Heat-sensitive moxibustion for lumbar disc herniation: a meta-analysis of randomized controlled trials

Objective

To assess the efficacy and safety of heat-sensitive moxibustion in the treatment of lumbar disc herniation (LDH).

Methods

Randomized controlled trials (RCTs) involving heat-sensitive moxibustion in the treatment of LDH were retrieved from the Chinese Biological Medical Literature database (1978–20011), Weipu database (1989–2011), Wanfang digital journal (1998–2011), China National Knowledge Internet (1979–2011), PubMed (1966–2011), EMBASE (1980–2011), and Cochrane Library (Issue 1, 2011). Hand-search of the relevant journals from the Library of Jiangxi University of Traditional Chinese Medicine was also adopted for the collection of data. Data were extracted and evaluated by two reviewers independently with a specially designed extraction form. The Cochrane Collaboration's Rev-Man 5.0.20 software was used for data analyses.

Results

A total of 6 trials involving 580 patients were included. Meta-analysis showed that the total effectiveness rate in the heat-sensitive moxibustion group was significantly different when compared with conventional moxibustion [RR=1.19, 95% CI [1.06, 1.33)] and diclofenac sodium [RR=1.47, 95% CI [1.17, 1.85)], but similar to that of acupuncture. The cure rate in the heat-sensitive moxibustion group was significantly different when compared with conventional moxibustion [RR=1.58, 95% CI (1.04, 2.40)] and diclofenac sodium [RR=1.91, 95% CI (1.01, 3.60)], but similar with that of acupuncture. In terms of the Japanese Orthopaedic Association scores, significant differences were noted in subjective indices, objective indices, and daily life subscales. Two trials reported that there were no adverse events over the duration of treatment.

Conclusion

Compared with conventional moxibustion, acupuncture, and diclofenac sodium, heat-sensitive moxibustion in the treatment of LDH is superior in efficacy. Further large-scale trials are required to define the role of heat-sensitive moxibustion in the treatment of this disease.     

采用CONSORT和STRICTA评价近5年针刺治疗偏头痛随机对照试验

目的采用试验报告统一标准(CONSORT)和针刺临床试验干预措施报告的标准(STRICTA)评价针刺治疗偏头痛随机对照试验(RCT)中英文文献的报告质量。 方法计算机检索PubMed、Cochrane Library、中国期刊全文数据库(CNKI)、维普期刊资源整合服务平台(VJIP)数据库,文种限制为中英文,检索时限为2012年1月至2017年4月。由2位评价者根据纳入与排除标准独立进行文献筛选,并采用国际公认的CONSORT声明和STRICTA标准评价报告质量。 结果最终纳入18篇文献,根据CONSORT条目,15篇(83.33%)描述各组的基线情况和临床特征;8篇(44.44%)提及产生随机分配序列的方法;10篇(55.56%)描述分配方案隐藏;10篇(55.56%)采用盲法;6篇(33.33%)提及样本含量的计算。根据STRICTA条目,8篇(44.44%)文献提及针刺反应;有11篇(61.11%)提及针刺深度;5篇文献(27.78%)报告治疗师的资历,亦提及医师的临床实践时间。 结论研究纳入的针刺治疗偏头痛中英文文献,根据CONSORT声明和STRICTA标准的条目,研究报告质量仍然存在不少问题。今后应提倡采用国际公认的CONSORT声明和STRICTA标准对针刺治疗的RCT进行规范报告。     

正清风痛宁制剂治疗慢性肾小球肾炎随机对照试验的系统评价和Meta分析

目的:评价正清风痛宁制剂治疗慢性肾小球肾炎(chronic glomerulonephritis,CGN)的疗效与安全性。方法:计算机检索PubMed、CoChrane library、Embase、中国知网、万方、维普,查找正清风痛宁制剂治疗CGN随机对照试验(randomized controlled trials,RCTs),按照CoChrane系统评价方法,采用Revman 5.3软件进行分析。结果:纳入5篇随机对照试验354例患者,分析显示减少蛋白尿方面,正清风痛宁制剂加载西药治疗组疗效优于西药对照组,且正清风痛宁制剂治疗组优于雷公藤多甙对照组。应用正清风痛宁制剂可能会引起胃肠道反应、皮疹等,但多数在停药或药物调整后恢复正常。结论:正清风痛宁制剂治疗CGN具有减少尿蛋白作用,安全性较好。但鉴于纳入研究方法学质量较低,临床需要大样本、多中心、高质量的随机对照试验加以验证。     

Effect of Banxiaxiexin Tang on treatment of functional dyspepsia: a Meta-analysis of randomized controlled trials

Objective

To evaluate the efficacy of Banxiaxiexin Tang compared with Western Medicine in the treatment of functional dyspepsia (FD) through Meta-analysis.

