A Pilot Study for Effectiveness and Safety of Adjunctive Pharmacopuncture to Acupuncture Treatment for Rotator Cuff Diseases: A Pragmatic Randomized Controlled Trial.

Purpose: Pharmacopuncture therapy has been used in the conservative treatment of rotator cuff disease adjuvant to acupuncture treatment. Despite the increasing utilization of pharmacopuncture therapy, there is still a lack of high-quality research to support its effectiveness. This pilot study aimed to assess the feasibility of pharmacopuncture therapy adjuvant to acupuncture treatment for rotator cuff disease. Patients and Methods: This was a parallel-grouped, pragmatic randomized controlled, pilot study. Forty patients were randomly allocated to either the experimental or the control group. All patients received acupuncture treatment for four weeks, and pharmacopuncture was additionally administered to the experimental group. After eight treatments were delivered over four weeks, follow-up assessments were performed. The primary outcome was the mean change in the visual analog scale (VAS) score for shoulder pain from baseline to visit 8. Secondary outcomes included shoulder pain and disability index (SPADI) at visits 4, 8, and 9, shoulder range of motion (ROM) at visits 4, 8, and 9, EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at visits 8 and 9, patient global impression of change (PGIC) at visits 8 and 9, and mean rescue medication consumption at visits 8 and 9. Results: Both groups showed that each treatment effectively improved rotator cuff disease in most assessments. Particularly, the group that received acupuncture plus pharmacopuncture required fewer rescue medications than the group that received acupuncture alone. However, there was little statistically significant difference between the two groups. There were no serious adverse events experienced by patients in this study. Conclusion: Although there was little statistical difference between the two groups, the combination of acupuncture and pharmacopuncture for rotator cuff disease was associated with a reduction in the rescue medicine dosage compared with acupuncture alone. Also, it confirmed the safety of pharmacopuncture therapy. This pilot study would help design future research on the effectiveness of pharmacopuncture in rotator cuff disease.

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.

Convolutional neural networks for estimating transport parameters of fibrous materials based on micro-computerized tomography images.

This study proposes a method for estimating the transport parameters of fibrous materials from x-ray micro-computed tomography (CT) images using convolutional neural networks (CNNs). Two-dimensional (2-D) micro-CT images and numerically obtained transport parameters were used to train the CNNs; Stokes flow and potential flow were used to numerically obtain the transport parameters using geometrical models extracted from the raw CT images. Then, analogously to constructing a three-dimensional image of the fibrous material by stacking the 2-D slice images, the volumetric transport parameters of the fibrous materials were calculated using the parameters of each 2-D image predicted by the trained CNN models. The transport parameters of the fibrous volume predicted by the CNN models showed good agreement with the measured values. In addition, the sound absorption coefficient was calculated by applying both the predicted and measured transport parameters to the semi-phenomenological sound propagation model and compared with the measured sound absorption coefficient. The results of the study confirm the feasibility of predicting transport parameters of fibrous materials using a neural network model based on raw micro-CT images.

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.

A Comparison of Biannual Two-Phase Low-Dose Liver CT and US for HCC Surveillance in a Group at High Risk of HCC Development.

BACKGROUND AND AIMS: Biannual ultrasonography (US) is a current recommendation for hepatocellular carcinoma (HCC) surveillance in a high-risk group. The sensitivity of US, however, has been low in patients with a high risk of developing HCC. We aimed to compare sensitivity for HCC of biannual US and two-phase low-dose computed tomography (LDCT) in patients with a high risk of HCC. METHODS: In this prospective single-arm study, participants with an annual risk of HCC greater than 5% (based on a risk index of ≥2.33) and who did not have a history of HCC were enrolled from November 2014 to July 2016. Participants underwent paired biannual US and two-phase LDCT 1-3 times. Two-phase LDCT included arterial and 3-min delayed phases. The sensitivity, specificity, and positive predictive value of HCC detection using US and two-phase LDCT were compared using a composite algorithm as a standard of reference. RESULTS: Of the 139 enrolled participants, 137 underwent both the biannual US and two-phase LDCT at least once and had follow-up images. Among them, 27 cases of HCC (mean size: 14 ± 4 mm) developed in 24 participants over 1.5 years. Two-phase LDCT showed a significantly higher sensitivity (83.3% [20/24] vs. 29.2% [7/24], p < 0.001) and specificity (95.6% [108/113] vs. 87.7% [99/113], p =0.03) than US. A false-positive result was reported in 14 participants at US and 5 participants at two-phase LDCT, resulting in a significantly higher positive predictive value of two-phase LDCT (33.3% [7/21] vs. 80% [20/25], p < 0.001). CONCLUSIONS: Patients with a risk index ≥2.33 showed a high annual incidence of HCC development in our study, and two-phase LDCT showed significantly higher sensitivity and specificity for HCC detection than US.

