Research on the development methodology for clinical practice guidelines for organic integration of traditional Chinese and Western medicine.

Integrated traditional Chinese medicine (TCM) and Western medicine (WM) is a new medical science grounded in the knowledge bases of both TCM and WM, which then forms a unique modern medical system in China. Integrated TCM and WM has a long history in China, and has made important achievements in the process of clinical diagnosis and treatment. However, the methodological defects in currently published clinical practice guidelines limit its development. The organic integration of TCM and WM is a deeper integration of TCM and WM. To realize the progression of "integration" to "organic integration", a targeted and standardized guideline development methodology is needed. Therefore, the purpose of this study is to establish a standardized development procedure for clinical practice guidelines for the organic integration of TCM and WM to promote the systematic integration of TCM and WM research results into clinical practice guidelines in order to achieve optimal results as the whole is greater than the sum of the parts.

The efficacy of Da Chaihu decoction combined with metformin tablets for type 2 diabetes mellitus: A systematic review and meta-analysis.

OBJECTIVE: To assess the efficacy of Da Chaihu decoction combined with metformin tablets on patients with type 2 diabetes compared with metformin alone. METHODS: This systematic review and meta-analysis is written based on 2020 PRISMA Extension for Chinese Herbal Medicines 2020 (PRISMA-CHM 2020) reporting guidelines. We reviewed all the relevant studies from a search of the following databases from inception to February 2022 without any language restriction: Excerpta Medica Database (EMBASE), Google Scholar, PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP Information, Wanfang Data, and the Chinese Biomedical Literature Database(CBM). Data were extracted and the quality was independently evaluated by two reviewers, based on the inclusion and exclusion criteria. Data were analyzed using the Cochrane software RevMan 5.3. RESULTS: Six randomized controlled trials comprising 516 participants were included. The meta-analysis revealed the Da Chaihu decoction combined with metformin tablets group was significantly superior to the metformin tablets group in terms of fasting blood glucose(FPG) (-0.66 mmol/L; 95 % CI (confidence intervals) [- 1.28, - 0.04]), plasma glucose 2 h after meal (2-h PG) (-1.18 mmol/L; 95 % CI [-1.94, -0.42]) in six RCTs, body mass index (BMI) (-3.07 mmol/L; 95 % CI [-6.89, 0.75]) in three RCTs, glycosylated hemoglobin (HbAlc) (-0.36 mmol/L; 95 % CI [-1.04, 0.31]) in three RCTs, and triglycerides (TG) (-0.76 mmol/L; 95 % CI [-1.37, -0.15]) in two RCTs. In two RCTs, there were significant differences in terms of total cholesterol (TC) (-0.97 mmol/L; 95 % CI [-1.18, -0.76]). CONCLUSIONS: Very low-quality research shows that Da Chaihu decoction combined with metformin tablets exert a certain level of efficacy on patients with type 2 diabetes compared with metformin alone. However, random sequence generation methodology was reported in five studies leading to the low quality of the included studies. None of the six studies depicted the blinding method, allocation concealment, selective reporting, and assessed the purity and potency of the product. This observation requires verification through high-quality, multi-center, double-blinded randomized controlled trials, and assesses the purity and potency of the product.

Reporting and methodological quality of meta-analyses of acupuncture for patients with migraine: A methodological investigation with evidence map.

