The effect of oral nutritional supplement therapy on nutritional status and quality of life in patients with esophageal cancer undergoing radiotherapy and chemotherapy: A protocol for randomized controlled trial

Background:The incidence of malnutrition in patients with esophageal cancer is high, which seriously affects the therapeutic effect and quality of life. Oral nutritional supplement is the first choice of nutritional support recommended by current guidelines, which can supplement the lack of energy and protein in patients with esophageal cancer, improve nutritional status and improve the quality of life, but there are few clinical studies. Therefore, the purpose of this randomized controlled trial is to evaluate the effect of oral nutritional supplement therapy on nutritional status and quality of life in patients with esophageal cancer treated undergoing radiotherapy and chemotherapy.Methods:This is a prospective randomized controlled trial to study the effects of oral nutritional supplement therapy on nutritional status and quality of life in patients with esophageal cancer undergoing radiotherapy and chemotherapy. This study is approved by the Clinical Research Society of our hospital. Patients will be randomly divided into ONS group and traditional diet group. The nutritional status, quality of life score and adverse reactions will be observed before and after radiotherapy and chemotherapy. The data will be analyzed by SPSS 16.0.Discussion:This study will evaluate the effect of oral nutritional supplement therapy on nutritional status and quality of life of patients with esophageal cancer undergoing radiotherapy and chemotherapy. The results of this experiment will establish clinical evidence for the application of oral nutritional supplement therapy in patients with esophageal cancer undergoing radiotherapy and chemotherapy.OSF Registration number:DOI 10.17605/OSF.IO/9ZW34.     

The clinical efficacy of Shengyu decoction in the treatment of anemia after PFNA for elderly intertrochanteric fracture: A protocol of prospective,randomized, controlled trial

Background:Femoral intertrochanteric fractures (ITF) occur frequently in the elderly, accounting for 45% of all hip fractures. Postoperative anemia after fracture tends to cause ischemia, hypoxia in cells, tissues and organs, increasing the rate of blood transfusion, risk of infection, disability and mortality. Meanwhile, traditional Chinese medicine is widely used in the treatment of anemia for activating blood circulation and removing blood stasis.Methods:This study is a prospective, outcome assessor-, and data analyst-blinded randomized controlled clinical trial. The objective of this proposed study was to investigate whether Shengyu Decoction could improve the symptoms of anemia after proximal femoral nail antirotation in elderly ITF patients. After qualifying for screening, patients will be randomized into 2 groups with an allocation ratio of 1:1. Hemoglobin concentration, HBL, and HHS score are outcome measurements. The other outcomes also included time to get out of bed, discharge to home, 30-day readmission rates, and mortality.Discussion:ITF is commonly occurring in senior citizens, and those who are senior in age generally suffer 1 or more basic diseases, whose nutritional status is already poor. Trauma and surgical stimulation not only aggravate the existing disease or induce corresponding cardiovascular complications, but also worsen the nutritional status, which can easily cause postoperative anemia in patients. Because of the limited clinical modalities available for the treatment of postoperative anemia after fracture surgery, and most of them have various side effects that are not easily tolerated by the elderly. Therefore, from a traditional Chinese medicine perspective, we proposed a protocol using mild Chinese herbal decoction to treat postoperative anemia in ITF.Registration number: OSF Registration number: DOI 10.17605/OSF.IO/JQ6ZF.     

Could Jinfukang alleviate the chemotherapy-related adverse effects in non-small cell lung cancer patients?: A protocol for a double-blind,randomized controlled trial

Background:Lung cancer is the main cause of cancer-related death in the world, and non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers. Cisplatin and its derivatives are the first-line chemotherapeutic drugs for patients with advanced lung cancer, but the chemotherapy-related adverse reactions greatly impact the quality of life (QOL) of patients and limit their use. Jinfukang is a commonly used traditional Chinese medicine preparation with anti-tumor effect in China, which has been approved by China Food and Drug Administration against NSCLC. At present, there is a lack of strict randomized controlled trials to study whether Jinfukang could alleviate the chemotherapy-related adverse effects in the treatment of advanced NSCLC. Therefore, we intend to perform a double-blind, placebo controlled, randomized trial to evaluate the effect of Jinfukang in alleviating the chemotherapy-related adverse effects of patients with advanced NSCLC.Methods:This is a prospective, double-blind, randomized, placebo controlled trial. According to the randomized control principle, 168 patients will be divided into treatment group and control group at 1:1 ratio. The patients in the two groups will be treated continuously for 3 cycles and followed up for 3 years. Outcome indicators include: the incidence of chemotherapy-related adverse effects, the progression-free survival (PFS), total effective rate, and QOL evaluation. We will use SPSS19.0 to analyze the results.Conclusions:This study will help to evaluate the effect of Jinfukang alleviating chemotherapy-related adverse effects in the treatment of advanced NSCLC.Trial registration:DOI 10.17605/OSF.IO/YWBSC     

