• Title/Summary/Keyword: independent trial

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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.

Management of Neuropathic Pain (신경병성 통증의 치료)

  • Kim, Yeong-In
    • Korean Journal of Psychosomatic Medicine
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    • v.7 no.2
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    • pp.274-280
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    • 1999
  • A variety of mechanism may generate pain resulting from injury to the central and peripheral nervous system. None of these mechanism is disease-specific, and several different pain mechanism may be simultaneously present in anyone patient, independent of diagnosis. Diagnosis of neuropathic pain is often easily made from information gathered on neurologic examination and from patient history. Although treatment of neuropathic pain may be difficult, optimum treatment can be achieved if the neurologist has a complete understanding of therapeutic options, the mainstay of which is pharmacotherapy. Selection of an appropriate rharmacologic agent is by trial and error since individual responses to different agents, doses, and serum levels are highly variable. An adequate trial for each agent tried is key to pharmacologic treatment of neuropathic pain. Tricyclic antidepressants are first-line agents, although other drugs, including anticonvulsants, local anesthetic antiarrhythmics, clonidine, opiates, and certain topical agents, also offer pain relief in some patient populations. The novel antidepressants venlafaxine and nefazodone are potentially useful new drugs that are better tolerated than tricyclic antidepressants. Also Gabapentine seems an interesting and promising drug for the treatment of neuropathic pain.

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Assessing Methodological Quality of Acupuncture Clinical Trials of Korea (한국 침 임상시험의 질 평가 및 분석)

  • Park, Ji-Eun;Kang, Kyung-Won;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.24 no.1
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    • pp.127-135
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    • 2007
  • Objectives: To evaluate the methodological quality of Korean Acupuncture Clinical trials Methods : Two independent researchers reviewed 12 protocols of Acupuncture clinical trials which were conducted in Korea 2006. Also, Survey Principal Investigator of those was conducted. We compare the results of protocol review with investigator reponses of actual practice. Quality assessment consisted of 5 items including random sequence generation, randomization method, allocation concealment, subject blinding, assessor blinding. Results : Randomization was performed using the proper procedure to insure that treatment assignment is unbiased and concealed from subjects in all clinical trials, According to protocols, 6(50%) of 12 clinical trials used computer-generated random numbers, 6(50%) remaining trials didn't describe the randomization method. Also all trials used appropriate randomization methods on the basis of the survey results: 8 trials used computer-generated random number, 2 used random table. Of 7 protocols in which allocation concealment was stated, 5(71%) reported appropriate method (Calling a central office or statisticians, Sealed opaque envelopes). However according to survey, 5(42%) of 12 trials used inappropriate allocation concealment (Keeping a master randomization list and referring to when subject entered the trial). In addition, the result of protocol review and survey response was not coincident in 5(42%) trials. Subject blinding was conducted in all except 1 clinical trials. Although 11(92%) of 12 trials were conducted using assessor blinding in actual practice, only 7(58%) reported that in protocol. Conclusion : Although randomization and blinding were conducted adequately, allocation concealment was used inadequately, Not only appropriate allocation concealment, but also every quality assessment item including randomization, blinding should be stated in more detail in protocol.

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The winning probability in Korean series of Korean professional baseball (한국 프로야구 우승 결정방식에서의 우승확률)

  • Cho, Daehyeon
    • Journal of the Korean Data and Information Science Society
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    • v.27 no.3
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    • pp.663-676
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    • 2016
  • In Korean professional baseball the championship team of the year is determined by the four series of games: semi-semi-playoff, semi-playoff, playoff and korean series. To the top 5 teams in a regular season privileges are given to play the games at post season. At semi-semi playoff the winner of two teams which are ranked at 4th and 5th place in the regular season can advance to the game of semi playoff. The winner at semi playoff advances to the playoff to play with the second place team in the regular season. Finally, the championship team is to be determined in the Korean series between the winner of the playoff and the first ranked team in the regular season. We propose methods of how to calculate the winning probabilities of each of high ranked 5 teams advancing to Korean series. From our proposed methods we can estimate the championship probabilities of each of high ranked 5 teams advancing to the Korean series only if we know the winning probabilities between two teams in the regular season or the post season.

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.

