• The Journal of Korean Medicine
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• v.38 no.3
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• pp.124-142
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• 2017

Objectives: This study aimed to learn what should be considered in [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer)] by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal product or gastric cancer developed already. Then, clinical trials for gastric cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of analysis with the regulations and guidelines of Ministry of Food and Drug Safety to suggest the issue that we will have to consider when making the [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer]. Results: As a result, few guidelines for anti-tumor agent and clinical trial with herbal medicinal product were searched in the national institution homepage. In addition, 10 articles were searched by using the combination following search term; 'stomach neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'TCM', 'TKM', 'trial'. Most trials included gastric cancer participants with medical history of operation. The type of intervention was various such as decoction, granules, and fluid of intravenous injection. Comparators were diverse such as placebo, conventional treatment including chemotherapy and nutritional supplement. The most frequently used outcome for efficacy was quality of life. Besides, the symptom score, tumor response, and survival rate were used. Safety was investigated by recording adverse events. Conclusion: We found out some issue by reviewing the existing guidelines and comparing it with clinical trials for gastric cancer and herbal medicinal products. These results will be utilized for developing [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer].

• Korean Journal of Acupuncture
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• v.29 no.4
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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.

• Journal of Gastric Cancer
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• v.17 no.3
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• pp.255-266
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• 2017

Purpose: Although Roux-en-Y (R-Y) reconstruction after distal gastrectomy has several advantages, such as prevention of bile reflux into the remnant stomach, it is rarely used because of the technical difficulty. This prospective randomized clinical trial aimed to show the efficacy of a novel method of R-Y reconstruction involving the use of 2 circular staplers by comparing this novel method to Billroth-I (B-I) reconstruction. Materials and Methods: A total of 118 patients were randomly allocated into the R-Y (59 patients) and B-I reconstruction (59 patients) groups. R-Y anastomosis was performed using two circular staplers and no hand sewing. The primary end-point of this clinical trial was the reflux of bile into the remnant stomach evaluated using endoscopic and histological findings at 6 months after surgery. Results: No significant differences in clinicopathological findings were observed between the 2 groups. Although anastomosis time was significantly longer for the patients of the R-Y group (P<0.001), no difference was detected between the 2 groups in terms of the total surgery duration (P=0.112). Endoscopic findings showed a significant reduction of bile reflux in the remnant stomach in the R-Y group (P<0.001), and the histological findings showed that reflux gastritis was more significant in the B-I group than in the R-Y group (P=0.026). Conclusions: The results of this randomized controlled clinical trial showed that compared with B-I reconstruction, R-Y reconstruction using circular staplers is a safe and feasible procedure. This clinical trial study was registered at www.ClinicalTrials.gov (registration No. NCT01142271).

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.30 no.3
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• pp.76-87
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• 2017

Objectives : This study aimed to analyze the recent acupuncture clinical trial on atopic dermatitis and to suggest the plan about how to improve its quality. Methods : Data were collected through electronic database including MEDLINE. We set up the search terms for "atopic dermatitis AND acupuncture" and limited period of data within 6 years and type for RCT(Randomized Clinical Trial), SR(Systemic Review). Results : Total 5 studies were selected. Two were RCTs, and the rest were SRs. RCTs were insufficient about acupoint selection criteria and foundation. SRs both pointed out that systematic clinical trial is required. Conclusions : Based on these, we suggested the plan as follows. 1. Selection criteria - We should reevalute the participants by using diagnostic criteria and scales. 2. Selection acupoints - We should present the foundation that why we choose these acupoints. 3. Establishing acupuncture and control group - We should make control group clearly after calculating the number of participants statistically. 4. Blinding - We should propse the method, type, procedure and evaluation about randomization. 5. Evaluation scale - We should select the suitable scales for research objectives.

• The Journal of Pediatrics of Korean Medicine
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• v.26 no.4
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• pp.32-37
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• 2012

Objectives: The purpose of this study was to obtain some understanding about Korean medicine treatment on language disorder in cerebral palsy for future practice and the research, from the clinical studies. Methods: The literature was searched using the database-China Academic Journals (CAJ). Clinical studies of Korean medicine treatment for language disorder in cerebral palsy, including Randomized controlled trial (RCT), case control study, case series, case report were analyzed. Results: Fifteen Clinical studies met our inclusion criteria; One case study and six case series, one non-randomized controlled trial and seven RCTs. Acupuncture treatment, especially Head acupuncture, was the major treatment for language disorder of cerebral palsy in clinical studies, as it was used in fourteen studies. Acupoint massage, tuina, and acupoint injection were employed as treatment methods in the studies. Acupuncture treatment was used for language disorder of cerebral palsy combined with language therapy and other rehabilitation treatment in many studies. The effectiveness in the treatment groups, regardless of treatment methods, was higher than that of control group in all RCT studies. Conclusions: The results of this study could be used in the practice and the future study about language disorder of cerebral palsy.

