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BACKGROUND: Although aggressive invasion and sequential lymph node metastasis (LNM) significantly affect the prognosis of patients with head and neck squamous cell carcinoma (HNSCC), studies on identifying the factors that regulate this process remain scarce. This study found an inhibitor of DNA binding 2 (ID2) as a novel molecule involved in the regulation of invasion and LNM of HNSCC and further verified its functional role. METHODS: The study examined the translational significance between ID2 expression levels and the presence of LNM as well as the prognosis for 119 patients with HNSCC after treatment. In addition, in vitro and in vivo experiments were performed using ID2 gene-modulated HNSCC cell lines to determine the functional role of ID2 in the invasion and LNM of HNSCC. RESULTS: Elevated levels of ID2 expression were closely associated with the presence of LNM in 119 patients with HNSCC, resulting in a poor prognosis. Overexpression of ID2-induced invasion and LNM of HNSCC cells was observed in vitro and in vivo. By contrast, knockdown of the ID2 gene diminished invasion and LNM of HNSCC cells. In addition, the ID2 expression level increased the expression level of matrix metalloproteinase 1 (MMP1), a molecule downstream to ID2. Furthermore, silencing of MMP1 in ID2-overexpressed HNSCC cells rescued the elevated invasion and LNM capabilities of these cells, suggesting that ID2 enhances invasion and LNM partly via MMP1 activation. CONCLUSION: In the invasion and LNM of HNSCC, ID2 plays an important role by modulating MMP1 expression, suggesting ID2-MMP1 axis to be a novel alternative therapeutic target for invasion and LNM of HNSCC.
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Neoplasias de Cabeça e Pescoço , Proteína 2 Inibidora de Diferenciação , Carcinoma de Células Escamosas de Cabeça e Pescoço , Linhagem Celular Tumoral , DNA , Neoplasias de Cabeça e Pescoço/genética , Humanos , Proteína 2 Inibidora de Diferenciação/genética , Metástase Linfática , Carcinoma de Células Escamosas de Cabeça e Pescoço/genéticaRESUMO
BACKGROUND: The purpose of this study was to investigate the effectiveness and safety between electroacupuncture (EA) combined with usual care (UC) and UC alone for pain reduction and functional improvement in patients with non-acute low back pain (LBP) after back surgery. METHODS: In this multicentre, randomised, assessor-blinded active-controlled trial, 108 participants were equally randomised to either the EA with UC or the UC alone. Participants in the EA with UC group received EA treatment and UC treatment twice a week for 4 weeks; those allocated to the UC group received only UC. The primary outcome was the VAS pain intensity score. The secondary outcomes were functional improvement (Oswestry Disability Index [ODI]) and the quality of life (EuroQol-5-dimension questionnaire [EQ-5D]). The outcomes were measured at Week 5. RESULTS: Significant reductions were observed in the VAS (mean difference [MD] -8.15; P=0.0311) and ODI scores (MD -3.98; P=0.0460) between two groups after 4 weeks of treatment. No meaningful differences were found in the EQ-5D scores and incidence of adverse events (AEs) between the groups. The reported AEs did not have a causal relationship with EA treatment. CONCLUSIONS: The results showed that EA with UC treatment was more effective than UC alone and relatively safe in patients with non-acute LBP after back surgery. EA with UC treatment may be considered as an effective, integrated, conservative treatment for patients with non-acute LBP after back surgery. CLINICAL TRIAL REGISTRATION: KCT0001939.
