• Title/Summary/Keyword: Double blind test

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The Efficacy and Safety of Beef Tallow Extract Including Cis-9-cetylmyristoleate in Patients with Osteoarthritis - As an Adjuvant Pharmacological Treatment -

  • Lee, Sang-Hoon;Kim, June-Hyuk;Cho, Whan-Seong;Seo, Sung-Wook;Kim, Sung-Kyu;Oh, Joo-Han
    • Preventive Nutrition and Food Science
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    • v.10 no.3
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    • pp.285-289
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    • 2005
  • In this double-blind, placebo-controlled trial, we assessed the efficacy and safety of beef tallow extract (BTE) including Cis-9-cetylmyristoleate in patients with arthritis. Between May and December 2003, we selected 80 patients (n=80) who showed/manifested arthritic symptoms and whose radiological findings were suggestive of arthritis, and randomly assigned them to placebo-controlled (n=40) and treatment group (n=40). The placebo (corn starch 350 mg) and BTE (208 mg) were orally administered to placebo-controlled and treatment group three times a day, respectively. We assessed the efficacy and safety based on the visual analogue scale (V AS) and modified knee society knee scores (MKSKS) at baseline and endpoint, respectively. To assess the safety, we monitored the adverse effects noted in liver, kidney, cardiovascular and gastrointestinal system for 3 weeks. Then, we performed not only a questionnaire study but also laboratory tests (e.g., liver function test, kidney function test, urinalysis, electrocardiography [EKG], complete blood cell counts [CBC] and chest X-ray). For statistical analysis, Student (-test and paired (-test were done using SPSS■ Version 11.0. Statistical significance was set at p < 0.05. The scores between V AS and MKSKS showed statistical significance (p < 0.05) with an improvement of $69.2\%$ (27/39) and $3.8\%$ (21/39) of treatment-group patients, respectively. Abnormal laboratory findings were noted in neither placebo-controlled nor treatment group. In conclusion, our results indicate that the administration of BTE was a safe and effective treatment regimen for patients with arthritis. In addition, the efficacy of BTE was more remarkable in alleviating the symptoms rather than improving the function.

Evaluation of transcutaneous electrical nerve stimulation as an adjunct therapy in trigeminal neuralgia - a randomized double-blind placebo-controlled clinical study

  • Bisla, Suman;Gupta, Ambika;Agarwal, Shalini;Singh, Harneet;Sehrawat, Ankita;Singh, Aarti
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.6
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    • pp.565-574
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    • 2021
  • Background: Trigeminal neuralgia (TN) is a severe form of pain that affects the daily activities of a patient. Transcutaneous electrical nerve stimulation (TENS) therapy is an emerging option for the treatment of acute and chronic pain. The aim of this study was to evaluate the effect of TENS therapy as an adjunct to drug therapy for the treatment of TN. Methods: A total of 52 patients diagnosed with TN according to the International Classification of Headache Disorders (version 3) were included. Each patient was randomized to either the TENS or placebo TENS groups. Intervention was given in continuous mode and 100-Hz frequency for 20 mins biweekly for 6 weeks. Parameters were measured at baseline, TENS completion and 3 months, 6 months, and 1 year of follow up. The parameters observed were mean carbamazepine dose, mean visual analog scale (VAS) score, mean present pain intensity (PPI) score, and functional outcome. Non-parametric analyses, one-way ANOVA and the Kruskal-Wallis test were applied for intragroup comparisons, while the Mann-Whitney U test and independent t-test were used for intergroup comparisons of variables. The chi-square test was applied to analyze categorical data. Results: Compared to the placebo TENS group, the mean dose of carbamazepine in the TENS group was significantly reduced at TENS completion, as well as at 6 months and 1 year follow up. Changes in mean VAS score, mean PPI score, and functional outcome did not show significant differences between the groups (P>0.05). Conclusion: TENS therapy does not lead to any changes in pain levels but it may reduce the mean dose of carbamazepine when used as an adjunct treatment in patients with TN.

