• Title/Summary/Keyword: Placebo Effect Analysis

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Effect of Ecklonia cava Extracts Supplementation on cognitive ability in mice (감태(甘苔)에서 추출한 Dieckol 성분이 쥐의 인지능력에 미치는 영향)

  • Oh, Jae-Keun;Song, Ki-Jae;Ji, Mu-Yeop;Yoon, Jin-Ho
    • The Korea Journal of Herbology
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    • v.29 no.6
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    • pp.103-109
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    • 2014
  • Objectives : The purpose of this study aimed to investigate that dieckol - isolated from Ecklonia cava - supplementation can improve cognitive ability in mice. Methods : 48-male mice(6 weeks old) were divided into four groups; High-Dieckol group(n=12), Low-Dieckol group(n=12), Placebo group(n=12), Control group(n=12) and they were administered orally 5 days per week for 4 weeks at the same time. We performed Morris water maze test, Passive avoidance test, Blood serotonin analysis. And there was examined on neurogenesis in dentate gyrus of hippocampus using 5-bromo-2'-deoxyuridine (BrdU) to label proliferating cells. Results : The results are as follows; As a Morris water maze results, Trial duration was significantly decreased in high dieckol group comparing to placebo group and control group. Distance to target was significantly decreased in high dieckol group and low dieckol group comparing to placebo group and control group. Mean speed was significantly low in high dieckol group comparing to low dieckol group, placebo group and control group. As a Passive avoidance test results, latency time was significantly long in high dieckol group comparing to low dieckol group, placebo group and control group. BrdU cell count was significantly high in high dieckol group comparing to low dieckol group, placebo group and control group. Conclusions : As a conclusion, it is considered that dieckol supplementation might improve learning and cognitive ability.

Hematologic and Serological Investigation of Effect on Gyeongokgo in Healthy Individuals : a Randomized, Subject-assessor-blind, Placebo-controlled, Single-center Pilot Study

  • Sunwoo, Yun-Young;Kim, Hye Jung;Kim, Ja Young;Yang, Na Rae;Lee, Jin Hyun;Park, Tae Yong
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.33 no.4
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    • pp.239-248
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    • 2019
  • There are no published data on Gyeongokgo (GOK) safety or efficacy despite being commonly use. The Gyeongokgo (GOK) is commonly used in traditional Korean medicine to promote a health qi and blood, but their objective data was not sufficient in clinical field. To investigate the safety and efficacy of GOK with hematologic and serologic testing and the change of the quality of life in healthy individuals. Randomized, subject-assessor-blind, placebo-controlled, single-center pilot study Participants and Interventions 29 healthy volunteer subjects were randomly placed into the GOK group (n = 20) or placebo control group (n = 9) and instructed to take one treatment packet (GOK or placebo) twice daily for 4 weeks. Subjects were assessed using the Fatigue Severity Scale (FSS) and Short Form 36 Health Survey (SF-36) and underwent hematologic and serologic tests and body composition analysis. The FSS total score (p = 0.093) and SF-36 general health index (p = 0.002) were improved following treatment in the GOK group. Post-treatment thyroid-stimulating hormone levels were increased in the GOK group compared with pre-treatment levels (p = 0.0042). C-reactive protein levels decreased (p = 0.0256) in the GOK group compared with that the placebo group. In time-series tests, GOK did not affect post-prandial serum triglycerides, glucose, insulin, or C-peptide levels. Notably, elevations in serum fasting triglycerides at 2- (p = 0.0333) and 4-hours (p = 0.0414) post-prandial were lower than those in the placebo group. GOK reduced fatigue levels and did not significantly affect laboratory test results performed to measure safety, serum glucose, and lipid profiles. Post-meal triglyceride levels were effectively reduced with treatment.

Efficacy of medications in adult patients with trigeminal neuralgia compared to placebo intervention: a systematic review with meta-analyses

  • Peterson-Houle, Georgia M.;AbdelFattah, Magda R.;Padilla, Mariela;Enciso, Reyes
    • 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.

Effects of GV1001 on Language Dysfunction in Patients With Moderate-to-Severe Alzheimer's Disease: Post Hoc Analysis of Severe Impairment Battery Subscales

