• Title/Summary/Keyword: randomized clinical trial

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Porcine-derived soft block bone substitutes for the treatment of severe class II furcation-involved mandibular molars: a prospective controlled follow-up study

  • Jae-Hong Lee;Ji-Hoo Han;Seong-Nyum Jeong
    • Journal of Periodontal and Implant Science
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    • v.53 no.6
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    • pp.406-416
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    • 2023
  • Purpose: No evidence exists regarding the advantages of periodontal regeneration treatment for furcation defects using soft block bone substitutes. Therefore, this randomized controlled trial aimed to assess the clinical and radiographic outcomes of regenerative therapy using porcine-derived soft block bone substitutes (DPBM-C, test group) compared with porcine-derived particulate bone substitutes (DPBM, control group) for the treatment of severe class II furcation defects in the mandibular molar regions. Methods: Thirty-five enrolled patients (test group, n=17; control group, n=18) were available for a 12-month follow-up assessment. Clinical (probing pocket depth [PPD] and clinical attachment level [CAL]) and radiographic (vertical furcation defect; VFD) parameters were evaluated at baseline and 6 and 12 months after regenerative treatment. Early postoperative discomfort (severity and duration of pain and swelling) and wound healing outcomes (dehiscence, suppuration, abscess formation, and swelling) were also assessed 2 weeks after surgery. Results: For both treatment modalities, significant improvements in PPD, CAL, and VFD were found in the test group (PPD reduction of 4.1±3.0 mm, CAL gain of 4.4±2.9 mm, and VFD reduction of 4.1±2.5 mm) and control group (PPD reduction of 2.7±2.0 mm, CAL gain of 2.0±2.8 mm, and VFD reduction of 2.4±2.5 mm) 12 months after the regenerative treatment of furcation defects (P<0.05). However, no statistically significant differences were found in any of the measured clinical and radiographic parameters, and no significant differences were observed in any early postoperative discomfort and wound healing outcomes between the 2 groups. Conclusions: Similar to DPBM, DPBM-C showed favorable clinical and radiographic outcomes for periodontal regeneration of severe class II furcation defects in a 12-month follow-up period.

Preliminary Study on Effectiveness of Dexamethasone-Soaked Gelatin Sponges for Reducing Pain after Lumbar Microdiscectomy : A Randomized Controlled Trial

  • Shin, Dong-Ah;Gong, Tae-Sik;Shin, Dong-Gyu;Kwon, Chang-Young;Kim, Hyoung-Ihl
    • Journal of Korean Neurosurgical Society
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    • v.39 no.1
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    • pp.11-15
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    • 2006
  • Objective : A prospective, randomized, controlled clinical study is performed to verify the effectiveness of epidural dexamethasone-soaked gelatin sponges to reduce postoperative pain following lumbar microdiscectomy. Methods : Twenty-three patients (10 men and 13 women) undergoing lumbar microdiscectomy were included. Five pieces of gelatin sponge measuring $1{\times}1cm$ [Gelfoam; Pharmacia & Upjohn. Kalamazoo, MI, USA], soaked with either 5mg dexamethasone or an equal amount [2mL] of saline, were left on the decompressed nerve root after unilateral hemilami-nectomy, flavectomy and discectomy. Results : Subjective visual analog scale[VAS] scores of leg pain in the dexamethasone group on the first, third and first postoperative days [2.5, 2.5, 1.7, respectively] were significantly lower than in the control group [5.0, 4.8, 3.6][P<0.05]. No side effects related to the dexamethasone-soaked gelatin sponges were observed. Conclusion : The intraoperative application of dexamethasone-soaked gelatin sponges during lumber microdiscetomy can provide effective-postoperative analgesia without complications.

