Minimally Invasive Craniopuncture Therapy vs. Conservative Treatment for Spontaneous Intracerebral Hemorrhage: Results from a Randomized Clinical Trial in China

Abstract

Background and purposes To evaluate the effects of minimally invasive craniopuncture therapy compared with conservative treatment in treating intracerebral hemorrhage (25-40 ml) in the basal ganglion. Methods A multicenter, randomized control clinical trial comprised 465 cases of hemorrhage in the basal ganglion from 42 hospitals in China. Three hundred and seventy-seven patients with hemorrhage were randomly assigned to receive minimally invasive craniopuncture therapy ( n = 195) or conservative control treatment ( n = 182). The main indices of evaluation were the degree of neurological impairment at the 14th day after treatment, activities of daily living at the end of the 3rd month and the case fatality within 3 months. Results Improvement of neurological function in the minimally invasive craniopuncture group was significantly better than that in the control group at the 14th day ( χ2 = 7 93, P = 0 02). At the end of the 3rd month, there was a significant difference between the two groups in activities of daily living score ( χ2 = 2313, P<0·001). The proportion of dependent survival patients (modified Rankin scale > 2) in the craniopuncture group (40·9%) was significantly lower than that in the conservative group (63·0%) at the end of the 3rd month ( χ2 = 16·95, P<0·01). There was no significant difference in the cumulative fatality rates within three months between the two groups [6·7% (13/195) in the craniopuncture group and 8·8% (16/182) in the conservative group]. Conclusions This minimally invasive craniopuncture technique can improve the independent survival of patients with small basal ganglion hemorrhage. It is a safe and practical technique in treating cerebral hemorrhage.