Treatment Emergent Symptom Scale Research Articles

Acupuncture at five Zang-shu and Ge-shu for bipolar depression: study protocol for a randomized controlled pilot trial

Background: Bipolar disorder is a very common, often misdiagnosed mental disorder strongly associated with comorbidity, disability, and premature mortality. Bipolar depression (i.e., depressive episode in bipolar disorder) is poorly responsive to available treatments. Acupuncture at five Zang-shu and Ge-shu, a prescription from Dr. Leting Wang, is a popular therapy for depression in China. Its effectiveness and safety for bipolar depression is yet to be verified by clinical study. Methods/design: The study is a single-center, prospective, randomized controlled trial involving 72 patients diagnosed with bipolar depression. Participants will be randomized either to the study group or the control group in a 1:1 ratio. All participants will receive mood stabilizer therapy. In addition, the study group will receive acupuncture therapy at five Zang-shu and Ge-shu, three times per week. The control group will orally take the antidepressant bupropion. Observation and intervention will last for 8 consecutive weeks. Outcome measurements include Hamilton Depression Rating Scale-17 (HAMD-17), Hamilton Anxiety Rating Scale (HAMA), Clinical Global Impression Scale (CGI), Young Manic Rating Scale (YMRS), Treatment Emergent Symptom Scale (TESS), serum levels of anti-inflammatory cytokines (IL-4, IL-10, TGF-β), pro-inflammatory cytokines (IL-1β, IL-6, TNF-α), brain-derived neurotrophic factor (BDNF) and C-Reactive Protein (CRP). Assessments will be conducted at baseline, 1st, 2nd, 4th and 8th week after randomization. Safety assessments will be performed throughout the study. Discussion: The results of this study are expected to verify the effectiveness and safety of acupuncture at five Zang-shu and Ge-shu for bipolar depression, and explore its therapeutic mechanisms from the point of anti- inflammation.

Effect of "Tiaoshen" acupuncture technique on mild depression and its underlying mechanism: A randomized controlled trial study protocol

BackgroundMild depression is not just a mental disease, but also a serious and long-term public health issue. It affects the quality of life of patients and can quickly develop into major depression. There are currently no effective drug treatments with high efficacy and few adverse reactions. Acupuncture may be an alternative treatment option. Preliminary experiments and practices have demonstrated that "Tiaoshen" acupuncture improves symptoms in patients who have depression, however the underlying data and method remain unclear at present. MethodsThis is a prospective, single-center, single-blind, randomized controlled trial. We plan to recruit 70 participants and randomly assign them to receive "Tiaoshen" acupuncture or traditional acupuncture at a ratio of 1:1. Then, all the participants will receive the appropriate acupuncture treatment for four weeks. The results of the Hamilton Depression Rating Scale (HDSR-24) will serve as the primary outcome, while the results of the Patient Health Questionnaire-9 (PHQ-9) and the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) will serve as secondary outcomes. Evaluations will be conducted at baseline, 1, 2, and 4 weeks after treatment initiation, and 1 and 3 months after treatment completion. The safety of the intervention will be evaluated every week using the Columbia-Suicide Severity Rating Scale (C-SSRS) and the Treatment Emergent Symptoms Scale (TESS). Serum levels of oxidative stress markers 8-iso-prostaglandin F2α (8-iso-PGF2α), superoxide dismutase (SOD), uric acid (UA), and total bilirubin (TBIL) will be measured at baseline and the end of the treatment. We will conduct a statistical analysis of intention to treat (ITT) and conformance to protocol set (PPS) data. DiscussionThis research aims to provide high-quality evidence for the efficacy and safety of "Tiaoshen" acupuncture as a treatment for mild depression. In addition, the mechanism through which acupuncture heals mild depression will be investigated.

Effect and safety of electroacupuncture on weight loss in obese patients with pre-diabetes: study protocol of a randomised controlled trial

IntroductionObesity has been identified as a significant risk factor for several chronic conditions, including diabetes, tumours and cardiovascular disease, and has been associated with increased mortality rates. Despite the well-established...

Doxepin is more effective than zolpidem in improving executive function in patients with insomnia disorder.

