Objective To review the current status of evidence-base medicine (EBM) research on traditional medicine in Japan. Methods Serial reports of EBM special committee of Japan Society for Oriental Medicine (JSOM) were reviewed. Results EBM special committee of JSOM was established earlier and carried out systematic reviews of Kampo treatment throughout Japan. The quality of preparations was standardized and reliable. Evidence Reports of Kampo Treatment 2009 (EKAT 2009) may be a promising promotion for Kampo treatment in Japan. Conclusion For the promotion and development of evidence-based Chinese medicine in China, we need to learn from EBM research projects of JSOM. Based on the current status of EBM research in China, special efforts should be made in validity of research data and scientific analysis and reports of non-randomized trials. According to the characteristics of traditional Chinese medicine, EBM research should be systematically carried out from simple to complex.
The background and status of the quality assessment instruments of clinical trials, and several frequently used instruments both domesticly and abroad were introduced, and the problems in this field were discussed.
ObjectivesTo systematically review the efficacy of unicompartmental knee arthroplasty on forgotten joint score (FJS) in patients with knee osteoarthritis.MethodsPubMed, EMbase, The Cochrane Library, Web of Science, CNKI, CBM, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) and cohort studies on unicompartmental knee arthroplasty on FJS in patients with knee osteoarthritis from inception to December 31st, 2019. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 2 RCTs and 11 cohort studies were included. The results of meta-analysis based on RCTs showed that: compared to posterior stabilized total knee arthroplasty (PS-TKA), unicompartmental knee arthroplasty could improve FJS on 12-month (MD=9.23, 95%CI 0.53 to 17.93, P=0.04) after operation. The results of meta-analysis based on cohort studies showed that: compared to PS-TKA, unicompartmental knee arthroplasty could improve FJS on 6-week (MD=8.90, 95%CI 6.87 to 10.94, P<0.000 01), 6-month (MD=18.72, 95%CI 8.71 to 28.74, P=0.000 2), 1-year after operation (MD=13.41, 95%CI 8.87 to 17.95, P<0.000 01), and the last follow-up (MD=0.99, 95%CI 0.47 to 1.54, P=0.000 2).ConclusionsCurrent evidence shows that, comparing with PS-TKA, unicompartmental knee arthroplasty in knee osteoarthritis shows advantage in the improvement of FJS. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.
Interpretation of results of clinical research should not only focus on statistical significance (P value less than 0.05) but also clinical significance. The minimal clinically significance difference (MCID) assists to answer the question with the results being clinically significant. In addition, MCID plays an important role in evidence assessment during clinical guideline development, sample size estimation for clinical trials, and clinical decision-making. This paper primarily introduces the terminology and definition of MCID and four common methods used to estimate MCID.
在缺乏数据进行 Meta 分析的系统评价中，通常使用替代合成方法，但这些方法却很少被报道，而模糊的方法阐述可能会导致人们质疑系统评价结果的真实性。无 Meta 分析数据合成（SWiM）报告规范是用于指导采用了替代合成方法评估干预措施效应的系统评价进行清晰报告的规范。本文介绍了 SWiM 规范的研制过程及 9 个 SWiM 报告条目及其相应的解释与示例。
ObjectiveTo investigate the effectiveness of retrograde muscle release in treatment of mild to moderate type ischemic muscle contracture of forearm classified by Tsuge.MethodsBetween March 2010 and September 2018, 11 patients with mild to moderate ischemic muscle contracture of forearm were treated with retrograde muscle release. There were 6 males and 5 females with an average age of 24 years (range, 16-29 years). According to Tsuge classification, 6 cases were mild type and 5 cases were moderate type. The interval between injury and operation was 9 months to 25 years, with a median of 17 years. The scar cords in the muscle of the middle one-third of the forearm was released firstly. If the standard of sufficient release was not reached, further releasing the scar cords in the muscle and the tense tendon structure in the proximal one-third of the forearm and the origins of the flexor muscles was necessary. If the standard was still not reached, the origins of the flexor muscles can be released and slid. The effectiveness was evaluated from six aspects of the range of motion of the hand and wrist, dexterity, grip strength, sensation, subjective function scores [quick-disability of the arm, shoulder, and hand questionnaire (Quick-DASH) and the patient-related wrist/hand evaluation (PRWHE)] and satisfaction.ResultsAll the incisions healed by first intention. Eight patients were followed up 1-106 months (median, 13 months). The range of motion of the hand and wrist was significantly improved, the results were excellent in 3 cases, good in 3 cases, and fair in 2 cases, with an excellent and good rate of 75%. The patient’s dexterity evaluation scored a perfect score of 12, which was close to the normal hand dexterity. At last follow-up, the grip strength on the affected side was 37.6%-95.5% of the contralateral side, with an average of 77.6%. Seven patients had normal sensation before and after operation, and the two-point discrimination of median nerve and ulnar nerve was 4-5 mm at last follow-up; 1 patient with forearm mechanical crush injury still felt numb after operation, and the two-point discrimination of median nerve and ulnar nerve was 8 mm and 7 mm, respectively. The Quick-DASH score was 0-15.9, with an average of 4.5, and the PRWHE score was 0-23.0, with an average of 6.6. All the patients were satisfied with the surgery and the effectiveness.ConclusionA targeted retrograde muscle release method for mild to moderate type ischemic contracture of forearm can achieve satisfactory effectiveness.