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.

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.

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 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.

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.

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.

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.

Simultaneous determination of the bioactive compounds from Sparassis crispa (Wulf.) by HPLC-DAD and their inhibitory effects on LPS-stimulated cytokine production in bone marrow-derived dendritic cell.

Sparassis crispa (Wulf.) belonging to the family of Sparassidaceae, has been widely used as an edible mushroom due to its unique flavor and functions to improve health. In this study, the compounds isolated from the extract of this mushroom were simultaneously quantified by the developed HPLC-DAD method and evaluated for the inhibitory activities on the production of the LPS-stimulated cytokines (IL-12p40, IL-6, and TNF-α) in bone marrow-derived dendritic cells (BMDCs). The contents of this compounds were 0.1928 ± 0.0118, 4.4137 ± 0.0240, 0.5237 ± 0.0005, 2.7303 ± 0.0206 mg/g for sparoside A (1), methyl 2,4-dihydroxy-3-methoxy-6-methylbenzoate (2), sparalide A (3), and 5'-deoxy-5'-methylthioadenosine (4), respectively, which demonstrated that they are the major constituents of this mushroom. Thus, our results were found that the sparoside A (1), 5-hydroxy-7-methoxyphthalide (6), 5-methoxy-7-hydroxyphthalide (7), nicotinamide (10), and adenosine (11) inhibit LPS-stimualted cytokine production, compound 6 is the most potent inhibitory activities on the production of IL-12p40, IL-6, and TNF-α with IC50 values of 0.19, 0.18, and 0.91 µM, respectively.

Current Status of Microbial Phenylethanoid Biosynthesis.

Phenylethanoids, including 2-phenylethanol, tyrosol, and salidroside are a group of phenolic compounds with a C6-C2 carbon skeleton synthesized by plants. Phenylethanoids display a variety of biological activities, including antibacterial, anticancer, anti-inflammatory, neuroprotective, and anti-asthmatic activities. Recently, successful microbial synthesis of phenylethanoids through metabolic engineering and synthetic biology approaches has been reported and could allow phenylethanoid production from alternative microbial sources. Here, we review the recent achievements in the synthesis of phenylethanoids by microorganisms. The work done so far will contribute to the production of diverse phenylethanoids using various microbial systems and facilitate exploration of further diverse biological activities of phenylethanoids.

Chemical Constituents of Apios americana Tubers and Their Inhibitory Activities on Nitric Oxide Production in Lipopolysaccharide-Stimulated RAW 264.7 Macrophages.

Apios americana is an important food crop producing edible tubers with high nutritional and medicinal values and is widely cultivated in many countries. Despite its usefulness, research on its secondary metabolites and biological activities has been limited. In the present study, a new coumaronochromone, (2 R,3 S)-3,7,4'-trihydroxy-5-methoxycoumaronochromone (1), and two new isoflavone glucosides, 7,2',4'-trihydroxy-5-methoxyisoflavone-4'- O-ß-d-glucopyranoside (3) and 5,7,4'-trihydroxyisoflavone-7- O-ß-d-gentiotrioside (5), were isolated from the tubers of A. americana via chromatographic separation. Seventeen known compounds (2, 4, and 6-20) were also obtained from this plant part. The chemical structures of 1, 3, and 5 were determined by the interpretation of spectroscopic data. The absolute structure of the new compound 1 was established from experimental and calculated electronic circular dichroism spectra. This is the first study to determine the absolute configuration of a 3-hydroxycoumaronochromone derivative. The potential anti-inflammatory activity of the 20 isolates obtained was evaluated by measuring their inhibitory effects on nitric oxide production in lipopolysaccharide-stimulated RAW 264.7 macrophages. Among the isolates, seven compounds (1, 3, 6-8, 15, and 20) showed substantial inhibition of nitric oxide production in RAW 264.7 cells, with the most active being compound 1 (IC50 value of 0.38 ± 0.04 µM).

Transabdominal Ultrasound Detection of Pancreatic Cysts Incidentally Detected at CT, MRI, or Endoscopic Ultrasound.

