Aggregate Data Drug Information System Research Articles

Efficacy of non-pharmacological interventions for primary dysmenorrhoea: a systematic review and Bayesian network meta-analysis

ObjectivesTo assess the relative benefits of various non-pharmacological interventions on treating primary dysmenorrhoea within a network meta-analysis.Study designSystematic review and Bayesian network meta-analysis.Inclusion criteriaRandomised controlled trial involving patient with primary...

Acupuncture methods for insomnia disorder in the elderly: protocol for a systematic review and network meta-analysis

BackgroundInsomnia disorder remains one of the most common sleep disorders in the elderly, with high prevalence and substantial consequences for patients’ general health. Despite that increasing clinical trials have indicated that acupuncture seems to be effective for insomnia disorder in the elderly, comparative efficacy and safety of different acupuncture methods for elderly individuals with insomnia disorder has been unclear. Therefore, this protocol outlined a plan to evaluate and rank the efficacy and safety of various acupuncture approaches for insomnia disorder in the elderly.MethodsA systematic search of 8 bibliographic databases will be conducted from their inception to 18 June 2023, including Cochrane Library, MEDLINE (via PubMed), Embase, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Wanfang Database, VIP Database, and Chinese Biomedical Literature Database (CBM). Randomized controlled trials investigating acupuncture methods for insomnia disorder in the elderly, published in English or Chinese will be included. The primary outcome is sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). Two reviewers will independently perform study selection, data extraction and risk assessment of bias. The quality of included literatures will be appraised using Cochrane risk-of-bias tool (ROB 2.0). ADDIS (Aggregate Data Drug Information System) V.1.16.8 will be used to conduct Bayesian network meta-analysis. The quality of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation System (GRADE).DiscussionIn this study, the results will provide credible evidence to assess the efficacy and safety of acupuncture therapies for elderly patients with insomnia disorder, assisting patients, physicians and clinical research investigators to select the most appropriate acupuncture method.Systematic review registrationThe protocol has been registered at OSF (https://osf.io/3kjpq/) with a registration number https://doi.org/10.17605/OSF.IO/3KJPQ.

Treatment of immunoglobulin-resistant kawasaki disease: a Bayesian network meta-analysis of different regimens.

This study aimed to gather evidence from clinical trials on the efficacy and safety of the available treatments for intravenous immunoglobulin (IVIG)-resistant Kawasaki disease (KD) in children. This work adopted the Newcastle-Ottawa scale to analyse the quality of the enrolled articles. A network meta-analysis was performed using clinical trials that compared drugs used to treat IVIG-resistant KD. Aggregate Data Drug Information System software v.1.16.5 was employed to analyse whether infliximab, second IVIG infusions, and intravenous pulse methylprednisolone (IVMP) were safe and effective. Ten studies, involving 704 patients with IVIG-resistant KD, were identified and analysed. Overall, infliximab exhibited remarkable antipyretic activity compared with the second IVIG infusions (2.46, 1.00-6.94). According to the drug rank, infliximab was the best option against IVIG-resistant KD. Regarding adverse effects, the infliximab group was more prone to hepatomegaly. A second IVIG infusion was more likely to result in haemolytic anaemia. IVMP treatment was more susceptible to bradycardia, hyperglycaemia, hypertension, and hypothermia. In addition, infliximab, IVMP, and the second IVIG infusions showed no significant differences in the risk of developing a coronary artery aneurysm (CAA). Infliximab was the best option against IVIG-resistant KD, and IVMP, infliximab, and second IVIG infusions have not significant differences of prevent CAA in patients with IVIG-resistant KD. Identifier: https://osf.io/3894y.

Deep muscle stimulator in the treatment of post-stroke spasticity: A protocol for systematic review and meta-analysis.