  • Hyuk Sung Kwon;Seong-Ho Koh;Seong Hye Choi;Jee Hyang Jeong;Hae Ri Na;Chan Nyoung Lee;YoungSoon Yang;Ae Young Lee;Jae-Hong Lee;Kyung Won Park;Hyun Jeong Han;Byeong C. Kim;Jinse Park;Jee-Young Lee;Kyu-Yong Lee;Sangjae Kim
    • Dementia and Neurocognitive Disorders
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    • v.22 no.3
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    • pp.100-108
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    • 2023
  • Background and Purpose: The efficacy and safety of GV1001 have been demonstrated in patients with moderate-to-severe Alzheimer's disease (AD). In this study, we aimed to further demonstrate the effectiveness of GV1001 using subscales of the Severe Impairment Battery (SIB), which is a validated measure to assess cognitive function in patients with moderate-to-severe AD. Methods: We performed a post hoc analysis of data from a 6 month, multicenter, phase 2, randomized, double-blind, placebo-controlled trial with GV1001 (ClinicalTrials.gov, NCT03184467). Patients were randomized to receive either GV1001 or a placebo for 24 weeks. In the current study, nine subscales of SIB-social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction, and orientation to name-were compared between the treatment (GV1001 1.12 mg) and placebo groups at weeks 12 and 24. The safety endpoints for these patients were also determined based on adverse events. Results: In addition to the considerable beneficial effect of GV1001 on the SIB total score, GV1001 1.12 mg showed the most significant effect on language function at 24 weeks compared to placebo in both the full analysis set (FAS) and per-protocol set (PPS) (p=0.017 and p=0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups. Conclusions: Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.

Effect of Saengmaeg-san Extract on Xerostomia in Stroke Patients : A Double-Blind Randomized Controlled Study (중풍환자의 구강건조증에 대한 생맥산의 효과 : 무작위배정 이중맹검 연구)

  • Lee, Dae-Hyun;Han, Hyun-Jin;Kim, Lak-Hyung;Kang, Sei-Young;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.32 no.4
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    • pp.542-549
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    • 2011
  • Objectives : The present study was made to evaluate the clinical effectiveness of Saengmaeg-san (生脈散) extract to treat xerostomia in stroke patients. Methods : The study design was a double-blind randomized controlled trial. Subjects were stroke patients with xerostomia. They were allocated to either the Saengmaeg-san (n=12) or placebo group (n=12). Saengmaeg-san extract or a placebo in similar opaque capsules was given three times a day for a week. The improvement of xerostomia was measured by the xerostomia-evaluating questionnaire, developed by the school of dentistry in Seoul National University, before baseline and one week later. Eleven of the Saengmaeg-san group and ten of the placebo group finished the trial and were analyzed. Paired samples t-test and Mann-Whitney test were applied to statistical analysis. Results : On three of the six questions, the Saengmaeg-san group improved significantly. On two of the six questions, the Saengmaeg-san group improved significantly more than the placebo group. On the other questions, the Saengmaeg-san group improved more than the placebo group, although significance was not reached. Conclusions : These results demonstrate that Saengmaeg-san extract is effective for treating xerostomia in stroke patients, and further studies should be conducted to provide more valuable information.

Effects of leucine-enriched essential amino acid supplementation on muscular fatigue and inflammatory cytokines in wheelchair basketball players

  • An, Young Hwan;Kim, Jisu;Kim, Hee-Jae;Lim, Kiwon
    • Korean Journal of Exercise Nutrition
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    • v.24 no.2
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    • pp.38-46
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    • 2020
  • [Purpose] This study aimed to investigate the effects of leucine-enriched essential amino acid (LEAA) supplementation on muscle fatigue and the level of inflammatory cytokines in wheelchair basketball players after a basketball game and interval training. [Methods] Of the ten recruited wheelchair basketball players (aged 34.5±8.9 years; lean body mass of 34.3±10.0 kg) who had spinal cord injury (SCI) and had undergone amputation, nine participated in the final test. These nine athletes received LEAA supplements (3 times 4.0 g/day) or placebo treatment in a double-blind, randomized, crossover study. We measured variables related to muscular fatigue and inflammatory response before the intense exercise and 4 days after recovery. [Results] The significant effect of LEAA supplementation was inhibition of circulating IL-6 levels in the LEAA-treated group compared with the placebo group (P < .05). However, no changes were observed in the TNF-α and creatinine kinase levels. Moreover, analysis of variance analysis showed no significant difference in the relative values of muscle soreness. However, the effect size analysis with Cohen's d reported a significant improvement in the relative values of whole body and back muscle soreness. [Conclusion] Our results revealed that LEAA supplementation before and after intense exercise could help reduce muscle soreness and IL-6 levels in wheelchair basketball players.

The Clinical Effect of Oxiracetam in Patients with Organic Brain Syndrome-Double Blind, Placebo-Controlled Study (기질성 뇌증후군에서 Oxiracetam의 임상적 효과에 대한 이중맹검 대조연구)

  • 이병철;권기한;권기한;송홍기;김성민;유경호;이현미;강경수;윤여훈
    • 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.