Patients with primary insomnia were randomly assigned to receive doxepin 6mg/dayorally or zolpidem 5-10mg/day orally. Polysomnography (PSG) and the Pittsburgh Sleep Quality Index (PSQI) were used at baseline and after the 8-week treatment to compare clinical efficacy in the two groups. Safety was assessed using the Treatment Emergent Symptom Scale (TESS). Executive function was evaluated using the Wisconsin sorting card test (WSCT). Of 120 patients enrolled in the study, 60 participants were assignedto each group. A total of 109 participants (53 in the doxepin group and 56 in the zolpidem group) completed the study. After treatment, the wake after sleep onset (WASO) and total sleep time (TST) values in the doxepin group were 80.3 ± 21.4min and 378.9 ± 21.9min, respectively, which were significantly better than those in the zolpidem group (132.9 ± 26.5min and 333.2 ± 24.2min, respectively; (P < 0.05)). The sleep onset latency (SOL) value in the zolpidem group (20.3 ± 4.7min) was significantly better than that in the doxepin group (28.2 ± 5.6min; P < 0.05). The sleep efficiency (SE) in the doxepin group was 77.8 ± 4.2%, which was significantly better than that in the zolpidem group (68.6 ± 5.0%; P < 0.05). The PSQI score of the doxepin group was 6.1 ± 1.1, which was significantly lower than that in the zolpidem group (7.9 ± 1.9; P < 0.05). The treatment adverse eventsin the doxepin group was 23.3%, which was significantly higher than that in the zolpidem group (13.3%; P < 0.05). The WSCT showed a significant improvement in persistent errors (PE), random errors (RE), and categories in the two groups after 8-week treatment, and the improvement in RE and the categories was more obvious in the doxepin group (P < 0.05). Both doxepin and zolpidem were found to be effective in improving sleep quality, but the effects exhibited different patterns. Doxepin improved executive function more effectively than zolpidem in patients with insomnia disorder.

The association of SOD and HsCRP with the efficacy of sulforaphane in schizophrenia patients with residual negative symptoms.

Emerging evidence indicates a connection between oxidative stress, immune-inflammatory processes, and the negative symptoms of schizophrenia. In addition to possessing potent antioxidant and anti-inflammatory properties, sulforaphane (SFN) has shown promise in enhancing cognitive function among individuals with schizophrenia. This study aims to investigate the efficacy of combined treatment with SFN in patients with schizophrenia who experience negative symptoms and its effect on the levels of superoxide dismutase (SOD) and the inflammatory marker, high-sensitivity C-reactive protein (HsCRP). Forty-five patients with schizophrenia were recruited, who mainly experienced negative symptoms during a stable period. In addition to the original treatments, the patients received SFN tablets at a daily dose of 90mg for 24weeks. At baseline, 12weeks, and 24weeks, the participants were interviewed and evaluated. The reduction rate of the Positive and Negative Syndrome Scale (PANSS) was used to assess each participant. The side effects scale of Treatment Emergent Symptom Scale (TESS) was applied to assess the adverse reactions. Additionally, the levels of the SOD, HsCRP, and other indicators were examined. The study findings revealed a significant decrease in PANSS negative subscale scores (P < 0.001). Furthermore, there was a significant increase in SOD activity and HsCRP levels (P < 0.001 and P < 0.05). Notably, the group of participants who exhibited a reduction in PANSS negative subscale scores demonstrated a significant improvement in HsCRP levels (P < 0.05). Our study suggests that SFN may potentially serve as a safe adjunctive intervention to improve the negative symptoms of schizophrenia. The potential mechanism by which SFN improves negative symptoms in schizophrenia patients may involve its anti-inflammatory properties, specifically its ability to reduce HsCRP levels. Trial registration ClinicalTrial.gov (ID: NCT03451734).

Effect of Tai Chi on knee pain and muscle strength in middle-aged and older adults with knee osteoarthritis: a randomized controlled trial protocol

