Oriental medicine as collaborating treatments with conventional treatments for knee osteoarthritis: A PRISMA-compliant systematic review and meta-analysis.

BACKGROUND: We aimed to evaluate the effectiveness and safety of oriental medicine (OM) treatments as monotherapy and add-on therapy compared to conventional treatments for knee osteoarthritis and assess the quality of evidence for these results. OM treatment included acupuncture, herbal medicine, pharmacoacupuncture, and moxibustion. METHODS: PubMed, Embase, Cochrane, Google Scholar, 4 Korean medical databases (KoreaMed, Korean Studies Information Service System, Research Information Service System, and Oriental Medicine Advanced Searching Integrated System), and one Chinese database (China National Knowledge Infrastructure) were searched for articles published between January 1, 2000, and January 1, 2021. Randomized controlled trials (RCTs) investigating the effect of OM interventions, single or combined with conventional treatments, on knee osteoarthritis were searched. The risk of bias and quality of evidence of the included studies were evaluated using the Cochrane Collaboration's risk of bias tool and Grading of Recommendations, Assessment, Development, and Evaluation methods, respectively. RESULTS: A total of 3911 relevant studies were retrieved and only 23 studies were included for systematic review. Most of the studies showed a significant effect on knee osteoarthritis. 21 studies comparing single OM treatment with conventional treatment were included in the meta-analysis. The effect size of standardized mean difference (SMD) was analyzed as a "small effect" with 0.48 (95% CI -0.80 to -0.16, Z = 2.98, P = .003). In addition, a meta-analysis of 4 studies comparing integrative treatment with conventional treatment showed a "very large effect" with 1.52 (95% CI -2.09 to -0.95, Z = 5.19, P < .001). CONCLUSION: Our results suggest that single OM treatment and integrative treatment significantly reduce pain in patients with knee osteoarthritis. However, there is a limited number of RCTs considering integrative treatment which implies more related RCTs should be conducted in the future.

Efficacy, Safety and Cost-Effectiveness of Thread-Embedding Acupuncture for Adhesive Capsulitis (Frozen Shoulder): A Study Protocol for a Multicenter, Randomized, Patient-Assessor Blinded, Controlled Trial.

Background: The aim of the present study is to confirm the efficacy, safety, and cost-effectiveness of thread-embedding acupuncture (TEA) in the treatment of adhesive capsulitis (AC). Methods: This is a randomized, sham-controlled, patient-assessor blinded trial with two parallel arms in a 1:1 ratio. A total of 160 participants with AC, also known as frozen shoulder, will be recruited and screened according to the eligibility criteria. Those who meet the eligibility criteria will be randomly allocated to a TEA group or a sham TEA (STEA) group. Both groups will receive either real TEA or thread-removed STEA treatment on nine acupoints once a week for 8 weeks while being blinded to the intervention. The shoulder pain and disability index will be evaluated as a primary outcome measure. In addition, a 100-mm pain visual analogue scale, rotator cuff quality of life scale, European Quality of Life 5-dimension 5-level scale, treatment satisfaction, safety assessment, and economic evaluation will be assessed as secondary outcome measures. Outcome assessments will be conducted for a total of 24 weeks, including a treatment period of 8 weeks and follow-up of 16 weeks, according to the schedule. Discussion: The results of this trial will provide a clinical basis for the efficacy, safety and cost-effectiveness of TEA in the treatment of patients with AC. Trial Registration Number: KCT0005920 (Clinical Research Information Service of the Republic of Korea). Registered on 22 February 2021.

Efficacy and safety evaluation of adjuvant auricular acupuncture for smoking cessation: A study protocol of randomized, assessor-blinded, pragmatic pilot trial.

