| BackgroundInsomnia is not cured today, significant side-effects and undertoward effects are obsevred with the treatment of phenobarbital.There are long history and experience on treatment insomnia with chinese medicine, for example the treatment of spleen and stomach from insomnia is the classical therapeutic. The banxia xiexin decoction is the classical effective formal treating dysfunction of stomach from chills accumulating with fever. Our research group had treated many insomnia patients with dysfunction of stomach from chills accumulating with fever effectively. So as to the randomed controlled clinical trial (RCT) was conducted, in order to provide the scientific data to guide the clincial diagnosis and treatment.Object iveThis clinical trial intends to discuss the clinical efficacy and safety of the herbal extract of banxia xiexin decoction treating insomnia patients with chills accumulating with fever by RCTMethodsChoosing72insomnia patients with chills accumulating with fever and assigning them to the treatment group took the herbal extract of banxia xiexin decoction, the controll group took the Tianmeng capsule at the rate of1:1. The treatment course lasts for1month. Observeing the sleep quality, the TCM syndrome curative effect, and the safety before and after treatment, to discuss the clinical efficacy and safety of the herbal extract of banxia xiexin decoction treating insomnia patients with chills accumulating with fever.Results(1)There were no significant difference base line condition between treatment and controll group, such as age, course of disease, gender composition, type and serious of insomnia(2) There were sixty patients treatment completed in the end of clinical trial (general expulsion rate is15.5%,11/71),31cases in the treatment group (expulsion rate is13.89%,5/36) and29cases in the controll group(expulsion rate is17.14%,6/35)(3) The total effect rate of treatment group was (88.90%,32/36) signif iciantly higher than the controll group (68.60%,24/35) on intent-to-treat (ITT) analysis(p<0.05).Per protocol total effect rates were90.30%(28/31) and72.40%(21/29) respectively (P>0.05).(4) The Chinese medicine syndrome scores decreased significiantly in the treatment and conctroll group after treatment. The D-value of Chinese medicine syndrome score (10.51±2.83) in the treatment group was more than (7.86±2.06) in the controll group on ITT analysis (P<0.05). The total effect rates were86.11%(31/36) and74.29%(26/35) respectively. The D-value of Chinese medicine syndrome score (9.67±2.39) in the treatment group was more than (7.06±2.28) in the controll group on per protocol (PP) analysis (P<0.05). Per protocol general effect rate was90.30%(28/31) in the treatment group versus75.90%(22/29) in the controll group (P>0.05)(5) General health were evaluated by Traditional Chinese medicine health scale in the two groups before and after treatment,the aspects of sleep and health evaluate in the treatment group were improved significiantly (P<0.05, VS the controll group) after treatment, the improvement of energy, pain, sleep and health evaluate in treatment group were more significant than the controll group (P<0.05).(6) There were two cases with diarrhea (adverse effect rate5.56%,2/36) int the controll group, one of which symptoms disappeared after treatment and the other withdrawaled. Three cases with excessive interal heat and poor appetite in the treatment group (adverse effect rate8.33%,3/36),one of which withdrawaled and other two cases symptoms disappeared after treatment. There were no significiant difference in the adverse effect rate between the two groups.ConclusionThe herbal extract of banxia xiexin decoction has good curative effect treating insomnia patients with chills accumulating with fever, improving the sleep quality and Chinese medicine syndrome. Meanwhile these clinical effect in the treatment group is better than controll group in the tendency, which is effective, safe and worthy of clinical recommendation. |
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