Spasticity is one of the most common complications and sequelae of stroke, with the main clinical manifestations being increased muscle tension, pain, stiffness, and other disorders. It not only increases the length of hospitalization and medical costs but also affects the quality of daily life and the stress of returning to society, increasing the burden on patients and their families. At present, 2 driver types of deep muscle stimulator (DMS) have been used in the clinical treatment of post-stroke spasticity (PSS) with good clinical results, but there is no evidence of clinical efficacy and safety. Therefore, this study aims to integrate direct and indirect comparative clinical evidence through a systematic review and network meta-analysis (NMA). According to the data, different driver types for DMS with the same body of evidence will be collected, analyzed, and sequenced in a quantitative and comprehensive manner and then screened for the optimal driver type of DMS device for PSS treatment. The study also aims to provide reference value and an evidence-based theoretical basis for the clinical optimization of DMS equipment selection. A comprehensive retrieval of China National Knowledge Infrastructure, Chinese scientific journal database, China biological feature database, Wanfang Chinese databases and the Cochrane Library, PubMed, Web of Science, and Embase foreign databases will be conducted. Randomized controlled trials of these 2 driver types of DMS devices combined with conventional rehabilitation training of PSS will be searched and published. The retrieval time is from the establishment of the database to December 20, 2022. The 2 first authors will screen references that meet the inclusion criteria, independently extract data according to predesigned rules, and assess the quality of the included studies and the risk of bias according to the Cochrane 5.1 Handbook criteria. R programming and Aggregate Data Drug Information System software will be used to perform a combined NMA of the data and to evaluate the probability of ranking for all interventions. The NMA and probability ranking will determine the best driver type of DMS device for PSS. This study will offer a comprehensive evidence-based approach to DMS therapy and assist doctors, PSS patients, and decision-makers in selecting a more efficient, secure, and cost-effective treatment option.

Complementary and alternative therapies for generalized anxiety disorder: A protocol for systematic review and network meta-analysis

Generalized anxiety disorder (GAD) is a prevalent and impairing psychiatric disorder, which is a great threat to people's mental health, and imposes a major burden on individuals, families and society. Complementary and alternative medicine (CAM) therapies is a potential treatment for GAD, however, the selection strategies of different CAM therapies in clinical practice is still unclear, and the purpose of this study is to evaluate the efficacy and acceptability of different CAM interventions using systematic review and network meta-analysis (NMA). Based on the strategy, the authors will retrieve a total of 9 electronic databases by January 2023. After a series of screening, the 2 researchers will use Aggregate Data Drug Information System (ADDIS) and Stata software to analyze the data extracted from randomized controlled trials (RCTs) of CAM therapies for the GAD. Finally, the evidence grade of the results will be evaluated. This study will provide a reliable evidence for the selection of CAM therapies for GAD. The results of this study will provide references for evaluating the influence of different CAM therapies for GAD, and provide a choice basis for clinical decision-making.

Acupoint application therapy for diarrhea-predominant irritable bowel syndrome: a protocol for systematic review and network meta-analysis

Irritable bowel syndrome is a chronic functional gastrointestinal disease, of which diarrhea-predominant irritable bowel syndrome (IBS-D) is a common subtype. In China, acupoint application therapy is currently widely used as an effective complementary therapy for IBS-D. In the clinical management of IBS-D, acupoint application is usually combined with other therapies, including acupuncture, moxibustion, and Chinese herbal and Western medicine. However, at present, evidence regarding the most effective options for treating IBS-D is insufficient. Therefore, this protocol proposes a systematic review and network meta-analysis for evaluating the effectiveness of acupoint application and its combination therapies in treating IBS-D, and for identifying the acupoint application-related treatments with the highest probability of being the best intervention. Six English electronic databases (PubMed, Ovid MEDLINE, Scopus, Web of Science, the Cochrane Library, and EMBASE), four Chinese electronic databases [China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (CQVIP), WanFang, and SinoMed), and one Japanese medical database (Citation Information by National Institute of Informatics (CiNii)] will be searched for eligible randomized controlled trials from their inception to June 1, 2022. The efficacy and safety of acupoint application therapy and its combination therapies for patients with IBS-D will be evaluated. The STATA 14.0 (StataCorp, USA) software package will be used for the meta-analysis. A Bayesian network meta-analysis (NMA) will be performed using R (version 4.0.2) and Aggregate Data Drug Information System (ADDIS, version 1.16.8) software packages. Bias risk will be assessed using the Cochrane Collaboration's risk of bias tool; specifically, publication bias will be evaluated using Egger's test and funnel plots. The rank probabilities of various outcomes for each intervention will be calculated, clustered, and ranked using the cumulative ranking curve method. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) method will be employed to assess the certainty of evidence for NMA outcomes. This study will aim to determine the clinical efficacy of acupoint application therapy and its combined therapy in the treatment of IBS-D and provide an evidence-based foundation for identifying the best acupoint application program.