BACKGROUND: Acupuncture has been widely used to relieve migraine-related symptoms. However, the findings of previous systematic reviews (SRs) and meta-analyses (MAs) are still not completely consistent. Their quality is also unknown, so a comprehensive study is needed. OBJECTIVE: To evaluate the reporting and methodological quality of these MAs concerning acupuncture for migraine, and summarize evidence about the efficacy and safety of acupuncture for migraine. SEARCH STRATEGY: PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, Chinese Biomedical Databases, Wanfang Data, and VIP databases were searched from inception to September 2020, with a comprehensive search strategy. INCLUSION CRITERIA: The pairwise MAs of randomized controlled trials (RCTs) concerning migraine treated by acupuncture or acupuncture-based therapies, with a control group that received sham acupuncture, medication, no treatment, or acupuncture at different acupoints were included. DATA EXTRACTION AND ANALYSIS: Two independent investigators screened studies, extracted relevant data, and assessed reporting and methodological quality using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2009 and A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2), then all results were cross-checked. Spearman correlation test was used to evaluate the correlation between reporting and methodological quality scores. RESULTS: A total of 20 MAs were included in this study. The included MAs indicated that acupuncture was efficacious and safe in preventing and treating migraine when compared with control intervention. There was a high correlation between reporting and methodological quality scores (rs = 0.87, P < 0.001). The quality of the included SRs needs to be improved mainly with regard to protocol and prospective registration, using a comprehensive search strategy, summarizing the strength of evidence body for key outcomes, a full list of excluded studies with reasons for exclusion, reporting of RCTs' funding sources, and assessing the potential impact of risk of bias in RCTs on MA results. CONCLUSION: Acupuncture is an effective and safe intervention for preventing and treating migraine, and could be considered as a good option for patients with migraine. However, the reporting and methodological quality of MAs included in this overview is suboptimal. In the future, AMSTAR 2 and PRISMA tools should be followed when making and reporting an SR with MA.

[Proposal of Living Evidence-based Guideline for Combination of Traditional Chinese and Western Medicine for Treatment of COVID-19].

In order to standardize the clinical diagnosis and treatment decision-making with traditional Chinese medicine for pa-tients of coronavirus disease 2019(COVID-19) and put the latest clinical study evidence into clinical practice, the international trust-worthy traditional Chinese medicine recommendations( TCM Recs) working group started the compilation of Living Evidence-based Guideline for Combination of Traditional Chinese and Western Medicine for Treatment of COVID-19 on the basis of the standards and re-quirements of WHO handbook, GRADE and RIGHT. This proposal mainly introduces the formulation methods and processes of the living guidelines in details, such as the composition of the working group, the collection and identification of clinical issues and out-comes, the production of the living systematic review and the consensus of recommendations. The guidelines will continue to monitor the clinical study evidences of TCM in the prevention and treatment of COVID-19, and conduct regular evidence updating, retrieval and screening. When there is new study evidence, the steering committee will evaluate the possibility of the evidence to change clinical practice or previous recommendations, so as to decide whether the recommendations for the guidelines shall be implemented or upda-ted. The main criteria considered in the guideline updating are as follows:(1) There are new high-quality randomized controlled trial(RCT) evidences for TCM uninvolved in the previous edition of the guidelines;(2) as for the TCM involved in the guidelines, living sys-tematic review shows that new evidence may change the direction or strength of the existing recommendations. The specific implementation of the living evidence-based guidelines will take this proposal as the study basis and framework, in order to ensure the standardization of the formulation process and methods. This will be the first exploration of the methodology for living guidelines in the field of TCM.

Systematic review and meta-analysis of vitamin D deficiency in different pregnancy on preterm birth: Deficiency in middle pregnancy might be at risk.

BACKGROUND: Current studies suggest that vitamin D deficiency during pregnancy can produce a certain effect for preterm birth (PTB), but there is no research showing whether vitamin D deficiency has a consistent effect in different pregnancies; thus, we conducted a systematic review and meta-analysis of 24 observational studies, grouping them according to the gestational age at the time of serum sampling, to investigate whether vitamin D deficiency in different periods of gestation has different effects on PTB and to provide an evidence-based basis for pregnant women to measure and supplement vitamin D. METHODS: The databases PubMed-Medline, EMBASE, the Cochrane Library, Web of Science, EBSCO, CBM, and CNKI were searched until February 2020. Two researchers independently assessed the eligibility and quality of studies, and STATA 12.0 software was used for meta-analysis. RESULT: Seven cohort studies, 13 case-control studies, and 4 cross-sectional studies were included from 2500 articles by inclusion and exclusion criteria. After adjusting for age, race, and other confounding factors, meta-analysis results showed that vitamin D deficiency in the first trimester, the second trimester, and the third trimester did not increase the risk of PTB (odds ratio (OR) = 1.01, 95% confidence interval (CI) (0.88, 1.16), P = .867; OR = 1.12, 95%CI (0.92, 1.37), P = .249; OR = 1.05, 95%CI (0.87, 1.27), P = .602). However, there was moderate heterogeneity in the study of vitamin D deficiency in the second trimester, and subgroup analysis suggested that vitamin D deficiency in the second trimester may increase the risk of PTB (OR = 1.33, 95%CI (1.15, 1.54), P = .000). A sensitivity analysis of the second trimester showed that excluding any 1 study did not significantly change the results. CONCLUSIONS: Vitamin D deficiency in early and late pregnancy may not be associated with PTB, while vitamin D deficiency in middle pregnancy is likely to have an important effect on PTB. Vitamin D levels should be measured in the second trimester of pregnancy, and vitamin D supplements should be provided if necessary.

