Project 3 - A Dose-Ranging Study of Chinese Herbal Medicine in Treating Patients

肠易激综合征(IBS)，以腹痛/不适和不安为特征 大便频率，是一种常见的功能性肠道疾病，占患者的相当大比例 可以在初级保健中心和二级转诊中心看到。对患者生活质量和经济状况的影响 对社会的负担是相当大的。然而，在中国，常规西医的结果 治疗IBS一直令人失望。几种潜在的新治疗药物已被撤回 因为严重的不良事件。中医药已被用于治疗慢性阻塞性肺疾病 BS在亚洲国家已有数百年的历史，但对其治疗功能的科学评估很少。最近，一位 一项方法学上强有力的20草药配方试验显示，对IBS患者有显著的益处。然而， 对于重复的临床研究，草药制剂的特征和定义不够充分。 项目概述：在完成化学表征(植物核心)之后，我们将进行 一项随机、安慰剂对照、双盲、II期剂量递增临床试验，以找到最安全的 该标准化20味制剂对117例年龄在18岁至75岁之间的各型患者的有效剂量 肠易激综合征。在三个剂量水平中的每一个水平下，39名参与者将随机接受为期8周的治疗 草药配方或安慰剂以2：1的比例分配，并将在基线、0、2、4、8和12周进行评估 对于临床上重要和可靠的结果，患者报告了总体症状改善。在 结论在第1次和第2次剂量水平中，在使用更高剂量的新的 参赛者队列。我们还将评估个别IBS症状、性质、严重程度、持续时间和频率 不良事件、生活质量、同时服用IBS药物和医疗保健利用情况，并将执行 出于安全目的进行血液测试。对研究用药的依从性将通过药片计数来验证。这样做的结果是 剂量范围研究将有助于确定未来使用的草药配方的最佳剂量 随机安慰剂对照试验，并与传统药物进行正面比较。

Irritable bowel syndrome (IBS), characterized by abdominal pain/discomfort and disturbed bowel frequency, is a common functional bowel disorder that accounts for a substantial proportion of patients seen in primary care and secondary referral centers. The impact on patients' quality of life and the economic burden on the community are considerable. However, the outcome of conventional Western medicine in reating IBS has been disappointing. Several potential new therapeutic agents have been withdrawn because of serious adverse events. Traditional Chinese medicine (TCM) has been used in the treatment of BS for centuries in Asian countries but scientific evaluation of its therapeutic function is scarce. Recently, a a methodologically strong trial of a 20-herb formula showing significant benefit for IBS patients. However, the herbal formulation is inadequately characterized and defined for repeated clinical studies. PROJECT SUMMARY: Subsequent to complete chemical characterization (Botanical Core), we will conduct a randomized, placebo-controlled, double-blind, phase II dose-escalation clinical trial to find an optimally safe and efficacious dosage of this standardized 20-herb preparation in 117 patients aged 18 to 75 with all types of IBS. At each of three dosage levels, 39 participants will be randomized to treatment for 8 weeks with the herbal formula or placebo in a 2:1 allocation ratio, and will be assessed at baseline, weeks 0, 2, 4, 8, and 12 for the clinically important and reliable outcome of patient reported global symptom improvement. At the conclusion of the 1st and 2nd dosage levels, safety will be assessed prior to using a higher dosage in a new cohort of participants. We also will assess individual IBS symptoms, nature, severity, duration, and frequencv of adverse events, quality of life, concurrent IBS medications and health care utilization, and will perform blood tests for safety purposes. Adherence to study medication will be verified by pill counts. Results of this dose-ranging study will help to identify the optimal dosage of the herbal formula to be used in future randomized placebo-controlled trials and in head-to-head comparisons with conventional Pharmaceuticals.