Surgical innovation is an important part of surgical research and practice. The evaluation of surgical innovation through the stages is similar to those for drug development, but with important differences. The Idea, Development, Exploration, Assessment, and Long-term follow-up (IDEAL) Framework and Recommendations represent a new paradigm for the evaluation of surgical intervention and devices which was developed in 2009. The IDEAL is a five-stage framework involving the nature stages of surgical innovation, together with recommendations for surgical research pathway. The Framework and Recommendations were updated and published in 2019, which added a pre-IDEAL stage if necessary. The updated IDEAL also underlines the purpose, key question and ethical issues for each stage. In the first paper of IDEAL Framework and Recommendations series, we conducted a comprehensive introduction of IDEAL (e.g. the development, updates and application of IDEAL) to promote the dissemination and application of IDEAL in China.
Objective To evaluate the efficacy and safety of Salviae miltiorrhizae Injection (include Danshen Injection and Fufang Danshen Injection) for chronic cor pulmonale. Design A systematic review of randomized clinical trials. Method Randomized trials comparing Salviae miltiorrhizae Injection plus routine treatment versus muting treatment alone were identified by electronic and manual searches. No blinding and language limitations were applied. The Jadad scale assessed the methodological quality of trials. Results Thirty randomized trials (n=2 161) were identified. The methodological quality of all trials included was low. The combined results (RR and 95%CI) of symptom scores was 1.20 (1.15 to 1.26). Because of the significant heterogeneity, many other markers of the blood rheology can not be combined. The reason for heterogeneity should include the differences among cases and studies. Because of lacking enough studies, the conclusions about mortality and oxidants/antioxidants markers were not b. Only a few studies had reported adverse events. Conclusions Based in the review, Salviae miltiorrhizae Injection may have positive effect on symptom scores in patients with chronic cor pulmonale. But for mortality, the markers of blood rheology and oxidants/antioxidants, there is no reliable conclusion. However, the evidence is not b due to the general low methodological quality, the variations among studies and experimental markers themselves, and lacking of more relevant and important markers. Further large trials are needed.
Objective To assess the efficacy and safety of Chinese medicinal herbs for asymptomatic hepatitis B virus(HBV) infection. Data Source The trials registers of the Cochrane Hepato-Biliary Group, the Cochrane Library and the Cochrane Complementary Medicine Field were searched in combination with MEDLINE, EMBASE, and handsearches of Chinese journals and conference proceedings. Data Selection Randomized clinical trials with 3 months follow-up comparing Chinese medicinal herbs versus placebo, no intervention, non-specific treatment, or interferon treatment for asymptomatic HBV carriers were included. No language and blinding limitations were applied. Data Extraction Data were extracted independently by two reviewers. The methodological quality of trials was assessed by the Jadad-scale plus allocation concealment. Results Three randomized clinical trials (307 patients) with low methodological quality following patients for three months or more after the end of treatment were included. Herbal compound Jianpi Wenshen recipe showed significant effects on clearance of HBV markers compared to interferon: relative risk 2.40 (95 % CI 1.01 to 5.72) for clearance of serum HBsAg, and 2.54 (1.13 to 5.70) for seroconversion of HBeAg to anti-HBe. Phyllanthus amarus and Astragalus membranaceus showed no significant antiviral effect compared with placebo. Analysis of pooling eight randomized clinical trials with less than three months follow-up did not show a significant benefit of Chinese medicinal herbs on viral markers. No serious adverse event was observed. Conclusions There is insufficient evidence for treatment of asymptomatic HBVcarriers using Chinese medicinal herbs due to the low quality of the trials. Further randomized, double blind, placebo-controlled trials are needed.
In phase II clinical trial of Compound Prescription of Huangyaozi (Dioscorea bulbifera L.), 7 cases out of 37 developed (18.92%) impairment of liver function. As a result, the ethic committee required researchers to report all data of safety of the drug and have all subjects rechecked about their liver function so as to provided reasonable evidence for the scientifical evaluation of the relationship between the drug and the adverse event and the succedent suspending of the clinical trial.
ObjectivesTo collect the methodology and original articles on the published cohort multiple randomized controlled trial (cmRCT), and evaluate the development and application of cmRCT.MethodsPubMed, EMbase, CNKI, WanFang Data and CBM databases were electronically searched to collect studies on cmRCT from inception to September 2019. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then qualitative analysis was conducted.ResultsA total of 21 studies were enrolled, including 5 original studies and 16 methodology studies. The design of cmRCT was proposed in year 2010 and continuous progress was observed, including aspect of informed consent and statistical analysis, etc. This design has been mainly utilized for chronic diseases (oncology etc.) in Europe; most of these ongoing studies were unpublished. However, to our knowledge, there were none published Chinese original studies or protocols using cmRCT design.ConclusionscmRCT design has been continuously developed and applied since its introduction. This design can be considered in Chinese studies based on Chinese large cohorts to provide more evidence for disease prevention and treatment.
