• The Korean Journal of Pain
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• 제31권1호
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• pp.27-38
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• 2018

Background: Related to escalating health care costs and the questionable effectiveness of multiple interventions including lumbar facet joint interventions, cost effectiveness or cost utility analysis has become the cornerstone of evidence-based medicine influencing coverage decisions. Methods: Cost utility of therapeutic lumbar facet joint nerve blocks in managing chronic low back pain was performed utilizing data from a randomized, double-blind, controlled trial with a 2-year follow-up, with direct payment data from 2016. Based on the data from surgical interventions, utilizing the lowest proportion of direct procedural costs of 60%, total cost utility per quality adjusted life year (QALY) was determined by multiplying the derived direct cost at 1.67. Results: Patients in this trial on average received $5.6{\pm}2.6$ procedures over a period of 2 years, with average relief over a period of 2 years of $82.8{\pm}29.6$ weeks with $19{\pm}18.77$ weeks of improvement per procedure. Procedural cost for one-year improvement in quality of life showed USD $2,654.08. Estimated total costs, including indirect costs and drugs with multiplication of direct costs at 1.67, showed a cost of USD $4,432 per QALY. Conclusions: The analysis of therapeutic lumbar facet joint nerve blocks in the treatment of chronic low back pain shows clinical effectiveness and cost utility at USD $2,654.08 for the direct costs of the procedures, and USD $4,432 for the estimated overall cost per one year of QALY, in chronic persistent low back pain non-responsive to conservative management.

• The Journal of Advanced Prosthodontics
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• 제11권3호
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• pp.147-154
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• 2019

PURPOSE. This study aimed to evaluate the effect of two different implant-abutment connection structures with identical implant design on peri-implant bone level. MATERIALS AND METHODS. This clinical study was a patient-blind randomized controlled trial following the CONSORT 2010 checklists. This trial was conducted in 24 patients recruited between March 2013 and July 2015. Implants with internal friction connection were compared to those with external hex connection. One implant for each patient was installed, replacing the second molar. Implant-supported crowns were delivered at four months after implant insertion. Standardized periapical radiographs were taken at prosthesis delivery (baseline), and one year after delivery. On the radiographs, distance from implant shoulder to first bone-to-implant contact (DIB) and peri-implant area were measured, which were the primary and secondary outcome, respectively. RESULTS. Eleven external and eleven internal implants were analyzed. Mean changes of DIB from baseline to 1-year postloading were 0.59 (0.95) mm for the external and 0.01 (0.68) mm for the internal connection. Although no significant differences were found between the two groups, medium effect size was found in DIB between the connections (Cohen's d = 0.67). CONCLUSION. Considering the effect size in DIB, this study suggested the possibility of the internal friction connection structure for more effective preservation of marginal bone.

• Journal of Ginseng Research
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• 제46권4호
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• pp.585-591
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• 2022

Background: Korean Red Ginseng (KRG) extract has been shown to have beneficial effects in patients with atherosclerosis, suggesting that KRG extract may be effective in preventing subsequent ischemic stroke in patients with severe atherosclerosis. Methods: This double-blind, placebo-controlled trial randomized patients with severe atherosclerosis in major intracranial arteries or extracranial carotid artery, to ginseng group and placebo group. They were given two 500-mg KRG tablets or identical placebo tablets twice daily for 12 months according to randomization. The primary endpoint was the composite of cerebral ischemic stroke and transient ischemic attack during 12 months after randomization. The secondary endpoints were change in volumetric blood flow of the intracranial vessels and the incidence of newly developed asymptomatic ischemic lesions. Any adverse events were monitored. Results: Fifty-eight patients were randomized from June 2016 to June 2017, 29 to ginseng and 29 to placebo, and 52 (28 and 24, respectively) completed the study. One patient in the placebo group, but none in the ginseng group, experienced ischemic symptoms (p = 0.46). Changes in volumetric blood flow and the presence of ischemic brain lesions did not differ significantly in the two groups, and none of these patients experienced adverse drug reactions. Conclusion: Ginseng was well tolerated by patients with severe atherosclerosis, with these patients showing good compliance with ginseng dosing. Ginseng did not show significant effects compared with placebo, although none of the ginseng-treated patients experienced ischemic events. Long-term studies in larger patient populations are required to test the effect of ginseng.

