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ObjectivesMany studies have confirmed that antibacterial agents can disrupt the human gut microbiota. In China, Tanreqing injection (TRQ) is a drug with antibacterial activity that is widely used in the treatment of respiratory infections. However, its specific influence on gut microbiota remains unclear. This study aimed to investigate the effect of TRQ on the gut microbiota of healthy volunteers.MethodsTwelve healthy adults received 20 ml of TRQ intravenously daily for 7 consecutive days. At six timepoints (Pre, on D1, D3, D5, D7 and follow-up visit) fecal samples were collected and analyzed using 16S rRNA gene sequencing.ResultsEleven people were included in the analysis finally. TRQ did not significantly alter gut microbiota diversity or richness (Shannon and Simpson and Chao1 index) in healthy people during the intervention. Gut microbial structure was stable (weighted and unweighted Unifrac). Using a machine learning method based on PLS-DA analysis, the separation trend on D7 at the genus level was found, returning to baseline two days after discontinuation. The abundance of major genus fluctuated on D7 compared with that prior to treatment, including an increase of unclassified_f_Enterobacteriaceae (13.0611%), a decrease of Bifidobacterium and Escherichia-Shigella (6.887%, 10.487%). Functional prediction analysis did not reveal any significant difference.ConclusionsOur study showed short-term use of TRQ at conventional doses may not cause perturbations to the gut microbiota in healthy adults. This finding provides some useful information for the safe use of TRQ in the treatment of respiratory infections.Clinical trial registrationhttps://www.medicalresearch.org.cn/, identifier MR-31-24-014367.

Background: Cervicogenic dizziness is a clinical syndrome characterized by neck pain and dizziness, which has a rising incidence in recent years. In China, manual therapy has been widely used in the treatment of cervicogenic dizziness, but there is no high-quality medical evidence to support its effectiveness and safety. The purpose of this study was to assess the safety and efficacy of Shi's manual therapy (SMT) on the treatment of cervicogenic dizziness. Methods: A multicenter randomized controlled trial (RCT) will perform on 106 patients (18≤ages≤65) who meet the diagnostic criteria of cervicogenic dizziness. Patients will be randomly allocated to the intervention group and the control group at a ratio of 1:1. Participants in the control group will be treated with Merislon (Betahistine Mesilate Tablets). Participants in the intervention group will be treated with SMT. The primary outcome is the response rate at week 2, which is defined as the proportion of patients who reduce their disability level measured by the Dizziness Handicap Inventory (DHI) score relative to baseline. Key secondary outcomes include DHI scores at weeks 1, 2, and 6 and changes from baseline, time to disappearance of dizziness symptoms, and recurrence rate of dizziness symptoms. Safety will be assessed by adverse events, physical examination and vital signs. Discussion: This trial aims to provide high-quality evidence-based medical data to demonstrate that SMT can reduce dizziness in patients with cervicogenic dizziness effectively and safely. Trial registration: Clinical Trial Registration Center NCT05604937. Registered on Nov 3, 2022. Protocol version: 1.0, November 20, 2022.

IntroductionThe characteristics and duties of clinical research nurses (CRNs) are constantly developing and changing with the progress of medical technology and increasing needs in patient care. With the continuous deepening and standardization of clinical trials, the importance and status of CRNs during the whole process of clinical trials are also increasingly valued.MethodsA scoping review of studies related to the characteristics and duties of CRNs was conducted to clarify relevant roles and concepts. An electronic search was conducted on three English databases (PubMed, Web of Science, Embase) and two Chinese databases (CNKI and Wanfang database) in December 2023. Two authors independently screened the literature, extracted information from the included literature, and summarized and reported the findings.ResultsA total of 26 articles published between 1991 and 2023 were analyzed, and four characteristics of CRNs were identified as participants and managers of clinical trials, caregivers and protectors of subjects, coordinators of research teams, and educators. Basic knowledge, skills and literacy, communication and coordination ability, and advanced research ability are the competencies required for CRNs.ConclusionFurther studies should focus on the importance of various characteristics of CRNs, so as to improve the quality of clinical trials and promote clinical evidence-based practice.

