients.     

Treatment of osteoporotic vertebral compressive fractures with percutaneous kyphoplasty and oral Zishengukang

OBJECTIVE:To observe the therapeutic effect of percutaneous kyphoplasty(PKP) and oral Zishengukang(ZSGK) for the treatment of osteoporotic vertebral compression fractures(OVCFs).METHODS:Seventy patients were randomly divided into a control group(PKP group) and an experimental group(PKP plus ZSGK group).The 35 patients in the experimental group were prescribed 6 g oral ZSGK three times a day for 90 days after PKP.Visual analog pain scale(VAS),Oswestry functional score,vertebral height and Cobb’s angle were recorded and compared before treatment and at one week,one month and three months after treatment.RESULTS:Vertebral height and Cobb’s angle significantly improved and VAS and Oswestry functional score were significantly lower in both groups after PKP than pre-operatively(P<0.01).Three months after treatment,VAS and Oswestry functional score in the experimental group were lower than controls(P<0.05),even though vertebral height and Cobb’s angle were comparable(P>0.05).CONCLUSION:PKP combined with oral ZSGK provide superior short-term and long-term symptom control after OVCF than PKP alone.     

Effect and Safety of Tongyan Spray (通咽喷雾剂) on Hyoid Motion in Patients with Dysphagia after Ischemic Stroke

Objective: To observe the effects and safety of Tongyan Spray (通咽喷雾剂) on the range and time of hyoid motion in patients with ischemic post-stroke dysphagia. Methods: Seventy-two patients with ischemic post-stroke dysphagia were selected and randomly assigned to a treatment group (36 cases) and a control group (36 cases) by a random number table from January 2013 to October 2014. All patients swallowed 4 kinds of barium meals with different traits respectively, and each patient underwent video fluoroscopy (VF) examination twice. In the treatment group, Tongyan Spray was sprayed to the pharynx on both sides and the middle part once respectively. The spray was applied 30 min before the second examination. Purified water at room temperature was used as placebo in the control group. The changes in the range and time of hyoid motion in both groups were observed before and after treatment. Results: Six patients dropped out in each group, and 60 patients completed the study and were included in the final analysis. Significant improvement was observed in the range of superior hyoid excursion distance and the time of hyoid motion in the treatment group compared with the control group (P<0.05). There were no obvious adverse reactions observed in oral mucosa in both groups during the whole study. Conclusion: Tongyan Spray was an effective and safe medicine for improving swallowing function in patients with ischemic post-stroke dysphagia.     

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.     

Thirty Cases of Obsession Treated by Point-Stimulation and with Small Dose of Chlorimipramine

Objective: To investigate the clinical therapeutic effects of point-stimulation for obsession. Methods: Sixty cases of obsession were divided into two groups: a control group of 30 cases treated with chlorimipramine (Ch1), and a treatment group of 30 cases treated by point-stimulation (PS) plus chlorimipramine (PS Chl). The therapeutic effects and side-effect were evaluated according to the criteria set in Yale-Brown Obsession Scale (Y-BOCS), Hamilton's depression scale (HAMD), brief psychiatric rating scale (BPRS) and treatment emergent symptom scale (TESS). Results: The cure rate and markedly effective rate were respectively 26.7% and 56.6% in the control group, and 43.3% and 50% in the treatment group, suggesting that the therapeutic effect in the treatment group was better than that in the control group. The incidence of adverse side-effects was 73.33% in the control group and 46.67% in the treatment group, with a significant difference between the two groups (P<0.05). Conclusion: Point-stimulation plus small dose of chlorimipramine was superior to the simple chlorimipramine treatment, indicating that the combined method was more effective and safe for obsession with less side effects.     

