Effectiveness and Safety of Adjunctive Pharmacopuncture to Acupuncture Treatment for Rotator Cuff Diseases: a Protocol for an Assessor-Blinded, Pragmatic Randomized Controlled, Pilot Trial.

Background: Shoulder pain is a common musculoskeletal disorder. Treatment can be surgical or non-surgical. Korean Medicine, including acupuncture and pharmacopuncture, is a part of conservative treatment. Pharmacopuncture, combining acupuncture with herbal medicine, has been used for musculoskeletal disorders since the 1960s, but clinical evidence on its effectiveness is lacking. Objectives: This study aims to assess the effectiveness and safety of pharmacopuncture for rotator cuff disease. Methods: A two-group, parallel, single-center, pragmatic, randomized, controlled, assessor-blinded trial will be conducted. A total of 40 patients will be recruited, starting in July 2022. All patients will be received acupuncture treatment, and pharmacopuncture will be applied to intervention group additionally. After eight treatments are delivered over four weeks, follow-up assessments will be performed. Results: Assessments will evaluate the effectiveness and safety of these treatments at baseline and at weeks 2 (2 W), 4 (4 W), and 8 (8 W). The primary outcome will be a visual analog scale (VAS) evaluation of shoulder pain levels. Assessments will include shoulder pain and disability index (SPADI), shoulder range of motion (ROM), EuroQol 5-Dimension 5-Level (EQ-5D-5L), patient global impression of change (PGIC), 'no worse than mild pain', and drug consumption rates. Conclusion: This study may offer a rationale for a future full-scale trial on the effectiveness and safety of pharmacopuncture treatment for rotator cuff disease and provide data on non-surgical treatment for the disease.

Effectiveness and safety of electroacupuncture and its cotreatment with electronic moxibustion in the treatment of patients with moderate benign prostatic hyperplasia using alpha blocker: An assessor-blinded, randomized, controlled pilot study.

BACKGROUND: Benign prostatic hyperplasia (BPH) is a disease that affects the quality of life by causing lower urinary tract symptoms (LUTS) in men. Electroacupuncture (EA) and moxibustion therapy have been suggested as an adjunct therapy for improving LUTS in patients with BPH, but clinical studies evaluating the effectiveness of EA and its cotreatment with electronic moxibustion (EM) in patients who have been prescribed alpha blockers have yet to be reported. Therefore, this study aimed to evaluate the effectiveness and safety of EA and EM. METHODS: Twenty-eight patients diagnosed with BPH were randomized to treatment group (TG, n = 14) or control group (CG, n = 14). The TG continued to use the previously prescribed alpha blocker and received the cotreatment of EA and EM 3 times a week for 6 weeks. The CG continued to use the previously prescribed alpha blocker alone for 6 weeks. The primary outcome was the mean change in the international prostate symptom score (IPSS) from baseline to week 6. The secondary outcomes were IPSS at week 3 and 12, clinical relevance, IPSS life satisfaction, EuroQol-Five dimensions, average urinary flow rate, maximum urinary flow rate, and prostate volume. RESULTS: The IPSS decreased at all time points with a statistically significant difference between the 2 groups (3W: P = .0313; 6W: P = .0010; 12W: P = .0304). Based on the minimal clinically important difference (MCID, 3 points), there were significant differences between the TG and the CG at week 3, 6, and 12 (3W: P = .0461; 6W: P = .0123; 12W: P = .0216). Significant group × week interaction effects were found for the IPSS score (P = .0018), as determined from analyses using repeated measures analysis of variance. There were no significant differences between the 2 groups in IPSS life satisfaction, EuroQol-Five dimensions, average urinary flow rate, maximum urinary flow rate, and prostate volume. CONCLUSION: EA and its cotreatment with EM might have a beneficial effect as an adjunct therapy in improving LUTS in patients with BPH. Large-scale randomized controlled trials are warranted to confirm the effectiveness and safety of EA and its cotreatment with EM.

Perioperative Magnesium for Postoperative Analgesia: An Umbrella Review of Systematic Reviews and Updated Meta-Analysis of Randomized Controlled Trials.