Influence of Early Postoperative Enteral Nutrition versus Placebo on Cell-Mediated Immunity,As Measured with the Multitest® CMI

Background: Patients who become anergic after surgery have a very high death rate, mainly due to infectious complications. It has earlier been shown that preoperative skin testing has predictive value for the clinical outcome in gastrointestinal surgery. This study investigated the effect of early postoperative enteral nutrition versus placebo on cell-mediated immunity with the Multitest® CMI and correlated the results to the clinical outcome and to the preoperative nutritional status. Methods: Sixty patients were randomized to receive either enteral nutrition or placebo. All patients were stratified in accordance with preoperative nutritional status. CMI tests were applied 2 days before surgery and days 1 and 5 postoperatively. All tests were applied and recorded by the same investigator. Results: No significant differences in the score were seen between the groups. Nine patients were malnourished. No significant difference was seen preoperatively with regard to nutritional status, but the malnourished patients had a lower median value on the 3rd postoperative day. In patients with complications the preoperative median CMI score was 17.0 mm (95% confidence limits, 10.5-24 mm), and in patients without complications 9.5 mm (95% confidence limits, 5.5-16 mm). This result is significant and unexpected. Ten patients were anergic preoperatively, and three of these developed complications (30%). The overall complication rate was 27 of 60 (45%). A change in immunologic status from responding preoperatively to anergy postoperatively was significantly associated with severe complications (P = 0.043). Conclusions: Early enteral nutrition does not influence the CMI score. Preoperative anergy was not related to increased mortality/morbidity, whereas the change in CMI response towards anergy was significant.     

Efficacy and safety of acupoint catgut embedding in treating postoperative pain of mixed hemorrhoids: A randomized controlled trial protocol

Background:Pain is a common complication after mixed hemorrhoids, which seriously affects the recovery of patients and prolongs the length of hospital stay. Acupoint catgut embedding has advantages in improving a variety of acute and chronic pain diseases, but there is still a lack of rigorous randomized controlled studies to verify its efficacy and safety in the treatment of postoperative pain of mixed hemorrhoids. Therefore, the purpose of this randomized controlled trial is to evaluate the clinical efficacy of acupoint catgut embedding in the treatment of postoperative pain of mixed hemorrhoids.Methods:This is a prospective randomized controlled trial to study the efficacy and safety of acupoint catgut embedding in the treatment of postoperative pain of mixed hemorrhoids. Approved by the clinical research ethics committee of our hospital, the patients were randomly divided into observation group and control group according to 1:1. The observation group received acupoint catgut embedding before the operation, while the control group received no special treatment. The efficacy and safety indexes were concerned after the operation, and the observation indexes included: resting state and visual analogue scale (VAS) score during defecation, postoperative hospitalization time, total amount of analgesic use, adverse reactions, etc. Finally, we carried on the data statistical analysis through the SPSS version 19.0.Discussion:This study will evaluate the efficacy and safety of acupoint catgut embedding in the treatment of postoperative pain of mixed hemorrhoids, and the results of this study will provide a new idea for the selection of postoperative analgesia for mixed hemorrhoids resection.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/T2ZGY.     

Nutrition in peri-operative esophageal cancer management

Introduction: Nutritional status and dietary intake are increasingly recognized as essential areas in esophageal cancer management. Nutritional management of esophageal cancer is a continuously evolving field and comprises an interesting area for scientific research.

Areas covered: This review encompasses the current literature on nutrition in the pre-operative, peri-operative, and post-operative phases of esophageal cancer. Both established interventions and potential novel targets for nutritional management are discussed.

