Efficacy and safety of nerve growth factor for the treatment of neurological diseases:a meta-analysis of 64 randomized controlled trials involving 6,297 patients

OBJECTIVE： China is the only country where nerve growth factor is approved for large-scale use as a clinical medicine. More than 10 years ago, in 2003, nerve growth factor injection was listed as a national drug. The goal of this article is to evaluate comprehensively the efficacy and safety of nerve growth factor for the treatment of neurological diseases. DATA RETRIEVAL： A computer-based retrieval was performed from six databases, including the Cochrane Library, PubMed, EMBASE, Sino Med, CNKI, and the VIP database, searching from the clinical establishment of nerve growth factor for treatment until December 31, 2013. The key words for the searches were ＂nerve growth factor, randomized controlled trials＂ in Chinese and in English. DATA SELECTION： Inclusion criteria： any study published in English or Chinese referring to randomized controlled trials of nerve growth factor; patients with neurological diseases such as peripheral nerve injury, central nerve injury, cranial neuropathy, and nervous system infections; patients older than 7 years; similar research methods and outcomes assessing symptoms; and measurement of nerve conduction velocities. The meta-analysis was conducted using Review Manager 5.2.3 software. MAIN OUTCOME MEASURES： The total effective rate, the incidence of adverse effects, and the nerve conduction velocity were recorded for each study. RESULTS： Sixty-four studies involving 6,297 patients with neurological diseases were included. The total effective rate in the group treated with nerve growth factor was significantly higher than that in the control group （P 〈 0.0001, RR： 1.35, 95%CI： 1.30-1.40）. The average nerve conduction velocity in the nerve growth factor group was significantly higher than that in the control group （P 〈 0.00001, MD. 4.59 m/s, 95%CI： 4.12-5.06）. The incidence of pain or sclero- ma at the injection site in the nerve growth factor group was also higher than that in the control group （P 〈 0.00001, RR： 6.30, 95%CI： 3.53-11.27）, but such adverse effects were mild. CONCLUSION： Nerve growth factor can significantly improve nerve function in patients with nervous system disease and is safe and effective.

Immediate Effect of Electro-acupuncture on Endometrial Blood Flow in Patients with Recurrent Implantation Failure:A Randomized Controlled Trial

Objective To investigate the immediate effects of electro-acupuncture(EA)on endometrial blood flow among recurrent implantation failure(RIF)patients.Methods Eighty RIF patients,enrolled from March 2022 to December 2022,were randomly allocated into either the EA group(40 cases)or the waiting-list(WL)group(40 cases)by using a random number table.The EA group underwent acupuncture at points of Shenting(GV 24),Baihui(GV 4),Benshen(GB 13),bilateral Zigong(EX-CA 1),Huangshu(KI 16),Sanyinjiao(SP 6)and Xuehai(SP10),and electric acupuncture apparatus was connected to EX-CA 1,KI 16,SP 6,and SP 10 with disperse-dense waves at 4/20 Hz frequencies for 30 min after transvaginal ultrasound,while the WL group received no intervention.The primary outcome measured was the endometrial volume blood flow.The secondary outcomes included the bilateral uterine artery index,endometrial volume,endometrial blood flow type,vascular distribution index(VI^(MV))for endometrial and ovary,clinical pregnancy rate,and embryo implantation rate.Results In the EA group,there was a notable decrease in the bilateral pulsatility index and a significant improvement in the endometrial blood flow type post-EA(P<0.05).Both the endometrial blood flow type and VI^(MV) for the endometrium and right ovary were markedly higher in the EA group compared to the WL group post-treatment(P<0.05).Conversely,no significant disparities were observed in vascular index,flow index,vascular blood flow index,uterine arterial blood flow indices,endometrial volume,clinical pregnancy rate and embryo implantation rate between the two groups after treatment(P>0.05).Besides,no adverse events related to EA were observed.Conclusions EA can promptly ameliorate VI^(MV) for the endometrial and right ovary,and endometrial blood flow type.Future randomized controlled trials are warranted to investigate the long-term effects of EA on blood flow of RIF patients and its implications for pregnancy outcomes.(Trial registration No.ChiCTR2200057377).

Effects of Traditional Chinese Medicine Shensong Yangxin Capsules on Heart Rhythm and Function in Congestive Heart Failure Patients with Frequent Ventricular Premature Complexes：A Randomized, Double-blind, Multicenter Clinical Trial

