Development of a Traditional Chinese Medicine Syndrome-Specific Scale for Ulcerative Colitis: The Large Intestine Dampness-Heat Syndrome Questionnaire

Evidence-Based Complementary and Alternative Medicine, Jul 2018

The aim of this study was to develop and validate the large intestine dampness-heat syndrome questionnaire (LIDHSQ) for patients with ulcerative colitis (UC). The domains and items of the LIDHSQ were developed according to standard procedures, namely, construct definition, item generation, language testing, content validity, pilot study, and validation study. At first, a total of 20 items in 3 domains were generated based on literature review and expert consultation. After the item selection, the LIDHSQ contains 11 items in three domains: disease-related domain (diarrhoea, abdominal pain, bloody purulent stool, and mucus stool), heat domain (fever, dry mouth, red tongue, yellow fur, and anal burning), and dampness domain (greasy fur and defecation disorder). The Cronbach's alphas of all domains were greater than 0.6. All of the intraclass correlation coefficients were greater than 0.8. The LIDHSQ and domain scores of the patients with LIDHS were higher than those of the patients with other syndromes (P < 0.001). The area under the receiver operating characteristic curve of the LIDHSQ was 0.900, with a 95% confidence interval of 0.872–0.928. When the cut-off value of the LIDHSQ was ≥ 7, the sensitivity and specificity were 0.867 and 0.854, respectively. The LIDHSQ is valid and reliable for measuring LIDHS in UC patients with good diagnostic efficacy. We recommend the use of the LIDHSQ in Chinese UC patients.

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Development of a Traditional Chinese Medicine Syndrome-Specific Scale for Ulcerative Colitis: The Large Intestine Dampness-Heat Syndrome Questionnaire

Development of a Traditional Chinese Medicine Syndrome-Specific Scale for Ulcerative Colitis: The Large Intestine Dampness-Heat Syndrome Questionnaire Xin-lin Chen,1 Yi Wen,2 Zu-chun Wu,1 Bei-ping Zhang,3 Zheng-kun Hou,4 Jun-lin Xiao,5 Man-qing Lin,2 Yue Hu,1 Zhe-li Wu,1 Jie-min Deng,1 Feng-bin Liu,4 and Tian-wen Liu3 1School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China 2The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China 3The Second Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China 4The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China 5The Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China Correspondence should be addressed to Feng-bin Liu; moc.361@361bfuil and Tian-wen Liu; moc.361@001newnaituil Received 23 March 2018; Revised 21 May 2018; Accepted 28 June 2018; Published 12 July 2018 Academic Editor: Raffaele Capasso Copyright © 2018 Xin-lin Chen 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. Abstract The aim of this study was to develop and validate the large intestine dampness-heat syndrome questionnaire (LIDHSQ) for patients with ulcerative colitis (UC). The domains and items of the LIDHSQ were developed according to standard procedures, namely, construct definition, item generation, language testing, content validity, pilot study, and validation study. At first, a total of 20 items in 3 domains were generated based on literature review and expert consultation. After the item selection, the LIDHSQ contains 11 items in three domains: disease-related domain (diarrhoea, abdominal pain, bloody purulent stool, and mucus stool), heat domain (fever, dry mouth, red tongue, yellow fur, and anal burning), and dampness domain (greasy fur and defecation disorder). The Cronbach's alphas of all domains were greater than 0.6. All of the intraclass correlation coefficients were greater than 0.8. The LIDHSQ and domain scores of the patients with LIDHS were higher than those of the patients with other syndromes (P < 0.001). The area under the receiver operating characteristic curve of the LIDHSQ was 0.900, with a 95% confidence interval of 0.872–0.928. When the cut-off value of the LIDHSQ was ≥ 7, the sensitivity and specificity were 0.867 and 0.854, respectively. The LIDHSQ is valid and reliable for measuring LIDHS in UC patients with good diagnostic efficacy. We recommend the use of the LIDHSQ in Chinese UC patients. 1. Introduction Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disorder of the colonic mucosa that starts in the rectum and generally extends proximally in a continuous manner through either part of or the entire colon. In the West, the incidence and prevalence of UC have increased over the past 50 years, up to 8-14/100,000 and 120-200/100,000 persons, respectively [1]. Some studies have reported that the incidence and prevalence rates of UC have increased gradually in China [2–5]. The incidence of UC varied from 0.07 to 4.90 per 100,000 people per year in China based on the results of a multinational, population-based study conducted between 2011 and 2013 [3]. It was estimated that the prevalence of UC in China is 11.6 per 100,000 people in 2016 [4]. Large intestine dampness-heat syndrome (LIDHS) is one of the most common UC syndromes [6–9]. Chen et al. reported that LIDHS accounted for 34.8% of the UC patients according to the results of a literature review [6]. Traditional Chinese medicine (TCM) is widely used to treat UC as a complementary and alternative medicine [10–16]. Some clinical research has reported that TCM therapies are effective for treating UC patients with LIDHS in the clinic [8, 13, 14]. Chinese herbal medicine can effectively inhibit intestinal inflammation for UC patients with LIDHS [8, 14]. The mainstay of LIDHS diagnosis was based on the experience of TCM doctors. However, the diagnosis of LIDHS is problematic. First, the diagnostic criteria for LIDHS in UC patients are not uniform. Five diagnostic criteria for LIDHS can be found in the literature [17–21]; however, these criteria all contain different items. For example, mucus stool was the main item in three criteria [17, 18, 21] but was not found in the others [19, 20]. The lack of consistent criteria increases the difficulty of diagnosing LIDHS. Second, there is a lack of validated and standardized LIDHS-specific scales in TCM clinical practice. Some researchers have reported that the standard development and validation procedures for health-related quality of life (HRQOL) or patient-reported outcomes (PRO) questionnaires can be effectively used to develop and assess TCM outcomes and syndromes [22–29]. For example, our team developed and validated TCM outcome (...truncated)


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Xin-lin Chen, Yi Wen, Zu-chun Wu, Bei-ping Zhang, Zheng-kun Hou, Jun-lin Xiao, Man-qing Lin, Yue Hu, Zhe-li Wu, Jie-min Deng, Feng-bin Liu, Tian-wen Liu. Development of a Traditional Chinese Medicine Syndrome-Specific Scale for Ulcerative Colitis: The Large Intestine Dampness-Heat Syndrome Questionnaire, Evidence-Based Complementary and Alternative Medicine, 2018, 2018, DOI: 10.1155/2018/4039019