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Terapia por Estimulação Elétrica/métodos , Eletroacupuntura/métodos , Dor Lombar/terapia , Manejo da Dor/métodos , Fusão Vertebral , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Resultado do TratamentoRESUMO
BACKGROUND: Alzheimer's disease (AD) is a neurodegenerative disorder characterized by progressive loss of cognitive abilities and memory leading to dementia. Electroacupuncture (EA) is a complementary alternative medicine approach, applying an electrical current to acupuncture points. In clinical and animal studies, EA causes cognitive improvements in AD and vascular dementia. However, EA-induced changes in cognition and microglia-mediated amyloid ß (Aß) degradation have not been determined yet in AD animals. Therefore, this study investigated the EA-induced molecular mechanisms causing cognitive improvement and anti-inflammatory activity in five familial mutation (5XFAD) mice, an animal model of AD. METHODS: 5XFAD mice were bilaterally treated with EA at the Taegye (KI3) acupoints three times per week for 2 weeks. To evaluate the effects of EA treatment on cognitive functions, novel object recognition and Y-maze tests were performed with non-Tg, 5XFAD (Tg), and EA-treated 5XFAD (Tg + KI3) mice. To examine the molecular mechanisms underlying EA effects, western blots, immunohistochemistry, and micro-positron emission tomography scans were performed. Furthermore, we studied synapse ultrastructures with transmission electron microscopy and used electrophysiology to investigate EA effects on synaptic plasticity in 5XFAD mice. RESULTS: EA treatment significantly improved working memory and synaptic plasticity, alleviated neuroinflammation, and reduced ultrastructural degradation of synapses via upregulation of synaptophysin and postsynaptic density-95 protein in 5XFAD mice. Furthermore, microglia-mediated Aß deposition was reduced after EA treatment and coincided with a reduction in amyloid precursor protein. CONCLUSIONS: Our findings demonstrate that EA treatment ameliorates cognitive impairment via inhibition of synaptic degeneration and neuroinflammation in a mouse model of AD.
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Doença de Alzheimer/patologia , Doença de Alzheimer/terapia , Disfunção Cognitiva/patologia , Disfunção Cognitiva/terapia , Modelos Animais de Doenças , Eletroacupuntura/métodos , Doença de Alzheimer/metabolismo , Animais , Encéfalo/metabolismo , Encéfalo/patologia , Disfunção Cognitiva/metabolismo , Feminino , Humanos , Inflamação/metabolismo , Inflamação/patologia , Inflamação/terapia , Camundongos , Camundongos TransgênicosRESUMO
BACKGROUND: Radial pressure pulse wave (RPPW) examination has been a key diagnostic component of traditional Chinese medicine. The objective of this study was to investigate the changes in RPPW along with various hemodynamic variables after acupuncture stimulation and to examine the validity of pulse diagnosis as a modern diagnostic tool. METHODS: We conducted acupuncture stimulation at both ST36 acupuncture points in 25 healthy volunteers. We simultaneously assessed the RPPW by pulse tonometry; heart rate variability (HRV) by electrocardiogram; photoplethysmogram (PPG) signals, respiration rate, peripheral blood flow velocity and arterial depth by ultrasonography; and cardiac output by impedance cardiography, before, during and after a session of acupuncture stimulation. RESULTS: We observed consistent patterns of increased spectral energy at low frequency (<10 Hz) and pulse power using RPPW examination and in the amplitude and systolic area of the PPG signal during the entire acupuncture session. The low- and high-frequency domains of HRV increased and decreased, respectively, during the acupuncture session. The peripheral blood velocity rose shortly after needle insertion, reached a maximum in the middle of the session and decreased afterwards. The augmentation index (AIX) and pulse transit time (PTT) obtained from RPPW did not change significantly. CONCLUSION: Acupuncture stimulation at ST36 in healthy subjects increased the peripheral pulse amplitudes (pressure pulse wave (PPW) and PPG), blood flow velocity (ultrasonography) and sympathetic nerve activity (HRV). The lack of changes in the AIX and PTT suggests that the increased pulse amplitudes and blood flow velocity may result from increased cardiac output. TRIAL REGISTRATION: Clinical Research Information Service ( KCT0001663 ).