Spin in Randomised Clinical Trial Reports of Interventions for Obesity (비만 중재 관련 무작위배정 비교임상연구 보고의 spin 연구)

  • Lee, Sle;Won, Jiyoon;Kim, Seoyeon;Park, Su Jeong;Lee, Hyangsook
    • Korean Journal of Acupuncture
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    • v.34 no.4
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    • pp.251-264
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    • 2017
  • Objectives : To identify the prevalence and types of spin in randomised controlled trials(RCTs) of obesity with statistically non-significant results for primary outcomes to provide adequate reporting directions. Methods : Spin is specific reporting strategy that could lead the readers to misinterpret the results of RCTs. RCTs on obesity with statistically non-significant primary outcomes published from July 2015 to June 2016 were retrieved from PubMed. All included RCTs were classified into 3 intervention categories. The identification and classification of spin in the included articles was performed by two independent researchers. Results : Among 46 RCTs with statistically non-significant primary outcomes, 32 studies were assessed as having at least one spin in title, abstract or main text. Of these, 9 articles were on complementary and alternative medicine, 7 on western medicine and 16 on dietary supplement and exercise. The frequency of spin among the types of interventions was similar. The most common type of spin was 'focusing on statistical significance within-group comparison' in results section of abstract and main text, and 'focusing only on treatment effectiveness with no consideration of statistical significance' in conclusion section of abstract and main text. Studies where random sequence generation was appropriately done was less likely to have spin. Conclusions : As a majority of obesity RCTs have spin, researchers should pay more attention to adequately interpreting and reporting statistically non-significant results.

The effect of otago exercise-based fall prevention education activities on balance, fall efficacy and activities of daily living in the subacute stroke patients: A randomized controlled clinical trial (오타고운동 기반 낙상예방교육활동이 아급성 뇌졸중 환자의 균형, 낙상 효능감 및 일상생활동작능력에 미치는 영향: 무작위 대조군 임상 연구)

  • Yoon, Hyun Sik;Han, Kyu Bum;Oh, Seung In;Lee, Da Bee;Song, Ha Hee;Song, Jeong Eun;Cha, Young Joo
    • Journal of Korean Physical Therapy Science
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    • v.27 no.1
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    • pp.1-8
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    • 2020
  • Background: This study analysed the effect of the fall prevention education activities on balance, fall efficacy, activities of daily living (ADL) of sub-acute stroke patients. Design: Randomized controlled trial. Methods: The subjects of the study were 24 subacute patients, who have onset period of less than 6 months. They are randomly allocated in the conventional therapy group (n=12) and fall prevention education group (n=12) and observed with frequency for 5 times a week for four weeks. Measuring took place before and after the experiment leading to following results of the Fall efficacy scale (FES), Berg balance scale (BBS) and Functional Independence Measure (FIM). Results: FES, BBS and FIM score was significantly greater in the post-test than in the pre-test in both groups (p<0.01). Independent t-test confirmed that the fall prevention education group showed much greater improvement change in the FES, BBS and FIM score than conventional therapy group (p<0.05). Conclusion: The present study demonstrated the importance of clinical contribution of the fall prevention education in the individuals with subacute stroke patients to the balance, fall efficacy and ADL following the stroke rehabilitation.

The Relationship Between Smoke-Yields and Tipping Materials of the Cigarette (담배 연기발생과 Tipping 재료와의 상관성 연구)

  • Kim, Young-Hoh;Lee, Young-Taek;Kim, Sung-Han;Kim, Chung-Ryul;Kim, Jong-Yeol;Shin, Chang-Ho;Lee, Keun-Hoi
    • Journal of the Korean Society of Tobacco Science
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    • v.20 no.1
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    • pp.131-138
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    • 1998
  • In order to minimize the trial frequency in the new filter cigarette design, we studied the relationship between smoke yield and tipping materials of cigarette. A three levels full factorial design involving filament denier (X1,2.5-3.3d), Porosity of the acetate filter plug wrap (X2, 3,500-16,000CU) and porosity of the tip paper (X3, 400-1,200CU) was used. Three independent factors (Xl, X2, X3) were chosen for their effects on the various responses and the function was expressed in terms of a quadratic polynomial equation, Y : $\beta$o + $\beta$1Xl + $\beta$2X2 + $\beta$3X3 + $\beta$11Xl2 + $\beta$22X22+ $\beta$33X32 + $\beta$12X1X2 + $\beta$13XIX3 $\beta$23X2X3 which measures the linear, quadratic, and interaction effects. Twenty-nine trial numbers were obtained as a results of using a three levels full factorial design and it was analyzed by the multiple regression analysis with backward stepwise in STATISTICA/pc under restricted conditions. Tar yields of the cigarette was affected by porosity of tip paper (0.66), filament denier (0.47) and porosity of plug wrap (0.28) in the decreasing order, and linear effect of tip paper porosity (B3) and filament denier (91) were significant at a level of 0.01($\alpha$). The filament denier and tipping paper porosity interaction F ratio among three factors had a P-value of 0,000041, indicating higher interaction between these factors. Based on the analysis of variance, the model fitted for Tar (Y1) was significant at 5% confidence level and the coefficient of determination (0.96) was the proportion of variability in the data fitted for by the model.

