Clinical efficacy and safety of Guipi decoction combined with escitalopram oxalate tablets in patients with depression

BACKGROUND Depression is a widespread mental health condition that requires effective treatment.In the treatment of depression,traditional Chinese medicine(TCM)offers obvious advantages,fewer adverse reactions,and a lower recurrence rate.AIM To evaluate the clinical benefits of Guipi decoction combined with escitalopram oxalate tablets for individuals with depression.METHODS In total,80 patients diagnosed as having depression were enrolled in the study and divided into either an experimental group or a control group.All of the patients were orally administered escitalopram oxalate tablets.Additionally,the experimental group received Jiajian Guipi decoction and reduced Governor vessel fumigation over 4 wk.TCM syndrome scores,Hamilton depression rating scale(HAM-D)scores,self-rating depression scale(SDS)scores,and Pittsburgh sleep quality index scores were measured for the two groups and compared before and after the treatment.The two groups were monitored for any adverse reactions.RESULTS After 4 wk of treatment,both groups exhibited a significant reduction in TCM syndrome scores compared with their pre-treatment scores(P<0.05).However,the experimental group exhibited significantly lower TCM syndrome scores than the control group(P<0.05).Similarly,the post-treatment SDS and HAM-D-24 scores were significantly lower in both groups than the pre-treatment scores(P<0.05),with the experimental group exhibiting lower scores than the control group(P<0.05).The total treatment efficiency was significantly better in the experimental group(97.14%)than in the control group(77.78%)(P<0.05).Furthermore,after 4 wk of treatment,the Pittsburgh sleep quality index scores for both groups were significantly lower than those before the treatment(P<0.05),with the experimental group exhibiting lower scores than the control group(P<0.05).The incidence of adverse reactions was significantly lower in the experimental group than in the control group(P<0.05).CONCLUSION The combination of Guipi decoction and escitalopram oxalate tablets was found to be an effective and safe treatment for depression.This combination could reduce TCM syndrome scores,improve depressive symptoms,and enhance sleep quality.

Guipi decoction effects on arginine vasopressin protein and gene expression in the hippocampus, ventromedial hypothalamic nucleus, and prefrontal lobe in rats with spleen deficiency

BACKGROUND： Arginine vasopressin has been shown to enhance learning in experimental animal models. OBJECTIVE： To determine whether Guipi decoction enhances memory and learning by increasing arginine vasopressin levels, and to verify the influence of Guipi decoction on arginine vasopressin protein and gene expression in the hippocampal CA1 region, prefrontal lobe cortex, and ventral nucleus of hypothalamus in rats with spleen deficiency. DESIGN, TIME AND SETTING： The randomized, neuropharmacological, control study was performed in the College of Basic Medical Sciences, Beijing University of Chinese Medicine between March 2002 and March 2005. MATERIALS： Sixty, healthy, male, Wistar rats were used to establish spleen deficiency models according to the traditional Chinese medicine principle of bitter drugs for purgation, improper diet, and overstrain. Arginine vasopressin-1 polyclonal anti-rabbit antibody immunohistochemistry kit and arginine vasopressin in situ hybridization kit were provided by Department of Neuroanatomy in Shanghai Second Military Medical University of Chinese PLA. METHODS： Sixty rats were divided into five groups at random： normal control （n = 11）, model （n = 13）, Guipi decoction （n = 12）, recipe control A （n = 12）, and recipe control B groups （n = 12）. Rats in the latter four groups received 7.5 g/kg of the drugs by intragastric administration each morning, which comprised Dahuang, Houpu, and Zhishi, prepared at a ratio of 2： 1 ： 1. The rats were fasted every other day, but were allowed free access to water at all times. The rats were forced to swim in 25℃ water until fatigued. Rats in the Guipi decoction and two recipe control groups were intragastrically administered 7.5 g/kg Guipi decoction, Chaihu Shugan powder, and Tianwang Buxin pellets, respectively, each afternoon. Rats in the normal group were intragastrically administered the same amount of normal saline. All rats were treated for 6 weeks. MAIN OUTCOME MEASURES： At 6 weeks after drug administration, rat brain tissues were harvested. Arginine vasopressin-positive protein products and arginine vasopressin mRNA-positive products in the ventral nucleus of hypothalamus, hippocampal CA1 region, and cortex of prefrontal lobe were determined using immunohistochemistry and in situ hybridization, respectively. Image collection and management were performed by means of an Olympus microscope and color image analyzer system. Average absorbencies were measured. RESULTS： Qualitative analysis： in the normal control group, the arginine vasopressin protein- and mRNA-positive cells were round and oval. The immunoreactive products were strongly positive, with a uniform coloration. In the model group, the arginine vasopressin protein- and mRNA-positive ceils exhibited a shortening or disappearance of neuronal processes, as well as cytoplasm that exhibited chromatic non-uniformity. After rats were administrated Guipi decoction, the arginine vasopressin protein- and mRNA-positive cells exhibited rough and long neuronal, and the intensity of cytoplasmic coloration was also enhanced. Quantitative analysis： in the model group, arginine vasopressin protein and mRNA expression was significantly less in the hippocampal CA1 region, cortex of prefrontal lobe, and ventral nucleus of hypothalamus, compared with the normal group. Compared with the model group, the above-mentioned indices were remarkably increased in the Guipi decoction group （P 〈 0.01）, and were more similar to normal levels. Rats treated with Chaihu Shugan powder or Tianwang Buxin pellets displayed increased arginine vasopressin protein and mRNA expression, but the therapeutic effect was inferior to Guipi decoction. CONCLUSION： Qualitative and quantitative analyses demonstrated that the Guipi decoction enhanced arginine vasopressin protein and gene expression in the hippocampal CA1 region, prefrontal lobe cortex, and ventral nucleus of hypothalamus in rats with spleen deficiency.

