• Title/Summary/Keyword: Double-blinded

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The Effect of Low, High Frequency Electroacupuncture on Functional Dyspepsia: A Randomized, Double Blinded, Two Arm Trial (기능성 소화불량증에 대한 저빈도, 고빈도 전침의 효능 비교 연구: 무작위배정, 이중맹검(피험자, 평가자), 평행군 설계)

  • Yeo, In Ho;Lee, Eun Yong;Lee, Cham Kyul
    • Journal of Acupuncture Research
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    • v.31 no.3
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    • pp.19-24
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    • 2014
  • Objectives : The purpose of this study is to investigate the efficacy of the electroacupuncture with different frequency on functional dyspepsia. Methods : We observed 30 functional dyspepsia patients from May, 2013 to June, 2014. This study was randomized and double blinded. The patients were divided into two groups. One group(group A) was treated with 3 Hz electroacupuncture and the other group(group B) was treated with 300 Hz electroacupuncture. We evaluated the treatment effect of each group by using visual analogue scale(VAS) and pressure algometer. Results : 1. Functional dyspepsia was significantly improved in group treated with 3 Hz electroacupuncture. 2. Functional dyspepsia was significantly improved in group treated with 300 Hz electroacupuncture. 3. As a result of evaluation there were no statistical significance between two groups. Conclusion : Both 3 Hz and 300 Hz electroacupuncture has significant effect on functional dyspepsia. But there is no significant difference between 3 Hz and 300 Hz electroacupuncture.

Adjuvant Sertraline Treatment for Chronic Schizophrenia : A Randomized, Double Blind, Placebo-Controlled Study (만성 정신분열증환자에 대한 Sertraline병합치료 효과)

  • Lee, Min-Soo;Kim, Yong-Ku;Lee, Sang-Kyu;Suh, Kwang-Yoon
    • Korean Journal of Biological Psychiatry
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    • v.4 no.1
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    • pp.127-131
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    • 1997
  • Objective : To evaluate the clinical efficacy of adjuvant sertraline treatment in chronic schizophrenic patients, we carried out a double-blind, placebo controlled study. Method : Thirty six inpatients who fulfilled DSM-III-R criteria for chronic schizophrenia were randomly assigned to sertraline and placebo groups in a double-blinded fashion. A history of at least 2 years of illness and at least six months of hospitalization were prerequisities for inclusion in the study. Patients were received sertraline 50mg or placebo for 8 weeks in addition to their routine haloperidol regimen. Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression(CGI), Simpson-Angus Scale(S-A) were evaluated at 5 points ; baseline, 2, 4, 6, and 8 weeks of treatment. Results : The groups were controlled for age, gender, and length of illness. There were no significant differences in three PANSS factros(positive, negative, general), CGI, and S-A scale scores at any between sertaline and placebo treatment. Conclusion : This placebo controlled study showed no significant effects of sertraline on negative and positive symptoms in chronic schizophrenic patients.

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Cardio-Pulmonary Effects of RF Fields Emitted from WCDMA Mobile Phones (WCDMA 휴대전화 전자파에 의한 심호흡계 영향)

  • Kwon, M.K.;Choi, J.L.;Choi, J.Y.;Jang, K.H.;Kim, S.K.;Kim, D.W.
    • Journal of Biomedical Engineering Research
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    • v.33 no.2
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    • pp.59-64
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    • 2012
  • With rapid increasing usage of smart phones, social concerns have arisen about the possible effects of electromagnetic fields emitted from wideband code division multiple access(WCDMA) mobile phones on human health. The number of people with self-reported electromagnetic hypersensitivity(EHS) who complain of various subjective symptoms such as headache, insomnia etc. has also recently increased. However, it is unclear whether EHS results from physiological or other origins. In this double-blinded study, we investigated physiological changes such as heart rate, respiration rate, and heart rate variability with real and sham exposures for 15 EHS and 17 non-EHS persons using a module inside a dummy phone. Experiment was conducted using a WCDMA module with average power of 24 dBm at 1950 MHz with the specific absorption rate of 1.57 W/kg using a headphone for 32 min. As a conclusion, WCDMA RF exposure did not have any effects on the physiological variables in either group.

