Tai chi for management of type 2 diabetes mellitus: A systematic review

Objective:Tai chi has been recommended for treating type 2 diabetes mellitus.The purpose of this systematic review was to evaluate evidence from controlled clinical trials testing the effectiveness of tai chi in treating type 2 diabetes mellitus.Methods:Systematic searches were conducted on 14 electronic databases without restrictions on either population characteristics or language of publication.The outcome measures considered for inclusion were changes in fasting blood glucose（FBG）,glycosylated haemoglobin A_1c(HbA_1c) and quality of life（QOL）.Results:Eight randomised clinical trials（RCTs） and two controlled clinical trials（CCTs） met all inclusion criteria.Three RCTs from 1 trial compared the effects of tai chi with sham exercise and failed to show effectiveness of tai chi on FBG,HbA_1c,or QOL.The other 3 RCTs tested the effects of tai chi compared with other types of exercise on FBG.The meta-analysis failed to show an FBG-lowering effect of tai chi[n=118,weighted mean difference（WMD）:-0.14 mmol/L,95%CI:-0.86 to 0.58,P=0.70].Four studies （2 RCTs and 2 CCT） compared tai chi with no treatment or self-management programme and failed to report significant differences between the experimental and control groups except for QOL from 1 RCT and 1 CCT. Conclusion:The existing evidence does not suggest that tai chi is an effective therapy for type 2 diabetes. Currently,there are few high-quality trials on which to make definitive judgements.     

Sodium Tanshinone Ⅱ A Sulfonate for Coronary Heart Disease: A Systematic Review of Randomized Controlled Trials

Objective: To assess whether an adjunctive therapy of Sodium Tanshinone ⅡA Sulfonate Injection(STS) is effective and safe in improving clinical outcomes in patients with coronary heart disease(CHD). Methods: A literature search was conducted through PubMed, the Cochrane Library, Knowledge Infrastructure Databases(CNKI), Chinese Biomedical Literature Database(SinoMed), Chinese Science and Technology Periodical Database(VIP) and Wanfang Database up to August 2017. Randomized controlled trials(RCTs) comparing STS with placebo or no additional treatments on the basis of standard conventional medicine therapies were included. The outcomes were all-cause mortality, major acute cardiovascular events(MACEs), cardiac function and inflammatory factors. The risk of bias assessment according to the Cochrane Handbook was used to evaluate the methodological quality of the included trials. Revman 5.3 software was used for data analyses. Results: A total of 22 RCTs involving 1,873 participants were included. All of the trials used STS as adjunctive treatment to standard conventional medicine therapy. Due to the poor quality of methodologies of most trials, only limited evidence showed that a combination of STS with percutaneous coronary intervention(PCI) or thrombolytic therapy(TT) might be more effective on reduction of all cause death rate than TT alone [risk ratio(RR) 0.25, 95% confidence interval(CI) 0.07 to 0.87] or PCI alone(RR 0.42, 95% CI 0.04 to 4.36). The results of 6 trials comparing STS plus TT with TT alone showed that the addition of STS significantly reduced the incidence of cardiac shock(RR 0.35, 95% CI 0.14 to 0.86), heart failure(RR 0.41, 95% CI 0.20 to 0.83) and arrhythmia(RR 0.21, 95% CI 0.12 to 0.46). STS combined with TT also showed a superior effect on cardiac function and inflammatory factor. No severe adverse event was reported related to STS. Conclusions: As an adjunctive therapy, STS combined with standard conventional medicine seems to be more effective on all-cause mortality or MACEs than conventional medicine treatment alone with less side effects. However, we cannot make a firm conclusion due to low quality of inclusion trials. Well-designed trials with high methodological quality are needed to validate the effect of STS for CHD patients.     