BACKGROUND: Smoking negatively impacts public health. There are several treatments to quit smoking, and nicotine replacement treatment (NRT) reportedly doubles the smoking cessation rate, with some limitations. Acupuncture is an alternative option with proven effects on smoking cessation. However, there has been no definite report that indicates the efficacy and safety of auricular acupuncture (AA) combined with NRT on smoking cessation. METHODS: This is a randomized, assessor-blind, and pragmatic pilot study. We will recruit 40 participants who want to stop smoking and randomly allocate them into an NRT group and an NRT + AA group with a 1:1 ratio. Participants will receive NRT for 4 weeks and the NRT + AA group will receive additional AA treatment with 5 AA points (Shenmen (TF4), lung (CO14), throat (TF3), inner nose (TG4), and endocrine (CO18)) twice a week for 4 weeks. Follow-up will be conducted 1 and 3 months after intervention completion. The primary outcome will be tobacco consumption and abstinence rate determined by calculating the rate of change in cigarette use and a urine test. Secondary outcomes will be the quality of life (EuroQol-5D and visual analogue scale), nicotine dependence (Fagerstrom test for nicotine dependence), nicotine withdrawal (Minnesota nicotine withdrawal scale), physical effects, satisfaction, and safety measurement (adverse events). RESULTS: We will investigate the efficacy and safety of AA combined with NRT treatment for smoking cessation. CONCLUSION: Our study will provide additional clinical evidence for AA as an adjuvant treatment for smoking cessation. TRIAL REGISTRATION NUMBER: Clinical Research Information Service (registration number: KCT0007212).

Effectiveness and safety of bee venom pharmacopuncture for rheumatoid arthritis: a systematic review protocol.

INTRODUCTION: Rheumatoid arthritis (RA) is the common autoimmune disease with low quality of life. The representative treatment is medication and medication usage has improved through update of clinical guidelines, however, there are still limitations. Bee venom (BV) has been reported to have meaningful therapeutic effects and the possibility of alternative options for RA through several types of studies, but there is no well-organised and recent published systematic review (SR). METHODS: We will search randomised controlled trials about the BV on RA from the inception to 31 May 2022 in various databases, manual research and contacting authors. Electronic databases will include MEDLINE, EMBASE, Cochrane library, China National Knowledge Infrastructure, CiNii, J-STAGE, KoreaMed, Korean Medical Database, Korean Studies Information Service System, National Digital Science Library, Korea Institute of Science and Technology Information and Oriental Medicine Advanced Searching Integrated System. With screening and reviewing process, we will identify the eligible studies and extract the needed data. The primary outcome will be the disease activity scores indicating the improvement of RA symptoms (American College of Rheumatology response criteria 20, 50, 70), functions (Health Assessment Questionnaire, Disease Activity Score of 28 joints), joint (Western Ontario and McMaster universities osteoarthritis index), pain (Visual Analogue Scale, Numerical Rating Scale) and effective rate. The secondary outcomes will be the RA-related blood test levels and adverse events. We will perform a meta-analysis by Review Manager software, the assessment of risk of bias by Cochrane Collaboration 'risk of bias' and the determination of quality of evidence by Grades of Recommendation, Assessment, Development and Evaluation. ETHICS AND DISSEMINATION: Our SR will suggest the clinical evidence of the use of BV for RA to patient, clinicians and policymakers. We will publish our results in a peer-review journal. PROSPERO REGISTRATION NUMBER: CRD42021238058.

The effectiveness and safety of Simiao Xiaobi decoction on rheumatoid arthritis: A study protocol for systematic review and meta-analysis.

BACKGROUND: Rheumatoid arthritis (RA) is a common chronic autoimmune disease that contributes to progressive disability, systemic complications, higher mortality, and societal burden. Typical symptoms of RA include symmetrical pain and swelling in multiple joints, morning stiffness, and elevated levels of erythrocyte sedimentation rate, C-reactive protein, and rheumatoid factor. The representative treatment for RA is medication, including disease-modifying antirheumatic drugs, glucocorticoids, and nonsteroidal anti-inflammatory drugs. However, these medications are not yet curative nor preventative and are associated with several adverse effects, leading to their discontinuation. Recent articles reported that Simiao Xiaobi decoction (SXD) could relieve the symptoms of RA by clinical trial and experimental study, but an evidence-based review on the effectiveness and safety of SXD on RA has not yet been provided. METHODS: Searching for randomized controlled trials on the use of SXD for RA will be performed by using multiple electronic databases, manual search, and contacting the authors by e-mail if needed. Studies will be selected according to the predefined criteria and the data collected on study participants, interventions, control groups, outcome measurements, their results, adverse events, and risk of bias will be summarized. The primary outcome will be the disease activity score (including effective rate, swollen joint count, tender joint count, and morning stiffness), and the secondary outcomes will be blood tests (including erythrocyte sedimentation rate, C-reactive protein, and rheumatoid factor) and adverse events. We will use Review Manager software to perform a meta-analysis, the Cochrane Collaboration "risk of bias" tool for assessing the risk of bias, and grades of recommendation, assessment, development and evaluation for the determination of the quality of evidence. TRIAL REGISTRATION NUMBER: https://inplasy.com; INPLASY202230026. RESULTS: We are going to investigate the effectiveness and safety of SXD for RA. CONCLUSION: This study will provide reliable evidence on whether SXD is effective on RA.

