• Title/Summary/Keyword: Randomized controlled clinical trials

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An Intensive Review On Clinical Thesis about Hwangryunhaedok-tang Pharmacopuncture Treatment: Focused on Case Reports and Controlled Studies in Korean Academic Journals (황련해독탕약침 치료에 대한 임상 논문 고찰: 국내 학술지의 증례보고와 대조군 연구 중심으로)

  • Lee, Soo-Hwan;Kim, Soon-Joong
    • Journal of Korean Medicine Rehabilitation
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    • v.29 no.2
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    • pp.171-188
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    • 2019
  • Objectives The purpose of this thesis is to compare and analyze outcomes of case studies and controlled studies about Hwangryunhaedok-tang (HHT) pharmacopuncture in clinical studies. Based on these studies reporting clinical effects by using HHT pharmacopuncture, we object to deduct the comparative review in applying clinical disorders limitedly. And conclusionally, by using this comparative review, we aim to make the fine evidence in treating clinical specific diseases. Methods We searched 106 studies about HHT pharmacopuncture from 6 Korean web databases by using in Korean word 'Hwangryunhaedok-tang pharmacopuncture'. This search had been progressed throughout 1 month (January, 2019). There was 106 thesis and we excluded studies that are not related to HHT pharmacopuncture, experimental research, not the case report or randomized controlled trials, non-randomized controlled trials, not using HHT pharmacopuncture, not using only one pharmacopuncture, and not using HHT pharmacopuncture for major treating method. As a result, 39 thesis are selected as a population. Results We analyzed 34 case reports and 5 controlled studies. As the final outcome, HHT pharmacopuncture was used in musculoskeletal diseases, dermatopathy, and 32 specific diseases. Conclusions After analyzing 39 studies, effective symptom changes clinically and statistically by using HHT pharmacopuncture herbal acupuncture were identified. However, these thesis designs were reported deficiently in many parts such as not excluding other confounding variables. After modifying defects of thesis design and conduct study, it can play a role as the evidence using HHT pharmacopuncture more precisely.

A Review of Clinical Researches for Herbal Medicine Treatment on Vitiligo (백반증의 한약 치료에 대한 임상 연구 고찰)

  • Park, Sul Gi;Park, So Hyun;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.34 no.2
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    • pp.57-74
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    • 2020
  • Objectives The purpose of this study is to analyze clinical studies on the efficacy and safety of herbal medicine in vitiligo by analyzing randomized controlled trials (RCTs). Methods Three electronic databases including the PubMed, EMBASE, and Cochrane library were used to search for randomized controlled trials, by using specific key words and criteria up to January 4th, 2020. Data in regards to years of publication, nation, demographic information, disease characteristics, duration of diseases, treatment methods, treatment period, outcome measures, results and adverse events were collected for this study. Results A total of 11 randomized controlled trials were selected and analyzed. The total effective rate of the treatment group treated with herbal medicine was significantly higher than that of the control group. In the other outcome measures, the treatment group also showed statistically significant differences in improving the outcome measures compared to the control group, or showed similar treatment effects to the control group. The most commonly used herbal medicines were Carthami Flos (紅花), Angelicae Gigantis Radix (當歸), Angelica dahurica Bentham et Hooker f. (白芷), Astragali Radix (黃芪), Glycyrrhizae Radix et Rhizoma (甘草), Salviae Miltiorrhizae Radix (丹參), Persicae Semen (桃仁), Araliae Continentalis Radix (獨活), Tribuli Fructus (白蒺藜), Psoraleae Semen (補骨脂) etc. Hardly any severe adverse events were reported from the trials selected. Conclusions Based on the results of the clinical studies, herbal medicine treatment could be an effective and safe option for vitiligo treatment and symptom improvement.

