• Asian Pacific Journal of Cancer Prevention
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• v.17 no.4
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• pp.2049-2053
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• 2016

Background: The LigaSure vessel sealing system has been proposed to save operation time and reduce intraoperative blood loss for various surgeries. However, its usage for gastric cancer is still controversial. The aim of the present meta-analysis was to compare the effectiveness of LigaSure with conventional surgery in gastrectomy. Materials and Methods: Sources were retrieved from the Cochrane Library, MEDLINE, EMBASE, SCOPUS and Google Scholar until February, 2015. All randomized controlled trials comparing LigaSure with conventional surgery in curative gastric cancer resection were selected. After data extraction, statistics were performed by Review Manager 5.1 software. Results: Three eligible randomized controlled trials were evaluated, with a total of 335 patients. The quality of the included trials was good, yet some methodological and clinical heterogeneity existed. There were no significant differences between the LigaSure and conventional groups in operative time (weighted mean difference [WMD], -22.95 minutes; 95% confidence interval [CI], [-59.75, 13.85]; P = 0.22), blood loss (WMD, -45.8 ml; 95% CI, [-134.5, 42.90]; P = 0.31), nor the incidence of surgical complications (odds ratio, 1.18; 95% CI, [0.68, 2.05]; P = 0.54). But there was a longer duration of hospital stay in LigaSure group (WMD, 1.41 days; 95% CI, [0.14, 2.68]; P = 0.03). Conclusions: All available randomized evidence has been summarized. LigaSure does not confer significant advantage over conventional surgery for curative gastric cancer resection. The usefulness of the device may be limited in gastrectomy. But, more trials are needed for further assessment of the LigaSure system for gastric cancer.

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.3
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• pp.979-983
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• 2012

Background : Previous studies have suggested a lack of complete cross-resistance between steroidal (exemestane) and non-steroidal aromatase inhibitors (nSAI). Methods : Eighty-eight metastatic breast cancer (MBC) patients who received 25 mg of exemestane orally once a day at the National Cancer Center, Korea, between 2003 and 2009, were reviewed retrospectively. All patients had received nSAI for metastatic disease prior to exemestane therapy. Results : The median age was 52 years (range, 33-79), and 13 (14.8%) patients were premenopausal who concomitantly received GnRH agonist. Exemestane was given as a second- (80.7%) or third-line (19.3%) hormone therapy. The clinical benefit (CB) rate (complete response + partial response + stable disease ${\geq}$ 24 weeks) was 30.7%, with a median CB duration of 10.0 months (range, 6.3-78.7). The median progression-free survival (PFS) was 3.0 months (95% confidence interval [CI], 1.99-4.01) and the overall survival (OS) 21.5 months (95% CI, 17.96-25.04), with a median followup of 50.3 months. Patients who achieved CB had longer OS than those patients who did not (29.6 vs 17.9 months; P=0.002). On univariate analysis of predictive factors, patients who had achieved CB from previous nSAI tended to show lower CB rate (24.6% vs 44.4%, respectively; P=0.063) and shorter PFS (2.8 vs 4.8 months, respectively; p=0.233) than patients who had not. Achieving CB from previous nSAI became independent predictive factor for CBR to exemestane on multivariable analysis (Odds ratio = 2.852, P = 0.040). Conclusions : Exemestane after nSAI failure was effective in prolonging CB duration. The drug's efficacy seemed to be inferior in patients who had benefit from previous nSAI use.

• The Journal of Internal Korean Medicine
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• v.28 no.2
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• pp.363-376
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• 2007

Objectives : This study was undertaken to learn what should be considered in a good clinical trial investigating a herbal medicine as an antidepressant. Methods : Five well-designed clinical trials published from 2000 to 2006 investigating SJWE in depressive disorder were selected. The trials were reviewed and compared in terms of methodology such as trial design, patient selection, efficacy & safety evaluation, and so on. On the basis of this review of the trials and the regulations and guidelines of KFDA, we suggest some points to be considered for a good clinical trial of a herb for depression. Results : Although every trial had its own unique design, procedure, objectives and so on, all trials used randomizing and double blinding methods. If there is no ethical problem, a placebo-controlled design should be considered in a herbal antidepressant clinical trial for depression. Conclusions : Some points to be considered in an optimal & good clinical trial for an antidepressive herbal medicine were suggested as follows: 1) randomizing and double blinding manner is essential, 2) if there is no ethical problem, placebo control design should be considered, 3) the trial period should be 6 weeks, 4) out-patients will be recruited as subjects, 5) investigators will be well-trained psychiatrists or medical doctors, 6) the number of subjects should be calculated by statistical methods, 7) subjects should be diagnosed by DSM-IV criteria, 8) subjects who have current risk of committing suicide should be excluded, etc.

