The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine.
The Chinese People's Liberation Army 921 Hospital of the Joint Logistics Support Force.
Medicine (Baltimore). 2021 Jan 22;100(3):e23887. doi: 10.1097/MD.0000000000023887.
Irritable bowel syndrome (IBS) is a common functional bowel disorder. The global incidence of IBS is as high as 9% to 23%, accounting for about 50% of outpatients in gastroenterology, and the new case detection rate is 0.2% every year. IBS has become a global gastrointestinal functional disease. Although IBS is not a life-threatening disease, it seriously affects the quality of life of patients, causing huge economic and mental burden to individuals, society and families. Lipi Guben decoction (LPGBD) is an important auxiliary treatment for IBS, but lack of robust Evidence-based medicine evidence proving its efficacy. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of LPGBD in the treatment of IBS.
In this randomized controlled trial, a total of 100 eligible patients will be allocated to the blank control group or LPGBD group in a ratio of 1:1. The treatment period was 12 weeks. The primary outcome measure will be the total clinical effective rate. The Secondary outcomes will include IBS clinical symptom scores, IBS-Severity Scoring System, IBS-Quality of life, Hamilton Rating Scale for Anxiety, Hamilton Rating Scale for Depression, and Bristol Stool Form Scale. The safety outcome will include Echocardiogram, blood examination (including blood routine test, liver function test, and renal function test), urine routine test and stool routine test. The evaluation indicators and all safety results will be performed at baseline, week 4, week 8 and week 12.
This study will be helpful to evaluate the efficacy and safety of LPGBD in the treatment of IBS.
LPGBD may improve the clinical efficacy of patients with IBS, which has important value in practical application.
Chictr20000039617, registration time: November 3, 2020.
肠易激综合征（IBS）是一种常见的功能性肠病。全球 IBS 的发病率高达 9%至 23%，占消化内科门诊的 50%左右，每年新发病例检出率为 0.2%。IBS 已成为全球性的胃肠道功能性疾病。虽然 IBS 不是一种危及生命的疾病，但它严重影响了患者的生活质量，给个人、社会和家庭带来了巨大的经济和精神负担。理脾固本汤（LPGBD）是治疗 IBS 的重要辅助治疗方法，但缺乏证明其疗效的稳健循证医学证据。因此，我们设计了一项随机对照试验，以评估 LPGBD 治疗 IBS 的疗效和安全性。
在这项随机对照试验中，将总共 100 名符合条件的患者以 1:1 的比例分配到空白对照组或 LPGBD 组。治疗期为 12 周。主要结局指标将是总临床有效率。次要结局将包括 IBS 临床症状评分、IBS 严重程度评分系统、IBS 生活质量、汉密尔顿焦虑量表、汉密尔顿抑郁量表和布里斯托粪便形状量表。安全性结局将包括超声心动图、血液检查（包括血常规检查、肝功能检查和肾功能检查）、尿常规检查和粪便常规检查。所有安全性结果和评估指标将在基线、第 4 周、第 8 周和第 12 周进行。
本研究将有助于评估 LPGBD 治疗 IBS 的疗效和安全性。
LPGBD 可能改善 IBS 患者的临床疗效，在实际应用中具有重要价值。
Chictr20000039617，注册时间：2020 年 11 月 3 日。
