The reporting quality of acupuncture-related traumatic adverse events: a systematic review of case studies in Korea.

BACKGROUND: Acupuncture is known for a harmless treatment when administered by well-trained clinicians. However, multiple case reports of traumatic adverse events (AEs) related to acupuncture treatments continue to be published in literature. In this review, we evaluated the reporting quality and conducted causality assessments of case studies that have reported acupuncture-related traumatic AEs in Korea. METHODS: Eight databases were searched from their inception to January 2024. Only Korean case studies that reported traumatic AEs following acupuncture procedures were included without any language restrictions. Reporting quality was evaluated based on patient characteristics, AEs, and acupuncture practice. Causality was assessed using the modified WHO-UMC causality criteria. RESULTS: Twenty-eight studies were included from a total of 1,154 identified studies. The quality of reporting in the included studies was low overall. While the descriptions of patient characteristics and AEs were relatively well detailed, most information on acupuncture practice was not reported at all. During the causality assessment, only three (10.7%) studies were judged to be "certain". Twelve (42.9%) studies were "unassessable" because they inadequately described the information necessary for decision-making. It was practically difficult to establish the causality between acupuncture and AEs, as well as the appropriateness of acupuncture practice. CONCLUSIONS: Insufficient and inappropriate reporting was observed in most case studies reporting acupuncture-related traumatic AEs in Korea. To overcome these limitations, we have suggested tentative guidelines in the form of a set of items that should be reported by future authors who plan to publish case studies on acupuncture-related traumatic AEs in a clinical setting.

Firefighters' medical use and Korean Medicine experience in Korea: A qualitative study protocol.

INTRODUCTION: Firefighters, compared to other occupational groups, are exposed more frequently in their working environment not only to physical issues, such as musculoskeletal disease, respiratory disease, and burns but also to mental health issues, such as PTSD and depression. Specifically, Korean firefighters experience significantly higher rates of work-related injuries compared to those in other countries. Recent statistics from the Korea National Fire Agency indicate a steady increase in the number of firefighting work-related injuries. However, there is a shortage of measures in place to address these issues. This study aims to investigate the health needs, overall healthcare usage, and unmet needs of firefighters in Korea. We also aim to investigate, through in-depth interviews, perceptions and hindering factors for integrative medicine approaches to fulfilling unmet needs. METHOD: This study was conducted in accordance with the consolidated criteria for reporting qualitative research. Convenience and snowball sampling methods will be used to recruit firefighters to participate in the study, and interviews will be conducted using a semi-structured interview guide. The data will be analyzed in four stages using the qualitative analysis method of Krippendorff. DISCUSSION: In this study, we examine the state of health issues and healthcare usage among Korean firefighters and investigate their perceptions of and needs for integrative medicine. In this way, we aim to explore how integrative medicine and Korean medicine approaches could improve and assist healthcare services for firefighters. Furthermore, our findings will provide policymakers and healthcare providers with the necessary basic information to develop integrative medicine systems suited to firefighters.

Efficacy and safety of acupuncture treatment for fatigue after COVID-19 infection: study protocol for a pilot randomized sham-controlled trial.

Background: As the coronavirus disease 2019 (COVID-19) pandemic has spread globally, its sequelae, called Long COVID, have persisted, troubling patients worldwide. Although fatigue is known to be the most frequent among Long COVID symptoms, its mechanism and treatment have not been clearly demonstrated. In 2022, we conducted a preliminary prospective case series and found that acupuncture and moxibustion were feasible interventions for fatigue. This study is a pilot patient-assessor-blinded randomized sham-controlled trial to evaluate the efficacy and safety of acupuncture treatment for patients with fatigue that has persisted for at least 4 weeks after recovery from COVID-19. Methods: Thirty patients will be recruited and randomly assigned to either the acupuncture or sham acupuncture treatment groups. Treatment will be conducted thrice a week for both groups during 4 weeks. The primary outcome will be the efficacy and safety of acupuncture, including numeric rating scale (NRS), brief fatigue inventory (BFI), fatigue severity scale (FSS), and adverse event evaluation. Secondary outcomes will be evaluation of improvement in the comorbid symptoms of fatigue and feasibility variables. Outcome variables will be assessed before treatment, 4 weeks after treatment, and 8 weeks after treatment completion. Discussion: The results of this study will be used to clarify the efficacy and safety of acupuncture treatment for persistent fatigue in patients with Long COVID. Additionally, the feasibility of the study design was validated to provide evidence for future full-scale randomized controlled trials.Clinical trial registration: identifier: KCT0008656 https://cris.nih.go.kr/cris/search/detailSearch.do?seq=24785&search_page=L.