Is Manipulative Therapy Clinically Necessary for Relief of Neck Pain? A Systematic Review and Meta-Analysis

Objective:To summarize and critically assess the efficacy of Eastern and Western manipulative therapies for the treatment of neck pain in adults. Methods:A search of Pub Med/MEDLINE, the Cochrane Central Register of Controlled Trials, Clinical Trials.gov, EMBASE, etc. from their inception date to January 2014 with Chinese, Japanese, and Korean databases. Two reviewers independently selected randomized controlled trials(RCTs) with negative control or blank control, extracted data and assessed methodological quality. Meta-analysis and levels of evidence were performed by Revman5.1 and Grades of Recommendations Assessment, Development and Evaluation(GRADE) approach. Results:Nineteen clinical trials with adequate randomization were included in this review, 11 of them had a low risk of bias. The primary outcome for shortterm pain had no significant differences, however, the secondary outcome, only the Numerical Pain Rating Scale(NPRS) score of intermediate-term [n=916, pooled mean differences(MD) =–0.29, P=0.02], the Neck Disability Index(NDI) score of short-term(n=1,145, pooled MD=–2.10, P0.01), and intermediate-term(n=987, pooled MD=–1.45, P=0.01) were significantly reduced with moderate quality evidence. However, it supported the minimally clinically important difference(MCID) of the Visual Analogue Scale and NPRS pain score to be 13 mm, while NDI was 3.5 points. The meta-analysis only suggested a trend in favor of manipulative therapy rather than clinical significance. Conclusions:The results do not support the existing evidences for the clinical value of Eastern or Western manipulative therapy for neck pain of short-term follow-up according to MCIDs. The limitations of our review related to blinding, allocation concealment and small sample size.     

Ginkgo Leaf Extract and Dipyridamole Injection as Adjuvant Treatment for Angina Pectoris: A Meta-Analysis of 41 Randomized Controlled Trials

Objective: To provide information about the effectiveness and safety of Ginkgo Leaf Extract and Dipyridamole Injection(GD) as one adjuvant therapy for treating angina pectoris(AP) and to evaluate the relevant randomized controlled trials(RCTs) with meta-analysis. Methods: RCTs concerning AP treated by GD were searched in China Biology Medicine Disc(SinoMed), PubMed, the China National Knowledge Infrastructure Database(CNKI), the Chinese Scientific Journals Database(VIP), Wanfang Database, Embase, and the Cochrane Library, from inception to February, 2017. The Cochrane Risk Assessment Tool was adopted to assess the methodological quality of the RCTs. The Review Manager 5.3 software was utilized to conduct the meta-analysis. Results: A total of 41 RCTs involving 4,462 patients were included in the meta-analysis. The results indicated that the combined use of GD and Western medicine(WM) against AP was associated with a higher total effective rate [risk ratio(RR)=1.25, 95% confidence interval(CI): 1.21–1.29, P0.01], total effective rate of electrocardiogram(RR=1.29, 95% CI: 1.21–1.36, P0.01). Additional, GD combined with WM could decrease the level of plasma viscosity [mean difference(MD)=–0.56, 95% CI: –0,81 to –0.30, P0.01], fibrinogen [MD=–1.02, 95% CI: –1.50 to –0.54, P0.01], whole blood low shear viscosity [MD=–2.27, 95% CI: –3.04 to –1.49, P0.01], and whole blood high shear viscosity(MD=–0.90, 95% CI: 1.37 to –0.44, P0.01). Conclusions: Comparing with receiving WM only, the combine use of GD and WM was associated with a better curative effect for patients with AP. Nevertheless, limited by the methodological quality of included RCTs more large-sample, multi-center RCTs were needed to confirm our findings and provide further evidence for the clinical utility of GD.     

Danshen Injection as Adjuvant Treatment for Unstable Angina Pectoris: A Systematic Review and Meta-analysis

Objective: To systematically evaluate the clinical effectiveness and safety of Danshen Injection(丹参注射液, DS) as one adjuvant treatment for conventional therapy with Western medicine(WM) for unstable angina pectoris(UAP). Methods: Using literature databases, a thorough and systematic retrieval of randomized controlled trials(RCTs) comparing DS plus WM with WM was conducted from inception to April 2015. The extracted data from included studies was analyzed by Review Manager 5.2 software. The Cochrane risk of bias tool was used to assess the quality of included studies, and Begg's and Egger's tests conducted by Stata 12.0 were used to evaluate the potential presence of publication bias. Results: A total of 17 RCTs, which involving 1,433 participants, were identified and reviewed. The meta-analysis indicated that the combined use of DS and WM was significantly superior to WM alone for UAP in terms of the total effectiveness rate of angina pectoris [risk ratio(RR) =1.23, 95% confidence interval(CI): 1.17, 1.29, P0.01] and the total effectiveness rate of electrocardiogram(ECG) [RR=1.18, 95%CI: 1.06, 1.30, P=0.001]. Additionally, DS could also further reduce the content of fibrinogen, adjust blood lipid level, correct T wave inversion, and so on. Fifteen adverse drug reactions were reported in two studies, Four of which appeared in the experimental group. Conclusion: Based on the systematic review, the combined use of DS and WM was more effective than WM alone, it can be further widely used in clinic, however, there was no exact conclusion for its safety.     