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Terapia por Acupuntura , Pressão Sanguínea , Frequência Cardíaca , Pontos de Acupuntura , Adulto , Velocidade do Fluxo Sanguíneo , Feminino , Voluntários Saudáveis , Hemodinâmica , Humanos , Masculino , Estudos Prospectivos , Adulto JovemRESUMO
Acupuncture treatment can be defined as a medical procedure with an acupuncture needle at acupoints. Establishing suitable control settings is essential, based on the target elements of the acupuncture therapy. In order to properly design a clinical trial or an experiment, a control group must be established. Here, we overview the significance of the control group and its limitations in acupuncture research. Clinical trials have employed a variety of study designs and controls for acupuncture treatment in order to compare the effects of actual treatments with control groups that include no treatment or treatment as usual, sham acupuncture at true acupoints, real acupuncture at non-acupoints, and sham acupuncture at non-acupoints. In order to determine the point-specificity of acupuncture, real acupuncture at non-acupoints should be taken into consideration, whereas sham acupuncture at the same true acupoints should be used to determine the needling-specific effect of acupuncture. It is crucial to choose the optimum control for acupuncture treatments depending on the study's main goal and to interpret the results in accordance with the research design.
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BACKGROUND: Acupotomy, a more invasive procedure than acupuncture, involves the use of a thicker needle with an integrated knife at the tip, necessitating safety research. We aimed to define relevant adverse events (AEs) and create a standardized form of the ACUPOtomy-related AEs CHECKlist (ACUPOCHECK). METHODS: Before conducting the Delphi process, a systematic review and pilot prospective study were conducted to gather information on previously reported AEs. Using these data, pilot versions of the ACUPOCHECK and Delphi questionnaires were developed. The Delphi questionnaire involved selecting types of AE for inclusion, establishing separate criteria for acupotomy-related AEs, and achieving a consensus on AE assessment. Thirteen Korean doctors with experience in acupotomy or AE research were recruited to participate in each Delphi round. Consensus was considered to have been reached if the critical value for the content validity ratio met or exceeded 0.538. RESULTS: The final ACUPOCHECK was developed using four rounds of the Delphi method and one face-to-face consensus meeting. It included 12 local AEs (pain, hemorrhage, bruise, hematoma, edema, pruritus, rash, infection, nerve damage, dysesthesia, movement impairment, and pneumothorax) and 14 systemic AEs (disease aggravation, needle fatigue, sleepiness, procedural nausea, procedural vomiting, procedural headache, procedural dizziness, sweating, procedural shock, syncope, dyspnea, procedural pain, sleep disorder, and postprocedural infection). Separate criteria were established for pain, hemorrhage and bruising: pain was defined as pain that occurrs during daily activities and persists for longer than 72 h, hemorrhage as bleeding that continues for ≥ 3 min despite pressure application, and bruising as having a bruise with a diameter of ≥ 3 cm. Open-ended descriptions were allowed for AEs not covered by the checklist, and severity and causality were assessed using the Common Terminology Criteria for Adverse Events and modified World Health Organization-Uppsala Monitoring Center criteria. CONCLUSION: ACUPOCHECK provides a standardization framework that can help research on traditional practices as well as new tools and techniques that are more invasive and may cause more severe AEs. Subsequent studies will use ACUPOCHECK to develop rational safety guidelines for acupotomy techniques. Please cite this article as: Jun H, Lee H, Yoon SH, Kwon CY, Jeon D, Lee JH, Leem J. Delphi study for developing a checklist of adverse events associated with acupotomy. J Integr Med. 2024; Epub ahead of print.
