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.

The effect of sham acupuncture can differ depending on the points needled in knee osteoarthritis: A systematic review and network meta-analysis.

Objective: In sham acupuncture-controlled acupuncture clinical trials, although sham acupuncture techniques are different from those of verum acupuncture, the same acupuncture points are often used for verum and sham acupuncture, raising the question of whether sham acupuncture is an appropriate placebo. We aimed to examine the effects of sham and verum acupuncture according to the points needled (same or different between verum and sham acupuncture) in knee osteoarthritis. Methods: Ten databases were searched to find randomized controlled clinical trials (RCTs) assessing the effects of verum acupuncture with sham acupuncture or waiting lists on knee osteoarthritis. Sham acupuncture was classified as using the same acupuncture points as those in verum acupuncture (SATV) or using sham points (SATS). A frequentist network meta-analysis (NMA) was conducted, and the certainty of evidence was evaluated. Results: A total of 10 RCTs involving 1628 participants were included. Verum acupuncture was significantly superior to SATS but not different from SATV in terms of pain reduction. Additionally, SATV was significantly superior to the waiting list. For physical function, no difference were found between verum acupuncture, SATV, and SATS. The certainty of evidence was low to moderate. Conclusion: For knee osteoarthritis, the pain reduction effect of acupuncture may differ according to the needling points of sham acupuncture, and the control group should be established according to the specific aim of the study design and treatment mechanism.

Different Outcomes According to Needling Point Location Used in Sham Acupuncture for Cancer-Related Pain: A Systematic Review and Network Meta-Analysis.

Numerous acupuncture studies have been conducted on cancer-related pain; however, its efficacy compared to sham acupuncture remains controversial. We confirmed whether the outcome of acupuncture differs according to the needling points of sham acupuncture for cancer-related pain. We searched 10 databases on 23 May 2023 to screen acupuncture trials using sham acupuncture or waiting list as controls for cancer-related pain. Sham acupuncture was classified into two types, depending on whether the needling was applied at the same locations as verum acupuncture (SATV) or not (SATS). A network meta-analysis (NMA) was performed on the basis of a frequentist approach to assess pain severity. Eight studies (n = 574 participants) were included in the review, seven of which (n = 527 participants) were included in the NMA. The pain severity was not significantly different between SATV and verum acupuncture, but verum acupuncture significantly improved pain severity compared to SATS. The risk of bias affecting the comparisons between the verum and sham acupuncture was generally low. Previous acupuncture trials for cancer-related pain showed differing outcomes of sham and verum acupuncture, depending on the needling points of sham acupuncture. The application of SATV cannot be considered a true placebo, which leads to an underestimation of the efficacy of verum acupuncture.

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.

Needling Point Location Used in Sham Acupuncture for Chronic Nonspecific Low Back Pain: A Systematic Review and Network Meta-Analysis.

Importance: When sham acupuncture is set as a control in evaluating acupuncture, the sham needling technique is usually different from acupuncture. However, the sham procedure is conducted either at the same points that are used for the acupuncture group or at nonindicated points. Objective: To assess whether the outcome of sham acupuncture varies according to the needling points in sham-controlled trials of acupuncture for chronic nonspecific low back pain (CLBP) as an example. Data sources: Searches of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and the Allied and Complementary Medicine Database were conducted on February 12, 2023. Study selection: Randomized clinical trials (RCTs) assessing the outcomes of acupuncture in sham acupuncture-controlled or waiting list-controlled trials on CLBP were included. Data extraction and synthesis: Two researchers independently extracted data on study characteristics and outcomes and assessed quality. Sham acupuncture was classified according to whether it was conducted at the same acupuncture points used in the acupuncture group, referred to as sham acupuncture therapy (verum) (SATV) or at different points, referred to as sham acupuncture therapy (sham) (SATS). Clinical similarity, transitivity, and consistency tests were conducted, followed by a random-effects frequentist network meta-analysis (NMA). Main outcomes and measures: The primary outcome was pain, and the secondary outcome was back-specific function. The first assessment after the end of treatment was chosen for analysis. Effect sizes are reported as standardized mean differences (SMD) with 95% CIs. The risk of bias was assessed using the Cochrane risk of bias tool, and the certainty of evidence for findings was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach. Results: Ten RCTs involving 4379 participants were included. In comparison with SATS, acupuncture was significantly associated with improvements in both pain (SMD, -0.33; 95% CI, -0.52 to -0.15) and function outcomes (SMD, -0.13; 95% CI, -0.25 to -0.02); however, there were no differences between acupuncture and SATV. In comparison with SATS, SATV was significantly associated with better pain (SMD, -0.45; 95% CI, -0.88 to -0.03) and function outcomes (SMD, -0.30; 95% CI, -0.56 to -0.05). The risk of bias that could affect the interpretation of the results was usually low, and the certainty of evidence was moderate to low. Conclusions and relevance: In this NMA, sham acupuncture needling at the same points as those in acupuncture was not a true placebo control for assessing the efficacy of acupuncture for CLBP and might underestimate the outcome of acupuncture in clinical settings.

