• Title/Summary/Keyword: randomized clinical trial

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A Systematic Review of Clinical Trials on Acupuncture on the Post-stroke Muscle Spasticity (중풍 후 강직의 침구치료에 대한 계통적 연구)

  • Seo, Byung-Kwan;Baek, Yong-Hyeon;Park, Dong-Suk
    • Journal of Acupuncture Research
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    • v.27 no.6
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    • pp.1-10
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    • 2010
  • Objectives : The aim of this systematic review was to assess the efficacy of acupuncture and its relevant modality on post-stroke muscle spasticity Methods : We included 7 randomized controlled trials(RCTs) and 1 crossover study on acupuncture on the post-stroke muscle spasticity. Articles searches were performed in various databases in October 2009. Eight studies from 38 articles met the inclusion criteria and were used to assess the quality of clinical trials by means of Jadad scale, STRICTA, CONSORT statement and cochrane-handbook for systematic reviews of interventions. Results : Electrical stimulation such as electroacupuncture and TENS on acupoints was used in five studies. Repeatition of electroacupuncture showed significant decrease of the post-stroke muscle spasticity and persistence of the effect. Only three studies were assessed high quality as the methodological assessment tool(Jadad scale) and none of the studies matched STRICTA recommendations. Conclusions : This systematic review shows that there is beneficial effects of electroacupuncture on the post-stroke muscle spasticity. Further study of large population with high methodological quality will be needed.

A review of herbal medicines for chemotherapy induced peripheral neuropathy (한약을 이용한 chemotherapy-induced peripheral neuropathy (CIPN) 치료 관련 무작위 배정 임상 시험에 대한 고찰)

  • Park, Bongki
    • Journal of Korean Traditional Oncology
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    • v.21 no.2
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    • pp.51-61
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    • 2016
  • Background : Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect in cancer patients who were exposed to chemotherapy. CIPN impacts on the quality of life and could delay chemotherapy. The aim of this review was to assess the therapeutic effectiveness of herbal medicine in CIPN patients. Methods : Randomized controlled trials (RCTs) were included in this review. We searched MEDLINE, Cochrane database, EMBASE, CNKI, Wanfang and four Korean databases without restrictions on time or language. The risk of bias was assessed using the Cochrane risk of bias tool. Results : Eleven RCTs involving 706 patients met the inclusion criteria. Eleven different herbal medicines were examined in the included trials. Almost RCTs showed insufficiency in the reporting randomization method and allocation concealment. One trial used allocation concealment and a double-blinding method. Five studies reported that participants dropped out of RCTs and conducted an 'as-treated analysis'. One trials reported adverse effects of herbal medicine. In ten of the eleven trials, the use of herbal medicine had shown significant differences in clinical symptoms or nerve conduction velocity. Conclusions : The use of herbal medicines for CIPN showed significant improvements in the management of CIPN. However, conclusions cannot be drawn because of the generally low quality of methodology and low quantity of data for each single herbal medicine. Further rigorous trials are needed.

Intraoperative discomfort associated with the use of a rotary or reciprocating system: a prospective randomized clinical trial

  • Gomes, Aline Cristine;Soares, Adriana Jesus;Souza, Erick M;Zaia, Alexandre Augusto;Silva, Emmanuel Joao Nogueira Leal
    • Restorative Dentistry and Endodontics
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    • v.42 no.2
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    • pp.140-145
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    • 2017
  • Objectives: The aim of this randomized, controlled, prospective clinical study was to evaluate patients' intraoperative discomfort during root canal preparations in which either multi-file rotary (Mtwo) or single-file reciprocating (Reciproc) systems were used. Materials and Methods: Fifty-five adult patients, aged between 25 and 69 years old, with irreversible pulpitis or pulp necrosis participated in this study. Either the mesiobuccal or the distobuccal canals for maxillary molars and either the mesiobuccal or the mesiolingual canals for mandibular molars were randomly chosen to be instrumented with Mtwo multi-file rotary or Reciproc single-file reciprocating systems. Immediately after each canal instrumentation under anesthesia, patient discomfort was assessed using a 1 - 10 visual analog scale (VAS), ranging from 'least possible discomfort' (1) to 'greatest possible discomfort' (10). The Wilcoxon signed-rank test was used to determine significant differences at p < 0.05. Results: Little intraoperative discomfort was found in all cases. No statistically significant differences in intraoperative discomfort between the 2 systems were found (p = 0.660). Conclusions: Root canal preparation with multi-file rotary or single-file reciprocating systems had similar and minimal effects on patients' intraoperative discomfort.

