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(1) Background: Facial palsy is a common health issue which leads to sequelae and disability. This systematic review aimed to assess the efficacy of laser therapy for the treatment of facial palsy. (2) Methods: Only randomized controlled trials comparing the effectiveness of laser therapy to non-laser intervention, no intervention, or placebo were searched for. Relevant studies were searched in seven electronic databases. Studies that examined the use of laser modalities for facial palsy management, with or without acupuncture, were also included. Two authors independently read and scored the methodological quality of the selected texts, and any disagreement was resolved by discussion or by intervention from the third author. (3) Results and conclusions: With five full-text articles, a methodological quality for each included study was assessed (kappa coefficient = 0.75). The laser therapy group in the mean difference measuring FDI showed an effect size of 8.15 compared to the control group; while measuring the paralysis score, an advantage was disclosed with an effect size of 0.22 compared to the control group.
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The purpose of this study was to investigate the clinical effect and safety of thread embedding acupuncture (TEA) in patients with facial nerve palsy sequelae. This was a retrospective observational study on 82 patients treated with TEA from January 2021 to May 2022. The Facial Disability Index (FDI) reported by patients and Sunnybrook Facial Grading System scores assessed by clinical practitioners were used to evaluate the intensity of facial movements, functional problems, and psychosocial status. One-way repeated measure analysis of variance showed that the Sunnybrook Facial Grading System scores improved significantly following the 2nd to 6th TEA treatments (Txs). FDI scores also showed significant increases except for the 4th Tx. Additionally, the physical scores improved significantly among the subscales of FDI, but the social/well-being scores did not. There were no reported serious adverse events or adverse events requiring medical Tx. TEA is a safe Tx that has a clinically cumulative effect, in terms of patient-oriented self-assessment of functional problems and objective facial movements, for treating facial nerve palsy sequelae.
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Terapia por Acupuntura , Paralisia de Bell , Paralisia Facial , Humanos , Nervo Facial , Paralisia de Bell/terapia , Estudos RetrospectivosRESUMO
Objective: The Synkinesis Assessment Questionnaire (SAQ) is a reliable tool to assess synkinesis symptoms; however, it is yet to be validated in Korea. Thus, this study aimed to translate and validate the Korean SAQ. Methods: This validation study was set in a clinic in Seoul, Korea, that provides general integrative medicine services. A total of 100 participants with facial palsy were enrolled. Participants completed the SAQ, House-Brackmann grade (HB grade), Sunnybrook Facial Grading System (SB), and Facial Disability Index (FDI). The forward-backward translation method was followed. Of the 100 participants, 31 underwent a second assessment for test-retest reliability. Internal consistency and test-retest reliability were evaluated using Cronbach's alpha coefficient. The construct validity of the Korean version of the SAQ was tested using Spearman's rank correlation coefficient. Results: The internal consistency score for the SAQ was 0.789, and the test-retest reliability score was 0.787. According to Spearman's rank correlation coefficient, the SAQ correlations to the synkinesis subdomain of SB score, total SB score, HB grade, and physical function domain in the FDI score were 0.366 (p < .001), -0.386 (p < .001), 0.315 (p = .001), and -0.269 (p = .007), respectively. All values were statistically significant. Conclusions: The Korean SAQ is a valid and reliable tool used to evaluate synkinesis in patients with facial palsy. Level of Evidence: Level 3.
