• Title/Summary/Keyword: randomized clinical trial

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Clinical Study of the Efficacy and. Safety of Jetongdan on Patients with Osteoarthritis of the Knee (퇴행성 슬관절염에 대한 제통단의 안전성과 효능 임상연구)

  • Seo Byung-Kwan;Ryu Seong-Ryong;Kang Jung-Won;An Kyungeh;Lee Sang-Hoon;Choi Do-Young;Kim Keon-Sik;Lee Doo-Ik;Lee Yun-Ho;Lee Jae-Dong
    • The Journal of Korean Medicine
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    • v.26 no.2 s.62
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    • pp.231-240
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    • 2005
  • Objectives: In order to investigate the efficacy and safety of the newly developed herbal medicine Jetongdan, a placebo­controlled, randomized clinical trial of patients with osteoarthritis of the knee was undertaken. Methods: Data were obtained from 80 patients with OA of the knee. After enrollment, they were asked to answer a disease-specific questionnaire (Western Ontario and McMaster Universities (WOMAC) OA index) and analyzed with the erythrocyte sedimentation rate (ESR) in order to evaluate the efficacy of Jetongdan, and analyzed for aspartate transaminase (AST) level, alanine transaminase (ALT) level, blood mea nitrogen (BUN) level, and creatinine (Cr) level in order to evaluate the safety of Jetongdan. Results: The liver function and renal function did not deteriorate after treatment with Jetongdan. Composite WOMAC score and physical function subscale was improved, but pain subscale, stiffness subscale, and ESR were not improved by. This was possibly because the baseline characteristics of the two groups were not homogenized after randomization. Conclusions: Jetongdan could be a promising treatment option for osteoarthritis of the knee. Further study in a larger population with appropriate severity grades is recommended.

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Systematic Review on Effect of Mirror Therapy on Upper Extremity Function for Stroke Patients (뇌졸중 환자의 상지기능 향상을 위한 거울치료 효과에 관한 체계적 고찰)

  • Park, Jin-Hyuck;Heo, Seo-Yoon
    • The Journal of the Korea Contents Association
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    • v.14 no.3
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    • pp.215-222
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    • 2014
  • Recent years, mirror therapy or mirror neuron therapy has been used to improve neural damage of upper extremities among stroke patients. This systematic review was conducted to assess the clinical effect of mirror therapy used for the treatment of upper extremities for patients with stroke. After literature search, researchers selected for 9 randomized controlled clinical trial studies registered up to October 2013 based on PubMed database, using the following search terms: mirror therapy, mirror neuron, stroke, paresis, hemiplegia, upper extremity. There were significant improves of distal upper extremity function in the use of mirror therapy groups but the research using range of motion(ROM) as outcome measure. In conclusion, mirror therapy was more effective than conventional therapies or sham therapies for upper recovery of distal upper extremity function among stroke patients.

The impact of caudally administrated tramadol on immune response and analgesic efficacy for pediatric patients: a comparative randomized clinical trial

  • Sayed, Jehan Ahmed;Elshafy, Sayed Kaoud Abd;Kamel, Emad Zareif;Riad, Mohamed Amir Fathy;Mahmoud, Amal Ahmed;Khalaf, Ghada Shalaby
    • The Korean Journal of Pain
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    • v.31 no.3
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    • pp.206-214
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    • 2018
  • Background: Immune responses appear to be affected by anesthetics and analgesics. We investigated the effects of caudal tramadol on the postoperative immune response and pain management in pediatric patients. Methods: Sixty ASA-I pediatric patients aged 3-10 years undergoing lower abdominal surgery. Patients were randomly assigned either to a caudal bupivacaine (0.25%) group (group B), or a group that received caudal tramadol (1 mg/kg) added to the bupivacaine (0.25%) (group T). Both were diluted in a 0.9% NaCl solution to a total volume of 1ml/ kg. The systemic immune response was measured by collecting blood samples preoperatively, at the end of anesthesia, and at 24 and 72 hours postoperatively, and studied for interleukin IL-6, C-reactive proteins (CRP) cortisol levels, and leucocytes with its differential count. Postoperative pain was assessed along with sedation scales. Results: Postoperative production of IL-6 was significantly higher in group B at the end of anesthesia, than at the $24^{th}$ hour, and at the $72^{nd}$ hour in group B and group T, respectively. The immune response showed leukocytosis with increased percentages of neutrophil and monocytes, and a decreased lymphocyte response rate within both groups with no significant differences between the groups. Cortisol and CRP were significantly higher in group B. Conclusions: Adding tramadol to a caudal bupivacaine block can attenuate the pro-inflammatory cytokine response, Cortisol, and CRP in children undergoing lower abdominal surgery.