Review of Clinical Studies of Oral Herbal Medicine Treatment for Pediatric Chickenpox using CNKI Database - Focused on Chinese Randomized Controlled Trials after 2000s - (CNKI로 검색한 소아 수두의 한약 내복 치료에 대한 임상연구 동향 - 2000년대 이후 RCT 연구를 중심으로-)

  • Choi, Jung Yoon;Kim, Jang Hyun;Min, Sang Yeon
    • The Journal of Pediatrics of Korean Medicine
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    • v.34 no.3
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    • pp.18-36
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    • 2020
  • Objectives The purpose of this study is to analyze Chinese randomized controlled trials (RCTs), and to evaluate the effectiveness and safety of the oral herbal medicine treatment for pediatric chickenpox. Methods We searched RCTs after 2000s from the China National Knowledge Infrastructure (CNKI). Afterwards, the year of publication, demographic information, duration of chickenpox, intervention, treatment duration, outcome measure, results and adverse events were investigated and analyzed for this study. Results 21 RCTs out of 219 studies were collected and analyzed. Although each composition of the herbal medicine was different, they have common ingredients such as 清熱解毒, 散結消腫, 疏散風熱, 涼血解毒, 解表散風 in order to make efficacy of 清熱解毒, 散結消腫, 疏散風熱, 涼血解毒, 解表散風. The oral herbal medicine showed better efficacy and safety to improve clinical symptoms such as total efficacy, cure rate, antipyretic time, antipruritic time, scab time, anti-rash time, hospitalization period and herpes recovery time compared to the western medicine treatment. Conclusions These results show that the oral herbal medicine treatment on chickenpox in children may be more effective in reducing of clinical symptoms compared to the western medicine treatment.

Pharmacokinetic Properties and Bioequivalence of Cefcapene Pivoxil Hydrochloride 75 mg in Korean Healthy Volunteers (건강한 한국인 피험자에서 Cefcapene Pivoxil Hydrochloride 75 mg 제제의 생물학적동등성시험)

  • Jeon, Ji-Young;Im, Yong-Jin;Hwang, Min-Ho;Kim, Yun-Jeong;Han, Su-Mi;Jo, Myeong-Jin;Kim, Hee-Sun;Kim, Sun-Young;Chae, Soo-Wan;Kim, Kang-Seog;Kim, Min-Gul
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.1
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    • pp.9-12
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    • 2012
  • Background: Cefcapene pivoxil hydrochloride, is an ester-type oral cephem antibiotic. This study was performed to compare the pharmacokinetics and evaluate the bioequivalence of two cefcapene pivoxil hydrochloride 75 mg formulations. Method: In a randomized $2{\times}2$ crossover study, sixty healthy male volunteers were randomly assigned into two groups. After a single dose of 75 mg cefcapene pivoxil hydrochloride oral administration, blood samples were collected at specific time intervals from 0-12 hours. The plasma concentrations of cefcapene pivoxil hydrochloride were determined by LC-MS/MS. The pharmacokinetic parameters were determined from the plasma concentration-time profiles of both formulations. The pharmacokinetic parameters such as $AUC_{last}$, $AUC_{inf}$ and $C_{max}$, were calculated and the 90% confidence intervals for test/reference ratio for pharmacokinetic parameters were obtained by analysis of variance on logarithmically transformed data. Results: The mean value for $AUC_{last}$ in test and reference drug was $4053.1{\pm}876.5\;ng{\cdot}hr/mL$ and $3595.7{\pm}1029.1\;ng{\cdot}h/mL$, respectively. The mean value for $C_{max}$ in test and reference drug was $1324.9{\pm}321.4$ ng/mL and $1159.1{\pm}335.9$ ng/mL, respectively. The 90% confidence intervals of the $AUC_{last}$ and $C_{max}$ ratio for test drug and reference drug were log 1.09-log1.22 and log 1.09-log1.24, respectively. No adverse events were reported by subjects or found on analysis of vital signs or laboratory tests. Conclusion: This single dose study found that the test and reference products met the regulatory criteria for bioequivalence in these health volunteers. Both formulations were safe and well tolerated in 75 mg of cefcapene pivoxil hydrochloride.

