Development of Clinical practice guidelines: procedure and standard / 中华胃肠外科杂志

In the last decade, the development of clinical practice guidelines in China has grown rapidly. However, with regards to the guidelines that have been established in the past, few were of high quality and in line with international standards. The main reason for this was that many clinical experts were not familiar with the procedures and rules of clinical guidelines before established, which lowered the quality seriously. Clinical practice guidelines are based on a clinical problem that is distilled into populations, interventions, comparison and outcome (PICO). After comprehensive systematic review, recommendations are made through evidence grading and strength of recommendation system. In addition, other issues should be noted such as pros and cons of the recommendation for specific population, preferences and values of the population, cost-effectiveness, and the health care system. A high-quality guideline requires multidimensional thinking (from clinicians, patients and policy makers), the implementation of a standard procedure (to ensure guidelines scientifically sound, honest and transparent), as well as the collaboration of multiple organizations (including experts, methodologists and policy makers).

Systematic review and Meta-analysis on randomized controlled trial of efficacy and safety for acupuncture versus Flunarizine in treatment of migraine / 中国中药杂志

To systematically evaluate the efficacy and safety of acupuncture versus Flunarizine hydrochloride in the treatment of migraine. Four Chinese databases(CNKI, VIP, WanFang, CBM), three English databases(Cochrane Library, EMbase, Medline) and ClinicalTrail.gov were systematically and comprehensively retrieved. The retrieval time was from the establishment of each database to January 8, 2020. Randomized controlled trial(RCT) for acupuncture versus Flunarizine in the treatment of migraine were screened out according to inclusion criteria and exclusion criteria. The included studies were evaluated with the Cochrane bias risk assessment tool. The included studies was conducted by RevMan 5.3, and the outcome indicators were evaluated for evidence quality and strength of recommendation by the GRADE system. A total of 1 033 literatures were retrieved, and 23 studies were finally included. Except for 4 multiarm tests, the total sample size was 1 548, including 785 in acupuncture group and 763 in Flunarizine group. The overall quality of the included studies was not high. Meta-analysis results showed that the acupuncture group was superior to the Flunarizine group in reduction of headache frequency(SMD=-1.00, 95%CI[-1.45,-0.54], P<0.000 1). In reduction of headache intensity, acupuncture group was superior to Flunarizine group(SMD=-1.05, 95%CI[-1.41,-0.68], P<0.000 01). In reduction of headache duration, acupuncture group was superior to Flunarizine group(SMD=-1.42, 95%CI[-1.83,-1.02], P<0.000 1). The acupuncture group was superior to Flunarizine group(MD=-0.17, 95%CI[-0.21,-0.13], P<0.000 01) in reduction of the painkillers taking frequency. The acupuncture group was superior to Flunarizine group(SMD=-0.94, 95%CI[-1.35,-0.52], P<0.000 1) in allevia-tion of paroxysmal symptoms, such as nausea and vomiting. The GRADE system showed that the evidence level of the above indicators was extremely low, and the strength of recommendation was low. As for the occurrence of adverse reactions, the adverse reactions reported in the acupuncture group included in the study were all mild adverse reactions, like drowsiness, subcutaneous bleeding, local pain, subcutaneous hematoma and dizziness needle. The available evidence showed that acupuncture has a better efficacy than Flunarizine hydrochloride in the treatment of migraine in adult patients. However, due to the high bias risk in the included studies, the conclusions of this study shall be adopted with caution, and more high-quality studies shall be carried out for verification in the future.

A meta-analysis of Gegen-Qinlian decoction for ulcerative colitis / 国际中医中药杂志

Objective To systematically evaluate the effectiveness and safety of Gegen-Qinlian decoction in treating ulcerative colitis.Methods We searched Cochrane Library, PubMed, CNKI, VIP, CBM and Wanfang online Data bases June, 2017. All of the randomized controlled trials(RCTs) of Gegen-Qinlian decoction compared with sulfasalazine in treating for ulcerative colitis were searched. The quality of RCTs meeting inclusion criteria was evaluated and the data were extracted; meta-analyses were performed with RevMan 5.3 software, and then the GRADE system was used to rate the level of evidence and strength of recommendation.Results Totally 5 RCTs were included into the study. The group treated withGegen-Qinlian decoction or combined with sulfasalazine was superior to the control group in total effective rate (RR=1.18, 95％ CI(1.06-1.30),P=0.002). There were no significant differences between the two groups in clinical symptom curative effect [RR=1.09, 95％CI (0.72-1.64), P=0.69], adverse reactions [RR=0.11, 95％ CI (0.01-1.92),P=0.13], Symptom curative effect [RR=1.33, 95％CI (0.95-1.88),P=0.10], mucosal lesions curative effect [RR=1.33, 95％CI(0.95-1.88), P=0.10]. Based on the GRADE system, the level of total effective rate and adverse reactions evidence was Grade C, and the strength of recommendation was 2. the level of the rest of the evidence was Grade D.Conclusions Compared with sulfasalazine,Gegen-Qinliandecoction or combined with sulfasalazine can be used as a treatment option.

