• Title/Summary/Keyword: Randomized controlled study

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Localized probiotic-guided pocket recolonization in the treatment of chronic periodontitis: a randomized controlled clinical trial

  • Kumar, Vikram;Singhal, Rameshwari;Rastogi, Pavitra;Lal, Nand;Pandey, Shivani;Mahdi, Abbas Ali
    • Journal of Periodontal and Implant Science
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    • v.51 no.3
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    • pp.199-212
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    • 2021
  • Purpose: This randomized clinical placebo-controlled trial was conducted to evaluate the effectiveness of Lactobacillus reuteri as a probiotic in guided pocket recolonization (GPR) for the treatment of chronic periodontitis (CP) adjunctive to scaling and root planing (SRP). Methods: Forty-eight CP patients were randomly assigned to 3 treatment groups: group 1 (SRP+placebo), group 2 (SRP+single application of probiotic), and group 3 (SRP+incremental application of probiotic). Clinical parameters were evaluated at baseline and at 8, 12, and 24 weeks, whereas biochemical parameters were measured at baseline and 12 weeks. Results: At 24 weeks, the probing pocket depth and clinical attachment level improved in all 3 groups from baseline with no significant intergroup differences; however, a statistically significant difference was observed in localized plaque and gingival scores between groups 1 and 3 (P<0.05). At 12 weeks, matrix metalloproteinase-8 (MMP-8), nitric oxide (NO), and gingipains-R (Rgps) levels improved in all 3 groups, with statistically significant differences between groups 1 and 3 for MMP-8 and NO (P<0.05), but no difference for Rgps levels. Conclusions: Within its limitations, the results of this study show that incremental 3-time application of L. reuteri as a probiotic led to improvements in clinical and biochemical parameters. This protocol can be a useful adjunct to SRP in the non-surgical management of CP.

Effects of nursing intervention programs for women with gestational diabetes: a systematic review of randomized controlled trials (임신성 당뇨병을 가진 임산부를 위한 간호중재 프로그램의 효과: 무작위 대조군 실험연구의 체계적 문헌고찰)

  • Kim, JooHee;Chung, ChaeWeon
    • Women's Health Nursing
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    • v.27 no.1
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    • pp.14-26
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    • 2021
  • Purpose: This study aimed to identify the effects of nursing intervention programs for women with gestational diabetes mellitus (GDM) through a critical review of recent studies. Methods: Studies related to effects of nursing intervention programs for women with GDM published in English or Korean between 2000 and 2019 were extracted from 10 electronic databases. The quality of the studies was evaluated and double-checked for accuracy by two reviewers using the Revised Cochrane Risk-of-Bias tool for randomized controlled trials. Results: Twenty studies were selected, of which 19 had a low risk of bias and one had a high risk of bias. Interventions fell into six main groups: (1) integrated interventions, (2) self-monitoring of blood glucose levels, (3) dietary interventions, (4) exercise, (5) psychotherapy, and (6) complementary therapy. This review found that nursing interventions for GDM were of many types, and integrated interventions were the most common. However, low-carbohydrate diets and blood glucose monitoring interventions did not show statistically significant results. Evidence shows that various nursing intervention programs applied to GDM improved diverse aspects of maternal, fetal, and neonatal health, including both physical and psychological aspects. Conclusion: The composition and delivery of integrated interventions continue to evolve, and these interventions affect physical and psychological indicators. Although interventions affecting physical health indicators (e.g., blood glucose levels, diet, and exercise) are important, many studies have shown that programs including psycho-emotional nursing interventions related to anxiety, depression, stress, self- efficacy, and self-management are also highly useful.

Meta-analysis of the Effect of Proprioceptive Neuromuscular Facilitation Training on Gait Ability in Patients with Storke

  • Jeun, Young-Ju
    • Journal of the Korea Society of Computer and Information
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    • v.26 no.8
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    • pp.165-172
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    • 2021
  • The purpose of this meta-analysis was to determine the efficacy of proprioceptive neuromuscular facilitation training on Gait. We included all randomized controlled trials assessing the efficacy of proprioceptive neuromuscular facilitation training on gait ability control in patients after stroke. This study was conducted according to the PRISMA guideline. CINAHL, PubMed and RISS were searched for studies published up to December 2020, and all randomized controlled trails assessing PNF intervention were included. This analysis included only randomized controlled trials. A total of 12 studies were selected from 1475 records obtained from the databases. The meta-analysis was performed using the R software. The overall intervention effect was moderate (standardized mean difference (SMD): 0.67, 95% confidence interval (CI): 0.50-0.84). Additionally, Gait rite (SMD: 0.69), 10m walking test (SMD: 0.59) had medium effect sizes. These findings indicate that PNF is an effective intervention for improving gait ability in patients stroke.