A Clinical Study of Shi Ho Cheong Gan-San on Blood Heat Pattern Atopic Dermatitis: a randomized, double-blind clinical trial (혈열형 아토피피부염에 대한 시호청간산의 유효성과 안전성 연구)

  • Choi, In-Hwa;Kim, Se-Hyun;Kim, Young-Chul;Yun, Young-Hee
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.24 no.1
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    • pp.96-110
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    • 2011
  • 목적 : 본 임상시험을 통하여 혈열(血熱)형으로 변증된 아토피피부염의 한약 치료 후 임상 효능과 안전성을 관찰함으로써 아토피피부염에 대한 한약치료의 유용성을 평가하고자 한다. 방법 : 본 임상시험은 무작위배정, 이중맹검, 양성대조군, 평행 설계로 진행되었다. 자의에 의해 임상시험 동의서에 서명한 대상자 중 선정기준 및 제외기준에 부합된 36명의 대상자들에게 시험약과 양성대조약 과립제를 1일 3회(5.0g* 3회/ 1일) 4주간 복용하도록 하였다. 36명 중 31명의 환자가 4주간의 치료를 종료하였다(시호청간산 복용군: n = 16, 소풍산 복용군: n =15). 아토피피부염 증상을 평가하기 위해 Scoring atopic dermatitis (SCORAD) index와 Eczemaarea and severity index (EASI) 를 사용하여 시험 시작 전과 4주 후 시험 종료일에 환자들의 피부소견을 평가하였다. 아토피 피부염에 대한 한약치료의 안정성을 평가하기 위하여 치료 전후 혈중 AST, ALT, BUN, creatinine 변화를 검토하여 한약치료의 간/신독성 여부에 대해 조사하였다. 결과 및 결론: 두 군 모두에서 유의하게 SCORAD 점수와 EASI 점수가 감소하였으나 두 군 간의 차이는 유의하지 않았다. 부종/구진, 찰상 항목의 점수에는 두 군 간에 유의한 차이가 관찰되었다. 31명의 환자에게서 한약 치료 후 간장과 신장에 미치는 독성이 발견되지 않았으며 한약투여와 관련된 이상반응은 보고되지 않았다. 위의 결과로부터 시호청간산과 소풍산이 혈열형 아토피피부염에 대한 효과적이고 안전한 치료 방법이 될 수 있을 것으로 생각된다.

Systemic review: The study on Rhinitis with acupuncture in PubMed and Chinese medical journals (비염(鼻炎)의 침구치료(鍼灸治療)에 대한 최근(最近) 연구(硏究) 동향(動向) -Pubmed와 중의학(中醫學) 학술지(學術紙)를 중심으로-)

  • Kim, Jeung-shin;Kim, Yong-suk;Nam, Sang-soo
    • Journal of Acupuncture Research
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    • v.21 no.1
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    • pp.70-85
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    • 2004
  • Objective: To research the trends of study related to rhinitis and acupuncture in PubMed, and to establish the hereafter direction of treating rhinitis with acupuncture Methods: We searched PubMed and chinese medical journals related to rhinitis and acupuncture. Results: 1. The pattern of the study was as follows: Review article(3), Randomized controlled trials(2), Clinical trial(11), Case report(12). 2. The effect of acupuncture on rhinitis is reported as follows: Acupucture treatment improves the scale of symptoms, nasal airways resistance and velocity of the mucociliary transport, decreasing absolute numbers of blood eosinophils, serum IgE and percentage of nasal eosinophils. Immunologically acupuncture treatment could reduce plasma IL-10 level, control IL-2, and balance between cell-specific pro-inflammatory and anti-inflammatory cytokines, TNF-${\alpha}$ and IL-10. After acupuncture treatment, there is statistically significant changes in IgA, IgE, E-rosette formative rate. 3. Many of these article have affirmative view for therapeutic effect of rhinitis with acupuncture. Statistical test was done only in 6 papers. There showed statically significant results in 4 articles, and in 2 article there showed some clinical improvement but no statically significant changes. 4. In Western countries, alternative treatments are frequent among adults with rhinitis or other allergic disease, and affirmative tendency for acupuncture treatment is increased.

