• Title/Summary/Keyword: Randomized Clinical Trials

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Review of Clinical Studies of Traditional Chinese Medicine Treatment for Growing Pains in China using CNKI Database (CNKI 검색을 통한 중국에서의 성장통의 한의학적 치료에 대한 임상연구 동향)

  • Doh, Tae Yun;Park, Sul Gi;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.33 no.2
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    • pp.32-47
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    • 2019
  • Objectives The purpose of this study is to investigate clinical studies on the effectiveness of Traditional Chinese Medicine treatment on growing pains in China, and to seek better methods to treat and study for growing pains in South Korea. Methods The clinical studies from the China Academic Journal (CAJ) in China National Knowledge Infrastructure (CNKI) that were published up to January 2019 were reviewed. The key word used were '生長痛', '發育期痛', '治療', '中?治療', '中藥'. Then, the literature were analyzed in regards to the treatment methods and results. Results Among the 35 searched studies, 1 randomized controlled trials, 16 case series, and 3 case reports were selected and analyzed. In most of the studies, the effectiveness of Traditional Chinese Medicine treatment on growing pains was significantly positive. The most commonly used herbs for oral administration were Glycyrrhizae Radix et Rhizoma (甘草), Achyranthis Bidentatae Radix (牛膝), Paeoniae Radix Alba (白芍藥), Dioscoreae Rhizoma (山藥), Angelicae Gigantis Radix (當歸), Astragali Radix (黃?), Atractylodis Rhizoma Alba (白朮), Poria Sclerotium (茯?) Rehmanniae Radix Preparata (熟地黃), Lycopodii Herba (伸筋草). Other treatment methods such as, external application of herb medicine, massage, acupuncture were also used to treat growing pains. Conclusion Based on the results of the clinical studies from China, the use of chinese medicine for treatment of growing pains has been shown to be effective. Additional clinical studies are needed to confirm these findings.

Clinical effectiveness of different types of bone-anchored maxillary protraction devices for skeletal Class III malocclusion: Systematic review and network meta-analysis

  • Wang, Jiangwei;Yang, Yingying;Wang, Yingxue;Zhang, Lu;Ji, Wei;Hong, Zheng;Zhang, Linkun
    • The korean journal of orthodontics
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    • v.52 no.5
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    • pp.313-323
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    • 2022
  • Objective: This study aimed to estimate the clinical effects of different types of bone-anchored maxillary protraction devices by using a network meta-analysis. Methods: We searched seven databases for randomized and controlled clinical trials that compared bone-anchored maxillary protraction with tooth-anchored maxillary protraction interventions or untreated groups up to May 2021. After literature selection, data extraction, and quality assessment, we calculated the mean differences, 95% confidence intervals, and surface under the cumulative ranking scores of eleven indicators. Statistical analysis was performed using R statistical software with the GeMTC package based on the Bayesian framework. Results: Six interventions and 667 patients were involved in 18 studies. In comparison with the tooth-anchored groups, the bone-anchored groups showed significantly more increases in Sella-Nasion-Subspinale (°), Subspinale-Nasion-Supramentale(°) and significantly fewer increases in mandibular plane angle and the labial proclination angle of upper incisors. In comparison with the control group, Sella-Nasion-Supramentale(°) decreased without any statistical significance in all treated groups. IMPA (angle of lower incisors and mandibular plane) decreased in groups with facemasks and increased in other groups. Conclusions: Bone-anchored maxillary protraction can promote greater maxillary forward movement and correct the Class III intermaxillary relationship better, in addition to showing less clockwise rotation of mandible and labial proclination of upper incisors. However, strengthening anchorage could not inhibit mandibular growth better and the lingual inclination of lower incisors caused by the treatment is related to the use of a facemask.

