Safety and effectiveness of Traditional Chinese Medicinal herbs for diabetic foot: a systematic review and Meta-analysis

Objective

To evaluate the safety and effectiveness of traditional Chinese medicinal herbs (TCMHs) as an adjunctive treatment for diabetic foot (DF).

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

ObjectiveTo systematically evaluate the clinical efficacy and safety of puerarin injection in the treatment of diabetic peripheral neuropathy (DPN).MethodsRandomized 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.ResultsTwenty-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 DPN in terms of total effective 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, no serious ADRs were reported.ConclusionsPuerarin 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.     

Effect of curcumin on rats/mice with diabetic nephropathy: a systematic review and Meta-analysis of randomized controlled trials

ObjectiveTo assess the renal protective effects of curcumin administration on diabetic rats/mice.MethodsDatabases were searched electronically and conference papers searched manually for search terms to find relevant studies. Articles were assessed independently by two reviewers. Review Manager 5.1 was used for data analysis.ResultsFourteen randomized controlled experiments were included. Meta-analysis demonstrated that blood sugar levels and kidney weight to body weight ratios in the model group were higher than those in the normal group, and the curcumin group had significantly lower mesangial area to glomerular area ratios compared with the model group, and also lower levels of urinary protein, blood urea nitrogen and serum creatinine.ConclusionsCurcumin shows protective effects on the kidneys of rats/mice with diabetes.     

Current situation on the reporting quality of randomized controlled trials in 5 leading Chinese medical journals

Objective： The Consolidated Standards for Reporting of Trials （CONSORT） statement has already proved to be an efficient standard for reporting quality of randomized controlled trials （RCTs）. However, most of the Chinese medical journals have not endorsed the CONSORT statement. The current situation about the reporting quality of RCTs in Chinese medical journals is still unclear. The purpose of the study was to evaluate the reporting quality of RCTs on papers published in 5 leading Chinese medical journals. Methods： We evaluated 232 original RCT papers using a reporting quality scale based on CONSORT statement from 2001 to 2006 in 5 Chinese medical journals （Journal type 1） without adoption of CONSORT and Chinese Journal of Evidence-based Medicine （Journal type 2） which adopted CONSORT in 2004. We measured the inclusion of 26 items for the reporting quality scale and 6 core items of each RCT report, gave score to each item and calculated the total score obtained in each report and the proportion of reports including individual items. The reporting quality of RCT trials from 2001 to 2003 （pre-adoption period） was compared with that from 2004 to 2006 （post-adoption period）. Results： The average reporting quality of RCTs was moderate （mean score, 15.18）, and the mean score of the 6 core items was low （mean score, 1.09） in 5 leading journals. The difference in the total score and the score of the 6 core items between pre-adoption period （2001-2003） and post-adoption period （2004-2006） was statistically significant （P=0.003; P=0.000）. Interaction between journal type and period was not significant （F=0.76; P=0.383）. We concluded that the change tendency of reporting quality between Journal type 1 and 2 was not different. But as to the core items of sequence concealment and intention-to-treat analysis, the increases were greater for Journal type 2 when evaluated against Journal type 1 （P=0.038; P=0.016）. Conclusion： The reporting quality of RCT trials in 5 leading Chinese medical journals is improving. However, the lack of important items in RCT trials remains a serious problem. We recommend the endorsement of the Consolidated Standards for Reporting of Trials statement in Chinese medical journals and the continuing education on evidence-based medicine in China.     

Influence of clinical pathways used the hospitals of Traditional Chinese Medicine on patients hospitalized with stroke: a systematic review and Meta-analysis

Objective

To evaluate the influence of clinical pathways in the hospitals using the Traditional Chinese Medicine in treatment of stroke in terms of postoperative complications, length of stay (LOS), costs incurred during hospitalization, compared with standard medical care.

Meta-analysis on randomized controlled trials for scalp acupuncture treatment of stroke: A systematic review

OBJECTIVE

To conduct a systematic review to assess the clinical effectiveness of scalp acupuncture (SA) for stroke.

Adherence reporting in clinical trials of type 2 Diabetes Metellius in the field of Traditional Chinese Medicine

OBJECTIVE

To assess the medication adherence reporting in clinical trials the field of Traditional Chinese Medicine (TCM) and the impact factors of medication adherence.

