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.

Herbal medicine for acute management and rehabilitation of traumatic brain injury: A protocol for a systematic review.

BACKGROUND: This systematic review protocol describes the methods that will be used to evaluate the efficacy and safety of herbal medicine in treating traumatic brain injury. METHODS AND ANALYSIS: The following electronic databases will be searched up to December 2018 without language or publication status restrictions: Medline, EMBASE, the Cochrane Central Register of Controlled Trials, Allied and Complementary Medicine Database, and Cumulative Index to Nursing and Allied Health Literature. We will also search Korean, Chinese, and Japanese databases. Any randomized controlled trials related to herbal medicine for traumatic brain injury will be included. The functional outcome, consciousness state, morbidity, and mortality will be assessed as primary outcomes. The quality of life, adverse events, and total effective rate will be evaluated as secondary outcomes. Two researchers will independently perform the study selection, data extraction, assessment of study quality, and evaluation of the quality of evidence for the main findings. Data synthesis and analysis will be performed using RevMan version 5.3. The results will be expressed as a risk ratio for the binary outcome and as the mean difference or standardized mean difference for a continuous outcome. We will synthesize the data by either fixed effects or random effects model according to a heterogeneity test or the number of studies included in the meta-analysis. The methodological quality of the included studies will be evaluated using the Cochrane Collaboration's risk of bias tool. The quality of evidence for each main outcome will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach. ETHICS AND DISSEMINATION: Ethical approval is not required because individual patient data are not included. The findings of this systematic review will be disseminated through a peer-reviewed publication or conference presentations. PROSPERO REGISTRATION NUMBER: CRD42018116559.

Development of a survey form through Delphi study about adverse events associated with the miniscalpel needle, for application in prospective observational studies regarding safety of miniscalpel needles: Study protocol.

BACKGROUND: Despite the wide usage of miniscalpel-needles (MSNs), information about MSN treatment-related adverse events (AEs) is insufficient. As the definition of AE might vary among physicians, without an exact definition for pain and hemorrhage, it is difficult to provide accurate information about AEs in MSN treatment to physicians, researchers, and patients. The aim of our study is to reach a consensus about the items and definitions of AEs that should be included in the survey form for prospective observational multicenter studies to record MSN treatment-related AEs. We will especially focus on obtaining a consensus on the definition of pain and hemorrhage caused by MSN treatment. METHODS: Our study protocol is composed of 6 steps. First, we will identify the aim of the study. Next, we will conduct a systematic review to investigate MSN treatment-related AEs reported till date in Korea. Third, we will conduct a pilot observational prospective single-center study on AEs in MSN treatment. We will develop a standardized case report form to record MSN treatment-related AEs, including the causality, severity, and details of the MSN procedure at every site. Next, based on the pilot study, the Delphi study questionnaire will be developed by a panel composed of 13 physicians. The Delphi study will have 4 rounds with open questions and 4-point Likert-scale closed questions. Through these rounds, we will develop a consensus about the items and definitions of AEs that should be included in the survey form for future multicenter studies about MSN treatment-related AEs. Following this, a face-to-face consensus meeting will be held for a final agreement of survey form. The final survey form will then be approved by the related academic society for dissemination. DISCUSSION: The aim of this protocol is to develop a survey form for future prospective observational multicenter studies on MSN treatment-related AEs. This protocol will present the research methodology for developing a survey form, which will improve consistency and reliability between MSN treatment studies. We believe that this protocol can evaluate the safety of MSN treatment. TRIAL REGISTRATION: Clinical Research Information Service: KCT0002849.

Herbal medicine Sihogayonggolmoryeo-tang or Chai-Hu-Jia-Long-Gu-Mu-Li-Tang for the treatment of post-stroke depression: A protocol for a systematic review and meta-analysis.

INTRODUCTION: This systematic review protocol describes the methods that will be used to evaluate the efficacy and safety of herbal medicine Sihogayonggolmoryeo-tang (SGYMT) or Chai-Hu-Jia-Long-Gu-Mu-Li-Tang for the treatment of post-stroke depression. METHODS AND ANALYSIS: The following electronic databases will be searched up to July 2018 without language or publication status restrictions: MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, Allied and Complementary Medicine Database (AMED), Cumulative Index to Nursing, and Allied Health Literature (CINAHL), and PsycARTICLES. We will also search Korean and Chinese databases. Any clinical randomized controlled trials related to SGYMT treatment for post-stroke depression will be included. Changes in the degree of depression and adverse events will be assessed as primary outcomes. The total effective rate and changes in neurological function, activities of daily living, and quality of life will be evaluated as secondary outcomes. Study selection, data extraction, assessment of study quality, and evaluation of the quality of evidence for the main findings will be performed independently by 2 researchers. The data synthesis and analysis will be performed using RevMan version 5.3. The results will be expressed as a risk ratio for dichotomous data and as the mean difference or standardized mean difference for continuous data. Data will be synthesized by either a fixed-effects or random-effects model according to a heterogeneity test or the number of studies included in the meta-analysis. The methodological quality of the included studies will be evaluated using the Cochrane Collaboration's risk of bias tool. The quality of evidence for each main outcome will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. ETHICS AND DISSEMINATION: Ethical approval is not required because individual patient data are not included. The findings of this systematic review will be disseminated through a peer-reviewed publication or conference presentations. PROSPERO REGISTRATION NUMBER: CRD42018102939.

