• Title/Summary/Keyword: Placebo-controlled study

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The Effect of Bee Venom Acupuncture(BVA) on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study (급성 족관절 염좌에 대한 봉약침 효과-무작위대조시험, 이중맹검)

  • Song, Ho-Seub
    • Journal of Pharmacopuncture
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    • v.8 no.2
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    • pp.11-16
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    • 2005
  • Objective : The aim of the study was to investigate the therapeutic effect of BVA in the treatment of patients with acute ankle sprain. Design : A prospective randomized double-blind study of BVA was conducted. Setting : The study was done in the Kyungwon University Seoul Hospital from August 1st, 2004 to June 15th, 2005. Patients : 30 patients diagnosed with acute ankle sprain, especially 2nd degree on the Ankle grade pain chart(AGPC) participated in the study, who were divided into two groups (A and B) randomly by a coordinator flipping a coin. Group A and B were relevant to control and BVA group respectively, of which a coordinator never informed any other participant involved. Eventually 13 of 17 in group A and 11 of 13 in Group B finished all the process of the clinical trial. Intervention : In both group A and B, The Procedure of acupuncture treatment was made similar by appearance that four acupoints such as 坵墟(GB40), 中封(LR4), 商丘(SP5), 解谿(ST41) of the injured side were selected and Normal saline aqua-acupuncture(control, as a placebo) or BVA was done and then acupuncture at 坵墟(GB40), 中封(LR4), 商丘(SP5), 解谿(ST41), 足三里(ST36), 陽陵泉(G34) of the affected side was given again. the needles were retained for 20 minutes under the infrared rays. The treatment was given daily for a week. Outcome Measures : Ankle-Hindfoot Scale (AHS) and Visual Analogue Scale(VAS) were followed by three treatments. Statistical Analysis : Analysis regarding variations in AHS and VAS is carried out by applying Mann-Whitney test and Wilcoxon signed rank test sign test with level of significance at 5%. Results : At the end of the treatment, there was significant statistical differences between the two groups in VAS and AHS as well, while at the 3rd day only a VAS showed statistical significance. In each group, both VAS and AHS showed statistical significance along with duration of treatment. Conclusions : BVA was thought to be effective alternatives for relieving symptoms of acute ankle sprain, although further study was needed on the large scale.

Clinical Efficacy and Safety of Yukgunja-tang for Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis

  • Park, SongWon;Lim, Seong-Woo
    • The Journal of Korean Medicine
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    • v.40 no.4
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    • pp.16-28
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    • 2019
  • Objectives: The purpose of this meta-analysis was to evaluate the effects of Yukgunja-tang(YGJT, Rikkunshito, Liujunzi) on Gastroesophageal Reflux Disease(GERD). Methods: Sixteen electronic databases were used to search for studies published through March 2019, and a randomized controlled study was conducted to study the effects of YGJT or modified YGJT on GERD. Study quality was assessed using the risk bias tool provided by Cochran, and data analysis was performed using Review Manager 5.3.0 software Results: Two-hundred and forty articles were initially searched, and 13 studies that satisfied the study criteria were evaluated qualitatively; 11 of the 13 were included in the meta-analysis. In the two studies, the effects of YGJT and a placebo were compared. Meta-analysis showed that YGJT significantly improved FSSG (Frequency Scale for the Symptoms of GERD) scores, but not GSRS (Gastrointestinal Symptom Rating Scale) scores (FSSG: MD -2.40, 95% CI [-5.31, 0.51], p=0.11, GSRS: MD 0.05, 95% CI [-0.12, 0.22], p=0.55). Meta-analysis of nine studies comparing the efficacies of YGJT and conventional medicine showed that YGJT had a significant clinical effect (OR 5.72; 95% CI [3.41, 9.61]; I2 p<0.00001). Conclusion: This study suggests that YGJT effectively relieves the symptoms of GERD. Unfortunately, owing to the small sample sizes, limitations of several methodological qualities, we believe large-scale clinical studies with less bias will provide evidence of qualitative improvement.