Erector spinae plane block for spinal surgery: a systematic review and meta-analysis

  • Liang, Xiao;Zhou, Weilong;Fan, Yuchao
    • The Korean Journal of Pain
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    • v.34 no.4
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    • pp.487-500
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    • 2021
  • Background: Although the erector spinae plane block has been used in various truncal surgical procedures, its clinical benefits in patients undergoing spinal surgery remain controversial. The aim of this meta-analysis was to evaluate the clinical benefits of erector spinae plane block in patients undergoing spinal surgery. Methods: We searched the Cochrane Library, PubMed, EMBASE, and China National Knowledge Infrastructure for randomized controlled trials comparing the erector spinae plane block with a nonblocked control for spinal surgery. Results: Twelve studies encompassing 696 subjects were included in our systematic review and meta-analysis. We found that the erector spinae plane block decreased postoperative pain scores and opioid consumption in the postoperative and intraoperative periods. Moreover, it prolonged the time to the first rescue analgesic, reduced the number of patients who required rescue analgesia, and lowered the incidence of postoperative nausea and vomiting. However, it did not exhibit efficacy in decreasing the incidence of urinary retention and itching or shortening the length of hospital stays, or the time to first ambulation. Conclusions: Erector spinae plane block improves analgesic efficacy among patients undergoing spinal surgery compared with nonblocked controls; however, there is insufficient evidence regarding the benefits of erector spinae plane block for rapid recovery.

Review of Clinical Research for Herbal Medicine in the Treatment of Influenza Compared with Oseltamivir (Oseltamivir를 투약한 양성대조군과 비교한 인플루엔자의 한약 치료 효과 - RCT 연구를 중심으로 -)

  • Jang, Eun Ha;Min, Sang Yeon;Kim, Jang Hyun
    • The Journal of Pediatrics of Korean Medicine
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    • v.33 no.3
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    • pp.1-14
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    • 2019
  • Objectives The purpose of this study is to analyze clinical studies on effectiveness of herbal medicine in influenza compared with Oseltamivir. Methods We searched the randomized controlled trials (RCTs) with herbal medicine treatment on influenza compared to Oseltamivir from the Pubmed, CNKI, OASIS, NDSL, J-stage, and CiNii. Results 14 out of 717 studies were selected and analyzed. The herbal medicine treatment had a significant effects on the alleviation of fever, cough, sore throat than the Oseltamivir control treatment. Herbal medicine had same therapeutic effectiveness like Oseltamivir on duration of influenza-like symptoms and viral shedding. No serious adverse reactions were reported from the herbal medicine treatment. Conclusions The results of these trials showed that the herbal medicine may be more effective than the Oseltamivir in the treatment of influenza. Well-designed RCTs for domestic herbal medicine treatment on influenza are needed to prove its efficacy clearly.

Consolidated Standards of Reporting Trials: The Reporting Guideline for Randomized Controlled Trials (Consolidated Standards of Reporting Trials의 소개: 무작위 대조군 연구의 보고 지침)

  • Jung, Hoi-In;Kim, Hee-Eun
    • Journal of dental hygiene science
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    • v.14 no.3
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    • pp.269-275
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    • 2014
  • Recently, there are lots methodologies to improve the quality of research in medical and public health fields. One of them is to checking a process of research with a reporting guideline before reporting paper. Especially, reporting guideline for randomized controlled trials (RCTs) is the consolidated standards of reporting trials (CONSORT). Therefore, this review describes the latest version of the CONSORT statement, CONSORT 2010, including intent, background, and contents of this. The CONSORT statement comprises a checklist of essential items that should be included in reports of RCTs and a diagram for documenting the flow of participants through a trial. This report guideline aims at providing guidance to authors about how to improve the reporting of their trials. As consulting the CONSORT, authors could be strictly reported about research methods and results. From this review, we expect to elevate the quality of such research about dental hygiene and to establish the foundation for evidence-based dental hygiene.

Daily walnut intake improves metabolic syndrome status and increases circulating adiponectin levels: randomized controlled crossover trial