Publication status and reporting quality of case reports on acupuncture-related adverse events: A systematic reviews of case studies.

Introduction: Case reports on acupuncture-related adverse events (AEs) have been consistently published in the literature. This review aims to assess the current publication status of case reports on acupuncture-related AEs and evaluate their reporting quality in order to identify areas for improvement. Methods: This study is a systematic review (SR) of case reports. Studies describing cases for acupuncture-related AEs between 2010 and 2023 (until July) were searched in PubMed, Embase, and local databases (China and Korea), as well as by hand-searching references included in published relevant SRs. A bibliometric analysis was conducted to examine the publication trends of the included literature. The appropriateness of the acupuncture described in the cases, the causality assessment between AEs and acupuncture treatment, and the presence of necessary items from the CAse REport guidelines (CARE) checklist were narratively analyzed. Results: A total of 169 case reports were included in this review. Over the past decade, an average of 12 case reports on acupuncture-related AEs were published annually. However, only 38.2% of the articles provided sufficient information to determine the appropriateness of the acupuncture treatment used in the reported cases, and considerable numbers of the included case reports did not suggest enough information for the assessment of a causal relationship. The majority of cases did not report the timeline (n = 164), patient perspectives (n = 157), and informed consent (n = 121) items from the CARE checklist. Discussion: Acupuncture-related AEs persist in being frequently reported in the literature. Nonetheless, the information concerning acupuncture and causality assessment within these publications is still found to be insufficient. The development of reporting guidelines for future case reports on acupuncture-related AEs is anticipated to promote an academic environment conducive to more comprehensive reporting.

The Opioid-Sparing Effect of Acupuncture After Abdominal Surgery: A Systematic Review and Meta-Analysis Protocol.

Purpose: Routine overprescribing of postoperative opioid analgesics may induce side effects and correlate with chronic opioid use following surgery. This review aims to evaluate the effectiveness and safety of acupuncture for opioid-sparing effects in patients who underwent abdominal surgery. Methods: Eleven databases in different languages, including English (Ovid MEDLINE, CENTRAL, EMBASE, CINAHL), Chinese, Korean, and Japanese, will be searched. Randomized controlled trials using acupuncture for postoperative pain control in adult patients undergoing abdominal surgery will be screened. All randomized controlled trials comparing acupuncture with no treatment, sham acupuncture, and conventional treatments will be included. The Cochrane risk of bias tool will be used to assess the risk of bias. The primary outcome will consist of a cumulative opioid consumption. Additionally, the number of cumulative opioid analgesic demands/requests, the time to initial opioid analgesic usage, postoperative pain, opioid-related side effects, and adverse events of acupuncture will be assessed. The mean differences or risk ratios with a 95% confidence interval will be calculated to estimate the pooled effect of acupuncture when it is possible to conduct a meta-analysis. Results: This study could confirm the effect of opioid-sparing on acupuncture after abdominal surgery. Conclusion: This study would evaluate the evidence on the effectiveness of acupuncture after abdominal surgery with a focus on opioid intake. It provides evidence to support decision-making on applying acupuncture for postoperative management. Registration Number: CRD42022311155.

Complementary and Alternative Medicine for Long COVID: Scoping Review and Bibliometric Analysis.