The efficacy of dexamethasone injection on postoperative pain in lower third molar surgery

  • Latt, Maung Maung;Kiattavorncharoen, Sirichai;Boonsiriseth, Kiatanant;Pairuchvej, Verasak;Wongsirichat, Natthamet
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.16 no.2
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    • pp.95-102
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    • 2016
  • Background: Surgery on the lower impacted third molar usually involves trauma in the highly vascularized loose connective tissue area, leading to inflammatory sequelae including postoperative pain, swelling, and general oral dysfunction during the immediate post-operative phase. This study aimed to investigate the effectiveness of preoperative injection of a single dose of 8 mg dexamethasone for postoperative pain control in lower third molar surgery. Methods: A controlled, randomized, split-mouth, prospective study involving lower third molar surgery was performed in 31 patients. The randomized sampling group was preoperatively injected, after local anesthesia, with a single dose of dexamethasone (8 mg in 2 ml) through the pterygomandibular space; 2 ml of normal saline (with no dexamethasone) was injected as a placebo. Results: The pain VAS score was significantly different on the day of the operation compared to the first post-operative day (P = 0.00 and 0.01, respectively), but it was not significantly different on the third and seventh postoperative day between the control and study groups. There was a significant reduction in swelling on the second postoperative day, and a difference between the second postoperative day and baseline value in the study group (P < 0.05). Trismus was highly significantly different on the second postoperative day and between baseline and second postoperative day between the groups (P = 0.04 and 0.02, respectively). Descriptive statistics and independent-samples t- test were used to assess the significance of differences. Conclusions: Injection of 8 mg dexamethasone into the pterygomandibular space effectively reduced the postoperative pain and other postoperative sequalae.

A Convergence Study on Immediate Effects of kinesio taping on upper extremity pain and muscle activation of lateral epicondyle DOMS (가쪽위관절융기의 지연성 근육통을 유발하여 키네시오 테이핑 적용이 상지의 통증과 근활성도 미치는 즉각적 효과에 관한 융합적 연구)

  • In, Tae-Sung;Kim, Kyung-Hun
    • Journal of the Korea Convergence Society
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    • v.11 no.5
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    • pp.73-80
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    • 2020
  • The purpose of this study was to investigate the immediate effects of kinesio taping on upper extremity pain and muscle activation of lateral epicondyle DOMS. This research is randomized controlled designd study and conducted as a single-blind. Twenty four subjects were participated in this study, All the patients were divided two group, were kinesio taping applied group, placebo kinesio taping applied group. The participants were tested pressure upper extremity pain threshold and muscle activation, pre-post intervention. After raining, the change values of the pain and muscle activation in KT group were significantly greater than PKT group(p<0.05). This findings show that kinesio taping training convergence interventions for lateral epicondyle DOMS pain and upper extremity. Continued development on convergence interventions for lateral epicondyle DOMS with pain and upper extremity in the practice are suggested.

Systematic Review of the Effects of Herbal Medicine Versus Synthetic Drugs on Helicobacter Pylori Infection (Helicobacter pylori Infection에 관한 합성의약품 대비 한약의 효과에 대한 체계적 문헌고찰: PubMED를 중심으로)

  • Cho, Eun Ji;Jeong, Seol;Gwak, Seung Yeon;Jerng, Ui Min
    • Herbal Formula Science
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    • v.29 no.4
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    • pp.285-295
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    • 2021
  • Objective : This systematic review was conducted to investigate the effect of herbal medicine on Helicobacter pylori(H. pylori) infection compared to amoxicillin included synthetic drugs. Methods : Relevant randomized controlled trials(RCTs) which were published prior to December 26, 2020, were collected using PubMED database. Risk of bias evaluation and data extraction were done independently by two reviewers, and the third reviewer reassessed mismatching parts. Results : Two RCTs testing two different herbal medicines against synthetic drugs solitary treatment or synthetic drugs with placebo for herbal medicine were included. One study reported that there was no significant difference between the eradication rate of synthetic drugs and the herbal medicine. The other study did not report the eradication rate of the herbal medicine. One study reported histologic severity, the other reported dyspepsia score as efficacy indicators. There was no adverse event reported in all studies. However, the number of included RCTs was too small, the quality of reported data was not enough to verify efficacy of herbal medicine, and there were some methodological problems. Conclusion : It was difficult to conclude that solitary treatment of herbal medicine was as effective as amoxicillin included synthetic drugs for H. pylori infection.

