Medicine

Study Protocol Titles: Erratum No abstract available

Huanglian Jiedu Decoction for treatment of multiple myeloma: A protocol for a systematic review and meta-analysis Background: Multiple myeloma can lead to lots of clinical problems including pain, fatigue, anemia, infections, renal failure, and so on. Huanglian Jiedu Decoction is a common conservative treatment for this disease in China. Therefore, we conducted a systematic review and meta-analysis to explore the efficacy of Huanglian Jiedu Decoction in the treatment of multiple myeloma. Methods: A systematic literature search for studies will be performed in 8 databases, including PubMed, Web of Science, Embase, the Cochrane library, ClinicalTrials.gov databases, Chinese National Knowledge Infrastructure Database, Wanfang database, and VIP database. The methodological quality of the included studies using the risk bias assessment tool of Cochrane. And the level of evidence for results is assessed by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) method. Statistical analysis is conducted with Revman 5.3. Results: This systematic review and meta-analysis will provide a synthesis of existed evidences for Huanglian Jiedu Decoction on multiple myeloma. Conclusion: The conclusion of this study will provide evidence to assess effectiveness of Huanglian Jiedu Decoction on multiple myeloma, which can further guide clinical decision-making. INPLASY registration number: INPLASY202060094

Three metachronous primary lung cancers in a chronic smoker: A case report and review of the literature Rationale: Lung cancer is a leading cause of cancer-related deaths. Smoking is major risk factor for initial and subsequent lung cancer especially in active smokers. Treatment of subsequent lung cancer depends on whether it is synchronous or metachronous. We report a rare case of triple metachronous lung cancer and review of literature of patients with triple metachronous cancers. This will be the second case reported of triple metachronous lung cancer. Patient concerns: A 60-year-old male, active smoker with diabetes mellitus, chronic obstructive pulmonary disease (COPD) and peripheral arterial disease presented with cough and hemoptysis. Initial computed tomography (CT) scan showed right upper lobe spiculated mass. Diagnosis: He underwent transthoracic needle biopsy for right upper lobe mass, showing primary lung adenocarcinoma (ADC)-Stage-IIIA. He continued to smoke and 9-years later had new left upper lobe spiculated nodule, which on surgical resection showed squamous cell carcinoma (SCC)-Stage-IA1. Despite counselling on smoking cessation, he was unable to quit. Six months later, he presented with shortness of breath and CT chest showing right hilar adenopathy in right upper and lower lobes. He underwent transbronchial biopsies of lesion which showed small cell lung carcinoma (SCLC). Interventions: His initial lung ADC-Stage-IIIA, was treated with chemotherapy, weekly thoracic radiation and additional chemotherapy cycles. Nine years later, his left upper lobe mass showing SCC-Stage-IA1 was deemed curative after apical resection and he was kept on surveillance. Six months later, after diagnosis of SCLC in right upper and lower lobe, patient was not a candidate for systemic chemotherapy due to poor performance status and opted for hospice care. Outcomes: His initial lung ADC-Stage-IIIA showed complete radiological response with chemotherapy and radiation. Subsequent SCC-Stage-IA1 was deemed curative after resection. Due to his poor performance status, he was not a candidate for chemotherapy for SCLC and patient opted for hospice care. Lessons: Smoking is a major risk factor for developing lung cancer and with continued smoking, patients are at higher risk for developing subsequent primary lung cancers. We recommend, patients with lung cancer must quit smoking, and those who do not, should remain on long-term surveillance.

Therapeutic effects of brain-computer interface-controlled functional electrical stimulation training on balance and gait performance for stroke: A pilot randomized controlled trial Background: Brain-computer interface-controlled functional electrical stimulation (BCI-FES) approaches as new feedback training is increasingly being investigated for its usefulness in improving the health of adults or partially impaired upper extremity function in individuals with stroke. Objective: To evaluate the effects of BCI-FES on postural control and gait performance in individuals with chronic hemiparetic stroke. Methods: A total of 25 individuals with chronic hemiparetic stroke (13 individuals received BCI-FES and 12 individuals received functional electrical stimulation [FES]). The BCI-FES group received BCI-FES on the tibialis anterior muscle on the more-affected side for 30 minutes per session, 3 times per week for 5 weeks. The FES group received FES using the same methodology for the same periods. This study used the Mann-Whitney test to compare the two groups before and after training. Results: After training, gait velocity (mean value, 29.0 to 42.0 cm/s) (P = .002) and cadence (mean value, 65.2 to 78.9 steps/min) (P = .020) were significantly improved after BCI-FES training compared to those (mean value, 23.6 to 27.7 cm/s, and mean value, 59.4 to 65.5 steps/min, respectively) after FES approach. In the less-affected side, step length was significantly increased after BCI-FES (mean value, from 28.0 cm to 34.7 cm) more than that on FES approach (mean value, from 23.4 to 25.4 cm) (P = .031). Conclusion: The results of the BCI-FES training shows potential advantages on walking abilities in individuals with chronic hemiparetic stroke.