BackgroundKnee osteoarthritis (KOA) is a highly prevalent joint disease among the middle-aged and elderly population that can lead to pain, functional impairment, decreased quality of life, and a large number of medical expenses. Physical therapy is one of the main treatment methods for KOA. In China, Tuina has been widely used in the treatment of KOA, but up to now, there is no high-quality medical evidence to support its effectiveness and safety. The purpose of this study was to objectively evaluate the efficacy and safety of Tuina in the treatment of KOA.MethodsA crossover design clinical trial was performed on 96 patients. The test group and the control group in the trial were allocated randomly in a ratio of 1:1. The test group received Tuina treatment for 4 weeks first and then received health education intervention for another 4 weeks. The control group received health education intervention for 4 weeks first and then received Tuina treatment for another 4 weeks. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) total score was chosen as the primary outcome. The WOMAC pain score, WOMAC stiffness, WOMAC daily activity score, and visual analog scale (VAS) score were the secondary outcomes. Adverse events during the intervention were collected in both groups.ResultsCompared with the baseline, the WOMAC total score, WOMAC pain score, WOMAC stiffness, WOMAC daily activity, and VAS score of patients in both groups were improved significantly at weeks 4 and 8 (p < 0.001). All patients who received Tuina treatment were significantly superior to those who received health education intervention in the WOMAC total score (194.96, 95% CI = 164.94–224.97, P < 0.001), WOMAC pain score (45.96, 95% CI = 35.82–56.09, P < 0.001), WOMAC stiffness (31.42, 95% CI = 26.37–36.46, P < 0.001), WOMAC daily activity (117.58, 95% CI = 97.56–137.61, P < 0.001), and VAS score (1.07, 95% CI = 0.83–1.32, P < 0.001). Both groups had no serious adverse events during the treatment.ConclusionThis trial demonstrated that Tuina can reduce joint pain in patients with KOA and improve the physical functions of the knee joint effectively and safely.Clinical trial registrationThis trial was registered in the Chinese Clinical Trial Registry (No. ChiCTR-TTRCC-13003157). http://www.chictr.org.cn/showproj.aspx?proj=6402.

Abstract Background Lumbar disc herniation (LDH) is a common chronic musculoskeletal disorder that seriously affects quality of life. The percutaneous endoscopic lumbar diskectomy (PELD) technique was developed to address spinal nerve root compression through direct visualization of pathological findings while minimizing tissue destruction upon exposure. It is an effective and safe treatment for LDH. However, recurrent LDH is a major concern after lumbar discectomy for primary LDH. A considerable number of clinical studies have reported that patients with LDH with radiculopathy could benefit from manual therapy. Shi’s manual therapy (SMT) was established based on traditional Chinese medicine (TCM) theory and has been shown to have a superior effect in alleviating muscle tension and loosening joints to improve lumbar and leg pain, radiculopathy, stiffness, activity discomfort, and related disorders. However, there is a lack of high-quality clinical evidence to support this conclusion. The purpose of this study is to evaluate the efficacy and safety of the combination of Shi’s manual therapy (SMT) and PELD for LDH with radiculopathy. Methods/design A multicenter randomized controlled trial (RCT) with a 1-year follow-up period will be performed. A total of 510 participants with LDH with radiculopathy will be recruited from four clinical centers. The sample size was estimated, and statistical analysis will be performed and supervised by biostatisticians from an independent third-party research institution. Two hundred fifty-five subjects will be randomly allocated to each group. The subjects in the control group will undergo PELD. Participants in the intervention group will be treated with a combination of SMT and PELD. Recurrence rate is the primary endpoint and the survival analysis of recurrence rate is the secondary endpoint, and the primary analysis of recurrence rate is the chi-square test and the secondary analysis of recurrence rate is survival analysis. The primary outcome measure is the recurrence rate of LDH with radiculopathy at the 1-year follow-up after treatment. The secondary outcome measures will be the ODI score, the VAS score for pain for the lumbar spine and lower limbs, the straight leg raise angle, the stability of the operated lumbar segment, and the SF-36 scores. Assessments will occur at baseline, postoperation, and 1 week, 4 weeks, 13 weeks, 26 weeks, and 1 year postoperation. In addition, adverse events related to clinical symptoms and signs and the results of laboratory tests will be documented during the clinical trials. Discussion This study will provide reliable evidence of the effectiveness and safety of the combination of SMT and PELD for LDH with radiculopathy. If the results are favorable, it is expected that patients with LDH with radiculopathy will benefit from this study, and many patients could gain a good alternative treatment for LDH with radiculopathy. Trial registration China Registered Clinical Trial Registration Center ChiCTR2000036515 . Registered on 13 November 2020.