Effectiveness and Safety Evaluation of Qixiong Zhongzi Decoction (芪芎种子汤) in Idiopathic Asthenozoospermia Treatment: A Randomized Controlled Trial

Objective: To evaluate the clinical effectiveness and safety of the Chinese medicine(CM) Qixiong Zhongzi Decoction(芪芎种子汤, QZD) in the treatment of patients with idiopathic asthenozoospermia. Methods: A total number of 66 patients with idiopathic asthenozoospermia were included and randomly divided into treatment and control groups by SAS-generated code from January 2015 to August 2016, 33 patients in each group. Patients in the treatment group were administered with 150 m L of QZD twice a day, whereas those in the control group were given 1 g of levocarnitine oral liquid twice a day. The two groups received the indicated medication for 12 weeks and were then followed up for 4 weeks. The primary outcome was sperm motility, and the secondary therapeutic indices were sperm volume, density, pregnancy probability, and CM syndrome score. The comparison between groups was carried out at 4, 8 and 12 weeks, respectively. The safety was determined before and after treatment. Results:(1) Drop-off: 5 cases(7.58%) were lost after treatment(2 from the treatment group and 3 from the control group).(2) Primary outcomes: after 8-and 12-week treatment, the progressive sperms in the two groups were significantly higher than the baseline(all P0.05); however, the treatment group showed greater improvement compared with the control group at 12-week treatment(22.7%±9.0% vs. 14.1%±8.8%, P0.05). The increasement of non-progressive grade sperms at both groups was observed at 8-and 12-week treatment with statistical difference(all P0.05), however, the treatment group showed remarkable improvement compared with the control group at 12-week treatment(38.7%±14.1% vs. 26.2%±15.4%, P0.05).(3) Secondary outcomes: no significant statistical differences were found in semen volume and density(4, 8, and 12-week treatment) and pregnancy probability of patients' wives(12-week treatment) between two groups(all P0.05), however, the CM syndrome score of the treatment group significantly declined compared with baseline level at each time points(all P0.05).(4) Safety: no obvious side reactions were found during the treatment in both groups. Conclusions: QZD could improve the progressive and non-progressive grade sperm in the treatment of idiopathic asthenozoospermia. It is safe with no obvious side effects.     

Effect of Huanshuai Recipe Oral Liquid (缓衰口服液) on Renal Dysfunction Progression in Patients with Atherosclerotic Renal Artery Stenosis

Objective:To investigate the effect of Huanshuai Recipe Oral Liquid(缓衰口服液,HSR) on retarding the progression of renal dysfunction in patients with atherosclerotic renal artery stenosis(ARAS).Methods:A total of 52 ARAS patients with the Chinese medicine(CM) syndrome of qi deficiency and blood stasis,phlegm and dampness retention were recruited and randomly assigned into the treatment group(36 cases) and the control group(16 cases).Both groups received a basic treatment(high-quality low-protein diet,blood pressure control,lipid-lowering,correcting the acidosis,etc.).In addition,the treatment group received 20 mL HSR and the control group received placebo,3 times a day for 6 months.Renal function(serum creatinine,blood urea nitrogen and uric acid) and blood lipids(cholesterol,triglycerides and low density lipoprotein) were examined monthly.The estimated glomerular filtration rate(eGFR) and CM syndrome score were compared between groups.Results:After treatment,compared with the control group,the serum creatinine level,uric acid level and CM syndrome score of the treatment group were significantly decreased(P0.05 or P0.01),and the eGFR in the treatment group were significantly increased(P0.05).Conclusion:HSR can effectively improve the renal function and clinical symptoms of ARAS patients.     

A Multicentral Randomized Control Study on Clinical Acupuncture Treatment of Bell＇s Palsy

To confirm the clinical therapeutic effects of acupuncture and moxibustion on Bell＇s palsy. Methods： 480 cases from 4 hospitals were enrolled for this study, among whom 439 cases completed the whole course of the study. The patients were randomly divided into the following 3 groups, a control group（treated with prednisone, vitamin B 1, vitamin B 12 and dibazol）, an acu-moxibustion group （treated with filiform needle plus moxibustion）, and a basic treatment plus acu-moxibustion group （treated with oral medicine like those in the control group plus acupuncture, and with moxibustion like in the acu-moxibustion group）. The whole treatment course lasted 4 weeks. The therapeutic effects were evaluated according to the symptoms and signs, House-Brackmann grading scale and facial disability indexes（FDI）. Results： All the 4 centers （hospitals） completed this study well, with no statistically significant difference found among the 4 centers in therapeutic effects. The patients with different conditions were well distributed in the 3 groups, thus the basic general data were comparable （P〉0.05）. The therapeutic effects of the two treatment groups were better than the control group （respectively P〈0.05 and P〈0.01）, and it was the best in the acu-moxibustion group （P〈0.01）. Conclusion： Acupuncture and moxibustion may exert definite therapeutic effects on Bell＇s palsy, better than that of the basic treatment group or the basic treatment plus acu-moxibustion group.     