Objective To systematically review the effectiveness and safety of Zhibitai vs. atorvastatin in the treatment of hyperlipidemia. Methods Randomized controlled trials (RCTs) about Zhibitai vs. atorvastatin for hyperlipidemia were electronically retrieved in databases of PubMed, CENTRAL (Issue 7, 2010), CBM,CNKI, VIP and WanFang Data from inception to July, 2012. Two reviewers independently screened literature, extracted data, and assessed methodological quality. Then, meta-analysis was conducted using RevMan 5.2 software. Results A total of 4 RCTs involving 519 cases were included. The results of meta-analysis showed, Zhibitai was superior to atorvastatin in reducing TG levels after 8-week treatment (MD= −0.12, 95%CI −0.23 to −0.01, P=0.03) and increasing HDL-C levels after 8-week treatment (MD= −0.16, 95%CI −0.22 to −0.11, P=0.000 01). But there was no significant difference in decreasing TC levels and LDL-C levels after 4-week treatment and 8-week treatment as well as decreasing TG levels after 4-week treatment between the two groups. No obvious adverse reaction occurred in the two groups, but atorvastatin may impair liver function. Conclusion Current evidence with weak strength shows that, Zhibitai is superior to atorvastatin in reducing TG levels, and increasing HDL-C levels after 8 weeks. However, they are alike in other blood-fat index and safety. Due to the limited quantity and quality of the included studies, more high quality RCTs are needed to verify the above conclusion.
A patient registry database is an important source of real-world data, and has been widely used in the assessment of drug and medical devices, as well as disease management. As the second part of the serial technical guidance for real-world data and studies, this paper introduces the concept and scope of potential uses of patient registry databases, proposes recommendations for planning and developing a patient registry database, and compares existing health and medical databases. This paper further develops essential quality indicators for developing a patient registry database, in expect to guide future studies.
ObjectiveTo systematically review the outcomes reported in clinical trials of post-stroke dysarthria.MethodsPubMed, The Cochrane Library, EMbase, CNKI, Sinomed, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) of post-stroke dysarthria from inception to December 6th, 2019. Two reviewers independently screened literature, extracted data and analyzed outcomes using qualitative method.ResultA total of 112 RCTs involving 39 outcomes (therapeutic effect assessment outcomes and safety outcomes) were included. The top 4 outcomes were the Frenchay dysarthria assessment scale, the dysarthria examination method developed by the Chinese rehabilitation center, the evaluation of the speech therapists or clinicians and GRBAS.ConclusionsCurrent evidence shows that there is no acceptable outcomes for post-stroke dysarthria. It is recommended to improve the suitable assessment scale for Chinese to improve quality of studies on post-strohe dysarthria.
Objective To define an objective evaluation model for metadata integrity of randomized controlled trials (RCTs) in traditional Chinese medicine (TCM), and to evaluate the data integrity of RCT reports published in TCM journals. Methods Retrieving Chinese medicine RCT literature and extracting data, using the metadata specification list and customized evaluation model defined in the project "Intelligent Construction and Application Demonstration of the Evidence System of Chinese Medicine Dominant Diseases" to analyze RCTs from the perspective of data integrity. Results A metadata interface specification and an objective evaluation model for RCT metadata integrity were proposed. A total of 37 361 articles of 10 diseases from 1986 to 2020 were evaluated. Among them, 6 743 reports failed to meet the basic requirements of metadata specifications. The proportion of reports with no missing required items was between 73% and 97%. "tcm_disease" and "num_drop_total" had a greater impact on completeness for the required items. The reporting rates of the items in the "age_sd" and "history_sd" in the "group" section, and "dosage", "dosage_form" and "dosage_freq" in the "interventions" section were low. The average score of RCT report was 71.39 points. Conclusions There is room for improvement in the integrity of RCT data in TCM, and data reporting is urgently required to be standardized. The metadata specification and completeness objective evaluation model proposed in this study can provide references for improving the data integrity of clinical trial reports of TCM.