The purpose of this study was to summarize and evaluate evidence on the effectiveness of perioperative magnesium as an adjuvant for postoperative analgesia. We conducted an umbrella review of the evidence across systematic reviews and meta-analyses of randomized controlled trials (RCTs) on the effect of perioperative magnesium on pain after surgical procedures. Two independent investigators retrieved pain-related outcomes and assessed the methodological quality of the evidence of included studies using the A MeaSurement Tool to Assess systematic Reviews (AMSTAR) tool, and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system. In addition, an updated meta-analysis of postoperative pain-related outcomes with a trial sequential analysis (TSA) was conducted. Of the 773 articles initially identified, 17 systematic reviews and meta-analyses of 258 RCTs were included in the current umbrella review. Based on the AMSTAR tool, the overall confidence of the included systematic reviews was deemed critically low to low. Pain score, analgesic consumption, time to first analgesic request, and incidence of analgesic request were examined as pain-related outcomes. According to the GRADE system, the overall quality of evidence ranged from very low to moderate. While the updated meta-analysis showed the beneficial effect of perioperative magnesium on postoperative analgesia, and TSA appeared to suggest sufficient existing evidence, the heterogeneity was substantial for every outcome. Although the majority of included systematic reviews and updated meta-analysis showed a significant improvement in outcomes related to pain after surgery when magnesium was administered during the perioperative period, the evidence reveals a limited confidence in the beneficial effect of perioperative magnesium on postoperative pain.

Effectiveness and Safety of Polydioxanone Thread Embedding Acupuncture Compared to Physical Therapy in the Treatment of Patients with Non-Specific Chronic Neck Pain: An Assessor-Blinded, Randomized, Controlled, Clinical Trial.

BACKGROUND: Thread embedding acupuncture (TEA) has recently been used as a conservative treatment method for non-specific chronic neck pain (CNP). The objective of this study was to evaluate the effectiveness and safety of TEA compared to physical therapy (PT) for treating patients with CNP. METHODS: A total of 128 patients diagnosed with CNP were randomly assigned to a TEA group and a PT group at a 1:1 ratio. The TEA group received four sessions of TEA, while the PT group received eight sessions of PT over 4 weeks. Outcomes were assessed using Neck Pain and Disability Scale (NPDS), clinically important difference (CID), cervical spinal angle, Beck Depression Inventory II (BDI-II), Beck Anxiety Inventory (BAI), Patient Global Impression of Change (PGIC), and EuroQol Five-Dimension (EQ-5D) at baseline and 5, 9, and 13 weeks. RESULTS: The TEA group showed significant improvement in NPDS compared to the PT group at 5, 9, and 13 weeks. Proportions of patients with decreased NPDS scores of more than 11.5 points (minimal CID) were significantly higher in the TEA group at 5, 9, and 13 weeks. There were significant differences between the two groups at 5, 9, and 13 weeks for BDI-II, and at 5 and 9 weeks for BAI. For EQ-5D, the TEA group showed significant improvement at 5, 9, and 13 weeks. There was no significant difference in cervical spinal angle between the two groups. For PGIC, better improvement was observed at 9 and 13 weeks in the TEA group. Adverse events associated with interventions were mostly temporary and mild. CONCLUSION: For patients with CNP, TEA treatment was found to be more effective than PT treatment for improving their pain and dysfunction, quality of life, and psychological distress. Despite some post-treatment discomfort, TEA treatment can be considered as a useful treatment method for patients with CNP. TRIAL REGISTRATION: This trial has been registered 5 April 2019 in Clinical Research Information Service of South Korea (CRIS- KCT0003720).

Gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) in Degenerative Knee Osteoarthritis Patients: Lessons and Responders from a Multicenter Randomized Placebo-Controlled Double-Blind Clinical Trial.

