Efficiency and safety evaluation of Baimaiointment for alleviating hypermyotonia following cerebral

BACKGROUND: Baimai ointment has Shujin and Huoluo efficiency. It has been confirmed by basic pharmacodynamic experiments that Baimai ointment has some therapeutic effects on stroke. However, the detailed evaluations of Baimai ointment on clinically treating stroke patients for function recovery are still insufficient with little reports.OBJECTIVE: To observe the efficiency and safety of Baimai ointment on alleviating hyperrnyotonia following cerebral infarction DESIGN: A randomized, parallel and controlled experiment.SETTING: Department of Neurology, Beijing Aerospace General Hospital.PARTICIPANTS: A total of 120 patients with acute front-cycle cerebral infarction were selected from Department of Neurology, Beijing Aerospace General Hospital from July to December 2006 and met the diagnosis criteria modified by Forth National Seminar on Cerebrovascular Disease. The experiment had got confirmed consent from local ethic committee. All 120 patients with cerebral infarction were randomly divided into experimental group (n =80; 32 in the acute phase, 32 in the recovery phase and 16 in the sequela phase) and control group (n =40; 16 in the acute phase, 16 in the recovery phase and 8 in the sequela phase).METHODS: Within 4 weeks after the patients were enrolled in this study, no other traditional Chinese medicines containing similar components were adopted besides routine supporting therapy. The Baimai ointment being consisted of Jianghuang, Roudoukou, Gansong, Yangqishi, Gancao, She, shannai,Zanghuixiang, Zangchangpu, Huajiao and Jianhua was used by trial group (20 g/ampoule, Tibet Lingzhiqizheng Tibetan Drug Factory; batch number: 050403), 2 3 times per day, the ointment was moderately coated traveling parts of Baimai.MAIN OUTCOME MEASURES: The evaluation of National Institutes of Health Stroke Scale (NIHSS),Modified Rankin Scale and Modified Ashworth Scale were performed before administration, 2 and 4 weeks after administration.RESULTS: All 120 patients with acute front-cycle cerebral infarction were involved in the final analysis. ①Evaluation of therapeutic effects: After 4 weeks, the comparison of overall muscular tension and muscular tension in acute phase between the two groups (acute phase, chronic phase and recovery phase) demonstrated that the experimental group improved significantly (Z = - 2.25, - 2.06, P ＜ 0.05). After 2 weeks, the change of muscular tension was not significantly different from baseline (P ＞ 0.05). Whereas after 4 weeks, the change of muscular tension in acute phase was significantly different from baseline (P ＜ 0.05); however, the change of muscular tension in recovery phase and sequelae phase was not significantly different from baseline (P ＞ 0.05). After the treatment, the overall NIHSS and disability score of both groups did not change significantly (P ＞ 0.05). ② Adverse reaction and side effect: There were two adverse events in experimental groups. One patient underwent petechia, and the symptom disappeared following stopping medication which did not reappear after remedication. The other patient complained of a pain coming from the place where the medication was used, and the symptom went away without treatment. Two cases of adverse events were not significantly correlated with the usage of medication, so both of which could not be confirmed to be adverse reactions.CONCLUSION: Baimai ointment achieves some therapeutic effects on treating hypermyotonia of cerebral infarction patients, especially significantly preventing the hypermyotonia in acute phase with good safety.