头针治疗帕金森病：一项随机对照试验的系统评价

Objective: To evaluate the effectiveness of scalp acupuncture (SA), a modern acupuncture technique specialized to neurological disorders, in managing motor function and symptoms for Parkinson''s disease (PD) patients. Methods: Two independent reviewers extracted data from all of the randomized clinical trials (RCTs) that assessed the efficacy of SA for PD compared with conventional therapies (CTs). Sixteen electronic databases were searched. The risk of bias was appraised with the Cochrane Collaboration tool, and the reporting of the included studies was evaluated by the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist and the revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guidelines. Results: In total, 4 RCTs met the inclusion criteria. As assessed by the Unified PD Rating Scale (UPDRS), 2 RCTs showed that SA combined with CTs proved superior to CTs alone [60 cases; weighted mean difference, –3.94; 95% confidence interval (CI), –6.05 to –1.84, P=0.01; I2=0%]. Based on the Webster scale, however, 3 RCTs showed no superior effect of SA when combined with CTs with high heterogeneity (154 cases; risk ratio, 1.29; 95% CI, 0.79 to 2.12, P=0.30; I2=84%). The Cochrane risk of bias, adherence to the CONSORT and the STRICTA checklist showed that the quality of all the included RCTs was generally low. Conclusions: The result of our systematic review and meta-analysis suggested that the effectiveness of SA for PD is promising, however, the evidence is not convincing. A sham-controlled RCT design that adheres to the CONSORT and STRICTA guidelines to overcome methodological weakness and that includes a large sample size is strongly recommended to confirm the precise effect of SA on PD.     

Can Ashi Points Stimulation Have Specific Effects on Shoulder Pain? A Systematic Review of Randomized Controlled Trials

Objective: To provide an evidence-based overview regarding the efficacy of Ashi points stimulation for the treatment of shoulder pain. Methods: A comprehensive search [Pub Med, Chinese Biomedical Literature Database, China National Knowledge Infrastructure(CNKI), Chongqing Weipu Database for Chinese Technical Periodicals(VIP) and Wanfang Database] was conducted to identify randomized or quasi-randomized controlled trials that evaluated the effectiveness of Ashi points stimulation for shoulder pain compared with conventional treatment. The methodological quality of the included studies was assessed using the Cochrane risk of bias tool. Rev Man 5.0 was used for data synthesis. Results: Nine trials were included. Seven studies assessed the effectiveness of Ashi points stimulation on response rate compared with conventional acupuncture. Their results suggested significant effect in favour of Ashi points stimulation [odds ratio(OR): 5.89, 95% confidence interval(CI): 2.97 to 11.67, P0.01, heterogeneity: χ2=3.81, P=0.70, I2=0% ]. One trial compared Ashi points stimulation with drug therapy. The result showed there was a significantly greater recovery rate in group of Ashi points stimulation(OR: 9.58, 95% CI: 2.69 to 34.12). One trial compared comprehensive treatment on the myofascial trigger points(MTr Ps) with no treatment and the result was in favor of MTr Ps. Conclusions: Ashi points stimulation might be superior to conventional acupuncture, drug therapy and no treatment for shoulder pain. However, due to the low methodological quality of included studies, a firm conclusion could not be reached until further studies of high quality are available.     