Objective To know the current status of multinational clinical trials (MNCTs) in East Asia, and to find the characters of MNCTs in countries/regions. Methods We downloaded the trial records of East Asia on May 8, 2008 from ClinicalTrials.gov and analyzed the data. Results The number of clinical trials sponsored by industry was 125 in China Mainland, 196 in Taiwan, 134 in Hong Kong, 264 in Korea, and 231 in Japan, respectively. Of the total 654 clinical trials in East Asia, 307 (47%) trials were MNCTs, most of which were conducted by Euro-American pharmaceutical companies, such as Pfizer, AstraZeneca, GlaxoSmithKline, Sanofi-Aventis and Bristol-Myers Squibb. Main therapeutic areas were cancer, followed by CNS diseases, cardiovascular diseases, infectious diseases, diabetes mellitus and respiratory diseases. Trials in phaseⅢwere 198 (65%), in phaseⅣ32 (10%), others in phaseⅡorⅠ. One hundred and ninety trials (62%) were double-blind clinical trials, about half of them using placebo. The characters of clinical trials in China were: ① Most of MNCTs were large scale trials with big sample size and many study sites; ② Most of local trials were phase Ⅲ trials; ③ There were no phase Ⅰ trials. The characters in Taiwan, Hong Kong and Korea were: 1) Most of the trials (84% in Taiwan and 93% in Hong Kong, 72% in Korea) were MNCTs, 2) A lot of large scale trials were conducted with each other. The characters of clinical trials in Japan were: ① MNCTs were only 17%, ② Large scale trials were fewer. Conclusion In East Asia, MNCTs are developing because of the initiation of the Europe and America pharmaceutical giants. It seems that the regulation in each country influence the development pattern of East Asia.
Objective To evaluate the effect of perioperative period clinical care mode through fast-track (FT) under nonminimal invasive operation on the inflammatory response of colorectal cancer resection. Methods Fifty-five patients underwent elective colorectal cancer resection were randomized divided into two groups: FT group (n=29) in which patients were performed FT perioperative care and tradition group (n=26) in which patients were received traditional perioperative care. The nonminimal invasive operations were performed in this study. The venous blood samples were respectively collected at 24 h before operation, at 24 h, 72 h, and 7 d after operation, and were used to detect the concentrations of serum C-reactive protein (CRP) and serum amyloid A protein (SAA).Results There was no complication such as infection, fistula of stoma and inflammatory ileus that was potential to influence the study results in two groups, and no patient died. The trend of changes in the concentrations of CRP and SAA of patients was accordant in each group. The peak concentrations of CRP and SAA of patients in FT group were respectively observed at 24 h after operation 〔CRP: (72.36±60.94) mg/L; SAA: (328.97±267.20) mg/L〕, while which were respectively delayed to 72 h after operation in tradition group 〔CRP: (112.71±63.92) mg/L; SAA: (524.18±331.03) mg/L〕. At the same time, the concentrations of CRP and SAA in FT group began to descend 〔CRP: (57.21±30.42) mg/L; SAA: (237.43±215.66) mg/L〕. The peak concentrations of CRP and SAA in tradition group were significantly higher than that in FT group (Plt;0.001) and the concentrations of CRP and SAA in FT group were significantly lower than those in tradition group at 72 h after operation (Plt;0.001). On 7 d after operation, the concentrations of CRP and SAA further decreased, but the difference between two groups was not significant (Pgt;0.05). Likewise, the concentrations of CRP and SAA at 7 d after operation were significant higher than those 24 h and 72 h after operation (Plt;0.001), lower than that 24 h before operation (Plt;0.001), respectively. Conclusion This study demonstrates that perioperative period clinical care mode through FT under non-minimal invasive operation can reduce the inflammatory response of colorectal carcinoma resections and scientific clinical care is an important means to promote quick rehabilitation.