Short and long-term efficacy of combining Fuzhengliqi mixture with acupuncture in treatment of functional constipation

OBJECTIVE: To explore the short and long-term efficacy of combining Fuzhengliqi mixture (FLM) with acupuncture in treating functional constipation (FC). METHODS: The 560 patients with confirmed diagnosis of FC were randomly assigned to four groups: FLM group, acupuncture group, combined therapy group, and control group. There were 140 cases in each group. The FLM group was administered FLM 60 mL twice a day, while the acupuncture group was treated with acupuncture at acupoints Tianshu (ST 25), Shangjuxu (ST 37), Zusanli (ST 36), Dachangshu (BL 25), and Zhigou (TE 6) twice a day, the combined therapy group with FLM and acupuncture, and the control group was administered mosapride (5 mg thrice a day) and Macrogol 4000 (10 g twice a day). The treatment lasted 6 weeks. The defecation interval, stool property, constipation symptoms, and accompanying symptomswere recorded, graded, and scored.The gastrointestinal transit time (GITT) and motilin (MTL) level in serum and life quality score were detected at three time points (pre-treatment, at the end of treatment, and 60 weeks post-treatment). Moreover, the adverse reactions were also observed. RESULTS: In the FLM group 2 cases were eliminated for not taking medication strictly according to the research plan and 1 case was lost to follow-up, while 2 cases in the acupuncture group and 2 cases in the combined therapy group were lost to follow-up. Compared with those detected pre-treat- ment, the defecation interval, stool property, consti- pation symptom grade, accompanying symptom grade, and GITT were all decreased markedly at the end of treatment in every group, while the MTL levels in serum and life quality score were increased markedly (P<0.01), the above-mentioned detecting indices were better in the combined therapy group than those in other groups (P<0.05). Compared with the end of treatment, above-mentioned detecting indices all recurred significantly in the FLM group and control group 60 weeks post-treatment (P>0.05), but these indices recurred insignificantly in the acupuncture and combined therapy groups (P>0.05). The short and long-term total effective rates in the combined therapy group were significantly different from those in other groups (P<0.05 or P<0.01). No serious adverse reactions were found in four groups. CONCLUSION: Both FLM and acupuncture can significantly shorten the defecation interval and GITT, increase MTL levels in serum, decrease the scores of stool property, constipation symptoms, and accompanying symptoms in patients with FC to increase their life quality. The combined therapy is much better in long-term efficacy and the safety is also good, worth spreading in clinical practice.     

Clinical Observation on Treatment of Ischemic Apoplexy by Electroacupuncture plus Acupoint-Injection

Objective: To observe the therapeutic effects of electroacupuncture plus acupoint-injection for ischemic apoplexy. Method: 78 cases of ischemic apoplexy were randomly divided into a treatment group of 39 cases treated by electroacupuncture plus acupoint-injection and a control group of 39 cases treated by electroacupuncture alone. Results: The neural functional defect score (NFDS) decreased while the functional independence mark (FIM) increased with obvious significant differences before and after treatment in both of the two groups. And there were very remarkable differences between the two groups in the changes of both NFDS and FIM after treatment (P<0.01), showing better results in the treatment group than that of the control group. Conclusion: Electroacupuncture plus acupoint-injection can promote the recovery of the neural function for the ischemic apoplexy patients and markedly enhance their daily living ability, with better effects than that in patients treated by electroacupuncture alone.     

