title: Qing-Yi decoction in participants with severe acute pancreatitis: a randomized controlled trial.
abstract: BACKGROUND
  Qing-Yi Decoction (QYD) has been used for severe acute pancreatitis (SAP) patients in China for many years. There were two kinds of QYD: Num 1. QYD (QYD1) which is used in the acute response stage of SAP and Num 2. QYD (QYD2) which is used in the second stage of SAP. This study aims to evaluate the therapeutic efficacy of QYD in participants with SAP.
  
  
  METHODS
  In this prospective, randomized, double-blind, placebo-controlled trial, participants aged 18-70 years within the first 7 days after acute onset of typical abdominal pain (the definition of SAP was according to the 2007 Guidelines for Management of Severe Acute Pancreatitis in China) were selected. The disease severity was determined by the Ranson, Acute Physiology and Chronic Health Evaluation II, and Balthazar CT scores. The test group received Western medicine and Chinese medicine (Num.1 QYD and Num.2 QYD), while the control group received Western medicine and placebo. The primary end-points were length of hospital stay, total hospitalization expenses, operation rate, and mortality. The secondary end-points were organ complications (i.e., heart failure, respiratory failure, acute renal failure, and hepatic failure), duration of paralytic ileus, infection, intensive care unit stay, and respirator use.
  
  
  RESULTS
  From March 2008 to July 2010, a total of 300 participants with severe acute pancreatitis were assessed for eligibility in West China Hospital, and 100 were eligible for randomized allocation. Eighty-five participants (46 in the test group; 39 in the control group) were included in the statistical analyses. The two groups were similar in their baseline clinical characteristics (age, sex, and etiology) and disease severity. After the interventions, there were no differences between the two groups for length of hospital stay (P = 0.323), total hospitalization expenses (P = 0.252), operation rate (P = 0.231), mortality (P = 0.462), organ complications (P > 0.05), intensive care unit stay (P = 0.209), and respirator use (P > 0.05). However, the duration [median (interquartile range)] of paralytic ileus, i.e., 4 (2-6) days vs. 6 (4-8) days (P = 0.014) and rate of infection, i.e., (13.0 % vs. 35.9 %) (P = 0.013) differed significantly.
  
  
  CONCLUSIONS
  QYD could restore gastrointestinal motility to normal and reduce the infection rates in the SAP patients who completed a full course of QYD treatment according to per protocol analysis.
authors.affiliation: Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, 610041 Sichuan Province China.
authors.forename: Weiwei
authors.initials: W
authors.lastname: Chen
authors.affiliation: Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, 610041 Sichuan Province China.
authors.forename: Xiaonan
authors.initials: X
authors.lastname: Yang
authors.affiliation: Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, 610041 Sichuan Province China.
authors.forename: Lei
authors.initials: L
authors.lastname: Huang
authors.affiliation: Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, 610041 Sichuan Province China.
authors.forename: Ping
authors.initials: P
authors.lastname: Xue
authors.affiliation: Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, 610041 Sichuan Province China.
authors.forename: Meihua
authors.initials: M
authors.lastname: Wan
authors.affiliation: Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, 610041 Sichuan Province China.
authors.forename: Jia
authors.initials: J
authors.lastname: Guo
authors.affiliation: Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, 610041 Sichuan Province China.
authors.forename: Lin
authors.initials: L
authors.lastname: Zhu
authors.affiliation: Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, 610041 Sichuan Province China.
authors.forename: Tao
authors.initials: T
authors.lastname: Jin
authors.affiliation: Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, 610041 Sichuan Province China.
authors.forename: Zongwen
authors.initials: Z
authors.lastname: Huang
authors.affiliation: Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, 610041 Sichuan Province China.
authors.forename: Guangyuan
authors.initials: G
authors.lastname: Chen
authors.affiliation: Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, 610041 Sichuan Province China.
authors.forename: Wenfu
authors.initials: W
authors.lastname: Tang
authors.affiliation: Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, 610041 Sichuan Province China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Xia