The Transformation of Acupuncture Practice Using Ultrasonography: Expert Opinions.

Importance: The rapidly growing use of ultrasound in South Korea has revolutionized the real-world application of acupuncture, making it a safer, more accurate treatment. However, little is known about the challenges Korean medicine doctors (KMDs) encounter, as well as the procedures and resources necessary for hygienic, safe ultrasound-guided acupuncture. Objective: This study aimed to investigate the purpose, indications, and procedure for ultrasound-guided acupuncture in Korean medicine (KM) practice and the challenges KMDs encounter in using ultrasonography. Methods: Eleven KMDs with expertise in practicing or teaching ultrasonography were consulted in detail. The purpose of ultrasonography in real-world practice, the overall process, resources utilized in ultrasound-guided procedures, and the unaddressed needs of KMDs were investigated. Results: Ultrasound guidance, employed for various diseases in KM practice, is crucial for pharmacopuncture and acupotomy to increase accuracy and safety. Ultrasoundguided acupuncture involves covering the probe, putting on sterile gloves, and scanning with disinfectants, though the exact steps vary among experts. They also suggested that a lack of insurance coverage was a common obstacle for KMDs utilizing ultrasonography. Conclusions and Relevance: Acupuncture with ultrasound guidance has become a prevalent procedure in South Korea. Standard procedure guidelines and insurance coverage for ultrasonography used for acupuncture procedures are essential to ensure safe, accurate procedures.

Efficacy and Safety of Acupoint Catgut Embedding for Knee Osteoarthritis: a Protocol for Systematic review and Meta-Analysis.

Background: Knee osteoarthritis causes physical dysfunction, and its prevalence increases with age. Although clinical studies examined acupoint catgut embedding in patients with knee osteoarthritis, no systematic reviews or meta-analyses have been conducted to date. We aim to comprehensively review the effects of acupoint catgut embedding on knee osteoarthritis. Methods: Eleven databases will be searched from inception to August 1, 2023, without language limitations. Additionally, two registration platforms-ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry-will be searched for ongoing trials. The primary outcomes will be assessed using the Visual Analog Scale and the Western Ontario and McMaster Universities Osteoarthritis Index. Secondary outcomes include the total effective rate, Lysholm Score, and adverse effects. Two reviewers will independently select the studies, extract data, and evaluate the risk of bias and the quality of evidence. Discussion: This systematic review will provide evidence regarding the safety and efficacy of acupoint catgut embedding in patients with knee osteoarthritis.

Real-world evidence of characteristics and factors influencing herbal medicine use for weight loss in adults.

Background: Obesity imposes a significant socioeconomic burden owing to its high prevalence. In response to the adverse outcomes associated with conventional pharmacotherapy and the challenges of low adherence to lifestyle interventions, herbal medicine has surfaced as an actively utilized approach for weight loss. Therefore, this study aimed to analyze the characteristics and influencing factors of herbal medicine users for weight loss in adults. Methods: Overall, 22,080 participants were included based on data from the Korea National Health and Nutrition Examination Survey from 2010 to 2019. Simple logistic regression analyses were used to derive the associations between herbal medicine use for weight loss and individual characteristics. Three models were constructed utilizing multiple logistic regression analyses to assess the associations between herbal medicine use for weight loss and the combined characteristics of predisposing, enabling, and need factors according to Andersen's model. Results: In the full adjustment model, women, younger adults, those with higher incomes, and individuals reporting higher levels of perceived stress were more prone to use herbal medicine for weight loss in the past year. Adults who identified body image as being fat/very fat, those who consumed alcohol, and those classified as severely obese by body mass index were also more prone to use herbal medicine for weight loss. In particular, adults with a higher rate and amount of weight loss in the past year were more likely to use herbal medicine for weight loss compared to those experiencing weight gain/no changes/loss of 0-3 kg. Conclusion: Our study was the first to derive the characteristics and influencing factors of herbal medicine users for weight loss among adults. These findings hold significant promise for informing future research endeavors and policy decision-making for effective resource distribution for obesity treatment.

Pharmacopuncture therapy for adhesive capsulitis: A pragmatic randomized controlled pilot study.

