Modified Xiaoyao powder for postpartum depression:A systematic review and meta-analysis

Objective:To evaluate the effectiveness and safety of modified Xiaoyao powder for postpartum depression(PPD)by conducting a systematic review of randomized controlled trials(RCTs).Methods:The Chinese National Knowledge Infrastructure Databases(CNKI),the Chinese Scientific Journals Database(VIP),Wanfang,Google Scholar,the SinoMed,Embase,Cochrane Library,and PubMed databases were searched from their inception to April 25,2023.The Cochrane Risk of Bias tool was used to assess the quality of the trials.We applied the risk ratio to present dichotomous data and the mean difference to present continuous data.Data with similar characteristics were pooled for meta-analysis and heterogeneity was assessed using I2.Results:This review included 35 trials involving 2848 participants.The quality of the included studies was low(unclear randomization processes and insufficient reporting of blinding).Participants treated with modified Xiaoyao powder plus Western medicine showed lower Hamilton Depression Scale(HAMD)depression score than those who used Western medicine alone(mean difference=-2.15;95%confidence interval:-2.52 to 1.78;P<.00001),and higher effective rate(relative risk=1.19;95%confidence interval:1.15 to 1.24;P<.00001),When comparing modified Xiaoyao alone with Western medicine,the HAMD depression score remained low,however,the efficacy rate was higher in the modified Xiaoyao group.Regarding adverse events,the modified Xiaoyao group reported weight gain,nausea,and diarrhea,but no severe adverse events were reported.Conclusion:Modified Xiaoyao may help relieve depression in PPD when used alone or in combination with Western medicine,with minor side effects.Therefore,future high-quality,large-sample size RCTs are warranted.

Bioactive constituents and action mechanism of Xiaoyao San for treatment of non-alcoholic fatty liver disease

Xiaoyao San(XYS)is a classic Chinese medicine prescription.It is traditionally used to relieve syndrome of“liver stagnation and spleen deficiency”,a common syndrome type in traditional Chinese medicine,through soothing liver,tonifying spleen,and nourishing blood.Correspondingly,XYS has long application in the treatment of depression,dyspepsia and liver diseases.Given the rising of cutting-edge researches on XYS,there’s a significant need to diligently uncover the bioactive constituents and action mechanisms of XYS for treating non-alcoholic fatty liver disease accordingly.

Suppression of hepatic steatosis in non-alcoholic steatohepatitis model by modified Xiaoyao San formula:Evidence,mechanisms and perspective

In this letter,we comment on a recent publication by Mei et al,in the World Journal of Hepatology,investigating the hepatoprotective effects of the modified Xiaoyao San(MXS)formula in a male rat model of non-alcoholic steatohepatitis(NASH).The authors found that MXS treatment mitigated hepatic steatosis and inflam-mation in the NASH model,as evidenced by the reduction in lipid droplets(LDs),fibrosis markers and lipogenic factors.Interestingly,these hepatoprotective effects were associated with androgen upregulation(based on metabolomics analysis of male steroid hormone metabolites),adenosine 5’-monophosphate-activated protein kinase(AMPK)activation,and restoration of phosphatase and tensin homolog(PTEN)expression.However,the authors did not clearly discuss the relationships between MXS-induced hepatic steatosis reduction in the NASH model,and androgen upregulation,AMPK activation,and restoration of PTEN expression.This editorial emphasizes the reported mechanisms and explains how they act or interact with each other to reduce hepatic steatosis and inflammation in the NASH model.As a perspective,we propose additional mechanisms(such as autophagy/lipophagy activation in hepatocytes)for the clearance of LDs and suppression of hepatic steatosis by MXS in the NASH model.A proper understanding of the mechanisms of MXS-induced reduction of hepatic steatosis might help in the treatment of NASH and related diseases.

Xiaoyao pill for treatment of functional dyspepsia in perimenopausal women with depression

AIM: To evaluate the efficacy and safety of the Xiaoyao pill for treatment of functional dyspepsia (FD) associated with perimenopausal depression.