A Systematic Review of the Effectiveness of Eastern-Western Integrative Medicine for Musculoskeletal Disorders (근골격계 질환의 한·양방협진치료 효과 연구에 대한 체계적 문헌 고찰)

  • Lee, Seung-Jin;Shin, Byung-Cheul;Song, Geun-Sung;Hwang, Eui-Hyoung;Yun, Young-Ju;Cho, Hyun-Woo
    • Journal of Korean Medicine Rehabilitation
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    • v.21 no.4
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    • pp.87-96
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    • 2011
  • Objectives: This study aims to systematically evaluate the effectiveness of Eastern-Western integrative medicine for musculoskeletal disorders compared with Eastern or Western Medicine. Methods: Systematic sea-mes of 9 major Korean databases were conducted for articles published up to July 2011. Searching keyword was "Integrative Medicine". Prospective studies dealt with musculoskeletal disorders by Eastern-Western integrative medicine were included. Quality assessment of included studies was evaluated by Cochrane risk of bias tool. Results: 470 studies in total were seamed, Amalg them 7 studies met our inclusion criteria(3 randomized controlled clinical trials, 2 non-randomized controlled trials and 2 uncontrolled clinical trials). Included studies dealt with lumbar pan(3), shoulder pain(2), pain after traffic injury(1), spinal compression fracture(1). Eastern-Western integrative medicine showed better or equal effect for the treatment of various muscloskeletal disorders compared with Eastern or Western medicine alone. Conclusions: There is very weak evidence for the effectiveness of Eastern-Western integrative medicine for musculoskeletal disorders compared with Eastern or Western medicine alone. Well designed randomized controlled trials with rigorous methodology are needed to evaluate the effectiveness of Eastern-Western integrative medicine objectively in the future.

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.

Neoadjuvant Chemotherapy for Resectable Esophageal Carcinoma: A Meta-analysis of Randomized Clinical Trials

  • Xu, Xiao-Hua;Peng, Xue-Hong;Yu, Ping;Xu, Xiao-Yuan;Cai, Er-Hui;Guo, Pi;Li, Ke
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.1
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    • pp.103-110
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    • 2012
  • Neoadjuvant chemotherapy for resectable esophageal carcinoma has been a focus of study, but no agreement has been reached on clinical randomized controlled trials and relevant systematic evaluation. The purpose of this study was to perform a meta-analysis on published randomized controlled trials (RCTs) that compared neoadjuvant chemotherapy and surgery with surgery alone for resectable esophageal carcinoma. Medline and manual searches was conducted in PubMed, ASCO (American Society of Clinical Oncology) meeting summary, Embase, the Cochrane Library (up to October 2010), Chinese Biomedical Literature Database, China National Knowledge Infrastructure, VIP Database, Wanfang Database. The selection contents were to identify all published and unpublished RCTs that compared neoadjuvant chemotherapy and surgery with surgery alone for resectable esophageal carcinoma. Sixteen RCTs which included 2,594 patients were selected. The risk ratio (RR) (95% confidence interval [CI]; P value), expressed as neoadjuvant chemotherapy and surgery versus surgery alone (treatment versus control), was 1.02 (0.95, 1.10; P=0.54) for 1-year survival, 1.29 (1.13, 1.47; P=0.0001) for 3-year survival, 1.31 (1.13, 1.51; P=0.0003) for 5-year survival, 1.00 (0.95, 1.04; P= 0.85) for rate of resection and 0.89 (0.64, 1.23; P=0.48) for operative mortality. The results showed that neoadjuvant chemotherapy for resectable esophageal carcinoma can raise the overall survival rate of patients with esophageal carcinoma, but it does not affect treatment-related mortality.

Is Gwibitang and its modification beneficial for alleviating symptoms in chronic fatigue syndrome: A systematic review and meta-analysis (귀비탕과 그 변방의 만성피로증후군 증상완화에 대한 효용성: 체계적인 문헌고찰)

