• Title/Summary/Keyword: randomized clinical controlled 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.

Review of Intention-to-Treat Analysis in Randomized Controlled Trials (무작위 대조군 실험 연구에서 치료의향분석 (Intention-to-treat analysis)에 대한 고찰)

  • Kim, Junghun Aj
    • Therapeutic Science for Rehabilitation
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    • v.9 no.2
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    • pp.27-38
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    • 2020
  • Introduction : This review aims to introduce an intention-to-treat analysis(ITT) method and demonstrate the importance of rigorous utilization of this method to researchers in Korea. Discussion : ITT analysis includes all data as results in randomized control trials (RCT). Thereby the result of RCT is high validated to adapt in the real-world so that the result should be expected at clinical practice. Therefore, many RCT quality assessment tools include the question of the utilization of ITT analysis in individual trials. However, many researchers omit to report ITT, not utilize ITT or use ITT incorrectly. Conclusion : Through this review, more Korean researchers may understand and utilize ITT which is expected to enhance the quality of RCT papers.

Current Clinical Evidence for Korean Red Ginseng in Management of Diabetes and Vascular Disease: A Toronto's Ginseng Clinical Testing Program

  • Vuksan, Vladimir;Sievenpipper, John;Jovanovski, Elena;Jenkins, Alexandra L.
    • Journal of Ginseng Research
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    • v.34 no.4
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    • pp.264-273
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    • 2010
  • While ginseng is reported to have a wide array of applications, there is growing evidence for its indications in diabetes and vascular disease. A clear connection, however, has not been established between ginseng's composition, dose and its targeted efficacy in humans. We therefore developed and initiated the Korean Red Ginseng Clinical Testing Program for diabetes and vascular function which is an efficacy and safety-based clinical screening model for ginseng. The most efficacious sources, ginsenoside profiles, doses, and modes of administration were examined in sequential, acute, followed by long term, randomized-controlled trials to investigate the efficacy and safety profiles. This review discusses the current state of the clinical research of Korean red ginseng program conducted in Toronto, paving the way for the use of clinically selected ginseng and its ginsenoside fractions in the management of diabetes and vascular diseases.

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.

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.

Effects of Cinnamon Supplementation on Lipid Profile: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

  • Hawal Lateef Fateh;Saman M. Amin
    • Clinical Nutrition Research
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    • v.13 no.1
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    • pp.74-87
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    • 2024
  • Since the effects of cinnamon supplementation on lipid profiles are still controversial, this study conducted a meta-analysis of randomized controlled trials to assess the effect of cinnamon supplementation on lipid profiles. The study was designed and conducted according to the guidelines of the 2020 preferred reporting items for systematic reviews and meta-analysis (PRISMA) statements. A systematic and comprehensive search was performed in several databases from inception up to 11 November 2023. The meta-analysis on the impact of Cinnamon on lipid profiles indicates a non-significant overall effect on low-density lipoprotein (weighted mean differences [WMD], -2.48; 95% confidence interval [CI], -9.70, 4.72). However, significant reductions are seen with doses < 500 mg/day (-10.26), and non-significant increases with doses ≥ 500 mg/day (1.18). The overall effect on high-density lipoprotein is non-significant (WMD, 3.97; 95% CI, -7.877, 15.831), showing varying responses at different doses. Triglycerides exhibit a significant overall reduction (WMD, -6.88; 95% CI, -12.62, -1.15), particularly in the < 500 mg/day group. The overall effect on cholesterol is non-significant (WMD, -4.314; 95% CI, -15.011, 6.384), with diverse responses at different doses. High heterogeneity underlines the importance of standardized study designs and further exploration of dosage-specific effects. Findings from this study suggest that cinnamon supplements might be beneficial to modulate the blood lipid profile.

Review of Randomized Controlled Trials on Korean Traditional Medicine Treatment for Postpartum Pain (산후신통의 한방 치료에 대한 무작위대조군연구에 관한 고찰)

  • Noh, Eun-Ji;Choi, Su-Ji;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.2
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    • pp.90-111
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    • 2020
  • Objectives: The purpose of this study was to analyze randomized controlled trials (RCTs) related to the effect and safety of Korean Traditional Medicine treatment for postpartum pain, and to suggest desirable future clinical research trend. Methods: Randomized controlled trials (RCTs) on postpartum pain were searched using domestic and foreign search engines to investigate the effect and safety of Korean Traditional Medicine on postpartum pain, and 12 studies were selected as a result. Results: There were 4 studies using Acupoint Therapy, 3 studies using Herbal Medicine, 3 studies using Using Acupoint Therapy and Herbal Medicine together, and 2 studies using Manipulative Therapy for postpartum pain. As control interventions, non-treatment, other Korean Traditional Medicine treatment, or Western medicine were used. All the studies reported a significant effect in experimental group compared to the control group, with no or minor side effects. Conclusions: Korean Traditional Medicine treatment showed effectiveness and safety for postpartum pain. In the future, it is necessary to eliminate the ambiguity of recruiting subjects and to study the most effective application method of Korean Traditional Medicine treatment for postpartum pain.

