• Title/Summary/Keyword: Randomized Clinical Trials

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Is Minimal Acupuncture an Adequate Control in Clinical Trials? (최소 침(Minimal Acupuncture)이 침 임상연구에서 적절한 대조군인가?)

  • Chae, Youn-Byoung;Kim, Song-Yi;Lee, Hye-Jung;Park, Hi-Joon
    • Korean Journal of Acupuncture
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    • v.25 no.2
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    • pp.71-85
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    • 2008
  • Objective : Acupuncture, one of the Oriental medical treatment techniques in East Asia, is growing in popularity all over the world. Based on bibliographical and clinical data, the depth of needling, i.e. superficial or deep needling, has been considered to be a variable as potential modifiers of needling effects, such as localization, manipulation of the needle, or elicitation of DeQi. The purpose of this review is to summarize clinical trials using minimal acupuncture and to evaluate its appropriateness as a control. Methods : A survey of computerized literature searches for randomized controlled trials using minimal acupuncture revealed that a total of 10 studies were published until April 2008. Results : Results obtained from clinical trials showed that acupuncture were more effective than minimal acupuncture in 3 out of 10 trials, while others were no more effective than control. However, minimal acupuncture might neither be a inert placebo nor be indiscriminable. Conclusion : Minimal acupuncture as 'placebo' controls seems misleading and scientifically unacceptable.

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Interventions for anesthetic success in symptomatic irreversible pulpitis: A network meta-analysis of randomized controlled trials

  • Sivaramakrishnan, Gowri;Alsobaiei, Muneera;Sridharan, Kannan
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.19 no.6
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    • pp.323-341
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    • 2019
  • Background: Local anesthetics alone or in combination with adjuncts, such as oral medications, have routinely been used for pain control during endodontic treatment. The best clinical choice amongst the vast numbers of agents and techniques available for pain control for irreversible pulpitis is unclear. This network meta-analysis combined the available evidence on agents and techniques for pulpal anesthesia in the maxilla and mandible, in order to identify the best amongst these approaches statistically, as a basis for future clinical trials. Methods: Randomized trials in MEDLINE, DARE, and COCHRANE databases were screened based on inclusion criteria and data were extracted. Heterogeneity was assessed and odds ratios were used to estimate effects. Inconsistencies between direct and indirect pooled estimates were evaluated by H-statistics. The Grading of Recommendation, Assessment, Development, and Evaluation working group approach was used to assess evidence quality. Results: Sixty-two studies (nine studies in the maxilla and 53 studies in the mandible) were included in the meta-analysis. Increased mandibular pulpal anesthesia success was observed on premedication with aceclofenac + paracetamol or supplemental 4% articaine buccal infiltration or ibuprofen+paracetamol premedication, all the above mentioned with 2% lignocaine inferior alveolar nerve block (IANB). No significant difference was noted for any of the agents investigated in terms of the success rate of maxillary pulpal anesthesia. Conclusion: Direct and indirect comparisons indicated that some combinations of IANB with premedication and/or supplemental infiltration had a greater chance of producing successful mandibular pulpal anesthesia. No ideal technique for maxillary anesthesia emerged. Randomized clinical trials with increased sample size may be needed to provide more conclusive data. Our findings suggest that further high-quality studies are required in order to provide definitive direction to clinicians regarding the best agents and techniques to use for mandibular and maxillary anesthesia for irreversible pulpitis.

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.

Current Status of Institutional Review Boards and Approvals of Clinical Research in Oriental Medical Hospitals in Korea: A Survey (국내 한방병원의 IRB 및 임상시험 실태조사)

  • Jung, Hee-Jung;Park, Ji-Eun;Choi, Snu-Mi
    • The Journal of Korean Medicine
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    • v.31 no.1
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    • pp.122-129
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    • 2010
  • Objective: To investigate institutional review boards and approved clinical trials of Oriental medical hospitals in Korea Methods: We e-mailed 16 Oriental medical hospitals a survey consisting of questions that addressed two topics, institutional review boards and the clinical trials they approved. The first part included questions about whether each hospital had an institutional review board, that board's staffing and education, reviews, and expedited reviews. The clinical trials portion covered the number and types of approved clinical trials, treatment methods, whether an investigator or a sponsor initiated the trials, diseases, time frame, and clinical trial fee. Results: We received a response to our e-mail from 14 hospitals, all of which had an institutional review board. The average number of institutional review board members was 13.57. Of these Oriental medical hospitals, 70% and 49% said that they regularly educated their institutional review board staff and clinical trial, investigators, respectively. 79% of the hospitals claimed to conduct regular reviews, and 50% said that they did so monthly. The number of approved clinical trials increased sharply from 11 in 2005 to 102 in 2008. 68% of these clinical trials were randomized, and the most-used treatment methods were herbal medicine (35%) and acupuncture (29%). The most common target diseases were circulatory (19%), urinogenital (14%), and musculoskeletal (13%) disease. Conclusions: Despite the rapid increase in clinical research in oriental medical hospitals, many more efforts including raising IRB quality, varying research diseases and increasing clinical trials in the hospitals located in non-metropolitan area, should be made.