A comprehensive quality analysis of randomized controlled clinical trials of Asian ginseng and American ginseng based on the CONSORT guideline

  • Chen, Weijie;Li, Xiuzhu;Chen, Zhejie;Hao, Wei;Yao, Peifen;Li, Meng;Liu, Kunmeng;Hu, Hao;Wang, Shengpeng;Wang, Yitao
    • Journal of Ginseng Research
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    • v.46 no.1
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    • pp.71-78
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    • 2022
  • Ginseng is an international herb that has been used for thousands of years. Two species most commonly applied and investigated in the ginseng family are Asian ginseng and American ginseng. The number of randomized controlled clinical trials (RCTs) has conspicuously increased, driven by the rapid development of ginseng. However, the reporting of RCT items of ginseng is deficient because of different trial designs and reporting formats, which is a challenge for researchers who are looking for the data with high quality and reliability. Thus, this study focused on providing an extensive analysis of these two species and examined the quality of the RCTs, based on the Consolidated Standards of Reporting Trials (CONSORT) guideline. Ninety-one RCTs conducted from 1980 to 2019 that were related to Asian ginseng and American ginseng used singly met our inclusion criteria. We found that the reporting quality of the two species has improved during the past 40 years. Publication date and sample size were significantly associated with the reporting quality. Rigorous RCTs designed for the species of ginseng are warranted, which can shed light on product research and development of ginseng in the future.

Recent Trends in Clinical Research of Herbal Medicine for Tic Disorder in Children - Focused on Chinese Randomized Controlled Trials - (소아 틱장애의 한약치료에 대한 최신 임상연구 동향 - 중국 무작위 대조군 임상연구를 중심으로 -)

  • Kim, Jae Hyun;Park, Yong Seok;Jeong, Yoon Kyoung;Chang, Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.36 no.1
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    • pp.38-56
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    • 2022
  • Objectives The purpose of this study was to analyze the trend of recent randomized controlled trials (RCTs) that used herbal medicine for the treatment of tic disorders in China and to evaluate the efficacy and safety of the treatment. Methods RCTs published from January 2017 to December 2021 were searched for using the China National Knowledge Infrastructure (CNKI). These were then analyzed using herbal medicine treatment methods and their results. Results A total of 35 randomized controlled trials were selected and analyzed. In most studies, evaluation indicators such as the Yale tic symptom scale and total effective rate were significantly improved in the herbal medicine treatment group compared to the control group. The most commonly used herb for tic disorder was Uncaria Rhynchophylla (釣鉤藤), followed by Glycyrrhizae Radix (甘草), Gastrodiae Rhizoma (天麻), Paeoniae Radix Alba (白芍藥), Batryticatus (白殭蠶), Poria (茯笭), and Bupleuri Radix (柴胡). In all studies that reported adverse events, herbal medicine was identified as a relatively safe treatment with fewer adverse reactions or no significant difference compared with the control group. Conclusions Based on the results of RCTs, herbal medicine has been shown to be safe and effective for the treatment of intellectual disability. However, additional well-designed large-scale clinical trials are needed to confirm these findings.

Clinical Effect of Gyeongok-go: A Systematic Review of Randomized Controlled Trials (경옥고의 임상 효능 : 체계적 고찰)

  • Kang, Heekyung;Han, Changwoo
    • The Journal of Internal Korean Medicine
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    • v.43 no.3
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    • pp.423-435
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    • 2022
  • Purpose: The purpose of this study was to confirm the clinical efficacy of Gyeongok-go. Methods: Public/Publisher MEDLINE (PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), Excerpta Medica dataBASE (EMBASE), Research Information Sharing Service (RISS), ScienceON, Korean Traditional Knowledge Portal (KTKP), and China National Knowledge Infrastructure (CNKI) were searched for randomized controlled clinical trials administering Gyeongok-go as an intervention, published from inception to December 31, 2021. The risk-of-bias of the included trials was assessed with the Cochrane risk-of-bias tool for randomized trials version 2. From the experimental and control groups of the selected trials, the mean value (or rate) of each outcome was extracted and statistically compared. Results: Statistically significant mean differences were in VO2max (MD 6.82), post-exercise heart rate (MD -8.76 at 5 min, -11.58 at 30 min, -14.6 at 60 min), senescence scale (MD -6.52), Th1 cells and Th2 cells in pulmonary tuberculosis (MD 2.79 and -1.64), yin-deficient and qi-deficient score (MD -9.64 and -9.76), and phlegm-dampness score (MD 5.56). Overall risk-of-bias was 20% low risk, 80% some concerns, and 0% high risk. There were no reports of adverse events. Conclusions: Gyeongok-go is likely to have the effect of improving cardiorespiratory endurance, increasing fatigue recovery ability, reducing senescence, and enhancing immune function in tuberculosis patients. Also, it is more suitable for those who are yin-deficient or qi-deficient, and those with phlegm-dampness probably need caution.