BackgroundKnee osteoarthritis (KOA) is a common public health problem and a leading cause of long-term pain, decreased muscle strength, and even disability. Tai Chi has been proved effective and highly recommended for KOA management worldwide. However, little is known about its benefits on quadriceps strength which is closely associated with relieving knee pain. This trial is designed to evaluate the efficacy and safety of Tai Chi on knee pain and muscle strength in middle-aged and older adults with KOA.MethodsA total of 100 participants will be randomly divided into a Tai Chi group (TC group) (1x/week for 12 weeks) and a control group with a health education and stretching program (1x/week for 12 weeks) with a follow-up period of 6 weeks. The primary outcome is the change of Western Ontario and McMaster Universities (WOMAC) pain subscale at week 12 compared with baseline. Secondary outcomes include WOMAC stiffness and function subscales, data from isokinetic dynamometry, gait analysis with electromyography (EMG), and a 36-item short form health survey (SF-36). The daily dose of pain-relieving medication will also be recorded. All adverse effects will be assessed by the Treatment Emergent Symptom Scale (TESS).DiscussionWe expect this randomized trial to evaluate the effectiveness of Tai Chi on relieving pain and increasing quadriceps strength in KOA patients. This protocol, if proven effective, will contribute to providing a promising alternative intervention for middle-aged and older adults with KOA.Trials registration numberThis trial has been registered in the China Clinical Trials Registry (registration number: ChiCTR2300069339).

Effect of transdermal drug delivery therapy on anxiety symptoms in schizophrenic patients.

To evaluate the efficacy and safety of transdermal drug delivery therapy for schizophrenia with anxiety symptoms. A total of 80 schizophrenic patients (34 males and 56 females) with comorbid anxiety disorders were randomly assigned to the treatment group (n = 40) and the control group (n = 40) with 6 weeks of follow-up. The patients in the treatment group received the standard antipsychotic drug treatment along with transdermal drug delivery therapy. The evaluation of the patients included the Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD-17), and treatment emergent symptom scale (TESS) at baseline, 3 weeks, and 6 weeks after transdermal drug delivery therapy. The Positive and Negative Symptom Scale (PANSS) was assessed at baseline and after 6 weeks of treatment. After 3 and 6 weeks of treatment, the HAMA scale scores in the treatment group were lower than those in the control group (p < 0.001). However, there were no significant differences in the HAMD-17 scale scores, PANSS total scores, and subscale scores between the two groups (p > 0.05). Additionally, no significant differences in adverse effects were observed between the two groups during the intervention period (p > 0.05). After 6 weeks of penetration therapy, there was a low negative correlation between total disease duration and the change in HAMA scale score (pretreatment-posttreatment) in the treatment group. Combined traditional Chinese medicine directed penetration therapy can improve the anxiety symptoms of patients with schizophrenia and has a safe profile.

Peony-Glycyrrhiza Decoction for Antipsychotic-Related Hyperprolactinemia in Patients with Schizophrenia: A Randomized Controlled Trial

Most antipsychotic drugs are dopamine receptor antagonists that usually lead to abnormal increases in prolactin concentrations and the development of hyperprolactinemia (HPRL), which in turn causes sexual dysfunction in patients. Peony-Glycyrrhiza Decoction (PGD) enhanced dopamine D2 receptors (DRD2) and dopamine transporter (DAT) and significantly reversed the expression of DRD2 and DAT. Therefore, we hypothesized that PGD might effectively improve hyperprolactinemia and alleviate sexual dysfunction in patients. We performed an 8-week randomized controlled study on 62 subjects with schizophrenia who were randomized into two groups. The experimental group was treated with the PGD intervention, and the control group did not receive treatment. The primary outcome indicators were the levels of sex hormones and the total Arizona Sexual Experience Scale (ASEX) score. There was a significant difference in PRL levels between the two groups at weeks 4 and 8. From the beginning to the end of the experiment, there was a significant increase in PRL levels in the control group, while there was no significant change in the experimental group. The ASEX scale assessed sexual function in both groups, and patients in the experimental group showed an improvement in sexual function at week 8. During the experiment, the two groups found no differences between Positive and Negative Syndrome Scale (PANSS) scores and Treatment Emergent Symptom Scale (TESS) scores. PGD significantly improved the patient's sexual function but was less effective in reducing prolactin levels and may prevent further increases in prolactin levels.

Efficacy of acupuncture for generalized anxiety disorder: A PRISMA-compliant systematic review and meta-analysis.

