Systematic review and meta-analysis of cardiac neurosis for development of clinical practice guidelines of Korean medicine.

Background: The development of clinical practice guidelines in traditional medicine requires evidence that sufficiently reflects the medical field. Cardiac neurosis is a disease that occurs because of problems in the autonomic nervous system and is characterized by symptoms of the circulatory system that are representative of autonomic dysfunction. In traditional medicine, the heart is considered to be involved in mental health problems, and cardiac neurosis is accompanied by a variety of mental symptoms. Furthermore, there is a categorized diagnosis for cardiac neurosis, and active empirical research is being conducted in China. Objective: This study aimed to systematically review and quantitatively synthesize the effects of Korean medicine treatments in patients with cardiac neurosis to develop evidence-based clinical practice guidelines for the treatment of autonomic dysfunction. Methods: Nine databases were searched for articles published before September 13, 2022. The methodological quality of the studies was assessed using the RoB tool. The primary outcomes were somatization, depression, anxiety, and effectiveness rate. The secondary outcome was the rate of adverse effects. Results: Based on a systematic literature review, 151 randomized controlled trials were selected and analyzed. For patients with cardiac neurosis, herbal medicine, combined treatment of herbal medicine and Western medicine, combined treatment of herbal medicine and acupuncture, acupuncture, and combined treatment of acupuncture and Western medicine showed better overall effects than Western medicine alone. Furthermore, the combined treatment of herbal medicine and psychotherapy and that of herbal medicine, psychotherapy, and Western medicine showed an overall better effect than the combined treatment of Western medicine and psychotherapy. Conclusion: A meta-analysis of articles revealed the effectiveness of Korean medicine treatments and verified the effectiveness of a Korean medicine treatment alone, Korean medicine combined treatment, and combined treatment of Korean medicine and Western medicine on cardiac neurosis. Limitations included the inability to verify the cause of high heterogeneity between studies and the poor quality of the included studies. Nevertheless, this systematic review and meta-analysis of cardiac neurosis showed that the disease concept of traditional medicine can also be organized based on the latest research. Future research related to traditional diseases such as these should be conducted. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022347992, identifier CRD42022347992.

Erratum: Withdrawal notice to: Electroacupuncture plus moxibustion for major depressive disorder: A randomized, sham-controlled, pilot clinical trial.

[This corrects the article DOI: 10.1016/j.imr.2021.100802.].

Effects of mobile mindfulness training on mental health of employees: A CONSORT-compliant pilot randomized controlled trial.

BACKGROUND: Employee stress and well-being affect organizational efficiency and productivity, as well as physical and psychological health of employees. Mindfulness is believed to reduce stress, prevent diseases, and promote well-being. Mindfulness has been used as the main component of various smartphone-based healthcare applications. Previous studies have suggested that mindfulness applications have a positive effect on employee stress and mental health. However, relatively few randomized controlled trials have examined the effectiveness of mindfulness applications on employees. This study aims to evaluate whether mobile mindfulness training (MMT) as a stress self-management tool improves employees' perceived stress, subjective well-being, and Mibyeong, a condition that is not a disease but shows obvious health abnormalities. METHODS: Participants were recruited through advertisements displayed at 3 workplaces, including a patent attorney's office, a construction company, and a public relations firm. A total of 45 employees were randomly assigned to 1 of 2 groups: the MMT group (Group A) receiving smartphone application-based mindfulness training, and a wait-list control (WLC) group (Group B), who received no intervention. Group A employees conducted MMT following daily and event guidelines for 4 weeks. In contrast, Group B employees did not receive any intervention in that time. The outcome variables were perceived stress, subjective well-being, and Mibyeong. Surveys were conducted at baseline, post-intervention, and follow-up (fourth week post-intervention). RESULTS: Demographic characteristics and baseline assessments were not significantly different between the 2 groups. The results of this study revealed that subjective well-being and Mibyeong were significantly improved in the MMT group compared with the WLC group. Moreover, this improvement was maintained up to at least 4 weeks later. However, perceived stress was not significantly reduced in the MMT group compared to the WLC group. CONCLUSION: Four weeks of MMT improved the subjective well-being and Mibyeong of employees. However, further studies are required to investigate the effect of MMT on other areas of mental health.