Network Meta-Analysis of All Available Regimens Based on Drug-Coated Balloon Angioplasty and Laser Atherectomy for Femoropopliteal In-Stent Restenosis

Purpose: Drug-coated balloon (DCB) angioplasty and laser atherectomy (LA) have been frequently utilized to treat femoropopliteal in-stent restenosis (ISR); however, no studies have concurrently compared available regimens, including DCB, LA+DCB, and LA + plain balloon angioplasty (PB). Therefore, we conducted this network meta-analysis to determine whether there were significant differences in outcomes among these regimens. Materials and Methods: A comprehensive search was conducted in PubMed, EMBASE, and the Cochrane library to identify all randomized controlled trials comparing DCB or LA-based regimes with POBA or each other for treating femoropopliteal in-stent restenosis (ISR) from their inception until March 2021. The primary outcome measure was binary restenosis, and secondary outcome measures were target lesion revascularization (TLR) and mortality, evaluated at 6 and 12 months, respectively. Statistical analysis was performed using Aggregate Data Drug Information System (ADDIS) 1.4 software, and all data were graphically summarized using Microsoft Excel software. Results: The final analysis included 11 studies, of which 6 studies compared DCB with PB, 2 studies compared PB vs LA+PB, 2 studies compared DCB vs LA+DCB, and 1 study compared LA+DCB with LA+PB. DCB was better than PB in decreasing binary restenosis at 6 (odds ratio [OR]: 0.22, 95% credible interval [CrI]: 0.04–0.91) and 12 (OR: 0.26, 95% CrI: 0.12–0.50) months. DCB was associated with lower TLR than PB at 6 months (OR: 0.31, 95% CrI: 0.13–0.69). LA+DCB was also superior to PB in treating binary restenosis at 12 months (OR: 6.10, 95% CrI: 1.94–24.41) and TLR at 6 months (OR: 5.32, 95% CrI: 1.43–28.06). There was no statistical difference in mortality between PB, DCB, and LA+PB. DCB and LA+DCB were the first 2 options for reducing binary restenosis and TLR. Conclusion: The current network meta-analysis demonstrates that both DCB and LA+DCB are superior to PB alone, and that DCB and LA+DCB may be the preferred treatment options for reducing binary restenosis and TLR. Clinical Impact The treatment for femoropopliteal in-stent restenosis (ISR) remains challenging clinical practice. One important reason is that no optimal treatment strategy was available. Drug-coated balloon angioplasty (DCB) and laser atherectomy (LA) have been extensively utilized to treat ISR; however, different combinations of these treatments further confused the clinicians’ choices. This network meta-analysis systematically investigated the difference between the currently available treatments regarding therapeutic effects and safety, indicating that DCB and LA+DCB may be the optimal treatment for decreasing the risk of binary restenosis and target lesion revascularization. The results of the current network meta-analysis help to resolve the confusion of clinicians in making the decision.

