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Importance: The Yi Shen Juan Bi (YSJB) pill has been used to treat rheumatoid arthritis (RA), with several studies reporting its anti-inflammatory effects and ability to prevent bone destruction. However, the lack of evidence regarding the effectiveness and toxicity of individual components of YSJB limits its widespread use.Objective: This protocol outlines a systematic review and/or meta-analysis to evaluate the effectiveness and safety of YSJB.Data Resources: We will search worldwide electronic databases, including MEDLINE, Cochrane Library, China National Knowledge Infrastructure, Wanfang, 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. In addition, we will conduct manual searches, and, if necessary, contact authors directly. The search will cover publications until June 2024.Study Selection: We will select randomized controlled trials (RCTs) that compare the use of YSJB for the treatment of RA against other treatments.Study Extraction and Synthesis: Data from the selected RCTs will be extracted, including sample size, patient characteristics, intervention details, and outcome measures. We will perform a meta-analysis using Review Manager software.Main Outcome(s) and Measure(s): The primary outcome measures will include disease activity scores such as effective rate, swollen joint count, tender joint count, and morning stiffness. Secondary outcome measures will include blood test results and adverse events.Results : : The results will reveal the effectiveness and safety of YSJB for the treatment of RA.Conclusion : s and Relevance: The findings will provide an evidence-based review of the use of YSJB for RA.S.

Objective: The surge in vehicles has escalated traffic volume, leading to an upswing in traffic accidents and subsequent disorders. Complex symptoms often characterize post-traumatic syndrome from these accidents. Traditional Korean medicine (TKM), increasingly used in car insurance, forms a substantial part of treatment costs. However, the current system lacks explicit fee guidelines and approval criteria for non-reimbursable TKM procedures, relying heavily on practitioners’ judgment without robust evidence-based decision-making. This scenario raises concerns about treatment appropriateness and transparency. We aim to explore physicians’ perspectives on utilizing TKM in emergency medicine, their participation sentiments, and their session selection process post-traffic accident. Methods: We collected TKM practitioners’ opinions regarding their role in clinical environment and involvement in treating patients after traffic accidents. The need for comprehensive and standardized protocols for the diagnosis, treatment, management, and prognosis of patients with post-traumatic syndrome is evident. Additionally, improvements that facilitate rational decision-making by medical consumers and protect the treatment rights of healthcare providers are necessary. Results has emphasized the importance of evidence-based decision-making, establishing appropriate fee structures and detailed criteria for non-reimbursable TKM-based procedures, and enhancing regulations for the reliability and transparency of TKM-based treatments in the context of car insurance. Results and conclusions: The perspective of healthcare providers directly involved in TKM-based treatments must be considered to maintain a sustainable vehicular insurance system, transcending administrative policy discourse. We highlighted the challenges and potential solutions for improving the effectiveness and appropriateness of TKM-based treatments in the context of car insurance.

Abstract Background This study, utilizing the claims data from the Health Insurance Review and Assessment Service of Korea, aimed to examine the 10-year (2010–2019) trends in various types of lumbar spine surgeries performed on patients diagnosed with lumbar herniated intervertebral disc (HIVD), and the current status of opioid prescriptions, as well as the duration of postoperative hospital stays based on the type of surgery performed. Method This retrospective cross-sectional study examined patients with one or more national health insurance claims carrying a primary or secondary diagnosis of HIVD (ICD-10 codes: M511, M518, M519) over a 10-year period (2010–2019). From the patients undergoing lumbar spine surgery, we selected those who did not require reoperation within 30 days following the initial lumbar surgery. Our final study sample comprised patients who underwent only one type of surgery. Results Among the patients diagnosed with HIVD and subsequently undergoing lumbar surgery between 2010 and 2019, a slight downward trend was observed in those undergoing open discectomy (OD); however, OD persistently accounted for the highest proportion over the 10 years. Percutaneous endoscopic lumbar discectomy (PELD) demonstrated a consistent upward trend from 2016 to 2018. When inspecting trends, we noted a consistent escalation over the decade in the postoperative opioid prescription rates of strong opioids (50.7% in 2010 to 77.8% in 2019) and tramadol (50.9% in 2010 to 76.8% in 2019). Analyzing these trends by surgery type, spinal fusion exhibited a slightly higher rate of opioid prescriptions than other lumbar surgeries. Regarding the length of postoperative hospital stays, patients undergoing PELD recorded the shortest stay (7.04 ± 6.78 days), while spinal fusion necessitated the longest (20.14 ± 12.18 days). Conclusion This study analyzed the trends in types of lumbar spine surgeries, opioid analgesic prescriptions, and length of hospital stays over 10 years (2010–2019) among patients with HIVD in Korea. Our data and findings provide valuable evidence that may prove beneficial for clinicians and researchers involved in HIVD-related practices.