Generalized anxiety disorder (GAD) tightly traps modern people. Its incidence shows an increased peak during the 2019 novel coronavirus (COVID-19) epidemic. Acupuncture is regarded as an effective way to relieve anxiety symptoms. However, there are still controversies. This study aimed to systematically evaluate the clinical efficacy of acupuncture in patients with GAD. Four English and 3 Chinese databases were searched from their inception to January 2022. Only randomized controlled trials (RCTs) in which acupuncture was the main intervention were included. The literature was independently screened and extracted by two investigators. The Cochrane Bias Risk Assessment Tool was used for quality evaluation. Analyses were conducted by RevMan 5.3.0 and STATA 15.0 software. The primary outcome was the Hamilton Anxiety Scale (HAMA). The secondary indicators were the total effective rate, the Self-Rating Anxiety Scale (SAS), and the Treatment Emergent Symptom Scale (TESS). Twenty-seven studies were included with a total of 1782 participants. The risk of performance bias or reporting bias for most of the included trials was unclear. Combined results showed the acupuncture group had better outcomes in the HAMA score [MD = -0.78, 95%CI (-1.09, -0.46)], the total effective rate [RR = 1.14, 95%CI (1.09, 1.19)], the SAS score [MD = -2.55, 95%CI (-3.31, -1.80)] compared with the control group. Regarding the number of adverse events, the acupuncture group was safer than the control group and scored less grade in the TESS score [MD = -1.54, 95%CI (-1.92, -1.17)]. Acupuncture can effectively relieve the anxiety symptoms of generalized anxiety disorder patients with fewer side effects, but randomized controlled trials with large sample size and high quality are also required to support the result.

Amisulpride augmentation therapy improves cognitive performance and psychopathology in clozapine-resistant treatment-refractory schizophrenia: a 12-week randomized, double-blind, placebo-controlled trial

BackgroundAlthough clozapine is an effective option for treatment-resistant schizophrenia (TRS), there are still 1/3 to 1/2 of TRS patients who do not respond to clozapine. The main purpose of this randomized, double-blind, placebo-controlled trial was to explore the amisulpride augmentation efficacy on the psychopathological symptoms and cognitive function of clozapine-resistant treatment-refractory schizophrenia (CTRS) patients.MethodsA total of 80 patients were recruited and randomly assigned to receive initial clozapine plus amisulpride (amisulpride group) or clozapine plus placebo (placebo group). Positive and Negative Syndrome Scale (PANSS), Scale for the Assessment of Negative Symptoms (SANS), Clinical Global Impression (CGI) scale scores, Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Treatment Emergent Symptom Scale (TESS), laboratory measurements, and electrocardiograms (ECG) were performed at baseline, at week 6, and week 12.ResultsCompared with the placebo group, amisulpride group had a lower PANSS total score, positive subscore, and general psychopathology subscore at week 6 and week 12 (PBonferroni < 0.01). Furthermore, compared with the placebo group, the amisulpride group showed an improved RBANS language score at week 12 (PBonferroni < 0.001). Amisulpride group had a higher treatment response rate (P = 0.04), lower scores of CGI severity and CGI efficacy at week 6 and week 12 than placebo group (PBonferroni < 0.05). There were no differences between the groups in body mass index (BMI), corrected QT (QTc) intervals, and laboratory measurements. This study demonstrates that amisulpride augmentation therapy can safely improve the psychiatric symptoms and cognitive performance of CTRS patients.ConclusionThis study indicates that amisulpride augmentation therapy has important clinical significance for treating CTRS to improve clinical symptoms and cognitive function with tolerability and safety.Trial registration Clinicaltrials.gov identifier- NCT03652974. Registered August 31, 2018, https://clinicaltrials.gov/ct2/show/NCT03652974

Shugan Jieyu capsule improve sleep and emotional disorder in coronavirus disease 2019 convalescence patients: a randomized, double-blind, placebo-controlled trial.

To evaluate the efficacy of the Shugan Jieyu capsule on improving sleep and emotional disorder during Coronavirus disease 2019 (COVID-19) convalescence. We conducted a randomized, double-blind, placebo-controlled trial, and recruit 200 COVID-19 convalescence patients and then divide the subjects into two groups respectively: the experimental group ( 100) and the control group ( 100). Patients in the control group were given doses as a placebo, while those in the experimental group were given Shugan Jieyu capsule. The investigators mainly observed the differences between the two groups before and after treatment in terms of the rate of reduction and the rate of efficiency in Hamilton Depression Scale (HAMD-17) total scores from baseline, and recorded the scores of Hamilton Anxiety Scale (HAMA), Patient Health Questionnaire-15 (PHQ-15), Insomnia Severity Index (ISI) and Treatment Emergent Symptom Scale at 2 week, the 4 week and the 6 week respectively after treatment, and compared the differences between the groups. And the occurrence of adverse events was recorded. After 6-week treatment, there were statistically significant differences in the rate of reduction as well as efficiency in HAMD-17 scores, HAMA Total Scores, PHQ-15 Score, ISI Score from baseline in the experimental group and control group (< 0.05). There were 4 adverse events in the experimental group and 1 in the control group. Shugan Jieyu capsule could significantly improve sleep and emotional disorder in patients during COVID-19 convalescence.