Background：Pharmacological therapy for congestive heart failure （CHF） with ventricular arrhythmia is limited.In the study,our aim was to evaluate the effects of Chinese traditional medicine Shensong Yangxin capsules （SSYX） on heart rhythm and function in CHF patients with frequent ventricular premature complexes （VPCs）.Methods：This double-blind,placebo-controlled,multicenter study randomized 465 CHF patients with frequent VPCs to the SSYX （n =232） and placebo groups （n =233） for 12 weeks of treatment.The primary endpoint was the VPCs monitored by a 24-h ambulatory electrocardiogram.The secondary endpoints included the left ventricular ejection fraction （LVEF）,left ventricular end-diastolic diameter,N-terminal pro-brain natriuretic peptide （NT-proBNP）,New York Heart Association （NYHA） classification,6-min walking distance （6MWD）,Minnesota Living with Heart Failure Questionnaire （MLHFQ） scores,and composite cardiac events （CCEs）.Results：The clinical characteristics were similar at baseline.SSYX caused a significantly greater decline in the total number of VPCs than the placebo did （-2145 ± 2848 vs.-841 ± 3411,P 〈 0.05）.The secondary endpoints of the LVEE NYHA classification,NT-proBNP,6MWD,and MLHFQ scores showed a greater improvements in the SSYX group than in the placebo group （ALVEF at 12th week：4.75 ± 7.13 vs.3.30 ± 6.53;NYHA improvement rate at the 8th and 12th week：32.6% vs.21.8%,40.5% vs.25.7%;mean level of NT-proBNP in patients with NT-proBNP 〉125 pg/ml at 12th week：-122 [Q1,Q3：-524,0] vs.-75 [Q1,Q3：-245,0];A6MWD at 12th week：35.1 ± 38.6 vs.17.2 ± 45.6;AMLHFQ at the 4th,8th,and 12th week：-4.24 ± 6.15 vs.-2.31 ± 6.96,-8.l 9 ± 8.41 vs.-3.25 ± 9.40,10.60 ± 9.41 vs.-4.83 ± 11.23,all P 〈 0.05）.CCEs were not different between the groups during the study period.Conclusions：In this 12-week pilot study,SSYX was demonstrated to have the benefits of VPCs suppression and cardiac function improvement with good compliance on a background of standard treatment for CHF.

Clinical curative effect of electric acupuncture on acute cerebral infarction:a randomized controlled multicenter trial

OBJECTIVE: To examine whether electric acupuncture can improve the daily life of patients with ischemic cerebral apoplexy at acute stage.METHODS: A stratified-block randomized controlled multicenter trial was designed for this study.Totally 340 patients with acute ischemic cerebral apoplexy were randomly divided into an electric acupuncture group and a control group. In the electric acupuncture group, 170 patients were treated with electric acupuncture and routine therapy, and170 patients in the control group with routine therapy alone. Major indexes for judging curative effect were Barthel index at 3- and 6- months follow-up visits and number of re-hospitalized patients. Mi-nor indexes for judging curative effect were change in the score for nervous dysfunction at 4and 12 weeks follow-up visits and number of patients persisting in rehabilitation treatment with acupuncture during follow-up visit.RESULTS: Baseline data at the time of case selection between the two groups were similar. The odds ratio(OR) was 0.92, and the 95% confidence interval(CI) was 0.49-1.73 in disabled rate and 0.73 and 0.51-1.05 in the number of re-hospitalized patients in the electric acupuncture group at 6-month follow up visit compared with the control group.There was no difference in the score for nervous dysfunction at the end of 12-week follow-up visit between the two groups. The score for nervous dysfunction at the end of 4-week treatment in the electric acupuncture group was significantly higher than that in the control group(P<0.05). The number of patients discharged from hospital who persisted in rehabilitation treatment with acupuncture in the acupuncture group was significantly higher than that in the control group.CONCLUSION: Using electric acupuncture to treat patients with acute ischemic cerebral apoplexy can effectively improve the nervous dysfunction scores after 4-week treatment and their ability to deal with daily life after 6-month follow-up visit. Systematic treatment with acupuncture may also reduce the number of patients with secondary apoplexy.

Systematic review and meta analysis of randomized controlled trials on Tianmagouteng decoction in treatment of primary hypertension with liverYang hyperactivity syndrome

OBJECTIVE： To assess the efficacy of Tianma- gouteng decoction in the treatment of primary hypertension with liver yang hyperactivity syndrome. METHODS： The databases of MEDLINE （1950- 2012）, EMbase （1980-2012）, China biology medicine （CBM） （1994-2012）, China national knowledge infrastructure （CNKI） （1989-2012）, Weipu （VIP） （1995-2012） and Wanfang （1989-2012） were searched and we performed manual searches for conference proceedings to select randomized controlled trials （RCTs） on Tianmagouteng decoction for the treatment of primary hypertension with liver Yang hyperactivity syndrome. Studies were en- rolled according to the study-selecting criteria. The methodological quality was evaluated, data were extracted and meta-analyses were conducted with RevMan 4.2 software. RESULTS： Nine RCTs were selected involving 784 patients with no significant difference in decrease in systolic blood pressure （SBP）[0R=1.02, 9.5% CI （-0.24, 2.29）, P=0.10] and diastolic blood pressure（DBP） [OR=0.56, 95% CI （-0.10,1.23）, P=0.11] between the Tianmagouteng group and the control group. While there was a significantly larger increase in serum superoxide dismutase （SOD）[OR= 6.26, 95% CI （1.27,11.66）, P=0. 01] in the Tianmagouteng group than that in the control group CONCLUSION： Tianmagouteng decoction can decrease both systolic and diastolic blood pressure and greatly increase serum SOD. Due to poor quality of included studies, the efficacy needs to be further assessed.