• Journal of Korean society of Dental Hygiene
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• v.14 no.6
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• pp.839-847
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• 2014

Objectives: The purpose of the study was to investigate the perception of clinical trials of dental hygienist. Methods: A self-reported questionnaire was filled out by 126 dental hygienists in Seoul, Kyonggi and other area from October 1 to November 15, 2012. The instrument of the study was adapted from Jung and reconstructed. The questionnaire consisted of general characteristics of the subjects(9 questions) and recognition for clinical trials(10 questions). Recognition for clinical trials instrument included recognition for clinical trial conception(2 questions), objective recognition(5 questions), and subjective recognition for clinical trial(3 questions). The instrument was score by Likert 5 scale and Cronbach alpha was 0.936 in the study. Data were analyzed by SPSS 20.0 program and set at p<0.05. Independent t-test, chi-square test, one way ANOVA, and post-hoc Duncan test were done. Results: Those who had higher ages and higher education tended to have longer clinical careers(p<0.05). There was a significant difference in clinical trials between the level of education, clinical dental hygienists and professors. The differences in problem perception for activation of clinical trial according to workplace appeared to lack of publicity and inadequacy of facilities(p<0.05). Conclusions: To improve the perception of the clinical trials in dental hygienists, it is necessary to prepare the human resources programs, the additional curricula, continuing education courses and active publicity.

• Journal of Pharmacopuncture
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• v.20 no.3
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• pp.179-193
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• 2017

Objectives: Nigella sativa (black seed or black cumin), which belongs to the Ranunculacea family, is an annual herb with many pharmacological properties. Among its many active constituents, thymoquinone (TQ) is the most abundant constituent of the volatile oil of Nigella sativa (N. sativa) seeds, and it is the constituent to which most properties of this herb are attributed. Methods: PubMed-Medline, Scopus, and Web of Science databases were searched to identify randomized control trials (RCTs) investigating the therapeutic effects of N. sativa and/or TQ. In this review, we investigated the clinical uses of N. sativa and TQ in the prevention and the treatment of different diseases and morbidity conditions in humans. Results: Black seed and TQ are shown to possess multiple useful effects for the treatment of patients with several diseases, such as inflammatory and auto-immune disorders, as well as metabolic syndrome. Also, other advantages, including antimicrobial, anti-nociceptive and anti-epileptic properties, have been documented. The side effects of this herbal medicine appear not to be serious, so it can be applied in clinical trials because of its many advantages. Conclusion: Some effects of N. sativa, such as its hypoglycemic, hypolipidemic and bronchodilatory effects, have been sufficiently studied and are sufficiently understood to allow for the next phase of clinical trials or drug developments. However, most of its other effects and applications require further clinical and animal studies.

• Korean Journal of Acupuncture
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• v.34 no.1
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• pp.8-36
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• 2017

Objectives : The aim of this study is to review the methodology of clinical trials conducted with the acupuncture and moxibustion treatment on functional dyspepsia. Methods : We searched four international databases and three Korean databases including English, Korean and Chinese, through March 2016 for randomized controlled trials(RCT) and non-randomized case-control trials(CCT) that evaluated the effects of the acupuncture and moxibustion on functional dyspepsia. We abstracted the designs of the trials and the method of acupuncture and moxibustion treatment according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture. Results : A total 117 papers were reviewed. The 106 studies were conducted in China. There were 111 RCTs(95%), and 6 CCTs(5%). Sixty eight studies(59%) were conducted with the manual acupuncture, 29 studies of electro-acupuncture(25%), 11 studies of moxibustion(9%), 5 studies of acupoints embedding therapy(4%), 4 studies of acupoint injection therapy(3%) were conducted. ST36, CV12, ST25 were most frequently used for acupoints to treat functional dyspepsia. In 59 studies(50%), western medication was used in the control group, and the effects of acupuncture and moxibustion were evaluated with the symptoms in most studies. Conclusions : These results suggest that it is necessary to develop more detailed reporting standards about acupuncture and moxibustion treatment method as the method of acupuncture and moxibustion is getting more diverse, and more objective tools are needed in evaluating functional dyspepsia.

