BACKGROUND: It has been demonstrated that the attack of persistent vegetative state is associated with the damaged neuron, which produces dopamine, and nervous pathway, the reduce of dopamine or malfunction of dopamine.OBJECTIVE: To observe the effect of self-made traditional Chinese medicine (TCM) Yishen Qiqiao Fang,which has the functions of supplementing qi and nourishing blood, resolving phlegm by promoting blood circulation, restoring consciousness and inducing resuscitation, on the contents of dopamine in serum and cerebrospinal fluid of patients in persistent vegetative state.DESIGN: An open randomized controlled clinical trial.SETTINGS: Nanjing University of Traditional Chinese Medicine, Nanjing Zijin Hospital.PARTICIPANTS: Thirty-eight inpatients of persistent vegetative state were selected from the Department of Neurology, Nanjing Zijin Hospital from August 2005 to November 2006. The patients were diagnosed according to the diagnostic standards set by the summary of a meeting for specialists in Nanjing. Informed contents were obtained from their relatives. According to the order of admission, the enrolled patients were divided into control group (n =20) and TCM treated group (n =20).METHODS: In the control group, the patients were treated with routine treatments for the symptoms. In the TCM treated group, the patients were treated with Yishen Qiqiao Fang besides the same treatments in the control group. TCM dispensing granules: each bag of mongolian milkvetch root, Chinese angelica and peach seed equaled to 10 g crude drug respectively; each bag of grassleaf sweetflag rhizome and dahurian angelica root equaled to 6 g crude drug respectively; Musk 0.05 g. The daily dosage for adults: 4 bags of mongolian milkvetch root, 2 bags of Chinese angelica, 0.05 g musk, 1 bag of peach seed, 2 bags of grassleaf sweetflag rhizome and 2 bags of dahurian angelica root, which should be given though nasal feeding or gastrostogavage before breakfast and supper every day, the course lasted for 2 months. The contents of dopamine in serum and cerebrospinal fluid were determined with enzyme immunoassay analyzer before and after treatment in both groups.MAIN OUTCOME MEASURES: Contents of dopamine in serum and cerebrospinal fluid before and after treatment in both groups.RESULTS: Totally 38 patients of persistent vegetative state were enrolled, 33 of them were involved in the final analysis of results, and the other 5 missed. The contents of dopamine in serum and cerebrospinal fluid had no obvious differences between the two groups both before and after treatment (P＞0.05). In the control group, the contents of dopamine in serum and cerebrospinal fluid had no obvious differences before and after treatment (P＞0.05). In the TCM treated group, the contents of dopamine in serum and cerebrospinal fluid after treatment were obviously higher than those before treatment (t =2.174, 2.485, P＜0.05).CONCLUSION: Yishen Qiqiao Fang can significantly increase the contents of dopamine in serum and cerebrospinal fluid of patients in persistent vegetative state, which may be one of the mechanisms for ameliorating persistent vegetative state.