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BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available

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BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay- per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] BMJ Open Safety and Efficacy of Herbal Medicine for Acute Intracerebral Hemorrhage (CRRICH): A Multicenter Randomized Controlled Trial ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2018-024932 Article Type: Research Date Submitted by the 25-Jun-2018 Author: Complete List of Authors: Zeng, Liling; The Second Clinical Medical Collage, Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine Wang, Jing; Neurology Department, Shenzhen Longhua New District Center Hospita, Shenzhen Tang, Guanghai; Shenyang No.2 traditional Chinese medical hospital, Shenyang, Liaoning Zhong, Jianbin ; Boji-affiliated Hospital of Sun Yat-sen University Xia , Zhangyong ; Liaocheng People's Hospital, Liaocheng clinical school of Taishan Medical University Li, Jiexia; Conghua City’s hospital of Chinese Medicine Chen, Guangsheng ; Boluo County People's Hospital Zhang, Yongbo ; Shouguang City People's Hospital Luo, Saihua; Lianjiang People's hospital Huang , Gan ; Yangjiang Hospital of Chinese Medicine Zhao, Qianshan; Jiangmen Wuyi Hospital of Chinese Medicine Wan, Yue ; Zhongshan Hospital of Hubei Province Chen , Chaojun; Guangzhou Hospital of Integrated traditional and west medicine Zhu, Kaiyun ; Panyu Hospital of Chinese Medicine Qiao , Hanzi; Guangdong Provincial hospital of Chinese medicine, Neurology Wang, Jian ; First Affiliated Hospital to Changchun University of Chinese Medicine Huang, Tao ; Guangdong Provincial hospital of Chinese medicine, Neurology Liu, Xian; Guangdong Provincial hospital of Chinese medicine, Neurology Zhang, Qixin ; Guangdong Provincial hospital of Chinese medicine, Neurology Lin, Rongming ; Guangdong Second Hospital of traditional Chinese Medicine Li, Haijun ; Guangdong Provincial hospital of Chinese medicine, Neurology Gong, Baoying ; Guangdong Provincial hospital of Chinese medicine, Neurology Chen, Xiuyan ; Guangdong Provincial hospital of Chinese medicine, Neurology Zhou, Yuexiang; Guangdong Provincial hospital of Chinese medicine, Neurology Wen, Zehuai; Guangdong Provincial Hospital of Chinese Medicine, Key For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 55 BMJ Open 1 2 3 Unit of Methodology in Clinical Research 4 Guo, Jianwen; Guangdong Provincial hospital of Chinese medicine, 5 Neurology 6 intracerebral hemorrhage, Herbal medicine < THERAPEUTICS, 7 Keywords: 8 randomized controlled trials, hematoma enlargement, CRRICH 9 10 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 55 1 2 3 4 Safety and Efficacy of Herbal Medicine for Acute Intracerebral 5 6 Hemorrhage (CRRICH): A Multicenter Randomized Controlled 7 8 9 Trial 10 11 Liling Zeng, Jing Wang, Guanghai Tang, Jianbin Zhong, Zhangyong Xia, Jiexia Li, 12 13 Guangsheng Chen, Yongbo Zhang, Saihua Luo, Gan Huang, Qianshan Zhao, Yue Wan, 14 15 Chaojun Chen, Kaiyun Zhu, Hanzi Qiao, Jian Wang, Tao Huang, Xian Liu, Qixin Zhang, 16 For peer review only 17 Rongming Lin, Haijun Li, Baoying Gong, Xiuyan Chen, Yuexiang Zhou, Zehuai Wen, 18 19 Jianwen Guo* 20 21 Jianwen Guo, MD,Neurologist. 22 23 Guangdong Provincial Hospital of Chinese Medicine, Guangdong University of Chinese 24 Medicine 25 26 111 Da De Rd., Yuexiu District, Guangzhou, Guangdong Province, 27 28 PRC, 510120 29 30 Telephone 86-20-81867705 31 32 FAX 86-20-81867705 33 34 35 Author affiliations (Liling Zeng, Jianwen Guo, Haijun Li, Qixin Zhang, Tao Huang, 36 37 Xian Liu, Baoying Gong, Xiuyan Chen, Yuexiang Zhou, Zehuai Wen, Hanzi Qiao) The 38 Second Clinical Medical Collage, Guangzhou University of Chinese Medicine, 39 Guangdong Provincial Hospital of Chinese Medicine,Guangzhou, China; (Jing 40 Wang)Shenzhen Longhua New District Center Hospita, Shenzhen, China.; (Jian Wang) 41 42 Changchun Chinese Medicine University affiliated hospital,Changchun,China; 43 (Zhangyong Xia) Liaocheng People's Hospital, Liaocheng clinical school of Taishan 44 Medical University, Liaocheng, China; (Jiexia Li)Conghua City’s hospital of Chinese 45 Medicine, Conghua, China; (Guangsheng