Department of Gastroenterology, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, No. 23 Meishuguan Back Street, Dongcheng District, Beijing 100010, China.
Evid Based Complement Alternat Med. 2013;2013:812143. doi: 10.1155/2013/812143. Epub 2013 Mar 17.
Background. Chinese herbal medicine (CHM) has been used in China and elsewhere to treat patients with functional dyspepsia (FD). However, controlled studies supporting the efficacy of such treatment are lacking. Objective. To assess the efficacy and safety of modified Ban xia xie xin decoction in patients with FD of cold and heat in complexity syndrome. Methods. We performed a randomized, double-blind, placebo-controlled trial involving patients from five centers. Patients with FD of cold and heat in complexity syndrome (n = 101) were randomly assigned to groups given either CHM modified Ban Xia Xie Xin decoction or placebo in a 2 : 1 ratio. Herbal or placebo granules were dissolved in 300 mL of boiled water cooled to 70°C. Patients in both groups were administered 150 mL (50°C) twice daily. The trial included a 4-week treatment period and a 4-week followup period. The primary outcomes were dyspepsia symptom scores, measured by the total dyspepsia symptom scale and the single dyspepsia symptom scale at weeks 0, 1, 2, 3, 4, and 8. Results. Compared with patients in the placebo group, patients in the CHM group showed significant improvements according to the total and single dyspepsia symptom scores obtained from patients (P < 0.01) and investigators (P < 0.01). Conclusions. CHM modified Ban Xia Xie Xin decoction appears to offer symptomatic improvement in patients with FD of cold and heat in complexity syndrome. Trial Registration. Chinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-10001074.
背景:中药(CHM)已在中国和其他地方用于治疗功能性消化不良(FD)患者。然而,缺乏支持这种治疗疗效的对照研究。目的:评估半夏泻心汤加减治疗寒热错杂型 FD 的疗效和安全性。方法:我们进行了一项随机、双盲、安慰剂对照试验,涉及来自五个中心的患者。寒热错杂型 FD 患者(n = 101)随机分为 CHM 半夏泻心汤加减组和安慰剂组,比例为 2:1。中药或安慰剂颗粒溶于 300 mL 煮沸后冷却至 70°C 的水中。两组患者均每日两次服用 150 mL(50°C)。试验包括 4 周的治疗期和 4 周的随访期。主要结局指标为消化不良症状评分,采用总消化不良症状评分和单一消化不良症状评分在 0、1、2、3、4 和 8 周进行测量。结果:与安慰剂组患者相比,中药组患者的总消化不良症状评分和单一消化不良症状评分均有显著改善(P < 0.01),且患者和研究者的评分均有显著改善(P < 0.01)。结论:半夏泻心汤加减可能为寒热错杂型 FD 患者提供症状改善。试验注册:中国临床试验注册中心(ChiCTR):ChiCTR-TRC-10001074。
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