Prolonged symptoms after the clearance of acute coronavirus disease 2019 (COVID-19) infection, termed long COVID, are an emerging threat to the post-COVID-19 era. Complementary and alternative medicine (CAM) interventions may play a significant role in the management of long COVID. The present study aimed to identify published studies on the use of CAM interventions for long COVID and provide an overview of the research status using bibliometric analysis. The present scoping review searched MEDLINE, Embase, and Cochrane Library from inception until November 2021 and identified published studies on CAM interventions for long COVID. A narrative analysis of the study types and effectiveness and safety of the CAM interventions are presented and a bibliometric analysis of citation information and references of the included publications were analyzed using the Bibliometrix package for R. An electronic database search identified 16 publications (2 clinical studies and 14 study protocols of systematic reviews or clinical studies) that were included in the present study. Dyspnea or pulmonary dysfunction, quality of life, olfactory dysfunction, and psychological symptoms after COVID-19 infection were assessed in the included publications. The two clinical studies suggested that Chinese herbal medications were effective in relieving symptoms of pulmonary dysfunction. Bibliometric analysis revealed the current trend of research publication in this area was driven by study protocols written by Chinese, Korean, and Indian authors. Thus, the present scoping review and bibliometric analysis revealed that there are few studies published about the use of CAM for long COVID and long-term management for COVID-19 survivors. Original studies on CAM interventions, including randomized controlled trials and systematic reviews, are required to actively support evidence for their use in the management of long COVID. PROSPERO registration: this trial is registered with CRD42021281526.

Deep autoencoder-powered pattern identification of sleep disturbance using multi-site cross-sectional survey data.

Pattern identification (PI) is a diagnostic method used in Traditional East Asian medicine (TEAM) to select appropriate and personalized acupuncture points and herbal medicines for individual patients. Developing a reproducible PI model using clinical information is important as it would reflect the actual clinical setting and improve the effectiveness of TEAM treatment. In this paper, we suggest a novel deep learning-based PI model with feature extraction using a deep autoencoder and k-means clustering through a cross-sectional study of sleep disturbance patient data. The data were obtained from an anonymous electronic survey in the Republic of Korea Army (ROKA) members from August 16, 2021, to September 20, 2021. The survey instrument consisted of six sections: demographics, medical history, military duty, sleep-related assessments (Pittsburgh sleep quality index (PSQI), Berlin questionnaire, and sleeping environment), diet/nutrition-related assessments [dietary habit survey questionnaire and nutrition quotient (NQ)], and gastrointestinal-related assessments [gastrointestinal symptom rating scale (GSRS) and Bristol stool scale]. Principal component analysis (PCA) and a deep autoencoder were used to extract features, which were then clustered using the k-means clustering method. The Calinski-Harabasz index, silhouette coefficient, and within-cluster sum of squares were used for internal cluster validation and the final PSQI, Berlin questionnaire, GSRS, and NQ scores were used for external cluster validation. One-way analysis of variance followed by the Tukey test and chi-squared test were used for between-cluster comparisons. Among 4,869 survey responders, 2,579 patients with sleep disturbances were obtained after filtering using a PSQI score of >5. When comparing clustering performance using raw data and extracted features by PCA and the deep autoencoder, the best feature extraction method for clustering was the deep autoencoder (16 nodes for the first and third hidden layers, and two nodes for the second hidden layer). Our model could cluster three different PI types because the optimal number of clusters was determined to be three via the elbow method. After external cluster validation, three PI types were differentiated by changes in sleep quality, dietary habits, and concomitant gastrointestinal symptoms. This model may be applied to the development of artificial intelligence-based clinical decision support systems through electronic medical records and clinical trial protocols for evaluating the effectiveness of TEAM treatment.

Saam Acupuncture for Treating Functional Dyspepsia: A Feasibility Randomized Controlled Trial.