Rheumatoid arthritis (RA) is an autoimmune disease primarily affecting the joints and requires various treatments, including medication, injection, and physiotherapy. Wu tou decoction (WTD) is a traditional Chinese medicine prescribed for RA, with several articles documenting its effectiveness in RA treatment. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of WTD for RA. We searched for randomized controlled trials (RCTs) comparing WTD with conventional treatments (including medication, injection, and physiotherapy) from its inception to May 2024. Primary outcomes were disease activity scores, including effective rate, tender joint count, and morning stiffness. Secondary outcomes comprised blood test results (erythrocyte sedimentation rate, C-reactive protein, and rheumatoid factor) and adverse events. Nineteen RCTs involving 1794 patients were included. Statistically, WTD demonstrated better improvement than conventional treatments (18 medications and 1 injection) across the effective rate, joint scale, and blood tests, regardless of the treatment type (monotherapy or combination therapy). Adverse events were reported in 11 studies, with no statistical differences observed between them. The numerical results showed that WTD may offer potential benefits for managing RA. However, the significant discrepancy between clinical practice and the low quality of the RCTs remains a limitation. Therefore, further well-designed studies with larger patient cohorts are needed to draw definitive conclusions.

Background: The incidence of facial palsy has been increasing. Many patients consult both Korean and Western physicians; however, no critical pathway (CP) for facial palsy has been established based on integrated medicine including Korean medicine, Western medicine, and complementary and alternative medicine. Thus, we developed and implemented an integrated CP for patients with acute facial palsy and investigated the satisfaction with CP. Methods: Overall, 20 patients who received treatment following the CP and 20 medical staff members involved in their care responded to a questionnaire survey. The questionnaire was developed based on a review of previous studies and focused on the satisfaction with the CP. Results: Patients’ satisfaction score with the integrated CP was ≥ 4.4 for all items using a 5-point Likert-type scale. Smooth and cooperative treatment procedures, time-saving practices, and a clear explanation of the integrated treatment plan were satisfactory factors. Additionally, they preferred incorporating specialized facial massage and receiving education on self-exercise or massage techniques as complementary therapies. The medical staff members expressed a high level of satisfaction with the CP; however, the work division and treatment guidelines must be improved. Conclusion: An integrated CP program for acute facial palsy was implemented, and the satisfaction levels of patients and medical staff members were assessed. The results revealed high levels of satisfaction, and several improvements identified will be incorporated into clinical practice going forward.

Colorectal cancer (CRC) poses a significant global health burden, necessitating innovative treatment strategies. This study evaluates the potential of Caulerpa racemosa extract, a natural compound, to modulate the transforming growth factor-beta (TGF-β) signaling pathway and induce apoptosis in CRC cells. HT-29 cells served as an in vitro CRC model. The cells were exposed to an n-hexane extract of C. racemosa, and TGF-β1 expression was assessed using immunofluorescence. Apoptosis was quantified via annexin V and propidium iodide staining through flow cytometry. C. racemosa extract significantly downregulated TGF-β1 expression compared to the control group, suggesting its potential as a CRC tumorigenesis and progression inhibitor. The extract displayed robust pro-apoptotic activity, with the 800 μg/mL dose significantly increasing early apoptotic cells compared to the 1200 μg/mL dose. Other dose comparisons showed no significant differences, indicating an optimal dosage range for early apoptosis induction at 800 μg/mL. The 1200 μg/mL dose also induced a notable increase in necrotic/late apoptotic cells compared to the control, triggering a more potent apoptotic response in advanced stages. Our study highlights the potential of C. racemosa extract to modulate the TGF-β signaling pathway and induce apoptosis in CRC cells. The observed dose-dependent effects on early and late apoptotic cells suggest potential applications as a preventive or therapeutic agent in CRC treatment. Further investigations are warranted to explore the extract's role in combatting CRC's complex pathogenesis.