• Journal of Oriental Neuropsychiatry
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• v.20 no.4
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• pp.137-148
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• 2009

Objectives : The purpose of this study is to review the recent trends in the clinical trial studies that have been published since 2004. Methods : We reviewed the Medline & Pubmedcentral databases by using searching word of "acupuncture". Then 20 articles were selected within total 803 articles. In oriental medicine journals in Korea, we investigated 6 journals represented Korean Oriental medicine and chose 13 articles. Results & Conclusions : 1. We found 33 articles in journals. 2. The patterns of study were as follows: Randomized Controlled Trials(18), Single case series clinical study(9), Case-Control clinical study(4), Randomized crossover Trial(1) and Prospective Clinical analysis(1). 3. The fields of study were as follows: Combined anxiety, depression & other psychiatic symptoms(18), Stress & heart rate variablity(5), The single study of anxiety(5), The single study of depression(3), Stress & pupil variablity(1), Stress and heart rate & pupil variablity(1). 4. The methods of acupuncture were as follows: Acupuncture on points of 14 meridians(24), Auricular acupuncture(3), Electro acupuncture(2) and Both Auricular & Electro acupuncture(1). 5. Stomach meridian(足陽明胃經) and ST36(足三里) were used mostly.

• Korean Journal of Acupuncture
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• v.32 no.1
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• pp.1-12
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• 2015

Objectives : The purpose of this study was to review the acupuncture and moxibustion therapy for gastroesophageal reflux disease(GERD) in China. Methods : The literatures were searched using the database-China Academic Journals(CAJ)(~2015.1.). Clinical studies of acupuncture and moxibustion therapy for GERD such as randomized controlled trial(RCT), non-randomized controlled trial(NRCT), case series, or case report were included. Results : Thirty studies met our inclusion criteria: 24 RCTs, 4 NRCTs, 1 case series, 1 case report. Various kinds of treatment such as body acupuncture, abdominal acupuncture, acupuncture therapy with finger on back-shu point, electroacupuncture, acupoint injection, auricular acupuncture, and moxibustion were used in the clinical studies. The treatment groups take herbal medicines at the same time in 16 studies, and proton pump inhibitor(PPI) and histamine 2 receptor antagonist were used as a comparative treatment in the most of studies. Acupuncture or moxibustion treatments were done daily or 2~3 times a week for 5 days~18 weeks. All of studies reported higher effective rate in the acupuncture or moxibustion treatment group compared to the western medication control group. Conclusions : The results of this study could be used for the future practice and the clinical research about the acupuncture and moxibustion therapy for GERD.

• Korean Journal of Acupuncture
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• v.28 no.4
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• pp.147-158
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• 2011

Objectives : The purpose of this study was to obtain some knowledge about the acupuncture treatments on Parkinson's disease for the future practice and the research from the clinical studies in China. Methods : The literatures were searched using the data base-China Academic Journals (CAJ) (1994-2011). Clinical studies of acupuncture for Parkinson's disease such as randomized controlled trial (RCT), non-randomized controlled trial (NRCT), case series, case report were included. Results : Of 145 articles, 52 Clinical studies met our inclusion criteria: 20 RCTs, 7 NRCTs, 22 case series and 3 case reports. Various kinds of acupuncture treatments such as scalp acupuncture, body acupuncture, abdominal acupuncture, acupoint injection, eye acupuncture and thick needle acupuncture (粗鍼) were used in the clinical studies. The treatment and control groups take Madopa Tablet (Levodopa + Benserazide HCl) in the same time in many studies, and Madopa treatment was used as a comparative treatment in the most of studies. Acupuncture treatment was done daily or 2~3 times a week for 2~20 weeks. All of studies reported high effective rate in the treatment group compared to control group. Conclusions : The results of this study could be used for the future study about the acupuncture therapy for Parkinson's disease.

• Journal of Pharmacopuncture
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• v.26 no.3
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• pp.238-246
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• 2023

Objectives: The purpose of this study was to evaluate the effectiveness of complex rehabilitation with and without acupuncture in a hospital setting. Methods: A randomized clinical trial was performed at Rehabilitation center "Kamenskoe Plato" in Almaty, Kazakhstan. 160 patients with Post COVID-19 condition were randomly equally divided into an acupuncture with complex rehabilitation methods and a only complex rehabilitation methods group in the period from March 1, 2022 to July 1, 2022. Either groups was performed for an 10-14 days period. The outcome measures were the Bartel index, the Borg scale, Modified Dyspnea Scale and the 6-minute walking test. Adverse events also were monitored and documented. Results: We found statistically significant improvement after the rehabilitation course with acupuncture in the all scales. And in the group without acupuncture, only on two scales: MDS and Borg scale. Conclusion: Rehabilitation with acupuncture is possible and effective in patients recovering from post-COVID-19. Our findings may be useful to guide clinicians taking care of patients with post-COVID-19.

• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.261-264
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• 1994

This paper proposes a new method for planning randomized clinical trials. This method is especially suited to comparison of a best standard or control treatment with an experimental treatment. Patients are allocated into two groups by a random or chance mechanism. Patients In the first group receive standard treatment; those in the second group are asked if they will accept the experimental therapy; if they decline. they receive the best standard treatment. In the analyses of results. all those in the second group. regardless of treatment. are compared with those in the first group. Any loss of statistical efficiency can be overcome by Increased numbers. This experimental plan is indeed a randomized clinical trial and has the advantage' that, before providing consent, a patient will know whether an experimental treatment is to be used.