Objective: Functional dyspepsia (FD) is a common gastrointestinal disorder that significantly affects sufferers' quality of life and increases the economic burden on society. Saam acupuncture, a form of traditional Korean acupuncture, is frequently used to treat FD in Korean medicine clinical settings. This study aimed to evaluate the feasibility and preliminary effectiveness and safety of Saam acupuncture for treating FD. Methods: We conducted a pilot, pragmatic, assessor-blinded randomized controlled trial. Patients with FD according to the ROME III criteria were randomly allocated to an acupuncture plus usual care group or a usual care group. Saam acupuncture based on individualized FD and systemic symptoms was conducted in the acupuncture group three times per week for 4 weeks. Study feasibility outcomes, including recruitment, completion, and acupuncture adherence rates, were calculated. In addition, preliminary evaluation of participant responses to the intervention was tested using the gastrointestinal symptom (GIS), FD-related quality of life (FD-QoL), visual analog scale (VAS), patient global assessment (PGA), and EuroQol-5 Dimensions (EQ-5D) scores. Results: Twenty-four participants who met the eligibility criteria were included. The recruitment and completion rates of the clinical trials were 60% and 79.2%, and the acupuncture adherence rate was 83.3%. Although there was no significant difference between the two groups in the dyspepsia symptoms as measured by GIS, VAS, and PGA at Week 4, significant differences were found between the two groups at the follow-up assessments (Weeks 8 and 12). In particular, the early satiety subscore of GIS was significantly improved in the Saam acupuncture group compared with the usual care group at Week 4. The quality of life measured by FD-QoL and EQ-5D improved only in the Saam acupuncture group, although there were no significant differences between the two groups. No adverse events related to Saam acupuncture were reported. Conclusions: Saam acupuncture can be a feasible, preliminarily effective, and safe treatment for FD. Further confirmatory trials with a larger sample size are needed to confirm its effectiveness and safety. The trail is registered with CRIS-KCT0000164, URL: https://cris.nih.go.kr/cris/search/detailSearch.do/2098.

Use of Traditional, Complementary and Integrative Medicine During the COVID-19 Pandemic: A Systematic Review and Meta-Analysis.

Background: Traditional, Complementary and Integrative Medicine (TCIM) has been reported to use for symptom management of coronavirus disease 2019 (COVID-19). The objective of this review was to identify the overall usage prevalence of TCIM interventions for COVID-19. Methods: Surveys on the general population and observational studies on the COVID-19 patient chart review were located in the search of PubMed, EMBASE and Cochrane Central Register of Controlled Trials databases in September 2021. Observational studies, such as cross-sectional studies, surveys, cohort studies and hospital-based patient case reviews, published in any language, reporting the usage of TCIM in the patients with COVID-19 or the general population during the COVID-19 pandemic were included in this review. Data screening and extraction were performed independently by two reviewers. The reporting quality of the included studies was assessed with the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement. To conduct a meta-analysis of the usage prevalence of various TCIM interventions, the effect size of the proportion for each intervention was calculated with the inverse variance method. The main outcome was usage prevalence of TCIM interventions among patients with COVID-19 or the general population during the COVID-19 pandemic. Results: A total of 62 studies were included in this review. The overall TCIM usage prevalence was estimated to be 0.64 (95% CI 0.54-0.73). The overall prevalence did not differ between the population-based survey (0.65, 95% CI 0.48-0.81) and the hospital-based patient case review (0.63, 95% CI 0.52-0.73). Statistical heterogeneity and comparatively low quality in reporting were observed, which should be cautiously considered when interpreting the results. Conclusion: Various TCIM interventions were reported to be used with comparatively high frequency. Future international collaborative research might overcome the main limitation of this study, i.e., the heterogeneity of the included data. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=278452, identifier: CRD42021278452.

Complementary and alternative medicine (CAM) interventions for COVID-19: An overview of systematic reviews.