OBJECTIVE: The objective of our study was to evaluate the detection rate of incidental pancreatic cysts on transabdominal ultrasound (TAUS) as well as factors influencing detection rates. MATERIALS AND METHODS: Nine hundred thirty-eight patients with 1064 pancreatic cysts who underwent both TAUS and other imaging examinations including CT, MRI, or endoscopic ultrasound (EUS) were enrolled. We reviewed formal reports and assessed the effect of cyst size and location and the effect of the correlative images for cyst detection on TAUS. Statistical analyses were performed using the chi-square test, t test, and Cramér value (V). RESULTS: The overall detection rate of TAUS was 88.3% (940/1064). Cysts detected on TAUS were more often in younger patients and male patients. The detected cysts (median, 13 mm; interquartile range [IQR], 8-18 mm) were significantly larger than the undetected cysts (median, 10 mm; IQR, 6-14 mm) (p < 0.0001). However, waist circumference did not affect the detection rate. The detection rate was significantly improved from 49.2% (289/587) to 86.7% (830/957) when TAUS was performed after correlative imaging (p < 0.001). Although the detection rate for cysts in the entire pancreas was significantly increased with correlative images (p < 0.001), the detection rate for cysts in the uncinate process showed a much greater increase using correlative images (p < 0.001). However, detection of cysts in the tail of the pancreas showed the least improvement using correlative images. The detection rate was significantly improved with correlative images for cysts 25 mm or smaller. CONCLUSION: Because the detection rate of TAUS for pancreatic cysts was significantly improved after CT, MRI, or EUS, TAUS could be a useful surveillance imaging tool for pancreatic cysts incidentally detected on CT, MRI, or EUS.

Quality Assessment of Randomized Controlled Trials of Moxibustion Using STandards for Reporting Interventions in Clinical Trials of Moxibustion (STRICTOM) and Risk of Bias (ROB).

OBJECTIVES: To assess the quality and completeness of published reports of randomized controlled trials (RCTs) of moxibustion. METHOD: We searched six databases to retrieve eligible RCTs of moxibustion published from 2000 to December 2015. We used the STandards for Reporting Interventions in Clinical Trials of Moxibustion (STRICTOM) and Risk of Bias (ROB) tool to assess the completeness of reporting of RCTs of moxibustion and evaluate the reporting quality of included RCTs. RESULTS: Thirty-four studies of moxibustion were analyzed using STRICTOM and ROB. Of the 34 studies, the completeness percentage of STRICTOM varied from 33% to 100% (mean 68%, median 67%). The completeness of STRICTOM items showed a rising tendency along with the publication year. The STRICTOM items of setting and context (14.7%), rationale for the control (17.6%), and response (26.4%) showed incomplete reporting. The number of RCTs that rated a low risk of bias for allocation concealment (n=6), blinding of participants and personnel (n=1), and blinding of outcome assessment (n=4) appeared to be small. CONCLUSION: The quality of reporting of RCTs of moxibustion remains incomplete according to the STRICTOM and ROB tool at present. Researchers should consider the STRICTOM and ROB for improving not only the completeness of reporting but also the study design. General guidelines for RCTs of moxibustion are also required.

A Feasibility Study of Moxibustion for Treating Anorexia and Improving Quality of Life in Patients With Metastatic Cancer: A Randomized Sham-Controlled Trial.

OBJECTIVE: The aim of this study was to determine the feasibility, acceptability, and safety of using moxibustion for treating anorexia and improving quality of life in patients with metastatic cancer. METHODS: We conducted a randomized sham-controlled trial of moxibustion. Sixteen patients with metastatic cancer were recruited from Daejeon, South Korea. The patients were randomly placed into a true or a sham moxibustion group and received 10 true or sham moxibustion treatments administered to the abdomen (CV12, CV8, CV4) and legs (ST36) over a 2-week period. Outcome measures included interest in participating in the trial, identification of successful recruitment strategies, the appropriateness of eligibility criteria, and compliance with the treatment plan (ie, attendance at treatment sessions). Clinical outcomes included results of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT), answers on the European Organization for Research and Treatment of Cancer 30-item core quality of life (EORTC QLQ-C30) questionnaires, scores on the visual analogue scale (VAS), and the results from blood tests and a safety evaluation. RESULTS: Moxibustion was an acceptable intervention in patients with metastatic cancer. Compliance with the treatment protocol was high, with 11 patients completing all 10 treatments. No serious adverse events related to moxibustion occurred, but 4 patients in the true moxibustion group reported mild rubefaction, which disappeared in a few hours. CONCLUSION: This study suggests that moxibustion may be safely used to treat anorexia and improve quality of life in patients with metastatic cancer. However, further research is needed to confirm this result.