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Prospective randomized clinical trial of hydrophilic tapered implant placement at maxillary posterior area: 6 weeks and 12 weeks loading

  • Kim, Seong-Beom;Yun, Pil-Young;Kim, Sang-Yun;Yi, Yang-Jin;Kim, Ji-Yun;Kim, Young-Kyun
    • The Journal of Advanced Prosthodontics
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    • v.8 no.5
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    • pp.396-403
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    • 2016
  • PURPOSE. Early loading of implant can be determined by excellent primary stability and characteristic of implant surface. The implant system with recently improved surface can have load application 4-6 weeks after installing in maxilla and mandible. This study evaluated the effect of healing period to the stability of hydrophilic tapered-type implant at maxillary posterior area. MATERIALS AND METHODS. This study included 30 patients treated by hydrophilic tapered-type implants (total 41 implants at maxilla) and classified by two groups depending on healing period. Group 1 (11 patients, 15 implants) was a control group and the healing period was 12 weeks, and Group 2 (19 patients, 26 implants) was test group and the healing period was 6 weeks. Immediately after implant placement, at the first impression taking, implant stability was measured using Osstell Mentor. The patients also took periapical radiographs after restoration delivery, 12 months after restoration and final followup period. The marginal bone loss around the implants was measured using the periapical radiographs. RESULTS. All implants were survived and success rate was 97.56%. The marginal bone loss was less than 1mm after 1 year postoperatively except the one implant. The stabilities of the implants were not correlated with age, healing period until loading, insertion torque (IT), the diameter of fixture and the location of implant. Only the quality of bone in group 2 (6 week) was correlated with the stability of implant. CONCLUSION. Healing period of 6 weeks can make the similar clinical prognosis of implants to that of healing period of 12 weeks if bone quality is carefully considered in case of early loading.

Developing and Evaluating a Drug Information Leaflet of Antidiabetics for Senior Citizens; Employing Performance-based User-testing (노인용 당뇨치료제 안전사용설명서 개발 및 평가: 수행능력 기반 사용자 평가 활용)

  • Kim, Jin;Shim, Haeri;Lee, Iyn-Hyang
    • Korean Journal of Clinical Pharmacy
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    • v.27 no.3
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    • pp.171-177
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    • 2017
  • Objective: The study purpose was to develop a drug information leaflet for the elderly and to evaluate it with performance-based user-testing. Methods: We performed a stratified randomized controlled trial. We recruited 62 elderly patients with age of 65 or above who were taking antidiabetic medications at the point of participating and excluded those who suffered illiteracy. We randomly allocated them into the intervention group with a leaflet for the elderly and the control group with a leaflet for the general public. Main outcome measures were to 'be able to find information' and to 'be able to understand information.' We measured outcome variables by employing performance-based user-testing and analyzed data to find any differences between two groups with t-tests, chi-squared tests or Fisher's exact tests accordingly. Results: More participants in the intervention group understood how to store their medications than those in the control group (intervention group 93% vs. control group 70%; p=0.02). There were no significant differences in other information items between two groups. Mostly 'being able to understand information' was lower than 'being able to find information.' The gaps between two outcome variables were about 10% in the intervention group and about 18% in the control group. The lowest understanding was observed in information relating to drug names and their potential adverse events. Conclusion: Without providing personalized drug information, it might be hard for the elderly to improve their drug knowledge even with leaflets that were developed specifically for the elderly.

Impact of Dual-Hemisphere Transcranial Direct Current Stimulation Combined with Modified Constraint-Induced Movement Therapy on Upper Limb Function in Chronic Stroke: A Single Blinded Randomized Controlled Trial (수정된 강제 유도 운동치료와 결합된 이중 반구 경두개 직류 자극이 만성 뇌졸중의 팔 기능에 미치는 영향 : 단일 맹검 무작위 통제 시험)