Background: Although several studies have reported the effectiveness of acupuncture treatment for adhesive capsulitis (AC), research on pharmacopuncture therapy for AC remains limited. We compared the effectiveness and safety of pharmacopuncture and physiotherapy for AC. Methods: This pragmatic, randomized, controlled, parallel-group pilot study enrolled patients with limitations of shoulder movement and a numeric rating scale (NRS) score for shoulder pain ≥5 randomized (1:1) to the pharmacopuncture therapy (PPT) and physiotherapy (PT) groups. Treatment sessions were administered twice weekly for 6 weeks, and the participants were followed up for 13 weeks after randomization. The primary outcome was the NRS score for shoulder pain, and the secondary outcomes were the visual analog scale (VAS), Shoulder Pain and Disability Index (SPADI), range of motion (ROM), patient global impression of change (PGIC), EuroQol 5-Dimension 5-Level (EQ-5D-5L), and Short Form 12 Health Survey (SF-12) scores. The intention-to-treat (ITT) analysis was set as the primary analysis. Results: Among 50 participants, for the primary endpoint (week 7) the PPT group showed a significantly superior improvement in NRS, VAS, SPADI, ROM for flexion, ROM for abduction, and EQ-5D-5L scores. The ROM for extension, ROM for adduction, physical component summary, and patient global impression of change were significantly better in the PPT than in the PT group, and these effects were sustained until week 13. Conclusion: In this pilot study, PPT showed better effects than PT, confirming the feasibility of a follow-up main study. Trial registration: Clinicaltrials.gov (NCT05292482) and cris.nih.go.kr (KCT0007198).

Development of the Korean Medicine Core Outcome Set for Facial Palsy: herbal medicine treatment of patients with facial palsy in primary clinics.

Introduction: Facial palsy (FP) significantly affects the quality of life of patients and poses a treatment challenge in primary healthcare settings. This study aimed to develop a Korean medicine (KM) core outcome set (COS) for FP, with a focus on evaluating the effectiveness of herbal medicine (HM) treatments in KM primary clinics. Methods: Outcomes and effect modifiers related to FP treatments were initially identified through related review articles. Subsequently, experts in the field took part in three rounds of modified Delphi consensus exercises to refine and prioritize these outcomes and effect modifiers. Additionally, primary KM clinicians were involved in a Delphi consensus round to assess the suitability and feasibility of the proposed COS in real-world clinical settings. Results: The initial review of related literature identified 44 relevant studies, resulting in an initial selection of 23 outcomes and 10 effect modifiers. The expert consensus process refined these to 8 key outcomes and 6 effect modifiers, which established the foundation of the COS-FP-KM. Subsequently, primary KM clinicians confirmed the practicality and applicability of the COS, endorsing its suitability for use in KM primary clinics. Conclusion: The COS-FP-KM establishes a standardized approach for assessing HM treatment effectiveness in FP patients in KM primary clinics. The COS-FP-KM encourages consistent outcome reporting and enhances patient care quality. Future work should aim to integrate broader stakeholder perspectives to refine and validate the COS further.

Pharmacopuncture Therapy as an Adjunctive Treatment for Patients with Lumbar Spinal Stenosis: A Pragmatic Randomized Controlled Pilot Trial.

Purpose: Pharmacopuncture therapy (PPT) combines medicinal extracts with acupuncture and is widely used as an adjunct in clinical practice. This study assessed the safety and feasibility of PPT in addition to conventional Korean Medicine treatment (CKMT), including electroacupuncture, cupping and infra-red, for lumbar spinal stenosis (LSS). Patients and Methods: Forty patients diagnosed with LSS were randomly assigned to undergo PPT with CKMT (experimental group) or CKMT alone (control group) at a 1:1 ratio, receiving 10 sessions of each intervention over five weeks. The primary clinical outcome was measured using the 100-mm Visual Analog Scale (VAS) for buttock and leg pain five weeks post-treatment. Secondary outcomes included clinically important difference (CID), Zurich Claudication Questionnaire, self-reported walking capacity, Modified-Modified Schober test, EuroQol 5-dimension 5-level questionnaire, and the patient's global impression of change. The adverse events were assessed at each visit. The analysis of covariance was conducted to compare between two groups. Results: Intervention completion rates were 95% and 100% in the experimental and control groups, respectively. No statistically significant differences were found between groups regarding the primary outcome (adjusted mean difference: 8.0; 95% confidence interval: -1.4-17.4). The mean difference in the 100-mm VAS for low back pain at week 5 (adjusted mean difference: 12.9; 95% confidence interval: 2.4-23.4) and the proportion of patients who reached the minimum CID was higher in the experimental group than in the control group. However, no significant differences were observed with other secondary outcomes. One patient in the experimental group experienced a systemic skin rash that resolved the same day, whereas the adverse events in the other group were mild and transient. Conclusion: This trial demonstrated the feasibility of add-on effects and the safety of pharmacopuncture in patients with LSS. Further studies are warranted to evaluate the add-on effects of PPT in treating LSS. Trial Registration: Clinical Research Information Service (CRIS), KCT0007229; registered on April 26, 2022.

