Evaluation of the efficacy and safety of Yukwool-tang for major depressive disorder in women: A randomized, double blinded, placebo-controlled, parallel trial.

BACKGROUND: Major depressive disorder (MDD) occurs more often in women than that in men due to various complex causes. This study aimed to evaluate the effectiveness and safety of Yukwool-tang (YWT) for MDD in women. METHODS: A total of 72 patients diagnosed with MDD and Korean version of the Hamilton Depression Rating Scale (K-HDRS) ≥ 14 points were randomly assigned to the YWT or placebo group, and 1 bottle (30 mg) of No-S solution and placebo was administered to the YWT and placebo groups, respectively, orally thrice a day for 8 weeks. The evaluation was conducted through K-HDRS, Korean version of the Beck Depression Inventory (BDI-K), Korean version of the Beck Hopelessness Scale (K-BHS), Korean version of the Insomnia Severity Index (ISI-K), State-Trait Anxiety Inventory (STAI-K), EuroQol-5 dimension (EQ-5D), and Pattern Identifications Tool for Depression (PITD). Fifty patients completed the trial. RESULTS: In the YWT group, the K-HDRS, BDI-K, K-BHS, ISI-K, STAI-K, and EQ-5D scores changed significantly at the 8th week, but there were no significant differences with the placebo. In subgroup analysis, the K-BHS score with an initial K-HDRS score < 18 points was significantly decreased compared to placebo at the 12th week (P < .05). In the YWT group, the ratio of Stagnation of Liver Gi () was the highest, but Dual Deficiency of the Heart and Spleen () became the highest after administration, which was also the highest in the placebo group both before and after administration. CONCLUSION: YWT improved depression and accompanying symptoms in women with MDD, although it was not significant compared to placebo, and it might be effective in improving the degree of hopelessness. The effect of YWT will become relatively clear through further research that can overcome certain limitations.

Attenuated facial movement in depressed women is associated with symptom severity, and nucleus accumbens functional connectivity.

It is assumed that mood can be inferred from one's facial expression. While this association may prove to be an objective marker for mood disorders, few studies have explicitly evaluated this linkage. The facial movement responses of women with major depressive disorder (n = 66) and healthy controls (n = 46) under emotional stimuli were recorded using webcam. To boost facial movements, the naturalistic audio-visual stimuli were presented. To assess consistent global patterns across facial movements, scores for facial action units were extracted and projected onto principal component using principal component analysis. The associations of component for facial movements with functional brain circuitry was also investigated. Clusters of mouth movements, such as lip press and stretch, identified by principal component analysis, were attenuated in depressive patients compared to those in healthy controls. This component of facial movements was associated with depressive symptoms, and the strengths of resting brain functional connectivity between nucleus accumbens and both posterior insular cortex and thalamus. The evaluation of facial movements may prove to be a promising quantitative marker for assessing depressive symptoms and their underlying brain circuitry.

What influences aromatase inhibitor continuation intention among breast cancer survivors?

Purpose: Aromatase inhibitors (AIs) are widely prescribed for postmenopausal women with breast cancer and are known to cause musculoskeletal pain. This study aimed to identify factors associated with AI continuation intention among breast cancer survivors (BCS). Methods: A cross-sectional survey was conducted on 123 BCS (stages I-III), who had been taking AIs for at least 6 weeks. Participants were recruited from a cancer center in Goyang, Korea, from September to November 2019. Descriptive statistics, Welch analysis of variance, Pearson correlation coefficients, and simple linear regression were used for the analysis. Results: Beliefs about endocrine therapy was a significant predictor of AI continuation intention (ß=.66, p<.001). The majority of participants (87.0%) reported experiencing musculoskeletal pain since taking AIs and the score for the worst pain severity within 24 hours was 5.08±2.80 out of 10. Musculoskeletal pain, however, was not associated with AI continuation intention. Fear of cancer recurrence (FCR) was clinically significant (≥13) for 74.0% of the respondents (mean, 17.62±7.14). Musculoskeletal pain severity and pain interference were significantly associated with FCR (r=.21, p<.05; r=.35, p<.01, respectively). Pain interference was significantly associated with beliefs about endocrine therapy (r=-.18, p<.05). Conclusion: AI continuation intention can be modified by reinforcing patients' beliefs about endocrine therapy. Musculoskeletal pain may have a negative effect on beliefs about endocrine therapy and increase FCR among BCS. Thus, awareness of musculoskeletal pain during AI therapy should be raised and further research is required to develop multidisciplinary pain management strategies and clinical guidelines to reinforce beliefs about endocrine therapy.