PRISMA extension for moxibustion 2020: recommendations, explanation, and elaboration.

BACKGROUND: Moxibustion is a common intervention of Chinese medicine (CM). Systematic reviews (SRs) on moxibustion are increasing. Although the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement provides guidelines for SRs, the quality of moxibustion-related SRs is still not satisfactory. In particular, descriptions of the interventions and the rationale for using moxibustion are insufficient. To address these inadequacies, the working group developed this PRISMA extension for reporting SRs of moxibustion (PRISMA-M 2020). METHODS: A group of CM clinical professionals, methodologists of SRs, reporting guideline developers, and journal editors developed this PRISMA-M 2020 through a comprehensive process that includes registration, literature review, consensus meetings, Delphi exercises for soliciting comments, and revision, resulting in this final draft. RESULTS: Seven of the 27 PRISMA checklist items, namely title (1), rationale (3), eligibility criteria (6), data item (11), additional analyses (16), study characteristics (18), and additional analysis (23), were extended, with specific reference to the application of moxibustion. Illustrative examples and explanations for each item are provided. CONCLUSION: The PRISMA-M 2020 will help improve the reporting quality of SRs with moxibustion. SYSTEMATIC REVIEW REGISTRATION: We have registered it on the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) network, particularly under the item of PRISMA-TCM: http://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-systematic-reviews/#65 .

CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM) : Recommendations, explanation and elaboration.

BACKGROUND: N-of-1 trial is a desired and appropriate approach to assessing the efficacy and safety of traditional Chinese medicine (TCM) interventions. There have been an increasing number of N-of-1 trials for TCM published. However, a lack of preferred reporting guidance led in the general poor reporting quality of these trials. Due to the unique characteristics of TCM, the working group developed this CONSORT Extension for reporting N-of-1 Trials for Traditional Chinese Medicine (CENT for TCM) to assist TCM researchers in reporting N-of-1 trials for TCM. METHODS: We registered CENT for TCM at the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network (available at equator-network.org). The development was a comprehensive process through collection of the initial reporting items, two-round scientific Delphi consensus survey with 17 panelists, revision and formation of the final reporting checklist. RESULTS: The checklist includes 25 items within six domains, eight items in which were extended and elaborated on the items of the CENT 2015 checklist. Explanation of the items were listed adequately considering the nature of TCM, introducing the concept of TCM syndrome differentiation and TCM interventions. CONCLUSIONS: CENT for TCM can be used to assess the completeness of the reporting of N-of-1 trials for TCM. The working group expect that CENT for TCM could be a practical tool to enhance the comprehensiveness and transparency of the design, implementation and reporting of N-of-1 trials for TCM.

Toward Evidence-Based Chinese Medicine: Status Quo, Opportunities and Challenges.

How to test the treatments of Chinese medicine (CM) and make them more widely accepted by practitioners of Western medicine and the international healthcare community is a major concern for practitioners and researchers of CM. For centuries, various approaches have been used to identify and measure the efficacy and safety of CM. However, the high-quality evidence related to CM that produced in China is still rare. Over the recent years, evidence-based medicine (EBM) has been increasingly applied to CM, strengthening its theoretical basis. This paper reviews the past and present state of CM, analyzes the status quo, challenges and opportunities of basic research, clinical trials, systematic reviews, clinical practice guidelines and clinical pathways and evidence-based education developed or conducted in China, pointing out how EBM can help to make CM more widely used and recognized worldwide.