BACKGROUND: Gyejigachulbutang (GUI-ZHI-JIA-SHU-FU-TANG, GCB) is an herbal formula widely prescribed in traditional East Asian medicine practice for arthritis and muscle pain. We evaluated the efficacy and safety of GCB for degenerative knee osteoarthritis (KOA). METHODS: Eighty patients with KOA were randomly assigned to the GCB group or the placebo group in a 1 : 1 ratio in two Korean medicine hospitals. Patients took GCB or placebo three times a day for 4 weeks. Primary outcome was the change in the visual analogue scale (VAS) score for knee pain from baseline to 4th week. Secondary outcomes were the change in the VAS score from baseline to 2nd week and 8th week, Korean Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC), European Quality of Life Five Dimensions questionnaire (EQ-5D), and safety. RESULTS: There was no significant difference between the compared indicators of the GCB and placebo groups. However, in subgroup analysis, GCB was effective for subjects with a BMI lower than 25 kg/m2. The dose of pain medication was significantly lower in the GCB group than in the placebo group after four weeks (p=0.016). There were no serious adverse events in the GCB group. CONCLUSIONS: GCB was not effective in primary outcome analysis. In exploratory subgroup analysis, GCB might be effective for individuals with BMI lower than 25 kg/m2 for the treatment of degenerative KOA. GCB may also help reduce the consumption of pain medication. Furthermore, research is required for our hypothesis. This trial is registered with KCT0003024.

Incidence Rate of Hypersensitivity Reactions to Bee-Venom Acupuncture.

INTRODUCTION: Bee-venom acupuncture (BVA) has been widely applied to various disorders including pain-related diseases; however, patients are often warned of adverse reactions such as anaphylaxis. This study aimed to estimate the risk of hypersensitivity reactions to BVA and to determine their clinical features. METHODS: We retrospectively surveyed the medical records of patients treated by BVA between January 2010 and April 2019 in Dunsan Hospital of Daejeon University, and all cases of allergic reactions and their clinical symptoms were analyzed. RESULTS: A total of 8,580 patients (males 4,081 and females 4,499) were treated with BVA which amounts to a total of 60,654 treatments (average 7.1 ± 14.8 times). A total of fifteen patients (7 males and 8 females) reported an allergic reaction (0.175%, 95% CI, 0.086-0.263) of type 1 hypersensitivity, indicating a rate of allergic reaction in 0.025% (95% CI, 0.012-0.037) of the total BVA treatments. The average number of BVA treatments in those patients was 6.9 ± 6.5 (males: 4.1 ± 3.4 and females: 9.3 ± 7.9). Among the cases of hypersensitivity reactions, 4 involved anaphylactic shock; therefore, the incidence rate of anaphylaxis was 0.047% (95% CI, 0.001-0.092) for the 8,580 subjects and 0.007% (95% CI, 0.000-0.013) for the 60,654 treatments. All grade 1 cases were recovered within 1 day, whereas others took up to 30 days for complete recovery. CONCLUSION: Our results may emphasize paying attention to unforeseeable risks of anaphylaxis after bee-venom acupuncture. This study could be essential reference data for the guidelines of appropriate use of bee-venom acupuncture and bee-venom-derived interventions in clinical applications.

Effectiveness and safety of polydioxanone thread-embedding acupuncture (TEA) and electroacupuncture (EA) treatment for knee osteoarthritis (KOA) patients with postoperative pain: An assessor-blinded, randomized, controlled pilot trial.

BACKGROUND: Degenerative knee osteoarthritis (KOA) shows an increase in morbidity with improvement in the living conditions and extended lifespans. Treatment for degenerative KOA has been gaining attention since it significantly affects the life of the elderly population and is also associated with increased expenses for medical services and high socioeconomic costs. Treatments for degenerative KOA include nondrug therapy, drug therapy, and surgical treatment. For cases that show little response to conservative treatment but have not involved severe deformation of the knee, procedures such as arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation can be performed. However, effective treatment is required for patients experiencing sustained knee pain after surgery. Although studies confirming the therapeutic effects of acupuncture or thread-embedding acupuncture (TEA) treatment for degenerative KOA have been reported, clinical studies on a combination of TEA and electroacupuncture (EA) in patients complaining of knee pain after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation have not yet been reported. Therefore, this study aimed to evaluate the effectiveness and safety of this combination treatment in patients with persistent knee pain after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation. METHODS/DESIGN: This study has been designed as a 2-group, parallel, single-center, randomized, controlled, assessor-blinded trial. Thirty-six patients with degenerative KOA who complained of pain even after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation will be randomized to either the (TEA + EA + Usual care) group or the (Usual care only) group in a 1:1 ratio. The patients in the (TEA + EA + Usual care) group will receive TEA treatment once a week for 4 weeks for a total of 4 sessions and EA twice a week for a total of 8 sessions while continuing usual care. The (Usual care only) group will only receive usual care for 4 weeks. To assess the efficacy of the TEA and EA combination treatment, the visual analogue scale, the Korean version of the Western Ontario and McMaster Universities Osteoarthritis Index, the EuroQol 5-Dimension 5-Level, and the doses of the rescue drug taken will be evaluated at baseline (1W) and weeks 2 (2W), 4 (4W), 6 (6W), and 8 (8W). The primary efficacy endpoint is the mean change in visual analogue scale at week 4 (4W) compared to baseline. Adverse events will be assessed at every visit. DISCUSSION: This study will provide useful data for evaluating the clinical efficacy and safety of TEA and electroacupuncture combination treatment for improving pain and quality of life after surgery for degenerative KOA. TRIAL REGISTRATION: Clinical Research Information Service of Republic of Korea (CRIS- KCT0004804), March 6, 2020.

