Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, No, 23 Meishuguan Back Street, Dongcheng District, Beijing, 100010, China.
BMC Complement Altern Med. 2013 Mar 2;13:54. doi: 10.1186/1472-6882-13-54.
BACKGROUND: Chinese herbal medicine (CHM) has been used in China and some other countries for the treatment of patients with functional dyspepsia (FD). However, controlled studies supporting the efficacy of such treatments in patients with FD are lacking. In this trial, we aimed to assess the efficacy and safety of modified LiuJunZi decoction in patients with FD of spleen-deficiency and qi-stagnation syndrome. METHODS: We performed a randomized, double-blind, placebo-controlled trial with patients from five centers. Patients with FD of spleen-deficiency and qi-stagnation syndrome (n = 160) were randomly assigned to groups given CHM modified LiuJunZi 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 follow-up 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. The secondary outcome was the change of radiopaque barium markers emptied from the stomach between week 0 and week 4 of treatment. RESULTS: Compared with patients in the placebo group, patients in the CHM group showed significant improvements according to the scores of total dyspepsia symptoms and single dyspepsia symptoms obtained from patients (P < 0.01) and investigators (P < 0.01). They also showed an improvement in the number of radiopaque barium markers emptied from the stomach (P < 0.05). CONCLUSIONS: CHM modified LiuJunZi decoction appears to offer symptomatic improvement in patients with FD of spleen-deficiency and qi-stagnation syndrome. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR): http://ChiCTR-TRC-10001074.
背景：中药（CHM）已在中国和其他一些国家用于治疗功能性消化不良（FD）患者。然而，缺乏控制研究来支持此类治疗在 FD 患者中的疗效。在这项试验中，我们旨在评估改良六君子汤对脾虚气滞型 FD 患者的疗效和安全性。
方法：我们在五个中心进行了一项随机、双盲、安慰剂对照试验，纳入 FD 脾虚气滞型患者（n=160），以 2:1 的比例随机分配至中药改良六君子汤组或安慰剂组。中药或安慰剂颗粒用 300ml 煮沸后冷却至 70°C 的水溶解。两组患者均每日口服两次，每次 150ml（50°C）。试验包括 4 周的治疗期和 4 周的随访期。主要结局是通过总消化不良症状量表和单消化不良症状量表在第 0、1、2、3、4 和 8 周测量的消化不良症状评分。次要结局是治疗第 0 周和第 4 周之间从胃排空的不透射线钡标志物的变化。
结果：与安慰剂组相比，中药组患者的总消化不良症状和单消化不良症状评分均显著改善（患者自评：P＜0.01；研究者评估：P＜0.01），且胃排空的不透射线钡标志物数量也有所改善（P＜0.05）。
结论：改良六君子汤中药似乎可改善脾虚气滞型 FD 患者的症状。
试验注册：中国临床试验注册中心（ChiCTR）：http://ChiCTR-TRC-10001074。
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