Chicken Egg Yolk Antibodies (IgY) for Prophylaxis and Treatment of Rotavirus Diarrhea in Human and Animal Neonates: A Concise Review

  • Thu, Hlaing Myat;Myat, Theingi Win;Win, Mo Mo;Thant, Kyaw Zin;Rahman, Shofiqur;Umeda, Kouji;Nguyen, Sa Van;Icatlo, Faustino C. Jr.;Higo-Moriguchi, Kyoko;Taniguchi, Koki;Tsuji, Takao;Oguma, Keiji;Kim, Sang Jong;Bae, Hyun Suk;Choi, Hyuk Joon
    • Food Science of Animal Resources
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    • v.37 no.1
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    • pp.1-9
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    • 2017
  • The rotavirus-induced diarrhea of human and animal neonates is a major public health concern worldwide. Until recently, no effective therapy is available to specifically inactivate the rotavirion particles within the gut. Passive immunotherapy by oral administration of chicken egg yolk antibody (IgY) has emerged of late as a fresh alternative strategy to control infectious diseases of the alimentary tract and has been applied in the treatment of diarrhea due to rotavirus infection. The purpose of this concise review is to evaluate evidence on the properties and performance of anti-rotavirus immunoglobulin Y (IgY) for prevention and treatment of rotavirus diarrhea in human and animal neonates. A survey of relevant anti-rotavirus IgY basic studies and clinical trials among neonatal animals (since 1994-2015) and humans (since 1982-2015) have been reviewed and briefly summarized. Our analysis of a number of rotavirus investigations involving animal and human clinical trials revealed that anti-rotavirus IgY significantly reduced the severity of clinical manifestation of diarrhea among IgY-treated subjects relative to a corresponding control or placebo group. The accumulated information as a whole depicts oral IgY to be a safe and efficacious option for treatment of rotavirus diarrhea in neonates. There is however a clear need for more randomized, placebo controlled and double-blind trials with bigger sample size to further solidify and confirm claims of efficacy and safety in controlling diarrhea caused by rotavirus infection especially among human infants with health issues such as low birth weights or compromised immunity in whom it is most needed.

Credibility of a Newly Developed Sham Moxibustion (피부 열전도 온도에 근거를 둔 거짓 뜸 개발 및 평가 연구)

  • Jang, Min-Ki;Yoon, Eun-Hye;Jung, Chan-Yung;Byun, Hyuk;Kim, Eun-Jung;Kim, Kyung-Ho;Kim, Kap-Sung;Lee, Seung-Deok
    • Journal of Acupuncture Research
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    • v.27 no.1
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    • pp.117-127
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    • 2010
  • Background : To demonstrate the efficacy of moxibustion therapy, randomized controled trials are required. But, clinical trials of moxibustion had limitations due to the absence of a sham moxibustion model for an appropriate placebo. Objectives : To develop a new sham moxibustion model based on the thermal characteristics of commercial indirect moxibustion, especially temperature, and to evaluate whether it could be applied in clinical trials. Methods : By applying heat insulation, we created a sham moxibustion device that was indistinguishable from a real one with the naked eye. It also stimulated heat but had inert remedial value. A clinical trial was performed on subjects to test double blinding. The subjects were randomly assigned into two groups, a treatment group and a sham group. Acupoint Zusanli($ST_{36}$) was used in each group for 3 times. A sham acupuncture credibility questionnaire was modified into a moxibustion credibility questionnaire and was filled out after treatment. Results : No major difference was detected in the subjects' baseline data. Most subjects and practitioners could not distinguish the sham moxibustion device from the real one. But, subjects who had experience of moxibustion therapy more likely to distinguish the sham moxibustion device from the real one than subjects who didn't have experience of moxibustion therapy. The treatment group showed a significant difference in the VAS(Visual Analog Scale) for intensity of sensation during treatment than that of the sham group. Conclusions : The sham moxibustion device in this study is proved sufficient and credible to be applied in investigations of the effect of moxibustion. But it is more appropriate for the people who don't have experience of moxibustion therapy.

