• Journal of Gastric Cancer
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• v.5 no.2
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• pp.79-88
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• 2005

Quality assurance may be defined as the complete set of systemic actions that is required to achieve a better treatment result by standardizing treatment and by using various audit programs. In general, application of a quality assurance program in surgery is considered to be more difficult than it is in chemotherapy or radiotherapy. However, recently, the importance of quality assurance in the surgical field has been emphasized in clinical trials comparing different surgical procedures and evaluating the role of postoperative adjuvant therapy. In the case of gastric cancer surgery, excellent quality assurance programs have rarely been applied in most large prospective clinical trials. Although the quality assurance in Dutch trial was conducted very systemically and strictly, the situation is quite different from ours. On the other hand, several quality assurance programs in Japanese trials comparing D2 and D2 plus para-arotic lymph node dissection seem to be applicable to Korean clinical trials. Several factors, including selection of appropriate surgeons based on personal experience and annual number of operations, standardization of surgical procedures by education and consensus, development of a unified database program, application of standardized perioperative management, and standardization of pathologic examination, are required to guarantee a successful multi-institutional prospective clinical trial. In contrast, one needs to realize that protocols that are too strict and sophisticated can make the enrollment of patients and surgeons more difficult and can promote protocol violation during the clinical trials. (J Korean Gastric Cancer Assoc 2005;5:79-88)

• The Korean Society of Law and Medicine
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• v.15 no.1
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• pp.211-237
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• 2014

Because of unpredictability and high possibility of abnormal results by clinical trials compared to general medical behaviors, a procedure for ensuring with sufficient explanations by investigators must be secured. Therefore, in a sequence of clinical trials, what kinds of scope, stage, and method of explanations provided by investigators, including doctors or researchers, to trial subjects are closely related to the compensation for damages by violation of liability for explanation. In case of application of clinical trials to patients who have critical illness such as cancer, issues of "Quality of Life" regarding trial subjects, cancer patients, should be discussed. Especially, in case of clinical trials for terminal cancer patients, the right of subjects' self-determination, which is a fundamental principle in medical behaviors, should be discussed. The right of self-determination includes participation in clinical trials for the possibility of life-sustaining even a little bit, or no participation in clinical trials in order to have a time for completing the rest of his life. Like this, if the extent and scope of explanations related to the issues of "Quality of Life" are raised as main issues, the evaluation of "Quality of Life", should be a prerequisite. In many occasions, realistically, despite bad results such as deaths or serious adverse drug reactions after clinical trials, it may not be easy for compensating to trial subjects or their survivors, who requested civil compensation for damage. Futhermore, in abnormal results after concealment of clinical trials or performance of clinical trials without permission, and in the case of trial subjects' failures of proving proximate cause between the clinical trials and abnormal results, problematic results such as no protection to the trial subjects could be occurred. In performing clinical trials, investigators should provide sufficient explanations for trial subjects and secure voluntary informed consents from the trial subjects. Therefore, clinical trials without trial subjects' permissions and the informed consent process violate trial subjects' rights of self-determination, and the investigators shall be liable for compensation for damages. Then, issues might be addressed are what are essential contents of patients' "rights of self-determination" infringed by clinical trials without subjects' permissions. Two perspectives about patients' rights of self-determination might be considered. One perspective regards physical distress of patients (subjects) from therapies without sufficient explanations as the crux of the matter. The other perspective regards infringement of human dignity caused by being subjects without permission as the crux of the matter irrespective of risks' big and small influences. This research follows perspective of the latter. Forming constant fiduciary relation between investigators (doctors) and subjects (patients) pursuant medical contracts, and in accordance with this fiduciary relation, subjects, who are patients, have expectations of explanations and treatments by the best ways. If doctors and patients set this forth as a premise, doctors should assume civil liability when doctors infringe patients' expectations.