The Efficacy and Safety of Modified Xiaoyao San for Perimenopausal Syndrome (PMS): A Systematic Review and Meta-Analysis

Objectives: To assess the efficacy and safety of modified Xiaoyao San (XYS) for treating Perimenopausal syndrome (PMS). Methods: Literature searches were carried out on PubMed, Cochrane Library, CNKI Database, Chinese Biomedical Literature Database, Wan Fang Database, and VIP Database up to December 2018. Hand search for further references was conducted. Study selection, data extraction, quality assessment, and data analyses were performed as request of the Cochrane standards. Results: Nine publications in total were suitable for inclusion. There was evidence that modified XYS was tested to be more effective in improving overall symptoms compared with HRT (odds ratio 3.50, 95% CI 2.56 to 4.78). Whereas HRT was more sensitive and direct in decreasing FSH (WMD 6.69, 95% CI 5.60 to 9.52) and LH (WMD 7.00, 95% CI, 5.75 to 8.25) in comparison with XYS group. It was also strongly supported that XYS had less adverse effect than HRT (odds ratio 0.07, 95% CI 0.05 to 0.10). Conclusion: Modified XYS might be more effective and safer in treatment of perimenopausal syndrome. However, due to poor methodological quality in the majority of included studies, the potential benefit and safety about XYS need to be confirmed in rigorously designed, multi-centre, and large-scale trials.

Novel insights into the effect of Xiaoyao san on corticosterone-induced hepatic steatosis:inhibition of glucocorticoid receptor/perilipin-2 signaling pathway

Objective:Xiaoyao san(XYS)is a classic traditional Chinese medicinal formula.It has been clinically administered to regulate liver function.However,its mechanisms in glucocorticoid-induced hepatic steatosis are unknown.This study aimed to investigate whether XYS protects against corticosterone(CORT)-induced hepatic steatosis,and to explore its mechanism.Methods:High-fat diet mice induced with hepatic steatosis by 2mg/kg CORT were administered 2.56 g/kg or 5.12 g/kg XYS daily for 7 weeks.The effects of XYS on hepatic steatosis in mice were evaluated by H&E and Oil Red O staining and by measuring their plasma lipids(triglyceride,total cholesterol,and free fatty acids).The mechanism of XYS against hepatic steatosis was investigated by network pharmacology,immunohistochemistry,western blotting,and gain-of-function/loss-offunction experiments.Results:XYS alleviated CORT-induced steatosis,decreased plasma lipids,and inhibited glucocorticoid receptor(GR)activation in the liver.Network pharmacology data indicated that XYS may have mitigated hepatic steatosis via GR which mediated adipose differentiation-related protein(ADFP).Gain-of-function/loss-of-function experiments in vitro confirmed that GR positively regulated ADFP expression.Conclusions:XYS ameliorated CORT-induced hepatic steatosis by downregulating the GR/ADFP axis and inhibiting lipid metabolism.Our studies implicate that XYS is promising as a therapy for CORT-induced hepatic steatosis,and lay the foundation for designing novel prophylactic and therapeutic strategies on CORT-induced hepatic steatosis.

Clinical Study on Effect of Xiaoyao Nose Drops (逍遥滴鼻液) in Stopping Episode of Migraine

Objective： To observe the effect of Xiaoyao Nose Drops （逍遥滴鼻液 , XYND） in stopping episode of migraine. Methods： Adopted was the randomized double-blinded placebo-controled method, with the 126 patients equally assigned to two groups, the treated group treated with XYND and the control group with placebo, and the therapeutic course was 30 days for all. The clinical total effective rate and effect in al- leviating headache were observed. And hemorrheological parameters as well as the blood flow of the anterior cerebral artery （ACA）, median cerebral artery （MCA） and posterior cerebral artery （PCA） were measured before and after treatment. Results： The clinical total effective rate and headache alleviating rate in the treated group were 93.33% and 96.67% respectively, while those in the control group were 18.33% and 20.00 % respectively, and comparison between the two groups showed significant difference （all P〈0.01）. The blood viscosity （high, middle and low shear）, plasma viscosity and fibrinogen got lowered significantly in the treated group after treatment, showing significant difference in comparison either with those before treatment or with those in the control group after treatment （P〈0.05 or P〈0.01）. The velocity of blood flow in all cerebral arteries lowered significantly, also showing significant difference in comparison either with those before treatment or with those in the control group after treatment （ P 〈 0.05 or P 〈 0.01 ）. Conclusion： XYND is effective in stopping the headache of patients with migraine, and worth applying in clinical practice.

