Objective To systematically review current status of Chinese DRIs, and compare the similarities and differences between Chinese and global DRIs, so as to provide references for regulating Chinese DRIs. Methods Such database as PubMed, ISI Web of knowledge, The Cochrane Library, CBM, WanFang Data, CNKI and VIP were electronically searched from inception to May 31st, 2013. The reviewers independently screened studies according to inclusion and exclusion criteria, extracted data. Then, descriptive analysis was performed for basic information of literature, formulation of different DRIs, and DRIs distribution by different ages. Results Initially, a total of 588 articles were retrieved, 42 of which were finally included, involving 14 guidelines, 12 systematic reviews (SRs), and 16 original studies. The results showed that, WHO guidelines and global systematic reviews focused on iron and fat-soluble vitamins (A and D); the original studies in China focused not only on iron and vitamin A but also on protein, calcium, zinc, and selenium. The included guidelines focused mainly on population aged 3-18 years old and pregnant women; and except for those two kinds of population, SRs also paid attention to adults aged more than 18 years. The original studies of Chinese DRIs were concerned about all kinds of population, mainly focused adults aged 18-45 years and school children aged 6-12 years. Among 16 included original studies, 4 were concerned about men and 2 about women. Conclusion Chinese DRIs need urgent updates and supplement. As the largest developing country, China has different disease burdens, consumption levels, dietary patterns, nutrients’ content, and security levels, compared with developed countries and other developing countries. To develop evidence-based Chinese DRIs that are suitable for native health and Chinese local conditions, we should drawing lessons from the currently available best DRIs standards, methods and evidence based on Chinese actual conditions, disease burden, and expert opinion.
ObjectivesTo compare the effects of different bariatric surgeries on reducing hemoglobin A1c (HbA1c) in overweight/obese patients with type 2 diabetes.MethodsRandomized controlled trials (RCTs) of bariatric surgery were systematically searched in PubMed, EMbase, The Cochrane Library, ClinicalTrials.gov, CNKI, WanFang Data and VIP databases from inception to February 20th, 2019. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then, meta-analysis was performed by using Stata 14.0 software and R 3.6.2 software.ResultsA total of 24 RCTs were included. Compared with non-surgical treatments, 5 out of 9 procedures significantly reduced HbA1c, and the probability order for the effect was as follows: sleeve gastrectomy with transit bipartition (SGTB) (MD=−3.60%, 95%CI −5.89 to −1.31, P=0.002), mini-gastric bypass (MGB) (MD=−2.36%, 95%CI −4.13 to −0.58, P=0.009), duodenal-jejunal bypass liner (DJBL) (MD=−1.85%, 95%CI −2.75 to −1.96, P<0.000 01), sleeve gastrectomy (SG) (MD=−1.48%, 95%CI −2.49 to −0.47, P=0.004), and Roux-en-Y gastric bypass (RYGB) (MD=−1.31%, 95%CI −2.02 to −0.59, P=0.003). The effects of biliopancreatic diversion with duodenal switch and gastric plication were uncertain. Adjustable gastric banding and Roux-en-Y gastrojejunostomy had no significant effects on HbA1c. Because of the limitations of small sample size and high risk of bias, the results of SGTB requires further validation. ConclusionsThe current evidence suggests that the bariatric surgeries that have relatively beneficial effects for lowering HbA1c treatment are MGB, DJB, SG and RYGB in sequence.
In order to promote the openness, transparency and standardization of clinical trials, improve the scientific and reliability of results, and reserve the manpower, material, and financial resources in the process of clinical trials, this study constructed an integrated intelligent management platform for clinical trials, which could carry out various types of clinical trials such as randomized controlled trials, non-randomized controlled trials, cohort studies, case-control studies, and cross-sectional studies simultaneously. The platform covers the whole process of scheme design, recruitment, follow-up, data analysis, and quality control. This paper mainly introduced the practical needs, design concept, basic framework and technical highlights to provide auxiliary tools for promoting the standardization and intelligence of clinical trials with energy saving and optimal efficiency.
