| Evidence classification method： |
The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method is used to rate the evidence supporting the recommendation opinions. According to the GRADE method, evidence quality is classified into four levels: high, medium, low, and extremely low (codes A, B, C, D respectively). RCTs are considered high-quality evidence, while observational studies are considered low-quality evidence. In the process of evidence grading, five downgrade factors (bias risk, inconsistency, indirectness, inaccuracy, and publication bias) and three upgrade factors (effect size, negative bias, and dose-response relationship) are considered. Evidence is presented through an evidence summary table, and recommendation opinions are graded according to the GRADE system for strength. The recommendation direction and strength are determined based on the nominal group method vote counting rules, including strong recommendation, weak recommendation, weak non recommendation, and strong non recommendation. |
| Purpose of the guideline: |
Multiple sclerosis (MS) is an autoimmune mediated white matter inflammatory demyelinating disease of the central nervous system, characterized by fluctuating recurrence remission and persistent disability progression. It is the leading cause of neurological disability in young adults. The disease modifying therapy (DMT) recommended by international guidelines, which mainly regulates immunity, has a prevalence rate of less than 20% in Chinese MS patients, with unclear clinical benefits/risks. One third of patients stop DMT treatment due to poor efficacy or side effects. Traditional Chinese medicine has the advantage of reducing damage and recurrence in the treatment of MS. The synergistic prevention and treatment of traditional Chinese and Western medicine is beneficial for reducing disability. Given the complexity of MS disease and the synergistic effect of traditional Chinese and Western medicine treatment methods, there is an urgent need to develop a Chinese MS diagnosis and treatment plan or guideline that clearly targets the application population and is safe and economical, in order to help clinical doctors make decisions in clinical practice.
The 2020 Comprehensive Social Survey Report on Multiple Sclerosis Patients in China shows that nearly 60% of MS patients in China have not received any treatment, and nearly 20% of MS patients have received DMT treatment. This guideline recommends the combination of traditional Chinese medicine and Western medicine for the treatment of MS patients with the above two types of characteristics, closely combining the current medical situation and health economics needs in China; Recommend different treatment plans for the onset and remission periods, reflecting a dynamic diagnosis and treatment model that combines disease and syndrome; Focusing on common complications, leveraging the comprehensive intervention advantages of traditional Chinese medicine, recommending treatment methods with certain evidence or high consensus, providing safe and effective treatment methods for clinical doctors, with good applicability, economy, and clinical operability.
Beijing University of Traditional Chinese Medicine Dongzhimen Hospital, as the leader unit of the National Administration of Traditional Chinese Medicine's Brain Disease Key Specialty Cooperation Group, has established a multiple sclerosis cooperation group, established a clinical registration platform for multiple sclerosis patients with traditional Chinese medicine characteristics, and led the drafting of the "Diagnosis and Treatment Guidelines for Common Diseases in Traditional Chinese Medicine Internal Medicine" released by the Chinese Association of Traditional Chinese Medicine in 2008, including the Traditional Chinese Medicine Diagnosis and Treatment Guidelines for Multiple Sclerosis. In 2011 and 2017, the National Administration of Traditional Chinese Medicine organized the development of multiple sclerosis diagnosis and treatment plans and clinical pathways, with Gao Ying and Zhou Li as the authors. In addition, Huang Dehui, as the main cooperative unit of the First Medical Center of the Chinese People's Liberation Army, participated in writing the Guidelines for the Diagnosis and Treatment of Multiple Sclerosis (2023), the Consensus of Chinese Experts on the Diagnosis and Treatment of Multiple Sclerosis 2018, and the Guidelines for the Diagnosis and Treatment of Optic Neuromyelitis Pedigree Diseases in China drafted and issued by the Chinese Medical Association.
This guide will closely integrate the current medical situation and health economics needs in China, and recommend the combination of traditional Chinese medicine and Western medicine for MS treatment; Recommend different treatment plans for the onset and remission periods, reflecting a dynamic diagnosis and treatment model that combines disease and syndrome; Focusing on common complications, leveraging the comprehensive intervention advantages of traditional Chinese medicine, recommending treatment methods with certain evidence or high consensus, providing safe and effective treatment methods for clinical doctors, with good applicability, economy, and clinical operability. By utilizing the multiple sclerosis clinical patient registration platform for promotion, we aim to enhance the overall MS treatment capability in China, reduce the disease and economic burden on MS patients, families, and society, and lay the foundation for broad application space and good prospects. |