Therapeutic effect of Chinese herbal medicine for strengthening qi, nourishing yin, and removing stasis on serum osteopontin and quality of life of patients with primary Sjogren's syndrome

Objective:To observe the therapeutic effect of Chinese herbal medicine for strengthening qi, nourishing yin,and removing stasis on serum osteopontin(OPN) and quality of life(QOL) in patients with primary Sjogren’s syndrome(pSS) and to study the correlation between OPN level and the disease.Methods:Sixtyeight pSS patients were randomly assigned to two groups:the treatment group(35 cases) treated by Chinese herbal medicine for strengthening qi,nourishing yin,and removing stasis combined with hydroxychloroquine sulfate tablet(HCQ) and the control group(33 cases) treated by HCQ only.Both were treated for 3 months. Before and after treatment,immunoglobulin G(IgG) level,erythrocyte sedimentation rate(ESR),and OPN level were measured.The QOL in patients was evaluated using the Short Form-36 Health Survey(SF-36) before and after treatment.Thirty healthy females were taken as the normal control.Results:Before treatment,levels of IgG,ESR,and OPN in patients were higher than those in the normal control.After 3 months of treatment, those in both treatment groups decreased but were lower in the treatment group than those in the control group (P<0.05).The scores of 8 dimensions of SF-36 were lower in the pSS patients than those in the normal control (P<0.05) and higher in the treatment group than in the control group after treatment(P<0.05).Furthermore, there was a positive correlation between the levels of OPN and the levels of IgG and ESR,and a negative correlation between OPN levels and the overall score of SF-36(P<0.05).Conclusions:Chinese herbal medicine for strengthening qi,nourishing yin,and removing stasis could alleviate pSS disease and improve the QOL.In addition,the OPN level might be used as an evaluating index for pSS disease.     

Post-marketing Re-evaluation of Tongxiening Granules (痛泻宁颗粒) in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome:A Multi-center,Randomized,Double-Blind,Double-Dummy and Positive Control Trial

Objective: To evaluate the efficacy and safety of Tongxiening Granules(痛泻宁颗粒, TXNG) in the treatment of irritable bowel syndrome with predominant diarrhea(IBS-D). Methods: A randomized, double-blind, double-dummy, and positive paral el control ed clinical trial was conducted from October 2014 to March 2016. Total y 342 patients from 13 clinical centers were enrolled and randomly assigned(at the ratio of 1:1) to a treatment group(171 cases) and a control group(171 cases) by a random coding table. The patients in the treatment group were administered oral y with TXNG(5 g per time) combined with pinaverium bromide Tablet simulator(50 mg per time), 3 times per day. The patients in the control group were given TXNG simulator(5 g per time) combined with pinaverium bromide Tablets(50 mg per time), 3 times per day. The treatment course lasted for 6 weeks. The improvement of Irritable Bowel Syndrome Symptom Severity Score(IBS-SSS) was used to evaluate the primary outcome. Secondary outcomes included adequate relief(AR) rate, Irritable Bowel Syndrome-Quality of Life Questionnaire(IBS-QOL), Hamilton Anxiety Scale(HAMA), Hamilton Depression Scale(HAMD), and the recurrence rate at fol ow-ups. Safety indices including the adverse events(AEs) and related laboratory tests were evaluated. Results: Primary outcome: IBS-SSS at baseline, weeks 2, 4, 6 showed no statistical significance in both full analysis set(FAS) and per protocol set(PPS, P0.05). After 6 weeks of treatment, the total effective rate of IBS-SSS scores in the treatment group(147/171, 86.0%) was higher than the control group(143/171, 83.6%) by FAS(P0.05). In regard to secondary outcomes, after 6-week treatment, there was no significant difference in AR rate, total score of IBS-QOL, improvement of HAMD and HAMA total scores between the two groups(P0.05). The recurrence rate at 8-week fol ow-up was 12.35%(10/18) in treatment group and 15.79%(12/76) in control group, respectivery(P0.05). A total of 21 AEs occurred in 15 cases, of which 11 occurred in 8 cases in the treatment group and 10 AEs in 7 cases in the control group. The incidence of AEs had no statistical significance between the two goups(P0.05). Conclusion: Tongxiening Granules could relieve the symptoms of patients with IBS-D and the treatment effect was comparable to pinaverium bromide.(No. ChiCTR-IPR-15006415)