Background: Respiratory disease has emerged as a global issue due to COVID-19. In particular, there has been an increased frequency of occurrence of symptoms such as cough, sputum, and dyspnea, which commonly accompany chronic obstructive pulmonary disease (COPD). Liriope platyphylla (LP) extract is known to improve respiratory function. LP extract ameliorates the symptoms commonly seen in bronchitis, asthma, and COPD and enhances immunity, as it has anti-inflammatory properties. In a previous study in rats, LP effectively improved respiratory inflammation levels. However, few randomized controlled trials have verified the effects of LP in respiratory disease and there have been no studies to determine the appropriate dose and duration to make it a more convenient functional health product. Based on previous studies, we would like to proceed with this clinical trial under the assumption that LP will help improve respiratory function and produce anti-inflammatory effects.Methods: This will be a single-center, randomized, double-blind, placebo-controlled pilot trial. Participants will randomly be allocated to receive either 1000 mg LP or placebo. The total duration of the clinical trial will be 4 to 6 weeks. A follow-up assessment will be conducted 4 weeks after screening, and the effect and safety of LP application will be assessed at this second visit. The primary outcome will be the breathlessness, cough, and sputum scale score. Secondary outcomes will include pulmonary function, clinical symptoms of cough and sputum (reported through a questionnaire), changes in immune cells, changes in immune factors used to analyze allergic inflammation in bronchi, antioxidant enzyme activity, nitric oxide level, and COPD assessment test score.Discussion: This study has limited inclusion and exclusion criteria and the intervention will be well-controlled. This will be the first randomized controlled trial to assess the efficacy and safety of LP extract in adults with cough and sputum. This study will provide insight into the mechanisms of the anti-inflammatory effects and improvement of respiratory function of LP.Abbreviations: CAT = COPD assessment test, FEV1 = forced expiratory volume in 1 second, FVC = forced vital capacity, LP = liriope platyphylla.
Background: Low back pain refers to pain that occurs mainly in lumbosacral spine, and is a clinically common symptom that 70% to 90% of people experience at least once during their lives.Objectives: We investigated the effect and safety of orthopedic device (LSM-01) for alleviate back pain caused by muscle tension in a randomized, single-blinded, sham-controlled, parallel-group, pilot trial to establish a basis for large-scale clinical trial.Methods: A total of 30 subjects were randomly assigned to 2 group: treatment group (LSM-01) and control group (sham device) received treatment with each device 2 to 3 times a week for a total of 6 treatment for 2 weeks. Primary outcome was visual analog scale (VAS); Secondary outcomes were pressure pain threshold (PPT), oswestry disability index (ODI), and patient global impression of change (PGIC). Statistical analysis is performed for full analysis set (FAS) population. Analysis of covariance (ANCOVA) for mean difference of VAS change and Mixed models of repeated measurements (MMRM) for the trend of VAS change were conducted to compare the differences between 2 groups before and after participants got treatment with the clinical trial device.Results: One participant dropped out due to personal reason and 29 participants completed the clinical pilot trial. We found that the degree of low back pain (VAS, PPT, PGIC) significantly decreased and after the trial in the treatment group compared to the control group. Also, there were no any side effects.Conclusion: LSM-01 can be effective in improving pain of low back pain. A future large-scale main trial will be conducted based on this pilot study results. Abbreviations: LBP = low back pain, ODI = oswestry disability index, PGIC = patient global impression of change, PPT = pressure pain threshold, VAS = visual analog scale.
This paper presents the clinical outcome of an 82-year-old female who experienced sudden back pain combined with lower limb paresthesia and weakness after epidural steroid injection. The magnetic resonance imaging of the thoracolumbar spine showed a spinal epidural hematoma (SEH) extending from T8 to L4. She was treated non-operatively in the traditional Korean medicine (TKM) hospital. The patient's progress was assessed using the Numerical Rating Scale (NRS), American Spinal Injury Association (ASIS), Spinal Cord Independence Measure version III (SCIM III), and self-reported symptoms. During the 22-day hospitalization period,the NRS score decreased from 7 to 2 points, the motor score on the ASIS scale increased from 65 to 95 points. The subjective sense of lower extremities was felt by 1 increased to 8. The SCIM III score increased from 32 to 69 points. These results suggest that TKM could effectively reduce pain and aid the rehabilitation of patients with SEH.
Miller Fisher syndrome (MFS) is a rare variant of Guillain?Barr? syndrome characterized by ocular paralysis, ataxia, and insensitivity. This report describes the effect of Complex Korean Medicine Treatment (CKMT) on a patient previously diagnosed with MFS presenting with diplopia and facial palsy. The distance at which diplopia occurs, the diplopia questionnaire, the range of diplopia, the degree of facial paralysis, and the degree of ptosis were evaluated at the time of admission and weekly for 1 month. After receiving CKMT for 4 weeks the 62-year-old female had improved symptoms of diplopia, bilateral facial palsy and ptosis caused by MFS. These results show the significant association of MFS with facial paralysis and the improvement achieved with CKMT.
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