Acupotomy versus Manual Acupuncture for the Treatment of Back and/or Leg Pain in Patients with Lumbar Disc Herniation: A Multicenter, Randomized, Controlled, Assessor-Blinded Clinical Trial.

BACKGROUND: Acupotomy, which involves the addition of a scalpel function to the conventional acupuncture treatment, has recently been applied as a conservative treatment method for lumbar disc herniation (LDH). This study investigated the effectiveness and safety of acupotomy, compared to manual acupuncture, for the treatment of patients with LDH. METHODS: A total of 146 patients diagnosed with LDH were randomly assigned to either the acupotomy group or the manual acupuncture group at a 1:1 ratio. Participants in both groups received four sessions of each intervention over 2 weeks. Outcome assessments based on the visual analog scale (VAS), Roland Morris Disability Questionnaire (RMDQ), Modified-Modified Schober Test (MMST), EuroQol Five Dimensions (EQ-5D), clinically important difference (CID), and patient global impression of change (PGIC) were conducted at baseline and at 2, 4, and 6 weeks post-randomization. RESULTS: The acupotomy group showed significant improvement in VAS and MMST at 2, 4, and 6 weeks than did the manual acupuncture group. RMDQ was significantly different between the two groups at 2 and 6 weeks. In EQ-5D, there was no significant difference between the two groups. The proportion of patients with ≥15 mm decrease on the VAS (minimal CID) was significantly higher in the acupotomy group at weeks 2 and 4. Better improvement in the PGIC at week 4 was also observed in the acupotomy group. Post-intervention muscle pain was reported, but there was no serious adverse event related to interventions. CONCLUSION: In this study, four sessions of acupotomy treatment were found to be effective in improving the pain intensity and range of motion of the lumbar region in patients with LDH. Despite post-treatment muscle pain, acupotomy treatment can be considered a preferred treatment method over manual acupuncture. TRIAL REGISTRATION: This trial has been registered 24 April 2018 in Clinical Research Information Service of South Korea (CRIS-KCT0002824).

Effectiveness and safety of electroacupuncture and its cotreatment with electronic moxibustion in the treatment of patients with moderate benign prostatic hyperplasia using alpha blocker: Study protocol for an assessor-blinded, randomized controlled clinical trial.

BACKGROUND: Benign prostatic hyperplasia (BPH) is a medical condition that affects the quality of life by causing lower urinary tract symptoms (LUTS) in 40% to 70% of men aged ≥60 years. Medication treatment is primarily recommended for patients with BPH if their symptom score based on the International Prostate Symptom score (IPSS) is above the moderate level. However, electroacupuncture (EA) and electronic moxibustion (EM), one of the most recent complementary and alternative treatments, are suggested as adjuvant treatments in the improvement of LUTS caused by BPH with respect to the limitations of medication treatments, such as side effects or no improvement in LUTS despite treatment. Therefore, this study aimed to evaluate the effectiveness and safety of EA and its cotreatment with EM for the improvement of LUTS in patients diagnosed with BPH using an alpha blocker but with moderate symptoms on the basis of IPSS. METHODS/DESIGN: This protocol is a 2-arm parallel-design, randomized, controlled assessor-blinded clinical trial. Seventy-eight patients diagnosed with BPH are randomized to one of the following groups: [EA and its cotreatment with EM + alpha blocker group] and [alpha blocker group]. [EA and its cotreatment with EM + alpha blocker group] continues to use the previously prescribed alpha blocker and visits the study institution 3 times a week for 6 weeks to receive the cotreatment of EA and EM. [Alpha blocker group] continues to use the previously prescribed alpha blocker for 6 weeks. To evaluate the effectiveness of the EA and its cotreatment with EM, the followings are measured: total score of the IPSS, IPSS quality of life assessment, EuroQol-Five dimension, maximum and average urinary flow rate (Qmax and Qave), and prostate size at the baseline, 3rd, 6th, and 12th weeks. The primary effectiveness endpoint measures the average change in the total score of the IPSS at the 6th week. Side effects are recorded at each visit. DISCUSSION: The results of this study are expected to provide useful information on the effectiveness and safety of the EA and its cotreatment with EM for patients with BPH with regard to the improvements in LUTS. TRIAL REGISTRATION: Clinical Research Information Service of Republic of Korea (CRIS-KCT0004411), October 31, 2019.