Discussion on the mechanism of Xiaoyao Wan in the treatment of depression and anxiety based on network pharmacology

In order to clarify the targets of Xiaoyao Wan in the treatment of depression and anxiety,the pharmacological database of traditional Chinese medicine system and the analysis platform(TCMSP)were used to search the chemical components and potential targets of Xiaoyao Wan.The databases of Malacards and Genecards were used to mine the targets related to depression and anxiety.With the help of Cytoscape3.2.1 software,the“Xiaoyao Wan-targets-diseases”network is constructed.The PPI network is constructed through String database.Common targets are enriched by cluster Profiler software package in R language.161 active components of Xiaoyao Wan were screened,and 247 targets related to Xiaoyao Wan were predicted(excluding repetitive targets).The related targets of depression and anxiety were 379,337 respectively.Through the intersection of Venny diagram,24 targets of Xiaoyao Wan,depression and anxiety were obtained.24 key targets were screened out by constructing the interaction network of Xiaoyao Wan,depression and anxiety.Pathway enrichment analysis showed that Xiaoyao Wan mainly acts on key targets involves D(2)dopamine receptor(DRD2),Interleukin-6(IL6),5-hydroxytryptamine receptor 2A(HTR2A),Interleukin-1 beta(IL1B),5-hydroxytryptamine receptor 3A(HTR3A),Sodium-dependent dopamine transporter(SLC6A3),D(1A)dopamine receptor(DRD1),Interleukin-10(IL10),Sodium-dependent noradrenaline transporterin(SLC6A2)and other key targets in the treatment of depression and anxiety,and participates in important pathway processes such as Serotonergic synapse,Dopaminergic synapse,Neuroactive ligand-receptor interaction and regulation of neurotransmitter levels.It is speculated that Xiaoyao Wan plays a role in the treatment of depression and anxiety by affecting neurotransmitters 5-HT and DA,participating in hypothalamic-pituitary-adrenal(HPA)and interfering in the process of inflammation.

A case study of Professor Li Ji's treatment of chest obstruction based on Xiaoyao Powder

Chest arthralgia refers to a disease characterized by chest pain, even chest pain, shortness of breath and inability to lie down. The disease is recurrent in clinical, causing great harm to the life of patients. In this paper, Professor Li Ji based on Xiaoyao Powder in the treatment of chest arthralgia two cases were analyzed, showing Professor Li Ji clinical treatment of chest arthralgia ideas and methods, in order to fill a corner for clinical treatment of chest arthralgia.

Effects of Danzhi Xiaoyao pill combined with metformin on related factors in patients with polycystic ovary syndrome

Objective:To study the clinical efficacy and effects of danzhi xiaoyao pill combined with metformin on related factors in patients with polycystic ovary syndrome (PCOS).Methods:A total of 80 patients with PCOS in our hospital from January 2014 to December 2017 were enrolled in this study. The subjects were divided into the control group (n=40) and the experimental group (n=40) randomly. The control group were treated with metformin, the experimental group were treated with danzhi xiaoyao pill combined with metformin, and the two groups were treated for 3 menstrual cycles. The serum CRP, IGF-1, TNF-α, FSH, LH, E2, T, FINS, FPG, VF, LEP, APN and HOMA-IR of the two groups before and after treatment were compared.Results: There were no significantly differences of the serum CRP, IGF-1, TNF-α, FSH, LH, E2, T, FINS, FPG, VF, LEP, APN and HOMA-IR of the two groups before treatment. After treatment, the serum CRP, IGF-1, TNF-α, LH, E2, T, FINS, FPG, VF, LEP and HOMA-IR of the two groups were significantly lower than before treatment, the serum APN of the two groups were significantly higher than before treatment, and that of the experimental group after treatment were significantly better than the control group. Conclusion: Danzhi xiaoyao pill combined with metformin on patients with PCOS has a good efficacy. It can reduce the inflammatory cytokines and sex hormones, and improve the insulin resistance and sugar, lipid metabolic disorders. Therefore, it is worthy of clinical application.

Clinical evaluation of Xiaoyao Jieyu prescription in the treatment of persistent postural-perceptual dizziness

Objective： The objective of this study is to evaluate the clinical efficacy of Xiaoyao Jieyu prescription （XJP） in the treatment of persistent postural-perceptual dizziness （PPPD）. Methods： A total of 33 PPPD patients were randomly divided into test group and control group. Two groups of patients were given psychological treatment. The test group was given XJP and the control group was given escitalopram. The course of treatment was 12 weeks. Before and after 4 weeks and 8 weeks and 12 weeks, the dizziness handicap inventory （DHI）, Hamilton anxiety scale （HAMA） and Hamilton Depression scale （HAMD） were used to evaluate the treatment effect. Results： The total scores of HAMA, HAMD, DHI and the respective factor scores of DHI significantly decreased in both groups after 4 weeks of treatment compared with those before the treatment （P 〈 0.01）. The DHI scores and the score of function, physiology at 8-week, 12-week, as well as the HAMA and HAMD scores at 4-week, 8-week, 12-week in the test group were significantly lower than those in the control group （P 〈 0.05）. The incidence of adverse reactions in the test group was significantly lower than the control group （P 〈 0.05）. Conclusion： XJP can improve the clinical symptoms of patients with PPPD. It can both improve the physical and functional symptoms of PPPD and reduce anxiety and depression. In the course of treatment, the adverse reaction of the prescription is less and mild. It has the advantages of high efficiency, safety, low price and easy access to materials.