Guipi decoction effects on brain somatostatin levels and receptor mRNA expression in rats with spleen deficiency

BACKGROUND： Somatostatin is abundant in the hypothalamus, cerebral cortex, limbic system, and mesencephalon. Somatostatin mRNA expression in the brain of rats with spleen deficiency is noticeably reduced, as well as attenuation of cognitive function. OBJECTIVE： To observe the interventional effect of Guipi decoction on somatostatin level and somatostatin receptor 1 （SSTRl） mRNA expression in different encephalic regions of rats with spleen deficiency, and to compare the interventional effects of Guipi decoction, Chaihu Shugan powder, and Tianwang Buxin pellet. DESIGN： A randomized controlled observation. SETTING： Basic Medical College, Beijing University of Traditional Chinese Medicine. MATERIALS： Fifty adult Wistar male rats, of clean grade, weighing （160 ± 10） g, were provided by Beijing Weitong Lihua Laboratory Animal Technology Co., Ltd. The protocol was performed in accordance with ethical guidelines for the use and care of animals. Somatostatin 1 polyclonal anti-rabbit antibody and SSTRl in situ hybridization kit were provided by Department of Neuroanatomy, Shanghai Second Military Medical University of Chinese PLA. The drug for developing rat models of spleen deficiency was composed of Dahuang, Houpu and Zhishi, and prepared at 2：1：1. Guipi decoction, Chaihu Shugan powder, and Tianwang Buxin pellet recipes were made according to previous studies. METHODS： This study was performed at the Basic Medical College, Beijing University of Traditional Chinese Medicine from March 2002 to March 2005. The rats were randomly divided into 5 groups, with 10 rats in each group： normal, model, Guipi decoction, Chaihu Shugan powd.er, and Tianwang Buxin pellet groups. Rat models of the latter 4 groups were developed by methods of purgation with bitter and cold nature drugs, improper diet, and overstrain. The rats received 7.5 g/kg of the drugs each morning and were fasted every other day, but were allowed free access to water at all times. The rats were forced to swim in 25 ℃ water until fatigued. Rats in the normal group were intragastrically administered the same amount of normal saline. Rats in the Guipi decoction, Chaihu Shugan powder, and Tianwang Buxin pellet groups were intragastrically administered 7.5 g/kg Guipi decoction, Chaihu Shugan powder, and Tianwang Buxin pellet, respectively, every afternoon. All rats were treated for 6 weeks. MAIN OUTCOME MEASURES： Somatostatin protein and SSTRI mRNA expression in the ventral nucleus of hypothalamus, hippocampal CAl region, and cortex of prefrontal lobe were determined by immunohistochemistry and in situ hybridization, respectively. RESULTS： Fifty rats were included in the final analysis. In the model group, expression of somatostatin protein and SSTRl mRNA in the ventral nucleus of hypothalamus, hippocampal CAl region, and cortex of prefrontal lobe were significantly less than in the normal group （P 〈 0.01）. Above-mentioned indices were identical in the Chaihu Shugan powder and model groups. However, expression of somatostatin protein and SSTRl mRNA were significantly higher in the Guipi decoction group compared to model group （P 〈 0.01）. In the Tianwang Buxin pellet group, SSTRl mRNA expression in rat ventral nucleus of hypothalamus and somatostatin level in rat hippocampal CAl region and cortex of prefrontal lobe, as well as ventral nucleus of hypothalamus, were significantly higher compared to model group （P 〈 0.01 ）. CONCLUSION： Somatostatin level and SSTRl mRNA expression in rats with spleen deficiency were lower than in normal rats. Guipi decoction and Tianwang Buxin pellet up-regulated somatostatin level and SSTRl mRNA expression.