Effectiveness and safety of polydioxanone thread embedding acupuncture compared to physical therapy in the treatment of patients with non-specific chronic neck pain: Study protocol for an assessor-blinded, randomized, controlled, clinical trial.

BACKGROUND: As the number of patients who suffer from non-specific chronic neck pain (CNP) is increasing in the Republic of Korea, conservative treatments for patients with CNP have been spotlighted. Although several studies on thread embedding acupuncture (TEA) treatment have been published for the treatment of such patients, no randomized controlled trial has been reported that investigates the effectiveness and safety of the TEA treatment compared with other conservative treatments for the treatment of patients with CNP. Therefore, the purpose of this trial is to compare the effectiveness and safety of TEA to those of physical therapy (PT) for the treatment of patients with CNP. METHODS/DESIGN: This study is planned as a parallel design, randomized, controlled, assessor-blinded, clinical study. One hundred twenty-eight patients diagnosed with CNP will be randomly assigned to either the TEA group or the PT group in a 1:1 ratio. Participants in the TEA group will receive 4 sessions of TEA treatment, while those in the PT group will receive 8 sessions of PT treatment over 4 weeks. An assessment of effectiveness based on the outcomes of the Neck Pain and Disability Scale (NPDS), cervical spinal angle, Beck Depression Inventory II (BDI-II), Beck Anxiety Inventory (BAI), Patient Global Impression of Change (PGIC), EuroQol-Five Dimension 3 level version (EQ-5D-3L), and Pressure Pain Threshold (PPT) will be conducted at baseline, and at 5, 9, and 13 weeks. The primary outcome is the mean change in the NPDS at 9 weeks. Adverse events (AEs) will be recorded at every visit. DISCUSSION: The results of this study will be expected to provide useful information for the effectiveness and safety of TEA treatment compared to PT treatment for patients with CNP. TRIAL REGISTRATION: Clinical Research Information Service of Republic of Korea (CRIS- KCT0003720), April 5, 2019.

Corrigendum to "Effectiveness and Safety of Acupotomy for Lumbar Disc Herniation: A Randomized, Assessor-Blinded, Controlled Pilot Study".

[This corrects the article DOI: 10.1155/2018/5871657.].

Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial.

BACKGROUND: Degenerative knee osteoarthritis is a leading cause of disability in the elderly. If patients do not respond to pharmacological or nonpharmacological intervention, total knee replacement surgery is recommended. However, owing to the contraindications and adverse effects of surgery, the need for a new treatment strategy is emerging. Traditional herbal medicine is a widely used intervention in east Asia to treat knee osteoarthritis. Gyejigachulbutang is one of the frequently prescribed herbal formulae. The aim of our study is to evaluate the efficacy and safety of gyejigachulbutang for knee osteoarthritis. METHODS: This study is a randomized, placebo-controlled, patient and assessor blinded, superiority clinical trial. A total of 80 patients with knee osteoarthritis will be enrolled. The participants will be randomly assigned to the gyejigachulbutang or placebo group in a 1:1 ratio in two Korean medical hospitals. Every participant will take gyejigachulbutang or placebo at a dose of 2.5 g three times a day for 4 weeks. Additional follow-up will be conducted 4 weeks after treatment completion. Any concomitant treatment to relive knee pain will not be allowed except for rescue medicine (acetaminophen). The primary outcome will be a comparison of the change in the visual analogue scale score for knee pain from baseline to visit 3 (week 4) for both the treatment and placebo groups. Secondary outcomes include clinical relevance, minimal clinically important difference, disability, quality of life, and safety. DISCUSSION: This protocol presents a research methodology for clinical trials of gyejigachulbutang for knee osteoarthritis. Various secondary outcomes make this trial more informative. Our trial will provide fundamental evidence for knee osteoarthritis management via herbal medicine treatment. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), KCT0003024 . Registered on 25 July 2018.

