Background： Functional dyspepsia （FD） is a common tipper gastrointestinal disorder worldwide, but the current treatments for FD are still unsatisfactory. The aims of this study were to investigate the efficacy and ...Background： Functional dyspepsia （FD） is a common tipper 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 eflbcts 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.展开更多
目的观察疏肝健脾方治疗功能性消化不良餐后不适综合征的临床疗效。方法将60例功能性消化不良餐后不适综合征(肝郁脾虚型)患者随机分入治疗组和对照组。治疗组予以中药疏肝健脾方,对照组予以多潘立酮片,疗程均为4周。通过中医症状积分...目的观察疏肝健脾方治疗功能性消化不良餐后不适综合征的临床疗效。方法将60例功能性消化不良餐后不适综合征(肝郁脾虚型)患者随机分入治疗组和对照组。治疗组予以中药疏肝健脾方,对照组予以多潘立酮片,疗程均为4周。通过中医症状积分量表、利兹消化不良问卷(Leeds dyspepsia questionnaire,LDQ)、水负荷试验和功能性消化不良生存质量量表(functional digestive disorder quality of life questionnaire,FDDQL)观察患者治疗前后临床疗效、临床症状、胃感觉功能和生存质量的变化。结果两组临床疗效的分布比较,差异具有统计学意义(P<0.05),治疗组疗效明显优于对照组。两组中医症状积分和LDQ问卷积分均较治疗前明显改善(P<0.05),治疗组优于对照组(P<0.05);治疗组餐后饱胀、早饱、胸胁胀痛、疲乏无力、便溏等症状改善均优于对照组(P<0.05)。两组治疗后胃感知阈值和胃不适阈值均显著降低(P<0.05);治疗组治疗前后胃感知阈值和胃不适阈值差值显著大于对照组(P<0.05)。两组总生存质量均较治疗前明显提高(P<0.05),治疗组患者总生存质量的改善优于对照组(P<0.05);治疗组患者日常生活、忧虑、睡眠、不适、健康感觉各单维度的改善均优于对照组(P<0.05)。结论疏肝健脾方能有效缓解功能性消化不良餐后不适综合征(肝郁脾虚型)患者的临床症状,改善其胃感觉功能和生存质量。展开更多
文摘Background： Functional dyspepsia （FD） is a common tipper 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 eflbcts 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.
文摘目的观察疏肝健脾方治疗功能性消化不良餐后不适综合征的临床疗效。方法将60例功能性消化不良餐后不适综合征(肝郁脾虚型)患者随机分入治疗组和对照组。治疗组予以中药疏肝健脾方,对照组予以多潘立酮片,疗程均为4周。通过中医症状积分量表、利兹消化不良问卷(Leeds dyspepsia questionnaire,LDQ)、水负荷试验和功能性消化不良生存质量量表(functional digestive disorder quality of life questionnaire,FDDQL)观察患者治疗前后临床疗效、临床症状、胃感觉功能和生存质量的变化。结果两组临床疗效的分布比较,差异具有统计学意义(P<0.05),治疗组疗效明显优于对照组。两组中医症状积分和LDQ问卷积分均较治疗前明显改善(P<0.05),治疗组优于对照组(P<0.05);治疗组餐后饱胀、早饱、胸胁胀痛、疲乏无力、便溏等症状改善均优于对照组(P<0.05)。两组治疗后胃感知阈值和胃不适阈值均显著降低(P<0.05);治疗组治疗前后胃感知阈值和胃不适阈值差值显著大于对照组(P<0.05)。两组总生存质量均较治疗前明显提高(P<0.05),治疗组患者总生存质量的改善优于对照组(P<0.05);治疗组患者日常生活、忧虑、睡眠、不适、健康感觉各单维度的改善均优于对照组(P<0.05)。结论疏肝健脾方能有效缓解功能性消化不良餐后不适综合征(肝郁脾虚型)患者的临床症状,改善其胃感觉功能和生存质量。