Efficacy and safety of Guipi Decoction combined with conventional Western medicine in the treatment of insomnia with deficiency of heart and spleen:a meta-analysis

Objective:To systematically evaluate the efficacy and safety of Guipi Decoction combined with Western medicine in the treatment of insomnia with deficiency of heart and spleen.Methods:English databases(PubMed,Web of Science,The Cochrane Library,EMBASE)and Chinese databases(CNKI,Wanfang database,China Biomedical Literature Service System,VIP database)were searched by computer.Randomized controlled trials of Guipi Decoction on insomnia with deficiency of heart and spleen were searched from the database construction to November 2021.After the first and second authors independently screened the literature,extracted the data and evaluated the risk of bias in the included studies,meta-analysis was performed using RevMan5.3 software.Results:A total of 9 RCTS were included after screening,including 914 patients.Meta-analysis results showed that:Total effective rate[RR=1.22,95%CI(1.16,1.30),P<0.00001],total PSQI score[MD=-3.05,95%CI(-3.96,-2.14),P=0.008],number of night awakening times[[MD=-1.18,95%CI(-1.42,-0.94),P<0.00001],adverse reaction rate[RR=0.32,95%CI(0.21,0.51),P<0.00001]were better than the control group,and the differences were statistically significant.Conclusion:The current evidence shows that,compared with pure using conventional western medicine,belongs to the spleen decoction combined western medicine therapy,cases both deficiency type of insomnia in the total effective rate,reducing the total PSQI score(improve sleep quality,sleep efficiency,sleep disorder,daytime function,etc.),reducing frequency of nighttime awakening,security,have more advantages.However,due to the limitation of the quality and quantity of articles included in the study,more randomized,double-blind,large-sample clinical studies are needed to confirm the above conclusions.

Clinical observation of Guipi Decoction Combined with non steroidal drugs on sleep in elderly patients with acute traumatic pain and Qi deficiency constitutionabortion

Objective:To explore the effect of Guipi Decoction Combined with non steroidal anti-inflammatory drugs on sleep time of elderly patients with traumatic pain and Qi deficiency constitution during hospitalization.Methods:A total of 52 elderly patients hospitalized in the orthopedic(trauma)ward of the Second Affiliated Hospital of Zhejiang Chinese Medical University from November 2020 to may 2021 were randomly divided into control group and treatment group.Patients in the control group were treated with loxoprofen sodium tablets immediately after admission,and placebo was added to loxoprofen sodium tablets from the second day of admission;The patients in the treatment group were treated with loxoprofen sodium tablets after admission.Guipi Decoction was added on the basis of loxoprofen sodium tablets from the second day of admission.Before and after admission,all patients used the TCM constitution classification judgment table to evaluate the score of qi deficiency and VAS;From the first day to the fourth day after admission,the bracelet was worn to monitor the sleep time(total sleep time,deep sleep time,light sleep time and awakening times)every night.The patients were scored by VAS after taking drugs every morning.Results:Finally 25 patients in the control group and 24 patients in the treatment group completed the experiment.There was no significant difference in gender,age,fracture location,chronic medical history VAS score and TCM Qi deficiency constitution score,between two groups at admission(P>0.05).At the time of discharge,the score of qi deficiency constitution in the treatment group was 33.724±12.634;The TCM Qi deficiency constitution score of the control group was 42.25±15.912,and there was significant difference between the two groups(P<0.05);and there was significant difference in VAS score between the two groups at discharge(P<0.05).There were significant differences in total sleep time,light sleep time,deep sleep time and night awakening times between the two groups on the second,third and fourth day of admission(P<0.05).Conclusion:1.Guipi Decoction can significantly improve the sleep time of patients with Qi deficiency acute traumatic pain.2.Guipi Decoction can not only improve the constitution of patients with Qi deficiency bias,but also improve the VAS score at discharge.