• 동의신경정신과학회지
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• 제33권4호
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• pp.389-400
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• 2022

Objectives: Depression is a highly prevalent disease, and the market for antidepressant drugs continues to grow at a steady rate. Although current antidepressants are reported to be effective, because of their low remission rate and side effects, new antidepressants are needed. The use of Banhahubak-tang (BHT) to treat the symptoms of depression is supported by experimental evidence. The proposed study will evaluate the efficacy and safety of BHT in treating depression. Methods: A randomized, waitlist-controlled, parallel clinical trial will be conducted to assess the efficacy of BHT in depression. A total of 84 participants with depression will be randomized into the intervention group or waitlist-control group at a 1:1 ratio. Patients in the intervention group will be administered BHT three times a day for four weeks and followed up for four more weeks after therapy completion. Patients in the waitlist-control group will undergo the same intervention and follow-up after a four-week waiting period. The primary outcome is change in the Korean version of the Hamilton Depression Rating Scale (K-HDRS) scores for major depressive disorders after four weeks. The secondary outcomes include scores on the K-HDRS, Korean Symptom Check List 95 (KSCL-95), Insomnia Severity Index (ISI), State-Trait Anxiety Inventory-Korean version (STAI-K), State-Trait Anger Expression Inventory-Korean version (STAXI-K), and the Instrument on Pattern Identifications for Depression and EuroQol-5 Dimension (EQ-5D). Conclusions: This trial will provide high-quality clinical evidence of the efficacy and safety of BHT in the management of depression.

• Korean Journal of Acupuncture
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• 제29권4호
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• pp.581-597
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• 2012

Objectives : To explore the experiences of patients with chronic low back pain(CLBP) in a randomized controlled trial(RCT) of acupuncture. Methods : Five qualitative focus group interviews were conducted at three Korean Medicine Hospitals. Two to 4 participants from the same group(real or sham acupuncture) in the RCT of acupuncture for CLBP discussed their experiences and perceptions of the clinical trial and the acupuncture treatment. Transcribed data were read independently by researchers and analyzed to categorize information and identify themes. Results : A total of 14 participants were included. Most of them discovered positive aspects of being a study subject and a patient. They recognized the differences between experimental and real-world clinical settings such as formal procedures of treatment, and different acupuncture device. Participants also expressed the weaker sensation of acupuncture compared to the previous experience. Especially, they were well aware of the 'subjects' role themselves, thus they observed their changes of symptom closely. As subjects were generally satisfied with their treatment and they had a good feeling to acupuncture after the trial, they expressed their willingness to participate in the future clinical trial of acupuncture. Conclusions : Our finding suggests that the Korean patients' experience of participating in an RCT was generally positive. Their tendency to perform the 'subject' role might affect the trial's process or overall results.

• 동의신경정신과학회지
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• 제22권2호
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• pp.1-13
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• 2011

Objectives : The purpose of this research is to examine the effects of Sa-am acupuncture Simpojeongkyeok treatment on Hwa-byung. Methods : The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collector and analyst were unaware of individuals which were receiving the treatment. Fifty volunteers were divided into a trial and a control group, each of which consisted of 25 subjects. The trial group was treated with Sa-am acupuncture Simpojeongkyeok, while needle insertion at non-acupoints was given to the control group. The Likert scale for major symptoms of Hwa-byung was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by of STAXI-K, STAI-K and BDI-K. Results : In the Likert scale comparison of major symptoms, total scores in both groups were decreased after treatment. However, a more significant decrease was found in those of trial group compared to those of the control group from a statistical perspective. The results measured by BDI scores also decreased significantly in the trial group after treatment. In comparison of STAXI and STAI scores, there were no significant differences found between the groups. Conclusions : The results suggest that Sa-am Acupuncture Simpojeongkyeok treatment is effective in the treatment of Hwa-byung.