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.

An evidence map on traditional medicine across health outcomes.

Background: Traditional medicine (TM) plays a significant role in healthcare either as part of the primary healthcare system or as an adjunct to conventional medicine. This study aimed to map systematic reviews (SRs) of TM modalities across health conditions and identify gaps in the research literature to facilitate priority setting in future TM research. Methods: We searched 17 databases from January 2018 to December 2022. Reviewers in pairs independently performed the database search, screened each record for inclusion, extracted data, and performed quality assessments using the AMSTAR 2 - A Measurement Tool to Assess systematic Reviews. To be included in this evidence map, the studies had to be SRs of clinical studies that evaluated the effectiveness of a TM modalities. The included SRs were analyzed according to TM modality, ICD-11 disease classification, and health outcomes, and visualized using graphical plots. Results: We retrieved 241,509 records. After excluding duplicate records, 181,616 titles and abstracts were screened and 20,856 records were selected for full-text assessment, of which 18,137 records were further excluded. The final 2719 included SRs were primarily in adults (2591) with only 128 SRs in the pediatric population. The most commonly evaluated health conditions were diseases of the digestive system, circulatory system, and genitourinary system, with herbal medicine (n = 1867) and acupuncture (n = 471) being the most investigated TM modalities in treating these illnesses. Based on AMSTAR 2 criteria, the methodology quality of the included SRs is considerably low. Conclusion: This evidence map provides a comprehensive overview of the extent and nature of the available research onTM modalities across health conditions. It provides an initial step towards characterizing the global evidence base and outlining gaps in the existing evidence. We regard this study as laying the basis for future research of TM modalities. Registration: The protocol of this map is registered in PROSPERO (CRD42023416355).

The Impact of Early Acupuncture on Bell's Palsy Recurrence: Real-World Evidence from Korea.

Evidence-based treatment for Bell's palsy includes the administration of steroids within 3 days of symptom onset. Additionally, a few studies have suggested the importance of combining early acupuncture treatment in the acute phase of Bell's palsy with steroids. This study aimed to observe the impact of early acupuncture for Bell's palsy using real-world health insurance data in Korea. This retrospective study extracted data from 45,986 adult patients with Bell's palsy who received steroids between 2015 and 2017 with a follow-up period of at least 3 years until 2020 from the Korea National Health Insurance database. They were divided into the early acupuncture group (n = 28,267) and the comparison group (n = 17,719) based on the presence of an acupuncture treatment code within 7 days of diagnosis. The impact of early acupuncture on the likelihood of Bell's palsy recurrence was evaluated using multivariate logistic regression. The patients in the early acupuncture group had a lower likelihood of recurrence (odds ratio: 0.81, 95% confidence interval: 0.69-0.95). This study observed a beneficial impact of early acupuncture on Bell's palsy using real-world health insurance data in Korea. Further research is required to confirm these findings.

Acupuncture for patients with Maigne's syndrome: A case series.