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Patients affected with facial palsy consult both traditional Korean medicine doctors and conventional medicine doctors. Considering that the optimal approach varies depending on the progress of the disease, there is a need for facial palsy management through integrated medical care. However, no critical pathway has been developed to manage facial palsy from an integrated medical perspective. The aims of this study were to (a) explore treatment utilization status and awareness for facial palsy; (b) understand possible traditional Korean medicine modalities; and (c) suggest interventions to be included in integrated medical service for treating facial palsy. Regarding existing papers in relevant field, draft of questionnaire was firstly established. Eight-person development committee was comprised and reviewed the draft and modified the items of questionnaire. As an independent committee, the authors of present study have rechecked the validity and reliability of modified items of questionnaire. A questionnaire was developed comprising 21 items, including demographic characteristics, clinical statement, recognition, and demands and directions to improve the quality of newly developing critical pathways. Using the services of the Association of Korean Medicine and Medistream, the questionnaire was sent via a web-based survey to traditional Korean medicine doctors. A total of 1017 valid questionnaires were collected from traditional Korean medicine doctors. Of the total doctors who responded, over 75% stated that they utilized integrated medical systems in various forms. Acupuncture, herbal medicine, and thermal therapy were presented as key traditional Korean medicine treatments to be included in the critical pathway for the establishment of integrated medical services. Conversely, corticosteroids, antivirals, and blood sugar management were chosen to be critical among conventional medical treatments. Considering the responses collected in the present study and the progressive nature of facial palsy, various interventions in both conventional and traditional Korean medicine services need to be included in relevant critical pathways. If the critical pathway developed based on the present study is established, relevant clinical practice guidelines could be made available in an integrated medical system.
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Paralisia de Bell , Paralisia Facial , Medicina Integrativa , Antivirais , Glicemia , Paralisia Facial/terapia , Humanos , Internet , Reprodutibilidade dos Testes , República da Coreia , Inquéritos e QuestionáriosRESUMO
Although thread embedding acupuncture (TEA) is widely used for facial nerve palsy (FNP) in Korea, it lacks clinical evidence. Therefore, a large-scale and long-term clinical trial is needed. It is necessary to standardize and optimize TEA treatment for clinical study. Hence, we collected information about how TEA in the facial region is performed in clinical practice using a web-based survey. A questionnaire was developed consisting of 22 essential items and 30 optional items including demographic characteristics, purpose of TEA, adverse events (AE), direct medical cost, required time, and current state of TEA treatment on FNP. The questionnaire was sent via e-mail to 23,910 traditional Korean medicine doctors (TKMD). A total of 427 respondents answered the questionnaire. The most common response for the purpose for TEA was cosmetic, followed by musculoskeletal disease and nervous system disease. The most common AE that resolved without medical treatment was bruising (90.4%). The most common AE that required medical treatment was dimple (30.5). Many respondents commonly used TEA for the sequelae of FNP (71.8%). The most frequent sequelae of FNP for which TEA was used as contracture around the mouth (75.3%). The most preferred treatment method was insertion of 6-10 monofilament threads using a 29-gauge needle at intervals of 2.2 ± 1.59 weeks in the sequelae period. The results of this survey can be used to standardize and optimize the procedure of TEA for FNP for further clinical research.
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Terapia por Acupuntura , Paralisia de Bell , Paralisia Facial , Humanos , Nervo Facial , Paralisia de Bell/terapia , Paralisia Facial/terapia , Progressão da Doença , Inquéritos e Questionários , InternetRESUMO
Background: Temporomandibular disorder (TMD) affects multiple tissues of the temporomandibular joint complex and manifests as orofacial pain and functional disturbance. While thread embedding acupuncture (TEA) is used for the treatment of TMD in clinical practice, sufficient clinical evidence is lacking. This pilot trial will explore the feasibility of a confirmatory randomized controlled trial (RCT) by considering the efficacy, safety, and cost-effectiveness of TEA to address pain, function, and quality of life in patients with TMD. Methods: This randomized, assessor-blinded, controlled trial will include two parallel arms. Thirty patients with TMD and temporomandibular joint pain more severe than 40 mm on the 100-mm visual analog scale (VAS) and aged 19-70 years will be recruited and randomly allocated to either TEA or usual care groups. The TEA group will receive treatment at 14 predefined acupoints once weekly for 4 weeks. The usual care group will receive physical therapy consisting of transcutaneous electrical nerve stimulation and infrared therapy. The average VAS score over the last week for temporomandibular pain after four sessions will be assessed as the primary outcome. Furthermore, maximum pain VAS, vertical opening movement, Graded Chronic Pain version 2, Jaw Functional Limitation Scale 20, Patient Global Impression of Change, Korean version of Beck's Depression Index, Short Form-12 Health Survey, EuroQol 5-Dimension 5-level, treatment expectation, rescue medication consumption, adverse events, and medical costs for economic evaluation will be measured and analyzed as secondary outcomes during four follow-up visits and after the termination of all sessions. Conclusion: The results of this trial will help evaluate the feasibility of a confirmatory RCT considering efficacy, safety, and cost-effectiveness and verify the effect size required to determine an appropriate sample size. Trial Registration Number: KCT0007421.