Safety and efficacy of Jujadokseo-hwan for memory deficit (amnesia) in mild neurocognitive disorder: A protocol for randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial.

BACKGROUND: Mild neurocognitive disorder (mNCD) is one of the degenerative diseases that results in memory deficit, and can progress to dementia. The effectiveness of drug therapy for mNCD is still debatable, but treatment of this disease has important implications for postponing or preventing dementia. Jujadokseo-hwan (JDH) is a traditional herbal medicine formulation that exhibits improvement in cognitive abilities and neuroprotective effects. In this study, we will evaluate the safety and efficacy of JDH compared to placebo in mNCD patients. METHODS AND DESIGN: This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial. After obtaining informed consent from all participants and performing the screening process, the participants will be equally divided into an experimental group and a control group. Each participant will visit the trial center 7 times during the 12 weeks of intervention. The follow up study will be conducted 12 weeks after the intervention ends. The primary outcome is the variance in Seoul verbal learning test-elderly's version (SVLT-E) score from baseline to 12 weeks. Secondary outcomes include scores/values for the following variables: SVLT-E, Rey complex figure test, Digit span test, Korean-Boston naming test, calculation ability, controlled oral word association test, Korean-color word stroop test, digit symbol coding, Korean-trail making test-elderly's version, Korean version of mini mental state examination for dementia screening, euro-qol-5 dimension, pattern identifications tool for cognitive disorders, Korean version of Montreal cognitive assessment, Korean quality of life-Alzheimer disease, computerized tongue image analysis system, blood pressure pulse analyzer, bioelectrical impedance analyzer, wearable electroencephalogram device, functional near-infrared spectroscopy system, and cost analysis. DISCUSSION: This is the first trial evaluating the efficacy of JDH for mNCD. We expect this trial will provide strong support for wide use of JDH for mNCD and lead to further research on herbal medicine treatments for mNCD. TRIAL REGISTRATION NUMBER: KCT0003570 (Registered in Clinical Research Information Service of the Republic of Korea, https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=12669).

Efficacy and safety of oral SOCG in treatment of major depressive disorder: A protocol for a phase II, randomized, double-blind, placebo controlled, parallel-groups, dose finding exploratory study.

INTRODUCTION: Major depressive disorder (MDD) is a common condition worldwide, and leads to degradation in quality of life and large socioeconomic costs. There has been increasing demand for new therapies with fewer side effects. SOCG (SOCG tablet) is a modified prescription of So-ochim-tang, which is widely used in Traditional Korean Medicine to treat MDD. We aim to evaluate the efficacy of SOCG in treating MDD, and identify the optimum dose. DESIGN: The protocol we are following is that of a Phase II clinical trial with a randomized, double blinded, placebo controlled, and parallel design. One hundred forty-eight participants will be randomly divided into 4 groups and treated for 8 weeks. OUTCOME MEASURES: The primary outcome will be the score in the Korean Version of the Hamilton Depression Rating Scale. Scores in the Korean version of the Beck Depression Inventory-II Korean Symptom Check List-95 (KSCL-95), State Trait Anxiety Inventory-Korean version, State- Trait Anger Expression Inventory- Korean version (STAXI-K), Insomnia Severity Index (ISI), and the EuroQol-5 Dimension (EQ-5D) will be considered as secondary outcomes. DISCUSSION AND CONCLUSIONS: Demonstration of human safety and efficacy of SOCG in the present trial and identification of the appropriate dose will justify a New Drug Application and a phase III clinical trial. Further, we expect that this new antidepressant will be able to increase cure rates, and alleviate the burden of medical expenses. TRIAL REGISTRATION NUMBER: Clinical Research Information Service, Republic of Korea (KCT0002763).