• Journal of Acupuncture Research
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• v.32 no.2
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• pp.123-130
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• 2015

Objectives : Primary dysmenorrhea is one of the most common female gynecological diseases. Acupuncture and moxibustion therapy have been used to treat dysmenorrhea in Korea. The aim of this review was to examine the effectiveness of acupuncture and moxibustion therapy for primary dysmenorrhea as described in studies in Korea. Methods : A total of 8 databases were searched, with the search concluding February 15, 2015. These were the Oriental Medicine Advanced Searching Integrated System, DBpia, Korean Studies Information Service System, National Digital Science Library, Korean Traditional Knowledge Portal, Research Information Sharing Service, and Pubmed. Randomized controlled Trails(RCTs) comparing acupuncture or moxibustion therapy with non acupoints stimulation or medication were selected. Data abstraction and assessment of methodology was conducted by authors and disagreements were resolved by discussion. Results : 7 trials were included in this review, with a total of 308 participants. 4 trials reported on acupuncture, 1 trial reported on acupress by magnet, 1 trial reported on pharmacopuncture, and the other trial reported on moxibustion. Quality of methodology was low. 2 trials showed that experimental therapy was effective for pain relief compared to the controlled group. However, 5 trials did not show a significant difference in pain relief. Conclusions : Acupuncture and moxibustion therapy may reduce period pain, however, it is needed for well designed RCTs in Korea.

• Journal of Acupuncture Research
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• v.29 no.3
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• pp.19-28
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• 2012

Objectives : The aim of this study is to evaluate present clinical evidence of oriental medical treatment for cancer in Korea. Method : A search was performed in the Korean Studies Information, Korea Institute of Science and Technology Information, KoreaMed, Oriental Medicine Advanced Searching Integrated System, National Assembly Library, RISS4u, DBPIA, and Oasis using the keyword 'cancer', 'leukemia', 'malignant tumor', 'lymphoma', 'multiple myeloma', 'melanoma'. The search period spanned between Jan 1, 1980~June 30, 2011 and the results were analyzed and evaluated according to the publication date, journal, method of treatment, type of study, and the primary outcome. Randomized clinical trials (RCTs) and Non randomized clinical trial(NRCT) were reviewed separately. Result : The results yielded 133 trials during the period of Jan 1, 1980~June 30, 2011. Most of the trials were concerned with lung cancer and 94 of the trials were simple case studies or case series studies. 61 trials used herbal Formula/herbal medicine as the primary method of treatment. A total of 4 RCTs existed compared to only one NRCT. Conclusion : The use of oriental medicine for the treatment of cancer is gaining popularity in the field of medical scientific research. However most of the studies that have been published up to date are mostly case studies or case series studies, and RCT/NRCT are rare. In order to provide appropriate evidence regarding the effectiveness of oriental medicine in the treatment of cancer, more rigorous and well-designed studies are warranted.

• Journal of Acupuncture Research
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• v.27 no.1
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• pp.109-116
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• 2010

Objectives : Since The Journal of Korean Acupuncture and Moxibustion Society(JKAMS) started publishing in 1984, randomised controlled trials(RCTs) and non-randomised clinical studies(NRSs) consistently have increased in quality and quantity. There has been no study on quality assessment of NRSs. Thus, this study evaluted non-randomised comparative clinical trials in the JKAMS to assess the quantity and quality. Methods : Upon extracting NRSs for assessing the intervention effects from all the articles published in the JKAMS from 1984 to 2009, assessments were made on methodological index for non-randomised studies(MINORS). Also, the analysis were made upon the proportion of non-randomised comparative clinical trials within original articles. The mean scores by research methods and years, and total scores and mean scores of yearly research methods were analyzed. Results : A total of 44 trials on non-randomised comparative clinical trials were selected. In 1980s, 4.3% of the total selected original articles, in 1990s, 4.1%, and in 2000s 14.2% were NRSs. According to the research designs, the mean scores of MINORS were Case-control study 18.3, Controlled before and after 18.5, Quasi randomised trial 18.5, and non randomised trial 17.9(out of 24), respectively. Cross-sectional study was the most frequently used(41.9%). Conclusion : Although NRSs consistently increased in quantity, the assessed mean scores were low and most articles used Cross-sectional study. Thus, there should be studied using appropriate research methods in the future.

• Journal of Acupuncture Research
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• v.30 no.3
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• pp.109-115
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• 2013

Objectives : This study was aimed to find the motivation and satisfaction of subjects who participated in acupuncture and moxibustion clinical trials and to suggest ways to improve clinical trial management. Methods : We conducted a survey and collected the data of 233 subjects of acupuncture and moxibustion clinical trials from 6 university hospitals. Results : For all 233 subjects, the mean of the total satisfaction score was 4.07 (perfect score 5.0), and the score was particularly high in aspects of the investigator and clinical research coordinator, but low in the site and sponsor aspects. There were no differences in the satisfaction degree with general characteristics. The satisfaction degree of the acupuncture and moxibustion clinical trials was strong positive correlated with participation benefits(r=0.595) and easy contact with the research team (r=0.500). Conclusions : Most subjects showed positive perception and interest in the clinical trials. Future studies should investigate how personal factors influence the satisfaction of subjects, should identify a specific classification criterion, and create a standardized protocol for the clinical trials.