• Korean Journal of Acupuncture
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• v.27 no.4
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• pp.85-97
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• 2010

목적 : 이 연구는 서로 다른 두 경혈이 심박변이도에 미치는 영향을 비교하고, 자율신경계에 미치는 영향을 평가하기 위해 수행하였다. 재료 및 방법 : 13명의 지원자가 3개의 세션에 균등하게 무작위 배정되었다. 각 세션에서 지원자들은 신맥(BL62), 조해(KI6), 또는 비경혈에 각각 침처치를 받았다. 10분간 휴식을 한 후에 자침 전, 유침기간, 발침 후 기간에 5분 동안 심박변이도 측정을 하였다. 유침기간에는 2분 간격을 두고 2회 심박변이도를 측정하였다. 결과 : 신맥에 자침한 군에서는 자침후 기간에 total power(TP)와 standard deviation N-N interval(SDNN)이 유의하게 증가하였다. 유침기간 중 첫 5분 동안의 TP와 SDNN은 자침전 값과 유의한 차이가 없었으며 유침기간 중 마지막 5분 동안에는 다소 증가하는 경향은 있었지만 통계적인 유의성은 없었다. 반면에 조해와 비경혈에 자침한 군에서는 TP와 SDNN에 유의한 변화가 관찰되지 않았다. 발침 후에 신맥자침군에서는 조해와 비경혈 자극군과 비교해서 TP가 유의하게 변화하였다. 그러나 SDNN은 발침 후에 세 군 사이에 유의한 차이가 없었다. 결론 : 이 실험 결과는 조해와 비교했을 때 신맥에 자침한 경우 심장 기능 및 자율신경계와 관련이 있는 대체적인 활성이 증가한다는 것을 보여주었다. 이 결과는 신맥 자침이 자율신경계와 관계되어 있는 심장의 기능에 미치는 영향을 통해서 경혈의 특이성을 관찰할 수 있음을 의미한다.

• Tuberculosis and Respiratory Diseases
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• v.51 no.1
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• pp.44-52
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• 2001

Background : Oxygen concentrators are convenient to operate and economical for patients with chronic obstructive pulmonary disease (COPD). However, oxygen concentrators are not manufactured domestically and the COPD patients are currently treated with imported oxygen concentrators. To evaluate the efficacy and safety of domestically developed prototype oxygen concentrator before clinical application, the efficacy and safety of the domestic oxygen concentrator were evaluate by comparing with the imported one. Material and Methods : The clinical tests were performed on 36 hyperhydrosis patients from April 1999 to August 1999. Domestic and imported oxygen concentrators were in turn applied to the same patient, who inspired oxygen for 60 minutes at a rate of 3 liters per minute through nasal prong. The oxygen concentrator, which was applied first, was randomly allocated. The arterial partial oxygen pressure ($PaO_2$) was estimated to compare the efficacy; and the carboxy hemoglobin(COHb), pH, arterial $CO_2$ partial pressure, pulse rate, blood pressure, and respiration rate to compare the safety before and after applying each oxygen concentrator. A student t-test was used to analyze the results. Result : In respect to efficacy, the difference in the change of $PaO_2$ before and after the application between two concentrators was not statistically significant. In respect to safety, the differences in the changes of COHb, pH, partial pressure of arterial $CO_2$, pulse rate, blood pressure, respiration rate between two concentrators were also not statistically significant. Conclusion : The domestically developed oxygen concentrator, showed satisfactory efficacy and safety when compared with the imported one.

• 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.

• Therapeutic Science for Rehabilitation
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• v.10 no.3
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• pp.7-22
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• 2021

Objective : The purpose of this study was to verify the effect of virtual reality interventions (VRIs) on cognitive function in individuals with stroke through a systematic literature review and meta-analysis. Methods : We reviewed randomized controlled trials (RCTs) the last 10 years using academic databases. PubMed, MEDLINE, and CINAHL were used for international studies, and DBpia, KISS, Kyoboscholar, and e-article were used for Korean studies. For the quantitative meta-analysis, subgroups of outcomes were classified into general cognitive function (G-CF), attention and memory (A&M), and executive function (EF). Results : Nine RCTs were analyzed. The total number of participants was 271 (140 in the experimental group). The effect size (Cohen's d) was estimated using a random effects model. The effect sizes of the outcome subgroups of were as follows: small to medium for G-CF (d=0.422; 95% CI: 0.101~0.742; p=0.010), small for A&M (d=0.249; 95% CI: -0.107~0.605; p=0.170), and medium for EF (d=0.666; 95% CI: 0.136~1.195; p=0.014). Conclusion : Considering the various stimuli provided by the virtual environment and the results from available research, virtual reality should be applied to interventions for integrated cognitive functions. In addition, it would be appropriate to be used as an additional intervention to traditional cognitive rehabilitation for stroke.

