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The Journal of Internal Korean Medicine 2016;37(1): 90-108. |
| 위식도역류질환 한약제제 임상시험 가이드라인 개발을 위한 관련 국내 가이드라인 분석 및 기존 한약임상시험과의 비교 |
| 한가진1,2, 임정태2,3, 김진성1, 이준희2,4 |
1경희대학교 한의과대학 비계내과학교실
2경희대학교한방병원 한의약임상시험센터
3경희대학교 대학원 임상한의학과 한의약임상연구학 전공
4경희대학교 한의과대학 사상체질과 |
| An Analysis of the Existing Guidelines and Clinical Trials for the Development of the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD) |
| Ga-jin Han1,2, Jung-tae Leem2,3, Jin-sung Kim1, Jun-hee Lee2,4 |
1Dept. of Gastroenterology, College of Korean Medicine, Kyung-Hee University
2Korean Medicine Clinical Trial Center, Kyung-Hee University Korean Medicine Hospital
3Dept. of Clinical Korean Medicine, Graduate School, Kyung-Hee University
4Dept. of Sasang Constitutional Medicine, College of Korean Medicine, Kyung-Hee University |
| Correspondence |
Jun-hee Lee ,Tel: +82-2-958-9280, Fax: +82-2-958-9234, Email: ssljh@khu.ac.kr
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Received: March 2, 2016, Accepted: March 30, 2016, Published online: March 31, 2016. |
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| ABSTRACT |
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). |
| Key words:
gastroesophageal reflux disease (GERD), herbal medicinal products, clinical trial, guideline |
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