Expert commentary: To ensure an optimal pre-operative status and to reduce peri-operative complications, it is key to assess nutritional status in all pre-operative esophageal cancer patients and to apply nutritional interventions accordingly. Since esophagectomy results in a permanent anatomical change, a special focus on nutritional strategies is needed in the post-operative phase, including early initiation of enteral feeding, nutritional interventions for post-operative complications, and attention to long-term nutritional intake and status. Nutritional aspects of pre-optimization and peri-operative management should be incorporated in novel Enhanced Recovery After Surgery programs for esophageal cancer.     

Auricular therapy improves gastrointestinal function in patients with gynecological laparoscopic surgery: A protocol for systematic review and meta analysis

Background:Gynecological laparoscopic surgery is the main method to treat gynecological diseases, but postoperative gastrointestinal reactions are more common in patients. Auricular therapy, as a characteristic therapy of Traditional Chinese Medicine, can improve gastrointestinal symptoms such as nausea and vomiting by stimulating the conduction of acupoints through the nervous system on internal organs, but there are studies questioning the efficacy of auricular therapy. Therefore, the purpose of this study is to prove the efficacy and safety of auricular therapy in promoting gastrointestinal function recovery after gynecological laparoscopic surgery, and to provide reference value for future clinical practice.Methods:To search English databases (PubMed, Excerpta Medical Database [Embase], Web of Science, the Cochrane Library) and Chinese databases (Chinese National Knowledge Internet [CNKI], WanFang, Viper, Chinese Biomedical Literature Database) by computer, and conduct a randomized controlled trial on the effect of aural point therapy on gastrointestinal function recovery of patients after gynecological laparoscopic surgery from the establishment of the database to October 2020. Two researchers independently evaluate the quality of the included studies and extract the data, and meta-analysis of the included literature is carried out using RevMan5.3 software.Results:In this study, the efficacy and safety of auricular therapy in the recovery of gastrointestinal function after gynecological laparoscopic surgery are evaluated from the aspects of first anal exhaust time, bowel sound recovery time, and incidence of gastrointestinal complications.Conclusion:This study will provide reliable evidence-based evidence for auricular therapy in the treatment of gastrointestinal function after gynecologic laparoscopic surgery.Ethics and dissemination:Private information from individuals will not be published. This systematic review also does not involve endangering participant rights. Ethical approval was not required. The results may be published in a peer-reviewed journal or disseminated at relevant conferences.OSF Registration number:DOI 10.17605 / OSF.IO / ZSPGA     

Efficacy and safety of Qigong Baduanjin exercise in the treatment of depression with insomnia: A randomized controlled study protocol

Background:Depression is a common mental illness often associated with insomnia. Baduanjin exercise has been found to improve depressive symptoms and has also been found to have good effects on insomnia. However, there are no rigorous clinical studies to evaluate the effects of Baduanjin exercise on depressed patients with insomnia, so this randomized controlled trial will evaluate the efficacy of Qigong Baduanjin exercise in treating depression with insomnia.Methods:This is a prospective randomized controlled trial to investigate the clinical efficacy of Baduanjin exercise in the treatment of depression with insomnia. The included patients will be randomly divided into a treatment group and control group. The treatment group will be treated with Baduanjin exercise and the control group will be treated with oral mirtazapine. After 8 weeks of continuous treatment, they will be followed up for 3 months. Observed indexes included Pittsburgh sleep quality index, Hamilton expression Rating Scale score, and adverse reactions. Finally, the data are statistically analyzed by SPSS 20.0 software.Discussion:This study will evaluate the efficacy and safety of Baduanjin exercise in the treatment of depression with insomnia, and the results of this study will provide a clinical basis for the treatment of depression with insomnia.Trial registration: OSF Registration number: DOI 10.17605/OSF.IO/KC48H     

Efficacy and safety of radiofrequency ablation versus laparoscopic hepatectomy for small hepatocellular carcinoma: A protocol for a randomized controlled trial

Background:Hepatocellular carcinoma (HCC) is one of the most common type of malignant tumors in adults, and is the most common cause of death in people with cirrhosis. Both laparoscopic hepatectomy (LH) and radiofrequency ablation (RFA) are radical treatments for small HCC. However, there is no international standard for the treatment of small HCC, and it is still controversial to choose LH or RFA in treating small HCC. We try to carry out a randomized, controlled, prospective study to compare the the short-term and long-term effects and safety of LH versus RFA in the treatment of small HCC.Methods:This study is a single-center, evaluator-blinded, randomized, controlled clinical trial (RCT). The patients will be randomly divided into RFA group and LH group in a 1:1 ratio according to a computer-generated randomization list. Postoperative complications rates, Alpha fetoprotein (AFP), hospital stay, 1, 2, 3-year overall survival (OS) rates, disease-free survival (DFS) rates and all possible adverse events will be recorded. Statistical analyses will be performed with SPSS v22.0 software.Conclusions:The study will compare the the short-term and long-term effects and safety of LH versus RFA in the treatment of small HCC.OSF Registration number:doi: 10.17605/OSF.IO/HNX2T     