Brain activity associated with memory and cognitive function during jaw-tapping movement in healthy subjects using functional magnetic resonance imaging.

OBJECTIVE: To determine whether jaw-tapping movement, a classically described as an indication of personal well-being and mental health, stimulates the memory and the cognitive regions of the brain and is associated with improved brain performance. METHODS: Twelve healthy right-handed female subjects completed the study. Each patient performed a jaw-tapping task and an n-back task during functional magnetic resonance imaging (fMRI). The subjects were trained to carry out the jaw-tapping movement at home twice a day for 4 weeks. The fMRI was repeated when they returned. RESULTS: During the first and second jaw-tapping session, both sides of precentral gyrus and the right middle frontal gyrus (BA 6) were activated. And during the second session of the jaw-tapping task, parts of frontal lobe and temporal lobe related to memory function were more activated. In addition, the total percent task accuracy in n-back task significantly increased after 4 weeks of jawtapping movement. After jaw-tapping training for 4 weeks, brain areas related to memory showed significantly increased blood oxygen level dependent signals. CONCLUSION: Jaw-tapping movement might be a useful exercise for stimulating the memory and cognitive regions of the brain.

The acute effect of acupuncture on endothelial dysfunction in patients with hypertension: a pilot, randomized, double-blind, placebo-controlled crossover trial.

OBJECTIVES: The objective of the study was to test whether acupuncture improves endothelial dysfunction in patients with hypertension and compare the effects of different acupoints to find out which one is the most suitable for the long-term follow-up study. DESIGN: This study is a pilot, randomized, double-blind, placebo-controlled crossover trial. Subjects were randomly assigned to a sequence of four acupuncture treatment phases, each for 15 minutes with a 7-day washout period in between. Acupuncture needles were inserted at bilateral ST 36; PC 6; ST 36 plus PC 6; and placebo points. SUBJECTS: Fifteen (15) patients with essential hypertension were the subjects. OUTCOME MEASURES: Flow-mediated dilation (FMD) and blood pressure were assessed before and after acupuncture treatment. RESULTS: FMD significantly improved with the acupuncture treatment at ST 36 (0.266 +/- 0.078 mm to 0.306 +/- 0.077 mm, p = 0.003) and ST 36 plus PC 6 (0.284 +/- 0.098 mm to 0.332 +/- 0.103 mm, p < 0.001). In contrast, FMD was unchanged after the acupuncture treatment at PC 6 or the placebo treatment. The FMD response to the acupuncture treatment at ST 36 plus PC 6 was significantly different from the response to the acupuncture treatment at PC 6 and the placebo treatment (p < 0.05, p < 0.01, respectively). The acupuncture treatment at ST 36 significantly increased FMD compared to the placebo treatment (p < 0.05). CONCLUSIONS: This study demonstrates that the acute treatment of acupuncture in hypertensive patients improves endothelial dysfunction. The beneficial effect of acupuncture could be of clinical importance to prevent the progression of cardiovascular diseases in hypertensive patients. However, the potential role of acupuncture treatment for long-term therapy has not been examined. Further studies will be necessary to demonstrate whether long-term acupuncture treatment can sustain the improvement in endothelial dysfunction.

Effects of scalp acupuncture versus upper and lower limb acupuncture on signal activation of blood oxygen level dependent (BOLD) fMRI of the brain and somatosensory cortex.

OBJECTIVE: The objective of this article is to investigate brain activity of scalp acupuncture (SA) as compared to upper and lower limb acupuncture (ULLA) using functional magnetic resonance imaging (fMRI). SUBJECTS AND METHODS: Ten (10) healthy right-handed female volunteers aged 20-35 were divided into 2 groups: a SA group and an ULLA group. The SA group had needles inserted at the left Sishencong (HN1), GB18, GB9, TH20, and the ULLA group at the right LI1, LI10, LV3, ST36 for 20 minutes, respectively. Both groups had tactile stimulation in the order of the right LI1, LI10, LV3, ST36 before and after acupuncture for a block of 21 seconds repeated 3 times. The blood oxygen level dependent (BOLD) fMRI was used to observe the brain and somatosensory cortex signal activation. RESULTS: We compared the signal activation before and after acupuncture needling, and the images showed signal activation after removing the acupuncture needles and the contralateral somatosensory association cortex, the postcentral gyrus, and the parietal lobe were more activated in the SA group. The right occipital lobe, the lingual gyrus, the visual association cortex, the right parahippocampal gyrus, the limbic lobe, the hippocampus, the left anterior lobe, the culmen, and the cerebellum were activated in the ULLA group. CONCLUSIONS: We concluded that there were different signal activations of BOLD fMRI before and after SA versus ULLA, which can be thought to be caused by the sensitivity of acupoints and the different sensory receptors to acupuncture needling.