Implementation strategy for introducing a clinical skills examination to the Korean Oriental Medicine Licensing Examination: a mixed-method modified Delphi study

PURPOSE: This study investigated the validity of introducing a clinical skills examination (CSE) to the Korean Oriental Medicine Licensing Examination through a mixed-method modified Delphi study METHODS: A 3-round Delphi study was conducted between September and November 2022. The expert panel comprised 21 oriental medicine education experts who were officially recommended by relevant institutions and organizations. The questionnaires included potential content for the CSE and a detailed implementation strategy. Subcommittees were formed to discuss concerns around the introduction of the CSE, which were collected as open-ended questions. In this study, a 66.7% or greater agreement rate was defined as achieving a consensus. RESULTS: The expert panel's evaluation of the proposed clinical presentations and basic clinical skills suggested their priorities. Of the 10 items investigated for building a detailed implementation strategy for the introduction of the CSE to the Korean Oriental Medicine Licensing Examination, a consensus was achieved on 9. However, the agreement rate on the timing of the introduction of the CSE was low. Concerns around 4 clinical topics were discussed in the subcommittees, and potential solutions were proposed. CONCLUSION: This study offers preliminary data and raises some concerns that can be used as a reference while discussing the introduction of the CSE to the Korean Oriental Medicine Licensing Examination.

The efficacy and safety of yukmijihwang-hwan (Liuweidihuang-wan) for type 2 diabetes mellitus without complications: A protocol for systematic review and meta-analysis.

BACKGROUND: This systematic review and meta-analysis of randomized controlled trials (RCTs) will aim to assess the efficacy and safety of Yukmijihwang-hwan for type 2 diabetes without complications. METHODS: To identify eligible studies, we will perform a systematic search of the following electronic databases: MEDLINE (PubMed), EMBASE, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Citation Information by NII, Korean Information Service System, Korean Medical Database, Oriental Medicine Advanced Searching Integrated System, and ScienceON. Search terms will include "Type 2 Diabetes" for participants as well as "Yukmijihwang-tang" or "Liuwei dihuang tang" for interventions. Two independent researchers will perform data extraction and assessment using Cochrane's risk of bias tool, with disagreements being resolved through discussions with a third researcher. RESULTS: This study will evaluate the antidiabetic effects of Yukmijihwang-hwan from 3 perspectives (blood glucose level, insulin resistance, and ß-cell function) as well as its safety by reviewing the reported adverse effects. CONCLUSION: This systematic review will provide evidence regarding the antidiabetic efficacy and safety of Yukmijihwang-tang in type 2 diabetes mellitus.

Efficacy of Geumguesingi-hwan (jinkuishenqi-wan, kinkijinki-gan) in decreasing blood glucose levels in patients with uncomplicated type 2 diabetes: A protocol for systematic review and meta-analysis.

BACKGROUND: The purpose of a systematic review and meta-analysis is to verify the clinical efficacy and safety of Geumguesingihwan for patients with uncomplicated type 2 diabetes. METHODS: The systematic review and meta-analysis will be performed following the guidelines of the National Evidence-based Healthcare Collaborating Agency. We will conduct a systematic search of randomized controlled trials in 8 electronic databases until August 31, 2021. RESULTS: This study will provide evidence regarding the clinical efficacy of Geumguesingi-hwan from the following 3 perspectives: improving blood glucose level, insulin resistance, and ß-cell function. Additionally, we will examine the safety of Geumguesingi-hwan by evaluating the adverse effects. CONCLUSIONS: This study will verify the antidiabetic efficacy and safety of Geumguesingi-hwan in patients with uncomplicated type 2 diabetes.

Efficacy of Hwangryunhaedok-tang (Huang-lian-jie-du-tang, Oren-gedoku-to) for patients with hyperlipidemia: a study protocol for a randomized, double-blind, placebo-controlled, parallel, investigator-initiated clinical trial.

BACKGROUND: The prevalence of hyperlipidemia continues to increase due to aging and lifestyle changes. Statins are currently used as the first choice for treating hyperlipidemia, but are limited by adverse reactions. Hwangryunhaedok-tang (HHT) has received attention as a promising intervention for hyperlipidemia through a few experimental and clinical trials. This study aims to explore the feasibility, effectiveness, and safety of HHT for hyperlipidemia treatment. METHODS: This is a study protocol for a randomized, double-blind, placebo-controlled, parallel, investigator-initiated, pilot clinical trial held in Daejeon, Republic of Korea. Thirty patients with hyperlipidemia will be randomly allocated to HHT or placebo granule groups in equal proportions. Participants will be administered HHT or placebo granules three times per day for 8 weeks and followed up for another 4 weeks. The primary outcome is low-density lipoprotein cholesterol at 8 weeks from the commencement of treatment. Other blood lipid parameters, biomarkers of atherosclerosis, the degree of arteriosclerosis, blood glucose parameters, blood pressure, anthropometric parameters, health-related quality of life, and the changes in the general symptoms of cold and hot patterns will be measured as secondary outcomes. Adverse events and laboratory test results will be investigated to assess the safety. Changes in the gut microbiome before and after intervention will also be assessed as an exploratory outcome through next-generation sequencing. Data will be recorded in electronic case report forms and analyzed using SAS® Version 9.4. DISCUSSION: This is a rigorously designed pilot clinical trial to explore the effect and safety of Hwangryunhaedok-tang compared to placebo control for patients with hyperlipidemia, thereby potentially facilitating better management of hyperlipidemia. The results of this pilot study could form the foundation for a future large-scale, confirmatory clinical trial. TRIAL REGISTRATION: Clinical Research Information Service KCT0004564 . Registered on December 18, 2019.