The Assessment of Risk of Bias on Randomised Controlled Trials of Oriental Medicine in Korea (한의학 관련 무작위배정비교임상연구의 비뚤림 위험 평가)

  • Lee, Yoon-Jae;Jang, Bo-Hyoung;Go, Ho-Yeon;Hyun, Min-Kyung;Park, Sun-Young;Lee, Chang-Hoon;Kim, Jin-Sung;Cho, Ki-Ho
    • The Journal of Korean Obstetrics and Gynecology
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    • v.24 no.4
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    • pp.105-113
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    • 2011
  • Objectives: To examine the current status of clinical research in oriental medicine, and to assess 'risk of bias'(ROB) of randomized clinical trials(RCTs) in oriental medicine in Korea. Methods: Special committee for EBM, KOMS(Korean Oriental Medicine Society) reviewed 17 journals related to oriental medicine in Korea (from the first issue to May 2010), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2010), and PubMed (1966 to May 2010). Then we selected eligible RCTs in terms of oriental medicine, and assessed 'risk of bias'. Results: We reviewed 12,653 articles from the 17 journals, and 41 articles from CENTRAL and PubMed. After non-clinical articles were excluded, 1,004 articles were left. Among them, the number of eligible studies in terms of oriental medicine was 306. In these eligible studies, 130 were RCTs. Of RCTs, 69 were on acupuncture, 25 on herbal medicine. The proportion of 'unclear' is high in the criteria of 'Allocation concealment', 'Blinding of participants and personnel', 'Blinding of outcome assessment' and 'Other bias'. On the other hand, 'low' has high in the criteria of 'Incomplete outcome data' and 'Selective reporting'. Conclusions: Risk of bias on oriental medicine is unclear in terms of 'allocation concealment' and 'blinding'. For high-quality research in oriental medicine, further research should be needed on randomization and blinding in the RCTs.

A Literature Review of Application of Sifeng Point (EX-UE 10) in Children (소아에서 사봉혈(四縫穴) 활용에 대한 문헌 조사)

  • Lee, Boram;Shin, Hye Jin;Lee, Jihong;Chang, Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.32 no.3
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    • pp.72-89
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    • 2018
  • Objectives The objective of this study is to investigate the application of Sifeng point (EX-UE 10) in children and to make suggestions for domestic research and clinical application by reviewing relevant randomized controlled trials. Methods Eight electronic databases including English, Chinese, Korean databases were comprehensively searched for randomized controlled trials evaluating the effects of Sifeng point in children up to May 2, 2018. We extracted the year of publication, country, target diseases or symptoms, location of Sifeng, acupuncture method; such as acupuncture tool and depth of insertion, and frequency, number, and duration of the treatment. Results Fifty studies were included for analysis. All the included studies were conducted in China, and studies were published from 1962 to 2017. The most frequent target symptom was anorexia (46%). In addition, Sifeng point was used for digestive diseases or symptoms such as diarrhea, constipation, and mesenteric lymphadenitis, as well as respiratory diseases or symptoms such as cough, cold, acute bronchiolitis, recurrent respiratory tract infections, bronchopneumonia, and asthmatic bronchitis. Also, allergic diseases such as chronic urticaria, and other variety of symptoms such as malnutrition, fever, and iron-deficiency anemia were treated with the Sifeng point. The location of Sifeng points was inconsistent, and the most common location of the Sifeng point was the midpoint of transverse creases of the proximal interphalangeal joints of the index, middle, ring and little fingers (84.2%). The most commonly used acupuncture tool was three-edged needle (40.9%). All included studies have the method of squeezing out blood or mucus from the Sifeng points. The treatment was mostly conducted once per week (35.4%), mostly repeated for 4 times (32.6%). The most common treatment duration was 4 weeks (18.6%). Conclusions We could identify acupuncture method and various indications for the Sifeng points treatment. Based on this study, there is a need for the clinical application and related researches on the Sifeng points in children in Korea. In addition, the treatment location of Sifeng point should be standardized.