Abstract Although it is known that proper nutrition is effective in managing sarcopenia, the most powerful nutrients have not yet been determined. This study is designed to investigate the effects of various nutritional approaches on muscle mass, muscle strength, and sarcopenia prevention in systematic reviews. In study design, network and pairwise meta-analyses of randomized clinical trials were considered. Clinical studies regarding the nutritional effects associated with the physiological activity of skeletal muscle and management of sarcopenia will be covered. The main outcomes will cover the following five elements: anti-fatigue impact with skeletal muscle, muscle atrophy prevention, differentiation level with skeletal muscular cell, anti-inflammatory effect, and muscle injury prevention. Authors will conduct the study selection, extracting data process, and methodological quality investigation. Systematic review registration OSF registry (ethical approval number: https://osf.io/ye4q7 ).

Herpes zoster (HZ) results from the reactivation of a varicella-zoster virus infection and is accompanied by moderate-to-severe pain in most patients. The most common treatment is medication; however, there are still limitations. Acupuncture reportedly has meaningful therapeutic effects and is a possible alternative option in HZ. However, no systematic reviews examining the use of acupuncture and electro-acupuncture (EA) alone have been published; in this study, we therefore aimed to systematically review those techniques. We searched for clinical trials of acupuncture and EA treatment for HZ up to October 2022. Trials that used acupuncture were included. Outcomes were visual analog scale (VAS) and effective rate. Secondary outcomes were time to pain relief, time to pain elimination, incrustation, decrustation, lastly incidence of post-herpetic neuralgia (PHN). In total, 22 randomized controlled trials were included in this research. Compared with conventional medication therapy, acupuncture was associated with a significant improvement in VAS, effective rate, and times to pain relief and elimination. Times to new blister cessation, incrustation, and decrustation (days) were significantly improved. Furthermore, the incidence rate of PHN was lower in acupuncture groups. The results suggest that acupuncture could be a reasonable treatment option for patients with HZ who suffer from pain and accompanying symptoms.

This study aimed to evaluate clinical practice guidelines (CPGs) for ankle sprains using the Appraisal of Guidelines for Research and Evaluation II tool, using electronic databases (GIN, PubMed, EMBASE, NCKM, CNKI, CiNii, WanFang database, RISS, and SCOPUS), to suggest strategies for improvement in the future. The search was performed on April 23, 2021 and 10 CPGs were selected for evaluation. Three CPGs were recommended without modification (Class A scores), five were recommended with modification (Class B), and two were not recommended (Class C scores). The CPG domain that received the lowest score was “applicability.” The traditional medicine CPGs scored higher [Class A (n = 1) and Class B (n = 1)] than the conventional Western medicine CPGs [Class A (n = 2), Class B (n = 4), and Class C (n = 2)] and were considered to be more methodical. In the future, more research into traditional medicine is required.

This study aimed to analyze auricular acupressure and auricular acupuncture used in smoking cessation research by analyzing published randomized controlled trials. Eight databases (PubMed, Cochrane, EMBASE, CNKI, CiNII, KMbase, KISS, OASIS) were searched until December 2021, and 21 out of 1,919 studies met inclusion criteria. Data on the treatment site, time, frequency, period, and outcomes were analyzed. Lung (MA-IC1) and Ear Shenmen (MA-TF1) were the most used acupoints. The number of treatments varied between a minimum of 2 to a maximum of 24, and treatment duration varied between a minimum of 2 weeks to a maximum of 8 weeks. Cigarette consumption and smoking cessation rate were the most studied outcome, followed by multiple other psychological indications.

Background Lumbar herniated intervertebral disc (LHIVD) is a frequently presented condition/disease in Korean medical institutions. In this study, the economics of thread embedding acupuncture (TEA) was evaluated in a randomized controlled trial comparing TEA with sham TEA (STEA). Methods This economic evaluation was analyzed from a limited social perspective, and the per-protocol set was from a basic analysis perspective. The cost-effectiveness analysis was based on the change in visual analog scale score, and the cost-utility analysis was based on the quality-adjusted life years. The final results were expressed as the average cost-effectiveness ratio and incremental cost-effectiveness ratio, and furthermore sensitivity analysis was performed to confirm the robustness of the results observed. Results The cost-effectiveness analysis showed that TEA was 9,908 won lower than STEA, while the decrease in 100 mm visual analog scale score was 8.5 mm greater in the TEA group compared with the STEA group (p > 0.05). The cost-utility analysis showed that TEA was 9,908 won lower than STEA, while the quality-adjusted life years of TEA was 0.0026 years higher than STEA (p > 0.05). These results were robust in the sensitivity analysis, but were not statistically significant. Conclusion In treating LHIVD, TEA appeared to have cost-effectiveness and cost-utility compared with STEA. However, there were no significant differences between the groups in terms of cost, effectiveness, and utility indicators. Therefore, results must be interpreted prudently; this study was the 1st to conduct an economic evaluation of TEA for LHIVD.