Effect of Xiaoyao San on the brain-gut axis in rats after chronic immobilization stress

Objective:To investigate the effect of Xiaoyao San on the brain-gut axis in rats exposed to chronic immobilization stress (ClS).Methods:Rats were divided into control,model,and treatment groups.The rats belonging to the model and treatment groups were subjected to CIS for 21 consecutive days,during which they were administered Xiaoyao San decoction [3.854 g/(kg· d)] or vehicle by gavage,and their body weight gain,food intake and water intake were monitored.The rats were subsequently subjected to the open field test (OFT) and D-XyloSe absorption test,and the expression levels of neuropeptides secreted by the hypothalamus and stomach were determined by enzyme-linked immunosorbent assay (ELISA),radioimmune analysis,or real-time fluorescence quantitative polymerase chain reaction.Gastric mucosal morphology was also assessed.Results:The model rats exhibited complex brain-gut axis abnormalities following exposure to CIS,abnormalities signified by decreases in food intake,reductions in digestive absorption,decreases in body weight,decreases in the total distances traveled and increases in the time in the central zone during the OFT,gastric mucosal lesion development and decreases in gastrointestinal hormone secretion.These changes were reversed after treatment with Xiaoyao San,which also regulated the secretion of both peripheral (serum and stomach) and central (hypothalamus) brain-gut peptides.Specifically,the levels of neuropeptide Y (NPY) and neuropeptide Y receptor Y5,which are secreted by the hypothalamus and promote digestive function,were increased in the Xiaoyao San-treated group compared with the model group.Furthermore,the levels of pro-opiomelanocortin (POMC) and its receptor,melanocortin-4 receptor (MC4R),which are secreted by the hypothalamus and inhibit digestive function,were significantly decreased in the treatment group compared with the model group.However,the levels of ghrelin (GHRL),gastrin (GAS) and motilin (MTL),which are secreted by the stomach,were significantly increased in the serum and stomach of the treatment group compared with the serum and stomach of the model group following Xiaoyao San treatment (P <.05 vs.the model group).Conclusion:Xiaoyao San attenuates CIS-induced gastrointestinal dysregulation by regulating the peptides secreted by both the hypothalamus and the gastrointestinal tract (GIT),suggesting that its effects are associated with the brain-gut axis.

Discussion on the mechanism of Xiaoyao Powder in the treatment of irritable bowel syndrome based on network pharmacology

Objective:To predict the key components and potential targets of Xiaoyao Powder in the treatment of irritable bowel syndrome(IBS)and explore its mechanism of action in the treatment of IBS.Methods:The active components and related targets of all compounds of Xiaoyao Powder were obtained by systematic Pharmacological Analysis platform of traditional Chinese Medicine(TCMSP).The related genes of IBS were collected by Genecards and TTD.The network model of"Xiaoyao powder-compound-target-IBS"was established by Cytoscape software.STRING and Metascape platforms were used to analyze drug-disease target protein interactions and conduct network construction and module analysis.Gene Ontology(GO)function enrichment and Kyoto Encyclopedia of genes and genomes(KEGG)pathway enrichment analysis were performed on the targets.Results:In the end,149 active ingredients,267 potential targets were obtained in Xiaoyao Powder and 1751 IBS-related targets were obtained from the platforms.One hundred and sixty-five related targets were involved in the treatment of IBS by Xiaoyao Powder,among which the key targets were MMP9,VEGFA,EGF,and IL-1B,TNF,IL-6.In the GO function enrichment analysis,1976 entries were obtained for biological processes,210 entries for molecular functions,and 122 entries for cellular components;KEGG pathway enrichment analysis was performed to obtain PI3K-Akt pathway,AGE-RAGE signaling pathway,Calcium signaling pathway.Conclusion:Xiaoyao Powder may treat IBS by strengthening intestinal barrier function,reducing visceral sensitivity,inhibiting oxidative stress and inflammation.