Study protocol of a pragmatic, randomised controlled pilot trial: clinical effectiveness on smoking cessation of traditional and complementary medicine interventions, including acupuncture and aromatherapy, in combination with nicotine replacement therapy.

INTRODUCTION: Nicotine dependence is a disease, and tobacco use is related to 6 million deaths annually worldwide. Recently, in many countries, there has been growing interest in the use of traditional and complementary medicine (T&CM) methods, especially acupuncture, as therapeutic interventions for smoking cessation. The aim of this pilot study is to investigate the effectiveness of T&CM interventions on smoking cessation. METHODS AND ANALYSIS: The STOP (Stop Tobacco Programme using traditional Korean medicine) study is designed to be a pragmatic, open-label, randomised pilot trial. This trial will evaluate whether adding T&CM methods (ie, ear and body acupuncture, aromatherapy) to conventional cessation methods (ie, nicotine replacement therapy (NRT), counselling) increases smoking cessation rates. Forty participants over 19 years old who are capable of communicating in Korean will be recruited. They will be current smokers who meet one of the following criteria: (1) smoke more than 10 cigarettes a day, (2) smoke less than 10 cigarettes a day and previously failed to cease smoking, or (3) smoke fewer than 10 cigarettes a day and have a nicotine dependence score (Fagerstrom Test for Nicotine Dependence) of 4 points or more. The trial will consist of 4 weeks of treatment and a 20 week follow-up period. A statistician will perform the statistical analyses for both the intention-to-treat (all randomly assigned participants) and per-protocol (participants who completed the trial without any protocol deviations) data using SAS 9.1.3. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Board (IRB) of the Dunsan Korean Medicine Hospital of Daejeon University (IRB reference no: DJDSKH-15-BM-11-1, Protocol No. version 4.1.).The protocol will be reapproved by IRB if it requires amendment. The trial will be conducted according to the Declaration of Helsinki, 7th version (2013). This study is designed to minimise the risk to participants, and the investigators will explain the study to the participants in detail. As an ethical clinical trial, the control group will also be given conventional cessation treatments, including NRT and counselling. Participants will be screened and provided with a registration number to protect their personal information. Informed consent will be obtained from the participants prior to enrolling them in the trial. Participants will be allowed to withdraw at anytime without penalty. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT02768025); pre-results.

Bogijetong decoction and its active herbal components protect the peripheral nerve from damage caused by taxol or nerve crush.

BACKGROUND: Bogijetong decoction (BGJTD) is a herbal drug formulation used in the traditional Asian medicine to treat neuropathic insults associated with diabetes and anticancer therapy. To understand the biological basis of BGJTD on protective effects against neuropathy, we investigated physiological and biochemical responses of the sciatic nerves deranged by taxol injection or crush injury in the rats. METHODS: Dissociated Schwann cells and neurons were prepared from the sciatic nerve and dorsal root ganglia (DRG) respectively and were treated with taxol and BGJTD. The sciatic nerve in the rat was injected with taxol or given crush injury. Animals were then administered orally with BGJTD. Effects of BGJTD treatment on cultured cells and in vivo sciatic nerves and DRG tissues were examined by immunofluorescence staining and western blot analysis. Sciatic nerve regeneration was assessed by histological observation using retrograde tracing technique and by behavioral hot plate test. Eighteen different herbal components of BGJTD were divided into 4 subgroups and were used to select herbal drugs that enhanced neurite outgrowth in cultured neurons. RESULTS: Morphological abnormalities in the sciatic nerve axons and DRG tissue caused by taxol injection were largely improved by BGJTD treatment. BGJTD treatment enhanced neurite outgrowth in cultured DRG neurons and improved Schwann cell survival. Phospho-Erk1/2 levels were elevated by BGJTD administration in the injured- or taxol-injected sciatic nerves. Vimentin phosphorylation catalyzed by cell division cycle 2 (Cdc2) kinase was induced from Schwann cells in the sciatic nerves after taxol injection and crush injury, and phospho-vimentin levels were further upregulated by BGJTD treatment. Retrograde tracing of DiI-labeled DRG sensory neurons revealed growth-promoting activity of BGJTD on axonal regeneration. A drug group (Be) composed of 4 active herbal components which were selected by neurite growth-enhancing activity was as effective as BGJDT for the recovery of thermal sensitivity of the hind paws which had been suppressed by taxol administration. CONCLUSIONS: These data suggest that BGJTD and its active herbal components may protects the peripheral nerve from damage caused by taxol injection and nerve crush.