Red ginseng for type 2 diabetes mellitus: A systematic review of randomized controlled trials

Objective:Red ginseng（RG,Panax ginseng C.A.Meyer） is one of the widely used herbs for treating type 2 diabetes mellitus（DM）.However,no systematic review of the effectiveness of RG for type 2 DM is available.This systematic review aimed to evaluate the current evidence for the effectiveness of RG in patients with type 2 DM.Methods:Electronic searches of 14 electronic databases were conducted without language restrictions.All randomized clinical trials（RCTs） with RG as a treatment for type 2 DM were considered for inclusion.Their methodological quality was assessed using the Cochrane criteria.Results:Four RCTs met our inclusion criteria.Their methodological quality was variable.Three of the RCTs compared the effectiveness of RG with placebo.The meta-analysis of these data failed to favor RG over placebo for fasting plasma glucose （FPG）[n=76,weighted mean difference（WMD）:-0.43 mmol/L;95%confidence interval（CI）:-1.16 to 0.30, P=0.25]and fasting plasma insulin（FPI）（n=76,WMD:-8.43 pmol/L;95%CI:-19.54 to 2.68,P=0.14） for 12 weeks of treatment.One RCT compared the effects of RG with no treatment.The results did not suggest favorable effects of RG on FPG,hemoglobin A_1c(HbA_1c) or 2-h blood glucose after a meal（PP2h）.Conclusions: The evidence for the effectiveness of RG in controlling glucose in type 2 DM is not convincing.Few included studies with various treatment regimens prohibit definitive conclusions.More rigorous studies are needed to clarify the effects of RG on this condition.     

Shenqi Fuzheng Injection(参芪扶正注射液) for Advanced Gastric Cancer:A Systematic Review of Randomized Controlled Trials

Objective:To evaluate the effectiveness of Shenqi Fuzheng Injection(参芪扶正注射液,SFI)combined with chemotherapy for advanced gastric cancer.Methods:Randomized controlled trials(RCTs) from10 databases were searched for this meta-analysis till December 31,2012 without language restriction.Grey literature and potential unpublished literature was also searched.The key search terms were "chemotherapy","Shenqi Fuzheng Injection" and "advanced gastric cancer".Criteria were built to select these clinical trials,in which SFI combined with chemotherapy was compared with chemotherapy alone for advanced gastric cancer.The methodological quality of each RCT was assessed using the Cochrane risk of bias tool.RevMan 5.1software was applied for data analyses.Results:Thirteen RCTs involving 860 patients met the selection criteria(all articles were from Chinese databases).The meta-analysis showed positive results for the use of SFI combined with chemotherapy according to quality of life in terms of the scores when compared with chemotherapy alone.Positive results were also obtained for the combination treatment,in terms of complete remission and partial remission efficacy rate,body weight and decreased adverse events including nausea and vomiting at grade 3-4,oral mucositis at grade 1-2,leucopenia at grade 3-4,and myelo-suppression at grade 1-2.Conclusions:This systematic review found encouraging albeit limited evidence for SFI combined with chemotherapy.However,to obtain stronger evidence without the drawbacks of trial design and the quality of studies,we recommend comparative effectiveness researches to test the effectiveness of combination treatment.     

Recent clinical trials of acupuncture in the west: Responses from the practitioners

In the West,hundreds of randomized controlled trials（RCTs）have been performed testing acupuncture.They include two types：those that compare acupuncture to other therapies,usual care or no treatment（pragmatic trials）,and those that have placebo controls（efficacy trials）.Acupuncture has generally performed well against other therapies or no treatment,but until recently,the evidence from placebo controlled trials has been considered equivocal or contradictory.A recent series of large RCTs,mostly performed in Germany and also in the US have included both pragmatic and placebo comparisons.The evidence poises a conundrum for the profession of acupuncture.This essay first describes the two types of RCTs used to examine acupuncture and examine the results of two recent large RCTs for chronic low back pain as representative examples of recent large studies.The essay then presents the most common Euro-American acupuncture professions＇ interpretation of these results.Western responses have included：（1）methodological weaknesses; （2）inappropriateness of placebo controls; （3）questions as to whether acupuncture placebo controls are＂inert＂; （4）rejection of evidence-based medicine epistemology; （5）discrepancy between acupuncture performed in RCTs with real world acupuncture; （6）enhanced placebo effects of acupuncture; and（7）needs to re-evaluate acupuncture theory.The authors do not necessarily agree with all of these responses; they are presented in an attempt to foster critical discussion.The paper also looks at recent neuroimaging experiments on acupuncture that may point to some worthwhile new avenues of investigation.Finally,the Euro-American health care policy consequences of these recent RCTs are discussed.     