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BACKGROUND: When patients continue to experience cough despite conventional treatment, East Asian traditional medicine (EATM) including herbal medicine and/or acupuncture has been frequently used. Previous systematic reviews of EATM treatment for chronic cough have been conducted mainly on herbal medicine, targeting patients with conditions that cause cough. In clinical practice, EATM interventions are not limited to herbal medicine, and considering that chronic cough is often caused by two or more conditions or unspecific causes, a comprehensive investigation is clinically relevant. We examined the current research status of EATM for chronic cough. METHODS: Based on Arksey and O'Malley's scoping review methodological framework, a total of six English, Chinese, Korean, and Japanese electronic databases were searched on August 2022. Any clinical studies on EATM targeting chronic cough patients (regardless of their cause) were included. RESULTS: Among 474 included studies, the study designs were mainly randomized controlled trials (72.4%), and the population was evenly distributed between children and adults. The cause of cough was not reported in most studies (56.1%). The common cause of cough was upper airway cough syndrome and post-respiratory infection (9.5%, each), followed by mixed cause (7.6%), nonspecific cause (5.9%), and gastroesophageal reflux disease (4.0%). EATM was conducted for a mean of 19.1 days, and herbal medicine was the most common (80.6%). Conventional medication was frequently used as a control (81.2%). For outcomes, the total effective rate was the most frequently utilized (94.3%), followed by cough severity (53.8%). EATM treatment showed positive outcomes in most studies. CONCLUSIONS: In future EATM studies, it is necessary to either specify the cause of chronic cough or to report that the study was targeting nonspecific chronic cough. In addition, high-quality studies assessing the efficacy of EATM with placebo control treatment should be conducted, using validated evaluation tools.
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Medicina Tradicional do Leste Asiático , Plantas Medicinais , Anormalidades do Sistema Respiratório , Adulto , Criança , Humanos , Tosse Crônica , Tosse/etiologia , Extratos Vegetais/uso terapêuticoRESUMO
Klebsiella pneumoniae is an uncommon cause of septic arthritis in adults. However, late detection can cause serious complications, including joint destruction and immobility. The purpose of this study was to report a case of successfully treated septic arthritis of the hip joint (SAHJ) caused by K. pneumoniae. A 49-year-old female patient presented to our hospital with fever and progressive severe pain in the right hip area. Although there was no abnormality on plain radiographs, ultrasonography revealed diffuse swelling of the right hip joint. Under ultrasonography guidance, the hip joint fluid was aspirated, and Gram staining and culturing were performed. The patient's pain was significantly reduced after the joint aspiration. The Gram staining and culturing revealed gram-negative bacilli, which were subsequently identified as K. pneumoniae. According to the results, systemic intravenous antibiotic (ceftriaxone) was administered without complications, and the patient was discharged on oral antibiotic (ciprofloxacin). Clinical cases of septic arthritis of the knee or sacroiliac joint have been occasionally reported in adults, but cases of SAHJ are rare. Moreover, K. pneumonia-induced SAHJ has not been reported to date. Therefore, we report this very rare case and its successful treatment.
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Background Bone fractures are important clinical events for both patients and professionals. Active treatment options are limited for delayed unions and for nonunions; surgery is common but not entirely risk-free. This report describes three cases of delayed union successfully treated with herbal decoction. Participants Three patients had trapezoid and 3rd metacarpal bone fractures, 2nd, and 5th metatarsal bone fractures, respectively. All three patients were diagnosed with delayed union by an independent orthopedic surgeon based on computed tomography (CT) scan/radiographic imaging and fracture duration without a healing process. Patients took herbal decoction, Jeopgol-tang, with individually added herbs based on symptom manifestations, twice daily for 56, 85 and 91 days with no additional interventions except for a splint that they had been wearing since fracture diagnosis. Outcomes Improvement of delayed union was evaluated using radiographic imaging or CT during treatment with Jeopgol-tang. Results After taking herbal medicine, callus and bony bridging were confirmed on follow-up imagings and the patients described their experience with pain reduction at an interview after recovery. Conclusions This case series suggests that the herbal decoction Jeopgol-tang warrants further investigation to establish its role as a complementary and integrative medicine treatment option for delayed unions.