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INTRODUCTION: Thread-embedding acupuncture (TEA) is a special type of acupuncture treatment in which medical threads are inserted into subcutaneous tissues or muscles at therapeutic points. TEA is a medical practice that combines acupuncture and medical threads. As such, it is necessary to evaluate the safety of TEA. This systematic review and meta-analysis aimed to assess the safety of TEA and reporting quality of studies regarding TEA. METHODS AND ANALYSIS: The systematic review will be conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and the Cochrane Handbook for Systematic Reviews of Interventions. Searching strategies will be systemically conducted using the following databases from their inception date to September 2022: MEDLINE, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), CiNii, J-STAGE, Korean Medical Database, Korean Studies Information Service System (KISS), ScienceON and Oriental Medicine Advanced Searching Integrated System (OASIS). The search strategies will be adjusted for each database as appropriate. The risk of bias will be assessed using the McMaster tool to identify the quality of harm assessment and reporting in study reports (McHarm). A meta-analysis will be used to synthesise the frequency and incidence of adverse events. ETHICS AND DISSEMINATION: No ethical approval and consent is required for this systematic review. The results of this systematic review will be disseminated through peer-reviewed publications and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42022297123.
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Terapia por Acupuntura , Medicina Tradicional do Leste Asiático , Terapia por Acupuntura/efeitos adversos , Terapia por Acupuntura/métodos , Viés , Humanos , Metanálise como Assunto , Projetos de Pesquisa , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: and purpose: Although several studies have reported that thread embedding acupuncture (TEA) is effective for lumbar herniated intervertebral disc (LHIVD), the evidence remains limited because previous studies had a high risk of bias. This study aimed to investigate the efficacy and safety of TEA for LHIVD through a rigorously designed trial. MATERIALS AND METHODS: This was a randomized, patient-assessor-blinded, sham-controlled trial. Participants were screened according to eligibility criteria, and 70 patients with LHIVD were randomly allocated to the TEA and sham TEA (STEA) groups in a 1:1 ratio. Both groups received TEA or STEA treatment at 23 acupoints once per week for eight weeks. Changes in low back pain, radiating pain, Oswestry disability index, Roland-Morris disability questionnaire, EuroQol 5-Dimensions 5-Levels, and global perceived effect were measured at baseline and at 4, 8, 12, and 16 weeks after screening and compared between the two groups. RESULTS: TEA showed no significant difference in all outcomes compared to STEA immediately after eight weeks of treatment. After an additional eight weeks of follow-up, TEA showed a more significant effect on the low back pain than STEA (p < 0.05) and showed a better tendency in maintaining or enhancing the improvement of radiating pain, function, and quality of life even after the end of treatment. No serious adverse events were observed. CONCLUSION: TEA is effective in improving low back pain in patients with LHIVD and may help improve function and quality of life, especially in the long term.
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Terapia por Acupuntura , Disco Intervertebral , Dor Lombar , Terapia por Acupuntura/métodos , Humanos , Dor Lombar/terapia , Qualidade de Vida , Resultado do TratamentoRESUMO
A significant number of individuals suffer from low back pain throughout their lifetime, and the medical costs related to low back pain and disc herniation are gradually increasing in Korea. Korean medicine interventions have been used for the treatment of lumbar intervertebral disc herniation. Therefore, we aimed to update the existing Korean medicine clinical practice guidelines for lumbar intervertebral disc herniation. A review of the existing guidelines for clinical treatment and analysis of questionnaires targeting Korean medicine doctors were performed. Subsequently, key questions on the treatment method of Korean medicine used for disc herniation in actual clinical trials were derived, and drafts of recommendations were formed after literature searches using the Grading of Recommendations, Assessment, Development and Evaluation. An expert consensus was reached on the draft through the Delphi method and final recommendations were made through review by the development project team and the monitoring committee. Fifteen recommendations for seven interventions for lumbar disc herniation were derived, along with the grade of recommendation and the level of evidence. The existing Korean medicine clinical practice guidelines for lumbar intervertebral disc herniation have been updated. Continuous updates will be needed through additional research in the future.