ObjectivesTo systematically review the efficacy and safety of Shenlingbaizhusan as adjuvant therapy for gastric cancer.MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, VIP and CBM databases were electronically searched to collect randomized controlled trials (RCTs) on efficacy and safety of Shenlingbaizhusan as adjuvant therapy for gastric cancer from inception to July 31st, 2018. 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 14 RCTs involving 1 142 patients were included. The results of meta-analysis showed that: compared with control group, Shenlingbaizhusan could improve the efficiency of gastric cancer patients (RR=1.55, 95%CI 1.31 to 1.84, P<0.000 01) and the living quality of patients (RR=1.70, 95%CI 1.39 to 2.07, P<0.000 01), and reduce the side effects such as nausea, vomiting, diarrhea and the the possibilities of recurrence. However there was no difference between two groups in bone marrow suppression.ConclusionsThe current evidence shows that Shenlingbaizhusan as adjuvant therapy has better curative effect on gastric cancer, which can improve the efficiency of treatment and quality of life, and reduce some adverse reactions of chemotherapy. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusions.
In order to improve the understanding of pragmatic randomized controlled trial (pRCT), to promote high-quality implementation of such trials, and to provide technical guidance for researchers to conduct such trials scientifically, the working group of China REal world data and studies ALliance (ChinaREAL) hereby develop a technical guidance. The guidance provides technical specifications of pRCT in terms of the concept and scope of application, planning and study design, conduct, data management and quality control, statistical analysis, and ethical issues. It emphasizes that the trial sites and settings, patient population, interventions, controls, outcomes, follow-ups and other factors should be considered when planning and designing. Meanwhile, the guidance recommends that estimation of sample sizes for different types of trial designs should be based on individual pRCTs, and it also provides suggestions for data management, quality control, principles of statistical analysis, analysis requirements for each type of trial designs, and ethical considerations.
ObjectivesTo investigate the efficacy and safety of Hou Gu Mi Xi (HGMX) in patients with nonorganic gastrointestinal disorders (NOGD) from the aspect of dietary therapy.MethodsA randomized, double-blind, parallel, placebo-controlled trial was performed. Patients with NOGD and spleen qi deficiency (SQD) syndrome were randomly assigned into HGMX or placebo group. Each received 30 g/day HGMX or placebo for one year. The outcomes included SQD scores, body weight, body mass index (BMI), gastrin-17, and adverse events (AEs) between HGMX and placebo groups, or subgroups divided by NOGD type or helicobacter pylori (Hp) infection, at the 0th, 2nd, 4th, 8th, 26th, or 52nd weeks’ follow-up.ResultsThe reduction of SQD scale score was found in the HGMX group compared with the placebo group at 4th week (MD=−9.40, 95%CI −18.53 to −0.27, P=0.044), 8th week (MD=−10.07, 95%CI −19.66 to −0.48, P=0.04), 26th week (MD=−12.45, 95%CI −22.31 to −2.59, P=0.014) and 52th week (MD=−17.25, 95%CI −28.53 to −5.97, P=0.003), respectively. In the subgroup analyses, HGMX showed significant efficacy in Hp-negative patients with the detailed reduction of SQD scale score being (MD=−15.20, 95%CI −28.16 to −2.24, P=0.022), (MD=−17.91, 95%CI −31.22 to −4.59, P=0.009) and (MD=−20.38, 95%CI −35.43 to −5.32, P=0.008) at the 8th, 26th and 52nd week, respectively, and in patients with chronic nonatrophic gastritis with the detailed reduction being (MD=−13.02, 95%CI −24.75 to −1.29, P=0.03), (MD=−12.43, 95%CI −24.36 to −0.5, P=0.041) and (MD=−15.90, 95%CI −30.72 to −1.08, P=0.036) at the 2nd, 26th and 52nd week, respectively, and in patients with functional gastrointestinal disease with the reduction being (MD=−18.22, 95%CI −35.75 to −0.69, P=0.042) at the 52nd week. However, no significant efficacy was found in Hp-positive patient at any time. HGMX was not associated with changes in weight, BMI, or gastrin-17. No AEs were reported in the HGMX group.ConclusionsHGMX improves SQD symptoms in patients with NOGD, especially Hp-negative patients, and has a good safety profile.