Clinical Research Information Service Research Articles

Prevalence and clinical characteristics of Sarcopenia in older adult patients with stable chronic obstructive pulmonary disease: a cross-sectional and follow-up study

BackgroundThe relationship between sarcopenia and chronic obstructive pulmonary disease (COPD) has been increasingly reported, and there is some overlap regarding their clinical features and pulmonary rehabilitation (PR) strategies. No Korean study has reported the actual prevalence of sarcopenia in patients with stable COPD who are recommended for pulmonary rehabilitation. This study evaluated the prevalence and clinical features of sarcopenia in older adult outpatients with stable COPD and the changes after 6 months.MethodsIn this cross-sectional and 6-month follow-up study, we recruited 63 males aged ≥ 65 diagnosed with stable COPD. Sarcopenia was diagnosed using the AWGS 2019 criteria, which included hand grip strength testing, bioelectrical impedance analysis, Short Physical Performance Battery administration, and Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falling screening tool administration. A 6-minute walk test (6 MWT) was conducted, forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), maximal inspiratory and expiratory pressures (MIP and MEP, respectively) and peak expiratory flow (PEF) were assessed, and patient-reported questionnaires were administered.ResultsAt baseline, 14 (22%) patients were diagnosed with possible sarcopenia, and eight (12.6%) were diagnosed with sarcopenia. There were significant differences in the age; body mass index; Body mass index, airflow Obstruction, Dyspnea, and Exercise index; modified Medical Research Council dyspnea scores; and International Physical Activity Questionnaire scores between the normal and sarcopenia groups. Whole-body phase angle, MIP, MEP, PEF, and 6-minute walk distance (6 MWD) also showed significant differences. Over 6 months, the proportion of patients with a reduced FEV1 increased; however, the proportion of patients with sarcopenia did not increase.ConclusionA relatively low prevalence of sarcopenia was observed in older adult outpatients with stable COPD. No significant change in the prevalence of sarcopenia was found during the 6-month follow-up period.Trial registrationThe study was registered with the Clinical Research Information Service (KCT0006720). Registration date: 30/07/2021.

The Investigation of Hyaluronic Acid (The Chaeum Premium No.2<sup>®</sup>) to Evaluate the Efficacy and Safety for Injection Laryngoplasty in Unilateral Vocal Cord Paralysis: A Single Center, Phase II Trial

Background and Objectives This study aimed to evaluate the clinical efficacy and safety of hyaluronic acid (HA) (The Chaeum Premium No.2<sup>®</sup>) for injection laryngoplasty (IL) in unilateral vocal cord paralysis (UVCP) patients.Materials and Method This clinical trial has been registered with the clinical research information service of the Republic of Korea (No. KCT0007597). Ten patients with UVCP were enrolled. Auditory-perceptual evaluation, acoustic analysis, aerodynamic analysis, electroglottography, laryngoscopy, and voice handicap index (VHI)-30 were assessed before injection, at 1, 3, and 6 months after injection.Results All auditory-perceptual parameters gradually showed statistically significant improvements at 1, 3, and 6 months after injection. Acoustic, aerodynamic parameters, electroglottography, and VHI-30 showed gradual improvements at 1 and 3 months after injection. Then, they showed slight deterioration 6 months after injection. There were no adverse effects in all patients.Conclusion IL using HA is an effective and safe treatment for UVCP patients.

Effects of dual-task resistance exercise on cognition, mood, depression, functional fitness, and activities of daily living in older adults with cognitive impairment: a single-blinded, randomized controlled trial

