• Journal of the Korean Society of Physical Medicine
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• v.15 no.1
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• pp.25-32
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• 2020

PURPOSE: This study examined the efficacy of an interferential current (IFC) treatment on the improvement of pain, disability, and quality of life in stroke patients with lumbago. METHODS: A double-blind, randomized clinical trial was conducted on 40 stroke patients with lumbago. The patients were allocated randomly into two groups: the IFC treatment group (n= 20) and the placebo treatment group (n= 20). The IFC group received 30 minutes of IFC treatment on the lumbar region, while the placebo group received IFC treatment but without real electrical stimulation. The intervention was administered five days a week for four weeks. The primary outcomes of pain intensity were measured using a visual analogue scale. The secondary measurements included the Barthel Index, Oswestry Disability Index (ODI), and health-related quality of life (HRQoL). RESULTS: The measurements were conducted before and after the two-week intervention period. Compared to the placebo treatment group, the IFC treatment group showed significantly greater improvement in the pain intensity (p<.05), ODI (p<.05), and SF-36 (p<.05) at the end of the intervention. No significant differences in the Barthel Index were found between the two groups. CONCLUSION: These findings show that an IFC treatment can improve pain, functional ability, and quality of life, highlighting the benefits of somatosensory stimulation from IFC in stroke patients with lumbago.

• Journal of the Korean Society of Physical Medicine
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• v.15 no.3
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• pp.21-27
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• 2020

PURPOSE: This study investigated the efficacy of interferential current (IFC) treatment on the improvement of pain, disability, and balance in patients with chronic nonspecific low back pain. METHODS: A double-blind randomized clinical trial was conducted with 40 patients with chronic nonspecific low back pain. The patients were randomly allocated into two groups: the IFC treatment group (n = 20) and the placebo treatment group (n = 20). The IFC group received 30 minutes of IFC treatment on the lumbar region, while the placebo group received IFC treatment without real electrical stimulation. The intervention was administered five days a week for two weeks. RESULTS: The primary outcomes of resting pain and pain during functional movement were measured by a visual analogue scale. The secondary measurements included the Oswestry disability index (ODI) for low back pain and postural sway. The measurements were performed before and after the two-week intervention period. Compared to the placebo treatment group, the IFC treatment group showed significantly greater improvement in pain during anterior trunk flexion in the standing position (p = .029), ODI (p = .039), and postural sway when subjects stood with their eyes closed (p = .010) at the end of the intervention. CONCLUSION: Our findings show that IFC treatment can improve pain, disability, and postural sway, thus, highlighting the benefits of somatosensory stimulation from IFC.

• YAKHAK HOEJI
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• v.37 no.5
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• pp.442-452
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• 1993

Previous experimental and clinical investigations suggest a possible role of new nootropic drug, oxiracetam, in improving cognitive performances in patients affected by organic brain syndrome. In this study, the cognitive and behavioral effects of oxiracetam treatment in patients with clinical symptoms of organic brain syndrome were evaluated. Sixty-six patients were enrolled and assigned to either oxiracetam or placebo, according to a randomized, double-blind design between two patient-groups. Either oxiracetam or placebo was orally given bid for 8 weeks ; daily dose of oxiracetam was 1600mg. All the patients, enrolled in this study, were diagnosed as having mild to moderate cognitive dysfunction as defined by a baseline Mini Mental State ExaminationKorean version (MMSE-K) score between 14 and 25. The patients under-went, at baseline, 4 weeks and 8 weeks after, routine laboratory study (CBC, SMA12, U/A, EKG) and the following neuropsychological tests ; MMSE-K, modified Korean Wechsler Intelligence Scale(MKWIS), Nurses' Observation Scale for Geriatric patients(NOSGER). Fifteen patients of whom were dropped out or excluded from the analysis because of poor compliance or violation of the protocol. Fiftyone patients (aged 54~78 years, male 25, female 26) were analyzed (vascular dementia, 30 ; senile dementia of Alzheimer type, 9 ; mixed type, 5 ; other cause, 7). Statistical analysis of the data demonstrated that the two groups were comparable at baseline. At the end of each study period the oxiracetam group scored significantly better on the majority of the tests evaluating cognitive function, psychometricity and the improvement rating scale of subjective symptoms than placebo group, in which worsening trends or no changes were seen on the whole. No side effects were noted during oxiracetam treatment. The present study, showing positive clinical findings after oxiracetam therapy, confirmed that this drug can be useful pharmacological treatment in organic brain syndrome.