An Analysis of the Efficacy of Local Steroid Injections for the Treatment of Subacromial Impingement Syndrome (견봉하 충돌증후군의 치료에서 스테로이드 국소주사의 효유성에 대한 분석)

  • Kim, Seung-Key;Park, Jong-Beom;Koh, Young-Seok;Chang-Han,
    • Clinics in Shoulder and Elbow
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    • v.1 no.1
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    • pp.35-39
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    • 1998
  • From May 1994 to May 1995, we performed a prospective controlled double-blind clinical study of 85 patients(85 shoulders). For inclusion in the study all patients met the following criteria: 1) a diagnosis of impingement syndrome by lidocaine injection test; 2) symptoms for at least three months; 3) no previous subacromial injection; 4) no evidence of rotator cuff tear. We excluded the patients from the study who showed a instability or other clear primary cause. The patients were randomized to receive either 5/subcc/ 2% lidocaine with 4ee of 20mg/cc Depomedrol(Group 1) in 45 cases or 5/subcc/ 2% lidocaine solely(Group 2) in 40 cases. At three month follow-up, all results were better in steroid group than control group. But at one year, improvement of pain and daily activity showed no difference between two groups. So we conclude that the use of subacromial steroid injection is effective for short-term therapy in the treatment of subacromial impingement syndrome, but the long-term effectiveness is doubtful.

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Study of Complementary Medical Therapy for Allergic Rhinitis in PubMed (PubMed를 통해 살펴 본 알레르기 비염에 대한 보완 의학적 최신 연구 경향)

  • Jung, Hye-Mi;Cho, Min-Jung;Seo, Un-Kyo
    • The Journal of Internal Korean Medicine
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    • v.30 no.3
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    • pp.534-549
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    • 2009
  • Objectives : To study trends in complementary medical therapy for the allergic rhinitis. This study analyzed research on allergic rhinitis in PubMed. Methods : We searched PubMed related to complementary medical therapy for allergic rhinitis. We analyzed 25 research papers and examined published journals, years countries, and their methods, objectives, results, interventions, participants, periods and instruments of assessment. Results : The method of studies was mostly randomized, double-blind, placebo-controlled trial. There were research papers concerning treatment and prevention with herbal medicine, acupuncture, diet, etc. There were more positive results compared to negative results for treatment and prevention. Most studies were carried out during the winter/spring period. The median for number of participants was 90.54 persons. Diagnostic criteria for enrolment were nasal symptoms, allergic skin test, serum, nasal discharge allergen specific IgE eosinophil, etc. Assessment for outcomes were nasal symptoms, serum, nasal discharge allergen specific IgE eosinophil and Quality of Life Questionnaire. Conclusions : It is necessary to study effects of acupuncture and herb medicines for allergic rhinitis and more in-depth research about trends in complementary medical therapy for allergic rhinitis.

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Efficacy of Oral Korean Red-ginseng on sCRP and Soreness after Muscle Damage

  • NA, Hyun-Jong
    • The Journal of Korean Medicine
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    • v.26 no.4
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    • pp.39-45
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    • 2005
  • Objectives: The study investigated the efficacy of oral Korean red-ginseng (RG) on sCRP response mediated by eccentric contraction-induced muscle damage and discussed its mechanism. Methods: Nineteen healthy young subjects (aged 24.4$\pm$2.07 yr) volunteered for this double blind test. They were classified into either the RG group (N=10) or placebo (P) group (N=9) during the 10-d experimental protocol. Blood samples were collected on T1 (baseline), T1 (1h), T2 (1d), T3 (2d) and T4 (3d) after eccentric contraction-induced injury on the seventh day. Statistical analyses were conducted using nonparametric methods (p<0.05). Results: The RG group increased sCRP more than P group and didn't increase soreness peak at T2, not significant. There were no correlations between soreness intensity and sCRP. Oral RG had little efficacy for reducing sCRP at the muscle damage-mediated acute phase; rather, it increased because of its proinflammatory cytokine production. Conclusions: Oral RG could stimulate proinflammatory cytokine production, and occasionally bal-pyo-beob could be helpful for the efficient recovery of muscle injury.

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Antihypertensive effect of an enzymatic hydrolysate from Styela clava flesh tissue in type 2 diabetic patients with hypertension

  • Ko, Seok-Chun;Jung, Won-Kyo;Lee, Seung-Hong;Lee, Dae Ho;Jeon, You-Jin
    • Nutrition Research and Practice
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    • v.11 no.5
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    • pp.396-401
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    • 2017
  • BACGROUND/OBJECTIVES: In this randomized, placebo-controlled, double-blind study, we evaluated the antihypertensive effects of enzymatic hydrolysate from Styela clava flesh tissue in patients with type 2 diabetes mellitus (T2DM) and hypertension. SUBJECTS/METHODS: S. clava flesh tissue hydrolysate (SFTH) (n = 34) and placebo (n = 22) were randomly allocated to the study subjects. Each subject ingested two test capsules (500 mg) containing powdered SFTH (SFTH group) or placebo capsules (placebo group) during four weeks. RESULTS: In the SFTH group, systolic and diastolic blood pressure decreased significantly 4 weeks after ingestion by 9.9 mmHg (P < 0.01) and 7.8 mmHg (P < 0.01), respectively. In addition, the SFTH group exhibited a significant decrease in hemoglobin $A_{1c}$ with a tendency toward improvement in homeostasis model assessment of insulin resistance, triglyceride, apolipoprotein B and plasma insulin levels after 4 weeks. No adverse effects were observed in other indexes, including biochemical and hematological parameters in both groups. CONCLUSION: The results of our study suggested that SFTH exerts a regulatory, antihypertensive effect in patients with T2DM and hypertension.