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Fraturas Ósseas , Fraturas não Consolidadas , Humanos , Fraturas não Consolidadas/diagnóstico por imagem , Fraturas não Consolidadas/cirurgia , Estudos Retrospectivos , Fraturas Ósseas/diagnóstico por imagem , Fraturas Ósseas/tratamento farmacológico , Fraturas Ósseas/cirurgia , RadiografiaRESUMO
Objectives: Chronic cough is a frequent condition worldwide that significantly impairs quality of life. Herbal medicine (HM) has been used to treat chronic cough due to the limited effectiveness of conventional medications. This study aimed to summarize and determine the effects of HM on patients with chronic cough. Methods: A comprehensive search of 11 databases was conducted to find randomized controlled clinical trials (RCTs) that reported the effects of HM for patients with chronic cough on 16 March 2023. The primary outcome was cough severity, and the secondary outcomes included cough-related quality of life, cough frequency, total effective rate (TER), and cough recurrence rate. The methodological quality of the included studies was assessed using the Cochrane risk of bias tool, and the certainty of the evidence for effect estimates was assessed using the Grading of Recommendations, Assessment, Development, and Evaluations tool. Results: A total of 80 RCTs comprising 7,573 patients were included. When HM was used as an alternative therapy to conventional medication, there were inconsistent results in improving cough severity. However, HM significantly improved cough-related quality of life and TER and significantly lowered the cough recurrence rate compared with conventional medication. When used as an add-on therapy to conventional medication, HM significantly improved cough severity, cough-related quality of life, and TER and significantly lowered the recurrence rate. In addition, HM had a significantly lower incidence of adverse events when used as an add-on or alternative therapy to conventional medication. The subgroup analysis according to age and cause of cough also showed a statistically consistent correlation with the overall results. The certainty of the evidence for the effect of HM was generally moderate to low due to the risk of bias in the included studies. Conclusion: HM may improve cough severity and cough-related quality of life, and lower the cough recurrence rate and incidence of adverse events in patients with chronic cough. However, due to the high risk of bias and clinical heterogeneity of the included studies, further high-quality placebo-controlled clinical trials should be conducted using a validated and objective assessment tool. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023418736, CRD42023418736.
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Background: Gyejibokryeong-hwan (GBH), a herbal mixture that is widely used for climacteric syndrome, is studied for its efficacy; however, no study evaluated the GBH indication, which is a blood-stasis pattern based on traditional Chinese medicine theory. Methods: This is a randomized, double-blinded, placebo-controlled clinical pilot trial. Fifty subjects with climacteric syndrome were recruited and randomly assigned to GBH group or placebo group. Subjects were administered GBH or placebo granules for 4 weeks followed by 4 weeks of observation period. For the primary outcome, the Menopause Rating Scale (MRS) was evaluated. For the secondary outcomes, quality of life, degrees of abdominal resistance and tenderness, blood-stasis pattern questionnaire and degree of upward movement of Qi were evaluated. Results: After 4-week intervention, the mean change of total MRS score significantly decreased in the GBH group compared to the placebo group (p = 0.037). The quality of life related to physical health (p = 0.008) and blood-stasis pattern (p = 0.018) significantly improved in the GBH group but not in the placebo group. Conclusion: Our findings provide evidence of the feasibility of recruiting subjects with GBH indications and show that GBH may have clinical efficacy for the treatment of menopausal symptoms, especially urogenital symptoms, without any significant adverse events. Trial registration: Clinical Research Information Service (CRIS identifier: KCT0002170).