Music for Pediatric Patients in Medical Settings: A Systematic Review of Randomized Controlled Trials (소아환자를 위한 음악: 무작위 임상연구의 체계적인 문헌고찰)

  • Lee, Jin Hyung
    • Journal of Music and Human Behavior
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    • v.10 no.2
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    • pp.1-33
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    • 2013
  • The aim of this study was to systematically review the latest clinical trials in music medicine and medical music therapy for pediatric patients. Thirteen databases were searched to obtain randomized controlled/crossover design studies published between the year 2000 and 2012 in English language. Out of 1012 articles retrieved in the initial search, fifteen studies were identified based on an exclusion criteria. Overall, selected articles involved children 1 month to 18 years, sample size of 11 to 150, and total participants of 987. Studies were classified and compared as music medicine or music therapy studies through a systematic synthesis assessing general characteristics, methodological quality, measured outcomes, types of interventions and the study results. Seven music medicine and eight music therapy studies measured seven dependent variables using thirty-six different measurement tools with a large heterogeneity in the selection, type, and method of music interventions. Evaluation of the methodological quality revealed that many studies did not provide a full report of the research method, and did not meet some or most methodological standards, such as randomization, allocation concealment, double or partial blinding, and intention to treat analysis. Although overall research results were positive if not significant, poor methodological quality and heterogeneity in design and intervention strategies raise the question of research bias and trustworthiness issues. The systematic review concluded that music may have a valuable clinical effect in addressing the physical and psychosocial needs of hospitalized children, although more rigorous, homogeneous and replicable studies are greatly needed.

A Study on Homogeneity Analysis of the Guipi Decoction for Treatment of Insomnia Disorder -Focusing on Randomized Controlled Clinical Trials in CNKI (불면장애에 사용된 귀비탕의 동질성 연구 -CNKI에서 검색한 무작위배정 임상연구를 중심으로-)

  • Kim, Dong-Hee;Sakong, Jong-Won;Kang, Chang-Wan;Lee, Sang-Hyup;Ha, Ji-Won;Kim, Bo-Kyung
    • Journal of Oriental Neuropsychiatry
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    • v.29 no.3
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    • pp.145-163
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    • 2018
  • Objectives: The study was designed to provide clinical evidence of homogeneity in analysis of the herbal medicine, Guipi decoction in treating insomnia, using a t-test of randomized controlled trials (RCTs). Methods: This study included RCTs that verified homogeneity of Guipi decoction in treating insomnia. Literature studies of CNKI (Chinese National Knowledge Infrastructure Database) were performed. The basic components group was made to the Guipi decoction of the Yixuerumen?s text. The excluded group was created with the number of herbs excluded from the basic components group. T-test performed that the effective rate in the basic components group and excluded groups. Results: The basic components of Guipi decoction contain Atractylodis Rhizoma Alba, Poria Sclerotium (Poria Sclerotium Cum Pini Radix), Polygalae Radix, Astragali Radix, Zizyphi Semen, Angelicae Gigantis Radix, Aucklandiae Radix, Glycyrrhiza uralensis Fischer, Ginseng Radix (Codonopsis Pilosulae Radix), Longanae Arillus. Herbs excluded from the basic components group were Longanae Arillus, Ginseng Radix (Codonopsis Pilosulae Radix), Glycyrrhiza uralensis Fischer and herbs added to the basic components group were Polygonum multiflorum Thunberg, Schisandrae Fructus, Salviae Militiorrhizae Radix, Paeoniae Radix Alba (in order from the most used to the least). T-test revealed the effective rate in the basic components group was not statistically significant compared to the excluded groups (p=0.161/p=0.162/p=0.103). Conclusions: Effectiveness in treatment of basic components of Guipi decoction and excluded groups were revealed to be homogeneous in treating insomnia. As the number of herbs in the basic components group decreased, mean value in effectiveness of treatment also decreased consequentially. However, there were no statistical significances.