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Effect of Slaked Lime and Borax Application upon Yield and Yield Components of Paddy Rice (소석회 및 붕사의 시용이 수도의 수량 및 수량구성요소에 미치는 영향)

  • Cho, D.S
    • KOREAN JOURNAL OF CROP SCIENCE
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    • v.10
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    • pp.61-71
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    • 1971
  • This study was conducted in order to investigate the effects of slaked lime and borax on the Akiochi paddy field. The pot trial(slaked lime was treated 0, 6, 10, 15g and borax 0, 0.75, 1.5g per pot) and the field trial(slaked lime was treated 0, 100, 200kg and borax 0, 10, 30, 50kg per 10are) respectively. The results are summarized as fo11ows. I. Pot Trial: 1. In a heavy treated of borax, appeared chlorosis on whole leaves(bottom) in early growing stage, However, in about 25 days after transplanting, these chlorosis were disappeared gradually. And in proportion to close by maturity after the ear-heading, changed to dark brown color and rolled at the end of upper leaves, finally withered. At the same time the part of the end of grains was also colored to dark brown. 2. Slaked lime effected to increase the ti1lering, hence increased the number of ear, on the other hand, borax showed the tendency of repression the tillering, conversely. 3. Borax effected to hurried up to heading date of rice plant, to which borax had been the plot of B$_1$ to 3 days and B$_2$ to 5 days, hurried up than control respectively, regardless of the quantities of slaked lime application. 4. According to the application of borax, the length of culm were shortened, otherwise the length of panicle were longished, then no recognized the. independent effect of slaked lime. 5. The number of grains per panicle were seemed like increased by treatment of slaked lime, but the grain were decreased in the heavy treatment of slaked lime and borax. These phenomena were showed in ratio of maturity likely tendency as above. 6. In the 1, 000 grains weight of brown rice, in the case of slaked lime was almost no significant, otherwise by increase the application of borax, increased the weight of 1, 000 grains and the size of the grains was greater. 7. The weight of rough rice and straw were showed the same tendency as the number of grains and maturity ratio. particularly, showed the phenomenon of the reduction by the heavy application of borax. II. Field trial: 1. In a heavy treated of borax, appeared chlorosis in a early growing stage, according to close by maturiting date after the ear-heading changed to dark brown the end of upper leaves, finally dried. 2. Slaked lime application accelerated the growth and increased the number of ear, but borax showed the tendency of repression the tillering. 3. Borax effected to hurried up to heading date of rice plant, according to heavy treatment of borax quickened heading date for 4 to 5 days. 4. As a whole, culm length was repressed by borax treatment. 5. Borax application 10kg per 10are advanced progress the maturity, but in the case of above 30kg per 10are of borax showed the tendency obstruction the maturity. 6. The yield of rough rice and brown rice recognized the independent effect of slaked lime and borax, respectively. the yield was decreased by the abundant of borax.

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Clinical comparison of resorbable and nonresorbable Barrier in guided tissue regeneration of human intrabony defects (흡수성 차폐막을 이용한 조직유도재생술의 임상적 효과)

  • Hur, Yin-Shik;Kwon, Young-Hyuk;Lee, Man-Sup;Park, Joon-Bong;Herr, Yeek
    • Journal of Periodontal and Implant Science
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    • v.29 no.1
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    • pp.193-207
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    • 1999
  • The purpose of this study was to compare the clinical results of guided tissue regeneration(GTR) using a resorbable barrier manufactured from an copolymer of polylactic acid (PLA) and polylaetic-glycolic acid(PLGA) with those of nonresorbable ePTFE barrier. Thirty two patients(25 to 59 years old) with one radiographically evident intrabony lesion of probing depth ${\geq}$6mm participated in a 6-month controlled clinical trial. The subjects were randomly divided into three independent groups. The first group(n=8) received a ePTFE barrier. The second group (n=12) received a resorbable PLA/PLGA barrier. The third group (n=12) received a resorbable PLA/PLGA barrier combined with an alloplastic bone graft. Plaque index (PI), gingival index(GI), probing depth(PD), gingival recession, clinical attachment level(CAL), and tooth mobility were recorded prior to surgery and at 3, 6 months postsurgery, Statistical tests used to analyze these data included independent t-test, paired t-test, one-way ANOVA. The results were as follows : 1. Probing depth was significantly reduced in all groups at 3, 6 months postsurgery and there were not significant differences between groups. 2. Clinical attachment level was significantly increased in all groups at 3, 6 months postsurgery and there were not significant differences between groups. 3. There were not significant differences in probing depth, clinical attachment level, gingival recession, tooth mobility between second group (PLA/PLGA barrier) and third group (PLA/PLGA barrier combined with alloplastic bone graft) 4. Tooth mobility was not significantly increased in all groups at 3, 6 months postsurgery and there were not significant differences between groups. In conclusion, PLA/PLGA resorbable barrier has similar clinical potential to eP'IFE barrier in GTR procedure of intrabony pockets under the present protocol.

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