BackgroundRegular exercise is emphasized for the improvement of functional capacity and independence of older adults. This study aimed to compare the effects of a dual-task resistance exercise program and resistance exercise on cognition, mood, depression, physical function, and activities of daily living (ADL) in older adults with cognitive impairment.MethodsA total of 44 older adults participated in the study. Participants were randomly allocated to an experimental group (n = 22) performing a dual-task resistance exercise program for cognitive function improvement and a control group (n = 22) performing a resistance exercise program. Both groups performed the exercise for 40 min per session, three times a week, for 6 weeks (18 sessions). Cognition, mood, depression, functional fitness, and ADL were quantified before and after the intervention using the Mini-Mental State Examination (MMSE), profile of mood states (POMS), geriatric depression scale (GDS), senior fitness test (SFT), and Korean version of ADL, respectively.ResultsThere was a significant time and group interaction on the MMSE (p = 0.044). There were no significant time and group interactions in the POMS, GDS, SFT, or ADL. Cognitive function (p < 0.001), mood (p < 0.001), depression (p < 0.001), functional fitness (p < 0.001), and ADL (p < 0.001) significantly improved after dual-task resistance exercise, and cognitive function (p < 0.001), mood (p < 0.001), depression (p < 0.001), functional fitness (p < 0.001), and ADL (p < 0.001) significantly improved after resistance exercise.ConclusionsDual-task resistance exercise is more effective than resistance exercise in improving cognitive function in older adults with cognitive impairment. Both dual-task resistance exercise and resistance exercise improves mood, depression, functional fitness, and ADL after the intervention. We propose using dual-task resistance exercises for cognitive and physical health management in the older adults with cognitive impairment.Trial registrationThis study was registered with the Clinical Research Information Service (WHO International Clinical Trials Registry Platform) (Registration ID, KCT0005389; Registration date, 09/09/2020).

Comparison between a tubeless, on-body automated insulin delivery system and a tubeless, on-body sensor-augmented pump in type 1 diabetes: a multicentre randomised controlled trial.

This study compares the efficacy and safety of a tubeless, on-body automated insulin delivery (AID) system with that of a tubeless, on-body sensor-augmented pump (SAP). This multicentre, parallel-group, RCT was conducted at 13 tertiary medical centres in South Korea. Adults aged 19-69 years with type 1 diabetes who had HbA1c levels of <85.8 mmol/mol (<10.0%) were eligible. The participants were assigned at a 1:1 ratio to receive a tubeless, on-body AID system (intervention group) or a tubeless, on-body SAP (control group) for 12 weeks. Stratified block randomisation was conducted by an independent statistician. Blinding was not possible due to the nature of the intervention. The primary outcome was the percentage of time in range (TIR), blood glucose between 3.9 and 10.0 mmol/l, as measured by continuous glucose monitoring. ANCOVAs were conducted with baseline values and study centres as covariates. A total of 104 participants underwent randomisation, with 53 in the intervention group and 51 in the control group. The mean (±SD) age of the participants was 40±11 years. The mean (±SD) TIR increased from 62.1±17.1% at baseline to 71.5±10.7% over the 12 week trial period in the intervention group and from 64.7±17.0% to 66.9±15.0% in the control group (difference between the adjusted means: 6.5% [95% CI 3.6%, 9.4%], p<0.001). Time below range, time above range, CV and mean glucose levels were also significantly better in the intervention group compared with the control group. HbA1c decreased from 50.9±9.9 mmol/mol (6.8±0.9%) at baseline to 45.9±7.4 mmol/mol (6.4±0.7%) after 12 weeks in the intervention group and from 48.7±9.1 mmol/mol (6.6±0.8%) to 45.7±7.5 mmol/mol (6.3±0.7%) in the control group (difference between the adjusted means: -0.7 mmol/mol [95% CI -2.0, 0.8 mmol/mol] (-0.1% [95% CI -0.2%, 0.1%]), p=0.366). No diabetic ketoacidosis or severe hypoglycaemia events occurred in either group. The use of a tubeless, on-body AID system was safe and associated with superior glycaemic profiles, including TIR, time below range, time above range and CV, than the use of a tubeless, on-body SAP. Clinical Research Information Service (CRIS) KCT0008398 FUNDING: The study was funded by a grant from the Korea Medical Device Development Fund supported by the Ministry of Science and ICT; the Ministry of Trade, Industry and Energy; the Ministry of Health and Welfare; and the Ministry of Food and Drug Safety (grant number: RS-2020-KD000056).

Assessing the Feasibility and Efficacy of Pre-Sleep Dim Light Therapy for Adults with Insomnia: A Pilot Study.