Meditation-based intervention for obsessive-compulsive disorder: A PRISMA-compliant systematic review and meta-analysis.

BACKGROUND: The purpose of this study was to investigate the effects of the meditation-based intervention on obsessive-compulsive disorder (OCD). METHODS: The following databases were searched up to April 2021: the Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, Medline (via PubMed), PsycARTICLES, 4 Korean databases (Korean Medical Database [KMbase], Koreanstudies Information Service System [KISS], National Digital Science Library [NDSL], and Oriental Medicine Advanced Searching Integrated System [OASIS]), and China National Knowledge Infrastructure (CNKI). The search terms related to meditation-based intervention and OCD were used. This systematic review was based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. The selected articles were evaluated using the Cochrane risk of bias tool. The Review Manager (RevMan) 5.4 was used to perform the meta-analysis. RESULTS: In all, 16 randomized controlled trials were selected. The meta-analysis showed that the group receiving the treatment combining medication and meditation-based intervention for OCD showed a more significant post-treatment improvement in Yale-Brown obsessive compulsive scale than the group receiving medication only. Compared with other non-medication interventions that are known to be effective in treating OCD, the Yale-Brown obsessive compulsive scale showed a significant improvement immediately after the meditation-based intervention. However, no significant difference was found in the follow-up monitoring data across all examined cases. CONCLUSION: This study was conducted to verify the effects of meditation-based intervention on OCD. The results suggested that combined treatment with medication and meditation-based intervention was more effective in treating OCD than medication alone; the positive effects of meditation-based intervention may be greater than the effects of other non-medication interventions. However, the lack of significant difference in the follow-up indicates that long-term effect of meditation-based interventions is unclear. TRIAL REGISTRATION NUMBER: PROSPERO CRD42021244408.

Efficacy and safety of Gyejibokryeong-hwan (GBH) in major depressive disorder: study protocol for multicentre randomised controlled trial.

BACKGROUND: Gyejibokryeong-hwan (GBH) is an herbal medicine composed of five herbs. It has been widely used to treat gynaecological diseases in traditional East Asian medicine. Recent animal studies suggest antidepressant effects of GBH. In this trial, we explore the efficacy and safety of GBH in patients with major depressive disorder and to identify the optimal dose for the next phase III trial. METHODS: This trial will enrol 126 patients diagnosed with major depressive disorder and not treated with antidepressants. Participants will be randomised to receive a high or a low dose of GBH or placebo granules. The study drugs will be administered three times a day, for 8 weeks. The 17-item Hamilton Depression Rating Scale (HDRS) will be used to measure the severity of depressive symptoms at weeks 2, 4, 6, 8, and 12. The primary efficacy endpoint is the change from baseline in HDRS-17 total score post-treatment at week 8. Analysis of covariance will be based on the baseline HDRS-17 total score and site as the covariates. Safety assessment will be based on the frequency of adverse events. The severity and causality of the study drug will be assessed. DISCUSSION: This study is designed to evaluate the efficacy and safety of GBH granules compared with placebo in patients with major depressive disorder. TRIAL REGISTRATION: Clinical Research Information Service KCT0004417 . Registered on November 1, 2019 (prospective registration).

Anti-anger Effects of Herbal Medicine: A Mini-Review of Rat Studies.

OBJECTIVE: To analyze the available data on the anti-anger effects of herbal medicines (HMs) as well as their underlying mechanisms in rat models. METHODS: From 6 electronic databases [PubMed, EMBASE, China National Knowledge Infrastructure (CNKI), Wanfang, Oriental Medicine Advanced Searching Integrated System (OASIS), and Research Information Sharing Service (RISS)], relevant animal experiments were searched by using "anger," "rats," and "animal" as search keywords. The last search was conducted on November 22, 2019, and all experiments involving rat models of anger and treatment using HMs published until the date of the search were considered. RESULTS: A total of 24 studies with 16 kinds of HMs were included. Most studies have used the "tail irritating method" and "social isolation and resident intruder" method to establish anger models. According to the included studies, the therapeutic mechanisms of HMs for anger regulation and important herbs by their frequency and/or preclinical evidence mainly incladed regulation of hemorheology (Bupleuri Radix, Paeoniae Radix Alba, and Glycyrrhizae Radix), regulation of sex hormones (Bupleuri Radix, Cyperi Rhizoma, and Paeoniae Radix Alba), regulation of neurotransmitters (Cyperi Rhizoma), regulation of anger-related genes (Bupleuri Radix, Glycyrrhizae Radix, and Paeoniae Radix Alba), and other effects. Overall, Liver (Gan) qi-smoothing herbs including Bupleuri Radix and Cyperi Rhizoma were the most frequently used. CONCLUSIONS: This review found the frequent methods to establish an anger model, and major mechanisms of anti-anger effects of HMs. Interestingly, some Liver qi-smoothing herbs have been frequently used to investigate the anti-anger effects of HM. These findings provide insight into the role and relevance of HMs in the field of anger management.