Mediating effect of social support on the association between life events and depression: A cross-sectional study of adolescents in Chongqing China Depression is one of the most common mental health problems in adolescents. The link between negative life events and depression has been well established. However, our understanding about the role of social support in the link, which is likely culture-dependent, is quite limited. This study aimed to determine the mediating effect of social support on the association between life events and depression in adolescents in Chongqing China. A total of 1512 adolescents aged 12 to 17 years old in Chongqing of China were selected using a stratified cluster sampling strategy. Depression symptoms, negative life events, and perceived social support of the participants were measured using the Children's Depression Inventory, Adolescent Life Event Scale, and Child and Adolescent Social Support Scale, respectively. Pearson correlation analyses were performed to detect their associations. A multivariate linear regression model was established to determine the association between life events and depression after adjustment for variations in socio-demographic variables. The mediating effect of social support on the association between negative life events and depression was tested using the structural equation model. About 16.8% of the participants were detected with depression. Depression was associated with negative life events and low levels of social support (P < .05). Both frequency and perceived importance of social support showed a mediating effect on the association between life events and depression. Social support has a mediating effect on the association between life events and depression. Strengthening social support may be considered as an effective interventional strategy on depression in adolescents.

Comparison of empirical high-dose and low-dose of meropenem in critically ill patients with sepsis and septic shock: A randomized controlled study protocol Background: Sepsis and septic shock syndrome are the main problems in modern medicine. Current treatment guidelines for the sepsis recommend an appropriate and timely antibiotic treatment. Meropenem has activity against a wide variety of Gramnegative and Gram-positive bacteria. At present, there are few studies on the application of high-does meropenem in the patients with sepsis and septic shock. We therefore carry out the randomized controlled research to compare the low-dose and high-dose meropenem in the critically ill sepsis and septic shock patients, and to assess the safety of the two regimens. Method: This is a prospective, single-center, and randomized research authorized through the local research ethics committee of Zhejiang Chinese Medical University (No.32198276). Sixty-four participants with a diagnosis of sepsis and septic shock are analyzed. Patients who meet the following conditions will be included: (1)patients older than 18 years old,(2)patients diagnosed with the sepsis and septic shock, and(3)patients (or their relatives) who have signed a consent. Patients with the following conditions will be excluded (1)patients with infective endocarditis and central nervous system infection;(2)Within 24 hours after the randomization of patients needing surgery;(3)Within 24 hours after the randomization, patients who received extracorporeal membrane oxygenation (ECMO);(4)Patients with known meropenem allergy. They are assigned to 2 groups, namely, the standard-does group and high-dose group, in the standard-does group, they receive low-dose meropenem (intravenous injection of 1 g meropenem for more than 30 minutes, followed by intravenous injection of 1 g meropenem for more than three hours every 8 hours), and in the high-dose group, patients receive high-does meropenem (intravenous injection of 2 g meropenem for more than 30 minutes, and then intravenous injection of 2 grams of meropenem for more than three hours every 8 hours). The main outcomes are the modified Acute Physiology and Chronic Health Evaluation II (APACHE II) and scores of Sequential Organ Failure Assessment (SOFA). And the secondary outcomes are the 14-day mortality and 28-day mortality, the rate of microbiological cure and clinical cure, ventilator-free days, vasopressor-free days, hospital-free days and the ICU-free days, as well as safety in the two regimen groups. All analysis in our work is carried out via utilizing the software of IBM SPSS Statistics for Windows, version 20. Results: Figure 1 reveal the primary outcomes and the secondary outcomes. Conclusion: This protocol can provide a reliable evidence for the safety and effectiveness of the high-dose meropenem in the critically ill sepsis and septic shock patients. Trial registration number: researchregistry6023

Effectiveness and safety of different medicines for Uremia pruritus: A protocol for systematic review and network meta analysis Introduction: A large number of patients will experience pruritus after uremia. Medicine is the preferred treatment for many doctors, but the effectiveness and safety of different medicines for uremia pruritus has not yet been comprehensively compared, based on network meta-analysis. Methods and analysis: According to the retrieval strategy, two team members independently searched the literature in 7 databases, and imported the retrieval results into the EndNote Software AQ8 (V.X9). After deleting repeated articles, they read the abstract and the full text, selected the articles that met the inclusion criteria and extracted valid information. The main results were visual analogue scale (VAS) and the secondary results were verbal rating scale (VRS), Dirk R Kuypers score, and adverse event incidence. The methodological quality evaluation was conducted from 7 aspects, according to The Cochrane Collaborative Tool, Stata Statistical Software (Version 14.0, Stata Corporation, College Station, TX) was used for data analysis. The level of evidence will be assessed by the Grading of Recommendations, Development and Evaluation (GRADE) instrument). Results: The results will rank the efficacy of drugs used to treat uremic pruritus and assess their safety. Conclusion: This study is the first to compare the efficacy and safety of medicines for uremic pruritus based on network analysis and will provide evidence and ideas for the treatment of uremic pruritus. INPLASY registration number: No. INPLASY202090103.