Clinical significance of potential drug–drug interactions in older adults with psychiatric disorders: a retrospective study

BackgroundPolypharmacy increases the risk of potential drug–drug interactions (pDDIs). This retrospective analysis was conducted to detect pDDIs and adverse drug reactions (ADRs) among older adults with psychiatric disorder, and identify pDDIs with clinical significance.MethodsA retrospective analysis was carried out based on the medical records of older adults with psychiatric disorders. Data on demographic characteristics, substance abuse, medical history, and medications were extracted. The Lexi-Interact online database was used to detect pDDIs. The minimal clinically important difference (MCID) was set as the change in the Treatment Emergent Symptom Scale (TESS) score between admission and discharge. The median and interquartile ranges were used for continuous variables, and frequencies were calculated for dichotomous variables. Poisson regression was implemented to determine the factors influencing the number of ADR types. The influencing factors of each ADR and the clinical significance of the severity of the ADR were analysed using binary logistic regression. P < 0.05 was considered statistically significant.ResultsA total of 308 older adults were enrolled, 171 (55.52%) of whom had at least 1 pDDI. Thirty-six types of pDDIs that should be avoided were found, and the most frequent pDDI was the coadministration of lorazepam and olanzapine (55.5%). A total of 26 ADRs induced by pDDIs were identified, and the most common ADR was constipation (26.05%). There was a 9.4 and 10.3% increase in the number of ADR types for each extra medical diagnosis and for each extra drug, respectively. There was a 120% increase in the number of ADR types for older adults hospitalized for 18–28 days compared with those hospitalized for 3–17 days. There was an 11.1% decrease in the number of ADR types for each extra readmission. The length of hospitalization was a risk factor for abnormal liver function (P < 0.05). The use of a large number of drugs was a risk factor for gastric distress (P < 0.05) and dizziness and fainting (P < 0.05). None of the four pDDIs, including coadministrations of olanzapine and lorazepam, quetiapine and potassium chloride, quetiapine and escitalopram, and olanzapine and clonazepam, showed clinical significance of ADR severity (P > 0.05).ConclusionspDDIs are prevalent in older adults, and the rate is increasing. However, many pDDIs may have no clinical significance in terms of ADR severity. Further research on assessing pDDIs, and possible measures to prevent serious ADRs induced by DDIs is needed to reduce the clinical significance of pDDIs.

Amisulpride steady-state plasma concentration and adverse reactions in patients with schizophrenia: a study based on therapeutic drug monitoring data.

The aim of the study was to evaluate the reference range of amisulpride for Chinese patients with schizophrenia and to assess its possible influencing factors based on therapeutic drug monitoring information. The relative adverse reactions of patients induced by amisulpride were also systematically investigated. A total of 425 patients with schizophrenia were assessed, including Positive and Negative Syndrome Scales, Treatment Emergent Symptom Scale, blood routine examination, hepatorenal function, lipids, hormones, as well as myocardial enzymes at baseline, and following treatment with amisulpride for 8 weeks. The steady-state plasma concentration of amisulpride was assayed using two-dimensional liquid chromatography. At the same dose, the amisulpride plasma concentration of patients combined with clozapine was higher than that without clozapine. The therapeutic reference range of amisulpride can be defined as 230.3-527.1 ng/ml for Chinese patients with schizophrenia. The potential side effects appear to be associated with significantly increased levels of LDH, CK, creatine kinase isoenzyme (CK-MB), TC and decreased level of E 2 , relative to the amisulpride plasma concentration. These findings could provide individualized medication and reduce the adverse effects of amisulpride for Chinese patients with schizophrenia.