上市中成药治疗2型糖尿病随机对照试验方法学系统综述

背景：临床疗效和特异性作用是治疗2型糖尿病选择用药的重要影响因素,而随机对照试验（randomized controlled trial,RCT）是评价临床疗效的有效方法。随着治疗2型糖尿病上市中成药种类的增多,其临床疗效定位及疗效评价的RCT的方法学值得探索。目的：调查治疗2型糖尿病上市中成药种类及其上市后对其进行临床疗效评价的RCT的方法学质量。检索策略：手工及电子检索《新编国家中成药》、《中华人民共和国药典临床用药须知中药卷》、国家食品药品监督管理局网站、中华人民共和国人力资源与社会保障部网站,查找治疗2型糖尿病的中成药;电子检索中文医学文献数据库：中国知网数据库、重庆维普中文科技期刊数据库、中国生物医学文献数据库网络版和万方数据。所有数据库检索时间从建库截止至2011年8月。纳入标准：筛选干预时间≥3个月的上市中成药治疗2型糖尿病的RCT报告。资料提取与分析：由两名系统评价员独立提取并筛选研究信息。以偏倚风险评价研究质量,资料提取表内容包括RCT的设计与方法、中成药种类、药品说明书报告的适应证、药品的功能主治。结果：检索出149种具有2型糖尿病治疗作用的中成药,其中以治疗阴虚热盛、气阴两虚、气阴两虚兼血瘀证候的中成药种类为主,各为48种（32％）、58种（39％）、22种（15％）。获得41篇符合纳入标准的RCT研究文献,无多中心RCT研究。偏倚风险分析显示,81％的研究只交代了使用随机分组方法但未报告随机数字产生的方法;98％的研究未报告随机序列隐藏的方法;5％的研究报告使用安慰剂;10％的研究报告了结局损耗;无1项研究报告使用意向性治疗分析;98％的研究报告了2型糖尿病诊断标准,研究对象主要是门诊为主无明显并发症的2型糖尿病患者（76％）;报告的样本量为（106±60）人,最小样本量为40人,最大样本量300人;纳入研究中未见终点结局报告。结论：纳入的RCT研究报告的研究对象、诊断标准、纳入和排除标准以及临床结局指标等研究内容未能体现中成药上市后对其进行临床疗效评价的目的,也未能反映中医辨证论治特色。建议尽快制定上市中成药临床疗效评价的设计、实施及报告规范,改善对上市中成药进行临床疗效评价的方法,促进中成药的合理使用。     

磷酸奥司他韦治疗流感疑似患者临床疗效分析

目的观察磷酸奥司他韦治疗流感流行季节中临床诊断的流感疑似患者的临床疗效。方法本研究为随机、对照、开放临床试验。入选患者72例,随机分为2组。治疗组36例,服用磷酸奥司他韦75mg,每日2次,共5d;对照组36例,服用症状缓解药物美息伪麻片。结果治疗前2组患者的病情严重程度无显著性差异(P>0·05)。治疗后,奥司他韦治疗组和对照组发热平均缓解时间分别为(38·67±20·31)h和(72·67±38·80)h,显著有统计学意义(P<0·0001)。发热持续时间治疗组比对照组平均缩短36h。奥司他韦治疗组和对照组其它症状的曲线下面积(AUC)分别为(410·33±290·55)分和(675·00±451·82)分,显著有统计学意义(P<0·005)。其他流感症状持续时间治疗组比对照组平均缩短27h。平均缓解时间分别为(46·45±31·71)h和(73·09±41·39)h(P<0·005)。2组观察期间并发症发生率和不良反应发生率显著均无统计学意义(P>0·05)。结论磷酸奥司他韦治疗临床诊断的流感疑似患者可以快速有效缓解症状,且不良反应少,应用安全。     

Impact of vitamin D supplementation on the outcome of tuberculosis treatment: a systematic review and meta-analysis of randomized controlled trials