The purpose of this study was to evaluate the effectiveness and safety of acupotomy for the treatment of patients with knee osteoarthritis. There were 9 databases searched to retrieve randomized controlled trials until August 3, 2019 regarding acupotomy versus conventional Western medicine, conventional Western medicine treatment with and without acupotomy, and Korean medicine treatment with and without acupotomy, and meta-analysis was performed. Of 303 potentially relevant studies retrieved, 43 were systematically reviewed. All studies were conducted in China. Effective rate, visual analogue scale, and Western Ontario and McMaster Universities Osteoarthritis index were used as the evaluation scales. The Ashi point was selected most frequently. In all studies, the intervention group was more effective than the control group. Meta-analysis revealed that acupotomy showed statistically significant beneficial results. Although acupotomy had a beneficial effect on knee osteoarthritis, the risk of bias of the included studies was not low. The majority of the results from the evaluation scales used were highly heterogeneous (> 50%) which reduced confidence in the estimation of effect, or had a small sample size. Further clinical research and development is required in the future.

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.

This literature review was designed to investigate the effects of the microneedle therapy system (MTS) on alopecia in experimental, and clinical studies. The MTS is acupuncture needling therapy delivered by a roller. A literature review of studies published before May 2020 was conducted using 9 online databases, and a total of 13 studies (4 in vivo studies and 9 clinical trials) were included. Most studies showed that the MTS was effective when used in combination with other treatments. In vivo studies reported an increased level of hair growth factors following treatment. Typically, 1.5 mm needles were used in the MTS treatment and photographic evaluation (by either camera or microscope) was reported in most studies. Oriental medicine research included 2 in vivo studies, which reported positive effects when combined with the MTS. There were no reported severe side effects. the MTS might be safe and has a drug delivery effect. Further studies need to be conducted regarding the frequency and needle length depending on the type of alopecia using Oriental and Western medicine.

The purpose of this study was to evaluate the evidence supporting the effectiveness of moxibustion treatment for osteoarthritis. There were 9 databases used to retrieve randomized controlled trials (RCTs) that used moxibustion as treatment for osteoarthritis. The quality of methodology for the RCTs was assessed using the Cochrane Risk of Bias tool [Review Manager (RevMan) Version 5.3 Windows, The Nordic Cochrane Centre, Copenhagen, Denmark]. The inclusion criteria for this review was met by 27 RCTs. All studies were conducted in China. A 4-week moxibustion treatment period was the most common. EX-LE4 and SP10 and GB34 acupoints were most frequently selected in the treatment of osteoarthritis. The most commonly used evaluation index was the visual analog scale (VAS). All studies, including a meta-analysis showed that moxibustion treatments were statistically significantly effective at treating knee osteoarthritis. However, well-designed randomized RCTs without a high risk of bias should be designed in the future.

Background Due to the aging population in Korea, knee osteoarthritis (KOA) has become an increasingly common condition. Many patients with KOA prefer analgesics, herbal medicines, acupuncture, or exercise, rather than arthroscopic surgery or a knee replacement. Gyebutang (GB) granules are a herbal extract widely used to treat KOA in traditional Korean medicine, but there is insufficient evidence of its efficacy and safety. Methods A multicenter, randomized, assessor-blinded, 2-armed parallel, controlled clinical trial has been designed to investigate the efficacy and safety of GB combined with acupuncture for the treatment of KOA. There will be 100 patients with KOA enrolled in the study from 3 traditional Korean medicine hospitals. The participants will be randomly allocated to an experimental group (GB and acupuncture) or a control group (celecoxib and acupuncture) in a 1:1 ratio. Both groups will receive acupuncture treatment once a week for 6 weeks; one group will receive GB and the other will receive celecoxib for the same duration. Results The primary outcome will be the change of knee osteoarthritic pain, based on scores on a 100 mm visual analog scale. The secondary outcomes will be scores on a numeric rating scale, the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life 5-dimension 5-level scale, and adverse events. Conclusion The results of this study will provide evidence of efficacy and safety of GB as a treatment for patients with KOA.