Effect of nursing intervention to guide early postoperative activities on rapid rehabilitation of patients undergoing abdominal surgery: A protocol for systematic review and meta-analysis

Background:Postoperative complications after abdominal surgery are high, and there is no reliable intervention program to prevent them. Some studies have pointed out that early postoperative activities have advantages in preventing the occurrence of complications, but lack of evidence-based basis. The purpose of this study is to systematically evaluate the effect of nursing intervention is guiding early postoperative activities on the rapid recovery of patients undergoing abdominal surgery.Methods:China National Knowledge Infrastructure, Wanfang, China Science and Technology Journal Database and Chinese Biomedical Database, PubMed, Embase, Web of Science and the Cochrane Library will be searched by computer, and a randomized controlled study is conducted on early participation in exercise programs after abdominal surgery from the establishment of the database to January 2021. The language is limited to English and Chinese. The quality of the included study is independently extracted and the literature quality is evaluated by 2 researchers, and the included literature is analyzed by Meta using RevMan5.3 software.Results:This study will evaluate the effect of nursing intervention is guiding early postoperative activities on the rapid rehabilitation of patients undergoing abdominal surgery through the indexes of postoperative quality of life score, the incidence of complications, mortality, length of stay and so on.Conclusion:This study will provide reliable evidence-based basis for establishing a reasonable and effective postoperative activity guidance program for patients undergoing abdominal surgery.Ethics and dissemination:Private information from individuals will not be published. This systematic review also does not involve endangering participant rights. Ethical approval will not be required. The results may be published in a peer-reviewed journal or disseminated at relevant conferences.OSF Registration number:DOI 10.17605/OSF.IO/59MD4     

Effects of Danhong injection on cardiac function and blood lipid in patients with angina pectoris of coronary heart disease: A protocol for randomized,double-blind,placebo-controlled clinical trial

Background:Angina pectoris of coronary heart disease is the leading cause of death worldwide. Danhong injection is a supplement for angina pectoris of coronary heart disease. A large number of studies have confirmed its efficacy and safety. However, there is no rigorous clinical study to evaluate the effects of Danhong injection on cardiac function and blood lipid in patients with angina pectoris of coronary heart disease.Methods:This is a prospective, randomized, double-blind, placebo-controlled trial to study the effects of Danhong injection on cardiac function and lipid profile in patients with angina pectoris of coronary heart disease. Participants will be randomly divided into treatment group and control group. The treatment group will be treated with Danhong injection and the control group will be treated with placebo under basic treatment according to recommended guideline, and followed up for 3 months after 14 consecutive days of treatment. Outcomes include: cardiac function (left ventricular end-diastolic diameter); left ventricular end-systolic diameter; left ventricular ejection fraction, blood lipid levels (total cholesterol; triacylglycerol; low density lipoprotein cholesterol; high density lipoprotein cholesterol), the number of angina attacks per week, total amount of nitroglycerin tablets, and adverse reactions.Discussion:This study will evaluate the efficacy of Danhong injection in improving cardiac function and blood lipid in patients with angina pectoris of coronary heart disease. The results of this study will provide reference for clinical use of Danhong injection to improve cardiac function and blood lipid in patients with angina pectoris of coronary heart disease.Trial registration: OSF Registration number: DOI 10.17605/OSF.IO/TPZJ5.     