The induction of apoptosis and autophagy in human hepatoma SMMC-7721 cells by combined treatment with vitamin C and polysaccharides extracted from Grifola frondosa.

Polysaccharides extracted from the mushroom Grifola frondosa (GFP) are a potential anticancer agent. The objective of this study was to investigate the effect of GFP and vitamin C (VC) alone and in combination on the viability of human hepatocarcinoma SMMC-7721 and HepG2 cells. Studies designed to detect cell apoptosis and autophagy were also conducted to investigate the mechanism. Results from the cell viability assay indicated that a combination of GFP (0.2 or 0.25 mg/mL) and VC (0.3 mmol/L) (GFP/VC) led to 52.73 and 53.93% reduction in cell viability of SMMC-7721 and HepG2 cells separately after 24 h. Flow cytometric analysis indicated that GFP/VC treatment induced cell cycle arrest at the G2/M phase, and apoptosis occurred in approximately 43.62 and 42.46% of the SMMC-7721 and HepG2 cells separately. Moreover, results of Hoechst33258 and monodansylcadaverine staining, and transmission electron microscopy, showed that GFP/VC induced apoptosis and autophagy in SMMC-7721 and HepG2 cells. Western blot analysis showed changes in the expression of apoptosis-related proteins [upregulation of BAX and caspase-3, downregulation of Bcl-2, and activation of poly-(ADP-ribose)-polymerase] and autophagy protein markers (upregulation of beclin-1 and microtubule-associated protein 1A/1B light chain-3). We also demonstrated that the expression of both Akt and p-Akt was enhanced, suggesting the PI3K/Akt/mTOR pathway might not be involved in this process. Our study shows that the combined application of GFP and VC induced cell apoptosis and autophagy in vitro, and might have antitumor activity in vivo.

Induction Effect to Apoptosis by Maitake Polysaccharide: Synergistic Effect of Its Combination With Vitamin C in Neuroglioma Cell.

Polysaccharide extracted from the Maitake mushroom (MP) is considered as a potential anticancer agent. The present study was performed to investigate the cytotoxic effects of MP and vitamin C (VC) alone and in combination on the viability of human neuroglioma M059 K cells in vitro. A combination of MP (1.0 mg/mL) and VC (0.4 mmol/L) led to a 53.10% reduction in cell viability and this treatment induced cell cycle arrest at the G2/M phase, and apoptosis occurred in 38.54% of the cells. Results of Hoechst 33258 staining and Western blot showed apoptotic cells appeared and changes in the expression of apoptosis-related proteins (upregulation of Bax and caspase-3, downregulation of Bcl-2, and activation of poly-(ADP-ribose)-polymerase). Moreover, the activities of caspase-3, caspase-8, and caspase-9 were enhanced in M059 K cells. The inhibiting effect of combined treatment with MP and VC on M059 K cells indicates the mechanism of anticancer activity involved induction of cell apoptosis.

Synergistic Apoptotic Effect of D-Fraction From Grifola frondosa and Vitamin C on Hepatocellular Carcinoma SMMC-7721 Cells.

The aim of this study was to investigate the anticancer effect of a combination of D-fraction polysaccharide from Grifola frondosa (DFP) and vitamin C (VC) on hepatocellular carcinoma in vitro. DFP is a bioactive extract from the maitake mushroom. Anticancer activity was demonstrated using various concentrations of DFP alone or in combination with VC against the human hepatocarcinoma SMMC-7721 cell line. To investigate the anticancer mechanism, studies designed to detect cell apoptosis were conducted. Results from the MTT assay indicated that a combination of DFP (0.2 mg/mL) and VC (0.3 mmol/L) led to a 70% reduction in cell viability. Flow cytometry results indicated that DFP/VC treatment induced apoptosis in approximately 65% SMMC-7721 cells. Cell cycle analysis identified cell cycle arrest at the G2/M phase following DFP/VC treatment for 48 hours. In addition, cellular morphological changes were observed using transmission electron microscopy. Western blot analysis revealed that the upregulation of BAX, downregulation of Bcl-2, activation of poly-(ADP-ribose)-polymerase (PARP), and the release of cytochrome c were observed in cells treated with the combination of DFP/VC, which showed that the mechanism of anticancer activity in the SMMC-7721 hepatocarcinoma cells involved induction of apoptosis.

