Background: Functional dyspepsia (FD) is a common upper gastrointestinal disorder worldwide, but the current treatments for FD are still unsatisfactory. The aims of this study were to investigate the efficacy and safety of Qi-Zhi-Wei-Tong granules in patients with postprandial distress syndrome (PDS)-predominant FD.
Methods: The study was conducted as a randomized, double-blinded, multicenter, placebo-controlled design in 197 patients with PDS. All participants received placebo treatment for 1 week. Patients whose total symptom score decreased by <50% after the placebo treatment were recruited into the 4-week treatment period, in which they were randomly assigned to be treated with either Qi-Zhi-Wei-Tong granules or placebo. The patients were then followed for 2 weeks without any treatment. Dyspeptic symptoms were scored at weeks 2 and 4 during the random treatment period and 2 weeks after the treatment. Anxiety and depression symptoms were also scored and compared.
Results: (1) The total effective rates in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 during the random treatment period and 2 weeks after treatment were all significantly higher than those in the placebo group (38.82% vs. 8.75%, P < 0.001; 69.14% vs. 16.25%, P < 0.001; 77.65% vs. 21.25%, P < 0.001). (2) The total dyspeptic symptoms scores in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 and 2 weeks after treatment were significantly lower than those in the placebo group. (3) The severity and frequency of each dyspeptic symptom at weeks 2 and 4 and the follow-up period were all significantly lower than those in the placebo group. (4) The anxiety scores in the Qi-Zhi-Wei-Tong granules group were significantly lower than those in the placebo group. (5) Qi-Zhi-Wei-Tong granules did not have more adverse effects than the placebo.
Conclusion: Qi-Zhi-Wei-Tong granules offer significant symptomatic improvement in PDS with no more adverse effects than placebo.
Trial registration: https://clinicaltrials.gov/, NCT02460601.
气滞胃痛颗粒治疗功能性消化不良餐后不适综合征疗效与安全性的多中心、随机、双盲、安慰剂对照临床试验摘要背景: 功能性消化不良是一种常见的上消化道功能性疾病，目前对于其药物治疗效果仍欠满意。本文旨在评估气滞胃痛颗粒对功能性消化不良的餐后不适综合征亚型的临床疗效与安全性。 方法: 采用随机、双盲、多中心、安慰剂对照的方法观察餐后不适综合征患者197例。对所有入组患者给予1周安慰剂治疗，1周后症状积分下降不大于50%的患者将被随机分配到气滞胃痛颗粒组或安慰剂组，2组治疗疗程均为4周，治疗结束后2周再次进行随访。在第0，2，4周和治疗结束后2周观察记录两组临床症状的改善情况，并采用Zung氏焦虑/抑郁自评量表（SAS/SDS）在第0，4和治疗结束后2周评估患者心理状态。 结果: 在第2，4周和治疗结束后2周，气滞胃痛颗粒组的总有效率（38.82%，69.14%，77.65%）均高于安慰剂组（8.75%，16.25%，21.25%），差异有统计学意义（P均< 0.001）;在第2，4周和治疗结束后2周，气滞胃痛颗粒组的症状积分低于安慰剂组，差异有统计学意义（P < 0.001）;在第2，4周和治疗结束后2周，气滞胃痛颗粒组的单症状（餐后饱胀不适、早饱）严重程度与频率均分别低于安慰剂组，差异有统计学意义（P < 0.05）;在第4周和治疗结束后2周，气滞胃痛颗粒组的SAS评分低于安慰剂组，差异有统计学意义（P < 0.001）;气滞胃痛颗粒组和安慰剂组均未发现严重不良事件，不良事件出现率为3.03%与3.06%，差异无统计学意义（P > 0.05）。 结论: 气滞胃痛颗粒治疗餐后不适综合征的综合疗效显著、稳定，无明显不良反应。.
Keywords: Clinical Trial; Functional Dyspepsia; Postprandial Distress Syndrome; Qi-Zhi-Wei-Tong Granules.