An Herbal Medicine, Yukgunja-Tang is more Effective in a Type of Functional Dyspepsia Categorized by Facial Shape Diagnosis: A Placebo-Controlled, Double-Blind, Randomized Trial

Hindawi Evidence-Based Complementary and Alternative Medicine Volume 2018, Article ID 8546357, 11 pages https://doi.org/10.1155/2018/8546357 Research Article An Herbal Medicine, Yukgunja-Tang is more Effective in a Type of Functional Dyspepsia Categorized by Facial Shape Diagnosis: A Placebo-Controlled, Double-Blind, Randomized Trial Seok-Jae Ko ,1 Jae-Woo Park ,1 Jae-hyung Lee,1 Jung-eun Lee,1 Na-yeon Ha,1 Seong-uk Nam,1 Jae-hong Lee ,1 Soo-Hyung Jeon,2 Jong-Won Kim ,2 Changwan Kang,3 Inkwon Yeo ,4 and Jinsung Kim 1 1 Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Kyungheedae-ro 26, Dongdaemun-gu, Seoul 02447, Republic of Korea 2 Department of Sasang Constitutional Medicine, College of Korean Medicine, Dong-Eui University, 62 Yangjeong-ro, Busanjin-gu, Busan 47227, Republic of Korea 3 Production Information Technology Engineering Major, Dong-Eui University, 62 Yangjeong-ro, Busanjin-gu, Busan 47227, Republic of Korea 4 Department of Statistics, Sookmyung Women’s University, Cheongpa-ro 47-gil 100, Yongsan-gu, Seoul 140-742, Republic of Korea Correspondence should be addressed to Jinsung Kim; Received 7 June 2018; Revised 10 August 2018; Accepted 12 September 2018; Published 1 October 2018 Guest Editor: Sang-Hoon Shin Copyright © 2018 Seok-Jae Ko et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Introduction. Functional dyspepsia (FD) is a functional gastrointestinal disorder characterized by persistent upper dyspeptic symptoms without organic lesions. There is no standard therapy for FD. Yukgunja-tang (YGJT) is an herbal medicine used for treating upper gastrointestinal symptoms in Asia. Studies on the effect of YGJT on FD have been conducted. However, the results were inconsistent. In Hyungsang medicine, traditional Korean medicine, FD patients are classified into bladder body (BB) or gallbladder body (GB) subtypes by the shape and angle of their faces. Each subtype may have different characteristics, physiology, and pathology of the same disease. YGJT is more effective for patients with BB subtype. The three-dimensional facial shape diagnostic system (3-FSDS) was shown to be effective in diagnosing BB or GB subtypes. This study aimed to investigate the effect of YGJT on FD patients classified using the 3-FSDS. Materials and Methods. The current study was a placebo-controlled, doubleblinded, randomized, two-center trial. Eligible patients were diagnosed with either BB or GB FD subtype using the 3-FSDS. Ninetysix participants (48 BB and 48 GB subtypes) were randomly allocated to treatment or control groups in a 2:1 ratio. YGJT or placebo was administered for eight weeks. The primary outcome was assessed using the total dyspepsia symptom scale (TDS), while the secondary outcomes were assessed using the single dyspepsia symptom scale (SDS), proportion of responders, visual analog scale, Nepean dyspepsia index, functional dyspepsia-related quality of life, and spleen qi deficiency questionnaire. Results and Discussion. The result of TDS showed the superior effect of YGJT on BB over GB subtype. The subgroup analysis of TDS and SDS scores showed the superior effect of YGJT over placebo. Other outcome variables did not show any significant differences between groups. Conclusion. YGJT may be considered for FD patients diagnosed with BB subtype using 3-FSDS. 1. Introduction Diagnosis by the shape and appearance of patients historically originated from ancient medical texts (Huangdi Neijing, Yellow Emperor’s Internal Classic) in Asia and many traditional Korean medicine (TKM) doctors have been using it until now [1]. Based on this diagnostic method, Park et al. developed a unique medicine theory called Hyungsang medicine [2]. According to Hyungsang medicine, patients are classified into various subtypes such as bladder body (BB) or gallbladder 2 Evidence-Based Complementary and Alternative Medicine body (GB) based on the shapes of their face and body [3]. Depending on the subtype, the cause and treatment of the disease may vary. For example, patients with BB subtype are more vulnerable to dyspepsia, obesity, and lethargy [4]. They lack yang and qi and produce a lot of dampness and phlegm; therefore, TKM practitioners tend to prescribe drugs to invigorate qi and reduce dampness and phlegm [4, 5]. Considering that Hyungsang diagnosis focuses on morphological features of patients, the excellence of TKM in distinguishing individual characteristics is emphasized. However, though it plays an important role for TKM doctors, Hyungsang diagnosis mostly depends on individual experience and perspectives of practitioners; therefore, the diagnoses of doctors are often inconsistent, which makes communication difficult among TKM doctors and hinders the advancement of Hyungsang medicine. In order to overcome these limitations, research on standardization and objectification of diagnosis by the appearance of patients has been actively conducted [6–8]. As a result, questionnaires, three-dimensional (3D) body measuring machines, and 3D face automatic recognizers have been developed [9–12]. A 3D facial shape diagnostic system (3-FSDS) consists of a 3D diagnostic scanner combined with a face 3D scanner, data acquisition program, and facial shape measurement and diagnostic program. Three-dimensional stereoscopic images of the frontal and temporal faces are acquired, and 3D coordinates are obtained to calculate distance, angle, and area. A significant variable is selected from the results after calculation, and BB or GB subtype is diagnosed. The 3-FSDS proved to be effective in diagnosing BB/GB subtypes in a clinical trial for the approval of the Korea Food and Drug Administration (KFDA), and its diagnostic rate was over 70%. In 2011, the device was approved by the KFDA (No. 11-500 Medical Image Analysis Apparatus, May 4, 2011). Functional dyspepsia (FD) is a common functional gastrointestinal disorder characterized by persistent or recurrent abdominal pain, discomfort, and other dyspeptic symptoms in the absence of organic diseases [13]. FD has a prevalence of approximately 11-25% in the total population, and about 50% of patients with FD complain of dyspepsia without any structural disease [14, 15]. Recently in the United Kingdom (UK), annual medical costs for FD have been reported to be more than one billion pounds, and the huge economic burden caused by FD has a considerable negative impact on the society [16, 17]. Several causative factors are involved in FD such as gastrointestinal motility disorder, sensory disturbance, and H. pylori infection, and they tend to interact with each other [18, 19]. Proton-Pump inhibitors, prokinetics, and dietary modifications are prescribed as western medical treatments [20]. However, due to unsatisfactory response to conventional treatments, patie (...truncated)