Evidence-based Chinese Medicine for Rheumatoid Arthritis

Chinese medicine (CM) has long been adopted for treatment of rheumatoid arthritis (RA). CM approaches RA as it does for other diseases by holistic treatment, focusing on the whole body condition, and giving a variety of applications in accordance with the stage and symptoms of the disease. For seeking the best evidence of CM in making decisions for the care of RA individual patients, a number of clinical studies have been conducted in China to gain credibility with the researchers’ unremitting efforts. But the heterogeneity in many of these clinical trials and the low quality of design in some previous studies present an obstacle to the meaningful systematic reviews (SR) and meta-analysis. Some favorable results in improvement of response to biomedicine and reduction of severe adverse reactions of conventional RA therapy should be carefully interpreted and need further research. Fortunately, more appropriate quality assurance and control of CM researches are raised for the implementation of CM in RA therapy to pave the evidence-based way. Guidelines for the diagnosis and treatment of RA recommend evidence to the clinicians. In future, randomized controlled trials (RCT) with smart and flexible design as a good approach to evaluate the effectiveness will be widely used in CM for RA clinical study, with better research methods suitable for certain CM clinical researches. The development of evidence-based CM for RA will be full of challenge and opportunity, but we have full confidence.     

Clinical Efficacy and Safety of Miniscalpel-Needle Treatment for Tension-Type Headache: A Systematic Review and Meta-Analysis

Objective: To investigate the clinical efficacy and safety of miniscalpel-needle(MSN) treatment for tension-type headache(TTH). Method: Seven medical databases were searched to identify randomized controlled trials(RCTs) evaluating the effect and safety of MSN treatment. All articles published up to November 15, 2018 were retrieved. A meta-analysis was conducted for the included studies, and the risk of bias was assessed. Primary outcomes were visual analogue scale(VAS) or numeric rating scale(NRS) score. Secondary outcomes were clinical effective rates including total effective rate(TER), markedly effective rate(MER), and totally cured rate(TCR) determined by improvement in clinical symptoms or VAS scores, the frequency of adverse events(AEs) that occurred during the study, and participant quality of life(QOL). Results: Seven RCTs involving 724 participants were included. MSN treatment showed significantly higher MER and TCR [relative risk(RR) 1.27, 95% confidence interval(CI) 1.01 to 1.61; RR 1.31, 95% CI 1.09 to 1.57, respectively], but not TER(RR 1.03, 95% CI 0.96 to 1.10) compared to acupuncture. MSN treatment plus conventional treatment showed significant lower VAS and higher TER, MER, and TCR(mean difference –3.54, 95% CI –3.80 to –3.28; RR 1.14, 95% CI 1.06 to 1.23; RR 2.31, 95% CI 1.50 to 3.58; RR 3.01, 95% CI 2.25 to 4.02, respectively) compared to conventional treatment. Conclusions: According to current evidence, MSN treatment as a monotherapy or as an adjunctive treatment to other existing treatments might have benefits on treating TTH. However, since the number and the sample size of studies included were both small and the methodological quality was poor, the findings of this review should be interpreted with great caution, and our confidence in the results is low. A high quality RCT using objective outcomes should be performed on this topic.     