Efficacy and safety of Shenxiong Glucose Injection in treatment of cerebral thrombosis:systematic review and Meta-analysis / 中国中药杂志

To systematically evaluate the efficacy and safety of Shenxiong Glucose Injection in the treatment of cerebral thrombosis.Randomized controlled trials( RCTs) of Shenxiong Glucose Injection for cerebral thrombosis were screened out by searching CNKI,Wan Fang,VIP,Sino Med,Cochrane Library,PubMed,EMbase,and Web of Science in a systematic way,and the Meta-analysis on finally included studies was conducted by using Handbook 5. 1 evaluation criteria and tools and Rev Man 5. 3 software. GRADE system( GRADE pro 3. 6. 1) was used to grade the evidence quality of key outcome indicators. A total of 25 studies were included,with a total sample size of 2 286 cases,1 144 in the experimental group and 1 142 in the control group. The results of Meta-analysis showed that the total effective rate of Shenxiong Glucose Injection combined with ozagrel in the treatment of cerebral thrombosis was better than that of ozagrel alone( RR = 1. 26,95%CI [1. 20,1. 32],P<0. 000 01); the total effective rate of conventional treatment plus Shenxiong Glucose Injection and ozagrel for cerebral thrombosis was better than that of conventional treatment combined with ozagrel( RR = 1. 26,95%CI [1. 09,1. 46],P = 0. 002). In addition,Shenxiong Glucose Injection combined with ozagrel could reduce the incidence of adverse reactions( RR = 0. 38,95%CI [0. 24,0. 60],P < 0. 000 1),improve the neurological impairment( MD14 d=-7. 19,95% CI[-9. 16,-5. 22],P< 0. 000 1; MD30 d=-5. 34,95% CI [-5. 85,-4. 83],P < 0. 000 1; MD42 d=-7. 03,95% CI [-7. 79,-6. 28],P<0. 000 01; MD60 d=-6. 18,95%CI [-6. 55,-5. 81],P< 0. 000 01; MD90 d=-4. 90,95% CI [-5. 74,-4. 06],P<0. 000 01),and improve activities of daily living( ADL)( MD = 15. 00,95%CI [12. 20,17. 80],P<0. 000 01). The mortality was only included in one study,and the sample size was small,requiring to be further verified by a large sample size. The adverse reactions mainly included lung infection,skin pruritus,gastrointestinal reaction and so on,all of which could be tolerated or disappeared without affecting the treatment. Based on the available data and methods,Shenxiong Glucose Injection combined with ozagrel for cerebral thrombosis could improve the total effective rate,neurological impairment,and ability of daily living,with no serious adverse reactions. The evidence quality level of GRADE system was low in the evaluation of total effective rate,mortality and incidence of adverse reactions.However,the quality of the included researches was not high,requiring rigorously designed and internationally standardized clinical trials with a large sample size to improve the quality of evidence.

Hypotensive resuscitation for traumatic hemorrhagic shock: a systematic review / 中华急诊医学杂志

Objective To systematically review the efficacy of hypotensive resuscitation for traumatic-hemorrhagic shock.Methods Randomized controlled trails (RCTs) or quasi-Randomized controlled trails (qRCTs) were searched in Pubmed,Embase and the Corchrane Library from inception to August 2015.Two reviewers respectively picked out the useful data and performed quality evaluation.Metaanalysis was carried out with RevMan 5.3 software,risk ratio (RR) and its 95％ confidence interval (CI) were pooled to estimate the enumeration data,and GRADE 3.6.1 software was used to rate the level of evidence.Results The results of meta-analysis and GRADE rating system which included 4 studies showed that:compared with conventional resuscitation,hypotensive resuscitation was associated with lower total mortality [RR =0.77,95％ CI:0.62-0.95,P =0.01;n =984,GRADE rating:moderate],and 24-hour mortality [RR =0.47,95％ CI:0.24-0.91,P =0.03;n =281,GRADE rating:moderate],but the subgroup analysis of total mortality showed that there were no significant differences in mortality between the subgroup of blunt or penetrating trauma and the subgroup of penetrating trauma.Conclusions Hypotensive resuscitation reduced total mortality and 24-hour mortality,and the quality of the evidence was moderate.The future studies should do further research to explore the efficacy of hypotensive resuscitation for different types of trauma.

Sistema GRADE para clasificar nivel de evidencia y grado de las recomendaciones para la elaboración de guías de buena práctica clínica / The GRADE system for classification of the level of evidence and grade of recommendations in clinical guideline reports

Actualmente existe gran inconsistencia en cómo los “desarrolladores de guías clínicas” en todo el mundo clasifican la calidad de la evidencia disponible y la fuerza de las recomendaciones, debido a que hay varios sistemas de clasificación. Por esa razón, los usuarios de las guías clínicas se enfrentan a retos profundos en la comprensión de guías clínicas. Importantes investigadores y gran número de ellos están adoptando el sistema GRADE para clasificar la calidad de la evidencia disponible y la fuerza de las recomendaciones cuando preparan manuscritos sobre guías clínicas. El sistema GRADE fue desarrollado por un grupo representativo de expertos en la elaboración de guías clínicas, muestra una clara separación entre el grado de evidencia y la fuerza de las recomendaciones, presenta una evaluación explícita sobre la importancia de los desenlaces finales de las diferentes estrategias de manejo, entre otras características. En esta breve revisión describimos las razones que explican la adopción de esta clasificación.

There is great inconsistency on how "Clinical Guideline Developers" worldwide rate the quality of evidence and strength of recommendations because there are several classification systems in use. Therefore, medical guideline users face profound challenges in understanding articles on Clinical Guidelines. Many researchers are adopting the GRADE system to classify the quality of the available evidence and the strength of recommendations when preparing a manuscript on Clinical Guidelines. The GRADE system has advantages over previous rating systems including being developed by a representative group of guideline developers, patent separation between quality of evidence and strength of recommendations, explicit evaluation of the importance of outcomes of alternative management strategies, and others. Consequently, in this brief review, we describe the reasons underlying the adoption of GRADE.