Research Progress of the Liver–Brain Cotreatment of Depression with Supplemented Danzhi Xiaoyao Powder

Traditional Chinese medicine(TCM)has unique advantages in preventing and treating depression based on holistic concepts and syndrome differentiation and treatment.Liver depression and spleen deficiency are the main syndrome of depression.Danzhi Xiaoyao powder has the efficacy of soothing the liver and relieving depression,nourishing blood,and strengthening spleen.Present studies have proven that it has antidepressant efficacy for the syndrome of liver depression and spleen deficiency.The basic research on pharmacodynamic substances has found that the main active ingredients of Danzhi Xiaoyao powder in the treatment of depression include bupleurum saponin,paeonol,gardenoside,angelica polysaccharide,sulfate polysaccharide,paeoniflorin,albiflorin,atractylone,etc.In clinical practice,Danzhi Xiaoyao powder is often modified to make it more suitable according to the characteristics of pathogenesis and changes in the disease condition.Our research group has found that“brain and spirit failure and liver failing to disperse”are the main pathogenesis of depression.Based on the theory of“liver–brain cotreatment,”the treatment principle of“dispersing the liver and relieving depression,strengthening brain and benefiting intelligence”was put forward.On the basis of Danzhi Xiaoyao powder,Shichangpu(Acori Tatarinowii Rhizoma)was added to enlighten the mind and Yuanzhi(Polygalae Radix)to calm the mind and benefit intelligence.The modified Danzhi Xiaoyao powder was formulated,and its clinical effects on depression were remarkable.Animal experiments also confirmed that modified Danzhi Xiaoyao powder can significantly improve the depression-like behavior of depression model rats and the mechanism may be related to the regulation of the hypothalamic–pituitary–adrenal axis,the increase of the content of 5-hydroxytryptamine,and norepinephrine,which provides a reference for the further promotion of the clinical application of modified Danzhi Xiaoyao powder in the treatment of depression.

Use of Danzhi Xiaoyao Powder in the Treatment of Diseases by Chief Physician Wang Defen: Case Examples

Danzhi Xiaoyao powder was first introduced by Xue Ji,a Ming Dynasty physician,in the“Summary of Internal Medicine.”It is primarily used for treating the syndrome of liver depression transforming into heat and is widely used in the treatment of dermatology,internal medicine,gynecology,and other multi-system diseases.This medical prescription is aptly dispensed,its detoxification effect is strong,and it is a representative medical prescription for soothing the liver,strengthening the spleen and stomach,as well as eliminating heat stagnation.Chief Physician Wang Defen inherited the academic experience of the fifth batch of nationally known Chinese medicine experts,under the guidance of Professor Ji Haiwang,a notable Chinese medicine practitioner in Shaanxi Province and Professor Shi Bingyin,a renowned endocrinologist.Through follow-up studies,the various methods and empirical prescriptions of Danzhi Xiaoyao powder applied by Chief Physician Wang Defen in the treatment of common clinical diseases are summarized.They have been proven to have conclusive efficacy,thus providing guidance and reference for the dialectical treatment using traditional Chinese medicine.

Effects of Xiaoyao San on exercise capacity and liver mitochondrial metabolomics in rat depression model

Objective: This study aimed to investigate the therapeutic effects of Xiaoyao San(XYS), a herbal medicine formula, on exercise capacity and liver mitochondrial metabolomics in a rat model of depression induced by chronic unpredictable mild stress(CUMS).Methods: A total of 24 male SD rats were randomly divided into four groups: control group(C), CUMS control group(M), Venlafaxine positive treatment group(V), and XYS treatment group(X). Depressive behaviour and exercise capacity of rats were assessed by body weight, sugar-water preference test, open field test, pole test, and rotarod test. The liver mitochondria metabolomics were analyzed by using liquid chromatography-mass spectrometry(LC-MS) method. TCMSP database and Gene Cards database were used to screen XYS for potential targets for depression, and GO and KEGG enrichment analyses were performed.Results: Compared with C group, rats in M group showed significantly lower body weight, sugar water preference rate, number of crossing and rearing in the open field test, climbing down time in the pole test,and retention time on the rotarod test(P < 0.01). The above behaviors and exercise capacity indices were significantly modulated in rats in V and X groups compared with M group(P < 0.05, 0.01). Compared with C group, a total of 18 different metabolites were changed in the liver mitochondria of rats in M group.Nine different metabolites and six metabolic pathways were regulated in the liver mitochondria of rats in X group compared with M group. The results of network pharmacology showed that 88 intersecting targets for depression and XYS were obtained, among which 15 key targets such as IL-1β, IL-6, and TNF were predicted to be the main differential targets for the treatment of depression. Additionally, a total of 1 553 GO signaling pathways and 181 KEGG signaling pathways were identified, and the main biological pathways were AGE-RAGE signaling pathway, HIF-1 signaling pathway, and calcium signaling pathway.Conclusion: XYS treatment could improve depressive symptoms, enhance exercise capacity, positively regulate the changes of mitochondrial metabolites and improve energy metabolism in the liver of depressed rats. These findings suggest that XYS exerts antidepressant effects through multi-target and multi-pathway.

