• Title/Summary/Keyword: Randomized Clinical Trials

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소아 기능성 위장 장애의 한약 치료에 대한 임상연구 동향 - 중의학 무작위 대조군 임상시험을 중심으로 (Trends in Clinical Research of Herbal Medicine Treatment for Functional Gastrointestinal Disorders in Children - Focused on Randomized Controlled Trials in traditional Chinese medicine)

  • 이지홍;이선행;장규태
    • 대한한방소아과학회지
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    • 제35권3호
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    • pp.67-88
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    • 2021
  • Objectives The purpose of this study is to analyze randomized clinical trials (RCTs) on traditional Chinese medicine to summarize its efficacy and safety for the treatment of functional gastrointestinal disorders (FGIDs) in children. Methods We searched literatures published up to March 19, 2021 using two Chinese electronic databases. Data regarding patients, interventions, results, and adverse events were extracted from RCTs of herbal medicine for children with FGIDs. Results A total of 34 RCTs were included: 16 trials on functional dyspepsia, 7 trials on functional constipation, 6 trials on functional abdominal pain, 4 trials on irritable bowel syndrome, and 1 trial on functional diarrhea. 26 of 29 trials that reported total effective rate, the treatment group showed a significant improvement compared to the control group. Most of other evaluation indicators, such as symptom score, symptom disappearance time, and recurrence rate also demonstrated statistically significant improvement. Of the 16 studies which reported safety, 5 studies reported no adverse reactions in either group, and 4 studies reported no statistically significant differences in the incidence of adverse events between two groups. Also, reported adverse events were mostly mild. Conclusions Herbal medicine may help improve symptoms of FGIDs in children. However, due to limited types of studies on sub-diseases of FGIDs and small sample sizes in each study, additional large scale clinical studies on various other FGIDs are necessary.

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

  • 채윤병;김송이;이혜정;박히준
    • Korean Journal of Acupuncture
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    • 제25권2호
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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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    • 제19권6호
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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.

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

  • 박슬기;박소현;이선행;이진용
    • 대한한방소아과학회지
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    • 제34권2호
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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.

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

  • 이승진;신병철;송근성;황의형;윤영주;조현우
    • 한방재활의학과학회지
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    • 제21권4호
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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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    • 제46권1호
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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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    • 제13권1호
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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.

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

  • 정희정;박지은;최선미
    • 대한한의학회지
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    • 제31권1호
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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.

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

  • 남은영
    • 한방비만학회지
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    • 제19권1호
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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.

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

  • 한은정;김윤범
    • 한방안이비인후피부과학회지
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    • 제15권1호
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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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