Cognitive improvement effects of electro-acupuncture for the treatment of MCI compared with Western medications: a systematic review and Meta-analysis.

BACKGROUND: Almost half of mild cognitive impairment (MCI) patients progress to dementia, which is associated with decreased quality of life and obstacles to independent living. Relevant management is expected to prevent MCI patients from progressing to dementia. In recent years, electroacupuncture (EA) has been used to treat various kinds of neurological disorders including MCI. This study evaluates the use of EA for MCI patients to increase cognitive function through a comparison with Western medications. METHODS: Randomized controlled trials (RCT) or systematical reviews (SR) of EA versus Western medications for MCI were searched using the following 10 databases: Pubmed, Cochrane Library, CINAHL, EMBASE, China National Knowledge Infrastructure (CNKI), National Digital Science Library (NDSL), Journal of Oriental Neuropsychiatry (JON), Korean Medical Database (KMBASE), KoreaMed, and OASIS, from October 2007 to August 2017, without language restriction. A methodological quality assessment of RCTs or SRs that met inclusion criteria was conducted using Cochrane Risk of bias (RoB) tool and a meta-analysis by RevMan (Review Manager) 5.3.5 version of Cochrane collaboration. RESULTS: Five RCTs with 257 patients met inclusion criteria and those were randomly divided into two groups: the EA group (n = 103) and Western medications group (n = 154). The methodological quality of the included studies showed high risk or/and unclear of risk of bias. The meta-analysis of five studies reported that the EA group was better than the Western medications group, improving the Mini Mental State Examination (MMSE) score by 0.65 [95% CI 0.28~1.01] higher mean difference, Montreal Cognitive Assessment (MoCA) score by 0.66 [95% CI 0.00~1.32] higher mean difference. Adverse effects were not reported in the selected studies. CONCLUSION: Electroacupuncture was an effective treatment for MCI patients by improving cognitive function. However, the included studies presented a low methodological quality and no adverse effects were reported. Thus, further comprehensive studies with a design in depth are needed to derive significant results.

Preclinical evaluation of the efficacy of an H5N8 vaccine candidate (IDCDC-RG43A) in mouse and ferret models for pandemic preparedness.

Because H5N1 influenza viruses continuously threaten the public health, the WHO has prepared various clades of H5N1 mock-up vaccines as one of the measures for pandemic preparedness. The recent worldwide outbreak of H5Nx virus which belongs to clade 2.3.4.4 and of which H5N6 subtype belongs and already caused human infection also increases the need of pandemic vaccine for such novel emerging viruses. In this study, we evaluated the protective efficacy and immunogenicity of an egg-based and inactivated whole-virus H5N8 (IDCDC-RG43A) developed by CDC containing HA and NA gene of the parent virus A/gyrfalcon/Washington/41088-6/2014. Mice vaccinated two times elicited low to moderate antibody titer in varying amount of antigen doses against the homologous H5N8 vaccine virus and heterologous intra-clade 2.3.4.4 H5N6 (A/Sichuan/26221/2014) virus. Mice immunized with at least 3.0 µg/dose of IDCDC-RG43A with aluminum hydroxide adjuvant were completely protected from lethal challenge with the mouse-adapted H5N8 (A/Environment/Korea/ma468/2015, maH5N8) as well as cleared the viral replication in tissues including lung, brain, spleen, and kidney. Vaccinated ferrets induced high antibody titers against clade 2.3.4.4 H5N8/H5N6 viruses and the antibody showed high cross-reactivity to clade 2.2 H5N1 but not to clade 1 and 2.3.4 viruses as measured by hemagglutinin inhibition and serum neutralization assays. Furthermore, administration of the vaccine in ferrets resulted in attenuation of clinical disease signs and virus spread to peripheral organs including lung, spleen, and kidney from high dose challenge with maH5N8 virus. The protective and immunogenic characteristic of the candidate vaccine are essential attributes to be considered for further clinical trials as a pre-pandemic vaccine for a potential pandemic virus.

