Angong niuhuang pill improves the neurological function of younger patients with basal ganglia and cerebral lobe intracerebral hemorrhage: A randomized controlled trial

Abstract

Background & Objective: Spontaneous intracerebral hemorrhage (SICH) is one of the stroke forms with the highest disability and mortality rates and significant differences in prognosis among patients with different locations of SICH. Angong Niuhuang Pill (ANP) 安宫牛黄丸 is one of the most well-known traditional Chinese patent medicines used in the clinical emergency treatment of cardio-cerebrovascular diseases. This prospective study was performed to determine the therapeutic effect of ANP in different locations of SICH. Methods: Patients with basal ganglia(n=81) and cerebral lobe (n=67) hemorrhage were randomly assigned into two groups: the standard medical management (SMM) group and the combined ANP as well as medical management group (ANP group). Fisher exact test and Mann- Whitney U test were used for comparing the differences between two groups. Primary and secondary outcomes were the 6-month modified Rankin Scale (mRS) scores and the 2-week Brunnstrom stage ratings. Results: For patients with basal ganglia hemorrhage and cerebral lobe hemorrhage, there were no significant differences observed between the ANP group and the SMM group in terms of patient age (53.1±5.3 vs 52.7±6.4; 54.7±4.8 vs 52.7±5.9), sex (male:64.3% vs 53.8%; 63.6% vs 58.8%), body mass index (25.1±2.1 vs 24.2±2.6; 25.6±2.0 vs 25.0±2.4), mean hematoma volume (17.1±6.6 vs 18.6±5.7; 18.4±7.4 vs 18.9±6.0), as well as the proportions of hypertension (88.1%vs71.8%; 90.9% vs 76.5%), alcoholism (40.5% vs 51.3%; 54.6% vs 41.2%), smoking (40.5% vs 38.5%; 36.4% vs 38.2%), and diabetes mellitus (21.4% vs 18%; 12.1% vs 17.7%). The proportion of basal ganglia hemorrhage patients with a 6-month mRS score of 0-2 in the ANP group was significantly higher than that in the SMM group (26.2% vs. 2.6%, P=0.004), but it was not significantly improved in patients with cerebral lobe hemorrhage (57.6% vs 38.2%, P=0.145). The 2-week Brunnstrom stage ratings of patients with basal ganglia hemorrhage were significant difference (P=0.048). But for patients with cerebral lobe hemorrhage, there was no significant difference (P=0.164). The incidence of liver dysfunction, renal dysfunction, gastrointestinal dysfunction, hypothermia and allergy in the two groups of patients was not significantly different. Conclusions: ANP has different therapeutic effects on different locations of SICH, and has the most obvious effect on improving the long-term neurological function of patients with basal ganglia hemorrhage.