Efficacy and safety of Buyang Huanwu decoction in the treatment of varicose veins of the lower extremities: A protocol of randomized controlled trial

Background:Varicose veins of the lower extremities are common chronic venous diseases in the clinic. Although Western medicine has various surgical methods to treat varicose veins in the lower extremities, there are still a variety of complications. Some studies have shown that Buyang Huanwu decoction treatment of varicose veins of the lower extremities has a certain effect, and can reduce the occurrence of postoperative complications, but there is no evidence of evidence-based medicine. The research carried out in this scheme is to systematically evaluate the efficacy and safety of Buyang Huanwu decoction in the treatment of varicose veins in the lower extremities, and to provide reliable evidence for guiding clinical practice.Methods:This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial, which studies the effectiveness and safety of Buyang Huanwu decoction in the treatment of varicose veins of the lower extremities. The patients are randomly and evenly divided into treatment group and control group, the former one is given Buyang Huanwu decoction and the latter one is given placebo. The study will last 49 days, including a 7-day washout period, 14-day intervention and 28-day follow-up, focusing on its efficacy and safety indicators. Observation indicators include: TCM syndrome score, Venous Clinical Severity Score (VCSS), Venous Disability Scote (VDS), Aberdeen Varicose Vein Questionnaire (AVVQ), Hemorheology Indicators, Adverse Reactions, etc. Data analysis is performed using SPSS 25.0 software.Discussion:This study will evaluate the effectiveness and safety of Buyang Huanwu decoction and provide clinical evidence for the treatment of varicose veins of the lower extremities.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/WGJXT.     

Effects of α lipoic acid combined with olmesartan medoxomil on blood glucose and oxidation indicators in patients with diabetic nephropathy: A protocol for a parallel,randomized, double-blind,controlled clinical trial

Background:Diabetic nephropathy (DN) is a common microvascular complication of diabetes, which poses a serious threat to the health and life of patients. There is evidence that both α lipoic acid and olmesartan medoxomil have positive effects in the treatment of DN, but whether the 2 have synergistic effects and the effects on blood glucose and oxidation indicators are controversial.Methods:This is a prospective parallel, randomized, double-blind, placebo-controlled trial to study the effects of α lipoic acid in combination with olmesartan medoxomil on blood glucose and oxidation indicators in patients with DN. Participants will be randomly assigned to a treatment group, which will receive α lipoic acid dispersive tablets combined with olmesartan medoxomil tablets, or a control group, which will receive olmesartan medoxomil tablets combined with placebo for 4 weeks, followed up for 12 weeks. Observation indicators include: glycemic indicators [fasting blood glucose, 2 hours postprandial blood glucose and glycosylated hemoglobin], the oxidation indicators [serum glutathione, superoxide dismutase, malondialdehyde, 8-hydroxydeox-yguanosine], and adverse reactions. Finally, SPASS 22.0 software will be used for statistical analysis of the data.Discussion:This study will evaluate the effects of α lipoic acid combined with olmesartan medoxomil on blood glucose and oxidation indicators in patients with DN. The results of this study will provide a reference for the clinical use of α lipoic acid combined with olmesartan medoxomil in the treatment of DN.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/VJWXS     

Efficacy of alanyl glutamine in nutritional support therapy for patients with sepsis: A protocol for systematic review and meta-analysis

Background:Sepsis is a systemic inflammatory response caused by infection, which is a common complication after severe infection, trauma, shock, and surgery, and is also an important factor in inducing septic shock and multiple organ dysfunction syndrome (MODS), and has become one of the important causes of death in critically ill patients. Septic patients with gastrointestinal transport function weakened, are prone to malnutrition, resulting in decreased immune function, thereby affecting the therapeutic effect. Clinical practice shows that the nutritional metabolism and immune response of patients with sepsis can be effectively improved by giving alanyl glutamine nutritional support treatment, but there is no evidence of evidence-based medicine. The study carried out in this protocol aims to evaluate the effectiveness of alanyl glutamine in nutritional support therapy for patients with sepsis.Methods:The Cochrane Library, PubMed, Embase, Web of Science, WHO International Clinical Trials Registry Platform, CNKI, CBM, VIP, and Wanfang databases were searched by computer, to retrieve all randomized controlled trials (RCTs) on nutritional support for the treatment of sepsis with alanyl glutamine from the date of database establishment to December 2020. Two researchers independently selected the study, extracted and managed the data. RevMan5.3 software was used to analyze the included literature.Results:This study observed the changes of serum albumin (ALB), prealbumin (PAB), hemoglobin (Hb), C-reactive protein (CRP), immunoglobulin (IgG, IgA, and IgM), APACHE II score before and after treatment to evaluate the efficacy of alanyl glutamine in nutritional support therapy for patients with sepsis.Conclusion:This study will provide reliable evidence for the application of alanyl glutamine in nutritional support therapy for patients with sepsis.OSF Registration number:DOI 10.17605/OSF.IO/VRZPJ.     