Introduction The Western Ontario and McMaster University osteoarthritis index (WOMAC) is the most commonly used indicator of disease-specific outcome in knee osteoarthritis for its convenience and reliability. It has two formats the paper-based WOMAC (p-WOMAC) and the electronic WOMAC (e-WOMAC). In China, the p-WOMAC has been widely used though e-WOMAC is yet untested. This study aims to test whether e-WOMAC is consistent with the p-WOMAC before and after the intervention.Methods and analysis A total of 70 patients from Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine will be randomly assigned in two groups, named, group A and group B. This study is divided into three stages. In the first stage, patients in group A will be evaluated first by p-WOMAC and then by e-WOMAC. Patients in group B will be evaluated by e-WOMAC and then by p-WOMAC. In the second stage of the study, drug interventions will be implemented. 200 mg celecoxib will be administered orally once a day starting from the second day of enrolment for a period of 21 days. In the third stage, postintervention evaluation will be conducted after administration. Patients in group A will be evaluated first by e-WOMAC and then by p-WOMAC. Patients in group B will be evaluated first by p-WOMAC and then by e-WOMAC. In order to avoid the possible bias because of patients’ potential memory, e-WOMAC and p-WOMAC will be taken for each patient at 15 min apart. The primary outcome of the study is the mean score difference in WOMAC, and the secondary outcomes are the score differences in WOMAC subscales: pain, stiffness and physical function.Ethics and dissemination The protocol has been approved by the Independent Review Board of SGH (approval number: 2020-814-21-01). The results of the trial will be submitted for publication in a peer-reviewed journal.Trial registration number ChiCTR2100050914.

COVID-19, an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread throughout the world. China has achieved rapid containment of this highly infectious disease following the principles of early detection, early quarantine and early treatment with integrated traditional Chinese and Western medicine. The inclusion of traditional Chinese medicine (TCM) in the Chinese protocol is based on its successful historic experience in fighting against pestilence. Current findings have shown that the Chinese medicine can reduce the incidence of severe or critical events, improve clinical recovery and help alleviate symptoms such as cough or fever. To date there are over 133 ongoing registered clinical studies on TCM/integrated traditional Chinese and Western medicine. The three Chinese patent medicines (Lianhua Qingwen Keli/Jiaonang (Forsythiae and Honeysuckle Flower Pestilence-Clearing Granules/Capsules), Jinhua Qinggan Keli (Honeysuckle Flower Cold-Relieving Granules) and Xuebijing (Stasis-Resolving & Toxin-Removing) Injection were officially approved by the National Medical Products Administration to list COVID-19 as an additional indication. The pharmacological studies have suggested that Chinese medicine is effective for COVID-19 probably through its host-directed regulation and certain antiviral effects.

Background: Spinal manipulative therapy (SMT) helps to reduce chronic low back pain (cLBP). However, the underlying mechanism of pain relief and the neurological response to SMT remains unclear. We utilized brain functional magnetic resonance imaging (fMRI) upon the application of a real-time spot pressure mechanical stimulus to assess the effects of SMT on patients with cLBP.Methods: Patients with cLBP (Group 1, n = 14) and age-matched healthy controls without cLBP (Group 2, n = 20) were prospectively enrolled. Brain fMRI was performed for Group 1 at three time points: before SMT (TP1), after the first SMT session (TP2), and after the sixth SMT session (TP3). The healthy controls (Group 2) did not receive SMT and underwent only one fMRI scan. During fMRI scanning, a real-time spot pressure mechanical stimulus was applied to the low back area of all participants. Participants in Group 1 completed clinical questionnaires assessing pain and quality of life using a visual analog scale (VAS) and the Chinese Short Form Oswestry Disability Index (C-SFODI), respectively.Results: Before SMT (TP1), there were no significant differences in brain activity between Group 1 and Group 2. After the first SMT session (TP2), Group 1 showed significantly greater brain activity in the right parahippocampal gyrus, right dorsolateral prefrontal cortex, and left precuneus compared to Group 2 (P < 0.05). After the sixth SMT session (TP3), Group 1 showed significantly greater brain activity in the posterior cingulate gyrus and right inferior frontal gyrus compared to Group 2 (P < 0.05). After both the first and sixth SMT sessions (TP2 and TP3), Group 1 had significantly lower VAS pain scores and C-SFODI scores than at TP1 (P < 0.001).Conclusion: We observed alterations in brain activity in regions of the default mode network in patients with cLBP after SMT. These findings suggest the potential utility of the default mode network as a neuroimaging biomarker for pain management in patients with cLBP.Clinical Trial Registration:Chinese Clinical Trial Registry, identifier ChiCTR1800015620.

