OBJECTIVETo observe the effect and safety of a comprehensive protocol of integrated Chinese and Western medicine (ICWM) in treating acute intracerebral hemorrhage (AICH).

METHODSA multi-center, single blinded, random and control clinical trial was adopted with 404 patients with AICH, they were divided into the treatment group (199 cases) treated with ICWM protocol, and the control group (205 cases) treated with Western medicine plus placebo, and AICH related indexes were assessed after treatment.

RESULTSCompared with the control group, the neurological deficit score (National Institute of Health Stroke Scale, NIHSS) determined on the 28th and the 90th day after treatment was ameliorated in the treatment group (P < 0.01). Moreover, the 90th day assessment showed that the mortality and severe disability rate was lower (BI < 75) (P <0.05), the complete rehabilitation and mild disability rate (BI > or = 95, P < 0.05), and the sociability rate (Functional Assessment Questionnaire, FAQ) were higher (P < 0.01) in the treatment group than those in the control group. The incidence of adverse reaction was 5.53%, manifested as non-infective diarrhea.

CONCLUSIONThe ICWM protocol used in this study may improve neural function and quality of life of AICH patients, and reduce the mortality and severe disability rate in those after 90 days' treatment, with only non-infective diarrhea as the adverse reaction.