Mesh fixation methods in open inguinal hernia repair: a protocol for network meta-analysis and trial sequential analysis of randomised controlled trials.

INTRODUCTION: Randomised clinical trials (RCTs) have been used to compare and evaluate different types of mesh fixation usually employed to repair open inguinal hernia. However, there is no consensus among surgeons on the best type of mesh fixation method to obtain optimal results. The choice often depends on surgeons' personal preference. This study aims to compare different types of mesh fixation methods to repair open inguinal hernias and their role in the incidences of chronic groin pain, risk of hernia recurrence, complications, operative time, length of hospital stay and postoperative pain, using Bayesian network meta-analysis and trial sequential analysis of RCTs. METHODS AND ANALYSIS: A systematic search will be performed using PubMed, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Chinese Biomedical Literature Database (CBM) and Chinese Journal Full-text Database, to include RCTs of different mesh fixation methods (or fixation vs no fixation) during open inguinal hernia repair. The risk of bias in included RCTs will be evaluated according to the Cochrane Handbook V.5.1.0. Standard pairwise meta-analysis, trial sequential analysis and Bayesian network meta-analysis will be performed to compare the efficacy of different mesh fixation methods. ETHICS AND DISSEMINATION: Ethical approval and patient consent are not required since this study is a meta-analysis based on published studies. The results of this network meta-analysis and trial sequential analysis will be submitted to a peer-reviewed journal for publication. PROTOCOL REGISTRATION NUMBER: PROSPERO CRD42015023758.

Shenqi Fuzheng Injection for advanced gastric cancer: a systematic review of randomized controlled trials.

OBJECTIVE: To evaluate the effectiveness of Shenqi Fuzheng Injection (, SFI) combined with chemotherapy for advanced gastric cancer. METHODS: Randomized controlled trials (RCTs) from 10 databases were searched for this meta-analysis till December 31, 2012 without language restriction. Grey literature and potential unpublished literature was also searched. The key search terms were "chemotherapy", "Shenqi Fuzheng Injection" and "advanced gastric cancer". Criteria were built to select these clinical trials, in which SFI combined with chemotherapy was compared with chemotherapy alone for advanced gastric cancer. The methodological quality of each RCT was assessed using the Cochrane risk of bias tool. RevMan 5.1 software was applied for data analyses. RESULTS: Thirteen RCTs involving 860 patients met the selection criteria (all articles were from Chinese databases). The meta-analysis showed positive results for the use of SFI combined with chemotherapy according to quality of life in terms of the scores when compared with chemotherapy alone. Positive results were also obtained for the combination treatment, in terms of complete remission and partial remission efficacy rate, body weight and decreased adverse events including nausea and vomiting at grade 3-4, oral mucositis at grade 1-2, leucopenia at grade 3-4, and myelo-suppression at grade 1-2. CONCLUSIONS: This systematic review found encouraging albeit limited evidence for SFI combined with chemotherapy. However, to obtain stronger evidence without the drawbacks of trial design and the quality of studies, we recommend comparative effectiveness researches to test the effectiveness of combination treatment.

[Network meta-analysis on selecting Chinese medical injections in radiotherapy for esophageal cancer].

