ABSTRACT
OBJECTIVE: To explore the clinical evaluation system reflecting the superiority and characteristics of comprehensive traditional Chinese medicine (TCM) therapy for acute stroke. METHODS: A randomized controlled trial with single blind in various therapeutic centers was applied on the patients with the acute stage of hemorrhagic stroke due to hypertension, who were allocated to the trial group and the control group. The trial group accepted the general Western medicine therapy and differential treatment of traditional Chinese medicine based on stage classification. Patients in the control group were treated with the general Western medicine and the placebo of traditional Chinese herbal medicine. The treatment effect was assessed at the 7th day, 14th day, 21st day, and 28th day of post-treatment and after 3-month follow-up. The clinical evaluation system included the syndromes of TCM (ZH), Glasgow coma standard (GCS), nerve functional failure (NF), activity of daily living (ADL), Barther index (BI), quality of life index (QLI) and functional activities questionnaire (FAQ). RESULTS: Four hundred and four patients with acute stroke were included. There were 178 cases with yang-syndrome and 21 cases with yin-syndrome in the trial group (n=199), and there were 165 cases with yang-syndrome and 40 cases with yin-syndrome in the control group (n=205). The rates of recovery and obvious improvement after 3-month treatment in the trial group and the control group were 86.5% and 73.6% respectively. There was significant difference between the two groups (P<0.01). The response sensitivity of the effect items indicated that the sensitivity of GCS began to increase from the 7th day and was high at the 14th day and the 21st day for all patients. The response sensitivity of the NF scale was high for all patients at the 14th day, the 21st day and the 28th day. The BI scale and the QLI scale were sensitive to the patients with light and middle stage of stroke at the 21st day, and were sensitive to the patients with light stage of stroke after 3-month follow-up. The FAQ scale was sensitive to the light stroke at the 21st day and after 3-month follow-up. The ADL scale was sensitive to all patients at the 28th day and the patients with light stage of stroke after 3-month follow-up. The ZH scale was sensitive to all patients from 0 to 7d, the 14th day, and the 28th day. The principle components analysis indicated these 7 items could reflect the condition of stroke from 0-7d, the 21st day and after 3-month follow-up, and could be used to evaluate the therapeutic effect of hemorrhagic stroke. ZH scale and FAQ scale were more sensitive than other effect items at the 28th day. CONCLUSION: The seven items (GCSbNFbBIbQLIbFAQbADLbZH) have high sensibility to all patients in the acute stage of hemorrhage stroke especially at the 21st day. The ZH score will change in accord with the condition of stroke, and is appropriate to reflect the condition of stroke. It is believed that the seven items can form the system of effect evaluation in different stages of stroke, and the ZH scale is a very important item.