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BACKGROUND: To evaluate safety of acupuncture treatment by Korean Medicine Doctors (KMDs), a prospective, practice-based survey on adverse events (AEs) associated with acupuncture was conducted. METHODS: From July 2016 to October 2017, KMDs were invited to participate in an online survey. Frequency was calculated as the number of AEs per 10,000 treatments; severity was assessed with the Common Terminology Criteria for Adverse Events Grading (Severity) Scale; and causality was evaluated using the World Health Organisation-Uppsala Monitoring Centre system for standardised case causality assessment. Associations between AE occurrence and KMDs' type of practice/clinical experience and patient age/gender/current medication(s) were analysed. RESULTS: Data on 37,490 acupuncture treatments were collected from 222 KMDs. At least one AE was reported from 4,518 acupuncture treatments, giving a frequency rate of 1,205 per 10,000 acupuncture treatments; this increased to 4,768 treatments when administrative problems related to defective devices or medical negligence were added, for a rate of 1,272 per 10,000 acupuncture treatments. Commonly reported AEs were bleeding, needle site pain, and bruising. Approximately 72.9% of AEs/administrative problems were assessed as they certainly occurred by acupuncture treatment in causality assessment. Most AEs/administrative problems were considered mild in severity and two life-threatening AEs were resolved with no sequelae. Compared to males, female patients were more likely to experience AEs and KMDs' clinical experience was not associated with reported AE occurrence. CONCLUSIONS: Although acupuncture-associated AEs occur commonly, they are largely transient and mild. Acupuncture performed by qualified KMDs may serve as a reliable medical treatment with acceptable safety profiles.
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Terapia por Acupuntura , Humanos , Masculino , Feminino , Estudos Prospectivos , Terapia por Acupuntura/efeitos adversos , Inquéritos e Questionários , Encaminhamento e Consulta , República da CoreiaRESUMO
BACKGROUND: Insomnia is one of the most frequent symptoms in people with cancer. Electroacupuncture has been widely used in people with cancer or insomnia. We explored the feasibility and preliminary effectiveness of electroacupuncture for cancer-related insomnia. METHODS: People with cancer and insomnia disorder were randomly allocated to electroacupuncture, sham-electroacupuncture, or usual care groups. Participants received either 10 sessions of electroacupuncture at real acupoints, sham-electroacupuncture at non-acupoints, or usual care in each group for 4 weeks. We calculated the recruitment, adherence, and completion rates of participants. The Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), sleep diary and actigraphy-derived sleep parameters, Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Montreal Cognitive Assessment (MoCA), and salivary levels of cortisol and melatonin were evaluated as outcome measures. RESULTS: Twenty-two participants were enrolled (8, 6, and 8 respectively in the electroacupuncture, sham-electroacupuncture, and usual care groups) and 20 participants completed the trials (8, 4, and 8 respectively). The recruitment, adherence, and completion rates were 78.57% (22/28), 95.45% (21/22), and 90.91% (20/22), respectively. Most of the participants had previously received conventional treatment for insomnia, but few had received Korean medicine treatment, without any demographic or clinical differences between groups. In the electroacupuncture group, there was a statistically significant reduction of 10.13 (mean) ± 8.15 (standard deviation) and 5 ± 3.70 points in mean ISI and PSQI scores at 4 weeks post-treatment (P = .0098 and .0066), compared with sham-electroacupuncture (2.06 ± 7.15 and 1.61 ± 4.34; P = .4796 and .3632) and usual care (3.25 ± 2.60 and 1.38 ± 2.13; P = .0096 and .1112). Although there was no significant difference in ISI score between groups at 4 weeks post-treatment, the electroacupuncture group continued to improve significantly at 4 weeks' follow-up, showing borderline and significant differences compared to the sham-electroacupuncture and usual care (P = .0614 and .0015). The FACT-F scores in electroacupuncture group showed a significant improvement compared with the sham-electroacupuncture group (P = .0305). No electroacupuncture-related adverse events were reported. CONCLUSIONS: Electroacupuncture might be feasible for cancer-related insomnia, despite slow participant recruitment. Additional trials with adequately powered sample sizes and a substantial change to the recruitment procedure are needed. TRIAL REGISTRATION: Clinical Research Information Service, KCT0002162 . Submitted 27 October 2016, Registered 2 December 2016 - Retrospectively registered (The first participant enrolment: 28 November 2016).
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Eletroacupuntura , Neoplasias , Distúrbios do Início e da Manutenção do Sono , Pontos de Acupuntura , Humanos , Neoplasias/complicações , Neoplasias/terapia , Distúrbios do Início e da Manutenção do Sono/terapia , Resultado do TratamentoRESUMO
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.