Background: Insomnia is increasingly recognized for its marked impact on public health and is often associated with various adverse health outcomes, including cardiovascular diseases and mental health disorders. The aim of this study was to investigate the efficacy of pre-sleep dim light therapy (LT) as a non-pharmacological intervention for insomnia in adults, assessing its influence on sleep parameters and circadian rhythms. Methods: A randomized, open-label, two-arm clinical trial was conducted over two weeks with 40 participants aged 20-60 years, all of whom had sleep disorders (CRIS, KCT0008501). They were allocated into control and LT groups. The LT group received exposure to warm-colored light, minimizing the blue spectrum, before bedtime. The study combined subjective evaluation via validated, sleep-related questionnaires, objective sleep assessments via actigraphy, and molecular analyses of circadian clock gene expression in peripheral blood mononuclear cells. Baseline characteristics between the two groups were compared using an independent t-test for continuous variables and the chi-squared test for categorical variables. Within-group differences were assessed using the paired t-test. Changes between groups were analyzed using linear regression, adjusting for each baseline value and body mass index. The patterns of changes in sleep parameters were calculated using a linear mixed model. Results: The LT group exhibited significant improvements in sleep quality (difference in difference [95% CI]; -2.00 [-3.58, -0.43], and sleep efficiency (LT: 84.98 vs. control: 82.11, p = 0.032), and an advanced Dim Light Melatonin Onset compared to the control group (approximately 30 min). Molecular analysis indicated a significant reduction in CRY1 gene expression after LT, suggesting an influence on circadian signals for sleep regulation. Conclusions: This study provides evidence for the efficacy of LT in improving sleep quality and circadian rhythm alignment in adults with insomnia. Despite limitations, such as a small sample size and short study duration, the results underscore the potential of LT as a viable non-pharmacological approach for insomnia. Future research should expand on these results with larger and more diverse cohorts followed over a longer period to validate and further elucidate the value of LT in sleep medicine. Trial registration: The trial was registered with the Clinical Research Information Service (KCT0008501).

Efficacy of a virtual nursing simulation-based education to provide psychological support for patients affected by infectious disease disasters: a randomized controlled trial.

Virtual simulation-based education for healthcare professionals has emerged as a strategy for dealing with infectious disease disasters, particularly when training at clinical sites is restricted due to the risk of infection and a lack of personal protective equipment. This research evaluated a virtual simulation-based education program intended to increase nurses' perceived competence in providing psychological support to patients affected by infectious disease disasters. The efficacy of the program was evaluated via a randomized controlled trial. We recruited 104 nurses for participation in the study and allocated them randomly and evenly to an experimental group and a control group. The experimental group was given a web address through which they could access the program, whereas the control group was provided with a web address that directed them to text-based education materials. Data were then collected through an online survey of competence in addressing disaster mental health, after which the data were analyzed using the Statistical Package for the Social Sciences(version 23.0). The analysis showed that the experimental group's disaster mental health competence (F = 5.149, p =.026), problem solving process (t = 3.024, p =.003), self-leadership (t = 2.063, p =.042), learning self-efficacy (t = 3.450, p =.001), and transfer motivation (t = 2.095, p =.039) significantly statistically differed from those of the control group. A virtual nursing simulation-based education program for psychological support can overcome limitations of time and space. The program would also be an effective learning resource during infectious disease outbreaks. This Korean clinical trial was retrospectively registered (21/11/2023) in the Clinical Research Information Service ( https://cris.nih.go.kr ) with trial registration number KCT0008965.

Modified Gwakjeongtang for Diarrhea-Predominant Irritable Bowel Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Pilot Clinical Trial.

Irritable bowel syndrome (IBS) is a chronic condition characterized by recurrent abdominal pain associated with bowel movements. Modified Gwakjeongtang (MGT), an herbal prescription rooted in traditional East Asian medicine, consists of thirteen botanical drugs known for their potential to enhance intestinal barrier function, regulate gastrointestinal motility, and exhibit anti-inflammatory and antioxidant properties. Despite a few previous clinical trials highlighting MGT's potential for IBS symptom management, limited evidence exists with placebo control. In this pilot randomized clinical trial protocol, we aim to exploratively evaluate the efficacy and safety of MGT in patients with diarrhea-predominant IBS (IBS-D) by comparing it with a placebo. A total of 60 IBS-D patients will be enrolled, and eligible participants will be randomly allocated to either the MGT or placebo groups. Over a 4-week period, they will receive MGT or placebo granules three times a day. The primary endpoint will be the overall response rate post-treatment, determined through daily assessments of abdominal pain intensity and stool consistency. This clinical trial protocol has received approval from the Korean Ministry of Food and Drug Safety for an investigational new drug application and Institutional Review Board of the Kyung Hee University Korean Medicine Hospital. The research findings will be submitted and published in international peer-reviewed journal. Clinical research information service (registration number: KCT0008523).