Different acupuncture therapies combined with rehabilitation in the treatment of scapulohumeral periarthritis: A protocol for systematic review and network meta-analysis Background: Scapulohumeral periarthritis is a disease that seriously affects human daily work and life, and greatly reduces peoples quality of life and affects human health all over the world. Now, many studies have shown that acupuncture and rehabilitation have a significant effect on scapulohumeral periarthritis. In this study, network meta-analysis was used to analyze and compare the clinical efficacy and difference of different acupuncture treatments on scapulohumeral periarthritis. Methods: All patients were diagnosed as scapulohumeral periarthritis by randomized controlled trial. Computer searches will be conducted on CNKI, Wan-Fang databases, VIP, CBM, Pubmed, Cochrane library, Embase, Web of Science. The retrieval period is from the date of database establishment to September 8, 2020. To avoid omissions, we will manually retrieve relevant references and conference papers. Finally, the risk of bias included in the study will be assessed according to the guidelines of the Cochrane Handbook for systematic review of interventions. All data analysis will be performed by Revman 5.3, WinBUGS1.4.3 and Stata14.2. Results: The effectiveness of each intervention was quantified. The main results included cure rate, total effective rate, VAS score and shoulder function score. Conclusion: Objective to provide evidence-based medicine basis for clinicians to choose more effective acupuncture therapy for scapulohumeral periarthritis. INPLASY Registration number: 202090035.

Clinical features of velamentous umbilical cord insertion and vasa previa: A retrospective analysis based on 501 cases To identify the risk factors associated with velamentous cord insertion (VCI) and investigate the association between adverse pregnancy outcomes and VCI in singleton pregnancies and those with vasa previa. A total of 59,976 single cases admitted from Qinhuangdao Maternal and Child Health Hospital and Qinhuangdao Beidaihe Hospital from January 2004 to January 2014 were included in this study. We retrospectively analyzed the perinatal complications, neonatal complications, and the clinical features, as well as the Color Doppler ultrasonography findings of the velamentous placenta and placenta previa. We reviewed the clinical data of 59,976 women with singleton pregnancies delivered in Qinhuangdao Maternal and Child Health Hospital and Qinhuangdao Beidaihe Hospital from January 2004 to January 2014. Risk factors and the risks of adverse pregnancy outcomes including admission to a neonatal unit, fetal death, preterm delivery, low birth weight of <2500 g, the infant being small for its gestation age, low Apgar scores (<7) at 1 and 5 minute were evaluated separately among women with and without VCI by means of logistic regression analyses. The prevalence of velamentous umbilical cord insertion was 0.84%, and the prevalence of vasa previa was 0.0017%. The independent risk factors for VCI were nulliparity, obesity, fertility problems, placenta previa, and maternal smoking. VCI was associated with a 1.83-, 2.58-, 3.62-, and 1.41-fold increase in the risk of retention in the neonatal unit, preterm delivery (<37 gestation weeks), low birth weight, and small-for-gestational age, compared to pregnancies involving normal cord insertion. Of the women with VCI, 16.1% underwent emergency cesarean section compared to 8.9% (P < .001) of women without VCI. The prevalence of VCI was 0.84% in singletons. The results suggest that VCI is a moderate risk condition resulted in increased risks of prematurity and impairment of fetal growth.

The efficacy of Chinese herbal medicine as an adjunctive therapy for colorectal cancer: A protocol for systematic review of randomized controlled trials Background: Colorectal cancer (CRC) is a public health problem and the world's leading cancer killer. It is a disease with high incidence and mortality. Although chemotherapy has achieved some success in the treatment of CRC, drug resistance and tumor metastasis caused by chemotherapy are still the main causes of death in patients with CRC. Notably, many side effects associated with chemotherapy, such as nausea, vomiting, and peripheral neurotoxicity, are major challenges in the treatment of patients with CRC. Chinese herbal medicine (CHM) has been widely used as an adjunctive therapy for CRC, but its efficacy and safety are still uncertain. The aim of this systematic review is to assess the efficacy and safety of CHM for the treatment of CRC. Methods: A comprehensive retrieval will be performed in the following electronic databases: PubMed, Cochrane Library, EMBASE, Web of Science, CNKI, SinoMed, VIP, and Wan Fang Data. The methodologic quality of randomized controlled trials will be assessed using the Cochrane risk assessment tool. Review Manager 5.3 software will be used for data synthesis and analysis. Funnel plot analysis and Egger test will be used to assess publication bias. The Grading of Recommendations Assessment, Development and Evaluation standard will be used to generate summary of finding table. Results: The results of this systematic review will be used to summarize and evaluate the evidence from randomized controlled clinical trials of CHM as adjuvant therapy for CRC. Conclusion: This review will provide a detailed summary of the evidence to assess the efficacy and safety of CHM for CRC. OSF Registration: DOI 10.17605/OSF.IO/X2SKJ

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