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Introduction: Gastroesophageal reflux-induced chronic cough (GERC) is one of the most common etiologies of chronic cough. Despite the growing prevalence and interest in GERC, no effective treatment is currently available. In our study, we used a combination of herbal medicines, Ojeok-san (OJS) plus Saengmaek-san (SMS), for the treatment of GERC. Methods: We conducted a pilot, randomized, placebo-controlled, parallel-arm, single-center clinical trial to assess the feasibility of our study protocol, as our study is the first herbal medicine trial for GERC. All enrolled participants were randomly assigned to either the intervention or placebo group in a 1:1 ratio and were administered trial drugs three times a day for 6 weeks, with an evaluation visit performed every 2 weeks for their efficacy and safety assessment until the follow-up visit (week 8). We evaluated the severity and frequency of cough, cough-specific quality of life, airway hypersensitivity, and reflux-related gastrointestinal symptoms, as well as pattern identification, to investigate the complex mechanisms of reflux cough syndrome. Results: A total of 30 participants were enrolled, and 25 completed the study at Kyung Hee University Korean Medicine Hospital from 26 December 2018 to 31 May 2021. OJS plus SMS significantly improved the cough diary score (CDS), cough visual analog scale, Korean version of the Leicester Cough Questionnaire, Hull Airway Reflux Questionnaire, and Gastrointestinal Symptom Rating Scale after the treatment compared to the baseline. Notably, OJS plus SMS showed significant efficacy in the daytime and total CDS compared with the placebo. Only one adverse event was observed during the trial, and no serious adverse events occurred. Additionally, we achieved successful results in feasibility outcomes by exceeding the ratio of 80%. Conclusion: We confirmed the feasibility of our trial design and demonstrated the potential of OJS plus SMS in relieving the severity of cough and GI symptoms in GERC patients with safe and successful feasibility results. We anticipate that our study results will be used as the basis for further large-scale, well-designed, confirmatory trials to evaluate the safety and efficacy of OJS plus SMS in GERC. Clinical Trial Registration: [https://cris.nih.go.kr], identifier WHO International Clinical Trials Registry Platform, Clinical Research Information Service [KCT0003115].
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[This corrects the article DOI: 10.1016/j.imr.2021.100802.].
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BACKGROUND: The first treatment option for major depressive disorder (MDD) is antidepressants, however, there is substantial demand for alternative therapies due to its low compliance and remission rates. This study was aimed to explore the effectiveness, safety, and feasibility of electroacupuncture plus moxibustion therapy for MDD. METHODS: Thirty adults with MDD were randomly assigned to the treatment group (TG) or control group (CG). The TG was treated with electroacupuncture plus moxibustion, and the CG received sham interventions at non-acupoints for 8 weeks. The primary outcome measure was the intergroup difference of the mean change of total score of the Hamilton rating scale for depression (HRSD) between baseline and week 9. Secondary outcome measures were Beck's depression inventory, insomnia severity index, the state-trait anxiety inventory, the EuroQol-5 dimension index, the measure yourself medical outcome profile version 2, and frontal alpha asymmetry measured by electroencephalography. Adverse events (AEs) were monitored for safety assessment. RESULTS: The primary outcome measure was not significantly different between the two groups (p=0.2641), although the scores of HRSD in both groups improved significantly after treatment. No significant difference was identified between groups in secondary outcome measures. The incidence of AE was not significantly different between the two groups (p=0.1067). CONCLUSION: A clinical trial using electroacupuncture plus moxibustion for MDD seems feasible. However, further studies with the larger size, adopting ideal controls are warranted to provide a confirmative conclusion to the efficacy and safety of electroacupuncture plus moxibustion for MDD. TRIAL REGISTRATION: The protocol was registered at Korean Clinical Trial Registry (CRIS-KCT0001810).