Korean Medicine Clinical Practice Guidelines for Lumbar Herniated Intervertebral Disc in Adults: Based on Grading of Recommendations Assessment, Development and Evaluation (GRADE).

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.

Thread embedding acupuncture for herniated intervertebral disc of the lumbar spine: A multicenter, randomized, patient-assessor-blinded, controlled, parallel, clinical trial.

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.

Quality assessment of conventional and traditional oriental medicine clinical practice guidelines for knee osteoarthritis using AGREE II instrument.

INTRODUCTION: Knee osteoarthritis is a degenerative disease and its prevalence tends to increase. Clinical practice guidelines (CPGs) are evidence-based recommendations for treatment that help policymakers, practitioners, and patients make more appropriate and efficient decisions during the course of management. This study aimed to evaluate the quality of knee osteoarthritis CPGs using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. METHOD: The retrieval engines and websites were utilized from January 2010 to December 2020. The search words were "Clinical practice guideline" OR "Critical practice guideline" OR "guideline∗" AND "Osteoarthritis." The quality of the CPGs was independently examined by four appraisers using the AGREE II instrument. Consequently, the selected CPGs were graded as Classes A, B, and C according to the level of recommendation. RESULT: In this study, 13 CPGs for knee osteoarthritis were selected and evaluated qualitatively using the AGREE II instrument. The overall quality percentage score was as follows: clarity of presentation, 72.6%, scope and purpose, 62.6%, rigor of development, 54.2%, stakeholder investment, 50.5%, editorial independence, 46.5%, applicability, 22.5%. CONCLUSION: Auxiliary materials for the treatment process of knee OA should be supplemented in future revised versions for quality improvement of knee OA CPGs. Also, more evidence should be accumulated to support the recommendation of traditional oriental medical treatments in the clinical field. From the perspective of integrative medicine, along with conventional pharmacological treatment, exercise, weight loss, and acupuncture can be combined together in clinical situations.

Thread-Embedding Acupuncture for the Treatment of Shoulder Instability: Protocol for a Randomized, Controlled, Patient-Assessor Blinded Pilot Study.

PURPOSE: This study aims to determine the feasibility of thread-embedding acupuncture (TEA) for the treatment of shoulder instability. PATIENTS AND METHODS: This is a patient-assessor blinded, randomized, sham-controlled trial with two parallel arms. A total of 40 patients with shoulder instability aged between 13 and 43 years will be recruited and screened using set inclusion and exclusion criteria. After screening, they will be randomly allocated to the TEA or sham TEA group. Patients in both groups will then receive TEA or sham TEA treatment on six acupoints once a week for 8 weeks, which will be followed by additional follow-up assessments at 4 and 8 weeks after the end of treatment. Changes in shoulder pain and disability will be assessed as the primary outcome, whereas 100-mm pain visual analogue scale, shoulder range of motion, rotator cuff quality of life index, EuroQol 5-dimension 5-levels, treatment satisfaction, economic evaluation, and safety will all be measured as secondary outcomes of the study. Outcome assessment will be conducted at baseline and at 4, 8, and 16 weeks after screening. CONCLUSION: The results from this trial will help to design further clinical trials on the efficacy, safety, and cost-effectiveness of performing TEA for shoulder instability. TRIAL REGISTRATION NUMBER: KCT0005921 (Clinical Research Information Service of the Republic of Korea).