Abstract Background Low back pain is a common symptom and continuous or recurrent pain results in chronic low back pain (CLBP). While many patients with CLBP have tried various treatments, complementary and alternative medicine including acupuncture and herbal medicine is one of the commonly used treatments. Palmijihwang-hwan is a herbal medicine used frequently in clinical practice but there has been no report of the efficacy, safety, or cost-effectiveness analysis of Palmijihwang-hwan for CLBP. Methods This study is a randomized, assessor-blinded, multicenter, clinical trial with two parallel groups. Four Korean medicine hospitals will recruit 84 participants and randomly allocate them into the control or treatment group in a 1:1 ratio. The control group will receive acupuncture treatment at 11 local and 4 distal acupuncture points for 20 min twice a week for 6 weeks. The treatment group will receive the same acupuncture treatment as the control group and also take Palmijihwang-hwan for 6 weeks. The primary outcome will be the change in visual analog scale (VAS) score between baseline (visit 1) and completion of the intervention (visit 12), and secondary outcomes will be pain-related clinical relevance (minimal clinical important difference or the proportion of the participants who decrease more than 30, or 50% on VAS), disability (Roland and Morris Disability Questionnaire), quality of life (EuroQol-5D), global assessment (Patient Global Impression of Change), and economic analysis (cost-effectiveness and cost-utility analysis). Additionally, safety will be assessed. Discussion The results of our study will provide the clinical evidence about the efficacy, safety, and cost-effectiveness analysis of Palmijihwang-hwan for CLBP. There will be a chance to provide multiple subdivided influence of this treatment with various outcome measures, but lack of placebo is our limitation. Trial registration Clinical Research Information Service, KCT0002998. Registered on 12 July 2018.

Background This study was designed to evaluate the clinical safety of Bee Venom (BV) pharmacopuncture at craniofacial acupuncture points. Methods This was a retrospective study of 108 patients diagnosed with peripheral facial paralysis, trigeminal neuralgia, or facial spasm who were admitted to Kyung Hee University Korean Medicine Hospital at Gangdong, from April 1st, 2017 to August 30th, 2017. Patients were allocated into either, Group 1 (the non-allergy group of patients who did not have an allergic reaction to BV) or Group 2, the group who had allergic reactions to BV. To evaluate the clinical safety of BV pharmacopuncture after each treatment, several criteria were used to measure any side effects: outcome, Common Terminology Criteria for Adverse Events scale, Mueller HL scale, treatment decision after adverse reaction, causality, measures performed for patients with adverse reactions, and efficacy assessment. Results BV pharmacopuncture delivered in 0.1-0.2 mL at a concentration of 1:30,000 at the craniofacial acupuncture points, showed no statistically significant differences in baseline characteristics between non-allergy Group 1 and allergy Group 2. Amongst the 108 patients, 11 reported side effects after BV pharmacopuncture treatment. These adverse events included rash (n = 7), pruritus (n = 5), swelling (n = 1), vesicles (n = 1), erythema (n = 1), and hives (n = 1). All side effects resolved without sequelae. Conclusions In this study, BV pharmacopuncture delivered at low doses at the craniofacial acupuncture points, resulted in 10% of patients experiencing non serious side effects suggesting that BV pharmacopuncture was clinically well tolerated.

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.

The purpose of this study was to review clinical studies of lumbar herniated intervertebral disc (LHIVD) treatment using acupuncture. Online database (PubMed, COCHRANE Library, EMBASE, CNKI, KISS, NDSL, KoreaMed, KMbase, OASIS, and KISTI) searches were conducted in May 2018. Studies that used acupuncture, electroacupuncture or warm needle acupuncture were included, along with participants who had lower back pain and radiating pain of their lower limbs consistent with radiological findings. Animal studies and nonclinical data were excluded. Data on treatment methods, site, time, frequency, period, and scales used were analyzed. There were 69 studies including 38 randomized controlled trials, 14 retrospective observational studies, and 17 clinical case studies. There were 51 acupoints selected for acupuncture treatment of LHIVD. The most frequently treated acupoints were BL23, BL25, BL24, and BL40. The mean treatment time, frequency, and duration were 26.06±6.70 mins, 6.29±1.70 times/week, and 20.57±11.04 days, respectively, in randomized controlled trials (RCT), and 18.62±4.60 mins, 11.58±3.99 times/week, and 34.43±17.62 days, respectively, in case/retrospective studies (mean±SD). This review collates information about acupuncture treatment methods for LHIVD.