Effect of Bufei granule on stable chronic obstructive pulmonary disease: a randomized, double blinded, placebo-controlled, and multicenter clinical study

OBJECTIVE: To study the therapeutic effect Bufei granule, which is a traditional Chinese drug that can enhance the immune function of the lung, on patients with stable chronic obstructive pulmonary disease(COPD).METHODS: This is a randomized, double blinded,placebo-controlled, and multicenter clinical study.Three medical centers in Tianjin, China, participated in the trial. A total of 140 patients with stable COPD were enrolled and randomized into two groups, with 70 patients in each. The treatment group was treated with Bufei granule, while the control group received Bufei placebo. The pharmacological treatment lasted for 12 weeks from the date of enrollment. Then, the indexes of patients were observed. Data were analyzed to study the effect of Bufei granule, with the frequency of acute exacerbation as the primary outcome. Traditional Chinese Medicine syndromes,Modified British Medical Research Council dyspnea scale score, St.George's respiratory questionnaire scores, pulmonary function, and serum inflammatory marker levels [including interleukin-6(IL-6), interleukin-8, tumor necrosis factor-α, and transformation growth factor-β1]were the secondary outcomes.RESULTS: During the 12-week treatment, treatment and control groups had no adverse reactions.The analysis of the indexes obtained from all patients showed that the therapeutic effect in the treatment group was significantly better than that in the control group because most of the similar probabilities of primary and secondary outcomes were less than 0.05,except for the level of IL-6.CONCLUSION: Bufei granule can treat patients with stable COPD by lowering the frequency of acute exacerbation, improving the quality of life,and alleviating the severity of inflammation.

Efficacy and safety of puerarin injection in treatment of diabetic peripheral neuropathy: a systematic review and Meta-analysis of randomized controlled trials

OBJECTIVE: To systematically evaluate the clinical efficacy and safety of puerarin injection in the treatment of diabeticperi pheral neuropathy(DPN).METHODS: Randomized controlled trials investigating the efficacy of puerarin injection on DPN were searched for in China National Knowledge Infrastructure Database, Chinese Scientific Journals Database, Wanfang Database, Chinese Biomedical Literature Database, PubMed, and Cochrane Library from establishment to April 30.Two reviewers independently retrieved and extracted the information.The included studies were assessed by the Cochrane risk of bias and analyzed by Review Manager 5.2 software.RESULTS: Twenty-two studies involving 1664 participants were included. The quality of the studies was found to be relatively low. Meta-analysis showed that puerarin injection combined with western medication was more effective than conventional therapy for rate, nerve conduction velocity(NCV), and hemorheology index. Six adverse drug reactions(ADRs) from puerarin injection were reported in two studies. Reactions included facial flushing, palpitations, and pain at infusion locations. However,noserious ADRs were reported.CONCLUSION: Puerarin injection was effective for the treatment of DPN. Puerarin can improve the total effective rate, correct NCV that was decreased by diabetes, and improve the hemorheology index.Puerarin was also relatively safe clinically. However,since the articles included in the study were not high-quality, more studies should be conducted to strengthen their findings.

Effectiveness and safety of heat-sensitive moxibustion on bronchial asthma:a Meta-analysis of randomized control trials

OBJECTIVE: To systematically evaluate the effectiveness and safety of heat-sensitive moxibustion(HSM)onasthma.METHODS: Large databases in China and overseas were searched by electronic and manual means to collect information on randomized controlled trials(RCTs).Two evaluators independently extracted data and evaluated the quality of RCTs according to Cochrane Review Handbook v5.0. RevMan v5.0.20 was used for statisticalanalyses.RESULTS: Fourteen RCTs involving 637 patients were collected.Thirteen RCTs compared the effects of HSM and Western Medicine. After 3-month treatment and after 6-month follow-up, there was no significant difference in effective rate [relative risk(RR)=1.01, 95% CI(0.92, 1.12), and 1.12,(0.93, 1.36),respectively], in the asthma control test score of asthma symptoms [weighted mean difference(WMD)=﹣1.54, 95% CI(﹣3.54, 0.47), and 1.41,(﹣0.48, 3.29), respectively] and in the forced expiratory volumein 1 second(FEV1)and peak expiratory flow(PEF). One RCT compared the effect of HSM with warm-suspended moxibustion. After 6-month follow-up, there was a significant difference in FEV1 and PEF [WMD=0.51, 95% CI(0.10, 0.92), and 1.78,(1.06, 2.50), respectively]. After 3-month treatment,there was no significant difference between the two groups. One RCT compared the effect of HSM with acupoint application. After 3-month treatment, there was no significant difference in the effectiverate[RR=0.68,95%CI(0.42,1.12)].CONCLUSION: HSM did not show superiority to conventional Western Medicine and acupoint application in terms of curative effects, and may be superior to warm-suspended moxibustion with regard to long-term curative effects. Because of low quality of the included RCTs, this conclusion must be bolstered with higher-quality RCTs.