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

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

Song Y ，Li M ，Sugimoto K ，Han Y ，Liu J ，Ma B ，Song H ，Zhang C ，Gao Y ，CARE-TCM Group ... -  《-》

Reasons and experience for patients with amyotrophic lateral sclerosis using traditional Chinese medicine: a CARE-TCM based mixed method study.

Jia Q ，Song Y ，Zhang C ，Li M ，Feng L ，Sugimoto K ，Zhang X ，Liu J ，Gao Y ... -  《BMC Complementary Medicine and Therapies》

China Stroke Registry for Patients With Traditional Chinese Medicine (CASES-TCM): Rationale and Design of a Prospective, Multicenter, Observational Study.

Background: Given the complexity of stroke treatment and the current widespread use of traditional Chinese medicine (TCM) in the absence of robust, large, long-term effectiveness and safety studies, and the lack of nationwide epidemiology and clinical characteristics of patients with stroke receiving TCM treatment, the acquisition of data from longitudinal cohorts is essential. We intend to generate the major clinical characteristics of patients with stroke who receive TCM treatment and to investigate the effectiveness and safety of TCM in the Chinese population. Methods: The China Stroke Registry for Patients with Traditional Chinese Medicine (CASES-TCM) study is a prospective, multicenter, observational disease registry aiming to register 20,000 hospitalized patients. Eligible adult patients with clearly diagnosed acute ischemic stroke or intracerebral hemorrhage within 7 days of symptom onset will be consecutively registered from 126 participating sites across China. Baseline data will be recorded, and all patients will be regularly followed up at 3, 6, 12, and 24 months after stroke onset. Collected data will be entered into a web-based system with high-level data security. The primary outcomes include the distribution of scores on the modified Rankin Scale at the 3-months follow-up, and recurrent stroke events within the 12-months follow-up. Conclusion: To our knowledge, the CASES-TCM study is the first and largest nationwide registry to document comprehensive data on TCM treatment in patients with acute stroke. The findings of this study will be valuable to improve our knowledge about TCM treatment for patients with stroke and its subsequent outcomes in the actual clinical setting, consequently facilitating and standardizing the optimization of individualized interventions with TCM for stroke prevention and treatment in China. Study registration: This study was registered with Clinicaltrials.gov (URL: https://clinicaltrials.gov/, Unique identifier: NCT04921397).

Feng L ，Kong L ，Dong X ，Lai X ，Zhang D ，Ren B ，Liu S ，Xie X ，Li C ，Song Y ，Du Y ，Cao K ，Zhang C ，Gao Y ，CASES-TCM Protocol Steering Group ... -  《Frontiers in Pharmacology》

Amyotrophic Lateral Sclerosis Symptom Score in Integrative Treatments (ALS-SSIT) for Evaluating Therapeutic Effect of Traditional Chinese Medicine: A Prospective Study.

To evaluate the reliability, validity, sensitivity, and clinical applicability of a new scale-the amyotrophic lateral sclerosis symptom score in integrative treatments (ALS-SSIT)-for measuring the effect of traditional Chinese medicine (TCM) in patients with amyotrophic lateral sclerosis (ALS). A total of 160 patients with ALS were enrolled and followed up for 6 months. All patients received TCM. Patients were evaluated at enrollment and at the end of 6 months with a new scale, the ALS-SSIT, developed after extensive consultations with TCM experts with several years of experience in the treatment of ALS. The 36-item Medical Outcomes Study Short Form (SF-36) scale and the amyotrophic lateral sclerosis functional rating scale (ALSFRS) were used as the reference standards. The acceptance rate and completion rate of the ALS-SSIT scale were high, and the content validity was confirmed by experts. Test-retest performed at enrollment and at 6 months showed good reliability of the ALS-SSIT scale (Cronbach α, 0.9172 and 0.9181, respectively). The ALS-SSIT scale score showed significant change at 6 months, indicating the ability to reflect the change in disease severity. The ALS-SSIT appears to be a feasible, reliable, and sensitive tool for the evaluation of the effect of TCM in patients with ALS.

Zheng X ，Schröder J ，Sima D ，Wang M ，Wang Q ，Pan W ... -  《-》

Quality assessment of clinical trial registration with traditional Chinese medicine in WHO registries.

This study aimed to assess the registration quality of clinical trials (CTs) with traditional Chinese medicine (TCM) in the WHO International Clinical Trials Registry Platform (ICTRP) and identify the common problems if any. The ICTRP database was searched for all TCM CTs that were registered up to 31 December 2017. Registered information of each trial was collected from specific registry involved in ICTRP through hyperlink. The primary analysis was to assess the reporting quality of registered trials with TCM interventions, which is based on the minimum 20 items of WHO Trial Registration Data Set (TRDS, V.1.2.1) plus optional additional three items recommended by ICTRP, and some specific items for TCM information (including TCM intervention, diagnosis, outcome and rationale). Descriptive statistics were additionally used to analyse the baseline characteristics of TCM trial registrations. A total of 3339 records in 15 registries were examined. The number of TCM registered trials has increased rapidly after the requirement of mandatory trial registration proposed by International Committee of Medical Journal Editors on 1 July 2005, and the top two registries were Chinese Clinical Trial Registry and ClincialTrials.gov. Of 3339 trials, 61% were prospective registration and 12.8% shared resultant publications. There were 2955 interventional trials but none of them had a 100% reporting rate of the minimum 20 items and additional three items. The reporting quality of these 23 items was not optimal due to 11 of them had a lower reporting rate (<65%). For TCM details, 49.2% lacked information on description of TCM intervention(s), 85.9% did not contain TCM diagnosis criteria, 92.6% did not use TCM outcome(s) and 67.1% lacked information on TCM background and rationale. The registration quality of TCM CTs should be improved by prospective registration, full completion of WHO TRDS, full reporting of TCM information and results sharing. Further full set of trial registration items for TCM trials should be developed thus to standardise the content of TCM trial registration.

Zhang X ，Tian R ，Yang Z ，Zhao C ，Yao L ，Lau C ，Wu T ，Shang H ，Zhang X ，Lu A ，Bian Z ... -  《BMJ Open》