Effectiveness and safety of hominis placental pharmacopuncture for chronic temporomandibular disorder: A multi-center randomized controlled trial

BackgroundHominis placental (HPP) extract has been approved by the Ministry of Food and Drug Safety in Korea for treating chronic liver diseases and postmenopausal syndrome. However, its efficacy and safety for treating chronic temporomandibular disorder (TMD) remains unclear. We aimed to assess the effectiveness and safety of HPP for treating chronic TMD compared with physical therapy (PT). MethodsThis study is a 2-arm parallel, multi-center, randomized controlled trial. We enrolled 82 chronic TMD patients from 2 Korean medicine hospitals between December 2019 and January 2021. We included patients with chronic TMD and randomly assigned them to undergo HPP or PT. The primary outcome was the difference in the scores for temporomandibular joint (TMJ) pain at baseline and week 6. The secondary outcomes were the scores for TMJ pain and bothersomeness, TMJ range of motion, the Korean version of Beck's depression index-Ⅱ, jaw functional limitation scale (JFLS) score, patient global impression of change (PGIC) scores, EuroQoL 5-dimension 5-level score, and short form-12 health survey (SF-12) scores. ResultsCompared with PT, HPP showed significantly superior effects on TMJ pain and bothersomeness, protrusive movement pain, JFLS (verbal, emotional, and global), SF-12, and PGIC scores at week 6 (P < 0.05). Compared with the PT group, the HPP group showed a significantly higher recovery rate (≥50 % reduction in the scores for TMJ pain at the 24-week follow-up). ConclusionHPP was more effective than PT managing pain and improving function and quality of life. Our findings demonstrate the effectiveness and safety of HPP for TMD treatment. Trial registrationThis study has been registered at clinicalTrials.gov (NCT04087005), Clinical Research Information Service (CRIS) (KCT0004437), and Ministry of Food and Drug Safety (No. 31886).

Effect of Porcine-Derived Absorbable Patch-Type Atelocollagen for Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Trial

Background: Even though arthroscopic rotator cuff repair is recognized as a standard treatment option, the risk of postoperative retear is a major concern. Purpose: To evaluate the effect of porcine-derived absorbable patch-type atelocollagen during arthroscopic rotator cuff repair. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 64 patients with rotator cuff tears diagnosed on magnetic resonance imaging (MRI) were enrolled prospectively from November 2020 to December 2021. Both groups had repairs using the suture bridge technique. For the atelocollagen group, before securing the lateral anchors, we inserted porcine-derived absorbable patch-type atelocollagen between the footprint and the tendon. On postoperative day 2, the patients underwent MRI to confirm containment of the patch-type atelocollagen. At 6 months and 1 year postoperatively, the signal intensity of the repaired tendon was assessed using MRI. Patients were evaluated using the Constant score as the primary outcome, along with the visual analog scale for pain; range of motion; American Shoulder and Elbow Surgeons score; University of California, Los Angeles, score; and Korean Shoulder Score preoperatively and at 2, 3, 6, and 12 months postoperatively. Results: No significant changes in the Constant score as primary outcome, pain or other functional scores, and range of motion were observed between the groups at 1 year postoperatively. The patch-type atelocollagen was confirmed to be contained by the time-zero MRI scan taken 2 days postoperatively. Among the 55 patients included in final analysis, 12 retear cases were recorded (21.8% retear rate). A significantly lower retear rate was found in the atelocollagen group, as 3 cases were observed in this group (10.3%) and 9 cases were observed in the conventional repair group (34.6%) (P = .048). Conclusion: The Constant score was not different between the groups. The retear rate after rotator cuff repair was significantly lower in the group that received porcine-derived absorbable patch-type atelocollagen compared with in the conventional group. Registration: KCT0005184 (Clinical Research Information Service [CRIS]; https://cris.nih.go.kr).

Optimized treatment parameter by computer simulation for high-intensity focused ultrasound treatment of uterine adenomyosis: Short-term and long-term results.