• 동의신경정신과학회지
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• 제23권1호
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• pp.31-48
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• 2012

Objectives: The purpose of this research is to examine the effects of acupuncture treatment on Hwa-byung patient's insomnia. Methods: The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collectors and analysts were unaware of individuals who were receiving the treatment. A total of thirty-seven volunteers were divided into 2 groups. 18 subjects were placed into a trial group and 19 subjects into a control group by a randomization table. The trial group was treated on bilateral Shigu, Ahnmyun, B62 (Shinmaek), and K6 (Chohae), while the control group was not given any other treatment. The ISI(Insomnia Severity Scale) was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by a Likert scale for major symptoms of Hwa-byung, PSQI, Hwa-byung scale, BDI, STAI, and STAXI. Results: In the ISI, PSQI, and the Likert scale regarding major symptoms of Hwa-byung, Hwa-byung scale, BDI, and STAI, more significant decreases were found in those concerning the trial group compared to those of the control group from a statistical perspective. However, in the STAXI, regarding the trial group, there was no significant decrease compared to the control group. Conclusions: The results suggest that acupuncture treatment is effective in the treatment regarding Hwa-byung patients who suffer from insomnia.

• 한국콘텐츠학회논문지
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• 제13권12호
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• pp.1036-1047
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• 2013

본 연구는 불면과 관련된 무작위임상시험의 해외 연구 동향을 살펴보기 위하여 시계열적 키워드 비교 분석 및 네트워크 분석을 실시하였다. 분석에 사용된 자료는 'Insomnia'와 'Randomized Clinical Trial'의 연관 키워드를 사용하여 ClinicalTrials의 379건, Web of Science의 132건을 선정하였다. 분석 결과, ClinicalTrials에서는 불면과 약물요법을 중심으로 인지행동요법, 우울 등의 키워드가 네트워크를 이루고 있었다. WOS에서는 ClinicalTrials의 결과에 멜라토닌 키워드가 추가적으로 나타났다. 또한, 연구 대상자 중 특징적으로 노인과 여성에 대한 연구가 꾸준히 진행되는 것으로 파악되었다.

• 한방안이비인후피부과학회지
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• 제21권2호
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• pp.94-101
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• 2008

Objectives : To discuss the types of control groups in randomized controlled trials (RCTs) of herbal medicine, and to provide suggestions for improving the design of control group in future clinical trials. Methods : We reviewed the 8 articles about clinical trial design of Chinese herbal preparation which were published from 2005 through 2008. We selected those articles from CNKI(中國知識基礎施設工程(http://www.cnki.net)). Results : It is necessary to have control group in randomized controlled trials(RCTs) of Korean herbal preparation. But there are problems in the selection of appropriate control group drug. This paper lists several problems about the choice of control drug and puts forward some proposals and countermeasures. There are problems such as ethics and manufacturing matching placebo and positive control herbal drug. Conclusion : To improve the quality of control group design, we introduce standard drug plus placebo drug method and add-on research for placebo control group design, double dummy technique, using negative control drug or composite control drug for active control group design.

• 한방안이비인후피부과학회지
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• 제30권2호
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• pp.1-18
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• 2017

Objectives : This review aims to evaluate a risk of bias by risk of bias tool and RoBANS(Risk of Bias Assessment tool for Non-randomized Study) tool for clinical trial papers proving treatment effect of Korean medicines to alopecia and provides the newest reason of effectiveness of herbs to alopecia. Methods : Data were collected through electronic database including NDSL, KISS, KMBASE, Koreantk, OASIS, KoreaMed, KISTI, Pubmed, Cochrane CENTRAL and CINAHL. Two experts in Oriental Medicine assessed risk of bias of randomized controlled trials by Cochrane group's Risk of Bias tool and non-randomized controlled trials by RoBANS tool after searching, reviewing and selecting papers. Results : Total number of selected trials is 20 including 4 randomized controlled trial, 13 non-randomized controlled trials and 3 case reports. This study evaluate the risk of bias of 17 papers including 4 randomized controlled trials and 13 non-randomized controlled trials except 3 case reports by risk of bias tool and RoBANS tool. All papers of randomized controlled trials are evaluated unclear for random sequence generation and allocation concealment as there are no word on them. And all papers of non-randomized controlled trials are evaluated unclear for blinding of outcome assessments and relatively low for others. Conclusions : Korean medicine intervention can be an effective for treatment in alopecia. It was evaluated by hair density, thickness and expert panel assessment of photographs and all results are statistically significant. But enhancing levels of evidence, we must try to reduce bias in researches and report a safety, protocol and IRB.