Moxibustion for managing type 2 diabetes mellitus: A systematic review

Objective:Moxibustion is currently used for treating diabetes mellitus（DM） as a non-drug intervention in East Asian countries.This systematic review aims to evaluate the effectiveness of moxibustion for managing the symptoms of type 2 DM patients.Methods:We searched MEDLINE,AMED,EMBASE,CINAHL, The Cochrane Library,six Korean databases,and four Chinese databases.Risk of bias was used for evaluating the quality of the included studies.Results:A total of 5 studies met the inclusion criteria for this review.All of the included studies had high risks of bias.One randomized clinical trial（RCT） compared the effectiveness of one-time moxibustion use with oral administration of glibenclimide and showed the significant effects of moxibustion on glycemic control.Another RCT tested the effectiveness of moxibustion plus conventional treatment,and the moxibustion group reported significant improvement in fasting and postprandial blood glucose levels compared with the conventional treatment group.Two RCTs compared the effectiveness of moxibustion versus acupuncture or moxibustion plus acupuncture,and the combined treatment showed the most favorable effects on the control of blood glucose,urine glucose,and glycocylated hemoglobin A_1C(HbA_1C).One uncontrolled observational study showed favorable effects of moxibustion on the response rate.Conclusions:It is difficult to conclude that moxibustion is an effective intervention for the control of type 2 DM due to the scarcity of trials and the low methodological quality of included studies.Further rigorous RCTs may be necessary to evaluate the effectiveness of moxibustion for type 2 DM.     

Chinese patent medicine for chronic obstructive pulmonary disease based on principles of tonifying Qi,promoting blood circulation by removing blood stasis,and resolving phlegm: a systematic review of randomized controlled trials

OBJECTIVE: To assess the efficacy and safety of Chinese patent medicine(CPM) with the principle of tonifying Qi, promoting blood circulation by removing blood stasis, and resolving phlegm(TQ-PBC-RP)in the management of stable chronic obstructive pulmonary disease(COPD).METHODS: A systematic review of randomized controlled trials(RCTs) identified from electronic databases and print was conducted. RCTs testing CPMs with TQ-PBC-RP against any type of controlled intervention in patients with stable COPD and assessing clinically relevant outcomes were included. Methodological quality was evaluated with the risk of bias tool according to systematic review handbook 5.0.2. Quality of evidence was estimatedby the rating approach developed by the Grading of Recommendations, Assessment, Development,and Evaluation Working Group.RESULTS: Thirteen eligible RCTs with 12 oral CPMs were tested. Significant differences between groups in favor of CPMs were not reported in all trials. Most trials included were deemed to be of low methodological quality with poor evidence quality.Because of large data heterogeneity, statistical pooling was not performed for all outcomes.CONCLUSION: The effectiveness of CPM in the treatment of stable COPD is not supported by evidence. Currently, evidence from RCTs is scarce and methodologically weak. Considering the popularity of CPMs among patients undergoing COPD, rigorously designed trials are warranted.     

Systematic review on randomized controlled clinical trials of acupuncture therapy for neurovascular headache

Objective:To evaluate the effectiveness of acupuncture as a treatment for neurovascular headache and to analyze the current situation related to acupuncture treatment.Methods:PubMed database (1966-2010),EMBASE database(1986-2010),Cochrane Library(Issue 1,2010),Chinese Biomedical Literature Database(1979-2010),China HowNet Knowledge Database(1979-2010),VIP Journals Database(1989-2010), and Wanfang database(1998-2010) were retrieved.Randomized or quasi-randomized controlled studies were included.The priority was given to high-quality randomized,controlled trials.Statistical outcome indicators were measured using RevMan 5.0.20 software.Results:A total of 16 articles and 1 535 cases were included. Meta-analysis showed a significant difference between the acupuncture therapy and Western medicine therapy [combined RR(random efficacy model)=1.46,95%CI(1.21,1.75),Z=3.96,P<0.0001],indicating an obvious superior effect of the acupuncture therapy;significant difference also existed between the comprehensive acupuncture therapy and acupuncture therapy alone[combined RR(fixed efficacy model)=3.35,95%CI (1.92,5.82),Z=4.28,P<0.0001],indicating that acupuncture combined with other therapies,such as points injection,scalp acupuncture,auricular acupuncture,etc.,were superior to the conventional body acupuncture therapy alone.Conclusions:The inclusion of limited clinical studies had verified the efficacy of acupuncture in the treatment of neurovascular headache.Although acupuncture or its combined therapies provides certain advantages,most clinical studies are of small sample sizes.Large sample size,randomized,controlled trials are needed in the future for more definitive results.     

