To improve the consistency of outcome documentation and address the potential for outcome reporting bias in clinical trials involving integrative Chinese and Western medicine (ICWM) for ulcerative colitis (UC), we aim to develop a customized core outcome set (COS) that incorporates input from various stakeholders. The study design of this COS has been informed by the Core Outcome Measures in Effectiveness Trials Initiative Handbook, with adherence to the guidelines from the Core Outcome Set-STAndards for Reporting statement and Core Outcome Set-STAndardised Protocol Items recommendations. Five groups of stakeholders will be invited to participate in the development of COS for clinical trials with ICWM for UC, including healthcare professionals, patients, COS developers, COS users, and methodologists. The process will involve five stages: (1) conducting a systematic review of outcomes reported in clinical trials and protocols to develop a list of potential outcome domains; (2) conducting semi-structured interviews to obtain important outcomes; (3) choosing the most important outcomes by conducting three-round Delphi surveys; (4) achieving a consensus in a face-to-face meeting to discuss the final COS; and (5) publication, dissemination and implementation of COS. Consequently, this specialized COS will be applicable to clinical trials involving both traditional Chinese medicine (TCM) and ICWM interventions. Please cite this article as: Zhang X, Zhang L, Wang J, Lau CT, Wang N, Zhang X, Wang P, Li J, Han F, Bian Z. A protocol for developing, disseminating and implementing a core outcome set for clinical trials of integrative Chinese and Western medicine for ulcerative colitis. J Integr Med. 2025; 23(6):654-659.
Colitis, Ulcerative/therapy* ; Humans ; Medicine, Chinese Traditional ; Clinical Trials as Topic ; Integrative Medicine ; Research Design ; Outcome Assessment, Health Care ; Delphi Technique

Background and Objectives: This study aims to clarify the systems underlying regulation and regulatory roles of hydrogen combined with 5-Aza in the myogenic differentiation of adipose mesenchymal stem cells (ADSCs). Methods: and Results: In this study, ADSCs acted as an in vitro myogenic differentiating mode. First, the Alamar blue Staining and mitochondrial tracer technique were used to verify whether hydrogen combined with 5-Aza could promote cell proliferation. In addition, this study assessed myogenic differentiating markers (e.g., Myogenin, Mhc and Myod protein expressions) based on the Western blotting assay, analysis on cellular morphological characteristics (e.g., Myotube number, length, diameter and maturation index), RT-PCR (Myod, Myogenin and Mhc mRNA expression) and Immunofluorescence analysis (Desmin, Myosin and β-actin protein expression). Finally, to verify the mechanism of myogenic differentiation of hydrogen-bound 5-Aza, we performed bioinformatics analysis and Western blot to detect the expression of p-P38 protein. Hydrogen combined with 5-Aza significantly enhanced the proliferation and myogenic differentiation of ADSCs in vitro by increasing the number of single-cell mitochondria and upregulating the expression of myogenic biomarkers such as Myod, Mhc and myotube formation. The expressions of p-P38 was up-regulated by hydrogen combined with 5-Aza. The differentiating ability was suppressed when the cells were cultivated in combination with SB203580 (p38 MAPK signal pathway inhibitor). Conclusions Hydrogen alleviates the cytotoxicity of 5-Aza and synergistically promotes the myogenic differentiation capacity of adipose stem cells via the p38 MAPK pathway. Thus, the mentioned results present insights into myogenic differentiation and are likely to generate one potential alternative strategy for skeletal muscle related diseases.

Objective:To investigate the clinical efficacy of Dog-Bone double button in the treatment of acute acromioclavicular dislocation under shoulder arthroscopy.Methods:A retrospective analysis was conducted of the 20 patients with acute acromioclavicular dislocation who had been treated at Department of Sports Medicine, Northern Jiangsu People's Hospital of Jiangsu Province from November 2018 to December 2020 by Dog-Bone double button under shoulder arthroscopy. They were 11 males and 9 females, aged from 31 to 63 years. Recorded were their visual analogue scale (VAS), Constant-Murley shoulder function score and range of shoulder anteflexion at preoperation and the last follow-up, as well as complications and the X-ray parameters at one month postoperation and the last follow-up [including coracoclavicular distance (CCD), distance between the upper and lower Dog-Bone titanium plates (DDD), angle between the coracoid process tunnel and the tangent line of the superior clavicle (CTCA), and widths of the clavicle tunnel and the coracoid process tunnel].Results:The 20 patients were followed up for 6 to 12 months (average, 10.5 months). Their preoperative VAS score, Constant score, and range of shoulder anteflexion were 3.0 (3.0, 4.0), 57.0 (54.3, 61.5) and 130° (110°, 140°), which were significantly improved to 0 (0, 0.8), 90.0 (86.5, 91.0) and 170° (170°, 180°) at the last follow-up ( P<0.05). Their CCD, DDD, CTCA, and widths of the clavicle tunnel and the coracoid process at one month postoperation were (5.0±1.0) mm, (32.4±3.5) mm, 91.7° (88.5°, 104.9°), 3.0 (3.0, 3.0) mm and 3.0 (3.0, 3.0) mm, which were significantly improved to (6.3±1.3) mm, (32.8±3.7) mm, 84.8° (81.8°, 92.0°), 3.5 (3.4, 3.6) mm and 3.2 (3.1, 3.3) mm with the exception of DDD at one month postoperation ( P<0.05). The last follow-up observed postoperative reduction loss in only one patient. Conclusion:For acute acromioclavicular joint dislocation, the Dog-Bone fixation technique under shoulder arthroscopy can lead to fine surgical efficacy and patient satisfaction, because it has advantages of limited trauma, good functional recovery of the shoulder, and effective prevention of reduction loss.

Objective:To investigate the clinical manifestation, genetic characteristics, treatment and prognosis of Crouzon-like syndrome.Methods:Clinical data of one case of Crouzon-like syndrome diagnosed in Children′s Hospital Affiliated to Zhengzhou University in May 2019 were collected, including clinical test, treatment plan, follow-up outcomes. The clinical characteristics and the mutation characteristics of IL11RA-related Crouzon-like syndrome were analyzed combined with the literature.Results:The male proband, five years and four months old, was admitted with the main clinical manifestations including headache, vomiting, exophthalmos, ocular hypertelorism, nasal root flat and scaphocephaly. CT showed that the cerebellar tonsil moved down slightly, the occipital magnum was full, the bilateral cranial plates were locally thinner, the bilateral cranial diameters were increased, and the cranial seams were closed. Magnetic resonance imaging showed ChiariⅠmalformation. The mutation c.40_63del and splice site mutation c.811-2A>G of the patient′s IL11RA gene were screened by whole exome sequencing. Sanger sequencing showed that the mutations are compound heterozygous and both are first reported. The mutation c.811-2A>G was derived from the patient′s mother, and the other one is de novo.Conclusions:The main clinical manifestations of Crouzon-like syndrome are craniosynostosis and midface hypoplasia and ocular deformity. The study identified two novel mutations in the Crouzon-like syndrome related IL11RA gene. Genetic sequencing is helpful for accurate diagnosis and timely surgical treatment.