This study aimed to investigate the efficacy and safety of using optimized parameters obtained by computer simulation for ultrasound-guided high-intensity focused ultrasound (HIFU) treatment of uterine adenomyosis in comparison with conventional parameters. We retrospectively assessed a single-institution, prospective study that was registered at Clinical Research Information Service (CRiS) of Republic of Korea (KCT0003586). Sixty-six female participants (median age: 44 years) with focal uterine adenomyosis were prospectively enrolled. All participants were treated with a HIFU system by using treatment parameters either for treating uterine fibroids (Group A, first 20 participants) or obtained via computer simulation (Group B, later 46 participants). To assess the treatment efficacy of HIFU, qualitative indices, including the clinically effective dysmenorrhea improvement index (DII), were evaluated up to 3 years after treatment, whereas quantitative indices, such as the nonperfused volume ratio and adenomyosis volume shrinkage ratio (AVSR), on MRI were evaluated up to 3 months after treatment. Quantitative/qualitative indices were compared between Groups A and B by using generalized linear mixed effect model. A safety assessment was also performed. Results showed that clinically effective DII was more frequently observed in Group B than in Group A (odds ratio, 3.69; P = 0.025), and AVSR were higher in Group B than in Group A (least-squares means, 21.61; P = 0.001). However, two participants in Group B developed skin burns at the buttock and sciatic nerve pain and required treatment. In conclusion, parameters obtained by computer simulation were more effective than the conventional parameters for treating uterine adenomyosis by using HIFU in terms of clinically effective DII and AVSR. However, care should be taken because of the risk of adverse events.

Evaluation of pulse oximeter at the nasal septum during general anesthesia: comparison with finger oximeter.

Though the finger is generally recommended for pulse oxygen saturation (SpO2) monitoring site, its reliability may be compromised in conditions of poor peripheral perfusion. Therefore, we compared the performance of nasal septum SpO2 monitoring with finger SpO2 monitoring relative to simultaneous arterial oxygen saturation (SaO2) monitoring in generally anesthetized patients. In 23 adult patients, comparisons of SpO2 measured at the nasal septum and finger with simultaneous SaO2 were made at four time points during the 90min study period. A pulse oximetry monitoring failure was defined as a > 10s continuous failure of in an adequate SpO2 data acquisition. Core temperature as well as finger-tip and nasal septum temperatures were simultaneously measured at 10min intervals. A total of 92 sets of SpO2 and SaO2 measurements were obtained in 23 patients. The bias and precision for SpO2measured at the nasal septum were - 0.8 ± 1.3 (95% confidence interval: - 1.1 to - 0.6), which was similar to those for SpO2measured at the finger (- 0.6 ± 1.4; 95% confidence interval: - 0.9 to - 0.4) (p = 0.154). Finger-tip temperatures were consistently lower than other two temperatures at all time points (p < 0.05), reaching 33.5 ± 2.3°C at 90min after induction of anesthesia. While pulse oximetry monitoring failure did not occur for nasal septum probe, two cases of failure occurred for finger probe. Considering the higher stability to hypothermia with a similar accuracy, nasal septum pulse oximetry may be an attractive alternative to finger pulse oximetry. Trail registration This study was registered with Clinical Research Information Service (CRIS: https://cris.nih.go.kr/cris/en/ ; ref: KCT0008352).

Evaluation of the Fusion Rate and Safety of Escherichia coli-Derived rhBMP-2 in Transforaminal Lumbar Interbody Fusion for Patients with Degenerative Lumbar Disease: A Prospective, Multicenter, Single-Arm Trial.

Background: Few studies have documented the viability of E. coli-derived recombinant human bone morphogenetic protein-2 (rhBMP-2) in transforaminal lumbar interbody fusion (TLIF). This study aimed to assess the safety and fusion rate of rhBMP-2 in TLIF. Methods: The study was conducted as a prospective, multicenter, single-arm trial, and 30 patients needing one- or two-level TLIF were enrolled. Fusion rate was assessed using the 12-month interbody fusion rate on CT. Postoperative problems, including seroma, radiculitis, and ectopic bone formation, which have been documented as risks associated with rhBMP-2 in prior studies, were recorded. Results: The study demonstrated fusion outcomes in all instances at 52 and 104 weeks post-surgery. Significant improvements were observed in clinical outcomes, with ODI, SF-36, and VAS scores, all achieving statistical significance (p < 0.0001). No perioperative adverse events requiring reoperation were reported, and there were no incidences of seroma, radiculitis, cage migration, grafted bone extrusion, postoperative neurologic deficit, or deep wound infection. Conclusions: The study demonstrates the high safety and efficacy in inducing bone fusion of E. coli-derived rhBMP-2 in TLIF, with a notable absence of adverse postoperative complications. Trial registration: This study protocol was registered at Korea Clinical Research Information Service (number identifier: KCT0004738) on July 2020.