The objective of this study was to review clinical trials of pharmacopuncture treatment for Frozen Shoulder and to evaluate trends in this field. The literature search was performed using PubMed, the Cochrane Library, China National Knowledge Infrastructure, and 5 Korean electronic databases. A combination of “pharmacopuncture,” “acupoint injection,” “Frozen Shoulder,” “adhesive capsulitis,” and “periarthritis of shoulder” search terms were used. A total of 9 studies were included in this review. The studies were classified into herbal extract-based (5 types) and animal-based (2 types) pharmacopuncture treatment of Frozen Shoulder. There were 14 different acupoints and Ashi points used in the 9 studies. The total volume of herbal extract-based pharmacopuncture injected was usually between 2 mL and 4 mL, and for animal-based pharmacopuncture it was 1 ml. In most studies of Frozen Shoulder, pain was reduced and function was significantly improved after pharmacopuncture treatment. These results demonstrate that pharmacopuncture alleviates pain and restores function in patients with Frozen Shoulder. Further studies must be conducted on pharmacopuncture for management of Frozen Shoulder.

Abstract 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.

Abstract 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.

This study aimed to investigate the feasibility of a combined treatment of bee venom acupuncture (BVA) and non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of non-specific chronic neck pain (NCNP). Patients with NCNP for ≥3 months were randomly allocated to a BVA, NSAIDs, or combined group (1:1:1), receiving 6 sessions of BVA, loxoprofen (180 mg daily), or a combination, respectively, for 3 weeks. Recruitment, adherence, and completion rates were calculated to assess feasibility. Bothersomeness, pain, disability, quality of life, depressive status, treatment credibility, and adverse events were assessed. In total, 60 participants were enrolled, and 54 completed the trial. Recruitment, adherence, and completion rates were 100%, 95%, and 90%, respectively. Bothersomeness, pain, disability, and depressive symptoms significantly improved in all groups after treatment (p < 0.05). The combined group showed continuous improvement during the follow-up period (p < 0.05). Quality of life was significantly improved (p < 0.05), and treatment credibility was maintained in the BVA and combined groups. No serious adverse events were reported. Combined treatment of BVA and NSAIDs are feasible for the treatment of NCNP, showing high persistence of the effect, credibility, and safety. Additional trials with longer follow-up are needed to confirm this effect.

Background Hominis placenta (HP) is used in Korean medicine to tonify qi and blood, and enrich yin and tonify yang. HP has been reported to have therapeutic effects. Methods A survey of international and Korean electronic databases was conducted using the search terms “hominis placenta pharmacopuncture” and “hominis placenta extract”. The search was limited to material published up to May 31, 2017. Results A total of 83 studies were included in this systematic review: 50 were clinical studies, 25 were basic studies, and 8 were other types of study. Among clinical studies, the most frequently treated disease groups were musculoskeletal diseases and nervous system diseases. In vitro studies were conducted mainly on anti-inflammatory, analgesic, and anti-cell necrosis models. Most of the in vivo studies were performed in rheumatoid arthritis or diabetic complications models. Conclusions HP pharmacopuncture has effects in the treatment of various diseases. Further large-scale randomized controlled trials are needed to improve the level of evidence for HP pharmacopuncture. It would be helpful if future in vitro and in vivo studies could identify the mechanism of action of HP pharmacopuncture.