Electroacupuncture plus moxibustion for major depressive disorder: A randomized, sham-controlled, pilot clinical trial.

BACKGROUND: The first treatment option for major depressive disorder (MDD) is antidepressants, however, there is substantial demand for alternative therapies due to its low compliance and remission rates. This study was aimed to explore the effectiveness, safety, and feasibility of electroacupuncture plus moxibustion therapy for MDD. METHODS: Thirty adults with MDD were randomly assigned to the treatment group (TG) or control group (CG). The TG was treated with electroacupuncture plus moxibustion, and the CG received sham interventions at non-acupoints for 8 weeks. The primary outcome measure was the intergroup difference of the mean change of total score of the Hamilton rating scale for depression (HRSD) between baseline and week 9. Secondary outcome measures were Beck's depression inventory, insomnia severity index, the state-trait anxiety inventory, the EuroQol-5 dimension index, the measure yourself medical outcome profile version 2, and frontal alpha asymmetry measured by electroencephalography. Adverse events (AEs) were monitored for safety assessment. RESULTS: The primary outcome measure was not significantly different between the two groups (p=0.2641), although the scores of HRSD in both groups improved significantly after treatment. No significant difference was identified between groups in secondary outcome measures. The incidence of AE was not significantly different between the two groups (p=0.1067). CONCLUSION: A clinical trial using electroacupuncture plus moxibustion for MDD seems feasible. However, further studies with the larger size, adopting ideal controls are warranted to provide a confirmative conclusion to the efficacy and safety of electroacupuncture plus moxibustion for MDD. TRIAL REGISTRATION: The protocol was registered at Korean Clinical Trial Registry (CRIS-KCT0001810).

Effectiveness and Safety of the Korean Medicine Senior Health Promotion Program Using Herbal Medicine and Acupuncture for Mild Cognitive Impairment: A Retrospective Study of 500 Patients in Seoul, Korea.

BACKGROUND: The management of mild cognitive impairment (MCI) is becoming increasingly important. The Korean Medicine Senior Health Promotion Program (KSHPP) was developed in 2016, and it has been in use to date. This study aimed to assess the effectiveness of KSHPP using herbal medicine and acupuncture for treating MCI and the safety of herbal medicine using liver and renal function tests. METHODS: We retrospectively reviewed the medical records of the participants with MCI. We assessed the Korean version of the Montreal Cognitive Assessment (MoCA-K), the Mini-Mental State Examination-Dementia Screening (MMSE-DS), and the Geriatric Depression Scale Short Form-Korea version (GDSSF-K) scores before and after KSHPP to determine its effectiveness. To evaluate its safety, the liver and renal function tests were conducted before and after herbal treatment. RESULTS: We enrolled 1002 participants, and 500 participants satisfied the inclusion criteria. Of 500 patients, 364 (72.8%) were depressed and 136 (27.2%) were not. The mean MoCA-K score significantly increased by 2.77 for the entire sample and 3.22 for the depressed sample (all P < 0.0001). The mean MMSE-DS score significantly increased by 2.19 for the entire sample and 2.51 for the depressed sample (all P < 0.0001); the mean GDSSF-K score significantly decreased by 1.73 for the entire sample and 2.68 for the depressed sample (all P < 0.0001). CONCLUSIONS: Our findings suggest that Korean medicine interventions can improve cognitive function and depression symptoms in patients with MCI. In addition, the results of the liver and renal function tests were analyzed as surrogate outcomes to assess the safety of herbal medicine. Based on these results, we expect that Korean medicine interventions can promote the cognitive and mental health of seniors. However, as there were several study limitations, particularly study design, practice effect, and short follow-up, these results must be interpreted with caution. We need a further long-term study with a rigorous design to retain confidence in the effectiveness and safety of KSHPP.