  • Kim, Sunho
    • Journal of The Korean Society of Integrative Medicine
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    • v.8 no.2
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    • pp.11-20
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    • 2020
  • Purpose : The purpose of this study was to research the effects of dual-hemisphere transcranial direct current stimulation (dual tDCS) and modified constraint-induced movement therapy (mCIMT) to improve upper extremity motor function after stroke. Methods : The study period was from August 2019 to November 2019, and included 24 patients who met the selection criteria. Participants were divided into 2 groups: dual tDCS and mCIMT, and sham dual tDCS and mCIMT group. Dual tDCS and mCIMT group performed mCIMT immediately after applying dual tDCS for 20 minutes, and sham dual tDCS and mCIMT group performed mCIMT immediately after applying sham tDCS for 20 minutes without turning on the power source. Total interventions were conducted 5 times per week for 4 weeks, and mCIMT was conducted for 30 minutes per session for both experimental and control groups. Fugl-Meyer assessment (FMA) and Motor Activity Log scale (MAL) were analyzed before and after 4 weeks of intervention. Results : Both experimental and control groups showed significant changes in FMA, Amount of Use (AOU), and Quality of Movement (QOM) of MAL. When the differences between groups was compared using ANCOVA, the experimental group showed a greater improvement in FMA and AOU of MAL than the control group. Conclusion : In order to enhance the effect of improving upper limb function of stroke patients, dual tDCS could be applied to provide more effective treatment in the clinical setting. Further studies will be needed in larger groups of stroke patients, including long-term follow-up, and multi-group comparisons through the establishment of anodal tDCS and mCIMT, cathodal tDCS, and mCIMT groups to clarify the effects of dual tDCS. In addition, research is needed to establish a protocol for tDCS, and this evidence-based intervention protocol is expected to be used in the clinical setting as an interventional method for various purposes.

Prophylactic antibiotics in intra-oral bone grafting procedures: a prospective, randomized, double-blind clinical trial

  • Lee, Jung-Woo;Lee, Jin-Yong;Kim, Soung-Min;Kim, Myung-Jin;Lee, Jong-Ho
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.38 no.2
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    • pp.90-95
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    • 2012
  • Objectives: This study was conducted in order to assess the efficacy of 1st generation cephalosporin as use as a single-dose preoperative prophylactic antibiotic for surgical wound infections resulting from intra-oral bone grafting procedures. Materials and Methods: A total of 23 patients who were to undergo intra-oral bone graft procedures participated in this study. After randomization, 2 grams of 1st generation cephalosporin was orally administered to both the experimental and placebo groups one hour prior to surgery in a double-blind fashion. Post-operatively, the experimental group (12 patients) was orally administered placebo three times a day for three days. The control group (11 patients) was orally administered 1st generation cephalosporin three times a day for three days. The postoperative course was observed for one month including the clinical parameters associated with infection. Results: Postoperative infections were noted in 1 out of 11 patients in the experimental group. No infections occurred in the control group. Conclusion: There was no significant difference in the incidence of postoperative infections between the two groups. Two grams of 1st generation cephalosporin administered orally one hour before surgery served as an effective prophylactic antibiotics therapy for intra-oral bone graft surgery.

Comparison of intrathecal versus intra-articular dexmedetomidine as an adjuvant to bupivacaine on postoperative pain following knee arthroscopy: a randomized clinical trial

  • Ismail, Eman A.;Sayed, Jehan A.;Bakri, Mohamed H.;Mahfouz, Reda Z.
    • The Korean Journal of Pain
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    • v.30 no.2
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    • pp.134-141
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    • 2017
  • Background: Postoperative pain is a common, distressing symptom following arthroscopic knee surgery. The aim of this study was to compare the potential analgesic effect of dexmedetomidine after intrathecal versus intra-articular administration following arthroscopic knee surgery. Methods: Ninety patients undergoing unilateral elective arthroscopic knee surgery were randomly assigned into three groups in a double-blind placebo controlled study. The intrathecal dexmedetomidine group (IT) received an intrathecal block with intrathecal dexmedetomidine, the intra-articular group (IA) received an intrathecal block and intra-articular dexmedetomidine, and the control group received an intrathecal block and intra-articular saline. The primary outcome of our study was postoperative pain as assessed by the visual analogue scale of pain (VAS). Secondary outcomes included the effect of dexmedetomidine on total postoperative analgesic use and time to the first analgesic request, hemodynamics, sedation, postoperative nausea and vomiting, patient satisfaction, and postoperative C-reactive protein (CRP) levels. Results: Dexmedetomidine administration decreased pain scores for 4 h in both the intrathecal and intra-articular groups, compared to only 2 h in the control patient group. Furthermore, there was a significant reduction in pain scores for 6 h in the intra-articular group. The time to the first postoperative analgesia request was longer in the intra-articular group compared to the intrathecal and control groups. The total meperidine requirement was significantly lower in the intra-articular and intrathecal groups than in the control group. Conclusions: Both intrathecal and intra-articular dexmedetomidine enhanced postoperative analgesia after arthroscopic knee surgery. Less total meperidine was required with intra-articular administration to extend postoperative analgesia to 6 h with hemodynamic stability.