Development of a multidisciplinary medication management program in nursing homes: protocol for a randomized controlled trial

BackgroundPolypharmacy and the use of potentially inappropriate medications are common among nursing home residents and are associated with negative outcomes. Although deprescribing has been proposed as a way to curtail these problems, the best way to implement multidisciplinary comprehensive medication review and deprescribing and its real impact in specific high-risk populations, such as nursing home residents, is still unclear. This multicenter randomized controlled clinical trial aims to assess the effects of a multidisciplinary mediation management program on medication use and health problems.MethodsA total of 1,672 residents aged ≥ 65 years from 22 nursing homes in South Korea who meet the targeted criteria, such as the use of ≥ 10 medications, are eligible to participate. The experimental group will receive a comprehensive medication review, deprescription, and multidisciplinary case conference with the help of platform. Outcomes will be measured at baseline, at the end of the intervention, as well as at 3, 6, 9, and 12 months after the end of the intervention. The primary endpoints will be the rate of adverse drug events, number of potentially inappropriate medications/potentially inappropriate medication users/two or more central nervous system drug/ central nervous system drug users, delirium, emergency department visits, hospitalization, and falls. The secondary endpoint will be the number of medications taken and polypharmacy users.DiscussionOur trial design is unique in that it aims to introduce a structured operationalized clinical program focused on reducing polypharmacy and potentially inappropriate medications in a nursing home setting with large samples.Trial registrationEthical approval was granted by the public institutional review board of the Ministry of Health and Welfare (2022-1092-009). The study is also registered with the Clinical Research Information Service (Identifier: KCT0008157, Development and evaluation of a multidisciplinary medication management program in long-term care facility residents Status: Approved First Submitted Date: 2023/01/18 Registered Date: 2023/02/03 Last Updated Date: 2023/01/18 (nih.go.kr) https://cris.nih.go.kr/), which includes all items from the World Health Organization Trial Registration Dataset.

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

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). 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. 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. 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. Clinical Research Information Service (CRIS), KCT0007229; registered on April 26, 2022.

External validation of the modified Marsh and Schnider models for medium-chain triglyceride propofol in target-controlled infusion anesthesia

BackgroundPropofol formulated with medium- and long-chain triglycerides (MCT/LCT propofol) has rapidly replaced propofol formulated with long-chain triglycerides (LCT propofol). Despite this shift, the modified Marsh and Schnider pharmacokinetic models developed using LCT propofol are still widely used for target-controlled infusion (TCI) of propofol. This study aimed to validate the external applicability of these models by evaluating their predictive performance during TCI of MCT/LCT propofol in general anesthesia.MethodsAdult patients (n = 48) undergoing elective surgery received MCT/LCT propofol via a TCI system using either the modified Marsh or Schnider models. Blood samples were collected at various target propofol concentrations and at specific time points, including the loss of consciousness and the recovery of consciousness (13 samples per patient). The actual plasma concentration of propofol was determined using high-performance liquid chromatography. The predictive performance of each pharmacokinetic model was assessed by calculating four parameters: inaccuracy, bias, divergence, and wobble.ResultsBoth the modified Marsh and Schnider models demonstrated predictive performances within clinically acceptable ranges for MCT/LCT propofol. The inaccuracy values were 24.4% for the modified Marsh model and 26.9% for the Schnider model. Both models showed an overall positive bias, 16.4% for the modified Marsh model and 16.6% for the Schnider model. The predictive performance of MCT/LCT propofol was comparable to that of LCT propofol, suggesting formulation changes might exert only a minor impact on the reliability of the TCI system during general anesthesia. Additionally, both models exhibited higher bias and inaccuracy at target concentrations ranging from 3.5 ~ 5 ug/ml than at concentrations between 2 ~ 3 ug/ml.ConclusionsThe modified Marsh and Schnider models, initially developed for LCT propofol, remain clinically acceptable for TCI with MCT/LCT propofol.Trial registrationThis study was registered at the Clinical Research Information Service of the Korean National Institute of Health (https://cris.nih.go.kr; registration number: KCT0002191; 06/01/2017).