Electroacupuncture plus moxibustion for major depressive disorder: A randomized, sham-controlled, pilot clinical trial.

BACKGROUND: The first treatment option for major depressive disorder (MDD) is antidepressants, however, there is substantial demand for alternative therapies due to its low compliance and remission rates. This study was aimed to explore the effectiveness, safety, and feasibility of electroacupuncture plus moxibustion therapy for MDD. METHODS: Thirty adults with MDD were randomly assigned to the treatment group (TG) or control group (CG). The TG was treated with electroacupuncture plus moxibustion, and the CG received sham interventions at non-acupoints for 8 weeks. The primary outcome measure was the intergroup difference of the mean change of total score of the Hamilton rating scale for depression (HRSD) between baseline and week 9. Secondary outcome measures were Beck's depression inventory, insomnia severity index, the state-trait anxiety inventory, the EuroQol-5 dimension index, the measure yourself medical outcome profile version 2, and frontal alpha asymmetry measured by electroencephalography. Adverse events (AEs) were monitored for safety assessment. RESULTS: The primary outcome measure was not significantly different between the two groups (p=0.2641), although the scores of HRSD in both groups improved significantly after treatment. No significant difference was identified between groups in secondary outcome measures. The incidence of AE was not significantly different between the two groups (p=0.1067). CONCLUSION: A clinical trial using electroacupuncture plus moxibustion for MDD seems feasible. However, further studies with the larger size, adopting ideal controls are warranted to provide a confirmative conclusion to the efficacy and safety of electroacupuncture plus moxibustion for MDD.

How Suppressed Anger Can Become an Illness: A Qualitative Systematic Review of the Experiences and Perspectives of Hwabyung Patients in Korea.

Background: In the clinical field, anger has generally been studied in terms of aggressive behavior. However, in Asians, anger suppression is more common than anger expression. Hwabyung is a culture-related anger syndrome in Korea and is known to occur due to the continued repression of anger. Investigating Hwabyung should lead to a better understanding of the multiple dimensions of anger. To explore Hwabyung patients' experiences and perspectives, a meta-aggregation approach was used to conduct a systematic review and a qualitative synthesis. Methods: A systematic search was conducted in MEDLINE/PubMed, EMBASE, Allied and Complementary Medicine Database (AMED), Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycARTICLES, and four Korean databases [Korean Medical Database (KMbase), Korean Studies Information Service System (KISS), National Digital Science Library (NDSL), and Oriental Medicine Advanced Searching Integrated System (OASIS)] in September 2020. Studies were included if they collected and analyzed qualitative data from Hwabyung patients. Qualitative research findings on the experiences and perspectives of Hwabyung patients in Korea were critically appraised and synthesized using the Joanna Briggs Institute methodology. Results: Seven eligible studies were included. The findings from those studies (i.e., theme or subtheme of qualitative research) were aggregated into categories (a group of similar findings) and synthesized findings (a group of categorized findings). Ultimately, 116 findings were aggregated into 15 categories. Finally, four synthesized findings were derived from the 15 categories: (i) anger arousal, (ii) blame, (iii) uncontrollable physical and emotional symptoms, and (iv) compromise and temporary coping. Conclusions: Patients with Hwabyung experience chronic anger through the complex cognitive processes involved in blame. Hwabyung negatively affects patients' physical, psychological, and social functions. Because Hwabyung patients feel as if they are losing control, due to emotional dysregulation and physical symptoms, professional support should be provided to facilitate their coping strategies. Further studies on Hwabyung can serve as a new model of pathological anger.

Nonpharmacological treatments for Tourette syndrome and tic disorders: A protocol for systematic review and network meta-analysis.