Background Vitamin D supplementation is believed to be beneficial in the treatment of patients with tuberculosis （TB）,however,results from clinical trials have been inconclusive.Methods We performed a systematic literature search across MEDLINE,EMBASE,the Cochrane Central Register of Controlled Trials,Springer,EBSCO,ProQuest,HighWire Press,and Web of Science,published as of December 2013.We individually inspected citations and extracted data independently.We estimated pooled risk ratios （RR） and 95％ confidence intervals （CI） using random-effect models.We also assessed risk of bias using the Jadad scale and the quality of the evidence using GRADE.We included all randomized controlled trials comparing vitamin D with or without standard TB therapy or placebo.Results A total of five studies were analyzed in our meta analysis covering 841 newly-diagnosed TB cases.Patients receiving vitamin D supplementation had a 39％ reduced risk of sputum smear or culture positive after six weeks of antiTB treatment than those in the control group,although this is not statistically significant （pooled RR 0.61,95％ CI 0.24 to 1.56,P=0.30）.Apart from an increased serum vitamin D level in the supplement group after eight weeks of treatment there was no evidence of any additional adverse effects related to vitamin D.Conclusions The meta analysis results indicate that vitamin D supplementation does not seem to have any beneficial effect in the treatment of TB.Future rigorous randomized controlled trials are needed to explore whether the supplementation of vitamin D could shorten treatment duration and to confirm whether the polymorphisms of vitamin D receptor have any potentially beneficial effect.     

中药治疗多发性硬化随机对照试验的系统综述和meta分析

背景：中药被广泛地应用于多发性硬化（multiplesclerosis,MS）的治疗,但对其疗效和安全性尚缺乏系统的评价。 目的：评价中药治疗MS的疗效和安全性。检索策略：检索中国知网数据库、中国生物医学文献数据库网络版、重庆维普中文科技期刊数据库、万方数据库、PubMed、Cochrane图书馆等数据库,检索时间从建库截止至2011年3月15日。 纳入标准：纳入比较中药与西药或安慰剂治疗MS的随机对照试验。对于中药联合西药与单纯使用西药比较的随机对照试验也予以纳入。 资料提取与分析：由两名评价员独立地进行文献的筛选,对纳入的研究进行质量评价及资料提取,用RevMan5．1．0软件进行meta分析。结果的效应指标为均数差（meandifference,MD）,均以95％可信区间（confidenceinterval,CI）表示。结果：共计纳入16项随机对照试验,涉及913例MS患者。所纳入的研究质量普遍较差。所纳入的研究中有13项研究报道了神经功能缺损,通过Kurtzke扩展残疾状态量表（KurtzkeExtendedDisabilityStatusScale,EDSS）评分进行测评,其中2项研究显示中药组的EDSS评分低于对照组,MD及95％CI为-0．88（-1．26,-0．50）,另外8项研究进行了描述性分析,显示治疗组的EDSS评分低于对照组;5项研究报道了中药治疗MS的复发率,2项研究显示,治疗组的复发率低于对照组,MD及95％CI为-0．34（-0．52,-0．16）,另外3项研究进行了描述性分析,显示治疗组复发率低于对照组。次要指标如无效率、临床症状评分、神经功能评分和免疫指标的改善均优于对照组。纳入的2项研究报道了磁共振成像下的病灶数目或范围,治疗组与对照组比较有改善的趋势,但无统计学差异。中药组的药物使用不良反应低于对照组,且能减轻激素使用的不良反应。 结论：根据现有证据,中医药治疗MS能改善神经功能缺损,降低复发率,改善临床症状、神经功能体征及免疫指标,且未发现明显的副作用,同时能减轻激素的副作用。但由于纳入的研究质量不高,仍需更多高质量研究以增加证据的强度。     

小柴胡汤治疗慢性乙型肝炎随机对照试验的系统评价

小柴胡汤是《伤寒论》中的经典方,广泛用于慢性肝病的治疗,尤其在日本每年有超过100万的慢性肝病病人使用。目的：运用循证医学系统综述方法评价小柴胡汤治疗慢性乙型肝炎的抗病毒及保肝疗效和安全性。检索策略：文献检索包括电子与手工检索。电子检索MEDLINE数据库、中国学术期刊全文数据库（CNKI）、中文科技期刊全文数据库（重庆维普）、中国生物医学文献数据库（Chinese Biomedical LiteratureDatabase,CBM）、中文生物医学期刊数据库（Chinese Medical Current Contents,CMCC）、中医药期刊文献数据库。检索日期截止至2009年11月8日。纳入标准：收集比较小柴胡汤与安慰剂、非特异性治疗、抗病毒药物治疗慢性乙肝的随机对照试验。小柴胡汤联用抗病毒药物与抗病毒药物比较的试验也予以纳入。资料提取与分析：两人独立提取资料,采用Cochrane协作网提供的软件RevMan 5.017进行资料分析。结局的效应指标为危险比率（risk ratio,RR）或均数差（mean difference,MD）,均以95%可信区间表示。结果：16篇随机对照试验共治疗1601名慢性乙肝病人满足纳入标准。所纳入的1篇英文文献质量较高,其余15篇中文文献质量普遍偏低。在肝功能及抗病毒效应的综合疗效评价分析中,小柴胡汤联合抗病毒药物治疗优于单用抗病毒药物,小柴胡汤与安慰剂在改善肝功能和抗病毒效应方面的差异无统计学意义,小柴胡汤与丹参注射液联用在肝功能恢复上优于非特异性治疗。纳入试验未报告小柴胡汤的副作用,抗病毒治疗对个别患者有较严重的副作用。结论：纳入本系统评价的部分试验表明小柴胡汤联合抗病毒药物治疗慢性乙肝具有改善肝功能和清除血清标志物的作用。但是由于用中文发表的临床试验质量较低,对那些疗效较好的中药制剂需要作进一步的验证,试验的设计及报告应按照国际规范执行。     

