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.     

需要以专业技能为基础的随机对照试验

虽然普遍认为常规随机对照试验是评价药物干预最可靠的方法，但对其在评价非药物干预(如外科手术)中的作用仍存在疑问。一般来说，常规随机对照试验将参加者随机分配到两种干预(A或B)之一，临床医生对其中一些参加者给予干预A，而对另一些参加者给予干预B。另外一种试验设计是以专业技能为基础的随机对照试验，将参加者分配给具有干预A专长的临床医生、或分配给具有干预B专长的临床医生，临床医生只施行其所专长的手术。     

The need for randomized controlled trials in podiatric medical research

The randomized controlled trial is the most robust method available to evaluate health-care treatments. If podiatric medical practice is to be based on rigorous evidence, then high-quality randomized controlled trials are needed to inform that practice. In this article, we examine the extent to which randomized controlled trials are used in recent podiatric medical research and appraise the quality of those that are available. Using the Cochrane database of all randomized controlled trials in health care, we found only six relevant trials undertaken in podiatric medicine since 1997. These studies were of variable quality. We also discuss the key features of a rigorous trial design. To date, the clinical practice of podiatric medicine is not adequately informed by the best available evidence. We call for more high-quality randomized controlled trials to be undertaken in podiatric medical research.     

Full impact of laboratory information system requires direct use by clinical staff: cluster randomized controlled trial

Objective

To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system.

Methods

Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs.

Results

For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p<0.001) and culture results (4 vs 8 days, p<0.001) and had a lower proportion of ‘late’ DSTs taking >60 days to arrive (p<0.001) than the control. For peripheral HCs, the intervention group had similar communication times for DST (median 22 vs 19 days, p=0.30) and culture (10 vs 9 days, p=0.10) results, as well as proportion of ‘late’ DSTs (p=0.57) compared with the control.

Conclusions

Only point-of-care HCs with direct access to the e-Chasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting.     

经鼻持续气道正压通气优先策略治疗毛细支气管炎的随机对照研究

目的:探讨经鼻持续气道正压通气(nasal continuous positive airway pressure,nCPAP)优先策略对毛细支气管炎的氧合及通气功能、气管插管率及住在儿科重症监护病房(pediatric intensive care unit,PICU)时间的影响。方法:按是否优先采用nCPAP策略,将符合研究标准的患儿随机分为非优先组与优先组。非优先组予以雾化、吸痰、吸氧等处理,具有气管插管指征时,行气管插管。优先组予以雾化、吸痰后即应用nCPAP,具有气管插管指征时行气管插管。结果:非优先组住PICU的时间为(101.07±18.68)h,优先组住PICU的时间为(98.28±13.74)h(P>0.05)。非优先组气管插管率26.19%,优先组气管插管率5.56%(P<0.05),但5≦CSS<9时,气管插管率无显著性差异(P>0.05)。两组治疗成功的患儿中,优先组在治疗12 h及24 h,Pa CO2、PaO_2/FiO_2均较治疗前改善(P<0.05);非优先组Pa CO2、PaO_2/FiO_2在治疗2 h、12 h与治疗前比较,均无明显改善(P>0.05),但两组间比较PaCO_2、FiO_2/PaO_2在12 h、24 h,优先组均较非优先组明显改善(P<0.05)。结论:nCPAP能有效改善毛细支气管炎的氧合情况及换气功能,减少气管插管的几率,并不延长毛细支气管炎住在PICU的时间。但对于呼吸窘迫不太严重的毛细支气管炎,可能不需要nCPAP优先策略呼吸支持。     

Transition from meeting abstract to full-length journal article for randomized controlled trials

Context  Not all research presented at scientific meetings is subsequently published and, even when it is, there may be inconsistencies between these results and what is ultimately printed. Although late-breaking trials sessions are now integrated into several major scientific meetings and the results are often promptly and prominently communicated, no studies have examined the publication fate and degree of consistency between meeting abstracts or presentations and subsequent full-length article publications for randomized controlled trials (RCTs) presented at these sessions. Objective  To compare RCT abstracts presented in the late-breaking trials session vs other sessions at a major scientific meeting and subsequent full-length publications. Design  RCTs were identified by hand searching abstract proceedings booklets and related Web sites for the American College of Cardiology scientific meetings (1999-2002). Subsequent full-length articles were identified via electronic databases. Main Outcome Measures  Publication fate and degree of consistency between meeting abstract results and subsequent full-length publication results. Results  The 86 late-breaking RCTs were significantly larger (median, 2737 patients vs 896; P<.001), were more likely to be preceded by a published design paper (27 [31%] vs 13 [13%]; P = .002), had higher quality scores when eventually published (mean Jadad score 2.69 vs 2.19; P = .01), and were less likely to report favorable results for the intervention than the 100 randomly chosen comparison RCTs presented in other sessions (50 [58%] vs 75 [75%]; P = .01; odds ratio 0.46; 95% confidence interval, 0.24-0.90). RCTs presented at the late-breaking trials sessions were significantly more likely to be published (79 [92%] vs 69 [69%]; P<.001) and appeared earlier after presentation (median 11.5 months vs 22.0 months; P<.001) than RCTs presented in other sessions, an association that persisted even after adjusting for sample size, conclusion of study, and RCT design: adjusted hazard ratio, 1.80 (95% confidence interval, 1.24-2.61). Sixty (41%) of the 148 RCTs that were subsequently published exhibited discrepancies between the efficacy estimate reported in the meeting abstract vs the one reported in the full-length article for the primary outcome. The mean change in effect was 0.44 SDs and in 20 cases (14%), the point estimate was statistically significant in only 1 member of the pair. The discrepancy rate was the same for late-breaking RCTs as for RCTs presented in other American College of Cardiology sessions (P = .92). Conclusions  Late-breaking trials were larger, more likely to be preceded by a design paper, and less likely to report positive results than RCTs presented at other sessions, but discrepancies between the meeting abstract results and subsequent full-length publication results were common even for late-breaking trials.      