Study of Efficacy and Safety of Tianwangbuxin-dan for Poststroke Depression: A Randomized, Double Blinded, Non-inferiority Trial (뇌졸중 후 우울증에 대한 천왕보심단의 유효성 및 안전성 연구 : 무작위 배정, 이중맹검, 비열등성 연구)

  • Lee, Il-Suk;Kim, Mun-Soo;Lee, Sang-Kwan
    • The Journal of Internal Korean Medicine
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    • v.35 no.2
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    • pp.145-156
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    • 2014
  • Objectives : The aim of this study was to compare Tianwangbuxin-dan to Fluoxetine for antidepressive efficacy and safety in poststroke depression (PSD). Methods : A randomized, double blinded, non-inferiority trial was conducted. 113 PSD patients were recruited from a stroke center. Except for the 25 excluded patients, 88 PSD patients were randomly given either Tianwangbuxin-dan 1100 mg or Fluoxetine 20 mg per a day for 16 weeks. PSD was evaluated using Beck's depression inventory (BDI) and Hamilton depression rating scale (HDRS) and followed every fourth week. Repeated measure analysis of variance (ANOVA) was used to compare and contrast the depression scores of the two groups and to compare them among the evaluation times, at the beginning, $4^{th}$, $8^{th}$, $12^{th}$ and $16^{th}$ weeks. In addition, independent t-tests were used to find the difference between two groups at every evaluation time. Results : Finally, 88 PSD patients were included in the study, 63 PSD patients completed the procedure and 25 PSD patients were dropped out by the incompliance or withdrawal of consent. Tianwangbuxin-dan (or Fluoxetine) improved the depression of stroke patients and the efficacy of Tianwangbuxin-dan was not inferior to that of Fluoxetine. In addition, there was no significant side effect in two groups. Conclusions : This study showed that antidepressive efficacy and safety of Tianwangbuxin-dan in PSD patients.

Study of Efficacy and Safety of Ginseng Seed Oil in Heathy Subjects Who Have Mild Liver Dysfunction : A Randomized, Double Blinded, Placebo-Controlled Study (경증의 간 기능 이상 소견을 보이는 건강한 성인에 대한 인삼종자오일의 유효성 및 안전성 연구 : 무작위배정, 이중눈가림, 위약대조 연구)

  • Kim, Young-Ji;Kwon, Jung-Yeon;Go, Ho-Yeon;Lee, Dong-Nyung;Ko, Sung-Kwon;Kong, Kyung-Hwan
    • The Journal of Korean Medicine
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    • v.39 no.2
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    • pp.36-55
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    • 2018
  • Objectives: The purpose of this study was to investigate the effectiveness and safety of ginseng seed oil in healthy subjects who have mild liver dysfunction. Methods: A randomized, double blinded, placebo-controlled trial was conducted. A total of 167 subjects visited Semyung University Hospital from July 1st, 2016 to June 10th 2017. Except for the 103 excluded subjects, 64 subjects were randomized into one of the two groups: an treatment group(n=33) and control group(n=31). Subjects were randomly given either ginseng oil seed capsules or indistinguishable placebo capsules(2 capsules per dose, twice per day). Laboratory tests(aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transpeptidase, triglyceride, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein-cholesterol) were performed to evaluate the effectiveness after 6, 12 weeks of treatment. Vital sign, laboratory test were performed to assess safety at every visit. Results: There were no significant differences in efficacy between treatment group and control group. There were some adverse events with no significant difference in symptoms and frequency between treatment group and control group. Conclusions: Although the efficacy of ginseng seed oil was not proved, ginseng seed oil did not worsen liver function and proved its safety. More study of ginseng seed oil and clinical trials are necessary to increase the usefulness of above-ground parts of ginseng.