To assess the clinical effect and safety of Chinese traditional medicine injection combined with radiotherapy for esophageal cancer. The relative randomized controlled trials (RCTs) of Chinese medical injections (CMI) combined with radiotherapy as well as simple radiotherapy for esophageal cancer were searched from PubMed, Cochrane Library, EMBASE, Chinese Biomedical Literature Database(CBM), China National Knowledge Infrastructure (CNKI), Wanfang Database and VIP Database as at September 2014. Two researchers completed the data extraction and quality evaluation independently. The data were analyzed by GeMTC 0.14.3 and Stata 12. 0 software. Finally, 43 RCTs involving 3 289 patients were finally included. The star network was constructed by different comparison groups. The results of network meta-analysis showed that the seven CMIs combined with radiotherapy was superior to simple radiotherapy in the treatment of esophageal cancer in efficacy, quality of life, and reduction in the incidence of nausea and leucopenia, but with no significant difference among the seven CMIs. Probability ranking result showed a great possibility for Shenqi Fuzheng and astragalus polysaccharide injections in improving the overall response rate and quality of life, which were followed by cinobufagin and kangai injections. However, only one study was included for Shenqi Fuzheng and astragalus polysaccharide injections. Therefore, cinobufagin or kangai injections were preferred in improving the overall response rate and quality of life. Aidi or compound sophora injections were better than other CMIs in reducing? the incidences of nausea (III-IV) and leukopenia. More RCTs of Shenqi Fuzheng and astragalus polysaccharide injections combined with radiotherapy for patients with esophageal cancer were expected in the future to confirm our results. Moreover, study findings will be reported, particularly for the adverse events in radiotherapy for esophageal cancer.

Reporting quality of systematic reviews/meta-analyses of acupuncture.

BACKGROUND: The QUOROM and PRISMA statements were published in 1999 and 2009, respectively, to improve the consistency of reporting systematic reviews (SRs)/meta-analyses (MAs) of clinical trials. However, not all SRs/MAs adhere completely to these important standards. In particular, it is not clear how well SRs/MAs of acupuncture studies adhere to reporting standards and which reporting criteria are generally ignored in these analyses. OBJECTIVES: To evaluate reporting quality in SRs/MAs of acupuncture studies. METHODS: We performed a literature search for studies published prior to 2014 using the following public archives: PubMed, EMBASE, Web of Science, the Cochrane Database of Systematic Reviews (CDSR), the Chinese Biomedical Literature Database (CBM), the Traditional Chinese Medicine (TCM) database, the Chinese Journal Full-text Database (CJFD), the Chinese Scientific Journal Full-text Database (CSJD), and the Wanfang database. Data were extracted into pre-prepared Excel data-extraction forms. Reporting quality was assessed based on the PRISMA checklist (27 items). RESULTS: Of 476 appropriate SRs/MAs identified in our search, 203, 227, and 46 were published in Chinese journals, international journals, and the Cochrane Database, respectively. In 476 SRs/MAs, only 3 reported the information completely. By contrast, approximately 4.93% (1/203), 8.81% (2/227) and 0.00% (0/46) SRs/Mas reported less than 10 items in Chinese journals, international journals and CDSR, respectively. In general, the least frequently reported items (reported≤50%) in SRs/MAs were "protocol and registration", "risk of bias across studies", and "additional analyses" in both methods and results sections. CONCLUSIONS: SRs/MAs of acupuncture studies have not comprehensively reported information recommended in the PRISMA statement. Our study underscores that, in addition to focusing on careful study design and performance, attention should be paid to comprehensive reporting standards in SRs/MAs on acupuncture studies.

Which is the best Chinese herb injection based on the FOLFOX regimen for gastric cancer? A network meta- analysis of randomized controlled trials.