The Analysis of Registration Status of Herbal Medicine and Medication Interventional Clinical Trials for Simple Obesity in Children and Adolescents -Focused on WHO ICTRP- (소아청소년 단순 비만에 대한 한약 및 약물 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 -)

  • Jeong Yoon Kyoung;Choi Seo Yeon;Bang Miran;Lee Boram;Chang Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.38 no.1
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    • pp.55-77
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    • 2024
  • Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

Effect of Korean Red Ginseng Extract on Blood Circulation in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled Trial (건강한 지원자에서 홍삼농축액의 혈행 개선 효과: 무작위, 이중맹검, 위약-대조 시험)

  • Shin, Kyeong-Seob;Lee, Jung-Jin;Kim, Yeong-Il;Yu, Ji-Yeon;Park, Eun-Seok;Im, Ji-Hyun;You, Soon-Hyang;Oh, Ki-Wan;Lee, Myung-Koo;Wee, Jae-Joon;Kim, Young-Sook;Yun, Yeo-Pyo
    • Journal of Ginseng Research
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    • v.31 no.2
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    • pp.109-116
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    • 2007
  • Korean red ginseng has broad efficacious effects against hypertension, diabetes, nociception, and cancer, and it counteracts weakness. It has been reported that Korean red ginseng is able to normalize blood pressure, improve cholesterol and lower blood glucose levels. We have recently reported that Korean red ginseng extract (KRGE) significantly prevented rat carotid arterial thrombosis in vivo, and inhibited platelet aggregation ex vivo and in vitro in a dose-dependent manner. The purpose of this study was to examine the effects of KRGE on blood circulation in human by measuring ex vivo platelet aggregation, plasma coagulation and serum lipid profiles in healthy volunteers. Subjects were randomly divided into three groups (placebo-group, KRGE-low dose group, KRGE-high dose group). Administration of KRGE to subjects significantly inhibited ADP-induced platelet aggregations both in KRGE-low dose group from $72.79{\pm}20.53$ to $62.00{\pm}23.06%$ (p=0.0009), and in KRGE-high dose group from $75.14{\pm}21.86$ to $64.52{\pm}24.72%$ (p=0.0039), respectively. Administration of KRGE to subjects also significantly inhibited collagen-induced platelet aggregations both in KRGE-low dose group from $85.52{\pm}12.57$ to $79.62{\pm}20.47%$ (p=0.0916), and in KRGE-high dose group from $80.24{\pm}18.11$ to $70.31{\pm}25.93%$ (p=0.0565), respectively. Whereas, KRGE has no significant effects on coagulation system, such as prothrombin time (PT) and activated partial thromboplastin time (APTT), and serum lipid profiles, such as total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol and triglyceride. KRGE also has no significant effects on hematological and serum biochemical profiles. These results suggest that KRGE has a potential to improve blood circulation through antiplatelet activity in human, and KRGE intake may be beneficial for the individuals with high risks of thrombotic and cardiovascular diseases.

Ginsenoside Rg1 supplementation clears senescence-associated β-galactosidase in exercising human skeletal muscle

