China amyotrophic lateral sclerosis registry of patients with Traditional Chinese Medicine (CARE-TCM): Rationale and design.

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE:

Traditional Chinese medicine (TCM) has become popular interventional treatment for amyotrophic lateral sclerosis (ALS). However, lack of knowledge about the general characteristics and long-term clinical outcomes hampers the development of herbal drugs for ALS.

AIM OF THE STUDY:

The China Amyotrophic Lateral Sclerosis Registry of Patients with Traditional Chinese Medicine (CARE-TCM) provides an opportunity to better understand which TCM interventions patients with ALS are receiving, what the characteristics of patients with ALS are, and how these interventions impact clinical measures.

MATERIALS AND METHODS:

This study includes a voluntary nationwide registry, and data will be collected prospectively using an electronic data system. Detailed data collection will be performed every 3 months for 5 years. Baseline characteristics and 5-year survival will be collected. This registry was initiated in March 2021. The number of participating medical centers will be about 30 hospitals, and the target procedure number will be 2000. We will also compare the results with those of other registries in China and other countries.

DISCUSSION:

The CARE-TCM registry will first provide real-world data regarding TCM and ALS in China, focusing on the clinical characteristics of ALS patients with TCM, disease phenotypes that respond best to TCM, and correlating clinical response with other parameters. The CARE-TCM can be very helpful to improve the efficiency and quality of TCM clinical trial design.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier: NCT04885374 (registered on May 8, 2021).

• Authors: Yuebo Song, Mingxuan Li, Kazuo Sugimoto, Yi Han, Jia Liu, Bin Ma, Hujie Song, Chi Zhang, Ying Gao, CARE-TCM Group
• Journal: Journal of ethnopharmacology (J Ethnopharmacol) Vol. 284 Pg. 114774 (Feb 10 2022) ISSN: 1872-7573 [Electronic] Ireland
• PMID: 34699945 (Publication Type: Journal Article)
• Copyright: Copyright © 2021 Elsevier B.V. All rights reserved.

Topics

• Amyotrophic Lateral Sclerosis (epidemiology, therapy)
• China (epidemiology)
• Humans
• Medicine, Chinese Traditional
• Registries