Abstract Background Cancer-related fatigue is one of the most common symptoms experienced by cancer patients, and it diminishes their quality of life. However, there is currently no confirmed standard treatment for cancer-related fatigue, and thus, many patients who suffer cancer-related fatigue seek complementary and alternative medicines such as moxibustion. Moxibustion is one of the most popular therapies in traditional Korean medicine used to manage fatigue. Recent studies have also demonstrated that moxibustion is effective for treating chronic fatigue. However, there is insufficient evidence supporting the effect of moxibustion against cancer-related fatigue. The aim of this study is to assess the efficacy and safety of moxibustion treatment for cancer-related fatigue. Methods/design A multi-center, three-armed parallel, randomized controlled trial will be conducted. Ninety-six patients with cancer-related fatigue will be recruited from three clinical research centers. They will be randomly allocated to one of three groups in a 1:1:1 ratio. The moxibustion group will receive moxibustion treatment at CV8, CV12, LI4 and ST36. The sham moxibustion group will receive sham moxibustion at non-acupoints. Both the moxibustion and sham moxibustion groups will receive 30-min treatments twice a week for 8 weeks. The usual care group will not receive moxibustion treatment. All participants will be educated via a brochure on how to manage cancer-related fatigue in daily life. The outcome measurements will be evaluated at baseline, week 5, week 9, and week 13 by assessors who are blinded to the group allocation. The primary outcome measure will be the mean change in the average scores of the Brief Fatigue Inventory before and after treatments between groups. The secondary outcome measures will be the mean difference in changes from baseline of the Brief Fatigue Inventory, functional assessments of cancer therapy-fatigue, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 scores, and Montreal Cognitive Assessment scores between groups. Safety will be assessed by monitoring adverse events at each visit. Discussion The results of this study will provide evidence to confirm whether moxibustion can be used as a therapeutic option for treating cancer-related fatigue. Trial registration Clinical Research Information Service KCT0002170 . Registered 16 December 2016.

Mangiferin is a natural immunomodulator found in plants including mango trees. The effects of mangiferin on chondrogenesis and cartilage repair have not yet been reported. This study was designed to determine the effect of mangiferin on chondrogenic differentiation in IL-1β-stimulated mesenchymal stem cells (MSCs) from subchondral bone and to explore the mechanisms underlying these effects. MSCs were isolated from the subchondral bone of rabbit and treated with mangiferin alone and/or interleukin-1β (IL-1β). Mangiferin induced chondrogenic differentiation in MSCs by upregulating transforming growth factor (TGF)-β, bone morphogenetic protein (BMP)-2, and BMP-4 and several key markers of chondrogenesis, including sex-determining region Y–box (SRY-box) containing gene 9 (SOX9), type 2α1 collagen (Col2α1), cartilage link protein, and aggrecan. In IL-1β-stimulated MSCs, mangiferin significantly reversed the production of TGF-β, BMP-2, BMP-4, SOX9, Col2α1, cartilage link protein, and aggrecan, as well as matrix metalloproteinase (MMP)-1, MMP-13, and a disintegrin and metalloproteinase with thrombospondin motifs (ADAMTS5). Mangiferin upregulated the phosphorylation of Smad 2, Smad 3, Smad 1/5/8, and SOX9 in IL-1β-stimulated MSCs. In the presence of mangiferin, SOX9 siRNA suppressed the activation of Smad 2, Smad 3, Smad 1/5/8, aggrecan, and Col2α1 expression. In conclusion, mangiferin exhibits both chondrogenic and chondroprotective effects on damaged MSCs and mediates these effects by targeting multiple aspects of the Smad and SOX9 signaling pathways.

Bee venom acupuncture (BVA) is an effective treatment for chronic low back pain (CLBP) through the pharmacological effects of bee venom and the simultaneous stimulation of acupoints. However, evidence of its efficacy and safety in humans remains unclear. Using a double-blind, randomized study, 54 patients with non-specific CLBP were assigned to the BVA and sham groups. All participants underwent six sessions of real or sham BVA for 3 weeks, in addition to administration of 180 mg of loxonin per day. The primary outcome, that is, “bothersomeness” derived from back pain, was assessed using the visual analog scale. Secondary outcomes included pain intensity, dysfunction related to back pain (Oswestry Disability Index), quality of life (EuroQol 5-Dimension), and depressive mood (Beck’s depression inventory). Outcomes were evaluated every week during the treatment period and followed up at weeks 4, 8, and 12. After 3 weeks of the treatment, significant improvements were observed in the bothersomeness, pain intensity, and functional status in the BVA group compared with the sham group. Although minimal adverse events were observed in both groups, subsequent recovery was achieved without treatment. Consequently, our results suggest that it can be used along with conventional pharmacological therapies for the treatment of CLBP.