  • Hwang, Hyo-Jeong;Liu, Yanan;Kim, Hyun-Sook;Lee, Heeseung;Lim, Yunsook;Park, Hyunjin
    • Nutrition Research and Practice
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    • v.13 no.2
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    • pp.105-114
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    • 2019
  • BACKGROUND/OBJECTIVES: Several previous studies have investigated whether regular walnut consumption positively changes heart-health-related parameters. The aim of this study was to investigate the effects of daily walnut intake on metabolic syndrome (MetS) status and other metabolic parameters among subjects with MetS. SUBJECTS/METHODS: This study was a two-arm, randomized, controlled crossover study with 16 weeks of each intervention (45 g of walnuts or iso-caloric white bread) with a 6 week washout period between interventions. Korean adults with MetS (n = 119) were randomly assigned to one of two sequences; 84 subjects completed the trial. At each clinic visit (at 0, 16, 22, and 38 weeks), MetS components, metabolic parameters including lipid profile, hemoglobin A1c (HbA1c), adiponectin, leptin, and apolipoprotein B, as well as anthropometric and bioimpedance data were obtained. RESULTS: Daily walnut consumption for 16 weeks improved MetS status, resulting in 28.6%-52.8% reversion rates for individual MetS components and 51.2% of participants with MetS at baseline reverted to a normal status after the walnut intervention. Significant improvements after walnut intake, compared to control intervention, in high-density lipoprotein cholesterol (HDL-C) (P = 0.028), fasting glucose (P = 0.013), HbA1c (P = 0.021), and adiponectin (P = 0.019) were observed after adjustment for gender, age, body mass index, and sequence using a linear mixed model. CONCLUSION: A dietary supplement of 45 g of walnuts for 16 weeks favorably changed MetS status by increasing the concentration of HDL-C and decreasing fasting glucose level. Furthermore, consuming walnuts on a daily basis changed HbA1c and circulating adiponectin levels among the subjects with MetS. This trial is registered at ClinicalTrials.gov as NCT03267901.

Safety and Efficacy of Flow Diverter Therapy for Unruptured Intracranial Aneurysm Compared to Traditional Endovascular Strategy : A Multi-Center, Randomized, Open-Label Trial

  • Kim, Junhyung;Hwang, Gyojun;Kim, Bum-Tae;Park, Sukh Que;Oh, Jae Sang;Ban, Seung Pil;Kwon, O-Ki;Chung, Joonho;Committee of Multicenter Research, Korean Neuroendovascular Society,
    • Journal of Korean Neurosurgical Society
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    • v.65 no.6
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    • pp.772-778
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    • 2022
  • Objective : Endovascular treatment of large, wide-necked intracranial aneurysms by coil embolization is often complicated by low rates of complete occlusion and high rates of recurrence. A flow diverter device has been shown to be safe and effective for the treatment of not only large and giant unruptured aneurysms, but small and medium aneurysms. However, in Korea, its use has only recently been approved for aneurysms <10 mm. This study aims to compare the safety and efficacy of flow diversion and coil embolization for the treatment of unruptured aneurysms ≥7 mm. Methods : The participants will include patients aged between 19 and 75 years to be treated for unruptured cerebral aneurysms ≥7 mm for the first time or for recurrent aneurysms after initial endovascular coil embolization. Participants assigned to a flow diversion cohort will be treated using any of the following devices : Pipeline Flex Embolization Device with Shield Technology (Medtronic, Minneapolis, MN, USA), Surpass Evolve (Stryker Neurovascular, Fremont, CA, USA), and FRED or FRED Jr. (MicroVention, Tustin, CA, USA). Participants assigned to a coil embolization cohort will undergo traditional endovascular coiling. The primary endpoint will be complete occlusion confirmed by cerebral angiography at 12 months after treatment. Secondary safety outcomes will evaluate periprocedural and post-procedural complications for up to 12 months. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes the aim and design of a multi-center, randomized, open-label trial to compare the safety and efficacy of flow diversion versus traditional endovascular treatment for unruptured cerebral aneurysms ≥7 mm.

Clinical and microbiological effects of the supplementary use of an erythritol powder air-polishing device in non-surgical periodontal therapy: a randomized clinical trial

  • Park, Eon-Jeong;Kwon, Eun-Young;Kim, Hyun-Joo;Lee, Ju-Youn;Choi, Jeomil;Joo, Ji-Young
    • Journal of Periodontal and Implant Science
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    • v.48 no.5
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    • pp.295-304
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    • 2018
  • Purpose: This study was undertaken to evaluate the clinical and microbiological effects of an erythritol powder air-polishing device (EPAP) as a supplement to scaling and root planing (SRP) therapy in patients with moderate chronic periodontitis. Methods: Clinical and microbiological evaluations were performed at 21 sites treated with SRP (control) and 21 sites treated with SRP+EPAP (test). All examinations were performed before treatment, 1 month after treatment, and 3 months after treatment. Results: There were no significant clinical differences between the test group and the control group. Microbiological analysis revealed that the relative expression level of Porphyromonas gingivalis was significantly lower in the test group than in the control group at 1 month after treatment. Clinical and microbiological results showed improvements at 1 month compared to baseline; in contrast, the results at 3 months after treatment were worse than those at 1 month after treatment. Conclusions: In this study, both SRP and SRP+EPAP were clinically and microbiologically effective as non-surgical periodontal treatments. In particular, the SRP+EPAP group showed an antimicrobial effect on P. gingivalis, a keystone bacterium associated with the onset of chronic periodontitis, in a short-term period. Periodic periodontal therapy, at intervals of at least every 3 months, is important for sustaining the microbiological effects of this treatment.

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.