Chuna Manual Therapy for Postpartum Low Back Pain: Systematic Review (출산 후 요통에 대한 추나요법의 효과: 체계적 문헌고찰)

  • Cho, Ju-chan;Park, In-hwa;Hwang, Man-Suk;Heo, In
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.16 no.2
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    • pp.1-8
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    • 2021
  • Objectives This study aimed to evaluate the effect of chuna manual therapy (CMT) for postpartum low back pain using a systematic review. Methods We performed a literature search using 12 electronic databases up to the end of September 2021. We included randomized controlled trials (RCTs) that evaluated the effect of CMT in the treatment of postpartum low back pain. The risk of bias was evaluated using the Cochrane risk-of-bias tool. Results Four randomized controlled trials were reported statistically significant effect in pain VAS, ODI and JOA of chuna manual therapy compared with moxibution, electro acupuncture, hyperthermia or usual care. As a result of assessing the risk of bias tool, most of the contents of the evaluation items were not identified, so it was evaluated as an uncertain risk. Conclusions CMT may be effective in treating postpartum low back pain. However, evidence was limited due to the small sample size, lack of well-designed RCTs and regional bias. Further well-designed studies are required to obtain stronger evidence.

Extracorporeal Shock Wave Therapy with Meridian and Acupoint Theory for Adhesive Capsulitis: A Systematic Review and Meta-analysis of Randomized Controlled Trials (경혈경락 이론에 근거한 체외충격파 치료가 유착성 관절낭염에 미치는 영향: 무작위 대조 임상연구에 대한 체계적 문헌고찰과 메타분석)

  • Han, Donghun;Park, In-hwa;Heo, In
    • Journal of Korean Medicine Rehabilitation
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    • v.32 no.2
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    • pp.55-63
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    • 2022
  • Objectives This review was conducted to evaluate effectiveness and safety of extracorporeal shock wave therapy (ESWT) with meridian and acupoint theory for adhesive capsulitis. Methods By December 2021, 11 electronic databases were reviewed with the key words 'extracorporeal shock wave' and '(acupuncture OR acupoint OR meridian)'. This key words was set up to increase the sensitivity of the search. After the search, adhesive capsulitis study was selected based on the title and abstract and then included after full-texts were read. Results Five randomized controlled trials were eligible in our inclusion criteria. The meta-analysis of 3 studies showed positive results for the using ESWT with meridian and acupoint theory for adhesive capsulitis compared with the control group on efficancy rate and range of shoulder flexion. Conclusions Some studies showed ESWT with meridian and acupoint theory were statistically effective to adhesive capsulitis. But the evidence is limited due to the defective design of the included randomized controlled trials (RCTs). So use of ESWT with meridian and acupoint theory for adhesive capsulitis has limited evidence. More well-designed RCTs are required to provide clearer evidence for this claim.

Analysis of Clinical Research Trends for Thread Embedding Acupuncture of Cervical Radiculopathy

  • Eun Sil, Heo;Hyun-Jong, Lee;Jung Hee, Lee;Sang Ha, Woo;Yun Kyu, Lee;Seong Hun, Choi;Jae Soo, Kim
    • Journal of Acupuncture Research
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    • v.39 no.4
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    • pp.283-296
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    • 2022
  • In this study, the evidence of thread embedding acupuncture (TEA) in treating cervical radiculopathy in randomized controlled trials was investigated. We searched 16 databases up to August 22, 2022. Of the 2,644 studies retrieved, 22 randomized controlled trials (2,483 participants) were selected. Quality assessments were performed using Cochrane's risk-of-bias tool and RevMan 5.4 software. Outcome measures in the included studies typically showed TEA had a significant therapeutic effect compared with simple acupuncture and other remedies, and TEA was better than sham TEA. Catgut and polydioxanone had no difference in effectiveness, however, catgut was considered to be less safe. TEA was shown to be more therapeutic when inserted deeper into the skin. Ultrasound guided TEA was more effective and safer than conventional TEA, and using a flat blade needle was better than conventional needles for TEA. No serious adverse events were reported from using TEA, and only a few mild side effects were observed. However, the limited number and heterogeneity of the included studies, together with the unclear methodological quality, indicate that higher-quality studies need to be conducted to determine the effectiveness and safety of TEA for cervical radiculopathy.

A Literature Review of Randomized Controlled Trials on Tobacco Cessation Using Auricular Acupuncture and Auricular Acupressure

  • Min-Gi, Jo;Jun-Yeong, Jang;Min-Jung, Ko;Sang-Yeup, Chae;Seungeun, Lee;Dongmin, Lee;Won Suk, Sung;Jung-Hyun, Kim;Bonhyuk, Goo;Yeon-Cheol, Park;Yong-Hyeon, Baek;Sang-Soo, Nam;Byung-Kwan, Seo
    • Journal of Acupuncture Research
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    • v.39 no.4
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    • pp.258-266
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    • 2022
  • This study aimed to analyze auricular acupressure and auricular acupuncture used in smoking cessation research by analyzing published randomized controlled trials. Eight databases (PubMed, Cochrane, EMBASE, CNKI, CiNII, KMbase, KISS, OASIS) were searched until December 2021, and 21 out of 1,919 studies met inclusion criteria. Data on the treatment site, time, frequency, period, and outcomes were analyzed. Lung (MA-IC1) and Ear Shenmen (MA-TF1) were the most used acupoints. The number of treatments varied between a minimum of 2 to a maximum of 24, and treatment duration varied between a minimum of 2 weeks to a maximum of 8 weeks. Cigarette consumption and smoking cessation rate were the most studied outcome, followed by multiple other psychological indications.