RATIONALE: Diagnosing the precise etiology of low back pain (LBP) is crucial for facilitating speedy recovery in patients. Maigne's syndrome (MS), commonly referred to as thoracolumbar junction syndrome, is a condition characterized by pain resulting from nerve entrapment, yet its underlying mechanisms remain poorly understood. This study presents a series of six case reports wherein patients diagnosed with MS received acupuncture treatment. PATIENT CONCERNS: Six individuals with LBP were included in the study, and all were diagnosed with MS. DIAGNOSES: The diagnosis was confirmed in all six patients through pinch-roll and thoracic vertebrae compression tests, indicating the presence of thoracolumbar junction syndrome. INTERVENTIONS: Acupuncture treatment was administered to all patients, primarily targeting the T11-L2 facet joints, with additional acupoints selected based on the specific nerve entrapment of MS including the superior cluneal, subcostal, and iliohypogastric nerves. OUTCOMES: Following acupuncture therapy, all patients reported improvements in their LBP symptoms, while four patients also exhibited amelioration in their thoracic vertebrae compression test results. LESSONS: These findings underscore the significance of promptly diagnosing the underlying cause of LBP and suggest that acupuncture may be an effective approach in alleviating MS-related pain.

Herbal Medicine Maekmundong-Tang on Patients with Nonspecific Chronic Cough: Study Protocol for a Double-Blind, Randomized Controlled Clinical Trial.

As the treatment of nonspecific chronic cough with conventional medications that treat cough according to the cause is limited, Maekmundong-tang (comprising Liriopis seu Ophiopogonis Tuber, Pinelliae Tuber, Oryzae Semen, Zizyphi Fructus, Ginseng Radix, and Glycyrrhizae Radix et Rhizoma) has been used empirically in the clinical setting of East Asian traditional medicine. This study is the first to explore the feasibility, preliminary effect, safety, and cost-effectiveness of Maekmundong-tang for nonspecific chronic cough. This study protocol is that of a double-blind, randomized, active-controlled, parallel-group clinical trial for comparing Maekmundong-tang with Saengmaek-san (comprising Liriopis seu Ophiopogonis Tuber, Ginseng Radix, and Schisandrae Fructus), a Korean national health insurance-covered herbal medicine for cough. A total of 30 nonspecific chronic cough patients will participate and receive the assigned herbal medicine for 6 weeks, and clinical parameters will be assessed at weeks 0 (baseline), 3 (midterm assessment), 6 (primary endpoint), 9, and 24 (follow-up). Study feasibility outcomes, including recruitment, adherence, and completion rates, will be assessed. Preliminary effects on cough severity, frequency, and quality of life will be evaluated using outcome measures, such as the Cough Symptom Score, Cough Visual Analog Scale, and the Leicester Cough Questionnaire. Adverse events and laboratory tests will be monitored for safety evaluation, and exploratory economic evaluations will be conducted. The results will provide evidence of Maekmundong-tang in the treatment of nonspecific chronic cough.

Protocol for a randomized controlled trial evaluating the effect of Hibiscus syriacus L. flower extract on sleep quality.

Introduction: Hibiscus syriacus L. flower (HSF) is a food ingredient commonly used for tea, and previous animal studies have reported its sleep-promoting effect. This study aims to test the potential of HSF extract as functional food that improves sleep in humans. Methods and analysis: Eighty participants with sleep disturbances who meet the inclusion/exclusion criteria will be enrolled in this study. Since the effect of HSF extract on sleep is considered to be that of a functional food rather than a medicine, participants with severe insomnia will be excluded from the study. The enrolled participants will be randomly assigned to the HSF extract or placebo groups in a 1:1 ratio. The HSF extract and placebo capsules will look identical, and participants, investigators, and outcome assessors will be blinded to the allocation. Four capsules of HSF extract or placebo will be orally administered 30-60 min before bedtime for 4 weeks. The primary outcome of this study will be the change in the Pittsburgh Sleep Quality Index (PSQI) global score from the baseline after 4 weeks. The subjective and objective changes in the participants' sleep will be evaluated using the Insomnia Severity Index (ISI), Epworth Sleep Scale (ESS), sleep diary, and polysomnography (PSG). The occurrence of adverse events will be closely monitored. Discussion: The results of this trial will provide data on the efficacy and safety of HSF extract in enhancing sleep quality. Based on the results, the potential of HSF extract as a functional food that improves sleep in humans will be evaluated, and the findings of the trial will be submitted to the Korean Ministry of Food and Drug Safety for consideration as a new functional ingredient that may help to improve sleep quality. Clinical trial registration: : Clinical Research Information Service: KCT0007314; Registered 19 May 2022, https://cris.nih.go.kr/cris/search/detailSearch.do/21497.

