• Journal of Gastric Cancer
• /
• v.16 no.2
• /
• pp.93-97
• /
• 2016

Several prospective studies on laparoscopy-assisted distal gastrectomy for early gastric cancer have been initiated, but no prospective study evaluating laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy has been completed to date. A non-randomized confirmatory trial was commenced in April 2015 to evaluate the safety of laparoscopy-assisted total gastrectomy and laparoscopy-assisted proximal gastrectomy for clinical stage I gastric cancer. A total of 245 patients will be accrued from 42 Japanese institutions over 3 years. The primary endpoint is the proportion of patients with anastomotic leakage. The secondary endpoints are overall survival, relapse-free survival, proportion of patients with completed laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy, proportion of patients with conversion to open surgery, adverse events, and short-term clinical outcomes. The UMIN Clinical Trials Registry number is UMIN000017155.

• Journal of Acupuncture Research
• /
• v.21 no.6
• /
• pp.195-207
• /
• 2004

목적 : 경추통에 대한 침구치료의 효과여부가 현재까지 시행된 무작위 대조군 시험의 검토에서 논란이 되고 있는데, 경추통에 대한 치료 효과의 검증에 최근 들어 경추 전만각도의 변화를 측정하는 것이 점차 많이 사용되고 있는 실정이다. 하지만 아직까지 변형된 형태의 경추 견인 등 몇몇 요소들이 경추전만을 변화시켰다는 보고는 있었으나, 침치료 중 深刺의 방법이 경추의 만곡을 변화시켰다는 보고는 없었다. 방법 : 자침의 방법 중 深刻(五刺法 중 合谷刺 또는 關刺)방법이 경추 전만의 변화를 주는가에 대하여 검증하기 위하여 심자 치료를 시행한 19명의 실험군과 치료를 시행하지 않고 단순히 방사선 촬영만 시행한 21명의 대조군의 단순 방사선 사진을 후향적 연구의 방법으로 비교하였으며, 아울러 심자 자침군에서는 VAS를 측정하여 통증의 정도의 변화를 함께 연구하였다. 결과 : 연구결과 자침을 시행하지 않은 대조군에서는 VAS와 경추 전만의 Cobb각도에서 유의성 있는 변화가 나타나지 않았으나, 심자의 방법으로 자침한 군에서는 치료 전후의 VAS가 유의한 차이를 나타내었고, 경추의 전만 각도에서도 경추 2번과 7번 사이의 Cobb의 각도에서 유의성 있는 변화를 나타내었다(p < 0.05). 결론 : 이러한 연구 결과들은 심자의 자침방법이 경주의 통증을 줄여줄 뿐만 아니라 경추의 구조적 변화를 일으킬 수 있음을 나타내 주는 것이다.

• Integrative Medicine Research
• /
• v.6 no.3
• /
• pp.317-324
• /
• 2017

Background: Bu-Zhong-Yi-Qi-Tang (BZYQT) has long been used for the treatment of severe weakness caused by general fatigue, loss of appetite, or indigestion. The aim of this feasibility study is to assess the effectiveness and safety of BZYQT for the treatment of functional dyspepsia (FD) with spleen qi deficiency. Methods: This study will be conducted at a single center as a prospective, nonrandomized, nonblinded, single-arm feasibility study. A total of 30 participants diagnosed with FD in accordance with the Rome III criteria will be enrolled. All patients will receive BZYQT for 4 weeks. The primary outcome is the change in the Nepean Dyspepsia Index-Korean version (NDI-K) scores between the baseline and 4-week images. The secondary outcomes include the tongue coating thickness, blood parameters, and BZYQT Questionnaire score. The NDI-K score will be acquired four times, at Weeks 0 (baseline), 2 (during treatment), 4 (after treatment), and 8 (after follow-up). Written informed consent will be obtained from all study participants prior to enrollment. This study has been approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital. This study protocol is registered with the national clinical trial registry of the World Health Organization International Clinical Trials Registry Platform. Results will be published in a journal and will be disseminated both electronically and in print. Discussion: The results of this study may serve as a guide for researchers seeking to effectively evaluate the effects of BZYQT.

• Journal of Oriental Neuropsychiatry
• /
• v.27 no.4
• /
• pp.261-274
• /
• 2016

Objectives: To determine the general characteristics of clinical studies about Hwabyung and assess their limitations and alternatives. Methods: Clinical studies that examined the effects of traditional Korean medicine intervention on Hwabyung were included in this study. A systematic search of English, Chinese, Japanese, and Korean databases was performed. The characteristics of included articles were described and those articles were assessed by Risk of Bias (RoB) tool or Risk of Bias for Nonrandomized Studies (RoBANS) tool. Results: Sixteen articles were selected from 1,826 articles. Most clinical studies about Hwabyung were published in Korea. The number of conducted trials was insufficient. The prevailing study design was randomized controlled trial. Traditional Korean medicine intervention used in the trials were acupuncture, herbal medicine, counselling, meditation, emotional freedom technique (EFT), music therapy, art therapy, and multi intervention program. Herbal medicine study used placebo as control while non-pharmacological intervention study mostly used no treatment as control. Most of the trials were supported by the government. Therefore, financial conflict of interest might not exist for results. We judged that some studies had a high risk of bias. In general, most of the studies with a high risk of bias were non-pharmacological intervention studies, and the risk of bias was mainly due to lack of blinding. Conclusions: More clinical studies of Hwabyung are needed. There are some issues about a suitable comparison and effective blinding strategy for non-pharmacological study. Improving methodological quality is required.