Background: Since the beginning of the Coronavirus disease 2019 (COVID-19) pandemic, various complementary and alternative medicines (CAMs) have been used in clinical practice. In this overview, we summarized the evidence for CAM interventions in the treatment of COVID-19 patients. Methods: For this overview, PubMed, Embase and Cochrane Library were searched from inception to October 2021. Systematic reviews (SRs) on the effectiveness and safety of CAM interventions for COVID-19 patients were located, and the MeaSurement Tool to Assess Systematic Reviews 2 (AMSTAR 2) was used to evaluate the reporting quality of the included SRs. Keywords including COVID-19 and CAM interventions were used for locating SRs. For evidence mapping, we created a two-dimensional bubble plot that included the width and strength of the evidence for each CAM intervention and specific outcome. Results: In this overview, we identified 24 SRs (21 for Traditional Chinese Medicine (TCM) medications, two for vitamin D and one for home-based activity). From the included SRs, TCM herbal medications were reported to show good results in decreasing the rate of disease progression (relative risk (RR) 0.30, 95% confidence intervals (CI) [0.20, 0.44]), time to the resolution of fever (standard mean difference (SMD) -0.98, 95% CI [-1.78, -0.17]) and rate of progression to severe COVID-19 cases (RR 0.34, 95% CI [0.18, 0.65]), but the evidence for other interventions did not show effectiveness with certainty. Gastric disturbance was a major adverse event of TCM medications. Conclusion: There is evidence that TCM medications are effective in the symptom management of COVID-19 patients. However, evidence for the effectiveness of most CAM interventions still needs evaluation.

Acupuncture for postoperative delirium (POD): A systematic review and meta-analysis protocol.

BACKGROUND: Postoperative delirium (POD) is a form of delirium that is newly diagnosed after a surgical procedure. This study aims to examine the effectiveness and safety of acupuncture treatment for POD in patients who underwent surgery. METHODS: Randomized controlled trials for patients diagnosed with POD using validated delirium assessment scales will be included in this review. Electronic databases, such as MEDLINE, EMBASE, CENTRAL, CINAHL (English DB), CNKI, Wanfang, VIP (Chinese database), KoreaMed, RISS, KISS, DBpia, OASIS (Korean DB), and J-STAGE (Japanese DB) will be searched without language limitation from their inception to October 2020. The intervention group will include patients who have received any type of acupuncture treatment for POD. The control group will include individuals with no treatment, sham acupuncture treatment, and conventional treatment. The primary outcome is the incidence of POD in each study. Quality assessment will be performed using the Cochrane risk of bias tool. A meta-analysis will be performed to pool the estimated effect. CONCLUSION: This study will provide evidence for acupuncture as a potential treatment for POD, in researchers, patients, and policy makers. DISSEMINATION: The result of the study will be disseminated through posters, press releases, conference presentations, and peer-reviewed papers. TRIAL REGISTRATION NUMBER: OSF 2020: (https://osf.io/usvdg).

Research Status Quo in Traditional Mongolian Medicine: A Bibliometric Analysis on Research Documents in the Web of Science Database.

OBJECTIVE: In this study, the current state of research on traditional Mongolian medicine (TMM) through a bibliometric analysis of research documents located in the Web of Science (WoS) database was assessed. METHODS: The WoS database was searched on September 2021 with the keywords "traditional Mongolian medicine." Publications on TMM scientific research were included in this study, without any language limitations. Bibliometric data from such publications were retrieved from the WoS database. Full records with cited reference lists were descriptively analyzed. To assess trends in TMM research topics, authors' keywords were analyzed. A thematic evolution map based on coword analysis was suggested. To analyze research networks among co-authors, affiliations, or countries of the authors, collaboration networks were evaluated. The Bibliometrix R package (3.1) was used for the analysis. RESULTS: A total of 234 scientific publications were included in the analysis. The top three countries of origin of the corresponding authors were China (n = 153), Japan (n = 28), and South Korea (n = 9). The top three relevant affiliations of the authors in the included publications were "Inner Mongolia Medical University," "Inner Mongolia University of Nationalities," and "National University of Mongolia." "Flavonoids," "cytotoxicity," "NMR," and "Tibetan medicine" were the most frequently used keywords in the included documents. Most publications focused on the chemical analysis and mechanism of effects of Mongolian herbal medications. There were few publications on nonpharmacological interventions such as bloodletting or TMM diagnostics, which should be promoted in future publications. CONCLUSION: There were only a limited number of publications on TMM identified through a search of the WoS database, using the keywords "Traditional Mongolian medicine." More improved strategy for searching for TMM publications must be established. Research publications on TMM, especially regarding nonpharmacological interventions, need to be promoted. In addition, collaboration with researchers worldwide needs to be encouraged in the future.

