Approximately 70 million people worldwide suffer from epilepsy, with about 9 million in China. About one-third of patients demonstrating resistance to traditional antiseizure medications (ASMs), Focal Cortical Stimulation (FCS) emerges as a novel neuromodulation therapy based on neural stimulation, showing potential in treating drug-resistant focal epilepsy. FCS reduces seizure frequency by diminishing abnormal excitability in cortical areas. Compared to traditional surgery, it carries lower risks and is particularly suited for patients whose epileptogenic foci are difficult to surgically localize. Its adjustability provides physicians with treatment flexibility, allowing them to tailor therapy based on patient conditions. Recent studies highlight the practical clinical application of FCS, underscoring its advantages in reducing the frequency of drug-resistant epilepsy seizures. The article concludes by exploring the future prospects of FCS, emphasizing the need for research in long-term efficacy assessment and patient adaptability, thus demonstrating its significant potential and direction for development in the field of epilepsy treatment.
The calculation of sample size is a critical component in the design phase of clinical trials incorporating health economic evaluations. A reasonable sample size is essential to ensure the scientific validity and accuracy of trial results. This paper summarizes the sample size calculation methods in the frequentist framework based on two health economic evaluation indicators: incremental cost-effectiveness ratio (ICER) and net benefit and examines these methods in terms of their applicable conditions, advantages, and limitations. The ICER method derives the sample size calculation formula by computing the ratio of incremental cost to incremental effect, while the net benefit method determines the economic viability of interventions by calculating incremental net benefit, subsequently leading to the formulation of the sample size calculation. Furthermore, this paper briefly discusses other sample size calculation methods, such as the classical Bayesian approach and the value of information analysis, providing a reference for calculating sample size in clinical trials with integrated health economic evaluations.
Objective To analyze the current research status, characteristics and development trends of traditional medicine-related clinical trials registration, and to provide ideas and directions for further development of traditional medicine clinical trials. Methods The International Traditional Medicine Clinical Trial Registry (ITMCTR) database was searched by computer from inception to June 30, 2024, with unlimited trial registration status, to collect all the clinical trials on traditional medicine, and analyze the basic information of the trials, the diseases studied and the interventions. Results A total of 4 349 clinical trials related to traditional medicine were included, with the number of registrations peaking in the second half of 2020, and showing a steady upward trend after 2023. The trial sponsors of the study covered 9 countries and a total of 34 provinces/autonomous regions/municipalities in China, led by Beijing, Shanghai, Guangdong, Sichuan, and Zhejiang provinces, accounting for 69.72% of the total. The financial support for the studies was dominated by local government funds in various provinces and cities, accounting for 29.66%. Disease types studied were mainly circulatory system diseases, musculoskeletal system or connective tissue diseases, and tumor diseases, accounting for 29.91% of the total. A total of 3 751 (86.3%) clinical trials were interventional studies, of which randomized parallel control was predominant, and 213 large-sample studies with a sample size of more than 1 000 cases were included. A total of 20 types of interventions were involved, of which 1 114 (29.86%) clinical trials utilized oral prescription of herbal medicine interventions. Conclusion Clinical trial enrollment in traditional medicine has increased overall, but with significant geographic unevenness. Oral herbal soup/granule intervention studies are the mainstream hotspots. It is recommended to strengthen international cooperation, enrich the types of interventions, refine the trial design, and raise the awareness of researchers about the registration of high-quality traditional medicine clinical trials.
Objective To introduce the use of Central Randomization System in clinical trials. Methods We discussed the application of Central Randomization System in clinical trials from object management, drug management and user management, and made a brief description of minimization method. Results Central Randomization Systems can guarantee the nnplementation of the scheme of randomization, and can be used in clinical trials with minimization. Conclusion Central Randomization Systems are feasible in clinical trials especially in traditional Chinese medicine and open clinical trials.
Statistical analysis of clinical trials has traditionally relied on frequentist methods, but Bayesian statistics has attracted considerable attention from regulators and researchers in recent years due to its unique advantages, and its use in clinical trials is increasing. Despite the obvious advantages of Bayesian statistics, the complexity of its design, implementation and analysis poses a number of challenges to its practical application, which may lead to an increased risk of unregulated use. This study aims to comprehensively sort out the application scenarios, common methods, special considerations and key elements of reporting of Bayesian statistical methods in clinical trials, with the aim of providing researchers with references for conducting Bayesian clinical trials, and promoting the scientific and rational application of Bayesian statistical methods in clinical trials.
In order to standardize the reporting of sham acupuncture and improve the quality of reporting of sham acupuncture, Beijing University of Chinese Medicine has developed a specific reporting guideline for sham acupuncture: SHam Acupuncture REporting (SHARE) which contains ten categories with nineteen items. This paper introduces the development methods and main contents of the guidelines to provide a reference for researchers to correctly understand and reasonably apply the guidelines.
The complete, transparent, and standardized reporting of the outcome of a clinical trial is a key factor in ensuring the practicality, reproducibility, and transparency of the trial, and reducing bias in selective reporting. The consolidated standards of reporting trials (CONSORT) 2010 statement provides normative guidelines for reporting clinical trials. In December 2022, JAMA released the guidelines for reporting outcomes in trial reports (CONSORT-Outcomes) 2022 extension, aiming to explain the entries related to trial outcomes, sample size, statistical methods, and auxiliary analysis in the CONSORT 2010 statement, to further improve the standards for outcome reporting in clinical trial reports. This article combines research examples to interpret the CONSORT-Outcomes 2022 extension, in order to provide normative references for domestic scholars to report clinical research results.
ObjectivesTo analyze the metrological characteristics of hypertension-related clinical trials registered on Chinese Clinical Trial Registry (ChiCTR), and discuss the characteristics and developmental trends of hypertension clinical trials registration in China.MethodsChiCTR were searched to collect hypertension-related clinical trials from inception to March 25th, 2018. The characteristics of registered trials were analyzed.ResultsA total of 135 registered trials were included, in which the trials from Beijing, Guangdong, Jiangsu, Chongqing and Shanghai accounted for 55.5%. 115 trials were pre-registered. The top three funding sources were from finance (32, 23.7%), self-financing (25, 18.5%) and hospital (20, 14.8%), respectively. Of all 79 randomized controlled trials, 55 were blank/missing in the entry of blinding method.ConclusionsThe number of hypertension-related clinical trials in ChiCTR tends to increase, however there are large regional disparities and incomplete, non-standardiazed information in the registration of clinical trials. The relevant departments should increase the publicity on the registration of clinical trials, raise the awareness of registration, and promote the development and registration of high quality clinical trials.
To solve the problems such as the incomplete and non-standard reporting outcomes in clinical trials, international methodologists have simultaneously launched guidelines for reporting outcomes in trial protocols and reports in 2022 on the basis of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and the Consolidated Standards of Reporting Trials (CONSORT) statement 2010. The SPIRIT-Outcomes 2022 extension and CONSORT-Outcomes 2022 extension recommend outcome-specific reporting items should be included prospectively in trial protocols and reports, regardless of trial design or population. This paper introduces and interprets the two guidelines for reporting outcomes, and discusses their significance and enlightenment to the research in the field of traditional Chinese medicine. For example, using the outcome reporting guidelines will help clinical researchers comprehensively consider issues related to outcomes when reporting protocols or results, which may improve the quality of research design and reporting. For core outcome set, the five core elements of outcomes may help researchers extracting and analyzing outcomes, which will standardize research; the explanation of medical terminology in the outcome reporting guidelines will contribute to the improvement of methodology in the field of traditional Chinese medicine.