BACKGROUND: A tic is a sudden, rapid, recurrent, nonrhythmic motor movement, or vocalization. Tic disorders are diagnosed based on the presence of motor or vocal tics, duration of tic symptoms, and age at onset. Current clinical practice guidelines strongly recommend behavioral therapies because they are more effective and safer than medications. To determine the most effective nonpharmacological intervention for tic disorders and Tourette syndrome, we will conduct a systematic review and network meta-analysis. METHODS: We will search the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PsycARTICLES, AMED, 3 Chinese databases (China National Knowledge Infrastructure, Chongqing VIP, and Wanfang Data), 3 Korean databases (Korean Medical Database, Korean studies Information Service System, and ScienceON), and a Japanese database (CiNii). There will be no language or date restrictions. The primary outcome will be the tic severity scale, the Yale Global Tic Severity Scale. The secondary outcomes will include the effective rate defined by the trial authors, dropout rate, and adverse events. Methodological quality will be assessed using the Cochrane risk of bias tool. RESULTS: Results of this review and network meta-analysis will be published in a peer-reviewed journal. CONCLUSIONS: This systematic review will assess the effectiveness of nonpharmacological interventions for treating tic disorders. A systematic review or meta-analysis will provide an unbiased overview of the existing evidence.

The mindfulness-based stress reduction program for improving sleep quality in cancer survivors: A systematic review and meta-analysis.

INTRODUCTION: This study aims to evaluate the efficacy and effectiveness of a mindfulness-based stress reduction (MBSR) program in improving sleep in cancer survivors. METHODS: Four electronic databases (Cochrane Library, EMBASE, PubMed, and PsycARTICLES) were searched for randomized controlled trials evaluating the effects of MBSR on the sleep of cancer survivors from their inception to May 2020. The primary outcome was sleep quality measured by validated questionnaires such as the Insomnia Severity Index and Pittsburgh Sleep Quality Index. The secondary outcomes were sleep parameters obtained from a sleep diary, polysomnography, and actigraphy. The included studies were critically appraised by the Cochrane risk of bias tool and meta-analyzed. RESULTS: Ten studies were included, and nine studies were analyzed quantitatively. MBSR significantly improved sleep quality compared to usual care (standardized mean difference -0.29, 95 % confidence interval -0.55 to -0.04, I2 = 58 %). However, there were no favorable results with sleep parameters. Compared to active controls, MBSR presented mixed results with sleep quality according to the outcomes and negative results with sleep parameters. CONCLUSION: This review suggests that MBSR helps cancer survivors improve sleep quality. Our results support the possibility of using MBSR for cancer survivors. However, its efficacy and effectiveness in improving sleep quality and sleep parameters are inconclusive because the number of included studies was few with inconsistent results. Further studies with high methodological quality are required to establish conclusive evidence about the efficacy and effectiveness of MBSR in improving sleep quality and sleep parameters in cancer survivors.

Do Cochrane reviews reflect the latest evidence on meditation and mindfulness-based interventions? A snapshot of the current evidence.

Growing evidence emphasizes the importance of meditation and mindfulness-based interventions (MBIs) in clinical settings. Here, we attempted to determine the clinical issues targeted by Cochrane reviews of meditation and MBIs and whether the judgements about quality/certainty as expressed by the Cochrane authors differed from that of non-Cochrane reviews and guidelines. The search database was the Cochrane Database of Systematic Reviews and the search date was December 31, 2019. Screening and selection of reviews was carried out by two independent authors. Overall, 20 reviews and four protocols were selected for this study. The effects of meditation and/or MBIs on various conditions described in the Cochrane reviews seemed ambiguous, with the exception of mindfulness-based stress reduction in breast cancer patients. However, we found some international clinical practice guidelines and latest non-Cochrane reviews describing meditation and MBIs to be more comprehensive and favorable. This gap is likely due to the priority-setting issues, which resulted in a lack of latest up-to-date evidence, as well as gaps in interventions of interest between Cochrane and non-Cochrane reviews.

Mindfulness meditation program for the elderly in Korea: A preliminary review for planning the program.

