A Randomized Controlled Trial Of Acupuncture For Acute Ischemic Stroke:a Pilot Study

OBJECTIVE: Acupuncture has been used in patients with stroke for many years. The studies on its effectiveness for stroke reported conflict results. These studies varied in inclusion criteria, sample size, and outcome measures, etc. And no study on long-term outcomes has been conducted in mainland China. To test whether acupuncture can improve activity of daily living (ADL) and long term institutionalization in acute ischeamic stroke, we carried out a pilot study with the aim to see whether a large scale ramdmization acupuncture in acute ischeamic stroke is feasible and warranted. METHODS: A multicenter randomized controlled trial was conducted in 6 hospitals in Chengdu China. Based on the same supportive treatments, 101 patients with acute ischeamic stroke were randomly assigned to a treatment with or without manual acupuncture. The treatment was studied 3-10 days after stroke onset. Acupuncture on acupoints was applied 5 times a week for 3-4 weeks. The primary outcome variables included death or dependence (dependence was defined as Barthel Index<60 or Modified Rankin Scale>3), and long term institutionalization at 3 and 6-month. The secondary outcome variable was Scandinavian Stroke Scale at one month or hospital discharge. The outcomes were assessed blindly.RESULTS: The eligible 101 patients were selected from 835 consecutive patients in 6 hospitals in Chengdu during 10 months period (from April 2001 to February 2002). The baseline data in each group were closely similar in all important prognostic variables. At the time of analysis 80.2% completed 3-month follow up and 52.5% completed 6-month follow-up. Only 3 patients were lost to follow up (accounted for 3.6%). No clinically important or statistically significant differences between two groups were observed for any of the outcome variables. No major adverse effects were observed in the treatment group.CONCLUSIONS: The present study with a limited sample size was not powered to give a firm conclusion on the effectiveness of acupuncture for acute ischeamic stroke. However, it was suggested that acupuncture was generally well tolerated by all patients and seemed safe. A large scale RCT is warranted and feasible in China.