Effect of non-pharmacological interventions for overweight/obese women with polycystic ovary syndrome on ovulation and pregnancy outcomes: a protocol for a systematic review and network meta-analysis

IntroductionMost overweight/obese women with polycystic ovary syndrome (PCOS) have infertility issues which are difficult to treat. Non-pharmacological interventions used for the management of infertility include lifestyle interventions, acupuncture therapies and...

Efficacy and safety of traditional Chinese medicine decoction in the treatment of adolescent myopia: A protocol for systematic review and network meta-analysis.

Background:Adolescent myopia has become a major public health problem in Asian countries and even the world. Due to its unstable prognosis and numerous complications, it has caused serious social and economic burden. As a common treatment in Asia, Chinese medicine has been shown to be effective in controlling the development of myopia, but its evidence-based medical evidence is not sufficient. Therefore, the purpose of this study is to evaluate the efficacy and safety of traditional Chinese medicine (TCM) in the treatment of adolescent myopia through network meta-analysis, and to provide evidence for clinical and scientific research.Methods:We searched seven databases for randomized controlled trials of TCM decoction for adolescent myopia, including PubMed, the Cochrane Library, EMbase, China National Knowledge Infrastructure, China Biological Medicine, Chinese Scientific Journals Database, and wan-fang databases, from the date of the establishment of each database to January 31, 2022. The network meta-analysis will be implemented through Aggregate Data Drug Information System 1.16.8 and Stata 13.0 software. Primary outcomes include distant vision, intraocular pressure, and diopter. Mean differences or odds ratios will be used for statistical analysis. We will ensure the reliability of the results through node-split model and heterogeneity analysis. In addition, the Cochrane Collaboration's tool and Grading of Recommendations Assessment, Development and Evaluation system will be used for the methodological quality and the evidence quality.Results:This study will provide reliable evidence for the clinical selection of TCM decoction in the treatment of adolescent myopia.Conclusion:The results of this study will evaluate the efficacy and safety of TCM decoction in the treatment of adolescent myopia, and provide decision-making references for future clinical and scientific research.Ethics and dissemination:This study did not require ethical approval. We will disseminate our findings by publishing results in a peer-reviewed journal.OSF registration number:DOI 10.17605/OSF.IO/VXQUP.

A Comparative Study of Different Stem Cell Transplantation for Spinal Cord Injury: A Systematic Review and Network Meta-Analysis

In the present study, we evaluated the efficacy and safety of different stem cell types for spinal cord injury (SCI) therapy to determine the superior treatment of SCI. A systematic literature search was performed using PubMed, Embase, the Cochrane Library, Web of Science, VIP, Chinese National Knowledge Infrastructure, and Wan Fang databases from initiation to January 30, 2021. A Bayesian network meta-analysis was performed using ADDIS (Aggregate Data Drug Information System) software. The PROSPERO registration number was CRD42020129635. We included 12 studies with 642 patients in the present study. A network meta-analysis revealed that bone mesenchymal stem cells (BMSCs) combined with rehabilitation training were significantly more effective than rehabilitation training alone in improving the American Spinal Injury Association (ASIA) impairment scale grade (odds ratio, 94.25; 95% confidence interval [CI], 6.71-9321.95), ASIA motor score (weighted mean difference [WMD], 6.67; 95% CI, 0.83-12.73), ASIA sensory functional score (WMD, 12.41; 95% CI, 3.42-21.72), and Barthel index (WMD, 7.24; 95% CI, 0.21-14.30). However, no statistically significant differences were observed between bone marrow mononuclear cells (MNCs) combined with rehabilitation training, umbilical cord-derived mesenchymal stem cells (UCMSCs) combined with rehabilitation training, or UCMSCs alone and rehabilitation alone for all indicators. In terms of safety, there were no serious and permanent adverse effects after transplantation of BMSCs, MNCs, or UCMSCs. BMSCs plus rehabilitation might be superior to other stem cell treatments of SCI in improving the ASIA impairment scale grade, ASIA motor score, ASIA sensory functional score, and Barthel index. The therapeutic effects of UCMSCs and MNCs remain to be confirmed.