BACKGROUND: The significance of mindfulness meditation (MM) has increased in recent years in both clinical settings and public health. However, ways to implement MM as a disease prevention or treatment method in the elderly is still a major challenge. A comprehensive analysis of previous studies on MM programs for the elderly in Korea will help build future integrated care programs that incorporate MM. METHODS: Seven international and Korean domestic electronic databases were searched to collect relevant clinical studies until May 30, 2020. RESULTS: Sixteen articles with twelve clinical studies were included in this review. The MM program was generally offered once a week over eight weeks with a duration of between 60 and 90 min per session. The main reason for participants' drop out was poor program compliance attributed to conflicting schedules, physical illness, or a change of mind. The program results were either positive or mixed, but the mindfulness level of the participants was improved. CONCLUSIONS: This review summarizes information obtained from previously published studies in Korea, on the design considerations, characteristics, and preliminary effectiveness of the MM program for the elderly. The findings can be used as preliminary data by future practitioners and/or researchers to design MM programs targeted toward the elderly; it could also help policymakers integrate MM-based strategies into integrated care programs to promote their mental health and well-being.

Effect of herbal medicine (Huanglian-jie-du granule) for somatic symptoms and insomnia in patients with Hwa-byung: A randomized controlled trial.

BACKGROUND: Huanglian-jie-du (HJD) granule, which is composed of representative "heat-clearing" herbs has been used for Hwa-byung. Hwa-byung is a culture-bound syndrome in Korea, characterized by distinct somatic symptoms such as chest congestion and heat sensation resulting from suppressed anger. We investigated the effect of HJD in patients with Hwa-byung. METHODS: Forty-four patients with Hwa-byung were recruited, and HJD or placebo granules were administered orally three times daily for seven days. The two primary outcomes were somatic symptoms, which were measured by Patient Health Questionnaire of physical symptoms (PHQ-15), and insomnia, which was measured by Insomnia Severity Index (ISI) at post-treatment. RESULTS: Between July 10 and October 31, 2017, 44 patients with Hwa-byung (mean age 36.68 years; and 38 female) were randomly assigned to HJD (n = 22) or placebo (n = 22) group. After administration of HJD or placebo granule for seven days, ISI score was lower in the HJD group compared to placebo group at post-treatment (adjusted mean difference -2.56 [95% CI -4.72 to -0.39], p = 0.0208). Meanwhile, there was no difference in PHQ-15 score between HJD group and placebo group at post-treatment (adjusted mean difference -0.50 [95% CI: -3.02-4.02], p = 0.7812). CONCLUSIONS: Our results suggest that the administration of HJD granule has a potential to improve insomnia in Hwa-byung patients. Effect of HJD granule for general somatic symptoms in Hwa-byung patients is unclear, and further researches are needed. TRIAL REGISTRATION: Clinical Research Information Service, KCT0002379.

Analysis of the bio-psychological characteristics of Sasang typology in Korean preschool children using the ponderal index and the temperament and character inventory.

OBJECTIVES: The aim of this study was to identify different physical and mental characteristics among three common Sasang types, Tae-eum, So-yang, and So-eum (except scarce type, Tae-Yang) in preschoolers, to improve constitutional diagnoses. METHODS: Our study included 65 boys and 67 girls from six kindergartens in South Korea. The number of children who were categorized as Tae-Yang, Tae-Eum, So-Yang, and So-Eum types were 1, 56, 40, and 35, respectively. We measured height, weight, mid-parental height, predicted adult height, ponderal index (PI), and findings from the junior temperament and character inventory 3 to 6. RESULTS: The Tae-eum type exhibited higher weight percentiles and PIs than the other types (p < 0.001), and the So-eum type displayed higher harm avoidance (HA) scores than the Tae-eum type (p = 0.033). CONCLUSIONS: Children with high PIs and low HA scores have a higher probability of being classified as the Tae-eum type than as the So-eum type.

Clinical Efficacy and Safety of Miniscalpel-Needle Treatment for Tension-Type Headache: A Systematic Review and Meta-Analysis.