Effects of vitamin D supplementation on metabolic indices and hs-CRP levels in gestational diabetes mellitus patients: a randomized, double-blinded, placebo-controlled clinical trial

  • Yazdchi, Roya;Gargari, Bahram Pourghassem;Asghari-Jafarabadi, Mohammad;Sahhaf, Farnaz
    • Nutrition Research and Practice
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    • v.10 no.3
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    • pp.328-335
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    • 2016
  • BACKGROUND/OBJECTIVES: Vitamin D plays an important role in the etiology of gestational diabetes mellitus (GDM). This study evaluated the effect of vitamin D supplementation on metabolic indices and hs-C-reactive protein (CRP) levels in GDM patients. SUBJECTS/METHODS: The study was a randomized, placebo-controlled, double-blinded clinical trial. Seventy-six pregnant women with GDM and gestational age between 24-28 weeks were assigned to receive four oral treatments consisting of 50,000 IU of vitamin $D_3$ (n = 38) or placebo (n = 38) once every 2 weeks for 2 months. Fasting blood glucose (FG), insulin, HbA1c, 25-hydroxyvitamin D, lipid profile, hs-CRP, and homeostasis model assessment-insulin resistance (HOMA-IR) were measured before and after treatment. Independent and paired t-tests were used to determine intra- and intergroup differences, respectively. ANCOVA was used to assess the effects of vitamin D supplementation on biochemical parameters. RESULTS: Compared with the placebo group, in the vitamin D group, the serum level of 25-hydroxyvitamin D increased (19.15 vs. -0.40 ng/ml; P < 0.01) and that of FG (-4.72 vs. 5.27 mg/dl; P = 0.01) as well as HbA1c (-0.18% vs. 0.17%; P = 0.02) decreased. Improvements in the lipid profiles were observed in the vitamin D group, but without statistical significance. Significant increases in concentrations of hs-CRP, FG, HbA1c, total cholesterol, and LDL cholesterol were observed in the placebo group. No significant change in fasting insulin and HOMA-IR was observed in either group. CONCLUSIONS: In GDM patients, vitamin D supplementation improved FG and HbA1c but had no significant effects on lipid profile or hs-CRP.

Interim Report about The Comparative Clinical Study of Efficacy of Gamisoyo-san(Jiaweixiaoyaosan) on Anxiety of Generalized Anxiety disorder (범불안장애의 불안증상에 대한 가미소요산의 제형별 효능 비교 임상연구의 중간보고)

  • Lim, Jung-Hwa;Seo, Bok-Nam;Lee, Sang-Ryong;Jung, In-Chul
    • 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.

Effect of Sihogayonggolmoryeo-Tang on Hwa-byung: A Multicenter, Randomized, Double-Blinded, Placebo-Control Trial

  • Choi, Woo-Chang;Lee, Hun-Soo;Kim, Ju-Yeon;Kang, Wee-Chang;Park, Yang-Chun;Kim, Geun-Woo;Kim, Jong-Woo;Jung, In Chul
    • Journal of Oriental Neuropsychiatry
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    • v.31 no.3
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    • pp.135-147
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    • 2020
  • Objectives: Hwa-byung is a mental illness. It is also known as a Korean culture-related syndrome. In traditional Korean medicine, Sihogayonggolmoryeo-tang is used to treat Hwa-byung related neuropsychiatric symptoms. The purpose of this research was to examine the effect of Sihogayonggolmoryeo-tang on Hwa-byung. Methods: A multicenter, randomized, double-blinded, placebo-controlled study was performed for 160 patients with Hwa-byung. Patients were divided into a Sihogayonggolmoryeo-tang group and a placebo group. Treatment period was 8 weeks. Hamilton Rating Scale for Anxiety (HAM-A), Likert scale for major symptoms of Hwa-byung, Hwa-byung Scale (HBS), Korean Beck Depression Inventory (K-BDI), Korean State-Trait Anxiety Inventory (K-STAI), Korean State-Trait Anger Expression Inventory (K-STAXI), and Korean WHO Quality of Life Scale Abbreviated Version (WHOQOL-BREF) were used to evaluate the effect of Sihogayonggolmoryeo-tang on Hwa-byung. We also used an Instrument of Pattern Identification for Hwa-Byung to evaluate different responses for six patterns of patients. Results: Scores of all the measurements improved significantly for each group, showing no significant differences between the two groups. In the case of deficiency of both Qi and blood pattern, the Sihogayonggolmoryeo-tang group showed a significant decrease in the HAM-A score compared to the placebo group. Conclusions: The effect of Sihogayonggolmoryeo-tang on Hwa-byung did not exceed that of the placebo. Further studies involving more elaborate pattern identification are needed.

