• 대한한방내과학회지
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• 제37권1호
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• pp.90-108
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• 2016

Objectives: This study aimed to learn what should be considered in the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD) by analyzing the existing guidelines and clinical trials.Methods: The development committee searched the existing guidelines for herbal medicinal products or GERD. Then, clinical trials related to GERD using herbal medicine were selected. The chosen trials were analyzed in terms of their inclusion and exclusion of participants, intervention, comparators, outcome, and trial design. Then, we compared the results of the analysis according to the regulations and guidelines of the Ministry of Food and Drug Safety to suggest the issues that we will have to consider when developing the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD).Results: As a result, few guidelines for GERD and clinical trials with herbal medicinal products were located in the national institution homepage. In addition, 8 articles were found using the following combination of search terms: “Gastroesophageal reflux disease”, “GERD”, “herbal medicine”, “herbal therapy”, “Korean Medicine”, “Traditional Chinese Medicine”, and “TCM”. Even though all trials had their own unique research questions, all studies were performed using a randomization method. Most trials included participants with reflux esophagitis, but two trials targeted proton pump inhibitor-refractory GERD. The type of intervention varied, such as decoction, granules, and capsules. Additionally, individualized herbal medicines were used in two studies. Comparators were diverse, such as placebo, Western medicine, and electro-acupuncture. The most frequently used outcome for efficacy was the effectiveness rate. In addition, the outcome for evaluating quality of life, esophageal mucosa and pressure, esophageal acid reflux, and recurrence rates were used. Safety was investigated by recording adverse events and carrying out laboratory tests.Conclusions: We identified some issues by reviewing the existing guidelines and comparing them with clinical trials for GERD and herbal medicinal products. These results will be utilized for developing the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD).

• Applied Microscopy
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• 제39권1호
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• pp.1-7
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• 2009

사람에서의 PCO와 몇몇 측면에서 유사한, 실험적으로 유발된 다낭성난소(polycystic ovary, PCO)는 장기간 작용하는 estradiol valerate (EV)에 의해 유발된다. 랫드에서 스테로이드로 유발한 PCO 모델에서 홍삼 총사포닌의 역할에 대한 우리의 이전연구는 전침이 난소의 nerve growth factor (NGF) 농도를 조절하는 것을 검증하였다. 실제로 PCO와 관련된 난소 기능부전의 병리기전에서 신경성 요소의 관련성은 난소로의 교감신경유출(sympathetic outflow)의 증가로 인해 높아진다. 따라서 본 연구에서는 치료제로서의 GTS 투여가 PCO를 유발한 랫드에서 교감신경 활성을 조절할 것이라는 가설을 시험해보고자 하였다. 본 연구에서는 스테로이드로 유발한 PCO에 내재하고 있는 병태생리학적 과정과 연관된 NGF 단백질과 NGF mRNA를 분석함으로써 이루어졌다. PCO가 유발된 랫드에서 EV 대조군은 oil 대조군과 비교하였을 때 유의적으로 높은 NGF mRNA의 발현을 나타내었으며, GTS 투여군은 EV 대조군에 비해 유의적으로 낮은 NGF mRNA의 발현을 나타내었다. 그러나 NGF 단백질은 oil 대조군에 비해 EV 대조군과 GTS 투여군에서도 유의적인 변화를 발견할 수 없었다. 이러한 결과는 EV가 설치류에서 낭종 형성과 무배란을 유발하는 병리학적 단계의 구성요소일 수 있는 난소의 신경향성 단계(neurotrophic state)를 조절한다고 생각할 수 있다.