OBJECTIVE: To investigate the clinical efficacy and safety of miniscalpel-needle (MSN) treatment for tension-type headache (TTH). METHOD: Seven medical databases were searched to identify randomized controlled trials (RCTs) evaluating the effect and safety of MSN treatment. All articles published up to November 15, 2018 were retrieved. A meta-analysis was conducted for the included studies, and the risk of bias was assessed. Primary outcomes were visual analogue scale (VAS) or numeric rating scale (NRS) score. Secondary outcomes were clinical effective rates including total effective rate (TER), markedly effective rate (MER), and totally cured rate (TCR) determined by improvement in clinical symptoms or VAS scores, the frequency of adverse events (AEs) that occurred during the study, and participant quality of life (QOL). RESULTS: Seven RCTs involving 724 participants were included. MSN treatment showed significantly higher MER and TCR [relative risk (RR) 1.27, 95% confidence interval (CI) 1.01 to 1.61; RR 1.31, 95% CI 1.09 to 1.57, respectively], but not TER (RR 1.03, 95% CI 0.96 to 1.10) compared to acupuncture. MSN treatment plus conventional treatment showed significant lower VAS and higher TER, MER, and TCR (mean difference -3.54, 95% CI -3.80 to -3.28; RR 1.14, 95% CI 1.06 to 1.23; RR 2.31, 95% CI 1.50 to 3.58; RR 3.01, 95% CI 2.25 to 4.02, respectively) compared to conventional treatment. CONCLUSIONS: According to current evidence, MSN treatment as a monotherapy or as an adjunctive treatment to other existing treatments might have benefits on treating TTH. However, since the number and the sample size of studies included were both small and the methodological quality was poor, the findings of this review should be interpreted with great caution, and our confidence in the results is low. A high quality RCT using objective outcomes should be performed on this topic.

Effect of the Emotional Freedom Techniques on anger symptoms in Hwabyung patients: A comparison with the progressive muscle relaxation technique in a pilot randomized controlled trial.

CONTEXT: Hwabyung is a psychosomatic disease resulting from the suppression of anger over an extended period. The Emotional Freedom Techniques (EFT) are meridian-based psychotherapy known to cure many psychosomatic diseases, and progressive muscle relaxation (PMR) is a therapeutic method that relieves physical and psychological tension by repeated tensing and relaxation of the muscles. OBJECT: In this study, we compared the effects of EFT and PMR in patients with Hwabyung. DESIGN: 40 patients were enrolled and randomized to receive 4 weeks of group sessions with either EFT (n = 20) or PMR (n = 20). Evaluations were conducted pre- and post-treatment and at 4-week and 24-week follow-ups after session end. MAIN OUTCOME MEASURES: The Hwabyung Scale, Visual Analogue Scale of Hwabyung Symptoms (VAS-HS), Beck Depression Inventory (BDI), State-Trait Anxiety Inventory (STAI), and State-Trait Anger Expression Inventory (STAXI) were administered as self-report tools. The analysis excluded 8 patients who never attended treatment and 1 patient meeting the exclusion criteria. RESULT: EFT (n = 15) and PMR (n = 16) improved Hwabyung symptoms (-13.95% and -11.46%, respectively), state anxiety (-12.57% and -12.64%, respectively), and depression (-32.11% and -18.68%, respectively) (p < 0.05 for all). Trait anger improved in EFT group (-13.4%, p = 0.004). There were no significant differences between the groups (p > 0.05) except for trait anger at post-treatment (p = 0.022 for between group). No adverse events were reported during the study.

Efficacy and safety of Sihogayonggolmoryeo-tang (Saikokaryukotsuboreito, Chai-Hu-Jia-Long-Gu-Mu-Li-Tang) for post-stroke depression: A systematic review and meta-analysis.