Rotigotine in the Treatment of Primary Restless Legs Syndrome:A Meta-analysis of Randomized Placebo-controlled Trials

The aim of this study was to summarize the efficacy and tolerability of rotigotine in the treatment of primary restless legs syndrome(RLS). Pub Med, EMBASE, and Cochrane Central Register of Controlled Trials(CENTRAL) were searched for English-language randomized controlled trials(RCTs) that assessed the effectiveness of rotigotine for RLS. The pooled mean change from baseline in International RLS(IRLS) Study Group Rating Scalescore and relative risk(RR) of response based on the Clinical Global Impression-Improvement(CGI-I) scale score were applied to evaluate the outcomes. The pooled proportions of adverse events(AEs) were also estimated. Six RCTs were included. The meta-analysis showed a favorable effectiveness of rotigotine versus placebo on RLS [mean change on IRLS score: mean difference(MD)=–4.80; 95% confidence interval(CI): –5.90 to –3.70; P<0.00001 and RR of response on CGI-I was 2.19; 95% CI: 1.86 to 2.58, P<0.00001]. The most common AEs were application site reactions, nausea, headache and fatigue. In general, rotigotine was well-tolerated in patients with primary RLS. Based on the findings from the meta-analysis, rotigotine was more significantly efficacious in the treatment of RLS than placebo. Nevertheless, long-term studies and more evidence of comparisons of rotigotine with other dopamine agonists are needed.     

Effect of Zhizhu Kuanzhong Capsules(枳术宽中胶囊) on Treatment of Functional Dyspepsia: A Meta-Analysis of Randomized Controlled Trials

Objective: To evaluate the effect of Zhizhu Kuanzhong Capsules(枳术宽中胶囊, ZKC) for functional dyspepsia(FD) through meta-analysis. Methods: Online databases, including PubMed, EM base, China National Knowledge Infrastructure, Wanfang Data, VIP database and Cochrane Library, were searched for randomized controlled trials(RCTs) of ZKC for FD from the inception to April, 2016. Trials were selected according to inclusion criteria and were evaluated with quality assessment standards in the Cochrane Handbook for Systematic Reviews of Interventions and Jadad scale. RevMan 5.3 and GRADEprofiler 3.6 were used for statistical analysis and evidence quality assessment. Results: Twenty-three trials with 2,496 patients were included and most of them were of poor methodological quality. ZKC alone or ZKC combined with routine Western medicine(WM) showed a better clinical effect rate compared with the control group of WM [odds ratio(OR)=3.32, 95% confidence interval(2.66, 4.15), P0.00001]. No serious adverse reactions were reported. Conclusions: ZKC alone or ZKC combined with routine WM could significantly improve the clinical effective rate in the treatment of FD. The quality of the evidence is low, so it is necessary to design multicenter, strictly randomized and double-blind controlled trials with large samples to validate the conclusions.     

Qingkailing Injection (清开灵注射液) for Treatment of Children Pneumonia Induced by Respiratory Syncytial Virus: A Meta-Analysis of Randomized Controlled Trials

Objective: To evaluate the efficacy and safety of Qingkailing Injection(清开灵注射液, QKL) for treatment of children pneumonia caused by respiratory syncytial virus(RSV). Methods: Randomized clinical trials(RCTs) comparing QKL with ribavirin injection in the treatment of children pneumonia induced by RSV were searched in Pub Med, Science Direct, Cochrane Library, Chinese VIP database, CNKI and Wanfang databases from their inception to March 2014. Meta-analyses were performed using RevMan 5.2 software. The methodological quality of the selected RCTs was evaluated by the Modified Jadad Score. The primary outcome measures were effective rate and the secondary outcomes were relief time of fever and cough. Results: Seven RCTs with 992 cases published from 2008 to 2013 were identified. The meta-analysis results indicated that QKL was more effective in cure rate [risk ratios(RR)=1.32, 95% CI(1.17, 1.50), P0.01], total effective rate [RR=1.07, 95% CI(1.02, 1.13), P=0.009] and less fever clearance time [mean difference=–0.73, 95% CI(–1.22, –0.23), P=0.004], compared with ribavirin injection in the treatment of RSV-induced children pneumonia. No dead case was reported in all trials. There were 3 trials mentioned adverse events, 2 reported no obvious adverse event occurred while 1 reported adverse events described as skin hypersensitivity, elevation of ALT, a mild abnormal of hepatic and renal function in both QKL and ribavirin group. Conclusions: QKL was an effective and relatively safe option for the treatment of RSV-induced children pneumonia. These therapeutic effects were promising but need to be interpreted with caution due to variations in the treatment and methodological weakness in the studies.     