Thread Embedded Acupuncture for Non-Specific Posterior Neck Pain: A PRISMA-Compliant Protocol for Systematic Review and Meta-Analysis.

PURPOSE: The prevalence of non-specific posterior neck pain (NPNP) has been increasing yearly. There are several treatments for NPNP, but in this review, we will focus on thread-embedded acupuncture (TEA). TEA is used in the Republic of Korea, Taiwan, and China for managing musculoskeletal diseases, obesity, and sequelae of facial palsy. However, there is insufficient evidence on its effectiveness and safety. This study aims to assess the efficacy and safety of TEA for NPNP. METHODS: We will search the following nine electronic databases, from their inception to May 2020: MEDLINE, Embase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Citation Information by the National Information infrastructure, Korean Studies Information Service System, National Digital Science Library, Oriental Medicine Advanced Searching Integrated System, and Research Information Service System. Only randomized controlled trials of TEA for NPNP will be included. The methodological quality of the included trials will be assessed using the Cochrane risk-of bias tool. To conduct the meta-analysis, the risk ratio and mean difference with the 95% confidence interval will be used. Sensitivity analyses will be conducted based on this protocol. 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 TEA can be effective for treating NPNP. REGISTRATION NUMBER: PROSPERO CRD42020188346.

Traditional Korean Medicine as Collaborating Treatments with Conventional Treatments for Knee Osteoarthritis: A Protocol for a Systematic Review and Meta-Analysis.

BACKGROUND: Knee osteoarthritis (OA) is a degenerative disease of the joint cartilage with no definite treatment in the early stage. Several previous review studies have shown that alternative medical treatments, including acupuncture, moxibustion, and herbal medicines, are effective in improving the symptoms of the disease and the patient's quality of life. However, no systematic review study has shown the effectiveness of the combination of conventional and alternative therapies. Therefore, the aim of our study is to determine the most effective combination therapies and to provide evidence for the effectiveness and safety of integrated therapies. This article describes the protocol for the methods that will be applied in our systematic review. METHODS: We will conduct an electronic search of nine databases: PubMed, Embase, Cochrane, Google Scholar (first 100 articles), four Korean databases (KoreaMed, Korean Studies Information Service System, Research Information Service System, and Oriental Medicine Advanced Searching Integrated System), and one Chinese database (China National Knowledge Infrastructure). Only randomized controlled studies that reported on both conventional treatment (drugs and hyaluronic acid) and traditional Korean medicine (acupuncture, moxibustion, and herbal medicines) will be selected. The primary outcomes will be pain and function of the joint. The secondary outcomes will include pain relief duration, total effective rate, incidence of adverse events, and quality of life. We will assess the methodological quality of the included studies using the Cochrane risk of bias tool. For the meta-analysis, standardized mean differences and risk ratios with 95% confidence intervals will be applied for continuous and dichotomous data, respectively. RESULTS: This review will evaluate the effectiveness and safety of several Korean medicine treatments combined with conventional treatments for knee OA. CONCLUSION: Our review will provide a good foundation for the integrative treatment of knee OA.

Quality assessment of traditional and conventional medicine clinical practice guidelines for osteoporosis.

ABSTRACT: Numerous studies have reported the variable quality of clinical practice guidelines (CPGs) across various domains. The aim of this study was to systematically assess the quality, methodology, and consistency of recently developed traditional and conventional medicine CPGs that focus on the management of osteoporosis and provide helpful recommendations for patients with osteoporosis.From June 2020 to July 2020, CPGs with osteoporosis targeting any age were systematically retrieved. All CPGs of traditional and conventional medicine related to the assessment and diagnosis, management, and clinical therapeutic and pharmacological recommendations with osteoporosis were eligible for inclusion in this study. The excluded documents included guidelines without recommendations, secondary publications derived from CPGs, consensus statements, or consensus conferences based on the opinion of panelists, systematic reviews, editorials, clinical trials, and single-author documents. The quality of CPGs was independently examined by three assessors using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument. AGREE II consists of 6 domains; scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, and editorial independence. Consequently, selected CPGs were graded as recommended (A), recommended with modifications (B), or not recommended (C), and the specific treatments and preventive recommendations in the CPGs were summarized.The quality of the 15 CPGs assessed varied across the AGREE II domains. The overall quality ranged from 3.0 to 6.0 out of 7. The domain that had the highest scores were "clarity of presentation," with a mean value of 69.0% (range 46%-83%); "editorial independence" had the lowest score of 30.2% (range 0%-75%). The conventional CPGs focused on pharmacological treatments, calcium and vitamin D intake, and prevention, while the traditional CPGs consistently emphasized on herbal medicine and non-pharmaceutical treatment and management.Further development of CPGs will require improvement in domains where low item scores have been obtained in the quality assessment in this present study. Further research is needed on alternative modalities for osteoporosis, especially complementary approaches, and higher quality CPGs are needed to facilitate evidence-based clinical practice.