Intervention to Improve Menstrual Health Among Adolescent Girls Based on the Theory of Planned Behavior in Iran: A Cluster-randomized Controlled Trial

  • Fatemeh, Darabi;Mehdi, Yaseri
    • Journal of Preventive Medicine and Public Health
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    • v.55 no.6
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    • pp.595-603
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    • 2022
  • Objectives: Poor menstrual health may lead to school absenteeism and adverse health outcomes for adolescents. The purpose of this study was to determine the effect of pubertal and menstrual health education on health and preventive behaviors among Iranian secondary school girls. Methods: A quasi-experimental study was conducted to evaluate the effectiveness of a health intervention program. A total of 578 students (including intervention and control participants) in 12 schools in Tehran Province, Iran were included by multistage random sampling. The program comprised seven 2-hour educational sessions. After confirming the reliability and validity of a researcher-made questionnaire, that questionnaire was used to collect the required data, and the groups were followed up with after 6 months. Results: After the educational intervention, the mean scores of menstrual health-related knowledge and constructs of the theory of planned behavior were significantly higher in the intervention group than in the control group (p<0.001 for all dimensions). Conclusions: The results of this study emphasize the effectiveness of menstrual health interventions in schools. These findings should also encourage health policy-makers to take committed action to improve performance in schools.

Research Trends of Randomized Controlled Trial Studies on the Herbal Treatment of Avascular Necrosis of the Femoral Head Using China National Knowledge Infrastructure Database (대퇴골두 무혈성 괴사의 탕약 치료에 대한 무작위대조군 연구의 최신 경향 분석: 중국지망(中國知網) 검색을 중심으로)

  • Kim, Hyeon-Jin;Ahn, Jae-Young;Shin, Na-Young;Koh, Ah-Ra;Lee, Young-Jin;Park, Jae-Eun;Lee, Min-Cheol;Jeon, Myung-Kyu;Kim, Hyun-Woo;Jo, Hye-Jeong;Chae, Go-Eun;Nam, Hye-Jin
    • Journal of Korean Medicine Rehabilitation
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    • v.32 no.3
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    • pp.37-53
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    • 2022
  • Objectives This study was conducted to investigate a randomized controlled trial study on the clinical treatment of herbal medicines for avascular necrosis of the femoral head. Methods By March 2022, the China National Knowledge Infrastructure (CNKI) was reviewed about randomized controlled trial studies on the herbal treatment of avascular necrosis of the femoral head through. The publication year, evaluation criteria, treatment period, treatment method and effectiveness were analyzed for articles published from 2017 to 2022. Results 16 articles were selected and 14 kinds of herbal medicines were used. In most studies, Western medical treatments such as injection therapy, oral drug administration, traction therapy and mid-frequency electric therapy were treated alone in the control group, and a combination of Western medical treatment and herbal treatment was administered to the experimental group. Conclusions In China, there have been many studies on herbal treatment for avascular necrosis of the femoral head. In Korea, more clinical studies on the herbal treatment of avascular necrosis of the femoral head are needed. This study will be helpful for future research in Korean medicine on avascular necrosis of the femoral head.

The Metformin Use and Gastric Cancer Risk (메트포르민의 사용과 위암 발생)

  • Kim, Young-Il
    • Journal of Digestive Cancer Reports
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    • v.8 no.2
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    • pp.97-101
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    • 2020
  • Metformin is a widely used first-line anti-diabetic drug worldwide. Epidemiologic studies using the large population-based cohort database have shown the association between metformin uses and reduced risk of various type cancers including gastric cancer. In the gastric cancer prevention, metformin use was associated with the significant reduction of gastric cancer risk, especially for long-term metformin users. However, there is no well-designed randomized controlled clinical trial investigating the effect of metformin as a chemopreventive drug for gastric cancer. Therefore, further well-designed clinical trials will be needed to implement metformin for chemoprevention of gastric cancer.

Systematic Review on Complementary and Alternative Medicine for Female Sexual Dysfunction (여성 성기능장애의 보완대체의학적 치료에 관한 논문 연구)