Safety and efficacy of 650 nm invasive laser acupuncture on non-specific chronic low back pain: A protocol for a multicenter randomized placebo-controlled trial.

Background: We aim to obtain clinical trial data regarding the safety, efficacy, and usefulness of invasive laser acupuncture (ILA) for non-specific chronic low back pain (NSCLBP) through a randomized placebo-controlled trial. Methods: Our clinical trial will be an assessor- and patient-blinded, prospective, parallel-arm, multi-center, randomized placebo-controlled clinical trial. One hundred and six participants with NSCLBP will be allocated evenly to the 650 ILA or control group. All participants will receive education on exercise and self-management. The 650 ILA group will undergo 650 nm ILA for 10 min, and the control group will undergo sham ILA for 10 min per visit, twice a week for 4 weeks, at bilateral GB30, BL23, BL24, and BL25. The primary outcome will be the proportion of responders (≥30% reduction in pain visual analogue scale [VAS] without increased use of painkillers) at 3 days after the intervention ends. The secondary outcomes will include changes in the scores of the VAS, European Quality of Life Five Dimension Five Level scale, and Korean version of the Oswestry Disability Index at 3 days after the intervention ends and 8 weeks after the intervention ends. Discussions: The results of our study will provide clinical evidence concerning the safety and efficacy of 650 nm ILA for the management of NSCLBP. Clinical trial registration: https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&focus=reset_12&search_page=M&pageSize=10&page=undefined&seq=21591&status=5&seq_group=21591, identifier KCT0007167.

Effectiveness of Pharmacopuncture Therapy in Adhesive Capsulitis: a Study Protocol for a Pragmatic Randomized Controlled Trial.

Background: Adhesive capsulitis is a progressive, idiopathic disorder that significantly impacts individuals̓ daily lives and increases their medical burden. Pharmacopuncture therapy, which combines acupuncture techniques with herbal medicine, involves injecting herbal extracts into specific acupoints. This study aims to determine the effectiveness and safety of pharmacopuncture therapy in comparison to physiotherapy (PT) for treating adhesive capsulitis. Methods: This research protocol outlines a two-arm, parallel, multi-center, pragmatic randomized controlled trial. Fifty participants will be randomly allocated to either the pharmacopuncture therapy or PT group, and they will receive 12 sessions of their respective therapies over a 6-week period. The primary outcome measure is the numeric rating scale for shoulder pain. Secondary outcomes include the visual analog scale score for shoulder pain, Shoulder Pain and Disability Index, Patients̓ Global Impression of Change score, Short Form-12 Health Survey Version 2 score, and EuroQol-5 Dimension. Statistical analysis will be conducted based on the intention-to-treat principle. Discussion: This trial may offer high-quality and reliable clinical evidence for evaluating the effectiveness and safety of pharmacopuncture therapy compared to PT in the treatment of adhesive capsulitis. Furthermore, this study will serve as a valuable guideline for practitioners when making clinical decisions and managing adhesive capsulitis.

Bangpungtongsung-san for patients with major depressive disorder: study protocol for a randomized controlled phase II clinical trial.

BACKGROUND: Bangpungtongsung-san (BTS) is a representative herbal medicine that has been widely used for patients with obesity in east Asian countries. Various preclinical studies have demonstrated the anti-depressive effect of BTS granules in various animal models of depression. This phase II trial aimed to explore the efficacy and safety of BTS in human patients with depression. METHODS: A total of 126 patients diagnosed with major depressive disorder and who are not underweight (body mass index ≥ 18.5 kg/m2) will be enrolled in this study. Eligible participants will be randomly allocated into three groups: the high-dose BTS, low-dose BTS, and placebo groups in a 1:1:1 ratio. BTS or placebo granules will be orally administered twice a day for 8 weeks. The BTS and placebo granules will be made to have identical color, scent, and shape, and participants and investigators will be blinded to the allocation. The primary efficacy endpoint is the change from baseline of the 17-item Hamilton Depression Rating Scale total score at 8 weeks. The superiority of the high- and low-dose BTS granules to the placebo granules will be tested. DISCUSSION: The results of this clinical trial will provide evidence on the efficacy and safety of BTS for patients with major depressive disorder. This study will be conducted in accordance with ethical and regulatory guidelines, and the results will be submitted and published in international peer-reviewed journals. TRIAL REGISTRATION: CRIS registration Number: KCT0007571; registered on 2022/07/26 ( https://cris.nih.go.kr/cris/search/detailSearch.do/23192 ).