Acupuncture and related therapies for carpal tunnel syndrome: A protocol for systematic review and Bayesian network meta-analysis.

Background:Carpal tunnel syndrome (CTS) is the most common peripheral nerve compression syndrome of the upper limb. Plenty of studies showed the effects of acupuncture therapy on relieving pain and improving functional status for CTS patients. Diverse types of acupuncture therapies have been used in the treatment for CTS, but their relative treatment effects are poorly understood. This study will evaluate the effects of different acupuncture and related therapies for CTS by conducting a systematic review and Bayesian network meta-analysis (NMA).Methods:We will search randomized controlled trials (RCTs) of acupuncture and related therapies for CTS in MEDLINE (via PubMed), EMBASE, Web of Science, Cochrane Library, Chinese Biomedical Database, China National Knowledge Infrastructure, VIP Database, Wanfang Database, WHO International Clinical Trials Registry Platform, ClinicalTrials.gov, Chinese Clinical Trial Register, and OpenGrey from inception to November 2021. Then, we will select eligible studies, extract data, and conduct risk of bias assessment using the Cochrane tool. Pairwise meta-analysis and Bayesian NMA will be performed in Stata 15.1 software and Aggregate Data Drug Information System 1.16.8 software. We will assess the quality of the evidence using the Confidence in Network Meta-Analysis application.Results:In this study, the treatment effects and safety of different acupuncture and related therapies for CTS will be evaluated.Conclusion:This study will provide evidence for choosing the optimal acupuncture and related therapies in the treatment for CTS.

The effectiveness of non-pharmacological interventions on cancer related fatigue in breast cancer patients: A protocol for systematic review and network meta-analysis.

AimTo assess the effect of different non‐pharmacological interventions on cancer‐related fatigue (CRF) in breast cancer (BC) patients and identify the most effective method for improving CRF.DesignA systematic review and network meta‐analysis.MethodsLiterature will be searched in the ongoing trail in the Clinical Trials.gov, World Health Organization, the International Clinical Trials Registry Platform, Cochrane Library, PubMed, EMBASE, Web of Science and CINAHL, from the inception until December 31, 2020. Two independent researchers will rigorously screen the literature according to the inclusion and exclusion criteria and assess the risk of bias based on the Cochrane Collaboration's Tool of RCTs. Stata 13.0 and Aggregate Data Drug Information System will be used for data analysis.ResultsThis protocol has been registered on the PROSPERO website (registration number is CRD42020222093). This study will provide the reliable evidence of the most effective non‐pharmacological intervention to improving CRF.

Acupuncture for heart failure: a Bayesian network systematic review and meta-analysis protocol.

Heart failure (HF) is the final stage of cardiovascular disease development, and clinical studies on acupuncture for the treatment of HF are increasing. However, the efficacy and safety of these acupuncture methods are unclear. The purpose of this study is to conduct a meta-analysis of the relevant randomized controlled trials (RCTs) to explain their efficacy and safety through high-quality evidence. The databases of the Cochrane Library, PubMed, Web of Science, SinoMed, China National Knowledge Infrastructure (CNKI), Wan-fang, and VIP will be searched from inception date to June 2021. The search will not be restricted by language. This study will include RCTs of various acupuncture methods for HF. Study selection, data extraction, and research quality assessments will be conducted independently by two researchers. The primary outcome is the efficacy rate and heart function, the secondary outcomes are quality of life scores, rehospitalization, and adverse reactions/events. The software RevMan 5.3 and Aggregate Data Drug Information System (ADDIS) will be used for network meta-analysis (NMA). Risk of bias, meta-regression, subgroup analysis, and sensitivity analysis will be performed, and the quality of evidence will be assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. This study will confirm the efficacy and safety of acupuncture in improving the clinical symptoms and heart function of HF, or elucidate which method of acupuncture is better suited to this purpose.