A Performance Assessment of Real-time Multichannel Audio Codec

  • Kim, Sunghan;Jang, Daeyoung;Hong, Jinwoo
    • The Journal of the Acoustical Society of Korea
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    • v.16 no.3E
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    • pp.56-61
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    • 1997
  • In this paper, we describe a real-time implementation of a multi-channel auido codec system that is based on the MPEG-1 audio algorithm. The major feature of this system is that it has a flexible multi-DSP system that can be adapted for various applications with using up to four TMS320C40 DSPs. The purpose of this paper is to present the problems of the system and is to describe the optimized methods to solve the problems in the view of hardware and software. Our audio codec is composed of an encoder an a decoder system and the bit rate of bitstream is up to 384 kbps. Fast input/output interfaces, DSP overloads, and inter-DSP communications methods with high speed are considered in multi-DSP H/W. Also, to run real-time in S/W, optimizing methods of algorithm are considered. After implementation of system, the subjective assessment method, and 'triple stimulus/hidden reference/double blind' that recommended by ITU-R TG10/3 is adopted for the quality of our system. All test items except one are awarded difference grades(diffgrade) better than 1-. Form the results, multi-channel audio system can be used for HDTV service.

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A Study for Reducing Pain from Injection of Lidocaine Hydrochloride (염산 Lidocaine 주입으로 초래되는 통증을 줄이는 방법에 대한 연구)

  • Jeong, Jae-Ho;Lee, Kyung-Ho
    • Journal of Yeungnam Medical Science
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    • v.11 no.1
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    • pp.30-34
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    • 1994
  • Local anesthetics produce pain during infiltration into skin. The relationship between local anesthetic-induced pain and pH of the local anesthetic solution has not been fully investigated. Commercial preparation of local anesthetics are prepared as acidic solutions of the salts to promote solubility and stability. And the acidity of local anesthetic solition may be related with the pain during infiltration of the solutione. So, we tried to neutralize the lidocaine hydrochloride solution which is one of the most frequently used local anesthetic agent. Sodium bicarbonate was used for neutralization. Sodium bicarbonate was mixed with lidocaine hydrochloride until the resulting pH of the solution become 7.4 which is identical to the acidity of body fluid. To identify the effect of neutralized lidocaine solution, we had a course of double blind test to 6 volunteers. Both forearm of each volunteer were injected with neutralized lidocaine and plain one, and the degree of pain was estimated by each volunteers. According to subjective description by the volinteers, everyone felt neutralized lidocaine injection site was less painful than plain lidocaine. We concluded that we could reduce pain from infiltration of lidocaine hydrochloride by neutralization of the anesthetic solution with sodium bicarbonate.

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Study of the Efficacy and Safety of "adenophorae radix extract" in the Obese Patients or Overweight (비만 및 과체중 환자에 대한 사삼추출물의 유효성 및 안전성 평가)

  • Kim, Gi-Tae;Go, Heung;Shin, Seon-Mi;Kim, Hyung-Jun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.25 no.2
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    • pp.131-141
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    • 2012
  • Objectives: The purpose of this study is to evaluate the efficacy and biosafety of Adenophorae Radix(AR) extract in obesity or overweight patient. Methods: This study is double-blind, randomized, placebo-controlled intervention Study. 30 patients with BMI $25{\leq}$ and 30> were allotted into two groups at random. In 0, $6^{th}$, $12^{th}$ week, we had checked body weight, waist line, hip line, body fat and abdominal CT scan. In 0, $12^{th}$ week, we also had checked lipid metabolism and biosafety with blood test. Results: AR treatment had a significant effect on suppressing body wight gain (p<0.01) and BMI index(p<0.01). AR treatment reduced plasma TG level but we couldn't find statistical significance. AR treatment had produced no adverse reactions. Conclusions: This study shows that Adenophorae Radix(AR) extract can reduce the weight, BMI. Adenophorae Radix(AR) extract can be used in obesity or overweight patient.

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.