Page 268 - 2025中醫藥與天然藥物聯合學術研討會-中醫藥與天然藥物的挑戰Ｘ機遇與未來大會手冊

CM-01

Efficacy and safety of hot natured Traditional Chinese Medicine for ischemic

stroke rehabilitation: A systematic review and meta-analysis of add-on and

head-to-head trials

2
1
4
1
3
Yi-Jyun Lu, Pei-Jhen Hsieh, Shih-Jung Huang, Ming-Hui Lee, Shih-Shiun Yang, Wei-
Cheng Tan, Kuei-Hung Lai*
,1
3

1 Graduate Institute of Pharmacognosy, Taipei Medical University, Taipei 110, Taiwan
2 School of Public Health, Taipei Medical University, Taipei 110, Taiwan
3 School of Pharmacy (Division of Clinical Pharmacy), Taipei Medical University, Taipei
110, Taiwan
4 School of Nutrition and Health Sciences, Taipei Medical University, Taipei 110, Taiwan
* E-mail: kueihunglai@tmu.edu.tw

Abstract
Ischemic stroke is a major contributor to long-term disability and mortality worldwide,
placing a significant burden on patients and healthcare systems. Although Western medicine
remains the standard care during rehabilitation, neurological recovery is often limited, and
adverse effects are common. In Traditional Chinese Medicine (TCM) theory, herbs with warm
or hot properties are believed to replenish Yang energy, promote circulation, and support
neurological restoration. While early studies suggest potential benefits, systematic evidence is
limited. To address this gap, we conducted a systematic review and meta-analysis evaluating
the efficacy and safety of hot natured TCM in ischemic stroke rehabilitation. Following
PRISMA 2020 and Cochrane Handbook guidelines, we identified 91 randomized trials and 7
controlled trials involving 9140 participants from six English and Chinese databases. Eligible
studies involved patients with ischemic stroke receiving oral hot-natured TCM, either as
monotherapy or adjunctive treatment during the rehabilitation phase. The primary outcome was
the National Institutes of Health Stroke Scale (NIHSS), with secondary outcomes including the
Barthel Index, Modified Rankin Scale, Fugl-Meyer Assessment, Chinese Stroke Scale,
Activities of Daily Living, and adverse events. Preliminary findings indicate that hot-natured
TCM significantly improves NIHSS and Barthel Index scores, suggesting enhanced
neurological and daily function recovery. Subgroup analysis revealed a linear relationship
between stroke severity and NIHSS improvement, with greater effects observed in more severe
cases. No significant differences in treatment outcomes were found among different hot-natured
herbal formulas. Furthermore, no notable increase in adverse events was reported. Meta-
analyses will be conducted using a random-effects model in R software. This review aims to
clarify the clinical role of hot-natured TCM and provide evidence for its potential integration
into stroke rehabilitation strategies.

Keywords: Ischemic stroke; Poststroke rehabilitation; Hot natured TCM; Meta-analysis;
NIHSS