The potential benefits and mechanisms of protein nutritional intervention on bone health improvement.

Osteoporosis commonly occurs in the older people and severe patients, with the main reason of the imbalance of bone metabolism (the rate of bone resorption exceeding the rate of bone formation), resulting in a decrease in bone mineral density and destruction of bone microstructure and further leading to the increased risk of fragility fracture. Recent studies indicate that protein nutritional support is beneficial for attenuating osteoporosis and improving bone health. This review summarized the classical mechanisms of protein intervention for alleviating osteoporosis on both suppressing bone resorption and regulating bone formation related pathways (promoting osteoblasts generation and proliferation, enhancing calcium absorption, and increasing collagen and mineral deposition), as well as the potential novel mechanisms via activating autophagy of osteoblasts, altering bone related miRNA profiles, regulating muscle-bone axis, and modulating gut microbiota abundance. Protein nutritional intervention is expected to provide novel approaches for the prevention and adjuvant therapy of osteoporosis.

Large dosage Huanglian (Rhizoma Coptidis) for T2DM: A protocol of systematic review and meta-analysis of randomized clinical trials.

INTRODUCTION: Type 2 diabetes mellitus(T2DM) is a widespread attention of the world's major health problems. The international diabetes federation (IDF) has released the "global overview of diabetes (ninth edition)". By 2019. It can lead to complications and even death. Among them, the use of Rhizoma Coptidis (Huanglian) at large dose has also been proved to be effective in clinical practice. However, due to the lack of evidence, there is no specific method or suggestion, so it is necessary to carry out systematic evaluation on coptis coptis and provide effective evidence for further research. METHODS AND ANALYSIS: We will search the following electronic databases from their inception to May 2020: Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure. Primary outcomes:fasting blood glucose and glycosylated haemoglobin (A1c). SECONDARY OUTCOMES: plasma insulin,blood lipid profile,adverse events,and cost associated with the intervention and hospital visit. Data will be extracted by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: The results of this study will systematically evaluate the effectiveness and safety of large dose of Huanglian intervention for people with T2DM. CONCLUSION: The systematic review of this study will summarize the current published evidence of large dose of Huanglian for the treatment of T2DM, which can further guide the promotion and application of it. ETHICS AND DISSEMINATION: This study is a systematic review, the outcomes are based on the published evidence, so examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations.Open Science Framework(OSF)registration number: July 21, 2020. https://osf.io/w7bj6.

Effect of music intervention on mental health in patients with diabetes mellitus: protocol for a systematic review and meta-analysis of randomizsed controlled trials.

INTRODUCTION: About 463 million adults aged 20-79 have diabetes globally. Mental disorders often exist in patients with diabetes as comorbidities, which can lead to aggravation of the diseases, increased difficulties in treatment, as well as elevated mortality rates. Music intervention has been applied in the treatment of comorbidities for 12 years now, but there are still no recommendations due to the lack of evidence. Thus, a meta-analysis is necessary to evaluate the effect of music intervention in treating mental disorders of patients with diabetes. METHODS AND ANALYSIS: We will search the following nine online electronic databases from their inception until March 2020: PubMed, Web of Science, Embase, EBSCO, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Database, Chinese Scientific Journal Database (VIP) and Chinese Biomedical and Medical Database. We also plan to search other relevant resources, including grey literature and the reference lists of relevant publications. Only randomised controlled trials of music intervention to treat depression or anxiety in patients with diabetes will be involved. The primary outcomes include the depression score and anxiety score measured on certain scales, and the secondary outcome is safety. Data extraction will be independently implemented by two researchers. The risk of bias will be evaluated through the Cochrane Collaboration's Risk of Bias tool. Eventually, all the data will be analysed via the Review Manager V.5.3 software. ETHICS AND DISSEMINATION: This meta-analysis will provide information about applying music intervention to treat depression or anxiety in patients with diabetes. No ethical approval is required because this meta-analysis is based on published data. The results of this systematic review will be published in a peer-reviewed journal.PROSPERO registration numberCRD42019146439.

Baihu Jia Renshen Decoction for type 2 diabetic mellitus: A protocol for systematic review and meta-analysis.

BACKGROUND: Diabetes mellitus (DM) is one of the main health problems that perplex people all over the world. The prevalence of DM is still increasing in spite of the great efforts have been made to control DM in recent years. Type 2 diabetes mellitus (T2DM) is the most common type of diabetes, accounting for about 90% of all DM cases. Traditional Chinese medicine has been used on treatment of DM and diabetic complications in China for many years. Baihu Jia Renshen Decoction (BJRD) is one of the oldest classic prescriptions of traditional Chinese medicine that applied in the field of diabetes' treatment. BJRD is proved to be effective after years of clinical practice and basic research. The application of BJRD improves the overall clinical efficacy of T2DM. Therefore, a systematic review is necessary to provide available evidence for BJRD in therapy of T2DM. METHODS: Different studies from various databases will be involved in this study. Only randomized controlled trials of T2DM patients diagnosed with World Health Organization 1999 diagnostic criteria will be included. We will search the literature in the databases from China Conference Paper Database, manual searching. Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, CNKI (China National Knowledge Internet), WanFang, VIP (Chongqing VIP), and CBM (China Biomedical Literature CDROM Database). The primary outcomes include 2 hour plasma glucose, fasting plasma glucose, hemoglobin A1c, homeostasis model assessment of insulin resistance, and fasting plasma insulin. The secondary outcomes include clinical efficacy and adverse events. Data will be extracted by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: This study will synthesize and provide high-quality evidence based on the data of the currently published BJRD for the treatment of T2DM, in terms of 2 hour plasma glucose, fasting plasma glucose, hemoglobin A1c, homeostasis model assessment of insulin resistance and fasting plasma insulin, clinical efficacy, and safety. CONCLUSION: This systematic review aims to evaluate the benefits and harms of BJRD for the treatment of T2DM reported in randomized controlled trials, and provide more options for clinicians and patients to treat T2DM. REGISTRATION NUMBER: INPLASY202040006.