Bailing Capsule combined with α-ketoacid tablets for stage 3 chronic kidney disease: Protocol of a double-blinded,randomized, controlled trial

Background:Chronic kidney disease (CKD) is a progressive and irreversible loss of kidney function. After stage 3, there will be increased risks of hypertension, heart failure, bone disease, anemia, gastrointestinal symptoms, and progression to end-stage kidney failure without proper intervention and treatment. Compound α-ketoacid tablets (KA) administration plays an important role in clinical CKD adjunctive therapy for patients with restricted protein intake. Bailing Capsule (BC), a commonly used Chinese patent medicine for renal diseases, could regulate human immune function, repair renal tubular epithelial cells, prevent renal tubular atrophy, and reduce kidney damage to improve renal function. In this study, we try to conduct a double-blinded, randomized, controlled trial to observe the efficacy and safety of BC combined with KA in treating patients with stage 3 CKD.Methods:This is a double-blinded, randomized, controlled trial. Patients will be randomly divided into treatment group (BC and KT) and control group (BC-simulation and KT) in a 1:1 ratio according to random number table. The treatment course will be 8 weeks, and the changes of subjective symptoms, patient global assessment (PGA) scale, serum creatinine, cystatin C, and estimated glomerular filtration rate, all related adverse events, vital sign measurements, and physical examinations will be recorded. SPSS 21.0 will be used for data analysis.Conclusions:The results will show whether BC combined with KA could alleviate the symptoms of fatigue, anorexia, halitosis, nausea, itching, and edema, improve kidney function in patients with CKD at stage 3.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/24AJ7.     

Efficacy of minimally invasive surgery for the treatment of hypertensive intracerebral hemorrhage: A protocol of randomized controlled trial

Introduction:Hypertensive intracerebral hemorrhage (HICH) is the most serious complication of hypertension. Clearing intracranial hematoma as soon as possible, reducing brain cell edema, and controlling intracranial pressure could effectively reduce neuron damage, lower patient mortality, and improve patient prognosis. At present, minimally invasive surgery (MIS) has been widely used and plays an important role in the treatment of HICH. However, it is still in controversies about the choice of surgical treatment and medication treatment for HICH. Therefore, we try to conduct a randomized, controlled, prospective trial to observe the efficacy of MIS treatment against HICH compared with medication treatment.Methods:Patients will be randomly divided into treatment group and control group in a 1:1 ratio using the random number generator in Microsoft Excel. Stereotactic soft channel minimally invasive intracranial hematoma puncture and drainage treatment and medication treatment will be applied respectively. The outcomes of intracerebral hemorrhage volume, Glasgow coma scale, National Institutes of Health Stroke Scale will be recorded.Conclusions:The findings of the study will be helpful for the choice of MIS and conservative treatment when treating HICH patients.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/ME6Y5.     

The safety and feasibility of comprehensive nutrition care in pregnant women with gestational diabetes mellitus: A protocol for systematic review and meta-analysis

Background:The argument on the efficacy of medical nutritional therapy and comprehensive nutritional care remains to be resolved. Therefore, we conducted this protocol of systematic review and meta-analysis to evaluate the efficacy between medical nutritional therapy and comprehensive nutritional care for patients with gestational diabetes mellitus (GDM).Methods:We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols reporting guidelines and the recommendations of the Cochrane Collaboration to conduct this study. Reviewers will search the PubMed, Cochrane Library, Web of Science, and EMBASE online databases using the key phrases “gestational diabetes mellitus,” “comprehensive nutrition care,” and “medical nutritional therapy” for all cohort studies published up to May 20, 2021. There is no restriction in the dates of publication or language in the search for the current review. The studies on cohort study focusing on comparing medical nutritional therapy and comprehensive nutrition care for GDM patients will be included in our meta-analysis. The outcomes include blood glucose levels, complications, weight change, and incidence of cesarean section. Where disagreement in the collection of data occurrs, this will be resolved through discussion.Results:We hypothesized that these 2 methods would provide similar therapeutic benefits.OSF registration number:10.17605/OSF.IO/SC8HJ.     