Background: The clinical diagnosis of atlantoaxial joint subluxation (AJS) in traditional Chinese medicine (TCM) is characterized by an unequal distance between the lateral mass of the atlas and the odontoid process on imaging, resulting in neck pain accompanied by symptoms such as dizziness, headache, and limited cervical mobility. In Shanghai, Shi cervical rotational manipulation (SCRM) is a commonly employed TCM manual therapy for treating this condition. Nevertheless, there is a lack of evidence-based medical information regarding the clinical efficacy and safety of this technique., Objective: The principal aim of this study is to evaluate the efficacy and safety of SCRM in patients diagnosed with AJS., Methods: This study is a prospective randomized controlled clinical trial that will be conducted at a single center and that has a follow-up period of 24 weeks. A total of 96 patients diagnosed with AJS will be recruited from outpatient and inpatient clinics at Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine. These patients will be randomly assigned to either the experimental group (SCRM) or the comparison group (basic cervical manipulation [BCM]). Treatment sessions consisting of SCRM or BCM will be administered twice a week for a duration of 4 weeks. Clinical monitoring indicators include the presence or absence of clinical symptoms as recorded on a symptom recording form, cervical imaging examination findings using cervical computed tomography, degree of neck pain measured by a visual analog scale (VAS), cervical range of motion assessed through cervical mobility measurement, degree of vertigo evaluated using the Vertigo Symptoms Scale-Chinese Version (VSS-C), and adverse events that may occur during the follow-up period. The time points for data collection and follow-up are baseline and postintervention (weeks 4, 8, 12, 16, 20, and 24)., Results: This paper presents an overview of the reasoning and structure of a prospective randomized controlled trial with the objective of investigating the clinical efficacy and safety of SCRM in patients with AJS by assessing improvements in clinical symptoms, neck pain severity, and vertigo severity and evaluating changes in cervical imaging findings. Recruitment was started in March 2023. By the end of May 2024, 76 patients were included in this project. The last follow-up data are predicted to be collected by the end of February 2025., Conclusions: This investigation will yield dependable evidence regarding the efficacy and safety of SCRM in patients with AJS., Trial Registration: Chinese Clinical Trial Registry ChiCTR2300068510; https://www.chictr.org.cn/showprojEN.html?proj=186883., International Registered Report Identifier (irrid): DERR1-10.2196/57865., (©Deng Zhen, Shang Haibin, Ai Youli, Yuan Weian, Wang Huihao, Zhan Hongsheng, Li Guozhong, Ding Ren, Shen Zhibi. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.08.2024.)

Objective: To investigate the antipyretic effect of early treatment with Traditional Chinese Medicine (TCM) on coronavirus disease 2019 (COVID-19) patients., Methods: We retrospectively analyzed 369 patients from January 26th, 2020 to April 15th, 2020, who had been diagnosed with COVID-19. Among 92 eligible cases, 45 cases were identified as treatment group Ⅰ ( 45) and 47 cases were identified as treatment group Ⅱ. Patients in the treatment group Ⅰ were treated with TCM herbal decoction within 5 d after admission. Patients in the treatment group Ⅱ were treated with TCM herbal decoction after the 6th admission day. The onset time of antipyretic effect, the antipyretic time, the time of negative oropharyngeal swab nucleic acid conversion, and the changes of cell count in blood routine test were compared., Results: The treatment group I showed shorter average antipyretic duration (4 7 d; <0.05), and shorter average time for polymerase chain reaction (PCR) nucleic acid test results to turn negative (7 11 d; <0.05) than the treatment group II. For patients ( 54) with body temperature>38 ℃, patients in the treatment group I had shorter median onset time of antipyretic effect than those in the treatment group II (3 4 d; <0.05). The absolute lymphocyte (LYMPH) count and absolute eosinophil (EOS) count on the 3rd day after admission and the neutrophil/lymphocyte ratio on the 6th day after admission of patients in the treatment group I were notably different from those in the treatment group II at the same time point (0.05). Based on Spearman's rank correlation analysis, the change of body temperature on the 3rd day after admission was positively correlated with the increase of EOS count and the increase of EOS count and LYMPH counts on the 6th day after admission (0.01)., Conclusions: Early TCM intervention within 5 d after hospital admission shortened the onset time of antipyretic effect and fever duration of COVID-19 patients, reduced the time required for PCR test results to turn negative. Moreover, early TCM intervention also improved the results of inflammatory markers for COVID-19 patients. LYMPH and EOS counts can be used as indicators of TCM antipyretic effect.