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BACKGROUND: There are various treatments for facial nerve palsy, and research into this topic is ongoing. In the present study, we carried out bibliometric and visualized analyses to identify the trends of research into facial nerve palsy treatment. METHODS: To identify articles, the SCOPUS database was searched for articles published from its inception to December 27, 2020. The search was conducted twice, with Search 1 investigating general treatment trends and Search 2 narrowing the scope to complementary and alternative treatment. The extracted keywords were analyzed using the Visualization Of Similarities (VOS) viewer. Through analysis of keywords, research hotspots in the treatment of facial nerve palsy were identified. RESULTS: A total of 1609 and 223 articles were identified in Searches 1 and 2, respectively. The number of articles published each year showed a tendency to increase, and most of the studies were only conducted in a few countries. In terms of subject area, "medicine" was overwhelmingly the most common(77.6%). Based on the analysis of 316 keywords in Search1, "medication treatment," and "complementary and alternative treatment" were the hotspots of research. CONCLUSION: This study provides the overall trends of facial nerve palsy treatment. To date, research on medication treatment has been main focus, and antiviral use among medication treatment and complementary and alternative treatment has emerged in recent years.
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Bibliometria , Doenças do Nervo Oculomotor/terapia , Publicações/estatística & dados numéricos , Nervo Facial/anormalidades , Nervo Facial/fisiopatologia , Humanos , Publicações/tendênciasRESUMO
Bee venom phospholipase A2 (bvPLA2) has been reported to have therapeutic effects such as neuroprotection, anti-inflammation, anti-nociception, anti-cancer properties, caused by increasing regulatory T cells (Tregs). The mechanism of Tregs modulation by bvPLA2 has been demonstrated by binding with the mannose receptor, CD206 in experimental models of several diseases. However, it remains unknown whether this mechanism can also be applied in human blood. In this study, we collected peripheral blood samples from healthy donors and analyzed the percentages of monocyte-derived dendritic cells with CD206 (CD206+ DCs) before expansion, the proportion of Tregs, and the subpopulations after expansion treated with bvPLA2 or PBS using flow cytometry and the correlations among them. The percentage of Tregs tended to be higher in the bvPLA2 group than in the control group. There were significant positive correlations between the CD206 population in hPBMC and the proportions of Tregs treated with bvPLA2, especially in the Treg fold change comparing the increase ratio of Tregs in bvPLA2 and in PBS. These findings indicate that bvPLA2 increased the proportion of Tregs in healthy human peripheral blood and the number of CD206+ DCs could be a predictor of the bvPLA2 response of different individuals.
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Venenos de Abelha/enzimologia , Fosfolipases A2/farmacologia , Linfócitos T Reguladores/efeitos dos fármacos , Adulto , Idoso , Venenos de Abelha/farmacologia , Feminino , Humanos , Leucócitos Mononucleares/efeitos dos fármacos , Masculino , Receptor de Manose/metabolismo , Pessoa de Meia-Idade , Receptores de Superfície Celular/metabolismoRESUMO
The objective of this review is to assess the clinical evidence for or against cupping as a treatment for hypertension. We searched the literature using 15 databases from their inception to 30 June 2009, without language restrictions. We included all clinical trials (CTs) of cupping to treat hypertension in human patients. Risk of bias was assessed using the Cochrane criteria. Two CTs met all inclusion criteria. One RCT (randomized CT) assessed the effectiveness of dry cupping on changes in cerebral vascular function compared with drug therapy. Their results suggested significant effect in favor of cupping on vascular compliance and degree of vascular filling. One uncontrolled observational study (UOS) tested wet cupping for acute hypertension and found that a one-time treatment reduced blood pressure. In conclusion, the evidence is not significantly convincing to suggest cupping is effective for treating hypertension. Further research is required to investigate whether it generates any specific effects for that condition.