Efficacy, Safety and Economic Evaluation of Wolbigachul-Tang for Chronic Cough Due to Upper Airway Cough Syndrome (UACS): A Study Protocol for Randomized, Double-Blind, Active-Comparator Controlled, Parallel, Exploratory Clinical Trial.

Upper airway cough syndrome (UACS) is a common cause of chronic cough characterized by upper airway symptoms, including nasal discharge and throat discomfort. Empirical treatments for UASC-induced chronic cough, such as first-generation antihistamines, have been used; however, the long-term use of these medicines has adverse effects. Therefore, we evaluate the efficacy, safety, and economic feasibility of Wolbigachul-tang (WBGCT), an herbal medication for UASC-induced chronic cough. This is a randomized, double-blind, active-comparator-controlled, parallel, and exploratory clinical trial. Thirty patients with UASC-induced chronic cough will be recruited and randomly allocated to the WBGCT and control groups in a 1:1 allocation ratio. The investigational medicine will be administered three times per day for 2 weeks (3 g of WBGCT at a time). The primary outcome measure is the cough symptom score measured at screening, before starting the trial, and after 2 and 4 weeks. Secondary outcome measures include the cough visual analog scale, nasal discharge score, questionnaire of clinical symptoms of cough and sputum, Leicester cough questionnaire-Korean version, integrative medicine outcome scale, integrative medicine patient satisfaction scale, and 5-level EuroQol 5-dimensional questionnaire, which will be assessed before starting the trial and after 2 and 4 weeks. This study aims to investigate the efficacy, safety, and economic feasibility of WBGCT in the treatment of chronic cough. Therefore, the results of this trial provide evidence for the application of WBGCT in the treatment of UACS-induced chronic cough.

Herbal Medicine Yukgunja-Tang for Functional Dyspepsia: A Protocol for a Randomized, Controlled, Multicenter Clinical Trial.

The herbal medicine Yukgunja-tang has been widely used for the treatment of functional dyspepsia (FD) in the clinical setting of East Asian traditional medicine. This paper presents a protocol for a randomized, assessor-blind, controlled, multicenter, three-arm parallel clinical trial comparing the effectiveness, safety, and cost-effectiveness of Yukgunja-tang with Pyeongwi-san and usual care. A total of 140 participants with Rome IV-diagnosed FD will be randomly assigned to either the Yukgunja-tang (n = 56), Pyeongwi-san (n = 56), or usual care (n = 28) groups. All participants will be educated on dietary guidelines for FD patients. Participants in the Yukgunja-tang and Pyeongwi-san groups will take investigational products for 6 weeks. All participants will be assessed for clinical parameters at weeks 0, 3, 6, 9, and 24. The primary outcome will be measured on the total dyspepsia symptom scale, and the secondary outcome will include the single dyspepsia symptom scale, overall treatment effect, the visual analog scale for dyspepsia, FD-related quality of life, hospital anxiety and depression scale, EuroQol-5 dimension, pattern identification, and serum levels of acyl-ghrelin and deacyl-ghrelin. Adverse events and laboratory tests will be monitored for safety assessment. The results will provide evidence of the effectiveness, safety, and cost-effectiveness of Yukgunja-tang in the treatment of FD.