  • Wu, Jinfu;Saovieng, Suchada;Cheng, I-Shiung;Liu, Tiemin;Hong, Shangyu;Lin, Chang-Yu;Su, I-Chen;Huang, Chih-Yang;Kuo, Chia-Hua
    • Journal of Ginseng Research
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    • v.43 no.4
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    • pp.580-588
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    • 2019
  • Background: Ginsenoside Rg1 has been shown to clear senescence-associated beta-galactosidase (SA-${\beta}$-gal) in cultured cells. It remains unknown whether Rg1 can influence SA-${\beta}$-gal in exercising human skeletal muscle. Methods: To examine SA-${\beta}$-gal change, 12 young men (age $21{\pm}0.2years$) were enrolled in a randomized double-blind placebo controlled crossover study, under two occasions: placebo (PLA) and Rg1 (5 mg) supplementations 1 h prior to a high-intensity cycling (70% $VO_{2max}$). Muscle samples were collected by multiple biopsies before and after cycling exercise (0 h and 3 h). To avoid potential effect of muscle biopsy on performance assessment, cycling time to exhaustion test (80% $VO_{2max}$) was conducted on another 12 participants (age $23{\pm}0.5years$) with the same experimental design. Results: No changes of SA-${\beta}$-gal were observed after cycling in the PLA trial. On the contrary, nine of the 12 participants showed complete elimination of SA-${\beta}$-gal in exercised muscle after cycling in the Rg1 trial (p < 0.05). Increases in apoptotic DNA fragmentation (PLA: +87% vs. Rg1: +133%, p < 0.05) and $CD68^+$ (PLA:+78% vs. Rg1:+121%, p = 0.17) occurred immediately after cycling in both trials. During the 3-h recovery, reverses in apoptotic nuclei content (PLA:+5% vs. Rg1 -32%, p < 0.01) and increases in inducible nitrate oxide synthase and interleukin 6 mRNA levels of exercised muscle were observed only in the Rg1 trial (p < 0.01). Conclusion: Rg1 supplementation effectively eliminates senescent cells in exercising human skeletal muscle and improves high-intensity endurance performance.

Systemic Review : The Study on acupuncture for tension-type headache and migrain in PubMed (PubMed에서 acupuncture와 tension-type headache and migrain로 검색한 최근 연구경향)

  • Kim, Kyung-min;Byun, Im-jeung;Woo, Hyun-su;Lee, Hyun-Jong;Ha, Ji-young;Kim, Jong-deog;Hong, Jang-mu;Lee, Jae-dong;Lee, Yun-ho;Choi, Do-young
    • Journal of Acupuncture Research
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    • v.20 no.1
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    • pp.191-201
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    • 2003
  • Objective : To research the trends of study related to tension-type headache and migrain with acupuncture in PubMed, and to establish the hereafter direction of acupuncture. for tension-type headache and migrain. Methods : We searched in PubMed, with tension-type headache, migrain and acupuncture limitted by abstract and enterz data 10 years. Results : 1. The pattern of the study was as follows: Review article(18), Clinical Trials(23), meta analysis(2) and rondomized controlled trials(16). We further estimated 23 articles. 2. Many of these studies provide equivocal results because of designs, sample size and the others, but in the majority of the trials were concludes that acupuncture offers benefits in the treatment of headache. 3. Acupuncture methods need individualization, a carefully selected placebo and cross-over design must have adequate time between the two treatment periods.

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The effectiveness of moxibustion on dysphagia after stroke; A Case Series

  • Cho, Ki-Ho;Kim, Tae-Hoon;Jung, Woo-Sang;Park, Seong-Uk;Moon, Sang-Kwan;Park, Jung-Mi;Ko, Chang-Nam;Kim, Young-Suk;Bae, Hyung-Sup
    • Advances in Traditional Medicine
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    • v.7 no.5
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    • pp.579-582
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    • 2008
  • This study was aimed to evaluate the effectiveness of moxibustion on dysphagia after stroke. We conducted his study in the Department of Cardiovascular and Neurologic Diseases (Stroke Center), Hospital of Oriental Medicine, Kyung Hee Medical Center, from May 1, 2005 to August 1, 2006. After recruiting dysphagia patients after stroke, we applied the Direct Moxibustion ($1.2\;{\times}\;1.4\;cm$) to the Chon-Jung acupoint 5 times, and assessed its effect on swallowing reflex by Swallowing Provocation Test (SPT) before and 30 min after treatment. Effectiveness of the swallowing reflex was assessed by the Latency Time of Swallowing Reflex (LTSR) which was checked from test starting to the onset of swallowing reflex. Thirty four subjects with dysphagia were treated with moxibustion. The mean of the latency time in swallowing reflex was shortened from $2.2\;{\pm}\;0.9$ to $1.5\;{\pm}\;0.5$ seconds after moxibustion, which had statistical significance (P < 0.001). We suggest that moxibustion at Chon-Jung could be useful for dysphagia after stroke. Further study with a randomized controlled trial compared to placebo is needed to confirm this suggestion.