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Pontos de Acupuntura , Hipertensão/terapia , Doença Aguda , Adulto , Determinação da Pressão Arterial , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Viés de Publicação , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Acupuncture has been widely used for relieving pain associated with musculoskeletal disorders, such as lateral epicondylitis. Although the effect of acupuncture on pain has been demonstrated in previous reviews, it is still under debate. This study is aimed at evaluating the efficacy of acupuncture to treat lateral epicondylitis and establishing the evidence systematically. METHODS: Nine databases will be searched from their inception to May 2020 without language or publication status restrictions, including 3 English databases (MEDLINE, Embase, the Cochrane Central Register of Controlled Trials), 5 Korean databases (Korean Medical Database, KoreaMed, Korean Studies Information Service System, Research Information Service System, Oriental Medicine Advanced Searching Integrated System), and 1 Chinese database (China Knowledge Network Database). Only randomized controlled trials will be included. Pain intensity will be considered as the primary outcome. Secondary outcomes will include the grip strength, total effective rate, and adverse events. Two independent researchers will perform the study selection, data extraction, and quality assessment. The methodological quality of the identified studies will be assessed using the Cochrane Collaboration's risk-of-bias tool. In the meta-analysis, continuous data will be expressed as mean and 95% confidence interval, and dichotomous data will be expressed as risk ratio and 95% confidence interval. RESULTS: The results of this study will be submitted to a peer-reviewed journal for publication. CONCLUSION: The results of this study would provide the evidence of whether acupuncture is effective for lateral epicondylitis. REGISTRATION NUMBER: PROSPERO CRD42020186824.
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Terapia por Acupuntura , Metanálise como Assunto , Revisões Sistemáticas como Assunto , Cotovelo de Tenista/terapia , Terapia por Acupuntura/efeitos adversos , Força da Mão , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Cotovelo de Tenista/fisiopatologia , Resultado do TratamentoRESUMO
BACKGROUND: Facial palsy involves paralysis of any structure affected by the facial nerve and affects facial appearance. Face palsy can result from congenital, idiopathic, neoplastic, infection-related, traumatic, malignant, diabetic, iatrogenic, and other inflammatory causes. Numerous studies have suggested that laser treatment is beneficial for managing facial palsy. The objectives of this review were to examine the effects of laser therapy in hastening recovery from long-term morbidity due to facial palsy. METHODS: We will conduct a systematic analysis of controlled trials reviewing the efficacy of any laser therapy designed to treat facial palsy in patients. We will search multiple electronic databases, trial registries, and bibliographies and will contact authors to identify missing study details. We will use systematic review software to independently filter studies and extract available data and then will summarize characteristics of the study populations, interventions, comparators, outcomes, and quality/risk of bias. Primary outcomes will be categorized into paralysis score, physical facial disability index (PFDI), social facial disability index (SFDI), and recovery rate of supracordal/infracordal lesions. Secondary outcomes will be considered based on study findings. Planned trial subgroup analyses will determine whether the participants had a chronic condition, the type of comparator (i.e., placebo/sham vs. usual care), and study quality/risk of bias. RESULTS: This review intends to establish evidence for laser therapies in improving recovery rates, particularly among patients with facial palsy. CONCLUSION: Its findings will be beneficial to clinicians and patients seeking innovative and effective ways to manage facial palsy and accompanying sequelae.