Shexian Bupleurum Alleviates Insomnia and Improves Symptoms of Anxiety and Depression: A Randomized Double-Blind Placebo-Controlled Clinical Trial

Objective: To observe the clinical efficacy of Shexian bupleurum on insomnia based on evaluation scales and polysomnogram (PSG). Methods: A total of 260 patients suffering from insomnia admitted to the outpatient department of Handan Central Hospital were included in a randomized, double blind, placebo-controlled trial. The patients were randomly divided into two groups: a control group (receiving placebo, n = 150), and an intervention group (receiving Shexian bupleurum treatment, n = 110). The clinical trial lasted for 4 weeks. The Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Patient Health Questionnaire (PHQ)-9, Generalized Anxiety Disorder (GAD)-7, 17 items of Hamilton Depression Scale (HAMD-17), and Hamilton Anxiety Scale (HAMA) were used to evaluate the patients at baseline as well as two weeks and four weeks after treatment; the Treatment Emergent Symptom Scale (TESS) was used to evaluate adverse reactions; polysomnography (PSG) was used to monitor and analyze their sleep characteristics at baseline and four weeks after treatment. Results: The PSQI, ISI, PHQ-9, HAMD-17, and HAMA scores of the intervention group significantly decreased compared to the control group, while the total sleep time, rapid eye movement sleep latency, stage 2 sleep, deep sleep, rapid eye movement sleep, and sleep efficiency of the intervention group significantly increased compared to the control group. The PHQ-9 score of the control group only decreased two weeks after treatment (p &lt; 0.05) compared to the intervention group. In addition, there were no obvious adverse events in both the intervention group and the control group. Conclusion: Shexian bupleurum not only improves sleep quality, but also relieves depression and anxiety in patients who suffer from insomnia.

Metformin in the Treatment of Amisulpride-Induced Hyperprolactinemia: A Clinical Trial.

ObjectiveTo evaluate the efficacy and safety of metformin in the treatment of amisulpride-induced hyperprolactinemia.MethodsA total of 86 schizophrenic patients who developed hyperprolactinemia after taking amisulpride were screened and randomly assigned to the metformin group (42 patients) and placebo group (44 patients) and followed up for eight weeks. The patients’ serum prolactin levels, blood glucose and lipids were measured at the baseline and the end of the intervention. The treatment emergent symptom scale (TESS) was also assessed.ResultsAfter eight weeks of intervention, serum prolactin levels in the metformin group decreased from (1737.360 ± 626.918) mIU/L at baseline to (1618.625 ± 640.865) mIU/L, whereas serum prolactin levels in the placebo group increased from (2676.470 ± 1269.234) mIU/L at baseline to (2860.933 ± 1317.376) mIU/L. There was a significant difference in prolactin changes (Fcovariance = 9.982, P = 0.002) between the two groups. There was no significant difference in the incidence of adverse drug reactions (P > 0.05) between the two groups.ConclusionMetformin is able to improve amisulpride-induced hyperprolactinemia with its safety.

Safety and efficacy of auricular acupuncture in patients with depression after percutaneous coronary intervention: A protocol for systematic review and meta-analysis.

Background:With the advantages of miniature damage and optimal effectiveness, percutaneous coronary intervention (PCI) has been performed in a large number of coronary artery disease patients. However, recent studies have indicated a higher incidence of depression on post-PCI patients. Acupuncture therapy is effective for depression. As a form of acupuncture, the auricular acupuncture has been used to relieve symptoms in patients with post-PCI depression, but its effectiveness and safety have not yet reached a definitive conclusion. Therefore, this systematic review and meta-analysis protocol is planned to evaluate the efficacy and safety of auricular acupuncture for depression in post-PCI patients.Methods:Six English databases (PubMed, Web of Science, MEDLINE, EMBASE, Springer Cochrane Library, and WHO International Clinical Trials Registry Platform) and 4 Chinese databases (Wan Fang Database, Chinese Scientific Journal Database, China National Knowledge Infrastructure Database, and Chinese Biomedical Literature Database) will be searched normatively according to the rule of each database from the inception to February 1, 2022. Two reviewers will independently conduct article selection, data collection, and risk of bias evaluation. Any disagreement will be resolved by discussion with the third reviewer. Either the fixed-effects or random-effects model will be used for data synthesis based on the heterogeneity test. The change in the scores on the Hamilton Depression Scale and the Self-rating Depression Scale will be used as the main outcome measure. All-cause mortality, cardiac mortality, major adverse cardiovascular events, rehospitalisation rate, and Quality of Life Scale as the secondary outcome. Treatment Emergent Symptom Scale, general physical examination (temperature, pulse, respiration, blood pressure), routine examination of blood, urine and stool, electrocardiogram, liver and kidney function examination as the security indexes. RevMan 5.3.5 will be used for meta-analysis.Results:This study will provide high-quality evidence to assess the efficacy and safety of auricular acupuncture for depression in post-PCI patients.Conclusion:This systematic review will explore whether auricular acupuncture is an effective and safe intervention for depression in post-PCI patients.INPLASY registration number:INPLASY202230003.