Effectiveness and safety of Jiawei Xiaoyao pill(加味逍遥丸)in the treatment of premenstrual syndrome(liver depression,spleen deficiency,and blood-heat syndrome):a multi-center,randomized,placebo-controlled trial

OBJECTIVE:To investigate the effectiveness and safety of Jiawei Xiaoyao pill(加味逍遥丸,JXP)in the treatment of symptoms associated with premenstrual syndrome(PMS).METHODS:A total of 144 regularly menstruating women with PMS were recruited at 8 sites in China from August 2017 to December 2018,and randomized to receive either a JXP or a matching placebo(12 g/d,6 g twice a day)for 3 menstrual cycles.The primary indicator was the reduced Daily Record of Severity of Problems(DRSP)scores in the luteal phase after 3 months of treatment.The safety outcomes included clinical adverse events(AEs),adverse reactions(ARs),changes in vital signs,and laboratory tests.RESULTS:JXP surpassed the placebo in reducing DRSP scores(psychological/somatic dysfunction)in the luteal phase over 3 menstrual cycles of treatment(PFAS=0.002,PPPS=0.001).Additionally,there were no significant differences in the incidence of AEs,severe AEs,withdrawal due to AEs and ARs between the two groups(all P>0.05),and no clinically significant adverse medical events related to the test drug observed.CONCLUSIONS:JXP was superior to the placebo in relieving the symptoms associated with PMS,which signified that JXP may be effective,safe,and welltolerated as an alternative therapy.

Jiawei Xiaoyao San in treatment of anxiety disorder and anxiety:A review

Jiawei Xiaoyao San(JWXYS)has shown excellent clinical efficacy in anxiety disorder,but has not yet attracted widespread attention.The animal experiments,clinical trials and mechanism studies of JWXYS were reviewed in this article,which may provide a reference for developing new anxiolytic drugs based on this prescription.The literature was searched in PubMed and CNKI and the documents written in English or with English abstracts were selected.JWXYS could reduce the anxiety symptoms of patients alone and reduce the adverse reactions when it is used in combination with other drugs in the clinic.In preclinical studies,JWXYS also showed therapeutic effects in reducing anxiety-like behavior.The mechanisms may include improving the hypothalamic–pituitaryadrenal(HPA)axis and hormone disorders,increasing neurotransmitter content,neurogenesis,and regulating the synthesis of related enzymes.This article shows that JWXYS could effectively treat anxiety disorders by regulating the central nervous system.In the future,with the participation of more researchers,it is expected to develop innovative drugs for the treatment of anxiety disorders based on JWXYS.

Effectiveness of Xiaoyao capsule(逍遥丸)on sleep disorders and mood disturbance in patients in recovery from coronavirus disease 2019:a randomized controlled trial

OBJECTIVE:To study the efficacy of Xiaoyao capsule(逍遥丸)in improving the clinical symptoms of sleep and mood disorders during recovery from coronavirus disease 2019(COVID-19).METHODS:The study cohort comprised 200 patients with sleep and mood disorders during recovery from COVID-19.Patients were randomized into the control group and the experimental group in a 1:1 ratio by blocked randomization.The patients received either Xiaoyao capsule(experimental group)or a placebo Xiaoyao capsule(control group)for 2 weeks.The improvements in the Traditional Chinese Medicine(TCM)syndrome scales,total effective rates,and disappearance rates of irritability,anxiety,and poor sleep were compared between the two groups.RESULTS:The TCM syndrome pattern scales,total effective rates,and disappearance rates of irritability,anxiety,and poor sleep did not significantly differ between the experimental group versus the control group in the full analysis set and the per protocol set after 1 and 2 weeks of treatment(P>0.05).CONCLUSIONS:Xiaoyao capsule do not significantly improve the clinical symptoms of sleep and mood disorders in patients in recovery from COVID-19.