Effectiveness of alendronate as an adjunct to scaling and root planing in the treatment of periodontitis: a meta-analysis of randomized controlled clinical trials

  • Chen, Jin;Chen, Qian;Hu, Bo;Wang, Yunji;Song, Jinlin
    • Journal of Periodontal and Implant Science
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    • v.46 no.6
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    • pp.382-395
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    • 2016
  • Purpose: Alendronate has been proposed as a local and systemic drug treatment used as an adjunct to scaling and root planing (SRP) for the treatment of periodontitis. However, its effectiveness has yet to be conclusively established. The purpose of the present meta-analysis was to assess the effectiveness of SRP with alendronate on periodontitis compared to SRP alone. Methods: Five electronic databases were used by 2 independent reviewers to identify relevant articles from the earliest records up to September 2016. Randomized controlled trials (RCTs) comparing SRP with alendronate to SRP with placebo in the treatment of periodontitis were included. The outcome measures were changes in bone defect fill, probing depth (PD), and clinical attachment level (CAL) from baseline to 6 months. A fixed-effect or random-effect model was used to pool the extracted data, as appropriate. Mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Heterogeneity was assessed using the Cochrane ${\chi}^2$ and $I^2$ tests. Results: After the selection process, 8 articles were included in the meta-analysis. Compared with SRP alone, the adjunctive mean benefits of locally delivered alendronate were 38.25% for bone defect fill increase (95% CI=33.05%-43.45%; P<0.001; $I^2=94.0%$), 2.29 mm for PD reduction (95% CI=2.07-2.52 mm; P<0.001; $I^2=0.0%$) and 1.92 mm for CAL gain (95% CI=1.55-2.30 mm; P<0.001; $I^2=66.0%$). In addition, systemically administered alendronate with SRP significantly reduced PD by 0.36 mm (95% CI=0.18-0.55 mm; P<0.001; $I^2=0.0%$) and increased CAL by 0.39 mm (95% CI=0.11-0.68 mm; P=0.006; $I^2=6.0%$). Conclusions: The collective evidence regarding the adjunctive use of alendronate locally and systemically with SRP indicates that the combined treatment can improve the efficacy of non-surgical periodontal therapy on increasing CAL and bone defect fill and reducing PD. However, precautions must be exercised in interpreting these results, and multicenter studies evaluating this specific application should be carried out.

A Review of Acupuncture Treatment Methods for Lumbar Herniated Intervertebral Disc

  • Kim, Sung Jin;Jeong, Seong Mok;Lee, Chang Hee;Yoon, Jin-Young;Shim, Sung Eun;Kim, Jeong Hyon;Goo, Bon Hyuk;Park, Yeon Cheol;Baek, Yong-Hyun;Nam, Sang Soo;Seo, Byung-Kwan
    • Journal of Acupuncture Research
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    • v.35 no.4
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    • pp.158-168
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    • 2018
  • The purpose of this study was to review clinical studies of lumbar herniated intervertebral disc (LHIVD) treatment using acupuncture. Online database (PubMed, COCHRANE Library, EMBASE, CNKI, KISS, NDSL, KoreaMed, KMbase, OASIS, and KISTI) searches were conducted in May 2018. Studies that used acupuncture, electroacupuncture or warm needle acupuncture were included, along with participants who had lower back pain and radiating pain of their lower limbs consistent with radiological findings. Animal studies and nonclinical data were excluded. Data on treatment methods, site, time, frequency, period, and scales used were analyzed. There were 69 studies including 38 randomized controlled trials, 14 retrospective observational studies, and 17 clinical case studies. There were 51 acupoints selected for acupuncture treatment of LHIVD. The most frequently treated acupoints were BL23, BL25, BL24, and BL40. The mean treatment time, frequency, and duration were $26.06{\pm}6.70$ mins, $6.29{\pm}1.70$ times/week, and $20.57{\pm}11.04$ days, respectively, in randomized controlled trials (RCT), and $18.62{\pm}4.60$ mins, $11.58{\pm}3.99$ times/week, and $34.43{\pm}17.62$ days, respectively, in case/retrospective studies ($mean{\pm}SD$). This review collates information about acupuncture treatment methods for LHIVD.