  • Nam, Donghyun
    • Herbal Formula Science
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    • v.28 no.2
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    • pp.199-209
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    • 2020
  • Objectives : The purpose of this systematic review is to confirm whether Gwibitang is beneficial in chronic fatigue syndrome (CFS). Methods : Clinical trials were searched from databases including Pubmed, Embase, Central Cochrane, CNKI, Wanfang, CQVIP, CiNii, OASIS, Koreamed, and NDSL. The eligible study design was limited into randomized controlled trial, quasi-randomized controlled trial and controlled clinical trial. The outcomes included general effectiveness as nominal scale, and fatigue severity, insomnia severity and quality of life as interval or ratio scale. The meta-analysis and assessment of risk of bias was performed based on the data extracted from the selected trials. Results : The results of eight randomized controlled trials (n=596) were included in the meta-analysis. The results of the synthesis showed Gwibitang is beneficial substantially for relieving and managing the general symptoms, and its heterogeneity was not in important level (RR 0.26 [95% CI 0.17, 0.39], Z=6.47, P<0.00001, I2=0%). Gwibitang was beneficial for alleviating fatigue (SMD -0.78 [95% CI -1.27, -0.30], Z=3.17, P=0.002), but its certainty was low. In case of insomnia, too few trials had been found and their risk of bias was substantial, so no conclusions had been brought to. Conclusions : We found an evidence that Gwibitang could be beneficial for managing and alleviating main symptoms in CFS patients.

Randomized Controlled Clinical Trials in the Journal of Korean Society of Chuna Manual Medicine for Spine and Nerves: A Quantitative and Qualitative Analysis (척추신경추나의학회지에 수록된 무작위대조임상 연구의 양적, 질적 분석)

  • Cho, Hyun-Woo;Lee, Hyeon-Yeop;Heo, Kwang-Ho;Hwang, Eui-Hyoung;Shin, Mi-Suk;Shin, Byung-Cheul
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.7 no.2
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    • pp.15-23
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    • 2012
  • Objectives: The aim of this study is to assess the quantity and quality of randomized controlled clinical trials (RCTs) published in the journal of Korean Society of Chuna Manual Medicine for Spine and Nerves (KSCMSN). Methods: All relevant RCTs were selected and extracted. Data extract of RCTs from all the articles published in the jounal of KSCMSN up to now, quantity assessment was made on the study design, sample size, intervention, control group and medical condition. of the consolidated standards of reporting trials (CONSORT) check list. Assessment was performed by 2 independent reviewers and disagreement was discussed based on concensus. Results: Among the 276 articles, 10 RCTs were published. 1st articles were published in 2003 and half of RCTs were published in 2011. All RCTs were parallel 2-arm designed. Average sample size was 29.2 per study and 14.6 per arm. Main intervention was consisted as acupuncture 40%, pharmacopuncture 30% and Chuna 30%. Average of adequacy of CONSORT check list was 10.3% and overall reports were insufficient. Conclusions: Though RCTs published in jounal of KSCMSN were increasing, the quality remains low. KSCMSN should make a effort to follow the CONSORT statement and improve the quantity and quality of studies.

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Herbal Medicine for Tension-type Headache: Systematic Review and Meta Analysis of Randomized Controlled Trials (긴장성두통에 대한 한약치료: 체계적 문헌고찰 및 메타분석)

  • Choi, Eun-Ji;Kwon, Chan-Young;Han, Kyung-Hun;Kim, Jong-Woo;Chung, Sun-Young
    • Journal of Oriental Neuropsychiatry
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    • v.26 no.4
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    • pp.383-406
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    • 2015
  • Objectives: People with tension-type headache generally take pain relievers, but long term dependency causes problems as well as side effects. The present study aimed to provide clinical evidence of herbal medicine for tension-type headache by systematic review of randomized controlled trials on the effect of herbal medicine for tension-type headache. Methods: Randomized or quasi-randomized controlled trials that verified effects of herbal medicine intervention on patients with tension-type headache were included in the study. A literature search of English, Japanese, Chinese, Korean databases was performed. The selected literature were assessed by Jadad scale and Risk of Bias. Results: Herein, 40 reports were selected from a total of 157. Meta-analyses of 2 trials indicated that the effective rate was significantly higher in the herbal medicine treatment group, as compared to the placebo control (risk ratio: 1.49, 95% confidence interval (CI): 1.23 to 1.80, p<0.0001, I2=0%). Four trials that compared herbal medicine with routine care with routine care only group showed a significantly higher effective rate of benefits for herbal medicine with routine care, as compared to routine care only (RR: 1.57, 95% CI: 1.18 to 2.10, p=0.002, I2=0%). Conclusions: The effective rate was significantly higher than control and adverse events were less in the treatment group. Pattern analysis (辨證) indicated that the studies on wind-fire pattern (風火證) were highest. Yougeun-bang (柔筋方) in prescription and Paeoniae Radix Alba (白芍藥) in medicinal herbs were most used. This finding could be widely utilized in future clinical practice and form the basis for the development of clinical practice guidelines in advance.