Acupotomy in Korean Medicine Doctors: A Preliminary Survey on Experiences, Perceptions, and Clinical Usage Status.

Acupotomy is a widely used medical intervention in traditional East Asian medicine, and efforts are being made to improve its effectiveness and safety. As a first step toward establishing more standardized procedural guidelines, a survey was conducted to explore the current clinical practice status and perceived adverse events (AEs) by Korean Medicine (KM) practitioners. The survey was developed via expert consensus and included information on clinical usage, perception, and the AEs experienced. The largest acupotomy society in Korea, which consists of 185 KM doctors, participated in an online survey conducted in September 2021. Of the 185 KM doctors, 107 (57.8%) responded. Musculoskeletal and connective tissue diseases accounted for 80.8% of suggested indications by KM doctors. Regarding the detailed procedure, there were considerable discrepancies between KM doctors. The most frequent acupotomy-related AEs observed by KM practitioners were bruises (77.3%), fatigue (57.7%), pain (51.8%), and hematoma (51.8%). Only 1.8% of the respondents answered that they had experienced severe AEs. Survey respondents answered that the use of imaging devices during acupotomy and the development of clinical practice guidelines are the most necessary policy requirements for promoting the use and ensuring the safety of acupotomy. To the best of our knowledge, this study marks the initial exploration into the KM physicians' clinical usage status, AEs experienced, and their requests for standardized guidelines and expanded health insurance coverage concerning acupotomy. Further research should include qualitative studies to assess patient experience and prospective observational studies to examine the effects of operator skills and treatment modalities on AEs and adherence.

Sham Acupuncture Is Not Just a Placebo.

Sham acupuncture should have two distinct features: first, it must be morphologically similar to verum acupuncture for blinding purposes, and second, it must not exert physiologically expected effects of verum acupuncture. While several types of sham acupuncture are currently used, there are on-going debates on which sham acupuncture can meet the criteria for being an appropriate control intervention in acupuncture research. In view of this situation, it is unreasonable to regard the use of sham acupuncture in acupuncture research as the same as the use of placebo drugs in drug research. Given the current research evidence that sham acupuncture can exert not only the originally expected non-specific effects but also sham acupuncture-specific effects, it would be misleading to simply regard sham acupuncture as the same as placebo. Therefore, researchers should be cautious when using the term sham acupuncture in clinical investigations.

Effectiveness and safety of herbal medicine Ukgansan for clinical symptoms in Parkinson's disease: A pilot, randomized, assessor-blinded clinical trial.