BACKGROUND: Few studies have directly compared clinical efficacy and safety among Chinese herb injections (CHIs) for gastric cancer (GC). The present study aimed to compare CHIs combined with FOLFOX regimens for GC to show which provides the best CHIs results. MATERIALS AND METHODS: 9 electronic databases and 6 gray literature databases were comprehensive searched in April 20, 2013. According to inclusion and exclusion criteria, two reviewers independently selected and assessed the included trials. The risk of bias tool described in the Cochrane Handbook version 5.1.0 and CONSORT statement were used to assess the quality of the trials. All calculations and graphs were performed and produced using ADDIS 1.16.5 software. RESULTS: A total of 541 records were searched and 38 RCTs met the inclusion criteria (2,761 participants), involving 10 CHIs. The results of network meta-analysis showed that compared with FOLFOX alone, combinations with Kanglaite, Astragalus polysaccharides, Cinobufacini, or Yadanziyouru injections could furthest strengthen ORR, improve the quality of life, reduce nausea and vomiting, and reduce the incidence of leukopenia (III-IV). CONCLUSIONS: Kanglaite injection, Astragalus polysaccharides injection, Yadanziyouru injection were superior to other CHIs in clinical efficacy and safety for GC. The conclusions now need to be confirmed by large sample size direct head-to-head studies.

[Based on evidence to establish reporting guidelines for TCM-featured acupuncture systematic reviews/Meta-analysis: a methodology discussion].

Existing reporting guidelines for systematic reviews/Meta-analysis (SRs/MAs) cannot meet the requirements of clinical practice and scientific research, so based on evidence, methods and thoughts on establishing reporting guidelines for TCM-featured acupuncture systematic reviews/Meta-analysis were proposed. Through literature analysis, according to evidence-based principle, preliminary ideas on methodology of establishing reporting guidelines for TCM-featured acupuncture systematic reviews /Meta-analysis were proposed. With consensus as one main research method, it was proposed that in the consensus that was selected and established by experts, the pro- portion of Chinese scholars should be increased to fully declare the opinions of Chinese acupuncturists, and by verification of practice and application, the reporting guidelines for TCM-featured acupuncture systematic reviews/Meta-analysis can be finally made.

[A systematic review regarding the effects of different kinds of selenium supplementations on Kaschin-Beck disease].

OBJECTIVE: To systematically assess the efficacy of different programs regarding the selenium supplementation formulae used for prevention and treatment of Kaschin-Beck disease (KBD) in children. METHODS: PubMed, EMBASE, Cochrane Library, SCI expanded, CNKI (Chinese National Knowledge Infrastructure), VIP (Chinese Science and Technique Journals Database), CBM (The Chinese Biomedical Database), Wanfang Database, CSCD (Chinese Science Citation Database) had been electronically searched. All the searching processes were up-dated to Dec 2012 to identify randomized trials (RCTs) and non-RCTs to compare the selenium supplementation formulae with placebo or with no intervention. Two reviewers assessed the methodological quality of the study design, including RCTs or non-RCTs according to Cochrane Handbook for Systematic Reviews of Interventions 5.1 or a checklist described by Deeks JJ, et al, respectively. Data was extracted independently. RESULTS: There were 14 RCTs and 12 non-RCTs papers included, but showing low methodological quality. Data from Meta analysis showed that selenium supplementation had caused the following progresses: radiologic improvement (RR = 3.28, 95%CI: 2.06 - 5.22), higher hair selenium (SMD = 2.05, 95%CI: 1.00 - 3.11) lower new radiologic lesions (OR = 0.18, 95%CI: 0.09 - 0.36) than in the placebo or with no treatment groups. Both selenium and vitamin C supplementation did not show differences in radiologic improvement of metaphysis (RR = 1.01, 95%CI: 0.84 - 1.22). Combination of selenium and vitamin E supplementation showed higher radiologic improvement than the placebo group. Combination of selenium and vitamin C supplementation had no influence on the difference in radiologic improvement or hair selenium than selenium supplementation. Selenium-enriched yeast showed higher radiologic improvement than sodium selenite (70.83% vs. 48.84%, P < 0.05). Selenium fertilization showed higher radiologic improvement than the non-treatment group (RR = 3.98, 95%CI: 2.25 - 7.05). Comprehensive intervention program and 'grain drying approach' also showed certain effects. CONCLUSION: Selenium supplementation could lead to better radiologic improvement and hair selenium, with lower new radiologic lesions. Current evidence supported its benefits on prevention and treatment of KBD. Large sample sized and well-designed trials together with the reporting on adverse outcome remained necessary.