Recent Clinical Research Trends on Acupuncture Treatment of Meniere's Disease (메니에르 병의 침 치료에 관한 최근 임상 연구 동향)

  • Lee, Kyou-Young;Hong, Chul-Hee
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.31 no.3
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    • pp.26-38
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    • 2018
  • Objectives : The purpose of this study is to investigate the possibility of applying acupuncture to the treatment of meniere's disease, which has no definite treatment methods, by analyzing the latest clinical researches about acupuncture treatment of meniere's disease. Methods : A case study and Randomized Controlled Trial (RCT) related to the acupuncture treatment of meniere's disease were searched using domestic and international thesis search engines including OASIS, CNKI, J-STAGE, PubMed. This study include acupuncture treatment and acupuncture combined with other treatments such as herbal medicine. The search was limitied to the publication date from 2000 to 2018 with free full text. Results : 17 cases were selected. There were 7 case studies in Korea, 5 case studies in China, and 5 RCT papers in China. All 12 cases reported improvement in meniere's disease and all RCT studies showed significantly higher treatment effects in the experimental group than in the control group. Conclusions : Acupuncture treatment showed significant effects for meniere's disease when applied alone or in combination with other treatments. In the future, various systematic studies should be conducted only for acupuncture treatment.

A literature review on controlling methods used in clinical trials of auricular acupuncture (이침 임상시험에서의 대조군에 대한 문헌고찰)

  • Lee, Ji-Young;Yim, Yun-Kyoung
    • Korean Journal of Acupuncture
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    • v.25 no.2
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    • pp.57-69
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    • 2008
  • Objectives : To review the controlling methods used in RCTs (randomized controlled trials) of auricular acupuncture. Methods : To investigate the controlling methods used in clinical trials of auricular acupuncture, 46 articles were retrieved from PUBMED (from August 1976 to August 2007, with limits: english, clinical trial) using the key words of "ear acupuncture", "auricular acupuncture", "auriculo-medicine", and sorted out according to the types of control treatments. Among them, 10 articles were selected based on STRICTA (Standards for Reporting Intervention in Controlled Trials of Acupuncture), and the controlling methods used in those articles were reviewed. Results : In clinical trials of auricular acupuncture, 'sham acupoints (non-acupoints and non-treatment acupoints included)', 'minimal acupuncture', 'pseudo-intervention', and 'placebo devices' have been used as controlling methods, but their 'inactivity' have been in question. To compensate the disadvantages of 'minimal acupuncture', and 'pseudo-intervention' control, placebo auricular acupuncture needles have been developed, although these needles didn't satisfy the conditions of 'blinding' and 'physical inactivity' simultaneously. Conclusions : Further researches on 'sham acupoints' and new development of 'placebo auricular acupuncture needles' are needed.

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Ultrasound guidance versus the blind method for intrauterine catheter insemination: A randomized controlled trial

  • Mubarak, Sarah;Yusoff, Noor Haliza;Adnan, Tassha Hilda
    • Clinical and Experimental Reproductive Medicine
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    • v.46 no.2
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    • pp.87-94
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    • 2019
  • Objective: The primary objective of this study was to compare clinical pregnancy rates in intrauterine insemination (IUI) treatment cycles with transabdominal ultrasound guidance during intrauterine catheter insemination (US-IUI) versus the "blind method" IUI without ultrasound guidance (BM-IUI). The secondary objective was to compare whether US-IUI had better patient tolerability and whether US-IUI made the insemination procedure easier for the clinician to perform compared to BM-IUI. Methods: This was a randomized controlled trial done at the Reproductive Medicine Unit of General Hospital Kuala Lumpur, Malaysia. We included women aged between 25 and 40 years who underwent an IUI treatment cycle with follicle-stimulating hormone injections for controlled ovarian stimulation. Results: A total of 130 patients were recruited for our study. The US-IUI group had 70 patients and the BM-IUI group had 60 patients. The clinical pregnancy rate was 10% in both groups (p> 0.995) and there were no significant difference between the groups for patient tolerability assessed by scores on a pain visual analog scale (p= 0.175) or level of difficulty for the clinician (p> 0.995). The multivariate analysis further showed no significant increase in the clinical pregnancy rate (adjusted odds ratio, 1.07; 95% confidence interval, 0.85-1.34; p= 0.558) in the US-IUI group compared to the BM-IUI group even after adjusting for potential covariates. Conclusion: The conventional blind method for intrauterine catheter insemination is recommended for patients undergoing IUI treatment. The use of ultrasound during the insemination procedure increased the need for trained personnel to perform ultrasonography and increased the cost, but added no extra benefits for patients or clinicians.