A Review of Recent Clinical Studies of Herbal Medicine Treatment for Children's Stomatitis : Focusing on Randomized Controlled Trials in Traditional Chinese Medicine (소아 구내염의 한약치료에 대한 임상연구 동향: 중의학 무작위대조군 임상시험을 중심으로)

  • Heo, Yu Jin;Lee, Shin Hee;Cho, Yun Soo
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.4
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    • pp.125-140
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    • 2021
  • Objectives This study aims to find out the recent trend of the herbal medicine treatment in children's stomatitis in China, and propose better methods to treat children's stomatitis in Korea. Methods The randomized controlled trials (RCT) relevant to 'Herbal medicine treatment on children's stomatitis' were searched using China Academic Journal (CAJ). The search method we used included search formula, (SU = '口內炎' + '口腔炎' + 'stomatitis') and (SU = '儿童' + '小儿' + 'children' + 'child') from 2000 to September 2021. Results A total of 9 RCTs were selected and analyzed. All reports showed that oral administration of herbal medicine were effective and improved clinical symptoms. The most-used herbal medicine category was Heat-clearing medicine (淸熱藥). Conclusions The literatures from China have shown that herbal medicine improves children's stomatitis. These outcomes may be helpful for the treatment of children's stomatitis in Korea. However, further studies are needed to develop treatment guidelines for children's stomatitis.

Clinical Effectiveness of Traditional Herbal Medicine in the Treatment of Chemotherapy-induced Leukopenia: A Systematic Review and Meta-analysis of Randomized Clinical Trials (항암화학요법 유발 백혈구감소증에 대한 한약치료의 효과 : 체계적 고찰 및 메타분석(2007-2017))

  • Kim, Min-serh;Jung, Yu-jin;Hong, Sang-hoon
    • The Journal of Internal Korean Medicine
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    • v.39 no.4
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    • pp.520-549
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    • 2018
  • Objectives: We performed a systematic review and meta-analysis to explore the recent clinical research trends regarding the effects of traditional herbal medicine (THM) on chemotherapy-induced leukopenia. Methods: Randomized controlled trials that verified effects of herbal medicine treating chemotherapy induced leukopenia were included in the study. A literature search was performed in the English, Chinese, and Korean databases for papers published from January 1, 2007, to September 1, 2017. The selected literature was assessed by Cochrane's Risk of Bias (RoB). Results: Forty-two of 232 randomized controlled trials met the inclusion criteria. The most commonly used herbal prescriptions called '升白湯 (shengbai decoction)' which means elevating the numbers of White blood cells (WBCs). And the mostly included herbs such as Astragali Radix, Angelicae Gigantis Radix, Atractylodis Rhizoma Alba, Codonopsis Pilosulae, Glycyrrhizae Radix, Ligustri Lucidi Fructus are commonly used to elevate qi, blood and yin. The count of WBC in peripheral blood, the level of leukopenia presented in WHO (World Health Organization), and clinical symptoms were used to evaluate the treatments. The effective rate was 68.6-98.18% and the effectiveness was significantly higher in the intervention group than in the control group in 38 articles (p<0.05). No serious adverse events were reported. Only five articles (5/42, 11.9%) were rated as having adequate methodological quality with a low level of bias. Conclusion: Some traditional herbal medicines may be effective as therapeutic treatments for chemotherapy-induced leukopenia, but the majority of reviewed studies were of poor quality. The present findings need to be confirmed by rigorously conducted high-quality trials, including pharmacokinetic studies, to confirm the absence of interactions between traditional herbal medicine agents and chemotherapy.