Methods

Literature was searched in the following databases: MEDLINE, Excerpta Medica Database, Chinese Medical Current Contents, China Science and Technology Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure. Randomized controlled trials evaluating the efficacy of Banxiaxiexin Tang for the treatment of FD were selected according to certain standards including clear general situation of patients, specific diagnostic criteria, definite clinical outcomes, etc. Articles were evaluated with quality assessment standards in the Cochrane Handbook for Systematic Reviews of Interventions. Meta-analysis was conducted with RevMan 5.0.23 software.

Results

Ten articles with a total of 972 patients were included. The comparison of efficacy between Banxiaxiexin Tang and Western Medicine showed a combined effect size [OR=2.75, 95% CI (1.86–4.07)] and combined effect of value of Z=5.07 (P<0.000 01), suggesting a significant difference between the groups.

Conclusion

Banxiaxiexin Tang was more effective than Western Medicine in treating FD.     

天舒胶囊治疗偏头痛40例

目的:比较天舒胶囊(川芎、天麻等)和氟桂利嗪对偏头痛的疗效。方法:82例偏头痛患者随机分为治疗组(40例)和对照组(42例)。治疗组给予天舒胶囊,每天3次,每次4粒(共1.36 g),饭后口服,连用2个月,对照组给予氟桂利嗪胶囊每晚1粒(5 mg)。治疗2个月。患者在观察期间不得服其它镇痛剂。记录偏头痛发作频率和每月头痛发作持续时间,停药后仍具有阳性结果的持续时间,出现副作用的时间。治疗前及治疗2个月时进行体重以及血、尿常规,肝、肾功能,心电图检查。随访1年。结果:天舒胶囊较氟桂利嗪减少偏头疼发作频率和每月头痛发作持续时间,停药后仍具有阳性结果的持续时间更长(P<0.05)。结论:天舒胶囊较氟桂利嗪减少偏头痛发作频率和严重程度,具有更持久的预防保护作用,副作用小且无锥体外系反应。     

川芎清脑颗粒联合氟桂利嗪对比单用氟桂利嗪治疗偏头痛疗效和安全性的Meta分析

目的:系统评价川芎清脑颗粒联合氟桂利嗪对比单用氟桂利嗪治疗偏头痛的疗效和安全性。方法:计算机检索中国知网、万方、维普、中国生物医学文献数据库、PubMed、EMbase、The Cochrane Library,搜集川芎清脑颗粒联合氟桂利嗪对比单用氟桂利嗪治疗偏头痛的随机对照试验(RCT)。筛选文献、提取资料后采用Jadad量表对纳入文献进行治疗评价,采用RevMan5.3软件对治疗总有效率、头痛程度视觉模拟评分(Visual Ana logue Score,VAS)及不良反应反生率等指标进行Meta分析。结果:共纳入9项RCT,共计883例患者。Meta分析结果显示:试验组治疗有效率[RR=1.20,95%CI(1.13,1.28),P<0.001]优于对照组,差异有统计学意义;治疗后患者头痛程度(VAS)评分[MD=-1.41,95%CI(-2.02,-0.81),P<0.001]低于单用氟桂利嗪,差异有统计学意义;两组比较不良反应发生率[OR=0.84,95%CI(0.28,2.56),P=0.76],差异无统计学意义(P>0.05)。结论:川芎清脑颗粒联合氟桂利嗪治疗偏头痛的疗效显著优于单用氟桂利嗪,在安全性方面二者没有差异。     

仙灵骨葆胶囊治疗原发性骨质疏松症随机对照试验的系统评价及Meta分析

评价仙灵骨葆胶囊治疗骨质疏松症的有效性和安全性。检索中文和英文数据库共8个(均自建库至2017年2月),按照预先设定的纳入标准与排除标准筛选临床试验,应用风险评估工具进行研究质量评价,提取数据并运用Rev Man 5.3软件进行Meta分析。共检索到1 895篇文献,最终纳入54个研究,总样本数为5 030例,试验组2 543例和对照组2 487例。仙灵骨葆胶囊vs CT(常规治疗)的干预措施下,仙灵骨葆胶囊治疗OP,SOP有效率优于对照组,提高OP患者骨密度[MD=0.08,95%CI(0.06,0.10)]。仙灵骨葆胶囊+CT vs CT的干预措施下,仙灵骨葆胶囊治疗OP,PMOP,SOP疗效优于对照组,提高OP患者骨密度[MD=0.04,95%CI(0.03,0.05)],提高POP患者骨密度[MD=0.08,95%CI(0.05,0.10)],提高SOP患者骨密度[MD=0.06,95%CI(0.05,0.07)],减缓OP患者骨质疏松性疼痛[MD=-0.93,95%CI(-1.16,-0.70)],提高OP患者碱性磷酸酶[MD=7.53,95%CI(5.91,9.14)],提高OP患者血钙[MD=0.03,95%CI(0.01,0.06)],提高OP患者骨钙素的含量[MD=4.09,95%CI(3.20,4.98)],提高SOP患者血磷含量[MD=0.03,95%CI(0.00,0.05)]。研究中报告的不良反应主要以肝损伤和胃肠道症状为主。仙灵骨葆胶囊单用或与其他西药联合使用,在治疗骨质疏松症方面的疗效优于单用西药治疗。但由于纳入研究存在潜在偏倚,研究结论仍需要更多高质量随机对照试验以提高证据级别。     