• Journal of Ginseng Research
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• v.42 no.4
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• pp.571-576
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• 2018

Background: Korean Red Ginseng (KRG) has been used in Asia for its various biological effects, but no studies have investigated the safety of its long-term intake. Therefore, the present study evaluated the safety of KRG intake for 24 weeks. Methods: We randomized 1,000 participants in a 1:1 ratio into two groups, which were treated daily with 2 g of KRG or a placebo for 24 weeks. The primary endpoint was all adverse events and adverse drug reactions (ADRs) that occurred after KRG or placebo administration, which were reported at week 4, 12, and 24 after the baseline visit. Results: In total, 192 and 211 participants experienced adverse events in the KRG and placebo groups (39.2% and 42.0%, respectively; p = 0.361), and 59 and 57 KRG- and placebo-treated individuals reported ADRs (12.0% and 11.4%, respectively; p = 0.737). The frequently occurring ADRs were pruritus (2.0%), headache (1.6%), diarrhea (1.4%), and dizziness (1.2%) in the KRG group and pruritus (2.0%), headache (1.8%), dizziness (1.6%), rash (1.4%), and diarrhea (1.2%) in the placebo group. Discontinuation of drug administration due to ADRs was reported in 13 participants, six (1.2%) and seven (1.4%) in the KRG and placebo groups, respectively (p = 0.814). No significant abnormal changes were revealed by anthropometric, laboratory, and vital sign measurements in the KRG group compared with those in the placebo group. Conclusion: The present study confirms the safety and tolerability of daily intake of 2 g of KRG for 24 weeks by healthy adults.

• Journal of Dental Anesthesia and Pain Medicine
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• v.21 no.5
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• pp.379-396
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• 2021

Background: Trigeminal neuralgia (TN) is characterized by brief, unilateral, sharp, stabbing, and shooting pain of the fifth cranial nerve. The objective of this systematic review with meta-analysis was to determine the effect of medications compared to placebo in adult patients with TN. Methods: Review authors identified randomized placebo-controlled trials (RCTs) from PubMed, Web of Science, Cochrane, and EMBASE up to February 2021. We assessed the inclusion and exclusion criteria as well as the risk of bias of the studies based on the Cochrane Handbook. A total of 324 unduplicated references were scanned independently and reduced to eight relevant RCTs, with 89 patients included. Medications investigated included oral carbamazepine, subcutaneous sumatriptan, lidocaine (intranasal, 8% spray on the oral mucosa or intravenous), buprenorphine (ganglionic local opioid analgesia), and oral Nav1.7, a selective sodium channel blocker. Results: Meta-analyses showed that overall patients receiving lidocaine reported a significantly lower post-treatment intensity of pain -3.8 points on a 0-10 scale (95% Cl = -4.653 to -2.873; P < 0.001). Patients who received lidocaine were 8.62 times more likely to have pain improvement than patients on placebo (P < 0.001). In one RCT, patients receiving oral carbamazepine showed a significant improvement in pain intensity of -32% compared to the placebo (P < 0.001). In one trial, patients receiving 3 mg subcutaneous sumatriptan had a significantly lower intensity of pain on average -6.1 points on a scale of 0-10 compared to placebo (P < 0.001) and a significant improvement in pain intensity of -75% compared to the improvement in the placebo group (P < 0.001). Patients who received subcutaneous sumatriptan were 10 times more likely to have pain improvement than those who received placebo (P = 0.001) in one study. Due to the unclear/high risk of bias and small sample size, the quality of the evidence for lidocaine in the treatment of TN was low. Conclusion: Further studies are needed for carbamazepine, sumatriptan, buprenorphine, and oral Nav1.7 sodium channel blockers, as only one study reported outcomes.

• Nutrition Research and Practice
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• v.14 no.2
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• pp.117-126
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• 2020

BACKGROUND/OBJECTIVES: Vitamin D and zinc are recognized for their roles in immune-modulation, and their deficiencies are suggested to be important risk factors for childhood infections. This study, therefore, undertook to assess the occurrence of infections in rural Indian schoolchildren, subsequent to daily supplementation with vitamin D-calcium or zinc for 6 months. SUBJECTS/METHODS: This was a randomized, double-blind, placebo-controlled trial in apparently healthy 6-12 year-old rural Indian children, recruited to 3 study arms: vitamin D arm (1,000 IU D3 - 500 mg calcium, n = 135), zinc arm (10 mg, n = 150) and placebo arm (n = 150). The infection status was assessed using a validated questionnaire, and the biochemical parameters of serum 25(OH)D and serum zinc were measured by ELISA and colorimetry, respectively. The primary outcome variable was occurrence of infections (upper respiratory and total infections). RESULTS: Serum 25(OH)D concentration in the vitamin D arm improved significantly by 34%, from 59.7 ± 10.9 nmol/L to 80 ± 23.3 nmol/L (P < 0.0001), but no improvement was observed for serum zinc concentration. While there was significant increase in the percentage of children reporting no or mild upper respiratory tract infections (URTI) and total infections (TI) in all three groups, improvements in the supplemented groups were similar to the placebo group. However, the vitamin D arm reported lower URTI and TI status in the vitamin D sufficient versus insufficient children. Also, URTI and TI status were found to be significantly (P < 0.0001) lower in children with improved 25(OH)D versus unchanged 25(OH)D. CONCLUSIONS: Vitamin D-calcium supplementation helped to improve the vitamin D status but exerts no effect on the occurrence of infections when compared to the placebo group. Improvement in the serum 25(OH)D concentrations and attainment of vitamin D sufficiency may exert a beneficial effect on the infection status and needs to be investigated further. To evaluate the efficacy of zinc supplementation, higher dosages need to be administered in future studies.