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Paralisia Facial/cirurgia , Terapia a Laser , Metanálise como Assunto , Projetos de Pesquisa , Revisões Sistemáticas como Assunto , Humanos , Resultado do TratamentoRESUMO
BACKGROUND: The sequelae of Bell's palsy cause critical problem in facial appearance, as well as social and psychological problems in the patient's life. The aim of the present study is to establish clinical evidence of thread-embedding acupuncture (TEA) in the treatment of sequelae of Bell's palsy. METHOD/DESIGN: This is a patient-assessor blinded, randomized, sham-controlled trial with two parallel arms. Fifty-six patients aged 19-65 years, who have experienced sequelae of Bell's palsy for >3 months, will be recruited and screened using the eligibility criteria. After screening, they will be randomly allocated to a TEA group or a sham TEA (STEA) group. Both groups will receive TEA or STEA treatment on ten predefined acupoints once a week for 8 weeks. Additionally, both groups will receive the same acupuncture treatment twice a week for 8 weeks as a concurrent treatment. Changes in the Facial Disability Index over 8 weeks will be assessed as the primary outcome. Furthermore, the House-Brackmann Grade, Facial Nerve Grading System 2.0, Sunnybrook Facial Grading System, facial stiffness score, lip mobility score, and treatment satisfaction score will be measured and analyzed as secondary outcomes. All outcomes will be assessed at baseline and at 4 and 8 weeks after screening. DISCUSSION: The results from this trial will help establish clinical evidence regarding the efficacy and safety of TEA in the treatment of patients with sequelae of Bell's palsy. TRIAL REGISTRATION NUMBER: KCT0002557 (Clinical Research Information Service of the Republic of Korea).
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Terapia por Acupuntura/métodos , Paralisia de Bell/terapia , Projetos de Pesquisa , Adolescente , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Índice de Gravidade de Doença , Método Simples-Cego , Adulto JovemRESUMO
BACKGROUND: Lumbar herniated intervertebral disc (LHIVD) is a frequent disease among patients attending Korean medicine hospitals, and it is associated with considerable medical expenses for the patients. Although several recent randomized clinical trials (RCTs) have reported that thread-embedding acupuncture (TEA) has a more favorable therapeutic effect on LHIVD than other types of acupuncture or other treatments, the evidence remains limited because these trials used poor assessment methods and had a high risk of bias. This study aims to evaluate the evidence for the effectiveness and safety of TEA for LHIVD. In this article, we describe our methods and plan for a systematic review. METHODS: We will conduct an electronic search of the following databases from their inception to May 2018: MEDLINE; EMBASE; COCHRANE; China National Knowledge Infrastructure (CNKI) (a Chinese database); CiNii and J-STAGE (Japanese databases); and KoreaMed, Korean Medical Database (KMbase), Korean Studies Information Service System (KISS), National Digital Science Library (NDSL), Korea Institute of Science and Technology Information (KISTI), Oriental Medicine Advanced Searching Integrated System (OASIS). RCTs investigating any type of TEA will be included. The risk of bias in each study will be evaluated using the Cochrane risk of bias tool. Risk ratios or mean differences with 95% confidence intervals will be used to show the effects of TEA if it will be possible to conduct a meta-analysis. Sensitivity analyses will also be conducted in this study. ETHICS AND DISSEMINATION: Ethical approval is not necessary as this paper does not involve patient data. The review will be published in a peer-reviewed journal or presented in a conference. TRIAL REGISTRATION NUMBER: PROSPERO CRD42019133060.
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Terapia por Acupuntura/métodos , Deslocamento do Disco Intervertebral/terapia , Terapia por Acupuntura/efeitos adversos , Adulto , Protocolos Clínicos , Humanos , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Resultado do Tratamento , Metanálise como AssuntoRESUMO
BACKGROUND: A lumbar herniated intervertebral disc (LHIVD) is a common problem that usually causes low back pain and radiating pain. The effectiveness of Bosinji, one of the herbal medicines used for low back pain and radiating pain in patient with LHIVD, has been reported in several studies; however, little clinical evidence is available owing to the methodological limitations in previous studies. Hence, the present study aims to establish the clinical evidence regarding the efficacy and safety of Bosinji in improving pain, function, and quality of life in LHIVD patients. METHOD/DESIGN: This is a multicenter, open-label, randomized, controlled, and equivalence trial with 2 parallel arms. A total of 74 patients who have low back pain and radiating pain due to LHIVD will be recruited and randomly allocated to the experimental group and control group. The patients in the experimental group and control group will take 2.5âg of Bosinji granule (1.523âg of Bosinji extract) or Loxonin tablet (60âmg of loxoprofen) 3 times a day for 6 weeks. Additionally, both groups will receive the same acupuncture treatment once a week for 6 weeks as a concurrent treatment. Changes in the 100-mm visual analogue scale (VAS) for low back pain after 6 weeks from baseline will be assessed as the primary outcome. Furthermore, the 100-mm VAS for radiating pain, Oswestry disability index (ODI), Roland-Morris disability questionnaire (RMDQ), EuroQol 5 Dimensions 5 Levels (EQ-5D-5L), global perceived effect (GPE), and deficiency syndrome of kidney index (DSKI) will be used to evaluate secondary outcomes. Outcomes will be assessed at baseline and at 3, 6, and 10 weeks after screening. For the safety evaluation, laboratory examinations including complete blood count, liver function test, renal function test, blood coagulation test, inflammation test, and urine analysis will be conducted before and after taking the medications. DISCUSSION: The results of this trial will be used to establish clinical evidence regarding the use of Bosinji with acupuncture treatment in the treatment of patients with LHIVD. TRIAL REGISTRATION NUMBER: NCT03386149 (clinicaltrials.gov) and KCT0002848 (Clinical Research Information Service of the Republic of Korea).