Swedish guidelines for registry-based randomized clinical trials

Abstract

During the last decade Sweden has invested in a national infrastructure for collection of structured clinical data in the form of healthcare registries (in Sweden known as Kvalitetsregister). These data can be combined with other public data using the national personal identifiers that are issued to Swedish citizens. The healthcare registries have an almost complete coverage of Swedish healthcare, and a large network of clinicians is involved in the quality assurance and continuous improvement of healthcare using these registries. Uppsala Clinical Research Center (UCR) has been a technology provider of large-scale national registries and has a strong background in clinical trial management. This effort combines the areas of healthcare registries and clinical trials into a novel way of performing clinical trials to be able to: 1) run clinical trials as an integrated part of normal clinic workflow; and 2) leverage the nationwide network of outcome reporting. This strategy was shown to be successful in the TASTE (Thrombus Aspiration in Myocardial Infarction) study. When TASTE had been published, the New England Journal of Medicine wrote a perspective on the study calling it ‘The randomized registry trial—the next disruptive technology in clinical research?’ Since then several studies have been conducted in this way with great success. UCR has been appointed, by Clinical Studies Sweden and the Swedish Research Council, to develop the Swedish national guidelines for registry-based randomized clinical trials in order to ensure the possibility for more organizations to run this kind of study. This paper describes key concepts of register-based randomized clinical trials and the development of Swedish national guidelines.     

常见的患者偏好随机对照试验方法介绍与评价

为了解决传统的随机对照试验在临床实际操作过程中面临的患者的偏好、伦理和依从性等,研究者们提出了患者偏好随机对照试验。介绍几种常用的患者偏好设计方案:患者偏好二阶段设计(Wennberg设计、Rücker设计)、全面队列设计(Brewin设计和Olschewski设计)、预随机设计和Korn设计等,并评价各个设计方案的优缺点,以便研究人员和临床医生根据研究目的、疾病特点等特征选择合适的方案。     

Designing and implementing multicenter clinical randomized controlled trials on moxibustion with large samples

Implementing clinical trials with large multicenter samples is an important way to scientifically evaluate and demonstrate the curative effect of moxibustion.At present,clinical trials on moxibustion with large multicenter samples are prospering in China.It is necessary for research units to have good research professionals and technical platforms as well as a highly standardized and scientifically feasible methodology of research.Taking tasks in the ongoing national 973 project and in the sci-tech support program of the "11th 5-year plan",for example,this research captures the characteristics of moxibustion,carries out deep analysis and introduces specific methods and the important significance of clinical research tasks on moxibustion in designing multicenter plans,implementing experiments,supervising quality and strengthening compliance.     

功能锻炼治疗神经根型颈椎病随机对照试验国内报告质量评价

目的:采用目前国际公认的CONSORT声明对功能锻炼治疗神经根型颈椎病的随机对照试验进行回顾性分析,并评估其报告质量,为以后功能锻炼干预神经根型颈椎病的临床研究的改进提供参考和依据。方法:计算机检索国内大型数据库,包括中国知网,万方数据库,维普数据库,筛选出符合要求的文献运用CONSORT声明进行质量评定。结果:根据规定的纳入和排除标准,共检索出符合标准的文献30篇,没有文献在文题中提到随机对照试验,2篇文献明确了试验设计类型,1篇文献进行样本量的计算,13篇文献明确随机分配的方法,1篇文献实施了盲法,7篇文献对基线资料使用表格形式展现,对于试验注册、试验方案和资助方面,没有文献提及。结论:关于功能锻炼治疗神经根型颈椎病随机对照试验有些方面做到了规范报道,但是也有一些方面需要完善提高,在以后的随机对照试验报告中应高度重视和认真参考CONSORT声明,以提高试验研究的准确性及可信性。