• Journal of Food Hygiene and Safety
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• v.37 no.3
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• pp.198-205
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• 2022

Hepatic diseases are divided into two types: alcoholic and non-alcoholic. Non-alcoholic liver injury finally induces fatty liver and damages liver function. Many studies have demonstrated that Ecklonia stolonifera has antioxidative, anti-inflammatory, and hepatoprotective activities. We conducted a 12-week double-blind, placebo-controlled, randomized trial to examine the efficacy of E. stolonifera extracts (ESE) on biochemical markers of hepatic function. Sixty-five subjects with mild or moderate liver injuries were randomly allocated to receive either 420 mg/d of ESE or a placebo for 12 weeks. Fifty-five participants completed the trial. No significant adverse events were observed among the subjects during the study. The primary end points were changes in plasma levels of aspartate transaminase (AST), alanine transaminase (ALT), and γ-glutamyltransferase (γ-GT). The secondary end points were changes in lipid profile levels, including total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL). Compared with the baseline, AST and ALT levels decreased significantly in the ESE group compared to those in the placebo group (P<0.001). In addition, γ-GT levels in the ESE group were significantly lower than those in the placebo group (P=0.016). There were no differences in the TC, TG, HDL, and LDL levels between groups. In conclusion, ESE consumption for 12 weeks improved liver parameters in subjects with liver injury. Regular consumption of ESE could maintain liver health in individuals at risk of hepatic damage.

• Biomedical Science Letters
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• v.16 no.1
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• pp.53-64
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• 2010

A randomized, double blind, placebo-controlled human intervention study involving 58 menopause women was performed to investigate the effect of pomegranate extracts on menopausal symptoms. The volunteers were randomly distributed into two groups, one taking pomegranate extracts (1.5 g/day) and the other being a placebo by taking oral administration for 8 weeks. The results from this study showed that duration of hot flush and sweating were significantly decreased by taking pomegranate extracts. In addition, menopausal rating scales and the Kuppermann index were significantly decreased in pomegranate extract taking group. This result suggests a possibility that pomegranate extracts can be helpful for menopause women.

• The Journal of Korean Medicine
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• v.28 no.1 s.69
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• pp.11-24
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• 2007

Objectives : Hemiplegic shoulder pain is one of the common sequelae of stroke. Although many different methods of treatment are applied, none have yet been proved to be effective. In this study we assessed the effectiveness of bee venom in patients with shoulder pain after stroke. Methods : This study was a double blinded, randomized, placebo-controlled clinical trial. All subjects received either 0.6 ml bee venom injection (venom:saline = 1:10000) or 0.6ml physiological saline solution (placebo) at three acupoints. The effectiveness was assessed by visual analogue scale, pain rating score, Fugl-Meyer assessment and passive external rotation. Results : There were 24 patients in the venom group and 22 patients in the placebo group. The venom group5,hewed more effectiveness in VAS and PRS than the placebo group. Conclusions : This study suggests that bee venom injection has significant analgesic effect on hemiplegic shoulder pain. Further study based on multi-centers, larger population, and long term 1311ow-up is needed to confirm this suggestion.

• Journal of Oriental Neuropsychiatry
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• v.21 no.3
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• pp.29-44
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• 2010

Objectives : The purpose of this research is to examine the efficacy of Gamisoyosan on anxiety of generalized anxiety disorder according to dosage form. Methods : In this randomized, double blinded, placebo-controlled study, we planned to give Gamisoyosan simple extract mixture or Gamisoyosan compound extract or controlled medication for major symptoms of generalized anxiety disorder. As preparatory research, Hamilton rating Scale for Anxiety(HAM-A) was measured as the 1st evaluative instrument, and Korean State-Trait Anxiety Inventory(STAI-K), Penn State Worry Questionnaire(PSWQ) Korean Beck's Depression Inventory (BDI-K), Symptom Checklist-90-Revised(SCL-90R), WHO Quality of Life Abbreviated(WHOQOL-BREF) and Heart Rate Variability(HRV) were also measured as the 2nd evaluative instrument at the before treatment. Results : Demographic characteristics showed that there are Clinical characteristics-vital signs are within the normal range. The characteristics of disease-chief complaint, pattern Identification and etiological factor of the highest frequency number were worry, heart deficiency with timidity(心膽虛怯), family matters. The average period of disease in subjects is 6.31years. The results of Chest PA, EKG and clinicopathologic examination are within the reference range. The Scores of HAM-A, STAI-K, PSWQ were measured above the cutoff point. There are significant positive correlations among HAM-A, STAI-K, BDI-K and among HAM-A, STAI-K, PSWQ. There are no significant correlations between PSWQ and BDI-K. Conclusions : We considered that selection of subjects in this research is appropriately accomplished And this methodology is expected to be applied to the subsequent research. And also, we hope to make up for this study through various study and discussion.