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Activating blood circulation to remove stasis treatment of hypertensive intracerebral hemorrhage: A multi-center prospective randomized open-label blinded-endpoint trial

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Abstract

Objective

To investigate the efficacy and safety of the Chinese herbal therapeutic regimen of activating blood circulation (TRABC) in treatment of hypertensive intracerebral hemorrhage (HICH).

Methods

This was a multi-center prospective randomized open-label blinded-endpoint (PROBE) trial with HICH admitted to 12 hospitals. Totally 240 participants were randomized to the treatment group treated with TRABC in addition to conventional Western treatment or the control group with conventional Western treatment equally for 3 months. Primary outcome was degree of disability as measured by modified Rankin Scale (mRS). Secondary outcomes were the absorption of hematoma and edema, National Institutes of Health Stroke Scale (NIHSS) scores and patient-reported outcome measures for stroke and Barthel activities of daily living index. Adverse events and mortality were also recorded.

Results

After 3 months of treatment, the rate of mRS 0-1 and mRS 0-2 in the treatment group was 72.5% and 80.4%, respectively, and in the control group 48.1% and 63.9%, respectively, with a significant difference between groups (P<0.01). Hematoma volume decreased significantly at day 7 of treatment in the treatment group than the control group (P=0.038). Average Barthel scores in the treatment group after treatment was 89.11±19.93, and in the control group 82.18±24.02 (P=0.003). NIHSS scores of the two groups after treatment decreased significantly compared with before treatment (P=0.001). Patient-reported outcomes in the treatment group were lower than the control group at day 21 and 3 months of treatment (P<0.05). There were 4 deaths, 2 in each group, and 11 adverse events, 6 in the treatment group and 5 in the control group.

Conclusion

The integrative therapy combined TRABC with conventional Western treatment for HICH could promote hematoma absorption thus minimize neurologic impairment, without increasing intracerebral hematoma expansion and re-bleeding.

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Authors and Affiliations

  1. Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China

    Jing-ya Li  (李净娅), Li-xin Yuan  (院立新), Gen-ming Zhang  (张根明), Li Zhou  (周 莉), Ying Gao  (高 颖) & Che Chen  (陈 澈)

  2. Tongzhou Traditional Chinese Medicine Hospital of Beijing, Beijing, 101100, China

    Qing-bin Li  (李庆彬)

Authors
  1. Jing-ya Li  (李净娅)
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  2. Li-xin Yuan  (院立新)
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  3. Gen-ming Zhang  (张根明)
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  4. Li Zhou  (周 莉)
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  5. Ying Gao  (高 颖)
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  6. Qing-bin Li  (李庆彬)
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  7. Che Chen  (陈 澈)
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Corresponding author

Correspondence to Gen-ming Zhang  (张根明).

Additional information

Supported by the Beijing Committee on Science and Technology, Project on Research on Two Standards of Traditional Chinese Medicine Treatment for Stroke (No. D101107049310003)

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Li, Jy., Yuan, Lx., Zhang, Gm. et al. Activating blood circulation to remove stasis treatment of hypertensive intracerebral hemorrhage: A multi-center prospective randomized open-label blinded-endpoint trial. Chin. J. Integr. Med. 22, 328–334 (2016). https://doi.org/10.1007/s11655-016-2467-7

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  • DOI: https://doi.org/10.1007/s11655-016-2467-7

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