Effects of Jie Yu Wan on Generalized Anxiety Disorder: A Randomized Clinical Trial.

Objective To systematically assess the clinical efficacy of the Jie Yu Wan (JYW) formula in treating generalized anxiety disorder (GAD). Methods A multicenter, prospective, double-blind, double-dummy, randomized controlled trial (RCT) was conducted at four hospitals in China. A total of one hundred thirty-three patients with GAD were enrolled from 2017 to 2019. This study aimed to evaluate the effects of a Traditional Chinese Medicine (TCM) JYW formula on GAD at eight weeks, with the use of Buspirone as the comparator. A stepwise dosing protocol was used (JYW: high dose 24 g/day, low dose 12 g/day; Buspirone: high dose 30 mg/day, low dose 15 mg/day) and the dose was adjusted depending on whether the treatment response of Hamilton Anxiety Scale (HAMA) score was less than or equal to 25% after one week. The primary outcome was a change in total score on the HAMA. The secondary outcomes included the Hamilton Depression Scale (HAMD), Clinical Global Impression (CGI) scale, and TCM Syndrome Scale. Adverse events were recorded using the Treatment Emergent Symptom Scale (TESS). Assessments were conducted at the baseline and 1, 2, 4, and 8 weeks. Results A total of one hundred thirty-three participants were randomly assigned to the JYW group (n = 66) and the Buspirone group (n = 67). One hundred twenty-one patients (91%) completed at least one follow-up session. There were no significant differences between the two groups in terms of gender, age, disease course, HAMA, HAMD, CGI, and TCM Syndrome Scale scores at baseline (all P > 0.05). Repeated-measures analysis of variance revealed statistically significant time effects for the HAMA (P=0.002), HAMD (P = 0.018), and CGI (P=0.001) in both groups. Sensitivity analyses supported the credibility of the main results (P > 0.05). The group effect was not significant for the HAMA (P=0.43), HAMD (P=0.27), CGI (P=0.37), and TCM Syndrome Scale (P=0.86). Furthermore, there were no significant interaction effects between time and group in terms of the HAMA (P=0.47), HAMD (P=0.79), CGI (P=0.67), and TCM Syndrome Scale (P=0.69). After one week, 53 patients (80%) of the JYW group and 52 patients (78%) of the Buspirone group were adjusted to high doses. The interaction effect between time, group, and the dose was determined by repeated measures ANOVA test, and the HAMA score served as the outcome measure. The interaction effect between time and dose was statistically significant (P=0.04), which shows that high-dose JYW (24 g/day) was more effective in decreasing patients' HAMA scores than low-dose JYW (12 g/day), and Buspirone had the same effect, which means that high-dose Buspirone (30 mg/day) was more effective than low dose. (15 mg/day). Conclusions The conclusion of this study supports that JYW and Buspirone can effectively alleviate the anxiety symptoms of GAD patients, which are both effective and safe for treatment of mild to moderate GAD. Besides, high-dose JYW or Buspirone are more effective than low-dose, which is of great importance in assisting clinical medication choice.

Clinical Efficacy of the Chinese Herbal Medicine Shumian Capsule for Insomnia: A Randomized, Double-Blind, Placebo-Controlled Trial.