Objective To assess efficacy of a mouthwash containing 0.1% cetylpiridinium on gingivitis and plaque and its safety. Methods Multi-center randomized double-blind trial with positive control and split-mouth comparison was designed. Scaling on teeth of left side were conducted at do then on those of right side at D8. The cases rinsed five times a day in same way with assigned agents. Efficacy was measured using before-after differences of clinical and microbial variables. Re-examinations were scheduled at D4 and D8. Brushing was refrained between D0 and D4, resumed between D4 and D8. Results There were 144 patients with gingivitis included, 4 lost follow up. Data of 69 cases in test group and 71 in control group could be analyzed. Baseline data analysis showed that distributions of sex, age and values of clinical and microbial variables in both groups were well comparable. At D4 plaque accumulations of the scaled side in both groups were in same level, and Gingival index (GI), sulcus bleeding index (SBI) and VAS for halitosis were significantly reduced. At D8 the measurements of plaque index (PI), GI, SBI and VAS of halitosis decreased significantly more than those of D4. More than half of the suspected pathogenic strains were eliminated and log value of its CFU/ml decreased significantly but at same level in both groups. The balance of intra-oral bacterial flora was not disturbed. Seventeen cases in test group (24.6%) had minor and transient adverse reactions related to the mouthwash. Antimicrobial tests in vitro confirmed that the test agent could kill or inhibit growth of the pathogenic bacteria involving with oropharyngeal infection, gingivitis, periodontal diseases and caries. Conclusion The mouthwash containing cetylpiridinium could inhibit plaque, reduce severity of gingivitis and halitosis, with acceptable minor adverse reactions, similar to those of the marketed cetylpiridinum solution.
Objective To assess the methodological quality of clinical studies using Shen-Mai injection as an adjunct therapy to tumor chemotherapy and to evaluate its efficacy and safety. Methods A comprehensive search strategy was designed to identify all randomized controlled trials (RCT) comparing Shen-Mai injection plus routine chemotherapy versus routine chemotherapy alone by searching for the CBMdisc (issue 3) and TCMLRS database (1981-2001). The methodological quality of the trials was assessed by two reviewers independently for which a meta analysis was perfermed. Results Thirteen RCTs met the inclusion criteria. methodological quality was poor (all the trials included were level C). Compared with the control group, the combined outcome of Shen-Mai injection increased the effect of chemotherapy (OR 1.73 95%CI 1.27 to 2.34, P＝0.000 4), reduced the side effect of bone marrow inhibition (OR 0.29, 95%CI 0.16 to 0.52, P＝0.000 04) in WBC counting and (OR 0.11, 95%CI 0.02 to 0.49, P＝0.004 in PLT count. And Shen-Mai injection relieved the symptoms of nausea and vomiting (OR 0.26, 95%CI 0.16 to 0.43, Plt;0.000 01). Conclusions The methodological quality of the trails using Shen-Mai injection should be improved. Based on the results of the review and the meta-analysis, Shen-Mai injection may have positive effects on chemotherapy in patients with malignant tumor, although the evidence is weak. No serious adverse events are reported. Further well-designed clinical trials should be performed.
Objective To systematically review the effectiveness of different therapies for chronic periapical lesion (CPL), such as different root canal surgeries and conventional root canal obturation. Methods The following databases such as The Cochrane Library, MEDLINE, EMbase, VIP, CNKI, CMB and WanFang Data were searched to collect the randomized controlled trials (RCTs) and concurrent controlled trials (CCTs) on CPL treated by both conventional root canal obturation and different root canal surgeries such as periapical curettage, retrograde obturation and apicoectomy. The references of the included studies were also retrieved, and the retrieval time was from inception to October 2012. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted the data, and assessed the quality. Then after cross-checking, the meta-analyses were performed by using RevMan 5.0 software. Results A total of 7 RCTs and 11 CCTs involving 1 663 patients were included. Among all 1 727 teeth, 1 661 met the inclusion criteria which contained 1 151 in the root canal surgeries groups, and 510 in the conventional groups. The methodological quality of all included studies was low. The results of meta-analysis showed that, in general, different root canal surgeries plus conventional root canal obturation were more effective than root canal obturation alone (RR=1.12, 95%CI 1.08 to 1.18, Plt;0.000 01). The results of sub-group analysis revealed that, the total effective rate of both retrograde obturation (RR=1.3, 95% CI 1.15 to 1.46, Plt;0.000 1) and apicoectomy (RR=1.23, 95% CI 1.04 to 1.46, P=0.02) was superior to that of periapical curettage, with significant differences in both sub-groups. But retrograde obturation took similar effect as apicoectomy did, without a significant difference (RR=0.96, 95% CI 0.83 to 1.11, P=0.61). Conclusion This systematic review suggests that, root canal obturation plus root canal surgeries is superior to root canal obturation alone in treating chronic periapical lesions. The comparison among different root canal surgeries reveals that, both apicoectomy and retrograde obturation are superior to periapical curettage. For the quantity and quality limitation of the included studies, additionally, the possibly existing bias because it is difficult to conduct surgeon and patient blind methods in root canal obturation and root canal surgeries in clinic, so the above conclusion has to be further proved by performing more well-designed and high quality RCTs.