Efficacy and safety of traditional Chinese medicine injections in the treatment of chronic obstructive pulmonary disease: A protocol for systematic review and network meta-analysis.

Background:Chronic obstructive pulmonary disease (COPD) is a widespread, heterogeneous disease characterized by chronic inflammation of the airway and the gradual blockage of air flow due to bronchial obstruction. At present, a large number of traditional Chinese medicine injections (TCMIs) has been applied in the clinical treatment of COPD. However, there is insufficient evidence of evidence-based medicine of the interaction between them. Therefore, the purpose of this study is through the network meta-analysis to evaluate the efficacy and safety of the different TCMIs treatment of COPD, offering reference and evidence for clinical application.Methods:We will search 7 databases for randomized controlled trials of TCMI for the COPD, including PubMed, the Cochrane Library, EMbase, China National Knowledge Infrastructure, China Biological Medicine, Chinese Scientific Journals Database, and Wan-fang databases, from the date of the establishment of each database to October 31, 2021. The network meta-analysis will be implemented through Aggregate Data Drug Information System 1.16.8 and Stata 13.0 software. Pulmonary function included forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and FEV1/FVC will be the primary outcomes, FEV1 as a percentage of the estimated value (FEV1%pred), maximal voluntary ventilation (MVV), MVV as a percentage of the estimated value (MVV%pred), 6 minutes walking distance, The St. George's Respiratory Questionnaire score, and safety/adverse event will be evaluated as secondary outcomes. Mean differences or odds ratios will be used for statistical analysis. We will ensure the reliability of the results through node-split model and heterogeneity analysis. In addition, methodological quality will be evaluated based on the Cochrane Collaboration's tool, and the quality of evidence will be evaluated according to the Grading of Recommendations Assessment, Development and Evaluation system.Results:This study will provide reliable evidence for the clinical selection of TCMI in the treatment of COPD.Conclusion:The results of this study will evaluate the efficacy and safety of TCMI in the treatment of COPD, and provide decision-making references for future clinical and scientific research.

Acupuncture methods for functional constipation: protocol for a systematic review and network meta-analysis.

Functional constipation (FC) is one of the most prevalent functional gastrointestinal disorders, with the most significant negative impact on health-related quality of life. Despite that multiple systematic reviews and clinical trials have suggested that acupuncture could be effective for FC treatment, the comparative effectiveness among various acupuncture approaches has remained unknown. This protocol proposed a plan to assess and rank the effectiveness and safety of different acupuncture methods for patients with FC. We will search 8 bibliographic databases from their inception to 30 June 2021, including the Cochrane Central Register of Controlled Trials, MEDLINE (via PubMed), EMBASE, Allied and Complementary Medicine Database, the Chinese Biomedical Literature Database (CBM), Wanfang Database, VIP Database, and China National Knowledge Infrastructure (CNKI). Randomized controlled trials (RCT) examining acupuncture methods for FC will be considered. The primary outcome is a measurement of the weekly stool frequency [including bowel movement (BM), spontaneous bowel movement (SBM), and complete SBM]. There will be at least 2 reviewers in charge of study selection, data extraction, risk of bias assessment. Bayesian network meta-analysis will be conducted using ADDIS (Aggregate Data Drug Information System) V.1.16.8. Meta-regression and subgroup analyses will also be performed, if feasible, to address the potential causes of inconsistency and heterogeneity. Furthermore, the strength of evidence will be appraised using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. In this study, we will provide evidence-based hierarchies for the effectiveness and safety of acupuncture therapies to manage constipated patients, assisting healthcare providers, physicians, and patients in making more informed treatment decisions. This study has been registered at PROSPERO (https://www.crd.york.ac.uk/prospero/) with a registration number CRD42021227920.

Non-pharmacological intervention for rehabilitation of post-stroke spasticity: A protocol for systematic review and network meta-analysis.