  • Jeong, Young-Min;Kim, Song-Baek;Choi, Chang-Min;Seo, Yun-Jung;Cho, Han-Baek
    • The Journal of Korean Obstetrics and Gynecology
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    • v.26 no.2
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    • pp.66-87
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    • 2013
  • Objectives: The aim of this study was to review systemically clinical trials on the trends of studies for Complementary and Alternative Medicine in the treatment of female sexual dysfunction and provide basic resource for future treatment and suggestions for improving research methods. Methods: Through medical website 'Pubmed', foreign clinical literatures about female sexual dysfunction were searched and domestic clinical literatures about female sexual dysfunction were searched using internet websites 'National assembly library', 'KISS', 'RISS', 'Korean traditional knowledge portal'. Results: Total 19 literatures were selected from January 2000 to June 2012. 15 foreign literatures were selected through medical website and 4 domestic literatures were chosen using internet websites or hand-searching. 5 literatures were published in 2008 and 13 literatures mentioned about age group of patients. FSFI is most common tool for female sexual dysfunction. 9 of 19 literatures were using Herbal medicine for treatment. 5 literatures were about CBT, 6 literatures were about Biofeedback and other one literatures are about Perineal massage. There were 14 Randomized controlled trials and 5 Non-randomized controlled trials. And randomized controlled trials were relatively low in risk of bias than non-randomized controlled trials. Conclusions: Upon these results, in similar future more clinical trials should be done and accumulate Evidence-based literatures.

Systematic Review of Soyeom Pharmacopuncture Therapy for Pain (임상에서 흔히 접하는 통증에 대한 소염약침요법의 체계적 문헌고찰)

  • Kim, Myeong-Kyu;Seo, Ha-Ra;Ha, Hyun-Ju;O, Tae-Yeong;Jeon, Dong-Hwi;Li, Yu-Chen;Lee, Jae-eun;Lee, Eun-Jung;Oh, Min-Seok
    • Journal of Korean Medicine Rehabilitation
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    • v.27 no.3
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    • pp.95-105
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    • 2017
  • Objectives To evaluate the evidence supporting the effectiveness of Soyeom pharmacopuncture therapy for Pain. Methods We conducted search across 6 electronic databases (Pubmed, CAJ, Oasis, RISS, DBPIA and KoreanTK) and 2 journals to find clinical trials that used Soyeom pharmacopuncture therapy as treatment for pain. The methodological quality of Randomized controlled clinical trials (RCTs) was assessed using the Cochrane Risk of Bias (RoB) tool, while NRCTs (Non-Randomized controlled clinical trials) were assessed using the Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Among 75 articles that were searched, 5 RCTs and 2 NRCTs were finally selected. Among 7 selected studies, all studies showed that Soyeom pharmacopuncture therapy has significant effect on Pain. Conclusions Our systematic review found encouraging but limited evidence of Soyeom pharmacopuncture therapy for Pain. We recommend clinical trials which compare the effectiveness of Soyeom pharmacopuncture therapy with other pharmacopuncture therapies to clarify the effectiveness of Soyeom pharmacopuncture therapy from other pharmacopuncture therapies.

Research Trends on the Thread Embedding Therapy of Low back pain in Traditional Chinese Medicine - Focusing on published articles in China (요통에 대한 매선 임상연구의 중국 현황 분석 - 중국 내(內) 출판 저널을 중심으로)

  • Jun, Purumea;Liu, Yan;Park, Ji-Eun;Jung, So-Young;Han, Chang-Hyun
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.31 no.1
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    • pp.25-35
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    • 2017
  • About 60% to 90% of a total population experience low back pain at least once of life, and about 35% to 79% among them experience a recurrent and chronic low back pain. thread-embedding therapy is mainly used to improve appearance or treat obesity in early stage, but recently it is also used to treat musculoskeletal pain. This study aimed to search Chinese study using thread-embedding therapy on low back pain and to analyse their methodology. Three Chinese database(CNKI(www.cnki.net), WANFANG(www.wanfangdata.com), WEIPU(www.cqvip.com)) were searched for clinical study of thread-embedding therapy up to March 2016. The characteristics of included studies and regimen of thread-embedding in those studies were analyzed. The total 21 studies (4 case studies, 16 non-randomized controlled trials, 1 randomized controlled trial) were included. All studies on thread embedding treatment of low back pain reported that its effectiveness was very good. The most frequently used acupoints was Ashi acupoints and acupoints on bladder meridian(BL) or governor vessel(GV). Thread-embedding therapy is considered very useful for low back pain in Traditional Chinese medicine. Further studies are needed to investigate the effect of thread-embedding therapy and to expand its application. This study is limited in that the literature search in the Chinese database were restricted.