Monitoring in clinical trials of complementary and alternative medicine.

BACKGROUND: Clinical trial monitoring is an essential activity for quality assurance (QA) to ensure the protection of human rights and the reliability and transparency of the data collection process. The purpose of this article is to enhance the understanding of monitoring process and major findings in clinical trials of complementary and alternative medicine (CAM). METHODS: Based on International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use (ICH-GCP), we summarized main concept of monitoring process. Personal experiences on monitoring for CAM studies were also narratively described. RESULTS: In this brief article, the basic concept of QA and quality control (QC), various monitoring activities during the study process, and major findings regarding clinical trials of CAM are suggested in an effort to improve understanding of monitoring in clinical research on CAM. CONCLUSION: When performing clinical trials for CAM-related interventions, the monitoring recommended in GCP is needed to be recognized as a mandatory element in the course of CAM research.

Teaching Clinical Trials in Korean Medicine: Novel Modules and Student Perceptions of Importance and Achievement.

Introduction: The teaching of evidence-based medicine (EBM) is currently acknowledged to be an important aspect of the medical-education curriculum. Most programs that teach focus on knowledge transfer and skill acquisition in relation to the principle of EBM, as well as the critical appraisal. We established a 12-week elective course to teach clinical studies for undergraduate students at a Korean Medicine (KM) college, evaluating student perceptions to assess the feasibility of key teaching modules. Methods: From March 2019 to June 2019, a course was conducted, with 19 students enrolled. The course consisted of 12 modules; the last 3 classes included hands-on exercises involving a simulated clinical crossover trial. The students' perceptions of the need for and learning achieved during each teaching module were evaluated using a survey on the last day of class. Results: In student assessments of the need for each module, the median score was >4 on a 5-point Likert scale. Among student self-achievement ratings for each module, the simulated clinical trial received the highest score (a median value of 5) among all modules. Conclusion: This novel class was perceived as feasible by undergraduate KM students. The findings show the importance of teaching clinical trials to improve students' critical appraisal skills; more appropriate programs and curricula should be developed in future.

Herbal Medicine for Vascular Dementia: An Overview of Systematic Reviews.

INTRODUCTION: Vascular dementia (VaD), a severe neurologic condition related to aging of the cerebrovascular structure, has been treated with herbal medications and products. In this overview of systematic reviews (SRs) on the effects of herbal medications, we aimed to summarize the current clinical evidence on the benefits of herbal drugs and to propose an evidence map outlining their effects on VaD. METHODS: SRs assessing their effects on cognitive function or performance and the associated safety, published until December 2018, were located from PubMed, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, China National Knowledge Infrastructure, and Oriental Medicine Advanced Searching Integrated System. A Measurement Tool to Assess systematic Reviews 2 was used to assess their overall confidence. A bubble plot was proposed to present the depth and width of the current status of the evidence supporting the use of individual herbal drugs. RESULTS: Ten SRs (4 on individual herbal medications and 6 on various herbal drugs) were included. The overall evidence on herbal medicines suggests that they are effective in improving cognitive function and performance. Individual herbal medications including FuFangHaiShe, NaoXinTong, YinDanXing- NaoTong, NaoMaiTai, ShenFuTang, and TongXinLuo showed favourable effects when assessed via a minimal mental state examination score but have limited evidence supporting their effectiveness due to the scarcity of randomized controlled trials. Concerning safety, most SRs did not outline the estimated risk ratio of adverse events. CONCLUSION: Herbal medications might have benefits for VaD patients but they need to be evaluated further.