Vitamin D supplementation in preventing the recurrence of benign paroxysmal positional vertigo.

To evaluate the effect of vitamin D supplementation on the recurrence rate of benign paroxysmal positional vertigo (BPPV). A single-center, prospective, double-blind, placebo-controlled, parallel-group randomized controlled trial was conducted between November 2018 and May 2020. After successful treatment with canalith repositioning maneuvers, patients diagnosed with BPPV were randomized to either the vitamin D (n = 20) or placebo (n = 18) group. Only patients with serum vitamin D levels <20 ng mL-1 were included. The vitamin D group received 7000 IU of vitamin D weekly for a year, while the placebo group received a matching placebo drug. The final endpoint was the BPPV recurrence rate and correlation with serum vitamin D levels after 6 and 12 months in both groups. Among 38 patients, 37 were followed up for 6 months and 30 for 12 months. Significantly higher serum vitamin D levels were observed in the vitamin D group compared to the placebo group at both the 6-month and 1-year follow-ups (p < .001 at each timepoint). The recurrence rate was lower in the vitamin D group than in the placebo group after 6 months (p = .008) and 1 year (p = .003). Vitamin D supplementation, in the absence of calcium, may be beneficial for patients prone to recurrent BPPV episodes, particularly when serum vitamin D levels are suboptimal (PRE20181024-001, Clinical Research Information Service, South Korea). 1b.

Alleviating effect of lavender (Lavandula angustifolia) and its major components on postherpetic pain: a randomized blinded controlled trial

BackgroundPostherpetic neuralgia (PHN) causes severe pain which can lead to decreased quality-of-life. This study aimed to evaluate the effects of inhalation of lavender (Lavandula angustifolia) oil and its major components (linalool and linalyl acetate) on the pain in patients with PHN.MethodsThis study was performed at an outpatient clinic. Sixty-four patients with postherpetic neuralgia were randomly allocated to a control group (almond oil) or one of three experimental groups (lavender oil, linalool, or linalyl acetate diluted in almond oil at concentration of 1% v/v), and the participants inhaled the aroma by natural breathing. Quality, severity, and intensity of pain were measured before and after the intervention.ResultsSix patients discontinued the intervention for personal reasons; hence, data from 58 patients were analyzed (control group, n = 14; 1% lavender oil group, n = 15; 1% linalool, n = 15; 1% linalyl acetate, n = 14). Reduction in sensory pain was greater in the 1% lavender oil group, 1% linalool group, and 1% linalyl acetate group than in the control group (all P < 0.001). Reduction in affective pain was greater in the 1% lavender group (P < 0.001) and the 1% linalool group (P = 0.007) than in the control group. Decreases in pain severity and intensity were significantly greater in all three intervention groups than in the control group.ConclusionsInhalation of lavender oil and its major volatile components effectively reduced the quality, severity, and intensity of postherpetic pain, suggesting that lavender oil, linalool, and linalyl acetate may each be an effective intervention for reducing pain in patients with postherpetic neuralgia.Trial registrationThis study was retrospectively registered on the Clinical Research Information Service. Registration number: KCT0007772, first registration 06/10/2022.

Effectiveness of mindfulness and Qigong training for self-healing in patients with Hwabyung and depressive disorder: a protocol for a randomized controlled trial.

Hwabyung is a Korean culture-bound syndrome characterized by anger-related physical and psychological symptoms. Depressive disorder is a common mental illness occurring worldwide, and has been reported to have a high comorbidity rate with Hwabyung. For patients with depressive disorders, differential diagnosis and combined treatment for Hwabyung should be considered. Mindfulness and Qigong may be effective alternatives for regulating emotions such as depression, anxiety, and anger. This study aims to investigate whether Mindfulness and Qigong Training for Self-Healing (MQT-SH) would improve emotional problems in patients with Hwabyung and depressive disorder. This study will be a two-arm block randomized controlled trial. A total of 64 participants will be recruited and randomly assigned to either experimental or control group. While the experimental group will perform MQT-SH for the first six weeks, the control group will receive no treatment. During the next six weeks, the control group will perform MQT-SH for ethical equity. Assessments will be conducted at baseline, post-intervention (6 weeks) and follow-up (12 weeks). The primary outcomes would be Hwabyung and depression, while the secondary outcomes would include anxiety, anger, and vitality. This study will provide a basis for assessing the effectiveness of mindfulness and Qigong training in patients with Hwabyung and depressive disorder. This study was approved by the Institutional Review Board of Kyung-Hee University Oriental Medicine Hospital in Gangdong (KHNMCOH 2023-09-003). The results will be disseminated through peer-reviewed publications. This trial was registered with the Clinical Research Information Service (CRIS), Republic of Korea, No. KCT0008937 and was registered on November 10, 2023.

