A randomized, double-blind, placebo-controlled clinical study of traditional Chinese medicine syndrome differentiation in the treatment of acute ischemic stroke

Abstract

Objectives The aim was to objectively evaluate the clinical efficacy of an experience prescription of Traditional Chinese Medicine(TCM) syndrome differentiation for stroke. Methods 102 patients with acute ischemic stroke were recruited. They were randomly assigned to the control group (n = 50) and the test group (n = 52). The control group was treated with western medicine and placebo. The test group was treated with western medicine and an experience prescription of TCM syndrome differentiation (antelope horn, sputum, Cynanchum otophyllum and turmeric) with addition according to the tongue coating. The two groups were treated for 14 days and followed up for 3 months. NIHSS, BI, mRS ≤ 2, complications, mortality, recurrence rate, safety indicators and economic indicators were oberserved. Results There was no statistical difference in NIHSS, BI, mRS ≤ 2, mortality and recurrence rate between the two groups on the fourteenth day and at 3-month follow-up (P > .05). The incidence of respiratory infection during the 14-day hospital stay in the test group was significantly lower than that in the control group (P = .015). After 14 days, PT, KPTT (P = .022) and INR (P = .013) in the test group were significantly higher than those in the control group in the normal range. The test group has a tendency to reduce the average daily hospitalization expenses (P = .053). Conlusions The experience prescription of TCM syndrome differentiation has no significant effect on the prognosis of acute ischemic stroke, but reduces the incidence of respiratory infection during hospitalization.