Efficacy of Shaobei injection in the treatment of grade II–III hemorrhoids and the effect on fibulin protein expression: A study protocol of a randomized controlled trial

Background:Hemorrhoids are a common and seriously disruptive condition that seriously affects people''s lives in terms of treatment. Injection therapy is an effective minimally invasive scheme for the treatment of grade II–III hemorrhoids, but its clinical application is limited by the adverse reactions caused by injection drugs. Some clinical studies have confirmed the efficacy and safety of Shaobei injection as a traditional Chinese medicine extract. However, there is no standard randomized controlled study to verify its efficacy and explore its potential mechanism.Methods:This is a prospective, randomized, single blind, parallel controlled trial to study the efficacy of Shaobei injection in the treatment of grade II–III hemorrhoids and its effect on the expression of fibulin-3 and fibulin-5 in fibulin protein family. The patients will be randomly divided into a treatment group and control group. The treatment group will be treated with Shaobei injection, and the control group will be treated with rubber band ligation. The observation indexes include: visual analysis scale, postoperative hospital stay, total use of painkillers, fibulin-3 and fibulin-5, hemorrhoids recurrence, and adverse events. Finally, the data will be statistically analyzed by SPASS 18.0 software.Discussion:This study will compare the efficacy of Shaobei injection with the rubber band ligation method in the treatment of grade II–III haemorrhoids and investigate its effect on the expression of fibulin-3 and fibulin-5 in the fibulin protein family. The results of this study will provide a basis for the clinical use of Paeoniflora injection as an alternative to traditional sclerosing agent in the treatment of grade II–III haemorrhoids.Trial registration: OSF Registration number:DOI 10.17605/OSF.IO/MKVDB     

Immunonutrition in patients undergoing esophageal cancer resection

Specialized nutritional support containing immunonutrients such as arginine, omega‐3 fatty acids, and ribonucleic acid significantly reduces the incidence of postoperative infective complications and hospital length of stay in elective surgery patients. However, immunonutrition use is not standard practice in esophago‐gastric units internationally. This review provides a clinical update regarding the use of immunonutrition in patients undergoing major gastrointestinal surgery and, in particular, esophageal cancer resection, and provides direction for future collaborative research. A review of MEDLINE and Cochrane Library databases was conducted for randomized controlled trials or meta‐analyses. A recent meta‐analysis demonstrated that preoperative immunonutrition use significantly reduces hospital length of stay and the incidence of postoperative complications in patients undergoing major elective surgery, particularly for gastrointestinal malignancies. Only three small randomized controlled trials have evaluated immunonutrition use in patients exclusively undergoing esophageal cancer surgery. These were unable to determine whether immune‐enhancing formulae positively influence key clinical outcomes such as mortality, hospital and intensive care unit length of stay, and postoperative morbidity in this patient group. Currently, there is insufficient evidence to recommend routine use of immunonutrition in patients undergoing esophageal cancer surgery. Future collaborative research should evaluate whether: (i) immunonutrition use positively influences key clinical outcomes in this population; (ii) these patients benefit from preoperative supplementation with an immune‐enhancing formula or whether they require postoperative continuation (perioperative approach) to combat their risk of complications after surgery; and (iii) these formulae can be used safely in those patients who develop sepsis.     

The efficacy and safety of silver needle in the treatment of rheumatoid arthritis: A protocol of randomized controlled trial

Background:Rheumatoid arthritis is a kind of chronic crippling disease, the condition is complex, the course of the disease is repeated, seriously affecting the quality of life of patients. Adverse reactions and drug resistance associated with conventional treatment can no longer meet the clinical need. Therefore, complementary and alternative therapies need to be explored. The evidence shows that silver needle therapy has advantages in the treatment of rheumatoid arthritis, but there is a lack of standard clinical studies to verify this conclusion.Methods:This is a prospective randomized controlled trial to study the efficacy and safety of silver needles in the treatment of rheumatoid arthritis. Approved by the Clinical Research Ethics Committee of our hospital. The patients are randomly divided into a treatment group (silver needle treatment group) or control group (routine western medicine treatment group). The patients are followed up for 2 months after 4 weeks of treatment. Observation indicators include: TCM symptom score, HAQDI score, DAS-28 score, laboratory indicators, adverse reactions and so on. Data will be analyzed using the statistical software package SPSS version 18.0 (Chicago, IL).Discussion:This study will evaluate the clinical efficacy of a silver needle in the treatment of rheumatoid arthritis. The results of this study will provide a reliable reference for the clinical use of a silver needle in the treatment of rheumatoid arthritis.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/4X5QB