Background:Post-stroke spasticity (PSS) is a major worldwide health problem, and timely and effective rehabilitation is associated with the risk of diabetes development; there are a variety of non-pharmacological interventions applied to the rehabilitation of PSS in these treatments; however, the relative efficacy and safety of different therapies remain uncertain, and we will conduct a systematic review and network meta-analysis to evaluate different non-pharmacological interventions. The relative efficacy and safety of intervention in PSS rehabilitation, thus providing evidence to support the optimization of the PSS rehabilitation program.Methods:We searched the following databases electronically, including four English literature databases (i.e., PubMed, Medline, Embase, and Cochrane Library) and two Chinese literature databases (i.e., China National Knowledge Infrastructure and VIP). We will also search for randomized controlled trials on non-pharmacological interventions for post-stroke spasticity, and the search time limit is from its establishment to May 2020. Two reviewers working independently will screen the titles, abstracts, and full papers. Data extraction will be completed by two independent authors. The primary outcome was the motor function. The secondary outcome was the assessment of daily living ability. We will use RevMan V.5.3 software to compute the data synthesis carefully when a meta-analysis is allowed. We will conduct Bayesian network meta-analysis using the Markov Chain Monte Carlo random effects model in Aggregate Data Drug Information System version 1.16.8 (Drugis, Groningen, NL).Results:This study provides a high-quality synthesis to assess the effectiveness and safety of non-pharmacological interventions for patients with PSS.Conclusion:The results of this study will provide evidence to judge whether non-pharmacological interventions are effective interventions for patients with post-stroke spasticity.Ethics and dissemination:The results of this meta-analysis and meta-regression will be disseminated through publication in a peer-reviewed journal and presented at a relevant conference. The data used in the network meta-analysis did not contain individual patient data. Therefore, ethical approval was not required.INPLASY registration number:INPLASY202140059

TCM nonpharmacological interventions for ankylosing spondylitis: A protocol for systematic review and network meta-analysis.

Ankylosing spondylitis (AS) is a common infammatory rheumatic disease that affects the axial skeleton. Traditional Chinese medicine (TCM) nonpharmacological interventions are gaining an increasing popularity for AS. Nevertheless, the evidence of efficacy and safety of random controlled trials (RCTs) remains controversial. This study aims to evaluate the efficacy and acceptability of different TCM nonpharmacological therapies by systematic review and network meta-analysis. According to the strategy, the authors will retrieve a total of 7 electronic databases by December 2020, including PubMed, the Cochrane Library, EMbase, China National Knowledge Infrastructure, China Biological Medicine, Chongqing VIP, and Wan-fang databases After a series of screening, 2 researchers will use Aggregate Data Drug Information System and Stata software to analyze the data extracted from the randomized controlled trials of TCM nonpharmacological interventions for AS. The primary outcome will be the improvement of Pain intensity and functional status/disability and the secondary outcomes will include lobal improvement, health-related quality of life, satisfaction with treatment, and adverse events. Both classical meta-analysis and network meta-analysis will be implemented to investigate direct and indirect evidences on this topic. The quality of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation instrument. This study will provide a reliable evidence for the selection of TCM nonpharmacological therapies in the treatment of AS. This study will generate evidence for different TCM nonpharmacological therapies for AS and provide a decision-making reference for clinical research. This study does not require ethical approval. The results will be disseminated through a peer-reviewed publication. DOI 10.17605/OSF.IO/FHD2U.

Complementary and alternative therapies for knee osteoarthritis: A protocol for systematic review and network meta-analysis.