Effectiveness and Safety of Polydioxanone Thread-Embedding Acupuncture as an Adjunctive Therapy for Patients with Chronic Nonspecific Neck Pain: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effectiveness and safety of treatment with thread-embedding acupuncture (TEA) using polydioxanone in addition to usual care for patients with chronic nonspecific neck pain (CNP) compared with treatment with usual care alone. METHODS: A single-center, assessor-blinded, two-armed randomized controlled trial was performed. One hundred and six outpatients with CNP were randomly allocated into the TEA plus usual care (TU) group or the usual care (UC) group in a 1:1 ratio. TEA treatments in the neck region were provided once a week for 4 weeks, and usual care, as needed, was allowed. The primary outcome was the mean Neck Pain and Disability Scale (NPDS) score. Secondary outcomes included clinical relevance measured by using the clinically important difference (CID), pressure pain threshold (PPT), Hospital Anxiety and Depression Scale (HADS), EuroQol-5 Dimension (EQ-5D), and patient global impression of change (PGIC). Participants were assessed at baseline and at weeks 3, 5, and 9. Statistical analyses included analysis of covariance with baseline score as a covariate. RESULTS: The TU group showed significant improvement in NPDS scores compared with the UC group (adjusted group difference, week 5: 13.74 [95% confidence interval: 7.57-19.90]; p < 0.0001 and week 9: 17.46 [11.15-23.76]; p < 0.0001). The proportion of patients with a decrease on the NPDS score of ≥11.5 points (minimal CID) was significantly higher in the TU group at weeks 5 and 9 than in the UC group. At weeks 5 and 9, significant differences were observed on the anxiety/depression subscale of HADS, EQ-5D, and PGIC between the two groups, but not the PPTs at three sites. Temporary stiffness was observed after TEA treatment, but no serious adverse events occurred. CONCLUSIONS: The results suggest that polydioxanone TEA is a safe and clinically beneficial adjunctive treatment for patients with CNP.

Efficacy and safety of polydioxanone thread embedded at specific acupoints for non-specific chronic neck pain: a study protocol for a randomized, subject-assessor-blinded, sham-controlled pilot trial.

BACKGROUND: This study aims to evaluate the efficacy and safety of thread-embedding acupuncture (TEA) with polydioxanone thread embedded at various acupoints, compared with sham TEA, for the treatment of non-specific chronic neck pain. METHODS/DESIGN: This study will be an 8-week-long, two-armed, parallel, randomized, subject-assessor-blinded, sham-controlled pilot trial. Fifty eligible patients will be randomly allocated into the real TEA group or the sham TEA group. The real TEA group will receive TEA treatment at 14 fixed acupoints in the neck region. The sham TEA group will receive the same treatment as the real TEA group, but with a sham device with the thread removed. Both groups will receive treatment once a week for a total of four sessions. The primary outcome will be the mean change in the visual analog scale (VAS) from baseline to week 6 (2 weeks post intervention). Clinical relevance (ratio of the number of patients with decreases on the VAS of ≥15 mm or with percentiles ≥ 30% and ≥ 50% relative to baseline to the total number of patients), Neck Disability Index, pressure pain threshold, the Hospital Anxiety and Depression Scale, EuroQol 5-Dimensions questionnaire, Patient Global Impression of Change, blinding test, and adverse events will be used to assess secondary outcomes. DISCUSSION: The results of this study will provide valuable data for a large-scale clinical trial to evaluate the clinical effects of polydioxanone TEA in the treatment of patients with non-specific chronic neck pain. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), Republic of Korea, KCT0002452 . Registered on 6 September 2017.

Clinical and cost-effectiveness of collaborative traditional Korean and Western medicine treatment for low back pain: A protocol for a prospective observational exploratory study.