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Lumbosacral radiculopathy (LR) is a musculoskeletal disorder or pain syndrome that is generally linked to the compression or irritation of the nerve root. There is a growing interest in the development of efficient acupuncture-based treatments for LR comparable to western medicine. Structured traditional Korean medical treatments including intensified acupuncture stimulus on the EX-B2 point using the G-shaped posture modified from the sitting posture were applied to four LR patients, and the outcomes were evaluated based on objective clinical endpoints including a numeric rating scale (NRS), the Oswestry disability index (ODI), the manual muscle test (MMT), neurological symptoms, and plantar photography. Patients showed improvements in NRS, ODI, MMT, and neurological symptoms without adverse effects during hospitalization and follow-up visits. Moreover, we observed substantial dissolvement of hyperkeratinization and parchedness of the soles of the feet, which was not reported previously. These four cases demonstrate the clinical usefulness of traditional medicine and the diagnostic applicability of plantar photography. However, further randomized controlled trials are required to confirm our findings.
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Terapia por Acupuntura , Radiculopatia , Humanos , Radiculopatia/terapia , Radiculopatia/diagnóstico , Manejo da Dor , Resultado do TratamentoRESUMO
OBJECTIVES: We aimed to compare the effectiveness and safety of Chuna manual therapy combined with usual care to those of usual care alone for treating whiplash injuries. DESIGN: A two-arm, parallel, assessor-blinded, multicenter pragmatic randomized clinical trial. SETTING: Three hospitals in Korea. PARTICIPANTS: Overall, 132 participants between 19 and 70 years of age, involved in traffic accidents and treated at three hospitals in Korea, >2 but <13 weeks prior to enrollment, with neck pain consistent with whiplash-associated disorder grades I and II and a numeric rating scale score ≥5 were included. INTERVENTIONS: Participants were equally and randomly allocated to the Chuna manual therapy and usual care (n = 66) or usual care (n = 66) groups and underwent corresponding treatment for three weeks. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the number of days to achieve a 50% pain reduction. Secondary outcomes included areas under the 50% numeric rating scale reduction curve: pain, disability, quality of life, and safety. RESULTS: The Chuna manual therapy + usual care group (23.31 ± 21.36 days; p = 0.01) required significantly fewer days to achieve 50% pain reduction compared to the usual care group (50.41 ± 48.32 days; p = 0.01). Regarding pain severity, functional index, and quality of life index, Chuna manual therapy and usual care were more effective than usual care alone. Safety was acceptable in both groups. CONCLUSIONS: In patients with subacute whiplash injury, Chuna manual therapy showed a rapid rate of recovery, high effectiveness, and safety.
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Manipulações Musculoesqueléticas , Traumatismos em Chicotada , Humanos , Recém-Nascido , Cervicalgia/terapia , Medição da Dor , Qualidade de Vida , Resultado do Tratamento , Traumatismos em Chicotada/terapiaRESUMO
This study aimed to compare the cost-effectiveness of manual therapy and usual care for patients with chronic neck pain. A cost-utility analysis alongside a pragmatic randomized controlled trial was conducted in five South Korean hospitals. Data were procured from surveys and nationally representative data. Participants were 108 patients aged between 19 and 60 years, with chronic neck pain persisting for at least 3 months and a pain intensity score of ≥5 on the numerical rating scale in the last 3 days. The study was conducted for 1 year, including 5 weeks of intervention and additional observational periods. Participants were divided into a manual therapy (Chuna) group and a usual care group, and quality-adjusted life-years, costs, and the incremental cost-effectiveness ratio were calculated. The quality-adjusted life-years of the manual therapy group were 0.024 higher than that of the usual care group. From the societal perspective, manual therapy incurred a lower cost-at $2,131-and was, therefore, the more cost-effective intervention. From a healthcare system perspective, the cost of manual therapy was higher, with an incremental cost-effectiveness ratio amount of $11,217. Manual therapy is more cost-effective for non-specific chronic neck pain management from both a healthcare system and societal perspective.