Effect of Traditional Chinese Medicine on oligoasthenospermatism: a narrative review

ObjectiveTo summarize the treatment of oligoasthenospermatism (OAS) with Traditional Chinese Medicine (TCM).MethodsThe literature describing OAS treatment with TCM in the past 4 years was searched. Three studies were reviewed, evaluated, and summarized. The etiology and pathogenesis, pattern differentiation, medicine administration, and combination of TCM with Western Medicine were all examined.ResultsTCM had an advantage in treating OAS and had fewer adverse events than conventional treatments.ConclusionAlthough TCM has an advantage in treating OAS and fewer adverse events, the efficacy of TCM and modern medicine on OAS is unsatisfactory.     

Application of Traditional Chinese Medicine injection in treatment of primary liver cancer:a review

OBJECTIVE:To investigate the application of Traditional Chinese Medicine Injections(TCMIs) for treatment of primary liver cancer(PLC).METHODS:A literature review was conducted using PubMed/Medline,Cochrane Library Controlled Clinical Trials Database,China National Knowledge Infrastructure(CNKI),China Scientific Journal Database(CSJD) and China Biology Medicine(CBM).Online websites including journal websites and databases of ongoing trials,as well as some Traditional Chinese Medicine journals that are not indexed in the electronic databases were also searched.RESULTS:The literature review showed that TCMIs as adjunctive medication for the treatment of PLC could regulate patient immunity,reduce bone marrow suppression,relieve clinical symptoms,and improve quality of life,as well as control disease progression and prolong survival time.CONCLUSION:Within the limitations of this review,we conclude that application of TCMIs as adjunctive medication may provide benefits for patients with PLC.Further large,high-quality trials are warranted.     

中药治疗冠心病室性早搏随机对照试验的系统评价

目的评价中药治疗冠心病室性早搏的有效性和安全性。方法根据Cochrane协作网系统评价方法,全面检索中国期刊全文数据库(CNKI,包库)、维普中文期刊数据库(VIP)、万方学术期刊全文数据库、中国生物医学文献服务系统(CBM)、中国生物医学期刊引文数据库(CMCI/CMCC整合版)、以及中医药、中西医结合在线数据库。筛选文献,评价质量,提取资料,并用RevMan5.1软件进行Meta分析。结果纳入8篇随机对照试验,1306例患者,所有试验改良Jadad质量评分≥4分。室性期前收缩疗效:参松养心胶囊优于美西律[RR=1.39,95%CI(1.14,1.69),P=0.001],参松养心胶囊优于心律宁[RR=1.37,95%CI(1.18,1.69),P<0.0001]。中医证候疗效:参松养心胶囊优于心律宁[RR=1.34,95%CI(1.21,1.49),P<0.001],复脉颗粒优于美西律[RR=2.17,95%CI(1.37,3.43),P=0.001]。心电图疗效:参松养心胶囊优于心律宁[RR=1.48,95%CI(1.15,1.90),P=0.002]。不良反应共13例,主要为恶心、食欲不振等胃肠道症状,未发现肝、肾功能异常。结论参松养心胶囊等中药能有效地改善冠心病室性期前收缩,而且安全可靠。     

