Demyelinating Diseases of the Central Nervous System Registry for Patients with Traditional Chinese Medicine (DATE-TCM) is an observational study aiming to better define the multidimensional (epidemiologic, demographic and clinical) characteristics of Demyelinating Diseases of the Central Nervous System (DDC) patients receiving Traditional Chinese medicine (TCM) treatment, the type and long-term safety and effectiveness of TCM in DDC populations, as well as the interaction of TCM treatment and disease-modifying therapy in the management of DDC.
Male or female participants with aged 18-65 years old; Diagnosis of DDC including multiple sclerosis (MS), Neuromyelitis optica spectrum disorder (NMOSD), and myelin oligodendrocyte glycoprotein-associated disease(MOGAD) according to relevant criteria or consensus; Patients who receive or are willing to receive TCM treatment including the Chinese herbal medicine, acupuncture, moxibustion, massage, taiji, and qigong; Informed written consent obtained from the patient, and/or his/her legally authorized representatives.
Refusal to give informed consent; Malignancies, infectious diseases (HBV, HCV, HIV, etc.), congenital or acquired severe immunodeficiency, significant cardiovascular, pulmonary, and hepatic diseases or conditions; Mental disturbance or severe cognitive impairment impeding necessary information gathering and assessment.
DATE-TCM includes all patients with Demyelinating Diseases of the Central Nervous System at beginning of study.
Other
Prospective
Traditional Chinese medicine (TCM)
Other interventionTCM treatment includes Chinese herbal medicine, acupuncture, moxibustion, massage, taiji, and qigong.
Annualized Aggregate Relapse Rate (ARR)
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The ARR was the mean of the annualized ARRs for all patients, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Total Number of Adverse Events During Evaluation
Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
Percentage of Participants With Adverse Events
Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
Time to 3-month Sustained Disability Progression
3-month sustained disability progression (DP) was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score \>5.5) that persisted for at least 3 months. EDSS scale ranges from 0 (Normal neurological exam, no disability) to 10 (Death) in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time.
Time to 6-month Sustained Disability Progression
6-month sustained disability progression (DP) was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score \>5.5) that persisted for at least 6 months. EDSS scale ranges from 0 (Normal neurological exam, no disability) to 10 (Death) in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time.
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