Chen)Boluo County People's Hospital, 46 Huizhou , China;(Qianshan Zhao)Jiangmen Wuyi Hospital of Chinese Medicine, 47 48 Jiangmen, China; (Chaojun Chen)Guangzhou Hospital of Integrated traditional and 49 west medicine, Guangzhou, China; (Yongbo Zhang)Shouguang City People's 50 Hospital,Shouguang,China; ( Gan Huang)Yangjiang Hospital of Chinese Medicine, 51 Yangjiang, Guangdong, China; (Kaiyun Zhu)Panyu Hospital of Chinese Medicine， 52 53 Guangzhou, China;(Saihua Luo)Lianjiang People's hospital, Lianjiang, China; 54 (Guanghai Tang)Shenyang No.2 traditional Chinese medical hospital, Shenyang, China; 55 (Jianbin Zhong)Boji-affiliated Hospital of Sun Yat-sen University, zengcheng, China; 56 (Yue Wan)Zhongshan Hospital of Hubei Province, Wuhan, Hubei, China；Guangdong 57 1 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 55 BMJ Open 1 2 3 Second Hospital of traditional Chinese Medicine(Rongming Lin) 4 5 6 ABSTRACT 7 8 9 Objective: To evaluated the safety and efficacy of herbal medicine for 10 11 the treatment of acute intracerebral hemorrhage (AICH) within a 6-h time 12 13 14 window. 15 16 For peer review only 17 Study design: A randomized, multicenter, double-blind, 18 19 placebo-controlled study performed in 14 hospitals in China. 20 21 22 23 Participants and Interventions: Patients with AICH were randomly 24 25 assigned to receive a placebo, the ICH-1 formula (8 herbs, including the 26 27 28 removing blood stasis (RBS) herbs hirudo and tabanus) or the ICH-2 29 30 formula (6 herbs without the RBS herbs hirudo and tabanus) within 6 h 31 32 of ICH onset. 33 34 35 36 Outcomes: The primary safety outcome was the hematoma enlargement 37 38 (HE)rate at 24 h and on 10 days after treatment. The secondary outcome 39 40 41 endpoint was incidence of poor prognosis (mortality or modified Rankin 42 43 Scale (mRS) score ≥5) assessed on 90 days after symptom onset. 44 45 46 Results: A total of 324 subjects were randomized between October 2013 47 48 49 and May 2016: 105 patients received placebo; 108 patients received the 50 51 ICH-1 formula; and 111 patients received the ICH-2 formula. The HE 52 53 54 rates at 24 h were 7.8% in the placebo group, 12.3% in the ICH-1 group, 55 56 and 7.5% in the ICH-2 group, and the HE rates on day 10 were 1.1% in 57 2 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 55 1 2 3 4 the placebo group, 1.1% in the ICH-1 group, and 3.1% in the ICH-2 5 6 group, with no significant differences between the groups (P>0.05). The 7 8 9 mortality rates were 3.8% in the placebo group, 2.8% in the ICH-1 group, 10 11 and 0.9% in the ICH-2 group,and the incidences of poor prognosis were 12 13 7.1% in the placebo group, 6.0% in the ICH-1 group, and 4.8% in the 14 15 16 ICH-2 groupFor at 3 peermonths, with review no significant onlydifferences between the 17 18 groups (P>0.05). However, the overall frequency of adverse events in the 19 20 21 ICH-1 group (12.1%) was higher than that in the placebo and ICH-2 22 23 groups (5.8% and 2.8%, respectively, P<0.022). The 3 cases of serious 24 25 26 adverse events were all in the ICH-1 group. 27 28 29 Conclusions: Ultra-early administration of RBS herbal medicine, within 30 31 6 h of ICH onset, for AICH patients did not exert significantly beneficial 32 33 34 effects on clinical outcomes, but increased the risk of bleeding, such as 35 36 gastrointestinal bleeding, and hematoma growth. 37 38 39 Clinical Trial Registration: URL:http//www.ClinicalTrials.gov. 40 41 42 Unique identifier: NCT01918722. 43 44 45 Keywords: intracerebral hemorrhage; herbal medicine; randomized 46 47 48 controlled trials; hematoma enlargement; CRRICH 49 50 51 Word count: 4568 52 53 54 55 56 57 3 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 55 BMJ Open 1 2 3 4 Strengths and limitations of this study 5 6 7 ▪ The CRRICH trial is the largest Multicenter clinical trial to examine the 8 9 safety and efficacy of a Chinese compound formula in patients with 10 11 12 HICH. 13 14 15 ▪ This study highlights the possibility that the early use of RBS herbal 16 For peer review only 17 medicine in HICH could increase the risk of bleeding, which spurs further 18 19 20 research on the safety of Chinese medicines.
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