Efficacy of mecasin for treatment of amyotrophic lateral sclerosis: A phase IIa multicenter randomized double-blinded placebo-controlled trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Amyotrophic lateral sclerosis (ALS) is a lethal neurodegenerative disorder characterized by progressive paralysis of voluntary muscles. Mecasin, the extract of modified jakyakgamchobuja-tang-a herbal preparation comprising of Radix Paeoniae Alba, Radix Glycyrrhizae, Radix Aconiti Lateralis Preparata, Radix Salviae Miltiorrhizae, Rhizoma Gastrodiae, Radix Polygalae, Curcuma Root, Fructus Chaenomelis, and Rhizoma Atractylodis Japonicae-shows neuroprotective and anti-neuroinflammatory effects and alleviates the symptoms in patients with ALS. AIM OF THE STUDY: This trial aimed to evaluate the efficacy and safety of mecasin in these patients. MATERIAL AND METHODS: Patients were randomized to receive mecasin 1.6 g daily, mecasin 2.4 g daily, or placebo for 12 weeks. The primary endpoint was the Korean version of ALS Functional Rating Scale-Revised (K-ALSFRS-R) score. The secondary endpoints were muscular atrophy measurements, pulmonary function test results, creatine kinase levels, body weight, safety, and scores of the Medical Research Council (MRC) scale for muscle strength; Visual Analog Scale for pain (VAS pain); Hamilton Rating Scale for Depression; and Fatigue Severity Scale. RESULTS: Among the 30 patients randomized, 24 completed the follow-up. Significant between-group differences were detected in the primary endpoint using the omnibus F-test. The changes in the K-ALSFRS-R score between 12 weeks and baseline were -0·25, -1·32, and -2·78 in the mecasin 1.6 g, mecasin 2.4 g, and placebo groups, respectively. The difference in the K-ALSFRS-R score between the mecasin 1.6 g and placebo groups was 2·53 points (95% confidence interval [CI]: 0·61-4·45), and that between the 2.4 g and placebo groups was 1·46 points (95% CI: 0·48-3·40). However, no significant differences were detected in the secondary endpoints (MRC: dyspnea, p = 0·139; VAS pain, p = 0·916; forced vital capacity, p = 0·373). The incidence of adverse events was similar and low in all groups. CONCLUSIONS: Mecasin may retard symptomatic progression without major adverse effects. A phase IIb study to evaluate its long-term effects in ALS is ongoing.

A Pilot Study for Effectiveness of Non-Pharmacological versus Pharmacological Treatment Strategies for Lumbar Disc Herniation: A Pragmatic Randomized Controlled Trial.

Purpose: We aimed to compare the efficacy, safety, and cost-effectiveness of non-pharmacological- and pharmacological treatment strategies for Lumbar disc herniation (LDH) in pragmatic clinical settings. Patients and Methods: This study was a pilot, two-armed, parallel pragmatic randomized controlled trial. Thirty patients aged 19-70 years with a numeric rating scale (NRS) score ≥5 for sciatica and confirmed LDH on magnetic resonance imaging (MRI) were included. Participants were assigned in a 1:1 ratio to non-pharmacological (non-Phm) or pharmacological (Phm) treatment group. They were treated for 8 weeks and a total follow-up period was 26 weeks after randomization. Non-Phm treatment included acupuncture, spinal manual therapy, etc., Phm included medication, injection, nerve block, etc., The primary outcome was a numeric rating scale (NRS) of radiating leg pain. NRS for low back pain, Oswestry disability index, visual analog scale, Fear-Avoidance Beliefs Questionnaire, patient global impression of change, Short Form-12 Health Survey, version 2, 5-level European Quality of Life-5 dimensions (EQ-5D) were also measured. Linear mixed model was used to evaluated the difference in change of outcomes from baseline between two groups. An economic evaluation was conducted using incremental cost-effectiveness ratios. Results: There was no significant difference between the two groups in the intervention period, but non-Phm group showed significantly greater degree of improvement in follow-up of Week 14. Difference in the NRS for sciatica and ODI were 1.65 (95% CI 0.59 to 2.71, p=0.003) and 8.67 (95% CI 1.37 to 15.98, p=0.21), respectively in Week 14. The quality-adjusted life year (QALY) value calculated by EQ-5D and Short Form-6 Dimension were 0.006 (95% CI -0.012 to 0.024, p=0.472) and 0.015 (95% CI -0.008 to 0.038, p=0.195) higher in non-Phm group than in Phm group. The cost was lower in non-Phm group than in Phm group (Difference: -682, 95% CI -3349 to 1699, p=0.563). Conclusion: We confirmed that the non-Phm treatment could be more cost-effective treatments than Phm treatments and feasibility of a large-scale of main study in future.

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.