Acupuncture for acute moderate thalamic hemorrhage: randomized controlled trial study protocol

Wang et al. BMC Complementary and Alternative Medicine (2017) 17:112 DOI 10.1186/s12906-017-1614-6 STUDY PROTOCOL Open Access Acupuncture for acute moderate thalamic hemorrhage: randomized controlled trial study protocol Chengwei Wang1, Chao You2, Lu Ma2, Mengyue Liu1, Meng Tian2 and Ning Li1* Abstract Background: Thalamic hemorrhage (TH) is a neurological insult with a high rate of morbidity and mortality. Moderate TH (10–30 ml) accounts for more than half of all TH. Treatment remains controversial. The role of acupuncture in patients with moderate TH is not clear. Methods: We will conduct a single-center, randomized, parallel group, and assessor-blinded clinical trial. A total of 488 patients with moderate TH will be randomly assigned to one of eight groups: 10–15 cc left sided TH study group (N = 61) and a corresponding control group (N = 61), 10–15 cc right sided TH study group (N = 61) and a corresponding control group, 15–30 cc left sided TH study group (N = 61) and a corresponding control group (N = 61), and 15–30 cc right sided TH study group (N = 61) and a corresponding control group. Study groups will receive acupuncture in addition to standard treatment, while control groups will receive standard treatment alone. The primary outcome will be change in National Institutes of Health Stroke Scale scores at 30 and 90 days after TH. The secondary outcomes will be death or major disability, defined as a score of 3 to 6 on the modified Rankin scale (in which a score of 0 indicates no symptoms, a score of 5 indicates severe disability, and a score of 6 indicates death) at 90-days, need for surgery at 30-days, Glasgow Outcome Scale (GOS) score at 90-days following TH onset, and the results of several additional group specific tests. The rate of adverse events will then be compared between the groups. Discussion: This study will attempt to answer the question of whether or not acupuncture can improve neurologic outcome following moderate TH. Trial registration: Chinese clinical trial registry (ChiCTR-IOR-16008362) Keywords: Acupuncture, Intracranial hemorrhage, Moderate thalamic hemorrhage, RCT Background Spontaneous intracerebral hemorrhage (ICH), noniatrogenic ICH without trauma, is the second most common and the most devastating form of all strokes with the poorest prognosis [1, 2]. Approximately 15% of all cases of spontaneous ICH occur in the thalamus [3–5]. The thalamus is a deep brain structure and is an important center for the transmission of neural signals [3, 6]. Due to its anatomical location and the vital functions that it performs, the decision * Correspondence: 1 Department of Integrated Traditional and Western Medicine, West China Hospital, Sichuan University, Chengdu, China Full list of author information is available at the end of the article of conservative or surgical management for TH remains controversial [2, 7, 8]. Management is influenced mainly by the clinical experience of the treating surgeon and the volume of the hematoma [9]. Patients with minor TH, especially volumes less than 10 cc, usually obtain favorable outcomes when treated with conservative measures. However, patients with major TH, greater than 30 cc, have mortality rates of more than 80%, no matter what treatment is selected [10]. Moderate TH (10–30 mL) constitutes more than half of all cases of TH, and these patients have a mortality rate of more than 30% [11]. As moderate TH is the most common form of TH, its prognosis carries the greatest weight in calculating the prognosis of all forms of TH. In patients with moderate TH, conservative © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Wang et al. BMC Complementary and Alternative Medicine (2017) 17:112 treatment alone versus surgical treatment is naturally a difficult decision to make. Because surgical treatment is invasive, adjacent structures may be damaged and neural pathways may be disrupted during surgical evacuation of a hematoma, thereby aggravating the degree of neurologic deficits or creating new ones. Meanwhile, conservative treatment alone does not offer the involved thalamic tissue the same type of relief that evacuation offers and is therefore felt to be a limited strategy in improving neurologic function. The limitations of both therapeutic strategies provide considerable room for better approaches or combinations of approaches. Two recognized mechanisms of brain injury from ICH have been established [12, 13]. Primary injury happens at the time of initial hemorrhage when direct damage to brain tissue occurs either secondary to the hematoma itself or to its mass effect on surrounding brain tissue. Secondary injury happens at some time following initial hemorrhage and includes neuronal death from either the inflammatory response to the hematoma, the release of toxic materials and other cytokines, the breakdown of the brain blood barrier, apoptosis, or the development of edema. While the pathophysiology of ICH provides many potential approaches for its treatment, enlargement of the hematoma and the development of surrounding edema have been identified as major contributors to the high morbidity and mortality of ICH and have thus been the major focus of potential treatment strategies [14–17]. Acupuncture, one of the major branches of Traditional Chinese Medicine (TCM), has long been used to treat acute stroke, including hemorrhagic stroke, in China as well as in many other East Asian countries. Acupuncture’s utility in the treatment of non-hemorrhagic stroke, which is now documented by the WHO (World Health Organization, 2002), has been widely researched [18]. In recent years, a number of studies using modern technologies have shown that acupuncture may have neuroprotective effects following hemorrhagic stroke as well [19–22]. One preclinical systematic review of 19 animal studies showed that GV20 (Baihui) based acupuncture can improve neurologic outcome by regulating the inflammatory response to a hematoma, inhibiting neuronal apoptosis, reducing cerebral edema, maintaining ATP supply, promoting nerve regeneration, maintaining neuronal membrane integrity, and promoting hematoma resorption [23]. In another animal study, acupuncture at the DU20 acupoint was reported to have a neuroprotective effect on cerebral hemorrhage by inhibiting Notch-Hes signaling in rat basal ganglia [24]. It has also been reported that electro-acupuncture treatment at the Zusanli (ST (...truncated)