The efficacy of laser therapy in patients with facial palsy: A protocol for systematic review and meta-analysis.

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.

Thread-embedding acupuncture for lumbar herniated intervertebral disc: Protocol for a systematic review and meta-analysis.

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.

Clinical efficacy and safety of thread-embedding acupuncture for treatment of the sequelae of Bell's palsy: A protocol for a patient-assessor blinded, randomized, controlled, parallel clinical trial.

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).

Traditional Korean Medicine Treatment for Patients with Wilting Disorder: A Literature Review of In Vivo Studies.

Wilting disorder is an abnormal condition characterized by weakness and paralysis of the upper and lower extremities. Pathogenesis and treatment target of the disorder are unclear; hence, allopathic treatment is generally used to relieve the symptoms. To investigate the treatment mechanism and effect of Traditional Korean Medicine (TKM) in patients with wilting disorder, we reviewed in vivo studies that focused on the effect of TKM on the main symptoms of wilting disorder and treatment of the diseases that can cause these symptoms. We electronically searched the PubMed, Cochrane, and CNKI (China National Knowledge Infrastructure) databases using the following search terms: (weakness OR motor function disorder) (myasthenia gravis OR Guillain-Barre syndrome OR amyotrophic lateral sclerosis OR paralysis OR polymyositis OR muscular dystrophy) AND (herbal medicine OR acupuncture OR bee-venom OR pharmacoacupuncture OR electro-acupuncture OR moxibustion). We selected 11 studies that demonstrated the effect of TKM treatment on the main symptoms of wilting disorder. In these studies, inducted models of amyotrophic lateral sclerosis, myasthenia gravis, Duchenne muscular atrophy, polymyositis, and Guillain-Barre syndrome were used. With regard to treatment, herbal medicine was used in five studies, and acupuncture and bee-venom pharmacoacupuncture were used in three studies each. Future research is needed to determine the effectiveness of TKM treatment in patients with diseases that can cause the main symptoms of wilting disorder.

A Review of Complementary and Alternative Medicine Therapies on Muscular Atrophy: A Literature Review of In Vivo/In Vitro Studies.

OBJECTIVE: The objective of this review is to evaluate the recent treatment and study trends of complementary and alternative medicine (CAM) treatments on muscular atrophy by reviewing in vivo/in vitro studies. MATERIALS AND METHODS: The searches were conducted via electronic databases including PubMed, the Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang MED, and five Korean databases. Only in vivo and in vitro studies were included in this study. RESULTS: A total of 44 studies (27 in vivo studies, 8 in vitro studies, and 9 in vivo with in vitro) were included. No serious maternal or fetal complications occurred. There were various animal models induced with muscular atrophy through "hindlimb suspension", "nerve damage", 'alcohol or dexamethasone treatment', "diabetes", "CKD", "stroke", "cancer", "genetic modification", etc. In 28 of 36 articles measuring muscle mass, CAM significantly increased the mass. Additionally, 10 of them showed significant improvement in muscle function. In most in vitro studies, significant increases in both the diameter of myotubes and muscle cell numbers were reported. The mechanisms of action of protein synthesis, degradation, autophagy, and apoptotic markers were also investigated. CONCLUSIONS: These results demonstrate that CAM could prevent muscular atrophy. Further studies about CAM on muscular atrophy are needed.

Clinical research on the efficacy and safety of Bosinji for low back pain with radiculopathy caused by herniated intervertebral disc of the lumbar spine: A protocol for a multicenter, randomized, controlled equivalence trial.

