ABSTRACT
ObjectiveTo confirm the clinical efficacy and safety of Yishen Yangxin Anshen tablets in the treatment of insomnia （heart-blood deficiency and kidney-essence insufficiency syndrome）. MethodA randomized block， double-blind， placebo-controlled， multi-center clinical trial design method was adopted， and a total of 480 patients with insomnia due to deficiency of heart blood and insufficiency of kidney essence （treatment group-control group 3∶1） from seven hospitals （Guang'anmen Hospital， China Academy of Chinese Medical Sciences， The First Clinical Hospital， Jilin Province Academy of Traditional Chinese Medicine（TCM）， The Second Affiliated Hospital of Liaoning University of TCM， The First Affiliated Hospital of Henan University of Chinese Medicine， Henan Province Hospital of TCM， Hebei General Hospital， The First Hospital of Hunan University of Chinese Medicine） were enrolled. The treatment group was given Yishen Yangxin Anshen tablets and the control group received placebo tablets （4 tablets/time， 3 times/day， 4 weeks of administration， 4 weeks of follow-up after drug withdrawal）. The sleep dysfunction rating scale （SDRS） score， pittsburgh sleep quality index （PSQI） score， TCM， polysomnography （PSG） indicators from four hospital （Guang'anmen Hospital， China Academy of Chinese Medical Sciences， Henan Province Hospital of TCM， Hebei General Hospital， The First Hospital of Hunan University of Chinese Medicine）， and other efficacy indicators were compared between the two groups before and after treatment. Through general physical examination， laboratory examination， and observation of adverse events， the safety of the drugs was evaluated. ResultThe baseline indexes of the two groups showed no significant difference and thus the two groups were comparable. After treatment， the total score of SDRS in the treatment group was lower than that in the control group （P<0.01）. After drug withdrawal for 4 weeks， the total score of SDRS demonstrated no significant change in the treatment group as compared with that at the end of treatment， indicating that the rebound change of curative effect was not obvious. After treatment， the total score of PSQI in the treatment group decreased as compared with that in the control group （P<0.01）， and the change of total score of PSQI in the treatment group was statistically significant （P<0.05） after drug withdrawal for 4 weeks but small， indicating that the rebound change of curative effect was not obvious. After treatment， the total effective rate about the TCM symptoms in the treatment group was higher than that in the control group （χ2=137.521，P<0.01）. After treatment， the disappearance rates of single indexes in the treatment group， such as difficulty in falling asleep， easily waking up after sleeping， early awakening， short sleep time， dreamfulness， palpitation， forgetfulness， dizziness， mental fatigue， and weakness of waist and knee， increased compared with those in the control group （P<0.01）. After treatment， the treatment group demonstrated fewer awaking times （AT）， longer total sleep time （TST）， lower ATA/TST ratio， and higher sleep efficiency （%） than the control group （P<0.05）. No abnormal value or aggravation related to drugs was observed in either group. The incidence of adverse events in the treatment group and the control group was 5.57% and 8.40% respectively. No serious adverse events or adverse events leading to withdrawal happened in either group. ConclusionYishen Yangxin Anshen tablets is effective and safe for patients with insomnia of deficiency of heart-blood and insufficiency of kidney-essence.
ABSTRACT
Objective To evaluated the effectiveness and safety ofLianhua Jizhi Tablets for acute trachitis and bronchitis with syndrome of phlegm-heat obstructing.Methods A randomized double-blind, placebo-controlled and multi-center clinical trial design was selected. Totally 240 cases were randomly divided into experimental group and control group, 120 cases in each group, of which 237 cases were included in the analysis of FAS. Experimental group was givenLianhua Jizhi Tablets, while control group was given placebo, 12 tablets/day, 7 days for a course. Curative effect of acute trachitis and bronchitis, TCM syndrome and disappearance of cough, cough and sputum symptom scores and area under the curve (AUC) were observed. The safety was evaluated. Results The cure rates of disease in experimental group and control group were 66.67% (78/117) and 29.17% (35/120), respectively;cure rates of TCM syndrome in experimental group and the control group were 68.38% (80/117) and 27.50% (33/120), respectively;there was statistically significant difference in area under the curve of cough and sputum symptom score between the two groups (P<0.01). Disappearance rates (cure) of daytime cough in experimental group and control group were 52.99% (62/117) and 13.33% (16/120), respectively;disappearance rates (cure) of nocturnal cough in experimental group and control group were 76.52% (88/115) and 31.90% (37/116), respectively;there were no side effects in experimental group.ConclusionLianhua Jizhi Tablets can significantly relieve clinic symptoms in the treatment of acute trachitis and bronchitis, and have good clinical efficacy and safety.