BACKGROUND: In South Korea, a few patients with low back pain (LBP) are currently being treated with a combination of traditional Korean medicine (KM) and Western medicine (WM). Although a recent research has reported results regarding patient satisfaction and exploratory effectiveness, evidence of comparative effectiveness still needs to be reviewed. The aim of this study is to evaluate the clinical and cost-effectiveness of KM and WM collaborative treatment (CT) compared with that of sole treatment (ST) for patients with LBP in Korea. METHOD/DESIGN: This multisite, prospective observational comparative effectiveness research study is part of a nationwide pilot project for KM and WM collaboration launched by the Korean Ministry of Health and Welfare. The duration of the study is 8 weeks, and the target number of inclusion is 360 patients. Participants receive treatment according to their treatment plan, and a researcher conducts investigations thrice, every 4 weeks. In the final analysis, the merged data from the participants' questionnaire responses, hospital medical records, and administrative data, and Health Insurance Review and Assessment service data will be compared between the CT and ST groups. DISCUSSION: This study will provide clinical and economic information about CT for LBP, which might be a milestone for establishing future polices about this collaboration in Korea. TRIAL REGISTRATION: The study protocol has been registered with the Clinical Research Information Service (KCT0002827).

Effectiveness and Safety of Acupotomy for Lumbar Disc Herniation: A Randomized, Assessor-Blinded, Controlled Pilot Study.

OBJECTIVE: Patients with lumbar disc herniation (LDH) suffer from pain, physical disabilities, and low quality of life. This study was designed to evaluate the effectiveness and safety of acupotomy in patients with LDH. METHOD: Fifty participants with LDH were recruited to this randomized, assessor-blinded, controlled study and randomly assigned to the acupotomy (n = 25) or manual acupuncture (n = 25) group. The acupotomy group received acupotomy four times in 2 weeks, while the manual acupuncture group received manual acupuncture six times in 2 weeks. The follow-up visit was planned in the 4th week (i.e., 2 weeks after the final intervention). The primary outcome was the change in the Visual Analogue Scale (VAS) at follow-up. The changes in the Oswestry Disability Index (ODI), Modified-Modified Schober Test (MMST), and EuroQol Five Dimensions (EQ-5D) questionnaire were also evaluated. An intention-to-treat analysis was applied and adverse events were recorded. RESULTS: The acupotomy group showed significant changes in VAS, ODI, and EQ-5D after intervention. VAS and ODI in the 4th week were lower in the acupotomy than in the manual acupuncture group. The acupotomy group showed consistent changes in VAS and ODI in the 1st, 2nd, and 4th week. No serious adverse event was reported in the acupotomy group. CONCLUSION: This study suggests greater therapeutic effects of acupotomy on relieving pain and improving the functional disability associated with LDH than those observed with manual acupuncture.

Effectiveness and safety of acupotomy for treating back and/or leg pain in patients with lumbar disc herniation: A study protocol for a multicenter, randomized, controlled, clinical trial.

BACKGROUND: As the number of patients suffering from back and/or leg pain due to lumbar disc herniation (LDH) is increasing in Korea, conservative treatments for patients with LDH have been spotlighted. Although several studies have been published on the use of acupotomy for the treatment of such patients, most of them are only case studies. Therefore, the purpose of this study is to compare the effectiveness and safety of acupotomy to those for manual acupuncture for the treatment of patients with LDH. METHODS/DESIGN: This study is planned as a multicenter, parallel design, randomized, controlled, clinical study. One hundred forty-six patients diagnosed with LDH will be randomly assigned to either the acupotomy group or the manual acupuncture group at a 1:1 ratio. Participants in both groups will receive a total of 4 interventions over 2 weeks. An effectiveness assessment based on the outcomes on the visual analog scale (VAS), Roland Morris Disability Questionnaire (RMDQ), Modified-Modified Schober Test (MMST), EuroQol Five Dimensions (EQ-5D), and Patient Global Impression of Change (PGIC) will be conducted at baseline and at 2, 4, and 6 weeks postrandomization. The primary outcome will be the mean change in the VAS for back and/or leg pain 4 weeks postrandomization. Adverse events will be recorded at every visit. DISCUSSION: The results of this study will provide evidence for the effectiveness and safety of acupotomy treatment for patients with LDH. TRIAL REGISTRATION: Clinical Research Information Service of South Korea (CRIS- KCT0002824), April 24, 2018.