The Systematic Review on Clinical Studies of Traditional Korean Medicine Treatment for Obesity in Menopausal Women (폐경 여성의 비만에 응용되는 한방치료에 대한 문헌 고찰)

  • Nam, Eun Young
    • Journal of Korean Medicine for Obesity Research
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    • v.19 no.1
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    • pp.56-67
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    • 2019
  • Objectives: The purpose of this study is to review clinical studies of herb medicine and acupuncture treatment on obesity in menopausal women. Methods: Key words "Obesity", "Menopause", "Herb medicine", "Acupuncture", "Moxibustion", "Catgut embedding" were searched on 9 database systems (PubMed Central, Cochrane Controlled Register of Trials, Embase, China Academic Journals, Korean Traditional Knowledge Portal, Oriental Medicine Advanced Searching Integrated System, Korean Studies Information Service System, National Digital Science Library, DBpia) on April 30th 2019. Results: 1 case report and 17 clinical trials were collected in accordance with the selection and exclusion criteria. Among the 17 trials, 6 were randomized controlled trials, 1 was controlled clinical trial, and 10 were single-arm trials. The types of intervention were herb medicine, electroacupuncture, acupuncture, auricular acupuncture, warm needle acupuncture, moxibustion, laser acupuncture, and catgut embedding. The study design, study results and method of intervention were analyzed. Conclusions: 1 case report described the effectiveness of pharmacopuncture, 4 trials described the effectiveness of herbal medicine, 2 of electroacupuncture, 1 of laser acupuncture, and 2 of catgut embedding. Among the 17 trials, 2 studies showed that herbal medicine treatment was more effective than no treatment or selective serotonin reuptake inhibitors, and 1 study showed that electroacupuncture was more effective than hormone therapy. All of 18 selected studies reported the effectiveness of weight reduction and abdominal obesity reduction after the traditional Korean medicine treatment for obesity in menopausal women.

Review of Clinical Trials on Aromatherapy in PubMed (PubMed 검색을 통해 살펴본 Aromatherapy의 임상연구동향에 관한 고찰)

  • Han, Eun-Jeung;Kim, Yoon-Bum
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.15 no.1
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    • pp.276-284
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    • 2002
  • Aromatherapy is becoming increasingly popular, however there are few clear indications for its use. To systematically review the clinical studies on aromatherapy, computcrized literature searches were performed from PubMed. Fourteen trials were located. The conclusions were as follows: 1. All the trials were published after 1993. 2. To analyze the publication journals, five of fourteen trials were on nursing, three of them on neuropsychiatry and one on dermatology. 3. Most widely used indications of aromatherapy were on general physical, psychological and physiological field. 4. On the procedure of aromatherapy, eight of them were by massage, three by inhalation, one by massage & inhalation and one by bath additive. 5. To analyze the publication type, all fourteen trials were clinical trials. Twelve of them were randomized controlled trials. Two of them were using single subject design. 6. To observe the sample size, five of them were under 10, four from 10 to 50, two from 50 to 100 and three above 100. 7. Eleven of fourteen trials were using inferential statistics. Eight of the eleven trials were significantly effective, but three had no statistical significance.

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DESIGN AND ANALYSIS OF RANDOMIZED CLINICAL TRIALS REQUIRING PROLONGED OBSERVATION OF EACH PATIENT I. INTRODUCTION AND DESIGN

  • Peto R.;Pike M.C.;Armitage P.;Breslow N.E.;Cox D.R.;Howard S.V.;Mantel N.;Mcpherson K.;Peto J.;Smith P.G.
    • 대한예방의학회:학술대회논문집
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    • 1994.02b
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    • pp.206-233
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    • 1994
  • The Medical Research Council has for some years encouraged collaborative clinical trials in leukaemia and other cancers, reporting the results in the medical literature. One unreported result which deserves such publication is the development of the expertise to design and analyse such trials. This report was prepared by a group of British and American statisticians, but it is intended for people without any statistical expertise. Part!, which appears in this issue, discusses the design of such trials; Part II, which will appear separately in the January 1977 issue of the Journal, gives full instructions for the statistical analysis of such trials by means of life tables and the logrank test, including a worked example, and discusses the interpretation of trial results, including brief reports of particular trials. Both parts of this report are relevant to all clinical trials which study time to death, and would be equally relevant to clinical trials which study time to other particular classes of untoward event: first stroke, perhaps, or first relapse, metastasis, disease recurrence, thrombosis, transplant rejection, or death from a particular cause. Part I, in this issue, collects together ideas that have mostly already appeared in the medical literature, but Part II, next month, is the first simple account yet published for non-statistical physicians of how to analyse efficiently data from clinical trials of survival duration. Such trials include the majority of all clinical trials of cancer therapy; in cancer trials, however, it may be preferable to use these statistical methods to study time to local recurrence of tumour, or to study time to detectable metastatic spread, in addition to studying total survival. Solid tumours can be staged at diagnosis; if this, or any other available information in some other disease is an important determinant of outcome, it can be used to make the overall logrank test for the whole heterogeneous trial population more sensitive, and more intuitively satisfactory, for it will then only be necessary to compare like with like, and not, by chance, Stage I with Stage III.

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