Huangqi Guizhi Wuwu decoction for diabetic peripheral neuropathy: Protocol for a systematic review.

BACKGROUND: Diabetic peripheral neuropathy (DPN) is one of the most common causes of disability in diabetic population, and its pathogenesis is related to a variety of factors. There is currently no effective treatment for such chronic disease. Traditional Chinese medicine has a long clinical history for the prevention and treatment of diabetes and chronic complications, and it also shows certain advantages in the treatment of DPN. Many clinical studies have confirmed that Chinese medicine Huangqi Guizhi Wuwu decoction (HGWD) can reduce the clinical symptoms and improve neuronal function of patients with DPN. So we intend to conduct a systematic review further clarified the effectiveness and safety of HGWD for DPN. METHODS: We will search each database from the built-in until June 2019. The English literature mainly searches Cochrane Library, PubMed, EMBASE, and Web of Science, while the Chinese literature comes from CNKI, CBM, VIP, and Wangfang database. Simultaneously we will retrieval clinical registration tests and grey literatures. This study only screen the clinical randomized controlled trials (RCTs) about HGWD for DPN to assess its efficacy and safety. The 2 researchers worked independently on literature selection, data extraction, and quality assessment. The dichotomous data is represented by relative risk (RR), and the continuous is expressed by mean difference (MD) or standard mean difference (SMD), eventually the data is synthesized using a fixed effect model (FEM) or a random effect model (REM) depending on whether or not heterogeneity exists. The clinical efficacy, median sensory nerve conduction velocity, median motor nerve conduction velocity, peroneal sensory nerve conduction velocity, and peroneal motor nerve conduction velocity were evaluated as the main outcomes. Fasting blood glucose, 2 hours postprandial blood glucose, hemorheology, and adverse reactions were secondary outcomes. Finally, meta-analysis was conducted by RevMan software version 5.3. RESULTS: This study will synthesize and provide high-quality evidence based on the data of the currently published HGWD for the treatment of DPN, especially in terms of clinical efficacy, neurological function, blood glucose, hemorheology, and safety. CONCLUSION: This systematic review aims to provide new options for HGWD treatment of DPN in terms of its efficacy and safety. PROSPERO REGISTRATION NUMBER: PROSPERO 2019 CRD42019132031.

Zusanli (ST36) acupoint injection for acute diarrhea in children under 5 years old: A protocol of systematic review and meta-analysis of randomized clinical trials.

BACKGROUND: Acute diarrhea is the 2nd highest prevalence disease among children under 5 years of age. It can cause malnutrition and even death in children, especially in developing country. Traditional Chinese medicine therapy has been applied and already in the guidelines for clinical practice of acute infectious diarrhea in children in China, but there is no specific methods or recommendations due to lacking of evidence. Zusanli acupoint injection as a form of acupuncture therapy, which is proved to be effective in randomised controlled trials (RCTs) and very suitable for children, has been used in acute diarrhea in children for a long time; therefore, a systematic review is necessary to provide available evidence for further study. METHODS: Different studies from various databases will be involved in this study. Only RCTs of children under 5 years of age diagnosed with acute diarrhea using any recognized diagnostic criteria will be included. We will search manually the literature in the databases from China Conference Paper Database. Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Internet, WanFang, Chongqing VIP, and China Biomedical Literature CDROM Database. Primary outcomes: clinical cure rate (clinical cure is defined as the frequency, timing and character of stool back to normal status, as well as disappearance of diarrhea symptoms), diarrhea duration (from admission to the cessation of diarrhea). SECONDARY OUTCOMES: stool frequency within 24 hours, rate of adverse effect. Data will be extracted by 2 researchers independently; risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: This study will synthesize and provide evidence based on the data of the currently published zusanli (ST36) acupoint injection for acute diarrhea in children under 5 years old, especially in terms of clinical efficacy and safety. CONCLUSION: This systematic review aims to evaluate the benefits and harms of zusanli acupoint injection for acute diarrhea in children under 5 years old reported in RCTs, and provide evidence reference in TCM field for Chinese guidelines on the treatment of acute diarrhea in children. ETHICS AND DISSEMINATION: This study is a systematic review; the outcomes are based on the published evidence, and hence examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations. PROSPERO REGISTRATION NUMBER: PROSPERO 2019 CRD42019135275.