Glycemic index of dietary formula may not be predictive of postprandial endothelial inflammation: a double-blinded, randomized, crossover study in non-diabetic subjects

  • Lee, Eun Ju;Kim, Ji Yeon;Kim, Do Ram;Kim, Kyoung Soo;Kim, Mi Kyung;Kwon, Oran
    • Nutrition Research and Practice
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    • v.7 no.4
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    • pp.302-308
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    • 2013
  • The emerging role of endothelial inflammation in diabetes has stimulated research interest in the effects of nutrition on related indices. In the current study we investigated whether the nutrient composition of dietary formula as reflected in glycemic index (GI) may be predictive of postprandial endothelial inflammation in non-diabetic subjects. A double-blinded, randomized, crossover study was conducted in non-diabetic subjects (n = 8/group). Each subject consumed three types of diabetes-specific dietary formulas (high-fiber formula [FF], high-monounsaturated fatty acid (MUFA) formula [MF] and control formula [CF]) standardized to 50 g of available carbohydrates with a 1-week interval between each. The mean glycemic index (GI) was calculated and 3-hour postprandial responses of insulin, soluble intercellular adhesion molecule-1 (sICAM-1), nitrotyrosine (NT) and free fatty acids (FFA) were measured. The MF showed the lowest mean GI and significantly low area under the curve (AUC) for insulin (P = 0.038), but significantly high AUCs for sICAM-1 (P<0.001) and FFA (P < 0.001) as compared to the CF and FF. The FF showed intermediate mean GI, but significantly low AUC for NT (P<0.001) as compared to the CF and MF. The mean GI was not positively correlated to any of the inflammatory markers evaluated, and in fact negatively correlated to changes in FFA (r = -0.473, P = 0.006). While the MF with the lowest GI showed the highest values in most of the inflammatory markers measured, the FF with intermediate GI had a modest beneficial effect on endothelial inflammation. These results suggest that nutrient composition of dietary formula as reflected in the GI may differently influence acute postprandial inflammation in non-diabetic subjects.

Effect of Foeniculum Vulgare (Fennel) on Sleep Quality of Menopausal Women: A Double-blinded, Randomized Placebo-controlled Trial

  • Afiat, Maliheh;Dizavandi, Fatemeh Rajab;Kargarfard, Leila;Vahed, Seyede Houra mosavi;Ghazanfarpour, Masumeh
    • Journal of Menopausal Medicine
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    • v.24 no.3
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    • pp.204-209
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    • 2018
  • Objectives: Aim of present study was designed to investigate the soporific effect of fennel among menopausal women. Methods: The present double-blinded and placebo-controlled trial examined the fennel effect on Pittsburgh Sleep Quality Index (PSQI). Total score and relevant 7 components, including sleep duration, sleep latency, use of sleeping medication, subjective sleep quality, sleep disturbances, daytime dysfunction and habitual sleep efficiency among 50 menopausal women compared to control group within a 12-week follow-up. Results: The patients in both groups reported no certain side effects and all subjects completed the study. The mean actual sleep duration was 5 hours and 66 minutes. Intergroup comparison revealed no statistically significant differences in the mean total PSQI score (P = 0.439), subjective sleep quality (P = 0.826), habitual sleep efficiency (P = 0.127), sleep disturbances (P = 0.130), use of sleeping medication (P = 0.52) and daytime dysfunction (P = 0.439). A tendency toward significant between 2 groups was seen concerning the sleep duration (P = 0.059). Intergroup comparison showed significantly borderline levels (P = 0.059). Conclusions: The treatment of 12 weeks with fennel caused a slight effect that did not reach to significant. These findings should be considered cautiously because of small sample size, short-term follow-up and subjective measure of sleep quality.