肾衰宁胶囊辅助治疗慢性肾衰竭随机对照试验的系统评价和Meta分析

慢性肾衰竭(CRF)是常见病之一,已有较多肾衰宁胶囊治疗CRF的临床试验。该研究系统评价肾衰宁胶囊辅助治疗CRF的疗效和安全性。计算机检索了11个英文和中文数据库(均至2015年10月),收集关于肾衰宁胶囊对CRF的随机对照试验。2名研究人员独立提取数据,并根据Cochrane Handbook 5.1评价纳入文献质量,采用Revman 5.3软件进行Meta分析。不适合Meta分析,仅进行描述性分析。共检索到429篇文献,最终纳入25个研究,总样本数为1 937例,试验组1 059例和对照组878例。在临床有效率、血尿素氮(BUN)、血肌酐(Scr)和肌酐清除率(Ccr)方面,治疗组肾衰宁胶囊均优于各对照组;但是对于升高血红蛋白(Hb),不能确定肾衰宁胶囊的疗效。无严重不良事件或不良反应报告。肾衰宁胶囊对于辅助治疗CRF有一定的疗效且相对安全,但由于所纳入研究质量不高,尚不能提供高质量证据证实该药的临床疗效,需要更多设计良好、规模较大的多中心随机对照试验进一步加以验证。     

电针双侧天枢穴对功能性便秘患者自觉症状的影响及疗效满意度评价:一项单中心、前瞻性随机对照临床试验

目的:比较电针天枢穴和药物治疗对改善功能性便秘患者症状疗效与治疗满意度的差异,评价不同深度电针刺激的治疗效果。方法:采用单盲、随机、平行对照试验研究方法将纳入的95例患者随机分为药物组(杜秘克药物治疗)、浅刺组(电针浅刺双侧天枢穴)和深刺组(电针深刺双侧天枢穴组),治疗4周,以周排便次数达4次的实际人数、便秘症状积分和治疗满意度积分为疗效判定指标进行评价。结果:电针两组在提高周排便次数达4次的患者比例、部分改善便秘症状积分及治疗满意度积分方面优于药物组(P0.05);深刺组较浅刺组在改善大便不尽感积分、治疗满意度积分等方面起效更快(P0.05)。结论:电针天枢穴治疗功能性便秘临床疗效肯定,深刺治疗较浅刺治疗具有起效快、治疗期间作用稳定的优点。     

桂枝茯苓胶囊/丸治疗慢性盆腔炎性疾病临床随机对照试验的系统评价

该研究系统评价桂枝茯苓胶囊/丸,治疗慢性盆腔炎性疾病的有效性和安全性。计算机检索中文全文期刊数据库、万方数据库、中国生物医学文献数据库及Pub Med,Embase,The Cochrane Library数据库,检索桂枝茯苓胶囊/丸治疗慢性盆腔炎的随机对照试验(RCT),检索时限均为建库至2017年2月。由2位评价员独立筛选文献、提取资料并评价纳入文献的偏倚风险,风险评估参照Cochran Handbook5.3推荐的偏倚风险评估工具。本研究共纳入30个RCT,涉及3 586例患者,30个研究均报告了临床有效率,提示桂枝茯苓(胶囊、丸)联合西药的临床疗效优于单纯西药[RR=1.20,95%CI(1.16,1.23)];3个研究报告了复发率,提示桂枝茯苓(胶囊、丸)联合西药的复发率低于单纯西药[RR=0.33,95%CI(0.18,0.62)];3个研究采用了hs-CRP、血浆粘度比,2个研究采用了肿瘤坏死因子、纤维蛋白为次要指标,提示桂枝茯苓(胶囊、丸)联合西药在抗炎、改善血循环方面优于单纯西药组。17个研究报告了不良反应,主要为胃肠道的刺激症状,桂枝茯苓(胶囊、丸)联合西药组的不良反应发生率低于单纯西药组,加用桂枝茯苓(胶囊、丸)未增加不良反应。现有证据表明,桂枝茯苓(胶囊、丸)联合西药临床疗效优于单纯西药组,在改善临床症状、降低复发率、抗炎、降低血浆粘度方面的疗效均优于单纯西药组,受纳入研究数量及质量的限制,该结论仍需开展高质量RCT研究进行验证。