Objectives: Parkinson's disease (PD) is a neurodegenerative disease in which patients are suffering various symptoms. Previous experimental studies suggested that herbal medicine Ukgansan (UGS) could be beneficial for PD. The aim of this pilot clinical trial was to evaluate the efficacy of UGS for improving clinical symptoms in patients with PD. Methods: Sixty patients with idiopathic PD were randomly assigned to receive either UGS plus acupuncture or acupuncture alone for 6 weeks. During the trial, all anti-parkinsonian medications were maintained. Subjects were evaluated for various clinical assessments of PD, including the Movement Disorder Society-Sponsored Revision of the Unified PD Rating Scale (MDS-UPDRS) and the 39-item Parkinson's Disease Questionnaire (PDQ-39), until 12 weeks. Results: In MDS-UPDRS between the groups, no significant time x group interaction was found. In the subgroup analysis of participants with anxiety, a significant time x group interaction was found in the PDQ-39 domain of mobility (P = 0.007), activities of daily living (P = 0.042), and the PDQ-39 summary index (P = 0.048). In addition, post-hoc analysis in participants with anxiety showed a significant decrease in the domains of mobility (P = 0.001) and activities of daily living (P = 0.013) at week 7. There were no adverse events associated with UGS. Conclusion: The additional administration of UGS has the potential to significantly improve the quality of life of PD patients with anxiety. In order to create more definitive evidence, clinical trials with more rigorous methodologies should be conducted in future. Clinical trial registration: http://cris.nih.go.kr, identifier: KCT0003444.

Herbal Medicines for Post-Acute Sequelae (Fatigue or Cognitive Dysfunction) of SARS-CoV-2 Infection: A Phase 2 Pilot Clinical Study Protocol.

Long-term sequelae refer to persistent symptoms or signs for >6 months after SARS-CoV-2 infection. The most common symptoms of sequelae are fatigue and neuropsychiatric symptoms (concentration difficulty, amnesia, cognitive dysfunction, anxiety, and depression). However, approved treatments have not been fully established. Herbal medicines are administered for 12 weeks to patients who continuously complain of fatigue or cognitive dysfunction for >4 weeks that only occurred after COVID-19 diagnoses. Based on the Korean Medicine syndrome differentiation diagnosis, patients with fatigue will be administered Bojungikgi-tang or Kyungok-go, whereas those with cognitive dysfunction will be administered Cheonwangbosim-dan. Results could support evidence that herbal medicines may mitigate fatigue and cognitive dysfunction caused by COVID-19. Furthermore, by investigating the effects of herbal medicines on changes in metabolite and immune response due to COVID-19, which may be responsible for sequelae, the potential of herbal medicines as one of the therapeutic interventions for post-acute sequelae of SARS-CoV-2 infection can be evaluated. Therefore, the effects of herbal medicine on fatigue and cognitive dysfunction sequelae due to COVID-19 will be elucidated in this study to provide an insight into the preparation of medical management for the post-acute sequelae of SARS-CoV-2 infection.

A nationwide survey on the management of the COVID-19 pandemic and respiratory disease in South Korea.

Background: This study aimed to explore individual prevalence of respiratory symptoms and to describe the Korean population's treatment approaches, preventive health behaviors, and mental health conditions during the pandemic. Methods: We analyzed responses from an online nationwide survey, conducted between February 2021 to May 2021, about people's experiences during the pandemic. Statistical analysis was also performed to see if there were any significant differences in treatment and prevention strategies between different groups of respondents (between those had respiratory symptoms, compared with those who did not, and between those tested positive for COVID-19, compared with those who did not). Results: A total of 2,177 survey respondents completed the survey and, of these, only 142 had experienced symptoms. The most frequently reported respiratory infections related symptoms were runny or blocked nose (47.6%), cough (45.5%), fever (44.1%), sore throat (42.0%), and fatigue (30.1%). More than half of the respondents (53.1%) used complementary and alternative medicine (CAM) approaches as means of preventive measures. In terms of preventive behaviors, the more emphasized behaviors were mask-wearing (58.9%) and hand-washing after coming home (42.7%). The majority of the respondents (64.9%) did not show signs of mental health issues. Conclusion: In South Korea, conventional medicine was mainly used for COVID-19 treatment whereas CAM was commonly used as preventive measures. COVID-19 was also found to have less impact on the general population's mental health. The findings of this study may shed light on how the pandemic impacted the general population.

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.

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.