Background:Knee osteoarthritis (KOA) is a degenerative disease, making a unique contribution to chronic pain, edema, and limited mobility of knee joint. This disease is an important factor affecting the quality of life of middle-aged and elderly people. Complementary and alternative medicine (CAM) therapies have been used clinically to treat KOA; however, the selection strategies of different CAM interventions in clinical practice are still uncertain, and the purpose of this study is to evaluate the efficacy and acceptability of different CAM therapies using systematic review and network meta-analysis.Methods:According to the strategy, the authors will retrieve a total of 7 electronic databases by October 2020, including PubMed, the Cochrane Library, EMbase, China National Knowledge Infrastructure, China Biological Medicine, Chongqing VIP, and Wan-fang databases After a series of screening, 2 researchers will use Aggregate Data Drug Information System and Stata software to analyze the data extracted from the randomized controlled trials of CAM therapies for the KOA. Finally, the evidence grade of the results will be evaluated.Results:This study will provide a reliable evidence for the selection of CAM therapies for KOA.Conclusion:The results of this study will provide references for evaluating the influence of different CAM therapies for KOA, and provide decision-making references for clinical research.Ethics and dissemination:This study does not require ethical approval. The results will be disseminated through a peer-reviewed publication.OSF registration number:DOI 10.17605/OSF.IO/GJMF4.

Traditional Chinese medicine for oral squamous cell carcinoma: A Bayesian network meta-analysis protocol.

Background:Traditional Chinese medicine is frequently used for malignant tumors in China, but in clinical practice, most practitioners choose appropriate Chinese medicines based on personal experience. In our study, Bayesian network meta-analysis will be used to identify differences in efficacy and safety between diverse traditional Chinese drugs for oral squamous cell carcinoma (OSCC).Methods:Relevant randomized controlled trials and prospective controlled clinical trials were searched from Medline, PubMed, Cochrane Library, Google Scholar, Excerpt Medica Database, Web of Science, China National Knowledge Infrastructure, China Scientific Journal Database, Chinese Biomedical Literature Database, and Wanfang Database from their establishment to September 2020. Study selection and data extraction will be performed independently by 2 researchers. Aggregate Data Drug Information System and R software were used for data synthesis. The evidentiary grade of the results will be also evaluated.Results:The results of this study will be published in a peer-reviewed journal, and provide reliable evidence for different traditional Chinese drugs on OSCC.Conclusions:The findings will provide reference for evaluating the efficacy and safety of different traditional Chinese medicine for OSCC, and provide a helpful evidence for clinicians to formulate the best adjuvant treatment strategy for OSCC patients.Trial registration number:INPLASY202090082.

Effect and safety of oral Chinese patent medicine for heart failure: A protocol for systematic review and network meta-analysis.

Background:Heart failure (HF) is the terminal stage of various common cardiovascular diseases with quite a frequent readmission and a high mortality rate, and brings heavy financial burdens to families and society. Oral Chinese patent medicine (CPM) has been widely applied in the treatment of HF in China because of its simplicity, cheapness, convenience, and high efficiency. However, due to the large number and broad clinical selectivity of oral CPMs, there is a lack of uniformity and clinical application standardization. To choose more effective and safe medicine among so many oral CPMs is particularly essential for further improving the therapeutic effect. In this study, the efficacy and safety of different oral CPMs will be compared by a network meta-analysis (NMA), and the best CPM will be selected for the treatment of HF.Methods:According to the search strategy, 4 English and 4 Chinese databases will be searched from the construction of the library to July 31, 2020. The NMA will include clinical randomized controlled trials (RCTs) of different oral CPMs in HF treatment. The methodological quality is assessed according to the bias risk assessment tool of Cochrane. The Bayesian NMA is performed by Aggregate Data Drug Information System (ADDIS), and the results are visualized using Stata 15.0 software. The GRADE approach is used to assess the quality of evidence and recommendation intensity.Results:The NMA will identify the best oral CPM in the complementary treatment of HF. A peer-reviewed journal will publish the results of the study.Conclusion:This study can provide reliable evidence for the efficacy and safety of oral CPMs in the treatment of HF, and help decision-makers and patients to select more effective and safer oral CPM.Protocol registration number:INPLASY202090053.