Omission of Breast Surgery in Predicted Pathologic Complete Response after Neoadjuvant Systemic Therapy: A Multicenter, Single-Arm, Non-inferiority Trial.

Advances in chemotherapeutic and targeted agents have increased pathologic complete response (pCR) rates after neoadjuvant systemic therapy (NST). Vacuum-assisted biopsy (VAB) has been suggested to accurately evaluate pCR. This study aims to confirm the non-inferiority of the 5-year disease-free survival of patients who omitted breast surgery when predicted to have a pCR based on breast magnetic resonance imaging (MRI) and VAB after NST, compared with patients with a pCR who had undergone breast surgery in previous studies. The Omission of breast surgery for PredicTed pCR patients wIth MRI and vacuum-assisted bIopsy in breaST cancer after neoadjuvant systemic therapy (OPTIMIST) trial is a prospective, multicenter, single-arm, non-inferiority study enrolling in 17 tertiary care hospitals in the Republic of Korea. Eligible patients must have a clip marker placed in the tumor and meet the MRI criteria suggesting complete clinical response (post-NST MRI size ≤ 1 cm and lesion-to-background signal enhancement ratio ≤ 1.6) after NST. Patients will undergo VAB, and breast surgery will be omitted for those with no residual tumor. Axillary surgery can also be omitted if the patient was clinically node-negative before and after NST and met the stringent criteria of MRI size ≤ 0.5 cm. Survival and efficacy outcomes are evaluated over five years. This study seeks to establish evidence for the safe omission of breast surgery in exceptional responders to NST while minimizing patient burden. The trial will address concerns about potential undertreatment due to false-negative results and recurrence as well as improved patient-reported quality of life issues from the omission of surgery. Successful completion of this trial may reshape clinical practice for certain breast cancer subtypes and lead to a safe and less invasive approach for selected patients. ClinicalTrials.gov Identifier: NCT05505357. Registered on August 17, 2022. Clinical Research Information Service Identifier: KCT0007638. Registered on July 25, 2022.

Comparison of Novel Telemonitoring System Using the Single-lead Electrocardiogram Patch With Conventional Telemetry System.

Although a single-lead electrocardiogram (ECG) patch may provide advantages for detecting arrhythmias in outpatient settings owing to user convenience, its comparative effectiveness for real-time telemonitoring in inpatient settings remains unclear. We aimed to compare a novel telemonitoring system using a single-lead ECG patch with a conventional telemonitoring system in an inpatient setting. This was a single-center, prospective cohort study. Patients admitted to the cardiology unit for arrhythmia treatment who required a wireless ECG telemonitoring system were enrolled. A single-lead ECG patch and conventional telemetry were applied simultaneously in hospitalized patients for over 24 hours for real-time telemonitoring. The basic ECG parameters, arrhythmia episodes, and signal loss or noise were compared between the 2 systems. Eighty participants (mean age 62±10 years, 76.3% male) were enrolled. The three most common indications for ECG telemonitoring were atrial fibrillation (66.3%), sick sinus syndrome (12.5%), and atrioventricular block (10.0%). The intra-class correlation coefficients for detecting the number of total beats, atrial and ventricular premature complexes, maximal, average, and minimal heart rates, and pauses were all over 0.9 with p values for reliability <0.001. Compared to a conventional system, a novel system demonstrated significantly lower signal noise (median 0.3% [0.1-1.6%] vs. 2.4% [1.4-3.7%], p<0.001) and fewer episodes of signal loss (median 22 [2-53] vs. 64 [22-112] episodes, p=0.002). The novel telemonitoring system using a single-lead ECG patch offers performance comparable to that of a conventional system while significantly reducing signal loss and noise. Clinical Research Information Service Identifier: KCT0008176.