Is the Chinese Medicinal Formula Guipi Decoction(归脾汤) Effectiveas AnAdjunctive Treatment for Depression？AMeta-Analysis of Randomized Controlled Trials

Objectives： To evaluate the effectiveness and safety of Guipi Decoction（归脾汤, GPD） as an adjunctive in the treatment of depression. Methods： A review of all relevant studies retrieved from a search of the following databases were conducted without any language restriction： Excerpt Medica Database（EMBASE）, Pub Med, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure（CNKI）, VIP Information, Wanfang Data, and the Chinese Biomedical Literature Database. Papers published until February 2013 were taken into consideration. The analysis was performed using the Cochrane software Revman 5.1. Results： Nine randomized controlled trials involving 620 patients with depression were included in this review. The meta-analysis revealed that compared with antidepressant therapy alone, treatment with a combination of GPD and an antidepressant drug significantly improved the symptoms of depression [weighted mean difference（WMD）： –3.09; 95% confidence interval（CI）： –4.11 to –2.07] and increased the rates of effectiveness（OR： 4.75; 95% CI： 2.66–8.51） as well as recovery（OR： 1.73; 95% CI： 1.17–2.56）. The adverse effects of GPD were not found to be significant in these studies. Conclusions： The findings of this meta-analysis were in keeping with the notion that GPD formulations were effective in the treatment of depression without causing any severe adverse effects. However, currently available evidence was of low quality and therefore inadequate to justify a strong recommendation of using GPD formulations in the management of depression.

Alterations of Gefitinib Pharmacokinetics by Co-administration of Herbal Medications in Rats

Objective： To evaluate the potential pharmacokinetic interactions of the anticancer agent gefitinib （Iressae） and the oriental medications Guipi Decoction （归脾汤, GPD, Guibi-tang in Korean） and Bawu Decoction （八物汤, BWD, Palmul-tang in Korean）. Methods： Methylceliulose （MC, control）, GPD （1,200 mg/kg）, or BWD （6,000 mg/kg） was orally administered to rats either as a single dose or multiple doses prior to gefitinib administration. To examine the effects of a single dose of the herbal medicines, gefitinib （10 mg/kg） was orally administered after 5 min or 1 h of MC or the herbal medicine pretreatments. To examine the effects of the multiple doses of the herbal medicines, gefltinib （10 mg/kg） was orally administered following 7 consecutive days of the administration of MC or each herbal medicine. The plasma concentrations of gefitinib were determined with liquid chromatography-tandem mass spectrometry assay. The plasma concentration-time profiles of gefitinib were analyzed with a noncompartmental analysis. Results： Gefitinib was rapidly absorbed and showed a mono- exponential decline with an elimination half-life of 3.7-4.1 h. The pharmacokinetics of gefitinib was not affected by GPD pretreatment. However, a significantly lower maximum plasma concentration （Crux, P〈0.05） and area under the curve （P〈0.05）, and a delayed time to reach Cmax （Tmax, P〈0.01） were observed in both single- and multiple- dose BWD-pretreated rats compared with the control rats. Conclusions： BWD and not GPD might delay and interfere with gefitinib absorption. Further evaluations of the clinical significance of these findings are needed.