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Medicina Herbária/métodos , Degeneração do Disco Intervertebral/tratamento farmacológico , Deslocamento do Disco Intervertebral/tratamento farmacológico , Dor Lombar/tratamento farmacológico , Terapia por Acupuntura/métodos , Anti-Inflamatórios não Esteroides/uso terapêutico , Humanos , Degeneração do Disco Intervertebral/patologia , Deslocamento do Disco Intervertebral/patologia , Dor Lombar/etiologia , Dor Lombar/psicologia , Região Lombossacral/patologia , Qualidade de Vida , Radiculopatia/complicações , República da Coreia/epidemiologia , Resultado do TratamentoRESUMO
PURPOSE: Parotid gland can be considered as a risk organ in whole brain radiotherapy (WBRT). The purpose of this study is to evaluate the parotid gland sparing effect of computed tomography (CT)-based WBRT compared to 2-dimensional plan with conventional field margin. MATERIALS AND METHODS: From January 2008 to April 2011, 53 patients underwent WBRT using CT-based simulation. Bilateral two-field arrangement was used and the prescribed dose was 30 Gy in 10 fractions. We compared the parotid dose between 2 radiotherapy plans using different lower field margins: conventional field to the lower level of the atlas (CF) and modified field fitted to the brain tissue (MF). RESULTS: Averages of mean parotid dose of the 2 protocols with CF and MF were 17.4 Gy and 8.7 Gy, respectively (p < 0.001). Mean parotid dose of both glands ≥20 Gy were observed in 15 (28.3%) for CF and in 0 (0.0%) for MF. The whole brain percentage volumes receiving >98% of prescribed dose were 99.7% for CF and 99.5% for MF. CONCLUSION: Compared to WBRT with CF, CT-based lower field margin modification is a simple and effective technique for sparing the parotid gland, while providing similar dose coverage of the whole brain.
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BACKGROUND AND PURPOSE: Since the introduction of CT-based simulation for use in whole brain radiotherapy (WBRT), we have observed that a large volume of the parotid glands is included in the radiation fields. The purpose of this study is to analyze the dose-volume statistics of the parotid glands in patients undergoing WBRT. MATERIALS AND METHODS: Thirty-two patients received WBRT using CT-based simulation with bilateral two-field arrangement. Daily fraction was 3 Gy with total dose of 30 Gy in 2 weeks. We analyzed the radiation dose from WBRT to the parotid glands. RESULTS: Average of the mean parotid dose was 17.5 Gy (range, 10.5-26.2) for both glands. Mean parotid doses ≥20 and ≥25 Gy were observed in 22 (34.4%) and 4 (6.3%) of 64 individual glands. The numbers of patients with a mean parotid dose of both glands ≥20Gy and ≥25 Gy were 12 (37.5%) and 1 (3.1%), respectively. CONCLUSIONS: Mean parotid dose was variable in patients with WBRT. According to the parotid dose and combined potential risk factors, parotid glands can be regarded as a risk organ in WBRT for improvement of patient quality of life.