Surgery combined with intraoperative hyperthermic intraperitoneal chemotherapy (IHIC) for gastric cancer: a systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: Adjuvant intraoperative hyperthermic intraperitoneal chemotherapy (IHIC) is a therapy which combines thermotherapy and intraperitoneal chemotherapy. It is theoretically powerful for patients with advanced gastric cancer (AGC), but is there evident advantage in clinical practice? We need evidence to guide our decision-making. OBJECTIVES: Meta-analysis was performed to assess the effectiveness and safety of adjuvant intraoperative hyperthermic intraperitoneal chemotherapy (IHIC) for patients with resectable locally advanced gastric cancer, and to provide the reference for clinical practice and study. METHODS: We searched the Cochrane Library, PubMed, Embase, Web of Science and Chinese databases (Chinese BioMedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI) and Wanfang) electronically and also retrieved papers from other sources (tracing related references and communication with other authors). All relevant randomised controlled trials (RCTs) were collected to compare surgery combined with IHIC to surgery without IHIC for AGC. There were no language restrictions. After independent quality assessment and data extraction by two reviewers, meta-analysis was conducted by RevMan 5.1 software. RESULTS: 16 RCTs involving 1,906 patients were included. Compared with surgery alone, combination therapy (surgery plus IHIC) was associated with a significant improvement in survival rate at 1 year (hazard ratio (HR) = 2.99; 95% confidence interval (CI) = 2.21 to 4.05; p < 0.00001), 2 years (HR = 2.43; 95%CI = 1.81 to 3.26; p < 0.00001), 3 years (HR = 2.63; 95%CI = 2.17 to 3.20; p < 0.00001), 5 years (HR = 2.49; 95%CI = 1.97 to 3.14; p < 0.00001), and 9 years (HR = 2.14; 95%CI = 1.38 to 3.32; p = 0.0007). Compared with surgery alone, combination therapy was associated with a significant reduction in recurrence rate at 2 years (RR = 0.42; 95%CI = 0.29 to 0.61; p < 0.00001), 3 years (RR = 0.35; 95%CI = 0.24 to 0.51; p < 0.00001) and 5 years (RR = 0.47; 95%CI = 0.39 to 0.56; p < 0.00001). IHIC was not found to be associated with higher risks of anastomotic leakage, ileus, bowel perforation, myelosuppression, gastrointestinal reaction and hypohepatia, but it increased the incidence of abdominal pain (RR = 21.46; 95%CI = 5.24 to 87.78; p < 0.00001). CONCLUSIONS: Compared with surgery alone, surgery combined with IHIC can improve survival rate and reduce the recurrence rate, with acceptable safety. However, safety outcomes should be further evaluated by larger samples and high quality studies. Additionally, hyperthermia for the intraperitoneal chemotherapy needs more clinical research.

[Meta-analysis on impact of Danshen on liver regeneration in rats].

OBJECTIVE: To assess the effect of Danshen on liver regeneration capacity of carbon tetrachloride-induced liver injury rats. METHOD: Computer retrieval of data from CJFD, CBM, Chinese science & technology journal full-text database and Chinese medical association digital journals, and such foreign databases as PubMed, EMBASE and SCI was included in the randomized controlled trials (RCT) of rat liver injury induced by carbon tetrachloride,with the search as at May 2012. A Meta analysis was made using Rev-Man 5.1 software. Using the GRADE system to addess five outcomes in stuay. RESULT: Two hundred and fourteen rats got involved in seven randomized trials. Meta analysis showed there were statistical differences between the Danshen group and the control group in alanine aminotransferase (ALT), aspartate aminotransferase (AST), superoxide dismutase (SOD), tumor necrosis factor-alpha (TNF-alpha) and hyaluronic acid (HA) after rat liver injury induced by carbon tetrachloride. When we used system to each outcome, because of serious limitations and indirect, they are all very low quality. CONCLUSION: Danshen shows certain promoting effect to liver regeneration in carbon tetrachloride-induced liver injury rats.