Clinical research on acupuncture — Concepts and guidance on efficacy and effectiveness research

Over the last few years a number of large acupuncture trials have been carried out in western countries.The following article draws on the experience from these recent large-scale trials on acupuncture to outline the way randomized trials could be used to answer questions on efficacy,effectiveness and efficiency.It will provide guidance,firstly on the underlying concepts of both efficacy and effectiveness and secondly on designing both types of trials.In addition,the controversy over specific and non-specific effects of acupuncture,emerging from the results of the above-mentioned trials,will be highlighted.Suggestions for future clinical research on acupuncture include:greater reflection on the complex approach of Chinese medicine, and transparent and detailed reporting according to CONSORT and STRICTA guidelines.The current data on acupuncture point-specific effects do indeed have relevance,however for valid decision-making on acupuncture,further clinical trials on effectiveness and cost-effectiveness are required to provide realistic benefit estimates for future health care.     

Systematic review of randomized controlled trials of traditional Chinese medicine treatment of non-acute bronchial asthma complicated by gastroesophageal reflux

OBJECTIVE:To assess the effectiveness and safety of Traditional Chinese Medicine(TCM) treatment of non-acute bronchial asthma complicated by gastroesophageal reflux.METHODS:We searched databases from MEDLINE,Cochrane Library,CNKI,VIP,CBM,Wanfang Data,and TCM Database Systems.All randomized,controlled trials(RTCs) of TCM treatment of non-acute asthma complicated by gastroesophageal reflux were included.Data were independently collected by two reviewers.The standards for assessing quality described in the Cochrane Handbook for Systematic Reviews of Interventions were used to evaluate articles.Meta-analyses were conducted using RevMan 5.0.17 software.Heterogeneity was assessed,and a corresponding effects model was used to merge and analyze results.Indexes used to evalu-ate curative effects were:clinical efficacy,symptom scores,pulmonary function values,and adverse incidents.Effectiveness was indicated using risk ratio(RR) or mean difference(MD),and 95% confidence intervals(CIs) were calculated.RESULTS:Six RCTs were included,involving 304 patients with non-acute asthma complicated by gastroesophageal reflux.The treatment groups received Chinese drugs alone or TCM combined with standard Western medical treatment,and the control groups received standard Western medical treatment alone.Standard Western medical treatment included anti-inflammatory drugs and bronchodilators for asthma,and drugs to promote gastric peristalsis and inhibit gastric acid production for gastroesophageal reflux.Methodological quality was low in all six RCTs.Two RCTs showed that clinical efficacy was higher in the treatment group than in the control group(RR:1.43,95%CI:1.10 to 1.87 vs RR:1.51,95% CI:1.09 to 2.08).One RCT showed that the asthma score was lowered more effectively in the treatment group than in the control group(MD:-1.10,95% CI:-2.04 to-0.16).Two RCTs showed that the gastroesophageal reflux score was reduced more effectively in the treatment group than in the control group(RR:-3.70,95% CI:-4.30 to 3.10 vs RR:-5.30,95% CI:-6.32 to-4.28).One RCT showed that some pulmonary function values were improved more effectively in the treatment group than in the control group(P< 0.05).No differences were seen in the various indexes between groups in the other RCTs.No adverse reactions,dropout rates,or follow-up rates were reported in any of the RCTs.CONCLUSIONS:The clinical symptoms ofnon-acute asthma complicated by gastroesophageal reflux can be improved by some Chinese drugs.Curative effects can be increased by combining the use of TCM with Western medicine.Because of the small quantity and low quality of research reported to date,it is necessary to conduct further RCTs to confirm these results.The results of this systematic review indicate that the quality of future clinical trials should be improved by including larger patient numbers,correctly randomizing patients into study groups,using blinding methods to measure and assess outcomes,and using accepted indexes to evaluate curative effects.