PurposeShumian capsule (SMC) is a patent Chinese herbal medicine that can soothe the liver and relieves depression, quiet the spirit. Here, we aimed to investigate the efficacy of SMC for treating insomnia using both scales and polysomnography (PSG).Patients and MethodsA randomized, double-blind, placebo-controlled trial was performed. Twenty-six insomnia patients randomly received SMC (n = 11) or placebo (n = 15) for four weeks. Pittsburgh Sleep Quality Inventory (PSQI), Insomnia Severity Index (ISI), 9-items Patient Health Questionnaire (PHQ-9), 7-items Generalized Anxiety Disorder (GAD-7), 17-item Hamilton Depression Rating Scale (HAMD-17), and Hamilton Anxiety Rating Scale (HAMA) were applied at the baseline and the 2nd, 4th week after treatment. Treatment Emergent Symptom Scale was used to assess adverse reactions. We used PSG to record and analyze sleep features at baseline and after four weeks.ResultsPSQI, ISI, PHQ-9, HAMD-17, and HAMA scores decreased significantly after SMC treatment. Also, the total sleep time, rapid-eye-movement (REM) sleep latency, stage 2 sleep, deep sleep, REM sleep, and sleep efficiency improved significantly after SMC treatment. In the placebo group, the only significant change was the decrease of PHQ-9 at week-2. Furthermore, both SMC and placebo reported no adverse events.ConclusionSMC could safely improve sleep quality with depression and anxiety remission in insomnia patients.

Efficacy of Artificial Intelligence-Assisted Psychotherapy in Patients With Anxiety Disorders: A Prospective, National Multicenter Randomized Controlled Trial Protocol.

BackgroundAnxiety disorders have the highest prevalence of all psychiatric disorders in China. Medication and psychotherapy are two main treatment approaches for this group of disorders, and when used in combinations are significantly more beneficial than medication alone. The resources are insufficient. The availability of psychotherapy is low due to the limited resources. Artificial intelligence (AI)-assisted psychotherapy offers an opportunity to develop an efficient and standardized psychotherapy model and improve the availability of psychotherapy, which is key to improve the clinical efficacy of anxiety disorder treatments.ObjectivesThe present protocol aims to determine whether medication plus AI-assisted psychotherapy has greater efficacy than medication alone in the treatment of anxiety disorders.MethodsWe will recruit patients in eight hospitals in China. Seven hundred and eight patients with anxiety disorders will be randomly allocated on a 1:1 basis to either medication plus AI-assisted psychotherapy group, or medication alone group. We have built an AI psychotherapy robot named XIAO AN. In this study we will deliver psychotherapy to patients in the medication plus AI-assisted psychotherapy group. Patients will be assessed at baseline and at the end of week 2, 4, 8, and 12. Follow-up assessments will be conducted at 3 and 6 months posttreatment. The primary outcome is change of Hamilton Anxiety Rating Scale (HAMA) score from baseline the end of 12-week treatment. A secondary efficacy outcome will be improvement in treatment at an early stage (score reduction in HAMA ≥25% after 2 weeks of treatment). Other measurements include Hamilton Depression Scale, Clinical Global Impression, Treatment Emergent Symptom Scale, Social Disability Screening Schedule, Insomnia Severity Index and so on. Scales will be assessed by independent raters who are blind to treatment allocation and analyses will be conducted by a statistician who is also blind to treatment allocation.DiscussionThis will be the first multicentered randomized controlled single-blind trial in China to assess the efficacy of medication plus AI-assisted psychotherapy compared with medication alone for anxiety disorders. The study has the potential to address the limitations of the limited availability of psychotherapy, and to augment the efficacy of the treatment of anxiety disorders in China.

Clinical efficacy of Vortioxetine and escitalopram in the treatment of depression.

Objectives:This study was aimed to investigate the efficacy and safety of vortioxetine hydrobromide in the treatment of major depressive disorder (MDD).Methods:One hundred and eighty patients with the newly diagnosed depression in our hospital between August 2018 and August 2019 were selected and randomly divided into an observation group and a control group, 90 each group. The control group was treated with escitalopram, and the observation group was treated with voltaxetine. The efficacy and adverse reactions were evaluated by the Hamilton Depression scale-17 (HAMD-17), Sheehan Disability Scale (SDS), Perceived Deficits Questionnaire-Depression (PDQ-D), and treatment emergent symptom scale (TESS) before treatment and at the end of the 8th and 24th week after treatment.Results:At the end of the 8th and 24th week after treatment, the HAMD-17 scores of the two groups were lower than those before treatment (P<0.05); at the end of the 8th and 24th week after treatment, the PDQ-D and SDS scores of the two groups were lower than those before treatment (P<0.05), and the above scores of the observation group were lower than those of the control group (P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P>0.05).Conclusion:Voltaxetine can improve cognitive function and clinical symptoms of patients with severe depression and has high safety, which is worth clinical attention.