This systematic review and meta-analysis aimed to analyze the efficacy and safety of Sihogayonggolmoryeo-tang (SGYMT), a classical herbal medicine consisting of 11 herbs, for treatment of post-stroke depression (PSD). Thirteen databases were comprehensively searched from their inception dates until July 2019. Only randomized controlled trials (RCTs) using SGYMT as a monotherapy or adjunctive therapy for PSD patients were included. Where appropriate data were available, meta-analysis was performed and presented as risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CIs). We assessed the quality of RCTs using the Cochrane risk of bias tool and the Jadad scale. The quality of evidence for each main outcome was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Twenty-one RCTs with 1,644 participants were included. In the comparison between the SGYMT and antidepressants groups, the SGYMT group scored significantly lower on both the Hamilton Depression Scale (HAMD) (8 studies; MD -2.08, 95% CI -2.62 to -1.53, I2 = 34%) and the National Institutes of Health Stroke Scale (NIHSS) (2 studies; MD -0.84, 95% CI -1.40 to -0.29, I2 = 19%), and significantly higher on the Barthel index (3 studies; MD 4.30, 95% CI 2.04 to 6.57, I2 = 66%). Moreover, the SGYMT group was associated with significantly fewer adverse events (6 studies; RR 0.13, 95% CI 0.05 to 0.37, I2 = 0%) than the antidepressants group. In the subgroup analysis, SGYMT treatment consistently reduced HAMD scores within the first 8 weeks of treatment, but thereafter this difference between groups disappeared. Comparisons between SGYMT combined with antidepressants, and antidepressants alone, showed significantly lower scores in the combination group for both HAMD (7 studies; MD = -6.72, 95% CI = -11.42 to -2.01, I2 = 98%) and NIHSS scores (4 studies; MD -3.03, 95% CI -3.60 to -2.45, I2 = 87%). In the subgroup analysis, the reductions of HAMD scores in the SGYMT combined with antidepressants group were consistent within 4 weeks of treatment, but disappeared thereafter. The quality of RCTs was generally low and the quality of evidence evaluated by the GRADE approach was rated mostly "Very low" to "Moderate." The main causes of low quality ratings were the high risk of bias and imprecision of results. Current evidence suggests that SGYMT, used either as a monotherapy or an adjuvant therapy to antidepressants, might have potential benefits for the treatment of PSD, including short-term reduction of depressive symptoms, improvement of neurological symptoms, and few adverse events. However, since the methodological quality of the included studies was generally low and there were no large placebo trials to ensure reliability, it remains difficult to draw definitive conclusions on this topic. Further well-designed RCTs addressing these shortcomings are needed to confirm our results.

Neurocircuitry of acupuncture effect on cognitive improvement in patients with mild cognitive impairment using magnetic resonance imaging: a study protocol for a randomized controlled trial.

BACKGROUND: Mild cognitive impairment (MCI) is defined as a decline in cognitive state with preservation of activities of daily living. Medications such as donepezil and rivastigmine have been commonly prescribed for MCI, but their use is controversial. Acupuncture has been widely used in Korea and has been shown to improve cognitive function. The aim of this study is to evaluate the efficacy of acupuncture for MCI and investigate the effect of acupuncture on structural and functional brain changes in patients with MCI. METHODS: This study is a randomized, assessor-blinded, sham-controlled trial. Fifty participants with MCI will be randomly assigned to the acupuncture group (n = 25) or sham acupuncture group (n = 25). The acupuncture group will receive acupuncture treatment at nine acupuncture points (GV20, EX-HN1, bilateral LI4, and ST36) twice a week for 12 weeks. The sham acupuncture group will receive sham acupuncture treatment at the same points with non-penetrating sham needles. Both groups will be restricted from all other treatments for the improvement of cognitive function. The primary outcome measure is the Digit Span Test (DST). The secondary outcome measures are the Digit Symbol Substitution Test (DSST), Korean version of Montreal Cognitive Assessment (MoCA-K), Seoul Neuropsychological Screening Battery-II (SNSB-II), Beck Depression Inventory-II (BDI-II), State-Trait Anxiety Inventory (STAI), working memory (WM) task performance score, and structural/functional brain changes. Outcomes will be assessed at screening, baseline, 4 and 8 weeks, and after the end of treatment. We will also observe adverse events. In the statistical analysis, a full analysis set and per-protocol analysis will be performed. DISCUSSION: This randomized clinical trial aims to examine the efficacy of acupuncture treatment for MCI. Neuropsychological tests, psychological inventories for measuring depression and anxiety, and magnetic resonance imaging will be performed to investigate the underlying neurological mechanisms and the association between cognition, emotion, and brain networks following acupuncture treatment. The results of the trial will provide evidence supporting the efficacy of acupuncture and also add to the neurobiological understanding of acupuncture treatment for MCI. TRIAL REGISTRATION: Clinical Research Information Service, KCT0002896 . Registered on 25 May 2018.