灯盏花注射液治疗脑梗死随机对照试验的系统评价

目的：系统评价灯盏花制剂治疗脑梗死的疗效及安全性。方法：搜集灯盏花治疗脑梗死随机对照试验的文献,筛选合格研究,应用Jadad评分法进行质量评价,运用异质性检验、Meta-分析、漏斗图分析、敏感度分析等方法统计相关数据。结果：19项符合纳入标准,Jadad评分显示所有研究得分均低于3分,属低质量文献。Meta-分析结果显示,总有效率比较的合并OR=3.61,95%CI为（2.93,4.44）。结论：Meta-分析结果提示灯盏花制剂有改善脑梗死患者全血流变指标及微循环、增加脑血流量、且其安全范围大,临床应用不良反应小。由于灯盏花治疗脑梗死随机对照试验的方法学质量较低,存在潜在的临床异质性及发表性偏倚,以及待评价研究等因素的影响,降低了上述结论的可靠性,因此本系统评价尚不能肯定证明灯盏花制剂对于脑梗死的疗效及安全性。     

阿齐霉素治疗呼吸、泌尿生殖系统细菌感染的临床随机对照研究

目的 :评价国产阿齐霉素 (Azithromycin)粉针剂对呼吸、泌尿生殖系统感染的临床疗效及安全性。　方法 :患者 1 6 0例 ,分为试验组 (阿齐霉素 ) 6 0例、对照组 (克拉霉素 ) 6 0例、非对照试验组 (阿齐霉素 ) 4 0例。给药方法为阿齐霉素 0 .5 g,每天 1次 ,静滴 ;克拉霉素 0 .5 g,每天 2次 ,静滴 ;疗程均为 5～ 7天。　结果 :1 0 0例应用阿齐霉素治疗的急性细菌性感染患者 ,总有效率为 92 .0 %。呼吸系统感染随机对照研究显示 ,试验组的痊愈率为 6 3.3%、有效率为 86 .7% ,略高于对照组的痊愈率 (5 5 .0 % )、有效率 (85 .0 % ) ,但在统计学上并无显著差异 (P>0 .0 5 ) ;非对照试验组 (泌尿生殖系统感染、化脓性扁桃体炎、皮肤软组织感染等 )的痊愈率为 97.5 % ,有效率为 1 0 0 .0 %。试验组患者感染菌清除率为 96 .7% ,略高于对照组清除率 93.3% ,统计学分析无显著差异。应用阿齐霉素的患者总不良反应发生率为1 3.0 % ,其中试验组为 1 5 .0 % ,明显低于对照组 (45 .0 % ,P<0 .0 1 )。　结论 :阿齐霉素粉针剂对呼吸系统、泌尿生殖系统、化脓性扁桃体炎、皮肤软组织感染不仅有很好的疗效 ,而且安全、可靠     

奥司他韦治疗流行性感冒的临床随机对照研究

目的观察奥司他韦治疗流行性感冒(简称流感)的临床疗效。方法采用随机、对照、开放性的临床试验设计。入选患者70例,可分析疗效病例共47例,随机分为两组,试验组22例,服用奥司他韦75mg,2次/d,共5d;对照组25例,接诊医生按既往经验给予药物治疗。结果两组患者发热、肌痛、乏力缓解时间,鼻卡他/鼻塞、咽喉痛、头痛、发冷/出汗症状持续时间间差异均有统计学意义(P<0.05);两组患者咳嗽缓解时间间差异无统计学意义(P>0.05)。与对照组相比,试验组抗菌药物使用率及急诊临时输液率均降低(P<0.05);两组患者的并发症发生率和药物不良反应发生率间差异均无统计学意义(P>0.05)。结论奥司他韦能够明显缩短流感主要症状持续时间,减少抗菌药物使用,降低患者临时输液率,且安全性好。     

从系统综述看中国随机对照试验的质量

随机对照试验是系统综述的证据来源,系统综述结论的可靠性与原始文献的质量息息相关。目前,中国的随机对照试验质量的现状尚不令人满意,导致系统综述在评价干预措施的疗效时难以得到确定的结论,仍需要进一步的高质量的随机对照试验研究加以证实。本文从中国随机对照研究文献质量的现状出发,探讨低质量临床研究文献的纳入对系统综述结论的影响,以及在此条件下如何进行系统综述,并介绍了评价随机对照试验质量的方法,最后提出提高中国临床随机对照试验质量的策略,包括培养诚信的科研环境和社会氛围,加强对临床医生的方法学培训,实施临床试验注册制度,重视临床研究的质量控制以及医学期刊对论文质量的把关。     

Western medication plus Traditional Chinese Medicine preparations in patients with chronic heart failure: a prospective,single-blind,randomized, controlled,and multicenter clinical trial

Objective

To assess the efficacy and safety in patients with chronic heart failure (CHF) of Western medication plus Traditional Chinese Medicine (TCM) preparations.