• Korean Journal of Acupuncture
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• v.31 no.1
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• pp.33-39
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• 2014

Objectives : This study was designed to evaluate the feasibility of further acupuncture research as an effective and safe treatment for reducing cancer-related upper abdominal pain in patients treated with Neurolytic celiac plexus block(NCPB). Methods : This study is a randomized controlled pilot clinical trial of 3-week duration. Fourteen patients will be recruited and randomly allocated to 2 groups: an acupuncture plus NCPB group(experimental group) and a NCPB group(control group). All patients will undergo one session of NCPB, but only the experimental group will receive three acupuncture sessions a week for 2 weeks(6 in total). The primary outcome will be measured using the visual analogue scale, and the secondary outcome will be measured using the Painvision system and the consumption of additional analgesics. Assessments will be made at baseline and at 1, 2, and 3 weeks thereafter(that is, the 3-week assessment will be made 1 week after treatment cessation). Conclusions : This clinical trial will inform the design of a full-scale trial. The outcomes will provide information to facilitate the incorporation of acupuncture into existing pain management methods such as NCPB in the treatment of cancer-related upper abdominal pain patients.

• The Journal of Internal Korean Medicine
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• v.44 no.4
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• pp.726-740
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• 2023

Objectives: This review investigated the research on warm herbal foot bath therapy (WHFT) for insomnia. Methods: A search was conducted on the China National Knowledge Infrastructure (CNKI) database to collect relevant studies published up to August 29, 2023. Randomized controlled trials (RCTs) comparing WHFT and sleeping pills in patients with insomnia were included. The methodological quality of the included studies was assessed using the Cochrane risk-of-bias assessment tool. The results of the meta-analysis were presented as risk ratios (RRs) or mean differences (MDs) and their 95% confidence intervals (CIs). Results: A total of 11 RCTs were included. WHFT as monotherapy resulted in a significantly higher total effective rate (TER) (RR, 1.25; 95% CI, 1.15 to 1.36; I²=25%) and an improved Pittsburgh Sleep Quality Index (PSQI) global sore (MD, -3.10; 95% CI, -4.24 to -1.95; I²=73%) compared to benzodiazepines. Additionally, WHFT as a combined therapy with benzodiazepines resulted in a significantly higher TER (RR, 1.15; 95% CI, 1.04 to 1.27; I²=0%) and an improved PSQI global score (MD, -2.23; 95% CI, -4.09 to -0.38; I²=80%) compared to benzodiazepines alone. In network analysis visualizing the components of HWFT, four clusters were discovered, and Polygoni Multiflori Ramuls and Ziziphi Spinosae Semen were the key herbs used in WHFT. Overall, the methodological quality of the included studies was poor. Conclusions: There was limited evidence that WHFT as a monotherapy or combined therapy was effective in improving insomnia. The findings can be used as basic data for future WHFT research in South Korea.

• Journal of the Korea Convergence Society
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• v.13 no.5
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• pp.35-43
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• 2022

It was to test the efficiency of essence containing scalp derived Leuconostoc mesenteroides extract on relieving hair loss and the possibility of the usage as the functional cosmetic's material. 41 subjects were classified as the control and test group and for 24 weeks, from Apr. 15th 2021 to Nov. 4th 2021, they were double blindness, contrast samples, single organs, and randomized human applicating tests were performed. The amount of hair had meaningful change (p<0.001) seen through phototricogram in 8,16,24 weeks each, and could tell the difference by researcher's bare eye after 24 weeks. Since there were meaningful changes (p<0.017) in subjective evaluation of the subject on after 8,16,24 weeks time, Essence which contains 1% of L. mesenteroides has efficiency on hair loss. Therefore, L. mesenteroides is expected to be used as various cosmetics to prevent hair loss.

• Journal of Gastric Cancer
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• v.5 no.3 s.19
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• pp.139-145
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• 2005

Gastric cancer is the most prevalent cancer in Korea and comprises the second cause of cancer death. Surgery only can provide chance of cure, but most locally advanced cancers recur after a curative resection, even though important advances in the surgical and nonsurgical treatments of gastric cancer have taken place. Preoperative chemotherapy theoretically can provide the advantages of reducing the bulk of tumor, which might improve the R0 resection rate, and of treating micrometastases early. Also, preoperative chemotherapy is expected to render unresectable tumors resectable without increasing postoperative morbidity and mortality. There are many new chemo-therapeutic agents available for the treatment of advanced gastric cancer, but still the most effective agent, the optimal time and number of cycle for administration are still not known. The addition of postoperative chemotherapy through an intraperitoneal route and/or radiotherapy might affect the outcome of surgery favorably, but that hasn't been proved yet. A multicenter prospective randomized phase III trial should be peformed to answer for those questions and to improve the curability of gastric cancer treatment.