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Korean Red Ginseng Improves Vascular Stiffness in Patients with Coronary Artery Disease

  • Chung, Ick-Mo;Lim, Joo-Weon;Pyun, Wook-Bum;Kim, Hye-Young
    • Journal of Ginseng Research
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    • v.34 no.3
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    • pp.212-218
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    • 2010
  • Korean red ginseng (KRG) has been shown to enhance endothelium-dependent vasorelaxation in experimental animals; however, little is known about its pharmacological effects on vascular stiffness in patients with coronary artery disease (CAD). This randomized, double-blind, placebo-controlled crossover trial was carried out to determine whether KRG has beneficial effects on arterial stiffness, cardiovascular risk factors such as plasma lipid profiles and blood pressure (BP), and Rho-associated kinase (ROCK) activity. Twenty patients (mean age, 62.5 years) with stable angina pectoris were given KRG (2.7 g/day) and a placebo alternatively for 10 weeks. Blood biochemical analysis and pulse wave velocity (PWV) recording were performed on day 0 and after the completion of each treatment. ROCK activity was assessed based on the level of phospho-$Thr^{853}$ in the myosin-binding subunit of myosin light chain phosphatase, determined by Western blot analysis of peripheral blood mononuclear cells. KRG significantly decreased the systolic BP, brachial ankle PWV, and heart femoral PWV in the patients (all p<0.05), but did not significantly alter the serum lipid profiles, including triglycerides and total, high-density lipoprotein, and low-density lipoprotein cholesterol levels. The ROCK activity tended to decrease (p=0.068) following KRG treatment. The placebo did not significantly alter any of the variables. In conclusion, KRG decreased systolic BP and arterial stiffness, probably via the inhibition of ROCK activity, in patients with CAD, but had a neutral effect on serum lipid profiles. Our data suggest that KRG has a therapeutic effect on CAD.

Efficacy and safety of low-dose naltrexone for the management of fibromyalgia: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis

  • Akhil Deepak Vatvani;Pratik Patel;Timotius Ivan Hariyanto;Theo Audi Yanto
    • The Korean Journal of Pain
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    • v.37 no.4
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    • pp.367-378
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    • 2024
  • Background: Fibromyalgia is characterized by the presence of chronic widespread pain that may impair patient's quality of life. Currently, the use of naltrexone as a therapeutic agent for fibromyalgia is not supported by enough evidence, especially from randomized controlled trials (RCTs). This study aims to analyze the efficacy and safety of low-dose naltrexone (LDN) for the management of fibromyalgia. Methods: A comprehensive search was conducted on the Scopus, Medline, ClinicalTrials.gov, and Cochrane Library databases up until May 20th, 2024. This review incorporates RCTs that examine the comparison between LDN and placebo in fibromyalgia patients. We employed random-effect models to analyze the odds ratio and mean difference (MD) for presentation of the outcomes. Results: A total of 4 RCTs with 222 fibromyalgia patients were incorporated. The results of our meta-analysis showed a significant reduction in pain scores (MD: -0.86, 95% confidence interval [CI]: -1.20, -0.51, P < 0.001, I2 = 33%) and higher increment in pressure pain threshold (MD: 0.17, 95% CI: 0.08, 0.25, P < 0.001, I2 = 0%) among fibromyalgia patients who received LDN than those who only received a placebo. The fibromyalgia impact questionnaire revised and pain catastrophizing scale did not differ significantly between the two groups. LDN was also associated with higher incidence of vivid dreams and nausea, but showed no significant difference with the placebo in terms of serious adverse events, headache, diarrhea, and dizziness. Conclusions: This study suggests the efficacy of LDN in mitigating pain symptoms for fibromyalgia patients with a relatively good safety profile.

The Economic Impact of the May 18 Democratic Uprising on the Regional Economy: A Synthetic Control Method (SCM) approach (5·18민주화운동이 지역경제에 미친 경제적 영향 분석: 통제집단합성법(SCM)을 이용한 접근)

  • Ryu, Deockhyun;Seo, Dongkyu
    • Analyses & Alternatives
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    • v.6 no.2
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    • pp.155-183
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    • 2022
  • The purpose of this study is to econometrically analyze the negative impact of the May 18 Democratic Uprising on the Gwangju/Jeonnam regionional economy using the Synthetic Control Method (SCM). The SCM SCM is a methodology similar to the difference-in-difference(DID) method of microeconometrics. It is applied to macroeconomic variables such as country, region, etc. to estimate the causal relationship between specific events and the dependent variable. In this study, as of 1980, local tax revenue data of metropolitan local governments were used as a proxy variable for the economy of the region, and the impact of the May 18 Democratic Uprising on the economy of Gwangju/Jeonnam region was analyzed through various socio-economic indicators. In this study, data were used to analyze from 1971 to 2000, and as a result of empirical analysis, local tax revenues in Gwangju/Jeonnam area were less collected than normal routes up to 17%. In addition, the significance of this analysis was confirmed through in-time placebo effect analysis and in-space placebo effect analysis, which are methods of analyzing the robustness of the control group synthesis method.