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 2.5 g of Bosinji granule (1.523 g of Bosinji extract) or Loxonin tablet (60 mg 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).

The efficacy and safety of herbal medicine BHH10 in postmenopausal women with osteoporosis: study protocol for a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial.

BACKGROUND: Osteoporosis is becoming more prevalent in aging societies worldwide, and the economic burden attributable to osteoporotic fractures is substantial. The medications presently available to treat osteoporosis have side effects, and the development of safer and more effective treatments is urgently needed. The aim of this study is to evaluate the efficacy and safety of BHH10, a traditional Korean herbal medicine, in the treatment of postmenopausal osteoporosis. METHODS/DESIGN: This is a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial and will include 168 postmenopausal women aged 55 years and older with osteoporosis. The participants will be recruited competitively from two sites of the Acupuncture and Moxibustion Department of Kyung Hee University Hospital of Korean Medicine, either Hoegidong or Gangdong in Seoul, Korea. Participants will be assigned randomly to one of two groups, the BHH10 group or the placebo group, in a 1:1 ratio, and will have five scheduled visits. Participants will take two tablets of BHH10 or placebo three times daily for 12 weeks. The primary efficacy outcome is the change in bone mineral density at the lumbar spine (L1-4) between baseline (visit 1) and 12 weeks after randomization (visit 5). Other outcome variables include changes in bone turnover markers, the Deficiency Syndrome of the Kidney Index, EuroQol five-dimension questionnaire score, and laboratory parameters, as well as adverse events. DISCUSSION: To our knowledge, this will be the first clinical trial to assess the efficacy and safety of BHH10 in postmenopausal women with osteoporosis. It is anticipated that the results will contribute to the development of traditional herbal medicines that can be used to treat osteoporosis in postmenopausal women in Korea. If the superiority of BHH10 over placebo is demonstrated, this study could provide the foundation for a phase III clinical trial. The results of the study will be published in a peer-reviewed journal. TRIAL REGISTRATION: Clinical Research Information Service, KCT0001842 . Registered on 14 March 2016.

Clinical research on the efficacy and safety of thread-embedding acupuncture for treatment of herniated intervertebral disc of the lumbar spine: a protocol for a multicenter, randomized, patient-assessor blinded, controlled, parallel, clinical trial.

BACKGROUND: A lumbar herniated intervertebral disc (LHIVD) is a common problem that usually causes lower back pain and neurological symptoms that manifest as radiating pain. Several studies have reported that thread-embedding acupuncture (TEA) is effective in the treatment of LHIVD. However, these studies were of low quality and there is therefore little clinical evidence for the effectiveness of TEA in this regard. The aim of the present study is to establish the clinical evidence regarding the efficacy and safety of TEA in the treatment of pain, function, and quality of life in patients with LHIVD. The study uses a rigorously designed, full-scale, randomized clinical trial (RCT) protocol. METHOD/DESIGN: This is a multicenter, randomized, patient-assessor blinded, sham-controlled trial with two parallel arms. Seventy patients with LHIVD who have lower back pain more severe than 40 mm on the 100-mm visual analogue scale (VAS), and who are aged 19-70 years, will be recruited and randomly allocated to a TEA group and sham TEA (STEA) group. Both groups will receive treatment on 23 predefined acupoints once a week for eight weeks; needles with the thread removed will be used in the STEA group, while normal TEA will be employed in the TEA group. Changes in the 100-mm VAS for lower back pain after eight weeks will be assessed as the primary outcome. Furthermore, the 100-mm VAS for radiating pain, Oswestry Disability Index, Roland-Morris disability questionnaire, EuroQol 5 Dimensions 5 Levels, and global perceived effect will be measured and analyzed as secondary outcomes. All outcomes will be assessed at baseline and at 4, 8, 12, and 16 weeks after screening. DISCUSSION: The results of this trial will help to establish the clinical evidence regarding TEA in the treatment of patients with LHIVD. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03236753 . Registered on August 2, 2017. Clinical Research Information Service of the Republic of Korea, KCT0002439 . Registered on August 1, 2017.